Title 9—Animals and Animal Products--Volume 2

§ 91.1 Definitions.

As used in this part, the following terms will have the meanings set forth in this section:

Accredited veterinarian. A veterinarian approved by the Administrator in accordance with part 161 of this chapter to perform functions specified in parts 1, 2, 3, and 11 of subchapter A, and subchapters B, C, and D of this chapter, and to perform functions required by cooperative State-Federal disease control and eradication programs.

Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.

Animal. Any member of the animal kingdom (except a human).

Animal and Plant Health Inspection Service (APHIS). The Animal and Plant Health Inspection Service of the United States Department of Agriculture.

APHIS representative. An individual who is authorized by APHIS to perform the function involved.

Date of export. The date animals intended for export are loaded onto an ocean vessel or aircraft or, if moved by land to Canada or Mexico, the date the animals cross the border.

Export health certificate. An official document issued in the United States that certifies that animals or other commodities listed on the certificate meet the export requirements of this part and the importing country.

Export inspection facility. A facility that is affiliated with a port of embarkation and that has been approved by the Administrator as the location where APHIS will conduct health inspections of livestock before they are loaded onto ocean vessels or aircraft for export from the United States.

Export isolation facility. A facility where animals intended for export are isolated from other animals for a period of time immediately before being moved for export.

Horses. Horses, mules, and asses.

Inspector. An individual authorized by APHIS to inspect animals and/or animal products intended for export from the United States.

Livestock. Horses, cattle (including American bison), captive cervids, sheep, swine, and goats, regardless of intended use.

Premises of export. The premises where the animals intended for export are isolated as required by the importing country prior to export or, if the importing country does not require pre-export isolation, the farm or other premises where the animals are assembled for pre-export inspection and/or testing, or the germplasm is collected or stored, before being moved to a port of embarkation or land border port.

Program diseases. Diseases for which there are cooperative State-Federal programs and domestic regulations in subchapter C of this chapter.

Program Handbook. A document that contains guidance and other information related to the regulations in this part. The Program Handbook is available on APHIS' import-export Web site (http://www.aphis.usda.gov/import_export/index.shtml).

State of origin. The State in which the premises of export is located.

§ 91.2 Applicability.

You may not export any animal or animal germplasm from the United States except in compliance with this part.

§ 91.3 General requirements.

(a) Issuance of export health certificates. (1) Livestock must have an endorsed export health certificate in order to be eligible for export from the United States.

(2) If APHIS knows that an importing country requires an export health certificate endorsed by the competent veterinary authority of the United States for any animal other than livestock or for any animal semen, animal embryos, hatching eggs, other embryonated eggs, or gametes intended for export to that country, the animal or other commodity must have an export health certificate endorsed by APHIS in order to be eligible for export from the United States.

(b) Content of export health certificates—(1) Livestock; minimum requirements. Regardless of the requirements of the importing country, at a minimum, the following information must be contained on an export health certificate for livestock:

(i) The species of each animal.

(ii) The breed of each animal.

(iii) The sex of each animal.

(iv) The age of each animal.

(v) The individual identification of the animals as required by § 91.5.

(vi) The importing country.

(vii) The consignor.

(viii) The consignee.

(ix) A certification that an accredited veterinarian inspected the livestock and found them to be fit for export.

(x) A signature and date by an accredited veterinarian.

(xi) An endorsement by the APHIS veterinarian responsible for the State of origin.

(2) Livestock; additional requirements. In addition to the minimum requirements in paragraph (b)(1) of this section, the export health certificate must meet any other information or issuance requirements specified by the importing country.

(3) Animals other than livestock, animal semen, animal embryos, hatching eggs, other embryonated eggs, and gametes. Export health certificates for animals other than livestock, animal semen, animal embryos, hatching eggs, other embryonated eggs, and gametes must meet any information requirements specified by the importing country.

(c) Inspection requirements for livestock. In order to be eligible for export, livestock must be inspected within the timeframe required by the importing country. If the importing country does not specify a timeframe, the livestock must be inspected within 30 days prior to the date of export.

(d) Testing requirements for livestock. All samples for tests of livestock that are required by the importing country must be taken by an APHIS representative or accredited veterinarian. The samples must be taken and tests made within the timeframe allowed by the importing country and, if specified, at the location required by the importing country. If the importing country does not specify a timeframe, the samples must be taken and tests made within 30 days prior to the date of export, except that tuberculin tests may be conducted within 90 days prior to the date of export. All tests for program diseases must be made in laboratories and using methods approved by the Administrator for those diseases. The Program Handbook contains a link to an APHIS Web site that lists laboratories approved to conduct tests for specific diseases. Approved methods are those specified or otherwise incorporated within the domestic regulations in subchapter C of this chapter.

(e) Movement of livestock, animals other than livestock, animal semen, animal embryos, hatching eggs, other embryonated eggs, or gametes with an export health certificate—(1) Livestock. An export health certificate for livestock must be issued and endorsed before the livestock move from the premises of export.

(2) Animals other than livestock, animal semen, animal embryos, hatching eggs, other embryonated eggs, and gametes. When an export health certificate is required by the importing country for any animal other than livestock or for animal semen, animal embryos, hatching eggs, other embryonated eggs, or gametes, it must be issued and, if required by the importing country, endorsed by an APHIS representative prior to departure of the animal or other commodity from the port of embarkation or the crossing of the land border port. When presented for endorsement, the health certificate must be accompanied by reports for all laboratory tests specifically identified on the certificate. The laboratory reports must either be the originals prepared by the laboratory that performed the tests or must be annotated by the laboratory that performed the test to indicate how the reports may be verified.

(f) Validity of export health certificate—(1) Livestock. Unless specified by the importing country, the export health certificate is valid for 30 days from the date of issuance, provided that the inspection and test results under paragraphs (c) and (d) of this section are still valid.

(2) Animals other than livestock, animal semen, animal embryos, hatching eggs, other embryonated eggs, and gametes. Unless specified by the importing country, the export health certificate is valid for 30 days from the date of issuance.

(Approved by the Office of Management and Budget under control number 0579-0432)

[81 FR 2980, Jan. 20, 2016, as amended at 81 FR 74279, Oct. 26, 2016]

§ 91.4 Prohibited exports.

No animal, animal semen, animal embryos, hatching eggs, other embryonated eggs, or gametes under Federal, State, or local government quarantine or movement restrictions for animal health reasons may be exported from the United States unless the importing country issues an import permit or other written instruction allowing entry of the animal, animal semen, animal embryos, hatching eggs, other embryonated eggs, or gametes, and APHIS concurs with the export of the animal, animal semen, animal embryos, hatching eggs, other embryonated eggs, or gametes.

§ 91.5 Identification of livestock intended for export.

Livestock that are intended for export must be identified in a manner that allows individual animals to be correlated to the animals listed in the export health certificate. If the importing country requires a specific or an additional form of identification, the livestock must also bear that form of identification.

(Approved by the Office of Management and Budget under control number 0579-0432)

§ 91.6 Cleaning and disinfection of means of conveyance, containers, and facilities used during movement; approved disinfectants.

(a) All export health certificates for livestock must be accompanied by a statement issued by an APHIS representative and/or accredited veterinarian that the means of conveyance or container in which the livestock will be transported from the premises of export has been cleaned and disinfected prior to loading the livestock with a disinfectant approved by the Administrator for purposes of this section or by a statement that the means of conveyance or container was not previously used to transport animals.

(b) Livestock moved for export may be unloaded only into a facility which has been cleaned and disinfected prior to such unloading with a disinfectant approved by the Administrator for purposes of this section, and has subsequently been inspected by an APHIS representative or accredited veterinarian. A statement certifying to such action must be attached to the export health certificate by the APHIS representative or accredited veterinarian.

(c) Approved disinfectants. The Administrator will approve a disinfectant for purposes of this section upon determining that the disinfectant is effective against pathogens that may be spread by the animals intended for export and, if the disinfectant is a chemical disinfectant, that it is registered or exempted for the specified use by the U.S. Environmental Protection Agency. The Program Handbook provides access to a list of disinfectants approved by the Administrator for use as required by this section. Other disinfectants may also be approved by the Administrator in accordance with this paragraph. The Administrator will withdraw approval of a disinfectant, and remove it from the list of approved disinfectants, if the disinfectant no longer meets the conditions for approval in this section.

(Approved by the Office of Management and Budget under control number 0579-0432)

§ 91.7 Pre-export inspection.

(a) All livestock intended for export by air or sea must receive a visual health inspection from an APHIS veterinarian within 48 hours prior to embarkation, unless the importing country specifies otherwise. The purpose of the inspection is to determine whether the livestock are sound, healthy, and fit to travel. The APHIS veterinarian will reject for export any livestock that he or she finds unfit to travel. The owner of the animals or the owner's agent must make arrangements for any livestock found unfit to travel. Livestock that are unfit to travel include, but are not limited to:

(1) Livestock that are sick, injured, weak, disabled, or fatigued;

(2) Livestock that are unable to stand unaided or bear weight on each leg;

(3) Livestock that are blind in both eyes;

(4) Livestock that cannot be moved without causing additional suffering;

(5) Newborn livestock with an unhealed navel;

(6) Livestock that have given birth within the previous 48 hours and are traveling without their offspring;

(7) Pregnant livestock that would be in the final 10 percent of their gestation period at the planned time of unloading in the importing country; and

(8) Livestock with unhealed wounds from recent surgical procedures, such as dehorning.

(b) The APHIS veterinarian must conduct the inspection at the export inspection facility associated with the port of embarkation of the livestock; at an export isolation facility, when authorized by the Administrator in accordance with paragraph (c) of this section; or at an export inspection facility other than the facility associated with the port of embarkation, when authorized by the Administrator in accordance with paragraph (d) of this section. Unless APHIS has authorized otherwise, any sorting, grouping, identification, or other handling of the livestock by the exporter must be done before this inspection. The APHIS veterinarian may also conduct clinical examination, including testing, of any livestock during or after this inspection if he or she deems it necessary in order to determine the animal's health. Any treatment related to this clinical examination performed on the animal must be performed by a licensed veterinarian. Finally, if the facility used to conduct the inspection is a facility other than the export inspection facility associated with the port of embarkation, it must be located within 28 hours driving distance under normal driving conditions from the port of embarkation; livestock must be afforded at least 48 hours rest, with sufficient feed and water during that time period, prior to the pre-export inspection; and the exporter must maintain contact information for a veterinarian licensed in the State of embarkation to perform emergency medical services, as needed, on the animals intended for export.

(c) Conditions for approval of pre-export inspection at an export isolation facility. (1) The Administrator may allow pre-export inspection of livestock to be conducted at an export isolation facility, rather than at an export inspection facility, when the exporter can show to the satisfaction of the Administrator that the livestock would suffer undue hardship if they had to be inspected at the export inspection facility, when the distance from the export isolation facility to the port of embarkation is significantly less than the distance from the export isolation facility to the export inspection facility associated with the port of embarkation, when inspection at the export isolation facility would be a more efficient use of APHIS resources, or for other reasons acceptable to the Administrator.

(2) The Administrator's approval is contingent upon APHIS having personnel available to provide services at that location. Approval is also contingent upon the Administrator determining that the facility has space, lighting, and humane means of handling livestock sufficient for the APHIS personnel to safely conduct required inspections. The Program Handbook contains guidance on ways to meet these requirements. Owners and operators may submit alternative plans for meeting the requirements to APHIS for evaluation and approval. Alternatives must be at least as effective in meeting the requirements as those described in the Program Handbook in order to be approved. Alternate plans must be approved by APHIS before the facility may be used for purposes of this section.

(d) The Administrator may allow pre-export inspection of livestock to be conducted at an export inspection facility other than the export inspection facility associated with the port of embarkation when the exporter can show to the satisfaction of the Administrator that the livestock would suffer undue hardship if they had to be inspected at the export inspection facility associated with the port of embarkation, when inspection at this different export inspection facility would be a more efficient use of APHIS resources, or for other reasons acceptable to the Administrator.

(e) The APHIS veterinarian will maintain an inspection record that includes the date and place of the pre-export inspection, species and number of animals inspected, the number of animals rejected, a description of those animals, and the reasons for rejection.

(f) If requested by the importing country or an exporter, the APHIS veterinarian who inspects the livestock will issue a certificate of inspection for livestock he or she finds to be sound, healthy, and fit to travel.

§ 91.8 Rest, feed, and water at an export inspection facility associated with the port of embarkation prior to export.

All livestock that are intended for export by air or sea and that will be inspected for export at an export inspection facility associated with the port of embarkation must be allowed a period of at least 2 hours rest at an export inspection facility prior to being loaded onto an ocean vessel or aircraft for export. Adequate food and water must be available to the livestock during the rest period. An inspector may extend the required rest period up to 5 hours, at his or her discretion and based on a determination that more rest is needed in order to have assurances that the animals are fit to travel prior to loading. Pre-export inspection of the animals must take place at the conclusion of this rest period.

§ 91.9 Ports.

(a) Except as provided in paragraph (b) of this section, livestock exported by air or sea may be exported only through ports designated as ports of embarkation by the Administrator. Any port that has an export inspection facility that meets the requirements of § 91.10 permanently associated with it is designated as a port of embarkation. The Program Handbook contains a list of designated ports of embarkation. A list may also be obtained from a Veterinary Services area office. Information on area offices is available on APHIS' import-export Web site (http://www.aphis.usda.gov/import_export/index.shtml).

(b) The Administrator may approve other ports for the exportation of livestock on a temporary basis with the concurrence of the port director. The Administrator will grant such temporary approvals only for a specific shipment of livestock, and only if pre-export inspection of that shipment has occurred at an export isolation facility or an export inspection facility not associated with the port of embarkation, as provided in § 91.7.

(c) Temporarily approved ports of embarkation will not be added to the list of designated ports of embarkation and are only approved for the time period and shipment conditions specified by APHIS at the time of approval.

(Approved by the Office of Management and Budget under control number 0579-0432)

§ 91.10 Export inspection facilities.

(a) Export inspection facilities must be approved by the Administrator before they may be used for any livestock intended for export. The Administrator will approve an export inspection facility upon determining that it meets the requirements in paragraph (b) of this section. This approval remains in effect unless it is revoked in accordance with paragraph (c) of this section, or unless any of the following occur, in which case reapproval must be sought:

(1) The owner of the facility changes.

(2) Significant damage to the facility occurs or significant structural changes are made to the facility.

(b)(1) Export inspection facilities must be constructed, equipped, and managed in a manner that prevents transmission of disease to and from livestock in the facilities, provides for the safe and humane handling and restraint of livestock, and provides sufficient offices, space, and lighting for APHIS veterinarians to safely conduct required health inspections of livestock and related business. The Program Handbook contains guidance on ways to meet these requirements. Owners and operators may submit alternative plans for meeting the requirements to APHIS for evaluation and approval; the address to which to submit such alternatives is contained in the Program Handbook. Alternatives must be at least as effective in meeting the requirements as the methods described in the Program Handbook in order to be approved. Alternatives must be approved by APHIS before being used for purposes of this section.

(2) For the purposes of approval or a subsequent audit, APHIS representatives must have access to all areas of the facility during the facility's business hours to evaluate compliance with the requirements of this section.

(3) The application for approval of an export inspection facility must be accompanied by a certification from the authorities having jurisdiction over environmental affairs in the locality of the facility. The certification must state that the facility complies with any applicable requirements of the State and local governments, and the U.S. Environmental Protection Agency regarding disposal of animal wastes.

(c) The Administrator will deny or revoke approval of an export inspection facility for failure to meet the requirements in paragraph (b) of this section.

(1) APHIS will conduct site inspections of approved export inspection facilities at least once a year for continued compliance with the standards. If a facility fails to pass the inspection, the Administrator may revoke its approval. If the Administrator revokes approval for a facility that serves a designated port of embarkation, the Administrator may also remove that port from the list of designated ports of embarkation.

(2) APHIS will provide written notice of any proposed denial or revocation to the operator of the facility, who will be given an opportunity to present his or her views on the issues before a final decision is made. The notice will list any deficiencies in detail. APHIS will provide notice of pending revocations at least 60 days before the revocation is scheduled to take effect, but may suspend facility operations before that date and before any consideration of objections by the facility operator if the Administrator determines the suspension is necessary to protect animal health or public health, interest, or safety. The operator of any facility whose approval is denied or revoked may request another inspection after remedying the deficiencies.

§ 91.11 Export isolation.

If an importing country requires export isolation for livestock, such isolation must occur before the animals may be moved to a port of embarkation, and both the manner in which this isolation occurs and the facility at which it occurs must meet the requirements specified by the importing country.

§ 91.12 Ocean vessels.

(a) Inspection of the ocean vessel—(1) Certification to carry livestock. Ocean vessels must be certified by APHIS prior to initial use to transport any livestock from the United States. The owner or the operator of the ocean vessel must make arrangements prior to the vessel's arrival at a designated port of embarkation in the United States for an APHIS representative to inspect the vessel while it is at that port of embarkation. Alternatively, at the discretion of the Administrator and upon request of the exporter, transporting company, or their agent, the inspection may be done at a foreign port. If APHIS determines that the ocean vessel meets the requirements of paragraph (d) of this section, APHIS will certify the vessel to transport livestock from the United States. APHIS may certify a vessel that does not meet all of the requirements in paragraph (d), provided that an exemption from the requirements the vessel does not meet has been granted to the vessel pursuant to paragraph (e) of this section. The certification will specify the species of livestock for which the vessel is approved. The certification will be valid for up to 3 years; however, the ocean vessel must be recertified prior to transporting livestock any time significant changes are made to the vessel, including to livestock transport spaces or life support systems; any time a major life support system fails; any time species of livestock not covered by the existing certification are to be transported; and any time the owner or operator of the ocean vessel changes. The owner or operator of the vessel must present the following documentation to APHIS prior to its initial inspection for certification and when requested by APHIS prior to subsequent inspections for recertification:

(i) General information about the vessel, including year built, length and breadth, vessel name history, port of registry, call sign, maximum and average speed, fresh water tank capacity and fresh water generation rate, and feed silo capacity (if the vessel has a silo);

(ii) A notarized statement from an engineer concerning the rate of air exchange in each compartment of the vessel;

(iii) The species of livestock that the vessel would transport;

(iv) Scale drawings that provide details of the design, materials, and methods of construction and arrangement of fittings for the containment and movement of livestock; provisions for the storage and distribution of feed and water; drainage arrangements; primary and secondary sources of power; and lighting;

(v) A photograph of the rails and gates of any pens;

(vi) A description of the flooring surface on the livestock decks; and

(vii) The following measurements: Width of the ramps; the clear height from the ramps to the lowest overhead structures; the incline between the ramps and the horizontal plane; the distance between footlocks on the ramps; the height of side fencing on the ramps; the height of the vessel's side doors through which livestock are loaded; the width of alleyways running fore and aft between livestock pens; and the distance from the floor of the livestock pens to the beams or lowest structures overhead.

(2) Prior to each voyage. Prior to loading any livestock intended for export from the United States, an APHIS representative must inspect the vessel to confirm that the ocean vessel has been adequately cleaned and disinfected as required by paragraph (b) of this section, has sufficient food and water for the voyage as required by paragraph (c) of this section, and continues to meet the requirements of paragraph (d) of this section. APHIS will schedule the inspection after the owner or operator of the ocean vessel provides the following information:

(i) The name of the ocean vessel;

(ii) The port, date, and time the ocean vessel will be available for inspection, and estimated time that loading will begin;

(iii) A description of the livestock to be transported, including the type, number, and estimated average weight of the livestock;

(iv) Stability data for the ocean vessel with livestock on board;

(v) The port of discharge; and

(vi) The route and expected length of the voyage.

(3) The information in paragraphs (a)(2)(i) through (a)(2)(vi) must be provided at least 72 hours before the vessel will be available for inspection.

(b) Cleaning and disinfection. (1) Any ocean vessel intended for use in exporting livestock, and all fittings, utensils, containers, and equipment (unless new) used for loading, stowing, or other handling of livestock aboard the vessel must be thoroughly cleaned and disinfected to the satisfaction of an APHIS representative prior to any livestock being loaded. The disinfectant must be approved by the Administrator. Guidance on cleaning and disinfecting ocean vessels may be found in the Program Handbook.

(2) The Administrator will approve a disinfectant for the purposes of this paragraph upon determining that the disinfectant is effective against pathogens that may be spread by the animals and, if the disinfectant is a chemical disinfectant, that it is registered or exempted for the specified use by the U.S. Environmental Protection Agency. The Program Handbook provides access to a list of disinfectants approved by the Administrator. Other disinfectants may also be approved by the Administrator in accordance with this paragraph. The Administrator will withdraw approval of a disinfectant, and remove it from the list of approved disinfectants in the Program Handbook, if the disinfectant no longer meets the conditions for approval in this section.

(3) All ocean vessels, upon docking at a U.S. port to load livestock, must have disinfectant foot baths at entryways where persons board and exit the ocean vessel, and require such baths before allowing any person to disembark.

(c) Feed and water. Sufficient feed and water must be provided to livestock aboard the ocean vessel, taking into consideration the livestock's species, body weight, the expected duration of the voyage, and the likelihood of adverse climatic conditions during transport. Guidance on this requirement may be found in the Program Handbook. Livestock aboard the vessel must be provided feed and water within 28 hours of the time they were last fed and watered within the United States.

(d) Accommodations for the humane transport of livestock; general requirements. Ocean vessels used to transport livestock intended for export must be designed, constructed, and managed to reasonably assure the livestock are protected from injury and remain healthy during loading and transport to the importing country. Except as provided below in paragraph (e) of this section, no livestock may be loaded onto an ocean vessel unless, in the opinion of an APHIS representative, the ocean vessel meets the requirements of this section. The Program Handbook contains guidance on ways to meet the requirements. Owners and operators may submit alternative means and methods for meeting the requirements to APHIS for evaluation and approval. Alternatives must be at least as effective in meeting the requirements as those described in the Program Handbook in order to be approved. Alternatives must be approved by APHIS before being used for purposes of this section.

(1) Pens. All pens, including gates and portable rails used to close access ways, must be designed and constructed of material of sufficient strength to securely contain the livestock. They must be properly formed, closely fitted, and rigidly secured in place. They must have smooth finished surfaces free from sharp protrusions. They must not have worn, decayed, unsound, or otherwise defective parts. Flooring must be strong enough to support the livestock to be transported and provide a satisfactory non-slip foothold. Pens on exposed upper decks must protect the livestock from the weather. Pens next to engine or boiler rooms or similar sources of heat must be fitted to protect the livestock from injury due to transfer of heat to the livestock or livestock transport spaces. Any fittings or protrusions from the vessel's sides that abut pens must be covered to protect the livestock from injury. Pens must be of appropriate size for the species, size, weight, and condition of the livestock being transported and take into consideration the vessel's route. Animals that may be hostile to each other may not be housed in the same pen.

(2) Positioning. Livestock must be positioned during transport so that an animal handler or other responsible person can observe each animal regularly and clearly to ensure the livestock's safety and welfare.

(3) Resources for sick or injured animals. The vessel must have an adequate number of appropriately sized and located pens set aside to segregate livestock that become sick or injured from other animals. It must also have adequate veterinary medical supplies, including medicines, for the species, condition, and number of livestock transported.

(4) Ramps, doors, and passageways. Ramps, doors, and passageways used for livestock must be of sufficient width and height for their use and allow the safe passage of the species transported. They must have secure, smooth fittings free from sharp protrusions and non-slip flooring, and must not have worn, decayed, unsound, or otherwise defective parts. Ramps must not have an incline that is excessive for the species of livestock transported and must be fitted with foot battens to prevent slippage at intervals suitable for the species. The sides of ramps must be of sufficient height and strength to prevent escape of the species of livestock transported.

(5) Feed and water. The feeding and watering system must be designed to permit all livestock in each pen adequate access to feed and water. The system must also be designed to minimize soiling of pens and to prevent animal waste from contaminating feed and water. Similarly, feed must be loaded and stored aboard the vessel in a manner that protects it from weather and sea water and, if kept under animal transport spaces, protects it from spillage from animal watering and feeding and from animal waste. If the normal means of tending, feeding, and watering of livestock on board the ocean vessel is wholly or partially by automatic means, the vessel must have alternative arrangements for the satisfactory tending, feeding, and watering of the animals in the event of a malfunction of the automatic means.

(6) Ventilation. Ventilation during loading, unloading, and transport must provide fresh air and remove excessive heat, humidity, and noxious fumes (such as ammonia and carbon dioxide). Ventilation must be adequate for variations in climate and weather and to meet the needs of the livestock being transported. Ventilation must be effective both when the vessel is stationary and when it is moving and must be turned on when the first animal is loaded. The vessel must have on board a back-up ventilation system (including emergency power supply) in good working order or replacement parts and the means, including qualified personnel, to make the repairs or replacements.

(7) Waste management. The vessel must have a system or arrangements, including a backup system in working order or alternate arrangements, for managing waste to prevent excessive buildup in livestock transport spaces during the voyage.

(8) Lighting. The vessel must have adequate illumination to allow clear observation of livestock during loading, unloading, and transport.

(9) Bedding. Bedding must be loaded and stored aboard the vessel in a manner that protects it from weather and sea water and, if kept under animal transport spaces, protects it from spillage from animal watering and feeding and from animal waste.

(10) Cleaning. The vessel must be designed and constructed to allow thorough cleaning and disinfection and to prevent feces and urine from livestock on upper levels from soiling livestock or their feed or water on lower levels.

(11) Halters and ropes. Halters, ropes, or other equipment provided for the handling and tying of horses or other livestock must be satisfactory to ensure the humane treatment of the livestock.

(12) Personnel. The owner or operator of the ocean vessel must have on board during loading, transport, and unloading at least 3 persons (or at least 1 person if fewer than 800 head of livestock will be transported) with previous experience with ocean vessels that have handled the kind(s) of livestock to be carried, as well as a sufficient number of personnel with the appropriate experience to be able to ensure proper care of the livestock. The APHIS representative assigned to inspect the ocean vessel prior to loading will determine whether the personnel aboard the vessel are sufficient and possess adequate experience, including, if necessary, veterinary experience, to ensure proper care of the livestock.

(13) Vessel stability. The vessel must have adequate stability, taking into consideration the weight and distribution of livestock and fodder, as well as effects of high winds and seas. If requested by APHIS, the owner or operator of the vessel must present stability calculations for the voyage that have been independently verified for accuracy.

(14) Means of humane euthanasia. Ocean vessels must maintain a means of humanely euthanizing sick or injured livestock aboard the vessel. One of the personnel aboard the vessel must be trained in humanely euthanizing livestock by using the means of euthanasia carried by the vessel.

(15) Life support systems. The ocean vessel must maintain replacement parts for major life support systems aboard the vessel, and the means, including qualified personnel, to make the repairs or replacements.

(16) Additional conditions. The vessel must meet any other condition the Administrator determines is necessary for approval, as dictated by specific circumstances and communicated to the owner and operator of the vessel, to protect the livestock and keep them healthy during loading, unloading, and transport to the importing country.

(e) Accommodations for the humane transport of livestock; vessels using shipping containers. An inspector may exempt an ocean vessel that uses shipping containers to transport livestock to an importing country from requirements in paragraph (d) of this section that he or she specifies, if the inspector determines that the containers themselves are designed, constructed, and managed in a manner to reasonably assure the livestock are protected from injury and remain healthy during loading, unloading, and transport to the importing country. During such inspections, particular attention will be paid to the manner in which containers are constructed, the space the containers afford to livestock transported within them, the manner in which the vessel would provide feed and water to the animals in the containers, and the manner in which air and effluent are managed within the containers. The Program Handbook contains exemption guidance.

(f) Operator's report. (1) The owner or operator of any ocean vessel used to export livestock (including vessels that use shipping containers) from the United States must submit a written report to APHIS within 5 business days after completing a voyage. The report must include the name of the ocean vessel; the name and address of all exporters of livestock transported on the vessel; the port of embarkation; dates of the voyage; the port where the livestock were discharged; the number of each species of livestock loaded; the number of each species that died and an explanation for those mortalities; and the number of animals that sustained injuries or sustained illnesses that were significant enough to require medical attention from the personnel entrusted with the care of the animals, as well as the nature of these injuries or illnesses. The report must also document any failure of any major life support system for the livestock, including, but not limited to, systems for providing feed and water, ventilation systems, and livestock waste management systems. Any such failure must be documented, regardless of the duration or whether the failure resulted in any harm to the livestock. The report must include the name, telephone number, and email address of the person who prepared the report and the date of the report. The report must be submitted to APHIS by facsimile or email. Contact numbers and addresses, as well as an optional template for the report, are provided in the Program Handbook.

(2) If an ocean vessel used to export livestock experiences any failure of a major life support system for livestock during the voyage, the owner or operator of the ocean vessel must notify APHIS immediately by telephone, facsimile, or other electronic means. Contact numbers and addresses are provided in the Program Handbook.

(3) Failure to provide timely reports as required by this section may result in APHIS disapproving future livestock shipments by the responsible owner or operator or revoking the vessel's certification under paragraph (a) of this section to carry livestock.

(Approved by the Office of Management and Budget under control number 0579-0432)

§ 91.13 Aircraft.

(a) Prior to loading livestock aboard aircraft, the stowage area of the aircraft and any loading ramps, fittings, and equipment to be used in loading the animals must be cleaned and then disinfected with a disinfectant approved by the Administrator, to the satisfaction of an APHIS representative, unless the representative determines that the aircraft has already been cleaned and disinfected to his or her satisfaction.

(1) The Administrator will approve a disinfectant for purposes of this section upon determining that the disinfectant is effective against pathogens that may be spread by the animals and, if the disinfectant is a chemical disinfectant, that it is registered or exempted for the specified use by the U.S. Environmental Protection Agency.

(2) The Program Handbook provides access to a list of disinfectants approved by the Administrator for use as required by this section. Other disinfectants may also be approved by the Administrator in accordance with paragraph (a)(1) of this section.

(3) The Administrator will withdraw approval of a disinfectant, and remove it from the list of approved disinfectants in the Program Handbook, if the disinfectant no longer meets the conditions for approval in this section.

(b) The time at which the cleaning and disinfection are to be performed must be approved by the APHIS representative, who will give approval only if he or she determines that the cleaning and disinfection will be effective up to the projected time the livestock will be loaded. If the livestock are not loaded by the projected time, the APHIS representative will determine whether further cleaning and disinfection are necessary.

(c) The cleaning must remove all garbage, soil, manure, plant materials, insects, paper, and other debris from the stowage area. The disinfectant solution must be applied with a device that creates an aerosol or mist that covers 100 percent of the surfaces in the stowage area, except for any loaded cargo and deck surface under it that, in the opinion of the APHIS representative, do not contain material, such as garbage, soil, manure, plant materials, insects, waste paper, or debris, that may harbor animal disease pathogens.

(d) After cleaning and disinfection is performed, the APHIS representative will sign and deliver to the captain of the aircraft or other responsible official of the airline involved a document stating that the aircraft has been properly cleaned and disinfected, and stating further the date, the carrier, the flight number, and the name of the airport and the city and state in which it is located. If an aircraft is cleaned and disinfected at one airport, then flies to a subsequent airport, with or without stops en route, to load animals for export, an APHIS representative at the subsequent airport will determine, based on examination of the cleaning and disinfection documents, whether the previous cleaning and disinfection is adequate or whether to order a new cleaning and disinfection. If the aircraft has loaded any cargo in addition to animals, the APHIS representative at the subsequent airport will determine whether to order a new cleaning and disinfection, based on both examination of the cleaning and disinfection documents and on the inspection of the stowage area for materials, such as garbage, soil, manure, plant materials, insects, waste paper, or debris, that may harbor animal disease pathogens.

(e) Cargo containers used to ship livestock must be designed and constructed of a material of sufficient strength to securely contain the animals and must provide sufficient space for the species being transported given the duration of the trip, as determined by APHIS.

§ 91.14 Other movements and conditions.

The Administrator may, upon request in specific cases, permit the exportation of livestock not otherwise provided for in this part under such conditions as he or she may prescribe in each specific case to prevent the spread of livestock diseases and to ensure the humane treatment of the animals during transport to the importing country.

§ 92.1 Definitions.

Active surveillance. Sample collection using a systematic or statistically designed survey methodology to actively seek out and find cases of animals with a restricted disease agent, or to determine the prevalence of the restricted disease agent in the population.

Adjacent region. Any geographic land area, whether or not identifiable by geological, political or surveyed boundaries, that shares common boundaries with any region.

Administrator. The Administrator of the Animal and Plant Health Inspection Service or any other employee of the Animal and Plant Health Inspection Service, United States Department of Agriculture, delegated to act in the Administrator's stead.

Animal and Plant Health Inspection Service (APHIS). The Animal and Plant Health Inspection Service of the United States Department of Agriculture.

Animals. All species of the animal kingdom, except man, including: Cattle, sheep, goats, other ruminants, swine, horses, asses, mules, zebras, dogs, poultry, and birds that are susceptible to communicable diseases of livestock and poultry or capable of being carriers of those diseases or their arthropod vectors.

Approved laboratory. A properly equipped institution in the exporting region, approved by the official authority who is responsible for animal health matters in that region, that is staffed by technically competent personnel under the control of a specialist in veterinary diagnostic methods who is responsible for the results.

Bovine. Bos taurus, Bos indicus, and Bison bison.

Communicable disease. Any contagious or infectious disease of animals. It can be transmitted either directly or indirectly to a susceptible animal from an infected animal, vector, inanimate source, or other sources.

Compartment. Any defined animal subpopulation contained in one or more establishments under a common biosecurity management system for which surveillance, control, and biosecurity measures have been applied with respect to a specific disease.

Contagious disease. Any communicable disease transmitted from one animal to another by direct contact or by feed, water, aerosol, or contaminated objects.

Disease agent. A virus, bacterium, or other organism that causes disease in animals.

Exporting region. A region from which shipments are sent to the United States.

European Union. The organization of Member States consisting of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland (Republic of), Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden. 1

1 For animal health purposes, APHIS considers that Northern Ireland is following European Union regulations and policies and is treating it the same as Member States of the European Union.

Import (imported, importation) into the United States. To bring into the territorial limits of the United States.

OIE. The World Organization for Animal Health.

OIE Code. The Terrestrial Animal Health Code of the World Organization for Animal Health.

OIE Terrestrial Manual. The Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the World Organization for Animal Health.

Passive surveillance. A surveillance system that does not depend on active participation by the responsible agency to seek out and monitor a restricted disease agent. The system relies on mandatory reporting, a pool of trained investigators, diagnostic submission procedures and laboratory support, and periodic public information and continuing education programs on diseases.

Prevalence. The number of cases of a disease in existence at a given time in a designated area.

Processed animal protein. Meat meal, bone meal, meat-and-bone meal, blood meal, dried plasma and other blood products, hydrolyzed protein, hoof meal, horn meal, poultry meal, feather meal, fish meal, and any other similar products.

Region. Any defined geographic land region identifiable by geological, political or surveyed boundaries. A region may consist of any of the following:

(1) A national entity (country);

(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.);

(3) Parts of several national entities combined into an area; or

(4) A group of national entities (countries) combined into a single area.

Region of controlled risk for bovine spongiform encephalopathy (BSE). 2 A region for which a risk assessment has been conducted sufficient to identify the historical and existing BSE risk factors in the region and that:

2 A list of regions classified by APHIS as regions of controlled risk for BSEs is available at http://www.aphis.usda.gov/import_export/animals/animal_disease_status.shtml.

(1) Has demonstrated that appropriate mitigations are being taken to manage all identified risks, but may not have been taken for the periods of time necessary to be classified as a region of negligible risk for BSE.

(2) Is a region in which it can be demonstrated through an appropriate control and audit that neither meat-and-bone meal nor greaves derived from ruminants has been fed to ruminants.

(3) Has demonstrated that Type A surveillance in accordance with Article 11.5.22 of the OIE Code, incorporated by reference in § 92.7, or with equivalent guidelines recognized by the Administrator is in place and the relevant points target, in accordance with Table 1 of Article 11.5.22 of the OIE Code, or with equivalent guidelines recognized by the Administrator has been met. Type B surveillance in accordance with Article 11.5.22 of the OIE Code, or with equivalent guidelines recognized by the Administrator, is sufficient in place of Type A surveillance or its equivalent once the relevant points target for Type A surveillance or its equivalent has been met.

(4) Meets one of the following conditions:

(i) Has had no case of BSE in the region or every case has been demonstrated to have been imported and has been completely destroyed; or

(ii) Has had at least one indigenous case, and all bovines described in either paragraph (4)(ii)(A) or (4)(ii)(B) of this definition, if still alive, are officially identified with unique individual identification that is traceable to the premises of origin of the animal, have their movements controlled, and, when slaughtered or at death, are completely destroyed:

(A) All bovines that, during their first year of life, were reared with a bovine determined to be infected with BSE during its first year of life, and that investigation showed consumed the same potentially contaminated feed as the infected animal during that period; or

(B) If the investigation was unable to determine whether the feed source that was used to feed the bovine known to be infected was also used to feed other bovines in the herd of the infected animal, all bovines born in the same herd as a BSE-infected bovine either within 12 months before or 12 months after the birth of the infected animal.

(5) Meets the conditions in one of or both paragraphs (5)(i) or (5)(ii) of this definition:

(i) Has met the following conditions, but not for at least the past 7 years:

(A) Conducted an ongoing awareness program for veterinarians, farmers, and workers involved in transportation, marketing, and slaughter of bovines to encourage reporting of bovines showing clinical signs that could be indicative of BSE;

(B) Required notification and investigation of all bovines showing clinical signs consistent with BSE; and

(C) Has carried out the examination, in accordance with internationally accepted diagnostic tests and procedures and in approved laboratories, of brain or other tissues collected as part of the surveillance and monitoring described in paragraphs (3) and (5)(i)(A) and (5)(i)(B) of this definition; or

(ii) Has prohibited the feeding to ruminants in the region of meat-and-bone meal and greaves derived from ruminants, but it cannot be demonstrated through an appropriate level of control and audit that the prohibited materials have not been fed to ruminants in the region for at least the past 8 years.

Region of negligible risk for bovine spongiform encephalopathy (BSE). 3 A region for which a risk assessment has been conducted sufficient to identify the historical and existing BSE risk factors in the region and that:

3 A list of regions classified by APHIS as regions of negligible risk for BSEs is available at http://www.aphis.usda.gov/import_export/animals/animal_disease_status.shtml.

(1) Has demonstrated that appropriate mitigations to manage all identified risks have been taken for each relevant period of time to meet each identified risk, as set forth in this definition.

(2) Has demonstrated that Type B surveillance in accordance with Article 11.5.22 of the OIE Code, incorporated by reference in § 92.7, or with equivalent guidelines recognized by the Administrator is in place and the relevant points target, in accordance with Table 1 of Article 11.5.22 of the OIE Code, or with equivalent guidelines recognized by the Administrator has been met.

(3) Meets one of the following conditions:

(i) Has had no case of BSE in the region or every case has been demonstrated to have been imported and has been completely destroyed; or

(ii) Has had at least one indigenous case, but every indigenous case was born more than 11 years ago, and all bovines described in either paragraph (3)(ii)(A) or (3)(ii)(B) of this definition, if still alive, are officially identified with unique individual identification that is traceable to the premises of origin of the animal, have their movements controlled, and, when slaughtered or at death, are completely destroyed:

(A) All bovines that, during their first year of life, were reared with a bovine determined to be infected with BSE during its first year of life, and that investigation showed consumed the same potentially contaminated feed as the infected animal during that period; or

(B) If the investigation was unable to determine whether the feed source that was used to feed the bovine known to be infected was also used to feed other bovines in the herd of the infected animal, all bovines born in the same herd as a BSE-infected bovine either within 12 months before or 12 months after the birth of the infected animal.

(4) Has, for at least the past 7 years:

(i) Conducted an ongoing awareness program for veterinarians, farmers, and workers involved in transportation, marketing, and slaughter of bovines to encourage reporting of bovines showing clinical signs that could be indicative of BSE;

(ii) Required notification and investigation of all bovines showing clinical signs consistent with BSE; and

(iii) Carried out the examination, in accordance with internationally accepted diagnostic tests and procedures and in approved laboratories, of brain or other tissues collected as part of the required surveillance and monitoring described in paragraphs (2) and (4)(i) and (4)(ii) of this definition.

(5) Has demonstrated through an appropriate level of control and audit that, for at least the past 8 years, neither meat-and-bone meal nor greaves derived from ruminants have been fed to ruminants in the region.

Region of undetermined risk for bovine spongiform encephalopathy (BSE). Any region that is not classified as either a region of negligible risk for BSE or a region of controlled risk for BSE.

Restricted disease agent. Any communicable disease agent or its vector not known to exist in the United States or that is subject to a Federal or cooperative Federal/State control or eradication program within the United States.

Specified risk materials (SRMs) from regions of controlled risk for BSE. Those bovine parts considered to be at particular risk of containing the BSE agent in infected animals, as listed in the FSIS regulations at 9 CFR 310.22(a).

Specified risk materials (SRMs) from regions of undetermined risk for BSE. Those bovine parts considered to be at particular risk of containing the BSE agent in infected animals, as listed in the FSIS regulations at 9 CFR 310.22(a), except that the following bovine parts from regions of undetermined risk for BSE are considered SRMs if they are derived from bovines over 12 months of age: Brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and the dorsal root ganglia.

Surveillance. Systems to find, monitor, and confirm the existence or absence of a restricted disease agent or agents in livestock, poultry and other animals. Surveillance may be passive or active.

United States. All of the States of the United States, the District of Columbia, Guam, the Northern Mariana Islands, Puerto Rico, the Virgin Islands of the United States, and all other territories and possessions of the United States.

Vector-borne disease. A disease transmitted to an animal through an intermediate arthropod vector, including ticks or insects.

[62 FR 56012, Oct. 28, 1997, as amended at 68 FR 16938, Apr. 7, 2003; 72 FR 67232, Nov. 28, 2007; 78 FR 72993, Dec. 4, 2013; 85 FR 11835, Feb. 28, 2020; 86 FR 45622, Aug. 16, 2021]

§ 92.2 Application for recognition of the animal health status of a region or a compartment.

(a) The representative of the national government(s) of any country or countries who has the authority to make such a request may request that APHIS recognize the animal health status of a region or a compartment. 1 Such requests must be made in English and must be sent to the Administrator, c/o Strategy and Policy, VS, APHIS, 4700 River Road, Unit 38, Riverdale, MD 20737-1231. (Where possible, include a copy of the request and accompanying information in electronic format.)

1 Additionally, APHIS may choose to initiate an evaluation of the animal health status of a foreign region or compartment on its own initiative. In such cases, APHIS will follow the same evaluation and notification procedures set forth in this section.

(b) Requests for recognition of the animal health status of a region, other than requests submitted in accordance with paragraph (c) of this section, must include, in English, the information in paragraphs (b)(1) through (8) of this section about the region. More detailed information regarding the specific types of information that will enable APHIS to most expeditiously conduct an evaluation of the request is available at: https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/export/international-standard-setting-activities-oie/regionalization/ct_reg_request or by contacting the National Director, Regionalization Evaluation Services, VS, APHIS, 4700 River Road, Unit 38, Riverdale, MD 20737.

(1) Scope of the evaluation being requested.

(2) Veterinary control and oversight.

(3) Disease history and vaccination practices.

(4) Livestock demographics and traceability.

(5) Epidemiological separation from potential sources of infection.

(6) Surveillance.

(7) Diagnostic laboratory capabilities.

(8) Emergency preparedness and response.

(c) Requests for recognition that a region is historically free of a disease based on the amount of time that has elapsed since the disease last occurred in a region, if it has ever occurred, must include, in English, the information in paragraphs (c)(1) through (6) of this section about the region. More detailed information regarding the specific types of information that will enable APHIS to most expeditiously conduct an evaluation of the request is available at: https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/export/international-standard-setting-activities-oie/regionalization/ct_reg_request or by contacting the National Director, Regionalization Evaluation Services, VS, APHIS, 4700 River Road, Unit 38, Riverdale, MD 20737. For a region to be considered historically free of a disease, the disease must not have been reported in domestic livestock for at least the past 25 years and must not have been reported in wildlife for at least the past 10 years.

(1) Scope of the evaluation being requested.

(2) Veterinary control and oversight.

(3) Disease history and vaccination practices.

(4) Disease notification.

(5) Disease detection.

(6) Barriers to disease introduction.

(d) Requests for recognition of the animal health status of a compartment must include, in English, the information in paragraphs (d)(1) through (8) of this section about the compartment. More detailed information regarding the specific types of information that will enable APHIS to most expeditiously conduct an evaluation of the request is available at: https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/export/international-standard-setting-activities-oie/regionalization/ct_reg_request or by contacting the National Director, Regionalization Evaluation Services, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 20737.

(1) Scope of the evaluation being requested.

(2) Veterinary control and oversight of the compartment.

(3) Disease history and vaccination practices.

(4) Livestock or poultry commodity movement and traceability.

(5) Epidemiologic separation of the compartment from potential sources of infection.

(6) Surveillance.

(7) Diagnostic laboratory capabilities.

(8) Emergency preparedness and response.

(e) A list of those regions for which an APHIS recognition of their animal health status has been requested, the disease(s) under evaluation, and, if available, the animal(s) or product(s) the region wishes to export, is available at: https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/export/international-standard-setting-activities-oie/regionalization/ct_reg_request.

(f) A list of countries that have requested an APHIS compartmentalization evaluation, and a description of the requested compartment is available at: https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/export/international-standard-setting-activities-oie/regionalization/ct_reg_request.

(g) If, after review and evaluation of the information submitted in accordance with paragraph (b), (c), or (d) of this section, APHIS believes the request can be safely granted, APHIS will indicate its intent and make its evaluation available for public comment through a document published in the Federal Register.

(h) APHIS will provide a period of time during which the public may comment on its evaluation. During the comment period, the public will have access to the information upon which APHIS based its evaluation, as well as the evaluation itself. Once APHIS has reviewed all comments received, it will make a final determination regarding the request and will publish that determination in the Federal Register.

(i) If a region or compartment is granted animal health status under the provisions of this section, the representative of the national government(s) of any country or countries who has the authority to make a regionalization or compartmentalization request may be required to submit additional information pertaining to animal health status or allow APHIS to conduct additional information collection activities in order for that region or compartment to maintain its animal health status.

(Approved by the Office of Management and Budget under control numbers 0579-0040 and 0579-0453)

[85 FR 11835, Feb. 28, 2020, as amended at 86 FR 68856, Dec. 3, 2021]

§ 92.3 Movement restrictions.

Whenever the European Commission (EC) establishes a quarantine for a disease in the European Union in a region the Animal and Plant Health Inspection Service recognizes as one in which the disease is not known to exist and the EC imposes prohibitions or other restrictions on the movement of animals or animal products from the quarantined area in the European Union, such animals and animal products are prohibited importation into the United States.

[68 FR 16938, Apr. 7, 2003]

§ 92.4 Reestablishment of a region or compartment's disease-free status.

This section applies to regions or compartments that are designated under this subchapter as free of a specific animal disease and then experience an outbreak of that disease.

(a) Interim designation. If a region or a compartment recognized as free of a specified animal disease in this subchapter experiences an outbreak of that disease, APHIS will take immediate action to prohibit or restrict imports of animals and animal products from the entire region, a portion of that region, or the compartment. APHIS will inform the public as soon as possible of the prohibitions and restrictions by means of a notice in the Federal Register.

(b) Reassessment of the disease situation. (1) Following removal of disease-free status from all or part of a region or a compartment, APHIS may reassess the disease situation in that region or compartment to determine whether it is necessary to continue the interim prohibitions or restrictions. In reassessing disease status, APHIS will take into consideration the standards of the World Organization for Animal Health (OIE) for reinstatement of disease-free status, as well as all relevant information obtained through public comments or collected by or submitted to APHIS through other means.

(2) Prior to taking any action to relieve prohibitions or restrictions, APHIS will make information regarding its reassessment of the region's or compartment's disease status available to the public for comment. APHIS will announce the availability of this information by means of a notice in the Federal Register.

(c) Determination. Based on the reassessment conducted in accordance with paragraph (b) of this section regarding the reassessment information, APHIS will take one of the following actions:

(1) Publish a notice in the Federal Register of its decision to reinstate the disease-free status of the region, portion of the region, or compartment;

(2) Publish a notice in the Federal Register of its decision to continue the prohibitions or restrictions on the imports of animals and animal products from that region or compartment; or

(3) Publish another document in the Federal Register for comment.

[85 FR 11836, Feb. 28, 2020]

§ 92.5 Determination of the BSE risk classification of a region.

All countries of the world are considered by APHIS to be in one of three BSE risk categories—negligible risk, controlled risk, or undetermined risk. These risk categories are defined in § 92.1. Any region that is not classified by APHIS as presenting either negligible risk or controlled risk for BSE is considered to present an undetermined risk. The listing of those regions classified by APHIS as having either negligible risk or controlled risk can be accessed on the APHIS Web site at http://www.aphis.usda.gov/import_export/animals/animal_disease_status.shtml. The listing can also be obtained by writing to APHIS at National Import Export Services, 4700 River Road Unit 38, Riverdale, MD 20737. APHIS may classify a region for BSE according to either paragraph (a) or paragraph (b) of this section.

(a) BSE risk classification based on OIE classification. If the OIE has classified a country as either BSE negligible risk or BSE controlled risk, APHIS will seek information to support concurrence with the OIE classification. This information could be publicly available information, or APHIS could request that countries supply the same information given to the OIE. APHIS will announce in the Federal Register, subject to public comment, each intent to concur with an OIE classification. APHIS will also post the summary of the BSE OIE ad hoc group conclusions for review during the comment period. The summaries would be available for review on the APHIS Web site at http://www.aphis.usda.gov/import_export/animals/reg_request.shtml. Following review of any comments received, the Administrator will announce his or her final determination regarding classification of the country in the Federal Register, along with a discussion of and response to pertinent issues raised by commenters. If APHIS recognizes a country as either negligible risk or controlled risk for BSE, the Agency will include that country in a list of regions of negligible risk or controlled risk for BSE, as applicable, that APHIS will make available to the public on the Agency's Web site at http://www.aphis.usda.gov/import_export/animals/animal_disease_status.shtml.

(b) Regions seeking classification as negligible or controlled risk that have not been classified by the OIE. A region that has not received classification by OIE as either negligible risk or controlled risk for BSE and that wishes to be classified by APHIS as negligible risk or controlled risk must submit to the Administrator a request for classification, along with documentation sufficient to allow APHIS to conduct an evaluation of whether the region meets the criteria for classification. A list of the documentation required can be accessed on the APHIS Web site at http://www.aphis.usda.gov/import_export/animals/reg_request.shtml. If, following evaluation of the information submitted, the Administrator determines that the region meets the criteria for classification as negligible risk or controlled risk, APHIS will announce that determination in the Federal Register and will make available to the public on the APHIS Web site the evaluation conducted by APHIS, as well as the information provided by the requesting region. APHIS will accept public comment on its intent. Following review of any comments received, the Administrator will announce his or her final determination regarding classification of the region in the Federal Register, along with a discussion of and response to pertinent issues raised by commenters.

(c) Retention of classification as either negligible risk or controlled risk. (1) As required by the OIE for countries classified as either negligible risk or controlled risk by the OIE, regions evaluated by APHIS and classified as negligible or controlled risk would need to submit updated information to APHIS each year. The required information includes documentation of the following:

(i) Relevant changes in BSE legislation, compared to the previous year;

(ii) The importation into the region during the year of cattle, processed animal protein, and products containing processed animal protein;

(iii) Audit findings in rendering plants and feed mills that process ruminant material or material from mixed species that contains ruminant material, related to the prohibition of the feeding to ruminants of processed animal protein;

(iv) Audit findings in rendering plants and feed mills that process nonruminant material, related to the prohibition of the feeding to ruminants of processed animal protein;

(v) Infractions at the types of facilities listed above;

(vi) If and why, in light of the audit findings, there has been no significant exposure of cattle to the BSE agent through consumption of processed animal protein of bovine origin;

(vii) Surveillance efforts;

(viii) All clinical BSE suspects; and

(ix) Any new cases of BSE.

(2) If APHIS at any time determines that a region no longer meets the criteria for the risk classification it had previously received, APHIS will remove the region from its list of regions so classified. If the OIE determines the region no longer meets the criteria for the risk classification it had previously received, APHIS may concur with the OIE determination or may request updated information from the region and determine whether to concur with the OIE decision APHIS will announce its intent in the Federal Register and accept public comment regarding that intent. Following review of any comments received, the Administrator will announce in the Federal Register his or her final determination regarding classification of the region, along with a discussion of and response to pertinent issues raised by commenters.

(Approved by the Office of Management and Budget under control number 0579-0393)

§ 92.6 Determination of the date of effective enforcement of a ruminant-to-ruminant feed ban.

(a) In order for APHIS to determine the eligibility of live bovines for importation from a region classified as BSE negligible risk or BSE controlled risk, APHIS must determine the date from which a ban on the feeding of ruminant material to ruminants has been effectively enforced in the region. APHIS will base its determination of the date of effective enforcement on the information included in the dossier the region submitted when it requested to be classified regarding BSE risk. The information APHIS will consider will include, but not be limited to:

(1) Policies and infrastructure for feed ban enforcement, including an awareness program for producers and farmers;

(2) Livestock husbandry practices;

(3) Disposition of processed animal protein produced from domestic bovines, including the feeding of such material to any animal species;

(4) Measures taken to control cross-contamination and mislabeling of feed; and

(5) Monitoring and enforcement of the ruminant-to-ruminant feed ban, including audit findings in rendering plants and feed mills that process ruminant material.

(b) After conducting its evaluation, APHIS will announce in the Federal Register for public comment the date APHIS considers to be the date of effective enforcement of a ruminant-to-ruminant feed ban in the requesting region, and will make available to the public the evaluation conducted by APHIS, as well as the supporting documentation. Following review of any comments received, the Administrator will announce his or her final determination in the Federal Register, along with a discussion of and response to pertinent issues raised by commenters.

§ 92.7 Incorporation by reference.

(a) Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than that specified in this section, USDA must publish notice of change in the Federal Register and the material must be available to the public. All approved material is available for inspection at the Animal and Plant Health Inspection Service (APHIS), and is available from the sources listed below. For information about the availability of this material at APHIS, call 301-851-3300 or write to National Import Export Services, 4700 River Road Unit 38, Riverdale, MD 20737. It is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(b) World Organization for Animal Health (OIE), 12, rue de Prony 75017 Paris, France, or email oie@oie.int, http://www.oie.int/eng/normes/Mcode/en_sommaire.htm.

(1) Terrestrial Animal Health Code, Chapter 11.5-Bovine Spongiform Encephalopathy, Article 11.5.22 (Surveillance activities), 22nd Edition, 2013.

(2) [Reserved]

(Approved by the Office of Management and Budget under control number 0579-0393)

§ 93.100 Definitions.

Wherever in this subpart the following terms are used, unless the context otherwise requires, they shall be construed, respectively, to mean:

Administrator. The Administrator of the Animal and Plant Health Inspection Service or any other employee of the Animal and Plant Health Inspection Service, United States Department of Agriculture, to whom authority has been or may be delegated to act in the Administrator's stead.

Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the United States Department of Agriculture (APHIS or Service.)

Animals. Cattle, sheep, goats, other ruminants, swine, horses, asses, mules, zebras, dogs, and poultry.

APHIS representative. A veterinarian or other individual employed by the Animal and Plant Health Inspection Service, United States Department of Agriculture, who is authorized to perform the services required by this part.

Birds. All members of the class aves (including eggs for hatching), other than poultry.

Commercial birds. Birds which are imported for resale, breeding, public display, or any other purpose, except pet birds, zoological birds, research birds, or performing or theatrical birds.

Communicable disease. Any contagious, infectious, or communicable disease of domestic livestock, poultry or other animals.

Department. The United States Department of Agriculture (USDA).

Highly pathogenic avian influenza (HPAI). Highly pathogenic avian influenza is defined as follows:

(1) Any influenza virus that kills at least 75 percent of eight 4- to 6-week-old susceptible chickens within 10 days following intravenous inoculation with 0.2 mL of a 1:10 dilution of a bacteria-free, infectious allantoic fluid or inoculation of 10 susceptible 4- to 8-week-old chickens resulting in an intravenous pathogenicity index (IVPI) of greater than 1.2;

(2) Any H5 or H7 virus that does not meet the criteria in paragraph (1) of this definition, but has an amino acid sequence at the haemagglutinin cleavage site that is compatible with highly pathogenic avian influenza viruses; or

(3) Any influenza virus that is not an H5 or H7 subtype and that kills one to five out of eight inoculated chickens and grows in cell culture in the absence of trypsin within 10 days.

Inspector. An employee of the Animal and Plant Health Inspection Service authorized to perform duties required under this subpart.

Licensed veterinarian. Any person licensed by any region or political subdivision thereof to practice veterinary medicine.

Pen-raised. Cared for in a fenced enclosure, such that the ratites are kept apart from wild ratites, poultry, and other animals; can be readily observed, and be restrained for inspection and treatment. A flock is not considered to be pen-raised if ratites captured in the wild have been added to it after March 8, 1994.

Performing or theatrical birds. Birds, except ratites, which are to be used in shows, theatrical acts or performances only.

Persons. Any individual, corporation, company, association, firm, partnership, society or joint stock company.

Pet birds. Birds, except ratites, which are imported for the personal pleasure of their individual owners and are not intended for resale.

Port Veterinarian. A veterinarian employed by the Animal and Plant Health Inspection Service to perform duties required under this part at a port of entry.

Poultry. Chickens, doves, ducks, geese, grouse, guinea fowl, partridges, pea fowl, pheasants, pigeons, quail, swans, and turkeys (including eggs for hatching).

Production season. That period of time, usually approximately 9 months each year, from the time ratites in a flock begin laying eggs until the ratites cease laying eggs.

Quarantine facility. A USDA facility, or a private facility approved by APHIS, for the secure housing of imported birds, poultry, or other animals for specified periods.

Ratites. Cassowaries, emus, kiwis, ostriches, and rheas.

Region. Any defined geographic land area identifiable by geological, political, or surveyed boundaries. A region may consist of any of the following:

(1) A national entity (country);

(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.);

(3) Parts of several national entities combined into an area; or

(4) A group of national entities (countries) combined into a single area.

Research birds. Birds which are to be used for research purposes only.

Smuggled birds. Any bird which has been brought into the United States contrary to any Federal law or regulation and which has been seized by any official of any Department of the United States Government or which has been abandoned to the United States.

United States. All of the States of the United States, the District of Columbia, Guam, Northern Mariana Islands, Puerto Rico, the Virgin Islands of the United States, and all other Territories and Possessions of the United States.

Veterinary Services. The Veterinary Services unit of the Department.

Zoological birds. Birds intended for breeding or public display, for recreational or educational purposes, at a zoological park.

Zoological park. A professionally operated zoo, park, garden or other place, maintained under the constant surveillance of a Doctor of Veterinary Medicine, for the exhibition of live animals, pigeons or birds, for the purpose of public recreation or education.

[55 FR 31495, Aug. 2, 1990, as amended at 56 FR 31865, July 12, 1991; 59 FR 10732, Mar. 8, 1994; 59 FR 47068, Sept. 14, 1994. Redesignated and amended at 62 FR 56012, 56013, Oct. 28, 1997; 79 FR 71004, Dec. 1, 2014]

§ 93.101 General prohibitions; exceptions.

(a) No product or bird subject to the provisions of this part shall be brought into the United States except in accordance with the regulations in this part and part 94 of this subchapter; 1 nor shall any such product or bird be handled or moved after physical entry into the United States before final release from quarantine orany other form of governmental detention except in compliance with such regulations; Provided, That the Administrator may upon request in specific cases permit products or birds to be brought into or through the United States under such conditions as he or she may prescribe, when he or she determines in the specific case that such action will not endanger the livestock or poultry of the United States. Unless otherwise indicated in the regulations, no live birds, and no hatching eggs from birds, shall be imported into the United States if the birds have originated from a region referenced in § 94.6(a) of this subchapter where highly pathogenic avian influenza or Newcastle disease is known to exist in commercial poultry populations, have transited highly pathogenic avian influenza- or Newcastle disease-affected regions, or have been vaccinated for the H5 or H7 subtype of avian influenza.

1 Importations of certain animals from various regions are absolutely prohibited under part 94 because of specified diseases.

(b)(1) Birds from Canada may be imported in accordance with this section or, except for ratites in accordance with the provisions applicable to importation of poultry from Canada as specified in §§ 93.205, 93.214, and 93.216 of this part.

(2) Ratites and hatching eggs of ratites may be imported into the United States only in accordance with the provisions in this part that apply to commercial and zoological birds, and, where specified, with the provisions that apply to ratites or hatching eggs of ratites.

(3) Except for ratites imported as zoological birds, and ratites and ratite hatching eggs imported from Canada in accordance with § 93.107, ratites and hatching eggs of ratites may not be imported into the United States unless the following conditions are met:

(i) The ratites or hatching eggs are produced by a pen-raised flock, and, in the case of ratites, maintained in a pen-raised flock;

(ii) Each ratite produced in the flock is identified with an identification number by means of a microchip implanted at 1-day of age in the pipping muscle of ostriches and in the upper neck of other ratites, each ratite added from outside the flock is identified in like manner upon arrival in the flock, except that the microchip need not be implanted in the pipping muscle or the upper neck, and each ratite already in the flock as of March 8, 1994 is identified in like manner, prior to the next visit to the flock premises by an APHIS representative under § 93.103(a)(2)(iv), except that the microchip need not be implanted in the pipping muscle or the upper neck;

(iii) On the date it is produced, each hatching egg produced in the flock is marked in indelible ink with the date of the production, and with identification, assigned by the national government of the region of export, of the premises and region from which the ratites or hatching eggs are intended for exportation;

(iv) The owner or manager of the premises from which the ratites or hatching eggs are intended for importation into the United States maintains on a daily basis a register listing the following:

(A) Number of live ratites hatched in the flock or added to the flock, and number of live ratites removed from the flock, and the microchip number for each of these ratites;

(B) Number of eggs produced in the flock and date of production, and number of eggs removed from the flock and date of production; and

(C) Number of eggs in incubator/hatcher and date of production;

(v) The owner or manager of the premises submits a copy of the registers to the National Veterinary Service of the region of export on a quarterly basis. The region of export in turn submits a copy of the registers to the Administrator upon his or her request; 2

2 Copies should be mailed to the Animal and Plant Health Inspection Service, Veterinary Services, Strategy and Policy, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231.

(vi) The region from which the ratites or hatching eggs are exported to the United States maintains a registry of premises that wish to export ratites or hatching eggs of ratites to the United States, that lists each ratite according to the microchip number required under paragraph (b)(3)(iv) of this section, and also maintains a count of hatching eggs of ratites produced on or added to the premises;

(vii) Before a premises is added to the registry, either a veterinary officer of the national government of the region of export, or an employee of that government responsible for the protection of fish and wildlife, visits the premises and determines that all ratites and hatching eggs of ratites are identified as required under paragraphs (b)(3)(ii) and (b)(3)(iii) of this section.

(viii) The region from which the ratites or hatching eggs of ratites are exported to the United States requires each premises from which ratites or hatching eggs of ratites are exported to the United States to receive approval from the National Veterinary Service of that region before ratites are added to the premises from outside the premises, and also prohibits the addition of ratites to a flock during production seasons;

(ix) The region from which ratites or hatching eggs of ratites are exported to the United States establishes a maximum number of hatching eggs of ratites that may be produced on each premises over a set production season. The ceiling for each premises is calculated jointly by a full-time salaried veterinary officer of the national government of the region of export and the APHIS representative who conducts the site visit required under § 93.103(a)(2)(iv), and is adjusted jointly by an APHIS representative and a full-time salaried veterinary officer of the national government of the region of export according to changes in the number of laying hens in the flock;

(x) The region of export conducts random inspections of each premises intending to export ratites or hatching eggs of ratites to the United States, at least twice during each production season, to ensure that all ratites and hatching eggs of ratites on the premises are identified as required under paragraphs (b)(3)(ii) and (b)(3)(iii) of this section. These inspections must be conducted by either a veterinary officer of the national government of the region of export or an employee of that government responsible for the protection of fish and wildlife. If any ratites or hatching eggs are not identified as required, the region of export must not issue the export certificate required under § 93.104(a). The region of export must record, on the copy of the report required to be sent to the Administrator under paragraph (b)(3)(v) of this section, whether all ratites and hatching eggs are identified as required;

(xi) The region of export requires each premises on which ratites or hatching eggs of ratites intended for export to the United States are kept to submit to the National Veterinary Service of that region a copy of the certificate required under § 93.104(a);

(xii) The person intending to import ratites into the United States provides the APHIS veterinary inspector at the intended port of entry with a reader capable of reading the microchip implanted in each of the ratites.

(4) Ratites and hatching eggs of ratites may not be imported into the United States in any container that holds hay, straw, grasses, wood chips, sawdust, or other materials likely to harbor ectoparasites. Ratites and hatching eggs of ratites that are imported into the United States in containers holding such materials will be refused entry.

(c)(1) Pet birds offered for entry from Canada and which are not known to be affected with or exposed to any communicable disease of poultry, which are caged (prior to release from the port of entry) and which are personal pets, may be imported by the owner thereof at any port of entry designated in §§ 93.103 or 93.203: Provided, That, such birds are found upon port of entry veterinary inspection under § 93.105 to be free of poultry diseases and at the time of entry the owner signs and furnishes to the Administrator, a statement stating that the bird or birds have been in his or her possession for a minimum of 90 days preceding the date of importation and that during such time such birds have not been in contact with poultry or other birds (for example, association with other avian species at exhibitions or in aviaries.)

(2)(i) Except for pet birds that have been in any region where highly pathogenic avian influenza exists, which are subject to the provisions of paragraph (c)(3) of this section, pet birds of United States origin that have not been outside the country for more than 60 days may be offered for entry under the provisions of paragraph (c)(1) of this section if:

(A) The pet birds are accompanied by an import permit issued by APHIS: Provided, that an import permit will not be required for pet birds returning from Canada or Mexico through a land border port; and

(B) The birds are also accompanied by a United States veterinary health certificate issued prior to the departure of the birds from the United States and the certificate shows the number from the leg band, tattoo, or microchip affixed to the birds prior to departure; and

(C) During port of entry veterinary inspection it is determined that the number from the leg band, tattoo, or microchip on the bird is the same as the one listed on the health certificate.

(ii) Except for pet birds that have been in any region where highly pathogenic avian influenza exists, which are subject to the provisions of paragraph (c)(3) of this section, pet birds of United States origin that have been outside the country for more than 60 days may be imported by their owner if:

(A) The pet birds are accompanied by an import permit issued by APHIS: Provided, that an import permit will not be required for pet birds returning from Canada or Mexico through a land border port; and

(B) The pet birds are found upon port of entry veterinary inspection to be free of poultry diseases; and

(C) The pet birds are accompanied by a United States veterinary health certificate issued prior to the departure of the birds from the United States and the certificate shows the number from the leg band, tattoo, or microchip affixed to the birds prior to departure; and

(D) During port of entry veterinary inspection it is determined that the number from the leg band, tattoo, or microchip on the bird is the same as the one listed on the health certificate; and

(E) The owner importing the pet birds signs and furnishes to the Administrator the following:

(1) A notarized declaration under oath or affirmation (or a statement signed by the owner and witnessed by a Department inspector) stating that the bird or birds have not been in contact with poultry or other birds while out of the region (for example, association with other avian species at exhibitions or at aviaries); and

(2) An agreement on VS Form 17-8, obtainable from a Federal inspector at the port of entry, stating:

(i) That the birds will be maintained in confinement in his or her personal possession separate and apart from all poultry and other birds for a minimum of 30 days following importation at the address where the birds are to be held and made available for health inspection and testing by Department inspectors upon request until released at the end of such period by such an inspector; and

(ii) That appropriate Federal officials in the State of destination will be immediately notified if any signs of disease are noted in any of the birds or any bird dies during that period. The owner importing such birds must comply with the provisions of the aforementioned agreement before the birds may be released from confinement. Except for pet birds that have been in any region where highly pathogenic avian influenza exists, lots of pet birds of United States origin which do not otherwise meet the requirements of paragraphs (c)(1) or (2) of this section may be offered for entry under the provisions of paragraph (c)(4) of this section.

(3) Any pet birds of United States origin that have been in any region identified in accordance with § 94.6(a)(2) of this subchapter as a region where highly pathogenic avian influenza exists, regardless of the length of time such birds have been outside of the United States, may only be imported through the port of Los Angeles, CA, Miami, FL, or New York, NY, and only under the following conditions:

(i) The birds meet the requirements of paragraphs (c)(2)(ii)(A) through (D) of this section; and

(ii) The birds are quarantined for a minimum of 30 days, and for such longer period as may be required by the Administrator in any specific case, at a USDA quarantine facility in accordance with § 93.106.

(4) Pet birds which are not known to be affected with or exposed to communicable diseases of poultry may be offered for entry at one of the ports of entry designated in § 93.102(a) under the following conditions:

(i) The pet birds shall be accompanied by a veterinary health certificate issued by a national government veterinary officer of the region of export stating that he or she personally inspected the birds listed on the health certificate and found them to be free of evidence of highly pathogenic avian influenza, Newcastle disease, chlamydiosis, and other communicable diseases of poultry, and that the birds were being exported in compliance with the laws and regulations of the region of export, or if exported from Mexico, shall be accompanied either by such a certificate or by a certificate issued by a veterinarian accredited by the National Government of Mexico and endorsed by a full-time salaried veterinary officer of the National Government of Mexico, thereby representing that the veterinarian issuing the certificate was authorized to do so. Certificates in a foreign language must be translated into English at the expense of the importer.

(ii) An advanced reservation fee as required by § 93.103(a)(3) and a request for space which has been confirmed in writing, at a USDA-operated quarantine facility shall be made with the port veterinarian 3 at the port where the birds are to be held for a minimum 30-day isolation in a biologically secure unit separate and apart from all other avian species, except, that birds arriving without an advanced reservation may be handled if an isolation unit is available, provided the reservation fee as required in § 93.103(a)(3) is paid. Pet birds offered for entry at a port of entry that has not been designated in § 93.102(a), or pet birds arriving without an advanced reservation at a port of entry designated in § 93.102(a) but at which isolation units are not available, shall be refused entry at such port. However, such pet birds may be transported at the owner's expense to another port of entry designated in § 93.102(a) if available quarantine space exists, if the reservation fee is paid and the birds are shipped to such other port under conditions deemed sufficient by the Administrator to prevent the spread of communicable diseases of poultry: Provided, That pet birds arriving with or without an advance reservation at the port of Hidalgo, Texas, will be transported at Department expense to the quarantine facility at Mission, Texas, if available quarantine space exists at that facility, until quarantine facilities are available at Hidalgo, Texas; and pet birds arriving with or without an approved reservation entered at the port of New York, New York, will be transported at Department expense to the quarantine facility at Newburgh, New York, if available quarantine space exists at the facility, until quarantine facilities are available at New York, New York. Following the isolation period, if such birds are found to be free from communicable diseases of poultry, the birds shall be returned at Department expense to the respective ports of Hidalgo, Texas, or New York, New York, as appropriate, for Agriculture release for entry through U.S. Customs.

3 The names and addresses of the port veterinarians, as well as a fee schedule for quarantine charges, are available from the Animal and Plant Health Inspection Service, Veterinary Services, 4700 River Road Unit 33, Riverdale, Maryland 20737-1231.

(iii) During the isolation period, the birds shall be subjected to such tests and procedures as required by the Administrator to determine whether the birds are free from communicable diseases of poultry.

(iv) Following the isolation period, if the birds are found to be free of communicable disease of poultry, the port veterinarian shall issue an agriculture release for entry through U.S. Customs. If the birds are found during port of entry inspection or during quarantine to be infected with or exposed to a communicable disease of poultry, such birds shall be refused entry and handled in accordance with § 93.106(a) of this part.

(v) The owner of the birds is responsible for all costs which result from these procedures and shall reimburse APHIS for governmental expenses in accordance with § 93.210 (b) and (c) of this part.

(d) The provisions in this subpart relating to birds shall not apply to healthy birds, except ratites, not known to be infected with or exposed, within the 90 days preceding the date of export from the region of origin, to communicable diseases of poultry, if an import permit 4 has been obtained under § 93.103 of this chapter and all conditions therein are observed; and if such birds are handled as follows:

4 Such permit may be obtained from the Animal and Plant Health Inspection Service, Veterinary Services, 4700 River Road Unit 33, Riverdale, Maryland 20737-1231 or by visiting http://www.aphis.usda.gov/animal_health/permits/”. Requests for approval of such facilities should also be made to the Deputy Administrator.

(1)(i) They are maintained under continuous confinement in transit through the United States aboard an aircraft, ocean vessel, or other means of conveyance; or

(ii) Except for birds in transit through Anchorage, Alaska, under § 93.103(c) of this part, which are not allowed to be unloaded, they are unloaded, in the course of such transit, into a bird holding facility which is provided by the carrier or its agent and has been approved 5 in advance by the Administrator in accordance with paragraph (d)(3) of this section as adequate to prevent the spread within the United States of any livestock or poultry disease, and they are maintained there under continuous confinement until loaded aboard a means of conveyance for transportation from the United States and are maintained under continuous confinement aboard such means of conveyance until it leaves the United States; the import permit will specify any additional conditions necessary to assure that the transit of the poultry or birds through the United States can be made without endangering the livestock or poultry of the United States, and that Department inspectors may inspect the poultry or birds on board such means of conveyance or in such holding facility to ascertain whether the requirements of this paragraph are met, and dispose of them in accordance with the Animal Health Protection Act (7 U.S.C. 8301 et seq.) if such conditions are not met; and

5 See footnote 4 in subpart A.

(2) The carrier or its agent executes and furnishes to the collector of Customs at the first port of arrival a declaration stating that the poultry or birds will be retained aboard such means of conveyance or in an approved holding facility during transhipment as required by this paragraph.

(3) Provisions for the approval of facilities required in this paragraph are:

(i) They must be sufficiently isolated to prevent direct or indirect contact with all other animals and birds while in the United States.

(ii) They must be so constructed that they provide adequate protection against environmental conditions and can be adequately cleaned, washed and disinfected.

(iii) They must provide for disposal of animal and bird carcasses, manure, bedding, waste and any related shipping materials in a manner that will prevent dissemination of disease.

(iv) They must have provisions for adequate sources of feed and water and for attendants for the care and feeding of birds in the facility.

(v) They must comply with additional requirements as may be imposed by the Administrator if deemed applicable for a particular shipment.

(vi) They must also comply with all applicable local, State and Federal requirements for environmental quality and with the provisions of the Animal Welfare Regulations in chapter I of this title, as applicable.

(e) Commercial birds, zoological birds, research birds, or pet birds may be imported into the United States if they meet the requirements of §§ 93.102(a), 93.103, 93.104, 93.105(a), and 93.106(a) which specifically apply to such birds and the requirements of all other sections in this part that are applicable to poultry generally.

(f) Performing or theatrical birds returning to the United States. (1) Performing or theatrical birds of United States origin that are returning to the United States from Canada or Mexico may be imported if:

(i) The birds are found upon port of entry veterinary inspection to be free of avian diseases; and

(ii) The birds are accompanied by a United States veterinary health certificate issued prior to the departure of the birds from the United States and the certificate shows the number from the leg band, tattoo, or microchip affixed to the birds prior to departure; and

(iii) During port of entry veterinary inspection it is determined that the number from the leg band, tattoo, or microchip on the birds is the same as the one listed on the health certificate.

(2) Except for performing or theatrical birds that have been in any region where highly pathogenic avian influenza exists, which are subject to the provisions of paragraph (f)(3) of this section, performing or theatrical poultry of United States origin that have been outside the United States in a region other than Canada or Mexico may be imported if:

(i) The birds meet the requirements of paragraphs (f)(1)(i) through (iii) of this section; and

(ii) The birds are accompanied by an import permit issued by APHIS; and

(iii) The owner importing the birds signs and furnishes to the Administrator the following:

(A) A notarized declaration under oath or affirmation (or a statement signed by the owner and witnessed by a Department inspector) stating that the birds have not been in contact with other birds while out of the region (for example, association with other avian species at exhibitions or at aviaries); and

(B) An agreement on VS Form 17-8, available electronically or through other authorized method, obtainable from a Federal inspector at the port of entry, stating:

(1) That the birds will be maintained in confinement in his or her personal possession separate and apart from all birds and other birds for a minimum of 30 days following importation at the address where the birds are to be held and made available for health inspection and testing by Department inspectors upon request until released at the end of such period by such an inspector; and

(2) That appropriate Federal officials in the State of destination will be immediately notified if any signs of disease are noted in any of the birds or any birds die during that period. The owner importing such poultry must comply with the provisions of the aforementioned agreement before the birds may be released from confinement. Except for performing or theatrical birds that have been in any region where highly pathogenic avian influenza exists, performing or theatrical birds of United States origin which do not otherwise meet the requirements of paragraphs (f)(1) or (2) of this section may be offered for entry under the provisions of § 93.101(c).

(3) Any performing or theatrical birds of United States origin that have been in any region identified in accordance with § 94.6(a)(2) of this subchapter as a region where highly pathogenic avian influenza exists may only be imported through the port of Los Angeles, CA, Miami, FL, or New York, NY, and only under the following conditions:

(i) The birds meet the requirements of paragraphs (f)(1)(i) through (iii) of this section; and

(ii) The birds are accompanied by an import permit issued by APHIS; and

(iii) The birds are quarantined for a minimum of 30 days, and for such longer period as may be required by the Administrator in any specific case, at a quarantine facility maintained by APHIS in accordance with paragraphs (c)(3)(ii) through (c)(3)(iv) of this section.

(g) Any smuggled bird shall:

(1) Be refused entry into the United States and be removed from the United States, 6 or

6 Birds that would require handfeeding will be refused entry.

(2) Be quarantined in a USDA-operated quarantine facility pending negative results to two consecutive tests for highly pathogenic avian influenza and Newcastle disease 7 administered not less than 30 days apart, with the first test administered within seven days after the bird enters the facility.

7 Such tests are conducted according to protocols for highly pathogenic avian influenza and Newcastle disease which are available upon request from the Administrator.

(3) Tissue samples from any smuggled bird which has died prior to release from quarantine shall be submitted for highly pathogenic avian influenza and Newcastle disease isolation. Smuggled birds shall also be subject to such other tests and procedures to determine whether the birds are free from communicable diseases of poultry other than highly pathogenic avian influenza and Newcastle disease when the port veterinarian determine that the bird in question has shown physical symptoms of being affected with or exposed to communicable diseases of poultry. A lot of smuggled birds placed into the quarantine facility shall be handled on an “all-in, all-out” basis: Provided, That birds of endangered and threatened species, as determined by the Department of the Interior (16 U.S.C. 1533, as amended) shall be separated for quarantine and testing as separate lots. If highly pathogenic avian influenza or Newcastle disease or any other communicable disease of poultry is diagnosed in any smuggled bird at any point or if it is determined that any smuggled bird has been exposed to highly pathogenic avian influenza or Newcastle disease or any other such communicable disease, such birds shall not be released from quarantine and shall be disposed of in accordance with procedures established by the Administrator to prevent the entry of communicable diseases of livestock or poultry into the United States. However, if endangered or threatened species are determined to be exposed such birds shall be held in permanent quarantine in accordance with such conditions as the Deputy Administrator may prescribe to protect poultry of the United States. At the time any smuggled bird enters the quarantine facility, it shall be identified in a manner approved by the Administrator.

(4) If the laboratory tests for highly pathogenic avian influenza and Newcastle disease are negative and as determined by the port veterinarian the birds are free of clinical evidence of diseases of poultry at the end of the quarantine period, the port veterinarian shall issue an agricultural release for entry of the birds through the United States Customs Service at the termination of the quarantine period. Providing that the sale of the smuggled birds is not contrary to any Federal law or regulation, expenses incurred by the Department for the handling of the smuggled birds under this paragraph shall be reimbursed from funds derived from the sale or disposition of the smuggled birds after their release from quarantine. Any smuggled bird which by law may not be sold, or so disposed, shall be quarantined in accordance with such procedures as the Deputy Administrator may establish to prevent the introduction of communicable diseases of livestock or poultry into the United States, in accordance with the law.

(Approved by the Office of Management and Budget under control numbers 0579-0220 and 0579-0245)

[55 FR 31495, Aug. 2, 1990. Redesignated at 62 FR 56012, Oct. 28, 1997]

Editorial Note:For Federal Register citations affecting § 93.101, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

§ 93.102 Ports designated for the importation of birds.

(a) Special ports for pet birds. The following ports are designated as ports of entry for pet birds imported under the provisions of § 93.101(c) and performing or theatrical birds imported under the provisions of § 93.101(f): Los Angeles and San Ysidro, CA; Miami, FL; New York, NY; Baudette, MN; and Hidalgo, TX.

(b) Designation of other ports. The Secretary of the Treasury has approved the designation as quarantine stations of the ports specified in this section. In special cases other ports may be designated as quarantine stations under this section by the Administrator, with the concurrence of the Secretary of the Treasury.

(c) Notwithstanding any other provisions of this section, all commercial birds, zoological birds, or research birds shall be imported only at a port of entry specified in § 93.105.

(d) Limited ports. The following ports are designated as ports of entry for pet birds imported under the provisions of § 93.101(c)(1) or (2) and performing or theatrical birds imported under the provisions of § 93.101(f): Anchorage and Fairbanks, AK; San Diego, CA; Jacksonville, Port Canaveral, St. Petersburg-Clearwater, and Tampa, FL; Atlanta, GA; Honolulu, HI; Chicago, IL; New Orleans, LA; Baltimore, MD; Portland, ME; Minneapolis, MN; Great Falls, MT; Covington, KY (Greater Cincinnati International Airport); Portland, OR; San Juan, PR; Galveston and Houston, TX; and Seattle, Spokane, and Tacoma, WA.

[55 FR 31495, Aug. 2, 1990, as amended at 59 FR 36026, July 15, 1994; 60 FR 16045, Mar. 29, 1995; 60 FR 25120, May 11, 1995; 61 FR 68125, Dec. 27, 1996. Redesignated and amended at 62 FR 56012, 56014, Oct. 28, 1997; 65 FR 38178, June 20, 2000; 67 FR 6370, Feb. 12, 2002]

§ 93.103 Import permits for birds; and reservation fees for space at quarantine facilities maintained by APHIS.

(a) Application for permit; reservation required. Before any permit application is submitted, all construction at the quarantine facility must be completed.

(1) For pet birds, commercial birds, research birds, zoological birds, and performing or theatrical birds, intended for importation into the United States, except as otherwise provided in §§ 93.101(b) and (c), 93.103(c), and 93.107(b), the importer shall first apply for and obtain an import permit. The importer (permit applicant) shall submit a completed VS form 17-128 for ratites or hatching eggs of ratites; or, for other birds, a completed VS form 17-20; or shall submit a document that states that it is an application for a permit to import ratites, hatching eggs of ratites, or birds other than ratites or hatching eggs of ratites. The application 8 must include the following information:

8 VS import permit application forms are available from local offices of Veterinary Services, which are listed in telephone directories, from Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Riverdale, MD 20737-1231, or by visiting https://www.aphis.usda.gov/aphis/resources/sa_epermits/eauth-epermits. For other permit requirements for birds, the regulations issued by the U.S. Department of the Interior (50 CFR parts 14 and 17) should be consulted.

(i) The name, address, and telephone number of the importer;

(ii) The status of the importer, such as individual, partnership, or corporation (if incorporated, include State where incorporated and date of incorporation);

(iii) Name and address of the quarantine facility;

(iv) Date of intended quarantine;

(v) The purpose of the importation;

(vi) The region of origin;

(vii) The name and address of the exporter;

(viii) The port of embarkation in the foreign region;

(ix) The mode of transportation, route of travel, and port of entry in the United States;

(x) The name and location of the quarantine facility in the United States to which delivery will be made from the port of entry, in accordance with § 93.106(c)(5);

(xi) A drawing of the floor plan for the facility showing the location of the bird holding area; equipment storage areas; office areas; clothes storage and change areas; feed storage areas; necropsy areas (showing entry and refrigeration); washing areas for equipment; shower areas; ventilation arrangements; and entries and exits; and, for a facility for hatching eggs of ratites in which the hatching eggs of one lot may be quarantined at the same time as the hatched chicks from a previously quarantined lot, the incubation/hatcher and bird (chick) holding areas; and

(xii) Date and certification, by signature of the importer (permit applicant), after the following language:

I certify that the information provided herein is true and correct to the best of my knowledge and belief, and agree to comply with the applicable regulations in title 9, Code of Federal Regulations, §§ 93.100 through 93.107;

(xiii) In addition, the application for a permit to import ratites or hatching eggs of ratites, except for ratites and hatching eggs of ratites imported from Canada in accordance with § 93.107, shall specify the number of ratites or hatching eggs intended for importation, the size of the flock of origin, and the location of the premises where the flock of origin is kept; and shall state that, from the date of application through the date of export, APHIS representatives shall be granted access to the premises where the flock of origin is kept. (For ratites intended for importation as zoological birds, the flock of origin shall be the ratites intended for importation.)

(2)(i) An import permit will be issued only after an APHIS representative has inspected the quarantine facility identified on the permit application, and has determined that it meets the standards set forth in § 93.106(c) of this part.

(ii) An application for a permit to import pet birds, commercial birds, research birds, zoological birds, and performing or theatrical birds, may be denied or withdrawn because of: Communicable disease conditions in the area or region of origin, or in a region where the shipment has been or will be held or through which the shipment has been or will be transported; deficiencies in the regulatory programs for the control or eradication of animal diseases and the unavailability of veterinary services in the above mentioned countries; the importer's failure to provide satisfactory evidence concerning the origin, history, and health status of the animals; the lack of satisfactory information necessary to determine that the importation will not be likely to transmit any communicable disease to livestock or poultry of the United States; the lack of APHIS personnel; any outstanding debts to APHIS the permit applicant has not paid when due; or any other circumstances which the Administrator believes require such denial or withdrawal to prevent the dissemination of any communicable disease of livestock or poultry into the United States, such as if:

(A) Any requirement of this subpart is not complied with;

(B) The importer (permit applicant) or any person responsibly connected with the importer's business, any person responsibly connected with the privately owned bird quarantine facility through which the importation is intended, or, in the case of the importation of ratites or ratite hatching eggs, the operator of the flock of origin or a person responsibly connected with the owner of the flock of origin, has been convicted of any crime under any law regarding the import or export of goods, regarding the quarantine of any animal or bird, or the illegal movement of goods within a region, or involving fraud, bribery, extortion, or of any other crime involving lack of the integrity needed for the conduct of operations affecting the importation of birds;

(C) The importer (permit applicant) or any person responsibly connected with the importer's business, any person responsibly connected with the privately owned bird quarantine facility intended for use for the importation, or, in the case of the importation of ratites or ratite hatching eggs, the operator of the flock of origin or a person responsibly connected with the owner of the flock of origin, threatens to forcibly assault or forcibly assaults, intimidates, or interferes with any APHIS representative or employee in or on account of the performance of his or her official duties, unless, promptly upon the incident being brought to the importer's attention by the authorized supervisor of the APHIS representative or employee, and to the satisfaction of that supervisor, the importer justifies the incident, takes effective steps to prevent a recurrence, or provides acceptable assurance that there will not be any recurrences; or

(D) For any violation of the regulations in this subpart.

(iii) In addition, a permit to import ratites or hatching eggs of ratites, except for ratites or hatching eggs of ratites imported from Canada in accordance with § 93.107, will be denied or withdrawn unless APHIS representatives are granted access to the premises where the flock of origin is kept (or, in the case of zoological birds, to the premises where the birds are kept), from the date of the application for the permit through the date of export.

(iv) Except for ratites intended for importation as zoological birds and ratites and hatching eggs of ratites imported from Canada in accordance with § 93.107, a permit to import ratites or hatching eggs of ratites will be denied or withdrawn unless an APHIS representative has visited the premises where the flock of origin is kept within the 12-month period before the intended importation and has determined that the flock is pen-raised and contains sufficient breeding pairs to produce the number of ratites or hatching eggs intended for importation.

(v) A permit to import ratites or hatching eggs of ratites will be denied or withdrawn if an inspection of the premises of the flock or origin, carried out by the national government of the region of export under § 93.101(b)(3), indicates that the ratites and hatching eggs are not identified and marked as required under § 93.101(b)(3).

(vi) For the purposes of this section, a person shall be deemed to be responsibly connected with an importer's business, a privately owned bird quarantine facility, or an owner of a flock of origin, if such person has an ownership, mortgage, or lease interest in the physical plant of the importer's business, the privately owned bird quarantine facility, or the farm of the flock of origin, or if such person is a partner, officer, director, holder or owner of 10 per centum or more of the voting stock of the importer's business, the privately owned bird quarantine facility, or the farm of the flock of origin, or is an employee of the importer's business, the privately owned bird quarantine facility, or the owner of the flock of origin.

(vii) A permit may be denied or withdrawn at any time by the Administrator, for any of the reasons provided in paragraphs (a)(2)(ii), (iii), (iv), or (v) of this section. Before such action is taken, the importer will be informed of the reasons for the proposed action and, upon request in case of a dispute of material facts, shall be afforded an opportunity for a hearing with respect to the merits or validity of such action, in accordance with rules of practice which shall be adopted for the proceeding. However, withdrawal of a permit shall become effective pending final determination in the proceeding, when the Administrator determines that such action is necessary to protect the public health, interest, or safety. Such withdrawal shall be effective upon oral or written notification, whichever is earlier, to the importer. In the event of oral notification, written confirmation shall be given to the importer as promptly as circumstances permit. This withdrawal shall continue in effect pending the completion of the proceeding and any judicial review thereof, unless otherwise ordered by the Administrator.

(viii) If APHIS receives more than one application for a permit to import birds through a specified port of entry at approximately the same time, such that APHIS personnel could provide services to only one importer (permit applicant) who requests them, APHIS will issue the permit to the first importer who meets the requirements of this subpart to deposit, with the Administrator, the completed cooperative and trust fund agreement, accompanied by the required deposit.

(3)(i) The importer or importer's agent shall pay or ensure payment of a reservation fee for each lot of birds to be quarantined in a facility maintained by USDA. For birds the reservation fee shall be 100 percent of the cost of providing care, feed, and handling during quarantine, as estimated by the quarantine facility's veterinarian in charge.

(ii) At the time the importer or the importer's agent requests a reservation of quarantine space, the importer or importer's agent shall pay the reservation fee by check or U.S. money order or ensure payment of the reservation fee by an irrevocable letter of credit from a commercial bank (the effective date on such letter of credit shall run to 30 days after the date the birds are scheduled to be released from quarantine); except that anyone who issues a check to the Department for a reservation fee which is returned because of insufficient funds shall be denied any further request for reservation of a quarantine space until the outstanding amount is paid.

(iii) Any reservation fee paid by check or U.S. money order shall be applied against the expenses incurred for services received by the importer or importer's agent in connection with the quarantine for which the reservation was made. Any part of the reservation fee which remains unused after being applied against the expenses incurred for services received by the importer or the importer's agent in connection with the quarantine for which the reservation was made, shall be returned to the individual who paid the reservation fee. If the reservation fee is ensured by a letter of credit, the Department will draw against the letter of credit unless payment for services received by the importer or importer's agent in connection with the quarantine is otherwise made at least 3 days prior to the expiration date of the letter of credit.

(iv) Any reservation fee shall be forfeited if the importer or the importer's agent fails to present for entry, within 24 hours following the designated time of arrival, the lot of birds for which the reservation was made: Except that a reservation fee shall not be forfeited if:

(A) Written notice of cancellation from the importer or the importer's agent is received by the office of the veterinarian in charge of the quarantine facility 9 during regular business hours (8:00 a.m. to 4:30 p.m. Monday through Friday, excluding holidays) no later than 15 days for birds prior to the beginning of the time of importation as specified in the import permit or as arranged with the veterinarian in charge of the quarantine facility if no import permit is required (the 15 day period shall not include Saturdays, Sundays, or holidays), or

9 The addresses of USDA quarantine facilities may be found in telephone directories listing the facilities or by contacting the Animal and Plant Health Inspection Service, Veterinary Services, Strategy and Policy, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231.

(B) The Administrator determines that services, other than provided by carriers, necessary for the importation of the poultry or birds within the requested period are unavailable because of unforeseen circumstances as determined by the Administrator, (such as the closing of an airport due to inclement weather or the unavailability of the reserved space due to the extension of another quarantine.)

(v) If the reservation fee was ensured by a letter of credit and the fee is to be forfeited under paragraph (a)(3)(iv) of this section, the Department will draw against the letter of credit unless the reservation fee is otherwise paid at least 3 days prior to the expiration date of the letter of credit.

(vi) When a reservation is cancelled in accordance with paragraph (a)(3)(iv)(A) of this section and the provisions of paragraph (a)(3)(iv)(B) of this section do not apply, a $40.00 cancellation fee shall be charged. If a reservation fee was paid, the cancellation fee shall be deducted from any reservation fee returned to the importer or the importer's agent. If the reservation fee was ensured by a letter of credit, the Department will draw the amount of the cancellation fee against the letter of credit unless the cancellation fee is otherwise paid at least 3 days prior to the expiration date of the letter of credit.

(4) Permit applications for ratites. (i) If quarantine space for ratites is desired at either the New York Animal Import Center or the Miami Animal Import Center, permit applications must be submitted to the New York Animal Import Center, USDA, APHIS, Veterinary Services, 200 Drury Lane, Rock Tavern, NY, 12575, or to the port veterinarian in charge of the New York Animal Import Center.

(ii) Quarantine space for ratites will be offered in the order that permit applications are or have been received, beginning with those permit applications received on August 12, 1991. Reservations for quarantine space at the Miami Animal Import Center will be limited to a maximum of 100 ratites per permit application. There will be a single waiting list for quarantine space at the Miami Animal Import Center and the New York Animal Import Center. Importers who prefer one of these two facilities over the other may remain on the waiting list until space opens up at the facility of their choice.

(b) Permit. Except as provided in paragraph (c) of this section, when a permit is issued, the original and two copies will be sent to the importer. It shall be the responsibility of the importer to forward the original permit and one copy to the shipper in the region of origin, and it shall also be the responsibility of the importer to insure that the shipper presents the copy of the permit to the carrier and makes proper arrangements for the original permit to accompany the shipment to the specified U.S. port of entry for presentation to the collector of customs. The time prescribed in permits from the importation of pet birds, commercial birds, zoological birds, or research birds, shall not exceed 30 days, and for performing or theatrical birds shall not exceed 90 days. Birds for which a permit is required by these regulations will not be eligible for entry if a permit has not been issued; if unaccompanied by such a permit; if shipment is from any port other than the one designated in the permit; if arrival in the United States is at any port other than the one designated in the permit; if the birds offered for entry differ from those described in the permit.

(c) Notwithstanding any other provisions in this part, importers are not required to obtain an import permit and provide the shipper with an original import permit for each individual shipment of birds other than ratites transiting the port of Anchorage, Alaska, if the following conditions are met:

(1) The importer applies for and obtains an import permit for multiple shipments of birds transiting the port of Anchorage, Alaska, in accordance with the provisions of this section and related requirements concerning application for the permit. However, the following information is not required on the application:

(i) The species, breed, and number of birds to be imported;

(ii) The region of origin;

(iii) The name and address of the exporter;

(iv) The port of embarkation in the foreign region;

(v) The mode of transportation and the route of travel;

(vi) The proposed date of arrival of the birds; and

(vii) The name and address of the person to whom the birds or poultry will be delivered.

(2) The importer completes a copy of the import permit obtained under paragraph (c)(1) of this section for each separate shipment of birds intended to transit the port of Anchorage, Alaska, by inserting the following information on a copy of the permit:

(i) The species, breed, and number of birds to be imported;

(ii) The region of origin;

(iii) The name and address of the exporter;

(iv) The port of embarkation in the foreign region;

(v) The mode of transportation and the route of travel;

(vi) The proposed date of arrival of the birds; and

(vii) The name and address of the person to whom the birds will be delivered.

(3) The importer, not less than 2 weeks prior to the anticipated date of arrival of each separate intransit shipment of birds at the port of Anchorage, Alaska, provides the port veterinarian with a copy of the completed import permit;

(4) A copy of the completed import permit accompanies each separate intransit shipment of birds or poultry to the port of Anchorage, Alaska;

(5) Import permits issued for multiple shipments of birds transiting the port of Anchorage, Alaska, will be valid only during the calendar year in which they are issued.

(Approved by the Office of Management and Budget under control number 0579-0040)

[55 FR 31495, Aug. 2, 1990, as amended at 56 FR 31866, July 12, 1991; 57 FR 21725, May 22, 1992; 59 FR 10733, Mar. 8, 1994; 59 FR 47068, Sept. 14, 1994; 59 FR 47235, Sept. 15, 1994; 59 FR 67614, Dec. 30, 1994; 61 FR 68125, Dec. 27, 1996. Redesignated and amended at 56012, 56014, Oct. 28, 1997; 65 FR 38178, June 20, 2000; 81 FR 40151, June 21, 2016; 86 FR 45622, Aug. 16, 2021]

§ 93.104 Certificate for pet birds, commercial birds, zoological birds, and research birds.

(a) General. All pet birds, except as provided for in § 93.101 (b) and (c) of this part; all research birds; and all commercial birds and zoological birds, including ratites and hatching eggs of ratites, offered for importation from any part of the world, shall be accompanied by a certificate issued by a full-time salaried veterinary officer of the national government of the exporting region, or issued by a veterinarian authorized or accredited by the national government of the exporting region and endorsed by a full-time salaried veterinary officer of the national government of that region.

(b) Birds other than ratites. The certificate for birds other than ratites must state:

(1) That all birds covered by the certificate have been inspected by the veterinarian issuing the certificate;

(2) That no evidence of Newcastle disease, highly pathogenic avian influenza, chlamydiosis, or other communicable disease of poultry was found among the birds;

(3) That insofar as has been possible to determine, the birds were not exposed to Newcastle disease, highly pathogenic avian influenza, chlamydiosis, or other communicable disease of poultry during the 90 days immediately preceding their exportation;

(4) That the birds have not been vaccinated with a vaccine for the H5 or H7 subtype of avian influenza; however, zoological birds that have been vaccinated for avian influenza subtypes H5 or H7 as part of an official program, using vaccine products approved and used under supervision by the veterinary authorities of the exporting country, may be imported under specific conditions as determined by the Administrator and specified in an import permit. Such birds must be exported with permanent individual identification and meet the other requirements for entry under this part, and will be subject to official testing and quarantine on arrival to the United States.

(5) That highly pathogenic avian influenza or Newcastle disease did not occur anywhere on the premises from which the birds were to be exported or on adjacent premises during the 90 days immediately preceding the exportation of the birds;

(6) That neither the premises from which the birds were to be exported nor any adjacent premises were located in any area under quarantine for poultry diseases at any time during the 90 days immediately preceding the exportation of the birds, and that the birds have not originated from or been moved through a region identified in accordance with § 94.6(a) of this subchapter as a region where highly pathogenic avian influenza exists; and

(7) That the birds were placed into new or appropriately sanitized packaging materials at the premises from which the birds were to be exported.

(c) Ratites other than hatching eggs. The certificate for ratites other than hatching eggs must state:

(1) That, except as provided in paragraph (c)(13) of this section, all ratites covered by the certificate, and their flock of origin, have been inspected by the veterinarian issuing the certificate;

(2) That, except when the certificate is for zoological birds or ratites imported from Canada in accordance with § 93.107, the flock of origin is pen- raised and the ratites covered by the certificate were produced and maintained in that flock;

(3) That no evidence of Newcastle disease, highly pathogenic avian influenza, chlamydiosis, or other communicable disease of poultry was found in the flock of origin;

(4) That insofar as has been possible to determine, the flock of origin was not exposed to Newcastle disease, highly pathogenic avian influenza, chlamydiosis, or other communicable disease of poultry during the 90 days immediately preceding the exportation;

(5) That none of the ratites intended for shipment to the United States have been vaccinated with Newcastle disease vaccine or with a vaccine for the H5 or H7 subtype of avian influenza;

(6) That highly pathogenic avian influenza or Newcastle disease did not occur anywhere on the premises where the flock of origin was kept or on adjacent premises during the 90 days immediately preceding the exportation;

(7) That neither the premises where the flock of origin was kept nor any adjacent premises was located in any area under quarantine for poultry diseases at any time during the 90 days immediately preceding the exportation, and that the ratites have not originated from or been moved through a region identified in accordance with § 94.6(a) of this subchapter as a region where highly pathogenic avian influenza exists;

(8) That, except as provided in § 93.107 for ratites imported from Canada for immediate slaughter, the ratites were treated at least 3 days but not more than 14 days before being loaded for shipment to the United States with a pesticide of a type and concentration sufficient to kill ectoparasites on the ratites;

(9) That the pesticide was applied to all body surfaces of the ratites under the supervision of the veterinarian issuing the certificate;

(10) That the ratites, after being treated for ectoparasites, did not have physical contact with, or share a pen or bedding materials with, any ratite not in the same shipment to the United States; and

(11) That the ratites were placed in new or appropriately sanitized packaging materials for shipment to the United States at the premises where the flock of origin was kept.

(12) The number of ratites contained in the shipment;

(13) That the number of ratites and hatching eggs of ratites exported from the flock of origin has not exceeded the ceiling required to be established under § 93.101(b)(3)(ix);

(14) That all the ratites and hatching eggs of ratites in the flock from which the ratites come were identified in accordance with § 93.101(b)(3);

(15) Except for ratites imported from Canada in accordance with § 93.107, the number of ratite laying hens in the flock from which the ratites come;

(16) For ratites required to be treated prior to shipment with a pesticide for ectoparasites, the certificate must also state the name, concentration, and date of administration of the pesticide used to treat the ratites;

(17) When ratites intended for importation are zoological birds, only the ratites to be imported must be inspected, and the provisions in paragraphs (c)(3), (c)(4), (c)(5), (c)(6), (c)(7), and (c)(11) that apply to the flock of origin shall apply only to the ratites intended for importation.

(d) Hatching eggs of ratites. The certificate for hatching eggs of ratites must state:

(1) That the flock of origin of the hatching eggs has been inspected by the veterinarian issuing the certificate;

(2) That, except when the certificate is for hatching eggs of ratites imported from Canada in accordance with § 93.107, the flock of origin is pen- raised, and the hatching eggs covered by the certificate were produced by that flock;

(3) That no evidence of Newcastle disease, highly pathogenic avian influenza, chlamydiosis, or other communicable disease of poultry was found in the flock of origin;

(4) That insofar as has been possible to determine, the flock of origin was not exposed to Newcastle disease, highly pathogenic avian influenza, chlamydiosis, or other communicable disease of poultry during the 90 days immediately preceding the exportation of the hatching eggs;

(5) That highly pathogenic avian influenza or Newcastle disease did not occur anywhere on the premises where the flock of origin was kept or on adjacent premises during the 90 days immediately preceding the exportation of the hatching eggs;

(6) That neither the premises where the flock of origin was kept nor any adjacent premises were located in any area under quarantine for poultry diseases at any time during the 90 days immediately preceding the exportation of the hatching eggs; and

(7) That the hatching eggs were placed into new or appropriately sanitized packaging materials for shipment to the United States at the premises where the flock of origin was kept.

(8) The number of hatching eggs contained in the shipment;

(9) That the number of ratites and hatching eggs of ratites exported from the flock of origin has not exceeded the ceiling required to be established under § 93.101(b)(3)(ix);

(10) That all the ratites and hatching eggs of ratites in the flock from which the hatching eggs come were identified in accordance with § 93.101(b)(3);

(11) Except for hatching eggs of ratites imported from Canada in accordance with § 93.107, the number of ratite laying hens in the flock from which the hatching eggs come.

(Approved by the Office of Management and Budget under control number 0579-0040)

[56 FR 31866, July 12, 1991; 56 FR 41726, Aug. 22, 1991, as amended at 57 FR 28080, June 24, 1992; 59 FR 10733, Mar. 8, 1994; 59 FR 47235, Sept. 15, 1994; 61 FR 56891, Nov. 5, 1996; 61 FR 68126, Dec. 27, 1996. Redesignated and amended at 62 FR 56012, 56014, Oct. 28, 1997; 76 FR 4053, Jan. 24, 2011; 79 FR 71005, Dec. 1, 2014]

§ 93.105 Inspection at the port of entry.

(a) All commercial birds, zoological birds, and research birds, including hatching eggs of ratites, but excluding other ratites, imported into the United States, must be inspected by the port veterinarian at the Customs port of entry, which may be any international airport, or any land-border port within 20 miles of an international airport, serviced by Customs, as well as, for Canadian-origin hatching eggs of ratites, ports listed in § 93.107 (c). However, hatching eggs of ratites may be shipped, in bond, from the port of first arrival to the Customs port of entry at which they will be quarantined, for inspection, at that port.

(b) All pet birds imported from any part of the world, except pet birds from Canada and pet birds meeting the provisions of § 93.101(c)(2), shall be subjected to inspection at the Customs port of entry by a veterinary inspector of APHIS and such birds shall be permitted entry only at the ports listed in § 93.102(a). Pet birds of Canadian origin and those birds meeting the provisions of § 93.101(c)(2) shall be subject to veterinary inspection at any of the ports of entry listed in § 93.102 and 93.203.

(c) Ratites, other than hatching eggs of ratites, imported from any part of the world must be inspected at the Customs port of entry by a veterinary inspector of APHIS and, except as provided in § 93.107(b) for ratites imported from Canada, shall be permitted entry only at one of the following ports of entry:

(1) Ostriches:

(i) Up to 36 inches in height (as measured from the top of the head to the base of the feet) or 30 pounds in weight: New York, NY; Stewart Airport, Newburgh, NY; and Miami, FL.

(ii) Exceeding 36 inches in height or 30 pounds in weight: New York, NY, and Stewart Airport, Newburgh, NY.

(2) Ratites other than ostriches: New York, NY; Stewart Airport, Newburgh, NY; and Miami, FL.

[55 FR 31495, Aug. 2, 1990, as amended at 56 FR 31867, July 12, 1991; 57 FR 21726, May 22, 1992; 59 FR 36026, July 15, 1994; 59 FR 47069, Sept. 14, 1994; 61 FR 68126, Dec. 27, 1996. Redesignated and amended at 62 FR 56012, 56014, Oct. 28, 1997; 65 FR 38178, June 20, 2000]

§ 93.106 Quarantine requirements.

(a) Birds other than ratites and hatching eggs of ratites. Each lot of pet birds, except as provided for in § 93.101(c) of this part; research birds; and commercial birds and zoological birds, except ratites and hatching eggs of ratites, imported into the United States shall be quarantined for a minimum of 30 days, and for such longer period as may be required by the Administrator, in any specific case, on an “all-in, all-out” basis, at a Customs port of entry, at a USDA quarantine facility when arrangements have been made in advance by the importer and approval is granted in the permit described in § 93.103, or in facilities that meet the requirements of paragraph (c) of this section. At a USDA quarantine facility each psittacine bird shall be individually identified by the Department within 7 days of the entry of the bird into the bird quarantine facility with a serially numbered legband which has been coded to the quarantine facility or by other suitable means of identification. The identification device must be approved by the Administrator, before it shall be used to identify birds under this section. Such means of identification shall be supplied by the Department at cost to the importer. The Department shall make an identification record at the time such bird is so identified containing the species of the bird, including the common and scientific name, and the number of the identification device placed on the bird. The daily log and the identification record shall be maintained for 12 months following the date of the release of the bird from quarantine. Prior to use of a privately owned quarantine facility, a Cooperative and Trust Fund Agreement as set forth in paragraph (c)(5) of this section shall be executed by the importer and the Department and appropriate funds shall be deposited with the Administrator pursuant to the Cooperative and Trust Fund Agreement. If the birds are found free of evidence of communicable diseases of poultry during quarantine, then the port veterinarian shall issue an agriculture release for entry through U.S. Customs. If the birds are found during port of entry inspection or during quarantine, to be infected with or exposed to a communicable disease of poultry, such birds shall be refused entry or shall be held for an additional period in quarantine until determined to be free of evidence of any communicable disease, or shall be otherwise disposed of as directed by the Administrator. See also paragraph (c)(3)(ii)(E) of this section.

(b) Ratites and hatching eggs of ratites. (1) Each lot of ratites imported from any part of the world except as provided in § 93.107, shall be quarantined upon arrival for a minimum of 30 days, and for such longer period as may be required by the Administrator to determine the ratites' freedom from ectoparasites and communicable diseases. Quarantine shall be on an “all-in, all-out” basis, as described in paragraph (c)(3)(ii)(A) of this section, at the New York Animal Import Center at Newburgh, NY, when the port of entry is either New York, NY, or Stewart Airport, Newburgh, NY; or at the Miami Animal Import Center, Miami, FL, when the port of entry is Miami, FL. Reservations for space in these quarantine facilities must be made in advance of arrival and in accordance with § 93.103 of this part.

(2) Each lot of hatching eggs of ratites imported from any part of the world except as provided in § 93.107, shall be quarantined upon arrival, incubated for the full incubation period (approximately 42 days), and held in quarantine for a minimum of 30 days following the hatch of the last chick in the lot, and for such longer period as may be required by the Administrator to determine the ratites' freedom from communicable diseases. Quarantine shall be conducted at a facility that meets the requirements of paragraph (c) of this section, and in the manner prescribed by paragraph (c) of this section.

(3) During the quarantine period, the ratites, including chicks hatched in quarantine, shall be tested for viral diseases of poultry, including highly pathogenic avian influenza and Newcastle disease. If any of the ratites exhibit evidence of other communicable diseases, they will be subjected to such additional tests as may be required by the Administrator to determine their freedom from communicable diseases. Ratites other than those imported as hatching eggs also shall be treated for ectoparasites 10 by an inspector until the inspector determines that the ratites are free of ectoparasites.

10 APHIS will use an EPA registered dust formulation that contains 5 percent carbaryl as the only active ingredient. The dust formulation will be used in accordance with all applicable directions, restrictions, and precautions on the label. Treated birds may not be slaughtered for food purposes.

(4) If the ratites, including chicks hatched during quarantine, are determined to be free of communicable diseases, the port veterinarian shall issue an agricultural release for entry through U.S. Customs. If the port veterinarian finds evidence of communicable disease, or exposure to communicable disease, during port of entry inspection or quarantine of the ratites, the ratites shall be refused entry, or shall be held in quarantine until they are determined to be free of communicable disease, or shall be otherwise disposed of as directed by the Administrator.

(c) Standards for privately owned bird quarantine facilities and handling procedures for importation of birds. Before the Administrator will issue an import permit for a lot of birds, the Administrator must determine that the privately owned bird quarantine facility to be used to quarantine birds imported into the United States (the facility) and its maintenance and operation meet the minimum requirements of paragraphs (c)(1) through (c)(5) of this section, that adequate APHIS personnel are available to provide services required by the facility, and that a Cooperative and Trust Fund Agreement between the importer and the Department has been executed, and the required funds have been deposited, in accordance with that agreement. The cost of the facility and all costs associated with its maintenance and operation must be borne by the importer, in accordance with the provisions of paragraph (e) of this section.

(1) Supervision of the facility. The facility shall be maintained under the supervision of the port veterinarian at the Customs port of entry.

(2) Physical plant requirements. The facility shall comply with the following requirements:

(i) Location. Each privately owned bird quarantine facility shall be located:

(A) Within the immediate metropolitan area of the port of entry to prevent the imported birds, while in transit to the quarantine facility, from introducing or disseminating disease to domestic poultry or livestock.

(B) At least one-half mile from any concentration of avian species, such as, but not limited to, poultry processing plants, poultry or bird farms, pigeon lofts, or other bird quarantine facilities. Factors such as prevailing winds, the efficiency of the air filtration system of the quarantine facility, possible exposure to poultry or birds moving in local traffic, etc., shall be taken into consideration.

(ii) Construction. Each quarantine facility shall consist of a single, self-contained building, which shall:

(A) Be constructed only with material that can withstand continued cleaning and disinfection. All solid walls, floors, and ceilings must be constructed of impervious material. All openings to the outside must be double-screened, with an interior screen of metal or nylon mesh that is impervious to biting insects such as gnats or mosquitos, and an exterior metal screen that is rodent-proof and is made of wire, such as rabbit wire, hardware cloth, or smooth welded wire, with mesh size no larger than 1 inch × 1.5 inches (2.54 cm × 3.81 cm). The interior and exterior screens must be separated by at least 3 inches (7.62 cm);

(B) Have a bird holding area of sufficient size to prevent overcrowding of the birds in quarantine. (All access into this holding area shall be from within the building and each entryway into such area shall be equipped with self-closing, double doors: Provided, That emergency exits to the outside may exist in the bird holding area if required by local fire ordinances. Such emergency exits shall be constructed so as to permit their opening from the inside of the facility only.);

(C) Have a ventilation capacity sufficient to control moisture and odor at levels that are not injurious to the health of the birds in quarantine;

(D) Have a vermin-proof feed storage area;

(E) Have office space for recordkeeping;

(F) Have a separate necropsy room which shall have refrigerated storage space for carcasses retained for laboratory examination and facilities adequate for specimen preparation and carcass disposal;

(G) Have a separate area for washing facility equipment;

(H) Have a shower at the entrance into the area comprised of the bird holding and necropsy rooms and a clothes storage and change area at each end of the shower area;

(I) Have a storage area for equipment necessary for quarantine operations;

(J) Have equipment necessary to maintain the facility in clean and sanitary condition, including insect and pest control equipment;

(K) Have a receptacle for soiled and contaminated clothing in the clothes change area located nearest the entrance to the bird holding area;

(L) All construction must be completed before any permit application is submitted in accordance with § 93.103.

(M) An APHIS representative shall inspect the facility to determine whether the facility complies with the standards set forth in this section before any permit is issued in accordance with § 93.103. Inspections shall take place at least once each year.

(N) In addition, a facility for hatching eggs of ratites, in which the hatching eggs of one lot may be quarantined at the same time as the hatched chicks from the previously quarantined lot, shall:

(1) Have a wall or a wall with a lockable door separating the incubator/hatcher area from the bird (chick) holding area, and this wall or wall-with-door shall provide an airtight seal between the two areas, shall be impervious to water, and shall be able to withstand continued cleaning and disinfection;

(2) Have a necropsy or sample collection area in both the incubator/hatcher area and the bird (chick) holding area; and

(3) Have separate entrances, showers, toilets, and dressing room facilities for the exclusive use of personnel working in the incubator/hatcher area and the bird (chick) holding area.

(O) The bird (chick) holding area in any facility for hatching eggs of ratites shall be of a size large enough to accommodate 75 percent of the incubator capacity, with a minimum of 10 square feet per egg.

(P) If a facility for hatching eggs of ratites has a sun room, the sun room shall be connected to the chick holding area by a wall with a lockable door. This wall; the other walls, if any; and the flooring, must be impervious to water and able to withstand continued cleaning and disinfection. All walls of the sun room must be at least 8 feet high.

(1) Any of the exterior walls may be replaced by a double-screened wall set in a concrete or concrete-block curb. The double screening shall be of wire mesh or wire mesh and nylon mesh, as provided in paragraph (c)(2)(ii)(A) of this section, with the interior and exterior screens of the sun room wall separated by at least 3 inches (7.62 cm); the concrete or concrete block curb must be at least 12 inches high, impermeable to water, and able to prevent the escape of water, manure, and debris.

(2) The sun room shall have a roof, such as a double-mesh-screened roof or a glass roof, that is both impervious to free-flying birds and biting insects (such as gnats or mosquitoes) and capable of preventing contact between chicks and free-flying birds.

(3) Be attended by personnel working in the bird (chick) holding area whenever chicks are in the sun room.

(iii) Sanitation and security. Arrangements shall exist for:

(A) A supply of water adequate to meet all watering and cleaning needs.

(B) Disposal of wastes by incineration or a public sewer system which meets all applicable environmental quality control standards;

(C) Control of surface drainage onto or from the facility to prevent any disease agent from entering or escaping;

(D) Protective clothing and footwear adequate to insure that workers at the facility have clean clothing and footwear at the start of each workday and at any time such articles become soiled or contaminated;

(E) Power cleaning and disinfecting equipment with adequate capacity to disinfect the facility and equipment;

(F) Sufficient stocks of a disinfectant authorized in § 71.10(a)(5) of this chapter;

(G) A security system which prevents contact of birds in quarantine with persons not authorized entry to the facility and with other birds and animals. Such a system shall include a daily log to record the entry and exit of all persons entering the facility and controls at all doorways and other openings to the facility to prevent escape or accidental entry of birds.

(3) Operational procedures. The following procedures shall be observed at the facility at all times.

(i) Personnel. Access to the facility shall be granted only to persons working at the facility or to persons specifically granted such access by the port veterinarian.

(A) All personnel granted access to the bird holding area or the incubator/hatcher area shall:

(1) Wear clean protective clothing and footwear upon entering the bird holding area or the incubator/hatcher area;

(2) Change protective clothing and footwear when they become soiled or contaminated;

(3) Shower when entering and leaving any bird holding area, any incubator/hatcher area, and any necropsy area. Showering when moving between the incubator/hatcher area and the bird holding area is not required when the eggs in the hatching area and the chicks in the holding area are part of the same lot;

(4) Work exclusively with one lot of birds until the lot's release from quarantine, and have no contact with other birds or poultry until the release date.

(B) The importer shall handle soiled clothing worn within the quarantine unit in a manner approved by the port veterinarian as adequate to preclude transmission of a poultry disease agent from the facility.

(ii) Handling of the birds in quarantine. The birds shall be kept in the quarantine facility for a minimum of 30 days and while in quarantine shall be handled in compliance with the following requirements:

(A) Each lot of birds to be quarantined shall be placed in the facility on an “all-in, all-out” basis. No birds shall be taken out of the lot while it is in quarantine except for diagnostic purposes and if additional birds are added to a lot, the total quarantine period for that lot shall be extended so that all birds will have completed at least 30 consecutive days of quarantine before release for entry into the commerce of the United States. The quarantine period may be extended as provided in paragraph (a) of this section.

(1) Hatching eggs of ratites comprising a single lot may be added to the facility in stages, provided the entire lot has been placed in the facility no later than 15 days after the arrival of the first shipment.

(2) If hatching eggs of ratites begin to hatch in the incubator/hatcher area while ratite chicks from the previously quarantined lot remain in the bird (chick) holding area, then the separate lots assume the status of a single lot, and will be released from quarantine in accordance with paragraph (c)(3)(ii)(A) of this section.

(B) The birds may be vaccinated during quarantine only with a vaccine that has been approved by the Administrator, and is administered by a licensed veterinarian under the direct supervision of a veterinarian employed by the Animal and Plant Health Inspection Service. The Administrator will approve a vaccine if:

(1) The vaccine is licensed by the Animal and Plant Health Inspection Service in accordance with § 102.5 of this chapter; and

(2) The vaccine is not one that is used to prevent Newcastle disease, avian influenza, or any other hemagglutinating virus of poultry. 11

11 A list of approved vaccines is available from the Animal and Plant Health Inspection Service, Veterinary Services, Strategy and Policy, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231.

(C) Birds of the psittacine family shall receive a balanced, medicated feed ration treatment containing not less than 1% CTC with not more than 0.7% calcium for the entire quarantine period as a precautionary measure against chlamydiosis (psittacosis).

(D) The importer shall immediately collect all birds which die in quarantine and hold them under refrigeration, within the facility, shall account for all birds in the shipment, and shall not dispose of any carcass or parts thereof unless authorized to do so by a Veterinary Medical Officer of APHIS of the Department. Birds that die enroute to the United States or while in quarantine shall be made available at the port of entry for necropsy by a Department poultry disease diagnostician who may submit specimens from such birds for laboratory examination.

(E) During the period of quarantine, the birds shall be subjected to such tests and procedures as are required in specific cases by the port veterinarian, to determine whether the birds are free from communicable diseases of poultry and it shall be the responsibility of the importer to identify individually each psittacine bird within 7 days of the entry of the bird into the quarantine facility with a serially numbered legband which has been coded to the quarantine facility or by other suitable means of identification. Any identification device must be approved by the Administrator, upon written request to him, before it shall be used to identify birds under this section. Such means of identification shall be supplied by the importer, and the importer shall insure that each bird is so identified at the time the bird is released from the facility. If Newcastle disease or highly pathogenic avian influenza is found or detected among any birds in quarantine, all birds in the facility shall be destroyed or refused entry and the entire facility shall be thoroughly cleaned and then disinfected as directed under the supervision of an inspector.

(F) The quarantine facility from which a lot of birds has been released shall be thoroughly cleaned and disinfected with a disinfectant authorized in § 71.10(a)(5) of this chapter, under supervision of an inspector before a new lot is placed in the facility.

(iii) Records. It shall be the responsibility of the importer to maintain a current daily log for each lot of birds, recording such information as the general condition of the birds each day, source of origin of the birds in the lot, total number of birds in the lot when imported, number of dead birds when lot arrived, date lot was placed into the facility, number of deaths each day in the lot during the quarantine period, necropsy results, and laboratory findings on birds that died during the quarantine date of prescribed tests and results, Department import permit numbers of each lot, date lot was removed from the facility, and any other observations pertinent to the general health of the birds in the lot. The importer shall also make an identification record, at the time each psittacine bird is identified, containing the species of the bird, including the common and scientific name and the number of the identification device placed on each psittacine bird. The daily log and the identification record shall be maintained for 12 months following the date of release of the bird from quarantine and shall be made available to APHIS personnel upon request.

(4) Additional requirements as to location, security, physical plant and facilities, sanitation, and other items may be imposed by the Administrator, in each specific case in order to assure that the quarantine of the birds in such facility will be adequate to enable determination of their health status, prevent spread of disease among birds in quarantine, and prevent escape of poultry disease agents from the facility.

(5) Cooperative and Trust Fund Agreement for services required by importer at a privately owned bird quarantine facility.

(i) When the Administrator determines that a privately owned bird quarantine facility meets the requirements set forth in paragraph (c) of this section, the Department and the importer shall execute a Cooperative and Trust Fund Agreement, as specified in paragraph (c)(5)(iii) of this section. In conjunction with the Cooperative and Trust Fund Agreement, the importer shall deposit with the Administrator a money order or cashier's check in an amount determined by the Administrator to cover all costs incurred by the Department in providing services in accordance with the provisions of the Cooperative and Trust Fund Agreement. Any unobligated funds will, upon request, be returned to the importer, after the birds' release from quarantine.

(ii) The Administrator may provide services required by the importer at a privately owned quarantine facility for the importation of birds on a first come, first served basis, if adequate APHIS personnel are available to provide those services, upon determining that the importer has executed a Cooperative and Trust Fund Agreement, and has deposited funds in an amount determined by the Administrator to be sufficient to cover all costs incurred by the Department in providing services in accordance with that agreement, as specified in paragraph (c)(5)(iii) of this section.

(iii) Cooperative and Trust Fund Agreement.

Cooperative And Trust Fund Agreement between ______ (name of importer) and the United States Department of Agriculture, Animal and Plant Health Inspection Service.

This agreement is made and entered into by and between __________ (name of importer), hereinafter referred to as the Importer, and the U.S. Department of Agriculture, Animal and Plant Health Inspection Service, hereinafter referred to as the Service, with respect to ____________ (quarantine facility and address of facility). Whereas, the Service is authorized pursuant to the Animal Health Protection Act (7 U.S.C. 8301 et seq.) to regulate the introduction of animals into the United States in order to prevent the introduction of animal and poultry diseases into the United States; and

Whereas, the Importer is interested in the importation of certain birds from regions presently under restrictions for such importation; and

Whereas, the Importer is equipped with a bird quarantine facility that meets the requirements of paragraph (c) of this section; and

Whereas, the Importer has requested the Service to conduct inspections, perform laboratory procedures, complete examinations, and supervise the isolation, quarantine, and care and handling of birds to insure that they meet the Department's quarantine requirements before release into the United States; and

Whereas, it is the intention of the parties hereto that such cooperation shall be for their mutual benefit and the benefit of the people of the United States;

Now therefore, for and in consideration of the promises and mutual covenants herein contained, the parties hereto do hereby mutually agree with each other as follows:

(A) The Importer Agrees:

(1) To operate the quarantine facility in accordance with all Federal Laws and regulations.

(2) To provide a current list of designated personnel employed by the Importer who will be used to handle and care for birds during the quarantine period. The list will include the legal names, current residential addresses, and social security numbers of the designated personnel. The list will be furnished to the port veterinarian at the time an application for an import permit to import birds into the quarantine facility is submitted to the Service. The list will be updated for any changes in or additions to the designated personnel in advance of such personnel working in the quarantine facility.

(3) To furnish to the Service a signed statement from each of the designated personnel employed by the Importer which provides that such personnel agree that for a period of 3 days from their most recent contact with birds in the quarantine facility, such personnel will refrain from having contact with other birds and poultry. This restriction ceases to apply on the date the birds are released from quarantine.

(4) To not permit any designated personnel which the Service determines to be unfit to be employed at a quarantine facility upon written notice from the Service. Such determination shall be based upon such employee's committing or aiding and abetting in the commission of any violation of title 9, Code of Federal Regulations, part 93. The Importer further agrees to suspend any designated employee from working at a quarantine facility when the Service has reason to believe that such employee has violated any provision of title 9, Code of Federal Regulations, part 93, and the Administrator has determined that the actions of such employee constitute a severe threat to introduce or disseminate a communicable disease of poultry into the United States. Such action shall be made upon receipt of notice from the Service requiring such action by the Importer.

(5) To allow the unannounced entry into the quarantine facility of Service personnel or other persons authorized by the Service for the purpose of inspecting birds in quarantine, the operations at the quarantine facility and to ascertain compliance with the Standards for quarantine facilities and handling procedures for importation of birds contained in title 9, Code of Federal Regulations, § 93.106(c).

(6) To provide permanent restrooms in both the clean and the quarantine areas of the quarantine facility.

(7) To provide a T.V. monitoring system or a window or windows sufficient to provide a full view of the quarantine area excluding the clothes changing area.

(8) To install a communication system between the clean and quarantine areas of the quarantine facility. Such communication system shall not interfere with the maintenance of the biological security of the quarantine area.

(9) To secure all windows and any openings in the quarantine facility in a manner satisfactory to the Department which will insure the biological security of the quarantine facility and prevent the unauthorized removal of birds.

(10) To install tamperproof hasps and to install hinges on doors from which the pins cannot be removed.

(11) To install a hood with a viewing window over the necropsy table.

(12) To bag waste material in leakproof bags. Such material shall be handled in a manner that spoilage is kept to a minimum and control of pests is maintained. Such material shall be disposed of by incineration or by public sewer or other method authorized by the Administrator to prevent the spread of disease. The disposition of such material shall only be under the direction and supervision of the Service.

(13) To feed chlortetracycline to psittacine birds, upon their arrival in the facility as prescribed in § 93.106(c)(3)(ii)(C).

(14) To install an electronic security system which is coordinated through or with the local police so that monitoring of the quarantine facility is maintained whenever Service personnel are not at the facility or, in lieu of such electronic monitoring system to arrange for continuous guarding of the facility with personnel from a bonded, security company. Provided, That, if highly pathogenic avian influenza or Newcastle disease is diagnosed in any of the birds in the quarantine facility, continuous guarding of the facility with personnel from a bonded security company shall be maintained by the Importer. The electronic security system if installed shall be of the “silent type” and shall be triggered to ring at the monitoring site and not at the facility. The electronic system shall be approved by Underwriter's Laboratories.

Written instructions shall be provided to the monitoring agency which shall require that upon activation of the alarm, the police and a representative of the Service designated by the Service shall be notified by the monitoring agency. Such instructions, as well as any changes in such instructions, shall be filed in writing with the Administrator. The Importer shall notify the Service whenever a break in security occurs or is suspected of occurring.

(15) To not have non-Service personnel in the quarantine area when birds are in the quarantine facility unless Service personnel are present.

(16) To have seals of the Service placed on all entrances and exits of the facility when determined necessary by the Service and to take all necessary steps to ensure that such seals are only broken in the presence of Service personnel.

(17) To decide what the disposition of a lot of birds will be within 48 hours following official notification that such a lot is infected with or exposed to highly pathogenic avian influenza or Newcastle disease. Final disposition of the infected or exposed lot is to be accomplished within 4 working days following official notification. Disposition of the birds will be under the supervision of the Service.

(18) To furnish a telephone number or numbers to the Service at which the Importer can be reached on a daily basis or furnish the same for an agent or representative that can act and make decisions on the Importer's behalf.

(19) To deposit with the Service, upon execution of this agreement, a money order or cashier's check, in an amount determined by the Administrator to be sufficient to defray all costs incurred by the Service in providing services required. If such costs exceed the deposited amount, the importer will pay for additional costs incurred, based on official accounting records, within 14 days of receipt of the bill showing the balance due.

(20) To provide for the maintenance and operation of the quarantine facility in accordance with standards for quarantine facilities and handling procedures for importation of birds contained in title 9, Code of Federal Regulations, § 93.106(c).

(B) The Service agrees:

(1) To furnish the services of technical and/or professional personnel needed to conduct inspections, perform laboratory procedures, complete examinations, and supervise the isolation, quarantine, and care and handling of birds being imported to ensure that they meet the Department's quarantine requirements before release into the United States.

(2) To issue permits 3 working days following receipt of the permit application, depending upon the availability of personnel to provide the services required for quarantine and the results of an APHIS representative's inspection of the quarantine facility.

(3) To provide the Importer within 30 days following receipt of a written request from the Importer, with an accounting of funds expended in providing services under paragraph (B)(1) of this agreement. Any unobligated balance upon termination or expiration of this agreement shall be returned to the Importer.

(4) To inform the Importer when a diagnosis of highly pathogenic avian influenza or Newcastle disease has been made in any facility.

(5) To promptly inform the Embassy or Consulate of the foreign region to which lots of birds, refused entry into the United States due to a diagnosis of highly pathogenic avian influenza or Newcastle disease, are to be shipped.

(6) To notify in writing the Importer of any designated employee which the Service believes should be suspended from work at the quarantine facility and the basis for such action. Similar notice shall be afforded to the designated employee. Subsequent to such suspension, the designated employee shall have the right to request an immediate review of such action by the Administrator, including presenting his or her views to the Administrator in an informal conference. If the Administrator makes a final determination that grounds existed to suspend such employee, he or she shall notify the Importer and the suspended employee of his or her decision and such employee shall be discharged by the Importer.

(7) Prior to any final determination being made by the Service concerning the discharge of any designated personnel employed by the Importer, the Service will inform, in writing, the Importer and the designated personnel of the basis for such action. If such person contests such action he or she shall be permitted to present his or her views to the Administrator, provided such request is made within 30 days of the receipt of the aforementioned written notice. If a final determination is made by the Administrator that such personnel should be discharged, he or she shall notify such personnel and the Importer of such determination.

(C) It is mutually understood and agreed:

(1) That a maximum capacity will be established for each quarantine lot. This will be based upon the capacity of the quarantine facility to handle the birds. The number of birds on the permits will not exceed this capacity.

(2) If the seals referred to in paragraph (c)(5)(iii)(A)(16) of this section are broken by other than Service personnel, it will be considered a breach in security and an immediate accounting of all birds in the facility shall be made by the Service. If any birds are determined to be missing from the facility, the quarantine period will be extended for an additional 30-day period.

(3) During the performance of this cooperative work, the Importer agrees to be bound by the equal opportunity and nondiscrimination provisions as set forth in exhibit B and nonsegregation of facilities provisions as set forth in exhibit C, 12 which are attached hereto and made a part thereof.

12 Import-Export Animals Staff, Veterinary Services, APHIS, USDA, will furnish each importer with copies of exhibits B and C prior to their signing the Cooperative and Trust Fund Agreement.

(4) No member of or delegate to Congress or resident commissioner, shall be admitted to any share or part of this agreement or to any benefit to arise therefrom; but this provision shall not be construed to extend to this agreement if made with a corporation of its general benefit.

(5) This agreement shall become effective upon date of final signature and shall continue until the permitted lot of birds is released from quarantine. This agreement may be amended by agreement of the parties in writing. It may be terminated by either party upon 30 days written notice to the other party.

Date Importer Date Administrator, Animal and Plant Health Inspection Service, United States Department of Agriculture

(d) Charges for services. The charges to be borne by the importer for services provided for quarantine facilities approved in accordance with paragraph (c) of this section shall be:

(1) The appropriate GS hourly rate (including appropriate premium pay in accordance with 5 U.S.C. 5541-5549) of the employee who actually performs the service, including his or her travel time and his or her travel expenses: Provided, however, Such time and travel expense shall not exceed the time and travel expense to and from his or her official duty station;

(2) All applicable user fees, as listed in part 130 of this chapter; and

(3) A surcharge for overhead based on the most current historical data available showing the percentage of APHIS funds expended for administrative support.

(e) Requirements of other Federal laws and regulations, such as the Department's Animal Welfare Regulations in subchapter A of this chapter shall also apply as applicable to the quarantine facilities.

[55 FR 31495, Aug. 2, 1990. Redesignated at 62 FR 56012, Oct. 28, 1997]

Editorial Note:For Federal Register citations affecting § 93.106, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

§ 93.107 Special provisions.

(a) In-bond shipments from Canada. Birds from Canada transported in-bond through the United States for immediate export shall be inspected at the border port of entry and, when accompanied by an import permit obtained under § 93.103 of this part and all conditions therein are observed, shall be allowed entry into the United States and shall be otherwise handled as provided in paragraph (d) of § 93.101.

(b) Ratites from Canada. Ratites that were hatched and raised in Canada or ratites that were legally imported into Canada and, upon arrival in Canada, were quarantined for a minimum of 28 days at a Canadian quarantine facility and remained in Canada for an additional 60 days following completion of quarantine may be imported into the United States:

(1) Without being quarantined upon arrival in the United States; and

(2) At any of the following ports of entry: Anchorage, AK; Fairbanks, AK; Los Angeles, CA; San Diego, CA; Denver, CO; Miami, FL; Tampa, FL; Atlanta, GA; Eastport, ID; Chicago, IL; New Orleans, LA; Boston, MA; Baltimore, MD; Houlton, ME; Jackman, ME; Detroit, MI; Port Huron, MI; Sault Ste. Marie, MI; Minneapolis, MN; Raymond, MT; Sweetgrass, MT; Buffalo, NY; Champlain, NY; New York, NY; Stewart Airport, Newburgh, NY; Dunseith, ND; Pembina, ND; Portal, ND; Portland, OR; San Juan, PR; Houston, TX; Highgate Springs, VT; Seattle, WA; and Sumas, WA; and

(3) If offered for entry at a Canadian land border port listed in § 93.203(b), without an import permit; and

(4) If consigned directly to slaughter from the port of entry, without being treated for ectoparasites within 3 to 14 days before shipment to the United States, as otherwise required by § 93.104(c)(8); and

(5) If in compliance with all of the applicable regulations of the U.S. Fish and Wildlife Service contained in Title 50, subchapter B, of the Code of Federal Regulations.

(c) Ratite eggs from Canada. Hatching eggs of ratites that were laid in Canada may be imported into the United States:

(1) Without being quarantined upon arrival in the United States; and

(2) At any of the ports of entry listed in paragraph (b)(2) of this section or authorized by § 93.105(a); and

(3) If offered for entry at a Canadian land border port listed in § 93.203(b), without an import permit; and

(4) If in compliance with all of the applicable regulations of the U.S. Fish and Wildlife Service contained in Title 50, subchapter B, of the Code of Federal Regulations.

[55 FR 31495, Aug. 2, 1990, as amended at 61 FR 68126, Dec. 27, 1996. Redesignated and amended at 56012, 56015, Oct. 28, 1997; 65 FR 38178, June 20, 2000; 67 FR 68022, Nov. 8, 2002]

§ 93.200 Definitions.

Wherever in this subpart the following terms are used, unless the context otherwise requires, they shall be construed, respectively, to mean:

Accredited veterinarian. A veterinarian approved by the Administrator in accordance with the provisions of part 161 of this title to perform functions specified in parts 1, 2, 3, and 11 of subchapter A, and subchapters B, C, and D of this chapter, and to perform functions required by cooperative state-federal disease control and eradication programs.

Administrator. The Administrator of the Animal and Plant Health Inspection Service or any other employee of the Animal and Plant Health Inspection Service, United States Department of Agriculture, to whom authority has been or may be delegated to act in the Administrator's stead.

Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the United States Department of Agriculture (APHIS or Service).

Animals. Cattle, sheep, goats, other ruminants, swine, horses, asses, mules, zebras, dogs, and poultry.

Commercial poultry. Chickens, doves, ducks, geese, grouse, guinea fowl, partridges, pea fowl, pheasants, pigeons, quail, swans, and turkeys (including eggs for hatching) which are imported for resale, breeding, public display, or any other commercial purpose.

Communicable disease. Any contagious, infectious, or communicable disease of domestic livestock, poultry or other animals.

Department. The United States Department of Agriculture (USDA).

Fever tick. Boophilus annulatus, including, but not limited to, the varieties Americana and Australia.

Highly pathogenic avian influenza (HPAI). Highly pathogenic avian influenza is defined as follows:

(1) Any influenza virus that kills at least 75 percent of eight 4- to 6-week-old susceptible chickens within 10 days following intravenous inoculation with 0.2 mL of a 1:10 dilution of a bacteria-free, infectious allantoic fluid or inoculation of 10 susceptible 4- to 8-week-old chickens resulting in an intravenous pathogenicity index (IVPI) of greater than 1.2;

(2) Any H5 or H7 virus that does not meet the criteria in paragraph (1) of this definition, but has an amino acid sequence at the haemagglutinin cleavage site that is compatible with highly pathogenic avian influenza viruses; or

(3) Any influenza virus that is not an H5 or H7 subtype and that kills one to five out of eight inoculated chickens and grows in cell culture in the absence of trypsin within 10 days.

Immediate slaughter. Consignment directly from the port of entry to a recognized slaughtering establishment 1 and slaughter thereat within two weeks from the date of entry.

1 The name of recognized slaughtering establishments approved under this part may be obtained from the Area Veterinarian in Charge, Veterinary Services, for the State of destination of the shipment.

Inspector. An employee of the Animal and Plant Health Inspection Service authorized to perform duties required under this subpart.

Operator. For the purpose of § 93.209, any person operating an approved quarantine facility.

Performing or theatrical poultry. Poultry which are to be used in shows, theatrical acts or performances only.

Port veterinarian. A veterinarian employed by the Animal and Plant Health Inspection Service to perform duties required under this part at a port of entry.

Poultry. Chickens, doves, ducks, geese, grouse, guinea fowl, partridges, pea fowl, pheasants, pigeons, quail, swans, and turkeys (including eggs for hatching).

Quarantine facility. A USDA facility, or a private facility approved by APHIS, for the secure housing of imported birds, poultry, or other animals for specified periods.

Region. Any defined geographic land area identifiable by geological, political, or surveyed boundaries. A region may consist of any of the following:

(1) A national entity (country);

(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.)

(3) Parts of several national entities combined into an area; or

(4) A group of national entities (countries) combined into a single area.

Swine. The domestic hog and all varieties of wild hogs.

United States. All of the States of the United States, the District of Columbia, Guam, Northern Mariana Islands, Puerto Rico, the Virgin Islands of the United States, and all other Territories and Possessions of the United States.

Veterinary services. The Veterinary Services unit of the Department.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56015, Oct. 28, 1997; 79 FR 71005, Dec. 1, 2014]

§ 93.201 General prohibitions; exceptions.

(a) No poultry or product subject to the provisions of this part shall be brought into the United States except in accordance with the regulations in this part and part 94 of this subchapter; 2 nor shall any such poultry or product be handled or moved after physical entry into the United States before final release from quarantine or any other form of governmental detention except in compliance with such regulations; Provided, That, the Administrator may upon request in specific cases permit poultry or products to be brought into or through the United States under such conditions as he or she may prescribe, when he or she determines in the specific case that such action will not endanger the livestock or poultry of the United States. Unless otherwise indicated in the regulations, no live poultry, and no hatching eggs from poultry, shall be imported into the United States if the poultry have originated from a region referenced in § 94.6(a) of this subchapter where highly pathogenic avian influenza or Newcastle disease is known to exist in commercial poultry populations, have transited highly pathogenic avian influenza- or Newcastle disease-affected regions, or have been vaccinated for the H5 or H7 subtype of avian influenza.

2 Importations of certain animals from various regions are absolutely prohibited under part 94 because of specific diseases.

(b) The provisions in this part 93 relating to poultry shall not apply to healthy poultry not known to be infected with or exposed, within the 90 days preceding the date of export from the region of origin, to communicable diseases of poultry, if an import permit 3 has been obtained under § 93.204 of this chapter and all conditions therein are observed; and if such poultry are handled as follows:

3 Such permit may be obtained from the Animal and Plant Health Inspection Service, Veterinary Services, Strategy and Policy, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231. Requests for approval of such facilities should also be made to the Deputy Administrator.

(1)(i) They are maintained under continuous confinement in transit through the United States aboard an aircraft, ocean vessel, or other means of conveyance; or

(ii) Except for poultry in transit through Anchorage, Alaska, under § 93.204(c) of this part, which are not allowed to be unloaded, they are unloaded, in the course of such transit, into an animal or bird holding facility which is provided by the carrier or its agent and has been approved 4 in advance by the Administrator in accordance with paragraph (b)(3) of this section as adequate to prevent the spread within the United States of any livestock or poultry disease, and they are maintained there under continuous confinement until loaded aboard a means of conveyance for transportation from the United States and are maintained under continuous confinement aboard such means of conveyance until it leaves the United States; the import permit will specify any additional conditions necessary to assure that the transit of the poultry through the United States can be made without endangering the livestock or poultry of the United States, and that Department inspectors may inspect the poultry on board such means of conveyance or in such holding facility to ascertain whether the requirements of this paragraph are met, and dispose of them in accordance with the Animal Health Protection Act (7 U.S.C. 8301 et seq.) if such conditions are not met; and

4 See footnote 3 in subpart B.

(2) The carrier or its agent executes and furnishes to the collector of Customs at the first port of arrival a declaration stating that the poultry will be retained aboard such means of conveyance or in an approved holding facility during transshipment as required by this paragraph.

(3) Provisions for the approval of facilities required in this paragraph are:

(i) They must be sufficiently isolated to prevent direct or indirect contact with all other animals and birds while in the United States.

(ii) They must be so constructed that they provide adequate protection against environmental conditions and can be adequately cleaned, washed and disinfected.

(iii) They must provide for disposal of animal and bird carcasses, manure, bedding, waste and any related shipping materials in a manner that will prevent dissemination of disease.

(iv) They must have provisions for adequate sources of feed and water and for attendants for the care and feeding of poultry in the facility.

(v) They must comply with additional requirements as may be imposed by the Administrator if deemed applicable for a particular shipment.

(vi) They must also comply with all applicable local, State and Federal requirements for environmental quality and with the provisions of the Animal Welfare Regulations in chapter I of this title, as applicable.

(c) Performing or theatrical poultry returning to the United States. (1) Performing or theatrical poultry of United States origin that are returning to the United States from Canada or Mexico may be imported if:

(i) The poultry are found upon port of entry veterinary inspection to be free of poultry diseases; and

(ii) The poultry are accompanied by a United States veterinary health certificate issued prior to the departure of the poultry from the United States and the certificate shows the number from the leg band, tattoo, or microchip affixed to the poultry prior to departure; and

(iii) During port of entry veterinary inspection it is determined that the number from the leg band, tattoo, or microchip on the poultry is the same as the one listed on the health certificate.

(2) Except for performing or theatrical poultry that have been in any region where highly pathogenic avian influenza exists, which are subject to the provisions of paragraph (c)(3) of this section, performing or theatrical poultry of United States origin that have been outside the United States in a region other than Canada or Mexico may be imported if:

(i) The poultry meet the requirements of paragraphs (c)(1)(i) through (iii) of this section; and

(ii) The poultry are accompanied by an import permit issued by APHIS; and

(iii) The owner importing the poultry signs and furnishes to the Administrator the following:

(A) A notarized declaration under oath or affirmation (or a statement signed by the owner and witnessed by a Department inspector) stating that the poultry have not been in contact with poultry or other birds while out of the region (for example, association with other avian species at exhibitions or at aviaries); and

(B) An agreement on VS Form 17-8, obtainable from a Federal inspector at the port of entry, stating:

(1) That the poultry will be maintained in confinement in his or her personal possession separate and apart from all poultry and other birds for a minimum of 30 days following importation at the address where the poultry are to be held and made available for health inspection and testing by Department inspectors upon request until released at the end of such period by such an inspector; and

(2) That appropriate Federal officials in the State of destination will be immediately notified if any signs of disease are noted in any of the poultry or any poultry die during that period. The owner importing such poultry must comply with the provisions of the aforementioned agreement before the poultry may be released from confinement.

(3) Any performing or theatrical poultry of United States origin that have been in any region listed in § 94.6(d) of this subchapter as a region where highly pathogenic avian influenza exists may only be imported through the port of Los Angeles, CA, Miami, FL, or New York, NY, and only under the following conditions:

(i) The poultry meet the requirements of paragraphs (c)(1)(i) through (iii) of this section; and

(ii) The poultry are accompanied by an import permit issued by APHIS; and

(iii) The poultry are quarantined for a minimum of 30 days, and for such longer period as may be required by the Administrator in any specific case, at a quarantine facility maintained by APHIS in accordance with §§ 93.209 and 93.210.

(d) The provisions in this part relating to poultry shall not be applicable to performing or theatrical poultry.

(e) Pigeons, doves, and other Columbiform species that have originated from or transited regions where highly pathogenic avian influenza is considered to exist may be imported into the United States under permit and controlled conditions to approved establishments subject to all applicable requirements in this part.

(Approved by the Office of Management and Budget under control number 0579-0245)

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 56012, 56015, Oct. 28, 1997; 68 FR 6344, Feb. 7, 2003; 69 FR 25825, May 10, 2004; 76 FR 4053, Jan. 24, 2011; 79 FR 71005, Dec. 1, 2014; 86 FR 45623, Aug. 16, 2021]

§ 93.202 Inspection of certain aircraft and other means of conveyance and shipping containers thereon; unloading, cleaning, and disinfection requirements.

(a) Inspection: All aircraft and other means of conveyance (including shipping containers thereon) moving into the United States from any foreign region are subject to inspection without a warrant by properly identified and designated inspectors to determine whether they are carrying any animal, carcass, product or article regulated or subject to disposal under any law or regulation administered by the Secretary of Agriculture for prevention of the introduction or dissemination of any communicable animal disease.

(b) Unloading requirements: Whenever in the course of any such inspection at any port in the United States the inspector has reason to believe that the means of conveyance or container is contaminated with material of animal (including poultry) origin, such as, but not limited to, meat, organs, glands, extracts, secretions, fat, bones, blood, lymph, urine, or manure, so as to present a danger of the spread of any communicable animal disease, the inspector may require the unloading of the means of conveyance and the emptying of the container if he or she deems it necessary to enable him or her to determine whether the means of conveyance or container is in fact so contaminated. The principal operator of the means of conveyance and his or her agent in charge of the means of conveyance shall comply with any such requirement under the immediate supervision of, and in the time and manner prescribed by, the inspector.

(c) Cleaning and disinfection: Whenever, upon inspection under this section, an inspector determines that a means of conveyance or shipping container is contaminated with material of animal origin so as to present a danger of the spread of any communicable animal disease, he or she shall notify the principal operator of the means of conveyance or his or her agent in charge, of such determination and the requirements under this section. The person so notified shall cause the cleaning and disinfection of such means of conveyance and container under the immediate supervision of, and in the time and manner prescribed by, the inspector.

(d) For purposes of this section, the term “shipping container” means any container of a type specially adapted for use in transporting any article on the means of conveyance involved.

[55 FR 31495, Aug. 2, 1990, as amended at 59 FR 67614, Dec. 30, 1994. Redesignated and amended at 62 FR 56012, 56015, Oct. 28, 1997; 68 FR 6344, Feb. 7, 2003]

§ 93.203 Ports designated for the importation of poultry.

(a) Air and ocean ports. The following ports have APHIS inspection and quarantine facilities necessary for quarantine stations and all poultry shall be entered into the United States through these stations, except as provided in paragraphs (b), (c), (d) and (e) of this section: Los Angeles, California; Miami, Florida; and Newburgh, New York.

(b) Canadian border ports. The following land border ports are designated as having the necessary inspection facilities for the entry of poultry from Canada: Eastport, Idaho; Houlton and Jackman, Maine; Detroit, Port Huron, and Sault Ste. Marie, Michigan; Baudette, Minnesota; Opheim, Raymond, and Sweetgrass, Montana; Alexandria Bay, Buffalo, and Champlain, New York; Dunseith, Pembina, and Portal, North Dakota; Derby Line and Highgate Springs, Vermont; Oroville and Sumas, Washington.

(c) Mexican border ports. The following land border ports are designated as having the necessary inspection facilities for the entry of poultry from Mexico: Brownsville, Hidalgo, Laredo, Eagle Pass, Del Rio, Presidio, and El Paso, Texas; Douglas, Naco, Nogales, Sasabe, and San Luis, Arizona; Calexico and San Ysidro, California; and Antelope Wells, and Columbus, New Mexico.

(d) Limited ports. The following ports are designated as having inspection facilities for the entry of poultry and poultry products such as poultry test specimens, or hatching eggs and day old chicks which do not appear to require restraint and holding inspection facilities: Anchorage and Fairbanks, Alaska; San Diego, California; Jacksonville, Port Canaveral, St. Petersburg-Clearwater, and Tampa, Florida; Atlanta, Georgia; Honolulu, Hawaii; Chicago, Illinois; New Orleans, Louisiana; Portland, Maine; Baltimore, Maryland; Minneapolis, Minnesota; Great Falls, Montana; Portland, Oregon; San Juan, Puerto Rico; Galveston and Houston, Texas; and Seattle, Spokane, and Tacoma, Washington.

(e) Designation of other ports. The Secretary of the Treasury has approved the designation as quarantine stations of the ports specified in this section. In special cases other ports may be designated as quarantine stations under this section by the Administrator, with the concurrence of the Secretary of the Treasury.

[55 FR 31495, Aug. 2, 1990, as amended at 58 FR 37642, July 13, 1993; 60 FR 16045, Mar. 29, 1995; 60 FR 25120, May 11, 1995. Redesignated at 56012, Oct. 28, 1997, as amended at 65 FR 38178, June 20, 2000; 67 FR 6370, Feb. 12, 2002; 67 FR 68022, Nov. 8, 2002]

§ 93.204 Import permits for poultry and for poultry test specimens for diagnostic purposes; and reservation fees for space at quarantine facilities maintained by APHIS.

(a) Application for permit; reservation required. (1) For poultry and poultry test specimens for diagnostic screening purposes, intended for importation from any part of the world, except as otherwise provided for in §§ 93.204(c), 93.214, 93.217, and 93.218, the importer shall first apply for and obtain from APHIS an import permit. The application shall specify the name and address of the importer; the species, breed, number or quantity of poultry or poultry test specimens to be imported; the purpose of the importation; the region of origin; the name and address of the exporter; the port of embarkation in the foreign region; the mode of transportation, route of travel, and the port of entry in the United States; the proposed date of arrival of the poultry or poultry test specimens to be imported; and the name of the person to whom the poultry or poultry test specimens will be delivered and the location of the place in the United States to which delivery will be made from the port of entry. Additional information may be required in the form of certificates concerning specific diseases to which the poultry are susceptible, as well as vaccinations or other precautionary treatments to which the poultry or poultry test specimens have been subjected. Notice of any such requirement will be given to the applicant in each case.

(2) An application for permit to import poultry may also be denied because of: Communicable disease conditions in the area or region of origin, or in a region where the shipment has been or will be held or through which the shipment has been or will be transported; deficiencies in the regulatory programs for the control or eradication of animal diseases and the unavailability of veterinary services in the above mentioned regions; the importer's failure to provide satisfactory evidence concerning the origin, history, and health status of the poultry; the lack of satisfactory information necessary to determine that the importation will not be likely to transmit any communicable disease to livestock or poultry of the United States; or any other circumstances which the Administrator believes require such denial to prevent the dissemination of any communicable disease of livestock or poultry into the United States.

(3)(i) The importer or importer's agent shall pay or ensure payment of a reservation fee for each lot of poultry to be quarantined in a facility maintained by USDA. For poultry, the reservation fee shall be 100 percent of the cost of providing care, feed, and handling during quarantine, as estimated by the quarantine facility's veterinarian in charge.

(ii) At the time the importer or the importer's agent requests a reservation of quarantine space, the importer or importer's agent shall pay the reservation fee by check or U.S. money order or ensure payment of the reservation fee by an irrevocable letter of credit from a commercial bank (the effective date on such letter of credit shall run to 30 days after the date the poultry are scheduled to be released from quarantine); except that anyone who issues a check to the Department for a reservation fee which is returned because of insufficient funds shall be denied any further request for reservation of a quarantine space until the outstanding amount is paid.

(iii) Any reservation fee paid by check or U.S. money order shall be applied against the expenses incurred for services received by the importer or importer's agent in connection with the quarantine for which the reservation was made. Any part of the reservation fee which remains unused after being applied against the expenses incurred for services received by the importer or the importer's agent in connection with the quarantine for which the reservation was made, shall be returned to the individual who paid the reservation fee. If the reservation fee is ensured by a letter of credit, the Department will draw against the letter of credit unless payment for services received by the importer or importer's agent in connection with the quarantine is otherwise made at least 3 days prior to the expiration date of the letter of credit.

(iv) Any reservation fee shall be forfeited if the importer or the importer's agent fails to present for entry, within 24 hours following the designated time of arrival, the lot of poultry for which the reservation was made: Except that a reservation fee shall not be forfeited if:

(A) Written notice of cancellation from the importer or the importer's agent is received by the office of the veterinarian in charge of the quarantine facility 5 during regular business hours (8:00 a.m. to 4:30 p.m., Monday through Friday, excluding holidays) no later than 15 days prior to the beginning of the time of importation as specified in the import permit or as arranged with the veterinarian in charge of the quarantine facility if no import permit is required (the 15 day period shall not include Saturdays, Sundays, or holidays), or

5 The addresses of USDA quarantine facilities may be found in telephone directories listing the facilities or by contacting the Animal and Plant Health Inspection Service, Veterinary Services, Strategy and Policy, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231.

(B) The Administrator determines that services, other than provided by carriers, necessary for the importation of the poultry within the requested period are unavailable because of unforeseen circumstances as determined by the Administrator, (such as the closing of an airport due to inclement weather or the unavailability of the reserved space due to the extension of another quarantine).

(v) If the reservation fee was ensured by a letter of credit and the fee is to be forfeited under paragraph (a)(3)(iv) of this section, the Department will draw against the letter of credit unless the reservation fee is otherwise paid at least 3 days prior to the expiration date of the letter of credit.

(vi) When a reservation is cancelled in accordance with paragraph (a)(3)(iv)(A) of this section and the provisions of paragraph (a)(3)(iv)(B) of this section do not apply, a $40.00 cancellation fee shall be charged. If a reservation fee was paid, the cancellation fee shall be deducted from any reservation fee returned to the importer or the importer's agent. If the reservation fee was ensured by a letter of credit, the Department will draw the amount of the cancellation fee against the letter of credit unless the cancellation fee is otherwise paid at least 3 days prior to the expiration date of the letter of credit.

(b) Permit. Except as provided in paragraph (c) of this section, when a permit is issued, the original and two copies will be sent to the importer. It shall be the responsibility of the importer to forward the original permit and one copy to the shipper in the region of origin, and it shall also be the responsibility of the importer to insure that the shipper presents the copy of the permit to the carrier and makes proper arrangements for the original permit to accompany the shipment to the specified U.S. port of entry for presentation to the collector of customs. Poultry and poultry test specimens for diagnostic screening purposes for poultry intended for importation into the United States for which a permit has been issued, will be received at the specified port of entry within the time prescribed in the permit which shall not exceed 14 days from the first day that the permit is effective for all permits, except that the time prescribed in permits from the importation of poultry shall not exceed 30 days, and for performing or theatrical poultry shall not exceed 90 days. Poultry and poultry test specimens for which a permit is required by these regulations will not be eligible for entry if a permit has not been issued; if unaccompanied by such a permit; if shipment is from any port other than the one designated in the permit; if arrival in the United States is at any port other than the one designated in the permit; if the poultry or poultry test specimens offered for entry differ from those described in the permit; or if the poultry or poultry test specimens are not handled as outlined in the application for the permit and as specified in the permit issued.

(c) Notwithstanding any other provisions in this part, importers are not required to obtain an import permit and provide the shipper with an original import permit for each individual shipment of poultry or pigeons transiting the port of Anchorage, Alaska, if the following conditions are met:

(1) The importer applies for and obtains an import permit for multiple shipments of poultry or pigeons transiting the port of Anchorage, Alaska, in accordance with the provisions of this section and related requirements concerning application for the permit. However, the following information is not required on the application:

(i) The species, breed, and number of poultry or pigeons to be imported;

(ii) The individual poultry identification;

(iii) The region of origin;

(iv) The name and address of the exporter;

(v) The port of embarkation in the foreign region;

(vi) The mode of transportation and the route of travel;

(vii) The proposed date of arrival of the poultry or pigeons; and

(viii) The name and address of the person to whom the poultry or pigeons will be delivered.

(2) The importer completes a copy of the import permit obtained under paragraph (c)(1) of this section for each separate shipment of poultry or pigeons intended to transit the port of Anchorage, Alaska, by inserting the following information on a copy of the permit:

(i) The species, breed, and number of poultry or pigeons to be imported;

(ii) The region of origin;

(iii) The name and address of the exporter;

(iv) The port of embarkation in the foreign region;

(v) The mode of transportation and the route of travel;

(vi) The proposed date of arrival of the poultry or pigeons; and

(vii) The name and address of the person to whom the poultry or pigeons will be delivered.

(3) The importer, not less than 2 weeks prior to the anticipated date of arrival of each separate intransit shipment of poultry or pigeons at the port of Anchorage, Alaska, provides the port veterinarian with a copy of the completed import permit;

(4) A copy of the completed import permit accompanies each separate intransit shipment of poultry or pigeons to the port of Anchorage, Alaska;

(5) Import permits issued for multiple shipments of poultry or pigeons transiting the port of Anchorage, Alaska, will be valid only during the calendar year in which they are issued.

[55 FR 31495, Aug. 2, 1990, as amended at 59 FR 67614, Dec. 30, 1994. Redesignated and amended at 56012, 56015, Oct. 28, 1997; 86 FR 45623, Aug. 16, 2021]

§ 93.205 Certificate for live poultry and hatching eggs.

(a) Live poultry. (1) All live poultry, except eggs for hatching, offered for importation from any region of the world shall be accompanied by a certificate stating that such poultry and their flock or flocks of origin were inspected on the premises of origin immediately before the date of movement from such region and that they were then found to be free of evidence of communicable diseases of poultry. The certificate shall also state that, as far as it has been possible to determine, during the 90 days prior to movement, the poultry were not exposed to communicable diseases of poultry and the premises were not in any area under quarantine. The certificate shall also state that the poultry have not been vaccinated with a vaccine for the H5 or H7 subtype of avian influenza. The certificate shall also state that the poultry have been kept in the region from which they are offered for importation since they were hatched, or for at least 90 days immediately preceding the date of movement, that the poultry have not originated from or have been moved through a region referenced in § 94.6(a) of this subchapter as a region where any form of highly pathogenic influenza exists, and that, as far as it has been possible to determine, no case of highly pathogenic avian influenza or Newcastle disease occurred on the premises where such poultry were kept, or on adjoining premises, during that 90-day period. The certificate must also state that the birds were placed into new or appropriately sanitized packaging materials at the premises from which the birds were to be exported.

(2) Live poultry certificates accompanying pigeons, doves, and other Columbiform species that have originated from or been moved through regions where highly pathogenic avian influenza is considered to exist must additionally state that the Columbiform species have been moved and handled under conditions specified on the import permit ensuring that their movement and handling involved no direct or indirect exposure to other animals, birds, and poultry.

(b) Hatching eggs. All eggs for hatching offered for importation from any part of the world shall be accompanied by a certificate stating that the flock or flocks of origin were found upon inspection to be free from evidence of communicable diseases of poultry, the hatching eggs are from poultry that have not been vaccinated with a vaccine for the H5 or H7 subtype of avian influenza, that during the 90 days prior to movement, the flock or flocks of origin were not exposed to communicable diseases of poultry and the premises were not in any area under quarantine, and that the hatching eggs and the flock or flocks of origin have not originated in or been moved through a region referenced in accordance with § 94.6(a) of this subchapter as a region where any form of highly pathogenic avian influenza exists. The certificate must also state that the hatching eggs were placed into new or appropriately sanitized packaging materials at the premises from which the hatching eggs were to be exported.

(c) Nature of certificate. The certificate required by this section shall be issued by a salaried veterinary officer of the national government of the region of origin, or if the articles are exported from Mexico, may alternatively be issued by a veterinarian accredited by the National Government of Mexico and endorsed by a full-time salaried veterinary officer of the National Government of Mexico, thereby representing that the veterinarian issuing the certificate was authorized to do so.

[76 FR 4053, Jan. 24, 2011, as amended at 78 FR 19083, Mar. 29, 2013; 79 FR 71006, Dec. 1, 2014]

§ 93.206 Declaration and other documents for poultry.

(a) The certificates, declarations, and affidavits required by the regulations in this part shall be presented by the importer or his or her agent to the collector of customs at the port of entry, upon arrival of poultry at such port, for the use of the veterinary inspector at the port of entry.

(b) For all poultry offered for importation, the importer or his or her agent shall first present two copies of a declaration which shall list the port of entry, the name and address of the importer, the name and address of the broker, the origin of the poultry, the number, breed, species, and purpose of the importation, the name of the person to whom the poultry will be delivered, and the location of the place to which such delivery will be made.

(c) Any declaration, permit, or other document for poultry required under this subpart may be issued and presented using a U.S. Government electronic information exchange system or other authorized method.

[55 FR 31495, Aug. 2, 1990, as amended at 81 FR 40151, June 21, 2016]

§ 93.207 Inspection at the port of entry.

Inspection shall be made at the port of entry of all poultry imported from any part of the world except as provided in §§ 93.215 and 93.220. All poultry found to be free from communicable disease and not to have been exposed thereto within 90 days prior to their exportation to the United States shall be admitted subject to the other provisions in this part; all other poultry shall be refused entry. Poultry refused entry, unless exported within a time fixed in each case by the Administrator, and in accordance with other provisions he or she may require in each case for their handling shall be disposed of as the Administrator may direct. Such portions of the transporting vessel, and of its cargo, which have been exposed to any such poultry or their emanations shall be disinfected in such manner as may be considered necessary by the inspector in charge at the port of entry, to prevent the introduction or spread of livestock or poultry disease, before the cargo is allowed to land.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 56012, 56015, Oct. 28, 1997; 68 FR 6344, Feb. 7, 2003]

§ 93.208 Articles accompanying poultry.

No litter or manure, fodder or other aliment, nor any equipment such as boxes, buckets, ropes, chains, blankets, or other things used for or about poultry governed by the regulations this part, shall be landed from any conveyance except under such restrictions as the inspector in charge at the port of entry shall direct.

§ 93.209 Quarantine requirements.

(a) Poultry, other than eggs for hatching, imported, except as provided in § 93.216 of this part, shall be quarantined for not less than 30 days, counting from the date of arrival at the port of entry. During their quarantine, such poultry shall be subject to any inspections, disinfections, and tests as may be required by the Administrator, to determine their freedom from communicable diseases of poultry, and their freedom from exposure to such diseases.

(b) Poultry eggs for hatching imported, except from regions designated in § 94.6(a) of this subchapter as free of Newcastle disease and highly pathogenic avian influenza, shall be quarantined from time of arrival at the port of entry until hatched and the poultry from such eggs shall remain quarantined for not less than 30 days following hatch. During their quarantine, such eggs for hatching and poultry from such eggs shall be subject to any inspections, disinfections, and tests as may be required by the Administrator, to determine their freedom from communicable diseases of poultry.

[55 FR 31495, Aug. 2, 1990, as amended at 61 FR 56891, Nov. 5, 1996. Redesignated and amended at 62 FR 56012, 56015, Oct. 28, 1997; 76 FR 4054, Jan. 24, 2011; 78 FR 19083, Mar. 29, 2013]

§ 93.210 Poultry quarantine facilities.

(a) Privately operated quarantine facilities. The importer, or his or her agent, of poultry subject to quarantine under the regulations in this part shall arrange for acceptable transportation to the privately operated quarantine facility and for the care, feed, and handling of the poultry from the time of unloading at the quarantine port to the time of release from quarantine. Such arrangements shall be agreed to in advance by the Administrator. All expenses resulting therefrom or incident thereto shall be the responsibility of the importer; APHIS assumes no responsibility with respect thereto. The quarantine facility must be suitable for the quarantine of such poultry and must be approved by the Administrator prior to the issuance of any import permit. The facilities occupied by poultry should be kept clean and sanitary to the satisfaction of the inspector assigned to supervise the quarantine. If for any cause the care, feed, or handling of poultry, or the sanitation of the facilities, is neglected, in the opinion of the inspector assigned to supervise the quarantine, such services may be furnished by APHIS in the same manner as though arrangements had been made for such services as provided by paragraph (b) of this section, and/or the poultry may be disposed of as the Administrator, may direct, including sale in accordance with the procedure described in paragraph (b) of this section. The importer, or his or her agent, shall request in writing such inspection and other services as may be required, and shall waive all claim against the United States and APHIS or any employee of APHIS for damages which may arise from such services. The Administrator may prescribe reasonable rates for the services provided under this paragraph. When it is found necessary to extend the usual minimum quarantine period, the importer, or his or her agent, shall be so advised in writing and shall pay for such additional quarantine and other services required. Payment for all services received by the importer, or his or her agent, in connection with each separate lot of poultry shall be made by certified check or U.S. money order prior to release of the poultry. If such payment is not made, the poultry may be sold in accordance with the procedure described in paragraph (b) of this section, or otherwise disposed of as directed by the Administrator.

(b) Quarantine facilities maintained by APHIS. The importer, or his or her agent, of poultry subject to quarantine under the regulations in this part shall arrange for acceptable transportation to the quarantine facility, and for the care, feed, and handling of the poultry from the time they arrive at the quarantine port to the time of release from quarantine. Such arrangements shall be agreed to in advance by the Administrator. The importer or his or her agent shall request in writing such inspection and other services as may be required, and shall waive all claim against the United States and APHIS or any employee of APHIS, for damages which may arise from such services. All expenses resulting therefrom or incident thereto shall be the responsibility of the importer; APHIS assumes no responsibility with respect thereto. The Administrator may prescribe reasonable rates for the services provided under this paragraph. When it is found necessary to extend the usual minimum quarantine period, the importer, or his or her agent, shall be so advised in writing and shall pay for such additional quarantine and other services required. Payment for services received by the importer, or his or her agent, in connection with each separate lot of poultry shall be made by certified check or U.S. money order prior to release of the poultry. If such payment is not made, the poultry may be sold in accordance with the procedure described in this paragraph or otherwise disposed of as directed by the Administrator. When payment is not made and the poultry are to be sold to recover payment for services received, the importer, or his or her agent, will be notified by the inspector that if said charges are not immediately paid or satisfactory arrangements made for payment, the poultry will be sold at public sale to pay the expense of care, feed, and handling during that period. The sale will be held after the expiration of the quarantine period, at such time and place as may be designated by the General Services Administration or other designated selling agent. The proceeds of the sale, after deducting the charges for care, feed, and handling of the poultry and other expenses, including the expense of the sale, shall be held in a Special Deposit Account in the United States Treasury for 6 months from the date of sale. If not claimed by the importer, or his or her agent, within 6 months from the date of sale, the amount so held shall be transferred from the Special Deposit Account to the General Fund Account in the United States Treasury.

(c) Amounts collected from the importer, or his or her agent, for service rendered shall be deposited so as to be available for defraying the expenses involved in this service.

§ 93.211 Quarantine stations, visiting restricted; sales prohibited.

Visitors shall not be admitted to the quarantine enclosure during any time that poultry are in quarantine except that an importer (or his or her accredited agent or veterinarian) may be admitted to the yards and buildings containing his or her quarantined poultry at such intervals as may be deemed necessary, and under such conditions and restrictions as may be imposed, by the inspector in charge of the quarantine station. On the last day of the quarantine period, owners, officers or registry societies, and others having official business or whose services may be necessary in the removal of the poultry may be admitted upon written permission from the said inspector. No exhibition or sale shall be allowed within the quarantine grounds.

§ 93.212 Manure from quarantined poultry.

No manure shall be removed from the quarantine premises until the release of the poultry producing same.

§ 93.213 Appearance of disease among poultry in quarantine.

If any contagious disease appears among poultry during the quarantine period special precautions shall be taken to prevent spread of the infection to other poultry in the quarantine station or to those outside the grounds. The affected poultry shall be disposed of as the Administrator may direct, depending upon the nature of the disease.

§ 93.214 Import permit and declaration for poultry.

(a) For poultry intended for importation from Canada, the importer shall first apply for and obtain from APHIS an import permit as provided in § 93.204: Provided, That an import permit is not required for poultry if offered for entry at a land border port designated in § 93.203(b).

(b) For all poultry offered for importation from Canada, the importer or his or her agent shall present two copies of a declaration as provided in § 93.206.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56015, Oct. 28, 1997]

§ 93.215 Special provisions.

(a) In-bond shipments from Canada. (1) Poultry from Canada transported in-bond through the United States for immediate export shall be inspected at the border port of entry and, when accompanied by an import permit obtained under § 93.204 of this part and all conditions therein are observed, shall be allowed entry into the United States and shall be otherwise handled as provided in paragraph (b) of § 93.201. Poultry not accompanied by a permit shall meet the requirements of this part in the same manner as poultry destined for importation into the United States, except that the Administrator may permit their inspection at some other point when he or she finds that such action will not increase the risk that communicable disease of livestock and poultry will be disseminated to the livestock or poultry of the United States.

(2) In-transit shipments through Canada. Poultry originating in the United States and transported directly through Canada may re-enter the United States without Canadian health or test certificates when accompanied by copies of the United States export health certificates properly issued and endorsed in accordance with regulations in part 91 of this chapter: Provided, That, to qualify for entry, the date, time, port of entry, and signature of the Canadian Port Veterinarian that inspected the poultry for entry into Canada shall be recorded on the United States health certificate, or a document containing the information shall be included with the certificate that accompanies the poultry. In all cases it shall be determined by the veterinary inspector at the United States port of entry that the poultry are the identical poultry covered by said certificate.

(b) Exhibition poultry. Poultry from the United States which have been exhibited at the Royal Agricultural Winter Fair at Toronto or other publicly recognized expositions in Canada, including racing, rodeo, circus, or stage exhibitions in Canada, and have not been in that region for more than 90 days are eligible for return to the United States without Canadian health or test certificates, if they are accompanied by copies of the United States health certificate, issued and endorsed in accordance with the export regulations contained in part 91 of this chapter for entry into Canada: Provided, That all poultry offered for re-entry upon examination by the veterinary inspector at the U.S. port of entry, are found by the inspector to be free of communicable diseases and exposure thereto and are determined to be the identical poultry covered by said certificates or that they otherwise qualified for entry into Canada under the Canadian regulations.

(Approved by the Office of Management and Budget under control number 0579-0020)

[55 FR 31495, Aug. 2, 1990, as amended at 59 FR 67133, Dec. 29, 1994. Redesignated and amended at 62 FR 56012, 56015, Oct. 28, 1997; 81 FR 40151, June 21, 2016]

§ 93.216 Poultry from Canada.

Poultry imported from Canada is not required to meet the requirements of § 93.209 but shall meet all other requirements of this part applicable to poultry or to animals generally.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56015, Oct. 28, 1997]

§ 93.217 Import permit and declaration for poultry.

(a) For poultry intended for importation from regions of Central America or of the West Indies, the importer shall first apply for and obtain from APHIS an import permit as provided in § 93.204: Provided, That the Administrator, when he or she finds that such action may be taken without endangering the livestock or poultry industry of the United States, may, upon request by any person, authorize the importation by such person, without such application or permit, from the British Virgin Islands into the Virgin Islands of the United States, of poultry consigned for immediate slaughter, and such authorization may be limited to a particular shipment or extend to all shipments under this paragraph by such person during a specified period of time.

(b) For all poultry offered for importation from regions of Central America or of the West Indies, the importer or his or her agent shall present two copies of a declaration as provided in § 93.206.

(c) All poultry offered for importation from regions of Central America and the West Indies shall also meet the additional requirements in §§ 93.205, 93.207, 93.209, and 93.210 to qualify for entry. All poultry which fail to meet these requirements shall be rejected entry and shall be disposed of as directed by the Administrator in accordance with applicable laws.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56015, Oct. 28, 1997]

§ 93.218 Import permits and applications for inspection for poultry.

(a) For poultry intended for importation from Mexico, the importer shall first apply for and obtain from APHIS an import permit as provided in § 93.204.

(b) For poultry intended for importation into the United States from Mexico, the importer or his or her agent shall deliver to the veterinary inspector at the port of entry an application, in writing, for inspection, so that the veterinary inspector and customs representatives may make mutually satisfactory arrangements for the orderly inspection of the poultry.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56016, Oct. 28, 1997]

§ 93.219 Declaration for poultry.

For all poultry offered for importation from Mexico, the importer or his or her agent shall present two copies of a declaration as provided in § 93.206.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56016, Oct. 28, 1997]

§ 93.220 Inspection at port of entry.

(a) All poultry offered for entry from Mexico, including such poultry intended for movement through the United States in bond for immediate return to Mexico, shall be inspected at the port of entry, and all such poultry found to be free from communicable disease and fever tick infestation and not to have been exposed thereto, shall be admitted into the United States subject to the other applicable provisions of this part. Poultry found to be affected with or to have been exposed to a communicable disease, or infested with fever ticks, shall be refused entry. Poultry refused entry, unless exported within a time fixed in each case by the Administrator, shall be disposed of as said Administrator may direct.

(b) Poultry covered by paragraph (a) of this section shall be imported through ports designated in § 93.203.

[55 FR 31495, Aug. 2, 1990, as amended at 57 FR 12190, Apr. 9, 1992. Redesignated and amended at 62 FR 56012, 56016, Oct. 28, 1997]

§ 93.300 Definitions.

Wherever in this subpart the following terms are used, unless the context otherwise requires, they shall be construed, respectively, to mean:

Accredited veterinarian. A veterinarian approved by the Administrator in accordance with the provisions of part 161 of this title to perform functions specified in parts 1, 2, 3, and 11 of subchapter A, and subchapters B, C, and D of this chapter, and to perform functions required by cooperative State-Federal disease control and eradication programs.

Administrator. The Administrator of the Animal and Plant Health Inspection Service or any other employee of the Animal and Plant Health Inspection Service, United States Department of Agriculture, to whom authority has been or may be delegated to act in the Administrator's stead.

Animals. Cattle, sheep, goats, other ruminants, swine, horses, asses, mules, zebras, dogs, and poultry.

Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the United States Department of Agriculture (APHIS or Service).

APHIS representative. A veterinarian or other individual employed by the Animal and Plant Health Inspection Service, United States Department of Agriculture, who is authorized to perform the services required by this part.

Code of practice. A voluntary system of procedures designed to reduce disease spread, that is established by the veterinarians and horse industry in a region and that includes procedures for the following: Testing for and treatment of the diseases, quarantine of horses that are affected with or are suspected of being affected with the disease, certification of whether horses have been affected with or exposed to the disease, and hygiene for personnel conducting treatments and specimen collections.

Communicable disease. Any contagious, infectious, or communicable disease of domestic livestock, poultry or other animals.

Department. The United States Department of Agriculture (USDA).

Fever tick. Boophilus annulatus, including, but not limited to, the varieties Americana and Australia.

Horses. Horses, asses, mules, and zebras.

Immediate slaughter. Consignment directly from the port of entry to a recognized slaughtering establishment 1 and slaughter thereat within two weeks from the date of entry.

1 The name of recognized slaughtering establishments approved under this part may be obtained from the Area Veterinarian in Charge, Veterinary Services, for the State of destination of the shipment.

Inspector. An employee of the Animal and Plant Health Inspection Service authorized to perform duties required under this subpart.

Licensed Veterinarian. Any person licensed by any country or political subdivision thereof to practice veterinary medicine.

Lot. A group of horses that, while held on a premises or conveyance, have had opportunity for physical contact with other horses in the group or with their excrement or discharges at any time during their shipment to the United States.

Lot-holding area. That area in a permanent, privately owned quarantine facility in which a single lot of horses is held at one time.

Nonquarantine area. That area in a permanent, privately owned quarantine facility that includes offices, storage areas, and other areas outside the quarantine area, and that is off limits to horses, samples taken from horses, and any other objects or substances that have been in the quarantine area during the quarantine of horses.

Operator. A person other than the Federal Government who owns or manages and has responsibility for the services provided by a temporary, privately owned quarantine facility or a permanent, privately owned quarantine facility.

Permanent, privately owned quarantine facility. A facility that offers quarantine services for horses to the general public on a continuing basis and that is owned and operated by an entity other than the Federal Government (also permanent facility).

Persons. Any individual, corporation, company, association, firm, partnership, society or joint stock company.

Port Veterinarian. A veterinarian employed by the Animal and Plant Health Inspection Service to perform duties required under this part at a port of entry.

Quarantine area. That area in a permanent, privately owned quarantine facility that comprises all of the lot-holding areas in the facility, and any other areas in the facility that horses have access to, including loading docks for receiving and releasing horses, and any areas used to conduct examinations of horses and take samples and where samples are processed or examined.

Recognized slaughtering establishment. 2 An establishment where slaughtering operations are regularly carried on under federal or state inspection and which has been approved by the Animal and Plant Health Inspection Service to receive animals for slaughter under this part.

2 See footnote 1 of this section.

Region. Any defined geographic land area identifiable by geological, political, or surveyed boundaries. A region may consist of any of the following:

(1) A national entity (country);

(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.)

(3) Parts of several national entities combined into an area; or

(4) A group of national entities (countries) combined into a single area.

State animal health official. The State official responsible for livestock and poultry disease control and eradication programs.

Temporary, privately owned quarantine facility. A facility that offers quarantine services for horses imported for a specific event and that is owned and operated by an entity other than the Federal Government (also temporary facility).

United States. All of the States of the United States, the District of Columbia, Guam, Northern Mariana Islands, Puerto Rico, the Virgin Islands of the United States, and all other Territories and Possessions of the United States.

Veterinarian in Charge. The veterinary official of the Animal and Plant Health Inspection Service, United States Department of Agriculture, who is assigned by the Administrator to supervise and perform the official animal health work of the Animal and Plant Health Inspection Service in the State concerned.

Veterinary Services. The Veterinary Services unit of the Department.

Weanling or yearling. Any horse, weaned from its dam, that was foaled not more than 731 days prior to its being offered for entry into the United States. A horse will not be considered to be a weanling or yearling if its first permanent incisors have erupted.

[55 FR 31495, Aug. 2, 1990, as amended at 56 FR 15489, Apr. 17, 1991; 61 FR 52239, Oct. 7, 1996. Redesignated and amended at 62 FR 56012, 56016, Oct. 28, 1997; 74 FR 31595, July 2, 2009; 88 FR 63000, Sept. 14, 2023]

§ 93.301 General prohibitions; exceptions.

(a) General prohibitions. No horse or product subject to the provisions of this part shall be brought into the United States except in accordance with the regulations in this part and part 94 of this subchapter; 1 nor shall any such horse or product be handled or moved after physical entry into the United States before final release from quarantine or any other form of governmental detention except in compliance with such regulations; Provided, That, the Administrator may upon request in specific cases permit horses to be brought into or through the United States under such conditions as he or she may prescribe, when he or she determines in the specific case that such action will not endanger the livestock or poultry of the United States.

1 Importations of certain animals from various regions are absolutely prohibited under part 94 because of specific diseases.

(b) General exceptions. The provisions in this part 93 relating to horses shall not apply to healthy horses in transit through the United States if they are not known to be infected with or exposed, within 60 days preceding the date of export from the region of origin, to communicable diseases of horses if an import permit 2 has been obtained under § 93.304 of this chapter and all conditions therein are observed; and if such horses are handled as follows:

2 Such permit may be obtained from the Animal and Plant Health Inspection Service, Veterinary Services, Strategy and Policy, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231.

(1)(i) They are maintained under continuous confinement in transit through the United States aboard an aircraft, ocean vessel, or other means of conveyance; or

(ii) They are unloaded, in the course of such transit, into a horse holding facility which is provided by the carrier or its agent and has been approved 3 in advance by the Administrator in accordance with paragraph (b)(3) of this section as adequate to prevent the spread within the United States of any livestock or poultry disease, and they are maintained there under continuous confinement until loaded aboard a means of conveyance for transportation from the United States and are maintained under continuous confinement aboard such means of conveyance until it leaves the United States; the import permit will specify any additional conditions necessary to assure that the transit of the horses through the United States can be made without endangering the livestock or poultry of the United States, and that Department inspectors may inspect the horses on board such means of conveyance or in such holding facility to ascertain whether the requirements of this paragraph are met, and dispose of them in accordance with the Animal Health Protection Act (7 U.S.C. 8301 et seq.) if such conditions are not met; and

3 See footnote 2 of this section.

(2) The carrier or its agent executes and furnishes to the collector of Customs at the first port of arrival a declaration stating that the horses will be retained aboard such means of conveyance or in an approved holding facility during transshipment as required by this paragraph.

(3) Provisions for the approval of facilities required in this paragraph are:

(i) They must be sufficiently isolated to prevent direct or indirect contact with all other animals and birds while in the United States.

(ii) They must be so constructed that they provide adequate protection against environmental conditions and can be adequately cleaned, washed and disinfected.

(iii) They must provide for disposal of horse carcasses, manure, bedding, waste and any related shipping materials in a manner that will prevent dissemination of disease.

(iv) They must have provisions for adequate sources of feed and water and for attendants for the care and feeding of horses in the facility.

(v) They must comply with additional requirements as may be imposed by the Administrator if deemed applicable for a particular shipment.

(vi) They must also comply with all applicable local, State and Federal requirements for environmental quality and with the provisions of the Animal Welfare Regulations in chapter I of this title, as applicable.

(c) Specific prohibitions regarding contagious equine metritis; exceptions—(1) Importation prohibited. Except as provided in paragraph (c)(2) of this section, notwithstanding the other provisions of this part concerning the importation of horses into the United States, the importation of all horses from any region that APHIS considers to be affected with contagious equine metritis (CEM) and the importation of all horses that have been in any such region within the 12 months immediately preceding their being offered for entry into the United States is prohibited.

(i) A list of regions that APHIS considers to be affected with CEM is maintained on the APHIS website at https://www.aphis.usda.gov/animalhealth/disease-status-of-regions. Copies of the list can be available via postal mail or email upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; AskRegionalization@usda.gov.

(ii) APHIS will add a region to the list upon determining that the disease exists in the region based on reports APHIS receives of outbreaks of the disease from veterinary officials of the exporting country, from the World Organization for Animal Health (OIE), or from other sources the Administrator determines to be reliable, or upon determining that the region trades horses freely with a region in which CEM exists without testing for CEM. APHIS will remove a region from the list after conducting an evaluation of the region in accordance with § 92.2 of this subchapter and finding that the disease is not present in the region. In the case of a region formerly not on this list that is added due to an outbreak, the region may be removed from the list in accordance with the procedures for reestablishment of a region's disease-free status in § 92.4 of this subchapter.

(2) Exceptions. The provisions of paragraph (c)(1) of this section shall not apply to the following:

(i) Wild (non-domesticated) species of equidae if captured in the wild or imported from a zoo or other facility where it would be unlikely that the animal would come in contact with domesticated horses used for breeding;

(ii) Geldings;

(iii) Weanlings or yearlings that have never been used for breeding, and whose age and breeding status are certified on the import health certificate required under § 93.314(a);

(iv) Horses imported in accordance with conditions prescribed by the Administrator as provided in § 93.301(a);

(v) Spanish Pure Breed horses imported for permanent entry from Spain or thoroughbred horses imported for permanent entry from France, Germany, Great Britain (England, Scotland, and Wales), the Ireland (Republic of), or Northern Ireland if the horses meet the requirements of paragraph (d) of this section;

(vi) Stallions or mares over 731 days of age imported for permanent entry if the horses meet the requirements of paragraph (e) of this section;

(vii) Horses over 731 days of age imported into the United States for no more than 90 days to compete in specified events if the horses meet the requirements of paragraph (f)(1) of this section;

(viii) Horses over 731 days of age imported into the United States for noncompetitive public exhibition and entertainment purposes if the horses meet the requirements of paragraph (f)(2) of this section; and

(ix) Horses temporarily exported from the United States or from another region not known to be affected with CEM to a region listed under paragraph (c)(1) of this section within the 12 months immediately preceding their being offered for entry into the United States if the horses meet the requirements of paragraph (g) of this section.

(d) Spanish Pure Breed horses from Spain and thoroughbred horses from France, Germany, Great Britain (England, Scotland, and Wales), Ireland (Republic of), and Northern Ireland. (1) Spanish Pure Breed horses from Spain and thoroughbred horses from France, Germany, Great Britain (England, Scotland, and Wales), Ireland (Republic of), and Northern Ireland may be imported for permanent entry if the horses meet the following requirements:

(i) Each horse is accompanied at the time of importation by an import permit in accordance with § 93.304;

(ii) Each horse is accompanied at the time of importation by an import health certificate issued in accordance with § 93.314(a). In addition to the information required by § 93.314(a), the veterinarian signing and issuing the certificate must certify that:

(A) He or she has examined the daily records of the horse's activities maintained by the trainer and certified to be current, true, and factual by the veterinarian in charge of the training or racing stable;

(B) He or she has examined the records of the horse's activities maintained by a breed association specifically approved by the Department 4 and certified by the breed association to be current, true, and factual for the following information:

4 The following breed associations and their record systems have been approved by the Department: Asociacion Nacional de Criadores de Caballos de Pura Raza Española for Spain; Weatherby's Ltd. for Great Britain (England, Scotland, and Wales), Ireland (Republic of), and Northern Ireland; France Galop for France; and Direktorium für Vollblutzucht und Rennen e.V. for Germany.

(1) Identification of the horse by name, sex, age, breed, and all identifying marks;

(2) Identification of all premises where the horse has been since reaching 731 days of age and the dates that the horse was at such premises;

(3) For thoroughbred horses, that none of the premises where the horse has been since reaching 731 days of age are breeding premises; and

(4) For Spanish Pure Breed horses from Spain, that since reaching 731 days of age:

(i) The horse has never been on a premises that is exclusively a breeding premises;

(ii) The horse has never been bred;

(iii) Breeding of the horse has never been attempted; and

(iv) The horse has never been commingled and left unattended with adult horses of the opposite sex;

(C) He or she has compared the records maintained by the approved breed association with the records kept by the trainer and has found the information in those two sets of records to be consistent and current;

(D) For Spanish Pure Breed horses and thoroughbred horses over 731 days of age, cultures negative for CEM were obtained from three sets of specimens collected within a 12-day period from the mucosal surfaces of the clitoral fossa and the clitoral sinuses, with one set of specimens including a specimen from the surfaces of the distal cervix or endometrium, of any female horses and from the surfaces of the prepuce, the urethral sinus, the distal urethra, and the fossa glandis, including the diverticulum of the fossa glandis, of any male horses. For both male and female horses, the sets of specimens must be taken within a 12-day period with no less than 72 hours between each set, and the last of these sets of specimens must be collected within 30 days prior to exportation. All specimens required by this paragraph must be collected by a licensed veterinarian who either is, or is acting in the presence of, the veterinarian signing the certificate; and

(E) All specimens required by paragraph (d)(1)(ii)(D) of this section were received within 48 hours of collection by a laboratory approved to culture for CEM by the national veterinary service of the region of export and were accompanied by a statement indicating the date and time of their collection.

(2) If any specimen collected in accordance with paragraph (d)(1)(ii)(D) of this section is found to be positive for CEM, the horse must be treated for CEM in a manner approved by the national veterinary service of the region of export. After the treatment is completed, at least 21 days must pass before the horse will be eligible to be tested again in accordance with paragraph (d)(1)(ii)(D) of this section. All treatments performed, and the dates of the treatments, must be recorded on the health certificate.

(3) Spanish Pure Breed horses and thoroughbred horses imported under paragraph (d)(1) of this section may be released upon completion of the Federal quarantine required under § 93.308. Spanish Pure Breed horses and thoroughbred horses found positive for CEM that have been treated and retested as provided in paragraph (d)(2) of this section shall, upon completion of the Federal quarantine required under § 93.308, be consigned to an approved State listed under paragraph (h)(7) or (8) of this section, where they shall be quarantined under State or Federal supervision until the stallions have met the testing and treatment requirements of paragraph (e)(3) of this section and the mares have met the testing and treatment requirements of paragraph (e)(5) of this section.

(e) Stallions and mares over 731 days of age from CEM-affected regions. (1) Stallions or mares over 731 days of age may be imported for permanent entry from a region listed under paragraph (c)(1) of this section if the horses meet the following requirements:

(i) Each horse is accompanied at the time of importation by an import permit issued in accordance with § 93.304. The import permit must indicate that, after completion of the Federal quarantine required in § 93.308, the stallion or mare will be consigned to a State that the Administrator has approved to receive such horses in accordance with paragraph (h) of this section;

(ii) The horses are accompanied at the time of importation by an import health certificate issued in accordance with § 93.314(a);

(iii) A set of specimens must be collected from each horse within 30 days prior to the date of export by a licensed veterinarian who either is, or is acting in the presence of, the veterinarian signing the certificate. For stallions, the set of specimens consists of one culture swab from each location shall be taken from the prepuce, the urethral sinus, the distal urethra, and the fossa glandis, including the diverticulum of the fossa glandis; for mares, the specimens must be collected from the mucosal surfaces of the clitoral fossa, clitoral sinuses, and the distal cervix or endometrium in nonpregnant mares. All of the specimens collected must be cultured for CEM with negative results in a laboratory approved to culture for CEM by the national veterinary service of the region of origin;

(iv) The horses described on the certificate must not have been used for natural breeding, for the collection of semen for artificial insemination in the case of stallions, or for artificial insemination in the case of mares, from the time the specimens were collected through the date of export;

(v) All specimens required by paragraph (e)(1)(iii) of this section must be received within 48 hours of collection by a laboratory approved to culture for CEM by the national veterinary service of the region of export and must be accompanied by a statement indicating the date and time of their collection; and

(vi) If any specimen collected in accordance with paragraph (e)(1)(iii) of this section is found to be positive for CEM, the stallion or mare must be treated for CEM in a manner approved by the national veterinary service of the region of export. After the treatment is completed, at least 21 days must pass before the horse will be eligible to be tested again in accordance with paragraph (e)(1)(ii) of this section. All treatments performed, and the dates of the treatments, must be recorded on the health certificate.

(2) Post-entry. (i) Stallions and mares imported under paragraph (e)(1) of this section must complete the Federal quarantine required under § 93.308. Upon completion of the Federal quarantine, stallions must be sent to an approved State listed under paragraph (h)(7) of this section, and mares must be sent to an approved State listed under paragraph (h)(8) of this section.

(ii) Stallions and mares must be transported to the approved State in a sealed vehicle. The seal may be broken only by an APHIS representative or a State animal health official at the horse's destination. If an APHIS representative or State animal health official is unavailable to break the seal due to extenuating circumstances, the State animal health official may designate the authority to unseal to an accredited veterinarian and will assume the responsibility for oversight and recordkeeping.

(iii) Once in the approved State, the stallions or mares shall be quarantined under State or Federal supervision until the stallions have met the testing and treatment requirements of paragraph (e)(3) of this section and the mares have met the testing and treatment requirements of paragraph (e)(5) of this section.

(iv) All tests and cultures required by paragraphs (e)(3) through (e)(5) of this section shall be conducted at the National Veterinary Services Laboratories, Ames, IA, or at a laboratory approved by the Administrator in accordance with § 71.22 of this chapter to conduct CEM cultures and tests.

(v) To be eligible for CEM culture or testing, all specimens collected in accordance with paragraphs (e)(3) through (e)(5) of this section must be received by the National Veterinary Services Laboratories or the approved laboratory within 48 hours of collection and must be accompanied by a statement indicating the date and time of their collection.

(3) Testing and treatment requirements for stallions. (i) Once the stallion is in the approved State, one specimen each shall be taken from the prepuce, the urethral sinus, the distal urethra, and the fossa glandis, including the diverticulum of the fossa glandis, of the stallion by an accredited veterinarian and be cultured for CEM. After negative results have been obtained, the stallion must be test bred to two test mares that meet the requirements of paragraph (e)(4) of this section. Upon completion of the test breeding:

(A) The stallion must be treated for 5 consecutive days by thoroughly cleaning and washing (scrubbing) its prepuce, penis, including the fossa glandis, and urethral sinus while the stallion is in full erection with a solution of not less than 2 percent surgical scrub chlorhexidine and then thoroughly coating (packing) the stallion's prepuce, penis, including the fossa glandis, and urethral sinus with an ointment effective against the CEM organism. 5 The treatment shall be performed by an accredited veterinarian and monitored by a State or Federal veterinarian.

5 A list of ointments effective against the CEM organism may be obtained from Strategy and Policy, VS, APHIS, 4700 River Road Unit 39, Riverdale, MD 20737-1231.

(B) Each mare to which the stallion has been test bred shall be cultured for CEM from three sets of specimens from the mucosal surfaces of the clitoral fossa and clitoral sinuses, with one set of specimens including a specimen from either the distal cervix or endometrium, between the third and fourteenth day after breeding (for the purposes of this section, the day after the date of breeding is considered the first day after breeding), with negative results. The sets of specimens must be collected on three separate occasions within a 12-day period with no less than 72 hours between each set. A complement fixation test for CEM must be done with negative results between the twenty-first and twenty-eighth day after the breeding.

(ii) If any culture or test required by this paragraph is positive for CEM, the stallion shall be treated as described in paragraph (e)(3)(i)(A) of this section and retested by being test bred to two mares no less than 21 days after the last day of treatment.

(iii) A stallion may be released from State quarantine only if all cultures and tests of specimens from the mares used for test breeding are negative for CEM and all cultures performed on specimens taken from the stallion are negative for CEM.

(4) Requirements for test mares. (i) Mares to be used to test stallions for CEM shall be permanently identified before the mares are used for such testing with the letter “T” or other permanent identification approved by APHIS on a case-by-case basis. The marking shall be permanently applied by an inspector, a State inspector, or an accredited veterinarian who shall use a hot iron, freezemarking, a lip tattoo, or other APHIS-approved method. If a hot iron or freezemarking is used, the marking shall not be less than 2 inches (5.08 cm) high and shall be applied to the left shoulder or left side of the neck of the mare. If a lip tattoo is used, the marking shall not be less than 1 inch (2.54 cm) high and 0.75 inch (1.9 cm) wide and shall be applied to the inside surface of the upper lip of the test mare.

(ii) The test mares must be qualified prior to breeding as apparently free from CEM and may not be used for breeding from the time specimens are taken to qualify the mares as free from CEM. To qualify, each mare shall be tested with negative results by a complement fixation test for CEM, and specimens taken from each mare shall be cultured negative for CEM. Sets of specimens shall be collected on three separate occasions from the mucosal surfaces of the clitoral fossa and the clitoral sinuses, with one set of specimens including a specimen from either the distal cervix or endometrium, within a 12-day period with no less than 72 hours between each set.

(iii) A test mare that has been used to test stallions for CEM may be released from quarantine only if:

(A) The test mare is found negative for CEM on all cultures and tests required under paragraph (e)(3)(ii) of this section; or

(B) The test mare is subjected to an ovariectomy by an accredited veterinarian under the direct supervision of a State or Federal veterinarian; or

(C) The test mare is treated and handled in accordance with paragraph (e)(5) of this section; or

(D) The test mare is moved directly to slaughter without unloading en route, is euthanized, or dies.

(5) Testing and treatment requirements for mares. (i) Once the mare is in the approved State, a complement fixation test for CEM must be done, and three sets of specimens shall be collected from the mucosal surfaces of the clitoral fossa and clitoral sinuses, with one set of specimens including a specimen from the surfaces of the distal cervix or endometrium in nonpregnant mares. The sets of specimens must be collected on three separate occasions within a 12-day period with no less than 72 hours between each set. An accredited veterinarian shall collect specimens and shall submit each set of specimens to the National Veterinary Services Laboratories in Ames, IA, or to a laboratory approved by the Administrator in accordance with § 71.22 of this chapter to conduct CEM cultures and tests.

(ii) After the three sets of specimens required by paragraph (e)(5)(i) of this section have been collected, an accredited veterinarian shall manually remove organic debris from the sinuses of each mare and then flush the sinuses with a cerumalytic agent. 6

6 Recommended protocols for the flushing of sinuses may be obtained from Strategy and Policy, VS, APHIS, 4700 River Road Unit 39, Riverdale, MD 20737-1231.

(iii) For 5 consecutive days after the sinuses have been cleaned, an accredited veterinarian shall aseptically clean and wash (scrub) the external genitalia and vaginal vestibule, including the clitoral fossa, with a solution of not less than 2 percent chlorhexidine in a detergent base and then fill the clitoral fossa and sinuses, and coat the external genitalia and vaginal vestibule with an antibiotic ointment effective against the CEM organism. 7

7 A list of ointments effective against the CEM organism may be obtained from Strategy and Policy, VS, APHIS, 4700 River Road Unit 39, Riverdale, MD 20737-1231.

(iv) A mare may be released from State quarantine only if all cultures performed on specimens taken from the mare are negative for CEM.

(v) If any culture required by this paragraph is positive for CEM, the mare shall be treated as described in paragraphs (e)(5)(ii) and (e)(5)(iii) of this section. No less than 21 days after the last day of treatment, the mare shall be tested again in accordance with paragraph (e)(5)(i) of this section. If all specimens are negative for CEM, the mare may be released from quarantine.

(f) Special provisions for temporary importation for competition or entertainment purposes. (1) Horses over 731 days of age may be imported into the United States for no more than 90 days to compete in specified events provided that the conditions in paragraphs (f)(3) through (f)(12) of this section are met.

(2) Horses over 731 days of age may be temporarily imported into the United States solely for noncompetitive public exhibition and entertainment purposes provided that the conditions in paragraphs (f)(3) through (f)(12) of this section are met.

(3) At the time of importation, each horse must be accompanied by an import permit in accordance with § 93.304 and a health certificate issued in accordance with § 93.314. For horses imported in accordance with paragraph (f)(2) of this section, the health certificate must also certify that cultures negative for CEM were obtained from three sets of specimens collected from the mucosal surfaces of the clitoral fossa and clitoral sinuses, with one set of specimens including a specimen from the surfaces of the distal cervix or endometrium, of any female horses and from the surfaces of the prepuce, the urethral sinus, the distal urethra, and the fossa glandis, including the diverticulum of the fossa glandis, of any male horses. For both female and male horses, the sets of specimens must be collected on three separate occasions within a 12-day period with no less than 72 hours between each set, and the last of these sets of specimens must be collected within 30 days prior to exportation. All specimens required by this paragraph must be collected by a licensed veterinarian who either is, or is acting in the presence of, the veterinarian signing the certificate.

(4) Following the horse's arrival in the United States:

(i) A horse imported in accordance with paragraph (f)(1) of this section may remain in the United States for not more than 90 days, except as provided in paragraph (f)(9) of this section.

(ii) A horse imported in accordance with paragraph (f)(2) of this section may remain in the United States indefinitely, except as provided in paragraph (f)(9) of this section, as long as the conditions of paragraphs (f)(3) through (f)(12) of this section are met and the horse's owner or importer applies for and obtains from APHIS an import permit, as provided for in § 93.304, each year prior to the anniversary date of the horse's arrival in the United States.

(5) While the horse is in the United States, the following conditions must be met:

(i) A horse imported in accordance with paragraph (f)(2) of this section:

(A) Must not be entered in competitions.

(B) Must be regularly used in performances or exhibitions, unless sick or injured. A horse that is no longer performing or being exhibited must be exported or made eligible for permanent entry in accordance with paragraph (f)(9) of this section.

(C) Must be kept with the other horses listed on the import permit, unless otherwise approved by an APHIS representative.

(ii) Except as provided in paragraph (f)(5)(viii) of this section, the horse must be moved according to the itinerary and methods of transport specified in the import permit provided for in § 93.304.

(iii) The horse must be monitored by an accredited veterinarian or APHIS representative to ensure that the provisions of paragraphs (f)(5)(ii), (f)(5)(vi), and (f)(5)(vii) of this section are met. If the monitoring is performed by an accredited veterinarian, the Veterinarian in Charge will ensure that the accredited veterinarian is familiar with the requirements of this section and spot checks will be conducted by an APHIS representative to ensure that the requirements of this section are being met. If an APHIS representative finds that requirements are not being met, the Administrator may require that all remaining monitoring be conducted by APHIS representatives to ensure compliance.

(iv) Except when in transit, the horse must be kept on a premises that has been approved by an APHIS representative. For horses imported in accordance with paragraph (f)(1) of this section, such approval may be oral or in writing. If the approval is oral, it will be confirmed in writing by the Administrator as soon as circumstances permit. For horses imported in accordance with paragraph (f)(2) of this section, the approval will be in writing. To receive approval, the premises:

(A) Must not be a breeding premises; and

(B) Must be or contain a building or temporary structure in which the horse can be kept in a stall that is separated from other stalls that contain horses that are not listed on the import permit, either by an empty stall, by an open area across which horses cannot touch each other, or by a solid wall that is at least 8 feet (2.4 meters) high.

(v) While in transit, the horse must be moved in either an aircraft or a sealed van or trailer. If the horse is moved in a sealed van or trailer, the seal may be broken only by an APHIS representative or State animal health official at the horse's destination, except in situations where the horse's life is in danger.

(vi) Except when actually competing, performing, or being exhibited or exercised, the horse must be kept in a pasture approved by APHIS or in a stall that is separated from other stalls containing horses that are not listed on the import permit, either by an empty stall, by an open area across which horses cannot touch each other, or by a solid wall that is at least 8 feet (2.4 meters) high.

(vii) The horse may not be used for breeding purposes (including artificial insemination or semen collection) and may not have any other sexual contact with other horses. The horse may not undergo any genital examinations, except that a horse imported in accordance with paragraph (f)(2) of this section may undergo genital examinations for diagnosis or treatment of a medical condition with the prior approval of an APHIS representative.

(viii) The horse may be moved for diagnosis or treatment of a medical condition with the prior approval of an APHIS representative.

(ix) After the horse is transported anywhere in the United States, any vehicle in which the horse was transported must be cleaned and disinfected in the presence of an APHIS representative, according to the procedures specified in §§ 71.7 through 71.12 of this chapter, before any other horse is transported in the vehicle.

(x) The cleaning and disinfection specified in paragraph (f)(5)(ix) of this section must be completed before the vehicle is moved from the place where the horse is unloaded. In those cases where the facilities or equipment for cleaning and disinfection are inadequate at the place where the horse is unloaded, the Administrator may allow the vehicle to be moved to another location for cleaning and disinfection when the move will not pose a disease risk to other horses in the United States.

(xi) The owner or importer of the horse must comply with any other provisions of this part applicable to him or her.

(6) Except as provided in paragraph (f)(7) of this section, if the owner or importer wishes to change the horse's itinerary or the methods by which the horse is transported from that which he or she specified in the application for the import permit, the owner or importer must make the request for change in writing to the Administrator. Requests for change must be submitted to APHIS no less than 15 days before the proposed date of the change. Requests may be submitted to APHIS by postal mail, commercial delivery service, fax, or e-mail. The change in itinerary or method of transport may not be made without the written approval of the Administrator, who may grant the request for change when he or she determines that granting the request will not endanger other horses in the United States and that sufficient APHIS personnel are available to provide the services required by the owner or importer.

(7) In response to an emergency or other unforeseen circumstances or events (e.g., weather-related transportation delays, vehicle breakdown, medical emergencies, etc.), the horse's itinerary or methods of transportation may be changed, with the prior approval of an APHIS representative, from that which is specified in the application for an import permit. Requests for such a change may be submitted to APHIS by telephone, postal mail, commercial delivery service, fax, or e-mail. Approval may be oral or in writing. If the approval is oral, it will be confirmed in writing by the Administrator as soon as circumstances permit.

(8) The Administrator may cancel, orally or in writing, the import permit provided for under § 93.304 whenever the Administrator finds that the owner or importer of the horse has not complied with the provisions of paragraphs (f)(3) through (f)(7) of this section or any conditions imposed under those provisions. If the cancellation is oral, the Administrator will confirm the cancellation and the reasons for the cancellation in writing as soon as circumstances permit. Any person whose import permit is canceled may appeal the decision in writing to the Administrator within 10 days after receiving oral or written notification of the cancellation, whichever is earlier. If the appeal is sent by mail, it must be postmarked within 10 days after the owner or importer receives oral or written notification of the cancellation, whichever is earlier. The appeal must include all of the facts and reasons upon which the person relies to show that the import permit was wrongfully canceled. The Administrator will grant or deny the appeal in writing as promptly as circumstances permit, stating the reason for his or her decision. If there is a conflict as to any material fact, a hearing will be held to resolve the conflict. Rules of practice concerning the hearing will be adopted by the Administrator.

(9) Except in those cases where an appeal is in process, any person whose import permit is canceled must move the horse identified in the import permit out of the United States within 10 days after receiving oral or written notification of cancellation, whichever is earlier. The horse is not permitted to enter competition, perform, or be exhibited from the date the owner or importer receives the notice of cancellation until the horse is moved out of the United States or until resolution of an appeal in favor of the owner or importer. Except when being exercised, the horse must be kept, at the expense of the owner or importer, in a stall on the premises where the horse is located when the notice of cancellation is received or, if the horse is in transit when the notice of cancellation is received, on the premises where it is next scheduled to compete, perform, or be exhibited according to the import permit. The stall in which the horse is kept must be separated from other stalls containing horses that are not listed on the import permit, either by an empty stall, by an open area across which horses cannot touch each other, or by a solid wall that is at least 8 feet (2.4 meters) high. In cases where the owners of the above specified premises do not permit the horse to be kept on those premises, or when the Administrator determines that keeping the horse on the above specified premises will pose a disease risk to horses in the United States, the horse must be kept, at the expense of the owner or importer, on an alternative premises approved by the Administrator.

(10) Stallions or mares over 731 days of age that are imported in accordance with paragraphs (f)(1) or (f)(2) of this section may be eligible to remain in the United States if the following is completed:

(i) Following completion of the itinerary specified in the import permit provided for in § 93.304, the horse's owner or importer applies for and receives a new import permit that specifies that the stallion or mare will be moved to an approved State listed under paragraph (h)(7) or (8) of this section; and

(ii) The stallion or mare is transported in a sealed vehicle that has been cleaned and disinfected to an approved facility in an approved State where it is quarantined under State or Federal supervision until the stallion or mare has met the testing and treatment requirements of paragraph (e)(3) or (e)(5) of this section.

(11) All costs and charges associated with the supervision and maintenance of a horse imported under paragraphs (f)(1) or (f)(2) of this section will be borne by the horse's owner or importer. The costs associated with the supervision and maintenance of the horse by an APHIS representative at his or her usual places of duty will be reimbursed by the horse's owner or importer through user fees payable under part 130 of this chapter.

(12) In the event that an APHIS representative must be temporarily detailed from his or her usual place of duty in connection with the supervision and maintenance of a horse imported under this paragraph (f), the owner or importer of the horse must execute a trust fund agreement with APHIS to reimburse all expenses (including travel costs, salary, per diem or subsistence, administrative expenses, and incidental expenses) incurred by the Department in connection with the temporary detail. Under the trust fund agreement, the horse's owner or importer must deposit with APHIS an amount equal to the estimated cost, as determined by APHIS, for the APHIS representative to inspect the premises at which the horse will compete, perform, or be exhibited; to conduct the monitoring required by paragraph (f)(5)(iii) of this section; and to supervise the cleaning and disinfection required by paragraph (f)(5)(ix) of this section. The estimated costs will be based on the following factors:

(i) Number of hours needed for an APHIS representative to conduct the required inspection and monitoring;

(ii) For services provided during regular business hours (8 a.m. to 4:30 p.m., Monday through Saturday, except holidays), the average salary, per hour, for an APHIS representative;

(iii) For services provided outside regular business hours, the applicable rate for overtime, night differential, or Sunday or holiday pay, based on the average salary, per hour, for an APHIS representative;

(iv) Number of miles from the premises at which the horse competes, performs, or is exhibited to the APHIS office or facility that is monitoring the activities;

(v) Government rate per mile for automobile travel or, if appropriate, cost of other means of transportation between the premises at which the horse competes, performs, or is exhibited and the APHIS office or facility;

(vi) Number of trips between the premises at which the horse competes, performs, or is exhibited and the APHIS office or facility that APHIS representatives are required to make in order to conduct the required inspection and monitoring;

(vii) Number of days the APHIS representative conducting the inspection and monitoring must be in “travel status”;

(viii) Applicable Government per diem rate; and

(ix) Cost of related administrative support services.

(13) If a trust fund agreement with APHIS has been executed by the owner or importer of a horse in accordance with paragraph (f)(12) of this section and APHIS determines, during the horse's stay in the United States, that the amount deposited will be insufficient to cover the services APHIS is scheduled to provide during the remainder of the horse's stay, APHIS will issue to the horse's owner or importer a bill to restore the deposited amount to a level sufficient to cover the estimated cost to APHIS for the remainder of the horse's stay in the United States. The horse's owner or importer must pay the amount billed within 14 days after receiving the bill. If the bill is not paid within 14 days after its receipt, APHIS will cease to perform the services provided for in paragraph (f)(5) of this section until the bill is paid. The Administrator will inform the owner or importer of the cessation of services orally or in writing. If the notice of cessation is oral, the Administrator will confirm, in writing, the notice of cessation and the reason for the cessation of services as soon as circumstances permit. In such a case, the horse must be kept, at the expense of the owner or importer and until the bill is paid, in a stall either on the premises at which the horse is located when the notice of cessation of services is received or, if the horse is in transit when the notice of cessation of services is received, on the premises at which it is next scheduled to compete, perform, or be exhibited according to the import permit. The stall in which the horse is kept must be separated from other stalls containing horses that are not listed on the import permit, either by an empty stall, by an open area across which horses cannot touch each other, or by a solid wall that is at least 8 feet (2.4 meters) high. In cases where the owners of the premises where the horse would be kept following a cessation of services do not permit the horse to be kept on those premises, or when the Administrator determines that keeping the horse on the premises will pose a disease risk to other horses in the United States, the horse must be kept, at the expense of the owner or importer, on an alternative premises approved by the Administrator. Until the bill is paid, the horse is not permitted to enter competition, perform, or be exhibited. Any amount deposited in excess of the costs to APHIS to provide the required services will be refunded to the horse's owner or importer.

(g) Special provisions for the importation of horses that have been temporarily exported to a CEM-affected region. If a horse originating from the United States has been temporarily exported for not more than 90 days to a CEM-affected region listed under paragraph (c)(1) of this section and returns to the United States during that time, or if a horse originating from a non-CEM affected region has been temporarily exported for not more than 90 days to a CEM-affected region during the 12 months preceding its proposed importation to the United States, the horse may be eligible for return, or for importation into the United States, without meeting the requirements of paragraphs (d) through (f) of this section, under the following conditions:

(1) The horse must be accompanied by a certificate that meets the requirements of § 93.314(a) of this part issued by each CEM-affected region that the horse has visited during the term of its temporary exportation, and each certificate must contain the following additional declarations:

(i) That the horse was held separate and apart from all other horses except for the time it was actually participating in an event or was being exercised by its trainer;

(ii) That the premises on which the horse was held were not used for any equine breeding purpose;

(iii) That breeding of the horse, either live or artificial, has never been attempted, nor has the horse had any other sexual contact or genital examination while in such region; and

(iv) That all transport while in such region was carried out in cleaned and disinfected vehicles in which no other horses were transported since such cleaning and disinfection;

(2) The horse is accompanied by an import permit issued in accordance with § 93.304 of this part at the time of exportation;

(3) If the horse was temporarily exported from the United States and is being returned to the United States, the horse must be accompanied by a copy of the United States health certificate issued for its exportation from the United States and endorsed in accordance with the export regulations in part 91 of this chapter;

(4) The horse must be examined by an inspector at the U.S. port of entry and found by the inspector to be the identical horse covered by the documents required by paragraphs (g)(1) through (3) of this section and found by the inspector to be free of communicable disease and exposure thereto; and

(5) The horse must be quarantined and tested at the U.S. port of entry as provided in § 93.308 of this part prior to release.

(h) Approval of States. In order for a State to be approved to receive stallions or mares over 731 days of age from a CEM-affected region listed under paragraph (c)(1) of this section that are imported under paragraph (e) of this section, the State must meet the following conditions:

(1) The State must enter into a written agreement with the Administrator, whereby the State agrees to enforce its laws and regulations to control CEM and to abide by the conditions of approval established by the regulations in this part.

(2) The State must agree to quarantine all stallions and mares over 731 days of age imported under the provisions of paragraph (e) of this section until the stallions have been treated in accordance with paragraph (e)(3) of this section and the mares have been treated in accordance with paragraph (e)(5) of this section.

(3) The State must agree to quarantine all mares used to test stallions for CEM until the mares have been released from quarantine in accordance with paragraph (e)(4) of this section.

(4) The State must agree to provide oversight during the test breeding of quarantined stallions.

(5) The State must have laws or regulations requiring that stallions over 731 days of age imported under paragraph (e) of this section be treated in the manner specified in paragraph (e)(3) of this section, and that mares over 731 days of age imported under paragraph (e) of this section be treated in the manner specified in paragraph (e)(5) of this section.

(6) Approval of any State to receive stallions or mares imported from regions affected with CEM may be suspended by the Administrator upon his or her determination that any requirements of this section are not being met. After such action is taken, the animal health authorities of the approved State will be informed of the reasons for the action and afforded an opportunity to present their views thereon before such suspension is finalized; however, such suspension of approval shall continue in effect unless otherwise ordered by the Administrator. In those instances where there is a conflict as to the facts, a hearing shall be held to resolve such conflict.

(7) A list of States approved by APHIS to receive stallions over 731 days of age imported under paragraph (e) of this section is maintained on the APHIS website at www.aphis.usda.gov/aphis/ourfocus/importexport/animal-import-and-export/equine. Copies of the list will also be available via postal mail, fax, or email upon request to Live Animal Imports, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road Unit 38, Riverdale, MD 20737.

(8) A list of States approved by APHIS to receive mares over 731 days of age imported under paragraph (e) of this section is maintained on the APHIS website at www.aphis.usda.gov/aphis/ourfocus/importexport/animal-import-and-export/equine. Copies of the list will also be available via postal mail, fax, or email upon request to Live Animal Imports, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road Unit 38, Riverdale, MD 20737.

(Approved by the Office of Management and Budget under control numbers 0579-0040, 0579-0165, 0579-0324, and 0579-0485)

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56016, Oct. 28, 1997]

Editorial Note:For Federal Register citations affecting § 93.301, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

§ 93.302 Inspection of certain aircraft and other means of conveyance and shipping containers thereon; unloading, cleaning, and disinfection requirements.

(a) Shipping container requirements. Shipping containers used to transport live equine(s) to the United States must meet the following requirements:

(1) Containers must be new or cleaned and disinfected in a manner that sufficiently reduces the risk of introduction or dissemination of any pests or diseases of livestock into the United States.

(2) Containers must be of sufficient size and construction to reasonably assure that live equine(s) are transported safely.

(3) Stocking density of live equine(s) must not be to an extent that impinges on the animals' safety during transportation.

(4) Guidance on how to meet these requirements may be found in the Live Animals Regulations (LAR), as amended, published by the International Air Transport Association (IATA) or the Terrestrial Animal Health Code published by the World Organization for Animal Health (WOAH). The Administrator may also approve alternative guidance than that described in the LAR or the Terrestrial Animal Health Code.

(b) Inspection: All aircraft and other means of conveyance (including shipping containers thereon) moving into the United States from any foreign region are subject to inspection without a warrant by properly identified and designated inspectors to determine whether they are carrying any animal, carcass, product or article regulated or subject to disposal under any law or regulation administered by the Secretary of Agriculture for prevention of the introduction or dissemination of any communicable animal disease.

(c) Unloading requirements: Whenever in the course of any such inspection at any port in the United States the inspector has reason to believe that the means of conveyance or container is contaminated with material of animal (including poultry) origin, such as, but not limited to, meat, organs, glands, extracts, secretions, fat, bones, blood, lymph, urine, or manure, so as to present a danger of the spread of any communicable animal disease, the inspector may require the unloading of the means of conveyance and the emptying of the container if he or she deems it necessary to enable him or her to determine whether the means of conveyance or container is in fact so contaminated. The principal operator of the means of conveyance and his or her agent in charge of the means of conveyance shall comply with any such requirement under the immediate supervision of, and in the time and manner prescribed by, the inspector.

(d) Cleaning and disinfection: Whenever, upon inspection under this section, an inspector determines that a means of conveyance or shipping container is contaminated with material of animal origin so as to present a danger of the spread of any communicable animal disease, he or she shall notify the principal operator of the means of conveyance or his or her agent in charge, of such determination and the requirements under this section. The person so notified shall cause the cleaning and disinfection of such means of conveyance and container under the immediate supervision of, and in the time and manner prescribed by, the inspector.

(e) Shipping container. For purposes of this section, the term “shipping container” means any container of a type specially adapted for use in transporting any article on the means of conveyance involved.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56016, Oct. 28, 1997; 68 FR 6344, Feb. 7, 2003; 88 FR 63001, Sept. 14, 2023]

§ 93.303 Ports designated for the importation of horses.

(a) Air and ocean ports. The following ports have APHIS inspection and quarantine facilities necessary for quarantine stations and all horses shall be entered into the United States through the following station(s), except as provided in paragraphs (b), (c), (d), (e), and (f) of this section, §§ 93.308(a), (b) and (c) and 93.317: Newburgh, New York.

(b) Canadian border ports. Land border ports designated for the entry of horses from Canada may be found on the APHIS website at www.aphis.usda.gov/aphis/ourfocus/importexport/animal-import-and-export/equine. Changes to the list of approved ports will be announced through notices published in the Federal Register.

(c) Mexican border ports. Land border ports designated for the entry of horses from Mexico may be found on the APHIS website at www.aphis.usda.gov/aphis/ourfocus/importexport/animal-import-and-export/equine. Changes to the list of approved ports will be announced through notices published in the Federal Register.

(d) Limited ports. Certain ports are designated as having inspection facilities for the entry of horses and horse products such as horse test specimens which do not appear to require restraint and holding inspection facilities. These ports may be found on the APHIS website at www.aphis.usda.gov/aphis/ourfocus/importexport/animal-import-and-export/equine. Changes to the list of approved ports will be announced through notices published in the Federal Register.

(e) Ports for horses to be quarantined at privately owned quarantine facilities. Horses, except horses from or which have transited any region in which African horsesickness is declared to exist, 1 may be entered into the United States at any port specified in paragraph (a) of this section, or at any other port designated as an international port or airport by the U.S. Customs Service and quarantined at privately owned quarantine facilities provided that applicable provisions of §§ 93.301(c), 93.304(a), 93.306, 93.308(a), (b) and (c), and 93.314 are met. These ports may be found on the APHIS website at www.aphis.usda.gov/aphis/ourfocus/importexport/animal-import-and-export/equine.

1 Information as to the regions where African horsesickness is declared to exist may be obtained from the Administrator.

(f) Designation of other ports. The Secretary of the Treasury has approved the designation as quarantine stations of the ports specified in this section. In special cases other ports may be designated as quarantine stations under this section by the Administrator, with the concurrence of the Secretary of the Treasury.

[55 FR 31495, Aug. 2, 1990. Redesignated at 62 FR 56012, Oct. 28, 1997]

Editorial Note:For Federal Register citations affecting § 93.303, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

§ 93.304 Import permits for horses and for horse specimens for diagnostic purposes; reservation fees for space at quarantine facilities maintained by APHIS.

(a) Application for permit; reservation required. (1)(i) For horses from or transiting regions listed in § 93.301(c)(1) of the regulations, horses intended for quarantine at a Federal quarantine or privately owned quarantine facility, and horse test specimens for diagnostic screening purposes, intended for importation from any part of the world, the importer shall first apply for and obtain from APHIS an import permit. The application shall specify the name and address of the importer; the species, breed, number or quantity of horses or horse test specimens to be imported; the purpose of the importation; individual horse identification which includes a description of the horse, name, age, markings, if any, registration number, if any, and tattoo or eartag; the region of origin; the name and address of the exporter; the port of embarkation in the foreign region; the mode of transportation, route of travel, and the port of entry in the United States; the proposed date of arrival of the horses or horse test specimens to be imported; and the name of the person to whom the horses or horse test specimens will be delivered and the location of the place in the United States to which delivery will be made from the port of entry. Additional information may be required in the form of certificates concerning specific diseases to which the horses are susceptible, as well as vaccinations or other precautionary treatments to which the horses or horse test specimens have been subjected, or other attestation regarding the health of the animals. Notice of any such requirements will be given to the applicant in each case.

(ii) Horses intended for importation under § 93.301(f)(1) of this part must meet the permit requirements of paragraph (a)(1)(i) of this section. Additionally, for horses intended for importation under § 93.301(f)(1) of this part, the horse's owner or importer must include the following information with the application for permit that is required by paragraph (a)(1)(i) of this section:

(A) That the application is being made for a horse that will remain in the United States for no more than 90 days;

(B) The names, dates, and locations of the events in which the horse will compete while in the United States;

(C) The names and locations of the premises on which the horse will be kept while in the United States, and the dates the horse will be kept on each premises; and

(D) The methods and routes by which the horse will be transported while in the United States.

(iii) Horses intended for importation under § 93.301(f)(2) must meet the permit requirements of paragraph (a)(1)(i) of this section. Additionally, for horses intended for importation under § 93.301(f)(2), the horse's owner or importer must include the following information with the application for permit that is required by paragraph (a)(1)(i) of this section:

(A) The individual identifying information required in paragraph (a)(1)(i) of this section for all horses to be imported.

(B) The permanent electronic identification of each horse to be imported, if applicable. In the event that a horse has permanent electronic identification, the horse must be accompanied by a compatible reader.

(C) Photographs (head and lateral views) that are sufficient to identify each horse on an electronic medium approved by APHIS.

(D) The proposed total length of stay in the United States.

(E) A description of the shows or events in which the horse will perform while in the United States.

(F) The names, dates, and locations of the venues in which the horse will perform while in the United States.

(G) The names and locations of the premises on which the horse will be kept while in the United States, and the dates the horse will be kept on each premises.

(H) The methods and routes by which the horse will be transported while in the United States.

(I) A written plan for handling sick or injured horses that includes:

(1) The name, address, and phone number of each accredited veterinarian who will provide veterinary services in the United States;

(2) The name, address, and phone number of medical facilities to be used to diagnose or treat sick or injured horses while in the United States; and

(3) A plan to return sick or injured horses to performance condition.

(J) An application for a trust fund or escrow account agreement with APHIS in accordance with § 93.301(f)(12).

(iv) Approval of an application for a permit to import a horse under § 93.301(f) of this part is contingent upon a determination by the Administrator that sufficient APHIS personnel are available to provide the services required. If more than one application for an import permit is received, APHIS personnel will be assigned in the order that applications that otherwise meet the requirements of this section are received.

(2) An application for permit to import horses from regions listed in § 93.301(c)(1) or horses intended for quarantine at a privately owned quarantine facility, may also be denied because of: Communicable disease conditions in the area or region of origin, or in a region where the shipment has been or will be held or through which the shipment has been or will be transported; deficiencies in the regulatory programs for the control or eradication of animal diseases and the unavailability of veterinary services in the above mentioned regions; the importer's failure to provide satisfactory evidence concerning the origin, history, and health status of the horses; the lack of satisfactory information necessary to determine that the importation will not be likely to transmit any communicable disease to livestock or poultry of the United States; or any other circumstances which the Administrator believes require such denial to prevent the dissemination of any communicable disease of livestock or poultry into the United States.

(3)(i) The importer or importer's agent shall pay or ensure payment of a reservation fee for each lot of horses to be quarantined in a facility maintained by USDA. For horses, the reservation fee shall be 100 percent of the cost of providing care, feed, and handling during quarantine, as estimated by the quarantine facility's veterinarian in charge.

(ii) At the time the importer or the importer's agent requests a reservation of quarantine space, the importer or importer's agent shall pay the reservation fee by check or U.S. money order or ensure payment of the reservation fee by an irrevocable letter of credit from a commercial bank (the effective date on such letter of credit shall run to 30 days after the date the horses are scheduled to be released from quarantine); except that anyone who issues a check to the Department for a reservation fee which is returned because of insufficient funds shall be denied any further request for reservation of a quarantine space until the outstanding amount is paid.

(iii) Any reservation fee paid by check or U.S. money order shall be applied against the expenses incurred for services received by the importer or importer's agent in connection with the quarantine for which the reservation was made. Any part of the reservation fee which remains unused after being applied against the expenses incurred for services received by the importer or the importer's agent in connection with the quarantine for which the reservation was made, shall be returned to the individual who paid the reservation fee. If the reservation fee is ensured by a letter of credit, the Department will draw against the letter of credit unless payment for services received by the importer or importer's agent in connection with the quarantine is otherwise made at least 3 days prior to the expiration date of the letter of credit.

(iv) Any reservation fee shall be forfeited if the importer or the importer's agent fails to present for entry, within 24 hours following the designated time of arrival, the horse for which the reservation was made: Except that a reservation fee shall not be forfeited if the Administrator determines that services, other than provided by carriers, necessary for the importation of the horses within the required period are unavailable because of unforeseen circumstances as determined by the Administrator (such as the closing of an airport due to inclement weather or the unavailability of the reserved space due to the extension of another quarantine).

(v) If the reservation fee was ensured by a letter of credit and the fee is to be forfeited under paragraph (a)(3)(iv) of this section, the Department will draw against the letter of credit unless the reservation fee is otherwise paid at least 3 days prior to the expiration date of the letter of credit.

(vi) If a reservation is canceled, the importer or the importer's agent will be charged a fee according to the following schedule:

Cancellation date | Fee

30 or more days before the scheduled reservation date | 25 percent of the reservation fee.

15-29 days before the scheduled reservation date | 50 percent of the reservation fee.

Less than 15 days before the scheduled reservation date | 100 percent of the reservation fee.

(vii) If the reservation fee was ensured by a letter of credit, the Department will draw the amount of the cancellation fee against the letter of credit unless the cancellation fee is otherwise paid at least 3 days prior to the expiration date of the letter of credit.

(b) Permit. (1) When a permit is issued, the original and two copies will be sent to the importer. It shall be the responsibility of the importer to forward the original permit and one copy to the shipper in the region of origin, and it shall also be the responsibility of the importer to ensure that the shipper presents the copy of the permit to the carrier and makes the necessary arrangements for the original permit to accompany the shipment to the specified U.S. port of entry for presentation to the collector of customs.

(2) Horses and horse test specimens for which a permit is required under paragraph (a) of this section will be received at the port of entry specified on the permit within the time prescribed in the permit, which shall not exceed 14 days from the first day that the permit is effective.

(3) Horses and horse test specimens for which a permit is required under paragraph (a) of this section will not be eligible for entry if:

(i) A permit has not been issued for the importation of the horse or horse test specimen;

(ii) If the horse or horse test specimen is unaccompanied by the permit issued for its importation;

(iii) If the horse or horse test specimen is shipped from any port other than the one designated in the permit;

(iv) If the horse or horse test specimen arrives in the United States at any port other than the one designated in the permit;

(v) If the horse or horse test specimen offered for entry differs from that described in the permit; or

(vi) If the horse or horse test specimen is not handled as outlined in the application for the permit and as specified in the permit issued.

(Approved by the Office of Management and Budget under control numbers 0579-0040, 0579-0324, and 0579-0485)

[55 FR 31495, Aug. 2, 1990. Redesignated at 62 FR 56012, Oct. 28, 1997]

Editorial Note:For Federal Register citations affecting § 93.304, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

§ 93.305 Declaration and other documents for horses.

(a) The certificates, declarations, and affidavits required by the regulations in this part shall be presented by the importer or his or her agent to the collector of customs at the port of entry, upon arrival of horses at such port, for the use of the veterinary inspector at the port of entry.

(b) For all horses offered for importation, the importer or his or her agent shall first present two copies of a declaration which shall list the port of entry, the name and address of the importer, the name and address of the broker, the origin of the horses, the number, breed, species, and purpose of the importation, the name of the person to whom the horses will be delivered, and the location of the place to which such delivery will be made.

(c) Any declaration, permit, or other document for horses required under this subpart may be issued and presented using a U.S. Government electronic information exchange system or other authorized method.

[55 FR 31495, Aug. 2, 1990,as amended at 81 FR 40151, June 21, 2016]

§ 93.306 Inspection at the port of entry.

Inspection shall be made at the port of entry of all horses imported from any part of the world except as provided in §§ 93.318 and 93.323. All horses found to be free from communicable disease and not to have been exposed thereto within 60 days prior to their exportation to the United States shall be admitted subject to the other provisions in this part; all other horses, to include horses dead upon presentation, and horses arriving in the same shipment as such horses unless the cause of death can be determined to be unrelated to foreign animal disease, shall be refused entry. Horses refused entry, unless exported within a time fixed in each case by the Administrator of Veterinary Service, and in accordance with other provisions he or she may require in each case for their handling shall be disposed of as the Administrator may direct. Such portions of the transporting vessel, and of its cargo, which have been exposed to any such horses or their emanations shall be disinfected in such manner as may be considered necessary by the inspector in charge at the port of entry, to prevent the introduction or spread of livestock or poultry disease, before the cargo is allowed to land.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56016, Oct. 28, 1997; 68 FR 6344, Feb. 7, 2003; 88 FR 63002, Sept. 14, 2023; 89 FR 24340, Apr. 8, 2024]

§ 93.307 Articles accompanying horses.

No litter or manure, fodder or other aliment, nor any equipment such as boxes, buckets, ropes, chains, blankets, or other things used for or about horses governed under any law or regulation administered by the Secretary of Agriculture for prevention of the introduction or dissemination of any pests or diseases of livestock, shall be landed from any conveyance except under such restrictions as the inspector in charge at the port of entry shall direct.

[88 FR 63002, Sept. 14, 2023]

§ 93.308 Quarantine requirements.

(a) Except as provided in this section and in § 93.324, horses intended for importation into the United States from any part of the world shall be shipped directly to a port designated in §§ 93.303 and 92.324 and be quarantined at said port until negative results to port of entry tests are obtained and the horses are certified by the port veterinarian to be free from clinical evidence of disease.

(1) Except as provided in §§ 93.317 (horses from Canada) and 93.324 (horses from Mexico), horses intended for importation from regions that APHIS considers to be affected with Venezuelan equine encephalomyelitis shall be quarantined at a port designated in § 93.303 to be evaluated for signs of Venezuelan equine encephalomyelitis. Each horse must be accompanied at the time of importation by an import permit in accordance with § 93.304.

(i) A list of regions that APHIS considers affected with Venezuelan equine encephalomyelitis is maintained on the APHIS website at www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/animal-health-status-of-regions. Copies of the list can be obtained via postal mail or email upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road Unit 38, Riverdale, Maryland 20737; AskRegionalization@usda.gov.

(ii) APHIS will add a region to the list upon determining that the disease exists in the region based on reports APHIS receives of outbreaks of the disease from veterinary officials of the exporting country, from the World Organization for Animal Health (WOAH), or from other sources the Administrator determines to be reliable. APHIS will remove a region from the list after conducting an evaluation of the region in accordance with § 92.2 of this subchapter and finding that the disease is not present in the region. In the case of a region formerly not on this list that is added due to an outbreak, the region may be removed from the list in accordance with the procedures for reestablishment of a region's disease-free status in § 92.4 of this subchapter.

(2) Horses intended for importation from regions APHIS considers to be affected with African horse sickness may enter the United States only at the port of New York, and must be quarantined at the New York Animal Import Center in Newburgh, New York, for at least 60 days. This restriction also applies to horses that have stopped in or transited a region considered affected with African horse sickness. Each horse must be accompanied at the time of importation by an import permit in accordance with § 93.304.

(i) A list of regions that APHIS considers affected with African horse sickness is maintained on the APHIS website at https://www.aphis.usda.gov/animalhealth/disease-status-of-regions. Copies of the list can be obtained via postal mail or email upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; AskRegionalization@usda.gov.

(ii) APHIS will add a region to the list upon determining that the disease exists in the region based on reports APHIS receives of outbreaks of the disease from veterinary officials of the exporting country, from the World Organization for Animal Health (OIE), or from other sources the Administrator determines to be reliable. APHIS will remove a region from the list after conducting an evaluation of the region in accordance with § 92.2 of this subchapter and finding that the disease is not present in the region. In the case of a region formerly not on this list that is added due to an outbreak, the region may be removed from the list in accordance with the procedures for reestablishment of a region's disease-free status in § 92.4 of this subchapter.

(3) Horses from regions where APHIS considers screwworm to exist may be imported into the United States only if they meet the requirements in paragraphs (a)(3)(i) through (vii) of this section, obtain an import permit in accordance with § 93.304, and meet all other applicable requirements of this part. A list of regions where screwworm is considered to exist is maintained on the APHIS website at www.aphis.usda.gov/animalhealth/disease-status-of-regions. Copies of the list will also be available via postal mail, fax, or email upon request to the Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road Unit 38, Riverdale, MD 20737; AskRegionalization@usda.gov. APHIS will add a region to the list upon determining that screwworm exists in the region based on reports APHIS receives of detections of the pest from veterinary officials of the exporting country, from WOAH, or from other sources the Administrator determines to be reliable. APHIS will remove a region from the list after conducting an evaluation of the region in accordance with § 92.2 of this subchapter and finding that screwworm is not present in the region. In the case of a region formerly not on this list that is added due to a detection, the region may be removed from the list in accordance with the procedures for reestablishment of a region's disease-free status in § 92.4 of this subchapter.

(i) A veterinarian must treat horses with ivermectin 3 to 5 days prior to the date of export to the United States according to the recommended dose prescribed on the product's label.

(ii) Horses must be examined for screwworm by a full-time salaried veterinary official of the exporting country within 24 hours prior to shipment to the United States. The official must fully examine the horses, including their external genitalia. If horses are found to be infested with screwworm, they must be treated until free from infestation.

(iii) At the time horses are loaded onto a means of conveyance for export, a veterinarian must treat any visible wounds on the animals with a solution of coumaphos dust at a concentration of 5 percent active ingredient.

(iv) Horses must be accompanied to the United States by a certificate signed by a full-time salaried veterinary official of the exporting country. The certificate must state that the horses, including their external genitalia, have been thoroughly examined and found free of screwworm and that the horses have been treated in accordance with paragraphs (a)(3)(i) and (iii) of this section.

(v) Horses must be quarantined upon arrival in the United States at a port designated in § 93.303 for at least 7 days.

(vi) Horses must be examined for screwworm by a veterinarian within 24 hours after arrival at a port designated in § 93.303. The examining veterinarian must examine horses, including their external genitalia, to determine whether the horse is infested with screwworm.

(vii) Horses must be held at the animal import center for a minimum of 7 days. On day 7, prior to the horses' release, the horses must be examined by a veterinarian at the expense of the owner or broker. For this examination, male horses must be tranquilized or sedated so that the external genitalia of the horses can be thoroughly examined. If screwworm is found during this examination, the horses must be held in quarantine and treated until free of infestation.

(4) To qualify for release from quarantine, all horses, except horses from Iceland, must test negative to official tests for dourine, glanders, equine piroplasmosis, and equine infectious anemia. 1 However, horses imported from Australia and New Zealand are exempt from testing for dourine and glanders. In addition, all horses must undergo any other tests, inspections, disinfections, and precautionary treatments that may be required by the Administrator to determine their freedom from communicable diseases.

1 Protocols for testing equines in import quarantine are available on the APHIS website at www.aphis.usda.gov/aphis/ourfocus/importexport/animal-import-and-export/equine/guidelines-docs-related-to-importing-equine.

(5) Any quarantine period required for a horse shall be counted using the first day after arrival of the horse at the quarantine facility as the first day of quarantine and may be extended for such additional period as the Administrator may require to determine its freedom from disease. Any horse which is positive to any of the port of entry tests named in this paragraph or any other test required by the Administrator, or which is found by the port veterinarian to exhibit evidence of communicable disease during quarantine shall be refused entry into the United States and removed by the importer to a country other than the United States within 10 days of the date that the importer is notified by APHIS that such horse has been refused entry into the United States. Upon request, the Administrator may grant additional time for the removal of a horse from the United States in any case in which he or she determines that delay is unavoidable due to unforeseen circumstances and the additional time for removal of the horse will not present a threat of the spread of communicable disease to other animals in the United States. At the option of the importer, such horse may be disposed of in accordance with such conditions as the Administrator believes necessary to prevent the dissemination of communicable disease into the United States. The importer shall be responsible for all costs of such removal or disposal.

(b) Temporary, privately owned quarantine facilities. Horses presented for entry into the United States as provided in § 93.303(e), except horses originating from regions in which Venezuelan equine encephalomyelitis or screwworm is declared to exist, may be quarantined in temporary, privately owned quarantine facilities that meet the requirements of paragraphs (b)(1) and (b)(2) of this section and that have been approved by the Administrator for a specific importation.

(1) Approval. Requests for approval and plans for proposed temporary facilities must be submitted no less than 15 days before the proposed date of entry of horses into the facility to APHIS, Veterinary Services, Strategy and Policy, 4700 River Road Unit 39, Riverdale, MD 20737-1231. Before facility approval can be granted, a veterinary medical officer of APHIS must inspect the facility to determine whether it complies with the standards set forth in this section: Provided, however, that approval of any temporary facility and use of such facility will be contingent upon a determination made by the Administrator that adequate personnel are available to provide required services at the facility. Approval of any facility may be refused and approval of any quarantine facility may be withdrawn at any time by the Administrator, upon his or her determination that any requirements of this section are not being met. Before such action is taken, the operator of the facility will be informed of the reasons for the proposed action by the Administrator and afforded an opportunity to present his or her views. If there is a conflict as to any material fact, a hearing will be held to resolve the conflict. The cost of the facility and all maintenance and operational costs of the facility will be borne by the operator.

(2) Standards and handling procedures. The facility must be maintained and operated in accordance with the following standards:

(i) Inspection. Inspection and quarantine services must be arranged by the operator or his or her agent with the APHIS Veterinarian in Charge for the State in which the approved facility is located 2 no less than 7 days before the proposed date of entry of the horses into the quarantine facility.

2 The name and the address of the Veterinarian in Charge in any State is available from APHIS, Veterinary Services, Strategy and Policy, 4700 River Road Unit 39, Riverdale, MD 20737-1231.

(ii) Physical plant requirements. (A) The facility must be located and constructed to prevent horses from having physical contact with animals outside the facility.

(B) The facility must be constructed only with materials that can withstand repeated cleaning and disinfection. Disinfectants authorized in 9 CFR part 71 must be used. All walls, floors, and ceilings must be constructed of solid material that is impervious to moisture. Doors, windows, and other openings of the facility must be provided with double screens that will prevent insects from entering the facility.

(iii) Sanitation and security. (A) The operator of the facility must arrange for a supply of water adequate to clean and disinfect the facility.

(B) All feed and bedding must originate from an area not under quarantine because of splenetic or tick fever (see part 72 of this chapter) and must be stored within the facility.

(C) Upon the death of any horse, the operator must arrange for the disposal of the horse's carcass by incineration. Disposal of all other waste removed from the facility during the time the horses are in quarantine or from horses that are refused entry into the United States must be either by incineration or in a public sewer system that meets all applicable environmental quality control standards. Following completion of the quarantine period and the release of the horses into the United States, all waste may be removed from the quarantine facility without further restriction.

(D) The facility must be maintained and operated in accordance with any additional requirements the Administrator deems appropriate to prevent the dissemination of any communicable disease.

(E) The facility must comply with all applicable local, State, and Federal requirements for environmental quality.

(iv) Personnel. (A) Access to the facility will be granted only to persons working at the facility or to persons specifically granted such access by an APHIS representative.

(B) The operator must provide attendants for the care and feeding of horses while in the quarantine facility.

(C) Persons working in the quarantine facility may not come in contact with any horses outside the quarantine facility during the quarantine period for any horses in the facility.

(v) Handling of horses in quarantine. Horses offered for importation into the United States that are quarantined in an approved temporary facility must be handled in accordance with paragraph (a) of this section while in quarantine.

(c) Permanent, privately owned quarantine facilities. Horses presented for entry into the United States as provided in § 93.303(e) may be quarantined in permanent, privately owned quarantine facilities approved by the Administrator as meeting the requirements of paragraphs (c)(1) through (c)(6) of this section.

(1) APHIS approval—(i) Approval procedures. Persons seeking APHIS approval of a permanent, privately owned quarantine facility must write to the Administrator, c/o Strategy and Policy, Veterinary Services, APHIS, 4700 River Road Unit 39, Riverdale, MD 20737-1231. The application letter must include the full name and mailing address of the applicant; the location and street address of the facility for which approval is sought; blueprints of the facility; a description of the financial resources available for construction, operation, and maintenance of the facility; the anticipated source or origin of horses to be quarantined, as well as the expected size and frequency of shipments; a contingency plan for horses needing emergency veterinary care; and a contingency plan for the disposal of all the horses capable of being housed in the facility.

(A) If APHIS determines that an application is complete and merits further consideration, the person applying for facility approval must enter into a service agreement with APHIS wherein the applicant agrees to pay the cost of all APHIS services associated with APHIS' evaluation of the application and facility. APHIS charges for the evaluation of the application and facility at hourly rates listed in part 130 of this chapter. This service agreement applies only to fees accrued during the application process. If the facility is approved by APHIS, facility owners must enter into a compliance agreement in accordance with paragraph (c)(2) of this section.

(B) Requests for approval must be submitted to APHIS at least 120 days prior to the date of application for local building permits. Requests for approval will be evaluated on a first-come, first-served basis.

(ii) Criteria for approval. Before a facility may operate as a permanent, privately owned quarantine facility for horses, it must be approved by APHIS. To be approved:

(A) The facility must meet all of the requirements of this section;

(B) The facility must meet any additional requirements that may be imposed by the Administrator in each specific case, as specified in the compliance agreement required under paragraph (c)(2) of this section, to ensure that the quarantine of horses in the facility will be adequate to determine their health status, as well as to prevent the transmission of diseases into, within, and from the facility; and

(C) The Administrator must determine that sufficient personnel, including one or more APHIS veterinarians and other professional, technical, and support personnel, are available to serve as APHIS representatives at the facility. If the facility is approved, APHIS representatives will be present at all import quarantine operations in order to monitor them and will be present in order to provide other technical services to ensure the biological security of the facility, including, but not limited to, those specified in paragraph (c)(4)(v)(H) of § 93.308. The Administrator's determination will be based on the expected size and frequency of shipments to the facility, as described in the application for approval of a permanent facility, as well as any other pertinent information in the application. APHIS will assign personnel to facilities requesting approval in the order that the facilities are approved. The Administrator has sole discretion on the number of APHIS personnel to be assigned to the facility.

(iii) Maintaining approval. To maintain APHIS approval, the operator must continue to comply with all the requirements of paragraph (c) of this section and the terms of the compliance agreement executed in accordance with paragraph (c)(2) of this section.

(iv) Denial or withdrawal of approval. Approval for a proposed permanent, privately owned quarantine facility may be denied or approval for a facility already in operation may be withdrawn at any time by the Administrator for any of the reasons provided in paragraph (c)(1)(iv)(C) of this section.

(A) Before facility approval is denied or withdrawn, the operator of the facility will be informed of the reasons for the proposed action by the Administrator and afforded an opportunity to present his or her views. If there is a conflict as to any material fact, APHIS will afford the operator, upon request, the opportunity for a hearing with respect to the merits or validity of such action.

(B) The Administrator may withdraw approval of an existing facility prior to a final determination in the hearing if the Administrator determines that such action is necessary to protect animal health or the public health, interest, or safety. Such withdrawal will be effective upon oral or written notification, whichever is earlier, to the operator of the facility. In the event of oral notification, APHIS will promptly give written confirmation to the operator of the facility. This withdrawal will continue in effect pending the completion of the hearing and any judicial review, unless otherwise ordered by the Administrator. In addition to withdrawal of approval for the reasons provided in paragraph (c)(1)(iv)(C) of this section, the Administrator will also automatically withdraw approval when the operator of any approved facility notifies the APHIS Veterinarian in Charge for the State in which the facility is located, in writing, that the facility is no longer in operation. 3

3 The name and address of the Veterinarian in Charge in any State is available from APHIS, Veterinary Services, Strategy and Policy, 4700 River Road Unit 39, Riverdale, MD 20737-1231.

(C) The Administrator may deny or withdraw approval of a permanent, privately owned facility if:

(1) Any requirement of this section or the compliance agreement is not complied with; or

(2) The operator fails to remit any charges for APHIS services rendered; or

(3) The operator or a person responsibly connected with the business of the quarantine facility acts as a paid agent (broker) for the importation or subsequent sale of horses; or

(4) The operator or a person responsibly connected with the business of the quarantine facility is or has been found by a court of competent jurisdiction to have violated any law or regulation pertaining to the importation or quarantine of any animal; or

(5) The operator or a person responsibly connected with the business of the quarantine facility is or has been convicted of any crime involving fraud, bribery, or extortion or any other crime involving a lack of the integrity needed for the conduct of operations affecting the importation of animals; or

(6) The approved quarantine facility has not been in use to quarantine horses for a period of at least 1 year.

(D) For the purposes of this section, a person is deemed to be responsibly connected with the business of the quarantine facility if such person has an ownership, mortgage, or lease interest in the facility's physical plant, or if such person is a partner, officer, director, holder, or owner of 10 percent or more of its voting stock, or is an employee in a managerial or executive capacity.

(v) Approval for existing facilities. Any permanent, privately owned quarantine facility operating under APHIS authorization on August 3, 2009 must be approved by APHIS to continue quarantine operations by August 3, 2010 or else must cease horse quarantine operations.

(2) Compliance agreement. (i) All permanent, privately owned quarantine facilities for horses must operate in accordance with a compliance agreement executed by the operator or his or her agent and the Administrator, which must be renewed on an annual basis.

(ii) The compliance agreement must provide that:

(A) The facility must meet all applicable requirements of this section;

(B) The operator agrees to have APHIS representatives present at all import quarantine operations at the facility in order to monitor the import quarantine operations;

(C) The operator agrees to be responsible for the cost of the facility; all costs associated with its maintenance and operation; all costs associated with the hiring of employees and other personnel to attend to the horses as well as to maintain and operate the facility; all costs associated with the care of quarantined horses, such as feed, bedding, medicines, inspections, testing, laboratory procedures, and necropsy examinations; and all APHIS charges for the services of APHIS representatives in accordance with this section and part 130 of this chapter;

(D) The operator agrees to bar from the facility any employee or other personnel at the facility who fails to comply with paragraph (c) of this section or other provisions of this part, any terms of the compliance agreement, or related instructions from APHIS representatives;

(E) The operator agrees to demonstrate, to the satisfaction of the Administrator, that the routine cleaning and maintenance of the facility, the daily care of animals in quarantine, the disposal of wastes at the facility, the cleaning and disinfection procedures employed by the facility, the handling, washing, and disposal of soiled and contaminated clothing worn within the facility, and the disposal of dead horses, whether onsite or offsite, adhere to the best practices of biological security and animal care;

(F) The operator agrees to random spot audits by APHIS representatives to determine whether employees and other personnel are complying with these practices; and

(G) The operator of the facility allows the Administrator to amend the compliance agreement at any time after approval of the facility in order to incorporate related instructions issued by APHIS representatives while the facility is operational

(3) Physical plant requirements. The facility must meet the following requirements as determined by an APHIS inspection prior to admitting horses into the facility:

(i) Location. The quarantine facility must be located in proximity to a port authorized under § 93.303(e). The site and the specific routes for the movement of horses from the port to the site must be approved by the Administrator based on consideration of whether the site or routes would put the horses in a position that could result in the transmission of communicable diseases to domestic horses.

(ii) Construction. The facility must be of sound construction, in good repair, and properly designed to prevent the escape of quarantined horses. It must have adequate capacity to receive and house shipments of horses as lots on an “all in, all out” basis, whereby separate lots of horses can be received and housed without contact with any other lots being quarantined at the facility. The facility must include the following:

(A) Perimeter fencing. The facility must be surrounded by a security fence of sufficient height and design to prevent the entry of unauthorized people and animals from outside the facility and to prevent the escape of the horses in quarantine.

(B) Entrances and exits. All entryways into the nonquarantine area of the facility must be equipped with a secure and lockable door. While horses are in quarantine, all access to the quarantine area for horses must be from within the building, and each such entryway to the quarantine area must be equipped with a series of solid self-closing double doors. Emergency exits to the outside are permitted in the quarantine area. Such emergency exits must be constructed so as to permit their being opened from the inside of the facility only.

(C) Windows and other openings. The facility must be constructed so that any windows or other openings in the quarantine area are double-screened with screening of sufficient gauge and mesh to prevent the entry or exit of insects and other vectors of diseases of horses and to provide ventilation sufficient to ensure the comfort and safety of all horses in the facility. The interior and exterior screens must be separated by at least 3 inches (7.62 cm). All screening of windows or other openings must be easily removable for cleaning, but must otherwise remain locked and secure at all times in a manner satisfactory to APHIS representatives in order to ensure the biological security of the facility.

(D) Lighting. The entire facility, including its stalls and hallways, must have adequate lighting.

(E) Loading docks. The facility must have separate docks for animal receiving and releasing and for general receiving and pickup, unless a single dock used for both purposes is cleaned and disinfected after each use in accordance with paragraph (c)(4)(iv)(F) of this section.

(F) Surfaces. The facility must be constructed so that the floor surfaces with which horses have contact are nonslip and wear-resistant. All floor surfaces with which the horses, their excrement, or discharges have contact must provide for adequate drainage. All floor and wall surfaces with which the horses, their excrement, or discharges have contact must be impervious to moisture and be able to withstand frequent cleaning and disinfection without deterioration. Ceilings and wall surfaces with which the horses, their excrement, or discharges do not have contact must be able to withstand cleaning and disinfection between shipments of horses. All floor and wall surfaces must be free of sharp edges that could cause injury to horses.

(G) Horse stalls. The stalls in which horses are kept must be large enough to allow each animal to make normal postural and social adjustments with adequate freedom of movement. Exercise equipment for horses may be kept in the stalls, provided that there will still be sufficient space within the stalls for the horses to move freely once the equipment is installed.

(H) Aisleways. The aisleways through which horses are moved to and from stalls must be wide enough to provide for safe movement of horses, including allowing horses to turn around in the aisleway, preventing horses in facing stalls from coming into contact with horses in the aisleway, and adequately ventilating the stalls.

(I) Means of isolation. Physical barriers must separate different lots of horses in the facility so that horses in one lot cannot have physical contact with horses in another lot or with their excrement or discharges. Stalls must be available that are capable of isolating any horses exhibiting signs of illness.

(J) Showers. A shower must be located at each entrance to the quarantine area. If the facility has a necropsy area, a shower must be located at the entrance to the necropsy area. A clothes-storage and clothes-changing area must be provided with each shower area. There must also be one or more receptacles near each shower so that clothing that has been worn into the quarantine area can be deposited in a receptacle prior to entering the shower.

(K) APHIS space. The facility must have adequate space for APHIS representatives to conduct examinations and testing of the horses in quarantine, prepare and package samples for mailing, and store the necessary equipment and supplies for duplicate samples. The space provided to conduct examinations and testing must include a refrigerator-freezer in which to store samples. The examination space must include equipment to provide for the safe inspection of horses. The facility must also include a secure, lockable office for APHIS use with enough room for a desk, chair, and filing cabinet.

(L) Necropsy area. The facility must either include an area for conducting necropsies onsite or must have designated an alternate facility at which a suitable necropsy area is available. If the facility has a necropsy area, it must be of sufficient size to perform necropsies on horses and be equipped with adequate lighting, hot and cold running water, a drain, a cabinet for storing instruments, a refrigerator-freezer for storing specimens, and an autoclave to sterilize veterinary equipment. If the facility does not have such an area, it must specify an alternate facility at which a suitable necropsy area is available, a route from the quarantine facility to the alternate facility's necropsy area, and the safeguards that will be in place to ensure that communicable diseases of horses are not spread during transit. This alternate facility and transport methodology must be approved by the Administrator under the procedures for requesting variances outlined in paragraph (c)(6) of this section.

(M) Storage. The facility must have sufficient storage space for equipment and supplies used in import quarantine operations. Storage space must include separate, secure storage for pesticides and for medical and other biological supplies, as well as a separate vermin-proof storage area for feed and bedding, if feed and bedding are stored at the facility. If the facility has multiple lot-holding areas, then separate storage space for any reusable supplies and equipment that are not disinfected after each use in accordance with part 71 of this chapter must be provided for each lot-holding area.

(N) Additional space needs. The facility must have an area for washing and drying clothes, linens, and towels and an area for cleaning and disinfecting equipment used in the facility. The facility must also include a work area for the repair of equipment.

(O) Restrooms. The facility must have permanent restrooms in both the quarantine and nonquarantine areas of the facility.

(P) Ventilation and climate control. The facility must be constructed with an air handling system capable of controlling and maintaining the ambient temperature, air quality, humidity, and odor at levels that are not injurious or harmful to the health of horses in quarantine. Air supplied to the quarantine area must not be recirculated or reused for other ventilation needs. Air handling systems for lot-holding areas must be separate from air handling systems for other operational and administrative areas of the facility. In addition, if the facility is equipped to handle more than one lot of horses at a time, the air handling system must be adequate to ensure that there is no cross-contamination of air between separate lot-holding areas.

(Q) Fire protection. The facility, including the lot-holding areas, must have a fire alarm voice communication system.

(R) Communication system. The facility must have a communication system between the nonquarantine and quarantine areas of the facility.

(iii) Sanitation. To ensure that proper animal health and biological security measures are observed, the facility must have the following:

(A) Equipment and supplies necessary to maintain the facility in clean and sanitary condition, including pest control equipment and supplies and cleaning and disinfecting equipment with adequate capacity to disinfect the facility and equipment.

(B) Any reusable equipment and supplies that are not disinfected after each use in accordance with part 71 of this chapter maintained separately for each lot of horses.

(C) Equipment and supplies used in the quarantine area maintained separately from equipment and supplies used in the nonquarantine area.

(D) A supply of potable water adequate to meet all watering and cleaning needs, with water faucets for hoses located throughout the facility. An emergency supply of water for horses in quarantine must also be maintained.

(E) A stock of disinfectant authorized in part 71 of this chapter or otherwise approved by the Administrator that is sufficient to disinfect the entire facility.

(F) The capability to dispose of wastes, including manure, urine, and used bedding, by means of burial, incineration, or public sewer. Other waste material must be handled in such a manner that minimizes spoilage and the attraction of pests and must be disposed of by incineration, public sewer, or other preapproved manner that prevents the spread of disease. Disposal of wastes must be carried out in accordance with the terms of the compliance agreement, and is subject to spot audits by APHIS representatives.

(G) The capability to dispose of horse carcasses in a manner approved by the Administrator and under conditions that minimize the risk of disease spread from carcasses.

(H) For incineration to be carried out at the facility, the facility must have incineration equipment that is detached from other facility structures and is capable of burning animal waste and refuse. The incineration site must also include an area sufficient for solid waste holding. Incineration may also take place at a local site away from the facility premises. All incineration activities, whether onsite or offsite, must be carried out in accordance with the terms of the compliance agreement, and are subject to spot audits by APHIS representatives.

(I) The capability to control surface drainage and effluent into, within, and from the facility in a manner that prevents the spread of disease into, within, or from the facility. If the facility is approved to handle more than one lot of horses at the same time, the drainage system must be adequate to ensure that there is no cross-contamination between lot-holding areas.

(iv) Security. Facilities must provide the following security measures:

(A) The facility and premises must be kept locked and secure at all times while horses are in quarantine.

(B) The facility and premises must have signs indicating that the facility is a quarantine area and no visitors are allowed.

(C) The facility and premises must be guarded at all times by one or more representatives of a bonded security company, or, alternatively, the facility must have an electronic security system that indicates the entry of unauthorized persons into the facility. Electronic security systems must be coordinated through or with the local police so that monitoring of the quarantine facility is maintained whenever APHIS representatives are not at the facility. The electronic security system must be of the “silent type” and must be triggered to ring at the monitoring site and not at the facility. The electronic security system must be approved by Underwriter's Laboratories. The operator must provide written instructions to the monitoring agency stating that the police and a representative of APHIS designated by APHIS must be notified by the monitoring agency if the alarm is triggered. The operator must also submit a copy of those instructions to the Administrator. The operator must notify the designated APHIS representative whenever a breach of security occurs or is suspected of having occurred. In the event that disease is diagnosed in quarantined horses, the Administrator may require the operator to have the facility guarded by a bonded security company in a manner that the Administrator deems necessary to ensure the biological security of the facility.

(D) The operator must furnish a telephone number or numbers to APHIS at which the operator or his or her agent can be reached at all times.

(E) APHIS is authorized to place APHIS seals on any or all entrances and exits of the facility when determined necessary by APHIS and to take all necessary steps to ensure that such seals are broken only in the presence of an APHIS representative. If someone other than an APHIS representative breaks such seals, APHIS will consider the act a breach in security and APHIS representatives will make an immediate accounting of all horses in the facility. If a breach in security occurs, APHIS may extend the quarantine period as long as necessary to determine that the horses are free of communicable diseases.

(4) Operating procedures. The following procedures must be observed at the facility at all times:

(i) Oversight by APHIS representatives. (A) Import quarantine operations at a privately owned quarantine facility may only be conducted with the physical presence of and monitoring by APHIS representatives. APHIS representatives are also authorized to perform the services required by this section and by the compliance agreement.

(B) If, as the result of a spot audit, or for any other reason, APHIS determines that the operator has failed to properly care for, feed, or handle quarantined horses as required in this paragraph (c) or in accordance with the terms of the compliance agreement, or has failed to maintain and operate the facility as provided in this paragraph (c) or in accordance with the terms of the compliance agreement, APHIS representatives will furnish such services, will make arrangements for the sale or disposal of quarantined horses at the quarantine facility owner's expense, or will begin the process for withdrawal of approval of the quarantine facility specified in paragraph (c)(1)(iv) of this section.

(ii) Personnel. (A) The operator must provide adequate personnel to maintain the facility and care for the horses in quarantine, including attendants to care for and feed horses, and other personnel as needed to maintain, operate, and administer the facility.

(B) The operator must provide APHIS with an up-to-date list of all personnel who have access to the facility. The list must include the names, current residential addresses, and employee identification numbers of each person. When the operator wishes to grant access to the facility to persons who have not previously had access to it, the operator must update the list prior to such persons having access to the quarantine facility.

(C) The operator must provide APHIS with signed statements from each employee and any other personnel hired by the operator and working at the facility in which the person agrees to comply with paragraph (c) of this section and applicable provisions of this part, all terms of the compliance agreement, and any related instructions from APHIS representatives pertaining to import quarantine operations, including contact with animals both inside and outside the facility.

(iii) Authorized access. Access to the facility premises as well as inside the quarantine area will be granted only to APHIS representatives, authorized employees, and other personnel of the operator assigned to work at the facility. All other persons are prohibited from the premises unless specifically granted access by an APHIS representative. Any visitors granted access must be accompanied at all times by an APHIS representative while on the premises or in the quarantine area of the facility.

(iv) Sanitary requirements. (A) All persons granted access to the quarantine area must:

(1) Shower when entering and leaving the quarantine area;

(2) Shower when leaving the necropsy area if a necropsy is in the process of being performed or has just been completed, or if all or portions of the examined animal remain exposed;

(3) Wear clean protective work clothing and footwear upon entering the quarantine area;

(4) Wear disposable gloves when handling sick horses and then wash hands after removing gloves; and

(5) Change protective clothing, footwear, and gloves when they become soiled or contaminated.

(B) The operator is responsible for providing a sufficient supply of clothing and footwear to ensure that all persons provided access to the quarantine area at the facility have clean, protective clothing, and footwear when they enter the quarantine area.

(C) The operator is responsible for the handling, washing, and disposal of soiled and contaminated clothing worn within the quarantine facility in accordance with the terms of the compliance agreement. At the end of each workday, work clothing worn into the quarantine area must be collected and kept in a bag until the clothing is washed. Used footwear must either be left in the clothes-changing area or cleaned with hot water (148 °F minimum) and detergent and disinfected in accordance with the terms of the compliance agreement. APHIS representatives may conduct spot audits of all handling, cleaning, and/or disposal of used clothing or used footwear.

(D) All equipment (including tractors) must be cleaned and disinfected prior to being used in the quarantine area of the facility with a disinfectant authorized in part 71 of this chapter or otherwise approved by the Administrator. The equipment must remain dedicated to the facility for the entire quarantine period. Any equipment used with quarantined horses (e.g., halters, floats, feed, water buckets, and exercise equipment) must remain dedicated to that particular lot of quarantined horses for the duration of the quarantine period or be cleaned and disinfected before coming in contact with horses from another lot. Prior to its removal from the quarantine premises, any equipment must be cleaned and disinfected in accordance with the terms of the compliance agreement. APHIS representatives may conduct spot audits of all cleaning and disinfection of equipment.

(E) Any vehicle, before entering or leaving the quarantine area of the facility, must be cleaned and disinfected in accordance with the terms of the compliance agreement within a time period authorized by the APHIS representative and with a disinfectant authorized in part 71 of this chapter or otherwise approved by the Administrator. APHIS representatives may conduct spot audits of all cleaning and disinfection of vehicles.

(F) If the facility has a single loading dock, the loading dock must be cleaned and disinfected after each use in accordance with the terms of the compliance agreement within a time period authorized by the APHIS representative and with a disinfectant authorized in part 71 of this chapter or otherwise approved by the Administrator. APHIS representatives may conduct spot audits of all cleaning and disinfection of the loading dock.

(G) That area of the facility in which a lot of horses has been held or has had access to must be thoroughly cleaned and disinfected, with a disinfectant authorized in part 71 of this chapter or otherwise approved by the Administrator, in accordance with the terms of the compliance agreement, upon release of the horses before a new lot of horses is placed in that area of the facility. APHIS representatives may conduct spot audits of all cleaning and disinfection of lot-holding areas.

(v) Handling of the horses in quarantine. (A) All horses must be handled in accordance with paragraph (a) of this section.

(B) Each lot of horses to be quarantined must be placed in the facility on an “all-in, all out” basis. No horse may be taken out of the lot while it is in quarantine, except for diagnostic purposes or as provided in paragraph (a)(5) of this section, and no horse may be added to the lot while the lot is in quarantine. Once import quarantine operations have been completed on a lot, but while the lot is still at the facility, a horse may be removed from that lot.

(C) The facility must provide sufficient feed and bedding for the horses in quarantine, and it must be free of vermin and not spoiled. Feed and bedding must originate from an area that is not listed in part 72 of this chapter as an area quarantined for splenetic or tick fever.

(D) Breeding of horses or collection of germplasm from horses is prohibited during the quarantine period.

(E) Horses in quarantine will be subjected to such tests and procedures as directed by an APHIS representative to determine whether they are free from communicable diseases of horses.

(F) Any death or suspected illness of horses in quarantine must be reported immediately to APHIS. The affected horses must be disposed of as the Administrator may direct, or depending on the nature of the disease, must be cared for as directed by APHIS to prevent the spread of the disease.

(G) Quarantined horses requiring specialized medical attention or additional postmortem testing may be transported off the quarantine site, if authorized by APHIS. A second quarantine site must be established to house the horses at the facility of destination (e.g., veterinary teaching hospital). In such cases, APHIS may extend the quarantine period for that horse and for its lot until the results of any outstanding tests or postmortem results are received.

(H) Should a horse be determined to be infected with or exposed to a Federally regulated disease of horses, arrangements for the final disposition of the infected or exposed horse must be accomplished within 10 days of the date that the importer is notified by the overseeing APHIS representative that the horse has been refused entry into the United States. APHIS representatives must be physically present at and directly monitor the subsequent disposition of the horse. The operator must have a preapproved contingency plan for the disposal of all horses housed at the facility prior to issuance of the import permit.

(I) Vaccination of horses in quarantine is prohibited. However, once import quarantine operations have been completed on a lot, but while the lot is still at the facility, horses in that lot may be vaccinated.

(vi) Records. (A) The facility operator must maintain a current daily record to record the entry and exit of all persons entering and leaving the quarantine facility.

(B) The operator must maintain the daily record, along with any records kept by APHIS and deposited with the operator, for at least 2 years following the date of release of the horses from quarantine and must make such records available to APHIS representatives upon request.

(5) Environmental quality. If APHIS determines that a privately operated quarantine facility does not meet applicable local, State, or Federal environmental regulations, APHIS may deny or suspend approval of the facility until appropriate remedial measures have been applied.

(6) Variances. The Administrator may grant variances to existing requirements relating to location, construction, and other design features of the physical facility, as well as to sanitation, security, operating procedures, recordkeeping, and other provisions of paragraph (c) of this section, but only if the Administrator determines that the variance causes no detrimental impact to the overall biological security of the import quarantine operations. The operator must submit a request for a variance from the requirements for the construction of the facility in paragraph (c)(3) of this section to the Administrator in writing prior to the construction of the facility. The operator must submit a request for a variance from the operational requirements in paragraph (c)(4) of this section to the Administrator in writing at least 30 days in advance of the arrival of horses to the facility. Any variance must also be expressly provided for in the compliance agreement.

(Approved by the Office of Management and Budget under control numbers 0579-0313 and 0579-0485)

[55 FR 31495, Aug. 2, 1990]

Editorial Note:For Federal Register citations affecting § 93.308, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

§ 93.309 Horse quarantine facilities; payment information.

(a) Privately operated quarantine facilities. The importer, or his or her agent, of horses subject to quarantine under the regulations in this part shall arrange for acceptable transportation to the privately operated quarantine facility and for the care, feed, and handling of the horses from the time of unloading at the quarantine port to the time of release from quarantine. Such arrangements shall be agreed to in advance by the Administrator. All expenses resulting therefrom or incident thereto shall be the responsibility of the importer; APHIS assumes no responsibility with respect thereto. The quarantine facility must be suitable for the quarantine of such horses and must be approved by the Administrator prior to the issuance of any import permit. The facilities occupied by horses should be kept clean and sanitary to the satisfaction of the inspector assigned to supervise the quarantine. If for any cause the care, feed, or handling of horses, or the sanitation of the facilities, is neglected, in the opinion of the inspector assigned to supervise the quarantine, such services may be furnished by APHIS in the same manner as though arrangements had been made for such services as provided by paragraph (b) of this section, and/or the horses may be disposed of as the Administrator, may direct, including sale in accordance with the procedure described in paragraph (b) of this section. The importer, or his or her agent, shall request in writing such inspection and other services as may be required, and shall waive all claim against the United States and APHIS or any employee of APHIS for damages which may arise from such services. The Administrator, may prescribe reasonable rates for the services provided under this paragraph. When it is found necessary to extend the usual minimum quarantine period, the importer, or his or her agent, shall be so advised in writing and shall pay for such additional quarantine and other services required. Payment for all services received by the importer, or his or her agent, in connection with each separate lot of horses shall be made by certified check or U.S. money order prior to release of the horses. If such payment is not made, the horses may be sold in accordance with the procedure described in paragraph (b) of this section, or otherwise disposed of as directed by the Administrator.

(b) Quarantine facilities maintained by APHIS. The importer, or his or her agent, of horses subject to quarantine under the regulations in this part shall arrange for acceptable transportation to the quarantine facility, and for the care, feed, and handling of the horses from the time they arrive at the quarantine port to the time of release from quarantine. Such arrangements shall be agreed to in advance by the Administrator. The importer or his or her agent shall request in writing such inspection and other services as may be required, and shall waive all claim against the United States and APHIS or any employee of APHIS, for damages which may arise from such services. All expenses resulting therefrom or incident thereto shall be the responsibility of the importer; APHIS assumes no responsibility with respect thereto. The Administrator may prescribe reasonable rates for the services provided under this paragraph. When it is found necessary to extend the usual minimum quarantine period, the importer, or his or her agent, shall be so advised in writing and shall pay for such additional quarantine and other services required. Payment for services received by the importer, or his or her agent, in connection with each separate lot of horses shall be made by certified check or U.S. money order prior to release of the horses. If such payment is not made, the horses may be sold in accordance with the procedure described in this paragraph or otherwise disposed of as directed by the Administrator. When payment is not made and the horses are to be sold to recover payment for services received, the importer, or his or her agent, will be notified by the inspector that if said charges are not immediately paid or satisfactory arrangements made for payment, the horses will be sold at public sale to pay the expense of care, feed, and handling during that period. The sale will be held after the expiration of the quarantine period, at such time and place as may be designated by the General Services Administration or other designated selling agent. The proceeds of the sale, after deducting the charges for care, feed, and handling of the horses and other expenses, including the expense of the sale, shall be held in a Special Deposit Account in the United States Treasury for 6 months from the date of sale. If not claimed by the importer, or his or her agent, within 6 months from the date of sale, the amount so held shall be transferred from the Special Deposit Account to the General Fund Account in the United States Treasury.

(c) Amounts collected from the importer, or his or her agent, for service rendered shall be deposited so as to be available for defraying the expenses involved in this service.

§ 93.310 Quarantine stations, visiting restricted; sales prohibited.

Visitors are not permitted in the quarantine enclosure during any time that the horses are in quarantine unless an APHIS representative specifically grants access under such conditions and restrictions as may be imposed by APHIS. An importer (or his or her agent or accredited veterinarian) may be admitted to the lot-holding area(s) containing his or her quarantined horses at such intervals as may be deemed necessary, and under such conditions and restrictions as may be imposed, by an APHIS representative. On the last day of the quarantine period, owners, officers or registry societies, and others having official business or whose services may be necessary in the removal of the horses may be admitted upon written permission from an APHIS representative. No exhibition or sale shall be allowed within the quarantine grounds.

[74 FR 31601, July 2, 2009]

§ 93.311 Milk from quarantined horses.

Milk or cream from horses quarantined under the provisions of this part shall not be used by any person other than those in charge of such horses, nor be fed to any animals other than those within the same enclosure, without permission of the inspector in charge of the quarantine station and subject to such restrictions as he or she may consider necessary to each instance. No milk or cream shall be removed from the quarantine premises except in compliance with all State and local regulations.

§ 93.312 Manure from quarantined horses.

No manure shall be removed from the quarantine premises until the release of the horses producing same.

§ 93.313 Appearance of disease among horses in quarantine.

If any contagious disease appears among horses during the quarantine period special precautions shall be taken to prevent spread of the infection to other animals in the quarantine station or to those outside the grounds. The affected horses shall be disposed of as the Administrator may direct, depending upon the nature of the disease.

§ 93.314 Horses, certification, and accompanying equipment.

(a) Horses offered for importation from any part of the world shall be accompanied by an original certificate endorsed by a salaried veterinary officer of the national government of the region of origin, or if exported from Mexico, shall be accompanied either by such a certificate or by a certificate issued by a veterinarian accredited by the National Government of Mexico and endorsed by a full-time salaried veterinary officer of the National Government of Mexico, thereby representing that the veterinarian issuing the certificate was authorized to do so. The certificate shall specify the name and address of the importer; the species, breed, number or quantity of horses or horse test specimens to be imported; the purpose of the importation; individual horse identification which requires a description of the horse, name, age, markings and, when present, registration number, tattoo, microchip, eartag, brand, if any; the region and premises of origin; the name and address of the exporter; and the destination address for release into the United States; and shows that:

(1) The horses described in the certificate have been in said region during the 60 days preceding exportation, or, for horses described in § 93.301(g), for the duration of their temporary exportation to each CEM-affected region;

(2) That each horse has been inspected on the premises of origin and found free of evidence of communicable disease and, insofar as can be determined, exposure thereto during the 60 days preceding exportation;

(3) That each horse has not been vaccinated with a live or attenuated or inactivated vaccine during the 14 days preceding exportation: Provided, however, that in specific cases the Administrator may authorize horses that have been vaccinated with an inactivated vaccine to enter the United States when he or she determines that in such cases and under such conditions as he or she may prescribe such importation will not endanger the livestock in the United States, and such horses comply with all other applicable requirements of this part;

(4) The horse, if applicable, has not been gelded during the 14 days preceding exportation;

(5) That, insofar as can be determined, no case of African horse sickness, dourine, glanders, surra, epizootic lymphangitis, ulcerative lymphangitis, equine piroplasmosis, Venezuelan equine encephalomyelitis, vesicular stomatitis, or equine infectious anemia has occurred on the premises of origin or on adjoining premises during the 60 days preceding exportation; and

(6) That, except as provided in § 93.301(g):

(i) The horses, except horses described in § 93.301(d), (e), and (f), have not been in any region listed in accordance with § 93.301(c)(1) on the APHIS website as affected with CEM during the 12 months immediately prior to their importation into the United States;

(ii) The horses have not been on any premises at any time during which time such premises were found by an official of the veterinary services of the national government of the region where such premises are located, to be affected with CEM;

(iii) The horses have not been bred by or bred to any horses from an affected premises; and

(iv) The horses have had no other contact with horses that have been found to be affected with CEM or with horses that were imported from regions affected with CEM.

(b) If a horse is presented for importation from a region where it has been for less than 60 days, the horse must be accompanied by a certificate that meets the requirements of paragraph (a) of this section that has been issued by a salaried veterinary officer of the national government of each region in which the horse has been during the 60 days immediately preceding its shipment to the United States. The dates during which the horse was in each region during the 60 days immediately preceding its exportation to the United States shall be included as a part of the certification.

(c) Following the port-of-entry inspection required by § 93.306 of this part, and before a horse offered for importation from any part of the world is released from the port of entry, an inspector may require the horse and its accompanying equipment to be disinfected as a precautionary measure against the introduction of foot-and-mouth disease or any other disease dangerous to the livestock of the United States.

(d) For purposes of this section, the term “original” means documentation is prepared and issued directly from the national government of the region of origin or annotated by the national government of the region of origin to indicate how the documentation may be verified. Any declaration, permit, or other required document for horses may be issued and presented using a United States Government electronic information exchange system or other method authorized by APHIS.

(Approved by the Office of Management and Budget under control number 0579-0485)

[61 FR 52245, Oct. 7, 1996. Redesignated and amended at 62 FR 56012, 56017, Oct. 28, 1997; 63 FR 53783, Oct. 7, 1998; 88 FR 63003, Sept. 14, 2023; 91 FR 18279, Apr. 10, 2026]

§ 93.315 Import permit and declaration for horses.

For all horses offered for importation from Canada, the importer or his or her agent shall present two copies of a declaration as provided in § 93.305.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56017, Oct. 28, 1997]

§ 93.316 Horses from Canada for immediate slaughter.

Horses imported from Canada for immediate slaughter shall be consigned from the port of entry directly to a recognized slaughtering establishment and there be slaughtered within two weeks from the date of entry. Such horses shall be inspected at the port of entry and otherwise handled in accordance with § 93.306. As used in this section, “directly” means without unloading en route if moved in a means of conveyance, or without stopping if moved in any other manner.

[55 FR 31495, Aug. 2, 1990, as amended at 59 FR 28216, June 1, 1994. Redesignated and amended at 62 FR 56012, 56017, Oct. 28, 1997]

§ 93.317 Horses from Canada.

(a) Except as provided in paragraph (d) of this section, horses from Canada shall be inspected as provided in § 93.306 and accompanied by a certificate as required by § 93.314, which shall include evidence of a negative test for equine infectious anemia for which blood samples were drawn during the 180 days preceding exportation to the United States and which test was conducted in a laboratory approved by the Canada Department of Agriculture or the United States Department of Agriculture. Horses accompanying their dams, which were foaled after their dam was so tested negative, need not be so tested and shall otherwise be handled as provided in § 93.314. Certificates required for horses from Canada must be issued or endorsed by a salaried veterinarian of the Canadian Government. USDA veterinary port inspection is not required for horses imported from Canada under temporary Customs authorization for a period of 30 days from the date of issue of the certificate and the certificate issued is valid for an unlimited number of importations into the United States during the 30-day period.

(b) Horses of United States origin that are imported into Canada under an export health certificate valid for a period of 30 days from the date of issue may re-enter the United States an unlimited number of times during the 30-day period, without USDA veterinary port inspection, at any Custom land border port of entry designated for animals from Canada, if accompanied by the original export health certificate under which they were permitted entry into Canada.

(c) Any horse imported into the United States from Canada through air or ocean ports of entry must obtain an import permit under § 93.304 and shall otherwise be handled as provided in §§ 93.305 and 93.314.

(d) Horses for immediate slaughter may be imported from Canada without the certification prescribed in paragraph (a) of this section, but shall be subject to the other applicable provisions of this part, and shall be accompanied by a certificate issued or endorsed by a salaried veterinarian of the Canadian Government stating that:

(1) The horses were inspected on the premises where assembled for shipment to the United States within the 30 days immediately prior to the date of export and were found free of evidence of communicable disease, and

(2) As far as can be determined, they have not been exposed to any such disease during the 60 days immediately preceding their exportation.

[55 FR 31495, Aug. 2, 1990, as amended at 56 FR 33863, July 24, 1991. Redesignated and amended at 62 FR 56012, 56017, Oct. 28, 1997; 88 FR 63004, Sept. 14, 2023; 89 FR 24340, Apr. 8, 2024]

§ 93.318 Special provisions.

(a) In-bond shipments from Canada. (1) Horses from Canada transported in-bond through the United States for immediate export shall be inspected at the border port of entry and, when accompanied by an import permit obtained under § 93.304 of this part and all conditions therein are observed, shall be allowed entry into the United States and shall be otherwise handled as provided in paragraph (b) of § 93.301. Horses not accompanied by a permit shall meet the requirements of this part in the same manner as horses destined for importation into the United States, except that the Administrator may permit their inspection at some other point when he or she finds that such action will not increase the risk that communicable diseases of livestock and poultry will be disseminated to the livestock or poultry of the United States.

(2) In-transit shipments through Canada. Horses originating in the United States and transported directly through Canada may re-enter the United States without Canadian health or test certificates when accompanied by copies of the United States export health certificates properly issued and endorsed in accordance with regulations in part 91 of this chapter: Provided, That, to qualify for entry, the date, time, port of entry, and signature of the Canadian Port Veterinarian that inspected the horses for entry into Canada shall be recorded on the United States health certificate, or a paper containing the information shall be attached to the certificate that accompanies the horses. In all cases it shall be determined by the veterinary inspector at the United States port of entry that the horses are the identical horses covered by said certificate.

(b) Exhibition horses. Except as provided in § 93.317(b), horses from the United States which have been exhibited at the Royal Agricultural Winter Fair at Toronto or other publicly recognized expositions in Canada, including racing, horse shows, rodeo, circus, or stage exhibitions in Canada, and have not been in that region for more than 90 days are eligible for return to the United States without Canadian health or test certificates, if they are accompanied by copies of the United States health certificate, issued and endorsed in accordance with the export regulations contained in part 91 of this chapter for entry into Canada: Provided, That in the case of horses for exhibition, including race horses, the certificates shall certify that negative results were obtained from official tests for equine infectious anemia for which blood samples were drawn within 180 days of the date that the horses are offered for return to the United States: And, provided further, That all horses offered for re-entry upon examination by the veterinary inspector at the U.S. port of entry, are found by the inspector to be free of communicable diseases and exposure thereto and are determined to be the identical horses covered by said certificates or are the natural increase of such horses born after official test dates certified on the dam's health certificate.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56017, Oct. 28, 1997]

§ 93.319 Import permit and declaration for horses.

For all horses offered for importation from or transiting through regions of Central America or of the West Indies, the importer or his or her agent shall have obtained an import permit under § 93.304 and shall present two copies of a declaration as provided in § 93.305.

(Approved by the Office of Management and Budget under control number 0579-0485)

[88 FR 63004, Sept. 14, 2023]

§ 93.320 Horses from or transiting through Central America and the West Indies.

Horses from or transiting through Central America and the West Indies shall be inspected as provided in § 93.306; shall be accompanied by a certificate and otherwise handled as provided in § 93.314; and shall be quarantined and tested as provided in § 93.308(a), (b) and (c): Provided, That any such horses that are found to be infested with fever ticks, Boophilus annulatus, shall not be permitted entry until they have been freed therefrom by dipping in a permitted arsenical solution or by other treatment approved by the Administrator.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56017, Oct. 28, 1997; 88 FR 63004, Sept. 14, 2023]

§ 93.321 Import permits and applications for inspection for horses.

For horses intended for importation into the United States from Mexico, the importer or his or her agent shall deliver to the veterinary inspector at the port of entry an application, in writing, for inspection, so that the veterinary inspector and customs representatives may make mutually satisfactory arrangements for the orderly inspection of the horses. The veterinary inspector at the port of entry will provide the importer or his or her agent with a written statement assigning a date when the horses may be presented for import inspection. Horses quarantined at a U.S. facility designated in § 93.303 must obtain an import permit under § 93.304.

(Approved by the Office of Management and Budget under control number 0579-0485)

[55 FR 31495, Aug. 2, 1990, as amended at 88 FR 63004, Sept. 14, 2023]

§ 93.322 Declaration for horses.

For all horses offered for importation from Mexico, the importer or his or her agent shall present two copies of a declaration as provided in § 93.305.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56017, Oct. 28, 1997]

§ 93.323 Inspection.

(a) All horses offered for entry from Mexico, including such horses intended for movement through the United States in bond for immediate return to Mexico, shall be inspected at a facility described in § 93.324, and all such horses found to be free from communicable disease and fever tick infestation, and not to have been exposed thereto, shall be admitted into the United States subject to the other applicable provisions of this part. Horses found to be affected with or to have been exposed to a communicable disease, or infested with fever ticks, shall be refused entry. Horses refused entry, unless exported within a time fixed in each case by the Administrator, shall be disposed of as said Administrator may direct.

(b) Horses covered by paragraph (a) of this section shall be imported through facilities described in § 93.324, which are equipped with facilities necessary for proper chute inspection, dipping, and testing, as provided in this part.

[55 FR 31495, Aug. 2, 1990, as amended at 58 FR 45238, Aug. 27, 1993. Redesignated at 62 FR 56012, 56017, Oct. 28, 1997]

§ 93.324 Detention for quarantine.

Horses intended for importation from Mexico shall be quarantined until they qualify for release from such quarantine, either at an APHIS facility designated in § 93.303 (a) or at a facility in Mexico. In order to qualify for such release, all horses while so detained shall test negative to an official test for dourine, glanders, equine piroplasmosis, equine infectious anemia, 1 and such other tests that may be required by the Administrator to determine their freedom from other communicable diseases. Such horses shall also be subjected to such other inspections and disinfections deemed necessary by the Administrator, and they shall be released from quarantine only if found to be free from any communicable disease upon inspection.

1 Protocols for testing equines in import quarantine are available on the APHIS website at www.aphis.usda.gov/aphis/ourfocus/importexport/animal-import-and-export/equine/guidelines-docs-related-to-importing-equine.

[55 FR 31495, Aug. 2, 1990, as amended at 56 FR 15489, Apr. 17, 1991; 58 FR 45238, Aug. 27, 1993; 59 FR 67614, Dec. 30, 1994; 60 FR 5128, Jan. 26, 1995; 61 FR 39853, July 31, 1996; 61 FR 52246, Oct. 7, 1996. Redesignated at 62 FR 56012, 56017, Oct. 28, 1997, as amended at 63 FR 3640, Jan. 26, 1998; 86 FR 45624, Aug. 16, 2021; 88 FR 63004, Sept. 14, 2023]

§ 93.325 Horses from Mexico.

Horses offered for entry from Mexico shall be inspected as provided in §§ 93.306 and 93.323; shall be accompanied by a certificate and otherwise handled as provided in § 93.314; and shall be quarantined and tested as provided in § 93.324: Provided, That horses offered for importation from tick-infected areas of Mexico shall be chute inspected, unless in the judgment of the inspector a satisfactory inspection can be made otherwise. If upon inspection they are found to be apparently free from fever ticks, before entering the United States they shall be dipped once in a permitted arsenical solution or be otherwise treated in a manner approved by the Administrator.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56017, Oct. 28, 1997]

§ 93.326 Horses for immediate slaughter.

Horses may be imported from Mexico, subject to the applicable provisions of §§ 93.321, 93.322, and 93.323 for immediate slaughter if accompanied by a certificate of a salaried veterinarian of the Mexican Government, or by a certificate issued by a veterinarian accredited by the Mexican Government and endorsed by a salaried veterinarian of the Mexican Government, thereby representing that the veterinarian issuing the certificate was authorized to do so, stating that he or she has inspected such horses on the premises of origin and found them free of evidence of communicable disease, and that, so far as it has been possible to determine, they have not been exposed to any such disease common to animals of their kind during the preceding 60 days, and if the horses are shipped by rail or truck, the certificate shall further specify that the horses were loaded into cleaned and disinfected cars or trucks for transportation directly to the port of entry. Such horses shall be consigned from a facility described in § 93.324 to a recognized slaughtering establishment and there slaughtered within 2 weeks from the date of entry. Such horses shall be moved from the port of entry in conveyances sealed with seals of the United States Government.

[55 FR 31495, Aug. 2, 1990, as amended at 57 FR 28080, June 24, 1992; 58 FR 45238, Aug. 27, 1993; 60 FR 5128, Jan. 26, 1995; 61 FR 39853, July 31, 1996. Redesignated and amended at 62 FR 56012, 56017, Oct. 28, 1997; 63 FR 3640, Jan. 26, 1998]

§ 93.400 Definitions.

Wherever in this subpart the following terms are used, unless the context otherwise requires, they shall be construed, respectively, to mean:

Accredited herd for brucellosis. A herd that meets APHIS' standards for accreditation for brucellosis status. Standards for accreditation are specified in import protocols.

Accredited herd for tuberculosis. A herd that meets APHIS' standards for accreditation for bovine tuberculosis status. Standards for accreditation are specified in import protocols.

Accredited veterinarian. A veterinarian approved by the Administrator in accordance with the provisions of part 161 of this title to perform functions specified in parts 1, 2, 3, and 11 of subchapter A, and subchapters B, C, and D of this chapter, and to perform functions required by cooperative state-federal disease control and eradication programs.

Administrator. The Administrator of the Animal and Plant Health Inspection Service or any other employee of the Animal and Plant Health Inspection Service, United States Department of Agriculture, to whom authority has been or may be delegated to act in the Administrator's stead.

Animal and Plant Health Inspection Service. Animal and Plant Health Inspection Service of the United States Department of Agriculture (APHIS or Service).

Animals. Cattle, sheep, goats, other ruminants, swine, horses, asses, mules, zebras, dogs, and poultry.

APHIS representative. A veterinarian or other individual employed by the Animal and Plant Health Inspection Service, United States Department of Agriculture, who is authorized to perform the services required by this part.

Area veterinarian in charge (AVIC). The veterinary official of APHIS who is assigned by the Administrator to supervise and perform the official animal health work of APHIS in the State concerned.

As a group. Collectively, in such a manner that the identity of the animals as a unique group is maintained.

Authorized USDA representative. An APHIS Veterinary Services employee, a USDA Food Safety and Inspection Service inspector, a State representative, an accredited veterinarian, or an employee of an accredited veterinarian, slaughtering establishment, or feedlot who is designated by the accredited veterinarian or management of the slaughtering establishment or feedlot to perform the function involved. In order to designate an employee to break official seals, an accredited veterinarian or the management of a slaughtering establishment or feedlot must first supply in writing the name of the designated individual to the APHIS AVIC in the State where the seals will be broken. Additionally, the management of a slaughtering establishment or feedlot must enter into an agreement with Veterinary Services in which the management of the facility agrees that only designated individuals will break the seals, that the facility will contact an APHIS representative or USDA Food Safety and Inspection Service inspector immediately if the seals are not intact when the means of conveyance arrives or if the animals being transported appear to be sick or injured due to transport conditions, and that the facility will cooperate with APHIS representatives, USDA Food Safety and Inspection Service inspectors, and State representatives in maintaining records of sealed shipments received.

Bovine. Bos taurus, Bos indicus, and Bison bison.

Bovine spongiform encephalopathy (BSE) minimal risk region. A region listed in § 94.18(a)(3) of this subchapter.

Brucellosis. Infection with or disease caused by Brucella abortus.

Brucellosis certified free herd. A herd in which all eligible cattle in the herd were negative to brucellosis tests under the Canadian requirements and which is officially certified by the Canadian Government as a brucellosis free listed herd.

Camelid. All species of the family Camelidae, including camels, guanacos, llamas, alpacas, and vicunas.

Cattle. Animals of the bovine species.

Certified status. A flock that has met requirements equivalent to the Export Certified status of the U.S. Scrapie Flock Certification Program while participating in a program under the supervision of the national veterinary authority of the region of origin, as determined by an evaluation conducted by APHIS of the program.

Cervid. All members of the family Cervidae and hybrids, including deer, elk, moose, caribou, reindeer, and related species.

Classical scrapie. Any form of scrapie that the Administrator has determined poses a significant risk of natural transmission.

Communicable disease. Any contagious, infectious, or communicable disease of domestic livestock, poultry or other animals.

Country mark. A permanent mark approved by the Administrator for identifying a sheep or goat to its country of origin.

Department. The United States Department of Agriculture (USDA).

Designated feedlot. A feedlot designated by the Administrator as one eligible to receive sheep and goats from regions not free of classical scrapie, and whose owner or legally responsible representative has signed an agreement as specified in § 93.435(c)(11) and is in full compliance with all the provisions of the agreement.

Exporting region. A region from which shipments are sent to the United States.

Federal veterinarian. A veterinarian employed and authorized by the Federal Government to perform the tasks required by this subpart.

Fever tick, Rhipicephalus annulatus, Rhipicephalus microplus, and any other species of tick determined by the Administrator to be a vector of bovine babesiosis and specified on the Internet at https://www.aphis.usda.gov/animalhealth/disease-status-of-regions.

Flock. Any group of one or more sheep or goats maintained on a single premise, or on more than one premises under the same ownership and between which unrestricted movement is allowed; or two or more groups of sheep or goats under common ownership or supervision on two or more premises that are geographically separated, but among which there is an interchange or movement of animals.

Flock of birth. The flock into which a sheep or goat is born.

Flock of residence. The flock:

(1) Within which an individual sheep or goat was born, raised, and resided until exported to the United States; or

(2) In which the sheep or goat resided for breeding purposes for 60 days or more until exported to the United States; or

(3) In which sheep and goats for export were assembled for export to the United States and maintained for at least 60 days immediately prior to export, without any addition of animals or contact with animals other than through birth, on a single premises, or on more than one premises under the same ownership and between which unrestricted movement occurred.

Goat. Any animal of the genus Capra.

Herd. Any group of one or more animals maintained on common ground; or two or more groups of animals under common ownership or supervision on two or more premises that are geographically separated, but among which there is an interchange or movement of animals.

Herd of origin. A herd of one or more sires and dams and their offspring from which animals in a consignment presented for export to the United States originate. The herd of origin may be the birth herd or the herd where the animal has resided for a minimum 4-month period immediately prior to movement, unless otherwise specified in an import criteria. Additional animals can be moved into a herd of origin during or after the 4-month qualifying period only if they:

(1) Originate from an accredited herd; or

(2) Originate from a herd of origin that tested negative to a whole herd test conducted within the last 12 months and the individual animals being moved into the herd also tested negative to any additional individual tests for tuberculosis and brucellosis required by the Administrator.

Immediate slaughter. Consignment directly from the port of entry to a recognized slaughtering establishment 1 and slaughtered within 2 weeks from the date of entry.

1 The name of recognized slaughtering establishments approved under this part may be obtained from the area veterinarian in charge for the State of destination of the shipment. The name and address of the area veterinarian in charge in any State is available from the Animal and Plant Health Inspection Service, Veterinary Services, Strategy and Policy, 4700 River Road Unit 39, Riverdale, MD 20737-1231.

Import protocol. A document issued by APHIS and provided to officials of the competent veterinary authority of an exporting region that specifies in detail the mitigation measures that will comply with the regulations in this part regarding the import of certain animals or commodities.

Individual test. A test for brucellosis or tuberculosis that is approved by the Administrator and that is administered individually in accordance with this part to ruminants that are susceptible to brucellosis or tuberculosis.

Inspector. Any individual authorized by the Administrator of APHIS or the Commissioner of Customs and Border Protection, Department of Homeland Security, to enforce the regulations in this subpart.

Killed and completely destroyed. Killed, or maintained under quarantine in a manner preventing disease spread until the animal is no longer living; and the remains have been disposed of in a manner preventing disease spread.

Lot. A group of ruminants that, while held on a conveyance or premises, has opportunity for physical contact with each other or with each other's excrement or discharges at any time between arrival at the quarantine facility and 60 days prior to export to the United States.

Lot-holding area. That area in a privately owned medium or minimum security quarantine facility in which a single lot of ruminants is held at one time.

Moved directly. Moved without unloading and without stopping except for refueling, or for traffic conditions such as traffic lights or stop signs.

Moved directly by land. Moved by rail, truck, or other land vehicle without unloading and without stopping except for refueling, or for traffic conditions such as traffic lights or stop signs.

Non-classical scrapie. Any form of scrapie the Administrator has determined poses a low risk of natural transmission.

Non-negative test results. Any test results for tuberculosis or brucellosis within the suspect, reactor, or positive range parameters of a pathogen assay that has been approved by the Administrator.

Nonquarantine area. That area of a privately owned medium or minimum security quarantine facility that includes offices, storage areas, and other areas outside the quarantine area, and that is off limits to ruminants, samples taken from ruminants, and any other objects or substances that have been in the quarantine area during the quarantine of ruminants.

Notifiable disease. A disease for which confirmed or suspected occurrences within a region must be reported to the competent veterinary authority or other competent authority of that region.

Official identification device or method. A means of officially identifying an animal or group of animals using devices or methods approved by the Administrator, including, but not limited to, official tags, tattoos, and registered brands when accompanied by a certificate of inspection from a recognized brand inspection authority. For animals intended for importation into the United States, the device or method of identification used must have been approved by the Administrator for that type of import before the animal is exported to the United States.

Officially identified. Individually identified by means of an official identification device or method.

Operator. A person other than the Federal Government who owns or operates, subject to APHIS' approval and oversight, a privately owned medium or minimum security quarantine facility.

Permitted dip. A dip permitted by the Administrator to be used in the official dipping of cattle for fever ticks and for dipping cattle and sheep for scabies.

Persons. Any individual, corporation, company, association, firm, partnership, society or joint stock company.

Port Veterinarian. A veterinarian employed by the Animal and Plant Health Inspection Service to perform duties required under this part at a port of entry.

Positive for a transmissible spongiform encephalopathy. A sheep or goat for which a diagnosis of a transmissible spongiform encephalopathy has been made.

Premises of origin. Except as otherwise used in § 93.423 of this subpart, the premises where the animal was born.

Prevalence. The number of affected herds occurring during the period specified in §§ 93.437 and 93.440. In some instances, the Administrator may allow calculation of prevalence based on affected herd-years to avoid penalizing regions with small herd numbers.

Privately owned medium security quarantine facility (medium security facility). A facility that:

(1) Is owned, operated, and financed by a person other than the Federal Government;

(2) Is subject to the strict oversight of APHIS representatives;

(3) Is constructed, operated, and maintained in accordance with the requirements for medium security facilities in § 93.412(d); and

(4) Provides the necessary level of quarantine services for the holding of ruminants in an indoor, vector-proof environment prior to the animals' entry into the United States. Quarantine services would have to include testing or observation for any OIE listed diseases and other livestock diseases exotic to the United States, as well as any other diseases, as necessary, to be determined by the Administrator.

Privately owned minimum security quarantine facility (minimum security facility). A facility that:

(1) Is owned, operated, and financed by a person other than the Federal Government;

(2) Is subject to the strict oversight of APHIS representatives;

(3) Is constructed, operated, and maintained in accordance with the requirements for minimum security facilities in § 93.412(d);

(4) Is used for the quarantine of ruminants that pose no significant risk, as determined by the Administrator, of introducing or transmitting to the U.S. livestock population any livestock disease that is biologically transmissible by vectors; and

(5) Provides the necessary level of quarantine services for the outdoor holding of ruminants, prior to the animals' entry into the United States. Quarantine services would have to include testing or observation for any OIE listed diseases and other livestock diseases exotic to the United States, as well as any other diseases, as necessary, to be determined by the Administrator.

Processed animal protein. Meat meal, bone meal, meat-and-bone meal, blood meal, dried plasma and other blood products, hydrolyzed protein, hoof meal, horn meal, poultry meal, feather meal, fish meal, and any other similar products.

Quarantine area. That area of a privately owned medium or minimum security quarantine facility that comprises all of the lot-holding areas in the facility and any other areas in the facility that ruminants have access to, including loading docks for receiving and releasing ruminants, and any areas used to conduct examinations of ruminants and take samples and any areas where samples are processed or examined.

Recognized slaughtering establishment. Any slaughtering establishment operating under the provisions of the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) or a State meat inspection act. 2

2 See footnote 1.

Region. Any defined geographic land area identifiable by geological, political, or surveyed boundaries. A region may consist of any of the following:

(1) A national entity (country);

(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.);

(3) Parts of several national entities combined into an area; or

(4) A group of national entities (countries) combined into a single area.

Ruminants. All animals which chew the cud, such as cattle, buffaloes, sheep, goats, deer, antelopes, camels, llamas and giraffes.

Sheep. Any animal of the genus Ovis.

Spayed heifer. A female bovine that has been neutered in a manner otherwise approved by the Administrator and specified in an import protocol.

State representative. A veterinarian or other person employed in livestock sanitary work by a State or political subdivision of a State who is authorized by such State or political subdivision of a State to perform the function involved under a memorandum of understanding with APHIS.

State veterinarian. A veterinarian employed and authorized by a State or political subdivision of a State to perform the tasks required by this subpart.

Steer. A sexually neutered male bovine.

Swine. The domestic hog and all varieties of wild hogs.

Temporary inspection facility. A temporary facility that is constructed of metal panels that can be erected and broken down alongside the transportation vessel carrying ruminants that are imported into the United States in accordance with § 93.408 of this subpart and that will be quarantined at a minimum or medium security quarantine facilities located more than 1 mile from the port of entry.

Transmissible spongiform encephalopathies (TSEs). A family of progressive and generally fatal neurodegenerative disorders thought to be caused by abnormal proteins, called prions, typically producing characteristic microscopic changes, including, but not limited to, non-inflammatory neuronal loss, giving a spongiform appearance to tissues in the brains and central nervous systems of affected animals.

TSE-affected sheep or goat. A sheep or goat suspected or known by the national veterinary authority of the region of origin to be infected with a transmissible spongiform encephalopathy prior to the disposal of the animal.

Tuberculosis. Infection with or disease caused by Mycobacterium bovis.

United States. All of the States of the United States, the District of Columbia, Guam, Northern Mariana Islands, Puerto Rico, the Virgin Islands of the United States, and all other Territories and Possessions of the United States.

Veterinary Services. The Veterinary Services unit of the Department.

Wether. A castrated male sheep or goat.

Whole herd test for brucellosis. A brucellosis test that has been approved by APHIS of all sexually intact bovines in a herd of origin that are 6 months of age or older, and of all sexually intact bovines in the herd of origin that are less than 6 months of age and were not born into the herd of origin, except those sexually intact bovines that are less than 6 months of age and originate directly from a currently accredited herd for brucellosis.

Whole herd test for tuberculosis. A tuberculosis test that has been approved by APHIS of all bovines in a herd of origin that are 6 months of age or older, and of all bovines in the herd of origin that are less than 6 months of age and were not born into the herd of origin, except those bovines that are less than 6 months of age and originate directly from a currently accredited herd for tuberculosis.

World Organization for Animal Health (OIE). The international organization recognized by the World Trade Organization for setting animal health standards, reporting global animal situations and disease status, and presenting guidelines and recommendations on sanitary measures related to animal health.

Zoological park. A professionally operated zoo, park, garden or other place, maintained under the constant surveillance of a Doctor of Veterinary Medicine, for the exhibition of live animals, pigeons or birds, for the purpose of public recreation or education.

[55 FR 31495, Aug. 2, 1990. Redesignated at 62 FR 56012, Oct. 28, 1997]

Editorial Note:For Federal Register citations affecting § 93.400, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

§ 93.401 General prohibitions; exceptions.

(a) General provisions. No ruminant or product subject to the provisions of this part shall be brought into the United States except in accordance with the regulations in this part and part 94 of this subchapter; 3 nor shall any such ruminant or product be handled or moved after physical entry into the United States before final release from quarantine or any other form of governmental detention except in compliance with such regulations. Notwithstanding any other provision of this subpart, the importation of any ruminant that is not a bovine, camelid, cervid, sheep, or goat is prohibited. Provided, however, the Administrator may upon request in specific cases permit ruminants or products of such to be brought into or through the United States under such conditions as he or she may prescribe, when he or she determines in the specific case that such action will not endanger the livestock of the United States.

3 Importations of certain animals from various regions are absolutely prohibited under part 94 because of specified diseases.

(b) Ruminants in transit. Except for ruminants prohibited entry, the provisions in this part relating to ruminants shall not apply to healthy ruminants in transit through the United States if they are not known to be infected with or exposed, within 60 days preceding the date of export from the region of origin, to communicable diseases of such ruminants, if an import permit 4 has been obtained under § 93.404 of this chapter and all conditions therein are observed; and if such ruminants are handled as follows:

4 Such permit may be obtained from the Animal and Plant Health Inspection Service, Veterinary Services, Strategy and Policy, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231. Requests for approval of such facilities should also be made to the Administrator.

(1)(i) They are maintained under continuous confinement in transit through the United States aboard an aircraft, ocean vessel, or other means of conveyance; or

(ii) They are unloaded, in the course of such transit, into a ruminant holding facility which is provided by the carrier or its agent and has been approved 5 in advance by the Administrator in accordance with paragraph (b)(3) of this section as adequate to prevent the spread within the United States of any livestock disease, and they are maintained there under continuous confinement until loaded aboard a means of conveyance for transportation from the United States and are maintained under continuous confinement aboard such means of conveyance until it leaves the United States; the import permit will specify any additional conditions necessary to assure that the transit of the ruminants through the United States can be made without endangering the livestock or poultry of the United States, and that Department inspectors may inspect the ruminants on board such means of conveyance or in such holding facility to ascertain whether the requirements of this paragraph are met, and dispose of them in accordance with the Animal Health Protection Act (7 U.S.C. 8301 et seq.) if such conditions are not met; and

5 See footnote 4 to subpart D.

(2) The carrier or its agent executes and furnishes to the collector of Customs at the first port of arrival a declaration stating that the ruminants will be retained aboard such means of conveyance or in an approved holding facility during transshipment as required by this paragraph.

(3) Provisions for the approval of facilities required in this paragraph are:

(i) They must be sufficiently isolated to prevent direct or indirect contact with all other animals and birds while in the United States.

(ii) They must be so constructed that they provide adequate protection against environmental conditions and can be adequately cleaned, washed and disinfected.

(iii) They must provide for disposal of ruminant carcasses, manure, bedding, waste and any related shipping materials in a manner that will prevent dissemination of disease.

(iv) They must have provisions for adequate sources of feed and water and for attendants for the care and feeding of ruminants in the facility.

(v) They must comply with additional requirements as may be imposed by the Administrator if deemed applicable for a particular shipment.

(vi) They must also comply with all applicable local, State and Federal requirements for environmental quality and with the provisions of the Animal Welfare Regulations in chapter I of this title, as applicable.

(c) Removal and loss of official identification devices. Official identification devices are intended to provide permanent identification of livestock and to ensure the ability to find the source of animal disease outbreaks. Removal of these devices is prohibited except at the time of slaughter. If an official identification device is lost, and it is necessary to retag an animal with a new official number, every effort should be made to correlate the new official number with the previous official number of the animal.

(d) Cleaning and disinfection prior to shipment. A means of conveyance used to transport an animal to the United States in accordance with this subpart must be cleaned and disinfected in a manner specified within an import protocol prior to transport, unless an exemption has been granted by the Administrator.

[55 FR 31495, Aug. 2, 1990, as amended at 59 FR 67614, Dec. 30, 1994. Redesignated and amended at 62 FR 56012, 56017, Oct. 28, 1997; 68 FR 6344, Feb. 7, 2003; 68 FR 31940, May 29, 2003; 69 FR 64651, Nov. 8, 2004; 78 FR 72996, Dec. 4, 2013; 85 FR 57952, Sept. 17, 2020; 86 FR 45624, Aug. 16, 2021; 86 FR 68857, Dec. 3, 2021]

§ 93.402 Inspection of certain aircraft and other means of conveyance and shipping containers thereon; unloading, cleaning, and disinfection requirements.

(a) Inspection: All aircraft and other means of conveyance (including shipping containers thereon) moving into the United States from any foreign region are subject to inspection without a warrant by properly identified and designated inspectors to determine whether they are carrying any animal, carcass, product or article regulated or subject to disposal under any law or regulation administered by the Secretary of Agriculture for prevention of the introduction or dissemination of any communicable animal disease.

(b) Unloading requirements: Whenever in the course of any such inspection at any port in the United States the inspector has reason to believe that the means of conveyance or container is contaminated with material of animal (including poultry) origin, such as, but not limited to, meat, organs, glands, extracts, secretions, fat, bones, blood, lymph, urine, or manure, so as to present a danger of the spread of any communicable animal disease, the inspector may require the unloading of the means of conveyance and the emptying of the container if he or she deems it necessary to enable him or her to determine whether the means of conveyance or container is in fact so contaminated. The principal operator of the means of conveyance and his or her agent in charge of the means of conveyance shall comply with any such requirement under the immediate supervision of, and in the time and manner prescribed by, the inspector.

(c) Cleaning and disinfection: Whenever, upon inspection under this section, an inspector determines that a means of conveyance or shipping container is contaminated with material of animal origin so as to present a danger of the spread of any communicable animal disease, he or she shall notify the principal operator of the means of conveyance or his or her agent in charge, of such determination and the requirements under this section. The person so notified shall cause the cleaning and disinfection of such means of conveyance and container under the immediate supervision of, and in the time and manner prescribed by, the inspector.

(d) For purposes of this section, the term “shipping container” means any container of a type specially adapted for use in transporting any article on the means of conveyance involved.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56017, Oct. 28, 1997; 68 FR 6344, Feb. 7, 2003]

§ 93.403 Ports designated for the importation of ruminants.

(a) Air and ocean ports. The following ports have APHIS inspection and quarantine facilities necessary for quarantine stations and all ruminants shall be entered into the United States through these stations, except as provided in paragraphs (b), (c), (d), (e), and (f) of this section; Miami, Florida; and Newburgh, New York.

(b) Canadian border ports. The following land border ports are designated as having the necessary inspection facilities for the entry of ruminants from Canada: Eastport, Idaho; Houlton and Jackman, Maine; Detroit, Port Huron, and Sault Ste. Marie, Michigan; Baudette, Minnesota; Opheim, Raymond, and Sweetgrass, Montana; Alexandria Bay, Buffalo, and Champlain, New York; Dunseith, Pembina, and Portal, North Dakota; Derby Line and Highgate Springs, Vermont; Oroville and Sumas, Washington.

(c) Mexican border ports. The following land border ports are designated as having the necessary inspection facilities for the entry of ruminants from Mexico: Brownsville, Hidalgo, Laredo, Eagle Pass, Del Rio, and Presidio, Texas: Douglas, Naco, Nogales, Sasabe, and San Luis, Arizona; Calexico and San Ysidro, California; and Antelope Wells, Columbus, and Santa Teresa, New Mexico.

(d) Special ports. Charlotte Amalie, St. Thomas, and Christiansted, St. Croix, in the United States Virgin Islands, are hereby designated as quarantine stations for the entry of ruminants from the British Virgin Islands into the United States Virgin Islands for immediate slaughter.

(e) Limited ports. The following ports are designated as having inspection facilities for the entry of ruminants and ruminant products such as ruminant test specimens which do not appear to require restraint and holding inspection facilities: Anchorage and Fairbanks, Alaska; San Diego, California; Jacksonville, St. Petersburg-Clearwater, and Tampa, Florida; Atlanta, Georgia; Honolulu, Hawaii, Chicago, Illinois; New Orleans, Louisiana; Portland, Maine; Baltimore, Maryland; Boston, Massachusetts; Minneapolis, Minnesota; Great Falls, Montana; Portland, Oregon; San Juan, Puerto Rico; Memphis, Tennessee (no live animals); El Paso, Galveston, and Houston, Texas; and Seattle, Spokane, and Tacoma, Washington.

(f) Designation of other ports. The Secretary of the Treasury has approved the designation as quarantine stations of the ports specified in this section. In special cases other ports may be designated as quarantine stations under this section by the Administrator, with the concurrence of the Secretary of the Treasury.

(g) Ports and privately owned quarantine facilities. Ruminants may be imported into the United States at any port specified in paragraph (a) of this section, or at any other port designated as an international port or airport by the Bureau of Customs and Border Protection, and quarantined at an APHIS-approved privately owned quarantine facility, provided the applicable provisions of §§ 93.401, 93.404(a), 93.407, 93.408, and 93.412 are met.

[55 FR 31495, Aug. 2, 1990, as amended at 57 FR 2010, Jan. 17, 1992; 58 FR 38283, July 16, 1993; 60 FR 16045, Mar. 29, 1995; 60 FR 25120, May 11, 1995. Redesignated and amended at 62 FR 56012, 56017, Oct. 28, 1997; 64 FR 23179, Apr. 30, 1999; 65 FR 38178, June 20, 2000; 67 FR 68022, Nov. 8, 2002; 71 FR 29773, May 24, 2006]

§ 93.404 Import permits for ruminants and for ruminant test specimens for diagnostic purposes; and reservation fees for space at quarantine facilities maintained by APHIS.

(a) Application for permit; reservation required. (1) For ruminants and ruminant test specimens for diagnostic screening purposes intended for importation from any part of the world, except as otherwise provided for in §§ 93.417, 93.422, and 93.424, the importer shall first apply for and obtain from APHIS an import permit. The application shall specify the name and address of the importer; the species, breed, number or quantity of ruminants or ruminant test specimens to be imported; the purpose of the importation; individual ruminant identification, which includes a description of the ruminant, name, age, markings, if any, registration number, if any, and tattoo or eartag; the region of origin; for cattle, the address of or other means of identifying the premises of the herd of origin and any other premises where the cattle resided prior to export, including the State or its equivalent, the municipality or nearest city, and the specific location of the premises, or an equivalent method, approved by the Administrator, of identifying the location of the premises; the name and address of the exporter; the port of embarkation in the foreign region; the mode of transportation, route of travel, and the port of entry in the United States; the name and address of the quarantine facility, if the ruminants are to be quarantined at a privately owned quarantine facility; the proposed date of arrival of the ruminants or ruminant test specimens to be imported; and the name of the person to whom the ruminants or ruminant test specimens will be delivered and the location of the place in the United States to which delivery will be made from the port of entry. Additional information may be required in the form of certificates concerning specific diseases to which the ruminants are susceptible, as well as vaccinations or other precautionary treatments to which the ruminants or ruminant test specimens have been subjected. Notice of any such requirement will be given to the applicant in each case.

(2) In addition to the requirements in paragraph (a)(1) of this section, the importer must submit the following information along with the application for an import permit:

(i) For sheep or goats imported for immediate slaughter, or for restricted feeding for slaughter:

(A) The slaughter establishment to which the animals will be imported; or

(B) The designated feedlot in which sheep and goats imported for restricted feeding for slaughter will be maintained until moved to slaughter.

(ii) For sheep and goats imported for purposes other than immediate slaughter or restricted feeding for slaughter:

(A) The flock identification number, if imported to a flock, and the premises or location identification number, of the flock or other premises to which the animals are imported as listed in the Scrapie National Database.

(B) For sheep and goats from regions not free from classical scrapie, the importer must provide documentation that the animal has reached and maintained certified status in a scrapie flock certification program determined by the Administrator to provide equivalent risk reduction as the Export Category of the U.S. Scrapie Flock Certification Program. The documentation must specify the address, or other means of identification, of the premises and flock of birth, and any other flock(s) in which the animals have resided.

(3) An application for permit to import will be denied for domestic ruminants from any region designated in § 94.1 of this chapter as a region where foot-and-mouth disease exists.

(4) An application for permit to import ruminants may also be denied because of: Communicable disease conditions in the area or region of origin, or in a region where the shipment has been or will be held or through which the shipment has been or will be transported; deficiencies in the regulatory programs for the control or eradication of animal diseases and the unavailability of veterinary services in the above mentioned regions; the importer's failure to provide satisfactory evidence concerning the origin, history, and health status of the ruminants; the lack of satisfactory information necessary to determine that the importation will not be likely to transmit any communicable disease to livestock or poultry of the United States; or any other circumstances which the Administrator believes require such denial to prevent the dissemination of any communicable disease of livestock or poultry into the United States.

(5) In specific cases, a permit may be issued for ruminants that would otherwise be prohibited importation due to TSEs pursuant to this subpart, if the Administrator determines the disease risk posed by the animals can be adequately mitigated through pre-entry or post-entry mitigation measures, or through combinations of such measures. These measures will be specified in the permit. If it is determined prior to or after importation that any pre-entry or post-entry requirements were not met, or the ruminants are affected with or have been exposed to TSEs, the ruminants, their progeny, and any other ruminants that have been housed with or exposed to the ruminants will be disposed of or otherwise handled as directed by the Administrator. Importers seeking a permit pursuant to this paragraph (a)(5) must send their request to the Administrator, c/o Strategy and Policy, VS, APHIS, 4700 River Road Unit 39, Riverdale, MD 20737-1231, or via the APHIS website at https://www.aphis.usda.gov/import_export/animals/live_animals.shtml.

(6) The Administrator may issue permits under paragraph (a)(5) of this section for male sheep determined to be AA at codon 136 and either RR, HR, KR, or QR at codon 171 and for female sheep determined to be AA at codon 136 and RR at codon 171 by the National Veterinary Services Laboratories or another laboratory approved by the Administrator. Such sheep must meet all requirements in this part for import other than the requirement that they originate in a flock or region free of classical scrapie. The permit will provide for post entry confirmation of the animal's scrapie susceptibility genotype and/or genetic testing for identity.

(7)(i) The importer or importer's agent shall pay or ensure payment of a reservation fee for each lot of ruminants to be quarantined in a facility maintained by USDA. For ruminants, the reservation fee shall be 100 percent of the cost of providing care, feed, and handling during quarantine, as estimated by the quarantine facility's veterinarian in charge.

(ii) At the time the importer or the importer's agent requests a reservation of quarantine space, the importer or importer's agent shall pay the reservation fee by check or U.S. money order or ensure payment of the reservation fee by an irrevocable letter of credit from a commercial bank (the effective date on such letter of credit shall run to 30 days after the date the ruminants are scheduled to be released from quarantine); except that anyone who issues a check to the Department for a reservation fee which is returned because of insufficient funds shall be denied any further request for reservation of a quarantine space until the outstanding amount is paid.

(iii) Any reservation fee paid by check or U.S. money order shall be applied against the expenses incurred for services received by the importer or importer's agent in connection with the quarantine for which the reservation was made. Any part of the reservation fee which remains unused after being applied against the expenses incurred for services received by the importer or the importer's agent in connection with the quarantine for which the reservation was made, shall be returned to the individual who paid the reservation fee. If the reservation fee is ensured by a letter of credit, the Department will draw against the letter of credit unless payment for services received by the importer or importer's agent in connection with the quarantine is otherwise made at least 3 days prior to the expiration date of the letter of credit.

(iv) Any reservation fee shall be forfeited if the importer or the importer's agent fails to present for entry, within 24 hours following the designated time of arrival, the lot of ruminants for which the reservation was made: Except that a reservation fee shall not be forfeited if:

(A) Written notice of cancellation from the importer or the importer's agent is received by the office of the veterinarian in charge of the quarantine facility 6 during regular business hours (8:00 a.m. to 4:30 p.m. Monday through Friday, excluding holidays) no later than 15 days for ruminants prior to the beginning of the time of importation as specified in the import permit or as arranged with the veterinarian in charge of the quarantine facility if no import permit is required (the 15 days period shall not include Saturdays, Sundays, or holidays), or

6 The addresses of USDA quarantine facilities may be found in telephone directories listing the facilities or by contacting the Animal and Plant Health Inspection Service, Veterinary Services, Strategy and Policy, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231.

(B) The Administrator determines that services, other than provided by carriers, necessary for the importation of the ruminants within the requested period are unavailable because of unforeseen circumstances as determined by the Administrator, (such as the closing of an airport due to inclement weather or the unavailability of the reserved space due to the extension of another quarantine).

(v) If the reservation fee was ensured by a letter of credit and the fee is to be forfeited under paragraph (a)(7)(iv) of this section, the Department will draw against the letter of credit unless the reservation fee is otherwise paid at least 3 days prior to the expiration date of the letter of credit.

(vi) When a reservation is cancelled in accordance with paragraph (a)(7)(iv)(A) of this section and the provisions of paragraph (a)(7)(iv)(B) of this section do not apply, a $40.00 cancellation fee shall be charged. If a reservation fee was paid, the cancellation fee shall be deducted from any reservation fee returned to the importer or the importer's agent. If the reservation fee was ensured by a letter of credit, the Department will draw the amount of the cancellation fee against the letter of credit unless the cancellation fee is otherwise paid at least 3 days prior to the expiration date of the letter of credit.

(b) Permit. When a permit is issued, the original and two copies will be sent to the importer. It shall be the responsibility of the importer to forward the original permit and one copy to the shipper in the region of origin, and it shall also be the responsibility of the importer to insure that the shipper presents the copy of the permit to the carrier and makes proper arrangements for the original permit to accompany the shipment to the specified U.S. port of entry for presentation to the collector of customs. Ruminants and ruminant test specimens for diagnostic screening purposes for ruminants intended for importation into the United States for which a permit has been issued, will be received at the specified port of entry within the time prescribed in the permit which shall not exceed 14 days from the first day that the permit is effective for all permits. Ruminants and ruminant test specimens for which a permit is required by these regulations will not be eligible for entry if a permit has not been issued; if unaccompanied by such a permit; if shipment is from any port other than the one designated in the permit; if arrival in the United States is at any port other than the one designated in the permit; if the ruminants or ruminant test specimens offered for entry differ from those described in the permit; if the ruminants or ruminant test specimens are not handled as outlined in the application for the permit and as specified in the permit issued; or if ruminants or swine other than those covered by import permits are aboard the transporting carrier.

(c) Wild ruminants from regions where foot-and-mouth disease exists. This paragraph (c) applies to the importation of wild ruminants, such as, but not limited to, giraffes, deer and antelopes, from regions designated in part 94 of this subchapter as countries in which foot-and-mouth disease exists.

(1) Permits for the importation of wild ruminants will be issued only for importations through the Port of New York, and only if the animals are imported for exhibition in a PEQ Zoo. A PEQ Zoo is a zoological park or other place maintained for the exhibition of live animals for recreational or educational purposes that:

(i) Has been approved by the Administrator in accordance with paragraph (c)(2) of this section to receive and maintain imported wild ruminants; and

(ii) Has entered into the agreement with APHIS set forth in paragraph (c)(4) of this section for the maintenance and handling of imported wild ruminants.

(2) Approval of a PEQ Zoo shall be on the basis of an inspection, by an authorized representative of the Department, of the physical facilities of the establishment and its methods of operation. Standards for acceptable physical facilities shall include satisfactory pens, cages, or enclosures in which the imported ruminants can be maintained so as not to be in contact with the general public and free from contact with domestic livestock; natural or established drainage from the PEQ Zoo which will avoid contamination of land areas where domestic livestock are kept or with which domestic livestock may otherwise come in contact; provision for the disposition of manure, other wastes, and dead ruminants within the PEQ Zoo; and other reasonable facilities considered necessary to prevent the dissemination of diseases from the PEQ Zoo. The operator of the PEQ Zoo shall have available the services of a full-time or part-time veterinarian, or a veterinarian on a retainer basis, who shall make periodic examinations of all animals maintained at the PEQ Zoo for evidence of disease; who shall make a post-mortem examination of each animal that dies; and who shall make a prompt report of suspected cases of contagious or communicable diseases to an APHIS representative or the State agency responsible for livestock disease control programs.

(3) Manure and other animal wastes must be disposed of within the PEQ Zoo park for a minimum of one year following the date an imported wild ruminant enters the zoo. If an APHIS veterinarian determines that an imported ruminant shows no signs of any communicable disease or exposure to any such disease during this 1-year period, its manure and other wastes need not be disposed of within the zoo after the 1-year period. If, however, an APHIS veterinarian determines that an imported ruminant does show signs of any communicable disease during this 1-year period, an APHIS veterinarian will investigate the disease and determine whether the ruminant's manure and other wastes may safely be disposed of outside the zoo after the 1-year period has ended.

(4) Prior to the issuance of an import permit under this section, the operator of the approved PEQ Zoo to which the imported ruminants are to be consigned, and the importer of the ruminants, if such operator and importer are different parties, shall execute an agreement covering each ruminant or group of ruminants for which the import permit is requested. The agreement shall be in the following form:

Agreement for the Importation, Quarantine and Exhibition of Certain Wild Ruminants and Wild Swine

________, operator(s) of the zoological park known as ____________________ (Name) located at ____________________ (City and state), and ____________________ (Importer) hereby request a permit for the importation of ________ (Number and kinds of animals) for exhibition purposes at the said zoological park, said animals originating in a region where foot-and-mouth disease exists and being subject to restrictions under regulations contained in part 93, title 9, Code of Federal Regulations.

In making this request, it is understood and agreed that:

1. The animals for which an import permit is requested will be held in isolation at a port of embarkation in the region of origin, approved by the Administrator as a port having facilities which are adequate for maintaining wild animals in isolation from all other animals and having veterinary supervision by officials of the region of origin of the animals. Such animals will be held in such isolation for not less than 60 days under the supervision of the veterinary service of that region to determine whether the animals show any clinical evidence of foot-and-mouth disease, or other communicable disease that is exotic to the United States or for which APHIS has an eradication or control program in 9 CFR chapter I, and to assure that the animals will not have been exposed to such a disease within the 60 days next before their exportation from that region.

2. Shipment will be made direct from such port of embarkation to the port of New York as the sole port of entry in the United States. If shipment is made by ocean vessel the animals will not be unloaded in any foreign port en route. If shipment is made by air, the animals will not be unloaded at any port or other place of landing, except at a port approved by the Administrator as a port not located in a region where foot-and-mouth disease exists or as a port in such a region having facilities and inspection adequate for maintaining wild animals in isolation from all other animals.

3. No ruminants or swine will be aboard the transporting vehicle, vessel or aircraft, except those for which an import permit has been issued.

4. The animals will be quarantined for not less than 30 days in the Department's Animal Import Center in Newburgh, New York.

5. Upon release from quarantine the animals will be delivered to the zoological park named in this agreement to become the property of the park and they will not be sold, exchanged or removed from the premises without the prior consent of APHIS. If moved to another zoological park in the United States, the receiving zoological park must be approved by the Administrator in accordance with paragraph 6 of this agreement.

6. The Administrator will approve the movement of an imported animal subject to this agreement if the Administrator determines that the animal has spent at least one year in quarantine in a PEQ Zoo following importation without showing clinical evidence of foot-and-foot mouth disease, or other communicable disease that is exotic to the United States or for which APHIS has an eradication or control program in 9 CFR chapter I, and determines that the receiving zoological park is accredited by the American Zoo and Aquarium Association (AZA), or the receiving zoological park has facilities and procedures in place related to preventing the spread of communicable animal diseases (including but not limited to procedures for animal identification, record keeping, and veterinary care) that are equivalent to those required for AZA accreditation. The Administrator will approve the movement of a carcass, body part, or biological specimen derived from an imported animal subject to this agreement if the Administrator determines that the animal has spent at least one year in quarantine in a PEQ Zoo following importation without showing clinical evidence of foot-and-foot mouth disease, or other communicable disease that is exotic to the United States or for which APHIS has an eradication or control program in 9 CFR chapter I, and determines that the carcass, body part, or biological specimen will be moved only for scientific research or museum display purposes.

(Signature of importer)

Subscribed and sworn to before me this ____ day of ____, ____.

(Title or designation) (Name of zoological park) By (Signature of officer of zoological park) (Title of officer)

Subscribed and sworn to before me this ____ day of ____,____

(Title or designation)

(Approved by the Office of Management and Budget under control numbers 0579-0040, 0579-0224, and 0579-0453)

[55 FR 31495, Aug. 2, 1990, as amended at 59 FR 28216, June 1, 1994; 59 FR 31924, June 21, 1994; 59 FR 67615, Dec. 30, 1994; 62 FR 23637, May 1, 1997. Redesignated and amended at 62 FR 56012, 56018, Oct. 28, 1997; 65 FR 38178, June 20, 2000; 68 FR 6344, Feb. 7, 2003; 68 FR 35533, June 16, 2003; 71 FR 29773, May 24, 2006; 83 FR 15492, Apr. 11, 2018; 86 FR 45624, Aug. 16, 2021; 86 FR 68857, Dec. 3, 2021]

§ 93.405 Health certificate for ruminants.

(a) Issuance and required information. All ruminants intended for importation from any part of the world, except as provided in §§ 93.423(c) and 93.428(d), shall be accompanied by a certificate issued by a full-time salaried veterinary officer of the national government of the region of origin, or issued by a veterinarian designated or accredited by the national government of the region of origin and endorsed by a full-time salaried veterinary officer of the national government of the region of origin, representing that the veterinarian issuing the certificate was authorized to do so. The certificate shall state:

(1) That the ruminants have been kept in that region during the last 60 days immediately preceding the date of shipment to the United States, and that during this time the region has been entirely free from foot-and-mouth disease, contagious pleuropneumonia, and surra; provided, however, that for wild ruminants for exhibition purposes, the certificate need specify only that the district of origin has been free from the listed diseases; and provided further, that for sheep and goats, with respect to contagious pleuropneumonia, the certificate may specify only that the district of origin has been free from this disease;

(2) That the ruminants are not in quarantine in the region of origin; and

(3) If the ruminants are from any region where screwworm is considered to exist, the ruminants may be imported into the United States only if they meet the requirements of paragraphs (a)(3)(i) through (iv) of this section and all other applicable requirements of this part. APHIS maintains a list of regions where screwworm is considered to exist on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/animal-health-status-of-regions. Copies of the list can be obtained via postal mail or email upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; AskRegionalization@usda.gov. APHIS will add a region to the list upon determining that screwworm exists in the region based on reports APHIS receives of detections of the pest from veterinary officials of the exporting country, from the World Organization for Animal Health (OIE), or from other sources the Administrator determines to be reliable. APHIS will remove a region from the list after conducting an evaluation of the region in accordance with § 92.2 of this subchapter and finding that screwworm is not present in the region. In the case of a region formerly not on this list that is added due to a detection, the region may be removed from the list in accordance with the procedures for reestablishment of a region's disease-free status in § 92.4 of this subchapter.

(i) A veterinarian must treat the ruminants with ivermectin 3 to 5 days prior to the date of export to the United States according to the recommended dose prescribed on the product's label.

(ii) The ruminants must be fully examined for screwworm by a full-time salaried veterinary official of the exporting country within 24 hours prior to shipment to the United States. If ruminants are found to be infested with screwworm, they must be treated until free from infestation.

(iii) At the time ruminants are loaded onto a means of conveyance for export, a veterinarian must treat any visible wounds on the animals with a solution of coumaphos dust at a concentration of 5 percent active ingredient.

(iv) The ruminants must be accompanied to the United States by a certificate signed by a full-time salaried veterinary official of the exporting country. The certificate must state that the ruminants have been thoroughly examined and found free of screwworm and that the ruminants have been treated in accordance with paragraphs (a)(3)(i) and (a)(3)(iii) of this section.

(b) Sheep and goats—(1) Information required. In addition to the statements required by paragraph (a) of this section, the certificate accompanying sheep or goats from any part of the world must also include the name and address of the importer; the number or quantity of sheep or goats to be imported; the purpose of the importation; the official individual sheep or goat identification applied to the animals; and, when required by § 93.435, the permanent country mark and other identification present on the animal, including registration number, if any; a description of each sheep or goat linked to the official identification number, including age, sex, breed, color, and markings, if any; the flock of residence; the address (including street, city, State, and ZIP Code) of the destination where the sheep or goats are to be physically located after importation, including the premises or location identification number assigned in the APHIS National Scrapie Database and when applicable the flock identification number; the name and address of the exporter; the port of embarkation in the region of export; the mode of transportation, route of travel and port of entry in the United States; and, for sheep or goats imported for purposes other than immediate slaughter or restricted feeding for slaughter, the certificate must specify the region of origin and, for regions not free of scrapie, the address or other identification of the premises and flock of birth, and any other flock in which the animals have resided.

(2) Additional statements. The certificate accompanying sheep or goats from any part of the world, except as provided in paragraph (b)(4) of this section for sheep or goats imported for immediate slaughter, and in paragraph (b)(5) of this section for sheep or goats for restricted feeding for slaughter, must also state that:

(i) The sheep or goats originated from a region recognized as free of classical scrapie by APHIS; or the animals have reached and maintained certified status or equivalent status in a scrapie flock certification program or equivalent program approved by APHIS;

(ii) The sheep or goats have not commingled with sheep or goats of a lower health status, or resided on the premises of a flock or herd of lower health status, after leaving the flock of residence and prior to arrival in the United States;

(iii) Any enclosure, container or conveyance in which the sheep or goats had been placed during the export process, and which had previously held sheep or goats, was cleaned and disinfected in accordance with § 54.7(e)(2) of this chapter prior to being used for the sheep or goats;

(iv) None of the female sheep or goats is carrying an implanted embryo from a lower health status flock; or that any implanted embryo meets the requirements for import into the United States when implanted, and documentation as required in part 98 of this subchapter is attached;

(v) The veterinarian issuing the certificate has inspected the sheep or goats, and their flock(s) of residence, within 30 days of consignment for import to the United States, and found the animals and the flock(s) of residence to be free of any evidence of infectious or contagious disease;

(vi) As far as it is possible for the veterinarian who inspects the animals to determine, none of the sheep or goats in the flock(s) of residence has been exposed to any infectious or contagious disease during the 60 days immediately preceding shipment to the United States; and

(vii) The animals' movement is not restricted within the country of origin due to animal health reasons.

(3) Test results. The certificate accompanying sheep or goats from any part of the world, except as provided in paragraph (b)(4) of this section for sheep or goats imported for immediate slaughter, or in paragraph (b)(5) of this section for sheep or goats for restricted feeding for slaughter, must also include:

(i) The results of any testing required in the import permit; and

(ii) Any other information required in the import permit.

(4) Sheep or goats imported for immediate slaughter. For sheep or goats imported for immediate slaughter, in addition to the statements required under paragraph (a) of this section, the certificate must include statements that:

(i) The region where the sheep or goats originated is recognized as free of classical scrapie by APHIS; or

(ii) The region where the sheep or goats originated has not been recognized as free of classical scrapie by APHIS but the following criteria have been met:

(A) TSEs in sheep and goats are compulsorily notifiable to the national veterinary authority of the region;

(B) An effective classical scrapie awareness, surveillance, monitoring, and control system is in place;

(C) TSE-affected sheep and goats are killed and completely destroyed;

(D) The sheep and goats selected for export showed no clinical sign of scrapie on the day of shipment and are fit for travel;

(E) The sheep and goats have not tested positive for, and are not suspect for, a transmissible spongiform encephalopathy; and

(F) The animals' movement is not restricted within the country of origin due to animal health reasons.

(5) Sheep or goats for restricted feeding for slaughter. For sheep or goats imported for restricted feeding for slaughter, in addition to the statements required under paragraph (a) of this section, the certificate must include statements that:

(i) The region where the sheep or goats originated is recognized as free of classical scrapie by APHIS; or

(ii) The region where the sheep or goats originated has not been recognized as free of classical scrapie by APHIS but the following criteria have been met:

(A) TSEs in sheep and goats are compulsorily notifiable to the national veterinary authority of the region;

(B) An effective classical scrapie awareness, surveillance, monitoring and control system is in place;

(C) TSE-affected sheep and goats are killed and completely destroyed;

(D) The sheep or goats showed no clinical sign of scrapie or any other infectious disease on the day of shipment and are fit for travel;

(E) The sheep or goats have not tested positive for, and are not suspect for, a transmissible spongiform encephalopathy;

(F) The animals' movement is not restricted within the country of origin due to animal health concerns;

(G) Female sheep and goats are not known to be pregnant, are not visibly pregnant, and female animals have not been exposed:

(1) To a sexually intact male at over 5 months of age; or

(2) To a sexually intact male within 5 months of shipment;

(H) The veterinarian issuing the certificate has inspected the sheep or goats for export, and their flock(s) of residence, within 30 days of consignment for shipment to the United States, and found the animals and the flock(s) of residence to be free of any evidence of infectious or contagious disease; and

(I) As far as it is possible for the veterinarian who inspects the animals to determine, none of the sheep or goats has been exposed to any infectious or contagious disease during the 60 days immediately preceding shipment to the United States.

(c) Refusal of entry. If ruminants are unaccompanied by the certificate as required by paragraphs (a) and (b) of this section, or if such ruminants are found upon inspection at the port of entry to be affected with a communicable disease or to have been exposed thereto, they shall be refused entry and shall be handled or quarantined, or otherwise disposed of as the Administrator may direct.

(Approved by the Office of Management and Budget under control numbers 0579-0040, 0579-0165, 0579-0234, 0579-0393, and 0579-0453)

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56018, Oct. 28, 1997]

Editorial Note:For Federal Register citations affecting § 93.405, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

§ 93.406 Diagnostic tests.

(a) [Reserved]

(b) Tuberculosis and brucellosis tests of goats. Except as provided in §§ 93.428(b) and 93.435, all goats offered for importation, except for immediate slaughter, shall be accompanied by a satisfactory certificate of a salaried veterinary officer of the national government of the region of origin, or if exported from Mexico, shall be accompanied either by such a certificate or by a certificate issued by a veterinarian accredited by the National Government of Mexico and endorsed by a full-time salaried veterinary officer of the National Government of Mexico, thereby representing that the veterinarian issuing the certificate was authorized to do so, showing that the goats have been tested for tuberculosis and brucellosis with negative results within 30 days of the date of their exportation. The said certificate shall give the dates and places of testing, method of testing, names of consignor and consignee, and a description of the goats, including breed, ages, markings, and tattoo and eartag numbers.

(c)-(d) [Reserved]

[55 FR 31495, Aug. 2, 1990, as amended at 57 FR 28080, June 24, 1992; 58 FR 68509, Dec. 28, 1993. Redesignated and amended at 62 FR 56012, 56018, Oct. 28, 1997; 66 FR 20190, Apr. 20, 2001; 68 FR 35533, June 16, 2003; 69 FR 21042, Apr. 20, 2004; 85 FR 57952, Sept. 17, 2020; 86 FR 68859, Dec. 3, 2021]

§ 93.407 Declaration and other documents for ruminants.

(a) The certificates, declarations, and affidavits required by the regulations in this part shall be presented by the importer or his or her agent to the collector of customs at the port of entry, upon arrival of ruminants at such port, for the use of the veterinary inspector at the port of entry.

(b) For all ruminants offered for importation, the importer or his or her agent shall first present two copies of a declaration which shall list the port of entry, the name and address of the importer, the name and address of the broker, the origin of the ruminants, the number, breed, species, and purpose of the importation, the name of the person to whom the ruminants will be delivered, and the location of the place to which such delivery will be made.

(c) Any declaration, permit, or other document for ruminants required under this subpart may be issued and presented using a U.S. Government electronic information exchange system or other authorized method.

[55 FR 31495, Aug. 2, 1990, as amended at 81 FR 40151, June 21, 2016]

§ 93.408 Inspection at the port of entry.

Inspection shall be made at the port of entry of all ruminants imported from any part of the world except as provided in § 93.421. All ruminants found to be free from communicable disease and not to have been exposed thereto within 60 days prior to their exportation to the United States shall be admitted subject to the other provisions in this part; all other ruminants except as provided in §§ 93.423(c) and 93.427(a) shall be refused entry. Ruminants refused entry, unless exported within a time fixed in each case by the Administrator, and in accordance with other provisions he or she may require in each case for their handling shall be disposed of as the Administrator may direct in accordance with the Animal Health Protection Act (7 U.S.C. 8301 et seq.). Such portions of the transporting vessel, and of its cargo, which have been exposed to any such ruminants or their emanations shall be disinfected in such manner as may be considered necessary by the inspector in charge at the port of entry, to prevent the introduction or spread of livestock or poultry disease, before the cargo is allowed to land.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56018, Oct. 28, 1997; 68 FR 6344, Feb. 7, 2003; 85 FR 57952, Sept. 17, 2020]

§ 93.409 Articles accompanying ruminants.

No litter or manure, fodder or other aliment, nor any equipment such as boxes, buckets, ropes, chains, blankets, or other things used for or about ruminants governed by the regulations in this part, shall be landed from any conveyance except under such restrictions as the inspector in charge at the port of entry shall direct.

§ 93.410 Movement from conveyances to quarantine station.

Platforms and chutes used for handling imported ruminants shall be cleaned and disinfected under APHIS supervision after being so used. The said ruminants shall not be unnecessarily moved over any highways nor allowed to come in contact with other animals, but shall be transferred from the conveyance to the quarantine grounds in boats, cars, or vehicles approved by the inspector in charge at the port of entry. Such cars, boats, or vehicles shall be cleaned and disinfected under APHIS supervision immediately after such use, by the carrier moving the same. The railway cars so used shall be either cars reserved for this exclusive use or box cars not otherwise employed in the transportation of animals or their fresh products. When movement of the aforesaid ruminants upon or across a public highway is unavoidable, it shall be under such careful supervision and restrictions as the inspector in charge at the port of entry and the local authorities may direct.

§ 93.411 Quarantine requirements.

(a) Except for cattle from Central America and the West Indies, and except for ruminants from Canada and Mexico, all ruminants imported into the United States shall be quarantined for not less than 30 days counting from the date of arrival at the port of entry.

(b) Wild ruminants shall be subject, during their quarantine, to such inspections, disinfection, blood tests, or other tests as may be required by the Administrator to determine their freedom from disease.

[61 FR 17238, Apr. 19, 1996. Redesignated at 62 FR 56012, Oct. 28, 1997]

§ 93.412 Ruminant quarantine facilities.

(a) Privately owned quarantine facilities. The operator of a privately owned medium or minimum security quarantine facility subject to the regulations in this subpart shall arrange for acceptable transportation from the port to the privately owned quarantine facility and for the care, feeding, and handling of the ruminants from the time of unloading at the port to the time of release from the quarantine facility. Such arrangements shall be agreed to in advance by the Administrator. All expenses related to these activities shall be the responsibility of the operator. The privately owned quarantine facility must be suitable for the quarantine of the ruminants and must be approved by the Administrator prior to the issuance of any import permit. The facilities occupied by the ruminants should be kept clean and sanitary to the satisfaction of the APHIS representatives. If for any cause, the care, feeding, or handling of ruminants, or the sanitation of the facilities is neglected, in the opinion of the overseeing APHIS representative, such services may be furnished by APHIS in the same manner as though arrangements had been made for such services as provided by paragraph (b) of this section. The operator must request in writing inspection and other services as may be required, and shall waive all claims against the United States and APHIS or any employee of APHIS for damages which may arise from such services. The Administrator may prescribe reasonable rates for the services provided under this paragraph. When APHIS finds it necessary to extend the usual minimum quarantine period, APHIS shall advise the operator in writing, and the operator must pay for such additional quarantine and other services required. The operator must pay for all services received in connection with each separate lot of ruminants as specified in the compliance agreement required under paragraph (d)(2) of this section.

(b) Quarantine facilities maintained by APHIS. The importer, or his or her agent, of ruminants subject to quarantine under the regulations in this part shall arrange for acceptable transportation to the quarantine facility, and for the care, feed, and handling of the ruminants from the time they arrive at the quarantine port to the time of release from quarantine. Such arrangements shall be agreed to in advance by the Administrator. The importer or his or her agent shall request in writing such inspection and other services as may be required, and shall waive all claim against the United States and APHIS or any employee of APHIS, for damages which may arise from such services. All expenses resulting therefrom or incident thereto shall be the responsibility of the importer; APHIS assumes no responsibility with respect thereto. The Administrator may prescribe reasonable rates for the services provided under this paragraph. When it is found necessary to extend the usual minimum quarantine period, the importer, or his or her agent, shall be so advised in writing and shall pay for such additional quarantine and other services required. Payment for services received by the importer, or his or her agent, in connection with each separate lot of ruminants shall be made by certified check or U.S. money order prior to release of the ruminants. If such payment is not made, the ruminants may be sold in accordance with the procedure described in this paragraph or otherwise disposed of as directed by the Administrator. When payment is not made and the ruminants are to be sold to recover payment for services received, the importer, or his or her agent, will be notified by the inspector that if said charges are not immediately paid or satisfactory arrangements made for payment, the ruminants will be sold at public sale to pay the expense of care, feed, and handling during that period. The sale will be held after the expiration of the quarantine period, at such time and place as may be designated by the General Services Administration or other designated selling agent. The proceeds of the sale, after deducting the charges for care, feed, and handling of the ruminants and other expenses, including the expense of the sale, shall be held in a Special Deposit Account in the United States Treasury for 6 months from the date of sale. If not claimed by the importer, or his or her agent, within 6 months from the date of sale, the amount so held shall be transferred from the Special Deposit Account to the General Fund Account in the United States Treasury.

(c) APHIS collection of payments from the importer, or his or her agent, or the operator, for service rendered shall be deposited so as to be available for defraying the expenses involved in this service.

(d) Standards for privately owned quarantine facilities for ruminants—(1) APHIS approval of facilities—(i) Approval procedures. Persons seeking APHIS approval of a privately owned medium or minimum security quarantine facility for ruminants must make written application to the Administrator, c/o Strategy and Policy, Veterinary Services, APHIS, 4700 River Road Unit 39, Riverdale, MD 20737-1231. The application must include the full name and mailing address of the applicant; the location and street address of the facility for which approval is sought; blueprints of the facility; a description of the financial resources available for construction, operation and maintenance of the facility; copies of all approved State permits for construction and operation of the facility (but not local building permits), as well as copies of all approved Federal, State, and local environmental permits; the anticipated source(s) or origin(s) of ruminants to be quarantined, as well as the expected size and frequency of shipments, and a contingency plan for the possible destruction and disposal of all ruminants capable of being held in the facility.

(A) If APHIS determines that an application is complete and merits further consideration, the person applying for facility approval must agree to pay the costs of all APHIS services associated with APHIS' evaluation of the application and facility. APHIS charges for evaluation services at hourly rates are listed in part 130 of this chapter. If the facility is approved by APHIS, the operator must enter into a compliance agreement in accordance with paragraph (d)(2) of this section.

(B) Requests for approval must be submitted at least 120 days prior to the date of application for local building permits. Requests for approval will be evaluated on a first-come, first-served basis.

(ii) Criteria for approval. Before a facility may be built to operate as a privately owned medium or minimum security quarantine facility for ruminants, it must be approved by APHIS. To be approved:

(A) APHIS must find, based on an environmental assessment, and based on any required Federal, State, and local environmental permits or evaluations secured by the operator and copies of which are provided to APHIS, that the operation of the facility will not have significant environmental effects;

(B) The facility must meet all the requirements of paragraph (d) of this section;

(C) The facility must meet any additional requirements that may be imposed by the Administrator in each specific case, as specified in the compliance agreement required under paragraph (d)(2) of this section, to ensure that the quarantine of ruminants in the facility will be adequate to enable determination of their health status, as well as to prevent the transmission of livestock diseases into, within, and from the facility; and

(D) The Administrator must determine whether sufficient personnel, including one or more APHIS veterinarians and other professional, technical, and support personnel, are available to serve as APHIS representatives at the facility and provide continuous oversight and other technical services to ensure the biological security of the facility, if approved. APHIS will assign personnel to facilities requesting approval in the order that the facilities meet all of the criteria for approval. The Administrator has sole discretion on the number of APHIS personnel to be assigned to the facility.

(iii) Maintaining approval. To maintain APHIS approval, the operator must continue to comply with all the requirements of paragraph (d) of this section as well as the terms of the compliance agreement executed in accordance with paragraph (d)(2) of this section.

(iv) Withdrawal or denial of approval. Approval of a proposed privately owned medium or minimum security quarantine facility may be denied or approval of a facility already in operation may be withdrawn at any time by the Administrator for any of the reasons provided in paragraph (d)(1)(iv)(C) of this section.

(A) Before facility approval is denied or withdrawn, APHIS will inform the operator of the proposed or existing facility and include the reasons for the proposed action. If there is a conflict as to any material fact, APHIS will afford the operator, upon request, the opportunity for a hearing with respect to the merits or validity of such action in accordance with rules of practice that APHIS adopts for the proceeding.

(B) Withdrawal of approval of an existing facility will become effective pending final determination in the proceeding when the Administrator determines that such action is necessary to protect the public health, interest, or safety. Such withdrawal will be effective upon oral or written notification, whichever is earlier, to the operator of the facility. In the event of oral notification, APHIS will give written confirmation to the operator of the facility as promptly as circumstances allow. This withdrawal will continue in effect pending the completion of the proceeding and any judicial review, unless otherwise ordered by the Administrator. In addition to withdrawal of approval for the reasons provided in paragraph (d)(1)(iv)(C) of this section, the Administrator will also automatically withdraw approval when the operator of any approved facility notifies the area veterinarian in charge for the State in which the facility is located, in writing, that the facility is no longer in operation. 7

7 The name and address of the area veterinarian in charge in any State is available from the Animal and Plant Health Inspection Service, Veterinary Services, Strategy and Policy, 4700 River road Unit 39, Riverdale, MD 20737-1231.

(C) The Administrator may deny or withdraw the approval of a privately owned medium or minimum security quarantine facility if:

(1) Any requirement of paragraph (d) of this section or the compliance agreement is not met; or

(2) The facility has not been in use to quarantine ruminants for a period of at least 1 year; or

(3) The operator fails to remit any charges for APHIS services rendered; or

(4) The operator or a person responsibly connected with the business of the facility is or has been convicted of any crime under any law regarding the importation or quarantine of any animal; or

(5) The operator or a person responsibly connected with the business of the facility is or has been convicted of a crime involving fraud, bribery, extortion, or any other crime involving a lack of integrity needed for the conduct of operations affecting the importation of animals; or

(6) Any other requirement under the Animal Health Protection Act (7 U.S.C. 8301-8317) or the regulations thereunder are not met.

(D) For the purposes of paragraph (d)(1)(iv) of this section, a person is deemed to be responsibly connected with the business of the facility if such person has an ownership, mortgage, or lease interest in the facility, or if such person is a partner, officer, director, holder, or owner of 10 percent or more of its voting stock, or an employee in a managerial or executive capacity.

(2) Compliance agreement. (i) A privately owned medium or minimum security quarantine facility must operate in accordance with a compliance agreement executed by the operator or other designated representative of the facility and by the Administrator. The compliance agreement must be signed by both parties before a facility may commence operations. The compliance agreement must provide that:

(A) The facility must meet all applicable requirements of paragraph (d) of this section;

(B) The facility's quarantine operations are subject to the strict oversight of APHIS representatives;

(C) The operator agrees to be responsible for the cost of building the facility; all costs associated with its maintenance and operation; all costs associated with the hiring of personnel to attend to the ruminants, as well as to maintain and operate the facility; all costs associated with the care of quarantined ruminants, such as feed, bedding, medicines, inspections, testing, laboratory procedures, and necropsy examinations; all costs associated with the death or destruction and disposition of quarantined ruminants; and all APHIS charges for the services of APHIS representatives in accordance with this section and part 130 of this chapter;

(D) The operator obtained, prior to execution of this agreement, a financial instrument (insurance or surety bond) approved by APHIS that financially guarantees the operator's ability to cover all costs and other financial liabilities and obligations of the facility, including a worst case scenario in which all quarantined ruminants must be destroyed and disposed of because of an animal health emergency, as determined by the Administrator.

(E) The operator will deposit with the Administrator, prior to commencing quarantine operations, a certified check or U.S. money order to cover the estimated costs, as determined by the Administrator, of professional, technical, and support services to be provided by APHIS at the facility over the duration of the quarantine. If actual costs incurred by APHIS over the quarantine period exceed the deposited amount, the operator will pay for any additional costs incurred by APHIS, based on official accounting records. Payment for all services received in connection with each lot of ruminants in quarantine shall be made prior to release of the ruminants. The operator must pay for any other costs incurred by APHIS with respect to the quarantine following the release of the ruminants, based on official records, within 14 days of receipt of the bill showing the balance due. APHIS will return to the operator any unobligated funds deposited with APHIS, after the release of the lot of ruminants from the facility and termination or expiration of the compliance agreement, or, if requested, credit to the operator's account such funds to be applied towards payment of APHIS services at a future date.

(ii) Prior to the entry of each subsequent lot of ruminants into the medium or minimum security facility, a new compliance agreement must be executed, and a certified check or U.S. money order to the Administrator must be deposited to cover the estimated costs, as determined by the Administrator, of professional, technical, and support services to be provided by APHIS at the facility over the duration of the quarantine.

(3) Physical plant requirements. A privately owned medium or minimum security quarantine facility must meet the following requirements as determined by an APHIS inspection before ruminants may be admitted to it.

(i) Location. (A) The medium or minimum security facility must be located at a site approved by the Administrator, and the specific routes for the movement of ruminants from the port must be approved in advance by the Administrator, based on consideration of whether the site or routes would put the animals in a position that could result in their transmitting communicable livestock diseases.

(B) In the case of a medium security facility, the facility must be located at least one-half mile from any premises holding livestock. In the case of a minimum security facility, the Administrator will establish the required minimum distance between the facility and other premises holding livestock on a case-by-case basis.

(C) If the medium or minimum security facility is to be located more than 1 mile from a designated port, the operator must make arrangements for the imported ruminants to be held in a temporary inspection facility to allow for the inspection of the imported ruminants by a Federal or State veterinarian prior to the animals' movement to the medium or minimum security facility.

(1) The temporary inspection facility must have adequate space for Federal or State veterinarians to conduct examinations and testing of the imported ruminants.

(2) The examination space of the temporary inspection facility must be equipped with appropriate animal restraining devices for the safe inspection of ruminants.

(3) The temporary inspection facility may not hold more than one lot of animals at the same time.

(4) In seeking APHIS approval of the temporary inspection facility, the operator must provide APHIS with the following information: The port of entry; a description of the temporary inspection facility; and the anticipated source(s) of the materials to be used for the facility.

(5) If the ruminants, upon inspection at the temporary inspection facility, are determined to be infected with or exposed to a disease that precludes their entry into the United States, the animals will be refused entry. Ruminants refused entry remain the responsibility of the operator, but subject to further handling or disposition as directed by the Administrator in accordance with § 93.408 of this subpart.

(6) APHIS' approval to build and operate a medium or minimum security facility outside the immediate vicinity of a designated port is contingent upon APHIS' approval of the temporary inspection facility at the port, as well as approval of the routes for the movement of ruminants from the port to the medium or minimum security facility.

(ii) Construction. The medium or minimum security facility must be of sound construction, in good repair, and properly designed to prevent the escape of quarantined ruminants. It must have adequate capacity to receive and hold a shipment of ruminants as a lot on an “all-in, all-out” basis and must include the following:

(A) Loading docks. The facility must include separate docks for animal receiving and releasing and for general receiving and pickup, or, alternatively, a single dock may be used for both purposes if the dock is cleaned and disinfected after each use in accordance with paragraph (d)(4)(iv)(D) of this section.

(B) Perimeter fencing. The facility must be surrounded by double-security perimeter fencing separated by at least 30 feet and of sufficient height and design to prevent the entry of unauthorized persons and animals from outside the facility and to prevent the escape of any ruminants in quarantine.

(C) Means of isolation. The facility must provide pens, chutes, and other animal restraining devices, as appropriate, for inspection and identification of each animal, as well as for segregation, treatment, or both, of any ruminant exhibiting signs of illness. The medium or minimum security facility must also have lot-holding areas of sufficient size to prevent overcrowding. A medium security facility may hold more than one lot of ruminants as long as the lots are separated by physical barriers such that ruminants in one lot do not have physical contact with ruminants in another lot or with their excrement or discharges. A minimum security facility may not hold more than one lot of animals at the same time.

(D) APHIS space. The facility must have adequate space for APHIS representatives to conduct examinations and draw samples for testing of ruminants in quarantine, prepare and package samples for mailing, and store duplicate samples and the necessary equipment and supplies for each lot of ruminants. The examination space must be equipped with appropriate animal restraining devices for the safe inspection of ruminants. The facility must also provide a secure, lockable office for APHIS use with enough room for a desk, chair, and filing cabinet.

(E) Storage. The facility must have sufficient storage space for equipment and supplies used in quarantine operations. Storage space must include separate, secure storage for pesticides and for medical and other biological supplies, as well as a separate storage area for feed and bedding, if feed and bedding are stored at the facility.

(F) Other work areas. The facility must include work areas for the repair of equipment and for cleaning and disinfecting equipment used in the facility.

(iii) Additional construction requirements for medium security facilities. For medium security facilities only, the following requirements must also be met:

(A) Self-contained building. The medium security facility must be constructed so that the quarantine area is located in a secure, self-contained building that contains appropriate control measures against the spread of livestock diseases biologically transmissible by vectors. All entryways into the nonquarantine area of the building must be equipped with a secure and lockable door. While ruminants are in quarantine, all access to the quarantine area must be from within the building. Each entryway to the quarantine area must be equipped with a solid self-closing door. Separate access must be provided within the quarantine area to each lot-holding area so that it is not necessary to move through one lot-holding area to gain access to another lot-holding area. Entryways to each lot-holding area within the quarantine area would also have to be equipped with a solid lockable door. Emergency exits to the outside may exist in the quarantine area if required by local fire ordinances. Such emergency exits must be constructed so as to permit their opening from the inside of the facility only.

(B) Windows and other openings. Any windows or other openings in the quarantine area must be double-screened with screening of sufficient gauge and mesh to prevent the entry or exit of insects and other vectors of livestock diseases and to provide ventilation sufficient to ensure the comfort and safety of all ruminants in the facility. The interior and exterior screens must be separated by at least 3 inches (7.62 cm). All screening of windows or other openings must be easily removable for cleaning, yet otherwise remain locked and secure at all times in a manner satisfactory to APHIS representatives in order to ensure the biological security of the facility.

(C) Surfaces. The medium security facility must be constructed so that the floor surfaces with which ruminants have contact are nonslip and wear-resistant. All floor surfaces with which the ruminants, their excrement, or discharges have contact must slope gradually to the center, where one or more drains of at least 8 inches in diameter are located for adequate drainage, or, alternatively, must be of slatted or other floor design that allows for adequate drainage. All floor and wall surfaces with which the ruminants, their excrement, or discharges have contact must be impervious to moisture and be able to withstand frequent cleaning and disinfection without deterioration. Other ceiling and wall surfaces with which the ruminants, their excrement, or discharges do not have contact must be able to withstand cleaning and disinfection between shipments of ruminants. All floor and wall surfaces must be free of sharp edges that could cause injury to ruminants.

(D) Ventilation and climate control. The medium security facility must be constructed with a heating, ventilation, and air conditioning (HVAC) system capable of controlling and maintaining the ambient temperature, air quality, moisture, and odor at levels that are not injurious or harmful to the health of ruminants in quarantine. Air supplied to lot-holding areas must not be recirculated or reused for other ventilation needs. HVAC systems for lot-holding areas must be separate from air handling systems for other operational and administrative areas of the facility. In addition, if the facility is approved to handle more than one lot of ruminants at a time, each lot-holding area must have its own separate HVAC system that is designed to prevent cross-contamination between the separate lot-holding areas.

(E) Lighting. The medium security facility must have adequate lighting throughout, including in the lot-holding areas and other areas used to examine ruminants and conduct necropsies.

(F) Fire protection. The medium security facility, including the lot-holding areas, must have a fire alarm and voice communication system.

(G) Monitoring system. The medium security facility must have a television monitoring system or other arrangement sufficient to provide a full view of the lot-holding areas.

(H) Communication system. The medium security facility must have a communication system between the nonquarantine and quarantine areas of the facility.

(I) Necropsy area. The medium security facility must have an area that is of sufficient size to perform necropsies on ruminants and that is equipped with adequate lighting, hot and cold running water, a drain, a cabinet for storing instruments, a refrigerator-freezer for storing specimens, and an autoclave to sterilize veterinary equipment.

(J) Additional storage requirements. Feed storage areas in the medium security facility must be vermin-proof. Also, if the medium security facility has multiple lot-holding areas, then separate storage space for supplies and equipment must be provided for each lot-holding area.

(K) Showers. In a medium security facility, there must be a shower at the entrance to the quarantine area. A shower also must be located at the entrance to the necropsy area. A clothes-storage and clothes-changing area must be provided at each end of each shower area. There also must be one or more receptacles near each shower so that clothing that has been worn in a lot-holding area or elsewhere in the quarantine area can be deposited in the receptacle(s) prior to entering the shower.

(L) Restrooms. The medium security facility must have permanent restrooms in both the nonquarantine and quarantine areas of the facility.

(M) Break room. The medium security facility must have an area within the quarantine area for breaks and meals.

(N) Laundry area. The medium security facility must have an area for washing and drying clothes, linens, and towels.

(iv) Sanitation. To ensure that proper animal health and biological security measures are observed, a privately owned medium or minimum security quarantine facility must provide the following:

(A) Equipment and supplies necessary to maintain the facility in a clean and sanitary condition, including pest control equipment and supplies and cleaning and disinfecting equipment with adequate capacity to disinfect the facility and equipment.

(B) Separately maintained sanitation and pest control equipment and supplies for each lot-holding area if the facility will hold more than one lot of ruminants at a time (applicable to medium security facilities only).

(C) A supply of potable water adequate to meet all watering and cleaning needs, with water faucets for hoses located throughout the facility. An emergency supply of water for ruminants in quarantine also must be maintained.

(D) A stock of disinfectant authorized in § 71.10(a)(5) of this chapter or otherwise approved by the Administrator that is sufficient to disinfect the entire facility.

(E) The capability to dispose of wastes, including manure, urine, and used bedding, by means of burial, incineration, or public sewer. Other waste material must be handled in such a manner that minimizes spoilage and the attraction of pests and must be disposed of by incineration, public sewer, or other preapproved manner that prevents the spread of disease. Disposal of wastes must be carried out under the direct oversight of APHIS representatives.

(F) The capability to dispose of ruminant carcasses in a manner approved by the Administrator and under conditions that prevent the spread of disease from the carcasses.

(G) For incineration to be carried out at the facility, incineration equipment that is detached from other facility structures and is capable of burning wastes or carcasses as required. The incineration site must include an area sufficient for solid waste holding. Incineration may also take place at a local site away from the facility premises. All incineration activities must be carried out under the direct oversight of an APHIS representative.

(H) The capability to control surface drainage and effluent into, within, and from the facility in a manner that prevents the spread of disease into, within, and from the facility. If the facility is approved to handle more than one lot of ruminants at the same time, there must be separate drainage systems for each lot-holding area in order to prevent cross contamination.

(v) Security. (A) A privately owned medium or minimum security quarantine facility must provide the following security measures:

(1) The facility and premises must be kept locked and secure at all times while the ruminants are in quarantine.

(2) The facility and premises must have signs indicating that the facility is a quarantine area and no visitors are allowed.

(3) The operator must furnish a telephone number or numbers to APHIS at which the operator or his or her agent can be reached at all times.

(4) APHIS is authorized to place seals on any or all entrances and exits of the facility, when determined necessary by APHIS to ensure security, and to take all necessary steps to ensure that the seals are broken only in the presence of an APHIS representative. If the seals are broken by someone other than an APHIS representative, it will be considered a breach in security, and an immediate accounting of all ruminants in the facility will be made by an APHIS representative. If a breach in security occurs, APHIS may extend the quarantine period as long as necessary to determine that the ruminants are free of communicable livestock diseases.

(5) In the event that a communicable livestock disease is diagnosed in quarantined ruminants, the Administrator may require that the operator have the facility guarded by a bonded security company, at the expense of the operator of the facility, in a manner that the Administrator deems necessary to ensure the biological security of the facility.

(B) A privately owned medium security facility also must provide the following security measures:

(1) The medium security facility and premises must be guarded at all times by one or more representatives of a bonded security company, or, alternatively, the medium security facility must have an electronic security system that prevents the entry of unauthorized persons into the facility and prevents animals outside the facility from having contact with ruminants in quarantine;

(2) If an electronic security system is used, the electronic security system must be coordinated through or with the local police so that monitoring of the facility is maintained whenever APHIS representatives are not at the facility. The electronic security system must be of the “silent type” and must be triggered to ring at the monitoring site and, if the operator chooses, at the facility. The operator must provide written instructions to the monitoring agency stating that the police and an APHIS representative designated by APHIS must be notified by the monitoring agency if the alarm is triggered. The operator also must submit a copy of those instructions to the Administrator. The operator must notify the designated APHIS representative whenever a break in security occurs or is suspected of occurring.

(4) Operating procedures. The following procedures must be followed at a privately owned medium or minimum security quarantine facility at all times:

(i) APHIS oversight. (A) The quarantine of ruminants at the facility will be subject to the strict oversight of APHIS representatives authorized to perform the services required by this subpart.

(B) If, for any reason, the operator fails to properly care for, feed, or handle the quarantined ruminants as required in paragraph (d) of this section, or in accordance with animal health and husbandry standards provided elsewhere in this chapter, or fails to maintain and operate the facility as provided in paragraph (d) of this section, APHIS representatives are authorized to furnish such neglected services at the operator's expense, as authorized in paragraph (a) of this section.

(ii) Personnel. (A) The operator must provide adequate personnel to maintain the facility and care for the ruminants in quarantine, including attendants to care for and feed ruminants, and other personnel as needed to maintain, operate, and administer the facility.

(B) The operator must provide APHIS with an updated list of all personnel who have access to the facility. The list must include the names, current residential addresses, and identification numbers of each person, and must be updated with any changes or additions in advance of such person having access to the quarantine facility.

(C) The operator must provide APHIS with signed statements from all personnel having access to the facility in which the person agrees to comply with paragraph (d) of this section and applicable provisions of this part, all terms of the compliance agreement, and any related instructions from APHIS representatives pertaining to quarantine operations, including contact with animals both inside and outside the facility.

(iii) Authorized access. (A) Access to the facility premises as well as inside the quarantine area will be granted only to APHIS representatives and other persons specifically authorized to work at the facility. All other persons are prohibited from the premises unless specifically granted access by an APHIS representative. Any visitors granted access must be accompanied at all times by an APHIS representative while on the premises.

(B) All visitors, except veterinary practitioners who enter the facility to provide emergency care, must sign an affidavit before entering the quarantine area, if determined necessary by the overseeing APHIS representative, declaring that they will not have contact with any susceptible animals outside the facility for at least 5 days after contact with the ruminants in quarantine, or for a period of time determined by the overseeing APHIS representative as necessary to prevent the transmission of communicable livestock diseases of ruminants.

(iv) Sanitary practices. (A) All persons granted access to the quarantine area must:

(1) Wear clean protective work clothing and footwear upon entering the quarantine area.

(2) Wear disposable gloves when handling sick animals and then wash hands after removing gloves.

(3) Change protective clothing, footwear, and gloves when they become soiled or contaminated.

(4) Be prohibited, if determined necessary by the overseeing APHIS representative, from having contact with any susceptible animals outside the facility for at least 5 days after the last contact with ruminants in quarantine, or for a longer period of time determined necessary by the overseeing APHIS representative to prevent the transmission of livestock diseases.

(B) All equipment (including tractors) must be cleaned and disinfected prior to being used in the quarantine area of the facility with a disinfectant that is authorized in § 71.10(a)(5) of this chapter or that is otherwise approved by the Administrator. The equipment must remain dedicated to the facility for the entire quarantine period. Any equipment used with quarantined ruminants must remain dedicated to that particular lot of ruminants for the duration of the quarantine period or be cleaned and disinfected before coming in contact with ruminants from another lot. Prior to its use on another lot of ruminants or its removal from the quarantine area, such equipment must be cleaned and disinfected to the satisfaction of an APHIS representative.

(C) Any vehicle, before entering or leaving the quarantine area of the facility, must be immediately cleaned and disinfected under the oversight of an APHIS representative with a disinfectant that is authorized in § 71.10(a)(5) of this chapter or that is otherwise approved by the Administrator.

(D) If the facility has a single loading dock, the loading dock must be immediately cleaned and disinfected after each use under the oversight of an APHIS representative with a disinfectant that is authorized in § 71.10(a)(5) of this chapter or that is otherwise approved by the Administrator.

(E) That area of the facility in which a lot of ruminants had been held or had access must be thoroughly cleaned and disinfected under the oversight of an APHIS representative upon release of the ruminants, with a disinfectant that is authorized in § 71.10(a)(5) of this chapter or that is otherwise approved by the Administrator, before a new lot of ruminants is placed in that area of the facility.

(F) For medium security facilities only, the following additional sanitary practices also must be followed:

(1) All persons granted access to the quarantine area, must:

(i) Shower when leaving the quarantine area.

(ii) Shower before entering a lot-holding area if previously exposed from access to another lot-holding area.

(iii) Shower when leaving the necropsy area if a necropsy is in the process of being performed or has just been completed, or if all or portions of the examined animal remain exposed.

(iv) Be prohibited, unless specifically allowed otherwise by the overseeing APHIS representative, from having contact with any ruminants in the facility, other than the lot or lots of ruminants to which the person is assigned or is granted access.

(2) The operator is responsible for providing a sufficient supply of clothing and footwear to ensure that workers and others provided access to the quarantine area of the facility have clean, protective clothing and footwear before entering the facility.

(3) The operator is responsible for the proper handling, washing, and disposal of soiled and contaminated clothing worn in the quarantine area in a manner approved by an APHIS representative as adequate to preclude the transmission of disease within and from the facility. At the end of each workday, work clothing worn into each lot-holding area and elsewhere in the quarantine area must be collected and kept in bags until the clothing is washed. Used footwear must either be left in the clothes changing area or cleaned with hot water (148 °F minimum) and detergent and disinfected as directed by an APHIS representative.

(v) Handling of ruminants in quarantine. (A) Each lot of ruminants to be quarantined must be placed in the facility on an “all-in, all-out” basis. No ruminant may be taken out of a lot while the lot is in quarantine, except for diagnostic purposes, and no ruminant may be added to a lot while in quarantine.

(B) The facility must provide sufficient feed and bedding for the ruminants in quarantine, and it must be free of vermin and not spoiled. Feed and bedding must originate from a region that has been approved by APHIS as a source for feed and bedding.

(C) Breeding of ruminants or collection of germ plasm from ruminants is prohibited during the quarantine period unless necessary for a required import testing procedure.

(D) Ruminants in quarantine will be subjected to such tests and procedures as directed by an APHIS representative to determine whether the ruminants are free of communicable livestock diseases. While in quarantine, ruminants may be vaccinated only with vaccines that have been approved by the APHIS representative and licensed in accordance with § 102.5 of this chapter. 8 Vaccines must be administered either by an APHIS veterinarian or an accredited veterinarian under the direct oversight of an APHIS representative.

8 A list of approved vaccines is available from the Center for Veterinary Biologics, USDA, APHIS, VS, 510 south 17th Street6, Suite 104, Ames, IA 50010.

(E) Any death or suspected illness of ruminants in quarantine must be reported immediately to the overseeing APHIS representative. The affected ruminants must be disposed of as the Administrator may direct or, depending on the nature of the disease, must be cared for as directed by APHIS to prevent the spread of disease.

(F) Quarantined ruminants requiring specialized medical attention or additional postmortem testing may be transported off the quarantine site, if authorized by APHIS. A second quarantine site must be established to house the ruminants at the facility of destination (e.g., veterinary college hospital). In such cases, APHIS may extend the quarantine period until the results of any outstanding tests or postmortems are received.

(G) Should the Administrator determine that an animal health emergency exists at the facility, arrangements for the final disposition of the infected or exposed lot of ruminants must be accomplished within 4 workdays following disease confirmation. Subsequent disposition of the ruminants must occur under the direct oversight of APHIS representatives.

(vi) Recordkeeping. (A) The operator must maintain a current daily log, to record the entry and exit of all persons entering and leaving the facility.

(B) The operator must retain the daily log, along with any logs kept by APHIS and deposited with the operator, for at least 2 years following the date of release of the ruminants from quarantine and must make such logs available to APHIS representatives upon request.

(5) Environmental quality. If APHIS determines that a privately owned medium or minimum security quarantine facility does not meet applicable local, State, or Federal environmental regulations, APHIS may deny or suspend approval of the facility until appropriate remedial measures have been applied.

(6) Other laws. A privately owned medium or minimum security quarantine facility must comply with other applicable Federal laws and regulations, as well as with all applicable State and local codes and regulations.

(7) Variances. The Administrator may grant variances to existing requirements relating to location, construction, and other design features of a privately owned medium security quarantine facility or minimum security quarantine facility as well as to sanitation, security, operating procedures, recordkeeping, and other provisions in paragraph (d) of this section, but only if the Administrator determines that the variance causes no detrimental impact to the health of the ruminants or to the overall biological security of the quarantine operations. The operator must submit a request for a variance to the Administrator in writing at least 30 days in advance of the arrival of the ruminants to the facility. Any variance also must be expressly provided for in the compliance agreement.

(Approved by the Office of Management and Budget under control number 0579-0232)

[55 FR 31495, Aug. 2, 1990. Redesignated at 62 FR 56012, Oct. 28, 1997, as amended at 71 FR 29773, May 24, 2006; 86 FR 45624, Aug. 16, 2021; 88 FR 49998, Aug. 1, 2023]

§ 93.413 Quarantine stations, visiting restricted; sales prohibited.

Visitors are not permitted in the quarantine enclosures during any time that ruminants are in quarantine unless the APHIS representative or inspector in charge specifically grants access under such conditions and restrictions as may be imposed by the APHIS representative or inspector in charge. An importer (or his or her accredited agent or veterinarian) may be admitted to the yards and buildings containing his or her quarantined ruminants at such intervals as may be deemed necessary, and under such conditions and restrictions as may be imposed, by the APHIS representative or the inspector in charge of the quarantine facility or station. On the last day of the quarantine period, owners, officers, or registry societies, and others having official business or whose services may be necessary in the removal of the ruminants may be admitted upon written permission from the APHIS representative or inspector in charge. No exhibition or sale shall be allowed within the quarantine grounds.

[71 FR 29779, May 24, 2006]

§ 93.414 Milk from quarantined ruminants.

Milk or cream from ruminants quarantined under the provisions of this part shall not be used by any person other than those in charge of such ruminants, nor be fed to any animals other than those within the same enclosure, without permission of the APHIS representative or inspector in charge of the quarantine station and subject to such restrictions as he or she may consider necessary to each instance. No milk or cream shall be removed from the quarantine premises except in compliance with all State and local regulations.

[55 FR 31495, Aug. 2, 1990. Redesignated at 62 FR 56012, Oct. 28, 1997, as amended at 71 FR 29779, May 24, 2006]

§ 93.415 Manure from quarantined ruminants.

No manure shall be removed from the quarantine premises until the release of the ruminants producing same.

§ 93.416 Appearance of disease among ruminants in quarantine.

If any contagious disease appears among ruminants during the quarantine period special precautions shall be taken to prevent spread of the infection to other animals in the quarantine station or to those outside the grounds. The affected ruminants shall be disposed of as the Administrator may direct, depending upon the nature of the disease.

§ 93.417 Import permit and declaration for ruminants.

(a) For ruminants intended for importation from Canada, the importer shall first apply for and obtain from APHIS an import permit as provided in § 93.404: Provided, That an import permit is not required for ruminants offered for entry at a land border port designated in § 93.403(b) if such ruminant is:

(1) A wether;

(2) A sheep or goat imported for immediate slaughter; or

(3) A ruminant other than a sheep or goat and that ruminant:

(i) Was born in Canada or the United States, and has been in no region other than Canada or the United States, or

(ii) Has been legally imported into Canada from some other region and unconditionally released in Canada so as to be eligible to move freely within that region without restriction of any kind and has been in Canada after such release for 60 days or longer.

(b) For all ruminants offered for importation from Canada, the importer or his or her agent shall present two copies of a declaration as provided in § 93.407.

[55 FR 31495, Aug. 2, 1990, as amended at 60 FR 13900, Mar. 15, 1995. Redesignated and amended at 62 FR 56012, 56018, Oct. 28, 1997]

§ 93.418 Cattle and other bovines from Canada.

(a) Health certificates. Cattle intended for importation from Canada must be accompanied by a certificate issued in accordance with § 93.405(a). The certificate must state that the cattle have been inspected and were found to be free from any evidence of communicable disease and that, as far as can be determined, they have not been exposed to any such disease during the preceding 60 days. Cattle found unqualified upon inspection at the port of entry will be refused entry into the United States.

(b)-(c) [Reserved]

(d) Conditions for importation. In addition to meeting the other requirements of this section, bovines may be imported from Canada only under the following conditions:

(1) The bovines are imported for immediate slaughter under § 93.420; or

(2) The bovines are imported for other than immediate slaughter under the following conditions:

(i) The bovines were born after March 1, 1999, the date determined by APHIS to be the date of effective enforcement of a ruminant-to-ruminant feed ban in Canada;

(ii) The bovines are imported only through a port of entry listed in § 93.403(b) or as provided for in § 93.403(f);

(iii) The bovines were officially identified prior to arriving at the port of entry in the United States with unique individual identification that is traceable to each bovine's premises of origin. No person may alter, deface, remove, or otherwise tamper with the official identification while the animal is in the United States or moving into or through the United States, except that the identification may be removed at slaughter; and

(iv) The bovines are permanently and humanely identified using one of the following additional methods:

(A) A “CΛN” mark properly applied with a freeze brand, hot iron, or other method, and easily visible on the live animal and on the carcass before skinning. Such a mark must be not less than 2 inches nor more than 3 inches high, and must be applied to each animal's right hip, high on the tail-head (over the junction of the sacral and first coccygeal vertebrae); or

(B) A tattoo with the letters “CΛN” applied to the inside of one ear of the animal; or

(C) Other means of permanent identification upon request if deemed adequate by the Administrator to humanely identify the animal in a distinct and legible way as having been imported from Canada.

(3) The bovines are accompanied by a certificate issued in accordance with § 93.405 that states, in addition to the statements required by § 93.405, that the conditions of paragraph (d)(2) of this section, as applicable, have been met.

(Approved by the Office of Management and Budget under control number 0579-0393)

[55 FR 31495, Aug. 2, 1990, as amended at 55 FR 49990, Dec. 4, 1990; 58 FR 37641, July 13, 1993; 59 FR 28216, June 1, 1994; 61 FR 17238, Apr. 19, 1996. Redesignated and amended at 62 FR 56012, 56018, Oct. 28, 1997; 71 FR 12997, Mar. 14, 2006; 78 FR 72996, Dec. 4, 2013; 78 FR 73993, Dec. 10, 2013; 85 FR 57952, Sept. 17, 2020]

§ 93.419 [Reserved]

§ 93.420 Ruminants from Canada for immediate slaughter other than sheep and goats.

(a) General requirements. The requirements for the importation of sheep and goats from Canada for immediate slaughter are contained in § 93.435. There are no BSE-related restrictions on the importation of cervids or camelids from Canada. All other ruminants imported from Canada for immediate slaughter, in addition to meeting all other applicable requirements of this part, may be imported only under the following conditions:

(1) The ruminants must be imported only through a port of entry listed in § 93.403(b) or as provided for in § 93.403(f) and be inspected at the port of entry and otherwise handled in accordance with § 93.408.

(2) The ruminants must be moved directly from the port of entry to a recognized slaughtering establishment in conveyances that are sealed with seals of the U.S. Government at the port of entry. The seals may be broken only at the recognized slaughtering establishment by an authorized USDA representative.

(3) The ruminants must be accompanied from the port of entry to the recognized slaughtering establishment by APHIS Form VS 17-33, which must include the location of the recognized slaughtering establishment.

(b) Bovines. In addition to meeting the requirements of paragraph (a) of this section, bovines may be imported from Canada for immediate slaughter only under the following conditions:

(1) The bovines must have been born after March 1, 1999, the date determined by APHIS to be the date of effective enforcement of a ruminant-to-ruminant feed ban in Canada;

(2) Before the animal's arrival at the port of entry into the United States, each bovine imported into the United States from Canada must be officially identified with unique individual identification that is traceable to the premises of origin of the animal. No person may alter, deface, remove, or otherwise tamper with the official identification while the animal is in the United States or moving into or through the United States, except that the identification may be removed at slaughter; and

(3) The bovines must be accompanied by a certificate issued in accordance with § 93.405 that states, in addition to the statements required by § 93.405, that the conditions of paragraphs (b)(1) and (b)(2) of this section have been met.

(Approved by the Office of Management and Budget under control numbers 0579-0234 and 0579-0393)

[78 FR 72996, Dec. 4, 2013, as amended at 86 FR 68859, Dec. 3, 2021; 87 FR 29, Jan. 3, 2022]

§ 93.421 Special provisions.

(a) In-bond shipments from Canada. (1) Cattle, sheep, and goats from Canada transported in-bond through the United States for immediate export shall be inspected at the border port of entry and, when accompanied by an import permit obtained under § 93.404 of this part and all conditions therein are observed, shall be allowed entry into the United States and shall be otherwise handled as provided in paragraph (b) of § 93.401. Ruminants not accompanied by a permit shall meet the requirements of this part in the same manner as ruminants destined for importation into the United States, except that the Administrator may permit their inspection at some other point when he or she finds that such action will not increase the risk that communicable diseases of livestock and poultry will be disseminated to the livestock or poultry of the United States.

(2) In-transit shipments through Canada. Ruminants originating in the United States and transported directly through Canada may re-enter the United States without Canadian health or test certificates when accompanied by copies of the United States export health certificates properly issued and endorsed in accordance with regulations in part 91 of this chapter: Provided, That, to qualify for entry, the date, time, port of entry, and signature of the Canadian Port Veterinarian that inspected the ruminants for entry into Canada shall be recorded on the United States health certificate, or a document containing information shall be included with the certificate that accompanies the ruminants. In all cases it shall be determined by the veterinary inspector at the United States port of entry that the ruminants are the identical ruminants covered by said certificate.

(b) Exhibition ruminants. Ruminants from the United States which have been exhibited at the Royal Agricultural Winter Fair at Toronto or other publicly recognized expositions in Canada, including racing, rodeo, circus, or stage exhibitions in Canada, and have not been in that region for more than 90 days are eligible for return to the United States without Canadian health or test certificates, if they are accompanied by copies of the United States health certificate, issued and endorsed in accordance with the export regulations contained in part 91 of this chapter for entry into Canada: Provided, That all ruminants offered for re-entry upon examination by the veterinary inspector at the U.S. port of entry, are found by the inspector to be free of communicable diseases and exposure thereto and are determined to be the identical ruminants covered by said certificates or are the natural increase of such ruminants born after official test dates certified on the dam's health certificate.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56018, Oct. 28, 1997; 81 FR 40151, June 21, 2016]

§ 93.422 Import permit and declaration for ruminants.

(a) For ruminants intended for importation from regions of Central America or of the West Indies, the importer shall first apply for and obtain from APHIS an import permit as provided in § 93.404: Provided, That the Administrator, when he or she finds that such action may be taken without endangering the livestock or poultry industry of the United States, may, upon request by any person, authorize the importation by such person, without such application or permit, from the British Virgin Islands into the Virgin Islands of the United States, of ruminants consigned for immediate slaughter, and such authorization may be limited to a particular shipment or extend to all shipments under this paragraph by such person during a specified period of time. The importation of cattle from any area infested with cattle fever ticks is prohibited except as provided in paragraph (c) of § 93.423.

(b) For all ruminants offered for importation from countries of Central America or of the West Indies, the importer or his or her agent shall present two copies of a declaration as provided in § 93.407.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56019, Oct. 28, 1997]

§ 93.423 Ruminants from Central America and the West Indies.

(a) In addition to all other applicable requirements of the regulations in this part, ruminants intended for importation from Central America and the West Indies, except as provided in paragraph (c) of this section, must be accompanied by a certificate issued in accordance with § 93.405(a) stating that the animals have been in that region at least 60 days immediately preceding the date of shipment to the United States; that he or she has inspected the ruminants on the premises of origin and found them free from evidence of any communicable disease; and that, as far as it has been possible to determine, the ruminants have not been exposed to any communicable disease during the preceding 60 days. If no such veterinary officer is available in the region of origin, ruminants, other than sheep and goats, may be accompanied by an affidavit of the owner or importer stating that such ruminants have been in the region from which they were directly shipped to the United States for a period of at least 60 days immediately preceding the date of shipment therefrom, and that during such period no communicable disease has existed among them or among animals of their kind with which they have come in contact. Ruminants for which such affidavit is presented, unless imported for immediate slaughter, shall be quarantined at the port of entry at least seven days and during that time shall be subjected to such dipping, blood tests or other tests, as may be required by the Administrator to determine their freedom from communicable diseases. If imported for immediate slaughter, such animals shall be handled as provided in § 93.420.

(b) The certificate accompanying sheep and goats intended for importation from Central America and the West Indies must, in addition to the statements required by paragraph (a) of this section, meet all of the requirements of § 93.405.

(c) Cattle, which have been infested with or exposed to fever ticks, may be imported from the British Virgin Islands into the United States Virgin Islands, for immediate slaughter, only, if they are free from fever ticks at the time of such importation; if they are entered through one of the ports designated in § 93.403(d) and are consigned to a recognized slaughtering establishment with facilities approved by the Administrator for holding the animals in isolation until slaughtered, which shall be within 14 days after the date of entry into the United States Virgin Islands; and if they are accompanied by a certificate of a responsible official of the government of the British Virgin Islands certifying that the cattle originated in and are being shipped directly from the British Virgin Islands, that they are free of fever ticks, and that, as far as it has been possible to determine, such cattle are free from evidence of communicable disease and have not been exposed to any such disease common to animals of their kind, other than bovine babesiosis, during the 60 days preceding their movement to the United States Virgin Islands.

(d) If ruminants are unaccompanied by the certificate or affidavit as required by paragraphs (a), (b), or (c) of this section, or if they are found upon inspection at the port of entry to be affected with a communicable disease or to have been exposed thereto, they shall be refused entry, except as provided in paragraph (c) of this section. Ruminants refused entry shall be handled or quarantined, or otherwise disposed of as the Administrator may direct.

(e) In addition to meeting all other applicable requirements of this part, bovines from Central America and the West Indies may be imported only in accordance with § 93.436.

(Approved by the Office of Management and Budget under control number 0579-0040)

[55 FR 31495, Aug. 2, 1990, as amended at 61 FR 17239, Apr. 19, 1996. Redesignated and amended at 62 FR 56012, 56019, Oct. 28, 1997; 68 FR 6344, Feb. 7, 2003; 78 FR 72997, Dec. 4, 2013; 80 FR 10324, Feb. 26, 2015; 85 FR 57952, Sept. 17, 2020]

§ 93.424 Import permits and applications for inspection of ruminants.

(a) For ruminants intended for importation from Mexico, the importer shall first apply for and obtain from APHIS an import permit as provided in § 93.404: Provided, that: An import permit is not required for sheep or goats imported for immediate slaughter if the animal is offered for entry at a land border port designated in § 93.403(c).

(b) For ruminants intended for importation into the United States from Mexico the importer or his or her agent shall deliver to the veterinary inspector at the port of entry an application, in writing, for inspection, so that the veterinary inspector and customs representatives may make mutual satisfactory arrangements for the orderly inspection of the animals. The veterinary inspector at the port of entry will provide the importer or his or her agent with a written statement assigning a date when the animals may be presented for import inspection.

[55 FR 31495, Aug. 2, 1990, as amended at 60 FR 13898, 13900, Mar. 15, 1995. Redesignated and amended at 56012, 56019, Oct. 28, 1997; 68 FR 35534, June 16, 2003; 85 FR 57952, Sept. 17, 2020, 86 FR 68859, Dec. 3, 2021]

§ 93.425 Declaration for ruminants.

For all ruminants offered for importation from Mexico, the importer or his or her agent shall present two copies of a declaration as provided in § 93.407.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56019, Oct. 28, 1997]

§ 93.426 Inspection at port of entry.

(a) All ruminants offered for entry from Mexico, including such ruminants intended for movement through the United States in bond for immediate return to Mexico, shall be inspected at the port of entry, and all such ruminants found to be free from communicable disease and fever tick infestation, and not to have been exposed thereto, shall be admitted into the United States subject to the other applicable provisions of this part. Ruminants found to be affected with or to have been exposed to a communicable disease, or infested with fever ticks, shall be refused entry except as provided in § 93.427(b)(2). Ruminants refused entry shall be handled or quarantined or otherwise disposed of as the Administrator may direct.

(b) Ruminants covered by paragraph (a) of this section shall be imported through ports, designated in § 93.403, which are equipped with facilities necessary for proper chute inspection, dipping, and testing, as provided in this part.

[55 FR 31495, Aug. 2, 1990, as amended at 60 FR 13898, Mar. 15, 1995. Redesignated and amended at 62 FR 56012, 56019, Oct. 28, 1997; 68 FR 6344, Feb. 7, 2003]

§ 93.427 Cattle and other bovines from Mexico.

Link to an amendment published at 74 FR 5, Jan. 2, 2009.

Link to a correction published at 74 FR 22091, May 12, 2009.

(a) Cattle and other ruminants from Mexico. Cattle and other ruminants from Mexico, except animals being transported in bond for immediate return to Mexico or animals imported for immediate slaughter, may be detained at the port of entry, and there subjected to such disinfection, blood tests, other tests, and dipping as required in this part to determine their freedom from any communicable disease or infection of such disease. The importer shall be responsible for the care, feed, and handling of the animals during the period of detention. In addition, each steer or spayed heifer imported into the United States from Mexico shall be identified with a distinct, permanent, and legible “M” mark applied with a freeze brand, hot iron, or other method prior to arrival at a port of entry, unless the steer or spayed heifer is being transported in bond for immediate return to Mexico or imported for slaughter in accordance with § 93.429. The “M” mark shall be between 3 inches (7.5 cm) and 5 inches (12.5 cm) high and wide, and shall be applied to each animal's right hip, within 4 inches (10 cm) of the midline of the tailhead (that is, the top of the brand should be within 4 inches (10 cm) of the midline of the tailhead, and placed above the hook and pin bones). The brand should also be within 18 inches (45.7 cm) of the anus.

(b)(1) Cattle from regions of Mexico that APHIS has determined to be free from fever ticks. APHIS has evaluated certain regions of Mexico in accordance with § 92.2 of this chapter, and determined that they are free from fever ticks; a list of all such regions is found on the internet at https://www.aphis.usda.gov/animalhealth/disease-status-of-regions. Copies of the list can be obtained via postal mail or email upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; AskRegionalization@usda.gov. Regions may be removed from the list based on a determination by APHIS that fever ticks exist in the region, on the discovery of tick-infested cattle from the region at a port of entry into the United States, or on information provided by a representative of the government of that region that fever ticks exist in the region. Cattle from regions of Mexico that APHIS has determined to be free from fever ticks may be imported into the United States subject to the following conditions:

(i) The cattle are accompanied by a certificate issued in accordance with § 93.405 that states that the cattle originate from a region of Mexico that APHIS has determined to be free from fever ticks.

(ii) If the cattle will transit to the United States through an area of Mexico that APHIS has not determined to be free from fever ticks, they are moved in a sealed means of conveyance, and that seal remains intact throughout such transit.

(iii) The cattle are presented for entry into the United States at a land border port of entry listed in § 93.403(c).

(iv) The cattle are segregated at the U.S. port of entry from cattle from regions of Mexico that APHIS has not determined to be free from fever ticks.

(v) The importer, or his or her agent, executes and delivers to the inspector at the port of entry an application for inspection or supervised dipping. In this application, the importer, or his or her agent, waive all claims against the United States for any loss or damage to the cattle occasioned by or resulting from inspection or dipping or from the fact that the cattle are later found still to be tick infested, and for any loss or damage to any other cattle in the importer's possession or control that come in contact with the dipped cattle.

(vi) The cattle are either inspected by an APHIS inspector at the port of entry for evidence of tick infestation or are treated with a tickicidal dip that is listed in § 72.13 of this chapter under the supervision of an inspector at the port of entry.

(vii) If any cattle are determined to be infested with fever ticks, the lot of cattle is refused entry and may only be imported into the United States subject to the requirements in paragraph (b)(2) of this section.

(2) Cattle from regions of Mexico that APHIS has not determined to be free from fever ticks. Cattle from regions of Mexico that APHIS has not determined to be free from fever ticks may only be imported into the United States subject to the following conditions:

(i) The cattle have been inspected by a veterinarian in Mexico and, in the determination of the veterinarian, are free from fever ticks and all evidence of communicable diseases, and have not been exposed to communicable diseases, other than bovine babesiosis, during the 60 days prior to movement to a port of entry into the United States.

(ii) The cattle have been treated in Mexico with a tickicidal dip that is listed in § 72.13 of this chapter within 7 to 14 days before being offered for entry into the United States.

(iii) The cattle are accompanied by a certificate issued in accordance with § 93.405 that states that this inspection and dipping have occurred.

(iv) The cattle are presented for entry into the United States at the port of entry at Santa Teresa, NM, or a port of entry within Texas that is listed in § 93.403(c).

(v) The importer, or his or her agent, executes and delivers to the inspector at the port of entry an application for inspection and supervised dipping. In this application, the importer, or his or her agent, agrees to waive all claims against the United States for any loss or damage to the cattle occasioned by or resulting from this dipping or from the fact that the cattle are later found to still be infested with ticks, and for any loss or damage to any other cattle in the importer's possession or control that come in contact with the dipped cattle.

(vi) When offered for entry, the cattle receive an inspection by an inspector. If free from fever ticks, the cattle are treated once with a tickicidal dip that is listed in § 72.13 of this chapter 7 to 14 days after the dipping required in paragraph (b)(2)(ii) of this section. If found to be infested with fever ticks, the cattle are refused entry and may not be inspected again at a port of entry until they are again dipped and 7 to 14 days have elapsed.

(vii) The cattle are not imported into an area of Texas that is quarantined in accordance with § 72.5 of this chapter for bovine babesiosis, or for tick infestation.

(c) Importation of Holsteins from Mexico. The importation of Holstein steers, Holstein spayed heifers, Holstein cross steers, and Holstein cross spayed heifers from Mexico is prohibited.

(d) [Reserved]

(e) BSE. In addition to meeting the requirements of this section and all other applicable requirements of this part, bovines may be imported from Mexico only under the following conditions:

(1) The bovines were born after November 30, 2007, the date determined by APHIS to be the date of effective enforcement of a ruminant-to-ruminant feed ban in Mexico.

(2) The bovines were officially identified prior to arriving at the port of entry in the United States with unique individual identification that is traceable to each bovine's premises of origin. No person may alter, deface, remove, or otherwise tamper with the official identification while the animal is in the United States or moving into or through the United States, except that the identification may be removed at slaughter.

(3) The bovines, if sexually intact, are permanently and humanely identified using one of the following additional methods:

(i) An “M” mark properly applied with a freeze brand, hot iron, or other method, and easily visible on the live animal and on the carcass before skinning. Such a mark must be between 3 inches (7.5 cm) and 5 inches (12.5 cm) high and wide, and must be applied to the upper right front shoulder of each animal; or

(ii) A tattoo with the letters “MX” applied to the inside of one ear of the animal; or

(iii) Other means of permanent identification upon request if deemed adequate by the Administrator to humanely identify the animal in a distinct and legible way as having been imported from Mexico.

(4) The bovines are accompanied by a certificate issued in accordance with § 93.405 that states, in addition to the statements required by § 93.405, that the conditions of paragraphs (e)(1) through (e)(3) of this section have been met.

(Approved by the Office of Management and Budget under control numbers 0579-0040, 0579-0224, 0579-0393, and 0579-0425)

[55 FR 31495, Aug. 2, 1990. Redesignated at 62 FR 56012, Oct. 28, 1997]

Editorial Note:For Federal Register citations affecting § 93.427, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

Effective Date Note:At 74 FR 5, Jan. 2, 2009, as corrected at 74 FR 22091, May 12, 2009, § 93.427 was amended, effective date delayed indefinitely.

§ 93.428 Sheep and goats and wild ruminants from Mexico.

(a) Sheep, goats, and native wild ruminants intended for import from Mexico must be imported in accordance with § 93.435, and shall be accompanied by a certificate issued in accordance with § 93.405 and stating, if such sheep and goats are shipped by rail or truck, that such animals were loaded into cleaned and disinfected cars or trucks for transportation direct to the port of entry. Notwithstanding such certificate, such sheep and goats shall be detained as provided in § 93.427(a) and shall be dipped at least once in a permitted scabies dip under supervision of an inspector.

(b) The certificate accompanying goats offered for importation from Mexico shall, in addition to the statements required by paragraph (a) of this section, state that such goats have been tested for tuberculosis and brucellosis with negative results within 30 days preceding their being offered for entry, and give the date and method of testing, the name of the consignor and of the consignee, and a description of the animals including breed, ages, markings, and tattoo and eartag numbers. Notwithstanding such certification, such goats shall be detained or quarantined as provided in § 93.427 and retested for brucellosis.

(c) If sheep or goats are unaccompanied by the certificate as required by paragraphs (a) and (b) of this section, or if they are found upon inspection or retesting, as provided for in this part, to be affected with a communicable disease or to have been exposed thereto, they shall be refused entry and shall be handled or quarantined, or otherwise disposed of as the Administrator may direct.

(d) Certificates will not be required for wild ruminants, other than sheep and goats, originating in and shipped direct from Mexico, but such animals are subject to inspection at the port of entry as provided in § 93.426.

(Approved by the Office of Management and Budget under control numbers 0579-0040 and 0579-0453)

[55 FR 31495, Aug. 2, 1990, as amended at 56 FR 367, Jan. 4, 1991; 57 FR 28081, June 24, 1992; 61 FR 17239, Apr. 19, 1996. Redesignated and amended at 62 FR 56012, 56019, Oct. 28, 1997; 68 FR 6344, Feb. 7, 2003; 86 FR 68859, Dec. 3, 2021]

§ 93.429 Ruminants for immediate slaughter.

Ruminants, other than sheep and goats, may be imported from Mexico, subject to the applicable provisions of §§ 93.424, 93.425, 93.426, and 93.427(b)(2) for immediate slaughter if accompanied by a certificate issued in accordance with § 93.405(a) and stating that the veterinarian who issued the certificate has inspected the animals in the herd from which the ruminants will be imported and found them free of evidence of communicable disease, and that, so far as it has been possible to determine, they have not been exposed to any such disease common to animals of their kind during the preceding 60 days, and if the ruminants are shipped by rail or truck, the certificate shall further specify that the ruminants were loaded into cleaned and disinfected cars or trucks for transportation directly to the port of entry. Such ruminants shall be moved from the port of entry in conveyances sealed with seals of the United States Government. Sheep and goats from any part of Mexico may be imported only in compliance with other applicable sections in this part.

[55 FR 31495, Aug. 2, 1990, as amended at 57 FR 28081, June 24, 1992; 61 FR 17239, Apr. 19, 1996. Redesignated and amended at 62 FR 56012, 56019, Oct. 28, 1997]

§§ 93.430-93.434 [Reserved]

§ 93.435 Sheep and goats.

(a) General provisions. (1) Sheep and goats imported from anywhere in the world shall be accompanied by a certificate issued in accordance with § 93.405. If the sheep or goats are not accompanied by the certificate, or if they are found upon inspection at the port of entry to be affected with or exposed to a communicable disease, they shall be refused entry and shall be handled or quarantined, or otherwise disposed of, as the Administrator may direct.

(2) All imported sheep and goats must be officially identified at the time of presentation for entry into the United States with official identification devices or methods and which will allow the animals not imported for immediate slaughter or for feeding for slaughter to be traced at any time to the farm or premises of birth, and for animals imported for immediate slaughter or for feeding for slaughter to the flock of residence. Official identification devices may not be removed or altered at any time after entry into the United States, except by an authorized USDA representative at the time of slaughter. A list of the acceptable types of official identification devices or methods may be found on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/imports/live-animal-imports.

(3) All imported sheep and goats other than for immediate slaughter or as provided in paragraph (c) of this section for restricted feeding for slaughter must be identified at the time of presentation for entry into the United States with a country mark using a means and in a location on the animal approved by the Administrator for this use. A list of the acceptable country marks may be found on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/imports/live-animal-imports.

(4) Except as provided in paragraph (b) of this section for sheep or goats imported for immediate slaughter, and in paragraph (c) of this section for sheep or goats for restricted feeding for slaughter, the importer shall maintain records of the sale, death or other disposition of all imported animals including the official identification number(s) and country marks on the animals at the time of import; a record of the replacement of any lost identification devices linking the new official identification number to the lost device number; the date and manner of disposition; and the name and address of the new owner. Such records must be maintained for a period of 5 years after the sale or death of the animal. The records must be available for APHIS to view and copy during normal business hours.

(b) Sheep and goats imported for immediate slaughter from anywhere in the world. (1) Sheep and goats for immediate slaughter may only be imported into the United States from countries or regions determined to be free of classical scrapie by APHIS, or that have scrapie awareness, surveillance, and control programs evaluated and determined by APHIS to be effective.

(2) Sheep and goats imported for immediate slaughter must be imported only through a port of entry listed in § 93.403(b) or as provided for in § 93.403(f) and be inspected at the port of entry and otherwise handled in accordance with § 93.408.

(3) The ruminants must be moved directly from the port of entry to a recognized slaughtering establishment in conveyances that are sealed with seals of the U.S. Government at the port of entry. The seals may be broken only at the recognized slaughtering establishment by an authorized USDA representative.

(4) The shipment must be accompanied from the port of entry to the recognized slaughtering establishment by APHIS Form VS 17-33.

(c) Sheep and goats imported for restricted feeding for slaughter. (1) Sheep and goats for restricted feeding for slaughter purposes may only be imported into the United States from countries or regions determined to be free of classical scrapie by APHIS, or that have scrapie awareness, surveillance, and control programs evaluated and determined by APHIS to be effective.

(2) The sheep and goats must be imported only through a port of entry allowed in § 93.403 in a means of conveyance sealed in the region of origin with seals of the national government of the region of origin. The seals may be broken either by an APHIS representative at the port of entry, or at the designated feedlot by an authorized APHIS representative. If the seals are broken by an APHIS representative, the means of conveyance must be resealed with seals of the U.S. Government before being moved to the designated feedlot; and

(3) The sheep and goats shall be inspected by the port veterinarian or other designated representative at the port of entry to determine that the animals are free from evidence of communicable disease and are considered fit for further travel; and

(4) The sheep and goats must be moved directly as a group from the port of entry to a designated feedlot; and

(5) The sheep and goats may not be commingled with any sheep or goats that are not being moved directly to slaughter from the designated feedlot; and

(6) The sheep and goats may be moved from the port of entry only to a feedlot designated in accordance with paragraph (c)(11) of this section and must be accompanied from the port of entry to the designated feedlot by APHIS Form VS 17-130 or other movement documentation stipulated in the import permit; and

(7) Upon arrival at the designated feedlot, the official identification for each animal must be reconciled by an APHIS veterinarian, or other official designated by APHIS, with the accompanying documentation; and

(8) The sheep and goats must remain at the designated feedlot until transported to a recognized slaughtering establishment. The sheep and goats must be moved directly to the recognized slaughtering establishment in a means of conveyance sealed by an accredited veterinarian, a State representative, or an APHIS representative with seals of the U.S. Government. The seals must be broken at the recognized slaughtering establishment only by an authorized USDA representative; and

(9) The sheep and goats must be accompanied to the recognized slaughtering establishments by APHIS Form VS 1-27 or other documentation stipulated in the import permits; and

(10) The sheep and goats must be slaughtered within 12 months of importation.

(11) To be eligible as a designated feedlot to receive sheep and goats imported for feeding, a feedlot must be approved by APHIS. To be approved by APHIS, the feedlot operator or his or her agent must enter into a compliance agreement with the Administrator. The compliance agreement must provide that the operator:

(i) Will monitor all imported feeder animals to ensure that they have the required official identification at the time of arrival to the feedlot; and will not remove official identification from animals unless medically necessary, in which case new official identification will be applied and cross referenced in the records. Any lost official identification will be replaced with eartags provided by APHIS for purposes of this paragraph (c)(11)(i) and will be linked as the new official identification with the lost identification. If more than one animal loses their official identification at the same time, the new official identification will be linked with all possible original identification numbers;

(ii) Will monitor all incoming imported feeder animals to ensure they have the required country mark, or will maintain all imported animals in separate pens from U.S. origin animals, and all sheep and goats that enter the feedlot are moved only for slaughter;

(iii) Will maintain records of the acquisition and disposition of all imported sheep and goats entering the feedlot, including the official identification number and all other identifying information, the age of each animal, the date each animal was acquired and the date each animal was shipped to slaughter, and the name and location of the plant where each animal was slaughtered. For imported animals that die in the feedlot, the feedlot will remove the official identification device if affixed to the animal, or will record any other official identification on the animal and place the official identification device or record of official identification in a file with a record of the disposition of the carcass;

(iv) Will maintain copies of the APHIS Forms VS 17-130 and VS 1-27 or other movement documentation deemed acceptable by the Administrator that have been issued for incoming animals and for animals moved to slaughter and that list the official identification of each animal;

(v) Will allow State and Federal animal health officials access to inspect its premises and animals and to review inventory records and other required files upon request;

(vi) Will keep required records for at least 5 years;

(vii) Will designate either the entire feedlot or pens within the feedlot as terminal for sheep and goats to be moved only directly to slaughter;

(viii) Will prevent fence-line contact with sheep or goats outside the designated feedlot;

(ix) Agrees that if inventory cannot be reconciled or if animals are not moved to slaughter as required, the approval of the feedlot to receive additional animals will be immediately withdrawn and any imported animals remaining in the feedlot will be disposed of as directed by the Administrator;

(x) Agrees that if an imported animal gives birth in the feedlot, the offspring will be humanely euthanized and the birth tissues and soiled bedding disposed of in a sanitary landfill or by another means approved by the Administrator; and

(xi) Agrees to maintain sexually intact animals of different genders over 5 months of age in separate enclosures.

(xii) For a feedlot to be approved to receive sheep or goats imported for feeding under this section, but which do not have a country mark, the compliance agreement must also provide that the feedlot will maintain all imported animals in separate pens from U.S. origin animals and that all sheep and goats that enter the feedlot are moved only for slaughter.

(d) Other importations. Sheep or goats imported other than as provided in paragraph (b) of this section for immediate slaughter or as provided in paragraph (c) of this section for sheep and goats imported for restricted feeding for slaughter must originate from a region recognized as free of classical scrapie by APHIS or from a flock that has certified status or equivalent status in a scrapie flock certification program or equivalent program approved by APHIS, or as provided in § 93.404(a)(5) or (6).

(e) Sheep and goats transiting the United States. Sheep or goats that meet the entry requirements for immediate slaughter in § 93.405 may transit the United States in accordance with § 93.401 regardless of their intended use in the receiving country.

(f) Classical scrapie status of foreign regions. APHIS considers classical scrapie to exist in all regions of the world except those declared free of this disease by APHIS.

(1) A list of regions that APHIS has declared free of classical scrapie is maintained on the APHIS website at https://www.aphis.usda.gov/import_export/animals/animal_disease_status.shtml. Copies of the list are also available via postal mail, fax, or email upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road Unit 38, Riverdale, Maryland 20737.

(2) APHIS will add a region to the list in paragraph (f)(1) only after conducting an evaluation of the region in accordance with § 92.2 of this subchapter and finding classical scrapie is not likely to be present in its sheep or goat populations. In the case of a formerly listed region removed due to an outbreak, the region may be returned to the list in accordance with the procedures for reestablishment of a region's disease-free status in § 92.4 of this subchapter. APHIS will remove a region from the list of those it has declared free of classical scrapie upon determining classical scrapie exists there based on reports APHIS receives of outbreaks of the disease in sheep or goats from veterinary officials of the exporting country, from the World Organization for Animal Health (OIE), from other sources the Administrator determines to be reliable, or upon determining that the region's animal health infrastructure, regulations, or policy no longer qualifies the region for such status.

(Approved by the Office of Management and Budget under control numbers 0579-0040, 0579-0101, and 0579-0453)

[86 FR 68859, Dec. 3, 2021]

§ 93.436 Bovines from regions of negligible risk, controlled risk, and undetermined risk for BSE.

The importation of bovines is prohibited, unless the conditions of this section and any other applicable conditions of this part are met. Once the bovines are imported, if they do not meet the conditions of this section, they must be disposed of as the Administrator may direct.

(a) Bovines from a region of negligible risk for BSE in which there has been no indigenous case of BSE. Bovines from a region of negligible risk for BSE, as defined in § 92.1 of this subchapter, in which there has been no indigenous case of BSE, may be imported only if the bovines are accompanied by an original certificate issued by a full-time salaried veterinary officer of the national government of the exporting region, or issued by a veterinarian designated or accredited by the national government of the exporting region and endorsed by a full-time salaried veterinary officer of the national government of the exporting region, representing that the veterinarian issuing the certificate was authorized to do so, and the certificate attests that the exporting region of the bovines is classified by APHIS as a negligible-risk region for BSE in which there has been no indigenous case of BSE.

(b) Bovines from a region of negligible risk for BSE in which there has been an indigenous case of BSE and bovines from a region of controlled risk for BSE. Bovines from a region of negligible risk for BSE, as defined in § 92.1 of this subchapter, in which there has been an indigenous case of BSE, and bovines from a region of controlled risk for BSE, as defined in § 92.1 of this subchapter, may be imported only under the following conditions:

(1) Prior to importation into the United States, each bovine is officially identified with unique individual identification that is traceable to the premises of origin of the animal. No person may alter, deface, remove, or otherwise tamper with the official identification while the animal is in the United States or moving into or through the United States, except that the identification may be removed at slaughter.

(2) The bovines are permanently and humanely identified before arrival at the port of entry with a distinct and legible mark identifying the exporting country. Acceptable means of permanent identification include the following:

(i) A mark properly applied with a freeze brand, hot iron, or other method, and easily visible on the live animal and on the carcass before skinning. Such a mark must be not less than 2 inches nor more than 3 inches high, and must be applied to each animal's right hip, high on the tail-head (over the junction of the sacral and first coccygeal vertebrae);

(ii) A tattoo with letters identifying the exporting country must be applied to the inside of one ear of the animal; or

(iii) Other means of permanent identification upon request if deemed adequate by the Administrator to humanely identify the animal in a distinct and legible way as having been imported from a region of negligible risk for BSE in which there has been an indigenous case of BSE or from a region of controlled risk for BSE.

(3) The bovines were born after the date from which the ban on the feeding of ruminants meat-and-bone meal or greaves derived from ruminants has been effectively enforced.

(4) The bovines are accompanied by an original certificate issued by a full-time salaried veterinary officer of the national government of the exporting region, or issued by a veterinarian designated or accredited by the national government of the exporting region and endorsed by a full-time salaried veterinary officer of the national government of the exporting region, representing that the veterinarian issuing the certificate was authorized to do so, and the certificate attests to the BSE risk classification of the exporting region and that the conditions of paragraphs (b)(1) through (b)(3) of this section have been met.

(5) If there has been an indigenous case of BSE in the exporting region, the following restrictions apply:

(i) Bovines that, during their first year of life, were reared with a bovine determined to be infected with BSE during its first year of life, and that an investigation showed consumed the same potentially contaminated feed as the infected animal during that period are not eligible for importation into the United States; and

(ii) If the investigation was unable to determine whether the feed source that was used to feed the bovine known to be infected was also used to feed other bovines in the herd of the infected animal, all bovines born in the same herd as a BSE-infected bovine either within 12 months before or 12 months after the birth of the infected animal are not eligible for importation into the United States.

(c) Bovines from a region of undetermined risk for BSE. Importation of bovines from a region of undetermined risk for BSE, as defined in § 92.1 of this subchapter, is prohibited; Except that: The Administrator may allow such imports on a case-by-case basis if the live bovines are imported for specific uses, including, but not limited to, show or exhibition, and under conditions determined by the Administrator to be adequate to prevent the spread of BSE.

(Approved by the Office of Management and Budget under control number 0579-0234)

[78 FR 72997, Dec. 4, 2013]

§ 93.437 Tuberculosis status of foreign regions.

(a) Level I regions. APHIS considers certain regions of the world to have a program that meets APHIS requirements for tuberculosis classification in accordance with § 93.438, and a prevalence of tuberculosis in their domestic bovine herds of less than 0.001 percent over at least the previous 2 years (24 consecutive months).

(b) Level II regions. APHIS considers certain regions of the world to have a program that meets APHIS requirements for tuberculosis classification in accordance with § 93.438, and a prevalence of tuberculosis in their domestic bovine herds equal to or greater than 0.001 percent, but less than 0.01 percent, over the previous 2 years (24 consecutive months).

(c) Level III regions. APHIS considers certain regions of the world to have a program that meets APHIS requirements for tuberculosis classification in accordance with § 93.438, and a prevalence of tuberculosis in their domestic bovine herds equal to or greater than 0.01 percent, but less than 0.1 percent, over the previous year (12 consecutive months).

(d) Level IV regions. APHIS considers certain regions of the world to have a program that meets APHIS requirements for tuberculosis classification in accordance with § 93.438, and a prevalence of tuberculosis in their domestic bovine herds equal to or greater than 0.1 percent, but less than 0.5 percent, over the previous year (12 consecutive months).

(e) Level V regions. APHIS considers certain regions of the world not to have a program that meets APHIS requirements for tuberculosis classification in accordance with § 93.438, to have a prevalence of tuberculosis in their domestic bovine herds equal to or greater than 0.5 percent, or to be unassessed by APHIS with regard to tuberculosis.

(f) Listing of regions. Lists of all Level I regions, Level II regions, Level III regions, Level IV regions, and Level V regions for tuberculosis are found online, at http://www.aphis.usda.gov/import_export/animals/live_animals.shtml. Changes to the lists will be made in accordance with § 93.438.

[85 FR 57953, Sept. 17, 2020]

§ 93.438 Process for requesting regional classification for tuberculosis.

(a) Request for regional classification; requirements. A representative of the national government(s) of any country or countries who has the authority to make such a request may request that APHIS classify a region for tuberculosis. Requests for classification or reclassification must be submitted to APHIS electronically or through the mail as provided at http://www.aphis.usda.gov/import_export/animals/live_animals.shtml. Guidance regarding how to complete a request in a manner that will allow APHIS to review it expeditiously is available at http://www.aphis.usda.gov/import_export/animals/reg_request.shtml, and may also be obtained by contacting the National Director, Regionalization Evaluation Services, Strategy and Policy Unit, VS, APHIS, 4700 River Road, Unit 38, Riverdale, MD 20737. At a minimum, in order for APHIS to consider the request complete, it must define the boundaries of the region, specify the prevalence level for tuberculosis within the region, and demonstrate the following:

(1) That there is effective veterinary control and oversight within the region;

(2) That tuberculosis is a notifiable disease within the region; and

(3) That the region has a program in place for tuberculosis that includes, at a minimum:

(i) Epidemiological investigations following the discovery of any infected animals or affected herds, or any animals or herds that have had non-negative test results following a test for tuberculosis, and documentation of these investigations;

(ii) Management of affected herds in a manner designed to eradicate tuberculosis from those herds in a timely manner, and documentation regarding this management;

(iii) Regulatory controls on the movement of livestock into, within, and from the region that correspond to the risk of dissemination of tuberculosis associated with such movement; and

(iv) Access to, oversight of, and quality controls for diagnostic testing for tuberculosis within the region.

(4) That the region has surveillance in place that is equivalent to or exceeds Federal standards for surveillance within the United States.

(b) APHIS evaluation. If, after reviewing and evaluating the request for classification, APHIS believes the region can be accurately classified for tuberculosis, APHIS will publish a notice in the Federal Register proposing to classify the region according to § 93.437, and making the information upon which this proposed classification is based available to the public for review and comment. The notice will request public comment.

(c) APHIS determination. (1) If no comments are received on the notice, or if comments are received but do not affect APHIS' proposed classification, APHIS will publish a subsequent notice in the Federal Register announcing that classification to be final and adding the region to the appropriate list on the APHIS website.

(2) If comments received on the notice suggest that the region be classified according to a different tuberculosis classification, and APHIS agrees with the comments, APHIS will publish a subsequent notice in the Federal Register making the information supplied by commenters available to the public, and proposing to classify the region according to this different classification. The notice will request public comment.

(3) If comments received on the notice suggest that insufficient information was supplied on which to base a tuberculosis classification, and APHIS agrees with the comments, APHIS will publish a subsequent notice in the Federal Register specifying the additional information needed before APHIS can classify the region.

(d) Maintaining classification and reclassification initiated by APHIS. If a region is classified under the provisions of this section, that region may be required to submit additional information or allow APHIS to conduct additional information collection activities in order for that region to maintain its classification. Moreover, if APHIS determines that a region's classification for tuberculosis is no longer accurate, APHIS will publish a notice in the Federal Register announcing the revised classification and setting forth the reasons for this reclassification.

(Approved by the Office of Management and Budget under control number 0579-0442)

[85 FR 57953, Sept. 17, 2020]

§ 93.439 Importation of ruminants from certain regions of the world; tuberculosis.

(a) Importation of certain ruminants prohibited. Notwithstanding any other provisions of this section, ruminants that are known to be infected with or exposed to tuberculosis and ruminants that have had a non-negative response to any test for tuberculosis at any time are prohibited importation into the United States.

(b) Identification of bovines imported for any purpose. Unless otherwise specified by the Administrator, bovines imported into the United States for any purpose must be officially identified and accompanied by a certificate, issued in accordance with § 93.405(a), that lists the official identification of the animals presented for import.

(c) Importation of bovines from a Level I region. Unless specified otherwise by the Administrator, bovines may be imported into the United States from a Level I region for tuberculosis in accordance with paragraph (b) of this section. 12

12 The importation of such bovines, as well as that of all other bovines covered by this section, is still subject to all other relevant restrictions of this part.

(d) Importation of bovines from a Level II region. (1) Sexually intact bovines may be imported into the United States from a Level II region for tuberculosis for purposes other than immediate slaughter provided that the bovines are subjected to an individual test for tuberculosis at the port of entry into the United States or during post-arrival quarantine in accordance with § 93.411, with negative results.

(2) Steers or spayed heifers may be imported into the United States from a Level II region for tuberculosis for purposes other than immediate slaughter in accordance with paragraph (b) of this section.

(e) Importation of bovines from a Level III region. (1) Bovines directly from currently accredited herds for tuberculosis. Bovines may be imported into the United States for purposes other than immediate slaughter directly from a currently accredited herd for tuberculosis in a Level III region for tuberculosis, provided that:

(i) The bovines are accompanied by a certificate, issued in accordance with § 93.405(a), with an additional statement that the bovines originate directly from a currently accredited herd for tuberculosis; and

(ii) If sexually intact, the bovines are subjected to an individual test for tuberculosis at the port of entry into the United States or during post-arrival quarantine in accordance with § 93.411, with negative results.

(2) Sexually intact bovines that do not originate directly from a currently accredited herd for tuberculosis may be imported into the United States from a Level III region for tuberculosis for purposes other than immediate slaughter, provided that:

(i) The bovines originate from a herd that was subjected to a whole herd test for tuberculosis on its premises of origin no more than 1 year prior to the export of the bovines to the United States, with negative results; and

(ii) The bovines are subjected to an individual test for tuberculosis at the port of entry into the United States or during post-arrival quarantine in accordance with § 93.411, with negative results; and

(iii) The bovines are accompanied by a certificate, issued in accordance with § 93.405(a), with an additional statement that the animals meet the conditions for importation in paragraph (e)(2)(i) of this section.

(3) Steers or spayed heifers that do not originate directly from a currently accredited herd for tuberculosis may be imported into the United States from a Level III region for tuberculosis for purposes other than immediate slaughter provided that:

(i) The steers or spayed heifers are subjected to an individual test for tuberculosis no more than 60 days prior to export of the bovines to the United States, with negative results; and

(ii) The steers or spayed heifers are accompanied by a certificate, issued in accordance with § 93.405(a), with an additional statement that the animals meet the conditions for importation in paragraph (e)(3)(i) of this section.

(f) Importation of bovines from a Level IV region. (1) Bovines may be imported into the United States for purposes other than immediate slaughter directly from a currently accredited herd for tuberculosis in a Level IV region for tuberculosis, provided that:

(i) The bovines are accompanied by a certificate, issued in accordance with § 93.405(a), with an additional statement that the bovines originate directly from a currently accredited herd for tuberculosis and, if steers or spayed heifers, meet the conditions for importation in paragraph (f)(1)(iii) of this section; and

(ii) If sexually intact, the bovines are subjected to an individual test for tuberculosis at the port of entry into the United States or during post-arrival quarantine in accordance with § 93.411, with negative results; and

(iii) If steers and spayed heifers, the bovines are subjected to an individual test for tuberculosis no more than 60 days prior to export of the bovines to the United States, with negative results.

(2) Sexually intact bovines that do not originate directly from a currently accredited herd for tuberculosis may be imported into the United States from a Level IV region for tuberculosis for purposes other than immediate slaughter, provided that:

(i) The bovines originate from a herd that was subjected to two whole herd tests for tuberculosis on its premises of origin and conducted no less than 9 months and no more than 15 months apart, with the second whole herd test conducted no less than 60 days and no more than 12 months prior the export of the bovines to the United States, with negative results each time; and

(ii) The bovines are subjected to an additional individual test for tuberculosis at the port of entry into the United States or during post-arrival quarantine in accordance with § 93.411, with negative results; and

(iii) The bovines are accompanied by a certificate, issued in accordance with § 93.405(a), with an additional statement that the bovines meet the requirements in paragraph (f)(2)(i) of this section.

(3) Steers or spayed heifers that do not originate directly from a currently accredited herd for tuberculosis may be imported into the United States from a Level IV region for tuberculosis for purposes other than immediate slaughter provided that:

(i) The bovines originate from a herd that was subjected to a whole herd test for tuberculosis on its premises of origin no more than 1 year prior to the export of the bovines, with negative results; and

(ii) The bovines are subjected to an additional individual test for tuberculosis no more than 60 days prior to export of the bovines to the United States, with negative results, except that the individual test is not required if the bovines are exported within 60 days of the whole herd test and were included in that test; and

(iii) The bovines are accompanied by a certificate, issued in accordance with § 93.405(a), with an additional statement that the bovines meet the requirements in this paragraph (f)(3).

(g) Importation of bovines from a Level V region. At the discretion of the Administrator, bovines may be imported into the United States from a Level V region for tuberculosis for purposes other than immediate slaughter, provided that:

(1) The bovines are subject to a pre-clearance program administered by APHIS and detailed in an import protocol published on the APHIS website; and

(2) The bovines are subjected to an additional individual test for tuberculosis at the port of entry into the United States or during post-arrival quarantine in accordance with § 93.411, with negative results; and

(3) The bovines are accompanied by a certificate, issued in accordance with § 93.405(a), with an additional statement that bovines meet the requirements in paragraphs (g)(1) and (2) of this section.

(Approved by the Office of Management and Budget under control number 0579-0442)

[85 FR 57954, Sept. 17, 2020]

§ 93.440 Brucellosis status of foreign regions.

(a) Level I regions. APHIS considers certain regions of the world to have a program that meets APHIS requirements for brucellosis classification in accordance with § 93.441, and a prevalence of brucellosis in their domestic bovine herds of less than 0.001 percent over at least the previous 2 years (24 consecutive months).

(b) Level II regions. APHIS considers certain regions of the world to have a program that meets APHIS requirements for brucellosis classification in accordance with § 93.441, and a prevalence of brucellosis in their domestic bovine herds equal to or greater than 0.001 percent, but less than 0.01 percent over at least the previous 2 years (24 consecutive months).

(c) Level III regions. APHIS considers certain regions of the world not to have a program that meets APHIS requirements for brucellosis classification in accordance with § 93.441, to have a herd prevalence equal to or greater than 0.01 percent, or to be unassessed by APHIS with regard to brucellosis prevalence.

(d) Listing of regions. Lists of all Level I, Level II, and Level III regions for brucellosis are found online, at http://www.aphis.usda.gov/import_export/animals/live_animals.shtml. Changes to the lists will be made in accordance with § 93.441.

[85 FR 57955, Sept. 17, 2020]

§ 93.441 Process for requesting regional classification for brucellosis.

(a) Request for regional classification; requirements. A representative of the national government(s) of any country or countries who has the authority to make such a request may request that APHIS classify a region for brucellosis. Requests for classification or reclassification must be submitted to APHIS electronically or through the mail as provided at http://www.aphis.usda.gov/import_export/animals/live_animals.shtml. Guidance regarding how to complete a request in a manner that will allow APHIS to review it expeditiously is available at http://www.aphis.usda.gov/import_export/animals/reg_request.shtml, and may also be obtained by contacting the National Director, Regionalization Evaluation Services, Strategy and Policy Unit, VS, APHIS, 4700 River Road, Unit 38, Riverdale, MD 20737. At a minimum, in order for APHIS to consider the request complete, it must define the boundaries of the region, specify the prevalence level for brucellosis within the region, and demonstrate the following:

(1) That there is effective veterinary control and oversight within the region;

(2) That brucellosis is a notifiable disease within the region;

(3) That the region has a program for brucellosis in place that includes, at a minimum:

(i) Epidemiological investigations following the discovery of any infected animals or affected herds, or any animals or herds that have had non-negative test results following a test for brucellosis, and documentation of these investigations;

(ii) Management of affected herds in a manner designed to eradicate brucellosis from those herds, and documentation regarding this management;

(iii) Regulatory controls on the movement of livestock into, within, and from the region that correspond to the risk of dissemination of brucellosis associated with such movement; and

(iv) Access to, oversight of, and quality controls on diagnostic testing for brucellosis within the region;

(4) That the region has surveillance in place that is equivalent to or exceeds Federal standards for brucellosis surveillance within the United States; and

(5) That, if the region vaccinates for brucellosis, it is in a manner that has been approved by APHIS.

(b) APHIS evaluation. If, after reviewing and evaluating the request for classification, APHIS believes the region can be accurately classified for brucellosis, APHIS will publish a notice in the Federal Register proposing to classify the region according to § 93.440, and making available to the public the information upon which this proposed classification is based. The notice will request public comment.

(c) APHIS determination. (1) If no comments are received on the notice, or if comments are received but do not affect APHIS' proposed classification, APHIS will publish a subsequent notice in the Federal Register announcing that classification to be final and adding the region to the appropriate list on the internet.

(2) If comments received on the notice suggest that the region be classified according to a different brucellosis classification, and APHIS agrees with the comments, APHIS will publish a subsequent notice in the Federal Register making the information supplied by commenters available to the public, and proposing to classify the region according to this different classification. The notice will request public comment.

(3) If comments received on the notice suggest that insufficient information was supplied on which to base a brucellosis classification, and APHIS agrees with the comments, APHIS will publish a subsequent notice in the Federal Register specifying the additional information needed before APHIS can classify the region.

(d) Maintaining classification and reclassification initiated by APHIS. If a region is classified under the provisions of this section, that region may be required to submit additional information or allow APHIS to conduct additional information collection activities in order for that region to maintain its classification. Moreover, if APHIS determines that a region's classification for brucellosis is no longer accurate, APHIS will publish a notice in the Federal Register announcing the revised classification and setting forth the reasons for this reclassification.

(Approved by the Office of Management and Budget under control number 0579-0442)

[85 FR 57955, Sept. 17, 2020]

§ 93.442 Importation of ruminants from certain regions of the world; brucellosis.

(a) Importation of certain ruminants prohibited. Notwithstanding any other provisions of this section, ruminants that are known to be infected with or exposed to brucellosis are prohibited importation into the United States.

(b) Identification of bovines imported for any purpose. Unless otherwise specified by the Administrator, bovines imported into the United States for any purpose must be officially identified and accompanied by a certificate, issued in accordance with § 93.405(a), that lists the official identification of the animals presented for import.

(c) Importation of steers and spayed heifers. Unless otherwise specified by the Administrator, steers and spayed heifers may be imported into the United States from a region in accordance with paragraph (b) of this section, without further restrictions under this part.

(d) Importation of sexually intact bovines from Level I regions. Unless specified otherwise by the Administrator, sexually intact bovines may be imported into the United States from a Level I region for brucellosis in accordance with paragraph (b) of this section. 13

13 The importation of such bovines, as well as that of all other bovines covered by this section, is still subject to all other relevant restrictions of this chapter.

(e) Importation of sexually intact bovines from a Level II region. (1) Sexually intact bovines directly from currently accredited herds for brucellosis. Sexually intact bovines may be imported into the United States for purposes other than immediate slaughter from a currently accredited herd for brucellosis in a Level II region for brucellosis, provided that the bovines are accompanied by a certificate, issued in accordance with § 93.405(a), with an additional statement that the bovines originate directly from a currently accredited herd for brucellosis.

(2) Sexually intact bovines that do not originate directly from a currently accredited herd for brucellosis. Sexually intact bovines that do not originate directly from a currently accredited herd for brucellosis may be imported into the United States from a Level II region for brucellosis for purposes other than immediate slaughter, provided that:

(i) The bovines originate from a herd that was subjected to a whole herd test for brucellosis on its premises of origin no more than 90 days and no less than 30 days prior to the export of the bovines to the United States, with negative results; and

(ii) The bovines are subjected to an additional individual test for brucellosis at the port of entry into the United States or during post-arrival quarantine in accordance with § 93.411, with negative results; and

(iii) The bovines are accompanied by a certificate, issued in accordance with § 93.405(a), with an additional statement that the bovines meet the requirements in paragraph (d)(2)(i) of this section.

(f) Importation of sexually intact bovines from a Level III region. (1) Sexually intact bovines directly from currently accredited herds for brucellosis. Sexually intact bovines may be imported into the United States for purposes other than immediate slaughter from a currently accredited herd for brucellosis in a Level III region for brucellosis, provided that:

(i) The bovines are subjected to an individual test for brucellosis at the port of entry into the United States or during post-arrival quarantine in accordance with § 93.411, with negative results; and

(ii) The bovines are accompanied by a certificate, issued in accordance with § 93.405(a), with an additional statement that the bovines originate directly from a currently accredited herd for brucellosis.

(2) Sexually intact bovines that do not originate directly from a currently accredited herd for brucellosis. Sexually intact bovines that do not originate directly from a currently accredited herd for brucellosis may be imported into the United States from a Level III region for brucellosis for purposes other than immediate slaughter, provided that:

(i) The bovines originate from a herd that was subjected to two whole herd tests for brucellosis on its premises of origin conducted no less than 9 months and no more than 15 months apart, with the second test taking place no more than 90 days and no less than 30 days prior to the export of the bovines to the United States, with negative results each time; and

(ii) The bovines are subjected to an additional individual test for brucellosis at the port of entry into the United States or during post-arrival quarantine in accordance with § 93.411, with negative results; and

(iii) The bovines are accompanied by a certificate, issued in accordance with § 93.405(a), with an additional statement that the bovines meet the requirements in paragraph (e)(2)(i) of this section.

(Approved by the Office of Management and Budget under control number 0579-0442)

[85 FR 57956, Sept. 17, 2020]

§ 93.500 Definitions.

Wherever in this subpart the following terms are used, unless the context otherwise requires, they shall be construed, respectively, to mean:

Accredited veterinarian. A veterinarian approved by the Administrator in accordance with the provisions of part 161 of this title to perform functions specified in parts 1, 2, 3, and 11 of subchapter A, and subchapters B, C, and D of this chapter, and to perform functions required by cooperative state-federal disease control and eradication programs.

Administrator. The Administrator of the Animal and Plant Health Inspection Service or any other employee of the Animal and Plant Health Inspection Service, United States Department of Agriculture, to whom authority has been or may be delegated to act in the Administrator's stead.

Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the United States Department of Agriculture (APHIS or Service).

Animals. Cattle, sheep, goats, other ruminants, swine, horses, asses, mules, zebras, dogs, and poultry.

APHIS representative. A veterinarian or other individual employed by the Animal and Plant Health Inspection Service, United States Department of Agriculture, who is authorized to perform the services required by this part.

Communicable disease. Any contagious, infectious, or communicable disease of domestic livestock, poultry or other animals.

Department. The United States Department of Agriculture (USDA).

Immediate slaughter. Consignment directly from the port of entry to a recognized slaughtering establishment 1 and slaughter thereat within two weeks from the date of entry.

1 The name of recognized slaughtering establishments approved under this part may be obtained from the Area Veterinarian in Charge, Veterinary Services, for the State of destination of the shipment.

Inspector. An employee of the Animal and Plant Health Inspection Service authorized to perform duties required under this subpart.

Official identification device or method. A means of officially identifying an animal or group of animals using devices or methods approved by the Administrator, including, but not limited to, official tags, tattoos, and registered brands when accompanied by a certificate of inspection from a recognized brand inspection authority.

Port veterinarian. A veterinarian employed by the Animal and Plant Health Inspection Service to perform duties required under this part at a port of entry.

Recognized slaughtering establishment. 2 An establishment where slaughtering operations are regularly carried on under federal or state inspection and which has been approved by the Animal and Plant Health Inspection Service to receive animals for slaughter under this part.

2 The name of recognized slaughtering establishments approved under this part may be obtained from the Area Veterinarian in Charge, Veterinary Services, for the State of destination of the shipment.

Region. Any defined geographic land area identifiable by geological, political, or surveyed boundaries. A region may consist of any of the following:

(1) A national entity (country);

(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.);

(3) Parts of several national entities combined into an area; or

(4) A group of national entities (countries) combined into a single area.

Ruminants. All animals which chew the cud, such as cattle, buffaloes, sheep, goats, deer, antelopes, camels, llamas and giraffes.

Swine. The domestic hog and all varieties of wild hogs.

United States. All of the States of the United States, the District of Columbia, Guam, Northern Mariana Islands, Puerto Rico, the Virgin Islands of the United States, and all other Territories and Possessions of the United States.

Veterinary Services. The Veterinary Services unit of the Department.

Zoological park. A professionally operated zoo, park, garden or other place, maintained under the constant surveillance of a Doctor of Veterinary Medicine, for the exhibition of live animals, pigeons or birds, for the purpose of public recreation or education.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56020, Oct. 28, 1997; 69 FR 64651, Nov. 8, 2004; 71 FR 29070, May 19, 2006; 72 FR 67232, Nov. 28, 2007; 76 FR 70039, Nov. 10, 2011; 77 FR 1391, Jan. 10, 2012]

§ 93.501 General prohibitions; exceptions.

(a) No swine or product subject to the provisions of this part shall be brought into the United States except in accordance with the regulations in this part and part 94 of this subchapter; 3 nor shall any such swine or product be handled or moved after physical entry into the United States before final release from quarantine or any other form of governmental detention except in compliance with such regulations; Provided, That, the Administrator may upon request in specific cases permit swine or products to be brought into or through the United States under such conditions as he or she may prescribe, when he or she determines in the specific case that such action will not endanger the livestock or poultry of the United States.

3 Importations of certain animals from various countries are absolutely prohibited under part 94 because of specified diseases.

(b) Except for swine prohibited entry, the provisions in this part 93 relating to swine shall not apply to healthy swine in transit through the United States if they are not known to be infected with or exposed, within 60 days preceding the date of export from the region of origin, to communicable diseases of such swine, if an import permit 4 has been obtained under § 93.504 of this Chapter and all conditions therein are observed; and if such swine are handled as follows:

4 Such permit may be obtained from the Animal and Plant Health Inspection Service, Veterinary Services, Strategy and Policy, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231. Requests for approval of such facilities should also be made to the Administrator.

(1)(i) They are maintained under continuous confinement in transit through the United States aboard an aircraft, ocean vessel, or other means of conveyance; or

(ii) They are unloaded, in the course of such transit, into a swine holding facility which is provided by the carrier or its agent and has been approved 5 in advance by the Administrator in accordance with paragraph (d)(3) of this section as adequate to prevent the spread within the United States of any livestock or poultry disease, and they are maintained there under continuous confinement until loaded aboard a means of conveyance for transportation from the United States and are maintained under continuous confinement aboard such means of conveyance until it leaves the United States; the import permit will specify any additional conditions necessary to assure that the transit of the swine through the United States can be made without endangering the livestock or poultry of the United States, and that Department inspectors may inspect the swine on board such means of conveyance or in such holding facility to ascertain whether the requirements of this paragraph are met, and dispose of them in accordance with the Animal Health Protection Act (7 U.S.C. 8301 et seq.) if such conditions are not met; and

5 See footnote 4 to subpart E.

(2) The carrier or its agent executes and furnishes to the collector of Customs at the first port of arrival a declaration stating that the swine will be retained aboard such means of conveyance or in an approved holding facility during transshipment as required by this paragraph.

(3) Provisions for the approval of facilities required in this paragraph are:

(i) They must be sufficiently isolated to prevent direct or indirect contact with all other animals and birds while in the United States.

(ii) They must be so constructed that they provide adequate protection against environmental conditions and can be adequately cleaned, washed and disinfected.

(iii) They must provide for disposal of swine carcasses, manure, bedding, waste and any related shipping materials in a manner that will prevent dissemination of disease.

(iv) They must have provisions for adequate sources of feed and water and for attendants for the care and feeding of swine in the facility.

(v) They must comply with additional requirements as may be imposed by the Administrator if deemed applicable for a particular shipment.

(vi) They must also comply with all applicable local, State and Federal requirements for environmental quality and with the provisions of the Animal Welfare Regulations in chapter I of this title, as applicable.

(c) Removal and loss of official identification devices. Official identification devices are intended to provide permanent identification of livestock and to ensure the ability to find the source of animal disease outbreaks. Removal of these devices is prohibited except at the time of slaughter. If an official identification device is lost and it is necessary to retag an animal with a new official number, every effort should be made to correlate the new official number with the previous official number of the animal.

[55 FR 31495, Aug. 2, 1990, as amended at 59 FR 67615, Dec. 30, 1994. Redesignated and amended at 62 FR 56012, 56020, Oct. 28, 1997; 68 FR 6344, Feb. 7, 2003; 69 FR 64651, Nov. 8, 2004; 86 FR 45624, Aug. 16, 2021]

§ 93.502 Inspection of certain aircraft and other means of conveyance and shipping containers thereon; unloading, cleaning, and disinfection requirements.

(a) Inspection: All aircraft and other means of conveyance (including shipping containers thereon) moving into the United States from any foreign region are subject to inspection without a warrant by properly identified and designated inspectors to determine whether they are carrying any animal, carcass, product or article regulated or subject to disposal under any law or regulation administered by the Secretary of Agriculture for prevention of the introduction or dissemination of any communicable animal disease.

(b) Unloading requirements: Whenever in the course of any such inspection at any port in the United States the inspector has reason to believe that the means of conveyance or container is contaminated with material of animal (including poultry) origin, such as, but not limited to, meat, organs, glands, extracts, secretions, fat, bones, blood, lymph, urine, or manure, so as to present a danger of the spread of any communicable animal disease, the inspector may require the unloading of the means of conveyance and the emptying of the container if he or she deems it necessary to enable him or her to determine whether the means of conveyance or container is in fact so contaminated. The principal operator of the means of conveyance and his or her agent in charge of the means of conveyance shall comply with any such requirement under the immediate supervision of, and in the time and manner prescribed by, the inspector.

(c) Cleaning and disinfection: Whenever, upon inspection under this section, an inspector determines that a means of conveyance or shipping container is contaminated with material of animal origin so as to present a danger of the spread of any communicable animal disease, he or she shall notify the principal operator of the means of conveyance or his or her agent in charge, of such determination and the requirements under this section. The person so notified shall cause the cleaning and disinfection of such means of conveyance and container under the immediate supervision of, and in the time and manner prescribed by, the inspector.

(d) For purposes of this section, the term “shipping container” means any container of a type specially adapted for use in transporting any article on the means of conveyance involved.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56020, Oct. 28, 1997; 68 FR 6344, Feb. 7, 2003]

§ 93.503 Ports designated for the importation of swine.

(a) Air and ocean ports. The following ports have APHIS inspection and quarantine facilities necessary for quarantine stations and all swine shall be entered into the United States through these stations, except as provided in paragraphs (b), (c), (d), (e), and (f) of this section: Los Angeles, California; Miami, Florida; and Newburgh, New York.

(b) Canadian border ports. The following land border ports are designated as having the necessary inspection facilities for the entry of swine from Canada: Eastport, Idaho; Houlton and Jackman, Maine; Detroit, Port Huron, and Sault Ste. Marie, Michigan; Baudette, Minnesota; Opheim, Raymond, and Sweetgrass, Montana; Alexandria Bay, Buffalo, and Champlain, New York; Dunseith, Pembina, and Portal, North Dakota; Derby Line and Highgate Springs, Vermont; Oroville and Sumas, Washington.

(c) Mexican border ports. The following land border ports are designated as having the necessary inspection facilities for the entry of swine from Mexico: Brownsville, Hidalgo, Laredo, Eagle Pass, Del Rio, Presidio, and El Paso, Texas; Douglas, Naco, Nogales, Sasabe, and San Luis, Arizona; Calexico and San Ysidro, California; and Antelope Wells, and Columbus, New Mexico.

(d) Special ports. Charlotte Amalie, St. Thomas, and Christiansted, St. Croix, in the United States Virgin Islands, are hereby designated as quarantine stations for the entry of swine from the British Virgin Islands into the United States Virgin Islands for immediate slaughter.

(e) Limited ports. The following ports are designated as having inspection facilities for the entry of swine and swine products such as swine test specimens which do not appear to require restraint and holding inspection facilities: Anchorage and Fairbanks, Alaska; San Diego, California; Jacksonville, St. Petersburg-Clearwater, and Tampa, Florida; Atlanta, Georgia; Honolulu, Hawaii; Chicago, Illinois; New Orleans, Louisiana; Portland, Maine; Baltimore, Maryland; Boston, Massachusetts; Minneapolis, Minnesota; Great Falls, Montana; Portland, Oregon; San Juan, Puerto Rico; Memphis, Tennessee (no live animals); Galveston and Houston, Texas; and Seattle, Spokane, and Tacoma, Washington.

(f) Designation of other ports. The Secretary of the Treasury has approved the designation as quarantine stations of the ports specified in this section. In special cases other ports may be designated as quarantine stations under this section by the Administrator, with the concurrence of the Secretary of the Treasury.

[55 FR 31495, Aug. 2, 1990, as amended at 58 FR 38283, July 16, 1993; 60 FR 16045, Mar. 29, 1995; 60 FR 25120, May 11, 1995. Redesignated at 62 FR 56012, Oct. 28, 1997, as amended at 64 FR 23179, Apr. 30, 1999; 65 FR 38178, June 20, 2000; 67 FR 68022, Nov. 8, 2002]

§ 93.504 Import permits for swine and for swine specimens for diagnostic purposes; and reservation fees for space at quarantine facilities maintained by APHIS.

(a) Application for permit; reservation required. (1) For swine and swine test specimens for diagnostic screening purposes, intended for importation from any part of the world, except as otherwise provided for in §§ 93.516 and 93.520, the importer shall first apply for and obtain from APHIS an import permit. The application shall specify the name and address of the importer; the species, breed, number or quantity of swine or swine test specimens to be imported; the purpose of the importation; individual swine identification which includes a description of the swine, name, age, markings, if any, registration number, if any, and tattoo or eartag; the region of origin; the name and address of the exporter; the port of embarkation in the foreign region; the mode of transportation, route of travel, and the port of entry in the United States; the proposed date of arrival of the swine or swine test specimens to be imported; and the name of the person to whom the swine or swine test specimens will be delivered and the location of the place in the United States to which delivery will be made from the port of entry. Additional information may be required in the form of certificates concerning specific diseases to which the swine are susceptible, as well as vaccinations or other precautionary treatments to which the swine or swine test specimens have been subjected. Notice of any such requirements will be given to the applicant in each case.

(2) An application for permit to import will be denied for domestic swine from any region designated in § 94.1 of this chapter as a region where foot-and-mouth disease exists.

(3) An application for permit to import swine may also be denied because of: Communicable disease conditions in the area or region of origin, or in a region where the shipment has been or will be held or through which the shipment has been or will be transported; deficiencies in the regulatory programs for the control or eradication of animal diseases and the unavailability of veterinary services in the above mentioned regions; the importer's failure to provide satisfactory evidence concerning the origin, history, and health status of the swine; the lack of satisfactory information necessary to determine that the importation will not be likely to transmit any communicable disease to livestock or poultry of the United States; or any other circumstances which the Administrator believes require such denial to prevent the dissemination of any communicable disease of livestock or poultry into the United States.

(4)(i) The importer or importer's agent shall pay or ensure payment of a reservation fee for each lot of swine to be quarantined in a facility maintained by USDA. For swine the reservation fee shall be 100 percent of the cost of providing care, feed, and handling during quarantine, as estimated by the quarantine facility's veterinarian in charge.

(ii) At the time the importer or the importer's agent requests a reservation of quarantine space, the importer or importer's agent shall pay the reservation fee by check or U.S. money order or ensure payment of the reservation fee by an irrevocable letter of credit from a commercial bank (the effective date on such letter of credit shall run to 30 days after the date the swine are scheduled to be released from quarantine); except that anyone who issues a check to the Department for a reservation fee which is returned because of insufficient funds shall be denied any further request for reservation of a quarantine space until the outstanding amount is paid.

(iii) Any reservation fee paid by check or U.S. money order shall be applied against the expenses incurred for services received by the importer or importer's agent in connection with the quarantine for which the reservation was made. Any part of the reservation fee which remains unused after being applied against the expenses incurred for services received by the importer or the importer's agent in connection with the quarantine for which the reservation was made, shall be returned to the individual who paid the reservation fee. If the reservation fee is ensured by a letter of credit, the Department will draw against the letter of credit unless payment for services received by the importer or importer's agent in connection with the quarantine is otherwise made at least 3 days prior to the expiration date of the letter of credit.

(iv) Any reservation fee shall be forfeited if the importer or the importer's agent fails to present for entry, within 24 hours following the designated time of arrival the lot of swine for which the reservation was made: Except that a reservation fee shall not be forfeited if:

(A) Written notice of cancellation from the importer or the importer's agent is received by the office of the veterinarian in charge of the quarantine facility 6 during regular business hours (8:00 a.m. to 4:30 p.m. Monday through Friday, excluding holidays) no later than 15 days prior to the beginning of the time of importation as specified in the import permit or as arranged with the veterinarian in charge of the quarantine facility if no import permit is required (the 15 day period shall not include Saturdays, Sundays, or holidays), or

6 The addresses of USDA quarantine facilities may be found in telephone directories listing the facilities or by contacting the Animal and Plant Health Inspection Service, Veterinary Services, Strategy and Policy, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231.

(B) The Administrator determines that services, other than provided by carriers, necessary for the importation of the swine within the requested period are unavailable because of unforeseen circumstances as determined by the Administrator, (such as the closing of an airport due to inclement weather or the unavailability of the reserved space due to the extension of another quarantined.)

(v) If the reservation fee was ensured by a letter of credit and the fee is to be forfeited under paragraph (a)(4)(iv) of this section, the Department will draw against the letter of credit unless the reservation fee is otherwise paid at least 3 days prior to the expiration date of the letter of credit.

(vi) When a reservation is cancelled in accordance with paragraph (a)(4)(iv)(A) of this section and the provisions of paragraph (a)(4)(iv)(B) of this section do not apply, a $40.00 cancellation fee shall be charged. If a reservation fee was paid, the cancellation fee shall be deducted from any reservation fee returned to the importer or the importer's agent. If the reservation fee was ensured by a letter of credit, the Department will draw the amount of the cancellation fee against the letter of credit unless the cancellation fee is otherwise paid at least 3 days prior to the expiration date of the letter of credit.

(b) Permit. When a permit is issued, the original and two copies will be sent to the importer. It shall be the responsibility of the importer to forward the original permit and one copy to the shipper in the region of origin, and it shall also be the responsibility of the importer to insure that the shipper presents the copy of the permit to the carrier and makes proper arrangements for the original permit to accompany the shipment to the specified U.S. port of entry for presentation to the collector of customs. Swine and swine test specimens for diagnostic screening purposes for swine intended for importation into the United States for which a permit has been issued, will be received at the specified port of entry within the time prescribed in the permit which shall not exceed 14 days from the first day that the permit is effective for all permits. Swine and swine test specimens for which a permit is required by these regulations will not be eligible for entry if a permit has not been issued; if unaccompanied by such a permit; if shipment is from any port other than the one designated in the permit; if arrival in the United States is at any port other than the one designated in the permit; if the swine or swine test specimens offered for entry differ from those described in the permit; if the swine or swine test specimens are not handled as outlined in the application for the permit and as specified in the permit issued; or if ruminants or swine other than those covered by import permits are aboard the transporting carrier.

(c) Wild swine from regions where foot-and-mouth disease exists. This paragraph (c) applies to the importation of wild swine from countries designated in part 94 of this subchapter as regions in which foot-and-mouth disease exists.

(1) Permits for the importation of wild swine will be issued only for importations through the Port of New York, and only if the animals are imported for exhibition in a PEQ Zoo. A PEQ Zoo is a zoological park or other place maintained for the exhibition of live animals for recreational or educational purposes that:

(i) Has been approved by the Administrator in accordance with paragraph (c)(2) of this section to receive and maintain imported wild swine; and

(ii) Has entered into the agreement with APHIS set forth in paragraph (c)(4) of this section for the maintenance and handling of imported wild swine.

(2) Approval of a PEQ Zoo shall be on the basis of an inspection, by an authorized representative of the Department, of the physical facilities of the establishment and its methods of operation. Standards for acceptable physical facilities shall include satisfactory pens, cages, or enclosures in which the imported swine can be maintained so as not to be in contact with the general public and free from contact with domestic livestock; natural or established drainage from the PEQ Zoo which will avoid contamination of land areas where domestic livestock are kept or with which domestic livestock may otherwise come in contact; provision for the disposition of manure, other wastes, and dead swine within the PEQ Zoo; and other reasonable facilities considered necessary to prevent the dissemination of diseases from the PEQ Zoo. The operator of the PEQ Zoo shall have available the services of a full-time or part-time veterinarian, or a veterinarian on a retainer basis, who shall make periodic examinations of all animals maintained at the PEQ Zoo for evidence of disease; who shall make a post-mortem examination of each animal that dies; and who shall make a prompt report of suspected cases of contagious or communicable diseases to appropriate state or federal livestock sanitary officials.

(3) Manure and other animal wastes must be disposed of within the PEQ Zoo park for a minimum of one year following the date an imported wild swine enters the zoo. If an APHIS veterinarian determines that an imported swine shows no signs of any communicable disease during this 1-year period, its manure and other wastes need not be disposed of within the zoo after the 1-year period. If, however, an APHIS veterinarian determines that the swine does show signs of any communicable disease during this 1-year period, an APHIS veterinarian will investigate the disease and determine whether the swine's manure and other wastes may safely be disposed of outside the zoo after the 1-year period has ended.

(4) Prior to the issuance of an import permit under this section, the operator of the approved PEQ Zoo to which the imported swine are to be consigned, and the importer of the swine, if such operator and importer are different parties, shall execute an agreement covering each swine or group of swine for which the import permit is requested. The agreement shall be in the following form:

Agreement for the Importation, Quarantine and Exhibition of Certain Wild Ruminants and Wild Swine

________, operator(s) of the zoological park known as ____________ (Name) located at ______________ (City and state), and ____________ (Importer) hereby request a permit for the importation of ________ (Number and kinds of animals) for exhibition purposes at the said zoological park, said animals originating in a region where foot-and-mouth disease exists and being subject to restrictions under regulations contained in part 93, title 9, Code of Federal Regulations.

In making this request, it is understood and agreed that:

1. The animals for which an import permit is requested will be held in isolation at a port of embarkation in the region of origin, approved by the Administrator as a port having facilities which are adequate for maintaining wild animals in isolation from all other animals and having veterinary supervision by officials of the region of origin of the animals. Such animals will be held in such isolation for not less than 60 days under the supervision of the veterinary service of that region to determine whether the animals show any clinical evidence of foot-and-mouth disease, or other communicable disease that is exotic to the United States or for which APHIS has an eradication or control program in 9 CFR chapter I, and to assure that the animals will not have been exposed to such a disease within the 60 days next before their exportation from that region.

2. Shipment will be made direct from such port of embarkation to the port of New York as the sole port of entry in this region. If shipment is made by ocean vessel, the animals will not be unloaded in any foreign port en route. If shipment is made by air, the animals will not be unloaded at any port or other place of landing, except at a port approved by the Administrator as a port not located in a region where foot-and-mouth disease exists or as a port in such a region having facilities and inspection adequate for maintaining wild animals in isolation from all other animals.

3. No ruminants or swine will be aboard the transporting vehicle, vessel or aircraft, except those for which an import permit has been issued.

4. The animals will be quarantined for not less than 30 days in the Department's Animal Import Center in Newburgh, New York.

5. Upon release from quarantine the animals will be delivered to the zoological park named in this agreement to become the property of the park and they will not be sold, exchanged or removed from the premises without the prior consent of APHIS. If moved to another zoological park in the United States, the receiving zoological park must be approved by the Administrator in accordance with paragraph 6 of this agreement.

6. The Administrator will approve the movement of an imported animal subject to this agreement if the Administrator determines that the animal has spent at least one year in quarantine in a PEQ Zoo following importation without showing clinical evidence of foot-and-mouth disease, or other communicable disease that is exotic to the United States or for which APHIS has an eradication or control program in 9 CFR chapter I, and determines that the receiving zoological park is accredited by the American Zoo and Aquarium Association (AZA), or the receiving zoological park has facilities and procedures in place related to preventing the spread of communicable animal diseases (including but not limited to procedures for animal identification, record keeping, and veterinary care) that are equivalent to those required for AZA accreditation. The Administrator will approve the movement of a carcass, body part, or biological specimen derived from an imported animal subject to this agreement if the Administrator determines that the animal has spent at least one year in quarantine in a PEQ Zoo following importation without showing clinical evidence of foot-and-foot mouth disease, or other communicable disease that is exotic to the United States or for which APHIS has an eradication or control program in 9 CFR chapter I, and determines that the carcass, body part, or biological specimen will be moved only for scientific research or museum display purposes.

(Signature of importer)

Subscribed and sworn to before me this ____ day of ____, ____

(Title or designation) (Name of zoological park) By (Signature of officer of zoological park) (Title of officer)

Subscribed and sworn to before me this ____ day of ____,____

(Title or designation)

(Approved by the Office of Management and Budget under control number 0579-0040)

[55 FR 31495, Aug. 2, 1990, as amended at 59 FR 28216, June 1, 1994; 59 FR 31924, June 21, 1994; 59 FR 67615, Dec. 30, 1994; 62 FR 23638, May 1, 1997. Redesignated and amended at 62 FR 56012, 56020, Oct. 28, 1997; 68 FR 6344, Feb. 7, 2003; 83 FR 15492, Apr. 11, 2018; 86 FR 45624, Aug. 16, 2021]

§ 93.505 Certificate for swine.

(a) All swine offered for importation from any part of the world except as provided in § 93.517 shall be accompanied by a certificate of a salaried veterinary officer of the national government of the region of origin, or if exported from Mexico, shall be accompanied either by such a certificate or by a certificate issued by a veterinarian accredited by the National Government of Mexico and endorsed by a full-time salaried veterinary officer of the National Government of Mexico, thereby representing that the veterinarian issuing the certificate was authorized to do so, stating that such swine have been kept in said region at least 60 days immediately preceding the date of movement therefrom and that said region during such period has been entirely free from foot-and-mouth disease, contagious pleuropneumonia, and surra: Provided, however, That certificates for wild swine for exhibition purposes need specify freedom from the said diseases of the district of origin only: And provided further, That in the case of swine the certificate, as far as it relates to contagious pleuropneumonia, may specify freedom from such disease of the district of origin only. For domestic swine, the certificate shall also show that the entire region of origin is free of African swine fever and swine vesicular disease and that, for 60 days immediately preceding the time of movement from the premises of origin, no swine erysipelas or swine plague has existed on such premises or on adjoining premises. Additionally, except for the APHIS-defined European CSF region, as defined in § 94.0 of this subchapter, for which additional certification is required under § 94.31(b)(6), for domestic swine the certificate shall show that the entire region of origin is free of classical swine fever.

(b) Swine from any region where screwworm is considered to exist may only be imported into the United States if they meet the requirements of paragraphs (b)(1) through (4) of this section and all other applicable requirements of this part. APHIS maintains a list of regions where screwworm is considered to exist on the APHIS website at https://www.aphis.usda.gov/animalhealth/disease-status-of-regions. Copies of the list can be obtained via postal mail or email upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; AskRegionalization@usda.gov. APHIS will add a region to the list upon determining that screwworm exists in the region based on reports APHIS receives of detections of the pest from veterinary officials of the exporting country, from the World Organization for Animal Health (OIE), or from other sources the Administrator determines to be reliable. APHIS will remove a region from the list after conducting an evaluation of the region in accordance with § 92.2 of this subchapter and finding that screwworm is not present in the region. In the case of a region formerly not on this list that is added due to a detection, the region may be removed from the list in accordance with the procedures for reestablishment of a region's disease-free status in § 92.4 of this subchapter.

(1) A veterinarian must treat the swine with ivermectin 3 to 5 days prior to the date of export to the United States according to the recommended dose prescribed on the product's label.

(2) The swine must be fully examined for screwworm by a full-time salaried veterinary official of the exporting country within 24 hours prior to shipment to the United States. If swine are found to be infested with screwworm, they must be treated until free from infestation.

(3) At the time swine are loaded onto a means of conveyance for export, a veterinarian must treat any visible wounds on the animals with a solution of coumaphos dust at a concentration of 5 percent active ingredient.

(4) The swine must be accompanied to the United States by a certificate signed by a full-time salaried veterinary official of the exporting country. The certificate must state that the swine have been thoroughly examined and found free of screwworm and that the swine have been treated in accordance with paragraphs (b)(1) and (b)(3) of this section.

(c) If swine are unaccompanied by the certificate as required by paragraph (a) of this section, or if such swine are found upon inspection at the port of entry to be affected with a communicable disease or to have been exposed thereto, they shall be refused entry and shall be handled or quarantined, or otherwise disposed of as the Administrator may direct.

(Approved by the Office of Management and Budget under control number 0579-0165)

[55 FR 31495, Aug. 2, 1990. Redesignated at 62 FR 56012, Oct. 28, 1997]

Editorial Note:For Federal Register citations affecting § 93.505, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

§ 93.506 Declaration and other documents for swine.

(a) The certificates, declarations, and affidavits required by the regulations in this part shall be presented by the importer or his or her agent to the collector of customs at the port of entry, upon arrival of swine at such port, for the use of the veterinary inspector at the port of entry.

(b) For all swine offered for importation, the importer or his or her agent shall first present two copies of a declaration which shall list the port of entry, the name and address of the importer, the name and address of the broker, the origin of the swine, the number, breed, species, and purpose of the importation, the name of the person to whom the swine will be delivered, and the location of the place to which such delivery will be made.

(c) Any declaration, permit, or other document for swine required under this subpart may be issued and presented using a U.S. Government electronic information exchange system or other authorized method.

[55 FR 31495, Aug. 2, 1990, as amended at 81 FR 40151, June 21, 2016]

§ 93.507 Inspection at the port of entry.

Inspection shall be made at the port of entry of all swine imported from any part of the world except as provided in § 93.519. All swine found to be free from communicable disease and not to have been exposed thereto within 60 days prior to their exportation to the United States shall be admitted subject to the other provisions in this part; all other swine shall be refused entry. Swine refused entry, unless exported within a time fixed in each case by the Administrator, and in accordance with other provisions he or she may require in each case for their handling shall be disposed of as the Administrator may direct. Such portions of the transporting vessel, and of its cargo, which have been exposed to any such swine or their emanations shall be disinfected in such manner as may be considered necessary by the inspector in charge at the port of entry, to prevent the introduction or spread of livestock or poultry disease, before the cargo is allowed to land.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56020, Oct. 28, 1997; 68 FR 6344, Feb. 7, 2003]

§ 93.508 Articles accompanying swine.

No litter or manure, fodder or other aliment, nor any equipment such as boxes, buckets, ropes, chains, blankets, or other things used for or about swine governed by the regulations in this part, shall be landed from any conveyance except under such restrictions as the inspector in charge at the port of entry shall direct.

§ 93.509 Movement from conveyances to quarantine station.

Platforms and chutes used for handling imported swine shall be cleaned and disinfected under APHIS supervision after being so used. The said swine shall not be unnecessarily moved over any highways nor allowed to come in contact with other swine, but shall be transferred from the conveyance to the quarantine grounds in boats, cars, or vehicles approved by the inspector in charge at the port of entry. Such cars, boats, or vehicles shall be cleaned and disinfected under APHIS supervision immediately after such use, by the carrier moving the same. The railway cars so used shall be either cars reserved for this exclusive use or box cars not otherwise employed in the transportation of swine or their fresh products. When movement of the aforesaid swine upon or across a public highway is unavoidable, it shall be under such careful supervision and restrictions as the inspector in charge at the port of entry and the local authorities may direct.

§ 93.510 Quarantine requirements.

Swine shall be quarantined for not less than 15 days, counting from the date of arrival at the port of entry. During their quarantine, wild swine shall be subject to such inspections, disinfection, blood tests, or other tests as may be required by the Administrator, to determine their freedom from disease and the infection of disease.

§ 93.511 Swine quarantine facilities.

(a) Privately operated quarantine facilities. The importer, or his or her agent, of swine subject to quarantine under the regulations in this part shall arrange for acceptable transportation to the privately operated quarantine facility and for the care, feed, and handling of the swine from the time of unloading at the quarantine port to the time of release from quarantine. Such arrangements shall be agreed to in advance by the Administrator. All expenses resulting therefrom or incident thereto shall be the responsibility of the importer; APHIS assumes no responsibility with respect thereto. The quarantine facility must be suitable for the quarantine of such swine and must be approved by the Administrator prior to the issuance of any import permit. The facilities occupied by swine should be kept clean and sanitary to the satisfaction of the inspector assigned to supervise the quarantine. If for any cause the care, feed, or handling of swine, or the sanitation of the facilities, is neglected, in the opinion of the inspector assigned to supervise the quarantine, such services may be furnished by APHIS in the same manner as though arrangements had been made for such services as provided by paragraph (b) of this section, and/or the swine may be disposed of as the Administrator, may direct, including sale in accordance with the procedure described in paragraph (b) of this section. The importer, or his or her agent, shall request in writing such inspection and other services as may be required, and shall waive all claim against the United States and APHIS or any employee of APHIS for damages which may arise from such services. The Administrator, may prescribe reasonable rates for the services provided under this paragraph. When it is found necessary to extend the usual minimum quarantine period, the importer, or his or her agent, shall be so advised in writing and shall pay for such additional quarantine and other services required. Payment for all services received by the importer, or his or her agent, in connection with each separate lot of swine shall be made by certified check or U.S. money order prior to release of the swine. If such payment is not made, the swine may be sold in accordance with the procedure described in paragraph (b) of this section, or otherwise disposed of as directed by the Administrator.

(b) Quarantine facilities maintained by APHIS. The importer, or his or her agent, of swine subject to quarantine under the regulations in this part shall arrange for acceptable transportation to the quarantine facility, and for the care, feed, and handling of the swine from the time they arrive at the quarantine facility, and for the care, feed, and handling of the swine from the time they arrive at the quarantine port to the time of release from quarantine. Such arrangements shall be agreed to in advance by the Administrator. The importer or his or her agent shall request in writing such inspection and other services as may be required, and shall waive all claim against the United States and APHIS or any employee of APHIS, for damages which may arise from such services. All expenses resulting therefrom or incident thereto shall be the responsibility of the importer; APHIS assumes no responsibility with respect thereto. The Administrator may prescribe reasonable rates for the services provided under this paragraph. When it is found necessary to extend the usual minimum quarantine period, the importer, or his or her agent, shall be so advised in writing and shall pay for such additional quarantine and other services required. Payment for services received by the importer, or his or her agent, in connection with each separate lot of swine shall be made by certified check or U.S. money order prior to release of the swine. If such payment is not made, the swine may be sold in accordance with the procedure described in this paragraph or otherwise disposed of as directed by the Administrator. When payment is not made and the swine are to be sold to recover payment for services received, the importer, or his or her agent, will be notified by the inspector that if said charges are not immediately paid or satisfactory arrangements made for payment, the swine will be sold at public sale to pay the expense of care, feed, and handling during that period. The sale will be held after the expiration of the quarantine period, at such time and place as may be designated by the General Services Administration or other designated selling agent. The proceeds of the sale, after deducting the charges for care, feed, and handling of the swine and other expenses, including the expense of the sale, shall be held in a Special Deposit Account in the United States Treasury for 6 months from the date of sale. If not claimed by the importer, or his or her agent, within 6 months from the date of sale, the amount so held shall be transferred from the Special Deposit Account to the General Fund Account in the United States Treasury.

(c) Amounts collected from the importer, or his or her agent, for service rendered shall be deposited so as to be available for defraying the expenses involved in this service.

§ 93.512 Quarantine stations, visiting restricted; sales prohibited.

Visitors shall not be admitted to the quarantine enclosure during any time that swine are in quarantine except that an importer (or his or her accredited agent or veterinarian) may be admitted to the yards and buildings containing his or her quarantined swine at such intervals as may be deemed necessary, and under such conditions and restrictions as may be imposed, by the inspector in charge of the quarantine station. On the last day of the quarantine period, owners, officers or registry societies, and others having official business or whose services may be necessary in the removal of the swine may be admitted upon written permission from the said inspector. No exhibition or sale shall be allowed within the quarantine grounds.

§ 93.513 Milk from quarantined swine.

Milk or cream from swine quarantined under the provisions of this part shall not be used by any person other than those in charge of such swine, nor be fed to any animals other than those within the same enclosure, without permission of the inspector in charge of the quarantine station and subject to such restrictions as he or she may consider necessary to each instance. No milk or cream shall be removed from the quarantine premises except in compliance with all State and local regulations.

§ 93.514 Manure from quarantined swine.

No manure shall be removed from the quarantine premises until the release of the swine producing same.

§ 93.515 Appearance of disease among swine in quarantine.

If any contagious disease appears among swine during the quarantine period special precautions shall be taken to prevent spread of the infection to other animals in the quarantine station or to those outside the grounds. The affected swine shall be disposed of as the Administrator may direct, depending upon the nature of the disease.

§ 93.516 Import permit and declaration for swine.

(a) For swine intended for importation from Canada, the importer shall first apply for and obtain from APHIS an import permit as provided in § 93.504: Provided, That an import permit is not required for swine offered for entry at a land border port designated in § 93.503(b) if such swine:

(1) Was born in Canada or the United States, and has been in no region other than Canada or the United States, or

(2) Has been legally imported into Canada from some other region and unconditionally released in Canada so as to be eligible to move freely within that region without restriction of any kind and has been in Canada after such release for 60 days or longer.

(b) For all swine offered for importation from Canada, the importer or his or her agent shall present two copies of a declaration as provided in § 93.506.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56020, Oct. 28, 1997]

§ 93.517 Swine from Canada.

(a) For purposes other than immediate slaughter. Swine offered for importation from Canada for purposes other than immediate slaughter shall be accompanied by a certificate issued or endorsed by a salaried veterinarian of the Canadian Government showing that said swine have been inspected on the premises of origin immediately before the date of movement therefrom and found to be free of evidence of communicable disease and that, as far as it has been possible to determine, they were not exposed to any such disease during the preceding 60 days; in addition, the certificate shall show that no classical swine fever or swine plague has existed on the premises of origin or on adjoining premises for such 60 days.

(b) For immediate slaughter. Swine for immediate slaughter may be imported from Canada without certification as prescribed in paragraph (a) of this section but shall be subject to the provisions of §§ 93.507, 93.516, and 93.518.

[55 FR 34195, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56020, Oct. 28, 1997; 68 FR 16938, Apr. 7, 2003]

§ 93.518 Swine from Canada for immediate slaughter.

Swine imported from Canada for immediate slaughter shall be consigned from the port of entry directly to a recognized slaughtering establishment and there be slaughtered within two weeks from the date of entry. As used in this section, “directly” means without unloading en route if moved in a means of conveyance, or without stopping if moved in any other manner.

[55 FR 31495, Aug. 2, 1990, as amended at 59 FR 28216, June 1, 1994. Redesignated at 62 FR 56012, Oct. 28, 1997]

§ 93.519 Special provisions.

(a) In-bond shipments from Canada. (1) Swine from Canada transported in-bond through the United States for immediate export shall be inspected at the border port of entry and, when accompanied by an import permit obtained under § 93.504 of this part and all conditions therein are observed, shall be allowed entry into the United States and shall be otherwise handled as provided in paragraph (b) of § 93.501. Swine not accompanied by a permit shall meet the requirements of this part in the same manner as swine destined for importation into the United States, except that the Administrator may permit their inspection at some other point when he or she finds that such action will not increase the risk that communicable diseases of livestock and poultry will be disseminated to the livestock or poultry of the United States.

(2) In-transit shipments through Canada. Swine originating in the United States and transported directly through Canada may re-enter the United States without Canadian health or test certificates when accompanied by copies of the United States export health certificates properly issued and endorsed in accordance with regulations in part 91 of this chapter: Provided, That, to qualify for entry, the date, time, port of entry, and signature of the Canadian Port Veterinarian that inspected the swine for entry into Canada shall be recorded on the United States health certificate, or a document containing the information shall be included with the certificate that accompanies the swine. In all cases it shall be determined by the veterinary inspector at the United States port of entry that the swine are the identical swine covered by said certificate.

(b) Exhibition swine. Swine from the United States which have been exhibited at the Royal Agricultural Winter Fair at Toronto or other publicly recognized expositions in Canada, including racing, rodeo, circus, or stage exhibitions in Canada, and have not been in that region for more than 90 days are eligible for return to the United States without Canadian health or test certificates, if they are accompanied by copies of the United States health certificate, issued and endorsed in accordance with the export regulations contained in Part 91 of this chapter for entry into Canada: Provided, That all swine offered for re-entry upon examination by the veterinary inspector at the U.S. port of entry, are found by the inspector to be free of communicable diseases and exposure thereto and are determined to be the identical swine covered by said certificates or are the natural increase of such swine born after official test dates certified on the dam's health certificate.

(Approved by the Office of Management and Budget under control number 0579-0020)

[55 FR 31495, Aug. 2, 1990, as amended at 59 FR 67133, Dec. 29, 1994. Redesignated and amended at 62 FR 56012, 56020, Oct. 28, 1997; 81 FR 40151, June 21, 2016]

§ 93.520 Import permit and declaration for swine.

For all swine offered for importation from countries of Central America or of the West Indies, the importer or his or her agent shall present two copies of a declaration as provided in § 93.506.

[55 FR 34195, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56020, Oct. 28, 1997]

§ 93.521 Declaration for swine.

For all swine offered for importation from Mexico, the importer or his or her agent shall present two copies of a declaration as provided in § 93.506.

[55 FR 34195, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56020, Oct. 28, 1997]

§ 93.600 Importation of dogs.

(a) All dogs. Dogs from any region of the world where screwworm is considered to exist may only be imported into the United States if they meet the requirements of paragraphs (a)(1) and (2) of this section and all other applicable requirements of this part. APHIS maintains a list of regions where screwworm is considered to exist on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/animal-health-status-of-regions. Copies of the list can be obtained via postal mail or email upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; AskRegionalization@usda.gov. APHIS will add a region to the list upon determining that screwworm exists in the region based on reports APHIS receives of detections of the pest from veterinary officials of the exporting country, from the World Organization for Animal Health (OIE), or from other sources the Administrator determines to be reliable. APHIS will remove a region from the list after conducting an evaluation of the region in accordance with § 92.2 of this subchapter and finding that screwworm is not present in the region. In the case of a region formerly not on this list that is added due to a detection, the region may be removed from the list in accordance with the procedures for reestablishment of a region's disease-free status in § 92.4 of this subchapter.

(1) Dogs must be accompanied by a certificate signed by a full-time salaried veterinary official of the region of origin stating that the dog has been inspected for screwworm within 5 days preceding its shipment to the United States.

(2) The certificate must state that the dog is either free from screwworm or was found to be infested with screwworm and was held in quarantine and treated until free from screwworm prior to leaving the region of origin.

(b) Dogs for handling livestock. Collie, Shepherd, and other dogs that are imported from any part of the world except Canada, Mexico, and regions of Central America and the West Indies and that are to be used in the handling of sheep or other livestock must be inspected and quarantined at the port of entry for a sufficient time to determine their freedom from tapeworm (Taenia spp.). If found to be infested with tapeworm, dogs must be treated under the supervision of an inspector at the port of entry until they are free from infestation.

(Approved by the Office of Management and Budget under control number 0579-0165)

[65 FR 67623, Nov. 13, 2000, as amended at 67 FR 11565, Mar. 15, 2002; 73 FR 50878, Aug. 29, 2008; 77 FR 1391, Jan. 10, 2012; 86 FR 45625, Aug. 16, 2021]

§ 93.700 Definitions.

Wherever in this subpart the following terms are used, unless the context otherwise requires, they shall be construed, respectively, to mean:

Administrator. The Administrator of the Animal and Plant Health Inspection Service or any other employee of the Animal and Plant Health Inspection Service, United States Department of Agriculture, delegated to act in the Administrator's stead.

Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the United States Department of Agriculture (APHIS).

Brushtail possum. Vulpine phalangers (Trichosurus vulpecula) of the family Phalangeridae.

Delivery. The transfer of goods or interest in goods from one person to another.

Enter (entry). To introduce into the commerce of the United States after release from government detention.

Hedgehog. All members of the family Erinaceidae.

Import (imported, importation). To bring into the territorial limits of the United States.

Inspector. An employee of the Animal and Plant Health Inspection Service authorized to perform duties required under this subpart.

Person. Any individual, corporation, company, association, firm, partnership, society, or joint stock company.

Region. Any defined geographic land area identifiable by geological, political, or surveyed boundaries. A region may consist of any of the following:

(1) A national entity (country);

(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.)

(3) Parts of several national entities combined into an area; or

(4) A group of national entities (countries) combined into a single area.

Tenrec. All members of the family Tenrecidae.

United States. All of the States of the United States, the District of Columbia, Guam, the Northern Mariana Islands, Puerto Rico, the Virgin Islands of the United States, and all other territories and possessions of the United States.

[55 FR 34195, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56020, Oct. 28, 1997]

§ 93.701 Prohibitions.

(a) No person may import a hedgehog or tenrec into the United States from any region designated in § 94.1 of this chapter as a region where foot-and-mouth disease exists.

(b) No person may import a brushtail possum or hedgehog into the United States from New Zealand.

(c) No person may import leopard tortoise (Geochelone pardalis), African spurred tortoise (Geochelone sulcata), or Bell's hingeback tortoise (Kinixys belliana) into the United States.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 56012, 56021, Oct. 28, 1997; 65 FR 15218, Mar. 22, 2000]

§ 93.702 Restrictions.

Hedgehogs and tenrecs not specifically prohibited from being imported under § 93.701 may be imported into the United States only in accordance with the regulations in this subpart.

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56021, Oct. 28, 1997]

§ 93.703 Ports designated for importation.

(a) Any person importing a hedgehog or tenrec into the United States may import it, except as provided in paragraph (b) of this section, only through the following ports:

(1) Air and ocean ports. Anchorage and Fairbanks, AK; San Diego and Los Angeles, CA; Denver, CO; Jacksonville, Miami, St. Petersburg-Clearwater, and Tampa, FL; Atlanta, GA; Chicago, IL; New Orleans, LA; Portland, ME; Baltimore, MD; Boston, MA; Minneapolis, MN; Great Falls, MT; Newburgh, NY; Portland, OR; San Juan, PR; Galveston and Houston, TX; and Seattle, Spokane, and Tacoma, WA.

(2) Canadian border ports. Eastport, ID; Houlton and Jackman, ME; Detroit, Port Huron, and Sault Ste. Marie, MI; Opheim, Raymond, and Sweetgrass, MT; Alexandria Bay, Buffalo, and Champlain, NY; Dunseith, Pembina, and Portal, ND; Derby Line and Highgate Springs, VT; Oroville and Sumas, WA.

(3) Mexican border ports. Douglas, Naco, Nogales, Sasabe, and San Luis, AZ; Calexico and San Ysidro, CA; Antelope Wells, and Columbus, NM; and Brownsville, Hidalgo, Laredo, Eagle Pass, Del Rio, Presidio, and El Paso, TX.

(b) The Secretary of the Treasury has approved the designation, as inspection stations, of the ports specified in paragraph (a) of this section. In special cases, the Administrator may designate other ports as inspection stations in accordance with this section, with the concurrence of the Secretary of the Treasury.

[60 FR 55181, Oct. 30, 1995. Redesignated at 62 FR 56012, Oct. 28, 1997, as amended at 65 FR 38178, June 20, 2000; 67 FR 68022, Nov. 8, 2002]

§ 93.704 Import permit.

(a) General requirements. No person may import a hedgehog or tenrec into the United States unless it is accompanied by an import permit issued by APHIS and is imported into the United States within 30 days after the proposed date of arrival stated in the import permit. The importer or his or her agent must notify the inspector at the port of first arrival of the date of arrival at least 72 hours before the hedgehog or tenrec arrives in the United States.

(b) Import permit required. Any person who desires to import a hedgehog or tenrec must submit an application (VS Form 17-129) for an import permit. Applications are available from, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Riverdale, Maryland 20737; or by visiting https://www.aphis.usda.gov/aphis/resources/sa_epermits/eauth-epermits. A separate application must be prepared for each shipment.

(c) Application for an import permit. The importer must complete, sign, and date the application for an import permit, which must include the following information:

(1) The name and address of the shipper in the region of origin of the hedgehog or tenrec intended for importation into the United States.

(2) The name, address, and telephone number of the importer.

(3) The port of embarkation.

(4) The region from which the hedgehog or tenrec will be shipped to the United States.

(5) The mode of transportation.

(6) The number, breed, species, and descriptions of the hedgehogs or tenrecs to be imported.

(7) The purpose of the importation.

(8) The route of travel, including all carrier stops en route.

(9) The proposed shipping and arrival dates.

(10) The port of first arrival in the United States.

(11) The name, mailing address, and telephone number of the person to whom the hedgehog or tenrec will be delivered in the United States.

(12) The location of the place where delivery will be made in the United States.

(13) Any remarks regarding the shipment.

(d) Issuance of an import permit. Upon receipt of the application, APHIS will review the application. If the hedgehog or tenrec appears to be eligible to be imported into the United States, APHIS will issue an import permit indicating the applicable requirements under this subpart for the importation of the hedgehog or tenrec. Even though an import permit has been issued for the importation of a hedgehog or tenrec, the animal may enter the United States only if all other applicable requirements of this subpart have been met.

(Approved by the Office of Management and Budget under control number 0579-0040)

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56021, Oct. 28, 1997; 81 FR 40151, June 21, 2016; 86 FR 45625, Aug. 16, 2021]

§ 93.705 Health certificate.

(a) No person may import a hedgehog or tenrec into the United States unless it is accompanied by a health certificate either issued by a full-time salaried veterinary officer of the national government of the exporting region or issued by a veterinarian authorized or accredited by the national government of the exporting region and endorsed by a full-time salaried veterinary officer of the national government of that region. The health certificate must contain the names and street addresses of the consignor and consignee and must state:

(1) That the hedgehog or tenrec originated in a region that has been recognized as free of foot-and-mouth disease by the USDA;

(2) That the hedgehog or tenrec has never been in a region where foot-and-mouth disease exists;

(3) That the hedgehog or tenrec has not been commingled with any other hedgehog or tenrec that originated in or has ever been in a region where foot-and-mouth disease exists;

(4) That the hedgehog or tenrec was inspected by the individual issuing the health certificate and was found free of any ectoparasites not more than 72 hours before being loaded on the means of conveyance which transported the animal to the United States;

(5) That all body surfaces of the hedgehog or tenrec were treated for ectoparasites under the supervision of the veterinarian issuing the health certificate at least 3 days but not more than 14 days before being loaded on the means of conveyance that transported the animal to the United States;

(6) That the pesticide and the concentration used would kill the types of ectoparasites that may infest the animal to be imported;

(7) That the hedgehog or tenrec, after being treated for ectoparasites in accordance with paragraphs (a)(5) and (a)(6) of this section, had physical contact only with, or shared a pen or bedding materials only with, treated hedgehogs or tenrecs in the same shipment to the United States; and

(8) The name and concentration of the pesticide used to treat the hedgehog or tenrec.

(b) [Reserved]

(Approved by the Office of Management and Budget under control number 0579-0040)

[55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56021, Oct. 28, 1997]

§ 93.706 Notification of arrival.

Upon the arrival of a hedgehog or tenrec at the port of first arrival in the United States, the importer or his or her agent must present the import permits and health certificates required by this subpart to the collector of customs for the use of the inspector at that port.

§ 93.707 Inspection at the port of first arrival.

(a) A hedgehog or tenrec from any part of the world must be inspected by an APHIS inspector at the port of first arrival. Subject to the other provisions in this subpart, a shipment of hedgehogs or tenrecs may enter the United States only if each hedgehog or tenrec in the shipment is found free of ectoparasites and any clinical signs of communicable diseases.

(b) If any hedgehog or tenrec in a shipment is found to be infested with ectoparasites or demonstrates any clinical signs of communicable diseases, then the entire shipment will be refused entry. The importer will be given the following options:

(1) Remove the shipment from the United States; or

(2) Release the shipment to the U.S. Department of Agriculture. The Administrator will destroy or otherwise dispose of the shipment as necessary to prevent the possible introduction into the United States of communicable animal diseases.

§ 93.800 Definitions.

The following terms, when used in this part, shall be construed as defined. Those terms used in the singular form in this part shall be construed as the plural form and vice versa, as the case may demand.

Accredited veterinarian. A veterinarian approved by the Administrator in accordance with part 161 of this chapter to perform functions specified in parts 1, 2, 3, and 11 of this chapter, and subchapters B, C, and D of this chapter; and to perform functions required by cooperative State-Federal disease control and eradication programs.

Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.

Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the United States Department of Agriculture (APHIS).

APHIS representative. A veterinarian or other person employed by APHIS in animal health activities, who is authorized to perform the function involved.

Enter (entered, entry) into the United States. To introduce into the commerce of the United States after release from government detention.

Import (imported, importation) into the United States. To bring into the territorial limits of the United States.

Incinerate (incinerated). To reduce to ash by burning.

Inspector. An employee of APHIS who is authorized to perform the function involved.

Person. Any individual, corporation, company, association, firm, partnership, society, joint stock company, or any other legal entity.

Region. Any defined geographic land area identifiable by geological, political, or surveyed boundaries. A region may consist of any of the following:

(1) A national entity (country);

(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.)

(3) Parts of several national entities combined into an area; or

(4) A group of national entities (countries) combined into a single area.

United States. All of the several States of the United States, the District of Columbia, Guam, the Northern Mariana Islands, Puerto Rico, the Virgin Islands of the United States, and all other territories and possessions of the United States.

United States health certificate. An official document issued by an APHIS representative or an accredited veterinarian at the point of origin of a movement of animals. It must show the identification tag, tattoo, or registration number of each animal to be moved; the age and sex of each animal to be moved; the number of animals covered by the document; the points of origin and destination; the consignor; and the consignee.

Veterinary Services. The Veterinary Services unit of the Animal and Plant Health Inspection Service of the United States Department of Agriculture.

[52 FR 29502, Aug. 10, 1987, as amended at 57 FR 23048, 23049, June 1, 1992. Redesignated and amended at 62 FR 56012, 56021, Oct. 28, 1997]

§ 93.801 Prohibitions.

Elephants, hippopotami, rhinoceroses, or tapirs shall not be imported or entered into the United States unless in accordance with this part.

[52 FR 29502, Aug. 10, 1987. Redesignated at 62 FR 56012, Oct. 28, 1997]

§ 93.802 Import permit.

(a) An elephant, hippopotamus, rhinoceros, or tapir shall not be imported into the United States unless accompanied by an import permit issued by APHIS and unless imported into the United States within 30 days after the proposed date of arrival stated in the import permit. The port veterinarian must be notified of the date of arrival at least 72 hours before the animal arrives in the United States.

(b) An application for an import permit may be obtained from Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Riverdale, Maryland 20737; or by visiting https://www.aphis.usda.gov/aphis/resources/sa_epermits/eauth-epermits. A separate application must be prepared for each shipment.

(c) The completed application shall include the following information:

(1) The name and address of the person intending to export an elephant, hippopotamus, rhinoceros, or tapir to the United States;

(2) The name and address of the person intending to import an elephant, hippopotamus, rhinoceros, or tapir into the United States;

(3) The species, breed, and number of elephants, hippopotami, rhinoceroses, or tapirs to be imported;

(4) The purpose of the importation;

(5) The port of embarkation;

(6) The name and concentration of the pesticide intended to be used to treat the elephant, hippopotamus, rhinoceros, or tapir for ectoparasites prior to the animal being transported to the United States;

(7) The mode of transportation;

(8) The route of travel;

(9) The port of entry in the United States and, if applicable, the address of the facility to be provided by the importer for inspection, treatment, and incineration pursuant to § 93.6 of this part;

(10) The proposed date of arrival in the United States; and

(11) The name and address of the person to whom the elephant, hippopotamus, rhinoceros, or tapir will be delivered in the United States.

(d) After receipt and review of the application by APHIS, an import permit indicating the applicable conditions under this part for importation into the United States shall be issued for the importation of the elephant, hippopotamus, rhinoceros, or tapir described in the application if such animal appears to be eligible to be imported. Even though an import permit has been issued for the importation of an elephant, hippopotamus, rhinoceros, or tapir, the animal may be imported only if all applicable requirements of this part are met.

[52 FR 29502, Aug. 10, 1987, as amended at 57 FR 23049, June 1, 1992; 59 FR 67615, Dec. 30, 1994. Redesignated at 62 FR 56012, Oct. 28, 1997; 81 FR 40151, June 21, 2016; 86 FR 45625, Aug. 16, 2021]

§ 93.803 Health certificate.

(a) An elephant, hippopotamus, rhinoceros, or tapir shall not be imported into the United States unless accompanied by a health certificate either signed by a salaried veterinarian of the national veterinary services of the region where the inspection and treatment required by this section occurred or signed by a veterinarian authorized by the national veterinary services of such region and endorsed by a salaried veterinarian of the national veterinary services of such region (the endorsement representing that the veterinarian signing the health certificate was authorized to do so), certifying:

(1) That the elephant, hippopotamus, rhinoceros, or tapir was inspected by the individual signing the health certificate and found free of any ectoparasites not more than 72 hours before being loaded on the means of conveyance which transported the animal to the United States; and

(2) That the elephant, hippopotamus, rhinoceros, or tapir was treated for ectoparasites at least 3 days but not more than 14 days before being loaded on the means of conveyance which transported the animal to the United States. The animal shall have been treated, under the supervision of the individual signing the health certificate, by being thoroughly wetted with a pesticide applied with either a sprayer with a hand-held nozzle, a spray-dip machine, or a dip vat; and

(3) That the elephant, hippopotamus, rhinoceros, or tapir, after being treated for ectoparasites in accordance with paragraph (a)(2) of this section, did not have physical contact with or share a pen or bedding materials with any elephant, hippopotamus, rhinoceros, or tapir not in the same shipment to the United States; and

(4) The name and concentration of the pesticide used to treat the animal (such pesticide and the concentration used must be adequate to kill the types of ectoparasites likely to infest the animal to be imported; a list of recommended pesticides and concentrations may be obtained from the Animal and Plant Health Inspection Service, Veterinary Services, Strategy and Policy, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231; and

(5) The name and address of the consignor and consignee.

(b) [Reserved]

[52 FR 29502, Aug. 10, 1987; 52 FR 35350, Sept. 18, 1987, as amended at 57 FR 23049, June 1, 1992; 59 FR 67615, Dec. 30, 1994. Redesignated and amended at 62 FR 56012, 56021, Oct. 28, 1997; 86 FR 45625, Aug. 16, 2021]

§ 93.804 Declaration upon arrival.

Upon arrival of an elephant, hippopotamus, rhinoceros, or tapir at a port of entry, the importer or the importer's agent shall notify APHIS of the arrival by giving an inspector a completed VS Form 17-29, “Declaration of Importation for Animals, Animal Semen, Birds, Poultry, and Eggs for Hatching.” (This form is available from Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Riverdale, Maryland 20737 or by visiting https://www.aphis.usda.gov/aphis/resources/forms/ct_vs_forms.) Forms may be provided to the inspector using a U.S. Government electronic information exchange system or other authorized method. The completed form must state:

(a) The port of entry;

(b) The date of arrival;

(c) The import permit number;

(d) The name of the carrier and identification of the means of conveyance;

(e) The name and address of the importer;

(f) The name and address of the broker;

(g) The region from which the elephant, hippopotamus, rhinoceros, or tapir was shipped;

(h) The number, species, and purpose of importation of the elephant, hippopotamus, rhinoceros, or tapir; and

(i) The name and address of the person to whom the elephant, hippopotamus, rhinoceros, or tapir will be delivered.

[52 FR 29502, Aug. 10, 1987; 52 FR 35350, Sept. 18, 1987, as amended at 57 FR 23049, June 1, 1992; 59 FR 67615, Dec. 30, 1994. Redesignated and amended at 62 FR 56012, 56021, Oct. 28, 1997, as amended at 81 FR 40151, June 21, 2016; 86 FR 45625, Aug. 16, 2021]

§ 93.805 Ports of entry, inspection, and treatment. 1

1 Importers must also meet all requirements of the U.S. Department of the Interior regulations relevant to the importation of elephants, hippopotami, rhinoceroses, and tapirs, including regulations concerning ports of entry.

(a) An elephant, hippopotamus, rhinoceros, or tapir shall be imported into the United States only:

(1) At Los Angeles, California; Miami, Florida; and Newburgh, New York; or

(2) On a case-by-case basis, at another port of entry if:

(i) The animals will be inspected and treated at a facility provided by the importer;

(ii) The Administrator has determined that the importer's facility is adequate for inspection, treatment, and incineration required under this section;

(iii) The Administrator has determined that an inspector is available to perform at the importer's facility the services that are required under this section; and

(iv) The Administrator has determined that an inspector is available to perform at the port of entry the services that are required under this section if the animals will be inspected and treated at a facility provided by the importer.

(b) An elephant, hippopotamus, rhinoceros, or tapir shall be entered into the United States only under the following conditions:

(1) Any documents accompanying the animal shall be subject to inspection by an inspector at the port of entry;

(2) If the animal is to be moved from the port of entry to a facility provided by the importer:

(i) At the port of entry the animal shall be subject to as much inspection by an inspector as is feasible and shall be sprayed or dipped, as feasible, under the supervision of an inspector and with a permitted dip listed in § 72.13(b) of this chapter;

(ii) At the port of entry, as much hay, straw, feed, bedding, and other material as can feasibly be removed from the shipping crate or vehicle containing the animal shall be removed, sealed in plastic bags, and incinerated by the importer under the supervision of an inspector;

(iii) At the port of entry, the shipping crate or the vehicle containing the animal shall be sealed by an inspector with an official seal of the United States Department of Agriculture:

(iv) If the animal is moved from the port of entry in a shipping crate, plastic must be fastened around the shipping crate so that all animal waste, hay, straw, feed, bedding, and other material accompanying the animal are retained inside the crate, but not so as to interfere with ventilation, feeding, and watering of the animal;

(v) After the arrival of the animal at the facility provided by the importer, the seal shall be broken by an inspector;

(3) The animal shall be inspected by an inspector within 24 hours of being unloaded at the port of entry or at a facility provided by the importer, and shall be treated under the supervision of an inspector, as follows:

(i) The animal shall be removed from its shipping crate or cargo hold, placed on a concrete or other nonporous surface, and physically inspected for ectoparasites by an inspector. If inspection and treatment are not performed upon unloading, the animal must be isolated from all other animals, except those in the same shipment, and kept in a facility with a nonporous floor and where any ectoparasites that may drop off the animal can be contained and destroyed, until the animal has been inspected and treated;

(ii) If the inspector finds no ectoparasites, the animal shall be sprayed or dipped one time in accordance with label instructions with a permitted dip listed in § 72.13(b) of this chapter; or

(iii) If the inspector finds ectoparasites, the animal shall be sprayed or dipped in accordance with label instructions with a permitted dip listed in § 72.13(b) of this chapter for as many times as necessary until the inspector finds no ectoparasites; and thereafter the animal shall be sprayed or dipped one additional time in accordance with label instructions with a permitted dip listed in § 72.13(b) of this chapter;

(4) All hay, straw, feed, bedding, and other material that has been placed with the animal at any time prior to the final treatment referred to in paragraph (b)(3) of this section, and any plastic sheet used to wrap any shipping crate, shall be sealed in plastic bags and incinerated under the supervision of an inspector;

(5) Any shipping crate shall be, under the supervision of an inspector, either cleaned and disinfected using a disinfectant listed in § 71.10 of this chapter or incinerated; and if the shipping crate is cleaned and disinfected, it shall then be treated under the supervision of an inspector with a permitted dip listed in § 72.13(b) of this chapter;

(6) Any means of conveyance used to transport an animal not in a shipping crate shall be, under the supervision of an inspector, cleaned and disinfected using a disinfectant listed in § 71.10 of this chapter and then treated with a permitted dip listed in § 72.13(b) of this chapter.

[52 FR 29502, Aug. 10, 1987, as amended at 57 FR 23049, June 1, 1992. Redesignated at 62 FR 56012, Oct. 28, 1997; 65 FR 38178, June 20, 2000]

§ 93.806 Animals refused entry.

Any elephant, hippopotamus, rhinoceros, or tapir refused entry into the United States for noncompliance with the requirements of this part shall be removed from the United States within a time period specified by the Administrator or shall be considered abandoned by the importer, and pending removal or abandonment, the animal shall be subject to such safeguards as the inspector determines necessary to prevent the possible introduction of ectoparasites into the United States. If such animal is not removed from the United States within such time period or is abandoned, it may be seized, destroyed, or otherwise disposed of as the Administrator determines necessary to prevent the possible introduction of ectoparasites into the United States.

[52 FR 29502, Aug. 10, 1987, as amended at 57 FR 23049, June 1, 1992. Redesignated at 62 FR 56012, Oct. 28, 1997]

§ 93.807 Other importations.

(a) Elephants, hippopotami, rhinoceroses, and tapirs are exempt from the regulations in this part under the following circumstances:

(1) They are imported from Canada and are accompanied by a document signed by a salaried veterinarian of the Canadian Government that states:

(i) They were not imported into Canada during the year preceding their importation into the United States; and

(ii) They did not, during the year preceding their importation into the United States, have physical contact with or share a pen or bedding materials with any elephant, hippopotamus, rhinoceros, or tapir imported into Canada during that year; or

(2) They were exported into Canada from the United States and then imported back into the United States accompanied by a United States health certificate.

(b) Notwithstanding other provisions in this part, the Administrator may in specific cases allow the importation and entry of elephants, hippopotami, rhinoceroses, or tapirs into the United States other than as provided for in this part under such conditions as the Administrator may prescribe to prevent the introduction of ectoparasites into the United States.

(Approved by the Office of Management and Budget under control number 0579-0020)

[52 FR 29502, Aug. 10, 1987; 52 FR 35350, Sept. 18, 1987, as amended at 57 FR 23049, June 1, 1992; 59 FR 67133, Dec. 29, 1994. Redesignated at 62 FR 56012, Oct. 28, 1997, as amended at 64 FR 23179, Apr. 30, 1999]

§ 93.900 Definitions.

Wherever in this subpart the following terms are used, unless the context otherwise requires, they shall be construed, respectively, to mean:

Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.

Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the United States Department of Agriculture (APHIS).

APHIS representative. A veterinarian or other individual employed by the Animal and Plant Health Inspection Service, United States Department of Agriculture, who is authorized to perform the services required by this part.

Certifying official. An individual authorized by the competent authority of a country to sign health certificates for aquatic animals.

Competent authority. The national veterinary services or other authority of a country, having the responsibility and competence for ensuring or supervising the implementation of aquatic animal health measures.

Container. A transport receptacle that is specially constructed to facilitate transportation of aquatic animals or aquatic animal products by one or several means of transport.

Department. The United States Department of Agriculture (USDA).

Fertilized egg. A viable fertilized ovum of an aquatic animal.

Gamete. The sperm or unfertilized egg of aquatic animals that is held or transported separately.

Inspector. An employee of the Animal and Plant Health Inspection Service authorized to perform duties required under this subpart.

Person. Any individual, corporation, company, association, firm, partnership, society or joint stock company.

Port veterinarian. A veterinarian employed by the Animal and Plant Health Inspection Service to perform duties required under this subpart at a port of entry.

Region. Any defined geographic land area identifiable by geological, political, or surveyed boundaries. A region may consist of any of the following:

(1) A national entity (country);

(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.);

(3) Parts of several national entities combined into an area; or

(4) A group of national entities (countries) combined into a single area.

Spring viremia of carp (SVC). A disease caused by infection with spring viremia of carp virus, a rhabodivrus capable of infecting several carp species, in addition to some other cyprinid and ictalurid fish species.

SVC-susceptible species. Common carp (Cyprinus carpio), grass carp (Ctenopharyngodon idellus), silver carp (Hypophthalmichthys molitrix), bighead carp (Aristichthys nobilis), Crucian carp (Carassius carassius), goldfish (Carassius auratus), tench (Tinca tinca), and sheatfish (Silurus glanis).

United States. All of the States of the United States, the District of Columbia, Guam, Northern Mariana Islands, Puerto Rico, the Virgin Islands of the United States, and all other territories and possessions of the United States.

§ 93.901 General restrictions; exceptions.

(a) No live fish, fertilized eggs, or gametes of SVC-susceptible species may be imported into the United States except in accordance with this subpart, 11 nor shall any such live fish, fertilized eggs, or gametes be moved from the port of entry after arrival until released by the port veterinarian; provided that the Administrator may, upon request in specific cases, allow the importation of SVC-susceptible live fish, fertilized eggs, or gametes under conditions other than those set forth in this subpart when the Administrator determines that such movement will not result in the introduction of SVC into the United States.

11 The importation of live cultures of SVC virus, preserved SVC virus viral RNA or DNA, tissue samples containing viable SVC virus, or other specimens intended for diagnostic or research purposes and which contain viable SVC virus may be imported only under permit in accordance with 9 CFR part 122.

(b) Other provisions of this subpart relating to the importation of live fish, fertilized eggs, and gametes shall not apply to shipments of SVC-susceptible species of live fish, fertilized eggs, or gametes in transit through the United States if an import permit has been obtained under § 93.903 and all conditions of the permit are observed; and if the live fish, fertilized eggs, and gametes are handled as follows:

(1) They are maintained under continuous confinement while in transit through the United States aboard an aircraft, ocean vessel, or other means of conveyance; or

(2) They are unloaded, in the course of such transit, into a holding facility 12 that is provided by the carrier or its agent and has been approved by the Administrator in accordance with paragraph (b)(4) of this section as adequate to prevent the spread within the United States of any finfish disease; they are maintained there under continuous confinement until loaded aboard a means of conveyance for transportation from the United States; and are maintained under continuous confinement aboard such means of conveyance until it leaves the United States.

12 Requests for approval of such facilities should be made to the Animal and Plant Health Inspection Service at the address provided in § 93.903 for permit applications.

(3) They are moved in accordance with any additional conditions prescribed in the permit and determined by the Administrator to be necessary to ensure that the live fish, fertilized eggs, or gametes through the United States do not introduce SVC into the United States.

(4) For a holding facility to be approved by the Administrator:

(i) The holding facility must be sufficiently isolated to prevent direct or indirect contact of the live fish, fertilized eggs, or gametes it contains with any other SVC-susceptible species in the United States;

(ii) The holding facility must be constructed to provide adequate protection against environmental conditions and so that it can be adequately cleaned, washed and disinfected;

(iii) Provision must be made for disposal of fish carcasses, shipping water, waste and any associated shipping materials in a manner that will prevent dissemination of disease;

(iv) Provision must be made for adequate sources of feed and water and for attendants for the care and feeding of live fish, fertilized eggs, or gametes in the facility;

(v) The holding facility must comply with all applicable local, State and Federal requirements for environmental quality.

(vi) The holding facility must comply with any additional requirements that may be imposed by the Administrator for a particular shipment if necessary to prevent the dissemination of disease.

(Approved by the Office of Management and Budget under control number 0579-0301)

[71 FR 51435, Aug. 30, 2006; 71 FR 54552, Sept. 15, 2006]

§ 93.902 Ports designated for the importation of live fish, fertilized eggs, and gametes.

(a) The following ports are designated as ports of entry for live fish, fertilized eggs, and gametes of SVC-susceptible species imported under this subpart:

(1) Air and ocean ports. Los Angeles and San Francisco, CA; Miami and Tampa, FL; Atlanta, GA; Honolulu, HI; Chicago, IL; Boston, MA; Newark, NJ; New York, NY; Portland, OR; Dallas-Ft. Worth, TX; and San Juan, PR.

(2) Canadian border ports. Detroit, MI; Buffalo-Niagara, NY; and Blaine and Seattle, WA.

(3) Mexican border ports. Otay Mesa, CA.

(b) Designation of other ports. Other ports may be designated by the Administrator in specific cases with the concurrence of the Secretary of the Department of Homeland Security.

§ 93.903 Import permits for live fish, fertilized eggs, and gametes.

(a) Live fish, fertilized eggs, or gametes of SVC-susceptible species imported into the United States must be accompanied by an import permit issued by APHIS and must be imported within 30 days after the proposed date of arrival stated in the import permit.

(b) An application for an import permit must be submitted for each shipment of live fish, fertilized eggs, or gametes of SVC-susceptible species to Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Riverdale, MD 20737-1231. Application forms for import permits may be obtained from this address.

(c) A completed application shall include the following information:

(1) The name and address of the person intending to export live fish, fertilized eggs, or gametes of SVC-susceptible species to the United States;

(2) The proposed date of shipment to the United States;

(3) The name and address of the person intending to import live fish, fertilized eggs, or gametes of SVC-susceptible species into the United States;

(4) The species and number of live fish, fertilized eggs, or gametes of SVC-susceptible species to be imported into the United States;

(5) The purpose of the importation;

(6) The port of embarkation;

(7) The mode of transportation;

(8) The route of travel, including all carrier stops en route;

(9) The port of entry in the United States;

(10) The proposed date of arrival in the United States; and

(11) The name and address of the person to whom the live fish, fertilized eggs, or gametes of SVC-susceptible species will be delivered in the United States.

(d) If APHIS determines that the live fish, fertilized eggs, or gametes are eligible for importation, APHIS will issue an import permit indicating the applicable conditions for importation. An import permit does not guarantee that any live fish, fertilized eggs, or gametes will be allowed entry into the United States; the fish, fertilized eggs, or gametes will be allowed to enter the United States only if they meet all applicable requirements of the permit and regulations.

(Approved by the Office of Management and Budget under control number 0579-0301)

[71 FR 51435, Aug. 30, 2006, as amended at 86 FR 45625, Aug. 16, 2021]

§ 93.904 Health certificate for live fish, fertilized eggs, and gametes.

(a) General. All live fish, fertilized eggs, and gametes of SVC-susceptible species that are imported from any region of the world must be accompanied by a health certificate issued by a full-time salaried veterinarian of the national government of the exporting region, or issued by a certifying official and endorsed by the competent authority of that country. The health certificate must be written in English or contain an English translation. The health certificate will be valid for 30 days from the date of issuance. The health certificate for the live fish, fertilized eggs, or gametes must state that:

(1) The live fish, fertilized eggs, or gametes were inspected by the veterinarian or certifying official who issued the certificate within 72 hours prior to shipment, and were found to be free of any clinical signs of disease consistent with SVC; and

(2) The live fish, fertilized eggs, or gametes covered by the health certificate meet the requirements of this section.

(b) Surveillance. The live fish, fertilized eggs, or gametes must meet the following conditions to be eligible for importation into the United States:

(1) The live fish, fertilized eggs, or gametes must originate in a region or establishment which conducts a surveillance program for SVC under the supervision of the competent authority.

(2) The region or establishment must demonstrate freedom from SVC through a minimum of 2-years' continuous health history, supported by laboratory testing by a pathogen detection facility approved for SVC viral assays by the competent authority.

(3) SVC-susceptible fish populations in the region or establishment must be tested at least twice annually, with at least 3 months between the tests and at times or under environmental conditions that would facilitate the detection of SVCV if it were present. Sampling procedures must utilize an assumed pathogen prevalence of 2 percent, with a corresponding confidence level of 95 percent. Samples must be collected and submitted by a certifying official or veterinarian recognized by the competent authority. The standard screening method for SVC must include isolation of SVCV in cell culture, using either the epithelioma papulosum cyprini (EPC) or fathead minnow (FHM) cell lines. However, the Administrator may authorize other assays for SVCV detection in lieu of virus isolation through cell culture, if the Administrator determines that such assays provide equivalent assurance of the SVC status of an exporting region or establishment. All viral testing results must be negative.

(c) Shipping containers. All live fish, fertilized eggs, and gametes must be shipped to the United States in new containers or in used containers that have been cleaned and disinfected in accordance with this section.

(1) Cleaning and disinfection of shipping containers must take place under the supervision of the veterinarian or certifying official who issues the health certificate.

(2) Cleaning and disinfection must be sufficient to neutralize any SVC virus to which shipping containers may have been exposed. Acceptable disinfection procedures include individual or combination treatments with: Solutions having a pH of 12 or higher or 3 or lower with a contact time of at least 10 minutes; heat at or above 56 °C for at least 15 minutes; chlorine solutions having a concentration of at least 500 ppm with a contact time of at least 10 minutes; iodine solutions having a concentration of at least 100 ppm with a contact time of at least 10 minutes; ultraviolet exposure (254 nm; min exposure of 10,000 microwatt seconds/cm 2); or other disinfectants such as Virkon used according to the manufacturer's directions. The Administrator may authorize other procedures if the Administrator determines they are adequate to neutralize the SVC virus.

(3) Cleaning and disinfection protocols must be referenced in the health certificate or in a separate cleaning and disinfection certificate accompanying the shipment to the U.S. port of entry.

(Approved by the Office of Management and Budget under control number 0579-0301)

§ 93.905 Declaration and other documents for live fish, fertilized eggs, and gametes.

(a) For all live fish, fertilized eggs, and gametes offered for importation under this subpart, the importer or his or her agent must submit the following documents to the collector of customs for use by the port veterinarian:

(1) All permits, certificates, or other documentation required by this subpart; and

(2) Two copies of a declaration that lists the port of entry, the name and address of the importer, the name and address of the broker, the origin of the live fish, fertilized eggs, or gametes, the number, species, and the purpose of the importation, the name of the person to whom the fish will be delivered, and the location of the place to which such delivery will be made.

(b) Any declaration, permit, or other document for live fish, fertilized eggs, and gametes required under this subpart may be issued and presented using a U.S. Government electronic information exchange system or other authorized method.

(Approved by the Office of Management and Budget under control number 0579-0301)

[71 FR 51435, Aug. 30, 2006, as amended at 81 FR 40152, June 21, 2016]

§ 93.906 Inspection at the port of entry.

(a) All live fish, fertilized eggs, and gametes of SVC-susceptible species imported from any part of the world must be presented for inspection at a port of entry designated under § 93.902. The APHIS port veterinarian must be notified at least 72 hours in advance of the arrival in the United States of a shipment of live fish, fertilized eggs, or gametes of SVC-susceptible species. Any shipment of live SVC-susceptible fish species that the port veterinarian determines to exhibit clinical signs consistent with SVCV infection or disease, or any shipments of live fish, fertilized eggs, and gametes of SVC-susceptible species that otherwise do not meet the requirements of this subpart, shall be refused entry.

(b) Shipments refused entry, unless exported within a time fixed in each case by the Administrator, and in accordance with other provisions he or she may require in each case for their handling, shall be disposed of as the Administrator may direct.

(Approved by the Office of Management and Budget under control number 0579-0301)

§ 94.0 Definitions.

As used in this part, the following terms shall have the meanings set forth in this section.

Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.

Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service, of the United States Department of Agriculture (APHIS.)

APHIS-defined European CSF region. A single region of Europe recognized by APHIS as low risk for classical swine fever.

(1) A list of areas included in the region is maintained on the APHIS website at https://www.aphis.usda.gov/animalhealth/disease-status-of-regions. Copies of the list are also available via postal mail or email upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; AskRegionalization@usda.gov.

(2) APHIS will add an area to the region after it conducts an evaluation of the area to be added in accordance with § 92.2 of this subchapter and finds that the risk profile for the area is equivalent with respect to classical swine fever to the risk profile for the region it is joining.

APHIS-defined European Poultry Trade Region. A single region consisting of Austria, Belgium, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain (England, Scotland, and Wales), Greece, Hungary, Ireland (Republic of), Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Northern Ireland, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden.

APHIS representative. An individual employed by Animal and Plant Health Inspection Service, United States Department of Agriculture, who is authorized to perform the function involved.

Approved establishment means an establishment authorized by Veterinary Services for the receipt and handling of restricted imported animal carcasses, products, and byproducts.

Authorized inspector. Any individual authorized by the Administrator of APHIS or the Commissioner of Customs and Border Protection, Department of Homeland Security, to enforce the regulations in this part.

Birds. All members of the class Aves (other than poultry or game birds).

Bovine. Bos taurus, Bos indicus, and Bison bison.

Bovine spongiform encephalopathy (BSE) minimal-risk region. A region that:

(1) Maintains, and, in the case of regions where BSE was detected, had in place prior to the detection of BSE in an indigenous ruminant, risk mitigation measures adequate to prevent widespread exposure and/or establishment of the disease. Such measures include the following:

(i) Restrictions on the importation of animals sufficient to minimize the possibility of infected ruminants being imported into the region, and on the importation of animal products and animal feed containing ruminant protein sufficient to minimize the possibility of ruminants in the region being exposed to BSE;

(ii) Surveillance for BSE at levels that meet or exceed recommendations of the World Organization for Animal Health (Office International des Epizooties) for surveillance for BSE; and

(iii) A ruminant-to-ruminant feed ban that is in place and is effectively enforced.

(2) In regions where BSE was detected, conducted an epidemiological investigation following detection of BSE sufficient to confirm the adequacy of measures to prevent the further introduction or spread of BSE, and continues to take such measures.

(3) In regions where BSE was detected, took additional risk mitigation measures, as necessary, following the BSE outbreak based on risk analysis of the outbreak, and continues to take such measures.

Cold spot. The area in a flexible plastic cooking tube or other type of container loaded with meat product, or the areas at various points along the belt in an oven chamber, slowest to reach the required temperature during the cooking process. The cold spot(s) for each container is experimentally determined before the cooking process begins, and once identified, remains constant.

Commercial birds. Birds that are imported for resale, breeding, public display, or any other purpose, except pet birds, zoological birds, research birds, or performing or theatrical birds.

Commercial poultry. Chickens, doves, ducks, geese, grouse, guinea fowl, partridges, pea fowl, pheasants, pigeons, quail, swans, and turkeys (including eggs for hatching) which are imported for resale, breeding, public display, or any other commercial purpose.

Contact. Known or potential commingling of products during processing or storage, or while being transported from any point to any other point. Contact includes the simultaneous processing in the same room, locker, or container, but not necessarily the same storage facility or conveyance, as long as adequate security measures are taken to prevent commingling, as determined by an authorized APHIS representative.

Container. For the purposes of § 94.1(c) and § 94.16(c), this term means a receptacle, sometimes refrigerated, which is designed to be filled with cargo, sealed, and then moved, without unsealing or unloading, aboard a variety of different transporting carriers.

Department. The United States Department of Agriculture (USDA, Department).

Direct transloading. The transfer of cargo directly from one means of conveyance to another.

Exporting region. A region from which shipments are sent to the United States.

Farm equipment. Equipment used in the production of livestock or crops, including, but not limited to, mowers, harvesters, loaders, slaughter machinery, agricultural tractors, farm engines, farm trailers, farm carts, and farm wagons, but excluding automobiles and trucks.

Flock of origin. The flock in which the eggs were produced.

Food Safety and Inspection Service. The Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture.

FSIS inspector. An individual authorized by the Administrator, Food Safety and Inspection Service, United States Department of Agriculture, to perform the function involved.

Game birds. Migratory birds, including certain ducks, geese, pigeons, and doves (“migratory” refers to seasonal flight to and from the United States); free-flying quail, wild grouse, wild pheasants (as opposed to those that are commercial, domestic, or pen-raised).

Highly pathogenic avian influenza (HPAI). Highly pathogenic avian influenza is defined as follows:

(1) Any influenza virus that kills at least 75 percent of eight 4- to 6-week-old susceptible chickens within 10 days following intravenous inoculation with 0.2 mL of a 1:10 dilution of a bacteria-free, infectious allantoic fluid or inoculation of 10 susceptible 4- to 8-week-old chickens resulting in an intravenous pathogenicity index (IVPI) of greater than 1.2;

(2) Any H5 or H7 virus that does not meet the criteria in paragraph (1) of this definition, but has an amino acid sequence at the haemagglutinin cleavage site that is compatible with highly pathogenic avian influenza viruses; or

(3) Any influenza virus that is not an H5 or H7 subtype and that kills one to five out of eight inoculated chickens and grows in cell culture in the absence of trypsin within 10 days.

House. A structure, enclosed by walls and a roof, in which poultry are raised.

Immediate export. The period of time determined by APHIS, based on shipping routes and timetables, to be the shortest practicable interval of time between the arrival in the United States of an incoming carrier and the departure from the United States of an outgoing carrier, to transport a consignment of products.

Import (imported, importation) into the United States. To bring into the territorial limits of the United States.

Indicator piece. A cube or slice of meat to be used for the pink juice test, required to meet minimum size specifications.

Mechanically separated meat. A finely comminuted product resulting from the mechanical separation and removal of most of the bone from attached skeletal muscle of bovine carcasses that meets the FSIS specifications contained in 9 CFR 319.5.

Newcastle disease. Newcastle disease is an acute, rapidly spreading, and usually fatal viral infection of poultry caused by an avian paramyxovirus serotype 1 that meets one of the following criteria for virulence: The virus has an intracerebral pathogenicity index (ICPI) in day-old chicks (Gallus gallus) of 0.7 or greater; or multiple basic amino acids have been demonstrated in the virus (either directly or by deduction) at the C-terminus of the F2 protein and phenylalanine at residue 117, which is the N-terminus of the F1 protein. The term “multiple basic amino acids” refers to at least three arginine or lysine residues between residues 113 and 116. In this definition, amino acid residues are numbered from the N-terminus of the amino acid sequence deduced from the nucleotide sequence of the F0 gene; 113-116 corresponds to residues −4 to −1 from the cleavage site. Failure to demonstrate the characteristic pattern of amino acid residues as described above may require characterization of the isolated virus by an ICPI test. A failure to detect a cleavage site that is consistent with virulent strains does not confirm the absence of a virulent virus.

Operator. The operator responsible for the day-to-day operations of a facility.

Personal use. Only for personal consumption or display and not distributed further or sold.

Pink juice test. Determination of whether meat has been thoroughly cooked by observation of whether the flesh and juices have lost all red and pink color.

Port of arrival. Any place in the United States at which a product or article arrives, unless the product or article remains on the means of conveyance on which it arrived within the territorial limits of the United States.

Positive for a transmissible spongiform encephalopathy. A sheep or goat for which a diagnosis of a transmissible spongiform encephalopathy has been made.

Poultry. Chickens, turkeys, swans, partridges, guinea fowl, pea fowl; nonmigratory ducks, geese, pigeons, and doves; commercial, domestic, or pen-raised grouse, pheasants, and quail.

Processed animal protein. Meat meal, bone meal, meat-and-bone meal, blood meal, dried plasma and other blood products, hydrolyzed protein, hoof meal, horn meal, poultry meal, feather meal, fish meal, and any other similar products.

Premises of origin. The premises where the flock of origin is kept.

Region. Any defined geographic land area identifiable by geological, political, or surveyed boundaries. A region may consist of any of the following:

(1) A national entity (country);

(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.)

(3) Parts of several national entities combined into an area; or

(4) A group of national entities (countries) combined into a single area.

Region of origin. For meat and meat products, the region in which the animal from which the meat or meat products were derived was born, raised and slaughtered; and for eggs, the region in which the eggs were laid.

Restricted zone for classical swine fever. An area, delineated by the relevant competent veterinary authorities of the region in which the area is located, that surrounds and includes the location of an outbreak of classical swine fever in domestic swine or detection of the disease in wild boar, and from which the movement of domestic swine is prohibited.

Ruminants. All animals that chew the cud, such as cattle, buffaloes, sheep, goats, deer, antelopes, camels, llamas and giraffes.

Sentinel bird. A chicken that has been raised in an environment free of pathogens that cause communicable diseases of poultry and that has not been infected with, exposed to, or immunized with any strain of virus that causes Newcastle disease.

Specified risk materials (SRMs) from regions of controlled risk for BSE. Those bovine parts considered to be at particular risk of containing the BSE agent in infected animals, as listed in the FSIS regulations at 9 CFR 310.22(a).

Specified risk materials (SRMs) from regions of undetermined risk for BSE. Those bovine parts considered to be at particular risk of containing the BSE agent in infected animals, as listed in the FSIS regulations at 9 CFR 310.22(a), except that the following bovine parts from regions of undetermined risk for BSE are considered SRMs if they are derived from bovines over 12 months of age: Brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and the dorsal root ganglia.

State. Any of the several States of the United States, the Commonwealth of the Northern Mariana Islands, the Commonwealth of Puerto Rico, the District of Columbia, Guam, the Virgin Islands of the United States, or any other territory or possession of the United States.

Suspect for a transmissible spongiform encephalopathy. (1) A sheep or goat that has tested positive for a transmissible spongiform encephalopathy or for the proteinase resistant protein associated with a transmissible spongiform encephalopathy, unless the animal is designated as positive for a transmissible spongiform encephalopathy; or

(2) A sheep or goat that exhibits any of the following signs and that has been determined to be suspicious for a transmissible spongiform encephalopathy by a veterinarian: Weight loss despite retention of appetite; behavior abnormalities; pruritus (itching); wool pulling; biting at legs or side; lip smacking; motor abnormalities such as incoordination, high stepping gait of forelimbs, bunny hop movement of rear legs, or swaying of back end; increased sensitivity to noise and sudden movement; tremor, “star gazing,” head pressing, recumbency, or other signs of neurological disease or chronic wasting.

Temperature indicator device (TID). A precalibrated temperature-measuring instrument containing a chemical compound activated at a specific temperature (the melting point of the chemical compound) identical to the processing temperature that must be reached by the meat being cooked. The Administrator will approve a TID for use after determining that the chemical compound in the device is activated at the specific temperature required.

Thoroughly cooked. Heated sufficiently to inactivate any pathogen that may be present, as indicated by the required TID or pink juice test.

United States. All of the States.

Veterinarian in Charge. The veterinary official of the Animal and Plant Health Inspection Service, United States Department of Agriculture, who is assigned by the Administrator to supervise and perform the official animal health work of the Animal and Plant Health Inspection Service in the State or area concerned.

Wild swine. Any swine which are allowed to roam outside an enclosure.

[52 FR 33801, Sept. 8, 1987]

Editorial Note:For Federal Register citations affecting § 94.0, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

§ 94.1 Regions where foot-and-mouth disease exists; importations prohibited.

(a) APHIS considers foot-and-mouth disease to exist in all regions of the world except those declared free of the disease by APHIS.

(1) A list of regions that APHIS has declared free of foot-and-mouth disease is maintained on the APHIS website at https://www.aphis.usda.gov/animalhealth/disease-status-of-regions. Copies of the list can be obtained via postal mail upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; AskRegionalization@usda.gov.

(2) APHIS will add a region to the list of those it has declared free of foot-and-mouth disease after it conducts an evaluation of the region in accordance with § 92.2 of this subchapter and finds that the disease is not present. In the case of a region formerly on this list that is removed due to an outbreak, the region may be returned to the list in accordance with the procedures for reestablishment of a region's disease-free status in § 92.4 of this subchapter. APHIS will remove a region from the list of those it has declared free of foot-and-mouth disease upon determining that the disease exists in the region based on reports APHIS receives of outbreaks of the disease from veterinary officials of the exporting country, from the World Organization for Animal Health (OIE), or from other sources the Administrator determines to be reliable.

(b) The importation of any ruminant or swine or any fresh (chilled or frozen) meat of any ruminant or swine 1 that originates in any region where foot-and-mouth disease exists, as designated in paragraph (a) of this section, or that enters a port in or otherwise transits a region in which foot-and-mouth disease exists, is prohibited:

1 Importation of animals and meat includes bringing the animals or meat within the territorial limits of the United States on a means of conveyance for use as sea stores or for other purposes.

(1) Except as provided in part 93 of this chapter for wild ruminants and wild swine;

(2) Except as provided in paragraph (d) of this section for fresh (chilled or frozen) meat of ruminants or swine that is otherwise eligible for importation under this part but that enters a port or otherwise transits a region where foot-and-mouth disease exists; and

(3) Except as provided in § 94.4 of this part for cooked or cured meat from regions where foot-and-mouth disease exists.

(4) Except as provided in § 94.29 for fresh (chilled or frozen) beef and ovine meat.

(c) The importation of any used farm equipment that originates in any region where foot-and-mouth disease exists, as designated in paragraph (a) of this section, is prohibited, unless the equipment is accompanied by an original certificate signed by an authorized official of the national animal health service of the exporting region that states that the equipment, after its last use and prior to export, was steam-cleaned free of all exposed dirt and other particulate matter. Such farm equipment is subject to APHIS inspection at the port of arrival. If it is found during such inspection to contain any exposed dirt or other particulate matter, it will be denied entry into the United States, unless, in the judgment of the APHIS inspector, the amount of exposed soil is minimal enough to allow cleaning at the port of arrival, and there are adequate facilities and personnel at the port to conduct such cleaning without risk of disease contamination.

(d) Except as otherwise provided in this part, fresh (chilled or frozen) meat of ruminants or swine raised and slaughtered in a region free of foot-and-mouth disease, as designated in paragraph (a) of this section, and fresh (chilled or frozen) beef and ovine meat exported in accordance with § 94.29, which during shipment to the United States enters a port or otherwise transits a region where foot-and-mouth disease exists, may be imported provided that all of the following conditions are met:

(1) The meat is accompanied by the foreign meat inspection certificate required by § 327.4 of this title and, upon arrival of the meat in the United States, the foreign meat inspection certificate is presented to an authorized inspector at the port of arrival;

(2) The meat is placed in the transporting carrier in a hold, compartment, or, if the meat is containerized, in a container that which was sealed in the region of origin by an official of such region with serially numbered seals approved by APHIS, so as to prevent contact of the meat with any other cargo, handling of the meat after the hold, compartment, or container is sealed, and the loading of any cargo into and the removal of any cargo from the sealed hold, compartment, or container en route to the United States;

(3) If any foreign official breaks a seal applied in the region of origin in order to inspect the meat, he or she then reseals the hold, compartment, or container with a new serially numbered seal; and, if any member of a ship's crew breaks a seal, the serial number of the seal, the location of the seal, and the reason for breaking the seal are recorded in the ship's log.

(4) The serial numbers of the seals used to seal the hold, compartment, or container are recorded on the foreign meat inspection certificate which accompanies the meat;

(5) Upon arrival of the carrier in the United States port of arrival, the seals are found by an APHIS representative to be intact, and the representative finds that there is no evidence indicating that any seal has been tampered with; Provided that, if the representative finds that any seal has been broken or has a different number than is recorded on the foreign meat inspection certificate, then the meat may remain eligible for entry into the United States only if APHIS personnel are available to inspect the hold, compartment, or container, the packages of meat, and all accompanying documentation; and the importer furnishes additional documentation (either copies of pages from the ship's log signed by the officer-in-charge, or certification from a foreign government that the original seal was removed and the new seal applied by officials of that government) that demonstrates to the satisfaction of the Administrator that the meat was not contaminated or exposed to contamination during movement from the region of origin to the United States; and

(6) The meat is found by an authorized inspector to be as represented on the foreign meat inspection certificate.

(Approved by the Office of Management and Budget under control numbers 0579-0015 and 0579-0195)

[30 FR 12118, Sept. 23, 1965]

Editorial Note:For Federal Register citations affecting § 94.1, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

§ 94.2 Fresh (chilled or frozen) products (other than meat), and milk and milk products of ruminants and swine.

(a) The importation of fresh (chilled or frozen) products (other than meat and milk and milk products) derived from ruminants or swine, originating in, shipped from, or transiting any region designated in § 94.1(a) as a region affected with foot-and-mouth disease is prohibited, except as provided in § 94.3 and parts 95 and 96 of this chapter.

(b) The importation of milk and milk products of ruminants and swine originating in, shipped from, or transiting any region designated in § 94.1(a) as a region affected with foot-and-mouth disease is prohibited, except as provided in § 94.16.

[40 FR 44123, Sept. 25, 1975, as amended at 62 FR 56022, Oct. 28, 1997; 77 FR 1392, Jan. 10, 2012; 83 FR 15493, Apr. 11, 2018]

§ 94.3 Organs, glands, extracts, or secretions of ruminants or swine.

The importation of fresh (chilled or frozen) organs, glands, extracts, or secretions derived from ruminants or swine, originating in any region where foot-and-mouth disease exists, as designated in § 94.1, except for pharmaceutical or biological purposes under conditions prescribed by the Administrator in each instance, is prohibited.

[28 FR 5980, June 13, 1963, as amended at 53 FR 48520, Dec. 1, 1988; 62 FR 56022, Oct. 28, 1997; 63 FR 67574, Dec. 8, 1998; 83 FR 15493, Apr. 11, 2018]

§ 94.4 Cured or cooked meat from regions where foot-and-mouth disease exists.

(a) The importation of cured meats derived from ruminants or swine, originating in any region where foot-and-mouth disease exists, as designated in § 94.1, is prohibited unless the following conditions have been fulfilled:

(1) All bones shall have been completely removed in the region of origin.

(2) The meat shall have been held in an unfrozen, fresh condition for at least 3 days immediately following the slaughter of the animals from which it was derived.

(3)(i) The meat shall have been thoroughly cured and fully dried in such manner that it may be stored and handled without refrigeration, as in the case of salami and other summer sausages, tasajo, xarque, or jerked beef, bouillon cubes, dried beef, and Westphalia, Italian and similar type hams. The term “fully dried” as used in this paragraph means dried to the extent that the water-protein ratio in the wettest portion of the product does not exceed 2.25 to 1.

(ii) Laboratory analysis of samples to determine the water-protein ratios will not be made in the case of all shipments of cured and dried meats. However, in any case in which the inspector is uncertain whether the meat complies with the requirements of paragraph (a)(3)(i) of this section, he will send a sample of the meat representative of the wettest portion to the Meat Inspection Division for analysis of the water-protein ratio. Pending such analysis the meat shall not be released or removed from the port of arrival.

(4) The cured meat shall be accompanied by a certificate issued by an official of the national government of the region of origin who is authorized to issue the foreign meat inspection certificate required by § 327.4 of this title, stating that such meat has been prepared in accordance with paragraphs (a)(1), (a)(2) and (a)(3)(i) of this section. Upon arrival of the cured meat in the United States, the certificate must be presented to an authorized inspector at the port of arrival.

(b) The importation of cooked meats from ruminants or swine originating in any region where foot-and-mouth disease exists, as designated in § 94.1, is prohibited, except as provided in this section.

(1) The cooked meat must be boneless and must be thoroughly cooked.

(2) The cooked meat must have been prepared in an establishment that is eligible to have its products imported into the United States under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) and the regulations in 9 CFR 327.2; must meet all other applicable requirements of the Federal Meat Inspection Act and regulations thereunder (9 CFR Chapter III); and must have been approved by the Administrator in accordance with paragraph (c) of this section.

(3) Canned product (canned meat), as defined in part 431 of this title, is exempt from the requirements in this section.

(4) Ground meat cooked in an oven. Ground meat must be shaped into patties no larger than 5 inches in diameter and 1-inch thick. Each patty must weigh no more than 115 grams, with fat content no greater than 30 percent. These patties must be broiled at 210 °C for at least 133 seconds, then cooked in moist heat (steam heat) in a continuous, belt-fed oven for not less than 20 minutes, to yield an internal exit temperature of at least 99.7 °C, as measured by temperature indicator devices (TID's) placed in temperature monitor patties positioned, before the belt starts moving through the oven, on each of the predetermined cold spots along the oven belt. TID's must be used at the beginning of each processing run.

(5) Meat cooked in tubes. Ground meat (which must not include cardiac muscle), cubes of meat, slices of meat, or anatomical cuts of meat (cuts taken from the skeletal muscle tissue) weighing no more than 5 kg (11.05 lbs) must be loaded into a flexible or semiflexible cooking tube constructed of plastic or other material approved by the U.S. Food and Drug Administration. The meat must then be cooked in either boiling water or in a steam-fed oven, in either a batch cooker or a continuous cooker, to reach a minimum internal temperature of 79.4 °C (175 °F) at the cold spot after cooking for at least 1.75 hours. Thoroughness of cooking must be determined by a TID registering the target temperature at the cold spot, or by the pink juice test as follows:

(i) Cubes of meat and ground meat. For cubes of meat, at least 50 percent of meat pieces per tube must be 3.8 cm (1.5 in) or larger in each dimension after cooking or, if more than 50 percent of the cubes of meat pieces per tube are smaller than 3.8 cm (1.5 in) in any dimension after cooking, or if the meat is ground meat, an indicator piece consisting of a single piece of meat of sufficient size for a pink juice test to be performed (3.8 cm (1.5 in) or larger in each dimension after cooking) must have been placed at the cold spot of the tube.

(ii) Slices of meat. At least 50 percent of the slices of meat must be 3.8 cm (1.5 in) or larger in each dimension after cooking or, if more than 50 percent of meat pieces are smaller than 3.8 cm (1.5 in) in any dimension after cooking, an indicator piece of sufficient size for a pink juice test to be performed (3.8 cm (1.5 in) or larger in each dimension after cooking) must be placed at the cold spot of the tube.

(iii) Anatomical cuts of meat. An indicator piece removed from an anatomical cut of meat after cooking must be removed from the center of the cut, farthest from all exterior points and be 3.8 cm (1.5 in) or larger in each dimension for performance of the pink juice test.

(6) Further processing of meat cooked in tubes. Cubes of meat, slices of meat, or anatomical cuts of meat (cuts taken from the skeletal muscle tissue) cooked in tubes in accordance with paragraph (b)(5) of this section may be processed further after cooking if the following provisions are met:

(i) For meat that is cooked and is intended for further processing, up to two tubes from each batch per cooker must be randomly selected by the official of the National Government of the region of origin who is authorized to issue the meat inspection certificate required by § 327.4 of this title. If a TID is not used, a cylindrical or square piece of at least 3.8 cm (1.5 in) in each dimension must be cut from the cold spot of each tube. The cylindrical or square piece will be the indicator piece for the pink juice test. The indicator piece or piece containing the TID must be sealed in plastic or other material approved by the U.S. Food and Drug Administration, and be accompanied by a certificate issued by the official who selected the tube. The certificate must provide the date the tube was cooked and the cooker and batch number, and the date the tube was selected for sampling. Each batch per cooker must have at least one but no more than two indicator pieces or pieces containing TID's. All indicator pieces and pieces containing TID's must be individually sealed, properly labeled, and enclosed together in one sealed box that accompanies the shipment. Any indicator pieces or pieces containing TID's that are not used to accompany a shipment to the United States must be destroyed following loading of the batch into a container; and

(ii) After removing the indicator piece or piece containing a TID, all remaining meat from the same batch may be cut into smaller cubes and sealed in plastic or other material approved by the U.S. Food and Drug Administration. After being processed into smaller cubes once, the meat may not be further processed before shipment to the United States. The cubes of meat and the indicator piece or piece containing a TID must be accompanied to the United States by a certificate as provided in paragraph (b)(8) of this section.

(7) Any TID used in accordance with paragraph (b)(4) or (b)(5) of this section must remain in the meat, as originally inserted, and must accompany the cooked meat whose temperature it has gauged when that meat is shipped to the United States.

(8) Pork rind pellets (pork skins). Pork rind pellets (pork skins) must be cooked in one of the following ways:

(i) One-step process. The pork skins must be cooked in oil for at least 80 minutes when oil temperature is consistently maintained at a minimum of 114 °C.

(ii) Two-step process. The pork skins must be dry-cooked at 260 °C for approximately 210 minutes after which they must be cooked in hot oil (deep-fried) at 104 °C for an additional 150 minutes.

(9) Certificate. (i) The cooked meat must be accompanied by a certificate issued by an official of the National Government of the region of origin who is authorized to issue the foreign meat inspection certificate required under § 327.4 of this title, stating: “This cooked meat produced for export to the United States meets the requirements of title 9, Code of Federal Regulations, § 94.4(b).” Upon arrival of the cooked meat in the United States, the certificate must be presented to an authorized inspector at the port of arrival.

(ii) For cooked meat that is further processed in accordance with paragraph (b)(6) of this section, the certificate must include the following statement, in addition to the certification required under paragraph (b)(9)(i) of this section: “No more than two tubes were randomly selected per batch per cooker for cutting an indicator piece or obtaining a piece containing a TID. The indicator piece or piece containing a TID represents a shipment of (describe form of processed product—e.g., diced cubes of a particular size). A piece containing a TID or a piece 3.8 cm (1.5 in) or larger in each dimension was cut from the cold spot of the tube, and was sealed and marked with the following cooking date, cooker, and batch: __________ and the following date of selection of the tube__________. The total number of indicator pieces or pieces containing TID's enclosed in a sealed box is__________.”

(10) The meat is inspected by an FSIS inspector at a port of arrival in a defrost facility approved by the Administrator 2 and the meat is found to be thoroughly cooked.

2 The names and addresses of approved defrost facilities and conditions for approval may be obtained from the Administrator, Animal and Plant Health Inspection Service, United States Department of Agriculture, Washington, DC 20250.

(i) Request for approval of any defrost facility must be made to the Administrator. The Administrator will approve a defrost facility only under the following conditions:

(A) The defrost facility has equipment and procedures that permit FSIS inspectors to determine whether meat is thoroughly cooked;

(B) The defrost facility is located at a port of arrival; and

(C) The defrost facility is approved by the Food Safety and Inspection Service, United States Department of Agriculture. 3

3 Conditions for the approval of any defrost facility by the Food Safety and Inspection Service, United States Department of Agriculture, may be obtained from the Import Inspection Division, International Programs, Food Safety and Inspection Service, United States Department of Agriculture, Washington, DC 20250.

(ii) The Administrator may deny approval of any defrost facility if the Administrator determines that the defrost facility does not meet the conditions for approval. If approval is denied, the operator of the defrost facility will be informed of the reasons for denial and be given an opportunity to respond. The operator will be afforded an opportunity for a hearing with respect to any disputed issues of fact. The hearing will be conducted in accordance with rules of practice that will be adopted for the proceeding.

(iii) The Administrator may withdraw approval of any defrost facility as follows: (A) When the operator of the defrost facility notifies the Administrator in writing that the defrost facility no longer performs the required services; or (B) when the Administrator determines that the defrost facility does not meet the conditions for approval. Before the Administrator withdraws approval from any defrost facility, the operator of the defrost facility will be informed of the reasons for the proposed withdrawal and given an opportunity to respond. The operator will be afforded a hearing with respect to any disputed issues of fact. The hearing will be conducted in accordance with rules of practice that will be adopted for the proceeding. If approval of a defrost facility is withdrawn, the Administrator will remove its name from the list of approved defrost facilities.

(c) Meat processing establishment; standards. (1) Before the Administrator will approve a meat processing establishment for export shipment of cooked meat to the United States, the Administrator must determine:

(i) That the meat processing establishment has furnished APHIS with a description of the process used to inactivate FMD virus that may be present in meat intended for export to the United States, and with blueprints of the facilities where this meat is cooked and packaged;

(ii) That an APHIS representative has inspected the establishment and found that it meets the standards set forth in paragraph (c)(2) of this section;

(iii) That the operator of the establishment has signed a cooperative service agreement with APHIS, stating:

(A) That all cooked meat processed for importation into the United States will be processed in accordance with the requirements of this part;

(B) that a full-time, salaried meat inspection official of the National Government of the exporting region will supervise the processing (including certification of the cold spot) and examination of the product, and certify that it has been processed in accordance with this section; and

(C) that APHIS personnel or other persons authorized by the Administrator may enter the establishment, unannounced, to inspect the establishment and its records; and

(iv) That the operator of the establishment has entered into a trust fund agreement with APHIS and is current in paying all costs for an APHIS representative to inspect the establishment for initial evaluation, and periodically thereafter, including travel, salary, subsistence, administrative overhead, and other incidental expenses (including an excess baggage provision up to 150 pounds). In accordance with the terms of the trust fund agreement, before the APHIS representative's site inspection, the operator of the processing establishment must deposit with the Administrator an amount equal to the approximate cost of one inspection by an APHIS representative, including travel, salary, subsistence, administrative overhead, and other incidental expenses (including an excess baggage provision up to 150 pounds). As funds from that amount are obligated, a bill for costs incurred based on official accounting records will be issued, to restore the deposit to the original level, revised as necessary to allow for inflation or other changes in estimated costs. To be current, bills must be paid within 14 days of receipt.

(2) Establishment. An APHIS representative will conduct an on-site evaluation, and subsequent inspections, as provided in § 94.4(c)(1), to determine whether the following conditions are met:

(i) The facilities used for processing cooked meat in the meat processing establishment are separate from the facilities used for processing raw meat (precooking, boning, preparation, and curing), with only the through-the-wall cooking system through which the meat product is delivered at the end of the cooking cycle connecting them; and there is at all times a positive air flow from the cooked to the raw product side;

(ii) The cooking equipment has the capacity to cook all meat pieces in accordance with § 94.4(b)(4) or (b)(5);

(iii) Workers who process cooked meat are at all times kept separate from workers who process raw meat, and have, for their exclusive use: A separate entrance, dining area, toilets, lavatories with cold and hot water, soap, disinfectants, paper towels, clothes hampers and waste baskets for disposal, and changing rooms stocked with the clean clothing and rubber boots into which all persons must change upon entering the establishment. Workers and all other persons entering the establishment must wash their hands and change into the clean clothing and boots provided in the changing rooms before entering the cooking facilities, and must leave this clothing for laundering and disinfecting before exiting from the establishment, regardless of the amount of time spent inside or away from the establishment;

(iv) Original records identifying the slaughtering facility from which the meat was obtained and the date the meat entered the meat processing establishment, and original certification (including temperature recording charts and graphs), must be kept for all cooked meat by the full-time salaried meat inspection official of the National Government of the exporting region assigned to the establishment, and must be retained for 2 years.

(Approved by the Office of Management and Budget under control number 0579-0015)

[28 FR 5980, June 13, 1963]

Editorial Note:For Federal Register citations affecting § 94.4, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

§ 94.5 Regulation of certain garbage.

(a) General restrictions—(1) Interstate movements of garbage from Hawaii and U.S. territories and possessions to the continental United States. Hawaii, Puerto Rico, American Samoa, the Commonwealth of the Northern Mariana Islands, the Federated States of Micronesia, Guam, the U.S. Virgin Islands, Republic of the Marshall Islands, and the Republic of Palau are hereby quarantined, and the movement of garbage therefrom to any other State is hereby prohibited except as provided in this section in order to prevent the introduction and spread of exotic plant pests and diseases.

(2) Imports of garbage. In order to protect against the introduction of exotic animal and plant pests, the importation of garbage from all foreign countries except Canada is prohibited except as provided in paragraph (c)(2) of this section.

(b) Definitions—Agricultural waste. Byproducts generated by the rearing of animals and the production and harvest of crops or trees. Animal waste, a large component of agricultural waste, includes waste (e.g., feed waste, bedding and litter, and feedlot and paddock runoff) from livestock, dairy, and other animal-related agricultural and farming practices.

Approved facility. A facility approved by the Administrator, Animal and Plant Health Inspection Service, upon his determination that it has equipment and uses procedures that are adequate to prevent the dissemination of plant pests and livestock or poultry diseases, and that it is certified by an appropriate Government official as currently complying with the applicable laws for environmental protection.

Approved sewage system. A sewage system approved by the Administrator, Animal and Plant Health Inspection Service, upon his determination that the system is designed and operated in such a way as to preclude the discharge of sewage effluents onto land surfaces or into lagoons or other stationary waters, and otherwise is adequate to prevent the dissemination of plant pests and livestock or poultry diseases, and that is certified by an appropriate Government official as currently complying with the applicable laws for environmental protection.

Carrier. The principal operator of a means of conveyance.

Continental United States. The 49 States located on the continent of North America and the District of Columbia.

Garbage. All waste material that is derived in whole or in part from fruits, vegetables, meats, or other plant or animal (including poultry) material, and other refuse of any character whatsoever that has been associated with any such material.

Incineration. To reduce garbage to ash by burning.

Inspector. A properly identified employee of the U.S. Department of Agriculture or other person authorized by the Department to enforce the provisions of applicable statutes, quarantines, and regulations.

Interstate. From one State into or through any other State.

Person. Any individual, corporation, company, association, firm, partnership, society, or joint stock company.

Shelf-stable. The condition achieved in a product, by application of heat, alone or in combination with other ingredients and/or other treatments, of being rendered free of microorganisms capable of growing in the product under nonrefrigerated conditions (over 50 °F or 10 °C).

Sterilization. Cooking garbage at an internal temperature of 212 °F for 30 minutes.

Stores. The food, supplies, and other provisions carried for the day-to-day operation of a conveyance and the care and feeding of its operators.

Yard waste. Solid waste composed predominantly of grass clippings, leaves, twigs, branches, and other garden refuse.

(c) Garbage generated onboard a conveyance—(1) Applicability. This section applies to garbage generated onboard any means of conveyance during international or interstate movements as provided in this section and includes food scraps, table refuse, galley refuse, food wrappers or packaging materials, and other waste material from stores, food preparation areas, passengers' or crews' quarters, dining rooms, or any other areas on the means of conveyance. This section also applies to meals and other food that were available for consumption by passengers and crew on an aircraft but were not consumed.

(i) Not all garbage generated onboard a means of conveyance is regulated for the purposes of this section. Garbage regulated for the purposes of this section is defined as “regulated garbage” in paragraphs (c)(2) and (c)(3) of this section.

(ii) Garbage that is commingled with regulated garbage is also regulated garbage.

(2) Garbage regulated because of movements outside the United States or Canada. For purposes of this section, garbage on or removed from a means of conveyance is regulated garbage, if, when the garbage is on or removed from the means of conveyance, the means of conveyance has been in any port outside the United States and Canada within the previous 2-year period. There are, however, two exceptions to this provision. These exceptions are as follows:

(i) Exception 1: Aircraft. Garbage on or removed from an aircraft is exempt from requirements under paragraph (c)(4) of this section if the following conditions are met when the garbage is on or removed from the aircraft:

(A) The aircraft had previously been cleared of all garbage and of all meats and meat products, whatever the country of origin, except meats that are shelf-stable; all fresh and condensed milk and cream from countries designated in § 94.1 as those in which foot-and-mouth disease exists; all fresh fruits and vegetables; and all eggs; and the items previously cleared from the aircraft as prescribed by this paragraph have been disposed of according to the procedures for disposing of regulated garbage, as specified in paragraphs (c)(4)(ii) and (c)(4)(iii) of this section.

(B) After the garbage and stores referred to in paragraph (c)(2)(i)(A) of this section were removed, the aircraft has not been in a non-Canadian foreign port.

(ii) Exception 2: Other conveyances. Garbage on or removed in the United States from a means of conveyance other than an aircraft is exempt from requirements under paragraph (c)(4) of this section if the following conditions are met when the garbage is on or removed from the means of conveyance:

(A) The means of conveyance is accompanied by a certificate from an inspector stating the following:

(1) That the means of conveyance had previously been cleared of all garbage and of all meats and meat products, whatever the country of origin, except meats that are shelf-stable; all fresh and condensed milk and cream from countries designated in § 94.1 as those in which foot-and-mouth disease exists; all fresh fruits and vegetables; and all eggs; and the items previously cleared from the means of conveyance as prescribed by this paragraph have been disposed of according to the procedures for disposing of regulated garbage, as specified in paragraphs (c)(4)(ii) and (c)(4)(iii) of this section.

(2) That the means of conveyance had then been cleaned and disinfected in the presence of the inspector; and

(B) Since being cleaned and disinfected, the means of conveyance has not been in a non-Canadian foreign port.

(3) Garbage regulated because of certain movements to or from Hawaii, territories, or possessions. For purposes of this section, garbage on or removed from a means of conveyance is regulated garbage, if at the time the garbage is on or removed from the means of conveyance, the means of conveyance has moved during the previous 1-year period, either directly or indirectly, to the continental United States from any territory or possession or from Hawaii, to any territory or possession from any other territory or possession or from Hawaii, or to Hawaii from any territory or possession. There are, however, two exceptions to this provision. These exceptions are as follows:

(i) Exception 1: Aircraft. Garbage on or removed from an aircraft is exempt from requirements under paragraph (c)(4) of this section if the following two conditions are met when the garbage is on or removed from the aircraft:

(A) The aircraft had been previously cleared of all garbage and all fresh fruits and vegetables, and the items previously cleared from the aircraft as prescribed by this paragraph have been disposed of according to the procedures for disposing of regulated garbage, as specified in paragraphs (c)(4)(ii) and (c)(4)(iii) of this section.

(B) After the garbage and stores referred to in paragraph (c)(3)(i)(A) of this section were removed, the aircraft has not moved to the continental United States from any territory or possession or from Hawaii, to any territory or possession from any other territory or possession or from Hawaii, or to Hawaii from any territory or possession.

(ii) Exception 2: Other conveyances. Garbage on or removed from a means of conveyance other than an aircraft is exempt from requirements under paragraph (c)(4) of this section if the following two conditions are met when the garbage is on or removed from the means of conveyance:

(A) The means of conveyance is accompanied by a certificate from an inspector stating that the means of conveyance had been cleared of all garbage and all fresh fruits and vegetables, and the items previously cleared from the means of conveyance as prescribed by this paragraph have been disposed of according to the procedures for disposing of regulated garbage, as specified in paragraphs (c)(4)(ii) and (c)(4)(iii) of this section.

(B) After being cleared of the garbage and stores referred to in paragraph (c)(3)(ii)(A) of this section, the means of conveyance has not moved to the continental United States from any territory or possession or from Hawaii; to any territory or possession from any other territory or possession or from Hawaii; or to Hawaii from any territory or possession.

(4) Restrictions on regulated garbage. (i) Regulated garbage may not be disposed of, placed on, or removed from a means of conveyance except in accordance with this section.

(ii) Regulated garbage is subject to general surveillance for compliance with this section by inspectors and to disposal measures authorized by the Plant Protection Act and the Animal Health Protection Act to prevent the introduction and dissemination of pests and diseases of plants and livestock.

(iii) All regulated garbage must be contained in tight, covered, leak-proof receptacles during storage on board a means of conveyance while in the territorial waters, or while otherwise within the territory of the United States. All such receptacles shall be contained inside the guard rail if on a watercraft. Such regulated garbage shall not be unloaded from such means of conveyance in the United States unless such regulated garbage is removed in tight, covered, leak-proof receptacles under the direction of an inspector to an approved facility for incineration, sterilization, or grinding into an approved sewage system, under direct supervision by such an inspector, or such regulated garbage is removed for other handling in such manner and under such supervision as may, upon request in specific cases, be approved by the Administrator as adequate to prevent the introduction and dissemination of plant pests and animal diseases and sufficient to ensure compliance with applicable laws for environmental protection. Provided that, a cruise ship may dispose of regulated garbage in landfills at Alaskan ports only, if and only if the cruise ship does not have prohibited or restricted meat or animal products on board at the time it enters Alaskan waters for the cruise season, and only if the cruise ship, except for incidental travel through international waters necessary to navigate safely between ports, remains in Canadian and U.S. waters off the west coast of North America, and calls only at continental U.S. and Canadian ports during the entire cruise season.

(A) Application for approval of a facility or sewage system may be made in writing by the authorized representative of any carrier or by the official having jurisdiction over the port or place of arrival of the means of conveyance to the Administrator, Animal and Plant Health Inspection Service, U.S. Department of Agriculture, Washington, DC 20250. The application must be endorsed by the operator of the facility or sewage system.

(B) Approval will be granted if the Administrator determines that the requirements set forth in this section are met. Approval may be denied or withdrawn at any time, if the Administrator determines that such requirements are not met, after notice of the proposed denial or withdrawal of the approval and the reasons therefor, and an opportunity to demonstrate or achieve compliance with such requirements, has been afforded to the operator of the facility or sewage system and to the applicant for approval. However, approval may also be withdrawn without such prior procedure in any case in which the public health, interest, or safety requires immediate action, and in such case, the operator of the facility or sewage system and the applicant for approval shall promptly thereafter be given notice of the withdrawal and the reasons therefore and an opportunity to show cause why the approval should be reinstated.

(iv) The Plant Protection and Quarantine Programs and Veterinary Services, Animal, and Plant Health Inspection Service, will cooperate with other Federal, State, and local agencies responsible for enforcing other statutes and regulations governing disposal of the regulated garbage to the end that such disposal shall be adequate to prevent the dissemination of plant pests and livestock or poultry diseases and comply with applicable laws for environmental protection. The inspectors, in maintaining surveillance over regulated garbage movements and disposal, shall coordinate their activities with the activities of representatives of the U.S. Environmental Protection Agency and other Federal, State, and local agencies also having jurisdiction over such regulated garbage.

(d) Garbage generated in Hawaii—(1) Applicability. This section applies to garbage generated in households, commercial establishments, institutions, and businesses prior to interstate movement from Hawaii, and includes used paper, discarded cans and bottles, and food scraps. Such garbage includes, and is commonly known as, municipal solid waste.

(i) Industrial process wastes, mining wastes, sewage sludge, incinerator ash, or other wastes from Hawaii that the Administrator determines do not pose risks of introducing animal or plant pests or diseases into the continental United States are not regulated under this section.

(ii) The interstate movement from Hawaii to the continental United States of agricultural wastes and yard waste (other than incidental amounts (less than 3 percent) that may be present in municipal solid waste despite reasonable efforts to maintain source separation) is prohibited.

(iii) Garbage generated onboard any means of conveyance during interstate movement from Hawaii is regulated under paragraph (c) of this section.

(2) Restrictions on interstate movement of garbage. The interstate movement of garbage generated in Hawaii to the continental United States is regulated as provided in this section.

(i) The garbage must be processed, packaged, safeguarded, and disposed of using a methodology that the Administrator has determined is adequate to prevent the introduction and dissemination of plant pests into noninfested areas of the United States.

(ii) The garbage must be moved under a compliance agreement in accordance with paragraph (e) of this section. APHIS will only enter into a compliance agreement when the Administrator is satisfied that the Agency has first satisfied all its obligations under the National Environmental Policy Act and all applicable Federal and State statutes to fully assess the impacts associated with the movement of garbage under the compliance agreement.

(iii) All such garbage moved interstate from Hawaii to any of the continental United States must be moved in compliance with all applicable laws for environmental protection.

(e) Compliance agreement and cancellation—(1) Any person engaged in the business of handling or disposing of garbage in accordance with this section must first enter into a compliance agreement with the Animal and Plant Health Inspection Service (APHIS). Compliance agreement forms (PPQ Form 519) are available without charge from local USDA/APHIS/Plant Protection and Quarantine offices, which are listed in telephone directories.

(2) A person who enters into a compliance agreement, and employees or agents of that person, must comply with the following conditions and any supplemental conditions which are listed in the compliance agreement, as deemed by the Administrator to be necessary to prevent the introduction and dissemination into or within the United States of plant pests and livestock or poultry diseases:

(i) Comply with all applicable provisions of this section;

(ii) Allow inspectors access to all records maintained by the person regarding handling or disposal of garbage, and to all areas where handling or disposal of garbage occurs;

(iii)(A) If the garbage is regulated under paragraph (c) of this section, remove garbage from a means of conveyance only in tight, covered, leak-proof receptacles;

(B) If the garbage is regulated under paragraph (d) of this section, transport garbage interstate in sealed, leak-proof packaging approved by the Administrator;

(iv) Move the garbage only to a facility approved by the Administrator; and

(v) At the approved facility, dispose of the garbage in a manner approved by the Administrator and described in the compliance agreement.

(3) Approval for a compliance agreement may be denied at any time if the Administrator determines that the applicant has not met or is unable to meet the requirements set forth in this section. Prior to denying any application for a compliance agreement, APHIS will provide notice to the applicant thereof, and will provide the applicant with an opportunity to demonstrate or achieve compliance with requirements.

(4) Any compliance agreement may be canceled, either orally or in writing, by an inspector whenever the inspector finds that the person who has entered into the compliance agreement has failed to comply with this section. If the cancellation is oral, the cancellation and the reasons for the cancellation will be confirmed in writing as promptly as circumstances allow. Any person whose compliance agreement has been canceled may appeal the decision, in writing, within 10 days after receiving written notification of the cancellation. The appeal must state all of the facts and reasons upon which the person relies to show that the compliance agreement was wrongfully canceled. As promptly as circumstances allow, the Administrator will grant or deny the appeal, in writing, stating the reasons for the decision. A hearing will be held to resolve any conflict as to any material fact. Rules of practice concerning a hearing will be adopted by the Administrator. This administrative remedy must be exhausted before a person can file suit in court challenging the cancellation of a compliance agreement.

(5) Where a compliance agreement is denied or canceled, the person who entered into or applied for the compliance agreement may be prohibited, at the discretion of the Administrator, from handling or disposing of regulated garbage.

(Approved by the Office of Management and Budget under control numbers 0579-0015, 0579-0054, and 0579-0292)

[71 FR 49317, Aug. 23, 2006]

§ 94.6 Carcasses, meat, parts or products of carcasses, and eggs (other than hatching eggs) of poultry, game birds, or other birds; importations from regions where Newcastle disease or highly pathogenic avian influenza is considered to exist.

(a) Disease status of regions for Newcastle disease and highly pathogenic avian influenza (HPAI)—(1) Regions in which Newcastle disease is not considered to exist. (i) A list of free regions is maintained on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/animal-health-status-of-regions. Copies of the list are also available via postal mail upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; AskRegionalization@usda.gov.

(ii) APHIS will remove a region from the list referenced in paragraph (a)(1)(i) of this section upon determining that Newcastle disease exists there based on reports APHIS receives of outbreaks of the disease in commercial birds or poultry from veterinary officials of the exporting country, from the World Organization for Animal Health (OIE), or from other sources the Administrator determines to be reliable. APHIS will add a region to this list after it conducts an evaluation of the region and finds that Newcastle disease is not likely to be present in its commercial bird or poultry populations. In the case of a region formerly on this list that is removed due to an outbreak, the region may be returned to the list in accordance with the procedures for reestablishment of a region's disease-free status in § 92.4 of this subchapter.

(2) Regions in which HPAI is considered to exist. (i) A list of affected regions is maintained on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/animal-health-status-of-regions. Copies of the list can be obtained via postal mail upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; AskRegionalization@usda.gov.

(ii) APHIS will consider a region to have HPAI and add it to this list referenced in paragraph (a)(2)(i) of this section upon determining that HPAI exists in commercial birds or poultry in the region based on reports APHIS receives of outbreaks of the disease from veterinary officials of the exporting country, from the OIE, or from other sources the Administrator determines to be reliable. APHIS will remove a region from this list only after it conducts an evaluation of the region and finds that HPAI is not likely to be present in its commercial bird or poultry populations.

(b) Carcasses, and parts or products of carcasses, including meat, from regions where Newcastle disease or HPAI is considered to exist. This paragraph applies to carcasses, and parts or products of carcasses, 4 including meat, of poultry, game birds, or other birds that were raised or slaughtered in any region where Newcastle disease or any subtype of HPAI is considered to exist (see paragraph (a) of this section); are imported from any such region; or are moved into or through any such region at any time before importation or during shipment to the United States.

4 Animal byproducts are regulated under part 95 of this subchapter.

(1) Carcasses of game birds, if eviscerated with heads and feet removed, may be imported from regions where Newcastle disease is considered to exist. Carcasses of game birds may not be imported from regions where any subtype of HPAI is considered to exist. Viscera, heads, and feet removed from game birds in any of these regions are ineligible for entry into the United States.

(2) Carcasses, or parts or products of carcasses, of poultry, game birds, and other birds from regions where Newcastle disease or HPAI are considered to exist may be imported for consignment to any museum, educational institution or other establishment which has provided the Administrator with evidence that it has the equipment, facilities, and capabilities to store, handle, process, or disinfect such articles so as to prevent the introduction or dissemination of Newcastle disease or HPAI into the United States, and which is approved by the Administrator. 5

5 The names and addresses of approved establishments may be obtained from, and requests for approval may be made to, Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, APHIS, 4700 River Road, Unit 38, Riverdale, Maryland 20737-1231.

(3) Carcasses, or parts or products of carcasses, including meat, of poultry, game birds, or other birds, may be imported if packed in hermetically sealed containers and if cooked by a commercial method after such packing to produce articles that are shelf stable without refrigeration.

(4) Carcasses and parts or products of carcasses, including meat, of poultry, game birds, or other birds, may be imported if they are accompanied by a certificate that is signed by a full-time, salaried veterinarian of the government agency responsible for animal health in the region and that specifies that the articles were cooked throughout to reach a minimum internal temperature of 74 °C (165 °F).

(5) Carcasses, and parts or products of carcasses, including meat, of poultry, game birds, or other birds, that originated in a region considered to be free of Newcastle disease and any subtype of HPAI, and that are processed (cut, packaged, or other processing) in a region where Newcastle disease or HPAI is considered to exist, may be imported under the following conditions:

(i) Shipment to processing establishments. All poultry, game bird, or other bird products from such regions shall be shipped from the Newcastle disease and HPAI-free region where they originated to a processing establishment 6 in the region where Newcastle disease or HPAI is considered to exist in closed containers sealed with serially numbered seals applied by an official of the national government of that region. They must be accompanied by a certificate that is signed by a full-time, salaried veterinarian of the government agency responsible for animal health in the region and that specifies the products' region of origin, the processing establishment to which the carcasses or parts or products are consigned, and the numbers of the seals applied to the shipping containers.

6 As a condition of entry into the United States, poultry species and poultry products addressed by the Poultry Products Inspection Act (PPIA, 21 U.S.C. 451 et seq.) and regulations thereunder (9 CFR, chapter III, part 381), must also meet all of the requirements of the PPIA and part 381, including requirements that the poultry or poultry products be prepared only in establishments approved by FSIS. Species subject to these requirements include chickens, turkeys, ducks, geese, guineas, ratites, or squabs.

(A) The poultry, game bird, or other bird carcasses or parts or products may be removed from containers at the processing establishment in the region where Newcastle disease or HPAI is considered to exist only after an official of the national government has determined that the seals are intact and free of any evidence of tampering. The official must attest to this fact by signing the certificate accompanying the shipment.

(B) [Reserved]

(ii) Handling of poultry, game bird, or other bird carcasses or parts or products. Establishments in regions where Newcastle disease or HPAI is considered to exist that process poultry, game bird, or other bird carcasses or parts or products for export to the United States:

(A) May not receive or handle any live poultry or birds.

(B) Must keep any records required by this section on file at the facility for a period of at least 2 years after export of processed products to the United States, and must make those records available to USDA inspectors during inspections.

(C) May process carcasses or parts or products that originate in any region, provided that:

(1) All areas, utensils, and equipment likely to contact the carcasses or parts or products to be processed, including skinning, deboning, cutting, and packing areas, are cleaned and disinfected between processing carcasses or parts or products from regions where Newcastle disease or HPAI is considered to exist and processing those from Newcastle disease and HPAI-free regions.

(2) Carcasses or parts or products intended for export to the United States are not handled, cut, or otherwise processed at the same time as any carcasses or parts or products not eligible for export to the United States.

(3) Carcasses or parts or products intended for export to the United States are packed in clean new packaging that is clearly distinguishable from that containing any carcasses or parts or products not eligible for export to the United States.

(4) Carcasses or parts or products are stored in a manner that ensures that no cross-contamination occurs.

(iii) Cooperative service agreement. Operators of processing establishments must enter into a cooperative service agreement with APHIS to pay all expenses incurred by APHIS in inspecting the establishment. APHIS anticipates that such inspections will occur once a year. The cooperative service account must always contain a balance that is at least equal to the cost of one inspection. APHIS will charge the cooperative service account for travel, salary, and subsistence of APHIS employees, as well as administrative overhead and other incidental expenses (including excess baggage charges up to 150 pounds).

(iv) Shipment to the United States. Poultry, game bird, or other bird carcasses or parts or products to be imported into the United States must be shipped from the region where they were processed in closed containers sealed with serially numbered seals applied by an official of the national government of that region. The shipments must be accompanied by a certificate signed by an official of the national government of the region where articles were processed that lists the numbers of the seals applied and states that all of the conditions of this section have been met. A copy of this certificate must be kept on file at the processing establishment for at least 2 years.

(6) Poultry, game bird, or other bird carcasses or parts or products that do not otherwise qualify for importation under paragraphs (b)(1) through (5) of this section may be imported only if the importer applies to, and is granted a permit by, the Administrator, authorizing such importation. A permit will be given only when the Administrator determines that such importation will not constitute a risk of introduction or dissemination of Newcastle disease or HPAI into the United States. Application for a permit may be made in accordance with paragraph (d) of this section.

(c) Eggs (other than hatching eggs) from regions where Newcastle disease or HPAI is considered to exist. Eggs (other than hatching eggs 7 ) from poultry, game birds, or other birds may be imported only in accordance with this section if they: Are laid by poultry, game birds, or other birds that are raised in any region where Newcastle disease or HPAI is considered to exist (see paragraph (a) of this section); are imported from any region where Newcastle disease or HPAI is considered to exist; or are moved into or through any region where Newcastle disease or HPAI is considered to exist at any time before importation or during shipment to the United States.

7 The requirements for importing hatching eggs are contained in part 93 of this chapter.

(1) With a certificate. The eggs may be imported if they are accompanied by a certificate signed by a salaried veterinary officer of the national government of the region of origin or, if exported from Mexico, accompanied either by such a certificate or by a certificate issued by a veterinarian accredited by the national government of Mexico and endorsed by a full-time salaried veterinary officer of the national government of Mexico, thereby representing that the veterinarian issuing the certificate was authorized to do so, and:

(i) The eggs are imported in cases marked with the identity of the flock of origin and sealed with the seal of the national government of the region of origin.

(ii) The certificate accompanying the eggs is presented to an authorized inspector when the eggs reach the port of arrival in the United States.

(iii) The certificate identifies the flock of origin and shows the region of origin, the port of embarkation, the port of arrival, the name and address of the exporter and importer, the total number of eggs, and cases of eggs, shipped with the certificate, and the date the certificate was signed.

(iv) The certificate states that the eggs qualify for importation in accordance with this section.

(v) The certificate states that no more than 90 days before the certificate was signed, a salaried veterinary officer of the national government of the region of origin or, if exported from Mexico, by a veterinarian accredited by the national government of Mexico, inspected the flock of origin and found no evidence of communicable diseases of poultry.

(vi) The eggs were washed, to remove foreign material from the surface of the shells, and sanitized on the premises of origin with a hypochlorite solution of from 100 ppm to 200 ppm available chlorine.

(vii) The eggs were packed on the premises of origin in previously unused cases.

(viii) Before leaving the premises of origin, the cases in which the eggs were packed were sealed with a seal of the national government of the region of origin by the salaried veterinarian of the national government of the region of origin who signed the certificate or, if exported from Mexico, by the veterinarian accredited by the national government of Mexico who signed the certificate.

(ix) In addition, if the eggs were laid in any region where Newcastle disease or HPAI is considered to exist (see paragraph (a) of this section), the certificate must also state:

(A) No Newcastle disease or HPAI occurred on the premises of origin or on adjoining premises during the 90 days before the certificate was signed.

(B) There is no evidence that the flock of origin was exposed to Newcastle disease or HPAI during the 90 days before the certificate was signed.

(C) The eggs are from a region free of HPAI, or from a flock of origin found free of Newcastle disease as follows: On the seventh and fourteenth days of the 21-day period before the certificate is signed, at least 1 cull bird (a sick or dead bird, not a healthy bird that was killed) for each 10,000 live birds occupying each poultry house certified for exporting table eggs was tested for Newcastle disease virus using embryonated egg inoculation technique. The weekly cull rate of birds of every exporting poultry house within the exporting farm does not exceed 0.1 percent. The tests present no clinical or immunological evidence of Newcastle disease by embryonated egg inoculation technique from tissues of birds that were culled and have been collected by a salaried veterinary officer of the national government of the region of origin or by a veterinarian accredited by the national government of Mexico. All examinations and embryonated egg inoculation tests were conducted in a laboratory located in the region of origin, and the laboratory was approved to conduct the examinations and tests by the veterinary services organization of the national government of that region. All results were negative for Newcastle disease.

(D) Egg drop syndrome is notifiable in the region of origin and there have been no reports of egg drop syndrome in the flocks of origin of the eggs, or within a 50 kilometer radius of the flock of origin, for the 90 days prior to the issuance of the certificate.

(2) To an approved establishment for breaking and pasteurization. The eggs may be imported if they are moved from the port of arrival in the United States, under seal of the United States Department of Agriculture, to an approved establishment for breaking and pasteurization. Establishments will be approved when the Administrator determines that pasteurization and sanitation procedures for handling the eggs, and for disposing of egg shells, cases, and packing materials, are adequate to prevent the introduction of Newcastle disease and HPAI into the United States.

(3) For scientific, educational, or research purposes. The eggs may be imported if they are imported for scientific, educational, or research purposes and the Administrator has determined that the importation can be made under conditions that will prevent the introduction of Newcastle disease and HPAI into the United States. The eggs must be accompanied by a permit obtained from APHIS prior to the importation in accordance with paragraph (d) of this section, and they must be moved and handled as specified on the permit to prevent the introduction of Newcastle disease and HPAI into the United States.

(4) Other. The eggs may be imported when the Administrator determines that the eggs have been cooked or processed or will be handled in a manner that will prevent the introduction of Newcastle disease and HPAI into the United States. The eggs must be accompanied by a permit obtained from APHIS prior to the importation in accordance with paragraph (d) of this section, and they must be moved and handled as specified on the permit to prevent the introduction of Newcastle disease and HPAI into the United States.

(d) To apply for a permit, contact Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Riverdale, Maryland 20737, or visit https://efile.aphis.usda.gov/s/vs-permitting-assistant.

(Approved by the Office of Management and Budget under control numbers 0579-0015, 0579-0245, 0579-0328, and 0579-0367)

[39 FR 39546, Nov. 8, 1974; 39 FR 41242, Nov. 26, 1974]

Editorial Note:For Federal Register citations affecting § 94.6, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

§ 94.7 Disposal of animals, meats, and other articles ineligible for importation.

(a) Ruminants and swine, and fresh (chilled or frozen) meats, prohibited importation under §§ 94.1, 94.8, 94.9, 94.10, 94.12, 94.14, or 94.18, which come into the United States by ocean vessel and are offered for entry and refused admission into this country, shall be destroyed or otherwise disposed of as the Administrator may direct, unless they are exported by the consignee within 48 hours, and meanwhile are retained under such isolation and other safeguards as the Administrator may require to prevent the introduction or dissemination of livestock diseases into the United States.

(b) Ruminants and swine, and fresh (chilled or frozen) meats, prohibited importation under §§ 94.1, 94.8, 94.9, 94.10, 94.12, 94.14, or 94.18, which come into the United States aboard an airplane or railroad car and are offered for entry and refused admission into this country, shall be destroyed or otherwise disposed of as the Administrator may direct, unless they are exported by the consignee within 24 hours, and meanwhile are retained under such isolation and other safeguards as the Administrator may require to prevent the introduction or dissemination of livestock diseases into the United States.

(c) Ruminants and swine, and fresh (chilled or frozen) meats, prohibited importation under §§ 94.1, 94.8, 94.9, 94.10, 94.12, 94.14, or 94.18, which come into the United States by any means other than ocean vessel, airplane, or railroad car and are offered for entry and refused admission into this country, shall be destroyed or otherwise disposed of as the Administrator may direct, unless they are exported by the consignee within 8 hours, and meanwhile are retained under such isolation and other safeguards as the Administrator may require to prevent the introduction or dissemination of livestock diseases into the United States.

(d) Ruminants and swine, and fresh (chilled or frozen) meats, prohibited importation under §§ 94.1, 94.8, 94.9, 94.10, 94.12, 94.14, or 94.18, which come into the United States by any means but are not offered for entry into this country, and other animals, meats, and other articles prohibited importation under other sections of this part, which come into the United States by any means, whether they are offered for entry into this country or not, shall be immediately destroyed or otherwise disposed of as the Administrator may direct at any time.

[68 FR 6345, Feb. 7, 2003]

§ 94.8 Pork and pork products from regions where African swine fever exists or is reasonably believed to exist.

(a) African swine fever exists or the Administrator has reason to believe that African swine fever exists in the regions listed under paragraph (a)(2) of this section.

(1) The Administrator bases the reason to believe African swine fever exists in a region on the following factors:

(i) When a region allows the importation of host animals, pork or pork products, or vectors of African swine fever from a region in which African swine fever exists under conditions which the Administrator has determined are less stringent than those prescribed by this chapter for importing host animals, pork or pork products, or vectors of African swine fever into the United States from a region in which African swine fever exists; or

(ii) When a region allows the importation or use of African swine fever virus or cultures under conditions which the Administrator has determined are less stringent than those prescribed by this chapter for the importation or use of African swine fever virus or cultures into or within the United States; or

(iii) When a region has a contiguous border with, or is subject to commercial exchange or natural spread of African swine fever host animals, host materials, or vectors with, another region with known outbreaks of African swine fever; or

(iv) A region's lack of a disease detection, control, or reporting system capable of detecting or controlling African swine fever and reporting it to the United States in time to allow the United States to take appropriate action to prevent the introduction of African swine fever into the United States; or

(v) Any other fact or circumstance found to exist which constitutes a risk of introduction of African swine fever into the United States.

(2) A list of regions where African swine fever exists or the Administrator has reason to believe that African swine fever exists is maintained on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/animal-health-status-of-regions. Copies of the list are also available via postal mail upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; AskRegionalization@usda.gov.

(3) APHIS will add a region to the list upon determining that the disease exists in the region based on reports APHIS receives of outbreaks of the disease from veterinary officials of the exporting country, from the World Organization for Animal Health (OIE), or from other sources the Administrator determines to be reliable, or upon determining that there is reason to believe the disease exists in the region. APHIS will remove a region from the list after conducting an evaluation of the region in accordance with § 92.2 of this subchapter and finding that the disease is not present and that there is no reason to believe the disease is present. In the case of a region formerly not on this list that is added due to an outbreak, the region may be removed from the list in accordance with the procedures for reestablishment of a region's disease-free status in § 92.4 of this subchapter.

(b) No pork or pork products may be imported into the United States from any region listed in this section unless:

(1) Such pork or pork product has been fully cooked by a commercial method in a container hermetically sealed promptly after filling but before such cooking, so that such cooking and sealing produced a fully-sterilized product which is shelf-stable without refrigeration; or

(2) Such pork or pork product is not otherwise prohibited importation under this part and is consigned directly from the port of arrival in the United States to a meat processing establishment operating under Federal meat inspection, approved by the Administrator, for further processing of such pork or pork product by heat.

(3) Such pork or pork product:

(i) Was processed in a single establishment that meets the requirements in paragraph (b)(5) of this section.

(ii) Was heated by other than a flash-heating method to an internal temperature of at least 69 °C. (156 °F.) throughout after the bones had been removed.

(iii) Is accompanied to the United States by an original certificate stating that all of the requirements of this section have been met. The certificate must be written in English. The certificate must be issued by an official of the national government of the region in which the processing establishment is located. The official must be authorized to issue the foreign meat inspection certificate required by part 327 of chapter III of this title. Upon arrival of the pork or pork products in the United States, the certificate must be presented to an authorized inspector at the port of arrival.

(4) The pork product is pork rind pellets (pork skins) that were cooked in one of the following ways in an establishment that meets the requirements in paragraph (b)(5) of this section:

(i) One-step process. The pork skins must be cooked in oil for at least 80 minutes when oil temperature is consistently maintained at a minimum of 114 °C.

(ii) Two-step process. The pork skins must be dry-cooked at a minimum of 260 °C for approximately 210 minutes after which they must be cooked in hot oil (deep-fried) at a minimum of 104 °C for an additional 150 minutes.

(5) The processing establishment 8 in a region listed in this section must comply with the following requirements:

8 As a condition of entry into the United States, pork or pork products must also meet all of the requirements of the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) and regulations thereunder (9 CFR, chapter III, part 327), including requirements that the pork or pork products be prepared only in approved establishments.

(i) All areas, utensils, and equipment likely to contact the pork or pork products to be processed, including skinning, deboning, cutting, and packing areas, and related utensils and equipment, must be cleaned and disinfected after processing pork or pork products not eligible for export to the United States and before processing any pork or pork products eligible for export to the United States.

(ii) Pork or pork products eligible for export to the United States may not be handled, cut, or otherwise processed at the same time as any pork or pork products not eligible for export to the United States.

(iii) Pork or pork products eligible for export to the United States must be packed in clean new packaging that is clearly distinguishable from that containing any pork or pork products not eligible for export to the United States.

(c) Pork or pork products consigned from the port of arrival to an approved establishment under the provisions of paragraph (b)(2) of this section shall be moved from the port of arrival to the approved establishment under Customs seals or seals of the Administrator, and shall be otherwise handled as the Administrator, may direct in order to guard against the introduction and dissemination of the contagion of African swine fever. Seals applied under this section shall not be broken except by persons authorized to do so by the Administrator.

(d) Pork or pork products imported into the United States from a region listed in this section which do not meet the requirements specified in this section shall be seized, quarantined, and disposed of as the Administrator, may direct in order to guard against the introduction and dissemination of the contagion of the disease.

(Approved by the Office of Management and Budget under control number 0579-0015)

[28 FR 5980, June 13, 1963]

Editorial Note:For Federal Register citations affecting § 94.8, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

§ 94.9 Pork and pork products from regions where classical swine fever exists.

(a) APHIS considers classical swine fever to exist in all regions of the world except those declared free of the disease by APHIS.

(1) A list of regions that APHIS has declared free of classical swine fever is maintained on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/animal-health-status-of-regions. Copies of the list are also available via postal mail upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; AskRegionalization@usda.gov.

(2) APHIS will add a region to the list of those it has declared free of classical swine fever after it conducts an evaluation of the region in accordance with § 92.2 of this subchapter and finds that the disease is not present. In the case of a region formerly on this list that is removed due to an outbreak, the region may be returned to the list in accordance with the procedures for reestablishment of a region's disease-free status in § 92.4 of this subchapter. APHIS will remove a region from the list of those it has declared free of classical swine fever upon determining that the disease exists in the region based on reports APHIS receives of outbreaks of the disease from veterinary officials of the exporting country, from the World Organization for Animal Health (OIE), or from other sources the Administrator determines to be reliable.

(b) The APHIS-defined European CSF region is a single region of low-risk for CSF.

(c) Except as provided in § 94.31 for the APHIS-defined European CSF region, no fresh pork or pork product may be imported into the United States from any region where classical swine fever is known to exist unless it complies with the following requirements: 9

9 See also other provisions of this part and parts 93, 95, and 96 of this chapter, and part 327 of this title, for other prohibitions and restrictions upon the importation of swine and swine products.

(1) Such pork or pork product has been treated in accordance with one of the following procedures:

(i) Such pork and pork product has been fully cooked by a commercial method in a container hermetically sealed promptly after filling but before such cooking, so that such cooking and sealing produced a fully sterilized product which is shelf-stable without refrigeration;

(ii) Such pork or pork product is in compliance with the following requirements:

(A) All bones were completely removed prior to cooking; and

(B) Such pork or pork product was heated by other than a flash-heating method to an internal temperature of 69 °C. (156 °F.) throughout;

(iii) Such pork or pork product is in compliance with the following requirements:

(A) All bones have been completely removed in the region of origin, and

(B) The meat has been held in an unfrozen, fresh condition for at least 3 days immediately following the slaughter of the animals from which it was derived, and

(C) The meat has been thoroughly cured and fully dried for a period of not less than 90 days so that the product is shelf stable without refrigeration: Provided, That the period of curing and drying shall be 45 days if the pork or pork product is accompanied to the processing establishment by a certificate of an official of the national government of a classical swine fever free region which specifies that:

(1) The pork involved originated in that region and the pork or pork product was consigned to a processing establishment in ____________ (a region not listed under paragraph (a) of this section as free of classical swine fever), in a closed container sealed by the national veterinary authorities of the classical swine fever free region by seals of a serially numbered type; and

(2) The numbers of the seals used were entered on the meat inspection certificate of the classical swine fever free region which accompanied the shipment from such free region: And, provided further, That the certificate required by paragraph (c)(3) of this section also states that: The container seals specified in paragraph (c)(1)(iii)(C)(1) of this section were found intact and free of any evidence of tampering on arrival at the processing establishment by a national veterinary inspector; and the processing establishment from which the pork or pork product is shipped to the United States does not receive or process any live swine, and uses only pork or pork product which originates in regions listed under paragraph (a) of this section as free of classical swine fever and processes all such pork or pork products in accordance with paragraph (c)(1)(i), (ii), or (iii) of this section; or

(iv) Pork rind pellets (pork skins) originating in regions where classical swine fever is known to exist may be imported into the United States provided they have been cooked in one of the following ways:

(A) One-step process. The pork skins must be cooked in oil for at least 80 minutes when oil temperature is consistently maintained at a minimum of 114 °C.

(B) Two-step process. The pork skins must be dry-cooked at a minimum of 260 °C for approximately 210 minutes after which they must be cooked in hot oil (deep-fried) at a minimum of 104 °C for an additional 150 minutes.

(2) Articles under paragraph (c)(1)(ii), (iii), or (iv) of this section were prepared in an inspected establishment that is eligible to have its products imported into the United States under the Federal Meat Inspection Act and § 327.2 of this title; and,

(3) In addition to the foreign meat inspection certificate required by § 327.4 of this title, pork and pork products prepared under paragraph (c)(1)(ii), (iii), or (iv) of this section shall be accompanied by a certificate that states that the provisions of paragraph (c)(1)(ii), (iii), or (iv) of this section have been met. This certificate shall be issued by an official of the national government of the region of origin who is authorized to issue the foreign meat inspection certificate required by § 327.4 of this title. 10 Upon arrival of the pork or pork products in the United States, the certificate must be presented to an authorized inspector at the port of arrival.

10 The certification required may be placed on the foreign meat inspection certificate prescribed by § 327.4 of this title or may be contained in a separate document.

(4) Small amounts of pork or pork product, subject to the restrictions in this section, may in specific cases be imported for purposes of examination, testing, or analysis if the importer applies for and receives written approval for such importation from the Administrator. Approval will be granted only when the Administrator determines that the articles have been processed by heat in a manner so that such importation will not endanger the livestock of the United States.

(d) Thoroughly cured and fully dried pork and pork products from regions where both classical swine fever and swine vesicular disease are known or considered to exist need not comply with paragraph (c)(1)(iii) of this section if they are in compliance with the provisions of § 94.12(b)(1)(iii) of this part.

(e) Uncooked pork or pork products that originated in a region considered to be free of classical swine fever (CSF) and are processed in a region where CSF exists may be imported into the United States under the following conditions:

(1) Shipment to approved establishments. (i) The uncooked pork or pork products must be shipped from the CSF-free region of origin in closed containers sealed with serially numbered seals applied by an official of the national government of that region. They must be accompanied by a certificate that is signed by an official of that region's national government and that specifies the product's region of origin, the name and number of the establishment of origin, and the processing establishment to which the uncooked pork or pork products are consigned, and the numbers of the seals applied to the shipping containers.

(ii) The uncooked pork or pork products may be removed from containers at the processing establishment in the region where CSF is considered to exist only after an official of that region's national government has determined that the seals are intact and free of any evidence of tampering.

(2) Handling of uncooked pork and pork products. Establishments 11 in regions where CSF is considered to exist that process uncooked pork or pork products for export to the United States:

11 See footnote 9.

(i) May not receive or handle any live swine;

(ii) May not receive, handle, or process uncooked pork or pork products that originate in regions affected with CSF;

(iii) Must keep the certificate required by paragraph (e)(1)(i) of this section on file at the facility for a period of at least 2 years after export of processed products to the United States, and must make those records available to USDA inspectors during inspections; and

(iv) Must be evaluated and approved by APHIS through a site inspection.

(3) Compliance agreement. The operators of the processing establishment must sign a compliance agreement with APHIS, stating that:

(i) All meat processed for importation to the United States will be processed in accordance with the requirements of this part; and

(ii) A full-time, salaried meat inspection official of the national government of the region in which the processing facility is located will supervise the processing and examination of the product, and certify that it has been processed in accordance with this section; and

(iii) APHIS personnel or other persons authorized by the Administrator may enter the establishment, unannounced, to inspect the establishment and its records.

(4) Cooperative service agreement. The processing establishment, or a party on its behalf, must enter into a cooperative service agreement with APHIS to pay all expenses incurred by APHIS for the initial evaluation of the processing establishment and periodically thereafter, including travel, salary, subsistence, administrative overhead, and other incidental expenses, including excess baggage up to 150 pounds. In accordance with the terms of the cooperative service agreement, before the APHIS representative's site inspection, the operator of the processing establishment or the party acting on their behalf must deposit with the Administrator an amount equal to the approximate cost of one inspection by an APHIS representative, including travel, salary, subsistence, administrative overhead, and other incidental expenses, including excess baggage up to 150 pounds. As funds from that amount are obligated, a bill for costs incurred based on official accounting records will be issued to restore the deposit to the original level, revised as necessary to allow for inflation or other changes in estimated costs. To be current, bills must be paid within 14 days of receipt.

(5) Shipment to the United States. Uncooked pork or pork products to be imported into the United States must be shipped from the region where they were processed in closed containers sealed with serially numbered seals applied by an official of the national government of that region. The shipments must be accompanied by a certificate signed by an official of the national government of the region where the pork or pork products were processed that lists the numbers of the seals applied and states that all of the conditions of this paragraph (e) have been met. The certificate shall also state that the container seals specified in paragraph (e)(1)(i) and (ii) of this section were found by an official of the region's national government to be intact and free of any evidence of tampering on arrival at the processing establishment in the CSF-affected region. A copy of this certificate must be kept on file at the processing establishment for at least 2 years.

(Approved by the Office of Management and Budget under control numbers 0579-0015 and 0579-0333)

[37 FR 21149, Oct. 6, 1972]

Editorial Note:For Federal Register citations affecting § 94.9, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

§ 94.10 Swine from regions where classical swine fever exists.

(a) APHIS considers classical swine fever to exist in all regions of the world except those declared free of the disease by APHIS.

(1) A list of regions that APHIS has declared free of classical swine fever is maintained on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/animal-health-status-of-regions. Copies of the list are also available via postal mail upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; AskRegionalization@usda.gov.

(2) APHIS will add a region to the list of those it has declared free of classical swine fever after it conducts an evaluation of the region in accordance with § 92.2 of this subchapter and finds that the disease is not present. In the case of a region formerly on this list that is removed due to an outbreak, the region may be returned to the list in accordance with the procedures for reestablishment of a region's disease-free status in § 92.4 of this subchapter. APHIS will remove a region from the list of those it has declared free of classical swine fever upon determining that the disease exists in the region based on reports APHIS receives of outbreaks of the disease from veterinary officials of the exporting country, from the World Organization for Animal Health (OIE), or from other sources the Administrator determines to be reliable.

(b) The APHIS-defined European CSF region is a single region of low-risk for CSF.

(c) Except as provided in § 94.31 for the APHIS-defined European CSF region, no swine that are moved from or transit any region where classical swine fever is known to exist may be imported into the United States, except for wild swine imported into the United States in accordance with paragraph (d) of this section.

(d) Wild swine may be allowed importation into the United States by the Administrator upon request in specific cases under § 93.501 or § 93.504(c) of this chapter.

[71 FR 29070, May 19, 2006, as amended at 71 FR 31070, June 1, 2006; 72 FR 30470, June 1, 2007; 72 FR 67232, Nov. 28, 2007; 75 FR 69857, Nov. 16, 2010; 76 FR 70039, Nov. 10, 2011; 77 FR 1393, Jan. 10, 2012; 78 FR 72998, Dec. 4, 2013; 86 FR 45626, Aug. 16, 2021]

§ 94.11 Restrictions on importation of meat and other animal products from specified regions.

(a) The meat of ruminants or swine, and other animal products, and ship stores, airplane meals, and baggage containing such meat or animal products originating in any region listed as provided in paragraph (a)(2) of this section may not be imported into the United States unless the requirements in this section, in addition to other applicable requirements of chapter III of this title, are met. However, meat and meat products that meet the requirements of § 94.4 do not have to comply with the requirements of this section. As used in this section, the term “other animal product” means all parts of the carcass of any ruminant or swine, other than meat and articles regulated under part 95 or part 96 of this chapter.

(1) The regions listed under paragraph (a)(2) of this section have been declared free of foot-and-mouth disease by APHIS as provided in § 94.1(a) but supplement their national meat supply by the importation of fresh (chilled or frozen) meat of ruminants or swine from regions that APHIS considers to be affected with foot-and-mouth disease as provided in § 94.1(a); or have a common land border with regions considered to be affected with foot-and-mouth disease; or import ruminants or swine from regions considered to be affected with foot-and-mouth disease under conditions less restrictive than would be acceptable for importation into the United States. Thus, the meat may be commingled with the fresh (chilled or frozen) meat of animals from an affected region, resulting in an undue risk of introducing foot-and-mouth disease into the United States.

(2) A list of regions whose products are regulated under this section is maintained on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/animal-health-status-of-regions. Copies of the list are also available via postal mail upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; AskRegionalization@usda.gov.

(3) APHIS will add a region to the list of those whose products are regulated under this section after conducting an evaluation of the region and determining that one or more of the circumstances described in paragraph (a)(1) of this section exists. APHIS will remove a region from the list upon conducting an evaluation of the region and determining that the circumstances in paragraph (a)(1) of this section no longer exist or upon determining that foot-and-mouth disease exists in the region.

(b) All meat or other animal product from such regions, whether in personal-use amounts or commercial lots (except that which has been fully cooked by a commercial method in a container hermetically sealed promptly after filling but before such cooking and sealing produced a fully sterilized product which is shelf-stable without refrigeration) shall have been prepared only in an inspected establishment that is eligible to have its products imported into the United States under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) and the regulations in § 327.2, chapter III of this title, issued thereunder, and shall be accompanied by a Department-approved meat inspection certificate prescribed in § 327.4 in chapter III of this title, or similar certificate approved by the Administrator, as adequate to effectuate the purposes of this section, regardless of the purpose or amount of product in the shipment.

(c) Additional certification. Meat of ruminants or swine or other animal products from any region listed under paragraph (a)(2) of this section must be accompanied by additional certification by a full-time salaried veterinary official of the agency in the national government that is responsible for the health of the animals within that region. Upon arrival of the meat of ruminants or swine or other animal product in the United States, the certification must be presented to an authorized inspector at the port of arrival. The certification must give the name and official establishment number of the establishment where the animals were slaughtered, and shall state that:

(1) The slaughtering establishment is not permitted to receive animals that originated in, or have ever been in, or that have been aboard a means of conveyance at the time such means of conveyance called at or landed at a port in, a region designated under § 94.1(a) as a region where foot-and-mouth disease exists;

(2) The slaughtering establishment is not permitted to receive meat or other animal products derived from ruminants or swine which originated in such a foot-and-mouth disease affected region, or meat or other animal products from a foot-and-mouth disease free region transported through a foot-and-mouth disease affected region except in containers sealed with serially numbered seals of the National Government of the noninfected region of origin;

(3) The meat or other animal product covered by the certificate was derived from animals born and raised in a region listed under § 94.1(a) as free of foot-and-mouth disease and the meat or other animal product has never been in any region in which foot-and-mouth disease existed;

(4) The meat or other animal product has been processed, stored, and transported to the means of conveyance that will bring the article to the United States in a manner to preclude its being commingled or otherwise in contact with meat or other animal products that do not comply with the conditions contained in this certificate.

(Approved by the Office of Management and Budget under control number 0579-0015)

[38 FR 2752, Jan. 30, 1973]

Editorial Note:For Federal Register citations affecting § 94.11, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

§ 94.12 Pork and pork products from regions where swine vesicular disease exists.

(a) APHIS considers swine vesicular disease to exist in all regions of the world except those declared free of the disease by APHIS.

(1) A list of regions that APHIS has declared free of swine vesicular disease is maintained on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/animal-health-status-of-regions. Copies of the list are also available via postal mail upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; AskRegionalization@usda.gov.

(2) APHIS will add a region to the list of those it has declared free of swine vesicular disease after it conducts an evaluation of the region in accordance with § 92.2 of this subchapter and finds that the disease is not present. In the case of a region formerly on this list that is removed due to an outbreak, the region may be returned to the list in accordance with the procedures for reestablishment of a region's disease-free status in § 92.4 of this subchapter. APHIS will remove a region from the list of those it has declared free of swine vesicular disease upon determining that the disease exists in the region based on reports APHIS receives of outbreaks of the disease from veterinary officials of the exporting country, from the World Organization for Animal Health (OIE), or from other sources the Administrator determines to be reliable.

(b) No pork or pork product may be imported into the United States from any region where swine vesicular disease is known to exist unless it complies with the following requirements and it is not otherwise prohibited importation into the United States under this part:

(1) Such pork or pork product has been treated in accordance with one of the following procedures:

(i) Such pork or pork product has been fully cooked by a commercial method in a container hermetically sealed promptly after filling, but before such cooking, so that such cooking and sealing produced a fully sterilized product which is shelf-stable without refrigeration.

(ii) Such pork or pork product is in compliance with the following requirements:

(A) All bones were completely removed prior to cooking; and

(B) Such pork or pork product received heat treatment in a commercially accepted manner used for perishable canned pork products so that it reached an internal temperature of 69 °C. (156 °F.) throughout.

(iii) Such pork or pork product if cured and dried is in compliance with the following requirements:

(A) All bones have been completely removed in the region of origin, and

(B) Such pork or pork products shall be consigned directly from the port of entry in the United States to a meat processing establishment operating under Federal meat inspection and approved by the Administrator, 12 for heating to an internal temperature of 166 °F. During movement from the port of entry to the meat processing establishment, the pork or pork products must be moved under Department seals or seals of the U.S. Customs Service, and shall be otherwise handled as the Administrator may direct in order to guard against the introduction and dissemination of swine vesicular disease. Seals applied under this section may not be broken except by persons authorized by the Administrator to do so.

12 The names and addresses of approved establishments may be obtained from, and request for approval of any establishment may be made to, the Animal and Plant Health Inspection Service, Veterinary Services, Strategy and Policy, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231. Establishments will be approved only if the Administrator determines that the imported articles will be so handled at the establishment as to prevent the introduction and dissemination of livestock or poultry diseases into the United States. Approval of any establishment may be refused or withdrawn only after the operator thereof has been given notice of the proposed action and has had an opportunity to present his views thereon.

(iv) Such pork or pork product, if it originated in a swine vesicular disease free region, has been cured and dried and is in compliance with the following requirements:

(A) All bones have been completely removed, either in the region of origin or in the region where the pork or pork products are processed; and

(B)(1) Such pork or pork product is accompanied from the swine vesicular disease free region of origin to the processing establishment in the swine vesicular disease affected region by a certificate signed by an official of the National Government of the swine vesicular disease free region of origin specifying that the pork or pork product involved originated in that region and the pork or pork product was consigned to a processing establishment in ____________ (a region not listed under paragraph (a)(1) of this section as free of swine vesicular disease), in a closed container sealed by the national veterinary authorities of the swine vesicular disease free region of origin by seals of a serially numbered type. The numbers of these seals shall be entered on this certificate; and

(2) The certificate required by paragraph (b)(3) of this section shall also state that:

(i) The container seals specified in paragraph (b)(1)(iv)(B)(1) of this section were found intact and free of any evidence of tampering on arrival at the processing establishment in the swine vesicular disease affected region by a national veterinary inspector of that region,

(ii) The processing establishment from which the pork or pork product was shipped to the United States does not receive or process any live swine, and uses only pork or pork products which originate in regions listed under paragraph (a)(1) of this section as free of swine vesicular disease; and

(iii) That such establishment processes all such pork or pork products in accordance with paragraph (b)(1)(i), (ii), (iii) or (iv) of this section.

(v) Such pork or pork product is in compliance with the following requirements:

(A) All bones were completely removed prior to cooking; and

(B) Such pork or pork product received continual heat treatment in an oven for a minimum of 10 hours so that it reached an internal temperature of 65 °C. (149 °F.) throughout. The oven temperature started at a minimum of 62 °C. (143.6 °F.) and reached at least 85 °C. (185 °F.).

(vi) Pork rind pellets (pork skins) must be cooked in one of the following ways:

(A) One-step process. The pork skins must be cooked in oil for at least 80 minutes when oil temperature is consistently maintained at a minimum of 114 °C.

(B) Two-step process. The pork skins must be dry-cooked at a minimum of 260 °C for approximately 210 minutes after which they must be cooked in hot oil (deep-fried) at a minimum of 104 °C for an additional 150 minutes.

(2) Articles under paragraph (b)(1)(ii), (iii) or (iv) of this section were prepared in an inspected establishment that is eligible to have its products imported into the United States under the Federal Meat Inspection Act and the regulations in § 327.2 in chapter III of this title.

(3) In addition to the foreign meat inspection certificate required in § 327.4 of this title, pork or pork products prepared under paragraph (b)(1)(ii), (iii) or (iv) of this section shall be accompanied by certification that paragraph (b)(1)(ii), (b)(1)(iii)(A), or (b)(1)(iv)(B)(2) of this section has been met. The certification shall be issued by an official of the national government of the region of origin who is authorized to issue the foreign meat inspection certificate required by § 327.4 of this title. 13 Upon arrival of the pork or pork products in the United States, the certificate must be presented to an authorized inspector at the port of arrival.

13 See footnote 10.

(4) Small amounts of pork or pork product subject to the restrictions of this section, may in specific cases be imported for purposes of examination, testing, or analysis, if the importer applies for and receives written approval for such importation from the Administrator, authorizing such importation. Approval will be granted only when the Administrator determines that the articles have been processed by heat in a manner so that such importation will not endanger the livestock of the United States.

(c) Requirements for pork-filled pasta products from regions affected with swine vesicular disease. (1) Pork-filled pasta products processed for export to the United States may only be filled with pork or pork products that are otherwise eligible to be exported to the United States and that meet the requirements of paragraph (b)(1)(i), (ii), or (v) of this section or of § 94.17.

(2) The operator of the pork-filled pasta processing facility must have signed a cooperative service agreement with APHIS prior to receipt of the pork intended to be used in pork-filled pasta products, stating that all such pork will be processed only in accordance with § 94.12 or § 94.17. Pursuant to the cooperative service agreement, the establishment must allow the unannounced entry into the establishment of APHIS representatives, or other persons authorized by the Administrator, for the purpose of inspecting the facilities, operations, and records of the establishment. The establishment must be current in paying all costs for such inspections (it is anticipated that such inspections will occur up to four times per year). These costs include travel, salary, subsistence, administrative overhead, and other incidental expenses (including an excess baggage provision up to 150 pounds). In accordance with the terms of the cooperative service agreement, the operator of the processing establishment must deposit with the Administrator an amount equal to the approximate costs for APHIS to inspect the establishment one time, including travel, salary, subsistence, administrative overhead and other incidental expenses (including an excess baggage provision up to 150 pounds), and, as funds from that amount are obligated, bills for costs incurred based on official accounting records will be issued to restore the deposit to its original level. Amounts to restore the deposit to its original level must be paid within 14 days of receipt of such bills.

(3) At the pasta processing establishment, pork intended to be used for pork-filled pasta products for export to the United States must be stored apart from any meat or meat products not eligible for export to the United States, either in a separate storage room or facility or in a separate area of the same storage room. Any storage room area reserved for pork or pork products eligible for export to the United States must be separated by at least 1 meter from any storage room area where meat or meat products ineligible for export to the United States are stored and must be marked by signs and by having its borders outlined on the floor.

(4) Prior to handling pork used for pork-filled pasta products intended for export to the United States, workers at the processing facility who handle pork or pork products in the facility must shower and put on a full set of clean clothes, or wait 24 hours after handling pork or pork products that are not eligible for importation into the United States.

(5) All equipment and machinery that will come in contact with the pork or other ingredients of pork-filled pasta products intended for export to the United States must be cleaned and disinfected before each use.

(6) Processing lines working with pork-filled pasta products for export to the United States must be totally dedicated to the production of such products for the time needed to complete a given lot. When any processing line in a facility is working with pork-filled pasta products intended for export to the United States, no other processing lines in the same facility may work on products using meat that is not eligible for export to the United States.

(7) Processing facilities that are completely dedicated to producing only pork-filled pasta products for export to the United States and do not receive, handle, or process any animal product not intended for export to the United States are exempt from the requirements of paragraphs (c)(3) through (c)(6) of this section.

(8) During processing, the pork-filled pasta must be steam-heated to a minimum internal temperature of 90 °C, then dried, cooled, and packed to make the product shelf stable without refrigeration.

(9) The processing facility must maintain under lock and key, for a minimum of 2 years, an original record of each lot of pork or pork products used for pork-filled pasta products for export to the United States. Each record must include the following:

(i) The date that the cooked or dry-cured pork product was received in the processing facility;

(ii) The number of packages, the number of hams or cooked pork products per package, and the weight of each package;

(iii) A lot number or other identification marks;

(iv) The health certificate that accompanied the cooked or dry-cured pork product from the slaughter/processing facility to the meat-filled pasta product processing facility; and

(v) The date that the pork or pork product used in the pasta started dry curing (if the product used is a dry-cured ham) or the date that the product was cooked (if the product used is a cooked pork product).

(10) The pork-filled pasta must be accompanied by a certificate issued by an official of the National Government of the region in which the pasta product is processed who is authorized to issue the foreign meat inspection certificate required under § 327.4 of this title, stating that the pork-filled pasta product has been processed in accordance with the requirements of this section.

Upon arrival of the pork-filled pasta in the United States, the certificate must be presented to an inspector at the port of arrival.

(Approved by the Office of Management and Budget under control numbers 0579-0015 and 0579-0214)

[38 FR 20610, Aug. 2, 1973]

Editorial Note:For Federal Register citations affecting § 94.12, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

§ 94.13 Restrictions on importation of pork or pork products from specified regions.

(a) Pork or pork products and ship's stores, airplane meals, and baggage containing pork or pork products, other than those articles regulated under part 95 or part 96 of this chapter, produced in any region listed under paragraph (a)(2) of this section may not be imported into the United States unless the requirements of this section, in addition to other applicable requirements of part 327 of this title, are met.

(1) The regions listed under paragraph (a)(2) of this section have been declared free of swine vesicular disease as provided in § 94.12(a) but supplement their national pork supply by the importation of fresh (chilled or frozen) meat of animals from regions where swine vesicular disease is considered to exist, or have a common border with such regions, or have trade practices that are less restrictive than are acceptable to the United States. Thus, the pork or pork products may be commingled with fresh (chilled or frozen) meat of animals from a region where swine vesicular disease is considered to exist, resulting in an undue risk of swine vesicular disease introduction into the United States.

(2) A list of regions whose products are regulated under this section is maintained on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/animal-health-status-of-regions. Copies of the list are also available via postal mail upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; AskRegionalization@usda.gov.

(3) APHIS will add a region to the list of those whose products are regulated under this section after conducting an evaluation of the region and determining that one or more of the circumstances listed in paragraph (a)(1) of this section exists. APHIS will remove a region from the list upon conducting an evaluation of the region and determining that the circumstances in paragraph (a)(1) of this section no longer exist or upon determining that swine vesicular disease exists in the region.

(b) All such pork or pork products, except those treated in accordance with § 94.12(b)(1)(i) of this part, shall have been prepared only in inspected establishments that are eligible to have their products imported into the United States under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) and under § 327.2 of this title and shall be accompanied by the foreign meat inspection certificate required by § 327.4 of this title. Upon arrival of the pork or pork products in the United States, the foreign meat inspection certificate must be presented to an authorized inspector at the port of arrival.

(c) Unless such pork or pork products are treated according to one of the procedures described in § 94.12(b) of this part, the pork or pork products must be accompanied by an additional certificate issued by a full-time salaried veterinary official of the agency in the national government responsible for the health of the animals within that region. Upon arrival of the pork or pork products in the United States, the certificate must be presented to an authorized inspector at the port of arrival. The certificate shall state the name and official establishment number of the establishment where the swine involved were slaughtered and the pork was processed. The certificate shall also state that:

(1) The slaughtering establishment is not permitted to receive animals that originated in a region considered to have swine vesicular disease or that have ever been in a region in which swine vesicular disease existed.

(2) The slaughtering establishment is not permitted to receive pork derived from swine which originated in such a region or pork from swine from a swine vesicular disease free region which has been transported through a region where swine vesicular disease is considered to exist except pork which was transported in containers sealed with serially numbered seals of the National Government of a region of origin listed under § 94.12(a) as a region considered free of the disease.

(3) The pork has been processed, stored, and transported to the means of conveyance that will bring the article to the United States in a manner that precludes its being commingled or otherwise coming in contact with pork or pork products that have not been handled in accordance with the requirements of this section.

(Approved by the Office of Management and Budget under control number 0579-0015)

[38 FR 20611, Aug. 2, 1973]

Editorial Note:For Federal Register citations affecting § 94.13, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

§ 94.14 Swine from regions where swine vesicular disease exists; importations prohibited.

(a) Swine vesicular disease is known to exist in all regions of the world except those listed under § 94.12(a) of this part. No swine which are moved from or transit any region in which swine vesicular disease is known to exist may be imported into the United States except wild swine imported in accordance with paragraph (b) of this section.

(b) Wild swine may be allowed importation into the United States by the Administrator upon request in specific cases under § 93.501 or § 93.504(c) of this chapter.

(Approved by the Office of Management and Budget under control number 0579-0040)

[54 FR 7395, Feb. 21, 1989, as amended at 55 FR 31558, Aug. 2, 1990; 59 FR 67134, Dec. 29, 1994; 62 FR 56023, Oct. 28, 1997; 77 FR 1394, Jan. 10, 2012]

§ 94.15 Transit shipment of articles.

(a) Any meat or other animal product or material (excluding materials that are required to be consigned to USDA-approved establishments for further processing) eligible for entry into the United States, as provided in this part or in part 95 of this subchapter, may transit the United States by air and ocean ports and overland transportation if the articles are accompanied by the required documentation specified in this part and in part 95.

(b) Any meat or other animal product or material not eligible for entry into the United States, as provided in this part or in part 95 of this subchapter, may transit air and ocean ports only, with no overland movement outside the airport terminal area or dock area of the maritime port, in the United States for immediate export if the conditions of paragraphs (b)(1) through (4) of this section are met.

(1) The articles must be sealed in leakproof containers bearing serial numbers during transit. Each container must remain under either Customs seal or foreign government seal during the entire time that it is in the United States.

(2) Before transit, the person moving the articles must notify, in writing, the authorized Customs inspector at both the place in the United States where the articles will arrive and the port of export. The notification must include the:

(i) Times and dates of arrival in the United States;

(ii) Times and dates of exportation from the United States;

(iii) Mode of transportation; and

(iv) Serial numbers of the sealed containers.

(3) The articles must transit the United States under Customs bond.

(4) The shipment is exported from the United States within 7 days of its entry.

(c) Pork and pork products from Baja California, Baja California Sur, Campeche, Chihuahua, Coahuila, Nuevo Leon, Quintana Roo, Sinaloa, Sonora, and Yucatan, Mexico, that are not eligible for entry into the United States in accordance with this part may transit the United States via land border ports for immediate export if the following conditions of paragraphs (c)(1) through (4) of this section are met:

(1) The person moving the pork and pork products must obtain a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors. To apply for a permit, file a permit application on VS Form 16-3 (available from APHIS, Veterinary Services, Strategy and Policy, 4700 River Road Unit 38, Riverdale, MD 20737-1231, or electronically at https://www.aphis.usda.gov/animal_health/permits/).

(2) The pork or pork products are packaged at a Tipo Inspección Federal plant in Baja California, Baja California Sur, Campeche, Chihuahua, Coahuila, Nuevo Leon, Quintana Roo, Sinaloa, Sonora, or Yucatan, Mexico, in leakproof containers and sealed with serially numbered seals of the Government of Mexico, and the containers remain sealed during the entire time they are in transit across Mexico and the United States.

(3) The person moving the pork and pork products through the United States notifies, in writing, the authorized Customs inspector at the United States port of arrival prior to such transiting. The notification must include the following information regarding the pork and pork products:

(i) Permit number;

(ii) Times and dates of arrival in the United States;

(iii) Time schedule and route to be followed through the United States; and

(iv) Serial numbers of the seals on the containers.

(4) The pork and pork products must transit the United States under Customs bond and must be exported from the United States within the time limit specified on the permit. Any pork or pork products that have not been exported within the time limit specified on the permit or that have not been transited in accordance with the permit or applicable requirements of this part will be destroyed or otherwise disposed of as the Administrator may direct pursuant to the Animal Health Protection Act (7 U.S.C. 8301 et seq.).

(d) Poultry carcasses, parts, or products (except eggs and egg products) from Baja California, Baja California Sur, Campeche, Chihuahua, Nuevo Leon, Quintana Roo, Sinaloa, Sonora, Tamaulipas, or Yucatan, Mexico, that are not eligible for entry into the United States in accordance with the regulations in this part may transit the United States via land ports for immediate export if the following conditions of paragraphs (d)(1) through (4) of this section are met:

(1) The person moving the poultry carcasses, parts, or products through the United States must obtain a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors. To apply for a permit, file a permit application on VS Form 16-3 (available from APHIS, Veterinary Services, Strategy and Policy, 4700 River Road Unit 38, Riverdale, MD 20737-1231, or electronically at https://www.aphis.usda.gov/animal_health/permits/).

(2) The poultry carcasses, parts, or products are packaged at a Tipo Inspección Federal plant in Baja California, Baja California Sur, Campeche, Chihuahua, Nuevo Leon, Quintana Roo, Sinaloa, Sonora, Tamaulipas, or Yucatan, Mexico, in leakproof containers with serially numbered seals of the Government of Mexico, and the containers remain sealed during the entire time they are in transit through Mexico and the United States.

(3) The person moving the poultry carcasses, parts, or products through the United States must notify, in writing, the authorized U.S. Customs and Border Protection (CBP) inspector at the United States port of arrival prior to such transiting. The notification must include the following information regarding the poultry to transit the United States:

(i) Permit number;

(ii) Times and dates of arrival in the United States;

(iii) Time schedule and route to be followed through the United States; and

(iv) Serial numbers of the seals on the containers.

(4) The poultry carcasses, parts, or products must transit the United States under U.S. Customs bond and must be exported from the United States within the time limit specified on the permit. Any poultry carcasses, parts, or products that have not been exported within the time limit specified on the permit or that have not transited in accordance with the permit or applicable requirements of this part will be destroyed or otherwise disposed of as the Administrator may direct pursuant to the Animal Health Protection Act (7 U.S.C. 8301 et seq.).

(e) Meat and other products of ruminants or swine from regions listed in § 94.11(a) and pork and pork products from regions listed in § 94.13 that do not meet the requirements of § 94.11(b) or § 94.13(a) may transit through the United States for immediate export, provided the provisions of paragraph (b) of this section are met, and provided all other applicable provisions of this part are met.

(Approved by the Office of Management and Budget under control numbers 0579-0040, 0579-0145, and 0579-0453)

[86 FR 68861, Dec. 3, 2021]

§ 94.16 Milk and milk products.

(a) The following milk products are exempt from the provisions of this part:

(1) Cheese, but not including cheese with liquid and not including cheese containing any item that is regulated by other sections of this part, unless such item is independently eligible for importation into the United States under this part;

(2) Butter; and

(3) Butteroil.

(b) Milk and milk products originating in, or shipped from, any region where foot-and-mouth disease is considered to exist under § 94.1(a) may be imported into the United States if they meet the requirements of paragraphs (b)(1), (2), or (3) of this section:

(1) They are in a concentrated liquid form and have been processed by heat by a commercial method in a container hermetically sealed promptly after filling but before such heating, so as to be shelf stable without refrigeration.

(2) They are dry milk or dry milk products, including dry whole milk, nonfat dry milk, dried whey, dried buttermilk, and formulations which contain any such dry milk products, and are consigned directly to an approved establishment 14 for further processing in a manner approved by the Administrator, as adequate to prevent the introduction or dissemination of livestock diseases into the United States. However, in specific cases, upon request by the importer to the Administrator, and approval by the Administrator, they may be stored for a temporary period in an approved warehouse 14 under the supervision of an inspector of the Animal and Plant Health Inspection Service pending movement to an approved establishment. Such products shall be transported from the United States port of first arrival to an approved establishment 14 or an approved warehouse, 14 and from an approved warehouse 14 to an approved establishment 14 only under Department seals or seals of the U.S. Customs Service. Such seals shall be broken only by such an inspector or other person authorized to do so by the Administrator. Such products shall not be removed from the approved warehouse 14 or approved establishment 14 except upon special permission by the Administrator, and upon compliance with all the conditions and requirements specified by him for such movement in each specific case.

14 The names and addresses of approved establishments or warehouses or information as to approved manner of processing, and request for approval of any such establishment, warehouse, or manner of processing may be made to the Animal and Plant Health Inspection Service, Veterinary Services, Strategy and Policy, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231. Any establishment or warehouse will be approved for the purpose of this section only if the operator has provided the Administrator, with satisfactory evidence that the establishment or warehouse has the equipment, facilities, and capability to store, handle and process the imported dry milk or dry milk product subject to § 94.16(b)(2) in a manner which will prevent the introduction or dissemination of livestock diseases into the United States. Similarly, processing methods will be approved only if the Administrator determines they are adequate to prevent the introduction or dissemination of such diseases into the United States. Approval of any establishment or warehouse or processing method may be refused or withdrawn by the Administrator only after the operator thereof has been given notice of the proposed action and has had an opportunity to present his views thereon, and upon a determination by the Administrator that the conditions for approval are not met. Approval of an establishment or warehouse may also be withdrawn after such notice and opportunity if the Administrator determines that such imported dry milk or milk products have been stored, handled, or processed by the operator thereof other than at an approved establishment or warehouse or other than in an approved manner.

(3) Milk and milk products not exempted under paragraph (a) and not of classes included within the provisions of paragraphs (b)(1) or (2) of this section may be imported if the importer first applies to and receives written permission from the Administrator, authorizing such importation. Permission will be granted only when the Administrator determines that such action will not endanger the health of the livestock of the United States. Products subject to this provision include but are not limited to condensed milk, long-life milks such as sterilized milk, casein and caseinates, lactose, and lactalbumin.

(4) Small amounts of milk and milk products subject to the restrictions of this part may in specific cases be imported for purposes of examination, testing, or analysis, if the importer applies to and receives written approval for such importation from the Administrator. Approval will be granted only when the Administrator determines that such action will not endanger the health of the livestock of the United States.

(c) Milk and milk products originating in and shipped from regions listed under § 94.1(a) as free of foot-and-mouth disease but which have entered a port or otherwise transited a region where APHIS considers the disease to exist may not be imported into the United States unless:

(1) The product was transported under serially numbered official seals applied at the point of origin of the shipment by an authorized representative of the region of such origin; except that, if any seal applied at the point of origin was broken by any foreign official to inspect the shipment, an authorized representative of that region applied a new serially numbered official seal to the hold, compartment, or container in which the milk or milk products were transported; and if any member of a ship's crew broke a seal, the serial number of the seal, the location of the seal, and the reason for breaking the seal were recorded in the ship's log.

(2) The numbers of such seals are listed on, or are on a list attached to, the bill of lading or similar document accompanying the shipment.

(3) Upon arrival of the carrier at the United States port, an inspector of the Animal and Plant Health Inspection Service determines that the seals are intact and that their numbers are in agreement with the numbers appearing on the accompanying document; Provided, That, if the representative finds that any seal has been broken or has a different number than is recorded on the accompanying document, then the milk or milk products may remain eligible for entry into the United States only if APHIS personnel are available to inspect the hold, compartment, or container, the cartons or other containers of milk or milk products, and all accompanying documentation; and the importer furnishes additional documentation (either copies of pages from the ship's log signed by the officer-in-charge, or certification from a foreign government that the original seal was removed and the new seal applied by officials of the government) that demonstrates to the satisfaction of the Administrator that the milk or milk products were not contaminated or exposed to contamination during movement from the region of origin to the United States.

(d) Except for milk and milk products imported from Canada, and except as provided in this paragraph, milk or milk products imported from a region listed under § 94.1(a) as free of foot-and-mouth disease must be accompanied by a certificate endorsed by a full-time, salaried veterinarian employed by the region of export. The certificate must state that the milk was produced and processed in a region listed under § 94.1(a) as free of foot-and-mouth disease, or that the milk product was processed in one such region from milk produced in another such region. The certificate must name the region in which the milk was produced and the region in which the milk or milk product was processed. Further, the certificate must state that, except for movement under seal as described in § 94.16(c), the milk or milk product has never been in a region in which foot-and-mouth disease exists. Milk or milk products from a region listed under § 94.1(a) as free of foot-and-mouth disease and that were processed in whole or in part from milk or milk products from a region not listed under § 94.1(a) as free of foot-and-mouth disease may be imported into the United States only in accordance with paragraph (b)(3) of this section.

(Approved by the Office of Management and Budget under control number 0579-0015)

[40 FR 44123, Sept. 25, 1975]

Editorial Note:For Federal Register citations affecting § 94.16, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

§ 94.17 Dry-cured pork products from regions where foot-and-mouth disease, African swine fever, classical swine fever, or swine vesicular disease exists.

Notwithstanding any other provisions in this part, dry-cured ham, pork shoulder, or pork loin, whether whole or sliced and packaged, shall not be prohibited from being imported into the United States if it meets the following conditions:

(a) Except for Italian-type hams, Serrano hams, Iberian hams, Iberian pork shoulders, and Iberian pork loins that have been processed in accordance with paragraph (i) of this section, the dry-cured ham, pork shoulder, or pork loin came from a swine that was never out of the region in which the dry-cured ham, pork shoulder, or pork loin was processed;

(b) The ham, pork shoulder, or pork loin came from a region determined by the Administrator, to have and to enforce laws requiring the immediate reporting to the national veterinary services in that region any premises found to have any animal infected with foot-and-mouth disease, African Swine fever, classical swine fever, or swine vesicular disease;

(c) The ham, pork shoulder, or pork loin came from a swine that was not on any premises where foot-and-mouth disease, African swine fever, classical swine fever, or swine vesicular disease exists or had existed within 60 days prior to slaughter;

(d) The whole ham, pork shoulder, or pork loin was accompanied from the slaughtering facility to the processing establishment by a numbered certificate issued by a person authorized by the government of the region of origin stating that the provisions of paragraphs (a) and (c) of this section have been met;

(e) The ham, pork shoulder, or pork loin was processed whole as set forth in paragraph (i) of this section in only one processing establishment; 15

15 As a condition of entry into the United States, pork and pork products must also meet all of the requirements of the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) and regulations thereunder (9 CFR, chapter III), including requirements that the pork or pork products be prepared only in approved establishments.

(f) The ham, pork shoulder, or pork loin was processed whole in a processing establishment that prior to the processing of any hams, pork shoulders, or pork loins in accordance with this section, was inspected by a veterinarian of APHIS and determined by the Administrator, to be capable of meeting the provisions of this section for processing hams, pork shoulders, or pork loins for importation into the United States;

(g) The ham, pork shoulder, or pork loin was processed whole in a processing establishment for which the operator of the establishment has signed an agreement with APHIS prior to receipt of the hams, pork shoulders, or pork loins for processing, stating that all hams, pork shoulders, or pork loins processed for importation into the United States will be processed only in accordance with the provisions of this part;

(h) Workers who handle fresh pork in the processing establishment where the dry-cured ham, pork shoulder, or pork loin was processed whole are required to shower and put on a full set of clean clothes, or to wait 24 hours after handling fresh pork, before handling hams, pork shoulders, or pork loins that have progressed in the aging/curing process as follows:

(1) In the case of Italian-type hams processed in accordance with paragraph (i)(1) of this section, those that have progressed beyond the final wash stage;

(2) In the case of Serrano hams or Iberian hams or pork shoulders processed in accordance with paragraphs (i)(2), (i)(3), or (i)(4) of this section, those that have progressed beyond salting; and

(3) In the case of Iberian pork loins processed in accordance with paragraph (i)(5) of this section, those that have progressed beyond being placed in a casing.

(i) The dry-cured ham, pork shoulder, or pork loin was processed whole in accordance with this paragraph. Except for pork fat treated to at least 76 °C (168.8 °F), which may have been placed over the meat during curing, the dry-cured pork product must have had no contact with any other meat or animal product during processing.

(1) Italian-type hams. The ham was processed for a period of not less than 400 days in accordance with the following conditions: after slaughter the ham was held at a temperature of 0-3 °C. (32-34.7 °F) for a minimum of 72 hours during which time the “aitch” bone and the foot was removed and the blood vessels at the end of the femur were massaged to remove any remaining blood; thereafter the ham was covered with an amount of salt equal to 4-6 percent of the weight of the ham, with a sufficient amount of water added to ensure that the salt had adhered to the ham; thereafter the ham was placed for 5-7 days on racks in a chamber maintained at a temperature of 0-4 °C. (32-39.2 °F) and at a relative humidity of 70-85 percent; thereafter the ham was covered with an amount of salt equal to 4-6 percent of the weight of the ham, with a sufficient amount of water added to ensure that the salt had adhered to the ham; thereafter the ham was placed for 21 days in a chamber maintained at a temperature of 0-4 °C. (32-39.2 °F.) and at a relative humidity of 70-85 percent; thereafter the salt was brushed off the ham; thereafter the ham was placed in a chamber maintained at a temperature of 1-6 °C. (33.8-42.8 °F.) and at a relative humidity of 65-80 percent for between 52 and 72 days; thereafter the ham was brushed and rinsed with water; thereafter the ham was placed in a chamber for 5-7 days at a temperature of 15-23 °C. (59-73.4 °F.) and a relative humidity of 55-85 percent; thereafter the ham was placed for curing in a chamber maintained for a minimum of 314 days at a temperature of 15-20 °C. (59-68 °F.) and at a relative humidity of 65-80 percent at the beginning and increased by 5 percent every 2 1/2 months until a relative humidity of 85 percent was reached.

(2) Serrano hams. Serrano hams were processed as follows (190-day minimum curing process):

(i) If the ham is received frozen, it was thawed in a chamber with relative humidity between 70 and 80 percent, with room temperature maintained at 12 °C to 13 °C (53.6 °F to 55.4 °F) for the first 24 hours, then at 13 °C to 14 °C (55.4 °F to 57.2 °F) until the internal temperature of the ham reached 3 °C to 4 °C (37.4 °F to 39.2 °F), at which point the blood vessels at the end of the femur were massaged to remove any remaining blood.

(ii) The ham was covered in salt and placed in a chamber maintained at a temperature from 0 °C to 4 °C (32 °F to 39.2 °F), with relative humidity between 75 and 95 percent, for a period no less than 0.65 days per kg and no more than 2 days per kg of the weight of the ham.

(iii) The ham was rinsed with water and/or brushed to remove any remaining surface salt.

(iv) The ham was placed in a chamber maintained at a temperature of 0 °C to 6 °C (32 °F to 42.8 °F), with a relative humidity of 70 to 95 percent, for no less than 40 and no more than 60 days;

(v) The ham was placed for curing in a chamber with a relative humidity of 60 to 80 percent and a temperature gradually raised in 3 phases, as follows:

(A) A temperature of 6 °C to 16 °C (42.8 °F to 60.8 °F), maintained for a minimum of 45 days;

(B) A temperature of 16 °C to 24 °C (60.8 °F to 75.2 °F), maintained for a minimum of 35 days;

(C) A temperature of 24 °C to 34 °C (75.2 °F to 93.2 °F), maintained for a minimum of 30 days;

(vi) Finally, with the relative humidity unchanged at 60 to 80 percent, the temperature was lowered to 12 °C to 20 °C (53.6 °F to 68 °F) and maintained at that level for a minimum of 35 days, until at least 190 days after the start of the curing process; Except that: In a region where swine vesicular disease exists, the ham must be maintained at that level an additional 370 days, until at least 560 days after the start of the curing process.

(3) Iberian hams. Iberian hams were processed as follows (365-day minimum curing process):

(i) If the ham is received frozen, it was thawed in a chamber with relative humidity between 70 and 80 percent, with room temperature maintained at 5.5 °C to 6.5 °C (41.9 °F to 43.7 °F) for the first 24 hours, then at 9.5 °C to 10.5 °C (49.1 °F to 50.9 °F) until the internal temperature of the ham reached 3 °C to 4 °C (37.4 °F to 39.2 °F), at which point the blood vessels at the end of the femur were massaged to remove any remaining blood.

(ii) The ham was covered in salt and placed in a chamber maintained at a temperature from 0 °C to 4 °C (32 °F to 39.2 °F), with relative humidity between 75 and 95 percent, and kept in the chamber for a period no less than 0.65 days per kg and no more than 2 days per kg of the weight of the ham;

(iii) The ham was rinsed with water and/or brushed to remove any remaining surface salt.

(iv) The ham was placed in a chamber maintained at a temperature of 0 °C to 6 °C (32 °F to 42.8 °F), with relative humidity of 70 to 95 percent, for no less than 40 and no more than 60 days.

(v) The ham was placed for curing in a chamber with a temperature of 6 °C to 16 °C (42.8 °F to 60.8 °F) and relative humidity of 60 to 80 percent for a minimum of 90 days.

(vi) The temperature was raised to 16 °C to 26 °C (60.8 °F to 78.8 °F) and the relative humidity reduced to 55 to 85 percent, for a minimum of 90 days.

(vii) Finally, with the relative humidity raised to 60 to 90 percent, the temperature was lowered to 12 °C to 22 °C (53.6 °F to 71.6 °F) and maintained at that level for a minimum of 115 days, until at least 365 days after the start of the curing process; Except that: In a region where swine vesicular disease exists, the ham must be maintained at that level an additional 195 days, until at least 560 days after the start of the curing process.

(4) Iberian pork shoulders. Iberian pork shoulders were processed as follows (240-day minimum curing process):

(i) If the pork shoulder is received frozen, it was thawed at a room temperature of 12 °C to 13 °C (53.6 °F to 55.4 °F), with the relative humidity between 75 and 85 percent, for approximately 24 hours, until the internal temperature reached 3 °C to 4 °C (37.4 °F to 39.2 °F), at which point the blood vessels in the scapular region were massaged to remove any remaining blood.

(ii) The pork shoulder was covered in salt and placed in a chamber maintained at a temperature of 0 °C to 4 °C (32 °F to 39.2 °F) with the relative humidity between 75 and 95 percent, for a period of no less than 0.65 days per kg and no more than 2 days per kg of the weight of the pork shoulder.

(iii) The pork shoulder was rinsed with water and/or brushed to remove any remaining surface salt.

(iv) The pork shoulder was placed in a chamber maintained at a temperature of 0 °C to 6 °C (32 °F to 42.8 °F) and a relative humidity of 70 to 95 percent for not less than 40 days and not more than 60 days.

(v) The pork shoulder was placed for curing in a chamber at a temperature of 6 °C to 16 °C (42.8 °F to 60.8 °F) and a relative humidity of 60 to 80 percent for a minimum of 90 days.

(vi) The temperature was raised to 16 °C to 26 °C (60.8 °F to 78.8 °F) and the relative humidity was changed to 55 to 85 percent, and those levels were maintained for a minimum of 90 days.

(vii) Finally, the temperature was reduced to 12 °C to 22 °C (53.6 °F to 71.6 °F) and the relative humidity was raised to 60 to 90 percent for a minimum of 45 days, until at least 240 days after the start of the curing process.

(5) Iberian pork loins. Iberian pork loins were processed as follows (130-day minimum curing process):

(i) If the pork loin is received frozen, it was thawed at a room temperature maintained at 11 °C to 12 °C (51.8 °F to 53.6 °F), with the relative humidity between 70 and 80 per cent for the first 24 hours, then between 75 and 85 percent, until the loin's internal temperature reached 3 °C to 4 °C (37.4 °F to 39.2 °F), at which point the external fat, aponeurosis, and tendons were cleaned from the loin.

(ii) The pork loin was covered in a pickle preparation (25-30 grams of salt for each kilogram of pork loin) and placed in a chamber where it was maintained at a relative humidity of 75 to 95 percent and a temperature of 3 °C to 4 °C (37.4 °F to 39.2 °F) for 72 hours.

(iii) The pork loin was removed from the pickle preparation (25-30 grams of salt for each kilogram of pork loin), externally cleaned (brushed or rinsed), placed in an artificial casing, and fastened shut with a metal clip.

(iv) The pork loin was placed for curing in a chamber with a relative humidity of 60 to 90 percent and a temperature gradually raised in 3 phases, as follows:

(A) A temperature of 2 °C to 6 °C (35.6 °F to 42.8 °F), maintained for a minimum of 20 days;

(B) A temperature of 6 °C to 15 °C (42.8 °F to 59.0 °F), maintained for a minimum of 20 days;

(C) A temperature of 15 °C to 25 °C (59.0 °F to 77.0 °F), maintained for a minimum of 40 days;

(v) Finally, with the relative humidity unchanged at 60 to 80 percent and the temperature lowered to 0 °C to 5 °C (32.0 °F to 41.0 °F), the pork loin was vacuum-packed and maintained under those conditions for a minimum of 15 days, until at least 130 days after the start of the curing process.

(j)(1) The whole ham, if it is Italian-type ham processed in accordance with paragraph (i)(1) of this section, bears a hot iron brand or an ink seal (with the identifying number of the slaughtering establishment) which was placed thereon at the slaughtering establishment under the direct supervision of a person authorized to supervise such activity by the veterinary services of the national government of the region of origin, bears a button seal (approved by the Administrator, as being tamper-proof) on the hock that states the month and year the ham entered the processing establishment and a hot iron brand (with the identifying number of the processing establishment and the date salting began) which were placed thereon at the processing establishment immediately prior to salting, under the supervision of a person authorized to supervise such activity by the veterinary services of the national government of the region of origin;

(2) The whole dry-cured ham, if it is processed in accordance with paragraphs (i)(2) or (i)(3) of this section, or the whole dry-cured pork shoulder, if it is processed in accordance with paragraph (i)(4) of this section, bears an ink seal (with the identifying number of the slaughtering establishment) which was placed thereon at the slaughtering establishment under the direct supervision of a person authorized to supervise such activity by the veterinary services of the national government of the region of origin, and an ink seal (with the identifying number of the processing establishment and the date the salting began) which was placed thereon at the processing establishment, immediately prior to salting, under the supervision of a person authorized to supervise such activity by the veterinary services of the national government of the region of origin; or

(3) The whole dry-cured pork loin, if it is processed in accordance with paragraph (i)(5) of this section, is packaged with material that bears a seal of the government of the region of origin which was placed thereon at the slaughtering establishment under the direct supervision of a person authorized to supervise such activity by the veterinary services of the national government of the region of origin, and bears a tamper-proof plastic tag, securely attached to the pork loin itself, that states the identifying number of the slaughtering establishment and the date the pork loin was placed in the pickle preparation under the supervision of a person authorized to supervise such activity by the veterinary service of the national government of the region of origin.

(k) The whole dry-cured ham, pork shoulder, or pork loin came from an establishment where a person authorized by the veterinary services of the national government of the region of origin to conduct activities under this paragraph, maintained original records (which shall be kept for a minimum of two years) identifying the dry-cured ham, pork shoulder, or pork loin by the date it entered the processing establishment, by the slaughtering facility from which it came, and by the number of the certificate which accompanied the dry-cured ham, pork shoulder, or pork loin from the slaughtering facility to the processing establishment, and where such original records are maintained under lock and key by such person, with access to such original records restricted to officials of the government of the region of origin, officials of the United States Government, and such person maintaining the records;

(l) The whole dry-cured ham, pork shoulder, or pork loin came from a processing establishment which allows the unannounced entry into the establishment of APHIS personnel, or other persons authorized by the Administrator, for the purpose of inspecting the establishment and records of the establishment;

(m) The dry-cured ham, pork shoulder, or pork loin was processed in accordance with one of the following criteria:

(1) The ham, if it is an Italian-type ham processed in accordance with paragraph (i)(1) of this section, was processed in a region which has submitted, through its veterinary services, to the Administrator, a written statement stating that it conducts a program to authorize persons to supervise activities specified under this section;

(2) The Serrano ham, processed in accordance with paragraph (i)(2) of this section, and came from any breed of large, white swine, including but not limited to Landrace, Pietrain, Duroc, Jersey, Hampshire, and Yorkshire breeds, and crosses of such breeds;

(3) The Iberian ham, processed in accordance with paragraph (i)(3) of this section, and came from a swine of the Iberico breed of pigs;

(4) The Iberian pork shoulder, processed in accordance with paragraph (i)(4) of this section, and came from a swine of the Iberico breed of pigs;

(5) The Iberian pork loin, if processed in accordance with paragraph (i)(5) of this section, and came from a swine of the Iberico breed of pigs.

(n) The whole dry-cured ham, pork shoulder, or pork loin came from a processing establishment that has entered into a cooperative service agreement executed by the operator of the establishment or a representative of the establishment and APHIS, and that pursuant to the cooperative service agreement is current in paying all costs for a veterinarian of APHIS to inspect the establishment (it is anticipated that such inspections will occur up to four times per year), including travel, salary, subsistence, administrative overhead, and other incidental expenses (including an excess baggage provision up to 150 pounds). In accordance with the terms of the cooperative service agreement, the operator of the processing establishment shall deposit with the Administrator, an amount equal to the approximate costs for a veterinarian to inspect the establishment one time, including travel, salary, subsistence, administrative overhead and other incidental expenses (including an excess baggage provision up to 150 pounds), and as funds from that amount are obligated, bills for costs incurred based on official accounting records will be issued to restore the deposit to its original level. Amounts to restore the deposit to its original level shall be paid within 14 days of receipt of such bills.

(o) The dry-cured ham, pork shoulder, or pork loin is accompanied at the time of importation into the United States by a certificate issued by a person authorized to issue such certificates by the veterinary services of the national government of the region of origin, stating:

(1) That all the provisions of this section have been complied with, including paragraphs (i) and (m) of this section;

(2) The paragraph of this section under which the dry-cured ham, pork shoulder, or pork loin was processed; and stating further that, if the product covered by the certificate:

(i) Is an Italian-type ham processed under paragraph (i)(1) of this section, it was processed for a minimum of 400 days;

(ii) Is a Serrano ham processed under paragraph (i)(2) of this section, it was:

(A) Processed for a minimum of 190 days in a region free of swine vesicular disease, in a facility authorized by the veterinary services of the national government of that region to process only meat from regions free of swine vesicular disease; or,

(B) Processed for a minimum of 560 days in any region, in a facility that may also process meat from regions where swine vesicular disease exists;

(iii) Is an Iberian ham processed under paragraph (i)(3) of this section, it was:

(A) Processed for a minimum of 365 days in a region free of swine vesicular disease, in a facility authorized by the veterinary services of the national government of that region to process only meat from regions free of swine vesicular disease; or,

(B) Processed for a minimum of 560 days in any region, in a facility that may also process meat from regions where swine vesicular disease exists;

(iv) Is a dry-cured pork shoulder, it was processed in accordance with paragraph (i)(4) of this section for a minimum of 240 days; or

(v) Is a dry-cured pork loin, it was processed in accordance with paragraph (i)(5) of this section for a minimum of 130 days.

(p) Whole hams, pork shoulders, and pork loins that have been dry-cured in accordance with paragraph (i) of this section may be transported to a facility in the same region for slicing and packaging in accordance with this paragraph.

(1) The slicing/packaging facility. (i) The slicing/packaging facility 16 must be inspected, prior to slicing and packaging any hams, pork shoulders, or pork loins in accordance with this paragraph, by an APHIS representative and determined by the Administrator to be capable of meeting the provisions of this paragraph.

16 See footnote 15.

(ii) The slicing/packaging facility must be either in a separate, physically detached building, or in a separate room in the facility where the whole ham, pork shoulder, or pork loin was dry-cured in accordance with paragraph (i) of this section. If the slicing/packaging facility is in a separate room, the room must have no direct access to areas in the facility where pork is cured and dried and it must be capable of being closed off from the rest of the facility so unauthorized individuals cannot enter.

(iii) The slicing/packaging facility, including all equipment used to handle pork and pork products, such as containers, work surfaces, slicing machines, and packaging equipment, must be cleaned and disinfected after sliced and packaged pork products that are not eligible for export to the United States leave the facility, and before whole dry-cured hams, pork shoulders, or pork intended for importation into the United States enter the facility for slicing and packaging. Cleaning and disinfecting must be adequate to ensure that disease agents of concern are killed or inactivated and that pork products intended for importation into the United States are not contaminated.

(iv) The slicing/packaging facility must maintain under lock and key for a minimum of 2 years, original records on each lot of whole dry-cured hams, pork shoulders, and pork loins entering the facility for slicing and packaging under this section, including:

(A) The approval number of the facility where the whole ham, shoulder, or loin was dry-cured in accordance with paragraph (i) of this section;

(B) The date the whole ham, shoulder, or loin started dry-curing;

(C) The date the whole ham, shoulder, or loin completed dry-curing;

(D) The date the whole ham, shoulder, or loin was sliced and packaged; and

(E) A copy of all certifications required under paragraph (p) of this section.

(v) Access to records required to be maintained under paragraph (p) of this section must be restricted to officials of the national government of the region of origin, representatives of the United States Government, and persons maintaining the records.

(vi) The operator of the slicing/packaging facility must have signed a cooperative service agreement with APHIS prior to receipt of the whole dry-cured hams, pork shoulders, or pork loins for slicing and packaging, stating that all hams, pork shoulders, or pork loins sliced and packaged at the facility for importation into the United States will be sliced and packaged only in accordance with this section.

(vii) The operator of the slicing/packaging facility must be current, in accordance with the terms of the cooperative service agreement signed with APHIS, in paying all costs for an APHIS representative to inspect the establishment, including travel, salary, subsistence, administrative overhead, and other incidental expenses.

(viii) The slicing/packaging facility must allow the unannounced entry into the establishment of APHIS representatives, or other persons authorized by the Administrator, for the purpose of inspecting the establishment and records of the establishment.

(ix) Workers at the slicing/packaging facility who handle pork or pork products in the facility must shower and put on a full set of clean clothes, or wait 24 hours after handling pork or pork products that are not eligible for importation into the United States, before handling dry-cured hams, pork shoulders, or pork loins in the slicing/packaging facility that are intended for importation into the United States.

(x) Pork products intended for importation into the United States may not be in the slicing/packaging facility at the same time as pork products not intended for exportation to the United States.

(2) Slicing and packaging and labeling procedures. (i) A full-time salaried veterinarian employed by the national government of the region of origin must inspect each lot of whole dry-cured hams, pork shoulders, and pork loins at the slicing/packaging facility, before slicing is begun, and must certify in English that it is eligible for importation into the United States in accordance with this section; and

(ii) Either a full-time salaried veterinarian employed by the national government of the region of origin, or, if the national government of the region of origin recognizes a local consortium as responsible for product quality, a representative of that local consortium, must certify in English that he or she personally supervised the entire process of slicing and packaging each lot of dry-cured hams, pork shoulders, and pork loins at the slicing/packaging facility; that each lot of dry-cured hams, pork shoulders, and pork loins was sliced and packaged in accordance with the requirements of this paragraph; and that the sliced and packaged pork ham, shoulder, or loin is the same dry-cured ham, pork shoulder, or pork loin certified under paragraph (p)(2)(i).

(iii) The sliced and packaged dry-cured pork ham, pork shoulder, or pork loin must be labeled with the date that processing of the meat under paragraph (i) of this section began, and with the date the meat was sliced and packaged.

(Approved by the Office of Management and Budget under control number 0579-0015)

[52 FR 11625, Apr. 10, 1987]

Editorial Note:For Federal Register citations affecting § 94.17, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

§ 94.18 Bovine spongiform encephalopathy; importation of edible products derived from bovines.

(a) The importation of meat, meat products, and other edible products derived from bovines is prohibited with regard to BSE, except as provided in this section and in §§ 94.19, 94.20, 94.21, 94.22, and 94.23.

(b) The following commodities derived from bovines may be imported into the United States without restriction regarding BSE, provided that all other applicable requirements of this part are met:

(1) Milk and milk products;

(2) Boneless skeletal muscle meat (excluding mechanically separated meat) that:

(i) Is derived from bovines that were not, prior to slaughter, subjected to a pithing process or to stunning with a device injecting compressed air or gas into the cranial cavity, and that passed ante-mortem and post-mortem inspection;

(ii) Has been prepared in a manner to prevent contamination with SRMs; and

(iii) Is accompanied to the United States by an original certificate stating that the conditions of paragraphs (b)(2)(i) and (b)(2)(ii) of this section have been met. The certificate must be issued and signed by a full-time salaried veterinary officer of the national government of the exporting region or signed by a person authorized to issue such certificates by the veterinary services of the national government of the exporting region.

(Approved by the Office of Management and Budget under control number 0579-0015)

[78 FR 72998, Dec. 4, 2013, as amended at 86 FR 68862, Dec. 3, 2021]

§ 94.19 Importation of meat, meat byproducts, and meat food products derived from bovines from regions of negligible risk for BSE.

Meat, meat byproducts, and meat food products, as defined by FSIS in 9 CFR 301.2-except that those terms as applied to bison shall have a meaning comparable to those provided in 9 CFR 301.2 with regard to cattle, and other than boneless skeletal meat that meets the conditions of § 94.18(b)(2)—may be imported from a region of negligible risk for BSE, as defined in § 92.1 of this subchapter, if the following conditions and all other applicable requirements of this part are met:

(a) The commodities were exported from a region of negligible risk for BSE.

(b) If BSE has been diagnosed in one or more indigenous bovines in the region of negligible risk, the commodities were derived from bovines subject to a ban on the feeding to ruminants of meat-and-bone meal or greaves derived from ruminants.

(c) The commodities were derived from bovines that passed ante-mortem and post-mortem inspections.

(d) The commodities are accompanied by an original certificate stating that the exporting region is classified by APHIS as a region of negligible risk for BSE and that the conditions of paragraphs (a) through (c) of this section, as applicable, have been met. The certificate must be issued and signed by a full-time salaried veterinary officer of the national government of the exporting region, or signed by a person authorized to issue such certificates by the veterinary services of the national government of the exporting region.

Note:

To be eligible to export meat, meat byproducts, and meat food products under the conditions of this section for human consumption, a region must also be one that has demonstrated to FSIS in accordance with 9 CFR 310.22 that its BSE risk status can reasonably be expected to provide the same level of protection from human exposure to the BSE agent as does prohibiting specified risk materials for use as human food in the United States.

(Approved by the Office of Management and Budget under control number 0579-0393)

[78 FR 72999, Dec. 4, 2013]

§ 94.20 Importation of meat, meat byproducts, and meat food products derived from bovines from regions of controlled risk for BSE.

Meat, meat byproducts, and meat food products, as defined by FSIS in 9 CFR 301.2—except that those terms as applied to bison shall have a meaning comparable to those provided in 9 CFR 301.2 with regard to cattle, and other than boneless skeletal meat that meets the conditions of § 94.18(b)(2)—may be imported from a region of controlled risk for BSE, as defined in § 92.1 of this subchapter, if the following conditions and all other applicable requirements of this part are met:

(a) The commodities were exported from a region of controlled risk for BSE.

(b) The commodities were derived from bovines that passed ante-mortem and post-mortem inspections.

(c) The commodities were derived from bovines that were not subjected to a stunning process, prior to slaughter, with a device injecting compressed air or gas into the cranial cavity, or to a pithing process.

(d) The commodities were produced and handled in a manner that ensured that such commodities do not contain and are not contaminated with either of the following:

(1) SRMs from regions of controlled risk for BSE; or

(2) Mechanically separated meat from the skull and vertebral column from bovines 30 months of age or older.

(e) The commodities are accompanied by an original certificate stating that the exporting region is classified by APHIS as a region of controlled risk for BSE, and that the conditions of this section have been met. The certificate must be issued and signed by a full-time salaried veterinary officer of the national government of the exporting region, or signed by a person authorized to issue such certificates by the veterinary services of the national government of the exporting region.

(Approved by the Office of Management and Budget under control numbers 0579-0015 and 0579-0393)

[78 FR 72999, Dec. 4, 2013]

§ 94.21 Importation of meat, meat byproducts, and meat food products derived from bovines from regions of undetermined risk for BSE.

Meat, meat byproducts, and meat food products, as defined by FSIS in 9 CFR 301.2-except that those terms as applied to bison shall have a meaning comparable to those provided in 9 CFR 301.2 with regard to cattle, and other than boneless skeletal meat that meets the conditions of § 94.18(b)(2)—may be imported from regions of undetermined risk for BSE, as defined in § 92.1 of this subchapter, if the following conditions and all other applicable requirements of this part are met:

(a) The commodities were derived from bovines that have never been fed meat-and-bone meal or greaves derived from ruminants.

(b) The commodities were derived from bovines that passed ante-mortem and post-mortem inspections.

(c) The commodities were derived from bovines that were not subjected to a stunning process, prior to slaughter, with a device injecting compressed air or gas into the cranial cavity, or to a pithing process.

(d) The commodities were produced and handled in a manner that ensured that such commodities do not contain and are not contaminated with any of the following:

(1) SRMs from regions of undetermined risk for BSE; or

(2) Mechanically separated meat from the skull and vertebral column from bovines over 12 months of age.

(e) The commodities are accompanied by an original certificate stating that the exporting region is a region of undetermined risk for BSE and that the conditions of this section have been met. The certificate must be issued and signed by a full-time salaried veterinary officer of the national government of the exporting region, or signed by a person authorized to issue such certificates by the veterinary services of the national government of the exporting region.

(Approved by the Office of Management and Budget under control number 0579-0393)

[78 FR 72999, Dec. 4, 2013]

§ 94.22 Meat or dressed carcasses of hunter-harvested bovines.

The meat or dressed carcass (eviscerated and the head is removed) is derived from a wild bovine that has been legally harvested in the wild, as verified by proof such as a hunting license, tag, or the equivalent that the hunter must show to the authorized inspector.

(Approved by the Office of Management and Budget under control number 0579-0393)

[78 FR 72999, Dec. 4, 2013]

§ 94.23 Importation of gelatin derived from bovines.

(a) The importation of gelatin derived from bovines is prohibited because of BSE, unless:

(1) The gelatin meets the requirements of either paragraph (b), (c), or (d), as well as the requirements of paragraph (e) of this section and all other applicable requirements of this part; or

(2) The gelatin is authorized importation under paragraph (f) of this section and meets all other applicable requirements of this part.

(b) The gelatin is derived from hides and skins, provided the gelatin has not been commingled with materials ineligible for entry into the United States.

(c) The gelatin is derived from the bones of bovines and originates in a region of negligible risk for BSE.

(d) The gelatin is derived from the bones of bovines, originates in a region of controlled risk or undetermined risk for BSE, and meets the requirements of paragraphs (d)(1) through (d)(4) of this section:

(1) The bones from which the gelatin was derived were derived from bovines that passed ante-mortem and post-mortem inspection.

(2) The bones from which the gelatin was derived did not include the skulls of bovines or the vertebral column of bovines 30 months of age or older.

(3) The bones were subjected to a process that includes all of the following steps, or to a process at least as effective in reducing BSE infectivity:

(i) Degreasing;

(ii) Acid demineralization;

(iii) Acid or alkaline treatment;

(iv) Filtration; and

(v) Sterilization at 138 °C (280.4 °F) or greater for a minimum of 4 seconds; and

(4) The gelatin has not been commingled with materials ineligible for entry into the United States.

(e) The gelatin is accompanied to the United States by an original certificate signed by a full-time salaried veterinary officer of the national government of the exporting region, or issued by a veterinarian designated by the national government of the exporting region and endorsed by a full-time salaried veterinary officer of the national government of the exporting region, representing that the veterinarian issuing the certificate was authorized to do so. The certificate must state that the requirements of paragraph (b), (c), or (d) of this section, as applicable, have been met and, for gelatin other than that described in paragraph (b) of this section, must indicate the BSE risk classification of the exporting region.

(f) The Administrator determines that the gelatin will not come into contact with ruminants in the United States and can be imported under conditions that will prevent the introduction of BSE into the United States, and the person importing the gelatin has obtained a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors. To apply for a permit, file a permit application on VS Form 16-3 (available from Strategy and Policy, Veterinary Services, APHIS, 4700 River Road, Unit 38, Riverdale, MD 20737-1231, or electronically at https://efile.aphis.usda.gov/s/vs-permitting-assistant). The application for such a permit must state the intended use of the gelatin and name and address of the consignee in the United States.

[78 FR 72999, Dec. 4, 2013, as amended at 86 FR 45627, Aug. 16, 2021]

§§ 94.24-94.25 [Reserved]

§ 94.26 Gelatin derived from horses, swine, or non-bovine ruminants.

Gelatin derived from horses, swine, or non-bovine ruminants must be accompanied at the time of importation into the United States by an official certificate issued by a veterinarian employed by the national government of the region of origin. The official certificate must state the species of animal from which the gelatin is derived.

(Approved by the Office of Management and Budget under control number 0579-0453)

[86 FR 68862, Dec. 3, 2021]

§ 94.27 [Reserved]

§ 94.28 Restrictions on the importation of poultry meat and products, and live birds and poultry, from the APHIS-defined European Poultry Trade Region.

(a) Poultry meat and products. In addition to meeting all other applicable provisions of this part, poultry meat and poultry products, including eggs and egg products (other than hatching eggs) imported from the APHIS-defined European Poultry Trade Region must meet the following conditions:

(1) The poultry meat and products must not have been derived from birds and poultry that were in any of the following regions or zones, unless the birds and poultry were slaughtered after the periods described, or unless the poultry meat and products are accompanied by a certificate specifying that the articles were cooked and processed in accordance with the regulations in § 94.6(b)(3) or (b)(4):

(i) Any region when the region was classified in § 94.6(a)(1)(i) as one in which Newcastle disease is considered to exist, or any region when the region was listed in accordance with § 94.6(a)(2)(i) as one in which HPAI is considered to exist, except for the APHIS-defined European Poultry Trade Region;

(ii) A restricted zone in the APHIS-defined European Poultry Trade Region established because of detection of Newcastle disease or HPAI in commercial poultry, from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority of the country or until 3 months (90 days) following depopulation of the poultry on affected premises in the restricted zone and the cleaning and disinfection of the last affected premises in the zone, whichever is later; or

(iii) A restricted zone in the APHIS-defined European Poultry Trade Region established because of detection of Newcastle disease or HPAI in racing pigeons, backyard flocks, or wild birds, from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority of the country.

(2) The poultry meat and products must not have been commingled with poultry meat and products derived from other birds and poultry that were in any of the regions or zones described in paragraphs (a)(1)(i) through (a)(1)(iii) of this section. Additionally, the poultry meat and products must not have been derived from poultry that were commingled with other poultry that were in any of the regions or zones described in paragraphs (a)(1)(i) through (a)(1)(iii) of this section.

(3) No equipment or materials used in transporting the birds or poultry from which the poultry meat and products were derived from the farm of origin to the slaughtering establishment may have been used previously for transporting live birds or poultry that do not meet the requirements of § 94.28(b), unless the equipment and materials have first been cleaned and disinfected.

(4) The poultry meat and products, including eggs and egg products (other than hatching eggs) must be accompanied by a certificate issued by an official of the competent veterinary authority of the APHIS-defined European Poultry Trade Region country who is authorized to issue the inspection certificate required by § 93.205 of this subchapter, stating that the applicable provisions of paragraphs (a)(1) through (a)(3) of this section have been met. The certification for poultry meat and products may be placed on the foreign meat inspection certificate required by § 381.196 of this title or may be contained in a separate document.

(b) Live birds and poultry. In addition to meeting all other applicable provisions of this title, live birds and poultry, except hatching eggs, imported from the APHIS-defined European Poultry Trade Region must meet the following conditions:

(1) The birds and poultry must not have been in any of the following regions or zones, unless the birds and poultry are exported to the United States after the periods described.

(i) Any region when the region was classified in § 94.6(a)(1)(i) as one in which Newcastle disease is considered to exist, or any region when the region was listed in accordance with § 94.6(a)(2)(i) as one in which HPAI is considered to exist, except for the APHIS-defined European Poultry Trade Region;

(ii) A restricted zone in the APHIS-defined European Poultry Trade Region established because of detection of Newcastle disease or HPAI in commercial poultry, from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority of the country or until 3 months (90 days) following depopulation of the poultry on affected premises in the restricted zone and the cleaning and disinfection of the last affected premises in the zone, whichever is later; or

(iii) A restricted zone in the APHIS-defined European Poultry Trade Region established because of detection of Newcastle disease or HPAI in racing pigeons, backyard flocks, and wild birds, from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority of the country.

(2) The birds and poultry must not have been commingled with other birds or poultry that have at any time been in any of the regions or zones described in paragraphs (b)(1)(i) through (b)(1)(iii) of this section.

(3) No equipment or materials used in transporting the birds and poultry may have been used previously for transporting birds or poultry that do not meet the requirements of this paragraph, unless the equipment and materials have first been cleaned and disinfected.

(4) The birds and poultry must be accompanied by a certificate issued by an official of the competent veterinary authority of the country who is authorized to issue the inspection certificate required by § 93.205 of this subchapter, stating that the applicable provisions of paragraphs (b)(1) through (b)(3) of this section have been met. The certification may be placed on the foreign meat inspection certificate required by § 381.196 of this title or may be contained in a separate document.

(c) Hatching eggs. Hatching eggs intended for import from the APHIS-defined European Poultry Trade Region are subject to all applicable provisions of paragraph (b) of this section, except that such hatching eggs may be moved through zones established because of detection of HPAI within the APHIS-defined European Poultry Trade Region provided that the hatching eggs are transported under official seal and accompanied by a certificate as indicated in paragraph (b)(4) of this section stating that the applicable provisions of paragraph (b) have been met. The import permit will require the seal number to be listed on the health certificate that accompanies the shipment and the veterinarian who places the seal will be required to sign his or her name under the seal number. Seals must not be broken until the shipment reaches its U.S. port of entry. Hatching egg shipment with seals that are not intact will be rejected upon inspection at the U.S. port of entry.

(d) Presentation of certificates. The certificates required by paragraphs (a)(4), (b)(4), and (c) of this section must be presented by the importer to an authorized inspector at the port of arrival, upon arrival of the birds, poultry, hatching eggs, or poultry meat and products at the port.

[78 FR 19084, Mar. 29, 2013, as amended at 79 FR 7568, Feb. 10, 2014; 86 FR 45627, Aug. 16, 2021]

§ 94.29 Restrictions on importation of fresh (chilled or frozen) beef and ovine meat from specified regions.

Notwithstanding any other provisions of this part, fresh (chilled or frozen) beef from a region in Argentina located north of Patagonia South and Patagonia North B, referred to as Northern Argentina (the region sometimes referred to as Patagonia North A is included in Northern Argentina); fresh (chilled or frozen) beef from a region in Brazil composed of the States of Bahia, Distrito Federal, Espírito Santo, Goiás, Mato Grosso, Mato Grosso do Sul, Minas Gerais, Paraná, Rio Grande do Sul, Rio de Janeiro, Rondônia, São Paulo, Sergipe, and Tocantins; fresh (chilled or frozen) beef from Paraguay; and fresh (chilled or frozen) beef and ovine meat from Uruguay may be exported to the United States under the following conditions:

(a) The meat is:

(1) Beef from animals that have been born, raised, and slaughtered in the exporting regions of Argentina or Brazil or in Paraguay; or

(2) Beef or ovine meat from Uruguay derived from animals that have been born, raised, and slaughtered in Uruguay.

(b) Foot-and-mouth disease has not been diagnosed in the exporting region of Argentina (for beef from Argentina), the exporting region of Brazil (for beef from Brazil), in Paraguay (for beef from Paraguay), or in Uruguay (for beef or ovine meat from Uruguay) within the previous 12 months.

(c) The meat comes from bovines or sheep that originated from premises where foot-and-mouth disease has not been present during the lifetime of any bovines and sheep slaughtered for the export of beef and ovine meat to the United States.

(d) The meat comes from bovines or sheep that were moved directly from the premises of origin to the slaughtering establishment without any contact with other animals.

(e) The meat comes from bovines or sheep that received ante-mortem and post-mortem veterinary inspections, paying particular attention to the head and feet, at the slaughtering establishment, with no evidence found of vesicular disease.

(f) The meat consists only of bovine parts or ovine parts that are, by standard practice, part of the animal's carcass that is placed in a chiller for maturation after slaughter and before removal of any bone, blood clots, or lymphoid tissue. The bovine and ovine parts that may not be imported include all parts of the head, feet, hump, hooves, and internal organs.

(g) All bone and visually identifiable blood clots and lymphoid tissue have been removed from the meat; except that bone-in ovine meat from Uruguay may be exported to the United States under the following conditions:

(1) The meat must be derived from select lambs that have never been vaccinated for FMD;

(2) The select lambs must be maintained in a program approved by the Administrator. Lambs in the program must:

(i) Be segregated from other FMD-susceptible livestock at a select lamb facility operated under the authority of the national veterinary authority of Uruguay;

(ii) Be subjected to an FMD testing scheme approved by the Administrator; and

(iii) Be individually identified with official unique identification that is part of a national traceability system sufficient to ensure that only the products of select lambs meeting all required criteria are exempt from the deboning requirement.

(3) Select lambs and their products must not be commingled with other animals and their products within the slaughter facility.

(h) The meat has not been in contact with meat from regions other than those listed in § 94.1(a).

(i) The meat came from carcasses that were allowed to maturate at 40 to 50 °F (4 to 10 °C) for a minimum of 24 hours after slaughter and that reached a pH below 6.0 in the loin muscle at the end of the maturation period. Measurements for pH must be taken at the middle of both longissimus dorsi muscles. Any carcass in which the pH does not reach less than 6.0 may be allowed to maturate an additional 24 hours and be retested, and, if the carcass still has not reached a pH of less than 6.0 after 48 hours, the meat from the carcass may not be exported to the United States.

(j) An authorized veterinary official of the government of the exporting region certifies on the foreign meat inspection certificate that the above conditions have been met.

(k) The establishment in which the bovines and sheep are slaughtered allows periodic on-site evaluation and subsequent inspection of its facilities, records, and operations by an APHIS representative.

(Approved by the Office of Management and Budget under control numbers 0579-0372, 0579-0414, 0579-0428, 0579-0449, and 0579-0487)

[80 FR 37952, July 2, 2015, as amended at 82 FR 6212, Jan. 19, 2017; 82 FR 42732, Sept. 12, 2017; 88 FR 77888, Nov. 14, 2023]

§ 94.30 Importation of poultry meat and other poultry products from Sinaloa and Sonora, Mexico.

Notwithstanding any other provisions of this part, poultry meat and other poultry products from the States of Sinaloa and Sonora, Mexico, may be imported into the United States under the following conditions:

(a) The poultry meat or other poultry products are derived from poultry born and raised in Sinaloa or Sonora and slaughtered in Sinaloa or Sonora at a federally inspected slaughter plant under the direct supervision of a full-time salaried veterinarian of the Government of Mexico, and the slaughter plant must be approved to export poultry meat and other poultry products to the United States in accordance with 9 CFR 381.196.

(b) If processed, the poultry meat or other poultry products were processed in either Sinaloa or Sonora, Mexico, in a federally inspected processing plant that is under the direct supervision of a full-time salaried veterinarian of the Government of Mexico.

(c) The poultry meat or other poultry products have not been in contact with poultry from any State in Mexico other than Sinaloa or Sonora or with poultry from any other region not listed in § 94.6 as a region where Newcastle disease is not known to exist.

(d) The foreign meat inspection certificate accompanying the poultry meat or other poultry products (required by 9 CFR 381.197) includes statements certifying that the requirements in paragraphs (a), (b), and (c) of this section have been met and, if applicable, listing the numbers of the seals required by paragraph (e)(1) of this section.

(e) The shipment of poultry meat or other poultry products has not been in any State in Mexico other than Sinaloa or Sonora or in any other region not listed in § 94.6 as a region where Newcastle disease is not known to exist, unless:

(1) The poultry meat or other poultry products arrive at the U.S. port of entry in shipping containers bearing intact, serially numbered seals that were applied at the federally inspected slaughter plant by a full-time salaried veterinarian of the Government of Mexico, and the seal numbers correspond with the seal numbers listed on the foreign meat inspection certificate; or

(2) The poultry meat or other poultry products arrive at the U.S. port of entry in shipping containers bearing seals that have different numbers than the seal numbers on the foreign meat inspection certificate, but, upon inspection of the hold, compartment, or container and all accompanying documentation, an APHIS representative is satisfied that the poultry containers were opened and resealed en route by an appropriate official of the Government of Mexico and the poultry meat or other poultry products were not contaminated or exposed to contamination during movement from Sinaloa or Sonora to the United States.

[65 FR 15526, Mar. 23, 2000. Redesignated at 70 FR 550, Jan. 4, 2005, as amended at 78 FR 19084, Mar. 29, 2013. Redesignated at 78 FR 72999, Dec. 4, 2013]

§ 94.31 Restrictions on the importation of pork, pork products, and swine from the APHIS-defined European CSF region.

(a) Pork and pork products. In addition to meeting all other applicable provisions of this part, fresh pork and pork products imported from the APHIS-defined European CSF region must meet the following conditions:

(1) The pork or pork products must not have been derived from swine that were in any of the following regions or zones, unless the swine were slaughtered after the periods described:

(i) Any region when the region was classified under §§ 94.9(a) and 94.10(a) as a region in which classical swine fever is known to exist, except for the APHIS-defined European CSF region;

(ii) A restricted zone in the APHIS-defined European CSF region established because of detection of classical swine fever in domestic swine, from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority or until 6 months following depopulation of the swine on affected premises in the restricted zone and the cleaning and disinfection of the last affected premises in the zone, whichever is later; or

(iii) A restricted zone in the APHIS-defined European CSF region established because of the detection of classical swine fever in wild boar, from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority.

(2) The pork and pork products must not have been commingled with pork or pork products derived from other swine that were in any of the regions or zones described in paragraphs (a)(1)(i) through (a)(1)(iii) of this section, unless the other swine were slaughtered after the periods described. Additionally, the pork and pork products must not have been derived from swine that were commingled with other swine that were in any of the regions or zones described in paragraphs (a)(1)(i) through (a)(1)(iii) of this section, unless the swine from which the pork or pork products were derived were slaughtered after the periods described.

(3) The swine from which the pork or pork products were derived must not have transited any region or zone described in paragraphs (a)(1)(i) through (a)(1)(iii) of this section, unless the swine were moved directly through the region or zone in a sealed means of conveyance with the seal determined to be intact upon arrival at the point of destination, or unless the swine were slaughtered after the periods described.

(4) No equipment or materials used in transporting the swine from which the pork or pork products were derived from the farm of origin to the slaughtering establishment may have been used previously for transporting swine that do not meet the requirements of this section, unless the equipment and materials have first been cleaned and disinfected.

(5) The pork and pork products must be accompanied by a certificate issued by an official of the competent veterinary authority who is authorized to issue the foreign meat inspection certificate required by § 327.4 of this title, stating that the applicable provisions of paragraphs (a)(1) through (a)(4) of this section have been met. 19

19 The certification required may be placed on the foreign meat inspection certificate required by § 327.4 of this title or may be contained in a separate document.

(b) Live swine. In addition to meeting all other applicable provisions of this title, live swine imported from the APHIS-defined European CSF region must meet the following conditions:

(1) The swine must be breeding swine.

(2) The swine must not have been in any of the following regions or zones, unless the swine are exported to the United States after the periods described:

(i) Any region when the region was classified under §§ 94.9(a) and 94.10(a) as a region in which classical swine fever is known to exist, except for the APHIS-defined European CSF region;

(ii) A restricted zone in the APHIS-defined European CSF region established because of the detection of classical swine fever in domestic swine, from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority or until 6 months following depopulation of the swine on affected premises in the restricted zone and the cleaning and disinfection of the last affected premises in the zone, whichever is later; or

(iii) A restricted zone in the APHIS-defined European CSF region established because of the detection of classical swine fever in wild boar, from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority.

(3) The swine must not have been commingled with other swine that have at any time been in any of the regions or zones described in paragraphs (b)(2)(i) through (b)(2)(iii) of this section, unless the swine are exported after the periods described.

(4) The swine must not have transited any region or zone described in paragraphs (b)(2)(i) through (b)(2)(iii) of this section, unless the swine were moved directly through the region or zone in a sealed means of conveyance with the seal determined to be intact upon arrival at the point of destination, or unless the swine are exported after the periods described;

(5) No equipment or materials used in transporting the swine may have been used previously for transporting swine that do not meet the requirements of this section, unless the equipment and materials have first been cleaned and disinfected.

(6) The swine must be accompanied by a certificate issued by a salaried veterinary officer of the competent veterinary authority, stating that the conditions of paragraphs (b)(1) through (b)(5) of this section have been met. 20

20 The certification required may be placed on the certificate required by § 93.505(a) of this chapter or may be contained in a separate document

(c) The certificates required by paragraphs (a)(5) and (b)(6) of this section must be presented by the importer to an authorized inspector at the port of arrival, upon arrival of the swine, pork, or pork products at the port.

(Approved by the Office of Management and Budget under control numbers 0579-0218 and 0579-0265)

[71 FR 29071, May 19, 2006. Redesignated at 71 FR 31070, June 1, 2006, as amended at 72 FR 67232, Nov. 28, 2007; 74 FR 18288, Apr. 22, 2009; 76 FR 4054, Jan. 24, 2011; 76 FR 70039, Nov. 10, 2011; 77 FR 1395, Jan. 10, 2012. Redesignated at 78 FR 72999, Dec. 4, 2013]

§ 94.32 Restrictions on the importation of live swine, pork, or pork products from certain regions free of classical swine fever.

(a) Live swine, pork, or pork products and ship stores, airplane meals, and baggage containing pork or pork products, other than those articles regulated under part 95 or part 96 of this chapter, may not be imported into the United States from a region listed under paragraph (a)(2) of this section unless the requirements in this section, in addition to other applicable requirements of part 93 of this chapter and part 327 of this title, are met.

(1) The regions listed under paragraph (a)(2) of this section have been declared free of classical swine fever (CSF) by APHIS in accordance with §§ 94.9(a) and 94.10(a) but either supplement their pork supplies with fresh (chilled or frozen) pork imported from regions considered to be affected by CSF, or supplement their pork supplies with pork from CSF-affected regions that is not processed in accordance with the requirements of this part, or share a common land border with CSF-affected regions, or import live swine from CSF-affected regions under conditions less restrictive than would be acceptable for importation into the United States. Thus, the live swine, pork, or pork products from those regions may be commingled with live swine, pork, or pork products from CSF-affected regions, resulting in a risk of CSF introduction into the United States.

(2) A list of regions whose live swine, pork, and pork products are regulated under this section is maintained on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/animal-health-status-of-regions. Copies of the list are also available via postal mail upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; AskRegionalization@usda.gov.

(3) APHIS will add a region to the list of those whose live swine, pork, and pork products are regulated under this section after conducting an evaluation of the region and determining that one or more of the circumstances described in paragraph (a)(1) of this section exists. APHIS will remove a region from the list upon conducting an evaluation of the region and determining that the circumstances in paragraph (a)(1) of this section no longer exist or upon determining that classical swine fever exists in the region.

(b) Live swine. The swine must be accompanied by a certification issued by a full-time salaried veterinary officer of the national government of the region of export. Upon arrival of the swine in the United States, the certification must be presented to an authorized inspector at the port of arrival. The certification must identify both the exporting region and the region of origin as a region listed under §§ 94.9 and 94.10 as free of CSF at the time the swine were in the region and must state that:

(1) The swine have not lived in a region classified under §§ 94.9 and 94.10 as a region in which CSF is known to exist;

(2) The swine have never been commingled with swine that have been in a region that is classified under §§ 94.9 and 94.10 as a region in which CSF is known to exist;

(3) The swine have not transited a region classified under §§ 94.9 and 94.10 as a region in which CSF is known to exist unless moved directly through the region to their destination in a sealed means of conveyance with the seal intact upon arrival at the point of destination; and

(4) The conveyances or materials used in transporting the swine, if previously used for transporting swine, have been cleaned and disinfected in accordance with the requirements of § 93.502 of this chapter.

(c) Pork or pork products. The pork or pork products must be accompanied by a certification issued by a full-time salaried veterinary officer of the national government of the region of export. Upon arrival of the pork or pork products in the United States, the certification must be presented to an authorized inspector at the port of arrival. The certification must identify both the exporting region and the region of origin of the pork or pork products as a region listed under §§ 94.9 and 94.10 as free of CSF at the time the pork or pork products were in the region and must state that:

(1) The pork or pork products were derived from swine that were born and raised in a region listed under §§ 94.9 and 94.10 as free of CSF and were slaughtered in such a region at a federally inspected slaughter plant that is under the direct supervision of a full-time salaried veterinarian of the national government of that region and that is eligible to have its products imported into the United States under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) and the regulations in § 327.2 of this title;

(2) The pork or pork products were derived from swine that have not lived in a region classified under §§ 94.9 and 94.10 as a region in which CSF is known to exist;

(3) The pork or pork products have never been commingled with pork or pork products that have been in a region that is classified under §§ 94.9 and 94.10 as a region in which CSF is known to exist;

(4) The pork or pork products have not transited through a region classified under §§ 94.9 and 94.10 as a region in which CSF is known to exist unless moved directly through the region to their destination in a sealed means of conveyance with the seal intact upon arrival at the point of destination; and

(5) If processed, the pork or pork products were processed in a region listed under §§ 94.9 and 94.10 as free of CSF in a federally inspected processing plant that is under the direct supervision of a full-time salaried veterinary official of the national government of that region.

(Approved by the Office of Management and Budget under control numbers 0579-0230 and 0579-0235)

[71 FR 31070, June 1, 2006, as amended at 72 FR 30470, June 1, 2007; 76 FR 15211, Mar. 21, 2011; 77 FR 1395, Jan. 10, 2012. Redesignated at 78 FR 72999, Dec. 4, 2013; 86 FR 45627, Aug. 16, 2021]

§ 94.33 Restrictions on importation of live poultry, poultry meat, and other poultry products from specified regions.

Argentina and the Mexican States of Campeche, Quintana Roo, and Yucatan, which are declared in § 94.6(a)(1) to be free of Newcastle disease, supplement their meat supply by the importation of fresh (chilled or frozen) poultry meat from regions designated in § 94.6(a) as regions where Newcastle disease is considered to exist, have a common land border with regions where Newcastle disease is considered to exist, or import live poultry from regions where Newcastle disease is considered to exist under conditions less restrictive than would be acceptable for importation into the United States. Thus, even though the Department has declared such regions to be free of Newcastle disease, live poultry originating in such free regions may be commingled with live poultry originating in an Newcastle disease-affected region and the meat and other animal products produced in such free regions may be commingled with the fresh (chilled or frozen) meat of animals from an Newcastle disease-affected region, resulting in an undue risk of introducing Newcastle disease into the United States. Therefore, live poultry, poultry meat and other poultry products, and ship stores, airplane meals, and baggage containing such meat or animal products originating in the free regions listed in this section may not be imported into the United States unless the following requirements, in addition to all other applicable requirements of part 93 of this chapter and of chapter III of this title, are met:

(a) Additional certification. Live poultry, poultry meat, and other poultry products from any region designated in this section must be accompanied by an additional certification by a full-time salaried veterinary officer of the national Government of the exporting region. Upon arrival of the live poultry, poultry meat, or other poultry product in the United States, the certification must be presented to an authorized inspector at the port of arrival.

(b) Live poultry. The certification accompanying live poultry must identify the exporting region of the poultry as a region designated in § 94.6(a) as free of Newcastle disease and highly pathogenic avian influenza at the time the poultry were in the region and must state that:

(1) The poultry have not been in contact with poultry or poultry products from any region where Newcastle disease is considered to exist;

(2) The poultry have not lived in a region where Newcastle disease is considered to exist; and

(3) The poultry have not transited through a region where Newcastle disease is considered to exist unless moved directly through the region in a sealed means of conveyance with the seal intact upon arrival at the point of destination.

(c) Poultry meat or other poultry products. The certification accompanying poultry meat or other poultry products must state that:

(1) The poultry meat or other poultry products are derived from poultry that meet all requirements of this section and that have been slaughtered in a region designated in § 94.6(a) as free of Newcastle disease and highly pathogenic avian influenza at a federally inspected slaughter plant that is under the direct supervision of a full-time salaried veterinarian of the national Government of the exporting region and that is approved to export poultry meat and other poultry products to the United States in accordance with § 381.196 of this title;

(2) The poultry meat or other poultry products have not been in contact with poultry meat or other poultry products from any region where Newcastle disease is considered to exist;

(3) The poultry meat or other poultry products have not transited through a region where Newcastle disease is considered to exist unless moved directly through the region in a sealed means of conveyance with the seal intact upon arrival at the point of destination; and

(4) If processed, the poultry meat or other poultry products were processed in a region designated in § 94.6(a) as free of Newcastle disease and highly pathogenic avian influenza in a federally inspected processing plant that is under the direct supervision of a full-time salaried veterinarian of the national Government of the exporting region.

(Approved by the Office of Management and Budget under control number 0579-0228)

[69 FR 3823, Jan. 27, 2004. Redesignated at 70 FR 550, Jan. 4, 2005, as amended at 71 FR 4813, Jan. 30, 2006; 76 FR 4055, Jan. 24, 2011; 78 FR 19084, Mar. 29, 2013. Redesignated at 78 FR 72999, Dec. 4, 2013]

§ 95.1 Definitions.

Whenever in the regulations in this part the following words, names, or terms are used they shall be construed, respectively, to mean:

Administrator means the Administrator, Animal and Plant Health Inspection Service, or any individual authorized to act for the Administrator.

Animal and Plant Health Inspection Service (APHIS) means the Animal and Plant Health Inspection Service of the United States Department of Agriculture.

Animal byproducts means hides, skins, hair, wool, glue stock, bones, hoofs, horns, bone meal, hoof meal, horn meal, blood meal, meat meal, tankage, glands, organs, or other parts or products of ruminants and swine unsuitable for human consumption.

Approved chlorinating equipment means equipment approved by Veterinary Services as efficient for the disinfection of effluents against the contagion of foot-and-mouth disease.

Approved establishment means an establishment approved by Veterinary Services for the receipt and handling of restricted import animal byproducts.

Approved sewerage system means a drainage system equipped and operated so as to carry and dispose of sewage without endangering livestock through the contamination of streams or fields and approved by the Veterinary Services.

Approved warehouse means a warehouse having facilities approved by Veterinary Services for the handling and storage, apart from other merchandise, of restricted import products.

Bird trophy. A carcass or part of a carcass of a wild bird taken as game during a hunting expedition for the purpose of processing into taxidermy mounts for personal exhibition.

Blood meal means dried blood of animals.

Bone meal means ground animal bones and hoof meal and horn meal.

Bovine. Bos taurus, Bos indicus, and Bison bison.

Bovine spongiform encephalopathy (BSE) minimal-risk region. A region listed in § 94.18(a)(3) of this subchapter.

Department means the United States Department of Agriculture.

Deputy Administrator of Veterinary Services means the Deputy Administrator of Veterinary Services.

Direct transloading. The transfer of cargo directly from one means of conveyance to another.

Exporting region. A region from which shipments are sent to the United States.

Glue stock means fleshings, hide cuttings and parings, tendons, or other collagenous parts of animal carcasses.

Hay and straw means dried grasses, clovers, legumes, and similar materials or stalks or stems of various grains, such as barley, oats, rice, rye, and wheat.

Highly pathogenic avian influenza (HPAI). Highly pathogenic avian influenza is defined as follows:

(1) Any influenza virus that kills at least 75 percent of eight 4- to 6-week-old susceptible chickens within 10 days following intravenous inoculation with 0.2 mL of a 1:10 dilution of a bacteria-free, infectious allantoic fluid or inoculation of 10 susceptible 4- to 8-week-old chickens resulting in an intravenous pathogenicity index (IVPI) of greater than 1.2;

(2) Any H5 or H7 virus that does not meet the criteria in paragraph (1) of this definition, but has an amino acid sequence at the haemagglutinin cleavage site that is compatible with highly pathogenic avian influenza viruses; or

(3) Any influenza virus that is not an H5 or H7 subtype and that kills one to five out of eight inoculated chickens and grows in cell culture in the absence of trypsin within 10 days.

Inspector. Any individual authorized by the Administrator of APHIS or the Commissioner of Customs and Border Protection, Department of Homeland Security, to enforce the regulations in this part.

Meat meal or tankage means the rendered and dried carcasses or parts of the carcasses of animals.

Offal. The inedible parts of a butchered animal.

Processed animal protein means meat meal, bone meal, meat and bone meal, blood meal, dried plasma and other blood products, hydrolyzed proteins, hoof meal, horn meal, poultry meal, feather meal, fish meal, and any other similar products.

Region. Any defined geographic land area identifiable by geological, political, or surveyed boundaries. A region may consist of any of the following:

(1) A national entity (country);

(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.)

(3) Parts of several national entities combined into an area; or

(4) A group of national entities (countries) combined into a single area.

Specified risk materials (SRMs) from regions of controlled risk for BSE. Those bovine parts considered to be at particular risk of containing the BSE agent in infected animals, as listed in the FSIS regulations at 9 CFR 310.22(a).

Specified risk materials (SRMs) from regions of undetermined risk for BSE. Those bovine parts considered to be at particular risk of containing the BSE agent in infected animals, as listed in the FSIS regulations at 9 CFR 310.22(a), except that the following bovine parts from regions of undetermined risk for BSE are considered SRMs if they are derived from bovines over 12 months of age: Brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and the dorsal root ganglia.

Tallow derivative. Any chemical obtained through initial hydrolysis, saponification, or transesterification of tallow; chemical conversion of material obtained by hydrolysis, saponification, or transesterification may be applied to obtain the desired product.

United States means the several States, the District of Columbia, Guam, the Northern Mariana Islands, Puerto Rico, the Virgin Islands of the United States, and all other territories and possessions of the United States.

Veterinary Services means the Veterinary Services unit of the Animal and Plant Health Inspection Service, United States Department of Agriculture.

[28 FR 5981, June 13, 1963, as amended at 56 FR 19796, Apr. 30, 1991; 56 FR 63869, Dec. 6, 1991; 62 FR 56024, Oct. 28, 1997; 66 FR 42600, Aug. 14, 2001; 70 FR 551, Jan. 4, 2005; 70 FR 71218, Nov. 28, 2005; 74 FR 66226, Dec. 15, 2009; 78 FR 73001, Dec. 4, 2013; 79 FR 71007, Dec. 1, 2014; 83 FR 15493, Apr. 11, 2018; 86 FR 68862, Dec. 3, 2021]

§ 95.2 Region of origin.

No products or materials specified in the regulations in this part shall be imported unless there be shown upon the commercial invoice, or in some other manner satisfactory to the Deputy Administrator, Veterinary Services, the name of the region of origin of such product or material: Provided, That the region of origin shall be construed to mean (a) in the case of an animal byproduct, the region in which such product was taken from an animal or animals, and (b) in the case of other materials, the region in which such materials were produced.

[28 FR 5981, June 13, 1963, as amended at 62 FR 56024, Oct. 28, 1997]

§ 95.3 Byproducts from diseased animals prohibited.

The importation of any animal byproduct taken or removed from an animal affected with anthrax, foot-and-mouth disease, highly pathogenic avian influenza, or Newcastle disease is prohibited.

[83 FR 15493, Apr. 11, 2018]

§ 95.4 Restrictions on the importation of processed animal protein, offal, tankage, fat, glands, tallow, tallow derivatives, and serum due to bovine spongiform encephalopathy.

(a) Except as provided in this section, or in § 94.15, any of the materials listed in paragraph (b) in this section derived from animals, or products containing such materials, are prohibited importation into the United States.

(b) The restricted materials are as follows:

(1) Processed animal protein, tankage, offal, tallow, and tallow derivatives, unless in the opinion of the Administrator, the tallow cannot be used in feed;

(2) Glands, unprocessed fat tissue, and blood and blood products;

(3) Processed fats and oils, and derivatives of processed animal protein, tankage, and offal; or

(4) Derivatives of glands and blood and blood products.

(c) The import prohibition in paragraph (a) of this section does not apply if the following conditions are met prior to importation:

(1) The material is derived from one of the following:

(i) A nonruminant species and the material is not ineligible for importation under § 95.13 or § 95.14;

(ii) Cervids or camelids, and the material is not ineligible for importation under the conditions of § 95.5;

(iii) Bovines, and the material is not ineligible for importation under the conditions of § 95.5, § 95.6, § 95.7, § 95.8, § 95.9, § 95.10, or § 95.12; or

(iv) Ovines or caprines, and the material is not ineligible for importation under the conditions of § 95.5.

(2) The facility demonstrates to APHIS that the materials intended for exportation to the United States were transported to and from the facility in a manner that would prevent cross-contamination by or commingling with prohibited materials.

(3) If the facility processes or handles any processed animal protein, inspection of the facility for compliance with the provisions of this section is conducted at least annually by a representative of the government agency responsible for animal health in the region, unless the region chooses to have such inspection conducted by APHIS. If APHIS conducts the inspections required by this section, the facility has entered into a cooperative service agreement executed by the operator of the facility and APHIS. In accordance with the cooperative service agreement, the facility must be current in paying all costs for a veterinarian of APHIS to inspect the facility (it is anticipated that such inspections will occur approximately once per year), including travel, salary, subsistence, administrative overhead, and other incidental expenses (including excess baggage provisions up to 150 pounds). In addition, the facility must have on deposit with APHIS an unobligated amount equal to the cost for APHIS personnel to conduct one inspection. As funds from that amount are obligated, a bill for costs incurred based on official accounting records will be issued to restore the deposit to the original level, revised as necessary to allow for inflation or other changes in estimated costs. To be current, bills must be paid within 14 days of receipt.

(4) The facility allows periodic APHIS inspection of its facilities, records, and operations.

(5) Each shipment to the United States is accompanied by an original certificate signed by a full-time, salaried veterinarian of the government agency responsible for animal health in the exporting region certifying that the conditions of paragraphs (c)(1) through (3) of this section have been met.

(6) The person importing the shipment has applied for and obtained from APHIS a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors by filing a permit application on VS Form 16-3, which may be obtained from Strategy and Policy, Veterinary Services, APHIS, 4700 River Road, Unit 38, Riverdale, MD 20737-1231, or electronically at https://efile.aphis.usda.gov/s/vs-permitting-assistant.

(d) Insulin otherwise prohibited under paragraphs (a) and (b) of this section may be imported if the insulin is for the personal medical use of the person importing it and if the person importing the shipment has applied for and obtained from APHIS a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors. To apply for a permit, file a permit application on VS Form 16-3, which is available from Strategy and Policy, Veterinary Services, APHIS, 4700 River Road, Riverdale, MD 20737-1231, or electronically at https://efile.aphis.usda.gov/s/vs-permitting-assistant. The application for such a permit must state the intended use of the insulin and the name and address of the consignee in the United States.

Note 1 to paragraph (d):

Insulin that is not prohibited from importation under this paragraph may be prohibited from importation under other Federal laws, including the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321 et seq.

(Approved by the Office of Management and Budget under control numbers 0579-0015, 0579-0234, and 0579-0393)

[78 FR 73001, Dec. 4, 2013, as amended at 86 FR 45627, Aug. 16, 2021; 86 FR 68862, Dec. 3, 2021]

§ 95.5 Processed animal protein derived from ruminants.

The importation of ruminant-derived processed animal protein, or any commodities containing such products, is prohibited unless the conditions of this section are met:

(a) The exporting region is a region of negligible risk for BSE; and

(1) The product has not been commingled or contaminated with ruminant meat-and-bone meal or greaves from a region of controlled or undetermined risk for BSE; and

(2) The product must be derived from ruminants that were subject to a ban on the feeding of ruminants with meat-and-bone meal or greaves derived from ruminants if it is either:

(i) Exported from a region of negligible risk for BSE in which there has been at least one indigenous case of BSE; or

(ii) Derived from ruminants that were in a region of negligible risk for BSE in which there has been at least one indigenous case of BSE.

(b) The exporting region is a region of controlled or undetermined risk, the product is ruminant-derived processed animal protein other than ruminant meat-and-bone meal or greaves, and it has been demonstrated that the product has not been commingled or contaminated with ruminant meat-and-bone meal or greaves from a controlled or undetermined risk region.

(c) Each shipment to the United States is accompanied by an original certificate signed by a full-time salaried veterinary officer of the national government of the exporting region, or issued by a veterinarian designated by the national government of the exporting region and endorsed by a full-time salaried veterinary officer of the national government of the exporting region, representing that the veterinarian issuing the certificate was authorized to do so. The certificate must state the exporting region and that the requirements of this section, as applicable, have been met.

(d) The person importing the processed animal protein obtains a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors by filing a permit application on VS Form 16-3. To apply for a permit, file a permit application on VS Form 16-3, which is available from Strategy and Policy, Veterinary Services, APHIS, 4700 River Road, Riverdale, MD 20737-1231, or electronically at https://efile.aphis.usda.gov/s/vs-permitting-assistant. The application for such a permit must state the intended use of the processed animal protein and name and address of the consignee in the United States.

(Approved by the Office of Management and Budget under control number 0579-0393)

[78 FR 73003, Dec. 4, 2013, as amended at 86 FR 45628, Aug. 16, 2021]

§ 95.6 Offal derived from bovines.

Offal derived from bovines is prohibited importation into the United States unless it meets the requirements for the importation of meat, meat products, and meat byproducts in either § 94.19, § 94.20, or § 94.21, with the exception of the requirements in §§ 94.19(c), 94.20(b), and 94.21(b), respectively. The person importing the offal must obtain a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors by filing a permit application on VS Form 16-3. To apply for a permit, file a permit application on VS Form 16-3, which is available from Strategy and Policy, Veterinary Services, APHIS, 4700 River Road, Riverdale, MD 20737-1231, or electronically at https://efile.aphis.usda.gov/s/vs-permitting-assistant. The application for such a permit must state the intended use of the offal and name and address of the consignee in the United States.

[86 FR 45628, Aug. 16, 2021]

§ 95.7 Collagen derived from bovines.

(a) The importation of collagen derived from bovines is prohibited because of BSE unless:

(1) The collagen meets the requirements of either paragraph (b), (c), or (d), as well as the requirements of paragraph (e) of this section and all other applicable requirements of this part; or

(2) The collagen is authorized importation under paragraph (f) of this section and meets all other applicable requirements of this part:

(b) The collagen is derived from hides and skins, provided the collagen has not been commingled with materials ineligible for entry into the United States.

(c) The collagen is derived from the bones of bovines that originated from a region of negligible risk for BSE.

(d) The collagen is derived from the bones of bovines that originated from a region of controlled or undetermined risk for BSE and meets the requirements of paragraphs (d)(1) through (d)(4) of this section:

(1) The bones from which the collagen was derived were derived from bovines that passed ante-mortem and post-mortem inspection;

(2) The bones from which the collagen was derived did not include the skulls of bovines or the vertebral column of bovines 30 months of age or older;

(3) The bones were subjected to a process that includes all of the following steps, or to a process at least as effective in reducing BSE infectivity:

(i) Degreasing;

(ii) Acid demineralization;

(iii) Acid or alkaline treatment;

(iv) Filtration; and

(v) Sterilization at 138 °C (280.4 °F) or greater for a minimum of 4 seconds; and

(4) The collagen has not been commingled with materials ineligible for entry into the United States.

(e) The collagen is accompanied to the United States by an original certificate signed by a full-time salaried veterinary officer of the national government of the exporting region, or issued by a veterinarian designated by the national government of the exporting region and endorsed by a full-time salaried veterinary officer of the national government of the exporting region, representing that the veterinarian issuing the certificate was authorized to do so. The certificate must state that the requirements of paragraph (b), (c), or (d) of this section, as applicable, have been met and, for collagen other than that described in paragraph (b) of this section, must indicate the BSE risk classification of the exporting region.

(f) The Administrator determines that the collagen will not come into contact with ruminants in the United States and can be imported under conditions that will prevent the introduction of BSE into the United States, and the person importing the collagen has obtained a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors. To apply for a permit, file a permit application on VS Form 16-3, which is available from Strategy and Policy, Veterinary Services, APHIS, 4700 River Road, Riverdale, MD 20737-1231, or electronically at https://efile.aphis.usda.gov/s/vs-permitting-assistant. The application for such a permit must state the intended use of the collagen and the name and address of the consignee in the United States.

(Approved by the Office of Management and Budget under control number 0579-0393)

[78 FR 73003, Dec. 4, 2013, as amended at 86 FR 45628, Aug. 16, 2021]

§ 95.8 Tallow derived from bovines.

(a) The importation of bovine-derived tallow is prohibited unless:

(1) The requirements of either paragraph (b), (c), or (d), as well as the requirements of paragraph (e) of this section are met; or

(2) The requirements of paragraph (f) of this section are met.

(b) The tallow is composed of a maximum level of insoluble impurities of 0.15 percent in weight; or

(c) The tallow originates from a region of negligible risk for BSE; or

(d) The tallow originates from a region of controlled risk for BSE, is derived from bovines that have passed ante-mortem and post-mortem inspections, and has not been prepared using SRMs as defined for regions of controlled risk for BSE in § 92.1 of this subchapter.

(e) The tallow is accompanied to the United States by an original certificate signed by a full-time salaried veterinary officer of the national government of the exporting region, or issued by a veterinarian designated by the national government of the exporting region and endorsed by a full-time salaried veterinary officer of the national government of the exporting region, representing that the veterinarian issuing the certificate was authorized to do so. The certificate must state that the requirements of paragraph (b), (c), or (d) of this section, as applicable, have been met and, for tallow other than that described in paragraph (b) of this section, must indicate the BSE risk classification of the exporting region.

(f) The Administrator determines that the tallow will not come into contact with ruminants in the United States and can be imported under conditions that will prevent the introduction of BSE into the United States, and the person importing the tallow has obtained a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors. To apply for a permit, file a permit application on VS Form 16-3, which is available from Strategy and Policy, Veterinary Services, APHIS, 4700 River Road, Riverdale, MD 20737-1231, or electronically at https://efile.aphis.usda.gov/s/vs-permitting-assistant. The application for such a permit must state the intended use of the tallow and the name and address of the consignee in the United States.

(Approved by the Office of Management and Budget under control number 0579-0393)

[78 FR 73003, Dec. 4, 2013, as amended at 86 FR 45628, Aug. 16, 2021]

§ 95.9 Derivatives of tallow derived from bovines.

(a) The importation of derivatives of tallow from bovines is prohibited unless the commodity meets the conditions of either paragraph (b), (c), (d), or (e) of this section as well as paragraph (f) of this section, or, alternatively, meets the conditions of paragraph (g) of this section.

(b) The commodity meets the definition of tallow derivative in § 95.1.

(c) The derivative is from tallow composed of a maximum level of insoluble impurities of 0.15 percent in weight.

(d) The derivative is from tallow that originates from a region of negligible risk for BSE.

(e) The derivative is from tallow that originates from a region of controlled risk for BSE, is derived from bovines that have passed ante-mortem and post-mortem inspections, and does not contain SRMs as defined for regions of controlled risk for BSE in § 92.1 of this subchapter.

(f) The tallow derivative is accompanied to the United States by an original certificate signed by a full-time salaried veterinary officer of the national government of the exporting region, or issued by a veterinarian designated by the national government of the exporting region and endorsed by a full-time salaried veterinary officer of the national government of the exporting region, representing that the veterinarian issuing the certificate was authorized to do so. The certificate must state that the requirements of paragraph (b), (c), (d), or (e) of this section, as applicable, have been met and, for tallow derivatives other than those described in paragraph (b) or (c) of this section, must indicate the BSE risk classification of the exporting region.

(g) The Administrator determines that the tallow derivative will not come into contact with ruminants in the United States and can be imported under conditions that will prevent the introduction of BSE into the United States, and the person importing the tallow derivative has obtained a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors. To apply for a permit, file a permit application on VS Form 16-3, which is available from Strategy and Policy, Veterinary Services, APHIS, 4700 River Road, Riverdale, MD 20737-1231, or electronically at https://efile.aphis.usda.gov/s/vs-permitting-assistant. The application for such a permit must state the intended use of the tallow derivative and the name and address of the consignee in the United States.

(Approved by the Office of Management and Budget under control number 0579-0393)

[78 FR 73003, Dec. 4, 2013, as amended at 86 FR 45628, Aug. 16, 2021]

§ 95.10 Dicalcium phosphate derived from bovines.

(a) The importation of dicalcium phosphate derived from bovines is prohibited unless:

(1) The requirements of either paragraph (b), (c), or (d) and the requirements of paragraph (e) of this section are met; or

(2) The requirements of paragraph (f) of this section are met.

(b) The dicalcium phosphate contains no trace of protein or fat; or

(c) The dicalcium phosphate originates from a region of negligible risk for BSE; or

(d) The dicalcium phosphate originates from a region of controlled risk for BSE, is derived from bovines that have passed ante-mortem and post-mortem inspections, and does not contain SRMs as defined for regions of controlled risk for BSE in § 92.1 of this subchapter.

(e) The dicalcium phosphate is accompanied by an original certificate signed by a full-time salaried veterinary officer of the national government of the exporting region, or issued by a veterinarian designated by the national government of the exporting region and endorsed by a full-time salaried veterinary officer of the national government of the exporting region, representing that the veterinarian issuing the certificate was authorized to do so. The certificate must indicate the BSE risk classification of the exporting region and state that the requirements of paragraph (b) (c), or (d) of this section, as applicable, have been met.

(f) The Administrator determines that the dicalcium phosphate will not come into contact with ruminants in the United States and can be imported under conditions that will prevent the introduction of BSE into the United States, and the person importing the dicalcium phosphate has obtained a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors. To apply for a permit, file a permit application on VS Form 16-3, which is available from Strategy and Policy, Veterinary Services, APHIS, 4700 River Road, Riverdale, MD 20737-1231, or electronically at https://efile.aphis.usda.gov/s/vs-permitting-assistant. The application for such a permit must state the intended use of the dicalcium phosphate and the name and address of the consignee in the United States.

(Approved by the Office of Management and Budget under control number 0579-0393)

[78 FR 73003, Dec. 4, 2013, as amended at 86 FR 45629, Aug. 16, 2021]

§ 95.11 Specified risk materials.

Notwithstanding any other provisions of this part, the importation of specified risk materials from controlled-risk regions or undetermined-risk regions for BSE, and any commodities containing such materials, is prohibited, unless the Administrator determines that the materials or other commodities will not come into contact with ruminants in the United States and can be imported under conditions that will prevent the introduction of BSE into the United States, and the person importing the materials or other commodities has obtained a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors. To apply for a permit, file a permit application on VS Form 16-3, which is available from Strategy and Policy, Veterinary Services, APHIS, 4700 River Road, Riverdale, MD 20737-1231, or electronically at https://efile.aphis.usda.gov/s/vs-permitting-assistant. The application for such a permit must state the intended use of the materials and other commodities and the name and address of the consignee in the United States.

[86 FR 45629, Aug. 16, 2021]

§ 95.12 Blood and blood products derived from bovines.

The importation of bovine blood and products derived from bovine blood is prohibited unless the following conditions and the conditions of all other applicable parts of this chapter are met:

(a) For blood collected at slaughter and for products derived from blood collected at slaughter:

(1) The blood was collected in a hygienic manner, as determined by the Administrator, that prevents contamination of the blood with SRMs; and

(2) The slaughtered animal passed ante-mortem inspection and was not subjected to a pithing process or to a stunning process with a device injecting compressed air or gas into the cranial cavity.

(b) For blood collected from live donor bovines and for products derived from blood collected from live donor bovines:

(1) The blood was collected in a hygienic manner, as determined by the Administrator, that prevents contamination of the blood with SRMs; and

(2) The donor animal was free of clinical signs of disease.

(c) The blood and blood products are accompanied to the United States by an original certificate that states that the conditions of this section have been met. The certificate must be issued by a full-time salaried veterinary officer of the national government of the exporting region, or issued by a veterinarian designated by the national government of the exporting region and endorsed by a full-time salaried veterinary officer of the exporting region, representing that the veterinarian issuing the certificate was authorized to do so.

(Approved by the Office of Management and Budget under control number 0579-0393)

[78 FR 73003, Dec. 4, 2013]

§ 95.13 Importation from regions of negligible risk for BSE of processed animal protein derived from animals other than ruminants.

The importation from regions of negligible risk for BSE of processed animal protein derived from animals other than ruminants is prohibited importation into the United States unless the following conditions are met:

(a) The processed animal protein is not prohibited importation under § 95.4;

(b) The processed animal protein imported into the United States in accordance with this section is accompanied by an original certificate signed by a full-time salaried veterinary officer of the national government of the exporting region, or issued by a veterinarian designated by the national government of the exporting region and endorsed by a full-time salaried veterinary officer of the national government of the exporting region, representing that the veterinarian issuing the certificate was authorized to do so, that indicates that the material is derived from animals other than ruminants.

(c) The person importing the shipment has applied for and obtained from APHIS a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors. To apply for a permit, file a permit application on VS Form 16-3, which is available from Strategy and Policy, Veterinary Services, APHIS, 4700 River Road, Riverdale, MD 20737-1231, or electronically at https://efile.aphis.usda.gov/s/vs-permitting-assistant.

(Approved by the Office of Management and Budget under control number 0579-0393)

[78 FR 73003, Dec. 4, 2013, as amended at 86 FR 45629, Aug. 16, 2021]

§ 95.14 Importation from regions of controlled risk or undetermined risk for BSE of processed animal protein derived from animals other than ruminants.

The importation from regions of controlled risk or undetermined risk for BSE of processed animal protein derived from animals other than ruminants is prohibited importation into the United States unless the following conditions are met:

(a) The processed animal protein is not prohibited importation under § 95.4;

(b) Except as provided in paragraph (c) of this section, the processed animal protein does not contain and was not commingled with material derived from ruminants originating in a BSE controlled- or undetermined-risk region;

(c) For blood meal, blood plasma, and other blood products, the material does not contain and was not commingled with ruminant blood or blood products prohibited importation into the United States under this part.

(d) Inspection of the facility for compliance with the provisions of this section is conducted at least annually by a competent authority of the government agency responsible for animal health in the region, unless the region chooses to have such inspections conducted by APHIS. The inspections must verify either that:

(1) All steps of processing and storing the material are carried out in a facility that has not been used for the processing or storage of materials derived from ruminants originating in a BSE controlled- or undetermined-risk region; or

(2) The material is produced in a manner that prevents contamination of the processed animal protein with materials prohibited importation into the United States.

(e) If APHIS conducts the inspections required by paragraph (d) of this section, the facility has entered into a cooperative service agreement executed by the operator of the facility and APHIS. In accordance with the cooperative service agreement, the facility must be current in paying all costs for a veterinarian of APHIS to inspect the facility (it is anticipated that such inspections will occur approximately once per year), including travel, salary, subsistence, administrative overhead, and other incidental expenses (including excess baggage provisions up to 150 pounds). In addition, the facility must have on deposit with APHIS an unobligated amount equal to the cost for APHIS personnel to conduct one inspection. As funds from that amount are obligated, a bill for costs incurred based on official accounting records will be issued to restore the deposit to the original level, revised as necessary to allow for inflation or other changes in estimated costs. To be current, bills must be paid within 14 days of receipt.

(f) The facility allows periodic APHIS inspection of its facilities, records, and operations.

(g) The processed animal protein imported into the United States in accordance with this section is accompanied by an original certificate signed by a full-time, salaried veterinary officer of the national government of the exporting region, or issued by a veterinarian designated by the national government of the exporting region and endorsed by a full-time, salaried veterinary officer of the national government of the exporting region, representing that the veterinarian issuing the certificate was authorized to do so, that states that the processed animal protein is not of ruminant origin and that conditions of this section have been met.

(h) The person importing the shipment has applied for and obtained from APHIS a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors. To apply for a permit, file a permit application on VS Form 16-3, which is available from Strategy and Policy, Veterinary Services, APHIS, 4700 River Road, Riverdale, MD 20737-1231, or electronically at https://efile.aphis.usda.gov/s/vs-permitting-assistant.

(Approved by the Office of Management and Budget under control number 0579-0393)

[78 FR 73003, Dec. 4, 2013, as amended at 86 FR 45629, Aug. 16, 2021]

§ 95.15 [Reserved]

§ 95.16 Untanned hides and skins and bird trophies; requirements for entry.

Untanned hides and skins and bird trophies 1 may be imported into the United States if they meet the requirements of this section. Except for ruminant hides or skins from Mexico, untanned hides and skins and bird trophies may also be imported if handled at an approved establishment as set forth in § 95.17.

1 The importation of bird trophies is also subject to restrictions under § 95.17.

(a) Untanned hides and skins. (1) Except for ruminant hides or skins from Mexico, any untanned hides or skins of ruminants from regions free of foot-and-mouth disease and any untanned hides or skins of swine from regions free of foot-and-mouth disease and African swine fever may be imported without further restriction.

(2) Untanned ruminant hides or skins may be imported from any region without other restriction if an inspector determines, based on inspection and upon examination of a shipper or importer certificate, that they are hard dried hides or skins.

(3) Except for ruminant hides or skins from Mexico, untanned abattoir hides or skins of ruminants may be imported from any region without other restriction if the following requirements are met:

(i) The ruminants from which the hides or skins were taken have been slaughtered under national government inspection in a region 2 and in an abattoir in which is maintained an inspection service that meets the requirements and has been approved pursuant to part 327 of this title; and

2 Names of these regions will be furnished upon request to the Animal and Plant Health Inspection Service, Veterinary Services, Strategy and Policy, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231.

(ii) The hides or skins are accompanied by a certificate bearing the seal of the proper department of that national government and signed by an official veterinary inspector of the region in which the ruminants were slaughtered. The certificate must state that the hides or skins were taken from ruminants slaughtered in an abattoir that meets the requirements of paragraph (a)(3)(i) of this section and that the hides or skins are free from anthrax and foot-and-mouth disease.

(4) Untanned ruminant hides or skins from any region may be imported without other restriction if an inspector determines, based on inspection and upon examination of a shipper or importer certificate, that they have been pickled in a solution of salt containing mineral acid and packed in barrels, casks, or tight cases while still wet with such solution. The solution must be determined by the inspector to have a pH of less than or equal to 5.

(5) Untanned ruminant hides or skins from any region may be imported without other restriction if an inspector determines, based on inspection and upon examination of a shipper or importer certificate, that they have been treated with lime in such manner and for such period as to have obviously been processed, to have become dehaired, and to have reached the stage of preparation for immediate manufacture into products ordinarily made from rawhide.

(b) Ruminant hides and skins from Mexico. Ruminant hides and skins from Mexico may enter the United States without other restriction if:

(1) They are free of ticks and have been subjected to any one of the treatments specified in paragraphs (a)(2), (a)(4), or (a)(5) of this section; or

(2) They are inspected and found to have been frozen solid for 24 hours by an inspector and are accompanied by a certificate attesting to that fact issued by the shipper or importer that is reviewed by the inspector, and are free from ticks; or

(3) They are free from ticks and are accompanied by a certificate issued by a full-time salaried veterinary officer of the Government of Mexico stating that they have been treated with an acaricide; or

(4) They are bovine hides taken from cattle that were subjected to a tickicidal dip in one of the permitted dips listed in § 72.13(b) of this chapter at a Mexican facility 7 to 12 days prior to slaughter, and are free from ticks.

(c) Bird trophies. Bird trophies from regions designated in § 94.6 of this subchapter as free of Newcastle disease and free of HPAI may be imported without further restriction if accompanied by a certificate of origin issued by the national government of the region of export.

(Approved by the Office of Management and Budget under control numbers 0579-0015 and 0579-0307)

[74 FR 66226, Dec. 15, 2009, as amended at 76 FR 28887, May 19, 2011; 78 FR 19085, Mar. 29, 2013. Redesignated and amended at 78 FR 73003, 73006, Dec. 4, 2013; 79 FR 71007, Dec. 1, 2014; 83 FR 15493, Apr. 11, 2018; 86 FR 45629, Aug. 16, 2021]

§ 95.17 Untanned hides, skins, and bird trophies; importations permitted subject to restrictions.

Except for ruminant hides or skins from Mexico, hides or skins or bird trophies offered for importation which do not meet the conditions or requirements of § 95.16 shall be handled and treated in the following manner after arrival at the port of entry:

(a) They shall be consigned from the coast or border port of arrival to an approved establishment and shall be subject to disinfection by such method or methods as the Deputy Administrator, Veterinary Services may prescribe unless the said establishment discharges drainage into an approved sewerage system or has an approved chlorinating equipment adequate for the proper disinfection of effluents: Provided, however, That upon permission of the Deputy Administrator, Veterinary Services such hides or skins or bird trophies may be stored for a temporary period in approved warehouses under bond, and under the supervision of an inspector: And provided further, That I. T. or inbound shipments of hides or skins or bird trophies may go forward under customs seals from a coast or border port of arrival, with the approval of an inspector at said port, to another port in the United States for consumption entry subject to the other provisions of this section.

(b) They shall be moved from the coast or border port of arrival or, in case of I. T. or in-bound shipments, from the interior port to the approved establishment in cars or trucks or in vessel compartments with no other materials contained therein, sealed with seals of the Department, which shall not be broken except by inspectors or other persons authorized by the Deputy Administrator, Veterinary Services so to do, or without sealing as aforesaid and with other freight when packed in tight cases or casks acceptable to the inspector in charge at the port of entry.

(c) They shall be handled at the approved establishment under the direction of an inspector in a manner approved by the Deputy Administrator, Veterinary Services to guard against the dissemination of foot-and-mouth disease, African swine fever, highly pathogenic avian influenza, and Newcastle disease. They shall not be removed therefrom except upon special permission of the Deputy Administrator, Veterinary Services and upon compliance with all the conditions and requirements of this section relative to the movement of the said hides and skins or bird trophies from the port of arrival to the said establishment.

(Approved by the Office of Management and Budget under control number 0579-0015)

[28 FR 5981, June 13, 1963, as amended at 59 FR 67134, Dec. 29, 1994; 74 FR 66227, Dec. 15, 2009; 76 FR 28887, May 19, 2011; 78 FR 19085, Mar. 29, 2013. Redesignated and amended at 78 FR 73003, 73006, Dec. 4, 2013; 79 FR 71007, Dec. 1, 2014; 83 FR 15494, Apr. 11, 2018]

§ 95.18 Wool, hair, and bristles; requirements for unrestricted entry.

Wool, hair, or bristles derived from ruminants and/or swine which do not meet the conditions or requirements specified in any one of paragraphs (a) to (d) of this section shall not be imported except subject to handling and treatment in accordance with § 95.19 after their arrival at the port of entry: Provided, however, That no bloodstained wool, hair, or bristles shall be imported under any condition:

(a) Such wool, hair, or bristles may be imported without other restriction if originating in and shipped directly from a region not declared by the Secretary of Agriculture to be infected with foot-and-mouth disease.

(b) Wool or hair clipped from live animals or pulled wool or hair may be imported without other restriction if the said wool or hair is reasonably free from animal manure in the form of dung locks or otherwise.

(c) Wool, hair, or bristles taken from sheep, goats, cattle, or swine, when such animals have been slaughtered under national government inspection in a region 3 and in an abattoir in which is maintained an inspection service determined by the Secretary of Agriculture to be adequate to assure that such materials have been removed from animals found at time of slaughter to be free from anthrax and foot-and-mouth disease, and to assure further the identity of such materials until loaded upon the transporting vessel, may be imported without other restriction if accompanied by a certificate bearing the seal of the proper department of said national government and signed by an official veterinary inspector of such region showing that the therein described wool, hair, or bristles were taken from animals slaughtered in such specified abattoir and found free from anthrax and foot-and-mouth disease.

3 See footnote 2 in § 95.16.

(d) Wool, hair, or bristles which have been scoured, thoroughly washed, or dyed may be imported without other restriction.

(Approved by the Office of Management and Budget under control number 0579-0015)

[28 FR 5981, June 13, 1963, as amended at 48 FR 57472, Dec. 30, 1983; 62 FR 56024, Oct. 28, 1997; 74 FR 66226, Dec. 15, 2009. Redesignated and amended at 78 FR 73003, 73006, Dec. 4, 2013; 83 FR 15494, Apr. 11, 2018]

§ 95.19 Wool, hair, and bristles; importations permitted subject to restrictions.

Wool, hair, or bristles offered for importation which do not meet the conditions or requirements of § 95.18 shall be handled and treated in the following manner after arrival at the port of entry:

(a) Such wool, hair, or bristles shall be consigned from the coast or border port of arrival to an approved establishment: Provided, however, That upon permission by the Deputy Administrator, Veterinary Services such wool, hair, or bristles may be stored for a temporary period in approved warehouses under bond and under the supervision of an inspector: And provided further, That I. T. on in-bond shipments of wool, hair, or bristles may go forward under customs seals from a coast or border port of arrival, with the approval of an inspector at said port, to another port for consumption entry, subject to the other provisions of this section.

(b) Such wool, hair, or bristles shall be moved from the coast or border port of arrival or, in the case of I. T. or in-bond shipments, from the interior port to the establishment in cars or trucks or in vessel compartments with no other materials contained therein, sealed with seals of the Department, which shall not be broken except by inspectors or other persons authorized by the Deputy Administrator, Veterinary Services so to do, or without sealing as aforesaid and with other freight when packed in tight cases acceptable to an inspector.

(c) Such wool, hair, or bristles shall be handled at the establishment under the direction of an inspector in a manner approved by the Deputy Administrator, Veterinary Services to guard against the dissemination of foot-and-mouth disease. Such products shall not be removed therefrom except upon special permission of the Deputy Administrator, Veterinary Services and upon compliance with all the conditions and requirements of this section relative to the movement of the said wool, hair, or bristles from the port of arrival to the said establishment.

(Approved by the Office of Management and Budget under control number 0579-0015)

[28 FR 5981, June 13, 1963, as amended at 59 FR 67134, Dec. 29, 1994. Redesignated and amended at 78 FR 73003, 73007, Dec. 4, 2013; 83 FR 15494, Apr. 11, 2018]

§ 95.20 Glue stock; requirements for unrestricted entry.

Glue stock which does not meet the conditions or requirements specified in any one of paragraphs (a) to (c) of this section shall not be imported except subject to handling and treatment in accordance with § 95.21 after arrival at the port of entry:

(a) Glue stock originating in and shipped directly from a region not declared by the Secretary of Agriculture to be infected with foot-and-mouth disease may be imported without other restriction.

(b) Glue stock may be imported without other restriction if found upon inspection by an inspector, or by certificate of the shipper or importer satisfactory to said inspector, to have been properly treated by acidulation or by soaking in milk of lime or a lime paste; or to have been dried so as to render each piece of the hardness of a sun-dried hide.

(c) Glue stock taken from cattle, sheep, goats, or swine slaughtered under national government inspection in a region 4 and in an abattoir in which is maintained an inspection service determined by the Secretary of Agriculture to be adequate to assure that such materials have been removed from animals found at time of slaughter to be free from anthrax and foot-and-mouth disease, and to assure further the identity of such materials until loaded upon the transporting vessel, may be imported without other restriction if accompanied by a certificate bearing the seal of the proper department of said national government and signed by an official veterinary inspector of such region showing that the therein described glue stock was taken from animals slaughtered in such specified abattoir and found free from anthrax and foot-and-mouth disease.

4 See footnote 2 in § 95.16.

(Approved by the Office of Management and Budget under control number 0579-0015)

[28 FR 5981, June 13, 1963, as amended at 48 FR 57472, Dec. 30, 1983; 62 FR 56024, Oct. 28, 1997; 74 FR 66226, Dec. 15, 2009. Redesignated and amended at 78 FR 73003, 73007, Dec. 4, 2013; 83 FR 15494, Apr. 11, 2018]

§ 95.21 Glue stock; importations permitted subject to restrictions.

Glue stock offered for importation which does not meet the conditions or requirements of § 95.20 shall be handled and treated in the following manner after arrival at the port of entry:

(a) It shall be consigned from the coast or border port of arrival to an approved establishment and shall be subject to disinfection by such method or methods as the Deputy Administrator, Veterinary Services may prescribe unless the said establishment discharges drainage into an approved sewerage system or has an approved chlorinating equipment adequate for the proper disinfection of effluents: Provided, however, That upon permission by the Deputy Administrator, Veterinary Services glue stock may be stored for a temporary period in approved warehouses under bond and under the supervision of an inspector: And provided further, That I. T. or in-bond shipments of glue stock may go forward under customs seals from a coast or border port of arrival with the approval of an inspector at said port to another port for consumption entry, subject, after arrival at the latter port, to the other provisions of this section.

(b) It shall be moved from the coast or border port of arrival or, in case of I. T. or in-bond shipments, from the interior port to the establishment in cars or trucks or in vessel compartments with no other materials contained therein, sealed with seals of the Department, which shall not be broken except by inspectors or other persons authorized by the Deputy Administrator, Veterinary Services so to do, or without sealing as aforesaid and with other freight when packed in tight cases or casks acceptable to an inspector at port of entry.

(c) It shall be handled at the establishment under the direction of an inspector in a manner approved by the Deputy Administrator, Veterinary Services to guard against the dissemination of foot-and-mouth disease. It shall not be removed therefrom except upon special permission of the Deputy Administrator, Veterinary Services and upon compliance with all the conditions and requirements of this section relative to the movement of the said glue stock from the port of arrival to the said establishment.

(Approved by the Office of Management and Budget under control number 0579-0015)

[28 FR 5981, June 13, 1963, as amended at 59 FR 67134, Dec. 29, 1994. Redesignated and amended at 78 FR 73003, 73007, Dec. 4, 2013; 83 FR 15494, Apr. 11, 2018]

§ 95.22 Bones, horns, and hoofs for trophies or museums; disinfected hoofs.

(a) Clean, dry bones, horns, and hoofs, that are free from undried pieces of hide, flesh, and sinew and are offered for entry as trophies or for consignment to museums may be imported without other restrictions.

(b) Clean, dry hoofs disinfected in the region of origin may be imported without other restrictions if the following conditions are met:

(1) The hoofs have been disinfected using one of the following methods:

(i) Dry heat at 180 °F (82.2 °C) for 30 minutes;

(ii) Soaking in boiling water for 20 minutes;

(iii) Soaking in a 0.1 percent chlorine bleach solution for 2 hours;

(iv) Soaking in a 5 percent acetic acid solution for 2 hours; or

(v) Soaking in a 5 percent hydrogen peroxide solution for 2 hours.

(2) The hoofs are accompanied by a certificate issued by the national government of the region of origin and signed by an official veterinary inspector of that region stating that the hoofs have been disinfected and describing the manner in which the disinfection was accomplished.

[28 FR 5981, June 13, 1963, as amended at 59 FR 9400, Feb. 28, 1994; 62 FR 56024, Oct. 28, 1997. Redesignated at 78 FR 73003, Dec. 4, 2013]

§ 95.23 Bones, horns, and hoofs; importations permitted subject to restrictions.

Bones, horns, and hoofs offered for importation which do not meet the conditions or requirements of § 95.22 shall be handled and treated in the following manner after arrival at the port of entry:

(a) They shall be consigned from the coast or border port of arrival to an approved establishment having facilities for their disinfection or their conversion into products customarily made from bones, horns, or hoofs: Provided, however, That I. T. or in-bond shipments of bones, horns, or hoofs may go forward under customs seals from a coast or border port of arrival, with the approval of an inspector at said port, to another port for consumption entry subject to the other provisions of this section.

(b) They shall be moved from the coast or border port of arrival or, in case of I. T. or in-bond shipments, from the interior port to the establishment in cars or trucks with no other materials contained therein, sealed with seals of the Department, which shall not be broken except by inspectors or other persons authorized by the Deputy Administrator, Veterinary Services so to do, or without sealing as aforesaid and with other freight when packed in tight cases or casks acceptable to an inspector at the port of entry.

(c) They shall be handled at the establishment under the direction of an inspector in a manner to guard against the dissemination of anthrax, foot-and-mouth disease, highly pathogenic avian influenza, and Newcastle disease, and the bags, burlap, or other containers thereof, before leaving the establishment, shall be disinfected by heat or otherwise, as directed by the Deputy Administrator, Veterinary Services or burned at the establishment. They shall not be removed therefrom except upon special permission of the Deputy Administrator, Veterinary Services and upon compliance with all the conditions and requirements of this section relative to the movement of the said bones, horns, and hoofs.

(Approved by the Office of Management and Budget under control number 0579-0015)

[28 FR 5981, June 13, 1963, as amended at 59 FR 67134, Dec. 29, 1994. Redesignated at 78 FR 73003, 73007, Dec. 4, 2013; 79 FR 71007, Dec. 1, 2014; 83 FR 15494, Apr. 11, 2018]

§ 95.24 Bone meal for use as fertilizer or as feed for domestic animals; requirements for entry.

Steamed or degelatinized or special steamed bone meal, which, in the normal process of manufacture, has been prepared by heating bone under a minimum of 20 pounds steam pressure for at least one hour at a temperature of not less than 250 °Fahrenheit (121 °Centigrade), may be imported without further restrictions for use as fertilizer or as feed for domestic animals if such products are free from pieces of bone, hide, flesh, and sinew and contain no more than traces of hair and wool. Bone meal for use as fertilizer or as feed for domestic animals which does not meet these requirements will not be eligible for entry.

[28 FR 5981, June 13, 1963. Redesignated at 78 FR 73003, Dec. 4, 2013]

§ 95.25 Blood meal, tankage, meat meal, and similar products, for use as fertilizer or animal feed; requirements for entry.

Dried blood or blood meal, lungs or other organs, tankage, meat meal, wool waste, wool manure, and similar products, for use as fertilizer or as feed for domestic animals, shall not be imported except subject to handling and treatment in accordance with paragraphs (a), (b), and (c) of § 95.27, unless:

(a) Such products originated in and were shipped directly from a region not declared by the Secretary of Agriculture to be infected with foot-and-mouth disease; or

(b) The inspector at the port of entry finds that such products have been fully processed by tanking under live steam or by dry rendering.

[28 FR 5981, June 13, 1963, as amended at 62 FR 56024, Oct. 28, 1997. Redesignated at 78 FR 73003, 73007, Dec. 4, 2013; 83 FR 15494, Apr. 11, 2018]

§ 95.26 Blood meal, blood albumin, intestines, and other animal byproducts for industrial use; requirements for unrestricted entry.

Blood meal, blood albumin, bone meal, intestines, or other animal materials intended for use in the industrial arts shall not be imported except subject to handling and treatment in accordance with § 95.27, unless such products originated in and were shipped directly from a region not declared by the Secretary of Agriculture to be infected with foot-and-mouth disease.

(Approved by the Office of Management and Budget under control number 0579-0015)

[28 FR 5981, June 13, 1963, as amended at 59 FR 67134, Dec. 29, 1994; 62 FR 56024, Oct. 28, 1997. Redesignated and amended at 78 FR 73003, 73007, Dec. 4, 2013; 83 FR 15494, Apr. 11, 2018]

§ 95.27 Blood meal, blood albumin, intestines, and other animal byproducts for industrial use; importations permitted subject to restrictions.

Blood meal, blood albumin, bone meal, intestines, or other animal materials intended for use in the industrial arts, which do not meet the conditions or requirements of § 95.26 shall be handled and treated in the following manner after arrival at the port of entry.

(a) They shall be consigned from the coast or border port of arrival to an approved establishment: Provided, however, That upon permission by the Deputy Administrator, Veterinary Services they may be stored for a temporary period in approved warehouses under bond and under the supervision of an inspector: And provided further, That I. T. or in-bond shipments of such products may go forward under customs seals from a coast or border port of arrival, with the approval of an inspector at said port, to another port of consumption entry, subject after arrival at the latter port to the other provisions of this section.

(b) They shall be moved from the coast or border port of arrival or, in the case of I. T. or in-bond shipments, from the interior port to the establishment in cars or trucks or in vessel compartments with no other materials contained therein, sealed with seals of the Department, which shall not be broken except by Veterinary Services inspectors or other persons authorized by the Deputy Administrator, Veterinary Services so to do, or without sealing as aforesaid and with other freight when packed in tight cases or casks acceptable to an inspector at the port of entry.

(c) They shall be handled at the establishment under the direction of an inspector in a manner to guard against the dissemination of foot-and-mouth disease. They shall not be removed therefrom except upon special permission of the Deputy Administrator, Veterinary Services and upon compliance with all the conditions and requirements of this section relative to the movement of the said products from the port of arrival to the said establishment.

(Approved by the Office of Management and Budget under control number 0579-0015)

[28 FR 5981, June 13, 1963, as amended at 59 FR 67134, Dec. 29, 1994. Redesignated and amended at 78 FR 73003, 73007, Dec. 4, 2013; 83 FR 15494, Apr. 11, 2018]

§ 95.28 Glands, organs, ox gall, and like materials; requirements for unrestricted entry.

Glands, organs, ox gall or bile, bone marrow, and various like materials derived from domestic ruminants or swine, intended for use in the manufacture of pharmaceutical products shall not be imported except subject to handling and treatment in accordance with § 95.29, unless such glands, organs, or materials originated in and were shipped directly from a region not declared by the Secretary of Agriculture to be infected with foot-and-mouth disease.

[28 FR 5981, June 13, 1963, as amended at 62 FR 56024, Oct. 28, 1997. Redesignated and amended at 78 FR 73003, 73007, Dec. 4, 2013; 83 FR 15494, Apr. 11, 2018]

§ 95.29 Glands, organs, ox gall, and like materials; importations permitted subject to restrictions.

Glands, organs, ox gall or bile, bone marrow, and various like materials derived from domestic ruminants or swine, which do not meet the requirements of § 95.28 may be imported for pharmaceutical purposes if in tight containers and consigned to an approved establishment: Provided, however, That upon special permission of the Deputy Administrator, Veterinary Services they may be stored for a temporary period in approved warehouses under bond and under the supervision of an inspector. They shall be handled and processed at the said establishment in a manner approved by the Deputy Administrator, Veterinary Services and the containers shall be destroyed or disinfected as prescribed by him. They shall not be removed therefrom except upon special permission of the Deputy Administrator, Veterinary Services and upon compliance with all the conditions and requirements of this section relative to the movement of the said glands, organs, ox gall, and like materials from the port of arrival to the said establishment.

(Approved by the Office of Management and Budget under control number 0579-0015)

[28 FR 5981, June 13, 1963, as amended at 59 FR 67134, Dec. 29, 1994. Redesignated and amended at 78 FR 73003, 73007, Dec. 4, 2013]

§ 95.30 Animal stomachs.

Stomachs or portions of the stomachs of ruminants or swine, other than those imported for food purposes under the meat-inspection regulations of the Department, shall not be imported without permission from the Deputy Administrator, Veterinary Services. Importations permitted shall be subject to such restrictions as the Deputy Administrator, Veterinary Services may deem necessary in each instance.

(Approved by the Office of Management and Budget under control number 0579-0015)

[28 FR 5981, June 13, 1963, as amended at 59 FR 67134, Dec. 29, 1994. Redesignated at 78 FR 73003, Dec. 4, 2013]

§ 95.31 Animal manure.

Manure of horses, cattle, sheep, other ruminants, and swine shall not be imported except upon permission from the Deputy Administrator, Veterinary Services. Importations permitted shall be subject to such restrictions as he may deem necessary in each instance: Provided, however, That manure produced by animals while in transit to the United States shall be subject only to the requirements of the Department regulations governing the importation of domestic livestock and other animals.

(Approved by the Office of Management and Budget under control number 0579-0015)

[28 FR 5981, June 13, 1963, as amended at 59 FR 67134, Dec. 29, 1994. Redesignated at 78 FR 73003, Dec. 4, 2013]

§ 95.32 Hay and straw; requirements for unrestricted entry.

Except as provided in § 95.39, hay or straw shall not be imported except subject to handling and treatment in accordance with § 95.33 after arrival at the port of entry, unless such hay or straw originated in and was shipped directly from a region not declared by the Secretary of Agriculture to be infected with foot-and-mouth disease.

[28 FR 5981, June 13, 1963, as amended at 62 FR 56024, Oct. 28, 1997. Redesignated and amended at 78 FR 73003, 73007, Dec. 4, 2013; 83 FR 15494, Apr. 11, 2018]

§ 95.33 Hay and straw; importations permitted subject to restrictions.

Except as provided in § 95.39, hay or straw which does not meet the conditions or requirements of § 95.32 shall be handled and treated in the following manner upon arrival at the port of entry:

(a) Hay or straw packing materials shall be burned or disinfected at the expense of the importer or consignee in the manner and at the time directed by the Deputy Administrator, Veterinary Services.

(b) Hay or straw for use as feeding material, bedding, or similar purposes shall be stored and held in quarantine for a period of not less than 90 days in an approved warehouse at the port of entry and shall be otherwise handled as directed by the Deputy Administrator, Veterinary Services.

[28 FR 5981, June 13, 1963. Redesignated and amended at 78 FR 73003, 73007, Dec. 4, 2013]

§ 95.34 Previously used meat covers; importations permitted subject to restrictions.

Cloth or burlap which has been used to cover fresh or frozen meats originating in any region designated in § 94.1 of this subchapter as a region in which foot-and-mouth disease exists, shall not be imported except under the following conditions:

(a) The cloth or burlap shall be consigned from the coast or border port of arrival to an establishment specifically approved for the purpose by the Deputy Administrator, Veterinary Services.

(b) The cloth or burlap shall be immediately moved from the coast or border port of arrival, or in case of I. T. or in-bond shipments from the interior port, to the establishment, in railroad cars or trucks, or in vessel compartments, with no other material contained therein, sealed with seals of the Department, which shall not be broken except by inspectors or other persons authorized by the Deputy Administrator, Veterinary Services: Provided, however, That upon permission of the Deputy Administrator, Veterinary Services, such cloth or burlap may be stored for a temporary period in approved warehouses at the port of arrival under bond and under the supervision of an inspector.

(c) The material shall be disinfected and otherwise handled at the establishment under the direction of an inspector in a manner approved by the Deputy Administrator, Veterinary Services to guard against the dissemination of foot-and-mouth disease, and the material shall not be removed therefrom, except upon special permission of the Deputy Administrator, Veterinary Services, until all of the conditions and requirements of this section have been complied with.

(Approved by the Office of Management and Budget under control number 0579-0015)

[28 FR 5981, June 13, 1963, as amended at 59 FR 67134, Dec. 29, 1994; 62 FR 56024, Oct. 28, 1997. Redesignated at 78 FR 73003, Dec. 4, 2013; 83 FR 15494, Apr. 11, 2018]

§ 95.35 Methods for disinfection of hides, skins, and other materials.

Hides, skins, and other materials required by the regulations in this part to be disinfected shall be subjected to disinfection by methods found satisfactory and approved from time to time by the Deputy Administrator, Veterinary Services.

[28 FR 5981, June 13, 1963. Redesignated at 78 FR 73003, Dec. 4, 2013]

§ 95.36 Transportation of restricted import products; placarding cars and marking billing; unloading enroute.

(a) Transportation companies or other operators of cars, trucks or other vehicles carrying import products or materials moving under restriction, other than those in tight cases or casks, shall affix to and maintain on both sides of all such vehicles durable placards not less than 5 1/2 by 6 inches in size, on which shall be printed with permanent black ink and in boldface letters not less than 1 1/2 inches in height the words “Restricted import product.” These placards shall also bear the words “Clean and disinfect this car or truck.” Each of the waybills, conductors' manifests, memoranda, and bills of lading pertaining to such shipments shall have the words “Restricted import product, clean and disinfect car or truck,” plainly written or stamped upon its face. If for any reason the placards required by this section have not been affixed to each car, or the billing has not been marked by the initial or the connecting carrier, or the placards have been removed, destroyed, or rendered illegible, the placards shall be immediately affixed or replaced and the billing marked by the initial or connecting carrier, the intention being that the billing accompanying the shipment shall be marked and each car, truck or other vehicle placarded as specified in this section from the time such shipment leaves the port of entry until it is unloaded at final destination and the cars, trucks or other vehicles are cleaned and disinfected as required by § 95.37.

(b) If it is necessary to unload enroute any of the materials or products transported in a placarded car, truck or other vehicle as provided in this section, the car, truck or other vehicle from which the transfer is made and any part of the premises in or upon which the product or material may have been placed in the course of unloading or reloading shall be cleaned and disinfected by the carrier, in accordance with the provisions of § 95.37, and the said carrier shall immediately report the matter, by telegraph, to the Deputy Administrator, Veterinary Services, Washington, DC 20251. Such report shall include the following information: Nature of emergency; place where product or material was unloaded; original points of shipment and destination; number and materials of the original car or truck; and number and initials of the car, truck or other vehicle into which the product or material is reloaded in case the original car or truck is not used.

(Approved by the Office of Management and Budget under control number 0579-0015)

[28 FR 5981, June 13, 1963, as amended at 48 FR 57472, Dec. 30, 1983. Redesignated and amended at 78 FR 73003, 73007, Dec. 4, 2013]

§ 95.37 Railroad cars, trucks, boats, aircraft and other means of conveyance, equipment or containers, yards, and premises; cleaning and disinfection.

Railroad cars, trucks, boats, aircraft and other means of conveyance, equipment or containers, yards, and premises which have been used in the transportation, handling, or storing of restricted import products or materials, other than those contained in leak proof cases or casks, shall be cleaned and disinfected with a disinfectant approved for use in this part under the supervision of the division at the time and in the manner provided in this section. Except as provided in paragraph (a) of this section, such railroad cars, trucks, boats, aircraft and other means of conveyance, equipment or containers, shall not be moved in interstate or foreign commerce until they have been so treated.

(a) Cars to be cleaned and disinfected by final carrier at destination. Cars required by this part to be cleaned and disinfected shall be so treated by the final carrier at destination as soon as possible after unloading and before the same are moved from such final destination for any purpose: Provided, however, That when the products or materials are destined to points at which an inspector or other duly authorized representative of Veterinary Services is not maintained or where proper facilities cannot be provided, the transportation company shall seal, bill, and forward the cars in which the products or materials were transported to a point to be agreed upon between the transportation company and Veterinary Services, and the transportation company shall there clean and disinfect the said cars under the supervision of Veterinary Services.

(b) Methods of cleaning and disinfecting. (1) Railroad cars, trucks, aircraft and means of conveyance other than boats, equipment or containers, required by this part to be cleaned and disinfected shall be treated in the following manner: Collect all litter and other refuse therefrom and destroy by burning or other approved method, clean the exterior and interior of the cars or trucks, and the areas of the aircraft or other means of conveyance, equipment or containers that may have been contaminated, and saturate the entire surface with a permitted disinfectant approved for use in this part.

(2) Boats required by this part to be cleaned and disinfected shall be treated in the following manner: Collect all litter and other refuse from the decks, compartments, and all other parts of the boat used for the transportation of the products or materials covered by this part, and from the portable chutes or other appliances, fixtures or areas used in loading and unloading same, and destroy the litter and other refuse by burning or by other approved methods, and saturate the entire surface of the said decks, compartments, and other parts of the boat with a permitted disinfectant approved for use in this part.

(3) Buildings, sheds, and premises required by this part to be disinfected shall be treated in the following manner: Collect all litter and other refuse therefrom and destroy the same by burning or other approved methods, and saturate the entire surface of the fencing, chutes, floors, walls, and other parts with a permitted disinfectant approved for use in this part.

(c) Permitted disinfectants. The disinfectants permitted for use in disinfecting railroad cars, trucks, boats, aircraft and other means of conveyance, equipment or containers, yards, and premises against infection of foot-and-mouth disease are freshly prepared solutions of:

(1) Sodium carbonate (4 percent) in the proportion of 1 pound to 3 gallons of water.

(2) Sodium carbonate (4 percent) plus sodium silicate (0.1 percent) in the proportion of 1 pound of sodium carbonate plus sodium silicate to 3 gallons of water.

(3) Sodium hydroxide (Lye) prepared in a fresh solution in the proportion of not less than 1 pound avoirdupois of sodium hydroxide of not less than 95 percent purity to 6 gallons of water, or one 13 1/2-ounce can to 5 gallons of water. 5

5 Due to the extreme caustic nature of sodium hydroxide solution, precautionary measures such as the wearing of rubber gloves, boots, raincoat and goggles should be observed. An acid solution such as vinegar shall be kept readily available in case any of the sodium hydroxide solution should come in contact with the body.

(d) Permitted disinfectants against ticks. The disinfectants permitted for use against tick infestation are liquefied phenol (U. S. P. strength 87 percent phenol) in the proportion of at least 6 fluid ounces to one gallon of water; or chlorinated lime (U. S. P. strength 30 percent available chlorine) in the proportion of one pound to three gallons of water; or any one of the cresylic disinfectants permitted by the Animal and Plant Health Inspection Service in the proportion of at least four fluid ounces to one gallon of water; or through application of boiling water if the treatment is against foot-and-mouth disease and tick infestation; or other disinfectants or treatments approved by the Deputy Administrator, Veterinary Services.

[28 FR 5981, June 13, 1963, as amended at 32 FR 19157, Dec. 20, 1967; 74 FR 66226, Dec. 15, 2009. Redesignated at 78 FR 73003, Dec. 4, 2013; 83 FR 15494, Apr. 11, 2018]

§ 95.38 Regulations applicable to products from Territorial possessions.

The regulations in this part shall be applicable to all the products and materials specified in this part which are offered for entry into the United States from any place under the jurisdiction of the United States to which the animal-quarantine laws of this country do not apply.

[28 FR 5981, June 13, 1963. Redesignated at 78 FR 73003, Dec. 4, 2013]

§ 95.39 Hay or straw and similar material from tick-infested areas.

Hay or straw, grass, or similar material from tick-infested pastures, ranges, or premises may disseminate the contagion of splenetic, Southern or Texas fever when imported for animal feed or bedding; therefore, such hay or straw, grass, or similar materials shall not be imported unless such material is first disinfected with a disinfectant specified in § 95.26(d).

[28 FR 5981, June 13, 1963. Redesignated at 78 FR 73003, Dec. 4, 2013]

§ 95.40 [Reserved]

§ 96.1 Definitions.

Administrator. The Administrator, Animal and Plant Health Inspector Service, or any person authorized to act for the Administrator.

Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the United States Department of Agriculture (APHIS or Service).

Animal casings. Intestines, stomachs, esophagi, and urinary bladders from cattle, sheep, swine, or goats that are used to encase processed meats in foods such as sausage.

APHIS representative. An individual employed by APHIS who is authorized to perform the function involved.

Authorized inspector. Any individual authorized by the Administrator of APHIS or the Commissioner of Customs and Border Protection, Department of Homeland Security, to enforce the regulations in this subpart.

Department. The United States Department of Agriculture.

Food and Drug Administration. The Food and Drug Administration of the United States Department of Health and Human Services.

Food Safety and Inspection Service. The Food Safety and Inspection Service of the United States Department of Agriculture.

Import (imported, importation) into the United States. To bring into the territorial limits of the United States.

Region. Any defined geographic land area identifiable by geological, political, or surveyed boundaries. A region may consist of any of the following:

(1) A national entity (country);

(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.)

(3) Parts of several national entities combined into an area; or

(4) A group of national entities (countries) combined into a single area.

United States. All of the States of the United States, the District of Columbia, Guam, the Northern Mariana Islands, Puerto Rico, the Virgin Islands of the United States, American Samoa, and the territories and possessions of the United States.

(Approved by the Office of Management and Budget under control number 0579-0015)

[57 FR 28082, June 24, 1992, as amended at 57 FR 29785, July 7, 1992; 59 FR 67134, Dec. 29, 1994; 62 FR 56024, Oct. 28, 1997; 70 FR 553, Jan. 4, 2005; 72 FR 53379, Sept. 18, 2007]

§ 96.2 Prohibition of casings due to African swine fever and bovine spongiform encephalopathy.

(a) Swine casings. The importation of swine casings that originated in or were processed in a region where African swine fever exists, as listed under § 94.8(a) of this subchapter, is prohibited, with the following exception: Swine casings that are processed in a region where African swine fever exists may be imported into the United States under the following conditions:

(1) Origin of casings. The swine casings were derived from swine raised and slaughtered in a region not listed under § 94.8(a) of this subchapter.

(2) Shipping requirements. The casings were shipped from the region of origin to a processing establishment in a region listed under § 94.8(a) of this subchapter in a closed container sealed with serially numbered seals applied by an official of the national government of the region of origin.

(3) Origin certificate. The casings were accompanied from the region of origin to the processing establishment by a certificate written in English and signed by an official of the national government of the region of origin specifying the region of origin, the processing establishment to which the swine casings were consigned, and the numbers of the seals applied.

(4) Integrity of seals. The casings were taken out of the container at the processing establishment only after an official of the national government of the region where the processing establishment is located determined that the seals were intact and free of any evidence of tampering and had so stated on the certificate referred to in paragraph (a)(3) of this section.

(5) The processing establishment. The casings were processed at a single processing establishment 1 in a region listed under § 94.8(a) of this subchapter. The processing establishment does not receive or process any live swine and uses only pork and pork products that originate in a region not listed under § 94.8(a) of this subchapter and that are shipped to the processing establishment in accordance with paragraphs (a)(2) through (a)(4) of this section.

1 As a condition of entry into the United States, pork or pork products must also meet all of the requirements of the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) and regulations under the Act (9 CFR, chapter III, part 327), including requirements that the pork or pork products be prepared only in approved establishments.

(6) Compliance agreement. The processing establishment is operated by persons who have entered into a valid written compliance agreement with APHIS to maintain on file at the processing establishment for at least 2 years copies of the certificates referred to in paragraph (a)(4) of this section, to allow APHIS personnel to make unannounced inspections as necessary to monitor compliance with the provisions of this section, and to otherwise comply with the provisions of this section.

(7) Cooperative service agreement. The processing establishment is operated by persons who have entered into a cooperative service agreement with APHIS. The establishment is current in paying for APHIS personnel to inspect the establishment (it is anticipated that such inspections will occur once per year). In addition, the processing establishment has on deposit with APHIS an unobligated amount equal to the cost for APHIS personnel to conduct one inspection, including travel, salary, subsistence, administrative overhead, and other incidental expenses (including excess baggage provisions up to 150 pounds).

(8) Compliance agreement cancellation. Any compliance agreement may be canceled orally or in writing by the inspector who is supervising its enforcement whenever the authorized inspector finds that such person has failed to comply with the provisions of this section or any conditions imposed by this section. If the cancellation is oral, the decision and the reasons will be confirmed in writing, as promptly as circumstances allow. Any person whose compliance agreement has been canceled may appeal the decision to the Administrator, in writing, within 10 days after receiving written notification of the cancellation. The appeal should state all of the facts and reasons upon which the person relies to show that the compliance agreement was wrongfully canceled. The Administrator will grant or deny the appeal, in writing, stating the reasons for such decision, as promptly as circumstances allow. If there is a conflict as to any material fact, a hearing will be held to resolve such conflict. Rules of Practice governing such a hearing will be adopted by the Administrator.

(9) Export certification. The casings are accompanied to the United States by an original certificate stating that all of the requirements of this section have been met. The certificate must be written in English. The certificate must be issued by an official of the national government of the region in which the processing establishment is located. The official must be authorized to issue the foreign meat inspection certificate required by part 327 in chapter III of this title. Upon arrival of the swine casings in the United States, the certificate must be presented to an authorized inspector at the port of arrival.

(b) Casings from ovines or caprines. The importation of casings, except stomachs, derived from ovines or caprines that originated in or were processed in any region listed in § 95.4(a)(4) are prohibited, unless the following conditions are met:

(1) The casings are accompanied by an original certificate that meets the requirements of § 96.3 and:

(i) States that the casings meet the conditions of this section;

(ii) Is written in English;

(iii) Is signed by an individual eligible to issue the certificate required under § 96.3; and

(iv) Is presented to an authorized inspector at the port of entry.

(2) [Reserved]

(c) Casings from bovines. The importation of casings derived from bovines is prohibited, unless the following conditions are met:

(1) If the casings are derived from bovines from a region of negligible risk for BSE, as defined in § 92.1 of this subchapter, the certificate required under § 96.3 indicates the APHIS BSE risk classification of the region in which the bovines were slaughtered and the casings were collected.

(2) If the casings are derived from bovines from a region of controlled risk for BSE or a region of undetermined risk for BSE, as defined in § 92.1 of this subchapter, the casings are not derived from the small intestine or, if the casings are derived from the small intestine, the casings are derived from that part of the small intestine that is eligible for use as human food in accordance with the requirements established by the Food Safety and Inspection Service at 9 CFR 310.22 and the Food and Drug Administration at 21 CFR 189.5.

(3) The casings are accompanied by an original certificate that meets the requirements of § 96.3 and paragraph (b)(1) of this section.

(Approved by the Office of Management and Budget under control number 0579-0015)

[65 FR 1307, Jan. 10, 2000, as amended at 70 FR 553, Jan. 4, 2005; 72 FR 53379, Sept. 18, 2007; 77 FR 1395, Jan. 10, 2012; 78 FR 73007, Dec. 4, 2013; 86 FR 68862, Dec. 3, 2021]

§ 96.3 Certificate for animal casings.

(a) No animal casings shall be imported into the United States from any foreign region unless they are accompanied by a certificate signed by either (1) a veterinarian salaried by the national government of the region in which the animals were slaughtered and the casings were collected, and who is authorized by the national government to conduct casings inspections and issue certificates, and who has inspected the casings before issuing the certificate and determined that the casings meet the criteria described in the Foreign Official Certificate for Animal Casings; or (2) a non-government veterinarian authorized to issue the certificate by the national government of the region in which the animals were slaughtered and the casings were collected, who has inspected the casings before issuing the certificate and determined that the casings meet the criteria described in the Foreign Official Certificate for Animal Casings. A certificate issued by a non-government veterinarian is valid only if the certificate is endorsed by a veterinarian salaried by the national government of the region in which the animals were slaughtered and the casings were collected.

(b) All signatures on the certificate shall be original.

(c) The certificate shall bear the insignia of the national government of the region in which the animals were slaughtered and the casings were collected, and shall be in the following form:

foreign official certificate for animal casings Place (City) ____________________ (Region) ________ (Date) ________

I hereby certify that the animal casings herein described were derived from healthy animals (cattle, sheep, swine, or goats), which received, ante mortem and post mortem veterinary inspections at the time of slaughter, are clean and sound, and were prepared and handled only in a sanitary manner and were not subjected to contagion prior to exportation.

Kind of casings Number of packages Weight Identification marks on the packages Consignor (Address) Consignee (Destination) Shipping marks Signature: Official issuing the certificate. (Non-government veterinarian authorized to issue the certificate by the national government of the region in which the animals were slaughtered and the casings were collected.) Official title: Signature: Official issuing the certificate. (Veterinarian salaried by the national government of the region in which the animals were slaughtered and the casings were collected.) Official title:

(d) In addition to meeting the requirements of this section, the certificate accompanying sheep casings from Canada must state that the casings meet the requirements of § 96.2(b) and the certificate accompanying bovine casings must state that the casings meet the requirements of either § 96.2(c)(1) or (c)(2) as applicable.

(Approved by the Office of Management and Budget under control number 0579-0015)

[28 FR 5986, June 13, 1963, as amended at 48 FR 57472, Dec. 30, 1983. Redesignated and amended at 57 FR 28082, June 24, 1992. Redesignated at 58 FR 47031, Sept. 7, 1993, as amended at 62 FR 56024, Oct. 28, 1997; 70 FR 553, Jan. 4, 2005; 72 FR 53379, Sept. 18, 2007; 78 FR 73008, Dec. 4, 2013]

§ 96.4 Uncertified animal casings; disposition.

Animal casings which are unaccompanied by the required certificate, those shipped in sheepskins or other skins as containers, and those found upon inspection to be unclean or unsound when offered for importation into the United States shall be kept in customs custody until exported or destroyed, or until disinfected and denaturated as prescribed by the Administrator, Animal and Plant Health Inspection Service (APHIS) in §§ 96.5 through 96.16.

[28 FR 5986, June 13, 1963. Redesignated and amended at 57 FR 28082, 28083, June 24, 1992; 57 FR 29785, July 7, 1992. Redesignated and amended at 58 FR 47031, Sept. 7, 1993]

§ 96.5 Instructions regarding handling certified animal casings.

(a) Animal casings are not classed as meat product, therefore the certificate required for foreign meat product is not acceptable for animal casings offered for importation.

(b) Casings offered for importation into the United States shall remain in customs custody at the port until released by an APHIS inspector for admission into the United States or otherwise disposed of as required by this part.

(c) The provision that under certain conditions casings which have been offered for importation shall be exported, shall be construed to mean the removal of the casings from the United States or its possessions.

(1) The provision that under certain conditions casings be destroyed shall be construed to mean the treatment or handling of the casings in a manner to take away completely the usefulness of them as by tanking or incineration.

(2) The provision that under certain conditions casings shall be disinfected and denatured shall be construed to mean such treatment and handling as will be prescribed by the Administrator, Animal and Plant Health Inspection Service (APHIS) to free them from pathogenic substances or organisms, or to render such substances and organisms inert; and that the nature of the casings be changed to make them unfit for eating without destroying other useful properties. For instance, each casing may be split throughout its length and after disinfection, as above indicated, be released for industrial use.

(d) Dried intestines offered for importation into the United States for use as gut strings or similar purpose are not regarded as animal casings within the meaning of this part. Such dried intestines are classed with tendons, sinews, and similar articles and are subject to the provisions of part 95.

[28 FR 5986, June 13, 1963. Redesignated and amended at 57 FR 28082, 28083, June 24, 1992; 57 FR 29785, July 7, 1992. Redesignated at 58 FR 47031, Sept. 7, 1993]

§ 96.6 Certified foreign animal casings arriving at seaboard or border port.

(a) Properly certified foreign animal casings arriving in the United States at a seaboard or border port where an APHIS inspector is stationed shall be released for entry by the inspector at the seaboard or border port.

(b) Properly certified foreign animal casings arriving in the United States at a seaboard or border port where no APHIS inspector is stationed, which are destined to a point in the United States where an APHIS inspector is stationed, shall be shipped in United States Customs custody to destination for release.

(c) Properly certified foreign animal casing arriving in the United States at a seaboard or border port where no APHIS inspector is stationed, which are destined to a point in the United States where no APHIS inspector is stationed, shall be transported in United States Customs custody to the nearest point where an APHIS inspector is stationed for release at that point.

(d) Properly certified foreign animal casings forming a part of a foreign meat consignment routed through a border port to an interior point in the United States shall be transported to destination as though the entire consignment consisted of meat. In such cases the APHIS inspector who inspects the meat at destination shall supervise the release of the casings.

[28 FR 5986, June 13, 1963, as amended at 57 FR 29785, July 7, 1992. Redesignated at 58 FR 47031, Sept. 7, 1993]

§ 96.7 Dried bladders, weasands, and casings.

Dried animal bladders, dried weasands, and all other dried animal casings offered for importation into the United States as food containers unaccompanied by foreign certification which have been retained in the dry state continuously for not less than 90 days from the date of shipment shown on the consular invoice, may be released for entry as food containers without disinfection.

[28 FR 5986, June 13, 1963. Redesignated at 58 FR 47031, Sept. 7, 1993]

§ 96.8 Uncertified casings; disinfection at seaboard port.

Uncertified foreign animal casings arriving at a seaboard port may be imported into the United States for use as food containers after they have been disinfected under the direct supervision of an APHIS inspector at the seaboard port.

[28 FR 5986, June 13, 1963, as amended at 57 FR 29785, July 7, 1992. Redesignated at 58 FR 47031, Sept. 7, 1993]

§ 96.9 Casings admitted on disinfection; sealing; transfer and disinfection.

Foreign animal casings offered for importation into the United States which are admitted upon disinfection shall be handled as follows:

(a) The containers of such casings shall be sealed on the steamship pier or other place of first arrival. Four seals shall be affixed to both ends of each tierce, barrel, and similar container in the space where the ends of the container enter the staves, by means of red sealing wax imprinted with the No. 3 Veterinary Services brass brand from which “insp'd & p's'd” and the establishment number have been removed.

(b) Uncertified animal casings sealed as above indicated shall be transferred from the steamship pier or other place of first arrival to the premises of the importer or other designated place, where they shall be disinfected by the importer under the supervision of an APHIS inspector before they are offered for sale. The object of this ruling is to place full responsibility for disinfection of casings on the original importer and to prevent the sale of casings subject to disinfection by the purchaser.

[28 FR 5986, June 13, 1963, as amended at 57 FR 29785, July 7, 1992. Redesignated at 58 FR 47031, Sept. 7, 1993]

§ 96.10 Uncertified casings; transportation for disinfection; original shipping containers; disposition of salt.

(a) Foreign animal casings imported into the United States without certification may be forwarded in customs custody to a USDA-approved facility for disinfection under APHIS supervision and release by the United States Customs authorities, provided that, before being transported over land in the United States, each and every container of such casings shall be disinfected by the application of a solution of sodium hydroxide prepared as follows:

(1) Sodium hydroxide (Lye) prepared in a fresh solution in the proportion of not less than 1 pound avoirdupois of sodium hydroxide of not less than 95 percent purity to 6 gallons of water, or one 13 1/2-ounce can to 5 gallons of water. 2

2 Due to the extreme caustic nature of sodium hydroxide solution, and of sodium carbonate solution to a lesser degree, precautionary measures such as the wearing of rubber gloves, boots, raincoat and goggles should be observed. An acid solution such as vinegar shall be kept readily available in case any of the sodium hydroxide solution should come in contact with the body.

(2) This solution shall be thoroughly applied to all exterior surfaces of the containers and be allowed to remain for at least thirty minutes to accomplish disinfection. The containers should then be washed with water to remove the caustic soda which otherwise might cause injury to the handlers of the packages.

(b) When uncertified foreign casings are removed from the original shipping containers these containers shall be destroyed by burning or promptly and thoroughly disinfected both inside and out with the solution and in the manner above prescribed. If these containers are to be re-used it is important that they be thoroughly washed both inside and out with water after disinfection has been completed, and in order to insure against the injurious effect of caustic soda remaining in the wood it is advisable to allow the containers to stand for not less than six hours filled with water.

(c) The salt removed from all original shipping containers of uncertified foreign animal casings shall be immediately dissolved in water and heated to boiling, or disposed of as provided in paragraph (c)(1) or (2) of this section as follows:

(1) Dissolve the salt in the proportion of 90 pounds of salt to 100 gallons of water. Add 2 3/4 gallons of C. P. hydrochloric acid containing not less than 35 percent actual HCl; mix thoroughly and allow the solution to stand for at least thirty minutes. The finished solution must contain not less than 1 percent actual hydrochloric acid. (This solution may be utilized in the disinfection of casings as prescribed in § 96.13.)

(2) Dissolve the salt in the proportion of 90 pounds of salt to 100 gallons of water. Add 20 pounds of 95 percent to 98 percent sodium hydroxide (commercial “76 percent caustic soda”) and stir until solution is complete; and allow it to stand for at least 30 minutes. (This solution may be utilized in the disinfection of casing containers as prescribed in paragraphs (a)(2) and (b) of this section.

(3) It is best to employ flaked caustic soda and not the variety which is very finely powdered. The fine powder is irritating and injurious to workers if it becomes suspended in the air. Containers of caustic soda should be kept tightly closed as the product deteriorates from contact with the air.

[28 FR 5986, June 13, 1963, as amended at 32 FR 19158, Dec. 20, 1967; 57 FR 29785, July 7, 1992. Redesignated and amended at 58 FR 47031, Sept. 7, 1993; 62 FR 56024, Oct. 28, 1997; 65 FR 1307, Jan. 10, 2000]

§ 96.11 Disinfecting plant and equipment for uncertified casings.

Uncertified foreign animal casings shall be disinfected only at a plant whose sanitation and disinfecting equipment have been approved by an APHIS inspector.

[28 FR 5986, June 13, 1963, as amended at 57 FR 29785, July 7, 1992. Redesignated at 58 FR 47031, Sept. 7, 1993]

§ 96.12 Uncertified casings not disinfected in 30 days; disposition.

Foreign animal casings offered for importation without certification shall be disinfected as prescribed in § 96.13 within a period of 30 days after arrival in the United States, subject to the ability of Division inspectors to cover their respective districts. Otherwise such casings shall be exported or destroyed.

[28 FR 5986, June 13, 1963. Redesignated and amended at 58 FR 47031, Sept. 7, 1993]

§ 96.13 Uncertified casings; disinfection with hydrochloric acid.

Foreign animal casings offered for importation into the United States without certification may be disinfected, as prescribed in this section, under the supervision of an APHIS inspector for use as food containers, as an alternative for foreign certification.

(a) Disinfect the casings in a solution made as follows: Dissolve 90 pounds common salt in 100 gallons water and mix. Add 2 3/4 gallons (10.35 liters) C. P. hydrochloric acid containing not less than 35 percent actual HCl and mix thoroughly. The finished solution must contain not less than 1 percent actual hydrochloric acid.

(b) Containers of the disinfectant solution may be either of wood or of metal, but the interior surfaces must be protected by means of an acid resistant coating.

(c) Not more than 175 pounds casings shall be treated with each 100 gallons of the solution. After the treatment of 175 pounds of casings, or at the end of the day if less than 175 pounds of casings are disinfected in any one day, the solution shall be discarded unless means are provided for accurately determining the loss of strength. In event means for accurately determining loss of strength are provided it will be permissible to restore the strength of the solution with fresh acid and use it repeatedly.

(d) Shake as much of the adherent salt as possible from the casings and weigh them. Bundles must be separated but individual hanks need not be untied. Place the casings in the disinfecting solution a few hanks at a time with vigorous agitation to insure the fullest possible contact of the solution with them. Then keep the casings completely submerged in the solution for not less than three-fourths of an hour.

(e) Remove the casings from the solution, rinse them with water, and place them in a solution containing 8 1/2 pounds of sodium bicarbonate in each 100 gallons of water. 100 gallons of this solution is sufficient for 175 pounds of casings. Keep the casings in this solution for 30 minutes, moving them about frequently and vigorously so as to insure complete contact of the solution with the casings. After this neutralization, remove the casings from the sodium bicarbonate solution and wash them to remove the excess of bicarbonate.

(Approved by the Office of Management and Budget under control number 0579-0015)

[28 FR 5986, June 13, 1963, as amended at 57 FR 29785, July 7, 1992. Redesignated at 58 FR 47031, Sept. 7, 1993, as amended at 59 FR 67134, Dec. 29, 1994]

§ 96.14 Uncertified casings; disinfection with saturated brine solution.

Foreign animal casings offered for importation into the United States upon disinfection, may either be disinfected with hydrochloric acid as at present or if preferred may be submerged in a saturated brine solution at a temperature not less than 127 °F. for at least 15 minutes. The time held as well as the temperature of such brine solution must be recorded on a one-hour dial of a recording thermometer and filed in the local APHIS office for official inspection at any time. In order that this required temperature may be more readily maintained, such casings must first be submerged in a brine solution at approximately 127 °F. for about five minutes immediately before the 15-minute recorded submersion period begins. This may be done either in the testing vat or a preliminary vat. By following this procedure the temperature will not vary unduly and thus cause unsatisfactory results. After removing the casings from the testing vat, it will be found advantageous to submerge them in another vat containing cold brine solution or cold water in order to remove the extra heat from the casings as promptly as possible, but of course this is optional with the importer. In order to obtain the most satisfactory results, the hanks, rings, and similar units must be separated as much as possible without untying, but “dolls” will not be permitted to be disinfected by this heating method. In order to keep the temperature of the brine in the testing vat of a uniform degree, it is necessary to agitate the solution occasionally by moving the casings. The tip of the recording thermometer should be located at a point which would be approximately at the bottom of the volume of casings being disinfected.

[28 FR 5986, June 13, 1963, as amended at 57 FR 29785, July 7, 1992. Redesignated at 58 FR 47031, Sept. 7, 1993]

§ 97.1 Overtime work at laboratories, border ports, ocean ports, and airports. 1

1 For designated ports of entry for certain animals, animal semen, poultry, and hatching eggs see 9 CFR §§ 93.102, 93.203, 93.303, 93.403, 93.503, 93.703, and 93.805 and for designated ports of entry for certain purebred animals see 9 CFR §§ 151.1 through 151.3.

(a) Any person, firm, or corporation having ownership, custody, or control of animals, animal byproducts, or other commodities or articles subject to inspection, laboratory testing, certification, or quarantine under this subchapter and subchapter G of this chapter, and who requires the services of an employee of the Animal and Plant Health Inspection Service or U.S. Customs and Border Protection on a Sunday or holiday, or at any other time outside the regular tour of duty of the employee, shall sufficiently in advance of the period of Sunday, holiday, or overtime service request the Animal and Plant Health Inspection Service or U.S. Customs and Border Protection inspector in charge to furnish the service and shall pay the Government at the rate listed in the following table, except as provided in paragraphs (a)(1), (a)(2), (a)(3), and (a)(4) of this section:

Overtime for Inspection, Laboratory Testing, Certification, or Quarantine of Plant, Plant Products, Animals, Animal Products or Other Regulated Commodities

Outside the employee's normal tour of duty | Overtime rates (per hour)

Nov. 2, 2015-Sept. 30, 2016 | Oct. 1, 2016-Sept. 30, 2017 | Beginning Oct. 1, 2017

Monday through Saturday and holidays | $75 | $75 | $75

Sundays | 99 | 99 | 100

(1) For any services performed on a Sunday or holiday, or at any time after 5 p.m. or before 8 a.m. on a weekday, in connection with the arrival in or departure from the United States of a private aircraft or private vessel, the total amount payable shall not exceed $25 for all inspection services performed by the U.S. Customs and Border Protection , Public Health Service, and the Department of Agriculture;

(2) Owners and operators of aircraft will be provided service without reimbursement during regularly established hours of service on a Sunday or holiday; and

(3) The overtime rate to be charged owners or operators of aircraft at airports of entry or other places of inspection as a consequence of the operation of the aircraft, for work performed outside of the regularly established hours of service is listed in the following table:

Overtime for Commercial Airline Inspection Services 1

Outside the employee's normal tour of duty | Overtime rates (per hour)

Nov. 2, 2015-Sept. 30, 2016 | Oct. 1, 2016-Sept. 30, 2017 | Beginning Oct. 1, 2017

Monday through Saturday and holidays | $64 | $65 | $65

Sundays | 85 | 86 | 86

1 These charges exclude administrative overhead costs.

(4) The overtime rate and all other charges, including minimum and commute compensation charges, to be billed for services provided by an employee of U.S. Customs and Border Protection shall be charged according to the provisions of this section, 5 CFR part 551, or 19 CFR 24.16.

(b) A minimum charge of 2 hours shall be made for any Sunday or holiday or unscheduled overtime duty performed by an employee on a day when no work was scheduled for him or her, or which is performed by an employee on his or her regular workday beginning either at least 1 hour before his or her scheduled tour of duty or which is not in direct continuation of the employee's regular tour of duty. In addition, each such period of Sunday or holiday or unscheduled overtime work to which the 2-hour minimum charge applies may include a commuted traveltime period (CTT) the amount of which shall be prescribed in administrative instructions to be issued by the Administrator, Animal and Plant Health Inspection Service or U.S. Customs and Border Protection for the areas in which the Sunday or holiday or overtime work is performed and such period shall be established as nearly as may be practicable to cover the time necessarily spent in reporting to and returning from the place at which the employee performs such Sunday, holiday or overtime duty. With respect to places of duty within the metropolitan area of the employee's headquarters, such CTT period shall not exceed 3 hours. It shall be administratively determined from time to time which days constitute holidays. The circumstances under which such CTT periods shall be charged and the percentage applicable in each circumstance are as reflected in the following table:

Actual time 1 charge—no minimum | 2-hour guarantee charge | Commuted 2 traveltime (CTT) charge

Charges for Inspection Within Metropolitan Area of Employee's Headquarters

Work beginning before daily tour begins:

8 to 59 minutes | Yes | No | None.

60 to 119 minutes | Yes | 1/2 CTT.

120 minutes or more | Yes | Full CTT.

Work beginning after daily tour ends:

Direct continuation | Yes | No | None.

Break-in-service of:

2-29 minutes | Yes | None.

30-60 minutes | Yes | 1/2 CTT.

61 minutes or more | Yes | Full CTT.

Charges for Inspection Services Performed Outside Metropolitan Area of Employee's Headquarters

Work beginning before daily tour begins:

8 to 59 minutes | Yes | No | 1/2 CTT.

60 minutes or more | Yes | Full CTT.

Work beginning after daily tour ends:

Direct continuations | Yes | No | 1/2 CTT.

2-59 minutes | No | Yes | 1/2 CTT.

60 minutes or more | No | Yes | Full CTT.

Charges for Call Out Inspection Service on Holiday or Nonworkday

Work beginning at any time | No | Yes | Full CTT.

1 Actual time charged when work is contiguous with the daily tour will be in quarter hour multiples, with service time of 8 minutes or more rounded up to the next quarter hour and any time of less than 8 minutes will be disregarded.

2 The full CTT allowance will be the amount of commuted traveltime prescribed for the place at which the inspections are performed. See part 97.2. One-half CTT is 1/2 of the full CTT period.

(c) As used in this section—

(1) The term private aircraft means any civilian aircraft not being used to transport persons or property for compensation or hire, and

(2) The term private vessel means any civilian vessel not being used (i) to transport persons or property for compensation or hire, or (ii) in fishing operations or in processing of fish or fish products.

(d)(1) Any principal, or any person, firm, partnership, corporation, or other legal entity acting as an agent or broker by requesting Sunday, holiday, or overtime services of an Animal and Plant Health Inspection Service or U.S. Customs and Border Protection inspector on behalf of any other person, firm, partnership, corporation, or other legal entity (principal), and who has not previously requested such service from an Animal and Plant Health Inspection Service inspector, must pay the inspector before service is provided.

(2) Since the payment must be collected before service can be provided, the Animal and Plant Health Inspection Service or U.S. Customs and Border Protection inspector will estimate the amount to be paid. Any difference between the inspector's estimate and the actual amount owed to the Animal and Plant Health Inspection Service will be resolved as soon as reasonably possible following the delivery of service, with the Animal and Plant Health Inspection Service or U.S. Customs and Border Protection either returning the difference to the agent, broker, or principal, or billing the agent, broker, or principal for the difference.

(3) The prepayment must be in some guaranteed form, such as money order, certified check, or cash. Prepayment in guaranteed form will continue until the Animal and Plant Health Inspection Service or U.S. Customs and Border Protection determines that the agent, broker, or principal has established an acceptable credit history.

(4) For security reasons, cash payments will be accepted only from 7 a.m. to 5 p.m., and only at a location designated by the Animal and Plant Health Inspection Service inspector or U.S. Customs and Border Protection.

(e)(1) Any principal, or any person, firm, partnership, corporation, or other legal entity requesting Sunday, holiday, or overtime services of an Animal and Plant Health Inspection Service inspector, and who has a debt to the Animal and Plant Health Inspection Service or U.S. Customs and Border Protection more than 60 days delinquent, must pay the inspector before service is provided.

(2) Since the payment must be collected before service can be provided, the Animal and Plant Health Inspection Service or U.S. Customs and Border Protection inspector will estimate the amount to be paid. Any difference between the inspector's estimate and the actual amount owed to the Animal and Plant Health Inspection Service or U.S. Customs and Border Protection will be resolved as soon as reasonably possible following the delivery of service, with the Animal and Plant Health Inspection Service or U.S. Customs and Border Protection either returning the difference to the agent, broker, or principal, or billing the agent, broker, or principal for the difference.

(3) The prepayment must be in some guaranteed form, such as money order, certified check, or cash. Prepayment in guaranteed form will continue until the debtor pays the delinquent debt.

(4) For security reasons, cash payments will be accepted only from 7 a.m. to 5 p.m., and only at a location designated by the Animal and Plant Health Inspection Service or U.S. Customs and Border Protection inspector.

(f) Reimbursable Sunday, holiday, or overtime services will be denied to any principal, or any person, firm, partnership, corporation, or other legal entity who has a debt to the Animal and Plant Health Inspection Service or U.S. Customs and Border Protection more than 90 days delinquent. Services will be denied until the delinquent debt is paid.

[38 FR 28814, Oct. 17, 1973]

Editorial Note:For Federal Register citations affecting § 97.1, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

§ 97.2 Administrative instructions prescribing commuted traveltime.

Each period of overtime and holiday duty as prescribed in § 97.1 shall in addition include a commuted traveltime period for the respective ports, stations, and areas in which employees are located. The prescribed computed traveltime periods are as follows:

Commuted Traveltime Allowances

[In hours]

Location covered | Served from | Metropolitan Area

Within | Outside

Alaska:

Anchorage | 1

Do | Palmer | 3

Arizona:

Douglas | 1

Do | Nogales | 6

Do | Phoenix | 6

Do | Sierra Vista | 3

Naco | Douglas | 2

Do | Nogales | 4

Do | Phoenix | 6

Do | Sierra Vista | 2

Nogales | 1

Do | Douglas | 6

Do | Phoenix | 6

Do | Sierra Vista | 3

San Luis | Phoenix | 6

Do | Yuma | 2

Sasabe | Douglas | 6

Do | Nogales | 4

Do | Phoenix | 6

Do | Sierra Vista | 6

Do | Tuscon | 3

California:

Calexico | San Ysidro | 6

Edwards Air Force Base | Los Angeles | 4

Los Angeles and Los Angeles International Airport | San Bernardino | 5

Do | Los Angeles | 2

Los Angeles Harbor, San Pedro, including Long Beach, Wilmington, and Terminal Island | Los Angeles | 2

March Field | ......do | 5

Mexicali | Calexico | 1

Newport Beach | ......do | 4

Ontario | ......do | 3

Ramona | San Ysidro | 2

Sacramento | ...... | 1

Do | San Francisco | 5

San Diego | ....... | 1

Do | San Ysidro | 2

San Francisco including, Alameda, Richmond, Pittsburg, and other ports in San Francisco and San Pablo Bay areas | 2

San Louis Obispo | San Pedro | 6

San Ysidro | ....... | 1

Stockton | San Francisco | 4

Colorado:

Stapleton International Airport, Denver | Arvada | 1

Do | Aurora | 2

Connecticut:

Bradley International Airport | Westerly, RI | 5

Do | Willington | 1

Bradley International Airport, Windsor Locks | Ashford | 1

Do | Hartford | 2

Do | N. Stonington, CT | 4

Do | Waterbury, CT | 3

Delaware:

Wilmington | Dover | 3

Florida:

Jacksonville | 2

Miami | 2

Port Everglades | Miami | 2

St. Petersburg | Tampa | 2

Do | Miami | 6

Tampa | 2

Do | Miami | 6

Georgia:

Atlanta International Airport | Acworth | 3

Do | Carrollton | 3

Do | Covington | 3

Do | Forsyth | 3

Port of Brunswick | Savannah | 4

Port of Savannah | ......do | 2

Port of St. Mary's | ......do | 6

Hawaii:

Kawaihae | Waimea | 1

Hilo | ......do | 3

Honolulu, including Aiea, Barber's Point Naval Air Station, Honolulu International Airport, West Loch, Middle Loch, East Loch, Pearl City and Waipahu | 2

Idaho:

Boise | Caldwell or Middleton | 2

Eastport | Bonners Ferry | 2

Do | Spokane, WA | 6

Illinois:

Chicago | 3

Do | Geneseo | 6

Do | Kirkland | 4

Springfield | 2

Indiana:

Indianapolis | 1

Do | Anderson | 2

Do | West Lafayette | 3

Iowa:

Ames | 1

Kentucky:

Standiford Field | Frankfort | 3

Do | Louisville | 1

Louisiana:

Acadian Regional Airport, New Iberia | Abbeville | 2

Any point below Chalmette and on the East Bank, Belle Chasse, LA, and points to and including Port Sulphur on the west bank | Baton Rouge | 4

Any point on the Mississippi River above the St. Charles-Jefferson Parish boundary to and including Gramercy | ......do | 2

Morgan City | ......do | 5

New Orleans including Orleans Parish and all points on the east bank of the Mississippi River from the St. Charles-Jefferson Parish boundary to and including Chalmette, LA, and all points on the west bank from the St. Charles-Jefferson Parish boundary to but excluding Belle Chasse, LA | ......do | 4

Undesignated ports | ......do | 3

Maine:

Bangor | Augusta | 3

Do | Newport | 1

Houlton | 1

Jackman | Augusta | 6

Do | Bangor | 5

Do | Newport | 5

Port of Portland | Augusta | 3

Do | Bangor | 6

Do | Concord, NH | 4

Maryland:

Baltimore: | 3

Largo | Bowie | 2

Do | Owings Mills | 3

Do | Easton | 4

Laurel | Bowie | 2

Do | Owings Mills | 3

Do | Easton | 4

Massachusetts:

Boston | 3

Do | Grafton | 4

Do | Loudon, NH | 5

Do | N. Attleboro | 4

Do | Westerly, RI | 4

Mexico:

Ciudad Acuna | Del Rio, TX | 1 1/2

Do | Eagle Pass, TX | 3

Do | Laredo, TX | 6

Do | Pleasanton, TX | 6

Juarez | El Paso, TX | 1

Nuevo Laredo | Del Rio, TX | 4

Do | Eagle Pass, TX | 5

Do | Laredo, TX | 1 1/2

Do | Pharr, TX | 6

Do | Pleasanton, TX | 5

Ojinaga | El Paso, TX | 6

Do | Presidio, TX | 1

Piedras Negras | Eagle Pass, TX | 1

Do | Laredo, TX | 5

Do | Pharr, TX | 10

Do | Pleasanton, TX | 5

Reynosa (Pharr International Bridge) | Eagle Pass, TX | 12

Do | Hidalgo, TX | 1

Do | Laredo, TX | 5

Do | Mission, TX | 1

Do | Pharr, TX | 1

San Jeronimo | El Paso, TX | 2

Do | Presidio, TX | 6

Do | Santa Theresa, NM | 1

Michigan:

Detroit | 3

Do | Beaverton | 6

Do | Chelsea | 3

Do | Clara | 6

Do | Kalamazoo | 5

Do | Lansing | 4

Do | Port Huran | 4

Port Huron | 1

Do | Beaverton | 6

Do | Chelsea | 6

Do | Clara | 6

Do | Detroit | 3

Do | Lansing | 5

Do | Kalamazoo | 6

Minnesota:

Minneapolis/St. Paul International Airport | 2

Do | Rochester | 3

Do | Princeton | 3

Noyes | Pembina | 1

Missouri:

Kansas City International Airport | Jefferson | 6

St. Louis Airport | Beaufort | 3

St. Louis Zoological Park | ......do | 3

Montana:

Bozeman | 1

Bozeman Laboratory | Bozeman | 1

Great Falls Airport | Great Falls | 1

Do | Helena | 5

Helena | 1

Port of Opheim | Plentywood | 5

Do | Opheim | 1

Port of Raymond | Plentywood | 1

Do | Raymond | 1

Port of Sweetgrass | Great Falls | 5

Do | Shelby | 2

Do | Sunburst/Sweetgrass | 1

Sweetgrass | 1

Nebraska:

Lincoln Airport | 1

New Jersey:

Newark International Airport | Hightstown | 2

Do | Mount Holly | 3

Do | Princeton | 2

Port of Salem | Hightstown | 3 1/2

Do | Mount Holly | 3

Do | Princeton | 4

New Mexico:

Columbus | 1

Do | Las Cruces | 4

Port of Columbus | Deming | 2

New York:

Alexandria Bay | 1

Buffalo | 2

Do | Akron | 2

Champlain | 1

Do | Highgate Springs, VT | 2

Do | Milton, VT | 3

Do | Calais, VT | 5

Malone | Champlain | 3

Newburgh | 1

Do | New York, NY | 4

New York | 3

Niagara Falls | Akron | 2

Odgensburg | 1

Port of Albany | 1

Rochester | Buffalo | 4

Rooseveltown | Odgensburg | 2

Rouses Point | Champlain | 1

Stewart Airport, Newburgh | Albany | 4

North Carolina:

Iredell | Franklin | 6

Do | Lumberton | 6

Do | Raleigh | 6

North Dakota:

Dunseith | Minot | 4

Do | Pembina | 6

Minot | 1

Peace Gardens | Bottineau | 1

Pembina | 1

Do | Fargo | 6

Do | Valley City | 6

Portal | 1

Do | Bismarck | 6

Do | Dickinson | 6

Do | Minot | 4

Ohio:

Vandalia Dayton International Airport | Greenville | 2

Do | Pickerington | 3

Wilmington | Greenville | 4

Do | Pickerington | 3

Oregon:

Hermiston | Troutdale | 6

Portland | Salem | 3

Do | Sunny Valley | 6

Do | Tigard | 2

Do | Troutdale | 2

Pennsylvania:

Harrisburg | Camp Hill | 1

Do | Morgantown | 3

Do | Northumberland | 2

Do | Shippensburg | 3

Philadelphia | 3

Puerto Rico:

Aquadilla | Aquadilla | 2

Salinas | San Juan | 4

San Juan | 2

Tennessee:

Fort Campbell, Clarkesville | Nashville | 2

Memphis | 2

Memphis | Gadsden | 4

Memphis | Jackson | 4

Nashville | 2

Texas:

Brownsville | 1

Do | Laredo or San Antonio | 6

Brownsville and Brownsville International Airport | Harlingen and San Benito | 1

Do | McAllen or Edinburg | 3

Do | Weslaco | 2

Dallas-Fort Worth International Airport | Decatur | 2

Do | Ft. Worth or Dallas | 2

Del Rio | 1

Do | Eagle Pass | 3

Do | Edinburg, McAllen or Mission | 6

Do | Laredo or San Antonio | 5

Eagle Pass | 1

Do | Del Rio | 3

Do | Edinburgh, McAllen or Mission | 6

Do | Laredo or San Antonio | 5

El Paso | 1

Do | Hatchita or Deming, NM | 6

Do | Las Cruces, NM | 3

Forney | Corsicana | 3

Do | Ft. Worth | 3

Do | Tyler | 3

Harlingen | Edinburg, McAllen or Mission | 2

Do | Weslaco | 1

Hidalgo | Brownsville | 3

Do | Edinburg, Mission and McAllen | 1

Do | Harlingen | 2

Do | Lyford | 2

Do | Rio Grande City | 2

Houston (including Houston Intercontinental Airport) | 2

Do | Bellville, TX | 4

Do | Bryan, TX | 4

Do | Georgetown, TX | 8

Do | Pleasanton, TX | 8

Laredo | 1

Do | Brownsville or San Antonio | 6

Do | Eagle Pass | 5

Do | McAllen, Edinburg or Mission | 6

Presidio | 1

Do | El Paso | 6

Utah:

Salt Lake City | Murray and Ogden | 2

Vermont:

Burlington International Airport | Burlington | 1

Do | Milton | 1

Do | Calais | 3

Derby Line | Milton | 4

Do | Calais | 4

Highgate | 1

Do | Milton | 2

Do | Calais | 4

Highgate Springs | ......do | 1

Virginia:

Dulles International Airport | Annapolis, MD | 3

Do | Richmond | 5

Do | Warrenton | 3

Port of Richmond | 2

Washington:

Blaine | 1

Do | Seattle | 6

Lynden | Blaine | 2

Do | Seattle | 6

Moses Lake | Oroville, WA | 6

Do | Spokane | 5

Do | Wenatchee | 3

Do | Yakima | 4

Oroville | 1

Sea-Tac Airport | Olympia | 3

Seattle | 2

Sumas | Blaine | 2

Do | Olympia | 6

Do | Seattle | 6

Tacoma | ......do | 3

Yelm | Olympia | 2

Do | Seattle | 3

Wisconsin:

Barron | Ripon | 6

Madison | 1

Monroe | Madison | 3

[39 FR 41356, Nov. 27, 1974]

Editorial Note:For Federal Register citations affecting § 97.2, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

§ 98.1 Prohibition.

An embryo shall not be imported or entered into the United States unless in accordance with the provisions of this part.

[50 FR 43563, Oct. 25, 1985. Redesignated at 56 FR 58808, Oct. 30, 1991]

§ 98.2 Definitions.

The following terms, when used in this subpart, shall be construed as defined. Those terms used in the singular form in this subpart shall be construed as the plural form and vice versa, as the case may demand.

Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.

Animal. Any cattle, sheep, goats, other ruminants, swine, horses, or asses.

Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the United States Department of Agriculture (APHIS).

Approved artificial insemination center. A facility approved or licensed by the national government of the region in which the facility is located to collect and process semen under the general supervision of such government.

Approved embryo transfer unit. A facility approved or licensed by the national government of the region in which the facility is located for the artificial insemination of donor dams or for conception as a result of artificial breeding by a donor sire and for collecting and processing embryos for export under the general supervision of such government.

Department. The United States Department of Agriculture.

Embryo. The initial stage of an animal's development after collection from the natural mother, while it is capable of being transferred to a recipient dam, but not including an embryo that has been transferred to a recipient dam.

Enter (entered, entry) into the United States. To introduce into the commerce of the United States after release from governmental detention at the port of entry.

Flock. A herd.

Herd. All animals maintained on any single premises; and all animals under common ownership or supervision on two or more premises which are geographically separated, but among which there is an interchange or movement of animals.

Import (imported, importation) into the United States. To bring into the territorial limits of the United States.

Inspector. An employee of APHIS who is authorized to perform the function involved.

Oocyte. The first and second maturation stages of a female reproductive cell prior to fertilization.

Person. Any individual, corporation, company, association, firm, partnership, society, joint stock company, or any other legal entity.

Region. Any defined geographic land area identifiable by geological, political, or surveyed boundaries. A region may consist of any of the following:

(1) A national entity (country);

(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.)

(3) Parts of several national entities combined into an area; or

(4) A group of national entities (countries) combined into a single area.

Transmissible spongiform encephalopathies (TSEs). A family of progressive and generally fatal neurodegenerative disorders thought to be caused by abnormal proteins, called prions, typically producing characteristic microscopic changes, including, but not limited to, noninflammatory neuronal loss, giving a spongiform appearance to tissues in the brains and nervous systems of affected animals.

United States. All of the several States of the United States, the District of Columbia, Guam, the Northern Mariana Islands, Puerto Rico, the Virgin Islands of the United States and all other territories and possessions of the United States.

[50 FR 43563, Oct. 25, 1985. Redesignated and amended at 56 FR 55808, Oct. 30, 1991; 57 FR 29194, July 1, 1992; 61 FR 17241, Apr. 19, 1996; 62 FR 56025, Oct. 28, 1997; 86 FR 68862, Dec. 3, 2021]

§ 98.3 General conditions.

Except as provided in subpart B of this part, an animal embryo shall not be imported into the United States unless it is from a region listed under § 94.1(a) of this chapter as being free of foot-and-mouth disease, and:

(a) The embryo is exported to the United States from the region in which it was conceived;

(b) The embryo was conceived as a result of artificial insemination with semen collected from a donor sire at an approved artificial insemination center, or the embryo as conceived as a result of natural breeding by a donor sire at an approved embryo transfer unit;

(c) If artificially inseminated, the donor dam conceived the embryo after being inseminated in an approved embryo transfer unit with semen collected at an approved artificial insemination center;

(d) At the time of collection of the semen used to conceive the embryo or at the time of natural breeding, the donor sire met all requirements the donor sire would have to meet under part 93 of this chapter for a health certificate required as a condition of importation into the United States; except that, for sheep and goats only, the donor sire must meet the scrapie requirements in § 98.35 instead of the requirements in § 93.435 of this chapter;

(e) At the time of collection of the embryo from the donor dam, the donor dam met all requirements the donor dam would have to meet under part 93 of this chapter for a health certificate required as a condition of importation into the United States; except that, for sheep and goats only, the donor dam must meet the requirements for embryo donors in § 98.10(a) instead of the requirements in § 93.435 of this chapter;

(f) There is no basis for denying an import permit for the donor sire or donor dam under § 93.304(a)(2) for horses, § 93.404(a)(3) or (4) for ruminants, and § 93.504(a)(2) or (3) for swine of this chapter;

(g) The embryo is collected and maintained under conditions determined by the Administrator to be adequate to protect against contamination of the embryo with infectious animal disease organisms; and

(h) The embryo was determined, based on microscopic examination, to have an intact zona pellucida at the time the embryo was placed into its immediate container (straw or ampule) for shipping.

(i) The embryo is contained in a shipping container which at the time of offer for entry is sealed with an official seal which was affixed to the shipping container by a full-time salaried veterinarian of the national animal health service of the region of origin or by a veterinarian authorized to do so by the national animal health service of the region of origin.

[50 FR 43563, Oct. 25, 1985, as amended at 55 FR 31558, Aug. 2, 1990; 56 FR 55809, Oct. 30, 1991; 57 FR 29194, July 1, 1992; 62 FR 56025, Oct. 28, 1997; 77 FR 1396, Jan. 10, 2012; 83 FR 15494, Apr. 11, 2018; 86 FR 68863, Dec. 3, 2021]

§ 98.4 Import permit.

(a) Except as provided in subpart B of this part, an animal embryo shall not be imported into the United States unless accompanied by an import permit issued by APHIS and unless imported into the United States within 14 days after the proposed date of arrival stated in the import permit.

(b) An application for an import permit must be submitted to the Animal and Plant Health Inspection Service, Veterinary Services, Strategy and Policy, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231. An application form for an import permit may be obtained from this staff.

(c) The completed application shall include the following information:

(1) The name and address of the person intending to export an embryo from the region of origin,

(2) The name and address of the person intending to import an embryo,

(3) The species, breed, and number of embryos to be imported,

(4) The purpose of the importation,

(5) The region in which the embryo is conceived,

(6) The port of embarkation,

(7) The mode of transportation,

(8) The route of travel,

(9) The port of entry in the United States,

(10) The proposed date of arrival in the United States,

(11) The name and address of the person to whom the embryo will be delivered in the United States, and

(12) The measures to be taken to ensure that the embryo is collected and maintained under conditions adequate to protect against contamination of the embryo with infectious animal disease organisms.

(d) Applications for a permit to import sheep and goat embryos and oocytes must include the flock identification number of the receiving flock and the premises or location identification number assigned in the APHIS National Scrapie Database; or, in the case of embryos or oocytes moving to a storage facility, the premises or location identification number must be included.

(e) After receipt and review of the application by APHIS, an import permit indicating the applicable conditions under this subpart for importation into the United States shall be issued for the importation of embryos described in the application if such embryos appear to be eligible to be imported. Even though an import permit has been issued for the importation of an embryo, the embryo may be imported only if all applicable requirements of this subpart are met.

[50 FR 43563, Oct. 25, 1985, as amended at 56 FR 55809, Oct. 30, 1991; 57 FR 29194, July 1, 1992; 59 FR 67616, Dec. 30, 1994; 62 FR 56025, Oct. 28, 1997; 86 FR 45629, Aug. 16, 2021; 86 FR 68863, Dec. 3, 2021]

§ 98.5 Health certificate.

(a) Except as provided in subpart B of this part, an animal embryo shall not be imported into the United States unless it is accompanied by a certificate issued by a full-time salaried veterinary officer of the national government of the region of origin, or issued by a veterinarian designated or accredited by the national government of the region of origin and endorsed by a full-time salaried veterinary officer of the national government of the region of origin, representing that the veterinarian issuing the certificate was authorized to do so. The certificate shall state:

(1) The dates, places, types, and results of all examinations and tests performed on the donor sire and donor dam as a condition for importation of the embryo, and the names and addresses of persons or laboratories conducting the examinations or tests, and a statement that any other requirements established by § 98.3 have been complied with,

(2) The name and address of the consignor and consignee,

(3) The name and address of the approved artificial insemination center where the semen for the embryo was collected, if applicable,

(4) The name and address of the approved embryo transfer unit where the donor dam was inseminated or bred and the embryo was collected, and

(5) The measures taken to ensure that the embryo was collected and maintained under conditions adequate to protect against contamination of the embryo with infectious animal disease organisms.

(b) [Reserved]

(Approved by the Office of Management and Budget under control numbers 0579-0040 and 0579-0453)

[50 FR 43563, Oct. 25, 1985, as amended at 56 FR 55809, Oct. 30, 1991; 61 FR 15183, Apr. 5, 1996; 61 FR 17241, Apr. 19, 1996; 62 FR 56025, Oct. 28, 1997; 86 FR 68863, Dec. 3, 2021]

§ 98.6 Ports of entry.

An embryo shall not be imported into the United States unless at a port of entry listed in § 93.303 for horses, § 93.403 for ruminants, or § 93.503 for swine of this chapter.

[50 FR 43563, Oct. 25, 1985, as amended at 55 FR 31558, Aug. 2, 1990; 62 FR 56025, Oct. 28, 1997]

§ 98.7 Declaration upon arrival.

Upon arrival of an embryo at a port of entry, the importer or the importer's agent shall notify APHIS of the arrival by giving an inspector a document stating:

(a) The port of entry,

(b) The date of arrival,

(c) Import permit number,

(d) Carrier, and identification of the means of conveyance,

(e) The name and address of the importer,

(f) The name and address of the broker,

(g) The region of origin of the embryo,

(h) The number, species, and purpose of importation of the embryo, and

(i) The name and address of the person to whom the embryo will be delivered.

[50 FR 43563, Oct. 25, 1985, as amended at 57 FR 29194, July 1, 1992; 62 FR 56025, Oct. 28, 1997]

§ 98.8 Inspection.

Any embryo offered for entry into the United States in accordance with this subpart and documents accompanying the embryo shall be subject to inspection by an inspector at the time the embryo is offered for entry in order to determine whether the embryo is eligible for entry. The import permit and the health certificate shall be given to the inspector.

[50 FR 43563, Oct. 25, 1985, as amended at 56 FR 55809, Oct. 30, 1991]

§ 98.9 Embryos refused entry.

Any embryo refused entry into the United States for noncompliance with the requirements of this subpart shall be removed from the United States within a time period specified by the Administrator or abandoned by the importer for destruction, and pending such action shall be subject to such safeguards as the inspector determines necessary to prevent the possible introduction into the United States of infectious animal diseases. If such embryo is not removed from the United States within such time period, or abandoned for destruction, it may be seized, destroyed, or otherwise disposed of as the inspector determines necessary to prevent the possible introduction into the United States of infectious animal diseases.

[50 FR 43563, Oct. 25, 1985, as amended at 56 FR 55809, Oct. 30, 1991; 57 FR 29194, July 1, 1992]

§ 98.10 Other importations.

Notwithstanding other provisions in this part, the Administrator may in specific cases allow the importation and entry into the United States of embryos other than as provided for in this part under such conditions as the Administrator may prescribe to prevent the introduction into the United States of infectious animal diseases.

[50 FR 43563, Oct. 25, 1985, as amended at 57 FR 29194, July 1, 1992]

§ 98.10a Sheep and goat embryos and oocytes.

(a) Sheep and goat embryos or oocytes collected from donors located in, or originating from, regions recognized by APHIS as free of classical scrapie, or from a flock or herd having certified status in a scrapie flock certification program recognized by APHIS as acceptable, may be imported in accordance with §§ 98.3 through 98.8. In addition to the requirements of § 98.5, the health certificate must indicate that the embryos or oocytes were collected, processed, and stored in conformity with the requirements in § 98.3(g).

(b) In vivo-derived sheep and goat embryos or oocytes collected from donors located in, or originating from, regions or flocks not recognized by APHIS as free of classical scrapie, may be imported in accordance with §§ 98.3 through 98.8 and the following conditions:

(1) The embryos or oocytes must be accompanied by a health certificate meeting the requirements listed in § 98.5, and with the following additional certifications:

(i) The embryos or oocytes were collected, processed and stored in conformity with the requirements in § 98.3(g).

(ii) For in vivo-derived sheep embryos only: The embryo is of the genotype AAQR or AARR based on official testing of the parents or the embryo.

(iii) Certificates for sheep embryos not of the genotype AAQR or AARR, and for all goat embryos, must contain the following additional certifications:

(A) In the country or zone:

(1) TSEs of sheep and goats are compulsorily notifiable to the national veterinary authority of the region;

(2) A scrapie awareness, surveillance, monitoring, and control system is in place;

(3) TSE-affected sheep and goats are killed and completely destroyed; and

(4) The feeding to sheep and goats of meat-and-bone meal of ruminant origin has been banned and the ban is effectively enforced in the whole country.

(B) The donor animals:

(1) Have been kept since birth in flocks or herds where no case of scrapie had been confirmed during their residency; and

(2) Are permanently identified to enable a traceback to their flock or herd of origin, and this identification is recorded on the certificate accompanying the embryo(s) and linked to the embryo container identification; and

(3) Showed no clinical sign of scrapie at the time of embryo/oocyte collection; and

(4) Have not tested positive for, and are not suspect for, a transmissible spongiform encephalopathy; and

(5) Are not under movement restrictions within the country or region of origin as a result of exposure to a transmissible spongiform encephalopathy.

(2) [Reserved]

(c) Any additional certifications or testing requirements established by APHIS, based on genetic susceptibility of the embryo or embryo parents, and/or on scrapie testing of the embryo donor, will be listed in the APHIS import permit. Such certifications or required test results must also be recorded on the health certificate accompanying the embryo(s).

(d) Sheep and goat embryos or oocytes may only be imported for transfer to recipient females in the United States if the flock or herd where the recipients reside is listed in the National Scrapie Database; except APHIS may permit importation of sheep and goat embryos or oocytes to an APHIS-approved storage facility where they may be kept until later transferred to recipient females in a flock or herd in the United States listed in the APHIS National Scrapie Database, and under such conditions as the Administrator deems necessary to trace the movement of the imported embryos or oocytes. Imported sheep or goat embryos or oocytes not otherwise restricted by the conditions of an import permit may be transferred from a listed flock or herd to any other listed flock or herd, or from an embryo storage facility to a listed flock or herd, with written notification to the responsible APHIS Veterinary Services Service Center.

(e) The importer, the owner of a recipient flock or herd where delivery of the embryos or oocytes is made, or the owner of an APHIS-approved embryo or oocyte storage facility must maintain records of the disposition (including destruction) of imported or stored embryos or oocytes for 5 years after the embryo or oocyte is transferred or destroyed. These records must be made available during normal business hours to APHIS representatives on request for review and copying.

(f) For in vitro-derived and manipulated sheep or goat embryos and oocytes, APHIS will make a case-by-case determination or establish conditions in an import permit that includes any additional mitigations deemed necessary to prevent the introduction of disease as provided in § 98.10.

(g) The owner of all sheep or goats resulting from embryos or oocytes imported under this section shall:

(1) Identify them at birth with a permanent official identification number consistent with the provisions of § 79.2 of this chapter; such identification may not be removed except at slaughter and must be replaced if lost;

(2) Maintain a record linking the official identification number to the imported embryo or oocyte including a record of the replacement of lost tags;

(3) Maintain records of any sale or disposition of such animals, including the date of sale or disposition, the name and address of the buyer, and the animal's official identification number; and

(4) Keep the required records for a period of 5 years after the sale or death of the animal. APHIS may view and copy these records during normal business hours.

(Approved by the Office of Management and Budget under control numbers 0579-0040, 0579-0101, and 0579-0453)

[86 FR 68863, Dec. 3, 2021]

§ 98.11 Definitions.

Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the United States Department of Agriculture.

Camelid. All species of the family Camelidae, including camels, guanacos, llamas, alpacas, and vicunas.

Cervid. All members of the family Cervidae and hybrids, including deer, elk, moose, caribou, reindeer, and related species.

Collection of embryos. Embryos removed from a single donor dam in one operation.

Embryo. The initial stages of development of an animal, after collection from the natural mother and while it is capable of being transferred to a recipient dam, but not after it has been transferred to a recipient dam.

Embryo collection unit. Area or areas where the donor dam will be bred to produce embryos for importation into the United States, and where the embryos will be collected, processed, and stored pending shipment to the United States.

Foreign Animal Disease Diagnostic Laboratory. The Foreign Animal Disease Diagnostic Laboratory of the Animal and Plant Health Inspection Service.

Herd of origin. The herd in which the donor dam is kept during the 60 days before the donor dam is required to be housed in an embryo collection unit, in accordance with § 98.17(a) of this subpart.

Import. To bring into the territorial limits of the United States.

Inspector. An employee of the Animal and Plant Health Inspection Service who is authorized to perform the function involved.

Official veterinarian. A full-time salaried veterinarian of the national government of the country of origin or a veterinarian employed by the Animal and Plant Health Inspection Service (APHIS), and designated by APHIS to supervise or conduct procedures required by this subpart, and to certify that requirements of this subpart have been met.

Person. Any individual, corporation, company, association, firm, partnership, society, joint stock company, or other legal entity.

Region. Any defined geographic land area identifiable by geological, political, or surveyed boundaries. A region may consist of any of the following:

(1) A national entity (country);

(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.);

(3) Parts of several national entities combined into an area; or

(4) A group of national entities (countries) combined into a single area.

Region of origin. The region in which the embryo is conceived and collected and from which the embryo is imported into the United States.

Ruminant. All animals which chew the cud, including cattle, buffaloes, camelids, cervids (deer, elk, moose, and antelope), sheep, goats, and giraffes.

Swine. The domestic hog and all varieties of wild hogs.

United States. All of the States of the United States, the District of Columbia, Guam, the Northern Mariana Islands, Puerto Rico, the Virgin Islands of the United States, and all other territories and possessions of the United States.

[56 FR 55809, Oct. 30, 1991, as amended at 61 FR 15183, Apr. 5, 1996; 62 FR 56025, Oct. 28, 1997; 78 FR 73008, Dec. 4, 2013]

§ 98.12 General prohibitions.

(a) Ruminant and swine embryos may not be imported from regions where foot-and-mouth disease exists except in accordance with this subpart.

(b) Ruminant and swine embryos may not be imported into the United States from any region other than the region in which they were conceived and collected.

[56 FR 55809, Oct. 30, 1991, as amended at 61 FR 15183, Apr. 5, 1996; 62 FR 56025, Oct. 28, 1997; 83 FR 15494, Apr. 11, 2018]

§ 98.13 Import permit.

(a) Ruminant and swine embryos and all test samples required by this subpart may be imported into the United States from regions where foot-and-mouth disease exists only if accompanied by import permits issued by the Animal and Plant Health Inspection Service (APHIS).

(b) An application for the import permits must be submitted to the Animal and Plant Health Inspection Service, Veterinary Services, Strategy and Policy, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231. Application forms also may be obtained at this same address. The application for a permit to import embryos will also serve as the application for a permit to import test samples for those embryos; separate applications are not required. The application must include the following information:

(1) The name and address of the exporter;

(2) The name and address of the importer;

(3) The name and address of the place where the donor dam will be bred and where the embryo(s) will be collected;

(4) The species, breed, and number of embryos to be imported;

(5) The purpose of the importation;

(6) The port of embarkation;

(7) The mode of transportation;

(8) The route of travel;

(9) The port of entry in the United States;

(10) The proposed date of arrival in the United States; and

(11) The name and address of the person to whom the embryos will be delivered in the United States.

(c) Applications for a permit to import sheep and goat embryos and oocytes must include the flock identification number of the receiving flock and the premises or location identification number assigned in the APHIS National Scrapie Database; or, in the case of embryos or oocytes moving to a storage facility, the premises or location identification number must be included.

(Approved by the Office of Management and Budget under control number 0579-0040)

[56 FR 55809, Oct. 30, 1991, as amended at 59 FR 67616, Dec. 30, 1994; 61 FR 15183, Apr. 5, 1996; 62 FR 56025, Oct. 28, 1997; 83 FR 15494, Apr. 11, 2018; 86 FR 45629, Aug. 16, 2021; 86 FR 68864, Dec. 3, 2021]

§ 98.14 Health certificate.

(a) Ruminant and swine embryos shall not be imported into the United States unless they are accompanied by a certificate issued by a full-time salaried veterinary officer of the national government of the region of origin, or issued by a veterinarian designated or accredited by the national government of the region of origin and endorsed by a full-time salaried veterinary officer of the national government of the region of origin, representing that the veterinarian issuing the certificate was authorized to do so.

(b) The health certificate must state:

(1) The name and address of the place where the embryos were collected;

(2) The name and address of the veterinarian who collected the embryos;

(3) The date of embryo collection;

(4) The identification and breed of the donor dam and donor sire;

(5) The number of ampules or straws covered by the health certificate and the identification number or code on each ampule or straw;

(6) The dates, types, and results of all examinations and tests performed on the donor dam and donor sire as a condition for importing the embryos;

(7) The dates and results of all tests performed on unfertilized eggs, nontransferrable embryos, and embryo collection and wash fluids;

(8) The names and addresses of the consignor and consignee;

(9) That the embryos are being imported into the United States in accordance with subpart B of 9 CFR part 98.

(c) If any of the information required by paragraph (b) of this section is provided in code, deciphering information must be attached to the health certificate.

(d) The health certificate accompanying sheep or goat embryos intended for importation from any part of the world shall, in addition to the statements required by paragraph (b) of this section, state that:

(1) The embryos' sire and dam have not been in any flock or herd nor had contact with sheep or goats which have been in any flock or herd where scrapie has been diagnosed or suspected during the 5 years prior to the date of collection of the embryos;

(2) The embryos' sire and dam showed no evidence of scrapie at the time the embryos were collected;

(3) Scrapie has not been suspected nor confirmed in any progeny of the embryos' donor dam; and

(4) The parents of the embryos' sire and dam are not, nor were not, affected with scrapie.

(e) There must be a separate health certificate for each collection of embryos.

(Approved by the Office of Management and Budget under control number 0579-0040)

[56 FR 55809, Oct. 30, 1991, as amended at 61 FR 15183, Apr. 5, 1996; 61 FR 17242, Apr. 19, 1996; 62 FR 56025, Oct. 28, 1997]

§ 98.15 Health requirements.

Ruminant and swine embryos may be imported from a region where foot-and-mouth disease exists only if all of the following conditions are met:

(a) The donor dam is determined to be free of communicable diseases based on tests, examinations, and other requirements, as follows:

(1) During the year before embryo collection, no case of the following diseases occurred in the embryo collection unit or in any herd in which the donor dam was present:

(i) Ruminant: Contagious bovine pleuropneumonia, foot-and-mouth disease, Rift Valley fever, or vesicular stomatitis; or

(ii) Swine: African swine fever, foot-and-mouth disease, classical swine fever, pseudorabies, swine vesicular disease, or vesicular stomatitis.

(2) During the year before embryo collection, no case of the following diseases occurred within 5 kilometers of the embryo collection unit or in any herd in which the donor dam was present:

(i) Ruminant: Contagious bovine pleuropneumonia, foot-and-mouth disease, Rift Valley fever, or vesicular stomatitis; or

(ii) Swine: African swine fever, foot-and-mouth disease, classical swine fever, pseudorabies, swine vesicular disease, or vesicular stomatitis.

(3) During the 60 days before embryo collection, the donor dam did not receive a vaccination for foot-and-mouth disease.

(4) During the 60 days before the donor dam was required to be in the embryo collection unit, in accordance with § 98.17(a) of this subpart, the donor dam remained in the same herd, and no ruminants or swine were added to that herd.

(5)(i) On the day of embryo collection, and again not less than 30 days nor more than 120 days afterward, one sample of at least 10 ml of serum was collected from the donor dam, frozen, and sent to the Foreign Animal Disease Diagnostic Laboratory for testing.

(ii) The donor dam was determined to be free of foot-and-mouth disease based upon tests of the pair of serum samples. In addition, if any of the following diseases exist in the region of origin, the donor dam was determined to be free of these diseases based upon additional tests of the serum samples:

(A) Ruminant: Contagious bovine pleuropneumonia, Rift Valley fever, or vesicular stomatitis; or

(B) Swine: African swine fever, classical swine fever, pseudorabies, swine vesicular disease, or vesicular stomatitis.

(iii) If the donor dam was in any herd during the year before embryo collection that was not certified free of brucellosis by the national government of the region of origin, the donor dam was determined to be free of brucellosis based on tests of the serum samples.

(iv) The only official test results will be those provided by the Foreign Animal Disease Diagnostic Laboratory.

(6) If the donor dam was in any herd during the year before embryo collection that was not certified free of tuberculosis by the national government of the region of origin, the donor dam was determined to be free of tuberculosis by an official veterinarian based on an intradermal tuberculin test. The test must have been administered to the donor dam by an official veterinarian not less than 30 days nor more than 120 days after embryo collection, and not less than 60 days after any previously administered intradermal test for tuberculosis.

(7)(i) Not less than 30 days nor more than 120 days after embryo collection, the donor dam was examined by an official veterinarian and found free of clinical evidence of the following diseases:

(A) Ruminant: Brucellosis, contagious bovine pleuropneumonia, foot-and-mouth disease, Rift Valley fever, tuberculosis, and vesicular stomatitis; or

(B) Swine: African swine fever, brucellosis, foot-and-mouth disease, classical swine fever, pseudorabies, swine vesicular disease, tuberculosis, and vesicular stomatitis.

(ii) All signs of any other communicable disease must be listed on the health certificate that accompanies the embryos to the United States.

(8)(i) Between the time the embryos were collected and all examinations and tests required by this subpart were completed, no animals in the embryo collection unit with the donor dam, or in the donor dam's herd of origin, exhibited any clinical evidence of:

(A) Ruminant: Brucellosis, contagious bovine pleuropneumonia, foot-and-mouth disease, Rift Valley fever, tuberculosis, and vesicular stomatitis; or

(B) Swine: African swine fever, brucellosis, foot-and-mouth disease, classical swine fever, pseudorabies, swine vesicular disease, tuberculosis, and vesicular stomatitis.

(ii) All signs of any other communicable disease must be listed on the health certificate that accompanies the embryos to the United States.

(b) The donor dam or donor sire is determined to be free of communicable diseases based on other testing or certifications if required by the Administrator. The Administrator may require additional testing or certifications if he or she determines that they are necessary to determine either the donor dam's or the donor sire's freedom from communicable diseases. Circumstances that may result in additional testing or certifications include, but are not limited to:

(1) The existence of communicable diseases of livestock, other than those diseases specifically listed, in the region of origin;

(2) A high prevalence or an increase in the incidence of a communicable disease in the region of origin;

(3) The use of natural breeding, rather than artificial insemination to conceive the embryos;

(4) The use of fresh, rather than frozen semen, for artificial insemination; and

(5) The use of semen collected at a site other than an artificial insemination center approved by the national government of the region of origin.

(c) Embryos produced by any donor dam or sire that dies before being examined and tested as required under this subpart will not be eligible for importation into the United States.

[56 FR 55809, Oct. 30, 1991, as amended at 61 FR 15183, Apr. 5, 1996; 62 FR 56025, Oct. 28, 1997; 68 FR 16940, Apr. 7, 2003; 78 FR 73008, Dec. 4, 2013; 83 FR 15494, Apr. 11, 2018; 86 FR 68864, Dec. 3, 2021]

§ 98.16 The embryo collection unit.

Ruminant and swine embryos may be imported into the United States from a region where foot-and-mouth disease exists only if they were conceived, collected, processed, and stored prior to importation at an embryo collection unit. The embryo collection unit may be located on the premises where the donor dam's herd of origin is kept, or at any other location, provided that the embryo collection unit has been inspected and approved by an APHIS veterinarian and that the following requirements are met:

(a) Animal holding and breeding area(s). The embryo collection unit must have an area or areas for holding the donor dams and for breeding them (either natural breeding or artificial insemination).

(b) Embryo collection area. The embryo collection must have a room or outdoor area for collection of embryos that contains a device or devices for restraining embryo donors during embryo collection. If a room, the floor, walls, and ceiling must be impervious to moisture and constructed of materials that can withstand repeated cleaning and disinfection. If an outdoor area, the area must have a floor that is impervious to moisture and is constructed of materials that can withstand repeated cleaning and disinfection. If the outdoor area also has walls or a roof, the walls or roof also must be impervious to moisture and be constructed of materials that can withstand repeated cleaning and disinfection.

(c) Embryo processing area. The embryo collection unit must have an enclosed room, which may be mobile, that is used only for processing embryos. The walls, floor, and ceiling of the room must be impervious to moisture and constructed of materials that can withstand repeated cleaning and disinfection. The room must contain a work surface for handling the embryos, such as a table or countertop that is impervious to moisture. The room also must contain a microscope with a minimum of 50x magnification, and equipment for freezing the embryos.

(d) Embryo storage area. The embryo collection unit must have one lockable area that is used only for storing frozen embryos intended for importation into the United States.

(e) Area for cleaning and disinfecting or sterilizing equipment. The embryo collection unit must have an enclosed room used for cleaning and disinfecting or sterilizing equipment used for artificial insemination or for collection, processing, or storage of embryos. The walls, floor, and ceiling of the room must be impervious to moisture and constructed of materials that can withstand repeated cleaning and disinfection.

[56 FR 55809, Oct. 30, 1991, as amended at 61 FR 15184, Apr. 5, 1996; 62 FR 56025, Oct. 28, 1997; 83 FR 15494, Apr. 11, 2018]

§ 98.17 Procedures.

(a) Housing of the donor dam. (1) Beginning at least 24 hours before a donor dam is bred to produce embryos for importation to the United States, the donor dam must be housed at an embryo collection unit.

(2) The donor dam must remain at the embryo collection unit until the embryos for importation into the United States have been collected.

(3) After collection of embryos, the donor dam must either remain at the embryo collection unit or be returned to the herd of origin and remain there until all examinations and tests required by this subpart have been completed.

(4) During the time the donor dam is in the embryo collection unit, in accordance with paragraphs (a)(1) through (a)(3) of this section, no animals may be in the embryo collection unit with the donor dam unless:

(i) They meet the requirements of § 98.15 of this subpart that are applicable to the donor dam at that time;

(ii) They are part of the donor dam's herd of origin; or

(iii) They are serving as donor sires for the production of embryos to be imported into the United States.

(b) Oversight and supervision. (1) All procedures associated with the production of embryos for importation into the United States, including artificial insemination, natural breeding, and cleaning and disinfection, must be performed under the oversight of an APHIS veterinarian. Collecting test samples, and collecting, processing, and storing embryos, must be supervised in person by an APHIS veterinarian.

(2) Officials from the Animal and Plant Health Inspection Service must be given access to all areas of the embryo collection unit and the donor dam's herd of origin during the time the donor dam is housed there, in accordance with paragraphs (a)(1) through (a)(3) of this section.

(c) Personnel. All personnel must put on clean outer garments, including disinfected boots, and must scrub their hands with soap and water each time they enter the embryo collection unit and before entering any room or area listed in § 98.16 of this subpart.

(d) Cleaning, disinfection, and sterilization. (1) All equipment that comes in contact with embryos or with media used for their collection or processing must be sterile. Equipment used for embryos from one donor dam, or with associated media, may not be used for embryos or associated media from any other donor dam until it has been resterilized.

(2) All equipment that comes in contact with a donor dam's secretions or excretions must be sterile and may not be used with any other donor dam until it has been resterilized.

(3) Containers used for storing embryos or for shipping embryos to the United States must be examined and found free of any organic matter and then disinfected before the ampules or straws are placed inside.

(4) The floor, ceiling, and walls of any room or outdoor area used for embryo collection, and the restraining device(s) used for this procedure, must be cleaned with soap and water and disinfected before the room or area is used to collect embryos intended for importation to the United States, and at least daily while in use for this purpose.

(5) The room and work surface used for processing embryos must be kept free of insects, rodents, trash, manure, and other animal matter and must be cleaned with soap and water and disinfected before the room is used for embryos intended for importation to the United States, and the work surface must be cleaned and disinfected at least daily while in use for this purpose.

(6) The area of the embryo collection unit used to store embryos intended for importation to the United States must be kept free of insects, rodents, trash, manure, and other animal matter and must be cleaned with soap and water and disinfected before being used to store the embryos.

(7) The room used for cleaning and disinfecting or sterilizing equipment used for artificial insemination or for collection, processing, or storage of embryos must be kept free of insects, rodents, trash, manure, and other animal matter and must be cleaned with soap and water and disinfected before being used to prepare equipment for donors of embryos intended for importation into the United States, and at least daily while in use for this purpose.

(e) Media; cryogenic agent. (1) All media containing products of animal origin and used for embryo collection and processing must be from sources in the United States or Canada.

(2) The liquid nitrogen used to freeze embryos may not have been used previously for any other products of animal origin.

(f) Collection and processing of embryos. (1) If embryos are collected in an outdoor area, they must be collected by using a closed collection system so that the embryos are not exposed to open air until they are inside the embryo processing room.

(2) Embryos from donors that do not meet the requirements of § 98.15 of this subpart that are applicable at the time of embryo collection may not be in the processing room at the same time as embryos intended for importation into the United States.

(3) Each embryo must be washed at least 10 times. Each wash must be accomplished by transferring the embryo into an aliquot of fresh medium that is 100 times the volume of the embryo plus any fluid transferred from the previous wash. No more than 10 embryos from the same flush may be washed together. A sterile micropipette must be used for each transfer, and the embryos must be well agitated throughout the entire volume of the wash before the next transfer. Embryos from different donors may not be washed together.

(4) After the last wash, each embryo must be microscopically examined over its entire surface at not less than 50 × magnification. An embryo may not be imported into the United States unless its zona pellucida is found to be intact and free from any adherent material.

(5) After washing and examination of the zona pellucida, embryos must be individually packaged in sterile ampules or straws and frozen in liquid nitrogen. The donor dam's and sire's identifications and breed, the date of embryo collection, the name and address of the place where the embryos were collected, and an identification number for the straw or ampule must be recorded with indelible markings on each ampule or straw. If any of this information is provided in code, deciphering information must be attached to the health certificate for the embryos.

(6) The Administrator may require additional measures to be taken in processing embryos after collection (for example, adding trypsin to the washes) if he or she determines that such measures are necessary to ensure the embryos freedom from infectious agents that may cause communicable diseases. Circumstances that may result in such additional measures being required include, but are not limited to:

(i) The existence of communicable diseases of livestock, other than those diseases specifically listed, in the region of origin; and

(ii) A high prevalence or an increase in the incidence of a communicable disease in the region of origin.

(g) Preparation of test samples; tests. (1) All nontransferrable embryos and unfertilized eggs from each collection of embryos intended for importation into the United States must be pooled, frozen in liquid nitrogen, and sent to the Foreign Animal Disease Diagnostic Laboratory for testing under the personal supervision of an APHIS veterinarian. The collection and last two wash fluids from the collection of embryos must be frozen and sent to the Foreign Animal Disease Diagnostic Laboratory for testing under the personal supervision of an APHIS veterinarian. Samples from different collections may not be mixed.

(2) All samples collected in accordance with paragraph (g)(1) of this section must be tested and found negative for viral contamination. The wash fluids also must be found negative for bacterial contamination. The only official results for these tests will be those provided by the Foreign Animal Disease Diagnostic Laboratory.

(h) Storage of embryos. (1) Frozen embryos to be imported into the United States must be stored in a locked area or must remain in the custody of an official veterinarian until they are sealed in accordance with paragraph (h)(2) of this section and released for shipment to the United States in accordance with § 98.18(a) of this subpart; except that, the embryos may be moved to a U.S. Department of Agriculture-operated animal import center in either New York, Hawaii, or Florida, under seal and in the custody of that individual, and remain in quarantine there until all tests and examinations required by this subpart have been completed and all test results have been provided by the Foreign Animal Disease Diagnostic Laboratory.

(2) Containers in which embryos will be imported into the United States must be sealed by an official veterinarian with the official seal of the region of origin or, if the official veterinarian is an employee of the Animal and Plant Health Inspection Service, with an official seal of the United States Department of Agriculture. The seal number must be recorded on the health certificate that accompanies the embryos to the United States.

(Approved by the Office of Management and Budget under control number 0579-0040)

[56 FR 55809, Oct. 30, 1991, as amended at 61 FR 15184, Apr. 5, 1996; 62 FR 56026, Oct. 28, 1997]

§ 98.18 Shipment of embryos to the United States.

(a) Release from the embryo collection unit. Except as provided in § 98.17(h)(1) of this subpart, embryos may not be moved from the embryo collection unit until all tests and examinations required by this subpart have been completed and the Import-Export Animals Staff, Veterinary Services, APHIS, has received written notification of all test results from the Foreign Animal Disease Diagnostic Laboratory.

(b) Route. The sealed shipping containers must be routed directly to the U.S. port of entry designated on the import permit.

(c) Ports of entry. The embryos may be imported into the United States only through a port of entry listed in § 93.203(a) of this chapter.

(d) Date of arrival in the United States. Embryos that arrive at the port of entry more than 14 days after the proposed date of arrival stated in the import permit will not be eligible for importation into the United States.

[56 FR 55809, Oct. 30, 1991, as amended at 62 FR 56026, Oct. 28, 1997]

§ 98.19 Arrival and inspection at the port of entry.

(a) Upon arrival at the port of entry, the importer or the importer's agent must present an inspector at the port with the original health certificate and the original import permit for the embryos.

(b) The shipping container and all straws or ampules containing embryos must be made available to an inspector at the port of entry for inspection, and may not be removed from the port of entry until an inspector determines that the embryos are eligible for entry in accordance with this subpart and releases them.

§ 98.20 Embryos refused entry.

If any embryos are determined to be ineligible for importation into the United States upon arrival at the port of entry, the importer must remove the embryos from the United States within 30 days, or the embryos will be destroyed.

§ 98.21 Embryos from sheep in regions other than Australia, Canada, and New Zealand.

Except for embryos from sheep in Australia, Canada, or New Zealand, embryos from sheep may only be imported into the United States if they comply with all applicable provisions of this subpart and with § 98.10a.

(Approved by the Office of Management and Budget under control numbers 0579-0040 and 0579-0101)

[61 FR 17242, Apr. 19, 1996]

§ 98.30 Definitions.

Whenever in this subpart of the following terms are used, unless the context otherwise requires, they shall be construed, respectively, to mean:

Administrator. The Administrator of the Animal and Plant Health Inspection Service or any other employee of the Animal and Plant Health Inspection Service, United States Department of Agriculture, to whom authority has been or may be delegated to act in the Administrator's stead.

Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the United States Department of Agriculture (APHIS or Service.)

Animals. Cattle, sheep, goats, other ruminants, swine, horses, asses, zebras, and poultry.

Cattle. Animals of the bovine species.

Communicable disease. Any contagious, infectious, or communicable disease of domestic livestock, poultry or other animals.

Department. The United States Department of Agriculture (USDA).

Establishment. The premises in which animals are kept.

Flock. A herd.

Herd. All animals maintained on any single premises; and all animals under common ownership or supervision on two or more premises which are geographically separated, but among which there is an interchange or movement of animals.

Horses. Horses, asses, mules, and zebras.

Inspector. An employee of the Animal and Plant Health Inspection Service authorized to perform duties required under this subpart.

Port veterinarian. A veterinarian employed by the Animal and Plant Health Inspection Service to perform duties required under this part at a port of entry.

Poultry. Chickens, doves, ducks, geese, grouse, guinea fowl, partridges, pea fowl, pheasants, pigeons, quail, swans, and turkeys (including eggs for hatching).

Region. Any defined geographic land area identifiable by geological, political, or surveyed boundaries. A region may consist of any of the following:

(1) A national entity (country);

(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.)

(3) Parts of several national entities combined into an area; or

(4) A group of national entities (countries) combined into a single area.

Restricted zone for classical swine fever. An area, delineated by the relevant competent veterinary authorities of the region in which the area is located, that surrounds and includes the location of an outbreak of classical swine fever in domestic swine or detection of the disease in wild boar, and from which the movement of domestic swine is prohibited.

Ruminants. All animals which chew the cud, such as cattle, buffaloes, sheep, goats, deer, antelopes, camels, llamas and giraffes.

Swine. The domestic hog and all varieties of wild hogs.

United States. All of the States of the United States, the District of Columbia, Guam, Northern Mariana Islands, Puerto Rico, the Virgin Islands of the United States, and all other Territories and Possessions of the United States.

[55 FR 31558, Aug. 2, 1990. Redesignated at 56 FR 55809, Oct. 30, 1991; 61 FR 17242, Apr. 19, 1996; 62 FR 56026, Oct. 28, 1997; 65 FR 56777, Sept. 20, 2000; 71 FR 29071, May 19, 2006; 72 FR 67233, Nov. 28, 2007; 76 FR 70039, Nov. 10, 2011; 77 FR 1396, Jan. 10, 2012; 86 FR 68864, Dec. 3, 2021]

§ 98.31 General prohibitions; exceptions.

(a) No product subject to the provisions of this subpart shall be brought into the United States except in accordance with the regulations in this subpart and part 94 of this subchapter; nor shall any such product be handled or moved after physical entry into the United States before final release from quarantine or any other form of governmental detention except in compliance with such regulations; Provided, That, except as prohibited by section 306 of the Act of June 17, 1930, as amended (19 U.S.C. 1306), the Administrator may upon request in specific cases permit products to be brought into or through the United States under such conditions as he or she may prescribe, when he or she determines in the specific case that such action will not endanger the livestock or poultry of the United States.

(b) Animal semen may not be imported into the United States from any region other than the region in which it was collected.

[55 FR 31558, Aug. 2, 1990. Redesignated at 56 FR 55809, Oct. 30, 1991, and amended at 58 FR 37643, July 13, 1993; 59 FR 26596, May 23, 1994; 62 FR 56026, Oct. 28, 1997]

§ 98.32 Inspection of certain aircraft and other means of conveyance and shipping containers thereon; unloading, cleaning, and disinfection requirements.

(a) Inspection: All aircraft and other means of conveyance (including shipping containers thereon) moving into the United States from any foreign region are subject to inspection without a warrant by properly identified and designated inspectors to determine whether they are carrying any animal, carcass, product or article regulated or subject to disposal under any law or regulation administered by the Secretary of Agriculture for prevention of the introduction or dissemination of any communicable animal disease.

(b) Unloading requirements: Whenever in the course of any such inspection at any port in the United States the inspector has reason to believe that the means of conveyance or container is contaminated with material of animal (including poultry) origin, such as, but not limited to, meat, organs, glands, extracts, secretions, fat, bones, blood, lymph, urine, or manure, so as to present a danger of the spread of any communicable animal disease, the inspector may require the unloading of the means of conveyance and the emptying of the container if he or she deems it necessary to enable him or her to determine whether the means of conveyance or container is in fact so contaminated. The principal operator of the means of conveyance and his or her agent in charge of the means of conveyance shall comply with any such requirement under the immediate supervision of, and in the time and manner prescribed by, the inspector.

(c) Cleaning and disinfection: Whenever, upon inspection under this section, an inspector determines that a means of conveyance or shipping container is contaminated with material of animal origin so as to present a danger of the spread of any communicable animal disease, he or she shall notify the principal operator of the means of conveyance or his or her agent in charge, of such determination and the requirements under this section. The person so notified shall cause the cleaning and disinfection of such means of conveyance and container under the immediate supervision of, and in the time and manner prescribed by, the inspector.

(d) For purposes of this section, the term “shipping container” means any container of a type specially adapted for use in transporting any article on the means of conveyance involved.

[55 FR 31558, Aug. 2, 1990. Redesignated at 56 FR 55809, Oct. 30, 1991; 62 FR 56026, Oct. 28, 1997; 68 FR 6345, Feb. 7, 2003]

§ 98.33 Ports designated for the importation of certain animal semen.

(a) Air and ocean ports. The following air and ocean ports are designated as having inspection facilities for the entry of animal semen: Los Angeles, California; Miami, Florida; and Newburgh, New York.

(b) Canadian border ports. The following land border ports are designated as having inspection facilities for the entry of animal semen from Canada: Eastport, Idaho; Houlton and Jackman, Maine; Detroit, Port Huron, and Sault Ste. Marie, Michigan; Baudette, Minnesota; Opheim, Raymond, and Sweetgrass, Montana; Alexandria Bay, Buffalo, and Champlain, New York; Dunseith, Pembina, and Portal, North Dakota; Derby Line and Highgate Springs, Vermont; Oroville and Sumas, Washington.

(c) Mexican border ports. The following land border ports are designated as having inspection facilities for the entry of animal semen from Mexico: Douglas, Naco, Nogales, San Luis, and Sasabe, Arizona; Calexico and San Ysidro, California; Antelope Wells, Columbus, and Santa Teresa, New Mexico; Brownsville, Del Rio, Eagle Pass, El Paso, Hidalgo, Laredo, and Presidio, Texas.

(d) Limited ports. The following limited ports are designated as having inspection facilities for the entry of animal semen: Anchorage and Fairbanks, Alaska; San Diego, California; Jacksonville, St. Petersburg-Clearwater, and Tampa, Florida; Atlanta, Georgia; Honolulu, Hawaii; Chicago, Illinois; New Orleans, Louisiana; Portland, Maine; Baltimore, Maryland; Boston, Massachusetts; International Falls and Minneapolis, Minnesota; Great Falls, Montana; Portland, Oregon; San Juan, Puerto Rico; Memphis, Tennessee; Galveston and Houston, Texas; Seattle, Spokane, and Tacoma, Washington.

(e) Designation of other ports. The Secretary of the Treasury has approved the designation as quarantine stations of the ports specified in this section. In special cases other ports may be designated as quarantine stations under this section by the Administrator, with the concurrence of the Secretary of the Treasury.

[55 FR 31558, Aug. 2, 1990. Redesignated at 56 FR 55809, Oct. 30, 1991, and amended at 58 FR 37643, July 13, 1993; 60 FR 16045, Mar. 29, 1995; 60 FR 25120, May 11, 1995; 64 FR 23179, Apr. 30, 1999; 65 FR 38178, June 20, 2000; 67 FR 68022, Nov. 8, 2002]

§ 98.34 Import permits for poultry semen and animal semen.

(a) Application for permit; reservation required. (1) For poultry semen and animal semen, intended for importation from any part of the world, except as otherwise provided for in § 98.36, the importer shall first apply for and obtain from APHIS an import permit. The application shall specify the name and address of the importer; the species, breed, quantity of animal semen to be imported; the purpose of the importation; individual animal identification (except poultry) which includes a description of the animal, name, age, markings, if any, registration number, if any, and tattoo or eartag; the region of origin; the name and address of the exporter; the port of embarkation in the foreign region; the mode of transportation, route of travel, and the port of entry in the United States; the proposed date of arrival of the animal semen to be imported; and the name of the person to whom the animal semen will be delivered and the location of the place in the United States to which delivery will be made from the port of entry. Additional information may be required in the form of certificates concerning specific diseases to which the animals are susceptible, as well as vaccinations or other precautionary treatments to which the animals or animal semen have been subjected. Notice of any such requirements will be given to the applicant in each case.

(2) An application for permit to import will be denied for semen from ruminants or swine from any region where it has been declared, under section 306 of the Act of June 17, 1930, that foot-and-mouth disease has been determined to exist, except as provided in paragraph (c) of this section.

(3) An application for permit to import poultry semen or animal semen may also be denied because of: Communicable disease conditions in the area or region of origin, or in a region through which the shipment has been or will be transported; deficiencies in the regulatory programs for the control or eradication of animal diseases and the unavailability of veterinary services in the above mentioned regions; the importer's failure to provide satisfactory evidence concerning the origin, history, and health status of the animals or animal semen; the lack of satisfactory information necessary to determine that the importation will not be likely to transmit any communicable disease to livestock or poultry of the United States; or any other circumstances which the Administrator believes require such denial to prevent the dissemination of any communicable disease of livestock or poultry into the United States.

(b) Permit. When a permit is issued, the original and two copies will be sent to the importer. It shall be the responsibility of the importer to forward the original permit and one copy to the shipper in the region of origin, and it shall also be the responsibility of the importer to insure that the shipper presents the copy of the permit to the carrier and makes proper arrangements for the original permit to accompany the shipment to the specified U.S. port of entry for presentation to the collector of customs. Animal semen intended for importation into the United States for which a permit has been issued, will be received at the specified port of entry within the time prescribed in the permit which shall not exceed 14 days from the first day that the permit is effective for all permits. Poultry semen and animal semen for which a permit is required by these regulations will not be eligible for entry if a permit has not been issued; if unaccompanied by such a permit; if shipment is from any port other than the one designated in the permit; if arrival in the United States is at any port other than the one designated in the permit; if the animal semen offered for entry differs from that described in the permit; or if the animal semen is not handled as outlined in the application for the permit and as specified in the permit issued.

(c) Animal semen from regions where foot-and-mouth disease exists. Importation of semen of ruminants or swine, originating in any region designated in paragraph (a) of § 94.1 of this subchapter as a region where foot-and-mouth disease is determined to exist, is prohibited, except that semen from ruminants or swine originating in such a region may be offered for entry into the United States at the port of New York and later released from such port provided the following conditions have been fulfilled:

(1) The importer has applied for and obtained an import permit for the semen in accordance with the provisions of this section and related requirements concerning application therefor, which permit is in effect at the time of importation, and has deposited with the Department prior to the issuance of the permit sufficient funds so as to be available for defraying estimated expenses to be incurred in connection with the proposed semen importation and following the issuance of the permit has deposited such other amounts as may be required from time to time to defray unanticipated costs or increased expenses. Such an import permit may be denied for the reasons specified in paragraph (a)(3) of this section. Furthermore, an import permit will be revoked unless the following conditions have been complied with:

(i) The donor animal shall have been inspected on the farm of origin or on another premises (the inspection may be on another premises only if a veterinarian of the Department has traced the donor animal back to its farm of origin) by a veterinarian of the United States Department of Agriculture who, in cooperation with the veterinary service of the region of origin of the donor animal, shall have determined, insofar as possible, that the donor animal was never infected with foot-and-mouth disease; that the donor animal was never on a farm or other premises where foot-and-mouth disease then existed; that the donor animal has not been on a premises that had an animal that was susceptible to the virus of foot-and-mouth disease and that was exposed to the disease during the 12 months immediately prior to the date of inspection of the donor animal; that the donor animal, if a swine, has never been vaccinated against foot-and-mouth disease; and that the donor animal was free from evidence of other communicable disease;

(ii) The donor animal shall have been permanently identified in a manner satisfactory to a veterinarian of this Department; a blood sample and an oesophageal-pharyngeal tissue sample (O-P sample) from such a donor ruminant and a blood sample from such a donor swine for tests as specified in paragraph (c)(1)(iv) of this section or other tests shall have been collected by a veterinarian of the United States Department of Agriculture and transported by air to the New York Port Veterinarian for delivery to the Foreign Animal Disease Diagnostic Laboratory, Greenport, New York, in containers approved by a veterinarian of this Department, sealed in the region of origin by a veterinarian of this Department; and pending the results of the tests, the donor animal shall have been kept in isolation on the farm of origin or other acceptable location under the supervision of a veterinarian of this Department, and during such isolation period no animal susceptible to foot-and-mouth disease shall have been permitted to enter such farm or location and no other source of exposure to foot-and-mouth disease shall have been present;

(iii) The blood samples from the donor animal shall have been negative to the tests specified in paragraph (c)(1)(iv) of this section made at the Foreign Animal Disease Diagnostic Laboratory, Greenport, New York, and to any other test for foot-and-mouth disease or other communicable disease prescribed by the Administrator.

(iv) In the case of a ruminant, each blood sample collected pursuant to paragraph (c)(1)(ii) or (vi) of this section shall have been tested for foot-and-mouth disease using the virus infection associated (VIA) test and each O-P sample collected pursuant to paragraph (c)(1)(ii) or (iv) of this section shall have been tested for foot-and-mouth disease using the virus isolation test. In the case of a swine, each blood sample collected pursuant to paragraph (c)(1)(ii) or (vi) of this section shall have been tested for foot-and-mouth disease using the virus infection associated (VIA) test and the virus neutralization test.” 1

1 The test procedures for the virus infection associated (VIA) test, the virus isolation test, and the virus neutralization test are available from the Chief, Foreign Animal Disease Diagnostic Laboratory, National Veterinary Services Laboratories, P.O. Box 848, Greenport, NY 11944.

(v) Following isolation, preliminary veterinary inspection, and testing while the donor animal was on the farm of origin or other acceptable location, the donor animal shall have been transported, under such conditions as the Department veterinarian prescribed to prevent exposure of the animal to the virus of foot-and-mouth disease, to an isolation facility properly equipped for the necessary care and maintenance of the donor animal and for the proper collection and handling of semen, approved by a veterinarian of this Department and under the direct supervision of such veterinarian;

(vi) The semen of the donor animal shall have been collected at the approved isolation facility under the direct supervision of a veterinarian of this Department (any number of collections may be made); such veterinarian shall take a 0.5 ml sample of semen from each semen collection; and all handling procedures, such as examination, dilution, refrigeration, and preparation of the semen for shipment, shall have been under the direct supervision of a veterinarian of this Department. In the case of a ruminant, a blood sample and an O-P sample shall have been taken from the donor animal by a veterinarian of the Department within 7 days after the final semen collection, and between 21 to 28 days after the taking of these samples another blood sample shall have been taken from the donor animal by a veterinarian of the Department. In the case of a swine, a blood sample shall have been taken from the donor animal by a veterinarian of the Department within 7 days after the final semen collection, and between 21 to 28 days after the taking of the sample, another blood sample shall have been taken from the donor animal by a veterinarian of the Department.

(2) The semen collected at the approved isolation facility shall have been at all times, except during air transportation to New York, in the custody of a veterinarian of this Department.

(3) The semen for which an import permit has been issued shall have been transported by air to the port of New York in liquid nitrogen containers approved by a veterinarian of this Department; sealed in the region of origin by a veterinarian of this Department; and accompanied by a statement by such veterinarian showing the identification of the donor animal and the dates the semen was collected, along with a certificate regarding the health status of the donor animal as of the date of shipment of the semen to the port of New York. All semen received at the port of New York shall be held under quarantine in liquid nitrogen storage at such port in the custody of APHIS until released or otherwise disposed of as provided in this section.

(4) The donor animal shall have been retained at the approved isolation facility in the region where the semen was collected until all of the applicable samples referred to in paragraph (c)(1)(vi) of this section have been collected by a veterinarian of the Department for tests as specified in paragraph (c)(1)(iv) of this section at the Foreign Animal Disease Diagnostic Laboratory, Greenport, New York, and any other tests as required by the Administrator.

(5) The semen sample from each collection shall have consisted of unprocessed semen without any added substances, and shall have been tested at the Foreign Animal Disease Diagnostic Laboratory, Greenport, New York. Such tests shall have been performed by injecting the semen samples into test animals which are susceptible to foot-and-mouth disease. The semen collected at the approved isolation facility, other than the semen samples, may be held in the region of origin or at the port of New York, at the option of the importer, until all of the testing required to be conducted under this section is completed.

(6) If it is determined that the requirements set forth in this paragraph have been complied with and there are no indications that the donor animal or the semen from the donor animal harbors the virus of foot-and-mouth disease or any other communicable disease and if the donor animal, blood samples from the donor animal, O-P samples (if applicable) from the donor animal, and semen samples from the donor animal are negative to all other tests required, the semen shall be released for shipment to the consignee listed by the importer; otherwise the semen shall be destroyed or disposed of as the Administrator, may direct.

(7) Porcine semen from the People's Republic of China. In addition to the other requirements of this part, porcine semen may be imported into the United States from the People's Republic of China (PRC) only after the official veterinary organization (OVO) of the PRC has certified that the PRC is free of African swine fever, and Teschen's disease, and after the following conditions have been fulfilled:

(i) The donor boars must pass a 60-day isolation/collection period in a facility jointly approved by the OVO of the PRC and the USDA as adequate to prevent exposure of the donor boars to infectious diseases. Any other swine at the isolation facility, such as teaser animals, must also meet the requirements of this paragraph. No animals may be added to the group after the start of the 60-day isolation/collection period. The Department will permit collection of semen to be initiated at the beginning of the isolation/collection period. The facility shall be cleaned and disinfected with a 4 percent sodium carbonate solution used in accordance with applicable label instructions in the presence of OVO quarantine personnel prior to the start of the isolation. During the isolation/collection period, personnel handling the animals shall not have contact with other domestic farm livestock (this term does not include pets such as dogs and cats). Raw animal food wastes (garbage) shall not be fed to the donor boars while in isolation. At the start of the isolation/collection period, and again after 14 days of isolation, all animals offered for collection of semen must be given an intramuscular injection of dihydrostreptomycin at a rate of 25 mg/kg dosage as a precautionary treatment for leptospirosis. Feed and bedding used during the isolation/collection period shall not originate from areas infected with epizootic diseases and must meet veterinary hygienic requirements established by the OVO of the PRC concerning freedom of the feed and bedding from contamination that could transmit diseases. During the isolation/collection period the swine at the collection center shall not have direct contact with, or exposure to, any other animals not included in the group at the isolation facility. Exposure consists of contact with yards, pens, or other facilities or vehicles that have been in contact with animals and have not been cleaned and disinfected.

(ii) Donor boars shall be selected from premises which are solely swine breeding operations. These premises must be located at the center of an area with a 16 km radius that was free of foot-and-mouth disease (FMD), swine vesicular disease (SVD), and classical swine fever for three years prior to semen collection. Donor boars shall not have been vaccinated against these diseases. There shall have been no cases of these diseases on these premises for five years prior to the collection of semen. There shall have been no animal introduced into these premises from farms affected with these diseases for three years prior to the collection of semen. There shall have been no evidence of brucellosis, tuberculosis, or pseudorabies on these premises or on premises adjacent to these premises for one year prior to the collection of semen.

(iii) During the 60-day isolation/collection period, the boars offered for collection of semen shall be subjected to the following tests, 2 in lieu of the tests required by paragraphs (c)(1)(iv) and (vi) of this section. If test samples from any donor boars are lost, damaged, or destroyed prior to testing, or if test results are inconclusive, the donor boars involved shall be subjected to retesting:

2 Technical information on laboratory methods and procedures for these tests may be obtained from the Administrator, c/o Director, National Veterinary Services Laboratories, P.O. Box 844, Ames, IA 50010.

(A) Foot-and-mouth disease:

(1) Microtiter virus neutralization (VN) test for types, A, O, C, and Asia. (The PRC will test for types A and O, and the United States will test for types C and Asia at the USDA Foreign Animal Disease Diagnostic Laboratory (FADDL)).

(2) Agar gel immunodiffusion (AGID) test using virus infection associated antigen (VIAA) in serum. (Animals having responses to the AGID test or reacting to the VN test at 1:10 dilution or greater shall be eliminated as semen donors, and all other swine in contact with them shall be retested within 30 days. If the whole group does not have the above responses and there is no clinical evidence of FMD, the group shall be eligible for collection of semen with respect to FMD. Otherwise, none of the group shall qualify as donors of semen for export.)

(B) Brucellosis: Standard tube test (STT) at less than 30 IU/ml, and card test (antigen and protocol to be supplied by USDA).

(C) Swine vesicular disease: Virus neutralization test at 1:40 dilution (serums to be tested at FADDL).

(D) Classical swine fever: Fluorescent antibody neutralization (FAN) test at 1:16 dilution.

(E) Japanese B encephalitis: Hemagglutination inhibition (HI) test, negative according to PRC standards.

(F) Pseudorabies: Virus neutralization at 1:4 dilution.

(G) Tuberculosis: Intradermal test using bovine PPD tuberculin (Positive animals will be necropsied. If there are lesions of TB in the test positive pigs, the whole group will be ineligible as semen donors. If no lesions are found, the rest of the pigs will be eligible as semen donors with respect to tuberculosis.

All samples of the above tests, except as noted for FMD, SVD, and TB, will be submitted to laboratories designated by the OVO of the PRC. At least 21 days after the final collection of semen for exportation, the donor animals will be retested for the diseases listed above, with the exception of tuberculosis and Japanese encephalitis. In addition, aliquots of each ejaculate of semen collected shall be submitted to FADDL for pathogen isolation tests for FMD, brucellosis, swine vesicular disease, classical swine fever, Japanese encephalitis, and pseudorabies.

(iv) The semen will not be eligible for release in the United States until all tests in paragraph (c)(7)(iii) of this section have been completed with negative results.

(v) Each semen straw or ampule for export must be identified with the name or identification number of the donor boar and with the date of collection. A USDA veterinarian shall certify that he or she has supervised the collection and processing of the semen and its storage until the time it is shipped to the United States. Each shipment will be accompanied by a USDA veterinarian unless the semen is shipped directly to the port of New York, with no stops en route. Shipment to the United States will be in accordance with the terms of a USDA import permit. Semen imported in accordance with this section shall be released by USDA to the importer only after all requirements of this section have been met.

(d) Sheep and goat semen from regions where scrapie exists. Importation of semen of sheep and goats is subject to the requirements in § 98.35(e). Applications for a permit to import sheep and goat semen must include statements that:

(1) All first generation (F1) progeny resulting from imported semen will be identified with a permanent official identification consistent with the provisions of § 79.2 of this chapter; and

(2) Records of any sale of F1 progeny, including the name and address of the buyer, will be kept for a period of 5 years. APHIS may view and copy these records during normal business hours.

[55 FR 31558, Aug. 2, 1990. Redesignated at 56 FR 55809, Oct. 30, 1991, as amended at 58 FR 37644, July 13, 1993; 59 FR 26596, May 23, 1994; 62 FR 56026, Oct. 28, 1997; 68 FR 16940, Apr. 7, 2003; 72 FR 64128, Nov. 15, 2007; 83 FR 15494, Apr. 11, 2018]

§ 98.35 Declaration, health certificate, and other documents for animal semen.

(a) The certificates, declarations, and affidavits required by the regulations in this subpart shall be presented by the importer or his or her agent to the collector of customs at the port of entry, upon arrival of animal semen at such port, for the use of the veterinary inspector at the port of entry.

(b) For all animal semen offered for importation, the importer or his or her agent shall first present two copies of a declaration which shall list the port of entry, the name and address of the importer, the name and address of the broker, the origin of the animal semen, the number, breed, species, and purpose of the importation, the name of the person to whom the animal semen will be delivered, and the location of the place to which such delivery will be made.

(c) All animal semen intended for importation into the United States shall be accompanied by a health certificate issued by a full-time salaried veterinary officer of the national government of the region of origin, or issued by a veterinarian designated or accredited by the national government of the region of origin and endorsed by a full-time salaried veterinary officer of the national government of the region of origin, representing that the veterinarian issuing the certificate was authorized to do so.

(d) The health certificate must state:

(1) The name and address of the place where the semen was collected;

(2) The name and address of the veterinarian who supervised the collection of the semen;

(3) The date of semen collection;

(4) The identification and breed of the donor animal;

(5) The number of ampules or straws covered by the health certificate and the identification number or code on each ampule or straw;

(6) The dates, types, and results of all examinations and tests performed on the donor animal as a condition for importing the semen;

(7) The seal number on the shipping container;

(8) The names and addresses of the consignor and consignee; and

(9) That the semen is being imported into the United States in accordance with subpart C of 9 CFR part 98.

(e) The certificates accompanying sheep semen collected from rams that are not of the genotypes AARR or AAQR, and for all goat semen shall, in addition to the statements required by paragraph (d) of this section, state that:

(1) The donor animals:

(i) Are permanently identified, to enable traceback to their establishment of origin; and

(ii) Neither showed clinical signs of scrapie at the time of semen collection nor developed scrapie between the time of semen collection and the export of semen to the United States; and

(iii) The donor animal is not, nor was not, restricted in the country of origin, or destroyed, due to exposure to a TSE.

(iv) Any additional certifications or testing requirements established by APHIS, based on genetic susceptibility of the semen donor, and/or on scrapie testing of the donor or semen, will be listed in the APHIS import permit. Such certifications or required test results must also be recorded on the health certificate accompanying the semen.

(2) In the region where the semen originates:

(i) Scrapie is a compulsorily notifiable disease; and

(ii) An effective surveillance and monitoring system for scrapie is in place; and

(iii) Affected sheep and goats are slaughtered and completely destroyed; and

(iv) The feeding of sheep and goats with meat-and-bone meal or greaves derived from ruminants has been banned and the ban effectively enforced in the whole region.

(3) Sheep and goat semen may only be imported for transfer to recipient females in the United States if the flock or herd in which recipients reside is listed in the National Scrapie Database; except that APHIS may permit importation of sheep and goat semen to an APHIS-approved storage facility where they may be kept until later transferred to recipient females in a flock or herd in the United States listed in the APHIS National Scrapie Database, and under such conditions as the Administrator deems necessary to trace the movement of the imported semen. Imported sheep or goat semen not otherwise restricted by the conditions of an import permit may be transferred from a listed flock or herd to any other listed flock or herd or from an approved semen storage facility to a listed flock or herd or another approved semen storage facility with written notification to the responsible APHIS Veterinary Services Service Center.

(4) The importer, the owner of a recipient flock or herd to which delivery of the semen is made, or the owner of an APHIS-approved semen storage facility must maintain records of the disposition (including destruction) of imported or stored semen for 5 years after the semen is transferred or destroyed. These records must be made available during normal business hours to APHIS representatives on request for review and copying.

(5) The owner of all sheep or goats resulting from semen imported under this section shall:

(i) Identify them at birth with a permanent official identification number consistent with the provisions of § 79.2 of this chapter; such identification may not be removed except at slaughter and must be replaced if lost;

(ii) Maintain a record linking the official identification number to the imported semen, including a record of the replacement of lost tags;

(iii) Maintain records of any sale or disposition of such animals, including the date of sale or disposition, the name and address of the buyer, and the animal's official identification number; and

(iv) Keep the required records for a period of 5 years after the sale or death of the animal. APHIS may view and copy these records during normal business hours.

(f) All shipping containers carrying animal semen for importation into the United States must be sealed with an official seal of the national veterinary service of the region of origin. The health certificate must show the seal number on the shipping container. The semen must remain in the sealed container until arrival in the United States and, at the U.S. port of entry, an inspector determines that either:

(1) The seal numbers on the health certificate and shipping container match; or

(2) The seal numbers on the health certificate and shipping container do not match, but an APHIS representative at the port of entry is satisfied that the shipping container contains the semen described on the health certificate, import permit, declaration, and any other accompanying documents.

(Approved by the Office of Management and Budget under control numbers 0579-0040 and 0579-0453)

[55 FR 31558, Aug. 2, 1990. Redesignated at 56 FR 55809, Oct. 30, 1991, as amended at 58 FR 37644, July 13, 1993; 61 FR 15184, Apr. 5, 1996; 61 FR 17242, Apr. 19, 1996; 62 FR 56026, Oct. 28, 1997; 65 FR 56777, Sept. 20, 2000; 72 FR 64128, Nov. 15, 2007; 86 FR 68864, Dec. 3, 2021]

§ 98.36 Animal semen from Canada.

(a) General importation requirements for animal semen from Canada.

If the product is . . . | Then . . .

(1) Equine semen | There are no importation requirements under this part.

(2) Sheep or goat semen | The importer or his agent, in accordance with §§ 98.34 and 98.35 of this part, must present: (i) An import permit; (ii) Two copies of a declaration; and (iii) A health certificate.

(3) Animal semen other than equine, sheep, or goat semen | See paragraph (b) of this section.

(b) Importation requirements for animal semen other than equine, sheep, or goat semen from Canada.

If the product is offered for entry at a . . . | And . . . | Or . . . | Then . . .

(1) Canadian land border port listed in § 98.33(b) of this part | The donor animal was born in Canada or the United States and has never been in a region other than Canada or the United States | The donor animal was legally imported into Canada, released to move freely in Canada, and has been released in Canada for no less than 60 days | The importer or his agent, in accordance with § 98.35 of this part, must present: (i) Two copies of a declaration; and (ii) A health certificate.

(2) Canadian land border port listed in § 98.33(b) of this part | The donor animal does not meet the special conditions listed above in paragraph (b)(1) of this table | The importer or his agent, in accordance with §§ 98.34 and 98.35 of this part, must present: (i) An import permit; (ii) Two copies of a declaration; and (iii) A health certificate.

(3) Port not listed in § 98.33(b) of this part | The importer or his agent, in accordance with §§ 98.34 and 98.35 of this part, must present: (i) An import permit; (ii) Two copies of a declaration; and (iii) A health certificate.

[65 FR 56778, Sept. 20, 2000]

§ 98.37 [Reserved]

§ 98.38 Restrictions on the importation of swine semen from the APHIS-defined European CSF region.

In addition to meeting all other applicable provisions of this part, swine semen imported from the APHIS-defined European CSF region, as defined in § 94.0 of this subchapter, must meet the following conditions:

(a) The semen must come from a semen collection center approved for export by the competent veterinary authority.

(b) The semen must not have been collected from a donor boar that was in any of the following regions or zones, unless the semen was collected after the periods described:

(1) Any region when the region was classified under §§ 94.9(a) and 94.10(a) of this chapter as a region in which classical swine fever is known to exist, except for the APHIS-defined European CSF region;

(2) A restricted zone in the APHIS-defined European CSF region established because of the detection of classical swine fever in domestic swine, from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority or until 6 months following depopulation of the swine on affected premises in the restricted zone and the cleaning and disinfection of the last affected premises in the zone, whichever is later; or

(3) A restricted zone in the APHIS-defined European CSF region established because of the detection of classical swine fever in wild boar, from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority.

(c) The semen must not have been collected from a donor boar that was commingled with swine that at any time were in any of the regions or zones described in paragraphs (b)(1) through (b)(3) of this section, unless the semen was collected after the periods described.

(d) The semen must not have been collected from a donor boar that transited any region or zone described in paragraphs (b)(1) through (b)(3) of this section during the periods described, unless the donor boar was moved directly through the region or zone in a sealed means of conveyance with the seal determined to be intact upon arrival at the point of destination, or unless the semen was collected after the periods described;

(e) The donor boar must be held in isolation for at least 30 days prior to entering the semen collection center.

(f) No more than 30 days prior to being held in isolation as required by paragraph (e) of this section, the donor boar must be tested with negative results with a classical swine fever test approved by the World Organization for Animal Health.

(g) No equipment or materials used in transporting the donor boar from the farm of origin to the semen collection center may have been used previously for transporting swine that do not meet the requirements of this section, unless such equipment or materials have first been cleaned and disinfected.

(h) The semen must be accompanied by a certificate issued by a salaried veterinary officer of the competent veterinary authority, stating that the provisions of paragraphs (a) through (g) of this section have been met. 3

3 The certification required may be placed on the certificate required under § 98.35(c) or may be contained in a separate document.

(Approved by the Office of Management and Budget under control numbers 0579-0218 and 0579-0265)

[71 FR 29072, May 19, 2006, as amended at 72 FR 67233, Nov. 28, 2007; 76 FR 70040, Nov. 10, 2011; 77 FR 1396, Jan. 10, 2012; 77 FR 74558, Dec. 17, 2012]

§ 99.1 Scope and applicability of rules of practice.

The Uniform Rules of Practice for the Department of Agriculture promulgated in subpart H of part 1, subtitle A, title 7, Code of Federal Regulations, are the Rules of Practice applicable to adjudicatory, administrative proceedings under the following statutory provisions:

Act of May 29, 1884, commonly known as the Animal Industry Act, section 7, as amended (21 U.S.C. 117), Act of August 30, 1890, section 6, as amended (21 U.S.C. 104), Act of February 2, 1903, commonly known as the Cattle Contagious Diseases Act of 1903, section 3, as amended (21 U.S.C. 122), Act of July 2, 1962, section 6(a), as amended (21 U.S.C. 134e), Act of May 6, 1970, section 2, as amended (21 U.S.C. 135a). The Animal Health Protection Act, section 10414 (7 U.S.C. 8313)

In addition, the Supplemental Rules of Practice set forth in subpart B of this part shall be applicable to such proceedings.

[48 FR 30095, June 30, 1983. Redesignated at 52 FR 29502, Aug. 10, 1987, as amended at 68 FR 6345, Feb. 7, 2003]

§ 99.10 Stipulations.

(a) At any time prior to the issuance of a complaint seeking a civil penalty under any of the Acts listed in § 99.1, the Administrator, in his discretion, may enter into a stipulation with any person in which:

(1) The Administrator or the Administrator's delegate gives notice of an apparent violation of the applicable Act, or the regulations issued thereunder, by such person and affords such person an opportunity for a hearing regarding the matter as provided by such Act;

(2) Such person expressly waives hearing and agrees to pay a specified penalty within a designated time; and

(3) The Administrator agrees to accept the penalty in settlement of the particular matter involved if the penalty is paid within the designated time.

(b) If the penalty is not paid within the time designated in such a stipulation, the amount of the stipulated penalty shall not be relevant in any respect to the penalty which may be assessed after issuance of a complaint.

[48 FR 30095, June 30, 1983. Redesignated and amended at 52 FR 29502, Aug. 10, 1987]

§ 101.1 Applicability.

When used in parts 101 through 117 of this subchapter, the meaning of the words and phrases listed shall be as defined in this part.

§ 101.2 Administrative terminology.

The following administrative words and phrases shall mean:

Adjacent herd. Adjacent herds are herds physically contiguous to the herd of origin; there are no herds between an adjacent herd and the herd of origin.

Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.

Adverse event. Any observation in animals, whether or not the cause of the event is known, that is unfavorable and unintended, and that occurs after any use (as indicated on the label or any off-label use) of a biological product, including events related to a suspected lack of expected efficacy. For products intended to diagnose disease, adverse events refer to a failure in product performance that hinders an expected discovery of the correct diagnosis.

Adverse event report. Direct communication concerning the occurrence of an adverse event from an identifiable first-hand reporter which includes the following information:

(1) An identifiable reporter;

(2) An identifiable animal;

(3) An identifiable biologic product; and

(4) One or more adverse events.

Animal and Plant Health Inspection Service. The agency in the Department of Agriculture responsible for administering the Virus-Serum-Toxin Act.

Biological products. The term biological products, also referred to in this subchapter as biologics, biologicals, or products, shall mean all viruses, serums, toxins (excluding substances that are selectively toxic to microorganisms, e.g., antibiotics), or analogous products at any stage of production, shipment, distribution, or sale, which are intended for use in the treatment of animals and which act primarily through the direct stimulation, supplementation, enhancement, or modulation of the immune system or immune response. The term “biological products” includes but is not limited to vaccines, bacterins, allergens, antibodies, antitoxins, toxoids, immunostimulants, certain cytokines, antigenic or immunizing components of live organisms, and diagnostic components, that are of natural or synthetic origin, or that are derived from synthesizing or altering various substances or components of substances such as microorganisms, genes or genetic sequences, carbohydrates, proteins, antigens, allergens, or antibodies.

(1) A product's intended use shall be determined through an objective standard and not a subjective one, and would be dependent on factors such as representations, claims (either oral or written), packaging, labeling, or appearance.

(2) The term analogous products shall include:

(i) Substances, at any stage of production, shipment, distribution, or sale, which are intended for use in the treatment of animals and which are similar in function to biological products in that they act, or are intended to act, through the stimulation, supplementation, enhancement, or modulation of the immune system or immune response; or

(ii) Substances, at any stage of production, shipment, distribution, or sale, which are intended for use in the treatment of animals through the detection or measurement of antigens, antibodies, nucleic acids, or immunity; or

(iii) Substances, at any stage of production, shipment, distribution, or sale, which resemble or are represented as biological products intended for use in the treatment of animals through appearance, packaging, labeling, claims (either oral or written), representations, or through any other means.

(3) The term treatment shall mean the prevention, diagnosis, management, or cure of diseases of animals.

Department. The U.S. Department of Agriculture.

Distributor. A person who sells, distributes, or otherwise places in channels of trade, one or more biological products he does not produce or import.

Division. A marketing unit established by the licensee which may be named on labels, advertisements and promotional material in addition to the name and address of the producer.

Domestic animals. All animals, other than man, including poultry.

Establishment. One or more premises designated on the establishment license.

Guidelines. Guidelines establish principles or practices related to test procedures, manufacturing practices, product standards, scientific protocols, labeling, and other technical or policy considerations. Guidelines contain procedures or standards of general applicability that are usually not regulatory in nature, but that are related to matters that fall under the Virus-Serum-Toxin Act. Guidelines issued by the agency include Veterinary Biologics Licensing Considerations, Memoranda, Notices, and Supplemental Assay Methods.

Herd. Any group of animals, including birds, fish, and reptiles, maintained at a common location (e.g. lot, farm or ranch) for any purpose. The herd (or flock) includes all animals subsequently housed at the common location. If the principal animals of a group are moved to a different location, the group is still considered the same herd.

Herd of origin. The herd from which the microorganism used as seed for production of an autogenous biologic is isolated. Offspring and excess breeding stock (not the principal animals) moved or sold from one group of animals to another have changed herds and are no longer considered part of the herd they originated from. Groups of animals under the same ownership but at different locations are separate herds.

Inspection. An examination made by an inspector to determine the fitness of animals, establishments, facilities, and procedures used in connection with the preparation, testing, and distribution of biological products and the examination or testing of biological products.

Inspector. Any officer or employee of Animal and Plant Health Inspection Service who is authorized by the Administrator to do inspection work.

Licensed establishment. An establishment operated by a person holding an unexpired, unsuspended, and unrevoked U.S. Veterinary Biologics Establishment License.

Licensee. A person to whom an establishment license and at least one product license has been issued.

Microorganisms. Microscopic or submicroscopic organisms, which are sometimes referred to as organisms, which may introduce or disseminate disease of animals.

Nonadjacent herd. Nonadjacent herds are all herds other than the herd of origin and other than herds adjacent to the herd of origin. Herds adjacent to the herd of origin but in a different State from the herd of origin are also considered nonadjacent herds.

Permittee. A person who resides in the United States or operates a business establishment within the United States, to whom a permit to import biological products has been issued.

Person. Any individual, firm, partnership, corporation, company, association, educational institution, State or local governmental agency, or other organized group of any of the foregoing, or any agent, officer, or employee of any thereof.

Premises. All buildings, appurtenances, and equipment used to produce and store biological products located within a particular land area shown on building plans or drawings furnished by the applicant or the licensee and designated by an address adequate for identification.

Prepare or preparation. Sometimes referred to as manufacture or produce, means the steps and procedures used in the processing, testing, packaging, labeling, and storing of a biological product.

Regulations. The provisions in parts 101 through 118 of this subchapter.

Research investigator or research sponsor. A person who has requested authorization to ship an experimental biological product for the purpose of evaluating such product, or has been granted such authorization.

Secretary. The Secretary of Agriculture of the United States or any officer or employee of the Department to whom authority has heretofore been delegated, or to whom authority may hereafter be delegated, to act in his stead.

Subsidiary. A corporation in which a corporate licensee owns in excess of 50 percent of the voting stock.

Veterinary Services. Veterinary Services unit of Animal and Plant Health Inspection Service of the Department.

Virus-Serum-Toxin Act. The Act of March 4, 1913, 37 Stat. 832-833; as amended December 23, 1985, Public Law 99-198, 99 Stat. 1654-1655; and as further amended September 28, 1988, Public Law 100-449, 102 Stat. 1868; 21 U.S.C. 151-159.

U.S. Veterinary Biological Product License. A document, sometimes referred to as a product license, which is issued pursuant to part 102 of this subchapter to the holder of an establishment license, as a part of and ancillary to the establishment license, and which authorizes production of a specified biological product in the designated licensed establishment.

U.S. Veterinary Biological Product Permit. A document, sometimes referred to as a permit, issued to a person authorizing the importation of specified biological products subject to restrictions and controls as provided in the regulations.

U.S. Veterinary Biologics Establishment License. A document referred to as an establishment license, which is issued pursuant to part 102 of this subchapter, authorizing the use of designated premises for production of biological products specified in one or more unexpired, unsuspended, and unrevoked product license(s).

[38 FR 8426, Apr. 2, 1973; 38 FR 9221, Apr. 12, 1973, as amended at 40 FR 46093, Oct. 6, 1975; 41 FR 44358, Oct. 8, 1976; 49 FR 22624, May 31, 1984; 52 FR 30131, Aug. 13, 1987; 56 FR 66782, 66783, Dec. 26, 1991; 57 FR 38756, Aug. 27, 1992; 62 FR 31328, June 9, 1997; 64 FR 43044, Aug. 9, 1999; 83 FR 22835, May 17, 2018]

§ 101.3 Biological products and related terms.

When used in conjunction with or in reference to a biological product, the following terms shall mean:

(a) Licensed biological product. A biological product prepared within a licensed establishment by a person holding an unexpired, unsuspended, and unrevoked product license for such product.

(b) Experimental biological product. A biological product which is being evaluated to substantiate an application for a product license or permit.

(c) Completed product. A biological product in bulk or final container produced in compliance with the regulations to final form and composition.

(d) Finished product. A completed product which has been bottled, sealed, packaged, and labeled as required by the regulations.

(e) Released product. A finished product released for marketing after all requirements have been satisfactorily complied with.

(f) Fraction. A specific antigen, its antibodies, or its antitoxin which constitutes a component of a biological product.

(g) Diluent. A liquid used to rehydrate a desiccated product or a liquid used to dilute another substance.

(h) Serial. The total quantity of completed product which has been thoroughly mixed in a single container and identified by a serial number: Provided, That, when all or part of a serial of liquid biological product is packaged as diluent for all or part of a serial of desiccated product, the resulting combination packages shall be considered a serial of the multiple fraction product.

(i) Subserial. Each of two or more properly identified portions of a serial which are further processed at different times or under different conditions such as, but not limited to, being desiccated in different size final containers and/or at different times.

(j) Outline of production. A detailed protocol of methods of manufacture to be followed in the preparation of a biological product and which may sometimes be referred to as an outline.

(k) Product Code Number. A number assigned by Animal and Plant Health Inspection Service to each type of licensed biological product.

(l) Harvest date. Unless otherwise specified in a filed Outline of Production, the harvest date shall be the date blood or tissues are collected for production or the date cultures of living microorganisms are removed from production incubators.

(m) Bacterin. An inactivated bacterial product consisting of an antigenic suspension of organisms or particulate parts of organisms, representing a whole culture or a concentrate thereof, with or without the unevaluated growth products, which has been inactivated as demonstrated by acceptable tests written into the filed Outline of Production for the product.

(n) Toxoid. An inactivated bacterial product which consists of a sterile, antigenic toxin or toxic growth product, which has resulted from the growth of bacterial organisms in a culture medium from which the bacterial cells have been removed, which has been inactivated without appreciable loss of antigenicity as measured by suitable tests, and which is nontoxic as demonstrated by acceptable tests written into the filed Outline of Production.

(o) Bacterin-toxoid. An inactivated bacterial product which is either:

(1) A suspension of organisms, representing a whole culture or a concentrate thereof, with the toxic growth products from the culture which has been inactivated without appreciable loss of antigenicity as measured by suitable tests, the inactivation of organisms and toxins being demonstrated by acceptable tests written into the filed Outline of Production: Provided, That it shall contain cellular antigens and shall stimulate the development of antitoxin; or

(2) A combination product in which one or more toxoids or bacterin-toxoids is combined with one or more bacterins or one or more bacterin-toxoids.

(p) Bacterial extract. An inactivated bacterial product which consists of the sterile, nontoxic, antigenic derivatives extracted from bacterial organisms or from culture medium in which bacterial organisms have grown.

(q) Combination package. Biological product consisting of two or more licensed biological products. Each completed product in final container is packaged together and mixed prior to administration. A combination package is issued a separate U.S. Veterinary Biological Product License and assigned a product code number to distinguish it from its component products, which also may be marketed individually unless otherwise restricted.

[38 FR 8426, Apr. 2, 1973, as amended at 42 FR 63770, Dec. 20, 1977; 50 FR 24903, June 14, 1985; 56 FR 66782, Dec. 26, 1991; 60 FR 14354, Mar. 17, 1995; 81 FR 59433, Aug. 30, 2016]

§ 101.4 Labeling terminology.

Terms pertaining to identification and packaging of biological products shall mean:

(a) Label. All written, graphic, or printed matter:

(1) Upon or attached to a final container of a biological product;

(2) Appearing upon any immediate carton or box used to package such final container; and

(3) Appearing on any accompanying enclosures (leaflets, inserts, or circulars) on which required information or directions as to the use of the biological product shall be found.

(b) Labeling. All labels and other written, printed, or graphic matter accompanying the final container.

(c) Final container. The unit, bottle, vial, ampule, tube, or other receptacle into which any biological product is filled for distribution and sale.

(d) True name. The name entered on the product license or permit at the time of issuance to differentiate the biological product from others: Provided, That, the principal part of such name shall be emphasized on such license or permit by being more prominently lettered than descriptive terms which may be necessary to complete the differentiation.

(e) Serial number. Numbers or numbers and letters used to identify and distinguish one serial from others.

(f) Expiration date. A date designating the end of the period during which a biological product, when properly stored and handled, can be expected with reasonable certainty, to be efficacious.

(g) Label number. A number assigned by Animal and Plant Health Inspection Service to each label or sketch submitted for review.

(h) Master label. The finished carton, container, or enclosure label for the smallest size final container that is authorized for a biological product, that serves as the Master template label applicable to all other size containers or cartons of the same product that is marketed by a licensee, subsidiary, division, or distributor.

[38 FR 8426, Apr. 2, 1973, as amended at 42 FR 63770, Dec. 20, 1977; 56 FR 66782, Dec. 26, 1991; 61 FR 29464, June 11, 1996]

§ 101.5 Testing terminology.

Terms used when evaluating biological products shall mean:

(a) Standard Requirement. Test methods, procedures, and criteria established by Animal and Plant Health Inspection Service for evaluating biological products to be pure, safe, potent, and efficacious, and not to be worthless, contaminated, dangerous, or harmful under the Act.

(b) Log. Logarithm computed to the base 10.

(c) Pure or purity. Quality of a biological product prepared to a final form relatively free of extraneous micro-organisms and extraneous material (organic or inorganic) as determined by test methods or procedures established by Animal and Plant Health Inspection Service in Standard Requirements or in the approved Outline of Production for such product, but free of extraneous microorganisms or material which in the opinion of the Administrator adversely affects the safety, potency, or efficacy of such product.

(d) Safe or safety. Freedom from properties causing undue local or systemic reactions when used as recommended or suggested by the manufacturer.

(e) Sterile or sterility. Freedom from viable contaminating microorganisms as demonstrated by procedures prescribed in part 113 of this subchapter, Standard Requirements, and approved Outlines of Production.

(f) Potent or potency. Relative strength of a biological product as determined by test methods or procedures as established by Animal and Plant Health Inspection Service in Standard Requirements or in the approved Outline of Production for such product.

(g) Efficacious or efficacy. Specific ability or capacity of the biological product to effect the result for which it is offered when used under the conditions recommended by the manufacturer.

(h) Dose. The amount of a biological product recommended on the label to be given to one animal at one time.

(i) Vaccinate. An animal which has been inoculated, injected, or otherwise administered a biological product being evaluated.

(j) Control animal. An animal, which may be referred to as a control, used in a test procedure for purposes of comparison or to add validity to the results.

(k) Day. Time elapsing between any regular working hour of one day and any regular working hour of the following day.

(l) Test results. Terms used to designate testing results are as follows:

(1) No Test. Designation used when a deficiency in the test system has rendered a test unsuitable for drawing a valid conclusion.

(2) Satisfactory. Designation is a final conclusion given to a valid test with results that meet the release criteria stated in the filed Outline of Production or Standard Requirement.

(3) Unsatisfactory. Designation is a final conclusion given to a valid test with results that do not meet the release criteria stated in the filed Outline of Production or Standard Requirement.

(4) Inconclusive. Designation used for an initial test when a sequential test design established in the filed Outline of Production or Standard Requirement allows further testing if a valid initial test is not satisfactory.

(m) Healthy. Apparently normal in all vital functions and free of signs of disease.

(n) Unfavorable reactions. Overt adverse changes which occur in healthy test animals subsequent to initiation of a test and manifested during the observation period prescribed in the test protocol which are attributable either to the biological product being tested or to factors unrelated to such product as determined by the responsible individual conducting the test.

(o) Master reference. A Master Reference is a reference whose potency is correlated, directly or indirectly, to host animal immunogenicity. The Master Reference may be used as the working reference in in vitro tests for relative potency. The Master Reference may also be used to establish the relative potency of a serial of product used in requalification studies and to establish the relative potency of working references. The preparation of a Master Reference as described in a filed Outline of Production may be:

(1) A completed serial of vaccine or bacterin prepared in accordance with a filed Outline of Production;

(2) A purified preparation of a protective immunogen or antigen; or

(3) A nonadjuvanted harvested culture of microorganisms.

(p) Working reference. A Working Reference is the reference preparation that is used in the in vitro test for the release of serials of product. Working References may be:

(1) Master References; or

(2) Serials of product that have been prepared and qualified, in a manner acceptable to Animal and Plant Health Inspection Service for use as reference preparations.

(q) Qualifying serial. (1) A serial of biological product used to test for immunogenicity when the Master or Working Reference is a purified antigen or nonadjuvanted harvest material. Qualifying serials shall be produced in accordance with the filed Outline of Production, tested for immunogenicity in accordance with methods deemed appropriate by the Animal and Plant Health Inspection Service, and have a geometric mean relative potency, when compared to the Master Reference, of not greater than 1.0 as established by: independent parallel line assays with five or more replicates; or other valid assay methods for determining relative antigen content which demonstrate linearity, specificity, and reproducibility at least equivalent to the parallel line assay and are acceptable to the Animal and Plant Health Inspection Service.

(2) Qualifying serials used to requalify or extend the dating period of a Master Reference shall be determined to be immunogenic in accordance with methods deemed appropriate by the Animal and Plant Health Inspection Service as provided in paragraph (a)(1) of this section, and, in addition, shall be within their permitted dating period and have been prepared in accordance with the production method described in the currently filed Outline of Production.

(r) Immunogenicity. The ability of a biological product to elicit an immune response in animals as determined by test methods or procedures acceptable to the Animal and Plant Health Inspection Service.

(s) Stability-indicating assay. A stability-indicating assay is a validated quantitative analytical procedure that can detect changes over time in a pertinent property of the product.

[38 FR 8426, Apr. 2, 1973, as amended at 40 FR 45419, Oct. 2, 1975; 41 FR 6751, Feb. 13, 1976; 43 FR 3701, Jan. 27, 1978; 56 FR 66782, 66783 Dec. 26, 1991; 62 FR 19037, Apr. 18, 1997; 79 FR 55969, Sept. 18, 2014; 83 FR 11143, Mar. 14, 2018]

§ 101.6 Cell cultures.

When used in conjunction with or in reference to cell cultures, which may be referred to as tissue cultures, the following terms shall mean:

(a) Batches of primary cells. A pool of original cells derived from normal tissue up to and including the 10th subculture.

(b) Cell line. A pool of cells which are 11 or more subcultures from the tissue of origin.

(c) Subculture. Each flask to flask transfer or passage regardless of the number of cell replications.

(d) Master Cell Stock (MCS). The supply of cells of a specific passage level from which cells for production of biologics originate.

[38 FR 8426, Apr. 2, 1973, as amended at 40 FR 45419, Oct. 2, 1975; 49 FR 22624, May 31, 1984]

§ 101.7 Seed organisms.

When used in conjunction with or in reference to seed organisms, the following shall mean:

(a) Master Seed. An organism at a specific passage level which has been selected and permanently stored by the producer from which all other seed passages are derived within permitted levels.

(b) Working Seed. An organism at a passage level between Master Seed and Production Seed.

(c) Production Seed. An organism at a specified passage level which is used without further propagation for initiating preparation of a fraction.

[49 FR 22625, May 31, 1984]

§ 102.1 Licenses issued by the Administrator.

Each establishment qualified to prepare biological products under the Virus-Serum-Toxin Act shall hold an unexpired and unrevoked U.S. Veterinary Biologics Establishment License issued by the Administrator and a U.S. Veterinary Biological Product License for each product prepared in such establishment unless the product is subject to the provisions of 9 CFR parts 103 or 106 of this subchapter.

[60 FR 48021, Sept. 18, 1995]

§ 102.2 Licenses required.

(a) Every person who prepares biological products subject to the Virus-Serum-Toxin Act shall hold an unexpired, unsuspended, and unrevoked U.S. Veterinary Biologics Establishment License and at least one unexpired, unsuspended, and unrevoked U.S. Veterinary Biological Product License issued by the Administrator to prepare a biological product.

(b) An applicant who applies for an establishment license must also apply for at least one product license. An establishment license will not be issued without a license authorizing the production of a biological product in the establishment.

[52 FR 11026, Apr. 7, 1987, as amended at 56 FR 66783, Dec. 26, 1991; 61 FR 52873, Oct. 9, 1996]

§ 102.3 License applications.

(a) U.S. Veterinary Biologics Establishment License. (1) The operator of each establishment of the kind specified in § 102.2 shall make written application to the Administrator for a license. Blank forms of application will be furnished upon request to Animal and Plant Health Inspection Service.

(2) When a person conducts more than one establishment, a separate application shall be made for each establishment.

(3) Whenever subsidiaries are to operate in an establishment for which license application is made, the applicant shall apply for permission for such subsidiaries to operate in the establishment and furnish therewith a complete statement regarding the relationship between the applicant and the subsidiaries.

(4) Facilities documents, prepared as prescribed in part 108 of this subchapter, shall accompany the application for license unless previously filed with Animal and Plant Health Inspection Service.

(5) Each application for a U.S. Veterinary Biologics Establishment License shall be accompanied by an application for one or more U.S. Veterinary Biological Product Licenses and the supporting documents required by paragraph (b)(2) of this section.

(6) A new application shall be made when a change of ownership, operation, or location of an establishment occurs; or prior to the expiration of a U.S. Veterinary Biologics Establishment License issued for an interim period of time.

(b) U.S. Veterinary Biological Product License. (1) The licensee of each establishment or applicant for an establishment license shall make written application to the Administrator for a U.S. Veterinary Biological Product License for each biological product to be prepared in the licensed establishment.

(2) Each application for a U.S. Veterinary Biological Product License shall be supported by:

(i) At least two copies of an Outline of Production prepared in accordance with §§ 114.8 and 114.9 of this subchapter; and

(ii) At least three copies of test reports and research data sufficient to establish purity, safety, potency, and efficacy of the product; and

(iii) Legends prepared as prescribed in § 108.5 of this subchapter designating which facilities are to be used in the preparation of each fraction; and

(iv) Labels in finished form or sketches prepared as prescribed in § 112.5 of this subchapter, together with information regarding all claims to be made on labels and in advertising matter to be used in connection with or related to the biological product.

(Approved by the Office of Management and Budget under control number 0579-0013)

[39 FR 37763, Oct. 24, 1974, as amended at 48 FR 57472, Dec. 30, 1983; 49 FR 21043, May 18, 1984; 50 FR 50763, Dec. 12, 1985; 56 FR 66783, Dec. 26, 1991; 75 FR 20772, Apr. 21, 2010]

§ 102.4 U.S. Veterinary Biologics Establishment License.

(a) Before a U.S. Veterinary Biologics Establishment License will be issued by the Administrator for any establishment, an inspection shall be made to determine whether the condition, equipment, facilities, and the like, of the establishment, and the methods used to prepare biological products are in conformity with the requirements in the regulations.

(b) A license shall not be issued unless:

(1) In the opinion of the Administrator, the condition of the establishment, including its facilities, and the methods of preparation of biological products are such as reasonably to assure that the products shall accomplish the purpose for which they are intended; and

(2) The Administrator is satisfied on the basis of information before him that:

(i) The establishment shall be operated in compliance with the Act and applicable regulations and be under the supervision of person(s) competent in the preparation of biological products; and

(ii) The applicant, or the person having the responsibility for producing biological products in the establishment, or both, is qualified by education and experience, and has demonstrated fitness to produce such products in compliance with the Act and regulations issued pursuant thereto; Provided, That, previous violations of the Act, or such regulations or both shall be relevant to the Administrator's determination of fitness.

(3) Written assurance is filed with Animal and Plant Health Inspection Service that the biological products which are licensed to be prepared therein shall not be so advertised as to mislead or deceive the purchasers and that the packages or containers in which the same are to be marketed shall not bear any statement, design, or device which is false or misleading in any particular.

(c) U.S. Veterinary Biologics Establishment Licenses shall be numbered.

(d) Two or more licenses may bear the same number when they are issued for establishments under the same ownership or control, provided a serial letter is added to one or more to identify each license and the product produced thereunder.

(e) When a U.S. Veterinary Biologics Establishment License is issued for an establishment, it shall not apply to more than one person at the same location, except that subsidiaries of the licensee, when named in the license, may operate thereunder at the establishment named. The licensee with its subsidiaries will be held responsible for all operations conducted in the licensed establishment.

(f) When a licensee no longer holds at least one unexpired, unsuspended, or unrevoked product license authorizing the preparation of a biological product, or is in the process of obtaining a product license, the establishment license shall no longer be valid and shall be returned to the Administrator. In the case where an establishment license expires or is suspended or revoked, any product license authorizing preparation of a product at such establishment shall be invalid indefinitely or for as long as the suspension is in effect.

(g) Any license issued under this part to establishments in which biological products are prepared shall be issued on condition that the licensee permit the inspection of such establishments, products, product preparation, and all relevant records as provided in part 115 of this subchapter. Failure to permit inspection may result in the license being suspended or revoked.

(h) The provisions of paragraph (b) of this section shall also be applicable to, and be considered by, the Administrator in connection with each application for an additional product license.

(Approved by the Office of Management and Budget under control number 0579-0013)

[39 FR 37762, Oct. 24, 1974; 39 FR 38364, Nov. 1, 1974, as amended at 41 FR 44359, Oct. 8, 1976; 48 FR 57472, Dec. 30, 1983; 52 FR 11026, Apr. 7, 1987; 52 FR 30131, Aug. 13, 1987; 56 FR 66783, Dec. 26, 1991; 60 FR 48021, Sept. 18, 1995; 61 FR 52873, Oct. 9, 1996; 62 FR 13294, Mar. 20, 1997]

§ 102.5 U.S. Veterinary Biological Product License.

(a) Authorization to produce each biological product shall be specified on a U.S. Veterinary Biological Product License, issued by the Administrator, and supplementary to the U.S. Veterinary Biologics Establishment License named therein.

(b) The following shall appear on the U.S. Veterinary Biological Product License:

(1) The U.S. Veterinary Biologics Establishment License Number for the establishment from which the product is released for marketing.

(2) The true name of the product.

(3) The product code number for the product.

(4) The date of issuance.

(5) Any restrictions designated by the Administrator under paragraph (e) of this section.

(6) When necessary to comply with § 102.6 of this part, a termination date and a brief description of requirements to be met for reissuance.

(c) The following provisions shall apply to all licensed biological products:

(1) Licensed biological products shall be prepared as required by the regulations and in accordance with a filed Outline of Production as prescribed in §§ 114.8 and 114.9 of this subchapter. No change shall be made in the preparation of a biological product without prior approval of the Administrator.

(2) In addition to restrictions imposed by the Administrator pursuant to paragraph (e) of this section, biological products may be subject to restrictions which are imposed by any State or other jurisdiction pertaining to the distribution and use of such products, based on local disease conditions.

(3) When requested by the Administrator, a licensee shall submit a list of licensed biological products prepared in the licensed establishment.

(d) Where the Administrator determines that the protection of domestic animals or the public health, interest, or safety, or both, necessitates restrictions on the use of a product, the product shall be subject to such additional restrictions as are prescribed on the license. Such restrictions may include, but are not limited to, limits on distribution of the product or provisions that the biological product is restricted to use by veterinarians, or under the supervision of veterinarians, or both.

(e) Any person may request that the distribution and use of a veterinary biological product be restricted if the restriction pertains to the protection of domestic animals or the public health, interest, or safety, or both. All requests must be sent, in writing, to the Director, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010. Requests must specify the restriction(s) being requested and must explain why the restrictions are needed. Copies of any supporting documents, such as scientific literature, published or unpublished articles, or data from tests, should be attached to the request. When a decision is reached regarding the request, the person submitting the request will be sent written notification of such decision.

(Approved by the Office of Management and Budget under control number 0579-0013)

[39 FR 37763, Oct. 24, 1974, as amended at 48 FR 57472, Dec. 30, 1983; 50 FR 50764, Dec. 12, 1985; 52 FR 11026, Apr. 7, 1987; 56 FR 66783, Dec. 26, 1991; 57 FR 38760, Aug. 27, 1992; 59 FR 67616, Dec. 30, 1994; 62 FR 13294, Mar. 20, 1997; 64 FR 43044, Aug. 9, 1999; 75 FR 20772, Apr. 21, 2010]

§ 102.6 Conditional licenses.

In order to meet an emergency condition, limited market, local situation, or other special circumstance, including production solely for intrastate use under a State-operated program, the Administrator may, in response to an application submitted as specified in § 102.3(b) of this part, issue a conditional U.S. Veterinary Biological Product License to an establishment under an expedited procedure which assures purity and safety, and a reasonable expectation of efficacy. Preparation of products under a conditional license shall be in compliance with all applicable regulations and standards and may be restricted as follows:

(a) The preparation may be limited to a predetermined time period which shall be established at the time of issuance and specified on the license. Prior to termination of the license, the licensee may request reissuance. Such requests shall be substantiated with data and information obtained since the license was issued. After considering all data and information available, the Administrator shall either reissue the U.S. Veterinary Biological Product License or allow it to terminate.

(b) Distribution may be limited to the extent necessary to assure that the product will meet the basic criteria for issuance of the conditional license.

(c) Labeling for the product may be required to contain information on the conditional status of the license.

[52 FR 11026, Apr. 7, 1987, as amended at 60 FR 48021; Sept. 18, 1995]

§ 103.1 Preparation of experimental biological products.

Except as otherwise provided in this section, experimental biological products which are neither composed of nor prepared with organisms or antigens used in biologicals already licensed, shall not be prepared in the production facilities of a licensed establishment. Upon application therefor, the Administrator may authorize the preparation of experimental products on the premises of a licensed establishment if he determines that such preparation will not result in contamination of the licensed products. Each request for permission to prepare an experimental biological product on licensed premises shall indicate the nature of the unlicensed product, designate facilities to be used, and specify precautions which will be taken to prevent contamination of licensed products. Such requests shall be submitted to the Administrator. Research facilities that are entirely separate and apart from facilities used for the preparation of licensed biological products will not be considered a part of the licensed premises for purposes of this section.

(Approved by the Office of Management and Budget under control number 0579-0013)

[30 FR 11848, Sept. 16, 1965, as amended at 48 FR 57473, Dec. 30, 1983; 56 FR 66783, Dec. 26, 1991]

§ 103.2 Disposition of animals administered experimental biological products or live organisms.

Safeguards as herein provided shall be established by the research investigator or research sponsor to control disposition of all animals administered experimental biological products or live organisms.

(a) Surviving test animals (including challenged control animals) shall not be removed from the premises on which the tests are conducted for at least 14 days after administration of an experimental biological product or live organisms: Provided, however, That this holding period may be increased or decreased as permitted or requested by the Administrator following review of all relevant information or data available.

(b) All animals administered experimental biological products which are to be slaughtered at establishments subject to the Federal Meat Inspection Act, as amended and extended (21 U.S.C. 601 et. seq.) are subject to the applicable requirements of § 309.16 of this title (Meat Inspection Regulations).

(c) Except as otherwise provided in this paragraph, the research investigator or research sponsor shall maintain adequate records relative to the disposition of each animal administered experimental biological products. These records shall be maintained for a minimum period of two years from the date that an experimental product was administered to such animal, and shall show the name and address of the owner; number, species, class and location of the animals; and if sold, the name and address of the consignee, buyer, commission, firm or abattoir: Provided, however, That a research investigator or research sponsor may be exempted from these recordkeeping requirements by the Administrator on the basis of acceptable data demonstrating that use of the experimental biological product will not result in the presence of any unwholesome condition in the edible parts of animals subsequently presented for slaughter.

(Approved by the Office of Management and Budget under control number 0579-0059)

[30 FR 11848, Sept. 16, 1965, as amended at 48 FR 57473, Dec. 30, 1983; 56 FR 66783, Dec. 26, 1991; 66 FR 21063, Apr. 27, 2001]

§ 103.3 Shipment of experimental biological products.

Except as provided in this section, no person shall ship or deliver for shipment in or from the United States, the District of Columbia, or any Territory of the United States any unlicensed biological product for experimental use in animals. For the benefit of license applicants and to permit and encourage research, a person may be authorized by the Administrator to ship unlicensed biological products for the purpose of evaluating such experimental products by treating limited numbers of animals, Provided, that, the Administrator determines that the conditions under which the experiment is to be conducted are adequate to prevent the spread of disease and approves the procedures set forth in the request for such authorization. Special restrictions or tests may be imposed, especially in the case of products containing live organisms, when they are deemed necessary or advisable by the Administrator. A request for authorization to ship an unlicensed biological product for experimental study and evaluation shall be accompanied by the following:

(a) One copy of a permit or letter of permission from the proper State or foreign animal health authorities of each State or foreign country involved.

(b) Two copies of a tentative list of the names of the proposed recipients and quantity of experimental product that is to be shipped to each individual. In the event of subsequent changes, additional information shall be furnished when such facts are known;

(c) Two copies of a description of the product, recommendations for use, and results of preliminary research work;

(d) A copy of the labels or label sketches which show the name or identification of the product and bear the statement “Notice! For experimental use only-Not For Sale” or equivalent. Such statement shall appear on final container labels, except that it may appear on the carton in the case of very small final container labels and labeling for diagnostic test kits. The U.S. Veterinary License legend shall not appear on such labels; and

(e) Two copies of a proposed general plan covering the methods and procedures for evaluating the product and for maintaining records of the quantities of experimental product prepared, shipped and used. At the conclusion of field studies, results shall be obtained, summarized, and submitted to the Animal and Plant Health Inspection Service.

(f) Data acceptable to the Administrator demonstrating that use of the experimental biological product in meat animals is not likely to result in the presence of any unwholesome condition in the edible parts of animals subsequently presented for slaughter.

(g) A statement from the research investigator or research sponsor agreeing to furnish, upon the Administrator's request, additional information concerning each group of meat animals involved prior to movement of these animals from the premises where the test is to be conducted. Such information shall include the owner's name and address; number, species, class and location of animals involved; date shipment is anticipated; along with name and address of consignee, buyer, commission firm or abattoir.

(h) Any information the Administrator may require in order to assess the product's impact on the environment.

[26 FR 7726, Aug. 18, 1961, as amended at 30 FR 11848, Sept. 16, 1965; 52 FR 30131, Aug. 13, 1987; 56 FR 66783, Dec. 26, 1991; 75 FR 20772, Apr. 21, 2010; 81 FR 59433, Aug. 30, 2016]

§ 104.1 Permit required.

Unless otherwise authorized or directed by the Administrator, each permit to import a biological product into the United States shall be issued in accordance with the regulations in this part.

(a) No biological product shall be brought into the United States unless a permit has been issued for such product. A separate U.S. Veterinary Biological Product Permit shall be required for each shipment of biological product to be imported: Provided, That, a permit shall also be required for each transit shipment of biological products moved through the United States.

(b) Each person importing biological products shall hold an unexpired, unsuspended, and unrevoked permit issued by Animal and Plant Health Inspection Service. Such person shall reside within the United States, or operate a business establishment within the United States, or both.

[38 FR 32916, Nov. 29, 1973, as amended at 56 FR 66783, Dec. 26, 1991; 56 FR 66783, Dec. 26, 1991]

§ 104.2 Permit authorized.

(a) Animal and Plant Health Inspection Service is authorized to issue three types of permits for importing biological products. They shall be:

(1) U.S. Veterinary Biological Product Permit for Research and Evaluation;

(2) U.S. Veterinary Biological Product Permit for Distribution and Sale; or

(3) U.S. Veterinary Biological Product Permit for Transit Shipment Only.

(b) A permit shall not be issued for a biological product from countries known to have exotic diseases, including but not limited to foot-and-mouth disease, highly pathogenic avian influenza, swine vesicular disease, Newcastle disease, and African swine fever, if in the opinion of the Administrator, such products may endanger the livestock or poultry of this country.

(c) A permit shall not be issued until an inspector has determined the condition of the equipment and facilities of the producer, of the applicant, or of both if such a determination is considered necessary by the Administrator.

(d) A permit shall not be issued for a biological product prepared in the United States, exported, and presented for reentry except as provided in § 104.4(d).

[38 FR 32916, Nov. 29, 1973, as amended at 56 FR 66783, Dec. 26, 1991; 56 FR 66783, Dec. 26, 1991; 78 FR 19085, Mar. 29, 2013; 83 FR 15495, Apr. 11, 2018]

§ 104.3 Permit application.

(a) Each person desiring to import a biological product shall make written application to Animal and Plant Health Inspection Service for a permit. Application forms are available on the Internet at (http://www.aphis.usda.gov/animal_health/vet_biologics/vb_forms.shtml) and application for a permit to import a veterinary biologic for research and evaluation or transit shipment may be made on the Internet at (http://www.aphis.usda.gov/animal_health/permits/vet_bio_permits.shtml).

(b) The application shall specify the type of permit required, the port of entry at which the product shall be cleared through Customs, the estimated quantity involved, and the anticipated date on which the importation shall be made.

(Approved by the Office of Management and Budget under control number 0579-0013)

[38 FR 32916, Nov. 29, 1973, as amended at 48 FR 57473, Dec. 30, 1983; 56 FR 66783, Dec. 26, 1991; 75 FR 20772, Apr. 21, 2010]

§ 104.4 Products for research and evaluation.

(a) An application for a U.S. Veterinary Biological Product Permit to import a biological product for research and evaluation shall be accompanied by a brief description of such product, methods of propagating antigens including composition of medium, species of animals or cell cultures involved, degree of inactivation or attenuation, recommendations for use, and the proposed plan of evaluation. The applicant shall also provide any information the Administrator may require in order to assess the product's impact on the environment.

(b)(1) A permit to import a biological product for research and evaluation shall not be issued unless the scientific capabilities of the investigator are determined to be adequate to safeguard domestic animals and protect public health, interest, or safety from any deleterious effects which might result from use of such product. Special restrictions or tests may be specified as part of the permit when they are deemed necessary or advisable by the Administrator.

(2) No person shall ship a product imported under this section for research and evaluation anywhere in or from the United States unless authorized by the Administrator in accordance with the provisions of § 103.3 of this subchapter.

(c) A biological product shall not be imported for Research and Evaluation which is not packaged and labeled in accordance with § 112.9 of this subchapter.

(d) When a licensed product has been exported from the United States, a permit may be issued to the producer for a small quantity of such product for in vitro Research and Evaluation tests: Provided, That, the importation of such product will not endanger the livestock or poultry of this country.

(Approved by the Office of Management and Budget under control number 0579-0013)

[38 FR 32916, Nov. 29, 1973, as amended at 48 FR 57473, Dec. 30, 1983; 52 FR 30131, Aug. 13, 1987; 56 FR 66783, Dec. 26, 1991]

§ 104.5 Products for distribution and sale.

An application for a U.S. Veterinary Biological Product Permit to import a biological product for Distribution and Sale shall be accompanied by supporting material necessary to satisfy the requirements provided in this section.

(a) A permit shall not be issued unless the conditions under which the biological product is to be prepared or the methods to be used are such as to reasonably insure that the product is pure, safe, potent, and efficacious.

(1) Two copies of blueprints of the producing foreign establishment shall be submitted with the application unless satisfactory plans are on file with Animal and Plant Health Inspection Service from a previous application. The production facilities to be used for each product prepared at the establishment shall be designated.

(2) The manufacturer shall submit written authorization for properly accredited inspectors to inspect without previous notification, and at such times as may be demanded by the aforesaid inspectors, all parts of the establishment in which biological products shall be prepared, all processes of preparation, and all records relative to such preparation.

(3) The manufacturer shall furnish written assurance that a biological product to be imported for Distribution and Sale shall be prepared under the supervision of a person competent by education and experience to handle all matters pertaining to the preparation of such product and that each biological product shall be prepared in accordance with the regulations applicable to the product or in a manner acceptable to the Administrator so as to carry out the purposes of the Act.

(4) The methods to be used in the preparation of each biological product shall be written into an approved Outline of Production prepared in accordance with the applicable provisions of part 114 of this subchapter. Two copies of such Outlines of Production shall be submitted to Animal and Plant Health Inspection Service and be approved before the permit is issued.

(5) Data shall be furnished by the applicant which establishes that the product involved complies with the provisions of the Act and the regulations issued pursuant thereto. When deemed necessary to obtain required information, Animal and Plant Health Inspection Service may require that the product be tested under field conditions within or outside the United States as the occasion demands.

(b) The permittee shall furnish the following:

(1) Adequate facilities for storing all imported biological products. An inspection of such facilities shall be made by inspectors before a permit is issued and additional inspections shall be made at any time subsequent to the importation of the biological products if deemed necessary by the Administrator;

(2) Information regarding all claims to be made on labels and advertising matter used in connection with or related to the biological product to be imported;

(3) Mounted copies of final container labels, carton labels, and enclosures to be used with the imported product as provided in part 112 of this subchapter; and

(4) Samples of each serial from each shipment of biological products imported or offered for importation. Such samples shall be collected, examined, and tested in a manner specified by the Administrator. The biological products being sampled shall not be further distributed by the permittee until released by Animal and Plant Health Inspection Service.

(Approved by the Office of Management and Budget under control number 0579-0013)

[38 FR 32916, Nov. 29, 1973, as amended at 48 FR 57473, Dec. 30, 1983; 49 FR 21044, May 18, 1984; 56 FR 66783, Dec. 26, 1991; 75 FR 20772, Apr. 21, 2010]

§ 104.6 Products for transit shipment only.

An application for a permit for Transit Shipment Only shall be required when a biological product is being shipped from one foreign country to another foreign country by way of the United States. The shipment shall move under a permit subject to the following restrictions:

(a) The shipment shall be confined to the carrier at all times when such shipment is to transit the United States on the same carrier on which it arrived. If the shipment is to be transferred to a carrier other than the one on which it shall arrive into the United States, a schedule of arrival and departure of each shipment shall be furnished by the permittee to Animal and Plant Health Inspection Service prior to arrival in the United States.

(b) The permittee shall be responsible to Animal and Plant Health Inspection Service for handling, storing, and forwarding of the biological product. Animal and Plant Health Inspection Service shall be notified of all shipments received and forwarded by the permittee and an accurate accounting shall be made.

(Approved by the Office of Management and Budget under control number 0579-0013)

[38 FR 32916, Nov. 29, 1973, as amended at 48 FR 57473, Dec. 30, 1983; 56 FR 66784, Dec. 26, 1991; 61 FR 52873, Oct. 9, 1996]

§ 104.7 Product permit.

(a) A permit shall be numbered and dated.

(b) The purpose for which the product is imported shall be specified on the permit as for Research and Evaluation, Distribution and Sale, or Transit Shipment Only.

(c) A permit shall not be used after the date specified.

[38 FR 32916, Nov. 29, 1973, as amended at 56 FR 66783, Dec. 26, 1991; 62 FR 13294, Mar. 20, 1997]

§ 104.8 Illegal shipments.

(a) Biological products which are presented for importation without a permit having been issued shall be returned to the country of origin at the expense of the importer or in lieu thereof, destroyed by Department personnel.

(b) Biological products for Distribution and Sale presented for importation under a permit and found to be worthless, contaminated, dangerous, or harmful shall, within a period of 30 days after such finding, be returned to the country of origin at the expense of the importer or in lieu thereof, destroyed by Department personnel: Provided, That such product shall not be returned to the country of origin while bearing a U.S. permit number on the label.

§ 105.1 Suspension or revocation.

(a) An establishment license, product license, or permit issued under the Virus-Serum-Toxin Act may be formally suspended or revoked after opportunity for hearing has been accorded the licensee or permittee as provided in part 123 of this subchapter if the Secretary is satisfied that the license or permit is being used to facilitate or effect the preparation, sale, barter, exchange, shipment, or importation contrary to said Act of any worthless, contaminated, dangerous, or harmful biological product. Such use may be found to exist if:

(1) The construction of the establishment in which the biological product is prepared is defective, or the establishment is not conducted as required by the regulations in parts 101 through 118 of this subchapter;

(2) The methods of preparation of the product are faulty, or the product contains impurities or lacks potency;

(3) The product is so labeled or advertised as to mislead or deceive the purchaser in any particular;

(4) The licensee, permittee, or the foreign manufacturer has failed to maintain and make available for inspection records in connection with the development and preparation of product, has failed to provide complete and accurate information when requested, or has failed to provide complete and accurate information in the Outline of Production or in reports and records;

(5) The licensee or permittee has violated or failed to comply with any provision of the Virus-Serum-Toxin Act or the regulations in this subchapter;

(6) The license or permit is otherwise used to facilitate or effect the preparation, sale, barter, exchange, shipment, or importation, contrary to the Virus-Serum-Toxin Act, of any worthless, contaminated, dangerous, or harmful biological product.

(b) In case of willfulness or where the public health, interest, or safety so required the Secretary may, without hearing, informally suspend such establishment license, product license, or permit upon the grounds set forth in paragraph (a) of this section pending determination of formal proceedings under part 123 of this subchapter for suspension or revocation of the license or permit.

[38 FR 23512, Aug. 31, 1973, as amended at 41 FR 44359, Oct. 8, 1976; 61 FR 52874, Oct. 9, 1996; 64 FR 43044, Aug. 9, 1999]

§ 105.2 Notification of infractions.

If an infraction of a requirement of a product license is brought to the attention of the licensee by written notification thereof by Animal and Plant Health Inspection Service, a subsequent violation of similar nature occurring with the same licensed biological product within 6 months of the said written notification shall be primafacie evidence of willful violation and the license for the product shall be subject to suspension or revocation under the provisions of § 105.1(b).

[42 FR 31430, June 21, 1977, as amended at 56 FR 66783, Dec. 26, 1991]

§ 105.3 Notices re: worthless, contaminated, dangerous, or harmful biological products.

(a) If at any time it appears that the preparation, sale, barter, exchange, shipment, or importation, as provided in the Virus-Serum-Toxin Act, of any biological product by any person holding a license or permit may be dangerous in the treatment of domestic animals, the Secretary may without hearing notify the licensee or permittee, and pending determination of formal proceedings instituted under part 123 of this subchapter for suspension or revocation of the license or permit insofar as it authorizes the manufacture or importation of the particular product, no person so notified shall thereafter so prepare, sell, barter, exchange, ship, deliver for shipment, or import such product.

(b) If a serial of biological product is found to be unsatisfactory according to applicable Standard Requirements, the Administrator may notify the licensee to stop distribution and sale of the serial.

(c) When notified to stop distribution and sale of a serial or subserial of a veterinary biological product under the provisions of paragraph (a) or (b) of this section, veterinary biologics licensees or permittees shall:

(1) Stop the preparation, distribution, sale, barter, exchange, shipment, or importation of the affected serial(s) or subserial(s) of any veterinary biological product pending further instructions from APHIS.

(2) Immediately, but no later than 2 days, send stop distribution and sale notifications to any wholesalers, jobbers, dealers, foreign consignees, or other persons known to have any such veterinary biological product in their possession, which instruct them to stop the preparation, distribution, sale, barter, exchange, shipment, or importation of any such veterinary biological product. All notifications shall be documented in writing by the licensee or permittee.

(3) Account for the remaining quantity of each serial(s) or subserial(s) of any such veterinary biological product at each location in the distribution channel known to the manufacturer (licensee) or importer (permittee).

(4) When required by the Administrator, submit complete and accurate reports of all notifications concerning stop distribution and sale actions to the Animal and Plant Health Inspection Service pursuant to § 116.5 of this subchapter.

(Approved by the Office of Management and Budget under control number 0579-0318)

[38 FR 23512, Aug. 31, 1973, as amended at 56 FR 66783, Dec. 26, 1991; 72 FR 17798, Apr. 10, 2007]

§ 105.4 Termination of licenses and permits for inactivity.

(a) If a biological product has not been prepared by a licensee, or imported by a permittee for a period of 5 years or more, the Administrator may require the licensee to show intent to resume production, or the permittee to show intent to resume importation, within 6 months of notification. If the licensee does not resume preparation, or the permittee does not resume importation, within 6 months of notification, or within a mutually agreeable period, the product license, or permit, may be terminated by the Administrator.

(b) When a license or permit is terminated, the licensee or permittee shall continue to be subject to the applicable records provisions of § 116.8.

[61 FR 52874, Oct. 9, 1996]

§ 106.1 Biological products; exemption.

The Administrator may exempt any biological product from one or more of the requirements of this subchapter if he determines that such product will be used by the Department or under the supervision or control of the Department in the prevention, control or eradication of animal diseases in connection with (a) an official USDA program; or (b) an emergency animal disease situation, or (c) a USDA experimental use of the product.

[45 FR 65184, Oct. 2, 1980, as amended at 56 FR 66783, Dec. 26, 1991]

§ 107.1 Veterinary practitioners and animal owners.

Products prepared as provided in paragraphs (a) and (b) of this section and facilities in which such products are prepared, shall be exempt from preparation pursuant to unsuspended and unrevoked establishment and product licenses. Persons exempt from licensure under this part shipping products which contain live organisms shall provide any information the Administrator may require prior to shipment, or at any other time deemed necessary, in order to assess the products' safety and effect on the environment. The shipment or delivery for shipment anywhere in or from the United States of any exempted product which is worthless, contaminated, dangerous, or harmful is prohibited, and any person shipping such product, or delivering such product for shipment, shall be subject to sanctions under the Act.

(a)(1) Products prepared by a veterinary practitioner (veterinarian) solely for administration to animals in the course of a State licensed professional practice of veterinary medicine by such veterinarian under a veterinarian-client-patient relationship and facilities in which such products are prepared shall be exempt from licensing under the Act and regulations. Such a relationship is considered to exist when:

(i) The veterinarian has assumed the responsibility for making medical judgments regarding the health of the animal(s) and the need for medical treatment, and the client (owner or other caretaker) has agreed to follow the instructions of the veterinarian; and when

(ii) There is sufficient knowledge of the animal(s) by the veterinarian to initiate at least a general or preliminary diagnosis of the medical condition of the animal(s). This means that the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s), and/or by medically appropriate and timely visits to the premises where the animal(s) are kept; and when

(iii) The practicing veterinarian is readily available for followup in case of adverse reactions or failure of the regimen.

(2) All steps in the preparation of product being prepared under the exemption in paragraph (a)(1) of this section must be performed at the facilities that the veterinarian utilizes for the day-to-day activities associated with the treatment of animals in the course of his/her State-licensed professional practice of veterinary medicine. A veterinary assistant employed by the veterinary practitioner and working at the veterinary practice's facility under the veterinarian's direct supervision may perform the steps in the preparation of product. Such preparation may not be consigned to any other party or sub-contracted to a commercial laboratory/manufacturing facility.

(3) Veterinarians preparing products subject to the exemption for products under this section shall maintain and make available for inspection by Animal and Plant Health Inspection Service representatives or other Federal employees designated by the Secretary such records as are necessary to establish that a valid veterinarian-client-patient relationship exists and that there is a valid basis for the exemption under this section.

(b) Products prepared by a person solely for administration to animals owned by that person shall be exempt from the requirement that preparation be pursuant to an unsuspended and unrevoked license.

[52 FR 30131, Aug. 13, 1987, as amended at 56 FR 66783, Dec. 26, 1991; 80 FR 26821, May 11, 2015]

§ 107.2 Products under State license.

(a) The Administrator shall exempt from the requirement of preparation pursuant to an unsuspended and unrevoked USDA establishment and product license, any biological product prepared solely for distribution within the State of production pursuant to a license granted by such State under a program determined by the Administrator to be consistent with the intent of the Act to prohibit the preparation, sale, barter, exchange, or shipment of worthless, contaminated, dangerous, or harmful biological products.

(b) A request for exemption under this section must be made by the appropriate State authority and shall include information demonstrating that:

(1) The State has the authority to license viruses, serums, toxins, and analogous products and establishments that produce such products; and

(2) The State has the authority to review the purity, safety, potency, and efficacy of such products prior to release to the market; and

(3) The State has the authority to review product test results to assure compliance with applicable standards of purity, safety, and potency prior to release to the market; and

(4) The State has the authority to deal effectively with violations of State law regulating viruses, serums, toxins, and analogous products; and

(5) The State effectively exercises the authority specified in paragraphs (b)(1) through (4) of this section consistent with the intent of the Act prohibiting the preparation, sale, barter, exchange, or shipment of worthless, contaminated, dangerous, or harmful viruses, serums, toxins, or analogous products.

(c) Each product to be exempted and each establishment preparing such product shall be identified by the State and the State shall give written notification to the Administrator of each such product and establishment. The State shall also give written notice to the Administrator of each new license issued and of each license terminated.

(d) In order to determine whether a State exercises its authority with respect to biological products and establishments and whether its laws and regulations are being achieved, the Administrator, in cooperation with proper State authorities, may conduct an on-site evaluation of the State's program which may include inspection of establishments and/or products to be included under the exemptions in this section.

[52 FR 30131, Aug. 13, 1987, as amended at 56 FR 66783, Dec. 26, 1991]

§ 108.1 Applicability.

Unless otherwise authorized by the Administrator, all buildings, appurtenances, and equipment used in the preparation of biological products shall be in compliance with the regulations in this part. Each land area on which such buildings and appurtenances are located shall be identified by an address which shall appear on the establishment license.

[39 FR 16854, May 10, 1974, as amended at 56 FR 66783, Dec. 26, 1991]

§ 108.2 Plot plans, blueprints, and legends required.

Each applicant for an establishment license shall prepare a plot plan showing all buildings for each particular land area, blueprints for each building used in the preparation of biological products and legends containing a brief description of all activities in each room or area.

§ 108.3 Preparation of plot plans.

Plot plans shall show all of the buildings on a particular land area, whether or not they are all used for the preparation and initial shipping of biological products: Provided, That, when a great number of buildings are on the same premises, only those surrounding the buildings used for preparation and initial shipping of biological products shall be shown. The presence of the remainder of the buildings may be accounted for by a single statement denoting the total number of such buildings not used for the preparation or shipping of biological products.

(a) Reduce the entire premises to any standard scale on one sheet of paper which meets any of the American standard trimmed sizes. Indicate the scale used.

(b) Clearly mark the boundaries of the licensed premises and indicate what marking denotes the boundaries. Such boundaries shall coincide with some readily apparent perimeter line. Identify all fences, walls, or streets.

(c) Show buildings as reduced dimensional drawings in the proper scale distance relationship with each other.

(d) Number, letter, or otherwise identify all buildings so that they may be correlated with the respective blueprints and legends.

(e) Describe on the plot plan the use of immediate adjacent properties such as, residential area, pasture, box factory, or the like.

(f) Show compass points.

(g) Show date of preparation.

(h) Apply signature of responsible official of the firm.

§ 108.4 Preparation of blueprints.

(a) Blueprints, drawn to any suitable scale, on regular blueprint paper or a good grade of white paper of any one of the American standard trimmed sizes shall be acceptable: Provided, That the same scale shall be used for future revisions unless the entire blueprint is revised. Indicate the scale used.

(b) Use a single sheet of paper for each floor of all buildings in which biological products are prepared. Illustrate in detail the areas in each building utilized for such preparation.

(c) If only a portion of a floor is used in the preparation of a biological product, the blueprint shall illustrate the entire floor in essentially the same detail throughout. All functions or activities performed in the remainder of the floor shall be indicated.

(d) Identify the floors if the drawing is not for all floors in a multiple-story building and identify activities on each floor.

(e) Identify all rooms by letters or numbers.

(f) Show the location of important stationary equipment by a suitable code which will be further identified on legends.

(g) Explain on the blueprint or on the legend, by a statement or listing, which rooms are equipped with water outlets, drains, and lighting. Show the location of doors and windows.

(h) Show compass points.

(i) Show building number.

(j) Show date of preparation.

(k) Apply signature of responsible official of firm.

§ 108.5 Preparation of legends.

A brief description of the activities performed in each room or area shall be prepared as provided in this section and shall be referred to as a legend. Legends shall be provided for each plot plan and each blueprint or drawing. All pages of the legends shall be numbered, identified with corresponding plot plan or blueprint, and submitted in booklet form either stapled together or clipped into a suitable folder.

(a) Plot plan legends shall show the following:

(1) Number of each building and the functions performed in each: Provided, That if it is a multiple-story building in which biological products are prepared or handled, briefly describe functions performed on each floor.

(2) A practical and nontechnical description of construction materials used throughout those buildings used entirely or partially for production and handling of biological products.

(b) Blueprint legends shall show the following:

(1) A listing of all rooms by identifying letters or numbers and the fractions prepared in each. Exceptions may be listed for general purpose areas or rooms. Functions performed in each area and room shall be described, whether the licensed or unlicensed products. In rooms where products are exposed to the surroundings, a description of decontamination procedures and other precautions against cross contamination shall be included.

(2) A listing of the coded stationary equipment.

(3) A general listing of other essential biological equipment such as mills, centrifuges, mixing tanks, bottling and sealing equipment, and the like, which are not regarded as stationary but are maintained in certain rooms.

[39 FR 16854, May 10, 1974, as amended at 40 FR 51413, Nov. 5, 1975; 50 FR 50764, Dec. 12, 1985]

§ 108.6 Revision of plot plans, blueprints, and legends.

Preliminary drawings may be submitted to Animal and Plant Health Inspection Service for comment prior to construction of new facilities or when remodeling is anticipated, old facilities are to be torn down, or other changes affecting the workflow are to be made. The licensee shall:

(a) Prepare revised plot plans, blueprints, or legends and submit to Animal and Plant Health Inspection Service for review and filing when changes have been completed. Also prepare a statement to accompany each revision to identify, by date of the superseded item, what is being superseded.

(b) Prepare a drawing of the revised rooms, unit, or section to the same scale as the blueprint on file which shall be stamped and applied to the existing blueprint. If changes are numerous, prepare a new blueprint.

(c) Drawings of new buildings may be added to existing plot plans. Indicate the distance from surrounding buildings and boundary lines.

(d) Any change prescribed in this section shall necessitate a change in one or more pages of the respective legends. The revised pages shall carry the same numbers as superseded pages.

[39 FR 16854, May 10, 1974, as amended at 56 FR 66783, Dec. 26, 1991]

§ 108.7 Filing of plot plans, blueprints, and legends.

Two copies of all plot plans, blueprints, and legends, including revisions, shall be submitted to Animal and Plant Health Inspection Service for review and filing. When the reviewer takes exception to a submitted item, such item shall be returned with appropriate comments for correction and resubmission. Acceptable submissions shall be stamped as filed and the date noted. One stamped copy shall be returned and two copies retained for Animal and Plant Health Inspection Service files.

[39 FR 16854, May 10, 1974, as amended at 56 FR 66783, Dec. 26, 1991; 75 FR 20772, Apr. 21, 2010]

§ 108.8 Construction of buildings.

(a) The floors, walls, ceilings, partitions, posts, doors, and all other parts of all structures, rooms, or facilities used for the preparation of biological products or ingredients of biological products at licensed establishments shall be of such material, construction, and finish as may be readily and thoroughly cleaned.

(b) All rooms used in connection with the preparation of biological products shall be so constructed and arranged as to prevent cross-contamination of such biological products. Halls or walkways shall be provided for the movement of personnel or materials to each biological products preparation area without going through another such area.

(c) Rooms or compartments separate from the remainder of the establishment shall be provided at licensed establishments for preparing, handling, and storing virulent or dangerous microorganisms and products.

(d) All rooms and compartments at licensed establishments shall have an adequate air handling system to supply proper ventilation sufficient to insure sanitary and hygienic conditions for the protection of the products and personnel.

(e) The supply of hot and cold water at licensed establishments shall be ample and clean. Adequate facilities shall be provided for the distribution of water in each establishment and for the washing of all containers, machinery, instruments, other equipment, and animals used in the preparation of a biological product.

(f) There shall be an efficient drainage and plumbing system for each licensed establishment and premises thereof, and all drains and gutters shall be properly installed with approved traps and vents.

§ 108.9 Dressing rooms and other facilities.

Each licensed establishment shall have dressing rooms, toilet facilities, and lavatory accommodations, including hot and cold running water, soap, towels, and the like. They shall be in sufficient number, ample in size, conveniently located, properly ventilated, and meeting all requirements as to sanitary construction and equipment.

(a) These rooms and facilities shall be separate from rooms or compartments in which biological products are prepared, handled, or stored.

(b) These rooms and facilities shall be so located in the establishment as to be readily accessible to all persons without having to enter or pass through biological products preparation areas.

§ 108.10 Outer premises and stables.

(a) The outer premises of licensed establishments, embracing docks, driveways, approaches, yards, pens, chutes, and alleys shall be drained properly and kept in a clean and orderly condition. No nuisance shall be allowed in any licensed establishment or on its premises.

(b) Stables or other premises for animals used in the production or testing of biological products at licensed establishments shall be properly ventilated and lighted, appropriately drained and guttered, and kept in sanitary condition.

(c) Every practical precaution shall be taken to keep licensed establishments free of flies, rats, mice, and other vermin. The accumulation, on the premises of an establishment, of any material in which flies or other vermin may breed is forbidden. Suitable arrangements, in keeping with the local health practices, shall be made for the disposal of all refuse.

§ 108.11 Water quality requirements.

A certification from the appropriate water pollution control agency, that the establishment is in compliance with applicable water quality control standards, pursuant to section 401 of the Federal Water Pollution Control Act, as amended (86 Stat. 877; 33 U.S.C. 1341), shall be filed with Animal and Plant Health Inspection Service for each licensed establishment.

[39 FR 16854, May 10, 1974, as amended at 56 FR 66783, Dec. 26, 1991]

§ 109.1 Equipment and the like.

(a) All containers, instruments, and other apparatus and equipment, before being used in preparing, handling, or storing biological products, at a licensed establishment, except as otherwise prescribed herein, shall be thoroughly sterilized by live steam at a temperature of at least 120 °C. for not less than one-half hour, or by dry heat at a temperature of at least 160 °C. for not less than one hour. If for any reason such methods of sterilization are impracticable, then a process known to be equally efficacious in destroying microorganisms and their spores may be substituted after approval by the Administrator.

(b) Instruments which are found to be damaged by exposure to the degree of heat prescribed in this section, after having been thoroughly cleaned, may be sterilized by boiling for not less than 15 minutes.

[23 FR 10051, Dec. 23, 1958, as amended at 34 FR 18119, Nov. 11, 1969; 56 FR 66783, Dec. 26, 1991]

§ 109.2 Sterilizers.

Steam and dry-heat sterilizers used in connection with the processing of biological products at licensed establishments shall be equipped with automatic temperature recording gauges: Provided, That other record keeping systems may be used when approved by the Administrator. When gauges are used, they shall be periodically standardized to assure accuracy. Charts and other temperature records made during production shall be available at all times charts and records shall be kept in accordance with part 116 of this chapter.

[35 FR 16039, Oct. 13, 1970, as amended at 56 FR 66783, Dec. 26, 1991]

§ 109.3 Pasteurizers.

All pasteurizing equipment shall meet the requirements in paragraphs (a), (b), and (c) of this section and be acceptable to Animal and Plant Health Inspection Service.

(a) Metal serum containers shall be used in licensed establishments. During the heating process, each container shall be surrounded by a separate water jacket or equivalent so that the entire container, including its lid, is heated to the required temperature. Each serum container shall be equipped with a motor-driven agitator and a separate automatic recording thermometer.

(b) Each water bath shall have an automatic temperature control to limit the temperature of the water to a maximum of 62 °C., an automatic recording thermometer, an indicating thermometer set in a fixed position, and circulating mechanism adequate to insure equal temperatures throughout the bath. The heating unit for the bath shall be separated from the serum container and the water jacket.

(c) Accurate thermometers at licensed establishments shall be used at frequent intervals to check temperatures of the serum as registered by recording thermometers.

[35 FR 16039, Oct. 13, 1970, as amended at 56 FR 66783, Dec. 26, 1991]

§ 112.1 General.

(a) Unless otherwise authorized or directed by the Administrator, each biological product prepared at a licensed establishment, or imported, shall be packaged and labeled as prescribed in this part before it is removed from the licensed establishment or presented for importation: Provided, That biological products to be imported for research and evaluation shall be subject to packaging and labeling requirements in § 112.9. Provided further, That, unless otherwise exempted, all preparation, including packaging and labeling, of biological products shall only be performed in a licensed establishment under an approved Outline of Production.

(b) No person shall apply or affix to or include with, or cause to be applied or affixed to or included with, any carton or final container of a biological product, any label, stamp, mark or statement that is false or misleading in any particular, is not in compliance with the regulations, or is not approved by APHIS.

(c) No person shall alter, mark or remove any approved labeling affixed to or included with any biological product prior to selling or otherwise distributing such product. In addition, no person shall mark any carton, other container, or final container of a biological product so as to falsify the labeling, make it misleading, or cause it to be illegible.

(d) Labels that are stamped, printed or glued directly on cartons, other containers, or final containers shall be legible throughout the dating period. Biological products bearing labels, which have been altered, mutilated, destroyed, obliterated or removed, shall be withheld from the market.

[38 FR 12094, May 9, 1973, as amended at 59 FR 43445, Aug. 24, 1994]

§ 112.2 Final container label, carton label, and enclosure.

(a) Unless otherwise provided, final container labels, carton labels, and enclosures (inserts, circulars, or leaflets) shall include the information specified in this section.

(1) The complete true name of the biological product which name shall be identical with that shown in the product license under which such product is prepared or the permit under which it is imported, shall be prominently lettered and placed giving equal emphasis to each word composing it. Descriptive terms used in the true name on the product license or permit shall also appear. Abbreviations of the descriptive terms may be used on the final container label if complete descriptive terms appear on the carton label and enclosure. The following exceptions are applicable to small final containers, and containers of interchangeable reagents included in diagnostic test kits:

(i) For small final containers, an abbreviated true name of the biological product, which shall be identical with that shown in the product license under which the product is prepared or the permit under which it is imported, may be used: Provided, That the complete true name of the product must appear on the carton label and enclosures;

(ii) In addition to the true name of the kit, the functional and/or chemical name of the reagent must appear on labeling for small final containers of reagents included in diagnostic kits: Provided, That the true name is not required on labeling for small final containers of interchangeable (non-critical) components of diagnostic kits.

(2) For biological product prepared in the United States or in a foreign country, the name and address of the producer (licensee, or subsidiary) or permittee and of the foreign producer, and an appropriate consumer contact telephone number: Provided, That in the case of a biological product exported from the United States in labeled final containers, a consumer contact telephone number is not required; however, small single dose containers marketed in the United States must include contact telephone information on carton and enclosures.

(3) The United States Veterinary Biologics Establishment License Number (VLN) or the United States Veterinary Biological Product Permit Number (VPN), and the Product Code Number (PCN) assigned by the Department, which shall be shown only as “VLN/PCN” and “VPN/PCN,” respectively, except that:

(i) Only the VLN or VPN is required on container labels of interchangeable (non-critical) components of diagnostic kits and container labels for individual products packaged together for co-administration.

(ii) The PCN may be used in lieu of the true name of the kit on small container labels for critical components of diagnostic kits.

(iii) Container labels for individually licensed biological products, when marketed as components of combination packages, must include a statement referring the consumer to the carton or enclosure for the PCN of the combination package.

(4) Storage temperature recommendation for the biological product stated as 2 to 8 °C or 35 to 46 °F, or both.

(5) Full instructions for the proper use of the product, including indications for use, target species, minimum age of administration, route of administration, vaccination schedule, product license restriction(s) that bear on product use, warnings, cautions, and any other vital information for the product's use; except that in the case of limited space on final container labels, a statement as to where such information is to be found, such as “See enclosure for complete directions,” “Full directions on carton,” or comparable statement.

(6) In the case of a multiple-dose final container, a warning to use entire contents when first opened: Provided, That a diagnostic or a desensitizing antigen packaged in a multiple-dose final container is exempt.

(7) The following warning statements, or equivalent statements, shall appear on the labeling as applicable:

(i) Products other than diagnostic kits: “Do not mix with other products, except as specified on this label.”

(ii) Injectable products and other products containing hazardous components: “In case of human exposure, contact a physician.”

(iii) Products containing viable organisms: “Inactivate unused contents before disposal.”

(8) In the case of a biological product recommended for use in domestic animals, the edible portion of which may be used for food purposes, a withholding statement of not less than 21 days to read: “Do not vaccinate within (insert number) days before slaughter” or “Do not vaccinate food-producing animals within (insert number) days before slaughter”: Provided, That longer periods shall be stated when deemed necessary by the Administrator. Very small final container labels are exempted from this requirement.

(9) The following information shall appear on the final container label and carton label, if any, but need not appear on the enclosure:

(i) A permitted expiration date;

(ii) The number of doses where applicable;

(iii) The recoverable quantity of the content of each final container stated in cubic centimeters (cc.) or milliliters (ml.) or units.

(iv) A serial number by which the product can be identified with the manufacturer's records of preparation: Provided, That when a liquid antigenic fraction is to be used instead of a water diluent for one or more desiccated antigenic fractions in a combination package, a hyphenated serial number composed of a serial number for the desiccated fraction and the serial number for the liquid fraction shall be used on the carton.

(v) A statement similar to “For more information regarding efficacy and safety data, go to productdata.aphis.usda.gov.

(10) In the case of a product that contains a preservative that is added during the production process and is not reduced to undetectable levels in the completed product through the production process, the statement “Contains [name of preservative] as a preservative” or an equivalent statement must appear on cartons and enclosures, if used. If cartons are not used, such information must appear on the final container label.

(11) The number of final containers of biological product and the number of doses in each final container shall be stated on each carton label for all cartons containing more than one final container of biological product. The number of final containers of diluent, if any, and the quantity in each shall also be stated on each carton label.

(12) An indications statement to read, “This product has been shown to be effective for the vaccination of healthy (insert name of species) ____ weeks of age or older against ____.” Provided, That in the case of very small final container labels or carton, a statement as to where such information is to be found, such as “See enclosure for complete directions,” “Full directions on carton,” or comparable statement.

(b) Labels may also include any other statement which is not false or misleading and may include factual statements regarding variable response of different animals when vaccinated as directed but may not include disclaimers of merchantability, fitness for the purpose offered, or responsibility for the product.

(c) Labels of biological products prepared at licensed establishments or imported shall not include any statement, design, or device, which overshadows the true name of the product as licensed or which is false or misleading in any particular or which may otherwise deceive the purchaser.

(d) Carton labels and enclosures shall be subject to paragraph (d)(1), (d)(2), and (d)(3) of this section.

(1) The statement, “Restricted to use by or under the direction of a veterinarian” or “Restricted to use by a veterinarian,” shall be used on all carton labels and enclosures when such restriction is prescribed on the product license.

(2) If the licensee states on the carton labels and enclosures of a product that its sales are restricted to veterinarians, then the entire production of that particular product in the licensed establishment shall be so restricted by the licensee.

(3) The statement “For use in animals only” may appear on the labeling as appropriate for a product to indicate that the product is recommended specifically for animals and not for humans.

(e) When label requirements of a foreign country differ from the requirements as prescribed in this part, special labels may be approved by APHIS for use on biological products to be exported to such country upon receipt of written authorization, acceptable to APHIS, from regulatory officials of the importing country, provided that:

(1) If the labeling contains claims or indications for use not supported by data on file with APHIS, the special labels for export shall not bear the VLN.

(2) All other labels for export shall bear the VLN unless the importing country provides documentation that the VLN is specifically prohibited. When laws, regulations, or other requirements of foreign countries require exporters of biological products prepared in a licensed establishment to furnish official certification that such products have been prepared in accordance with the Virus-Serum-Toxin Act and regulations issued pursuant to the Act, such certification may be made by APHIS.

(f) Multiple-dose final containers of liquid biological product and carton tray covers showing required labeling information are subject to the requirements in this paragraphs.

(1) If a carton label or an enclosure is required to complete the labeling for a multiple-dose final container of liquid biological product, only one final container, with a container of diluent if applicable, shall be packaged in each carton: Provided, That if the multiple-dose final container is fully labeled without a carton label or enclosure, two or more final containers, and a corresponding number of diluent containers, may be packaged in a single carton which shall be considered a shipping box. Labels or stickers for shipping boxes shall not contain false or misleading information, but need not be submitted to APHIS for approval.

(2) When required labeling information is shown on a carton tray cover, it must be printed on the outside face of such tray cover where it may be read without opening the carton. The inside face of the tray cover may contain information suitable for an enclosure.

(Approved by the Office of Management and Budget under control number 0579-0013)

[38 FR 12094, May 9, 1973, as amended at 39 FR 16856, May 10, 1974; 41 FR 44359, Oct. 8, 1976; 42 FR 11825, Mar. 1, 1977; 42 FR 29854, June 10, 1977; 42 FR 41850, Aug. 19, 1977; 48 FR 57473, Dec. 30, 1983; 56 FR 66784, Dec. 26, 1991; 80 FR 39674, July 10, 2015; 81 FR 59433, Aug. 30, 2016; 81 FR 78500, Nov. 8, 2016]

§ 112.3 Diluent labels.

Each final container of diluent, other than a liquid biological product, packaged with desiccated biological products shall bear a label that includes the following:

(a) The name—Sterile Diluent.

(b) True name of the biological product with which the diluent is packaged, except that when the firm packages all desiccated biological products with the same diluent, or two or more types of diluent are used, and the licensees' methods of identification and storage insure that all products are packaged with the correct type of diluent, labels affixed to the containers of diluent are exempt from this provision.

(c) The recoverable quantity of contents in cubic centimeters (cc) or milliliters (ml).

(d) A serial number by which the diluent can be identified with the manufacturer's records of preparation;

(e) Name and address of the licensee or the permittee;

(f) In the case of a diluent with which a desiccated biological product is to come in contact while the diluent is in its original container; and,

(1) Is in a multiple-dose container, a positive warning that all of the biological product shall be used at the time the container is first opened; and/or

(2) The biological product is composed of viable or dangerous organisms or viruses, the notice, “Inactivate unused contents before disposal.”

(g) The establishment license number or the permit number, as the case may be, in one of the forms provided in § 112.2(a)(3).

[38 FR 12094, May 9, 1973; 38 FR 13476, May 22, 1973, and amended at 39 FR 16856, May 10, 1974; 81 FR 59434, Aug. 30, 2016]

§ 112.4 Subsidiaries, divisions, distributors, and permittees.

Labels used by subsidiaries, divisions, distributors, and permittees shall be affixed by the licensee in a licensed establishment where the product is produced. Such labels shall comply with requirements for their review, approval, and filing as provided in the regulations.

(a) Subsidiaries. Labels to be used on a licensed biological product prepared by a subsidiary operating in a licensed establishment shall be submitted in accordance with § 112.5. Only labels approved for use on such product shall be used by the subsidiary.

(b) Divisions. Labels to be used on a licensed biological product prepared in a licensed establishment for distribution by a division or marketing unit of the licensee shall be submitted in accordance with § 112.5. The name, address, and license number of the licensee shall be prominently placed on such labels. The relationship of the division or marketing unit to the licensee shall appear prominently on the label by use of the term “division of” or equivalent.

(c) Distributors. The name and address of the distributor or any statement, design, or device shall not be placed on the labels or containers of a licensed biological product in a manner which could be false or misleading or which could indicate that the distributor is the manufacturer of such product or operating under the license number shown on the label. The manufacturer shall be identified by name, address, and license number with the term “manufactured by,” “produced by,” or an equivalent term prominently placed in connection therewith. The name and address of the distributor may be placed on labels or containers if the term “distributor,” or “distributed by,” or an equivalent term is prominently placed in connection therewith.

(d) Permittees. The name and address of the permittee and any statement, design, or device shall not be placed on the labels or containers of a biological product imported for sale and distribution in accordance with § 104.5 in a manner which could be false or misleading or which could falsely indicate that the permittee is the manufacturer of such product. The manufacturer shall be identified by name and address with the term “manufactured by,” “produced by,” or an equivalent term prominently placed in connection therewith. Reference to the permittee shall be made by name, address, and permit number with the term “imported by,” “produced for,” or an equivalent term prominently placed in connection therewith.

[50 FR 46417, Nov. 8, 1985, as amended at 59 FR 43445, Aug. 24, 1994]

§ 112.5 Review and approval of labeling.

Labels used with biological products prepared at licensed establishments or imported for general distribution and sale must be submitted to the Animal and Plant Health Inspection Service for review for compliance with the regulations and approval in writing prior to use, except as provided in paragraph (d) of this section and under the master label system provided in paragraph (e) of this section.

(a) Transmittal forms, available on the APHIS Web page at http://www.aphis.usda.gov/animalhealth/cvb/forms, shall be used with each submission of sketches (including proofs) and labels. Separate forms shall be used for each biological product but only one copy of the form shall be used for all sketches and labels submitted at the same time for the same biological product.

(b) A data summary, available on the Internet at productdata.aphis.usda.gov, shall be used with each submission of efficacy and safety data in support of a label claim. Manufacturers will submit the efficacy and safety data information with either the efficacy and safety studies or at the time of label submission. This information will be posted at productdata.aphis.usda.gov to allow public disclosure of product performance.

(c) Sketches may be submitted for comment to Animal and Plant Health Inspection Service by the licensee or permittee before preparing the finished label. Such sketches shall be returned to the licensee or permittee with comments, if any. Failure of the reviewer to take exception to a sketch shall not constitute approval of a finished label subsequently prepared.

(d)(1) Labels must be submitted to the Animal and Plant Health Inspection Service for review and written approval. Only labels which are approved as provided in paragraph (e) of this section may be used. When changes are made in approved labels, the new labels shall be subject to review and approval before use: Provided, That certain minor changes may be made in labels for products with approved labels or master labels, and the revised labels may be used prior to review by APHIS, with the provision that a new label or master label bearing these changes is submitted to APHIS for review and written approval within 60 days of label use, and that such minor changes do not render the product mislabeled or the label false and misleading in any particular.

(2) Minor label changes that may be made under the provision for products with approved labels or master labels are:

(i) Changes in the physical dimensions of the label provided that such change does not affect the legibility of the label;

(ii) Changes in the color of label print or background, provided that such changes do not affect the legibility of the label;

(iii) The addition or deletion of a Trade Mark (TM) or Registered (R) symbol;

(iv) The correction of typographical errors;

(v) Adding, changing, deleting, or repositioning label control numbers, universal product codes, or other inventory control numbers;

(vi) Revising or updating logos;

(vii) Changing the telephone contact number;

(viii) Adding, changing, or deleting an email and/or Web site address;

(ix) Changing the establishment license or permit number assigned by APHIS, and/or changing the name and/or address of the manufacturer or permittee, provided that such changes are identical to information on the current establishment license or permit; and

(x) Adding or changing the name and/or address of a distributor.

(e) Labels and sketches submitted shall be prepared in the number and manner prescribed in this paragraph.

(1) Copies required:

(i) For label sketches, submit two copies of each sketch of a final container label, carton label, and enclosure. Sketches must be legible, and must include all information specified in § 112.2. One copy of each sketch will be returned with applicable comments, and one copy will be held on file by APHIS for no more than one year after processing, until replaced by a finished label: Provided, That sketches submitted in support of an application for a license or permit shall be held as long as the application is considered active.

(ii) For master label sketches, submit for each product two copies of each sketch of an enclosure, label for the smallest size final container, and carton label; Provided, That labels for larger size containers and/or cartons that are identical, except for physical dimensions, need not be submitted. One copy of each master label sketch will be returned with applicable comments, and one copy will be held on file by APHIS for one year after processing, until replaced by a finished master label that is submitted according to paragraph (e)(1)(iii) of this section: Provided, That master label sketches submitted in support of an application for license or permit shall be held as long as the application is considered active.

(iii) For finished labels, submit two copies of each finished final container label, carton label, and enclosure: Provided, That when an enclosure is to be used with more than one product, one extra copy shall be submitted for each additional product. One copy of each finished label will be retained by APHIS. One copy will be stamped and returned to the licensee or permittee. Labels to which exceptions are taken shall be marked as sketches and handled under paragraph (e)(1)(i) of this section.

(iv) For finished master labels, submit for each product two copies each of the enclosure and the labels for the smallest size final container and carton. Labels for larger sizes of containers or cartons of the same product that are identical, except for physical dimensions, need not be submitted. Such labels become eligible for use concurrent with the approval of the appropriate finished master label, provided that the marketing of larger size final containers is approved in the filed Outline of Production, and the appropriate larger sizes of containers or cartons are identified on the label mounting sheet. When a master label enclosure is to be used with more than one product, one extra copy for each additional product shall be submitted. One copy of each finished master label will be retained by APHIS. One copy will be stamped and returned to the licensee or permittee. Master labels to which exception are taken will be marked as sketches and handled under paragraph (e)(1)(ii) of this section.

(2) Mounting:

(i) Each label or sketch shall be securely fastened to a separate sheet of heavy bond paper (8 1/2″ × 11″) in such a manner that all information is available for review.

(ii) Two-or three-part cartons, including “sleeves,” shall be considered as one label. All parts shall be submitted together.

(iii)(A) When two final containers are packaged together in a combination package, the labels for each shall be mounted on the same sheet of paper and shall be treated as one label. For diagnostic test kits, the labels for use on the individual reagent containers to be included in the kit shall be mounted together on a single sheet of paper, if possible; if necessary, a second sheet of paper may be used. The carton label and enclosure shall be mounted on separate individual sheets.

(B) If either final container label is also used alone or in another combination package, sets of separate labels for each biological product with which it is used shall be submitted for review.

(iv) When the same final container label is applied by different methods such as paper or screen printing, one of each shall be mounted on the same sheet of paper as one submission.

(3) To appear on the top of each page:

(i)(A) Name and product code number of the biological product as it appears on the product license or permit.

(B) Extra copies of enclosures to be used with another product shall bear the name and code number of the product affected.

(ii)(A) Designation of the specimen as a label or master label: sketch, final container label, carton label, or enclosure.

(B) If two final container labels or multiple parts are on one sheet, each shall be named, and the label or part being revised shall be designated.

(iii) Size of package (dose, ml., cc., or units) for which the labels or enclosures are to be used.

(4) To appear on the bottom of each page in the lower left hand corner, if applicable:

(i) The dose size(s) to which the master label applies.

(ii) The APHIS assigned number for the label or sketch to be replaced.

(iii) The APHIS assigned number for the label to be used as a reference for reviewing the submitted label.

(f) Special requirements for foreign language labels:

(1) An accurate English translation must accompany each foreign language label submitted for approval. A statement affirming the accuracy of the translation must also be included.

(2) Foreign language portion of a bilingual label shall be a true translation of the English portion. Reference to additional information on the enclosure shall not be made unless that enclosure is also bilingual.

(g) When a request is received from Animal and Plant Health Inspection Service, the licensee or permittee shall submit a list of all approved labels currently being used. Each label listed shall be identified as to:

(1) Name and product code number as it appears on the product license or permit for the product; and

(2) Where applicable, the size of the package (doses, ml., cc., or units) on which the label shall be used; and

(3) Label number and date assigned; and

(4) Name of licensee or subsidiary appearing on the label as the producer.

(h) At the time of an inspection, or when requested by APHIS, licensees or permittees shall make all labels and master labels, including labels approved for use but exempted from filing under the master label system, available for review by authorized inspectors. Such labels shall be identical to the approved label or master label except for physical dimensions, reference to recoverable volume or doses and/or certain minor differences permitted in accordance with paragraph (d) of this section.

(Approved by the Office of Management and Budget under control number 0579-0013)

[38 FR 12094, May 9, 1973, as amended at 48 FR 57473, Dec. 30, 1983; 49 FR 21044, May 18, 1984; 56 FR 66783, Dec. 26, 1991; 59 FR 43445, Aug. 24, 1994; 61 FR 29464, June 11, 1996; 61 FR 33175, June 26, 1996; 64 FR 43044, Aug. 9, 1999; 75 FR 20772, Apr. 21, 2010; 80 FR 39675, July 10, 2015; 81 FR 47005, July 20, 2016; 81 FR 59435, Aug. 30, 2016]

§ 112.6 Packaging biological products.

(a) Multiple-dose final containers of a biological product with final container labeling including all information required under the regulations may be packaged one or more per carton with a container(s) of the proper volume of diluent, if required, for that dose as specified in the filed Outline of Production: Provided, That cartons containing more than one final container of product must comply with the conditions set forth in paragraphs (c)(1) through (4) of this section. Multiple-dose final containers of a product that require a carton or enclosure in order to provide all information required under the regulations shall be packaged one container per carton with the proper volume of diluent, if required, for that dose as specified in the filed Outline of Production.

(b) Single-dose final containers of a product need not be packaged one per carton. For single-dose products which require a diluent for administration, the number of containers of the proper amount of diluent specified in the filed Outline of Production for the number of doses contained in the carton shall be included in each carton.

(c) Poultry products for mass administration (including but not limited to administration through drinking water and spray) and products used in automatic vaccinating systems (including but not limited to pneumatic beak injectors and automated needle injectors) may be packaged in multiple-dose final containers as specified in the filed Outline of Production. Poultry products for manual administration to individual birds shall not exceed 1,000 doses in each final container. Diluent need not be packaged with the final container(s) of the product, but the licensee shall provide the required number of containers of diluent as specified in the filed Outline of Production. The following requirements apply to cartons containing more than one final container of poultry product:

(1) They shall be sealed prior to leaving the licensed establishment.

(2) The contents may not be repackaged.

(3) The contents of such cartons may not be sold in fractional units.

(4) The following statement must appear in a prominent place on the carton label: “Federal regulations prohibit the repackaging or sale of the contents of this carton in fractional units. Do not accept if seal is broken.”

(d) Diluent for the following products need not be packaged with the final container(s) of the product, but the licensee shall provide the consumer with the required number of containers of the proper amount of diluent as specified in the filed Outline of Production:

(1) Marek's Disease Vaccine.

(2) Poultry vaccines administered to individual birds using automatic vaccinating equipment.

(e) Final containers of biological product prepared at a licensed establishment, or imported, in cartons or other containers shall not be removed from such cartons or containers for sale or distribution, unless each final container bears, or is packaged in a carton with, complete and approved labeling which is affixed to or included with each container by the licensed establishment producing the product or by the producer in the case of imported product: Provided, That this paragraph is not intended to apply to licensed veterinary practitioners administering or dispensing biological products in the course of their practice under a veterinary-client-patient-relationship as that term is used in § 107.1.

(f) Labels which are affixed to or included with a biological product shall not be removed or altered in any manner.

[47 FR 8761, Mar. 2, 1982, as amended at 48 FR 12691, Mar. 28, 1983; 59 FR 43445, Aug. 24, 1994; 64 FR 43044, Aug. 9, 1999; 81 FR 59435, Aug. 30, 2016]

§ 112.7 Special additional requirements.

The label requirements in this section are additional to those prescribed elsewhere in this part.

(a) In the case of biological products containing live Newcastle Disease virus, a caution statement indicating that Newcastle Disease can cause inflammation of the eyelids of humans, and a warning to the user to avoid infecting his eyes shall be included on the enclosure.

(b) In the case of a biological product containing infectious bronchitis virus, all labels shall show the infectious bronchitis virus type or types used in the product. Abbreviation is permitted.

(c) In the case of a biological product containing inactivated rabies virus, carton labels, enclosures, and all but very small final container labels shall include a warning against freezing and the recommendations provided in this paragraph.

(1) That vaccine be administered to animals at 3 months of age or older, with a repeat dose 1 year later.

(2) Subsequent revaccination as determined from the results of duration of immunity studies conducted as prescribed in § 113.209, paragraph (b) or (c), or both.

(d) In the case of a biological product containing modified live rabies virus, the carton labels, enclosures, and all but very small final container labels shall include the recommendations provided in this paragraph.

(1) For low egg-passage (below the 180th egg-passage level) the statement “For Use in Dogs Only! Not For Use in Any Other Animal!”

(2) For other vaccines containing modified live rabies virus, the statement “For Use In (designate animal(s)) Only! Not For Use In Any Other Animal!”

(3) Intramuscular injection at one site in the thigh shall be recommended.

(4) The statement “In event of accidental exposure to the vaccine virus, the possible hazard to human health should be considered and State Public Health Officials should be consulted for specific recommendations” shall be prominently placed on all carton labels and on enclosures, if used.

(5) That vaccine be administered to animals at 3 months of age or older, with a repeat dose 1 year later.

(6) Subsequent revaccination as determined from the results of duration of immunity studies conducted as prescribed in § 113.312, paragraph (b) or (c), or both.

(e) Labeling for all products for use in mammals must bear an appropriate statement concerning use in pregnant animals.

(1) For bovine rhinotracheitis vaccine or bovine virus diarrhea vaccine containing modified live virus, all labeling except small final container labels shall bear the following statement: “Do not use in pregnant cows or in calves nursing pregnant cows.”: Provided, That such vaccines which have been shown to be safe for use in pregnant cows may be excepted from this label requirement by the Administrator.

(2) For other modified live and inactivated vaccine, labeling shall bear a statement appropriate to the level of safety that has been demonstrated in pregnant animals.

(i) Products known to be unsafe in pregnant animals shall include statements such as “Do not use in pregnant animals,” or “Unsafe for use in pregnant animals,” or an equivalent statement acceptable to APHIS.

(ii) Products without safety documentation acceptable to APHIS, but not known to be unsafe, labeling shall include the statement “This product has not been tested in pregnant animals” or an equivalent statement acceptable to APHIS.

(3) For modified live vaccines containing agents with potential reproductive effects but having acceptable pregnant animal safety data on file with APHIS, labeling still must bear the following statement concerning residual risk: “Fetal health risks associated with the vaccination of pregnant animals with this vaccine cannot be unequivocally determined during clinical trials conducted for licensure. Appropriate strategies to address the risks associated with vaccine use in pregnant animals should be discussed with a veterinarian.”

(f) For biological products recommending annual booster vaccinations, such recommendations must be supported by data acceptable to APHIS. In the absence of data that establish the need for booster vaccination, labeling must bear the following statement: “The need for annual booster vaccinations has not been established for this product; consultation with a veterinarian is recommended.”

(g) In the case of a liquid product authorized in a filed Outline of Production to be used as a diluent in a combination package, the carton labels and enclosures used for serials which are either not tested for bactericidal or viricidal activity or have been found unsatisfactory by such test shall contain the statement: “CAUTION: DO NOT USE AS DILUENT FOR LIVE VACCINES.”

(h) In the case of wart vaccine, recommendations shall be limited to use in cattle. Indications for use shall be for prophylactic use only, as an aid in the control of viral papillomas (warts). All labels shall include a dosage recommendation of at least 10 ml to be given subcutaneously and the dose repeated in 3 to 5 weeks.

(i) All but very small final container labels for feline panleukopenia vaccines shall contain the following recommendations for use:

(1) Killed virus vaccines. Vaccinate healthy cats with one dose, except that if the animal is less than 12 weeks of age, a second dose should be given no earlier than 16 weeks of age.

(2) Modified live virus vaccines. Vaccinate healthy cats with one dose, except that if the animal is less than 12 weeks of age, a second dose should be given no earlier than16 weeks of age.

(j) In the case of normal serum, antiserum, or antiserum derivatives, the type of preservative used shall be indicated on all labels.

(k) Unless acceptable data has been filed with Animal and Plant Health Inspection Service, to show that development of corneal opacity is not associated with the product, carton labels and enclosures used with biological products containing modified live canine hepatitis virus or modified live canine adenovirus Type 2 shall bear the following statement: “Occasionally, transient corneal opacity may occur following the administration of this product.”

(l) All labels for autogenous biologics must specify the name of the microorganism(s) or antigen(s) that they contain, and shall bear the following statement: “Potency and efficacy of autogenous biologics have not been established. This product is prepared for use only by or under the direction of a veterinarian or approved specialist.”

(m) In the case of biological products containing Marek's disease virus, all labels shall specify the Marek's disease virus serotype(s) used in the product.

(n) All labels for conditionally licensed products shall bear the following statement: “This product license is conditional; efficacy and potency have not been fully demonstrated.”

(Approved by the Office of Management and Budget under control number 0579-0013)

[38 FR 12094, May 9, 1973]

Editorial Note:For Federal Register citations affecting § 112.7, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

§ 112.8 For export only.

The applicable regulations for packaging and labeling a biological product produced in the United States shall apply to such biological product if exported from the United States except as otherwise provided in this section. Only labels approved as provided in § 112.5 shall be used.

(a) Biological products which have been packaged and labeled for export or which have been exported, shall be subject to the applicable provisions in this paragraph.

(1) After leaving the licensed establishment, a biological product shall not be bottled, repackaged, relabeled, or otherwise altered in any way while in the United States; and

(2) An exported biological product shall not be returned to the United States: Provided, That, in the case of a biological product exported in labeled final containers, the Administrator may authorize by permit the importation of a limited number for research and evaluation by the producing licensee; and

(3) An exported biological product which is bottled, rebottled, or altered in any way in a foreign country shall not bear a label which indicates by establishment license number that it has been prepared in the United States.

(b) Desiccated and frozen liquid products, packaged and labeled as for domestic use, may be exported without the diluent required for rehydration or dilution, as the case may be, if the labeling includes adequate instructions for preparing the product for use and the words “For Export Only”.

(c) Final containers of products, labeled or unlabeled, may be exported in sealed shipping boxes, adequately identified as to contents with an approved label, and plainly marked “For Export Only”: Provided, That such products shall not be diverted to domestic use.

(d) Completed inactivated liquid products, antiserums, and antitoxins, may be exported in large multiple-dose containers identified with an approved label that contains the words “For Export Only” prominently displayed.

(e) Concentrated inactivated liquid product, completed except for dilution to the proper strength for use, may be exported in large multiple-dose containers identified with an approved label that contains the words “For Export Only” prominently displayed.

[38 FR 12094, May 9, 1973, as amended at 39 FR 19202, May 31, 1974; 40 FR 46093, Oct. 6, 1975; 43 FR 11145, Mar. 17, 1978; 56 FR 66784, Dec. 26, 1991]

§ 112.9 Biological products imported for research and evaluation.

A biological product imported for research and evaluation under a permit issued in accordance with § 104.4, with the exception of products imported under § 104.4(d), shall be labeled as provided in this section.

(a) The label shall identify the product and the name and address of the manufacturer and shall provide instructions for proper use of the product, including all warnings and cautions needed by the permittee to safely use the product.

(b) Labels on each product to be further distributed in accordance with § 103.3 shall bear the statement “Notice! For Experimental Use Only—Not for Sale!”

(c) The labeling shall contain any other information deemed necessary by the Administrator and specified on the permit.

[50 FR 46417, Nov. 8, 1985, as amended at 56 FR 66784, Dec. 26, 1991]

§ 112.10 Special packaging and labeling.

A biological product, which requires special packaging and/or labeling not provided for in this part, shall be packaged and/or labeled in accordance with requirements written into the approved outline for such product.

§ 113.1 Compliance.

The regulations in this part apply to each serial or subserial of a licensed biological product manufactured in a licensed establishment and to each serial or subserial of a biological product in each shipment imported for distribution and sale.

§ 113.2 Testing aids.

To better ensure consistent and reproducible test results when Standard Requirement tests prescribed in the regulations are conducted, National Veterinary Services Laboratories, U.S. Department of Agriculture, may provide testing aids, when available, to licensees, permittees, and applicants for licenses and permits. Such aids shall be as follows:

(a) Supplemental Assay Method (SAM) is a technical bulletin containing detailed instructions for conducting a test. Such instructions shall be in accordance with the procedures currently being followed at National Veterinary Services Laboratories and as improved, proven procedures are developed, shall be revised and reissued prior to application.

(b) Standard Reference Preparation is a serum, virus, bacterial culture, or antigen to be used in test systems for direct comparison with serials of biological products under test.

(c) Standard Test Reagent is a serum, antitoxin, fluorescent antibody conjugate, toxin, virus, bacterial cultural, or antigen to be used in test systems but not for direct comparison with serials of biological products under test.

(d) Seed cultures are small quantities of standard organisms to be propagated by the recipient to establish a supply for use.

(e) Test Code Number is a number assigned by Animal and Plant Health Inspection Service to each test procedure specified in the Standard Requirements and in each filed Outline of Production where such test is conducted to support a request for release of a serial or subserial.

[39 FR 21041, June 18, 1974, as amended at 40 FR 758, Jan. 3, 1975; 50 FR 21799, May 29, 1985; 56 FR 66784, Dec. 26, 1991]

§ 113.3 Sampling of biological products.

Each licensee and permittee shall furnish representative samples of each serial or subserial of a biological product manufactured in the United States or imported into the United States as prescribed in this section. Additional samples may be purchased in the open market by a Animal and Plant Health Inspection Service representative.

(a) Either an employee of the Department of Agriculture, of the licensee, or of the permittee, as designated by the Administrator shall select prerelease samples of biological product in the number prescribed in paragraph (b) of this section. Each sample shall be marked for identification by the person making the selection after which they shall be packaged by the licensee or permittee, as the case may be, and forwarded to National Veterinary Services Laboratories; except that an employee of the Department may forward or deliver the samples to National Veterinary Services Laboratories if such action deemed advisable by the Administrator.

(1) Selection shall be made as follows:

(i) Nonviable liquid biological products—either bulk or final container samples of completed product shall be selected for purity, safety, or potency tests. Biological product in final container shall be selected to test for viable bacteria and fungi.

(ii) Viable liquid biological products; samples shall be in final containers and shall be randomly selected at the end of the filling operation. Bulk containers of completed product may be sampled when authorized by the Administrator.

(iii) Desiccated biological products; samples shall be in final containers and shall be randomly selected if desiccated in the final container. Biological products desiccated in bulk shall be sampled at the end of the filling operation.

(iv) Representative samples of each serial or subserial in each shipment of imported biological products shall be selected.

(2) Comparable samples shall be used by Animal and Plant Health Inspection Service, the licensee, and the permittee for similar tests.

(3) When bulk samples of completed product in liquid form are to be tested as prescribed in paragraph (a)(1) of this section, the number of such samples from each serial and the minimum quantity of product to be provided in each sample shall be stated in the filed Outline of Production.

(b) Unless otherwise prescribed by the Administrator, the number of final container samples to be selected from each serial and subserial shall be:

(1) Vaccines:

(i) Six multiple-dose samples of Brucella Abortus Vaccine;

(ii) Twelve samples of all other live bacterial vaccines;

(iii) Two samples of Coccidiosis Vaccine;

(iv) Eighteen samples of Rabies Vaccine, Modified Live Virus;

(v) Sixteen samples of all other vaccines consisting of live microorganisms;

(vi) Thirty single-dose or 14 multiple-dose samples of Equine Encephalomyelitis Vaccine, Killed Virus;

(vii) Twenty-two single-dose or 14 multiple-dose samples of Rabies Vaccine, Killed Virus;

(viii) Sixteen single-dose or 12 multiple-dose samples of all other vaccines consisting of killed microorganisms.

(2) Bacterins and bacterin-toxoids:

(i) Twelve samples of single-fraction products;

(ii) Thirteen samples of two-fraction products;

(iii) Fourteen samples of products consisting of 3 or more fractions.

(3) Antiserums: Twelve samples of antiserum recommended for large animals or 14 samples of antiserum recommended for small animals or the number of reagent serum samples prescribed in the filed Outline of Production for the product.

(4) Antitoxins:

(i) Fourteen single-dose or 12 multiple dose samples of Tetanus Antitoxin;

(ii) Twelve samples of all other antitoxins.

(5) Toxoids:

(i) Eighteen single-dose or 12 multiple dose samples of all toxoids.

(6) Antigens: Twelve samples of poultry antigens or 20 samples of tuberculin or four samples of all other diagnostic antigens.

(7) Diagnostic test kits: Two samples of diagnostic test kits. The licensee or permittee will hold one of these selected samples at the storage temperature recommended on the label while awaiting a request by the animal and Plant Health Inspection Service to submit the additional sample. If submission is not requested by the Animal and Plant Health Inspection Service, the additional sample may be returned to the serial inventory after the serial is released. In the case of diagnostic test kits in which final packaging consists of multiple microtiter test plates or strips, the licensee or permittee may submit a specified number of test plates or strips along with all other test reagents as prescribed in a filed Outline of Production and retain a similar amount as a second sample for submission upon request. When the initial sample is not representative of final packaging by the licensee of permittee, e.g., does not consist of all the microtiter test plates or strips, the second sample is not eligible to be returned to serial inventory after the serial is released.

(8) Autogenous biologics: With the exception of the first serial or subserial, 10 samples must be selected and submitted to the Animal and Plant Health Inspection Service from each serial or subserial of an autogenous biologic eligible to be shipped that consists of more than 50 containers. For first serials or subserials eligible for shipment consisting of more than 50 containers, 10 samples from each serial or subserial must be selected and held for submission to the Animal and Plant Health Inspection Service upon request in accordance with paragraph (e)(4) of this section. For serials or subserials of autogenous biologic with 50 or fewer containers, no samples, other than those required by paragraph (e) of this section, are required.

(9) Miscellaneous: The number of samples from products not in the categories provided for in paragraphs (b)(1) through (b)(8) of this section shall be prescribed in the filed Outline of Production for the product.

(c) Prelicensing and Outline of Production changes: Samples needed to support a license application or a change in the Outline of Production for a licensed product shall be submitted only upon request from the animal and Plant Health Inspection Service. Except for miscellaneous products specified in paragraph (b)(9) of this section, the number of such samples shall be at least one and one-half times the number prescribed for such product in paragraph (b) of this section. Samples of Master Seeds and Master Cell Stocks with a minimum individual volume of 1 ml shall be submitted as follows:

(1) Ten samples of Bacterial Master Seeds.

(2) Thirteen samples of viral Master Seeds or nonviral Master Seeds requiring cell culture propagation. For Master Seeds isolated or passed in a cell line different from the species of intended use, an additional 2 samples are required for each additional species. For Master Seeds grown in cell culture and intended for use in more than one species, an additional 2 samples are required for each additional species.

(3) Thirty-six samples of at least 1 ml each or six samples of at least 1 ml each, one sample of at least 20 ml, and one sample of at least 10 ml of Master Cell Stocks. In the case of Master Cell Stocks which are persistently infected with a virus, an additional four samples of at least 1 ml each are required. If these persistently infected cell stocks are intended for use in more than one species, an additional two samples of at least 1 ml each are required for each additional species.

(4) Four samples of the Master Cell Stock + n (highest passage) cells.

(d) Sterile diluent: A sample of Sterile Diluent shall accompany each sample of product, other than Marek's Disease Vaccine, if such diluent is required to rehydrate or dilute the product before use. The volume of diluent shall be an appropriate amount to rehydrate or dilute the product. Samples of Sterile Diluent prepared for use with Marek's Disease Vaccine shall be submitted upon request from the Animal and Plant Health Inspection Service.

(e) Reserve samples shall be selected from each serial and subserial of biological product. Such samples shall be selected at random from final containers of completed product by an employee of the Department, of the licensee, or of the permittee, as designated by the administrator. Each sample shall:

(1) Consist of 5 single-dose packages, 2 multiple-dose packages, or 2 diagnostic test kits, except that, in the case of diagnostic test kits in which final packaging consists of multiple microtiter test plates or strips, a sample may consist of a specified number of test plates or strips along with all other test reagents as prescribed in a filed Outline of Production;

(2) Be adequate in quantity for appropriate examination and testing;

(3) Be truly representative and in final containers;

(4) Be held in a special compartment set aside by the licensee or permittee for holding these samples under refrigeration at the storage temperature recommended on the labels for 6 months after the expiration date stated on the labels. The samples that are stored in this manner shall be delivered to the Animal and Plant Health Inspection Service upon request.

(Approved by the Office of Management and Budget under control number 0579-0013)

[38 FR 29886, Oct. 30, 1973, as amended at 40 FR 758, Jan. 3, 1975; 40 FR 49768, Oct. 24, 1975; 41 FR 56627, Dec. 29, 1976; 48 FR 9506, Mar. 7, 1983; 48 FR 57473, Dec. 30, 1983; 50 FR 21799, May 29, 1985; 56 FR 66784, Dec. 26, 1991; 60 FR 14356, Mar. 17, 1995; 67 FR 15713, Apr. 3, 2002]

§ 113.4 Exemptions to tests.

(a) The test methods and procedures contained in all applicable Standard Requirements shall be complied with unless otherwise exempted by the Administrator and provided that such exemption is noted in the filed Outline of Production for the product.

(b) Test methods and procedures by which the biological products shall be evaluated shall be designated in the Outline of Production for such products.

[38 FR 29887, Oct. 30, 1973, as amended at 56 FR 66784, Dec. 26, 1991]

§ 113.5 General testing.

(a) No biological product shall be released prior to the completion of tests prescribed in a filed Outline of Production or Standard Requirements for the product to establish the product to be pure, safe, potent, and efficacious.

(b) Tests of biological products shall be observed by a competent employee of the manufacturer during all critical periods. A critical period shall be the time when certain specified reactions must occur in required tests to properly evaluate the results.

(c) Records of all tests shall be kept in accordance with part 116 of this chapter. Results of all required tests prescribed in the filed Outline of Production or the Standard Requirements for the product shall be submitted to Animal and Plant Health Inspection Service. Blank forms shall be furnished upon request to Animal and Plant Health Inspection Service.

(d) When the initial or any subsequent test is declared a No Test, the reasons shall be reported in the test records, the results shall not be considered as final, and the test may be repeated. When a test is declared satisfactory, the test designation is considered to be a final conclusion. When a test is declared unsatisfactory, the test designation is considered to be a final conclusion. When the initial or any subsequent test is declared inconclusive, the reasons shall be reported in the test records, the result shall not be considered as final, and the test may be repeated as established in the filed Outline of Production or Standard Requirement. If a test is designated inconclusive or No Test and the biological product is not further tested, the test designation of unsatisfactory is the final conclusion.

(e) When new test methods are developed and approved by Animal and Plant Health Inspection Service, biological products tested thereafter shall be evaluated by such methods, and if not found to be satisfactory when so tested shall not be released.

(Approved by the Office of Management and Budget under control number 0579-0059)

[34 FR 18004, Nov. 4, 1969, as amended at 39 FR 25463, July 11, 1974; 40 FR 45420, Oct. 2, 1975; 40 FR 46093, Oct. 6, 1975; 41 FR 6751, Feb. 13, 1976; 48 FR 57473, Dec. 30, 1983; 56 FR 66784, Dec. 26, 1991; 79 FR 55969, Sept. 18, 2014]

§ 113.6 Animal and Plant Health Inspection Service testing.

A biological product shall with reasonable certainty yield the results intended when used as recommended or suggested in its labeling or proposed labeling prior to the expiration date.

(a) The Administrator is authorized to cause a biological product, manufactured in the United States or imported into the United States, to be examined and tested for purity, safety, potency, or efficacy; in which case, the licensee or permittee shall withhold such product from the market until a determination has been made.

(b) The final results of each test conducted by the licensee and Animal and Plant Health Inspection Service shall be considered in evaluating a biological product. A serial or subserial which has been found unsatisfactory by a required test prescribed in a filed Outline of Production or Standard Requirement is not in compliance with the regulations and shall not be released for market.

[34 FR 18004, Nov. 7, 1969, as amended at 40 FR 45420, Oct. 2, 1975; 40 FR 53378, Nov. 18, 1975; 41 FR 6751, Feb. 13, 1976; 56 FR 66784, Dec. 26, 1991]

§ 113.7 Multiple fractions.

(a) When a biological product contains more than one immunogenic fraction, the completed product shall be evaluated by tests applicable to each fraction.

(b) When similar potency tests are required for more than one fraction of a combination biological product, different animals must be used to evaluate each fraction except when written Standard Requirements or outlines of production make provisions and set forth conditions for use of the same animals for testing different fractions.

(c) When the same safety test is required for more than one fraction, requirements are fulfilled by satisfactory results from one test of the completed product.

(d) When an inactivated fraction(s) is used as a diluent for a live virus fraction(s), the inactivated fraction(s) may be tested separately and the live virus fraction(s) may be tested separately: Provided, That, the viricidal test requirements prescribed in § 113.100 are complied with.

(e) Virus titrations for a multivirus product shall be conducted by methods which will quantitate each virus.

[34 FR 18004, Nov. 7, 1969, as amended at 40 FR 46093, Oct. 6, 1975; 56 FR 66785, Dec. 26, 1991]

§ 113.8 In vitro tests for serial release.

(a) Master Seed which has been established as pure, safe, and immunogenic shall be used for preparing seed for production as specified in the Standard Requirements or in the filed Outline of Production. The Administrator may exempt a product from a required animal potency test for release when an evaluation can, with reasonable certainty, be made by:

(1) Subjecting the master seed to the applicable requirements prescribed in §§ 113.64, 113.100, 113.200, and 113.300;

(2) Testing the Master Seed for immunogenicity in a manner acceptable to the Animal and Plant Health Inspection Service (APHIS);

(3) Establishing satisfactory potency for the product in accordance with the following provisions:

(i) Potency for live products may be determined by log10 virus titer or determining the live bacterial count based on the protective dose used in the Master Seed immunogenicity test plus an adequate overage for adverse conditions and test error; and

(ii) Potency for inactivated products may be determined using tests for relative antigen content by comparing the antigen content of the test serial to a reference preparation using a parallel line immunoassay or equivalent method which measures linearity, specificity, and reproducibility in a manner acceptable to APHIS.

(b) In the case of live products, each serial and subserial of desiccated product derived from an approved Master Seed and bulk or final container samples of each serial of completed liquid product derived from an approved Master Seed shall be evaluated by a test procedure acceptable to APHIS. On the basis of the results of the test, as compared with the required minimum potency, each serial and subserial shall either be released to the firm for marketing or withheld from the market. The evaluation of such products shall be made in accordance with the following criteria:

(1) If the initial test shows the count or titer to equal or exceed the required minimum, the serial or subserial is satisfactory without additional testing.

(2) If the initial test shows the count or titer to be lower than the required minimum, the serial or subserial may be retested, using double the number of samples. The average counts or titers obtained in the retests shall be determined. If the average is less than the required minimum, the serial or subserial is unsatisfactory without further consideration.

(3) If the average is equal to or greater than the required minimum, the following shall apply to live virus vaccines:

(i) If the difference between the average titer obtained in the retests and the titer obtained in the initial test is 10 0.7 or greater, the initial titer may be considered a result of test system error and the serial or subserial considered satisfactory for virus titer.

(ii) If the difference between the average titer obtained in the retests and the titer obtained in the initial test is less than 10 0.7, a new average shall be determined using the titers obtained in all tests. If the new average is below the required minimum, the serial or subserial is unsatisfactory.

(4) If the average is equal to or greater than the required minimum, the following shall apply to bacterial vaccines:

(i) If the average count obtained in the retests is at least three times the count obtained in the initial test, the initial count may be considered a result of test system error and the serial or subserial considered satisfactory for bacterial count.

(ii) If the average count obtained in the retests is less than three times the count obtained in the initial test, a new average shall be determined using the counts obtained in all tests. If the new average count is below the required minimum, the serial or subserial is unsatisfactory.

(5) Exceptions. When a product is evaluated in terms other than log10 virus titer or organism count, an appropriate difference between the average potency value obtained in the retests and the potency value obtained in the initial test shall be established for use in paragraphs (b)(3) and (b)(4) of this section to evaluate such products and shall be specified in the product Standard Requirement or filed Outline of Production.

(c) In the case of inactivated products, bulk or final container samples of completed product from each serial derived from an approved Master Seed, shall be evaluated for relative antigen content (potency) as compared with an unexpired reference by a parallel line immunoassay or other procedure acceptable to APHIS. Firms currently using immunoassays which do not satisfy this requirement shall have 2 years from the effective date of the final rule to update their filed Outlines of Production to be in compliance with this requirement unless granted an extension by the Administrator based on a showing by the firm seeking the extension that they have made a good faith effort with due diligence to achieve compliance. On the basis of the results of such test procedures, each serial that meets the required minimum potency shall be released to the firm for marketing; each serial not meeting the required minimum potency shall be withheld from the market. The evaluation of such products shall be made in accordance with the following criteria:

(1) A test that results in no valid lines is considered a “no test” and may be repeated.

(2) An initial test (test 1) that results in valid lines that are not parallel is considered a valid equivocal test. Release of the serial may not be based on such test since the result cannot be termed “satisfactory” or “unsatisfactory.”

(3) If the initial test (test 1) shows that potency equals or exceeds the required minimum potency, the serial is satisfactory without additional testing.

(4) If the initial test (test 1) is an equivocal test due to lack of parallelism, the serial may be retested up to three times (tests 2, 3, and 4) with disposition to be as specified in paragraphs (c)(4)(i) and (ii) of this section; Provided, That, if the serial is not retested or the other provisions of this section are not satisfied, the serial shall be deemed unsatisfactory.

(i) If: The first retest (test 2) following an initial equivocal test; the second retest (test 3) following two consecutive equivocal tests (tests 1 and 2); or the third retest (test 4) following three consecutive equivocal tests (tests 1, 2, and 3) shows that the potency equals or exceeds the required minimum potency, the serial is satisfactory.

(ii) If the first retest (test 2) following an initial equivocal test shows that potency is less than the required minimum potency, disposition of the serial will be based on the outcome of retests 2 and 3 (tests 3 and 4) as follows: if either retest (test 3 or 4) shows that potency is less than the required minimum potency, the serial is unsatisfactory. If either retest 2 or retest 3 (tests 3 or 4) is an equivocal test, or in the event that each retest (tests 2, 3, and 4) following an initial equivocal test is also an equivocal test, the accumulated test results shall be considered indicative of a lack of potency and release of the serial withheld. In which case, the licensee may submit data confirming the continued validity of the test system to APHIS for review and approval. If the data are acceptable to APHIS, the potency test may be repeated by the firm, subject to the provisions specified in paragraphs (i) and (ii) and confirmatory testing by APHIS.

(5) If the initial test (test 1) shows that potency is less than the required minimum potency, the serial may be retested a minimum of two times (tests 2 and 3) but not more than three times (tests 2, 3, and 4) with disposition as specified in paragraphs (c)(5) (i) and (ii) of this section; Provided, That, if the serial is not retested or the other provisions of this section are not satisfied, the serial shall be deemed unsatisfactory.

(i) If two consecutive retests (tests 2 and 3) show that potency of the serial equals or exceeds the required minimum potency, the serial is satisfactory. If one of the two retests (test 2 or 3) shows that the potency is less than the required minimum potency, the serial is unsatisfactory.

(ii) If one of the retests (tests 2 or 3) shows that the potency equals or exceeds the required minimum potency and the other retest (test 2 or 3) is an equivocal test, a third retest (test 4) may be performed. If the third retest (test 4) shows that the potency of the serial equals or exceeds the required minimum potency, the serial is deemed satisfactory. If both retests (tests 2 and 3) or if the third retest (test 4) is an equivocal test, the accumulated test results shall be considered indicative of a lack of potency and release of the serial withheld, in which case the licensee may submit data confirming the continued validity of the test system to APHIS for review and approval. If the data are acceptable to APHIS, the potency test may be repeated by the firm, subject to the provisions specified in paragraphs (c)(4) (i) and (ii) and (c)(5) (i) and (ii) of this section, and confirmatory testing by APHIS.

(d) Extending the dating of a reference. All determinations of relative antigen content using parallel line immunoassays or equivalent methods shall be conducted with an unexpired reference. The lot of reference used to determine antigenic content shall have an initial dating period equal to the dating of the product or as supported by data acceptable to APHIS, except that frozen references may have an initial dating of up to 5 years, Provided, That the request for dating of the frozen references beyond the dating of the product is supported by preliminary data acceptable to APHIS and includes provisions for monitoring the stability of the reference to determine when the potency starts to decline and for taking the appropriate steps to requalify a reference with declining potency either by testing a Qualifying Serial in host animals or by providing other evidence of immunogenicity, e.g., antibody titers or laboratory animal test data previously correlated to host animal protection in a manner acceptable to APHIS. Prior to the expiration date, such reference may be granted an extension of dating, Provided, That its immunogenicity has been confirmed using a Qualifying Serial of product in a manner acceptable to APHIS. The dating period of the Master Reference and Working Reference may be extended by data acceptable to APHIS if the minimum potency of the Master Reference is determined to be adequately above the minimum level needed to provide protection in the host animal. If a new Master Reference is established, it shall be allowed an initial dating period equal to the dating of the product or as supported by data acceptable to APHIS, except that frozen references may have an initial dating period of 5 years, or as supported by data acceptable to APHIS. Prior to the expiration date, such reference may be granted an extension of dating by confirming its immunogenicity using a Qualifying Serial of product.

(e) Final container samples of completed product derived from Master Seed found immunogenic in accordance with paragraph (a) of this section and found satisfactory in accordance with paragraphs (b) and (c) of this section may also be subjected to an animal potency test by Animal and Plant Health Inspection Service as provided in this paragraph. Products shall be used according to label directions including dose(s) and route of administration.

(1) A one stage test using 20 vaccinates and 5 controls or a two stage test using 10 vaccinates and 5 controls for each stage shall be used. The criteria used for judging the specific response in the controls and vaccinates shall be in accordance with the test protocol used in the Master Seed immunogenicity test.

(2) If at least 80 percent of the controls do not show specific responses to challenge, the test is inconclusive and may be repeated. If a vaccinate shows the specific responses to challenge expected in the controls, the vaccinate shall be listed as a failure.

(3) The results of the testing shall be evaluated according to the following table:

Cumulative totals

Stage | Number of animals | Failures for satisfactory serials | Failures for unsatisfactory serials

1 | 10 | 1 or less | 3 or more.

2 (or 1) | 20 | 4 or less | 5 or more.

(4) When a serial has been found unsatisfactory for potency by the test provided in paragraphs (e)(1), (2), and (3) of this section, the serial shall be withheld from the market and the following actions taken:

(i) The Administrator shall require that at least two additional serials prepared with the same Master Seed be subjected to similar animal potency tests by Animal and Plant Health Inspection Service or the licensee or both.

(ii) If another serial is found unsatisfactory for potency, the product shall be removed from the market while a reevaluation of the product is made and the problem is resolved.

[49 FR 22625, May 31, 1984, as amended at 56 FR 66784, 66786, Dec. 26, 1991; 62 FR 19038, Apr. 18, 1997; 72 FR 72564, Dec. 21, 2007; 79 FR 31021, May 30, 2014]

§ 113.9 New potency test.

A potency test written into the filed Outline of Production for a product shall be considered confidential information by Animal and Plant Health Inspection Service until at least two additional product licenses are issued for the product or unless use of the test is authorized by the licensee, in which case, such potency test may be published as part of the Standard Requirement for the product.

(a) Until a potency test is published as part of the Standard Requirement for the product, reference to such a test shall be made in the filed Outline of Production and the test shall be conducted.

(b) When a potency test has been published as part of the Standard Requirement, such test shall be conducted unless the product is specifically exempted as provided in § 113.4.

[40 FR 14084, Mar. 28, 1975, as amended at 56 FR 66784, Dec. 26, 1991]

§ 113.10 Testing of bulk material for export or for further manufacture.

When a product is prepared in a licensed establishment for export in large multiple-dose containers as provided in § 112.8(d) or (e) of this subchapter or for further manufacturing purposes as provided in § 114.3(d) of this subchapter, samples of the bulk material shall be subjected to all required tests prescribed in the filed Outline of Production or Standard Requirements for the product. Samples of concentrated liquid product shall be diluted to a volume equal to the contents of the sample times the concentration factor prior to initiating potency tests.

[49 FR 45846, Nov. 21, 1984]

§ 113.25 Culture media for detection of bacteria and fungi.

(a) Ingredients for which standards are prescribed in the United States Pharmacopeia, or elsewhere in this part, shall conform to such standards. In lieu of preparing the media from the individual ingredients, they may be made from dehydrated mixtures which, when rehydrated with purified water, have the same or equivalent composition as such media and have growth-promoting buffering, and oxygen tension-controlling properties equal to or better than such media. The formulas for the composition of the culture media prescribed in §§ 113.26 and 113.27 are set forth in the United States Pharmacopeia, 19th Edition.

(b) The licensee shall test each quantity of medium prepared at one time from individual ingredients and the first quantity prepared from each lot of commercial dehydrated medium for growth-promoting qualities. If any portion of a lot of commercial dehydrated medium is held for 90 days or longer after being so tested, it shall be retested before use. Two or more strains of micro-organisms that are exacting in their nutritive requirements shall be used. More than one dilution shall be used to demonstrate the adequacy of the medium to support the growth of a minimum number of micro-organisms.

(c) The sterility of the medium shall be confirmed by incubating an adequate number of test vessels and examining each for growth. Additional control may be used by incubation of representative uninoculated test vessels for the required incubation period during each test.

(d) A determination shall be made by the licensee for each biological product of the ratio of inoculum to medium which shall result in sufficient dilution of such product to prevent bacteriostatic and fungistatic activity. The determination may be made by tests on a representative biological product for each group of comparable products containing identical preservatives at equal or lower concentrations. Inhibitors or neutralizers of preservatives, approved by the Administrator, may be considered in determining the proper ratio.

[35 FR 16039, Oct. 13, 1970, as amended at 37 FR 2430, Feb. 1, 1972; 41 FR 27715, July 6, 1976; 56 FR 66784, Dec. 26, 1991]

§ 113.26 Detection of viable bacteria and fungi except in live vaccine.

Each serial and subserial of biological product except live vaccines shall be tested as prescribed in this section unless otherwise specified by the Administrator. When cell lines, primary cells, or ingredients of animal origin used in the preparation of a biological product are required to be free of viable bacteria and fungi, they shall also be tested as prescribed in this section.

(a) The media to be used shall be as follows:

(1) Fluid Thioglycollate Medium with 0.5 percent beef extract shall be used to test for bacteria in biological products containing clostridial toxoids, bacterins, and bacterin-toxoids.

(2) Fluid Thioglycollate Medium with or without 0.5 percent beef extract shall be used to test for bacteria in biological products other than clostridial toxoids, bacterins, and bacterin-toxoids.

(3) Soybean-Casein Digest Medium shall be used to test biological products for fungi; provided, that Fluid Thioglycollate Medium without beef extract shall be substituted when testing biological products containing mercurial preservatives.

(b) Test procedure:

(1) Ten test vessels shall be used for each of two media selected in accordance with paragraph (a)(1), (a)(2), or (a)(3) of this section. Each test vessel shall contain sufficient medium to negate the bacteriostatic or fungistatic activity in the inoculum as determined in § 113.25(d).

(2) Inoculum:

(i) When completed product is tested, 10 final container samples from each serial and each subserial shall be tested. One ml from each sample shall be inoculated into a corresponding individual test vessel of culture medium: Provided, That, if each final container sample contains less than 2 ml, one-half of the contents shall be used as inoculum for each test vessel.

(ii) When cell lines, primary cells, or ingredients of animal origin are tested, at least a 20 ml test sample from each lot shall be tested. One ml shall be inoculated into each test vessel of medium.

(3) Incubation shall be for an observation period of 14 days at 30 °to 35 °C. to test for bacteria and 14 days at 20 °to 25 °C. to test for fungi.

(4) If the inoculum renders the medium turbid so that the absence of growth cannot be determined by visual examination, subcultures shall be made on the seventh to eleventh day from biological products prepared from clostridial toxoids, bacterins, and bacterin-toxoids and the third to seventh day for other biological products. Portions of the turbid medium in amounts of not less than 1.0 ml. shall be transferred to 20 to 25 ml. of fresh medium, and incubated the balance of the 14-day period.

(c) Examine the contents of all test vessels for macroscopic microbial growth during the incubation period. When demonstrated by adequate controls to be invalid, the test may be repeated. For each set of test vessels representing a serial or subserial in a valid test, the following rules shall apply:

(1) If no growth is found in any test vessel, the serial or subserial meets the requirements of the test.

(2) If growth is found in any test vessel, one retest to rule out faulty technique may be conducted using 20 unopened final container samples.

(3) If growth is found in any test vessel of the final test, the serial, subserial, or ingredients to be used in the preparation of a biological product, as the case may be, is unsatisfactory.

[35 FR 16039, Oct. 13, 1970, as amended at 37 FR 2430, Feb. 1, 1972; 39 FR 21042, June 18, 1974; 40 FR 758, Jan. 3, 1975; 40 FR 14084, Mar. 28, 1975; 56 FR 66784, Dec. 26, 1991]

§ 113.27 Detection of extraneous viable bacteria and fungi in live vaccines.

Unless otherwise specified by the Administrator or elsewhere exempted in this part, each serial and subserial of live vaccine and each lot of Master Seed Virus and Master Seed Bacteria shall be tested for extraneous viable bacteria and fungi as prescribed in this section. A Master Seed found unsatisfactory shall not be used in vaccine production and a serial found unsatisfactory shall not be released.

(a) Live viral vaccines. Each serial and subserial of live viral vaccine shall be tested for purity as prescribed in this paragraph. However, products of chicken embryo origin recommended for administration other than by parenteral injection may be tested as provided in paragraph (e) of this section.

(1) Soybean Casein Digest Medium shall be used.

(2) Ten final container samples from each serial and subserial shall be tested.

(3) Immediately prior to starting the test, frozen liquid vaccine shall be thawed, and desiccated vaccine shall be rehydrated as recommended on the label with accompanying diluent or with sterile purified water.

(4) To test for bacteria, place 0.2 ml of vaccine from each final container into a corresponding individual vessel containing at least 120 ml of Soybean Casein Digest Medium. Additional medium shall be used if the determination required in § 113.25(d) indicates the need for a greater dilution of the product. Incubation shall be at 30 °to 35 °C for 14 days.

(5) To test for fungi, place 0.2 ml of vaccine from each final container sample into a corresponding individual vessel containing at least 40 ml of Soybean Casein Digest Medium. Additional medium shall be used if the determination required in § 113.25(d) indicates the need for a greater dilution of the product. Incubation shall be at 20 °to 25 °C for 14 days.

(6) Examine the contents of all test vessels macroscopically for microbial growth at the end of the incubation period. If growth in a vessel cannot be reliably determined by visual examination, judgment shall be confirmed by subcultures, microscopic examination, or both.

(7) For each set of test vessels representing a serial or subserial tested according to these procedures, the following rules shall apply:

(i) If growth is found in 2 or 3 test vessels of the initial test, 1 retest to rule out faulty technique may be conducted using 20 unopened final container samples.

(ii) If no growth is found in 9 or 10 of the test vessels in the initial test, or 19 or 20 vessels in the retest, the serial or subserial meets the requirements of the test.

(iii) If growth is found in four or more test vessels in the initial test, or two or more in a retest, the serial or subserial is unsatisfactory.

(b) Live bacterial vaccines. Each serial or subserial of live bacterial vaccine shall be tested for purity as prescribed in this paragraph.

(1) Soybean Casein Digest Medium and Fluid Thioglycollate Medium shall be used.

(2) Ten final container samples from each serial and subserial shall be tested.

(3) Immediately prior to starting the test, frozen liquid vaccine shall be thawed, and desiccated vaccine shall be rehydrated as recommended on the label with accompanying diluent or with sterile purified water. Product recommended for mass vaccination shall be rehydrated at the rate of 30 ml sterile purified water per 1,000 doses.

(4) To test for extraneous bacteria, place 0.2 ml of vaccine from each final container into a corresponding individual vessel containing at least 40 ml of Fluid Thioglycollate Medium. Additional medium shall be used if the determination required in § 113.25(d) indicates the need for a greater dilution of the product. Incubation shall be at 30 °to 35 °C for 14 days.

(5) To test for extraneous fungi, place 0.2 ml of vaccine from each final container into a corresponding individual vessel containing at least 40 ml of Soybean Casein Digest Medium. Additional medium shall be used if the determination required in § 113.25(d) indicates the need for a greater dilution of the product. Incubation shall be at 20 °to 25 °C for 14 days.

(6) Examine the contents of all test vessels macroscopically for atypical microbial growth at the end of the incubation period. If growth of extraneous microorganisms cannot be reliably determined by visual examination, judgment shall be confirmed by subculturing, microscopic examination, or both.

(7) For each set of test vessels representing a serial or subserial tested according to these procedures, the following rules shall apply:

(i) If extraneous growth is found in 2 or 3 test vessels of the initial test, 1 retest to rule out faulty technique may be conducted using 20 unopened final container samples.

(ii) If no extraneous growth is found in 9 or 10 test vessels in the initial test, or 19 or 20 vessels in the retest, the serial or subserial meets the requirements of the test.

(iii) If extraneous growth is found in 4 or more test vessels in the initial test, or 2 or more in a retest, the serial or subserial is unsatisfactory.

(c) Master Seed Virus. Not less than 4 ml of each lot of Master Seed Virus shall be tested. Frozen liquid Master Seed Virus shall be thawed, and desiccated Master Seed Virus shall be rehydrated with Soybean Casein Digest Medium immediately prior to starting the test.

(1) To test for bacteria, place 0.2 ml of the sample of Master Seed Virus into 10 individual vessels each containing at least 120 ml of Soybean Casein Digest Medium. Incubation shall be at 30 °to 35 °C for 14 days.

(2) To test for fungi, place 0.2 ml of the sample of Master Seed Virus into 10 individual vessels each containing at least 40 ml of Soybean Casein Digest Medium. Incubation shall be at 20 °to 25 °C for 14 days.

(3) Examine the contents of all test vessels macroscopically for microbial growth at the end of the incubation period. If growth in a vessel cannot be reliably determined by visual examination, judgment shall be confirmed by subcultures, microscopic examination, or both.

(4) For each set of test vessels representing a lot of Master Seed Virus tested according to these procedures, the following rules shall apply:

(i) If growth is found in any test vessel of the initial test, one retest to rule out faulty technique may be conducted using a new sample of Master Seed Virus.

(ii) If growth is found in any test vessel of the final test, the lot of Master Seed Virus is unsatisfactory.

(d) Master Seed Bacteria. Not less than 4 ml of each lot of Master Seed Bacteria shall be tested. Frozen liquid Master Seed Bacteria shall be thawed, and desiccated Master Seed Bacteria shall be rehydrated with sterile purified water immediately prior to starting the test.

(1) To test for extraneous bacteria, place 0.2 ml of the sample of Master Seed Bacteria into 10 individual vessels each containing at least 40 ml of Fluid Thioglycollate Medium. Incubation shall be at 30 °to 35 °C for 14 days.

(2) To test for extraneous fungi, place 0.2 ml of the sample of Master Seed Bacteria into 10 individual vessels each containing at least 40 ml of Soybean Casein Digest Medium. Incubation shall be at 20 °to 25 °C for 14 days.

(3) Examine the contents of all test vessels macroscopically for atypical microbial growth at the end of the incubation period. If growth of extraneous microorganisms cannot be reliably determined by visual examination, judgment shall be confirmed by subcultures, microscopic examination, or both.

(4) For each set of test vessels representing a lot of Master Seed Bacteria tested according to these procedures, the following rules shall apply:

(i) If extraneous growth is found in any test vessel of the initial test, one retest to rule out faulty technique may be conducted using a new sample of Master Seed Bacteria.

(ii) If extraneous growth is found in any test vessel of the final test, the lot of Master Seed Bacteria is unsatisfactory.

(e) Live viral vaccines of chicken embryo origin recommended for administration other than by parenteral injection, which were not tested or have not been found free of bacteria and fungi by the procedures prescribed in paragraph (a) of this section, may be tested according to the procedures prescribed in this paragraph.

(1) Brain Heart Infusion Agar shall be used with 500 Kinetic (Kersey) units of penicillinase per ml of medium added just prior to pouring the plates.

(2) Ten final containers from each serial and each subserial shall be tested.

(3) Immediately prior to starting the test, frozen liquid vaccine shall be thawed, and lyophilized vaccine shall be rehydrated to the quantity recommended on the label using the accompanying sterile diluent or sterile purified water. Product recommended for mass vaccination shall be rehydrated at the rate of 30 ml sterile purified water per 1,000 doses.

(4) From each container sample, each of 2 plates shall be inoculated with vaccine equal to 10 doses if the vaccine is recommended for poultry or 1 dose if the vaccine is recommended for other animals. Twenty ml of medium shall be added to each plate. One plate shall be incubated at 30 °to 35 °for 7 days and the other plate shall be incubated at 20 °to 25 °C for 14 days.

(5) Colony counts shall be made for each plate at the end of the incubation period. An average colony count for the 10 samples representing the serial or subserial shall be made for each incubation condition.

(6) For each set of test vessels representing a serial or subserial tested according to these procedures, the following rules shall apply:

(i) If the average count at either incubation condition exceeds 1 colony per dose for vaccines recommended for poultry, or 10 colonies per dose for vaccines recommended for other animals in the initial test, 1 retest to rule out faulty technique may be conducted using 20 unopened final containers.

(ii) If the average count at either incubation condition of the final test for a serial or subserial exceeds 1 colony per dose for vaccines recommended for poultry, or 10 colonies per dose for vaccines recommended for other animals, the serial or subserial is unsatisfactory.

[48 FR 28430, June 22, 1983, as amended at 56 FR 66784, Dec. 26, 1991]

§ 113.28 Detection of mycoplasma contamination.

The heart infusion test, using heart infusion broth and heart infusion agar, provided in this section shall be conducted when a test for mycoplasma contamination is prescribed in an applicable Standard Requirement or in the filed Outline of Production for the product.

(a) Media additives provided in this paragraph shall be prepared as follows:

(1) DPN-Cysteine Solution:

(i) Use Nicotinamide adenine dinucleotide (oxidized) and L-Cysteine hydrochloride.

(ii) Prepare 1 gram/100 milliliters (ml) purified water (1 percent solution) of each. Mix the solutions together; the cysteine reduces the DPN. Filter sterilize, dispense in appropriate amounts and store frozen at −20 degrees centigrade.

(2) Inactivated horse serum—horse serum which has been inactivated at 56 °C for 30 minutes.

(b) Heart infusion broth shall be prepared as provided in this paragraph.

(1) Dissolve in 970 ml of purified water, 25 grams of heart infusion broth, 10 grams of proteose peptone No. 3, and either 5 grams of yeast autolysate or 5 ml of fresh yeast extract.

(2) Add the following:

1 percent tetrazolium chloride (ml) | 5.5

1 percent thallium acetate (ml) | 25

Penicillin (units) | 500,000

Inactivated horse serum (ml) | 100

(3) Adjust pH to 7.9 with NaOH, filter sterilize, and dispense 100 ml aliquots into 125 ml flasks and store until needed.

(4) Add 2 ml of DPN-Cysteine solution to each 100 ml of broth on day of use.

(c) Heart Infusion Agar shall be prepared as provided in this paragraph.

(1) Dissolve in 900 ml of purified water by boiling the following:

Heart infusion agar (g) | 25

Heart-infusion broth (g) | 10

Proteose peptone No. 3 (g) | 10

1 pct thallium acetate (ml) | 25

(2) Cool the medium and adjust pH to 7.9 with NaOH.

(3) Autoclave the medium.

(4) Cool the medium 30 minutes in a 56 °C waterbath.

(5) Dissolve 5 grams of yeast autolysate in 100 ml of distilled water, filter sterilize, and add to the medium.

(6) Add to the medium:

126 ml of inactivated horse serum 21 ml of DPN-Cysteine solution 525,000 units of Penicillin. Dispense 10 ml aliquots into 60 × 15 mm disposable culture dishes or petri dishes.

(d) The test procedure provided in this paragraph shall be followed when conducting the mycoplasma detection test.

(1) Preparation of inoculum. Immediately prior to starting the test, frozen liquid vaccine shall be thawed, and lyophilized vaccine shall be rehydrated to the volume recommended on the label with mycoplasma medium. In the case of a lyophilized biological product, e.g., 1,000 dose vial of poultry vaccine to be administered via the drinking water, the vaccine shall be rehydrated to 30 ml with mycoplasma medium. In the case of a cell line or a sample of primary cells, the inoculum shall consist of the resuspended cells. Control tests shall be established as provided in paragraph (d)(4) of this section.

(2) Inoculation of plate. Plate 0.1 ml of inoculum on an agar plate and make a short, continuous streak across the plate with a pipet. Tilt the plate to allow the inoculum to flow over the surface.

(3) Inoculation of flask of medium. Transfer 1 ml of the inoculum into a flask containing 100 ml mycoplasma medium and mix thoroughly. Incubate the flask at 33 to 37 °C for 14 days during which time, one of four agar plates shall be streaked with 0.1 ml of material from the incubating flask of inoculated medium on the 3d day, one on the 7th day, one on the 10th day, and one on the 14th day post-inoculation.

(4) Control tests shall be conducted simultaneously with the detection test using techniques provided in paragraphs (d)(2) and (3) of this section, except the inoculum for the positive control test shall be selected mycoplasma cultures and the negative control test shall be uninoculated medium from the same lot used in the detection test.

(5) All plates shall be incubated in a high humidity, 4-6 percent CO2 atmosphere at 33 °to 37 °C for 10-14 days and examined with a stereoscopic microscope at 35x to 100x or with a regular microscope at 100x.

(e) Interpretation of test results.

(1) If growth appears on at least one of the plates in the positive control test and does not appear on any of the plates in the negative control test, the test is valid.

(2) If mycoplasma colonies are found on any of the plates inoculated with material being tested, the results are positive for mycoplasma contamination.

[38 FR 29887, Oct. 30, 1973, as amended at 41 FR 6752, Feb. 13, 1976; 41 FR 32882, Aug. 6, 1976]

§ 113.29 Determination of moisture content in desiccated biological products.

Methods provided in this section must be used when a determination of moisture content in desiccated biological products is prescribed in an applicable Standard Requirement or in the filed Outline of Production for the product. Firms currently using methods other than those provided in this section for determining the moisture content in desiccated biological products have until November 5, 2004 to update their Outlines of Production to be in compliance with this requirement.

(a) Final container samples of completed product shall be tested. The weight loss of the sample due to drying in a vacuum oven shall be determined. All procedures should be performed in an environment with a relative humidity less than 45 percent. The equipment necessary to perform the test is as follows:

(1) Cylindrical weighing bottles with airtight glass stoppers.

(2) Vacuum oven equipped with validated thermometer and thermostat. A suitable air-drying device should be attached to the inlet valve.

(3) Balance, accurate to 0.1 mg (rated precision ±0.01mg).

(4) Desiccator jar equipped with phosphorous pentoxide, silica gel, or equivalent.

(5) Desiccated vaccine in original sealed vial. Sample and control should be kept at room temperature in their original airtight containers until use.

(b) Test procedure:

(1) Thoroughly cleaned and labeled sample-weighing bottles with stoppers should be allowed to dry at 60 ±3 °C under vacuum at less than 2.5 kPa.

(i) Transfer hot bottles and stoppers into the desiccator and allow to cool to room temperature.

(ii) After bottles have cooled, insert stoppers and weigh and record the weights of the bottles as “A.”

(iii) Return weighing bottles to the desiccator.

(2) Remove the sample container seal.

(i) Using a spatula, break up the sample plug and transfer the required amount of sample to the previously tared weighing bottle.

(ii) Insert the stopper and weigh and record the weights of the weighing bottles as “B.”

(3) Place the weighing bottle with the stopper at an angle in the vacuum oven. Set the vacuum to <2.5 kPa and the temperature to 60 ±3 °C.

(4) After a minimum of 3 hours of drying time, turn off the vacuum pump and allow dry air to bleed into the oven until the pressure inside the oven is equalized with the prevailing atmospheric pressure.

(5) While the bottle is still warm, replace the stopper in its normal position and transfer the weighing bottle to the desiccator.

(i) Allow a minimum of 2 hours for the weighing bottle to cool to room temperature or for its weight to reach equilibrium.

(ii) Weigh, and record the weight as “C.”

(6) Calculate the percentage of moisture in the original sample as follows:

(B−C)/(B−A) × (100) = Percentage of residual moisture, where:

A = tare weight of weighing bottle

B−A = weight of sample before drying

B−C = weight of sample after drying

(7) The results are considered satisfactory if the percentage of residual moisture is less than or equal to the manufacturer's specification.

[68 FR 57608, Oct. 6, 2003]

§ 113.30 Detection of Salmonella contamination.

The test for detection of Salmonella contamination provided in this section shall be conducted when such a test is prescribed in an applicable Standard Requirement or in the filed Outline of Production for the product.

(a) Samples shall be collected from the bulk suspension before bacteriostatic or bactericidal agents have been added. When tissue culture products are to be tested, 1 ml of tissue extract used as the source of cells or 1 ml of the minced tissue per se shall be tested.

(b) Five ml of the liquid vaccine suspension shall be used to inoculate each 100 ml of liquid broth medium (tryptose and either selenite F or tetrathionate). The inoculated media shall be incubated 18-24 hours at 35-37 °C.

(c) Transfers shall be made to either MacConkey agar or Salmonella-Shigella agar, incubated for 18-24 hours and examined.

(d) If no growth typical of Salmonella is noted, the plates shall be incubated an additional 18-24 hours and again examined.

(e) If suspicious colonies are observed, further subculture on suitable media shall be made for positive identification. If Salmonella is found, the bulk suspension is unsatisfactory.

[38 FR 29888, Oct. 30, 1973]

§ 113.31 Detection of avian lymphoid leukosis.

The complement-fixation test for detection of avian lymphoid leukosis provided in this section shall be conducted on all biological products containing virus which has been propagated in substrates of chicken origin: Provided, An inactivated viral product shall be exempt from this requirement if the licensee can demonstrate to Animal and Plant Health Inspection Service that the agent used to inactivate the vaccine virus would also inactivate lymphoid leukosis virus.

(a) Propagation of contaminating lymphoid leukosis viruses, if present, shall be done in chick embryo cell cultures.

(1) Each vaccine virus, cytopathic to chick embryo fibroblast cells, shall be effectively neutralized, inactivated, or separated so that minimal amounts of lymphoid leukosis virus can be propagated on cell culture during the 21-day growth period. If a vaccine virus cannot be effectively neutralized, inactivated, or separated, a sample of another vaccine prepared the same week from material harvested from each source flock (or other sampling procedure acceptable to Animal and Plant Health Inspection Service) used for the preparation of the questionable vaccine virus that cannot be neutralized, inactivated, or separated shall be tested each week during the preparation of such questionable vaccine.

(2) When cell cultures are tested, 5 ml of the final cell suspension as prepared for seeding of production cell cultures shall be used as inoculum. When vaccines are tested, the equivalent of 200 doses of Newcastle disease vaccine or 500 doses of other vaccines for use in poultry, or one dose of vaccine for use in other animals shall be used as inoculum. Control cultures shall be prepared from the same cell suspension as the cultures for testing the vaccine.

(3) Uninoculated chick embryo fibroblast cell cultures shall act as negative controls. One set of chick fibroblast cultures inoculated with subgroup A virus and another set inoculated with subgroup B virus shall act as positive controls, A and B respectively.

(4) The cell cultures shall be propagated at 35-37 °C for at least 21 days. They shall be passed when necessary to maintain viability and samples harvested from each passage shall be tested for group specific antigen.

(b) The microtiter complement-fixation test shall be performed using either the 50 percent or the 100 percent hemolytic end point technique to determine complement unitage. Five 50 percent hemolytic units or two 100 percent hemolytic units of complement shall be used for each test.

(1) All test materials, including positive and negative controls, shall be stored at −60 °C or colder until used in the test. Before use, each sample shall be thawed and frozen three times to disrupt intact cells and release the group specific antigen.

(2) The antiserum used in the microtiter complement-fixation test shall be a standard reagent supplied or approved by the Animal and Plant Health Inspection Service. Four units of antiserum shall be used for each test.

(3) Presence of complement-fixing activity in the harvested samples (from passages) at the 1:4 or higher dilution, in the absence of anticomplementary activity, shall be considered a positive test unless the activity can definitely be established to be caused by something other than lymphoid leukosis virus, subgroups A and/or B. Activity at the 1:2 dilution shall be considered suspicious and the sample further subcultured to determine presence or absence of the group specific antigen.

(4) Biological products or primary cells which are found contaminated with lymphoid leukosis viruses are unsatisfactory. Source flocks from which contaminated material was obtained are also unsatisfactory.

[38 FR 29888, Oct. 30, 1973, as amended at 38 FR 32917, Nov. 29, 1973; 39 FR 21042, June 18, 1974; 56 FR 66784, Dec. 26, 1991]

§ 113.32 Detection of Brucella contamination.

The test for detection of Brucella contamination provided in this section shall be conducted when such a test is prescribed in an applicable Standard Requirement or in a filed Outline of Production for the product.

(a) One ml of the minced tissue used as the source of cells or 1 ml of the extract of the tissue prior to the addition of antibiotics, diluent and stabilizer, shall be inoculated onto each of three tryptose agar plates and incubated in a 10 percent CO2 atmosphere at a temperature of 35-37 °C for at least 7 days.

(b) If colonies are identified as Brucella, the biological product is unsatisfactory.

(c) If colonies suspicious of Brucella are observed but cannot be identified as a Brucella species, either

(1) The biological product shall be regarded as unsatisfactory and destroyed; or

(2) Further subculture or other procedures shall be carried out until a positive identification can be made.

[38 FR 29888, Oct. 30, 1973]

§ 113.33 Mouse safety tests.

One of the mouse safety tests provided in this section shall be conducted when such test is prescribed in a Standard Requirement or in the filed Outline of Production for a biological product recommended for animals other than poultry: Provided, That if the inherent nature of one or more ingredients makes the biological product lethal or toxic for mice but not lethal or toxic for the animals for which it is recommended, the licensee shall demonstrate the safety of such product by an acceptable test written into such Outline of Production.

(a) Final container samples of completed product from live virus vaccines shall be tested for safety using young adult mice in accordance with the test provided in this paragraph.

(1) Vaccine prepared for use as recommended on the label shall be tested by inoculating eight mice intraperitoneally or subcutaneously with 0.5 mL (the inoculation volume may be divided among more than one injection site), and the animals observed for 7 days.

(2) If unfavorable reactions attributable to the product occur in any of the mice during the observation period, the serial or subserial is unsatisfactory. If unfavorable reactions which are not attributable to the product occur, the test shall be declared a No Test and may be repeated: Provided, That, if the test is not repeated, the serial or subserial shall be declared unsatisfactory.

(b) Bulk or final container samples of completed product from liquid products, such as but not limited to antiserums and bacterins, shall be tested for safety in accordance with the test provided in this paragraph.

(1) Unless otherwise prescribed in the Standard Requirement or approved in a filed Outline of Production for the product, a 0.5 ml dose shall be injected intraperitoneally or subcutaneously into eight mice and the animals observed for 7 days.

(2) If unfavorable reactions attributable to the product occur in any of the mice during the observation period, the serial or subserial is unsatisfactory. If unfavorable reactions which are not attributable to the product occur, the test shall be declared a No Test and may be repeated: Provided, That, if the test is not repeated, the serial or subserial shall be declared unsatisfactory.

[38 FR 34727, Dec. 18, 1973, as amended at 39 FR 16857, May 10, 1974; 72 FR 72564, Dec. 21, 2007]

§ 113.34 Detection of hemagglutinating viruses.

The test for detection of hemagglutinating viruses provided in this section shall be conducted when such a test is prescribed in an applicable Standard Requirement or in the filed Outline of Production for the product.

(a) Final container samples of completed product rehydrated as recommended on the label shall be used as inoculum: Provided, That poultry vaccines distributed without diluent shall be rehydrated with 30 ml of sterile distilled water per 1,000 doses and used as inoculum. When one or more fractions are to be used in combination with Newcastle Disease Vaccine, test samples shall be collected from bulk suspensions of each prior to mixing with the Newcastle Disease Vaccine.

(b) Each of ten 9- to 10-day-old embryonating eggs from Newcastle disease susceptible flocks shall be inoculated into the allantoic cavity with 0.2 ml of the undiluted inoculum.

(1) Test five uninoculated embryos of the same age and from the same flock as those used for the test as negative controls.

(2) Test an allantoic fluid sample of Newcastle disease virus as a positive control.

(c) Three to five days post-inoculation, a sample of allantoic fluid from each egg shall be tested separately by a rapid plate test for hemagglutinating activity using a 0.5 percent suspension of fresh chicken red blood cells.

(d) If the results are inconclusive, one or two blind passages shall be made using fluids from each of the original test eggs. Fluids from dead and live embryos may be pooled separately for inoculum in these passages.

(e) If hemagglutinating activity attributable to the product is observed, the serial is unsatisfactory.

[38 FR 29889, Oct. 30, 1973]

§ 113.35 Detection of viricidal activity.

The test for detection of viricidal activity provided in this section shall be conducted when such a test is prescribed in an applicable standard requirement or in the filed Outline of Production for each inactivated liquid biological product used as diluent for a desiccated live virus vaccine in a combination package.

(a) Bulk or final container samples of completed product from each serial shall be tested.

(b) The product shall be tested with each virus fraction for which it is to be used as a diluent. If the vaccine to be rehydrated contains more than one virus fraction, the test shall be conducted with each fraction after neutralization of the other fraction(s), and/or dilution of the vaccine beyond the titer range of the other fraction(s), or the test shall be conducted using representative single-fraction desiccated vaccines which are prepared by the licensee and which are licensed. Provided, That the Administrator may authorize licensees to prepare and use unlicensed single-fraction vaccines for this purpose.

(c) Test procedure: (1) Rehydrate at least two vials of the vaccine with the liquid product under test according to label recommendations and pool the contents.

(2) Rehydrate at least two vials of the vaccine with the same volume of sterile purified water and pool the contents.

(3) Neutralize to remove other fractions, if necessary.

(4) Hold the two pools of vaccine at room temperature (20 °to 25 °C) for 2 hours. The holding period shall begin when rehydration is completed.

(5) Titrate the virus(es) in each pool of vaccine as provided in the filed Outline of Production or an applicable standard requirement.

(6) Compare respective titers.

(d) If the titer of the vaccine virus(es) rehydrated with the product under test is more than 0.7 log10 below the titer of the vaccine virus(es) rehydrated with sterile purified water, the product is unsatisfactory for use as diluent.

(e) If the product is unsatisfactory in the first test, one retest to rule out faulty techniques may be conducted using four vials of the vaccine for each pool and the acceptability of the product judged by the results of the second test.

(f) Liquid products found to be unsatisfactory for use as diluent by this test are not prohibited from release as separate licensed products if labeled as prescribed in § 112.7(g).

[44 FR 25412, May 1, 1979, as amended at 56 FR 66784, Dec. 26, 1991; 64 FR 43044, Aug. 9, 1999]

§ 113.36 Detection of pathogens by the chicken inoculation test.

The test for detection of extraneous pathogens provided in this section shall be conducted when such a test is prescribed in an applicable Standard Requirement or in the filed Outline of Production for the product.

(a) The biological product to be tested shall be prepared for use as recommended on the label, or in the case of desiccated vaccine to be used in poultry, rehydrated with sterile distilled water at the rate of 30 ml per 1,000 doses.

(b) At least 25 healthy susceptible young chickens, properly identified and obtained from the same source and hatch, shall be immunized at least 14 days prior to being put on test. The immunizing agent shall be the same as the product to be tested but from a serial previously tested and found satisfactory.

(c) At least 20 of the previously immunized birds shall be inoculated with 10 label doses of the vaccine being tested by each of the following routes: Subcutaneous, intratracheal, eye-drop, and comb scarification (1 cm 2). Twenty birds may be used for each route or combination of routes.

(d) At least five birds shall be isolated as control birds.

(e) All birds shall be observed for 21 days for signs of septicemic diseases, respiratory diseases, or other pathologic conditions.

(f) If the controls remain healthy and unfavorable reactions attributable to the product occur in the vaccinates, the serial or subserial tested is unsatisfactory. If the controls do not remain healthy or if unfavorable reactions not attributable to the product occur in the vaccinates, or both, the test shall be declared a No Test and may be repeated: Provided, That, if the test is not repeated, the serial of subserial tested shall be considered unsatisfactory.

[38 FR 29889, Oct. 30, 1973, as amended at 39 FR 21042, June 18, 1974; 43 FR 7610, Feb. 24, 1978]

§ 113.37 Detection of pathogens by the chicken embryo inoculation test.

The test for detection of extraneous pathogens provided in this section shall be conducted when such a test is prescribed in an applicable Standard Requirement or in the filed Outline of Production for the product.

(a) The biological product to be tested shall be prepared for use as recommended on the label, or in the case of desiccated vaccine to be used in poultry, rehydrated with sterile distilled water at the rate of 30 ml per 1,000 doses.

(b) One volume of the prepared vaccine shall be mixed with up to nine volumes of sterile heat-inactivated specific antiserum to neutralize the vaccine virus in the product. Each lot of antiserum shall be demonstrated by virus neutralization tests not to inhibit other viruses known to be possible contaminants.

(c) After neutralization, 0.2 ml of the vaccine-serum mixture shall be inoculated into each of at least 20 fully susceptible chicken embryos.

(1) Twenty embryos, 9 to 11 days old, shall be inoculated on the chorio-allantoic membrane (CAM) with 0.1 ml, and in the allantoic sac with 0.1 ml.

(2) Eggs shall be candled daily for 7 days. Deaths occurring during the first 24 hours shall be disregarded but at least 18 viable embryos shall survive 24 hours post-inoculation for a valid test. Examine all embryos and CAM's from embryos which die after the first day. When necessary, embryo subcultures shall be made to determine the cause of a death. The test shall be concluded on the seventh day post-inoculation and the surviving embryos (including CAM's) examined.

(d) If death and/or abnormality attributable to the inoculum occur, the serial is unsatisfactory: Provided, That, if there is a vaccine virus override, the test may be repeated, using a higher titered antiserum.

[38 FR 29889, Oct. 30, 1973, as amended at 39 FR 21042, June 18, 1974]

§ 113.38 Guinea pig safety test.

The guinea pig safety test provided in this section shall be conducted when prescribed in a Standard Requirement or approved Outline of Production for a biological product. When desiccated products are tested, final container samples of completed product prepared for administration in the manner recommended on the label shall be used. When liquid products are tested, either bulk or final container samples of completed product shall be used.

(a) Unless otherwise specified in the Standard Requirement or approved Outline of Production for the product, a 2 ml dose shall be injected either intramuscularly or subcutaneously into each of two guinea pigs and the animals observed for 7 days.

(b) If unfavorable reactions attributable to the product occur in either of the guinea pigs during the observation period, the serial or subserial is unsatisfactory. If unfavorable reactions which are not attributable to the product occur, the test shall be declared a No Test and may be repeated: Provided, That, if the test is not repeated, the serial or subserial shall be declared unsatisfactory.

[39 FR 16857, May 10, 1974; 39 FR 20368, June 10, 1974]

§ 113.39 Cat safety tests.

The safety tests provided in this section shall be conducted when prescribed in a standard requirement or in the filed Outline of Production for a biological product recommended for use in cats.

(a) The cat safety test provided in this paragraph shall be used when the Master Seed Virus is tested for safety.

(1) The test animals shall be determined to be susceptible to the virus under test as follows:

(i) Throat swabs shall be collected from each cat and individually tested on susceptible cell cultures for the presence of the virus. Blood samples shall also be drawn and individual serum samples tested for antibody to the virus.

(ii) The cats shall be considered susceptible if swabs are negative for virus isolation and the serums are free of virus antibody at the 1:2 final dilution in a 50 percent plaque reduction test or other serum-neutralization test of equal sensitivity.

(iii) When determining susceptibility to a virus which does not lend itself to the methods in paragraphs (a)(1)(i) and (ii) of this section, a method acceptable to Animal and Plant Health Inspection Service shall be used.

(2) Each of at least 10 susceptible cats shall be administered a sample of the Master Seed Virus equivalent to the amount of virus to be used in one cat dose of the vaccine, by the method to be recommended on the label, and the cats observed each day for 14 days.

(3) If unfavorable reactions attributable to the virus occur in any of the cats during the observation period, the Master Seed Virus is unsatisfactory. If unfavorable reactions occur which are not attributable to the Master Seed Virus, the test shall be declared a No Test and repeated: Provided, That, if not repeated, the Master Seed Virus shall be unsatisfactory.

(b) The cat safety test provided in this paragraph shall be used when a serial of vaccine is tested for safety before release.

(1) Each of two healthy cats shall be administered 10 cat doses by the method recommended on the label and the cats observed each day for 14 days.

(2) If unfavorable reactions attributable to the biological product occur during the observation period, the serial is unsatisfactory. If unfavorable reactions occur which are not attributable to the product, the test shall be declared a No Test and repeated: Provided, That, if not repeated, the serial shall be unsatisfactory.

[44 FR 58898, Oct. 12, 1979, as amended at 56 FR 66784, Dec. 26, 1991]

§ 113.40 Dog safety tests.

The safety tests provided in this section shall be conducted when prescribed in a Standard Requirement or in the filed Outline of Production for a biological product recommended for use in dogs. Serials which are not found to be satisfactory when tested pursuant to the procedures in this section may not be released for shipment.

(a) The dog safety test provided in this paragraph shall be used when the Master Seed Virus is tested for safety.

(1) The test animals shall be determined to be susceptible to the virus under test by a method acceptable to the Animal and Plant Health Inspection Service.

(2) Each of at least 10 susceptible dogs shall be administered a sample of the Master Seed Virus equivalent to the amount of virus to be used in one dog dose of the vaccine, by the method recommended on the label, and the dog shall be observed each day for 14 days.

(3) If unfavorable reactions attributable to the virus occur in any of the dogs during the observation period, the Master Seed Virus is unsatisfactory. If unfavorable reactions occur which are not attributable to the Master Seed Virus, the test shall be declared a No Test and may be repeated: Provided: That, if the test is not repeated, the Master Seed Virus shall be considered unsatisfactory.

(b) The dog safety test provided in this paragraph shall be used when a serial of vaccine is tested for safety before release.

(1) Each of two healthy dogs shall be administered 10 dog doses by the method recommended on the label and the dogs shall be observed each day for 14 days.

(2) If unfavorable reactions attributable to the biological product occur during the observation period, the serial is unsatisfactory. If unfavorable reactions occur which are not attributable to the biological product, the test shall be declared a No Test and may be repeated: Provided, That, if the test is not repeated, the serial shall be considered unsatisfactory.

[60 FR 14358, Mar. 17, 1995]

§ 113.41 Calf safety test.

The calf safety test provided in this section shall be conducted when prescribed in a Standard Requirement or in the filed Outline of Production for a product.

(a) Test procedure. Each of two calves shall be injected with the equivalent of 10 doses of vaccine administered in the manner recommended on the label and observed each day for 21 days.

(b) Interpretation. If unfavorable reactions attributable to the product occur in either of the calves during the observation period, the serial or subserial is unsatisfactory. If unfavorable reactions which are not attributable to the product occur, the test shall be declared a No Test and may be repeated: Provided, That, if the test is not repeated, the serial or subserial shall be declared unsatisfactory.

[39 FR 27428, July 29, 1974]

§ 113.42 Detection of lymphocytic choriomeningitis contamination.

The test for detection of lymphocytic choriomeningitis (LCM) virus provided in this section shall be conducted when such a test is prescribed in an applicable Standard Requirement or in a filed Outline of Production. Vaccine virus may be neutralized with specific antiserum when necessary.

(a) Each of at least 10 mice obtained from a source free of LCM shall be injected in the footpad of a hindfoot with 0.02 ml of the material being tested and observed each day for 21 days.

(b) If any of the mice show swelling in the injected footpad or if more than one becomes systemically abnormal, the material being tested is unsatisfactory.

[42 FR 6794, Feb. 4, 1977]

§ 113.43 Detection of chlamydial agents.

The test for chlamydial agents provided in this section shall be conducted when such a test is prescribed in an applicable standard requirement or in a filed Outline of Production.

(a) The yolk sac of 6-day-old chicken embryos shall be injected. Three groups of 10 embryos shall be used sequentially.

(1) The inoculum for each embryo in the first group shall consist of 0.5 ml of a mixture of equal parts of the seed virus with phosphate buffered saline that may contain Streptomycin, Vancomycin, Kanamycin, or a combination thereof. Not more than 2 mg/ml of each antibiotic shall be used.

(2) On the 10th day postinoculation, the yolk sac of viable embryos shall be harvested, pooled, homogenized as a 20 percent suspension in phosphate buffered saline antibiotic diluent, and 0.5 ml of the mixture injected into the second group of chicken embryos. This process shall be repeated for the injection of the third group of embryos using the yolk sacs of viable embryos from the second group.

(3) For each of the three passages, embryo deaths occurring within 48 hours of injection shall be disregarded, except that if more than three such deaths occur at any passage, that passage shall be repeated.

(b) If one or more embryo deaths occur at any passage after 48 hours postinjection, the yolk sacs from each of the dead embryos shall be subcultured into 10 additional embryos. If one or more embryo deaths again occur due to chlamydial agents, the Master Seed Virus is unsatisfactory for use to produce vaccine.

[44 FR 58899, Oct. 12, 1979]

§ 113.44 Swine safety test.

The swine safety test provided in this section shall be conducted when prescribed in a Standard Requirement or in the filed Outline of Production for a product.

(a) Test procedure. (1) Inject each of two swine of the minimum age for which the product is recommended with the equivalent of two doses of bacterial vaccine or 10 doses of viral vaccine.

(2) Administer vaccine in the manner recommended on the label.

(3) Observe swine each day for 21 days.

(b) Interpretation. If unfavorable reactions attributable to the product occur in either of the swine during the observation period, the serial or subserial is unsatisfactory. If unfavorable reactions which are not attributable to the product occur, the test shall be declared a No Test and may be repeated; Provided, That, if the test is not repeated, the serial or subserial shall be declared unsatisfactory.

[48 FR 33476, July 22, 1983]

§ 113.45 Sheep safety test.

The sheep safety test provided in this section shall be conducted when prescribed in a Standard Requirement or in the filed Outline of Production for a product.

(a) Test procedure. (1) Inject each of two sheep of the minimum age for which the product is recommended with the equivalent of two doses of bacterial vaccine or 10 doses of viral vaccine.

(2) Administer vaccine in the manner recommended on the label.

(3) Observe sheep each day for 21 days.

(b) Interpretation. If unfavorable reactions attributable to the product occur in either of the sheep during the observation period, the serial or subserial is unsatisfactory. If unfavorable reactions which are not attributable to the product occur, the test shall be declared a No Test and may be repeated; Provided, That, if the test is not repeated, the serial or subserial shall be declared unsatisfactory.

[48 FR 33476, July 22, 1983]

§ 113.46 Detection of cytopathogenic and/or hemadsorbing agents.

The tests for detection of cytopathogenic and/or hemadsorbing agents provided in this section shall be conducted when prescribed in an applicable Standard Requirement or in the filed Outline of Production for a product.

(a) Test for cytopathogenic agents. One or more monolayers that are at least 6 cm 2 and at least 7 days from the last subculture shall be tested as provided in this paragraph.

(1) Stain each monolayer with a suitable cytological stain.

(2) Examine the entire area of each stained monolayer for evidence of inclusion bodies, abnormal number of giant cells, or other cytopathology indicative of cell abnormalities attributable to an extraneous agent.

(b) Test for hemadsorbing agents. One or more monolayers that are at least 6 cm 2 and at least 7 days from the last subculture shall be tested as provided in this paragraph.

(1) Wash the monolayer with several changes of phosphate buffered saline.

(2) Add an appropriate volume of a 0.2 percent red blood cell suspension to uniformly cover the surface of the monolayer of cultured cells. Suspensions of washed guinea pig and chicken red blood cells shall be used. These suspensions may be mixed before addition to the monolayer or they may be added separately to individual monolayers.

(3) Incubate the monolayer at 4 °C for 30 minutes, wash with phosphate buffered saline, and examine for hemadsorption.

(4) If no hemadsorption is apparent, repeat step (b)(2) of this section and incubate the monolayers at 20-25 °C for 30 minutes, wash with phosphate buffered saline, and examine again for hemadsorption. If desired, separate monolayers may be used for each incubation temperature.

(c) If specific cytopathology or hemadsorption attributable to an extraneous agent is found, the material under test is unsatisfactory and shall not be used to prepare biological products. If an extraneous agent is suspected because of cytopathology or hemadsorption and cannot be eliminated as a possibility by additional testing, the material under test is unsatisfactory.

[50 FR 441, Jan. 4, 1985, as amended at 58 FR 50252, Sept. 27, 1993]

§ 113.47 Detection of extraneous viruses by the fluorescent antibody technique.

The test for detection of extraneous viruses by the fluorescent antibody technique provided in this section shall be conducted when prescribed in an applicable Standard Requirement or in a filed Outline of Production for a product.

(a) Monolayer cultures of cells (monolayers), at least 7 days after the last subculturing, shall be processed and stained with the appropriate antiviral fluorochrome-conjugated antibody as specified in paragraph (b) of this section.

(1) Three groups of one or more monolayers shall be required for each specific virus prescribed in paragraph (b) of this section.

(i) At the time of the last subculturing, one group of test monolayers shall be inoculated with approximately 100-300 FAID50 of the specific virus being tested for as positive controls.

(ii) One group of monolayers shall be the “material under test.”

(iii) One group of monolayers, that are of the same type of cells as the test monolayers and that have been tested as prescribed in §§ 113.51 or 113.52 (whichever is applicable), shall be prepared as negative controls.

(2) Each group of monolayers shall have a total area of at least 6 cm 2.

(3) Positive control monolayers may be fixed (processed so as to arrest growth and assure attachment of the monolayer to the surface of the vessel in which they are grown) before 7 days after subculturing if fluorescence is enhanced by doing so, Provided, That a monolayer of the material under test is also fixed at the same time as the positive control and a monolayer of the material under test is also fixed at least seven days after subculturing. Monolayers that are fixed before 7 days after subculturing shall be stained at the same time as the test monolayers and negative controls fixed at least 7 days after subculturing.

(b) The antiviral fluorochrome-conjugated antibodies to be used shall depend on the type of cells required to be tested for extraneous viruses as specified in an applicable Standard Requirement or in a filed Outline of Production. Antiviral fluorochrome-conjugated antibodies specific for the extraneous viruses shall be applied to each respective type of cell in accordance with the following list. Under certain circumstances, additional tests may need to be conducted, as determined by the Administrator. When a specific antiviral fluorochrome-conjugated antibody is used in testing for the listed extraneous viruses specified in more than one cell type, it need only be applied to the most susceptible cell type.

(1) All cells shall be tested for:

(i) Bovine virus diarrhea virus;

(ii) Reovirus; and

(iii) Rabies virus.

(2) Bovine, caprine, and ovine cells shall, in addition, be tested for:

(i) Bluetongue virus;

(ii) Bovine adenoviruses;

(iii) Bovine parvovirus; and

(iv) Bovine respiratory syncytial virus.

(3) Canine cells shall, in addition, be tested for:

(i) Canine coronavirus;

(ii) Canine distemper virus; and

(iii) Canine parvovirus.

(4) Equine cells shall, in addition, be tested for:

(i) Equine herpesvirus; and

(ii) Equine viral arteritis virus.

(5) Feline cells shall, in addition, be tested for:

(i) Feline infectious peritonitis virus; and

(ii) Feline panleukopenia virus.

(6) Porcine cells shall, in addition, be tested for:

(i) Porcine adenovirus;

(ii) Porcine parvovirus;

(iii) transmissible gastroenteritis virus; and

(iv) Porcine hemagglutinating encephalitis virus.

(7) Firms that do not have rabies virus on premises either for research or production purposes are exempt from having to produce positive rabies virus control monolayers. Fixed positive rabies virus control monolayers will be provided by the National Veterinary Services Laboratories.

(c) After staining, each group of monolayers shall be examined for the presence of specific fluorescence attributable to the presence of extraneous viruses.

(1) If the material under test shows any evidence of specific viral fluorescence, it is unsatisfactory and may not be used; Provided, That, if specific fluorescence attributable to the virus being tested for is absent in the positive control monolayers, the test is a No Test and may be repeated.

(2) If the fluorescence of the monolayers inoculated with the specific virus as positive controls is equivocal, or if the negative monolayers show equivocal fluorescence indicating possible viral contamination, or both, the test shall be declared a No Test, and may be repeated; Provided, That, if the test is not repeated, the material under test shall be regarded as unsatisfactory for use in the production of biologics.

[60 FR 24548, May 9, 1995]

§ 113.50 Ingredients of biological products.

All ingredients used in a licensed biological product shall meet accepted standards of purity and quality; shall be sufficiently nontoxic so that the amount present in the recommended dose of the product shall not be toxic to the recipient; and in the combinations used shall not denature the specific substances in the product below the minimum acceptable potency within the dating period when stored at the recommended temperature.

[38 FR 29889, Oct. 30, 1973]

§ 113.51 Requirements for primary cells used for production of biologics.

Primary cells used to prepare biological products shall be derived from normal tissue of healthy animals. When prescribed in an applicable Standard Requirement or in the filed Outline of Production, each batch of primary cells used to prepare a biological product shall be tested as prescribed in this section. A batch of primary cells found unsatisfactory by any prescribed test shall not be used. A serial of biological product shall not be released if produced from primary cells that are found unsatisfactory by any prescribed test.

(a) Final container samples of completed product or samples of the final pool of harvested material or samples of each subculture of cells used to prepare the biological product shall be shown free of mycoplasma as prescribed in § 113.28. The sample for testing shall consist of at least 75 cm 2 of actively growing cells or the equivalent in harvest fluids; Provided, That all sources of cells in the batch of primary cells are represented.

(b) Final container samples of completed product or samples of the final pool of harvested material or samples of each subculture of cells used to prepare the biological product shall be shown free of bacteria and fungi as prescribed in § 113.26 or § 113.27 (whichever is applicable).

(c) A monolayer at least 75 cm 2 from each batch of primary cells or each subculture of primary cells used to prepare a biological product shall be shown free of extraneous agents as prescribed in this paragraph.

(1) The test monolayer shall be maintained using the medium (with additives) and under conditions similar to those used to prepare biological products.

(i) Monolayers of avian origin shall be maintained for at least 14 days and shall be subcultured at least once during the maintenance period. All but the last subculture shall result in a new monolayer of at least 75 cm 2. The last subculture shall meet the minimum area requirement specified in §§ 113.46 and 113.47.

(ii) Monolayers not of avian origin shall be maintained for at least 28 days and shall be subcultured at least twice during the maintenance period. All but the last subculture shall result in a new monolayer of at least 75 cm 2. The last subculture shall meet the minimum area requirement specified in §§ 113.46 and 113.47.

(2) Monolayers shall be examined regularly throughout the required maintenance period for evidence of the presence of cytopathogenic agents. If evidence of a cytopathogenic agent is found, the batch of primary cells is unsatisfactory.

(3) At the conclusion of the required maintenance period, monolayers shall be tested for:

(i) Cytopathogenic and/or hemadsorbing agents as prescribed in § 113.46;

(ii) Extraneous viruses by the fluorescent antibody technique as prescribed in § 113.47.

[50 FR 442, Jan. 4, 1985, as amended at 60 FR 24549, May 9, 1995]

§ 113.52 Requirements for cell lines used for production of biologics.

When prescribed in an applicable Standard Requirement or in a filed Outline of Production each cell line used to prepare a biological product shall be tested as prescribed in this section. A cell line found unsatisfactory by any prescribed test shall not be used. A serial of biological product shall not be released if produced from a cell line that is found unsatisfactory by any prescribed test.

(a) General requirements. (1) A complete record of the cell line shall be kept, such as, but not limited to, the source, passage history, and medium used for propagation.

(2) A Master Cell Stock (MCS) shall be established at a specified passage level for each cell line. The passage level and identity of the MCS and the highest passage level (MCS + n) intended for use in the preparation of a biological product shall be specified in the Outline of Production for the product.

(3) Sufficient 1.0 ml or larger aliquots of MCS and MCS + n shall be prepared, kept in a frozen state, and made available to Animal and Plant Health Inspection Service (APHIS) upon request for performing the tests prescribed in this section.

(4) Each lot of cells shall be monitored for the characteristics determined to be normal for the cell line, such as, but not limited to, microscopic appearance, growth rate, acid production, or other observable features.

(b) The MCS shall be shown to be of the same species of origin as that reported in paragraph (a)(1) of this section by the following method:

(1) At least four monolayers with a total area of at least 6 cm 2 shall be grown to at least 80 percent confluency.

(2) The monolayers shall be removed from their media, processed, stained, and examined.

(i) At least two monolayers shall be stained with an antispecies fluorchrome-conjugated antibody unrelated to the species of origin of the MCS.

(ii) At least two monolayers shall be stained with an antispecies fluorochrome-conjugated antibody specific to the species of origin of the MCS.

(iii) All monolayers shall be examined for evidence of specific fluorescence.

(3) If specific fluorescence is not found in the monolayers stained with the conjugate specific to the species of origin of the MCS, the cell line is unsatisfactory and shall not be used for vaccine production.

(4) If nonspecific fluorescence is found in the monolayers stained with conjugate from an unrelated species of origin or other results make the test results equivocal, the procedure shall be repeated until either specific fluorescence is found only in the monolayers stained with conjugate specific to the species of origin of the MCS and not in the control monolayers or specific fluorescence cannot be identified and the MCS is declared unsatisfactory.

(5) Alternate tests to determine the species of origin of the MCS may be used if approved by APHIS.

(c) The MCS and either each subculture of cells used to prepare a biological product or the final pool of harvested material (with or without the stabilizer) or final container samples of completed product for each serial of such product shall be shown to be free of mycoplasma as prescribed in § 113.28. The sample for testing shall consist of at least 75 cm 2 of actively growing cells or the equivalent, in harvest fluids. The cells shall represent all sources of cells in the batch.

(d) The MCS and either each subculture used to prepare a biological product or the final pool of harvested material for each serial of such product or final container samples of completed product for each serial of such product shall be tested for bacteria and fungi as prescribed in § 113.26 or § 113.27 (whichever is applicable). If bacteria or fungi are found in the MCS, the MCS shall not be used. If bacteria or fungi are found in a subculture, the subculture shall not be used.

(e) A monolayer at least 75 cm 2 from each MCS shall be shown free of extraneous agents as prescribed in this paragraph.

(1) The test monolayer shall be maintained for at least 21 days using the medium (with additives) intended for growth and maintenance and under conditions similar to those used to prepare biological products.

(2) Cells shall be subcultured at least two times during the maintenance period. All but the last subculture shall result in at least one new monolayer of at least 75 cm 2. The last subculture shall meet the minimum area requirement specified in §§ 113.46 and 113.47 and paragraph (f) of this section.

(3) Monolayers shall be examined regularly throughout the 21-day maintenance period for evidence of the presence of cytopathogenic agents. If evidence of a cytopathogenic agent is found, the MCS is unsatisfactory.

(4) At the conclusion of the 21-day maintenance period, monolayers shall be tested for:

(i) Cytopathogenic and/or hemadsorbing agents as prescribed in § 113.46; and

(ii) Extraneous agents by the fluorescent antibody technique as prescribed in § 113.47.

(f) At the conclusion of the 21-day maintenance period provided in paragraph (e) of this section, at least one monolayer of at least 75 cm 2 shall also be shown free of extraneous agents as prescribed in this paragraph.

(1) Alternately freeze and thaw the monolayer(s) three times. Centrifuge the disrupted cells at no greater than 2,000 × g for no more than 15 minutes to remove cellular debris. Divide the supernatant into equal aliquots and dispense 1.0 ml onto each of at least one monolayer (at least 75 cm 2) of:

(i) Vero (African green monkey kidney) cell line;

(ii) Embryonic cells, neonatal cells, or a cell line of the same species of origin as the MCS if different than provided in paragraph (f)(1)(i) of this section;

(iii) Embryonic cells, neonatal cells, or a cell line of the species for which the vaccine is recommended if different than provided in paragraph (f)(1)(ii) of this section; and

(iv) Embryonic cells, neonatal cells, or a cell line of bovine origin if not specified in paragraphs (f)(1)(ii), and (iii) of this section.

(2) The monolayers of cells specified in paragraphs (f)(1)(i), (ii), (iii), and (iv) of this section shall be maintained for at least 14 days after inoculation with the aliquot of disrupted MCS. Monolayers shall be subcultured at least once during the maintenance period. All but the last subculture shall result in a new monolayer of at least 75 cm 2. The last subculture shall meet the minimum area requirement specified in §§ 113.46 and 113.47.

(3) Monolayers shall be examined regularly throughout the 14-day maintenance period for evidence of the presence of cytopathogenic agents. If evidence of a cytopathogenic agent is found, the MCS is unsatisfactory.

(4) At the conclusion of the 14-day maintenance period, monolayers shall be tested for:

(i) Cytopathogenic and/or hemadsorbing agents as prescribed in § 113.46; and

(ii) Extraneous viruses by the fluorescent antibody technique as prescribed in § 113.47.

(g) The karyology of cells lines used in the production of biologics shall be examined as follows. A minimum of 50 mitotic cells shall be examined at both the MCS and MCS + n. The modal number in the MCS + n shall not exceed plus or minus 15 percent of the modal number of the MCS. Any marker chromosomes present in the MCS shall persist at the MCS + n. If the modal number exceeds the limits and/or the marker chromosomes do not persist (through the MCS + n passage level), the cell line shall not be used for vaccine production.

(h) If direct or indirect evidence exists that a cell line which is intended for use in the preparation of a vaccine may induce malignancies in the species for which the product is intended, that cell line shall be tested for tumorigenicity/oncogenicity by a method acceptable to APHIS.

[50 FR 442, Jan. 4, 1985; 50 FR 3316, Jan. 24, 1985, as amended at 56 FR 66784, Dec. 26, 1991; 60 FR 24549, May 9, 1995]

§ 113.53 Requirements for ingredients of animal origin used for production of biologics.

Each lot of ingredient of animal origin which is not subjected to heat sterilization or other sterilization methods acceptable to Animal and Plant Health Inspection Service (APHIS), such as, but not limited to serum and albumin, used to prepare a biological product shall be tested as prescribed in this section by the licensee or a laboratory acceptable to VS. Results of all tests shall be recorded by the testing laboratory and made a part of the licensee's records. A lot of ingredient found unsatisfactory by any prescribed test shall not be used to prepare a biological product. A serial of biological product shall not be released if produced using an ingredient that is found unsatisfactory by any prescribed test.

(a) Samples of each lot of ingredient of animal origin which is not subjected to heat sterilization, used to prepare a biological product shall be shown free of mycoplasma by the method prescribed in § 113.28.

(b) Samples of each lot of ingredient or animal origin which is not subjected to heat sterilization of other sterilization methods acceptable to APHIS used to prepare a biological product shall be shown free of bacteria and fungi as prescribed in § 113.26.

(c) Samples of each lot of ingredient of animal origin, except porcine trypsin, which is not subjected to heat sterilization or other viricidal procedure acceptable to APHIS used in the preparation of biological products shall be tested as prescribed in this paragraph;

(1) Monolayers at least 75 cm 2 of Vero (African green monkey kidney) cell line and of primary cells or a cell line of the same species of origin as the ingredient shall be used in the test. Cell lines used shall have been found satisfactory when tested as prescribed in § 113.52 and primary cells used shall have been found satisfactory when tested as prescribed in § 113.51.

(2) At least 3.75 ml or 15 percent of the ingredient shall be used in the growth medium for the preparation of at least 75 cm 2 test monolayers. The ingredient shall also be used in the growth medium when monolayers are subcultured. If the ingredient being tested is cytotoxic when tested in this manner, other procedures may be used if approved by APHIS.

(3) The test monolayers shall be maintained for at least 21 days.

(4) Cells shall be subcultured at least two times during the maintenance period. All but the last subculture shall result in at least one new monolayer of at least 75 cm 2. The last subculture shall meet the minimum area requirements specified in §§ 113.46 and 113.47.

(5) Monolayers shall be examined regularly throughout the 21-day maintenance period for evidence of cytopathogenic agents. If evidence of a cytopathogenic agent is found, the ingredient is unsatisfactory.

(6) At the conclusion of the 21-day maintenance period, monolayers shall be tested for:

(i) Cytopathogenic and/or hemadsorbing agents as prescribed in § 113.46; and

(ii) Extraneous viruses by the fluorescent antibody technique as prescribed in § 113.47.

(d) Each lot of porcine trypsin which has not been treated to inactivate porcine parvovirus (PPV) in a manner acceptable to VS shall be tested for PPV as prescribed in this paragraph.

(1) Not less than 5.0 grams of trypsin shall be dissolved in a volume of suitable diluent sufficient to fill a centrifuge angle head. After centrifuging for 1 hour at 80,000 × g, the pellet material shall be reconstituted in distilled water and inoculated into a flask containing 75 cm 2 of a 30 to 50 percent confluent monolayer culture of primary porcine cells or a porcine cell line of proven equal PPV susceptibility. An additional flask of cells shall be held as a negative control.

(2) The test and control monolayers shall be maintained for at least 14 days and subcultured at least once during the maintenance period.

(3) At the end of the 14-day maintenance period, and 4 to 7 days after the last subculturing, monolayers shall be tested for the presence of porcine parvovirus by the fluorescent antibody technique as prescribed in § 113.47(c).

(e) A sample of serum from each donor horse used to produce a lot of equine serum used in the preparation of biological products recommended for use in horses shall be tested at a laboratory approved by Animal and Plant Health Inspection Service using the Coggins test for equine infectious anemia antibodies. If antibodies to equine infectious anemia are found, the lot of serum is unsatisfactory.

[50 FR 442, Jan. 4, 1985; 50 FR 3316, Jan. 24, 1985, as amended at 56 FR 66784, Dec. 26, 1991; 60 FR 24549, May 9, 1995]

§ 113.54 Sterile diluent.

Sterile Diluent shall be supplied in a final container by the licensee when such diluent is required for rehydration or dilution of the vaccine.

(a) Sterile Diluent may be distilled or deionized water or it may be a special liquid solution formulated in accordance with an acceptable outline on file with Animal and Plant Health Inspection Service.

(b) Each quantity prepared at one time in a single container and bottled into final containers shall be designated as a serial. Each serial shall be given a number which shall be used in records, test reports, and on the final container label.

(c) Final container samples from each serial shall be tested for bacteria and fungi in accordance with the test provided in § 113.26. Any serial found to be unsatisfactory shall not be released.

[39 FR 27428, July 29, 1974, as amended at 56 FR 66784, Dec. 26, 1991]

§ 113.55 Detection of extraneous agents in Master Seed Virus.

Unless otherwise prescribed in a Standard Requirement or in a filed Outline of Production, each Master Seed Virus (MSV) shall be tested as prescribed in this section. A MSV found unsatisfactory by any prescribed test shall not be used. A serial of biological product shall not be released if produced from a MSV that is found unsatisfactory by any prescribed test.

(a) At least a 1.0 ml aliquot per cell culture of MSV shall be dispensed onto monolayers (at least 75 cm 2 in area) of:

(1) Vero (African green monkey kidney) cell line;

(2) Embryonic cells, neonatal cells, or a cell line of the species for which the vaccine is recommended; and

(3) Embryonic cells, neonatal cells, or a cell line of the species of cells in which the MSV is presently being propagated if different than prescribed in paragraphs (a)(1) and (a)(2) of this section. Cell lines used shall have been found satisfactory when tested as prescribed in § 113.52 and primary cells used shall have been found satisfactory when tested as prescribed in § 113.51. If the MSV is cytopathic for or causes hemadsorption in the cells in which it is to be tested, the MSV shall be neutralized with monospecific antiserum supplied or approved by Animal and Plant Health Inspection Service (APHIS) or counteracted by a method approved by APHIS.

(b) At least one monolayer of each cell type used in the test shall be maintained as an uninoculated control.

(c) Each monolayer shall be maintained at least 14 days.

(d) Cells shall be subcultured at least once during the maintenance period. All but the last subculture shall result in at least one new monolayer at least 75 cm 2. The last subculture shall meet the minimum area requirement specified in §§ 113.46 and 113.47.

(e) Monolayers shall be examined regularly throughout the 14-day maintenance period for evidence of cytopathogenic agents. If evidence of a cytopathogenic agent is found, the MSV is unsatisfactory.

(f) At the conclusion of the 14-day maintenance period, monolayers shall be tested for:

(1) Cytopathogenic and/or hemadsorbing agents as prescribed in § 113.46;

(2) Extraneous agents by the fluorescent antibody technique as prescribed in § 113.47.

[50 FR 444, Jan. 4, 1985, as amended at 56 FR 66784, Dec. 26, 1991]

§ 113.64 General requirements for live bacterial vaccines.

When prescribed in an applicable Standard Requirement or in the filed Outline of Production, a live bacterial vaccine shall meet the requirements in this section.

(a) Purity test. Final container samples of completed product from each serial and subserial, and samples of each lot of Master Seed Bacteria shall be tested for the presence of extraneous viable bacteria and fungi in accordance with the test provided in § 113.27(b).

(b) Safety tests. (1) Samples of completed product from each serial or first subserial and samples of each lot of Master Seed Bacteria shall be tested for safety in young adult mice in accordance with the test provided in § 113.33(b) unless:

(i) The bacteria or agents in the vaccine are inherently lethal for mice.

(ii) The vaccine is recommended for poultry.

(2) Samples of completed product from each serial or first subserial of live bacterial vaccine shall be tested for safety in one of the species for which the product is recommended as follows:

(i) Live bacterial vaccine recommended for use in dogs shall be tested as provided in § 113.40, except that dogs shall be injected with the equivalent of two doses of vaccine administered as recommended on the label.

(ii) Live bacterial vaccine recommended for use in cattle shall be tested as provided in § 113.41, except that calves shall be injected with the equivalent of two doses of vaccine administered as recommended on the label.

(iii) Live bacterial vaccine recommended for use in sheep shall be tested as provided in § 113.45.

(iv) Live bacterial vaccine recommended for use in swine shall be tested as provided in § 113.44.

(c) Identity test. At least one of the identity tests provided in this paragraph shall be conducted for the Master Seed Bacteria and final container samples from each serial or first subserial of completed biological product. A known positive control (reference) provided or approved by Animal and Plant Health Inspection Service shall be included in such tests.

(1) Fluorescent antibody test. The direct fluorescent antibody staining technique shall be conducted using suitable smears of the vaccine bacteria. Fluorescence typical for the bacteria concerned shall be demonstrated. Fluorescence shall not occur in control smears treated with specific antiserum.

(2) Tube agglutination test. A tube agglutination test shall be conducted with a suitable suspension of the vaccine bacteria using the constant antigen decreasing serum method with specific antiserum. Agglutination typical for the bacteria shall be demonstrated. Agglutination shall not occur with negative serum used as a control in this test.

(3) Slide agglutination test. The rapid plate (slide) agglutination test shall be conducted with suitable suspensions of the vaccine bacteria using the hanging drop, slide or plate method, with specific antiserum. Agglutination typical for the bacteria shall be demonstrated by microscopic or macroscopic observation. Agglutination shall not occur with negative serum used as a control in this test.

(4) Characterization tests. Applicable biochemical and cultural characteristics shall be demonstrated as specified in the filed Outline of Production.

(d) Ingredient requirements. Ingredients used for the growth and preparation of Master Seed Bacteria and of live bacterial vaccine shall meet the requirements provided in § 113.50. Ingredients of animal origin shall meet the applicable requirements provided in § 113.53.

(e) Moisture content. The maximum percent moisture in desiccated vaccines shall be stated in the filed Outline of Production and shall be established by the licensee as follows:

(1) Prelicensing. Data obtained by conducting accelerated stability tests and bacterial counts shall be acceptable on a temporary basis.

(2) Licensed products. Data shall be obtained by determining the percent moisture and bacterial count at release and expiration on a minimum of 10 consecutive released serials.

(3) Final container samples of completed product from each serial and subserial must be tested for moisture content in accordance with the test provided in § 113.29.

[48 FR 33476, July 22, 1983, as amended at 54 FR 19352, May 5, 1989; 56 FR 66784, Dec. 26, 1991; 68 FR 57608, Oct. 6, 2003]

§ 113.65 Brucella Abortus Vaccine.

Brucella Abortus Vaccine shall be prepared as a desiccated live culture bacterial vaccine from smooth colonial forms of the Brucella abortus organism, identified as Strain 19. Each serial and subserial shall be tested for purity, potency, and moisture content. A serial or subserial found unsatisfactory by a prescribed test shall not be released.

(a) Purity tests. Each serial and subserial shall be tested for purity as provided in this paragraph.

(1) Macroscopic and microscopic examination shall be made on bulk samples from production containers. If organisms not typical of Brucella abortus organisms are evident, the serial or subserial is unsatisfactory.

(2) Two final container vials of completed product shall be tested by inoculating one tube of Dextrose Andrades broth with gas tube and one tube of thioglycollate broth from each vial. The inoculated media shall be incubated at 35 to 37 °C for 96 hours. If growth not typical of Brucella abortus organisms is evident, the serial or subserial is unsatisfactory.

(3) Bacterial dissociation test. Final container samples of completed product from each serial and subserial shall be tested for bacterial dissociation. Smooth colonies are the desired form. Rough colonies are undesirable terminal dissociation forms. Intermediate and intermediate-to-rough are also undesirable.

(i) The sample container shall be rehydrated and streaked on one potato agar plate in such a manner as to produce confluent colonies. Artificial reflected light shall be used so that the rays pass through the plate at a 45 °angle.

(ii) If the vaccine contains more than 5 percent rough colonies or more than 15 percent total undesirable colonies, the serial or subserial is unsatisfactory. If organisms or growth not characteristic of Brucella abortus are found, the serial or subserial is unsatisfactory. The test may be repeated one time using double the number of samples: Provided, That, if the test is not repeated, the serial or subserial is unsatisfactory.

(b) Bacterial count requirements for reduced dose vaccine. Each serial and each subserial shall be tested for potency.

(1) Two final container vials of completed product shall be tested for the number of viable organisms per dose of rehydrated vaccine. A bacterial count per vial shall be made on tryptose agar plates from suitable dilutions using 1 percent peptone as a diluent. The inoculated media shall be incubated at 35 to 37 °C for 96 hours.

(2) If the average count of the two final container samples of freshly prepared vaccine contains less than 3.0 or more than 10.0 billion organisms per dose, the serial or subserial is unsatisfactory.

(3) If the average count on the initial test is less than the minimum or greater than the maximum required in paragraph (b)(2) of this section, the serial or subserial may be retested one time using four additional final container vials. The average count of the retest is determined. If the average count of the four vials retested is less than the required minimum or greater than the required maximum, the serial or subserial is unsatisfactory. If the average count of the four vials retested is within the required limits described in paragraph (b)(2) of this section, the following shall apply:

(i) If the average count obtained in the initial test is less than one-third or more than three times the average count obtained on the retest, the average count of the initial test shall be considered the result of test system error and the serial or subserial is satisfactory.

(ii) If the average count obtained in the initial test is one-third or more than the average retest count or three times or less than the average retest count, a new average count shall be determined from the counts of all six vials. If the new average is less than the minimum or greater than the maximum required in paragraph (b)(2) of this section, the serial or subserial is unsatisfactory.

(4) If tested at any time within the expiration period, each dose of rehydrated vaccine must contain at least 3.0 billion viable organisms per dose.

(c) Bacterial count requirements for standard vaccine. Each serial and subserial shall be tested for potency.

(1) Two final container samples shall be tested for the number of viable organisms per milliliter of rehydrated vaccine. One bacterial count per vial shall be made on tryptose agar plates from suitable dilutions using 1 percent peptone as a diluent. The inoculated media shall be incubated at 35 to 37 °C for 96 hours.

(2) If the average count of the two final container samples of freshly prepared vaccine does not contain at least 10 billion viable organisms per milliliter, the serial or subserial is unsatisfactory.

(3) If the initial bacterial count is less than 10 billion organisms per milliliter, the serial or subserial may be retested one time using four samples. If the average count of the four vials retested is less than the required minimum, the serial or subserial is unsatisfactory.

(4) If tested at any time within the expiration period, each milliliter of rehydrated vaccine does not contain at least 5 billion viable organisms per milliliter, the serial or subserial is unsatisfactory.

[39 FR 16857, May 10, 1974. Redesignated at 39 FR 25463, July 11, 1974, and amended at 40 FR 758, Jan. 3, 1975; 50 FR 23794, Jan. 6, 1985]

§ 113.66 Anthrax Spore Vaccine—Nonencapsulated.

Anthrax Spore Vaccine—Nonencapsulated shall be a live spore suspension prepared from nonencapsulated variants of Bacillus anthracis. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed.

(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.64 and the requirements in this section.

(b) Each lot of Master Seed shall be tested for immunogenicity as follows:

(1) Forty-two susceptible guinea pigs from the same source each weighing 400 to 500 grams, shall be used as test animals (30 vaccinates and 12 controls).

(2) An arithmetic mean spore count of vaccine produced from the highest passage of the Master Seed shall be established before the immunogenicity test is conducted. The guinea pigs used as vaccinates shall be injected as recommended on the label with a predetermined number of vaccine spores. To confirm the dosage, five replicate spore counts shall be conducted on a sample of the vaccine dilution used.

(3) Fourteen to fifteen days postvaccination the vaccinates and controls shall each be challenged with not less than 4,500 guinea pig LD50 of a virulent suspension of Bacillus anthracis furnished or approved by Animal and Plant Health Inspection Service and observed for 10 days.

(4) If at least 10 of the 12 controls do not die from Bacillus anthracis within the 10-day postchallenge observation period the test is invalid and may be repeated.

(5) If at least 27 of 30 of the vaccinates do not survive the 10-day postchallenge observation period, the Master Seed is unsatisfactory.

(6) An Outline of Production change shall be made before authority for use of a new lot of Master Seed shall be granted by Animal and Plant Health Inspection Service.

(c) Test Requirements for Release. Each serial and subserial shall meet the applicable general requirements prescribed in 9 CFR 113.64 and the requirements in this paragraph. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.

(1) Safety test. Samples of completed product from each serial or first subserial shall be tested for safety in sheep or goats by the methods described in 9 CFR 113.45(a).

(2) Spore Count Requirements. Final container samples of completed product shall be tested for spore count. Samples shall be diluted in tenfold steps. Each dilution expected to yield 30 to 300 colonies per plate shall be plated in triplicate on tryptose agar, inverted, and incubated at 35 to 70 °C for 24 hours to 28 hours. Each plate having uniformly distributed colonies shall be counted and an average count determined. To be eligible for release, each serial and each subserial shall have a spore count sufficiently greater than that of the vaccine used in the immunogenicity test to assure that when tested at any time within the expiration period, each serial and subserial shall have a spore count of at least twice that used in the immunogenicity test but not less than 2,000,000 spores per dose.

[50 FR 23794, June 6, 1985, as amended at 56 FR 66784, Dec. 26, 1991; 72 FR 72564, Dec. 21, 2007]

§ 113.67 Erysipelothrix Rhusiopathiae Vaccine.

Erysipelothrix Rhusiopathiae Vaccine shall be prepared as a desiccated live culture of an avirulent or modified strain of Erysipelothrix rhusiopathiae. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for vaccine production.

(a) The Master Seed shall meet the applicable requirements prescribed in § 113.64 and the requirements in this section.

(b) Each lot of Master Seed used for vaccine production shall be tested for immunogenicity. The selected bacterial count from the lot of Master Seed shall be established as follows:

(1) Thirty Erysipelothrix rhusiopathiae susceptible swine shall be used as test animals (20 vaccinates and 10 controls) for each route of administration recommended on the label.

(2) An arithmetic mean count of the colony forming units from vaccine produced from the highest passage of the Master Seed shall be established before the immunogenicity test is conducted. The 20 swine to be used as vaccinates shall be injected as recommended on the label with a predetermined quantity of vaccine bacteria. The 10 control swine shall be held separately from the vaccinates. To confirm the dosage calculation, an arithmetic mean count shall be established by conducting five replicate titrations on a sample of the bacterial vaccine dilution used. Only plates containing between 30 and 300 colonies shall be considered in a valid test.

(3) The vaccinates and controls shall be examined and their average body temperature determined prior to challenge. Fourteen to twenty-one days postvaccination, the vaccinates and controls shall be challenged with a virulent Erysipelothrix rhusiopathiae culture and observed for 7 days. The challenge culture and instructions for preparation and use shall be obtained from Animal and Plant Health Inspection Service.

(4) A satisfactory challenge shall be evidenced in the controls by a high body temperature or clinical signs including, but not limited to acute illness with hyperemia of the abdomen and ears, possibly terminating in sudden death; moribundity, with or without metastatic skin lesions; depression with anorexia, stiffness, and/or joint involvement; or any combination of these symptoms and lesions.

(5) If at least 80 percent of the controls do not show characteristic signs during the observation period including, but not limited to a body temperature of 105.6 °F or higher on at least 2 consecutive days, the test shall be considered a No Test: Provided, That control pigs which meet the criteria requirements for susceptibility except for high body temperature shall be considered susceptible if sacrificed and organisms identified as Erysipelothrix rhusiopathiae can be isolated from the blood, spleen, or other organs.

(6) To demonstrate immunity after challenge, the vaccinates shall remain free of clinical signs and the body temperature shall not exceed 104.6 °F on 2 or more consecutive days. If at least 90 percent of the vaccinates do not remain free from clinical signs and high body temperature throughout the observation period, the Master Seed is unsatisfactory.

(7) An Outline of Production change shall be made before authority for use of a new Master Seed shall be granted by Animal and Plant Health Inspection Service.

(c) Test requirements for release. Each serial and subserial shall meet the applicable requirements in § 113.64 and the requirements in this paragraph. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.

(1) Safety test. Samples of completed product from each serial or first subserial shall be tested for safety in young adult mice as prescribed in § 113.33(b) and in swine as prescribed in § 113.44.

(2) Bacterial count requirements. Final container samples of completed product from each serial and each subserial shall be tested for bacterial count using the method used in paragraph (b)(2) of this section. Two replicate titrations shall be conducted on each sample. To be eligible for release, each serial and subserial shall have a bacterial count sufficiently greater than that of the vaccine used in the immunogenicity test to assure that, when tested at any time within the expiration period, each serial and subserial shall have a bacterial count two times greater than that used in such immunogenicity test.

[50 FR 23795, June 6, 1985, as amended at 56 FR 66784, Dec. 26, 1991; 72 FR 72564, Dec. 21, 2007]

§ 113.68 Pasteurella Haemolytica Vaccine, Bovine.

Pasteurella Haemolytica Vaccine, Bovine, shall be prepared as a desiccated live culture bacterial vaccine of an avirulent or modified strain of Pasteurella haemolytica, identified as serotype 1. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed.

(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.64 and the requirements in this section.

(b) Each lot of Master Seed used for vaccine production shall be tested for immunogenicity. The immunogenicity of a selected bacterial count from the lot of Master Seed shall be established as follows:

(1) Fifteen Pasteurella haemolytica susceptible calves shall be used as test animals (10 vaccinates and 5 controls) for each route of administration recommended on the label.

(2) An arithmetic mean count of the colony forming units from vaccine produced from the highest passage of the Master Seed shall be established before the immunogenicity test is conducted. The 10 calves to be used as vaccinates shall be injected as recommended on the label with a predetermined quantity of vaccine bacteria. The five control calves shall be held separately from the vaccinates. To confirm the dosage calculation, five replicate titrations on a sample of the bacterial vaccine used. Only plates containing between 30 and 300 colonies shall be considered a valid test.

(3) The vaccinates and controls shall be examined and their average body temperature determined prior to challenge. Fourteen to twenty-one days post vaccination, the vaccinates and controls shall each be challenged by the respiratory route with a (virulent) pneumonia producing Pasteurella haemolytica culture and observed for 4 to 7 days. The challenge culture and instructions for preparation for use shall be furnished or approved by the Animal and Plant Health Inspection Service.

(4) A satisfactory challenge shall be evidenced in the controls by progression of clinical signs consistent with respiratory system infection following challenge, including but not limited to lacrimation, mucoid nasal exudates, expiratory dyspnea, tachypnea, pulmonary rales, and cough possibly terminating in death; moribundity, depression with anorexia, diarrhea with substantial weight loss; or any combination of these symptoms.

(5) Lung lesion response to challenge will be assessed in all calves. Lung lesions will be assessed at necropsy in calves that succumb to challenge. Surviving calves will be euthanized on day 4 to 7 following challenge and lung lesions assessed at necropsy. Lung lesion scores will be used in the assessment of the response to challenge exposure. If a significant difference in lung lesion scores cannot be demonstrated between vaccinates and controls using a scoring system approved by the Animal and Plant Health Inspection Service, the Master Seed is unsatisfactory.

(6) An Outline of Production change must be made before authority for use of a new lot of Master Seed is granted by the Animal and Plant Health Inspection Service.

(c) Test requirements for release. Each serial and subserial shall meet the applicable general requirements prescribed in §§ 113.8 and 113.64 and the requirements in this paragraph. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.

(1) Safety test. Samples of completed product from each serial or first subserial shall be tested for safety in calves as provided in §§ 113.41(a) and 113.41(b) except, that the equivalent of two doses of vaccine shall be used and administered in the manner recommended on the label.

(2) Bacterial count requirements. Final container samples of completed product shall be tested for bacterial count using the method used in paragraph (b)(2) of this section. Two replicate titrations shall be conducted on each serial and subserial. Each sample shall be rehydrated with accompanying sterile diluent to the volume indicated on the label. To be eligible for release, each serial and subserial shall have a bacterial count sufficiently greater than that of the vaccine used in the immunogenicity test to assure that, when tested at any time within the expiration period, each serial and subserial shall have a bacterial count at least two times greater than that used in the immunogenicity test.

[55 FR 35559, Aug. 31, 1990, as amended at 72 FR 72564, Dec. 21, 2007]

§ 113.69 Pasteurella Multocida Vaccine, Bovine.

Pasteurella Multocida Vaccine, Bovine, shall be prepared as a desiccated live culture bacterial vaccine of an avirulent or modified strain of Pasteurella multocida, of bovine origin. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed.

(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.64 and the requirements in this section.

(b) Each lot of Master Seed used for vaccine production shall be tested for immunogenicity. The immunogenicity of a selected bacterial count from the lot of Master Seed shall be established as follows:

(1) Fifteen Pasteurella multocida susceptible calves shall be used as test animals (10 vaccinates and 5 controls) for each route of administration recommended on the label.

(2) An arithmetic mean count of the colony forming units from vaccine produced from the highest passage of the Master Seed shall be established before the immunogenicity test is conducted. The 10 calves to be used as vaccinates shall be injected as recommended on the label with a predetermined quantity of vaccine bacteria. The five control calves shall be held separately from the vaccinates. To confirm the dosage calculation, arithmetic mean count shall be established by conducting five replicate titrations on a sample of the bacterial vaccine used. Only plates containing between 30 and 300 colonies shall be considered a valid test.

(3) The vaccinates and controls shall be examined and their average body temperature determined prior to challenge. Fourteen to twenty-one days post vaccination, the vaccinates and controls shall each be challenged by the respiratory route with a (virulent) pneumonia producing Pasteurella multocida culture and observed for 4 to 10 days. The challenge culture and instructions for preparation for use shall be furnished or approved by the Animal and Plant Health Inspection Service.

(4) A satisfactory challenge shall be evidenced in the controls by progression of clinical signs consistent with respiratory system infection following challenge, including but not limited to acute illness with higher body temperature and respiration rate, lacrimation, mucoid nasal exudate, expiratory dyspnea, tachypnea, pulmonary rales, and cough, possibly terminating in death; moribundity, depression with anorexia; diarrhea with substantial weight loss; or any combination of these symptoms.

(5) Lung lesion response to challenge will be assessed in all calves. Lung lesions will be assessed at necropsy in calves that succumb to challenge. Surviving calves will be euthanized on day 4 to 10 following challenge and lung lesions assessed at necropsy. Lung lesion scores will be used in the assessment of the response to challenge exposure. If a significant difference in lung lesion scores cannot be demonstrated between vaccinates and controls using a scoring system approved by the Animal and Plant Health Inspection Service, the Master Seed is unsatisfactory.

(6) An Outline of Production change must be made before authority for use of a new lot of Master Seed is granted by the Animal and Plant Health Inspection Service.

(c) Test requirements for release. Each serial and subserial shall meet the applicable general requirements prescribed in §§ 113.8 and 113.64 and the requirements in this paragraph. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.

(1) Safety Test. Samples of completed product from each serial or first subserial shall be tested for safety in calves as provided in §§ 113.41(a) and 113.41(b), except that the equivalent of two doses of vaccine shall be used and administered in the manner recommended on the label.

(2) Bacterial count requirements. Final container samples of completed product shall be tested for bacterial count using the method used in paragraph (b)(2) of this section. Two replicate titrations shall be conducted on each serial and subserial. Each sample shall be rehydrated with accompanying sterile diluent to the volume indicated on the label. To be eligible for release, each serial and subserial shall have a bacterial count sufficiently greater than that of the vaccine used in the immunogenicity test count per dose established to assure that, when tested at any time within the expiration period, each serial and subserial shall have a bacterial count at least two times greater than that used in the immunogenicity test.

[55 FR 35560, Aug. 31, 1990, as amended at 72 FR 72564, Dec. 21, 2007]

§ 113.70 Pasteurella Multocida Vaccine, Avian Isolate.

Pasteurella Multocida Vaccine, Avian Isolate, shall be prepared as a desiccated live culture of an avirulent or modified strain of Pasteurella multocida. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for vaccine production.

(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.64 and the requirements in this section.

(b) Each lot of Master Seed used for vaccine production shall be tested for immunogenicity in each species and for each serotype for which the Master Seed is claimed to give protection.

(1) Thirty Pasteurella multocida susceptible birds shall be used as test animals (20 vaccinates and 10 controls) for each bird species, route of administration, and serotype for which protection is claimed on the label.

(2) An arithmetic mean count of colony forming units from vaccine produced from the highest passage of Master Seed shall be established before the immunogenicity test is conducted. The 20 birds to be used as vaccinates shall be inoculated, as recommended on the label with a predetermined quantity of vaccine bacteria. The 10 control birds shall be held separately from the vaccinates. To confirm the dosage calculation, an arithmetic mean count shall be established by conducting five replicate titrations on a sample of the bacterial vaccine used. Only plates containing between 30 and 300 colonies shall be considered in a valid test.

(3) Not less than 14 days after vaccination, each of 20 vaccinates and each of 10 unvaccinated controls shall be challenged intramuscularly or by other methods acceptable to the Animal and Plant Health Inspection Service with a virulent Pasteurella multocida strain, for which protection is claimed, and observed daily for a 14 day post-challenge period.

(4) Eight or more of the unvaccinated controls must die for the test to be valid. If at least 16 of 20 of the vaccinates do not survive the 14-day postchallenge period, the Master Seed is unsatisfactory at the selected bacterial count.

(c) Test requirements for release. Each serial and subserial shall meet the applicable requirements in §§ 113.8 and 113.64 and the requirements in this paragraph. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.

(1) Safety test. Samples of completed product from each serial or first subserial shall be tested for safety.

(i) Ten birds of a species for which the vaccine is recommended shall be given the equivalent of 10 doses each of the vaccine and observed for 10 days. If the vaccine is recommended for more than one species, only one species needs to be tested.

(ii) If unfavorable reactions attributable to the vaccine occur during the observation period in two or more of the test birds, the serial is unsatisfactory.

(iii) If unfavorable reactions occur which are not attributable to the test vaccine, the test is a No Test and may be repeated. If the results of the next test are not satisfactory, or if the test is not repeated, the serial shall be considered unsatisfactory.

(2) Bacterial count requirements. Final container samples of completed product shall be tested for bacterial count using the method used in paragraph (b)(2) of this section. Two replicate titrations shall be conducted on each serial and subserial. Each sample shall be rehydrated with accompanying sterile diluent to the volume indicated on the label. To be eligible for release, each serial and subserial shall have a bacterial count sufficiently greater than that of the vaccine used in the immunogenicity test count per dose established to assure that, when tested at any time within the expiration period, each serial and subserial shall have a bacterial count at least two times greater than that used in the immunogenicity test.

[55 FR 35560, Aug. 31, 1990, as amended at 59 FR 19633, Apr. 25, 1994; 64 FR 43044, Aug. 9, 1999; 72 FR 72564, Dec. 21, 2007]

§ 113.71 Chlamydia Psittaci Vaccine (Feline Pneumonitis), Live Chlamydia.

Chlamydia Psittaci Vaccine (Feline Pneumonitis), Live Chlamydia, shall be prepared from chlamydia-bearing cell culture fluids or embryonated chicken eggs. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed.

(a) The Master Seed shall meet the applicable requirements prescribed in § 113.300 and the requirements in this section. Master Seed propagated in chicken embryos shall be tested for pathogens by the chicken embryo test prescribed in § 113.37. If found unsatisfactory by any prescribed test, the Master Seed shall not be used.

(b) Each lot of Master Seed used for vaccine production shall be tested for immunogenicity. The immunogenicity of a selected dose from the lot of Master Seed shall be established as follows:

(1) Thirty feline pneumonitis susceptible cats shall be used as test animals (20 vaccinates and 10 controls). Blood samples shall be drawn and individual serum samples tested. The cats shall be considered suitable for use if all serums are negative for pneumonitis antibody in a complement fixation test or other test of equal sensitivity.

(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed shall be established before the immunogenicity test is conducted. The 20 cats used as vaccinates shall be administered a predetermined quantity of vaccine by the method to be recommended on the label and the remaining 10 cats shall be held as controls. To confirm the dosage calculations, five replicate titrations shall be conducted on a sample of the vaccine dilution used. If two doses are used, five replicate confirming titrations shall be conducted on each dose.

(3) Fourteen or more days after the final dose of vaccine, the vaccinates and controls shall each be challenged intranasally with a minimum of 10,000 yolk sac LD50 of virulent feline pneumonitis furnished or approved by the Animal and Plant Health Inspection Service and observed each day for 28 days postchallenge. The rectal temperature of each animal shall be taken and the presence or absence of clinical signs noted and recorded each day.

(i) If less than 8 of 10 controls show clinical signs of feline pneumonitis infection other than fever, the test is a No Test and may be repeated.

(ii) If a significant difference in clinical signs other than fever or chlamydia shedding cannot be demonstrated between vaccinates and controls using a scoring system approved by the Animal and Plant Health Inspection Service, the Master Seed is unsatisfactory.

(4) An Outline of Production change must be made before authority for use of a new lot of Master Seed is granted by the Animal and Plant Health Inspection Service.

(c) Test requirements for release: Except for § 113.300(a)(3)(ii), each serial and subserial shall meet the requirements prescribed in § 113.300 and in this paragraph. Final container samples of completed product shall be tested. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.

(1) The test for pathogens prescribed in § 113.37 shall be conducted on each serial or one subserial of avian origin vaccine.

(2) Chlamydia titer requirements. Final container samples of completed product shall be tested for chlamydia titer using the titration method used in paragraph (b)(2) of this section. To be eligible for release, each serial and each subserial shall have a titer sufficiently greater than the titer of vaccine used in the immunogenicity test prescribed in paragraph (b) of this section to assure that when tested at any time within the expiration period, each serial and subserial shall have a titer 0.7 greater than that used in such immunogenicity test but not less than 2.5 ID50 per dose.

[55 FR 35561, Aug. 31, 1990, as amended at 56 FR 66786, Dec. 26, 1991; 72 FR 72564, Dec. 21, 2007]

§ 113.100 General requirements for inactivated bacterial products.

Unless otherwise prescribed in an applicable Standard Requirement or in the filed Outline of Production, an inactivated bacterial product shall meet the applicable requirements in this section.

(a) Purity tests. (1) Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.

(2) Each lot of Master Seed Bacteria shall be tested for the presence of extraneous viable bacteria and fungi in accordance with the test provided in § 113.27(d).

(b) Safety tests. Bulk or final container samples of completed product from each serial shall be tested for safety in young adult mice in accordance with the test provided in § 113.33(b) unless:

(1) The product contains material which is inherently lethal for mice. In such instances, the guinea pig safety test provided in § 113.38 shall be conducted in place of the mouse safety test.

(2) The product is recommended for poultry. In such instances, the product shall be safety tested in poultry as defined in the specific Standard Requirement or Outline of Production for the product.

(3) The product is recommended for fish, other aquatic species, or reptiles. In such instances, the product shall be safety tested in fish, other aquatic species, or reptiles as required by specific Standard Requirement or Outline of Production for the product.

(c) Identity test. Methods of identification of Master Seed Bacteria to the genus and species level by laboratory tests shall be sufficient to distinguish the bacteria from other similar bacteria according to criteria described in the most recent edition of “Bergey's Manual of Systematic Bacteriology” or the American Society for Microbiology “Manual of Clinical Microbiology”. If Master Seed Bacteria are referred to by serotype, serovar, subtype, pilus type, strain or other taxonomic subdivision below the species level, adequate testing must be used to identify the bacteria to that level. Tests which may be used to identify Master Seed Bacteria include, but are not limited to:

(1) Cultural characteristics,

(2) Staining reaction,

(3) Biochemical reactivity,

(4) Fluorescent antibody tests,

(5) Serologic tests,

(6) Toxin typing,

(7) Somatic or flagellar antigen characterization, and

(8) Restriction endonuclease analysis.

(d) Ingredient requirements. Ingredients used for the growth and preparation of Master Seed Bacteria and of final product shall meet the requirements provided in § 113.50. Ingredients of animal origin shall meet the applicable requirements provided in § 113.53.

(e) Only serials tested for viricidal activity in accordance with the test provided in § 113.35 and found satisfactory by such test shall be packaged as diluent for desiccated fractions in combination packages.

(f) If formaldehyde is used as the inactivating agent, and the serial has not been found satisfactory by the viricidal activity test, bulk or final container samples of completed product from each serial must be tested for residual free formaldehyde content using the ferric chloride test. 1 Firms currently using tests for residual free formaldehyde content other than the ferric chloride test have until July 14, 2004 to update their Outline of Production to be in compliance with this requirement.

1 The procedures for performing the ferric chloride test for residual free formaldehyde may be obtained from USDA, APHIS, Center for Veterinary Biologics-Laboratory, 1800 Dayton Road, P.O. Box 844, Ames, IA 50010.

(1) The residual free formaldehyde content of biological products containing clostridial antigens must not exceed 1.85 grams per liter (g/L).

(2) The residual free formaldehyde content of bacterins, bacterin-toxoids, and toxoids, other than those containing clostridial antigens, must not exceed 0.74 grams per liter (g/L).

[39 FR 16862, May 10, 1974. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 60 FR 14355, Mar. 17, 1995; 68 FR 35283, June 13, 2003; 79 FR 31021, May 30, 2014]

§ 113.101 Leptospira Pomona Bacterin.

Leptospira Pomona Bacterin shall be produced from a culture of Leptospira pomona which has been inactivated and is nontoxic. Each serial of biological product containing Leptospira pomona fraction shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.

(a) Purity test. Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.

(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.38.

(c) Potency test. Bulk or final container samples of completed product shall be diluted with physiological saline so that each 0.25 ml contains not more than 1/800th of the dose recommended on the label and shall be tested for potency, using the two-stage test provided in this paragraph.

(1) Vaccinates. Inject each of at least 10 but not more than 12 young adult hamsters, each weighing 50 to 90 grams, with 0.25 ml of the diluted bacterin either subcutaneously or intramuscularly, in accordance with the label recommendations for use.

(2) Controls. Retain at least 10 but not more than 12 additional hamsters from the same group as unvaccinated controls.

(3) Challenge. From 14 to 18 days postvaccination, challenge each of 10 vaccinates and each of 10 controls intraperitoneally with a suspension of virulent Leptospira pomona organisms, using a dose of 10-10,000 hamster LD50 as determined by titration.

(4) Post-challenge period. Observe the vaccinates and controls for 14 days post-challenge and record all deaths. If eight or more controls die of leptospirosis, the test is valid and the results shall be evaluated according to the following table:

Stage | Number of vaccinates | Cumulative number of vaccinates | Cumulative total dead hamsters for satisfactory serial | Cumulative total dead hamsters for unsatisfactory serial

1 | 10 | 10 | 2 or less | 5 or more.

2 | 10 | 20 | 5 or less | 6 or more.

(5) If three or four vaccinates die in the first stage, the second stage shall be conducted in a manner identical to the first stage.

(6) If the second stage is used, each serial shall be evaluated according to the second part of the table. On the basis of cumulative results, each serial shall either pass or fail.

[39 FR 16862, May 10, 1974, as amended at 40 FR 20067, May 8, 1975; 45 FR 40100, June 13, 1980. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66785, Dec. 26, 1991]

§ 113.102 Leptospira Icterohaemorrhagiae Bacterin.

Leptospira Icterohaemorrhagiae Bacterin shall be produced from a culture of Leptospira icterohaemorrhagiae which has been inactivated and is nontoxic. Each serial of biological product containing Leptospira icterohaemorrhagiae fraction shall meet the applicable requirements in § 113.100 and be tested for purity, safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.

(a) Purity test. Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.

(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.38.

(c) Potency test. Bulk or final container samples of completed product shall be diluted with physiological saline so that each 0.25 ml contains not more than 1/80th of the dose recommended on the label and shall be tested for potency, using the two-stage test provided in this paragraph.

(1) Vaccinates. Inject each of at least 10 but not more than 12 young adult hamsters, each weighing 50 to 90 grams, with 0.25 ml of the diluted bacterin either subcutaneously or intramuscularly, in accordance with the label recommendations for use.

(2) Controls. Retain at least 10 but not more than 12 additional hamsters from the same group as unvaccinated controls.

(3) Challenge. From 14 to 18 days postvaccination, challenge each of 10 vaccinates and each of 10 controls intraperitoneally with a suspension of virulent Leptospira icterohaemorrhagiae organisms, using a dose of 10-10,000 hamster LD50 as determined by titration.

(4) Post-challenge period. Observe the vaccinates and controls for 14 days post-challenge and record all deaths. If eight or more controls die from leptospirosis, the test is valid and the results shall be evaluated according to the following table:

Stage | Number of vaccinates | Cumulative number of vaccinates | Cumulative total dead hamsters for satisfactory serial | Cumulative total dead hamsters for unsatisfactory serial

1 | 10 | 10 | 2 or less | 5 or more.

2 | 10 | 20 | 5 or less | 6 or more.

(5) If three or four vaccinates die in the first stage, the second stage shall be used. The second stage shall be conducted in a manner identical to the first stage.

(6) If the second stage is used, each serial shall be evaluated according to the second part of the table. On the basis of cumulative results, each serial shall either pass or fail.

[39 FR 16862, May 10, 1974, as amended at 45 FR 40100, June 13, 1980. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66785, Dec. 26, 1991]

§ 113.103 Leptospira Canicola Bacterin.

Leptospira Canicola Bacterin shall be produced from a culture of Leptospira canicola which has been inactivated and is nontoxic. Each serial of biological product containing Leptospira canicola fraction shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. Serials found unsatisfactory by any prescribed test shall not be released.

(a) Purity test. Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.

(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.38.

(c) Potency test. Bulk or final container samples of completed product shall be diluted with physiological saline so that each 0.25 ml contains not more than 1/80th of the dose recommended on the label and shall be tested for potency, using the two-stage test provided in this paragraph.

(1) Vaccinates. Inject each of at least 10 but not more than 12 young adult hamsters, each weighing 50 to 90 grams, with 0.25 ml of the diluted bacterin either subcutaneously or intramuscularly, in accordance with the label recommendations for use.

(2) Controls. Retain at least 10 but not more than 12 additional hamsters from the same group as unvaccinated controls.

(3) Challenge. From 14 to 18 days postvaccination, challenge each of 10 vaccinates and each of 10 controls intraperitoneally with a suspension of virulent Leptospira canicola organisms, using a dose of 10-10,000 hamster LD50 as determined by titration.

(4) Post-challenge period. Observe the vaccinates and controls for 14 days post-challenge and record all deaths. If eight or more controls die from leptospirosis, test is valid and the results shall be evaluated according to the following table:

Stage | Number of vaccinates | Cumulative number of vaccinates | Cumulative total dead hamsters for satisfactory serial | Cumulative total dead hamsters for unsatisfactory serial

1 | 10 | 10 | 2 or less | 5 or more.

2 | 10 | 20 | 5 or less | 6 or more.

(5) If three or four vaccinates die in the first stage, the second stage shall be used. The second stage shall be conducted in a manner identical to the first stage.

(6) If the second stage is used, each serial shall be evaluated according to the second part of the table. On the basis of cumulative results, each serial shall either pass or fail.

[39 FR 16862, May 10, 1974, as amended at 45 FR 40100, June 13, 1980. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66785, Dec. 26, 1991]

§ 113.104 Leptospira Grippotyphosa Bacterin.

Leptospira Grippotyphosa Bacterin shall be produced from a culture of Leptospira grippotyphosa which has been inactivated and is nontoxic. Each serial of biological product containing Leptospira grippotyphosa fraction shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.

(a) Purity test. Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.

(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.38.

(c) Potency test. Bulk or final container samples of completed product shall be diluted with physiological saline so that each 0.25 ml contains not more than 1/800th of the dose recommended on the label and shall be tested for potency, using the two-stage test provided in this paragraph.

(1) Vaccinates. Inject each of at least 10 but not more than 12 young adult hamsters, each weighing 50 to 90 grams, with 0.25 ml of the diluted bacterin either subcutaneously or intramuscularly, in accordance with the label recommendations for use.

(2) Controls. Retain at least 10 but not more than 12 additional hamsters from the same group as unvaccinated controls.

(3) Challenge. From 14 to 18 days postvaccination, challenge each of 10 vaccinates and each of 10 controls intraperitoneally with a suspension of virulent Leptospira grippotyphosa organisms, using a dose of 10-10,000 hamster LD50 as determined by titration.

(4) Post-challenge period. Observe the vaccinates and controls for 14 days post-challenge and record all deaths. If eight or more controls die of leptospirosis, the test is valid and the results shall be evaluated according to the following table:

Cumulative Totals

Stage | Number of vaccinates | Dead hamsters for acceptance | Dead hamsters for rejection

1 | 10 | 2 or less | 5 or more.

2 | 20 | 5 or less | 6 or more.

(5) If three or four vaccinates die in the first stage, the second stage shall be conducted in a manner identical to the first stage.

(6) If the second stage is used, each serial shall be evaluated according to the second part of the table. On the basis of cumulative results, each serial shall either pass or fail.

[40 FR 17003, Apr. 16, 1975, as amended at 40 FR 23989, June 4, 1975; 45 FR 40100, June 13, 1980. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66785, Dec. 26, 1991]

§ 113.105 Leptospira Hardjo Bacterin.

Leptospira Hardjo Bacterin shall be produced from a culture of Leptospira hardjo which has been inactivated and is nontoxic. Each serial of biological product containing Leptospira hardjo fraction shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.

(a) Purity test. Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.

(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.38.

(c) Potency test. Bulk or final container samples of completed product from each serial shall be tested for potency using the test written into the filed Outline of Production.

[40 FR 17003, Apr. 16, 1975, as amended at 40 FR 20067, May 8, 1975. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66785, Dec. 26, 1991]

§ 113.106 Clostridium Chauvoei Bacterin.

Clostridium Chauvoei Bacterin shall be produced from a culture of Clostridium chauvoei which has been inactivated and is nontoxic. Each serial of biological product containing Clostridium chauvoei fraction shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. Serials found unsatisfactory by any prescribed test shall not be released.

(a) Purity test. Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.

(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.38.

(c) Potency test. Bulk or final container samples of completed product from each serial shall be tested for potency using the two-stage test provided in this paragraph.

(1) Each of at least 8 but not more than 10 guinea pigs, each weighing 300 to 500 grams, shall be injected subcutaneously with a guinea pig dose. A second guinea pig dose shall be injected 21 to 23 days after the first dose. Each guinea pig dose shall be one-fifth of the dose recommended on the label for a calf.

(2) Clostridium chauvoei challenge material, available upon request from Animal and Plant Health Inspection Service, shall be used for challenge 14 to 15 days following the last injection of the product. Each of eight vaccinates and each of five additional nonvaccinated guinea pigs for controls shall be injected intramuscularly with approximately 100 LD50 of challenge material. This dose shall be determined by statistical analysis of results of titrations of the challenge material. The vaccinates and controls shall be observed for 3 days postchallenge and all deaths recorded.

(3) For a valid test, at least 80 percent of the controls shall die within the 3 day post-challenge observation period. If this requirement is met, the results of the potency test shall be evaluated according to the following table:

Stage | Number of vaccinates | Cumulative number of vaccinates | Cumulative total number of deaths for a satisfactory test | Cumulative total number of deaths for an unsatisfactory test

1 | 8 | 8 | 1 or less | 3 or more.

2 | 8 | 16 | 4 or less | 5 or more.

The second stage shall be required only when exactly two animals die in the first stage. The second stage shall be conducted in a manner identical to the first stage.

[39 FR 16862, May 10, 1974, as amended at 45 FR 40100, June 13, 1980. Redesignated at 55 FR 35562, Aug. 31, 1990 and amended at 56 FR 66784, 66785, Dec. 26, 1991]

§ 113.107 Clostridium Haemolyticum Bacterin.

Clostridium Haemolyticum Bacterin shall be produced from a culture of Clostridium haemolyticum which has been inactivated and is nontoxic. Each serial of biological product containing Clostridium haemolyticum fraction shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.

(a) Purity test. Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.

(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.38.

(c) Potency test. Bulk or final container samples of completed product from each serial shall be tested for potency using the two-stage test provided in this paragraph.

(1) Each of at least 8 but not more than 10 guinea pigs, each weighing 300 to 500 grams, shall be injected subcutaneously with a guinea pig dose. A second guinea pig dose shall be injected 21 to 23 days after the first dose. Each guinea pig dose shall be one-fifth of the dose recommended on the label for a calf.

(2) Clostridium haemolyticum challenge material, available upon request from Animal and Plant Health Inspection Service, shall be used for challenge 14 to 15 days following the last injection of the product. Each of eight vaccinates and each of five additional nonvaccinated guinea pigs for controls shall be injected intramuscularly with approximately 100 LD50 of challenge material. This dose shall be determined by statistical analysis of results of titrations of the challenge material. The vaccinates and controls shall be observed for 3 days postchallenge and all deaths recorded.

(3) For a valid test, at least 80 percent of the controls shall die within the 3 day post-challenge observation period. If this requirement is met, the results of the potency test shall be evaluated according to the following table:

Stage | Number of vaccinates | Cumulative number of vaccinates | Cumulative total number of deaths for a satisfactory test | Cumulative total number of deaths for an unsatisfactory test

1 | 8 | 8 | 1 or less | 3 or more.

2 | 8 | 16 | 4 or less | 5 or more.

The second stage shall be required only when exactly two animals die in the first stage. The second stage shall be conducted in a manner identical to the first stage.

[39 FR 16862, May 10, 1974, as amended at 40 FR 20067, May 8, 1975; 45 FR 40100, June 13, 1980. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66784, 66785, Dec. 26, 1991]

§ 113.108 Clostridium Novyi Bacterin-Toxoid.

Clostridium Novyi Bacterin-Toxoid shall be produced from a culture of Clostridium novyi which has been inactivated and is nontoxic. Each serial of biological product containing Clostridium novyi fraction shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.

(a) Purity test. Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.

(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.38.

(c) Potency test. Bulk or final container samples of completed product from each serial shall be tested for potency using the Alpha toxin-neutralization test provided in this paragraph.

(1) When used in this test, the following words and terms shall mean:

(i) International antitoxin unit. (I.U.) That quantity of Alpha Antitoxin which reacts with Lo and L + doses of Standard Toxin according to their definitions.

(ii) Lo dose. The largest quantity of toxin which can be mixed with one unit of Standard Antitoxin and not cause sickness or death in injected mice.

(iii) L + dose. The smallest quantity of toxin which can be mixed with one unit of Standard Antitoxin and cause death in at least 80 percent of injected mice.

(iv) Standard antitoxin. The Alpha Antitoxin preparation which has been standardized as to antitoxin unitage on the basis of the International Clostridium novyi Alpha Antitoxin Standard and which is either supplied by or acceptable to the Animal and Plant Health Inspection Service. The antitoxin unit value shall be stated on the label.

(v) Standard toxin. The Alpha toxin preparation which is supplied by or is acceptable to the Animal and Plant Health Inspection Service.

(vi) Diluent. The solution used to make proper dilutions prescribed in this test. Such solutions shall be made by dissolving 1 gram of peptone and 0.25 gram of sodium chloride in each 100 ml of distilled water; adjusting the pH to 7.2; autoclaving at 121 °C for 25 minutes; and storing at 4 °C until used.

(2) Each of at least eight rabbits of a strain acceptable to the Animal and Plant Health Inspection Service, each weighing 4-8 pounds, shall be injected subcutaneously with not more than half of the recommended cattle dose. Provided, That, if the product is recommended only for sheep, half of the recommended sheep dose shall be used. A second dose shall be given not less than 20 days nor more than 23 days after the first dose.

(3) Fourteen to seventeen days after the second dose, all surviving rabbits shall be bled, and the serum tested for antitoxin content.

(i) At least seven rabbits are required to make an acceptable serum pool.

(ii) Equal quantities of serum from each rabbit shall be combined and tested as a single pooled serum.

(iii) If less than seven rabbits are available, the test is invalid and shall be repeated: Provided, That, if the test is not repeated, the serial shall be declared unsatisfactory.

(4) The antitoxin content of the rabbit serums shall be determined by the serum neutralization test as follows:

(i) Make a dilution of Standard Antitoxin to contain 0.1 International Unit of antitoxin per ml.

(ii) Make a dilution of Standard Toxin in which 0.1 Lo dose is contained in a volume of 1 ml or less. Make a second dilution of Standard Toxin in which 0.1 L + dose is contained in a volume of 1 ml or less.

(iii) Combine 0.1 International Unit of Standard Antitoxin with 0.1 Lo dose of diluted Standard Toxin and combine 0.1 International Unit of Standard Antitoxin with 0.1 L + dose of diluted Standard Toxin. Each mixture is adjusted to a final volume of 2.0 ml with diluent.

(iv) Combine 0.1 Lo dose of diluted Standard Toxin with a 0.2 ml volume of undiluted serum. The mixture is adjusted to a final volume of 2.0 ml with diluent.

(v) Neutralize all toxin-antitoxin mixtures at room temperature for 1 hour and hold in ice water until injections of mice can be made.

(vi) Five Swiss white mice, each weighing 16-20 grams, shall be used for each toxin-antitoxin mixture. A dose of 0.2 ml shall be injected intravenously into each mouse. Conclude the test 72 hours post injection and record all deaths.

(5) Test Interpretation shall be as follows:

(i) If any mice inoculated with the mixture of 0.1 International Unit of Standard Antitoxin and 0.1 Lo doses of Standard Toxin die, the results of the serum neutralization test are a No Test and shall be repeated: Provided, That, if the test is not repeated, the serial shall be declared unsatisfactory.

(ii) If less than 80 percent of the mice inoculated with the mixture of 0.1 International Unit of Standard Antitoxin and 0.1 L + doses of Standard Toxin die, the results of the serum neutralization test are a No Test and shall be repeated: Provided, That, if the test is not repeated, the serial shall be declared unsatisfactory.

(iii) If any mice inoculated with the mixture of 0.2 ml undiluted serum with 0.1 Lo dose of Standard Toxin die, the serum is considered to contain less than 0.50 International Units per ml.

(iv) If the single pooled serum from seven or more rabbits contains less than 0.5 International Unit per ml, the serial is unsatisfactory.

[39 FR 16862, May 10, 1974, as amended at 45 FR 40101, June 13, 1980. Redesignated at 55 FR 35562, Aug. 31, 1990; 56 FR 37825, Aug. 9, 1991, as amended at 56 FR 66784, 66785, Dec. 26, 1991]

§ 113.109 Clostridium Sordellii Bacterin-Toxoid.

Clostridium Sordellii Bacterin-Toxoid shall be produced from a culture of Clostridium sordellii which has been inactivated and is nontoxic. Each serial of biological product containing Clostridium sordellii fraction shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.

(a) Purity test. Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.

(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.38.

(c) Potency test. Bulk or final container samples of completed product from each serial shall be tested for potency using the toxin-neutralization test provided in this paragraph.

(1) When used in this test, the following words and terms shall mean:

(i) International antitoxin unit. (I.U.) That quantity of antitoxin which reacts with Lo and L + doses of Standard Toxin according to their definitions.

(ii) Lo dose. The largest quantity of toxin which can be mixed with one unit of Standard Antitoxin and not cause sickness or death in injected mice.

(iii) L + dose. The smallest quantity of toxin which can be mixed with one unit of Standard Antitoxin and cause death in at least 80 percent of injected mice.

(iv) Standard antitoxin. The antitoxin preparation which has been standardized as to antitoxin unitage on the basis of the International Clostridium sordellii Antitoxin Standard and which is either supplied by or acceptable to the Animal and Plant Health Inspection Service. The antitoxin unit value shall be stated on the label.

(v) Standard toxin. The toxin preparation which is supplied by or is acceptable to the Animal and Plant Health Inspection Service.

(vi) Diluent. The solution used to make proper dilutions prescribed in this test. Such solutions shall be made by dissolving 1 gram of peptone and 0.25 gram of sodium chloride in each 100 ml of distilled water; adjusting the pH to 7.2; autoclaving at 121 °C for 25 minutes; and storing at 4 °C until used.

(2) Each of at least eight rabbits of a strain acceptable to the Animal and Plant Health Inspection Service, each weighing 4-8 pounds, shall be injected subcutaneously with not more than half of the recommended cattle dose: Provided, That, if the product is recommended only for sheep, half of the recommended sheep dose shall be used. A second dose shall be given not less than 20 days nor more than 23 days after the first dose.

(3) Fourteen to seventeen days after the second dose, all surviving rabbits shall be bled, and the serum tested for antitoxin content.

(i) At least seven rabbits are required to make an acceptable serum pool.

(ii) Equal quantities of serum from each rabbit shall be combined and tested as a single pooled serum.

(iii) If less than seven rabbits are available, the test is a No Test and shall be repeated: Provided, That, if the test is not repeated, the serial shall be declared unsatisfactory.

(4) The antitoxin content of the rabbit serums shall be determined by the serum neutralization test as follows:

(i) Make a dilution of Standard Antitoxin to contain 1.0 international unit of antitoxin per ml.

(ii) Make a dilution of Standard Toxin in which 1.0 Lo dose is contained in a volume of 1 ml or less. Make a second dilution of Standard Toxin in which 1.0 L + dose is contained in a volume of 1 ml or less.

(iii) Combine 1.0 International Unit Standard Antitoxin with 1.0 Lo dose of diluted Standard Toxin and combine 1.0 International Unit of Standard Antitoxin with 1.0 L + dose of diluted Standard Toxin. Each mixture is adjusted to a final volume of 2.0 ml with diluent.

(iv) Combine 1.0 Lo dose of diluted Standard Toxin with a 1.0 ml volume of undiluted serum. This mixture is adjusted to a final volume of 2.0 ml with diluent.

(v) Neutralize all toxin-antitoxin mixtures at room temperature for 1 hour and hold in ice water until injections of mice can be made.

(vi) Five Swiss white mice, each weighing 16-20 grams, shall be used for each toxin-antitoxin mixture. A dose of 0.2 ml shall be injected intravenously into each mouse. Conclude the test 72 hours post injection and record all deaths.

(5) Test Interpretation shall be as follows:

(i) If any mice inoculated with the mixture of 1.0 International Unit of Standard Antitoxin and 1.0 Lo doses of Standard Toxin die, the results of the serum neutralization test are a No Test and shall be repeated: Provided, That, if the test is not repeated, the serial shall be declared unsatisfactory.

(ii) If less than 80 percent of the mice inoculated with the mixture of 1.0 International Unit of Standard Antitoxin and 1.0 L + doses of Standard Toxin die, the results of the serum neutralization test are a No Test and shall be repeated: Provided, That, if the test is not repeated, the serial shall be declared unsatisfactory.

(iii) If any mice inoculated with the mixture of 1.0 ml undiluted serum with 1.0 Lo dose of Standard Toxin die, the serum is considered to contain less than 1.0 International Units per ml.

(iv) If the single pooled serum from seven or more rabbits contains less than 1.0 International Unit per ml, the serial is unsatisfactory.

[39 FR 16862, May 10, 1974, as amended at 42 FR 61247, Dec. 2, 1977; 45 FR 40101, June 13, 1980. Redesignated at 55 FR 35562, Aug. 31, 1990; 56 FR 37826, Aug. 9, 1991; 56 FR 66784, 66785, Dec. 26, 1991; 79 FR 55969, Sept. 18, 2014]

§ 113.110 Clostridium Botulinum Type C Bacterin-Toxoid.

Clostridium Botulinum Type C Bacterin-Toxoid shall be produced from a culture of Clostridium botulinum Type C which has been inactivated and is nontoxic. Each serial of biological product containing Clostridium botulinum Type C fraction shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.

(a) Purity test. Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.

(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.33(b).

(c) Potency test. Bulk or final container samples of completed product from each serial shall be tested for potency, using susceptible mink as test animals. At least five vaccinates and three unvaccinated controls of the same source and approximately the same age shall be used.

(1) Each of the vaccinates shall be injected subcutaneously with the dose recommended on the label for mink. Twenty-one to twenty-eight days post-injection, the vaccinates and the controls shall be challenged intraperitoneally with botulinum Type C toxin which has been titrated in mice to provide for a 10 4.0 mouse MLD dose. The titration technique shall include inoculation of the mice intraperitoneally.

(2) The vaccinates and controls shall be observed for 7 days post-challenge and signs of botulism and deaths noted. For a valid test, the controls shall die of botulism. If the test is valid and 80 percent of the vaccinates do not remain free of botulism, the serial is unsatisfactory.

[39 FR 16862, May 10, 1974, as amended at 40 FR 759, Jan. 3, 1975. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66785, Dec. 26, 1991]

§ 113.111 Clostridium Perfringens Type C Toxoid and Bacterin-Toxoid.

Clostridium Perfringens Type C Toxoid and Clostridium Perfringens Type C Bacterin-Toxoid shall be produced from a culture of Clostridium perfringens Type C which has been inactivated and is nontoxic. Each serial shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. Any serial found unsatisfactory by a prescribed test shall not be released.

(a) Purity test. Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.

(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.33(b).

(c) Potency test. Bulk or final container samples of completed product from each serial shall be tested for potency using the Beta toxin-neutralization test provided in this paragraph.

(1) When used in this test, the following words and terms shall mean:

(i) International antitoxin unit. (I.U.) That quantity of Beta Antitoxin which reacts with L 0 and L + doses of Standard Toxin according to their definitions.

(ii) L 0 dose. The largest quantity of toxin which can be mixed with one unit of Standard Antitoxin and not cause sickness or death in injected mice.

(iii) L + dose. The smallest quantity of toxin which can be mixed with one unit of Standard Antitoxin and cause death in at least 80 percent of injected mice.

(iv) Standard antitoxin. The Beta Antitoxin preparation which has been standardized as to antitoxin unitage on the basis of the International Clostridium perfringens Beta Antitoxin Standard and which is either supplied by or acceptable to Animal and Plant Health Inspection Service. The antitoxin unit value shall be stated on the label.

(v) Standard toxin. The Beta toxin preparation which is supplied by or is acceptable to Animal and Plant Health Inspection Service.

(vi) Diluent. The solution used to make proper dilutions prescribed in this test. Such solutions shall be made by dissolving 1 gram of peptone and 0.25 grams of sodium chloride in each 100 ml of distilled water; adjusting the pH to 7.2; autoclaving at 250 °F for 25 minutes; and storing at 4 °C until used.

(2) Each of at least eight rabbits of a strain acceptable to APHIS, each weighing 4-8 pounds, shall be injected subcutaneously with not more than half of the largest recommended dose for any species indicated on the product label. A second equivalent dose shall be given not less than 20 days nor more than 23 days after the first does.

(3) Fourteen to seventeen days after the second dose, all surviving rabbits shall be bled and the serum tested for antitoxin content.

(i) At least seven rabbits are required to make an acceptable serum pool.

(ii) Equal quantities of serum from each rabbit shall be combined and tested as a single pooled serum.

(iii) If less than seven rabbits are available, the test is a No Test and shall be repeated: Provided, That, if the test is not repeated, the serial shall be declared unsatisfactory.

(4) The antitoxin content of the rabbit serums shall be determined as follows:

(i) Make a dilution of Standard Antitoxin to contain 10 International Units of antitoxin per ml.

(ii) Make one dilution of Standard Toxin to contain 10 L 0 doses per ml and make a second dilution of Standard Toxin to contain 10 L + doses per ml.

(iii) Combine 10 International Units of Standard Antitoxin with 10 L 0 doses of diluted Standard Toxin and combine 10 International Units of Standard Antitoxin with 10 L+ doses of diluted Standard Toxin.

(iv) Combine 1 ml of undiluted serum with 10 L0 doses of diluted Standard Toxin.

(v) Neutralize all toxin-antitoxin mixtures at room temperature for 1 hour and hold in ice water until injections of mice can be made.

(vi) Five Swiss white mice, each weighing 16-20 grams, shall be used for each toxin-antitoxin mixture. A dose of 0.2 ml shall be injected intravenously into each mouse. Conclude the test 24 hours post-injection and record all deaths.

(5) Test Interpretation shall be as follows:

(i) If any mice inoculated with the mixture of 10 International Units of Standard Antitoxin and 10 L0 doses of Standard Toxin die, the results of the test are a No Test and shall be repeated: Provided, That, if the test is not repeated, the serial shall be declared unsatisfactory.

(ii) If less than 80 percent of the mice inoculated with mixture of 10 International Units of Standard Antitoxin and 10 L+ doses of Standard Toxin die, the results of the test are a No Test and shall be repeated: Provided, That, if the test is not repeated, the serial shall be declared unsatisfactory.

(iii) If any mice inoculated with the mixture of serum with 10 L0 doses of Standard Toxin die, the serum is considered to contain less than 10 International Units per ml. and the serial is unsatisfactory

[39 FR 16862, May 10, 1974, as amended at 40 FR 759, Jan. 3, 1975; 40 FR 41088, Sept. 5, 1975. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66784, 66785, Dec. 26, 1991; 62 FR 31330, June 9, 1997; 79 FR 55969, Sept. 18, 2014]

§ 113.112 Clostridium Perfringens Type D Toxoid and Bacterin-Toxoid.

Clostridium Perfringens Type D Toxoid and Clostridium Perfringens Type D Bacterin-Toxoid shall be produced from a culture of Clostridium perfringens Type D which has been inactivated and is nontoxic. Each serial shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. Any serial found unsatisfactory by a prescribed test shall not be released.

(a) Purity test. Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.

(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.33(b).

(c) Potency test. Bulk or final container samples of completed product from each serial shall be tested for potency using the Epsilon toxin-neutralization test provided in this paragraph.

(1) When used in this test, the following words and terms shall mean:

(i) International antitoxin unit. (I.U.) That quantity of Epsilon Antitoxin which reacts with L0 and L+ doses of Standard Toxin according to their definitions.

(ii) L0 dose. The largest quantity of toxin which can be mixed with one-tenth unit of Standard Antitoxin and not cause sickness or death in injected mice.

(iii) L+ dose. The smallest quantity of toxin which can be mixed with one-tenth unit of Standard Antitoxin and cause death in at least 80 percent of injected mice.

(iv) Standard antitoxin. The Epsilon Antitoxin preparation which has been standardized as to antitoxin unitage on the basis of the International Clostridium perfringens Epsilon Antitoxin Standard and which is either supplied by or acceptable to Animal and Plant Health Inspection Service. The antitoxin unit value shall be stated on the label.

(v) Standard toxin. The Epsilon toxin preparation which is supplied by or is acceptable to Animal and Plant Health Inspection Service.

(vi) Diluent. The solution used to make proper dilutions prescribed in this test. Such solutions shall be made by dissolving 1 gram of peptone and 0.25 gram of sodium chloride in each 100 ml of distilled water; adjusting the pH to 7.2; autoclaving at 250 °F for 25 minutes; and storing at 4 °C until used.

(2) Each of at least eight rabbits of a strain acceptable to APHIS, each weighing 4-8 pounds, shall be injected subcutaneously with not more than half of the largest recommended dose for any species indicated on the product label. A second equivalent dose shall be given not less than 20 days nor more than 23 days after the first dose.

(3) Fourteen to seventeen days after the second dose, all surviving rabbits shall be bled, and the serum tested for antitoxin content.

(i) At least seven rabbits are required to make an acceptable serum pool.

(ii) Equal quantities of serum from each rabbit shall be combined and tested as a single pooled serum.

(iii) If less than seven rabbits are available, the test is a No Test and shall be repeated: Provided, That, if the test is not repeated, the serial shall be declared unsatisfactory.

(4) The antitoxin content of the rabbit serums shall be determined as follows:

(i) Make a dilution of Standard Antitoxin to contain 1 International Unit of antitoxin per ml.

(ii) Make one dilution of Standard Toxin to contain 10 Lo doses per ml and make a second dilution of Standard Toxin to contain 10 L+ doses per ml.

(iii) Combine 1 International Unit of Standard Antitoxin with 10 Lo doses of diluted Standard Toxin and Combine 1 International Unit of Standard Antitoxin with 10 L+ doses of diluted Standard Toxin.

(iv) Dilute 1 ml of serum with 1 ml of diluent (1:2) and combine 1 ml of this solution with 10 Lo doses of diluted Standard Toxin.

(v) Neutralize all toxin-antitoxin mixtures at room temperature for 1 hour and hold in ice water until injections of mice can be made.

(vi) Five Swiss white mice, each weighing 16-20 grams, shall be used for each toxin-antitoxin mixture. A dose of 0.2 ml shall be injected intravenously into each mouse. Conclude the test 24 hours post-injection and record all deaths.

(5) Test Interpretation shall be as follows:

(i) If any mice inoculated with the mixture of 1 International Unit of Standard Antitoxin and 10 Lo doses of Standard Toxin die, the results of the test are a No Test and shall be repeated: Provided, That, if the test is not repeated, the serial shall be declared unsatisfactory.

(ii) If less than 80 percent of the mice inoculated with mixture of 1 International Unit of Standard Antitoxin and 10 L+ doses of Standard Toxin die, the results of the test area No Test and shall be repeated: Provided, That, if the test is not repeated, the serial shall be declared unsatisfactory.

(iii) If any mice inoculated with the mixture of serum with 10 Lo doses of Standard Toxin die, the serum is considered to contain less than 2 International Units per ml, and the serial is unsatisfactory.

[39 FR 16865, May 10, 1974; 39 FR 20783, June 14, 1974. Redesignated at 39 FR 25463, July 11, 1974, and amended at 40 FR 759, Jan. 3, 1975; 40 FR 41088, Sept. 5, 1975. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66784, 66785, Dec. 26, 1991; 62 FR 31331, June 9, 1997; 79 FR 55969, Sept. 18, 2014]

§ 113.113 Autogenous biologics.

Autogenous biologics shall be prepared from cultures of microorganisms which have been inactivated and are nontoxic. Such products shall be prepared only for use by or under the direction of a veterinarian under a veterinarian-client-patient relationship, Provided, That, such products may be prepared for use under the direction of a person of appropriate expertise in specialized situations such as aquaculture, if approved by the Administrator.

Each serial of an autogenous biologic shall meet the requirements in this section, and if found unsatisfactory by any prescribed test shall not be used.

(a) Seed requirements. The microorganisms used as seed to prepare autogenous biologics shall be microorganisms which are isolated from sick or dead animals in the herd of origin and which there is reason to believe are the causative agent(s) of the current disease affecting such animals.

(1) More than one microorganism isolated from the same herd may be used as seed.

(2) Under normal circumstances, microorganisms from one herd must not be used to prepare an autogenous biologic for another herd. The Administrator, however, may authorize preparation of an autogenous biologic for use in herds adjacent to the herd of origin, when adjacent herds are considered to be at risk. To request authorization to prepare a product for use in herds adjacent to the herd of origin, the establishment seeking authorization must submit to the Administrator (in c/o the Director, Center for Veterinary Biologics, Inspection and Compliance, 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010) the following information. (If any of the data are unavailable, the applicant for authorization should indicate that such data are unavailable and why.)

(i) Name, address, and phone number of the owner of the herd of origin.

(ii) Attending veterinarian's name, address, and phone number.

(iii) Animal species and number in herd of origin.

(iv) Identification of microorganism(s), at least to genus.

(v) Diagnosis or clinical signs of the disease observed.

(vi) Name and address of the person who isolated the microorganism(s) and the date of isolation.

(vii) Number of doses of autogenous biologic requested and vaccination schedule.

(viii) Each adjacent herd owner's name, address, and phone number.

(ix) Number of animals and species in each adjacent herd.

(x) The attending veterinarian's or approved specialist's assessment of the involvement of the adjacent herd(s) with the disease observed.

The applicant shall give notice to the State Veterinarian or other appropriate State Official in writing when an autogenous biologic is to be used in adjacent herds.

(3) The Administrator may authorize preparation of an autogenous biologic for use in herds which are not adjacent to the herd of origin, but which he or she considers to be at risk of infection with the same microorganism(s). Except as provided below, the same information which is required for preparation of such product for use in herds adjacent to the herd of origin must be submitted to the Administrator (in c/o the Director, Center for Veterinary Biologics, Inspection and Compliance, 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010) for authorization to prepare a product for use in herds not adjacent to the herd of origin. Because the recipient herd involved may not be known when autogenous biologics are to be used in other geographic areas, the following data may be used in place of the data required in paragraphs (a)(2)(viii) and (a)(2)(ix) of this section.

(i) Names and addresses of practitioners in the area in place of the name, address, and phone number of the adjacent herd owner.

(ii) The geographic designations of the area involved.

(iii) A summary of the epidemiology of the disease situation that links the designated geographic areas with the herd of origin.

In addition, an applicant for authorization under this paragraph (a)(3) shall provide written approval from the State Veterinarian or other appropriate State Official in the State in which the autogenous biologic is to be used in nonadjacent herds.

(4) Under normal circumstances, microorganism(s) used for the production of autogenous biologics may not be older than 15 months from the date of isolation, or 12 months from the date of harvest of the first serial of product produced from the microorganism(s), whichever comes first. The Administrator, however, may authorize production of additional serials from microorganism(s) older than the above stated time periods, Provided, That, the person requesting such authorization submits the following supporting information to the address listed in paragraph (a)(3):

(i) The attending veterinarian's or approved specialist's current assessment of the continued involvement of a herd with the originally isolated microorganism(s), including a summary of the diagnostic work that has been done to support this assessment.

(ii) Evidence of satisfactory protection from the previous use of the autogenous biologic produced from the microorganisms involved.

(iii) Any other information the Administrator may require in order to determine the need to use the microorganism to make additional serials.

(b) Restrictions. Unless otherwise authorized by the Administrator, each serial of an autogenous biologic shall be subject to the following restrictions:

(1) Microorganisms used to prepare autogenous biologics shall not be maintained in the licensed establishment beyond the time authorized for use in production.

(2) The expiration date of the autogenous biologic shall not exceed 18 months from the date of harvest.

(c) Testing requirements for autogenous biologics. (1) Final container samples of completed product from the first serial or subserial of an autogenous biologic produced from an isolate shall be tested for purity as prescribed in § 113.26, and for safety as prescribed in § 113.33(b) or § 113.38 except that:

(i) When the number of final containers in a serial or subserial is 50 or less, two final container samples from each serial and subserial shall be tested as prescribed in § 113.26(b): Provided, That, 1 ml aliquots from each sample may be inoculated into five corresponding individual test vessels of each of the test media required.

(ii) Serials which are satisfactory after the third day of observation of purity test cultures and of safety test animals may be released for shipment to the customer and the tests continued throughout the required period; and

(iii) Serials released on the basis of satisfactory results of third day observations shall be immediately recalled if evidence of contamination occurs in test cultures or if any of the test animals used to demonstrate product safety, sicken, or die during the observation period.

(iv) Test summaries must be submitted to the Administrator (in c/o the Director, Center for Veterinary Biologics, Inspection and Compliance, 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010) on a quarterly basis by the 21st day of January, April, July, and October or more often as required by the Administrator.

(2) Each serial or subserial of autogenous bacterial product other than the first serial or subserial produced from an isolate shall meet the applicable general requirements prescribed in § 113.100 and the special requirements prescribed in this section. Each serial or subserial of autogenous viral product other than the first serial or subserial produced from an isolate shall meet the applicable general requirements prescribed in § 113.200 and the special requirements prescribed in this section. A serial or subserial found unsatisfactory by any prescribed test shall not be released.

(i) Purity test. Final container samples of completed product from each serial and subserial shall be tested for viable bacteria and fungi as provided in § 113.26. When the number of final containers in a serial or subserial is 50 or less, two final container samples from each serial and subserial shall be tested as prescribed in § 113.26(b): Provided, That, 1 ml aliquots from each sample may be inoculated into five corresponding individual test vessels of each of the test media required.

(ii) Safety test. Bulk of final container samples of completed product from each serial shall be tested for safety as provided in § 113.33 (b) or § 113.38.

(iii) Identification. All microorganisms used for the production of autogenous biologics shall be identified as follows: Bacteria, fungi, and mycoplasma shall be identified at least to genus and species. Viruses shall be identified at least to family. After 15 months from the date of isolation, or 12 months from the harvest date of the first serial of autogenous product produced from a microorganism, whichever comes first, characterization and identification shall be completed to strain and/or serotype before such microorganism may be used for production.

(iv) Antigenicity, or immunogenicity, and potency. Persons seeking authorization to prepare additional serials of autogenous biologics from microorganisms that are older than 24 months from the date of isolation, shall be required to conduct the following additional tests:

(A) Completed product shall be tested for antigenicity or immunogenicity in the species for which the product is recommended or in another animal species whose immunological response has been shown in the scientific literature to correlate with the response of the species for which the product is recommended. Such tests shall be conducted in accordance with a protocol developed by the licensee and approved by the Administrator and the results submitted to the Director, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010 for review. Microorganisms not shown to be antigenic (that is, not shown to induce a significant serological response) or immunogenic by such approved tests shall not be used for the preparation of such product.

(B) Bulk or final container samples of completed product from each serial of such autogenous biologics containing fractions for which standard requirement potency test procedures have been established shall be tested for potency in accordance with applicable standard requirement potency tests provided in 9 CFR part 113. If the culture of microorganisms used to produce such fractions is shown to be of a different strain or serotype than the reagent or challenge microorganisms used in the standard requirement potency test, reagents or challenges of the same strain or serotype as the microorganism used for production may be used.

(C) If no standard requirement potency test procedures have been established for a fraction(s) in the autogenous biologic, such fraction(s) of each serial of product shall be tested for potency using a developmental potency test described in the filed outline of production or shall at least be standardized to contain an antigenic mass for such fraction(s) that has been shown to be antigenic or immunogenic in accordance with paragraph (c)(2)(iv)(A) of this section.

[57 FR 38756, Aug. 27, 1992, as amended at 59 FR 67616, Dec. 30, 1994; 64 FR 43044, Aug. 9, 1999; 67 FR 15714, Apr. 3, 2002; 75 FR 20773, Apr. 21, 2010]

§ 113.114 Tetanus Toxoid.

Tetanus Toxoid shall be produced from a culture of Clostridium tetani which has been inactivated and is nontoxic. The toxoid may be either absorbed, precipitated, or purified and concentrated. Each serial of biological product containing tetanus toxoid fraction shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. A serial or subserial found unsatisfactory by any prescribed test shall not be released.

(a) Purity test. Final container samples of completed product from each serial and subserial shall be tested for viable bacteria and fungi as provided in § 113.26.

(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.33(b).

(c) Potency test. Bulk or final container samples of completed product from each serial shall be tested for potency. A group of 10 guinea pigs consisting of an equal number of males and females weighing 450 to 550 grams shall each be injected subcutaneously with 0.4 of the largest dose recommended on the product labels.

(1) Six weeks after injection, all surviving guinea pigs shall be bled and equal portions of serum, but not less than 0.5 ml from each, shall be pooled. For a valid test, the pool shall contain the serum from at least eight animals.

(2) The antitoxin titer of the pooled serum shall be determined in antitoxin units (A.U.) per ml using an enzyme-linked immunosorbent assay method acceptable to the Animal and Plant Health Inspection Service.

(3) If the antitoxin titer of the serum pool is at least 2.0 A.U. per ml, the serial is satisfactory. If the antitoxin titer of the serum pool is less than 2.0 A.U. per ml, the serial may be retested by the following procedure: Provided, That, if the serial is not retested, it shall be declared unsatisfactory.

(4) For serials in which the serum pool contains less than 2.0 A.U. per ml, the individual serum that constituted the pool may be tested by the enzyme-linked immunosorbent assay. If at least 80 percent of the individual serums have an antitoxin titer of at least 2.0 A.U. per ml, the serial is satisfactory. If less than 80 percent of the individual serums have an antitoxin titer of at least 2.0 A.U. per ml, the serial may be retested in 10 guinea pigs using the procedure described in (c)(1) and (2) above. The antitoxin titer of the pooled serum from the guinea pigs used in the retest shall be averaged with the antitoxin level of the pooled serum from the initial test. If the average of the two pools is at least 2.0 A.U. per ml, the serial is satisfactory. If the average of the two pools is less than 2.0 A.U. per ml, the serial is unsatisfactory and shall not be retested further.

[39 FR 16862, May 10, 1974, as amended at 46 FR 23224, Apr. 24, 1981; 50 FR 24905, June 14, 1985. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 37827, Aug. 9, 1991; 56 FR 66785, Dec. 26, 1991]

§ 113.115 Staphylococcus Aureus Bacterin-Toxoid.

Staphylococcus Aureus Bacterin-Toxoid shall be prepared from toxoided broth cultures of selected toxogenic strains of Staphylococcus aureus which has been inactivated and is nontoxic. Each serial of biological product containing Staphylococcus Aureus Bacterin-Toxoid shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.

(a) Purity test. Final container samples of completed product from each serial shall be tested for viable bacteria and fungi as provided in § 113.26.

(b) Safety test. Bulk or final container samples of completed product shall be tested for safety as provided in § 113.33(b). Also, the rabbits used in the potency test provided in paragraph (c) of this section shall constitute an additional safety test. If unfavorable reactions attributable to the product occur in any of the rabbits during the observation period, the serial is unsatisfactory.

(c) Potency test. Rabbits, each weighing 2000-3000 grams, shall be used as test animals. Either a five rabbit individual serum test or an eight rabbit pooled serum test shall be conducted. At the start of the test, individual serums from the five rabbits or pooled serums from the eight rabbits shall contain less than 0.2 alpha antitoxin units per ml.

(1) Each rabbit shall be given a series of not more than three intramuscular injections at 7 day intervals (1.0 ml, 2.0 ml, 3.0 ml) and observed from 7-14 days following the third injection. At the end of the observation period, a blood sample shall be taken from each rabbit.

(2) The sample of serum from each rabbit, if the five rabbit individual test is conducted or a pooled sample of equal quantities of serum from the rabbits if the eight rabbit pooled serum test is conducted, shall be tested to determine the staphylococcus alpha antitoxin units per ml as provided in paragraphs (c)(3), (4), (5), (6), (7), and (8) of this section.

(3) Inactivate rabbit serum 56 °C for 30 minutes.

(4) Make serial twofold dilutions of the serum samples and conduct the test, using 1 ml of the serial dilutions. Appropriate controls should be included for accurate interpretations.

(5) Add 1 ml of the standardized toxin containing the established “Lh” dose. The “Lh” dose is the amount of toxin which when mixed with one unit of standard antitoxin produces a 50 percent hemolysis of rabbit red blood cells.

(6) Incubate toxin-antitoxin mixture at room temperature for 30 minutes and add 1 ml of a 1.5 percent suspension of washed freshly drawn rabbit red blood cells suspended in normal saline to each tube. Mix and incubate the combined product in a 37 °C water bath for 1 hour. Refrigerate at 5 °C overnight.

(7) Read the hemolysis produced and establish the 50 percent end point. The 50 percent end point of hemolysis should be established by determining the size of the button produced by the unlysed red blood cells.

(8) Determine the units of antitoxin per 1 ml of serum.

(9) If the individual samples from four of the five rabbits in the individual serum test or the pooled samples from the eight rabbits in the pooled serum test do not contain three alpha antitoxin units per ml, the serial is unsatisfactory.

[39 FR 16862, May 10, 1974. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66785, Dec. 26, 1991]

§ 113.116 Pasteurella Multocida Bacterin, Avian Isolate, Type 4.

Pasteurella Multocida Bacterin, Avian Isolate, Type 4 shall be prepared from cultures of Pasteurella multocida, avian isolate, Type 4 (Little and Lyons classification), which have been inactivated, and are nontoxic. Each serial of biological product containing Pasteurella Multocida Bacterin, Avian Isolate, Type 4, shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency, as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.

(a) Purity test. Final container samples of completed product shall be tested for viable bacteria and fungi as provided in 9 CFR 113.26.

(b) Safety test. Observation of the vaccinated turkeys during the prechallenge period of the potency test provided in paragraph (c) of this section shall constitute the safety test. If unfavorable reactions that are attributable to the product occur, the serial is unsatisfactory. If unfavorable reactions that are not attributable to the product occur in one turkey, test results shall be determined by observing the remaining 20 turkeys. The test is a No Test and may be repeated if unfavorable reactions that are not attributable to the product occur in two or more turkeys, but the serial is unsatisfactory if the test is not repeated.

(c) Potency test. Bulk or final container samples of completed product shall be tested for potency of the Type 4 strain, using the two-stage test provided in this paragraph. Turkeys at least 6 weeks old obtained from the same source and hatch shall be properly identified and used as provided in this paragraph.

(1) Vaccinates. Each of not more than 21 turkeys shall be vaccinated with the dose and by the route recommended on the label. A second dose shall be given after 3 weeks and the turkeys observed for an additional 2-week prechallenge period.

(2) Unvaccinated controls. Each of not more than 11 turkeys shall be held as controls.

(3) Challenge. Not less than 14 days after the second dose, each of 20 vaccinates, and each of 10 unvaccinated controls shall be challenged intramuscularly with virulent Pasteurella multocida, Strain P-1662, Type 4 (Little and Lyons classification) and observed daily for a 14-day postchallenge period. Only dead birds shall be considered in evaluating the product.

(4) Validity requirements. Eight or more unvaccinated controls must die for the test to be valid. If this requirement is met, the potency test results are evaluated according to stage one of the following table. The test is a No Test and may be repeated if the validity requirement is not met, but the serial is unsatisfactory if the test is not repeated.

Stage | Number of vaccinates | Cumulative number of vaccinates | Cummulative total number of dead vaccinates for______

Satisfactory serial | Unsatisfactory serial

1 | 20 | 20 | 6 or less | 9 or more.

2 | 20 | 40 | 15 or less | 16 or more.

(5) The serial shall pass or fail based on the stage one results of the potency test. However, the second stage may be conducted if seven or eight vaccinates die in stage one, but the serial is unsatisfactory if the second stage is not conducted.

(6) The second stage shall be conducted in a manner identical to the first stage. The serial shall be evaluated according to stage two of the table. On the basis of accumulated results from the data of both stage tests, a serial shall either pass or fail the second stage.

[47 FR 5795, Feb. 4, 1982; 47 FR 6817, Feb. 17, 1982, as amended at 52 FR 9117, Mar. 23, 1987. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66785, Dec. 26, 1991]

§ 113.117 Pasteurella Multocida Bacterin, Avian Isolate, Type 1.

Pasteurella Multocida Bacterin, Avian Isolate, Type 1, shall be prepared from cultures of Pasteurella multocida, avian isolate, Type 1 (Little and Lyons classification), which have been inactivated and are nontoxic. Each serial of biological product containing Pasteurella Multocida Bacterin, Avian Isolate, Type 1, shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.

(a) Purity test. Final container samples of completed product shall be tested for viable bacteria and fungi as provided in § 113.26.

(b) Safety test. Observation of the vaccinated chickens during the prechallenged period of the potency test provided in paragraph (c) of this section shall constitute the safety test. If unfavorable reactions that are attributable to the product occur, the serial is unsatisfactory. If unfavorable reactions that are not attributable to the product occur in one chicken, test results shall be determined by observing the remaining 20 chickens. The test is a No Test and may be repeated if unfavorable reactions that are not attributable to the product occur in two or more chickens, but the serial is unsatisfactory if the test is not repeated.

(c) Potency test. Bulk or final container samples of completed product shall be tested for potency of the Type 1 strain, using the two-stage test provided in this paragraph. Chickens, at least 12 weeks of age, obtained from the same source and hatch, shall be properly identified and used as provided in this paragraph.

(1) Vaccinates. Each of not more than 21 chickens shall be injected with the dose and by the route recommended on the label. A second dose shall be injected after 3 weeks and the chickens observed for an additional 2 week prechallenge period.

(2) Unvaccinated controls. Each of not more than 11 chickens shall be held as controls.

(3) Challenge. Not less than 14 days after the second injection, each of 20 vaccinates, and each of 10 unvaccinated controls shall be challenged intramuscularly with a minimum of 250 colony-forming units of virulent Pasteurella multocida, Strain X-73, Type 1 (Little and Lyons classification) and observed daily for a 14-day postchallenge period. Only dead birds shall be considered in evaluating the product.

(4) Validity requirements. Eight or more unvaccinated controls must die for the test to be valid. If these requirement are met, the potency test results are evaluated according to stage one of the following table. The test is a No Test and may be repeated if the validity requirements are not met, but the serial is unsatisfactory if the test is not repeated.

Stage | Number of vaccinates | Cumulative number of vaccinates | Cummulative total number of dead vaccinates for______

Satisfactory serial | Unsatisfactory serial

1 | 20 | 20 | 6 or less | 9 or more.

2 | 20 | 40 | 15 or less | 16 or more.

(5) The serial shall pass or fail based on the stage one results of the potency test. However, the second stage may be conducted if seven or eight vaccinates die in stage one, but the serial is unsatisfactory if the second stage is not conducted.

(6) The second stage shall be conducted in a manner identical to the first stage. The serial shall be evaluated according to stage two of the table. On the basis of accumulated results from the data of both stage tests, a serial shall either pass or fail the second stage.

[39 FR 16866, May 10, 1974; 39 FR 20368, June 10, 1974, as amended at 40 FR 759, Jan. 3, 1975; 40 FR 23989, June 4, 1975; 47 FR 5195, Feb. 4, 1982; 52 FR 9118, Mar. 23, 1987. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66785, Dec. 26, 1991]

§ 113.118 Pasteurella Multocida Bacterin, Avian Isolate, Type 3.

Pasteurella Multocida Bacterin, Avian Isolate, Type 3, shall be prepared from culture of Pasteurella multocida, avian isolate, Type 3 (Little and Lyons classification), which have been inactivated and are nontoxic. Each serial of biological product containing Pasteurella Multocida Bacterin, Avian Isolate, Type 3, shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency, as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.

(a) Purity test. Final container samples of completed product shall be tested for viable bacteria and fungi as provided in § 113.26.

(b) Safety test. Observation of the vaccinated turkeys during the prechallenge period of the potency test provided in paragraph (c) of this section shall constitute the safety test. If unfavorable reactions that are attributable to the product occur, the serial is unsatisfactory. If unfavorable reactions that are not attributable to the product occur in one turkey, test results shall be determined by observing the remaining 20 turkeys. The test is a No Test and may be repeated if unfavorable reactions that are not attributable to the product occur in two or more turkeys, but the serial is unsatisfactory if the test is not repeated.

(c) Potency test. Bulk or final container samples of completed product shall be tested for potency of the Type 3 strain, using the two-stage test provided in this paragraph. Turkeys, at least 6 weeks of age, obtained from the same source and hatch, shall be properly identified and used as provided in this paragraph.

(1) Vaccinates. Each of not more than 21 turkeys shall be injected with the dose and by the route recommended on the label. A second dose shall be injected after 3 weeks and the turkeys observed for an additional 2 week prechallenge period.

(2) Unvaccinated controls. Each of not more than 11 turkeys shall be held as controls.

(3) Challenge. Not less than 14 days after the second injection, each of 20 vaccinates, and each of 10 unvaccinated controls shall be challenged intramuscularly with a minimum of 150 colony-forming units of virulent Pasteurella multocida, Strain P-1059, Type 3 (Little and Lyons Classification) and observed daily for a 14-day postchallenge period. Only dead birds shall be considered in evaluating the product.

(4) Validity requirements. Eight or more unvaccinated controls must die for the test to be valid. If these requirements are met, the potency test results are evaluated according to stage one of the following table. The test is a No Test and may be repeated if the validity requirements are not met, but the serial is unsatisfactory if the test is not repeated.

Stage | Number of vaccinates | Cumulative number of vaccinates | Cummulative total number of dead vaccinates for______

Satisfactory serial | Unsatisfactory serial

1 | 20 | 20 | 6 or less | 9 or more.

2 | 20 | 40 | 15 or less | 16 or more.

(5) The serial shall pass or fail based on the stage one results of the potency test. However, the second stage may be conducted if seven or eight vaccinates die in stage one, but the serial is unsatisfactory if the second stage is not conducted.

(6) The second stage shall be conducted in a manner identical to the first stage. The serial shall be evaluated according to stage two of the table. On the basis of accumulated results from the data of both stage tests, a serial shall either pass or fail the second stage.

[39 FR 16862, May 10, 1974, as amended at 40 FR 759, Jan. 3, 1975; 47 FR 5196, Feb. 4, 1982; 52 FR 9118, Mar. 23, 1987. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66785, Dec. 26, 1991]

§ 113.119 Erysipelothrix Rhusiopathiae Bacterin.

Erysipelothrix Rhusiopathiae Bacterin shall be produced from a culture of Erysipelothrix rhusiopathiae which has been inactivated and is nontoxic. Each serial of biological product containing Erysipelothrix rhusiopathiae shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.

(a) Purity test. Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.

(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.38.

(c) Potency test. Bulk or final container samples of completed product from each serial shall be tested for potency using the mouse protection test provided in this paragraph. A mouse dose shall be 1/10 of the least dose recommended on the label for swine. Such swine dose shall not be less than 1 ml.

(1) The ability of the bacterin being tested (Unknown) to protect mice shall be compared with a Standard Reference Bacterin (Standard) which is either supplied by or acceptable to Animal and Plant Health Inspection Service.

(2) At least three threefold dilutions shall be made with the Standard and the same threefold dilutions shall be made for each Unknown. Dilutions shall be made with physiological saline solution.

(3) For each dilution of the Standard and each dilution of an Unknown, a group of at least 20 mice, each weighing 16 to 22 grams, shall be used. Each mouse in each group shall be injected subcutaneously with one mouse dose of the appropriate dilution.

(4) Each of 20 injected mice from each group shall be challenged subcutaneously 14 to 21 days after being injected. A dose containing at least 100 mouse LD50 of a suitable culture of Erysipelothrix rhusiopathiae shall be used. All survivors in each group of mice shall be recorded 10 days postchallenge.

(5) Test for valid assay: At least two dilutions of the Standard shall protect more than 0 percent and two dilutions shall protect less than 100 percent of the mice injected. The lowest dilution of the Standard shall protect more than 50 percent of the mice. The highest dilution of the Standard shall protect less than 50 percent of the mice.

(6) The relative potency (RP) of the Unknown is determined by comparing the 50 percent endpoint dilution (highest bacterin dilution protecting 50 percent of the mice) of the Unknown with that of the standard by the following formula:

(7) If the RP of the Unknown is less than 0.6, the serial being tested is unsatisfactory.

(8) If the 50 percent endpoint of an Unknown in a valid test cannot be calculated because the lowest dilution does not exceed 50 percent protection, that serial may be retested in a manner identical to the initial test: Provided, That, if the Unknown is not retested or if the protection provided by the lowest dilution of the Standard exceeds the protection provided by the lowest dilution of the Unknown by six mice or more; or, if the total number of mice protected by the Standard exceeds the total number of mice protected by the Unknown by eight mice or more, the serial is unsatisfactory.

(9) If the 50 percent endpoint of an Unknown in a valid test cannot be calculated because the highest dilution exceeds 50 percent protection, the Unknown is satisfactory without additional testing.

(10) If the RP is less than 0.6, the serial may be retested by conducting two independent replicate tests in a manner identical to the initial test. The average of the RP values obtained in the retests shall be determined. If the average RP is less than 0.6, the serial is unsatisfactory without further testing. If the average RP obtained in the retests is equal to or greater than 0.6, the following shall apply:

(i) If the RP obtained in the original test is one-third or less than the average RP obtained in the retests, the initial RP may be considered a result of test system error and the serial is satisfactory for potency.

(ii) If the RP value obtained in the original test is more than one-third the average RP obtained in the retests, a new average shall be determined using the RP values obtained in all tests. If the new average is less than 0.6, the serial is unsatisfactory.

[39 FR 16862, May 10, 1974, as amended at 40 FR 759, Jan. 3, 1975; 40 FR 20067, May 8, 1975; 40 FR 51414, Nov. 5, 1975; 44 FR 71408, Dec. 11, 1979; 50 FR 23795, June 6, 1985; 51 FR 23731, July 1, 1986. Redesignated at 55 FR 35562, Aug. 31, 1990; 56 FR 66558, Dec. 24, 1991; 56 FR 66784, 66785, Dec. 26, 1991]

§ 113.120 Salmonella Typhimurium Bacterin.

Salmonella Typhimurium Bacterin shall be prepared from a culture of Salmonella typhimurium which has been inactivated and is nontoxic. Each serial of biological product containing Salmonella typhimurium fraction shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.

(a) Purity test. Final container samples of completed product shall be tested for viable bacteria and fungi as provided in § 113.26.

(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.33(b).

(c) Potency test. Bulk or final container samples of completed product from each serial shall be tested for potency using the mouse test provided in this paragraph. A mouse dose shall be 1/20 of the least dose recommended on the label for other animals which shall not be less than 2 ml.

(1) The ability of the bacterin being tested (Unknown) to protect mice shall be compared with a Standard Reference Bacterin (Standard) which is either supplied by or acceptable to Animal and Plant Health Inspection Service.

(2) At least three tenfold dilutions shall be made with the Standard and the same tenfold dilutions shall be made for each Unknown. The dilutions shall be made in Phosphate Buffered Saline.

(3) For each dilution of the Standard and each dilution of an Unknown, a group of at least 20 mice, each weighing 16-22 grams, shall be used. Each mouse in a group shall be injected intraperitoneally with one mouse dose of the appropriate dilution. Each mouse shall be revaccinated on day 14, using the same schedule.

(4) Each of 20 vaccinated mice per group shall be challenged intraperitoneally 7-10 days after the second vaccination with a 0.25 ml dose containing 100-10,000 mouse LD50 as determined by titration, of a suitable culture of Salmonella typhimurium. All survivors in each group of mice shall be recorded 14 days postchallenge.

(5) Test for valid assay: At least two dilutions of the Standard shall protect more than 0 percent and two dilutions shall protect less than 100 percent of the mice injected. The lowest dilution of the Standard shall protect more than 50 percent of the mice. The highest dilution of the Standard shall protect less than 50 percent of the mice.

(6) The relative potency (RP) of the Unknown is determined by comparing the 50 percent endpoint dilution (highest bacterin dilution protecting 50 percent of the mice) of the Unknown with that of the Standard by the following formula:

(7) If the RP of the Unknown is less than 0.30, the serial being tested is unsatisfactory.

(8) If the 50 percent endpoint of an Unknown cannot be calculated because the lowest dilution does not exceed 50 percent protection, that serial may be retested in a manner identical to the initial test; Provided, That, if the Unknown is not retested or if the protection provided by the lowest dilution of the Unknown by six mice or more; or, if the total number of mice protected by the Standard exceeds the total number of mice protected by the Unknown by eight mice or more, the serial being tested is unsatisfactory.

(9) If the 50 percent endpoint of an Unknown in a valid test cannot be calculated because the highest dilution exceeds 50 percent protection, the Unknown is satisfactory without additional testing.

(10) If the RP is less than the minimum required in paragraph (c)(7) of this section, the serial may be retested by conducting two independent replicate tests in a manner identical to the initial test. The average of the RP values obtained in the retests shall be determined. If the average RP is less than the required minimum, the serial is unsatisfactory. If the average RP obtained in the retests is equal to or greater than the required minimum, the following shall apply:

(i) If the RP obtained in the original test is one-third or less than the average RP obtained in the retests, the initial RP may be considered a result of test system error and the serial is satisfactory.

(ii) If the RP value obtained in the original test is more than one-third the average RP obtained in the retests, a new average shall be determined using the RP values obtained in all tests. If the new average is less than the minimum required in paragraph (c)(7) of this section, the serial is unsatisfactory.

[40 FR 17003, Apr. 16, 1975, as amended at 42 FR 59487, Nov. 18, 1977; 48 FR 31008, July 6, 1983. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66784, 66785, Dec. 26, 1991]

§ 113.121 Pasteurella Multocida Bacterin.

Pasteurella Multocida Bacterin shall be prepared from a culture of Pasteurella multocida strains other than avian which have been inactivated and are nontoxic. Each serial of biological product containing Pasteurella multocida fraction shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.

(a) Purity test. Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.

(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.33(b). The subcutaneous route is to be used.

(c) Potency test. Bulk or final container samples of completed product from each serial shall be tested for potency using the mouse test provided in this paragraph. A mouse dose shall be 1/20 of the least dose recommended on the label for other animals which shall not be less than 2 ml.

(1) The ability of the bacterin being tested (Unknown) to protect mice shall be compared with a Standard Reference Bacterin (Standard) which is either supplied by or acceptable to Animal and Plant Health Inspection Service.

(2) At least three fivefold dilutions shall be made with the Standard and the same fivefold dilutions shall be made for each Unknown. The dilutions will be made in Phosphate Buffered Saline.

(3) For each dilution of the Standard and each dilution of each Unknown, a group of at least 20 mice, each weighing 16-22 grams, shall be used. Each mouse in a group shall be injected intraperitoneally with one mouse dose of the appropriate dilution. Each mouse shall be revaccinated on day 14, using the same schedule.

(4) Each of 20 injected mice per group shall be challenged intraperitoneally 10-12 days after the second vaccination with a 0.2 ml dose containing 100-10,000 mouse LD50, as determined by titration, of a suitable culture of Pasteurella multocida. All survivors in each group of mice shall be recorded 10 days postchallenge.

(5) Test for valid assay: At least two dilutions of the Standard shall protect more than 0 percent and two dilutions shall protect less than 100 percent of the mice injected. The lowest dilution of the Standard shall protect more than 50 percent of the mice. The highest dilution of the Standard shall protect less than 50 percent of the mice.

(6) The relative potency (RP) of the Unknown is determined by comparing the 50 percent endpoint dilution (highest bacterin dilution protecting 50 percent of the mice) of the Unknown with that of the Standard by the following formula:

(7) If the RP of the Unknown is less than 0.50, the serial being tested is unsatisfactory.

(8) If the 50 percent endpoint of an Unknown cannot be calculated because the lowest dilution does not exceed 50 percent protection, that serial may be retested in a manner identical to the initial test: Provided, That, if the Unknown is not retested or if the protection provided by the lowest dilution of the Standard exceeds the protection provided by the lowest dilution of the Unknown by six mice or more; or, if the total number of mice protected by the Standard exceeds the total number of mice protected by the Unknown by eight mice or more, the serial being tested is unsatisfactory.

(9) If the 50 percent endpoint of an Unknown in a valid test cannot be calculated because the highest dilution exceeds 50 percent protection, the Unknown is satisfactory without additional testing.

(10) If the RP is less than the minimum required in paragraph (c)(7) of this section, the serial may be retested by conducting two independent replicate tests in a manner identical to the initial test. The average of the RP values obtained in the retests shall be determined. If the average RP is less than the required minimum, the serial is unsatisfactory. If the average RP obtained in the retests is equal to or greater than the required minimum, the following shall apply:

(i) If the RP obtained in the original test is one-third or less than the average RP obtained in the retests, the initial RP may be considered a result of test system error and the serial is satisfactory.

(ii) If the RP value obtained in the original test is more than one-third the average RP obtained in the retests, a new average shall be determined using the RP values obtained in all tests. If the new average is less than the minimum required in paragraph (c)(7) of this section, the serial is unsatisfactory.

[40 FR 17004, Apr. 16, 1975, as amended at 42 FR 59487, Nov. 18, 1977; 48 FR 31008, July 6, 1983. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66784, 66785, Dec. 26, 1991]

§ 113.122 Salmonella Choleraesuis Bacterin.

Salmonella Choleraesuis Bacterin shall be prepared from a culture of Salmonella choleraesuis which has been inactivated and is nontoxic. Each serial of biological product containing Salmonella choleraesuis fraction shall meet the applicable requirements in 9 CFR 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.

(a) Purity test. Final container samples of completed product shall be tested for viable bacteria and fungi as provided in 9 CFR 113.26.

(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in 9 CFR 113.33(b).

The subcutaneous route shall be used when the product is in combination with Pasteurella Multocida Bacterin.

(c) Potency test. Bulk or final container samples of completed product from each serial shall be tested for potency using the mouse test provided in this paragraph. A mouse dose shall be 1/20 of the least dose recommended on the label for other animals which shall not be less than 2 ml.

(1) The ability of the bacterin being tested (Unknown) to protect mice shall be compared with a Standard Reference Bacterin (Standard) which is either supplied by or acceptable to Veterinary Services.

(2) At least three fivefold dilutions shall be made with the Standard and the same fivefold dilution shall be made for each Unknown. The dilutions shall be made in Phosphate-Buffered Saline.

(3) For each dilution of the Standard and each dilution of an Unknown, a group of at least 20 mice, each weighing 16 to 22 grams, shall be used. Each mouse in a group shall be injected intraperitoneally with one mouse dose of the appropriate dilution. Each mouse shall be revaccinated on day 14, using the same schedule.

(4) Each of 20 vaccinated mice per group shall be challenged intraperitoneally 7 to 10 days after the second vaccination with a 0.25 ml dose containing 10-1,000 mouse LD50 as determined by titration of a suitable culture of Salmonella choleraesuis. All survivors in each group of mice shall be recorded 14 days postchallenge.

(5) Test for valid assay: At least two dilutions of the Standard shall protect more than 0 percent and two dilutions shall protect less than 100 percent of the mice injected. The lowest dilution of the Standard shall protect more than 50 percent of the mice. The highest dilution of the Standard shall protect less than 50 percent of the mice.

(6) The relative potency (RP) of the Unknown is determined by comparing the 50 percent endpoint dilution (highest bacterin dilution protecting 50 percent of the mice) of the Unknown with that of the Standard by the following formula:

(7) If the RP of the Unknown is less than 0.50, the serial being tested is unsatisfactory.

(8) If the 50 percent endpoint of an Unknown cannot be calculated because the lowest dilution does not exceed 50 percent protection, that serial may be retested in a manner identical to the initial test; Provided, That, if the Unknown is not retested or if the protection provided by the lowest dilution of the Standard exceeds the protection provided by the lowest dilution of the Unknown by six mice or more; or, if the total number of mice protected by the Standard exceeds the total number of mice protected by the Unknown by eight mice or more, the serial being tested is unsatisfactory.

(9) If the 50 percent endpoint of an Unknown in a valid test cannot be calculated because the highest dilution exceeds 50 percent protection, the Unknown is satisfactory without additional testing.

(10) If the RP is less than the minimum required in paragraph (c)(7) of this section, the serial may be retested by conducting two independent replicate tests in a manner identical to the initial test. The average of the RP values obtained in the retests shall be determined. If the average RP is less than the required minimum, the serial is unsatisfactory. If the average RP obtained in the retests is equal to or greater than the required minimum, the following shall apply:

(i) If the RP obtained in the original test is one-third or less than the average RP obtained in the retests, the initial RP may be considered a result of test system error and the serial is satisfactory.

(ii) If the RP value obtained in the original test is more than one-third the average RP obtained in the retests, a new average shall be determined using the RP values obtained in all tests. If the new average is less than the minimum required in paragraph (c)(7) of this section, the serial is unsatisfactory.

[43 FR 25077, June 9, 1978, as amended at 48 FR 31008, July 6, 1983. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66785, Dec. 26, 1991]

§ 113.123 Salmonella Dublin Bacterin.

Salmonella Dublin Bacterin shall be prepared from a culture of Salmonella dublin which has been inactivated and is nontoxic. Each serial of biological product containing Salmonella dublin fraction shall meet the applicable requirements in 9 CFR 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.

(a) Purity test. Final container samples of completed product shall be tested for viable bacteria and fungi as provided in 9 CFR 113.26.

(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in 9 CFR 113.33(b).

(c) Potency test. Bulk or final container samples of completed product from each serial shall be tested for potency using the mouse test provided in this paragraph. A mouse dose shall be 1/20 of the least dose recommended on the label for other animals which shall not be less than 2 ml.

(1) The ability of the bacterin being tested (Unknown) to protect mice shall be compared with a Standard Reference Bacterin (Standard) which is either supplied by or acceptable to Veterinary Services.

(2) At least three tenfold dilutions shall be made with the Standard and the same tenfold dilutions shall be made for each Unknown. The dilutions shall be made in Phosphate-Buffered Saline.

(3) For each dilution of the Standard and each dilution of an Unknown, a group of at least 20 mice, each weighing 16 to 22 grams, shall be used. Each mouse in a group shall be injected intraperitoneally with one mouse dose of the appropriate dilution. Each mouse shall be revaccinated on day 14, using the same schedule.

(4) Each of 20 vaccinated mice per group shall be challenged intraperitoneally 7 to 10 days after the second vaccination with a 0.25 ml dose containing 1,000-100,000 mouse LD50 as determined by titration of a suitable culture of Salmonella dublin. All survivors in each group of mice shall be recorded 14 days postchallenge.

(5) Test for valid assay: At least two dilutions of the Standard shall protect more than 0 percent and two dilutions shall protect less than 100 percent of the mice injected. The lowest dilution of the Standard shall protect more than 50 percent of the mice. The highest dilution of the Standard shall protect less than 50 percent of the mice.

(6) The relative potency (RP) of the Unknown is determined by comparing the 50 percent endpoint dilution (highest bacterin dilution protecting 50 percent of the mice) of the Unknown with that of the Standard by the following formula:

(7) If the RP of the Unknown is less than 0.30, the serial being tested is unsatisfactory.

(8) If the 50 percent endpoint of an Unknown cannot be calculated because the lowest dilution does not exceed 50 percent protection, that serial may be retested in a manner identical to the initial test; Provided, That, if the Unknown is not retested or if the protection provided by the lowest dilution of the Standard exceeds the protection provided by the lowest dilution of the Unknown by six mice or more; or, if the total number of mice protected by the Standard exceeds the total number of mice protected by the Unknown by eight mice or more, the serial being tested is unsatisfactory.

(9) If the 50 percent endpoint of an Unknown in a valid test cannot be calculated because the highest dilution exceeds 50 percent protection, the Unknown is satisfactory without additional testing.

(10) If the RP is less than the minimum required in paragraph (c)(7) of this section, the serial may be retested by conducting two independent replicate tests in a manner identical to the initial test. The average of the RP values obtained in the retests shall be determined. If the average RP is less than the required minimum, the serial is unsatisfactory. If the average RP obtained in the retests is equal to or greater than the required minimum, the following shall apply:

(i) If the RP obtained in the original test is one-third or less than the average RP obtained in the retests, the initial RP may be considered a result of test system error and the serial is satisfactory.

(ii) If the RP value obtained in the original test is more than one-third the average RP obtained in the retests, a new average shall be determined using the RP values obtained in all tests. If the new average is less than the minimum required in paragraph (c)(7) of this section, the serial is unsatisfactory.

[43 FR 25077, June 9, 1978, as amended at 48 FR 31009, July 6, 1983. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66785, Dec. 26, 1991]

§ 113.200 General requirements for killed virus vaccines.

When prescribed in an applicable Standard Requirement or in the filed Outline of Production, a killed virus vaccine shall meet the applicable requirements in this section.

(a) Killing agent. The vaccine virus shall be killed (inactivated) by an appropriate agent. The procedure involved may be referred to as inactivation. Suitable tests to assure complete inactivation shall be written into the filed Outline of Production.

(b) Cell culture requirements. If cell cultures are used in the preparation of the vaccine, primary cells shall meet the requirements in § 113.51 and cell lines shall meet the requirements in § 113.52.

(c) Purity tests—(1) Bacteria and fungi. Final container samples of completed product from each serial shall be tested as prescribed in § 113.26.

(2) Avian origin vaccine. Bulk pooled material or final container samples from each serial shall also be tested for:

(i) Salmonella contamination as prescribed in § 113.30; and

(ii) Lymphoid leukosis virus contamination as prescribed in § 113.31; and

(iii) Hemagglutinating viruses as prescribed in § 113.34.

(3) Mycoplasma. If the licensee cannot demonstrate that the agent used to kill the vaccine virus would also kill mycoplasma, each serial of the vaccine shall be tested for mycoplasma as prescribed in § 113.28, prior to adding the killing agent. Material found to contain mycoplasma is unsatisfactory for use.

(4) Extraneous viruses. Each lot of Master Seed Virus used to prepare killed virus vaccine recommended for animals other than poultry shall meet the requirements for extraneous viruses as prescribed in § 113.55.

(d) Safety tests. Final container samples of completed product from each serial shall be tested for safety in guinea pigs as prescribed in § 113.38 and for safety in mice as prescribed in § 113.33: Provided, That, vaccines recommended for use only in poultry are exempt from this requirement.

(e) Viricidal activity test. Only serials tested for viricidal activity in accordance with the test provided in § 113.35 and found satisfactory by such test shall be packaged as diluent for desiccated fractions in combination packages.

(f) Formaldehyde content. If formaldehyde is used as the killing agent, the residual free formaldehyde content must not exceed 0.74 grams per liter (g/L) as determined using the ferric chloride test. 2 Firms currently using tests for residual free formaldehyde content other than the ferric chloride test have until July 14, 2004 to update their Outline of Production to be in compliance with this requirement.

2 The procedures for performing the ferric chloride test for residual free formaldehyde may be obtained from USDA, APHIS, Center for Veterinary Biologics-Laboratory, 1800 Dayton Road, P.O. Box 844, Ames, IA 50010.

[39 FR 27428, July 29, 1974, as amended at 40 FR 23989, June 4, 1975; 43 FR 49528, Oct. 24, 1978. Redesignated at 55 FR 35562, Aug. 31, 1990; 68 FR 35283, June 13, 2003; 79 FR 31021, May 30, 2014]

§§ 113.201-113.203 [Reserved]

§ 113.204 Mink Enteritis Vaccine, Killed Virus.

Mink Enteritis Vaccine, Killed Virus, shall be prepared from virus-bearing cell culture fluids or tissues obtained from mink that have developed mink enteritis following inoculation with virulent mink enteritis virus. Each serial shall meet the applicable requirements prescribed in § 113.200 and special requirements prescribed in this section. Any serial found unsatisfactory by a prescribed test shall not be released.

(a) Safety test. Vaccinates used in the potency test in paragraph (b) of this section shall be observed each day prior to challenge. If unfavorable reactions attributable to the vaccine occur, the serial is unsatisfactory. If unfavorable reactions not attributable to the vaccine occur, the test shall be declared a No Test and may be repeated: Provided, That, if the test is not repeated, the serial is unsatisfactory.

(b) Potency test. Bulk or final container samples of completed product shall be tested for potency using 10 mink enteritis susceptible mink (five vaccinates and five controls) as follows:

(1) Vaccination. Each of the five vaccinates shall be injected with one dose of vaccine as recommended on the label and observed each day for 14 days.

(2) Challenge. At least 2 weeks after the last inoculation, the five vaccinates and the five controls shall be challenged with virulent mink enteritis virus and observed each day for 12 days. Fecal material shall be collected on one day between days 4-8 (inclusive) postchallenge from each test animal that remains free of enteric signs and tested for the presence of mink enteritis virus by cell culture with fluorescent antibody examination.

(3) Interpretation. A serial is satisfactory if at least 80 percent of the vaccinates remain free of enteric signs and do not shed virus in the feces, while at least 80 percent of the controls develop clinical signs of mink enteritis or shed virus in the feces. If at least 80 percent of the vaccinates remain free of enteric signs and do not shed virus in the feces, while less than 80 percent of the controls develop clinical signs of mink enteritis or shed virus in the feces, the test is considered a No Test and may be repeated: Provided, That, if at least 80 percent of the vaccinates do not remain well and free of detectable virus in the feces, the serial is unsatisfactory.

[39 FR 27428, July 29, 1974. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66786, Dec. 26, 1991; 60 FR 14361, Mar. 17, 1995]

§ 113.205 Newcastle Disease Vaccine, Killed Virus.

Newcastle Disease Vaccine (Killed Virus) shall be prepared from virus-bearing tissues or fluids obtained from embryonated chicken eggs or cell cultures. With the exception of § 113.200(c)(2)(iii), each serial shall meet the applicable general requirements prescribed in § 113.200 and special requirements prescribed in this section. A serial found unsatisfactory by a prescribed test shall not be released.

(a) Safety test. The prechallenge part of the potency test in paragraph (b) of this section shall constitute a safety test. If unfavorable reactions attributable to the product occur in any of the vaccinates, the serial is unsatisfactory. If unfavorable reactions which are not attributable to the product occur, the test shall be declared a No Test and may be repeated: Provided, That, if the test is not repeated, the serial shall be declared unsatisfactory.

(b) Potency test. A vaccination-challenge test shall be conducted using susceptible chickens 2 to 6 weeks of age at time of vaccination, properly identified and obtained from the same source and hatch.

(1) Ten or more chickens shall be vaccinated as recommended on the label and kept isolated under observation for at least 14 days.

(2) After at least 14 days post-vaccination, the vaccinates and at least 10 unvaccinated chickens that have been kept isolated as controls shall be challenged with a virulent strain of Newcastle disease virus supplied by or approved by Veterinary Services and the vaccinates observed each day for 14 days.

(3) If at least 90 percent of the controls do not show typical signs of Newcastle disease or die, the test is a No Test and may be repeated. If at least 90 percent of the vaccinates do not remain normal, the serial is unsatisfactory.

[39 FR 27428, July 29, 1974. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66786, Dec. 26, 1991]

§ 113.206 Wart Vaccine, Killed Virus.

Wart Vaccine, Killed Virus, shall be prepared from virus-bearing epidermal tumors (warts) obtained from a bovine. Each serial shall meet the requirements prescribed in this section and any serial found unsatisfactory by a prescribed test shall not be released.

(a) Purity. Final container samples of completed product shall meet the requirements for purity as prescribed in § 113.200 (c)(1) and (3).

(b) Safety. Bulk or final container samples of completed product shall meet the requirements for safety as prescribed in §§ 113.33(b) and 113.38.

(c) Formaldehyde content. Bulk or final container samples of completed product shall meet the requirements for formaldehyde content as prescribed in § 113.200(f).

(d) Potency and efficacy. The efficacy of wart vaccine has been demonstrated to the satisfaction of Veterinary Services as being a valuable biological product. The inherent nature of the product precludes the possible development of serial to serial potency tests and none is required: Provided, That,

(1) The vaccine shall be a tissue extract representing at least 10 percent weight to volume suspension of wart tissue; and

(2) The vaccine shall be limited to use in the prevention of warts in cattle. Labeling recommendations shall be in accordance with § 112.7(h).

[40 FR 14084, Mar. 28, 1975, as amended at 40 FR 23989, June 4, 1975; 40 FR 30803, July 23, 1975. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66786, Dec. 26, 1991; 81 FR 59436, Aug. 30, 2016]

§ 113.207 Encephalomyelitis Vaccine, Eastern, Western, and Venezuelan, Killed Virus.

Encephalomyelitis Vaccine, Eastern, Western, and Venezuelan, Killed Virus, shall be prepared from virus-bearing cell culture fluids. Each serial or subserial shall meet the requirements prescribed in this section and the general requirements prescribed in § 113.200, except those in § 113.200(d). Any serial or subserial found unsatisfactory by a prescribed test shall not be released.

(a) Safety test. Bulk samples of completed product from each serial shall be tested for encephalomyelitis virus inactivation.

(1) Each of at least ten 6 to 12 hour old chickens shall be injected subcutaneously with 0.5 ml of the product and the chickens observed each day for 10 days.

(2) If unfavorable reactions attributable to the product occur in the chickens during the observation period, the serial is unsatisfactory. If unfavorable reactions not attributable to the product occur, the test is a No Test and may be repeated: Provided, That, if the test is not repeated, the serial is unsatisfactory.

(b) Potency test. Bulk or final container samples of completed product from each serial shall be tested for potency in accordance with the two-stage test provided in this paragraph. For each fraction contained in the product—Eastern type, Western type, or Venezuelan type—the serological interpretations required in this test shall be made independently. A serial or subserial found unsatisfactory for any of the fractions shall not be released.

(1) For this test, a guinea pig dose shall be one-half the amount recommended on the label for a horse and shall be administered as recommended for a horse. Each of 10 healthy guinea pigs (vaccinates) shall be injected with two guinea pig doses with an interval of 14 to 21 days between doses. Two additional guinea pigs from the same source shall be held as controls.

(2) Fourteen to 21 days after the second injection, serum samples from each vaccinate and each control shall be tested by a plaque reduction, serum neutralization test using Vero 76 cells.

(3) If the control serum samples show a titer of 1:4 or greater for any fraction, the test is a No Test for that fraction and may be repeated: Provided, That, if four or more of the vaccinate serum samples show a titer of less than 1:40 for the Eastern type fraction, less than 1:40 for the Western type fraction, or less than 1:4 for the Venezuelan type fraction, the serial or subserial is unsatisfactory without further testing.

(4) If two or three of the vaccinate serum samples show a titer of less than 1:40 for the Eastern type fraction, less than 1:40 for the Western type fraction, or less than 1:4 for the Venezuelan type fraction, the second stage of the test may be used for the relevant fraction(s): Provided, That, if a fraction is found acceptable by the first stage of the test, the second stage need not be conducted for that fraction.

(5) If the second stage is used and four or more of the vaccinate serum samples show a titer of less than 1:40 for the Eastern type fraction or the Western type fraction, or less than 1:4 for the Venezuelan type fraction, the serial or subserial is unsatisfactory.

(6) The results shall be evaluated according to the following table:

Cumulative Totals

Stage | Vaccinates | Failures for acceptance | Failures for rejection

1 | 10 | 1 or less | 4 or more.

2 | 20 | 3 or less | Do.

[39 FR 44714, Dec. 27, 1974, as amended at 40 FR 14084, Mar. 28, 1975; 42 FR 45284, Sept. 9, 1977. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66786, Dec. 26, 1991; 61 FR 67930, Dec. 26, 1996]

§ 113.208 Avian Encephalomyelitis Vaccine, Killed Virus.

Avian Encephalomyelitis Vaccine (Killed Virus) shall be prepared from virus-bearing tissues or fluids obtained from embryonated chicken eggs. Each serial shall meet the general requirements prescribed in § 113.200 and the requirements prescribed in this section. Any serial found unsatisfactory by a prescribed test shall not be released.

(a) Safety tests. (1) The prechallenge part of the potency test prescribed in paragraph (b) of this section shall constitute a safety test. If any of the vaccinates develop clinical signs of disease or die due to causes attributable to the product, the serial is unsatisfactory.

(2) An inactivation test for viable avian encephalomyelitis (AE) virus shall be conducted on each serial. The test shall be conducted using susceptible chicken embryos: Provided, That, if a non-embryo adapted virus is used for vaccine production, the test shall be conducted in susceptible chickens.

(i) Chicken Embryo Test. Each of 15 or more AE susceptible 5 or 6 day old embryos shall be injected in the yolk sac with 0.2 ml of the vaccine. For a valid test, at least 80 percent of the embryos shall survive for 48 hours post-inoculation (PI). Eleven to 13 days PI, all embryos surviving the 48 hour PI period shall be examined for gross lesions of AE; all these embryos shall be normal or the serial is unsatisfactory. Concurrently, five additional embryos from the same source shall be injected with live AE virus of the production strain to serve as positive controls. At least 4 of the 5 embryos shall show evidence of AE virus infection during the 11 to 13 day PI period or the test shall be considered a No Test and repeated: Provided, That, if the test is not repeated, the serial shall be declared unsatisfactory.

(ii) Chicken test. Each of 10 or more AE susceptible 7 day old chickens shall be injected intracerebrally with 0.1 ml vaccine each. The chickens shall be observed each day for 28 days. If any chickens show clinical signs of AE, the serial is unsatisfactory. Concurrently, 5 additional chickens from the same source shall be injected intracerebrally with live AE virus of the production strain to serve as positive controls. At least 4 of the 5 controls shall show evidence of AE virus infection during the observation period or the test shall be a No Test and may be repeated: Provided, That, if the test is not repeated, the serial shall be unsatisfactory.

(b) Potency test. Bulk or final container samples of completed product from each serial or one subserial shall be tested. Ten or more AE-susceptible chickens (vaccinates), 4 weeks or older, properly identified and obtained from the same source and hatch, shall be injected as recommended on the label. At least 10 additional AE-susceptible chickens, properly identified and obtained from the same source and hatch shall be kept in isolation as controls.

(1) At least 28 days post-injection, the vaccinates and the controls shall be challenged intramuscularly with a virulent AE virus and the chickens observed each day for 21 days.

(2) If at least 80 percent of the controls do not show clinical signs of or die from AE infection, the test is a No Test and may be repeated.

(3) If at least 80 percent of the vaccinates do not remain normal, the serial is unsatisfactory.

[39 FR 12958, Dec. 27, 1974, as amended at 40 FR 41088, Sept. 5, 1975. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66786, Dec. 26, 1991]

§ 113.209 Rabies Vaccine, Killed Virus.

Rabies Vaccine (Killed Virus) shall be prepared from virus-bearing cell cultures or nerve tissues obtained from animals that have developed rabies infection following injection with rabies virus. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed Virus.

(a) The Master Seed Virus shall meet the applicable requirements prescribed in § 113.200 and the requirements prescribed in this section.

(1) Each lot of Master Seed Virus propagated in tissue or cells of avian origin shall also be tested for extraneous pathogens by procedures prescribed in § 113.37.

(2) Each lot of Master Seed Virus propagated in primary cell cultures of mouse or hamster origin or brain tissues of mouse origin shall be tested for lymphocytic choriomeningitis (LCM) virus by the procedure prescribed in § 113.42. If LCM virus is detected, the Master Seed Virus is unsatisfactory.

(b) The immunogenicity of vaccine prepared with virus at the highest passage from the Master Seed shall be established in each species for which the vaccine is recommended. Tests shall be conducted in accordance with a protocol filed with Animal and Plant Health Inspection Service before initiation of the tests. The vaccine shall be prepared using methods prescribed in the Outline of Production. If Rabies Vaccine is to be in combination with other fractions, the product to be tested shall include all fractions to be tested.

(1) The preinactivation virus titer must be established as soon as possible after harvest by at least five separate virus titrations. A mean relative potency value of the vaccine to be used in the host animal potency test must be established by at least five replicate potency tests conducted in accordance with the standard NIH test for potency in chapter 37 of “Laboratory Techniques in Rabies,” Fourth Edition (1996), edited by F.X. Meslin, M.M. Kaplan, and H. Koprowski, World Health Organization, Geneva, Switzerland (ISBN 92 4 154479 1). The provisions of chapter 37 of “Laboratory Techniques in Rabies,” Fourth Edition (1996), are the minimum standards for achieving compliance with this section and are incorporated by reference. These provisions state that the challenge virus standard to be used as the challenge in the NIH test and the reference vaccine for the test are available from the national control authority. In the United States, that authority is the Animal and Plant Health Inspection Service's Center for Veterinary Biologics Laboratory, located at 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010; phone (515) 337-6100; fax (515) 337-6120. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the World Health Organization Publications Center USA, 49 Sheridan Avenue, Albany, NY 12210. Copies may be inspected at the Animal and Plant Health Inspection Service, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(2) The dose of vaccine to be used in the immunogenicity test shall be no more than the amount which, on the basis of The NIH Test For Potency, has been diluted to the proposed minimum acceptable potency value. 1

(3) Test animals shall be uniform and have no neutralizing antibodies to rabies as determined by serum-neutralization (SN) tests.

(i) Twenty-five or more animals shall be used as vaccinates. Each shall be administered a dose of vaccine at the proposed minimum potency level and by the method specified in the Outline of Production.

(ii) Ten or more additional animals shall be held as controls.

(iii) On or about 30, 90, 180, 270, and 365 days postvaccination, all test animals shall be bled and individual serum samples tested for neutralizing antibodies to rabies virus.

(iv) All surviving test animals shall be challenged intramuscularly with virulent rabies virus furnished or approved by Animal and Plant Health Inspection Service 1 year after vaccinations, except as provided in (b)(4) of this section. The challenged animals shall be observed each day for 90 days as prescribed in § 113.5(b). The brain of each test animal that dies following challenges shall be examined for rabies by the fluorescent antibody test or other method acceptable to Animal and Plant Health Inspection Service.

(v) Requirements for acceptance in challenge tests shall be death due to rabies in at least 80 percent of the controls while at least 22 of 25 or 26 of 30 or a statistically equivalent number of the vaccinates remain well for a period of 90 days.

(4) An alternative to challenging all surviving test animals in accordance with paragraph (b)(3)(iv) of this section may be used when the test animals are of species other than carnivores. Vaccinates shall be challenged at 1 year postvaccination. These shall include five vaccinates with the lowest SN titers at the 270th-day bleeding, five vaccinates with the lowest SN titers at the 365th-day bleeding, and all vaccinates with SN titers below 1:10 by the mouse SN test or below 1:16 by the rapid-fluorescent-focus-inhibition test at any bleeding. At least five SN-negative controls of each species shall be challenged at the same time as the vaccinates. All SN titers shall be titrated to an endpoint. All of the challenged vaccinates must remain well for a period of 90 days, and at least 80 percent of the controls must die of rabies for a satisfactory test without further challenge. If one or more of the vaccinates die from rabies, all the remaining vaccines, regardless of titer, along with the five controls shall be challenged. The cumulative results from the two challenges shall be evaluated for acceptance as specified in paragraph (b)(3)(v) of this section.

(5) An Outline of Production change shall be made before authority for use a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.

(c) If more than 1 year duration of immunity is to be claimed, a duration of immunity test for the additional time shall be conducted and interpreted as prescribed in paragraph (b) of this section for the 1 year test. The test animals shall be monitored serologically at least every 180 days. The time of challenge may be adjusted accordingly.

(d) Test requirements for release: Each serial and each subserial shall meet the general requirements prescribed in § 113.200 and special requirements in this paragraph.

(1) Purity test. Primary cell cultures of hamster origin or brain tissues of mouse origin used in vaccine production shall be tested for LCM virus as prescribed in § 113.42. Hamster origin cells shall be disrupted and undiluted cell fluids from each lot shall be tested. Where mouse brains are used in production, at least five mice which have not been injected with rabies virus shall be sacrificed and a 10 percent suspension of brain material shall be prepared and tested.

(2) Safety tests. Bulk samples from each serial shall be tested for virus inactivation and safety as follows:

(i) At the end of the inactivation period, each of 20 12 to 16 gram mice shall be injected intracerebrally with 0.03 ml and two rabbits shall be injected into each cerebral hemisphere with 0.25 ml and observed each day for 21 days. The brains of animals dying between the fourth and 21st day post-injection shall be checked for rabies virus. Material from each brain recovered shall be injected into each of five mice and the mice observed each day for 14 days. The fluorescent antibody test or serum neutralization test shall be used to confirm the presence or absence or live rabies virus. If live rabies virus is confirmed, the serial is unsatisfactory unless reprocessed in accordance with § 114.18.

(ii) A test for safety in three young seronegative animals of the most susceptible species for which the vaccine is recommended shall be conducted. Each shall in injected intramuscularly with one recommended dose of vaccine. If unfavorable reactions attributable to the product occur during a 28 day observation period, the serial is unsatisfactory.

(3) Potency test. Bulk or final container samples of completed product from each serial must be tested for potency by tests conducted in accordance with the standard NIH test for potency in Chapter 37 of “Laboratory Techniques in Rabies,” Fourth Edition (1996), which is incorporated by reference at paragraph (b)(1) of this section. The relative potency of each serial must be at least equal to that used in an approved host animal immunogenicity test.

[39 FR 44715, Dec. 27, 1974, as amended at 42 FR 6794, Feb. 4, 1977; 43 FR 49528, Oct. 24, 1978; 50 FR 20090, May 14, 1985. Redesignated at 55 FR 35562, Aug. 31, 1990; 56 FR 66784, 66786, Dec. 26, 1991; 61 FR 31823, June 21, 1996; 64 FR 45420, Aug. 20, 1999; 69 FR 18803, Apr. 9, 2004; 75 FR 20773, Apr. 21, 2010]

§ 113.210 Feline Calicivirus Vaccine, Killed Virus.

Feline Calicivirus Vaccine, Killed Virus, shall be prepared from virus-bearing cell culture fluids. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for preparing seeds for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed.

(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.200.

(b) The Master Seed shall be tested for chlamydial agents as prescribed in § 113.43.

(c) The immunogenicity of vaccine prepared from the Master Seed in accordance with the Outline of Production shall be established by a method acceptable to Animal and Plant Health Inspection Service. Vaccine used for this test shall be at the highest passage from the Master Seed and prepared at the minimum preinactivation titer specified in the Outline of Production.

(d) Test requirements for release. Each serial and subserial shall meet the applicable general requirements prescribed in § 113.200 and the special requirements provided in this paragraph. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.

(1) Safety. Vaccinates used in the potency test in paragraph (d)(2) of this section shall be observed each day during the prechallenge period. If unfavorable reactions occur, including oral lesions, which are attributable to the vaccine, the serial is unsatisfactory. If unfavorable reactions occur which are not attributable to the vaccine, the test is inconclusive and may be repeated. If the test is not repeated, the serial is unsatisfactory.

(2) Potency. Bulk or final container samples of completed product shall be treated for potency as follows:

(i) Eight feline calicivirus susceptible cats (five vaccinates and three controls) shall be used as test animals. Throat and nasal swabs shall be collected from each cat and individually tested on susceptible cell cultures for the presence of feline calicivirus. Blood samples shall be drawn and individual serum samples tested for neutralizing antibody. The cats shall be considered suitable for use if all swabs are negative for virus isolation and all serums are negative for calicivirus antibody at the 1:2 final dilution in a 50 percent plaque reduction test or other test of equal sensitivity.

(ii) The five cats used as vaccinates shall be administered one dose of vaccine by the method recommended on the label. If two doses are recommended, the second dose shall be given after the interval recommended on the label.

(iii) Fourteen or more days after the final dose of vaccine, the vaccinates and controls shall each be challenged intranasally with virulent feline calicivirus furnished or approved by Animal and Plant Health Inspection Service and observed each day for 14 days postchallenge. The rectal temperature of each animal shall be taken and the presence or absence of clinical signs, particularly lesions on the oral mucosa, noted and recorded each day.

(iv) If three of three controls do not show clinical signs of feline calicivirus infection other than fever, the test is inconclusive and may be repeated.

(v) If a significant difference in clinical signs cannot be demonstrated between vaccinates and controls using a scoring system approved by Animal and Plant Health Inspection Service and prescribed in the Outline of Production, the serial is unsatisfactory.

[50 FR 433, Jan. 4, 1985. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66784, 66786, Dec. 26, 1991]

§ 113.211 [Reserved]

§ 113.212 Bursal Disease Vaccine, Killed Virus.

Bursal Disease Vaccine, Killed Virus, shall be prepared from virus-bearing cell culture fluids or embryonated chicken eggs. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for preparing seeds for vaccine production. All serials shall be prepared from the first through the fifth passage from the Master Seed.

(a) The Master Seed shall meet the applicable requirements prescribed in § 113.200.

(b) Each lot of Master Seed shall be tested for pathogens by the chicken embryo inoculation test prescribed in § 113.37, except that, if the test is a No Test because of a vaccine virus override, the chicken inoculation test prescribed in § 113.36 may be conducted and the virus judged accordingly.

(c) The immunogenicity of vaccine prepared in accordance with the Outline of Production shall be established by a method acceptable to Animal and Plant Health Inspection Service. Vaccine used for this test shall be at the highest passage from the Master Seed and prepared at the minimum preinactivation titer specified in the Outline of Production. The test shall establish that the vaccine, when used as recommended on the label, is capable of inducing an immune response in dams of sufficient magnitude to provide significant protection to offspring.

(d) Test requirements for release. Each serial and subserial shall meet the applicable general requirements prescribed in § 113.200 and the special requirements in this paragraph. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.

(1) Safety. Vaccinates used in the potency test in paragraph (d)(2) of this section shall be observed each day during the prechallenge period. If unfavorable reactions attributable to the vaccine occur, the serial is unsatisfactory. If unfavorable reactions which are not attributable to the vaccine occur, the test is a No Test and may be repeated. If the test is not repeated, the serial is unsatisfactory.

(2) Potency. Bulk or final container samples of completed product from each serial shall be tested for potency using the two-stage potency test provided in this paragraph.

(i) Vaccinates. Inject each of 21 susceptible chickens 14 to 28 days of age, properly identified and obtained from the same source and hatch, with one dose of vaccine by the route recommended on the label and observe for at least 21 days.

(ii) Controls. Retain at least 10 additional chickens from the same source and hatch as unvaccinated controls.

(iii) Challenge. Twenty-one to 28 days postvaccination, challenge 20 vaccinates and 10 controls by eyedrop with a virulent infectious bursal disease virus furnished or approved by Animal and Plant Health Inspection Service.

(iv) Postchallenge period. Four days postchallenge, necropsy all chickens and examine each for gross lesions of bursal disease. For purposes of this test, gross lesions shall include peribursal edema and/or edema and/or macroscopic hemorrhage in the bursal tissue. Vaccinated chickens showing gross lesions shall be counted as failures. If at least 80 percent of the controls do not have gross lesions of bursal disease in a stage of the test, that stage is considered inconclusive and may be repeated. In a valid test, the results shall be evaluated according to the following table:

Stage | Number of vaccinates | Cumulative number of vaccinates | Cumulative total number of failures for—

Satisfactory serial | Unsatisfactory serial

1 | 20 | 20 | 3 or less | 6 or more.

2 | 20 | 40 | 8 or less | 9 or more.

(v) If four or five vaccinates show lesions of bursal disease in the first stage, the second stage may be conducted in a manner identical to the first stage. If the second stage is not conducted, the serial is unsatisfactory.

(vi) If the second stage is used, each serial shall be evaluated according to the second part of the table on the basis of cumulative results.

[50 FR 434, Jan. 4, 1985. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66784, 66786, Dec. 26, 1991; 79 FR 55969, Sept. 18, 2014]

§§ 113.213-113.214 [Reserved]

§ 113.215 Bovine Virus Diarrhea Vaccine, Killed Virus.

Bovine Virus Diarrhea Vaccine, Killed Virus, shall be prepared from virus-bearing cell culture fluids. Only Master Seed virus which has been established as pure, safe, and immunogenic shall be used for preparing seed cultures for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed.

(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.200 and the requirements of this section.

(b) The immunogenicity of vaccine prepared from the Master Seed in accordance with the Outline of Production shall be established by a method acceptable to the Animal and Plant Health Inspection Service. Vaccine used for this test shall be at the highest passage from the Master Seed and at the minimum preinactivation titer provided in the Outline of Production.

(c) Test requirements for release. Each serial and subserial shall meet the applicable general requirements prescribed in § 113.200 and the special requirements provided in this paragraph. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.

(1) Safety. Vaccinates used in the potency test in paragraph (c)(2) of this section shall be observed each day during the prechallenge period. If unfavorable reactions occur, including respiratory signs, which are attributable to the vaccine, the serial is unsatisfactory. If unfavorable reactions occur which are not attributable to the vaccine, the test is a No Test and may be repeated one time. If results of the second test are not satisfactory, or if the test is not repeated, the serial is unsatisfactory.

(2) Potency. Bulk or final container samples of completed product shall be tested for potency using the method described in this paragraph.

(i) Eight bovine virus diarrhea susceptible calves (five vaccinates and three controls) shall be used as test animals. Individual serum samples shall be collected, inactivated, and individually tested for neutralizing antibody.

(ii) A constant virus decreasing serum neutralization test in cell culture using 50-300 TCID50 of virus shall be used. Calves shall be considered susceptible if there is no neutralization at 1:2 final serum dilution. Other tests of equal sensitivity approved by the Animal and Plant Health Inspection Service may be used.

(iii) The five calves used as vaccinates shall be administered one dose of vaccine as recommended on the label. If two doses are recommended, the second dose shall be given according to the interval recommended on the label.

(iv) Fourteen days or more after the last vaccination, blood samples shall be drawn and the individual serum samples inactivated and tested for bovine virus diarrhea virus neutralizing antibody by the same method used to determine susceptibility.

(v) Test interpretation. If the controls have not remained seronegative at 1:2, the test is a No Test (NT) and may be repeated. If at least four of the five vaccinates in a valid test have not developed 50 percent endpoint titers of 1:8 or greater, the serial is unsatisfactory, except as provided in paragraph (c)(2)(vi) of this section.

(vi) Virus Challenge Test. If the results of a valid serum neutralization test are unsatisfactory, the vaccinates and controls may be challenged with virulent bovine virus diarrhea virus furnished or approved by the Animal and Plant Health Inspection Service. The animals shall be observed for 14 days post-challenge. If two of the three control calves do not show a temperature rise to 104.5 °F and develop respiratory or clinical signs of bovine virus diarrhea, the test is a No Test and may be repeated one time. If two or more vaccinates show a temperature of 104.0 °F for 2 or more days and develop respiratory or clinical or other signs, the serial is unsatisfactory.

(vii) The prevaccination and postvaccination sera from a satisfactory potency test shall be submitted to the National Veterinary Services Laboratories for confirmatory testing.

[55 FR 35562, Aug. 31, 1990]

§ 113.216 Bovine Rhinotracheitis Vaccine, Killed Virus.

Infectious Bovine Rhinotracheitis Vaccine, Killed Virus, shall be prepared from virus-bearing cell culture fluids. Only Master Seed virus which has been established as pure, safe, and immunogenic shall be used for preparing seed cultures for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed.

(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.200 and the requirements of this section.

(b) The immunogenicity of vaccine prepared in accordance with the Outline of Production shall be established by a method acceptable to the Animal and Plant Health Inspection Service. Vaccine used for this test shall be at the highest passage from the Master Seed and at the minimum preinactivation titer provided in the Outline of Production.

(c) Test requirements for release. Each serial and subserial shall meet the requirements prescribed in § 113.200 and the special requirements provided in this paragraph. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.

(1) Safety. Vaccinates used in the potency test in paragraph (c)(2) of this section shall be observed each day during the prechallenge period. If unfavorable reactions occur, which are attributable to the vaccine, the serial is unsatisfactory. If unfavorable reactions occur which are not attributable to the vaccine, the test is a No Test and may be repeated one time. If the results of the second test are not satisfactory, or if the test is not repeated, the serial is unsatisfactory.

(2) Potency. Bulk or final container samples of completed product shall be tested for potency using the method described in this paragraph.

(i) Eight infectious bovine rhinotracheitis susceptible calves (five vaccinates, three controls) shall be used as test animals. Individual serum samples shall be collected, inactivated, and individually tested for neutralizing antibody.

(ii) A constant virus decreasing serum neutralization test in cell culture using 50-300 TCID50 of virus shall be used. Calves shall be considered susceptible if there is no neutralization at 1:2 final serum dilution. Other tests of equal sensitivity acceptable to the Animal and Plant Health Inspection Service may be used.

(iii) The five calves used as vaccinates shall be administered one dose of vaccine as recommended on the label. If two doses are recommended, the second dose shall be given according to the interval recommended on the label.

(iv) Fourteen or more days after the last vaccination, blood samples shall be drawn and the individual serum samples inactivated and tested for infectious bovine rhinotracheitis virus neutralizing antibody by the same method used to determine susceptibility.

(v) Test interpretation. If the three controls have not remained seronegative at 1:2, the test is a No Test (NT) and may be repeated. If at least four of the five vaccinates in a valid test have not developed 50 percent endpoint titers of 1:8, the serial is unsatisfactory, except as provided in paragraph (c)(2)(vi) of this section.

(vi) Virus Challenge Test. If the results of a valid serum neutralization test are unsatisfactory, the vaccinates and controls may be challenged with virulent infectious bovine rhinotracheitis virus furnished or approved by the Animal and Plant Health Inspection Service. The animals shall be observed each day for 14 days post-challenge. If two of the three control calves do not show a temperature rise to 104.5 °F and develop respiratory or other clinical signs of infectious bovine rhinotracheitis, the test is a No Test (NT) and may be repeated one time. If more than one of the vaccinates shows a temperature of 104.0 °F for 2 or more days or if more than one of the vaccinates develops respiratory or clinical or other signs, the serial is unsatisfactory.

(vii) The prevaccination and postvaccination sera from a satisfactory potency test shall be submitted to the National Veterinary Services Laboratories for testing by the Animal and Plant Health Inspection Service.

[55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66786, Dec. 26, 1991]

§ 113.300 General requirements for live virus vaccines.

When prescribed in an applicable Standard Requirement or in the filed Outline of Production, a live virus vaccine shall meet the applicable requirements in this section.

(a) Purity tests—(1) Bacteria and fungi. Final container samples of completed product and comparable samples of each lot of Master Seed Virus shall be tested for bacteria and fungi in accordance with the test provided in § 113.27.

(2) Mycoplasma. Final container samples of completed product and comparable samples of each lot of Master Seed Virus shall be tested for mycoplasma in accordance with the test provided in § 113.28.

(3) Avian Origin Vaccine. Samples of each lot of Master Seed Virus and bulk pooled material or final container samples from each serial shall also be tested for:

(i) Salmonella contamination as prescribed in § 113.30; and

(ii) Lymphoid leukosis virus contamination as prescribed in § 113.31; and

(iii) Hemagglutinating viruses as prescribed in § 113.34.

(4) Extraneous viruses. Each lot of Master Seed Virus used to prepare live virus vaccine recommended for animals other than poultry shall meet the requirements for extraneous viruses as prescribed in § 113.55

(b) Safety tests. Samples of each lot of Master Seed Virus and final container samples of completed product from each serial or first subserial of live virus vaccine recommended for animals other than poultry shall be tested for safety in at least one species for which the vaccine is intended using methods prescribed in §§ 113.39, 113.40, 113.41, 113.44, and 113.45 or in a filed Outline of Production. The mouse safety test prescribed in § 113.33(a) shall also be conducted unless the virus or agent in the vaccine is inherently lethal for mice.

(c) Virus identity test. At least one of the virus identity tests provided in this paragraph or a suitable identity test prescribed in the filed Outline of Production shall be conducted on the Master Seed Virus and final container samples from each serial or first subserial of biological product.

(1) Fluorescent antibody test. The fluorescent antibody test shall be conducted using virus inoculated cells and uninoculated control cells. Cells shall be stained with fluorochrome conjugated specific antiserum. Fluorescence typical of the virus concerned shall be demonstrated in the inoculated cells. The control cells shall remain free of such fluorescence.

(2) Serum neutralization test. The serum neutralization test shall be conducted using the constant serum-decreasing virus method with specific antiserum. For positive identification, at least 100 ID50 of vaccine virus shall be neutralized by the antiserum.

(d) Cell Culture Requirements. If cell cultures are used in the preparation of Master Seed Virus or of the vaccine, primary cells shall meet the requirements prescribed in § 113.51, cell lines shall meet the requirements prescribed in § 113.52, and ingredients of animal origin shall meet the applicable requirements in § 113.53.

(e) Moisture content. (1) The maximum moisture content in desiccated vaccines must be stated in the filed Outline of Production.

(2) Final container samples of completed product from each serial or subserial must be tested for moisture content in accordance with the test prescribed in § 113.29.

[39 FR 27430, July 29, 1974, as amended at 43 FR 49528, Oct. 24, 1978; 50 FR 1042, Jan. 9, 1985; 54 FR 19352, May 5, 1989. Redesignated at 55 FR 35562, Aug. 31, 1990; 60 FR 24549, May 9, 1995; 68 FR 57608, Oct. 6, 2003]

§ 113.301 Ovine Ecthyma Vaccine.

Ovine Ecthyma Vaccine shall be prepared from tissue culture fluids or virus-bearing tissues obtained from sheep that have developed ovine ecthyma following inoculation with virulent ovine ecthyma virus. Ovine Ecthyma Vaccine is exempt from the requirements prescribed in §§ 113.27 and 113.300(a), (b), and (c). Each serial shall meet the moisture requirements in § 113.300(e) and the special requirements prescribed in this section. Any serial found unsatisfactory by a prescribed test shall not be released.

(a) Safety tests. (1) Bulk or final container samples of completed product from each serial shall be tested for safety as prescribed in § 113.38.

(2) The prechallenge period of the potency test shall constitute a safety test. If unfavorable reactions attributable to the vaccine occur in either of the vaccinates during the observation period, the serial is unsatisfactory.

(b) Potency test. Final container samples of completed product from each serial and each subserial shall be tested for potency using susceptible lambs. The vaccine shall be prepared as recommended for use on the label.

(1) Each of two lambs (vaccinates) shall be vaccinated by application of the vaccine to a scarified area on the medial surface of the thigh and observed each day for 14 days.

(2) The immunity of the two vaccinates and one or more unvaccinated lambs (controls) shall be challenged in the same manner as for vaccination, using the opposite thigh.

(3) If typical signs of ovine ecthyma, such as hyperemia, vesicles, and pustules do not develop on the controls during the first 2 weeks following challenge and persist for approximately 30 days, the test is a No Test and may be repeated.

(4) If the vaccinates do not show a typical immune reaction, the serial is unsatisfactory: Provided, That, an initial active reaction with hyperemia which resolves progressively and disappears within 2 weeks, may be characterized as a typical immune reaction.

[39 FR 27430, July 29, 1974. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66786, Dec. 26, 1991]

§ 113.302 Distemper Vaccine—Mink.

Distemper Vaccine—Mink shall be prepared from virus-bearing cell culture fluids. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed Virus.

(a) The Master Seed Virus shall meet the applicable requirements prescribed in § 113.300 and the requirements prescribed in this section.

(b) The lot of Master Seed Virus shall be tested for extraneous viruses as follows:

(1) To detect virulent canine distemper virus, each of two distemper susceptible mink or ferrets shall be inoculated with 1 ml of the Master Seed Virus and observed each day for 21 days. If undesirable reactions occur in either test animal, the lot of Master Seed Virus is unsatisfactory.

(2) Master Seed Virus propagated in chicken embryos shall be tested for pathogens by the chicken embryo test prescribed in § 113.37 except lesions typical of distemper virus may be disregarded. If found unsatisfactory, the Master Seed Virus shall not be used.

(c) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity. The selected virus dose from the lot of Master Seed Virus shall be established as follows:

(1) At least 25 distemper susceptible mink shall be used as test animals. Blood samples shall be drawn from these animals and individual serum samples tested. The mink shall be considered susceptible if the results are negative at a 1:2 final serum dilution in a varying serum-constant virus neutralization test with less than 500 ID50 of canine distemper virus. Other means of insuring susceptibility may be used if prior approval from Animal and Plant Health Inspection Service is received.

(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. At least 20 mink shall be vaccinated with a predetermined quantity of vaccine virus and at least 5 additional mink shall be held as unvaccinated controls. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.

(3) At least twenty-one days post-injection, the immunity of each of the vaccinates and the controls shall be challenged with the same size dose of virulent distemper virus and observed each day for 21 days.

(i) If at least 80 percent of the controls do not die or show severe signs of distemper, the test is a No Test and may be repeated.

(ii) If at least 19 of 20, 27 of 30, or 36 of 40 of the vaccinates do not survive without showing clinical signs of distemper during the observation period, the Master Seed Virus is unsatisfactory.

(4) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be authorized by Animal and Plant Health Inspection Service.

(d) Test requirements for release: Each serial and subserial shall meet the general requirements prescribed in § 113.300 and the requirements in this paragraph. Final container samples of completed product shall be tested. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.

(1) Mink safety test. Each of 2 mink shall be vaccinated with the equivalent of 10 doses of vaccine rehydrated with sterile diluent and administered in the manner recommended on the label. The mink shall be observed each day for 21 days. If unfavorable reactions attributable to the product occur in either of the mink during the observation period, the serial or subserial is unsatisfactory. If unfavorable reactions which are not attributable to the product occur, the test shall be declared a No Test and may be repeated: Provided, That if the test is not repeated, the serial or subserial shall be declared unsatisfactory.

(2) Potency Test. An in vitro potency test shall be conducted. To be eligible for release, each serial and subserial shall have a virus titer sufficiently greater than the titer of vaccine virus used in the immunogenicity test prescribed in paragraph (c) of this section to assure that, when tested at any time within the expiration period, each serial and subserial shall have a virus titer 10 0.7 greater than that used in such immunogenicity test when tested by the method used in paragraph (c)(2) of this section.

[40 FR 53000, Nov. 14, 1975, as amended at 48 FR 33471, July 22, 1983. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66784, 66786, Dec. 26, 1991; 72 FR 72564, Dec. 21, 2007]

§ 113.303 Bluetongue Vaccine.

Bluetongue Vaccine shall be prepared from virus-bearing cell culture fluids. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for preparing the seeds for vaccine production. All serials of vaccine shall be prepared from the first through the tenth passage from the Master Seed.

(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.300 and the requirements in this section.

(b) Each lot of Master Seed shall be tested for transmissibility and reversion to virulence in sheep using a method acceptable to Animal and Plant Health Inspection Service. If reversion to virulence is demonstrated, the Master Seed is unsatisfactory.

(c) Each lot of Master Seed used for vaccine production shall be tested for immunogenicity. The selected virus dose from the lot of Master Seed shall be established as follows:

(1) Twenty-five lambs, susceptible to the bluetongue virus serotype contained in the vaccine, shall be used as test animals (20 vaccinates and 5 controls). Blood samples shall be drawn from these animals and individual serums tested. A lamb shall be considered susceptible if there is no neutralization at a 1:2 final serum dilution in a constant virus varying serum neutralization test with 60 to 300 TCID50 of bluetongue virus or another method acceptable to Animal and Plant Health Inspection Service.

(2) A geometric mean titer of the vaccine produced from the highest passage from the Master Seed shall be established before the immunogenicity test is conducted. The 20 lambs to be used as vaccinates shall be administered a predetermined quantity of vaccine virus by the method recommended on the label. To confirm the virus dosage administered, five replicate virus titrations shall be conducted on a sample of the vaccine used.

(3) At least once during the period of 14 to 18 days postvaccination, individual serum samples shall be collected from each of the vaccinates and tested for virus neutralizing antibody using the 60 to 300 TCID50 of bluetongue virus.

(4) Twenty-one to twenty-eight days postvaccination the vaccinates and the controls shall each be challenged with virulent bluetongue virus and observed for 14 days. The rectal temperature of each animal shall be taken and recorded for 17 consecutive days beginning 3 days prechallenge. The presence or absence of lesions or other clinical signs of bluetongue noted and recorded on each of 14 consecutive days postchallenge.

(i) If at least four of the five controls do not show clinical signs of bluetongue and a temperature rise of 3 °F or higher over the prechallenge mean temperature, the test shall be considered a No Test and may be repeated.

(ii) If at least 19 of the 20 vaccinates tested as prescribed in paragraph (c)(3) of this section do not have bluetongue neutralizing antibody titers of 1:4 final serum dilution or higher, or if more than one of the vaccinates shows a temperature rise of 3 °F or higher than its prechallenge mean temperature for 2 or more days, or if more than one of the vaccinates exhibits clinical signs of bluetongue, the Master Seed is unsatisfactory.

(5) An Outline of Production change shall be made before authority for use of a new lot of Master Seed shall be granted by Animal and Plant Health Inspection Service.

(d) Test requirements for release. Each serial and subserial shall meet the applicable general requirements prescribed in § 113.300 and the requirements in this paragraph. Final container samples of completed product shall be tested. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.

(1) Safety test. The mouse safety test prescribed in § 113.33(a) and the lamb safety test prescribed in § 113.45 shall be conducted.

(2) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the titration method used in paragraph (c)(2) of this section. To be eligible for release, each serial and subserial shall have a virus titer sufficiently greater than the titer of vaccine virus used in the immunogenicity test prescribed in paragraph (c) of this section to assure that when tested at any time within the expiration period, each serial and subserial shall have a virus titer of 10 0.7 greater than that used in such immunogenicity test.

[50 FR 23796, June 6, 1985. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66784, 66786, Dec. 26, 1991; 72 FR 72564, Dec. 21, 2007]

§ 113.304 Feline Panleukopenia Vaccine.

Feline Panleukopenia Vaccine shall be prepared from virus-bearing cell culture fluids. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed Virus.

(a) The Master Seed Virus shall meet the applicable general requirements prescribed in § 113.300 and the requirements prescribed in this section.

(b) The lot of Master Seed Virus shall be tested for other agents as follows:

(1) To detect virulent feline panleukopenia virus or virulent mink enteritis virus, each of two feline panleukopenia susceptible cats, as determined by the criteria prescribed in paragraph (c)(1) of this section, shall be injected subcutaneously with the equivalent of one cat dose each and the cats observed each day for 21 days. If either or both cats show signs of disease or reduced white blood cell counts below 50 percent of the normal level established by an average of three or more counts taken prior to injection, the Master Seed Virus is unsatisfactory.

(2) To detect chlamydial agents, the Master Seed Virus shall be tested as prescribed in § 113.43.

(c) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity. The selected virus dose from the lot of Master Seed Virus shall be established as follows:

(1) Twenty-five feline panleukopenia susceptible cats shall be used as test animals (20 vaccinates and 5 controls). Blood samples drawn from each cat shall be individually tested for neutralizing antibody against feline panleukopenia virus to determine susceptibility.

(i) A constant virus-carrying serum neutralization test in tissue culture using 100 to 300 TCID50 of virus shall be used.

(ii) Cats shall be considered susceptible if there is no neutralization at a 1:2 final serum dilution.

(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. The 20 cats used as vaccinates shall be injected with a predetermined quantity of vaccine virus and the remaining five cats held as uninjected controls. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.

(3) Fourteen days post-injection, the vaccinates and the controls shall be challenged with virulent feline panleukopenia virus furnished by Animal and Plant Health Inspection Service and the cats observed each day for 14 days.

(i) If at least 80 percent of the controls do not show clinical signs of feline panleukopenia during the observation period, the test is a No Test and may be repeated. Clinical signs of feline panleukopenia shall include a pronounced leukopenia wherein the white cell count drops to 4,000 or less per cubic mm, or the white cell count drops to less than 25 percent of the normal level established by an average of three or more counts taken prior to challenge.

(ii) If at least 19 of the 20 vaccinates do not survive the observation period without showing clinical signs of feline panleukopenia as described in paragraph (c)(3)(i) of this section, the Master Seed Virus is unsatisfactory.

(4) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.

(d) Test requirements for release. Each serial and subserial shall meet the requirements prescribed in § 113.300 and in this paragraph. Final container samples of completed product shall be tested. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.

(1) Safety test. The mouse safety test prescribed in § 113.33(a) and the cat safety test prescribed in § 113.39 shall be conducted.

(i) Each of two healthy cats shall be injected with 10 cat doses by the method recommended on the label and the cats observed each day for 14 days.

(ii) If unfavorable reactions attributable to the biological product occur during the observation period, the serial is unsatisfactory. If unfavorable reactions occur which are not attributable to the product, the test shall be declared a No Test and repeated: Provided, That, if not repeated, the serial shall be unsatisfactory.

(2) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the titration method used in paragraph (c)(2) of this section. To be eligible for release, each serial and each subserial shall have a virus titer sufficiently greater than the titer of vaccine virus used in the immunogenicity test prescribed in paragraph (c) of this section to assure that when tested at any time within the expiration period, each serial and subserial shall have a virus titer of 10 0.7 greater than that used in such immunogenicity test but not less than 10 2.5 TCID50 per dose.

[39 FR 44716, Dec. 27, 1974, as amended at 40 FR 53378, Nov. 18, 1975; 43 FR 25078, June 9, 1978; 43 FR 41186, Sept. 15, 1978; 44 FR 58900, Oct. 12, 1979; 48 FR 33471, July 22, 1983. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66784, 66786, Dec. 26, 1991; 72 FR 72564, Dec. 21, 2007]

§ 113.305 Canine Hepatitis and Canine Adenovirus Type 2 Vaccine.

Canine Hepatitis Vaccine and Canine Adenovirus Type 2 Vaccine shall be prepared from virus-bearing cell culture fluids. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used in preparing the production seed virus for vaccine production. All serials shall be prepared from the first through the fifth passage from the Master Seed Virus.

(a) The Master Seed Virus shall meet the applicable requirements prescribed in § 113.300 except that the dog safety test prescribed in § 113.40(a) shall be conducted by the intravenous route.

(b) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity by one or both of the following methods:

(1) Immunogenicity for canine hepatitis. Twenty-five canine hepatitis susceptible dogs shall be used as test animals (20 vaccinates and 5 controls). Blood samples shall be drawn from these animals and individual serum samples tested. The dogs shall be considered susceptible if the results are negative at a 1:2 final serum dilution in a varying serum-constant virus neutralization test using 50 to 300 TCID50 of canine adenovirus.

(i) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. The 20 dogs to be used as vaccinates shall be injected with a predetermined quantity of vaccine virus and the remaining five dogs held as uninjected controls. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.

(ii) Not less than 14 days postinjection, the vaccinates and the controls shall each be challenged intravenously with virulent infectious canine hepatitis virus furnished or approved by the Animal and Plant Health Inspection Service and observed each day for 14 days.

(A) If at least four of the five controls do not show severe clinical signs of canine hepatitis, the test is a No Test and may be repeated.

(B) If at least 19 of the 20 vaccinates do not survive without showing clinical signs of infectious canine hepatitis during the observation period, the Master Seed Virus is unsatisfactory.

(2) Immunogenicity for canine adenovirus Type 2. Thirty canine adenovirus type 2 susceptible dogs shall be used as test animals (20 vaccinates and 10 controls). Blood samples shall be drawn from these animals and individual serum samples tested. The dogs shall be considered susceptible if the results are negative at a 1:2 final serum dilution in a varying serum-constant virus neutralization test using 50 to 300 TCID50 of canine adenovirus.

(i) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. The 20 dogs to be used as vaccinates shall be injected with a predetermined quantity of vaccine virus and the remaining 10 dogs held as uninjected controls. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.

(ii) Not less than 14 days postinjection, the vaccinates and the controls shall be challenged by exposure to a nebulized aerosol of virulent canine adenovirus type 2 furnished or approved by the Animal and Plant Health Inspection Service and observed each day for 14 days postchallenge. The rectal temperature of each animal shall be taken and the presence of respiratory or other clinical signs of canine adenovirus type 2 noted and recorded each day.

(A) If at least 6 of 10 controls do not show clinical signs of canine adenovirus type 2 infection other than fever, the test is a No Test and may be repeated.

(B) If a significant difference in clinical signs in a valid test cannot be demonstrated between vaccinates and controls using a scoring system approved by the Animal and Plant Health Inspection Service, the Master Seed Virus is unsatisfactory.

(iii) An Outline of Production change shall be made before authorization for use of a new lot of Master Seed Virus shall be granted by the Animal and Plant Health Inspection Service.

(c) Test requirements for release. Each serial and subserial shall meet the requirements prescribed in § 113.300 and in this paragraph. Final container samples of completed product shall be tested. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.

(1) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the titration method used in paragraph (b)(1)(i) and/or (b)(2)(i) of this section. To be eligible for release, each serial and each subserial shall have a virus titer sufficiently greater than the titer of vaccine virus used in the immunogenicity test(s) prescribed in paragraph (b) of this section to assure that when tested at any time within the expiration period, each serial and subserial shall have a virus titer of 10 0.7 greater than that used in such immunogenicity test(s) but not less than 10 2.5 TCID50 dose. If both immunogenicity tests in paragraph (b) of this section are conducted and a different amount of virus is used in each test, the virus titer requirements shall be based on the higher of the two amounts.

(2) [Reserved]

[60 FR 14361, Mar. 17, 1995, as amended at 72 FR 72564, Dec. 21, 2007]

§ 113.306 Canine Distemper Vaccine.

Canine Distemper Vaccine shall be prepared from virus-bearing cell culture fluids or embryonated chicken eggs. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed Virus.

(a) Master Seed Virus. The Master Seed Virus shall meet the applicable requirements prescribed in § 113.300 and the requirements prescribed in this section.

(1) To detect ferret virulent canine distemper virus, each of five canine distemper susceptible ferrets shall be injected with a sample of the Master Seed Virus equivalent to the amount of virus to be used in one dog dose and observed each day for 21 days. If undesirable reactions are observed during the observation period, the lot of Master Seed is unsatisfactory.

(2) Master Seed Virus propagated in tissues or cells of avian origin shall be tested for pathogens by the chicken embryo test prescribed in § 113.37. If found unsatisfactory, the Master Seed Virus shall not be used.

(b) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity. The selected virus dose from the lot of Master Seed Virus shall be established as follows:

(1) Twenty-five canine distemper susceptible dogs shall be used as test animals (20 vaccinates and 5 controls). Blood samples shall be drawn from these animals and individual serum samples tested. The dogs shall be considered susceptible if the results are negative at a 1:2 final serum dilution in a varying serum-constant virus neutralization test using 50 to 300 TCID50 of canine distemper virus.

(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. The 20 dogs used as vaccinates shall be injected with a predetermined quantity of vaccine virus and the remaining five dogs held as uninjected controls. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.

(3) At least 14 days post-injection, the vaccinates and the controls shall each be challenged intracerebrally with virulent canine distemper virus furnished or approved by the Animal and Plant Health Inspection Service and observed each day for 21 days.

(i) If at least four of the five controls do not die and the survivor, if any, does not show clinical signs of canine distemper the test is a No Test and may be repeated.

(ii) If at least 19 of the 20 vaccinates do not survive without showing clinical signs of canine distemper during the observation period, the Master Seed Virus is unsatisfactory.

(4) An Outline of Production change shall be made before authorization for use of a new lot of Master Seed Virus shall be granted by the Animal and Plant Health Inspection Service.

(c) Test requirements for release. Except for § 113.300(a)(3)(ii), each serial and subserial shall meet the requirements prescribed in § 113.300 and in this paragraph. Final container samples of completed product shall be tested. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.

(1) The test for pathogens prescribed in § 113.37 shall be conducted on each serial or one subserial of avian origin vaccine.

(2) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the titration method used in paragraph (b)(2) of this section. To be eligible for release, each serial and subserial shall have a virus titer sufficiently greater than the titer of vaccine virus used in the immunogenicity test prescribed in paragraph (b) of this section to assure that when tested at any time within the expiration period, each serial and subserial shall have a virus titer of 10 0.7 greater than that used in such immunogenicity test but not less than 10 2.5 TCID50 per dose.

[60 FR 14362, Mar. 17, 1995, as amended at 72 FR 72564, Dec. 21, 2007]

§ 113.308 Encephalomyelitis Vaccine, Venezuelan.

Encephalomyelitis Vaccine, Venezuelan, shall be prepared from virus-bearing cell culture fluids. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for preparing seeds for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed.

(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.300 except (b), and the requirements prescribed in this section.

(b) Each lot of Master Seed shall be tested for immunogenicity. The selected virus dose from the lot of Master Seed shall be established as follows:

(1) Tests conducted by the Department have established that horses having Venezuelan equine encephalomyelitis antibody titers of 1:20 by the hemagglutination-inhibition (HI) method or 1:40 by the serum neutralization (SN) method were immune to challenge with virulent virus. The immunogenicity test is based on the demonstration of a serological response of at least that magnitude following vaccination of serologically negative horses.

(2) At least 22 horses (20 vaccinates and 2 controls), susceptible to Venezuelan equine encephalomyelitis, shall be used as test animals. Blood samples shall be taken from each horse and the serums individually tested for neutralizing antibody. Horses shall be considered susceptible if there is no neutralization at a 1:2 final serum dilution in a constant virus-varying serum neutralization test using 60 to 300 TCID50 of Venezuelan equine encephalomyelitis virus.

(3) A geometric mean titer of the vaccine produced from the highest passage of the Master Seed shall be established using a method acceptable to Veterinary Services before the immunogenicity test is conducted. The 20 horses used as vaccinates shall be injected with a predetermined quantity of vaccine virus by the method to be recommended on the label. To confirm the dosage administered, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.

(4) Twenty-one to twenty-eight days postvaccination, blood samples shall be drawn from all test animals. For a valid test, the controls shall remain seronegative at 1:2 final serum dilution. In a valid test, if at least 19 of 20 vaccinates do not have antibody titers of at least 1:20 in a hemagglutination-inhibition test or at least 1:40 in a serum neutralization test, the Master Seed is unsatisfactory.

(5) An Outline of Production change shall be made before authority for use of a new lot of Master Seed shall be granted by Animal and Plant Health Inspection Service.

(c) Test requirements for release. Each serial and subserial shall meet the applicable general requirements prescribed in § 113.300 and special requirements in this paragraph. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.

(1) Safety test. The mouse safety test prescribed in § 113.33(b) shall be conducted.

(2) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the method in paragraph (b)(3) of this section. To be eligible for release, each serial and subserial shall have a virus titer sufficiently greater than the titer of the vaccine used in the immunogenicity test prescribed in paragraph (b) of this section to assure that, when tested at any time within the expiration period, each serial and subserial shall have a virus titer of 10 0.7 greater than that used in the immunogenicity test, but not less than 10 2.5 TCID50 per dose.

[50 FR 23797, June 6, 1985. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66784, 66786, Dec. 26, 1991; 72 FR 72564, Dec. 21, 2007]

§ 113.309 Bovine Parainfluenza3 Vaccine.

Bovine Parainfluenza3 Vaccine shall be produced from virus-bearing cell culture fluids. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine production. All serials of vaccine shall be prepared from the first through the tenth passage from the Master Seed Virus.

(a) The Master Seed Virus shall meet the applicable general requirements prescribed in § 113.300.

(b) Each lot of Master Seed Virus shall meet the special requirements prescribed in this section.

(c) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity. The selected virus dose from the lot of Master Seed Virus shall be established as follows:

(1) Twenty-five bovine parainfluenza, susceptible calves shall be used as test animals (20 vaccinates and five controls). Blood samples shall be drawn from these animals and individual serums tested. Also, nasal specimens shall be collected for virus isolation attempts. The calves shall be considered susceptible if:

(i) The results are negative at a 1:2 final serum dilution in a varying serum constant virus neutralization test with less than 500 TCID50 of bovine parainfluenza3 virus; and

(ii) Shall be negative to bovine parainfluenza3 virus isolation attempts from the nasal specimens on the day of injection.

(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. The 20 calves to be used as vaccinates shall be injected with a predetermined quantity of vaccine virus and the remaining five calves held as uninjected controls. To confirm the dosage calculation, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.

(3) The vaccinates and controls shall be examined for clinical signs of respiratory disease and the body temperature taken and recorded on each of the first 14 consecutive days post-injection. The vaccinates shall be bled on day 6 ±2 days post-injection.

(4) Three to four weeks post-vaccination, all calves shall be bled for serum antibodies and nasal specimens shall be collected for PI3 virus isolation. On the same day, all vaccinates and controls shall be given acceptable challenge PI3 virus titrating at least 10 7.0 TCID50 per ml and the animals observed for 14 days. Two ml of the challenge virus shall be instilled in each nostril or shall be inhaled as an aerosol suspension. Upon request, challenge virus and instructions shall be furnished by Animal and Plant Health Inspection Service.

(5) Each animal shall be examined for clinical signs of respiratory disease and the body temperature recorded on each of the 14 consecutive days of the post-challenge observation period. Each day for at least the first 10 days post-challenge, nasal specimens for virus isolation attempts shall be taken. All animals shall be bled on day 6 ±2 days post-challenge, and all animals shall be bled at least once 14 to 28 days post-challenge for serum antibody studies.

(6) Satisfactory Test Criteria:

(i) All virus isolations attempts shall be by culture and at least one subculture in PI3 susceptible cells for a total of at least 14 days.

(ii) Two to four weeks post-vaccination, at least 19 of the 20 vaccinates shall have PI3 neutralizing antibody titers of at least 1:4 and all five controls shall be negative at 1:2 dilution. None of the post-vaccination serums collected from the vaccinates on day 6 ±2 days shall reveal serum neutralization antibody titers of 1:32 or greater based upon final dilution.

(iii) Satisfactory resistance to challenge by vaccinates shall be determined by a significant difference between virus isolation rates from vaccinates and controls. The virus neutralization titers of post-challenge serums and respiratory symptoms and temperatures from all animals shall be considered in the evaluation of the test validity.

(7) Designated animal alternates for test animals showing anamnestic antibody responses (titers 1:32 or greater) on day 6 serums may be included in the study under the following provisions:

(i) No more than five alternates shall be allowed for the vaccinates and no more than two for the controls.

(ii) Alternates shall be subject to all requirements outlined for the animals for which they are alternates.

(iii) Antibody values from alternate animals may be used only to replace values from up to and including five vaccinates which develop antibody of 1:32 or greater by day 6 ±2 days post-vaccination or up to and including two controls which develop antibody titers of 1:32 or greater by day 6 ±2 days post-challenge.

(8) A sequential test procedure may be used in lieu of the 20 calf requirement. A beta value of .05 and a tolerance level of .78 shall be required.

(9) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.

(d) Test requirements for release: Each serial and subserial shall meet the applicable general requirements prescribed in § 113.300 and the requirements in this paragraph. Final container samples of completed product shall be tested except as prescribed in paragraph (d)(1) of this section. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.

(1) Purity test. The test for Brucella contamination prescribed in § 113.32 shall be conducted on each batch of primary cells intended for production use.

(2) Safety test. The mouse safety test prescribed in § 113.33(a) and the calf safety test prescribed in § 113.41 shall be conducted.

(3) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the titration method used in paragraph (c)(2) of this section. To be eligible for release, each serial and each subserial shall have a virus titer per dose sufficiently greater than the titer of vaccine virus used in the immunogenicity test prescribed in paragraph (c) of this section to assure that when tested at any time within the expiration period, each serial and subserial shall have a virus titer of 10 0.7 greater than that used in the immunogenicity test but not less than 10 2.5 TCID50 per dose.

[39 FR 44719, Dec. 27, 1974, as amended at 40 FR 41089, Sept. 5, 1975; 43 FR 49529, Oct. 24, 1978; 48 FR 33472, July 22, 1983. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66784, 66786, Dec. 26, 1991; 60 FR 14357, Mar. 17, 1995; 72 FR 72564, Dec. 21, 2007]

§ 113.310 Bovine Rhinotracheitis Vaccine.

Bovine Rhinotracheitis Vaccine shall be prepared from virus-bearing cell culture fluids. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine production. All serials of vaccine shall be prepared from the first through the tenth passage from the Master Seed Virus.

(a) The Master Seed Virus shall meet the applicable general requirements prescribed in § 113.300.

(b) Each lot of Master Seed Virus shall meet the special requirements prescribed in this section.

(c) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity. The selected virus dose from the lot of Master Seed Virus shall be established as follows:

(1) Twenty-five infectious bovine rhinotracheitis susceptible calves shall be used as test animals (20 vaccinates and five controls). Blood samples shall be drawn from these animals and individual serums tested. The calves shall be considered susceptible if the results are negative at a 1:2 final serum dilution by the virus plaque reduction method.

(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. The 20 calves to be used as vaccinates shall be injected with a predetermined quantity of vaccine virus and the remaining five calves held as uninjected controls. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.

(3) At least once during a period of 14 to 28 days post-vaccination, individual serum samples shall be collected for virus-neutralization tests from each of the vaccinates. The test virus shall be 100 to 500 TCID50 bovine rhinotracheitis virus. Results shall be used in making a determination as prescribed in paragraph (c)(6) of this section.

(4) The vaccinates and the controls shall each be challenged with virulent infectious bovine rhinotracheitis virus and observed for 14 days. The rectal temperature of each animal shall be taken and the presence or absence of respiratory or other clinical signs of bovine rhinotracheitis noted and recorded on each of the 14 consecutive days.

(5) If at least four of the five controls do not show clinical signs of infectious bovine rhinotracheitis and a marked temperature rise to 104.5 °F. or higher post-challenge, the test shall be considered a No Test and may be repeated.

(6) If less than 19 of the post-injection serum samples tested as prescribed in paragraph (c)(3) of this section show neutralization in all tubes of the 1:2 final serum dilution, or if more than one of the vaccinates show a temperature of 103.5 °F. or higher for 2 or more days, or if more than one of the vaccinates exhibit respiratory or other clinical signs of infectious bovine rhinotracheitis, or both, the Master Seed Virus is unsatisfactory.

(7) A sequential test procedure may be used in lieu of the 20 calf requirement. A beta value of .05 and a tolerance level of .78 shall be required.

(8) An outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.

(d) Test requirements for release: Each serial and subserial shall meet the applicable general requirements prescribed in § 113.300 and the requirements in this paragraph. Final container samples of completed product shall be tested except as prescribed in paragraph (d)(1) of this section. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.

(1) Purity test. The test for Brucella contamination prescribed in § 113.32 shall be conducted on each batch of primary cells intended for production use.

(2) Safety test. The mouse safety test prescribed in § 113.33(a) and the calf safety test prescribed in § 113.41 shall be conducted.

(3) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the titration method used in paragraph (c)(2) of this section. To be eligible for release, each serial and each subserial shall have a virus titer per dose sufficiently greater than the titer of vaccine virus used in the immunogenicity test prescribed in paragraph (c) of this section to assure that when tested at any time within the expiration period, each serial and subserial shall have a virus titer of 10 0.7 greater than that used in the immunogenicity test but not less than 10 2.5 TCID50 per dose.

[39 FR 44720, Dec. 27, 1974, as amended at 40 FR 20067, May 8, 1975; 40 FR 23989, June 4, 1975; 40 FR 41089, Sept. 5, 1975; 43 FR 49529, Oct. 24, 1978; 48 FR 33472, July 22, 1983. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66784, 66786, Dec. 26, 1991; 72 FR 72564, Dec. 21, 2007]

§ 113.311 Bovine Virus Diarrhea Vaccine.

Bovine Virus Diarrhea Vaccine shall be prepared from virus-bearing cell culture fluids. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine production. All serials of vaccine shall be prepared from the first through the tenth passage from the Master Seed Virus.

(a) The Master Seed Virus shall meet the applicable general requirements prescribed in § 113.300.

(b) Each lot of Master Seed Virus shall meet the special requirements prescribed in this section.

(c) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity. The selected virus dose from the lot of Master Seed Virus shall be established as follows:

(1) Twenty-five bovine virus diarrhea susceptible calves shall be used as test animals (20 vaccinates and five controls). Blood samples shall be drawn from these animals and individuals serum samples tested. The calves shall be considered susceptible to bovine virus diarrhea virus infection if the results are negative at a 1:2 final serum dilution in a varying serum-constant virus neutralization test with less than 500 TCID50 of bovine virus diarrhea virus.

(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. The 20 calves to be used as vaccinates shall be injected with a predetermined quantity of vaccine virus and the remaining five calves held as uninjected controls. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.

(3) At least once during a period 14 to 28 days post-vaccination, individual serum samples shall be collected for virus-neutralization tests from each of the vaccinates. The test virus shall be less than 500 TCID50 of bovine virus diarrhea virus. The white cell count for all vaccinates and controls shall be established at least 3 days just before challenge. Results shall be used in making a determination as prescribed in paragraph (c)(5) of this section.

(4) The vaccinates and the controls shall each be challenged with virulent bovine virus diarrhea virus and observed for 14 consecutive days. The white cell count shall be determined daily on each animal from the second through the eighth day post-challenge. If leukopenia does not develop in at least four of the five controls as compared with the vaccinates, the test shall be considered a No Test and may be repeated.

(5) If less than 19 of the post-injection serum samples, tested as prescribed in paragraph (c)(3) of this section, show neutralization in all tubes of the 1:8 dilution; or if more than one of the vaccinates exhibits respiratory or other clinical signs of bovine virus diarrhea post-challenge; or both, the Master Seed Virus is unsatisfactory.

(6) A sequential test procedure may be used in lieu of the 20 calf requirement. A beta value of .05 and a tolerance level of .78 shall be required.

(7) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.

(d) Test requirements for release: Each serial and subserial shall meet the applicable general requirements prescribed in § 113.300 and the requirements in this paragraph. Final container samples of completed product shall be tested except as prescribed in paragraph (d)(1) of this section. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.

(1) Purity test. The test for Brucella contamination prescribed in § 113.32 shall be conducted on each batch of primary cells intended for production use.

(2) Safety test. The mouse safety test prescribed in § 113.33(a) and the calf safety test prescribed in § 113.41 shall be conducted.

(3) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the titration method used in paragraph (c)(2) of this section. To be eligible for release, each serial and each subserial shall have a virus titer per dose sufficiently greater than the titer of vaccine virus used in the immunogenicity test prescribed in paragraph (c) of this section to assure that when tested at any time within the expiration period, each serial and subserial shall have virus titer of 10 0.7 greater than that used in the immunogenicity test but not less than 10 2.5 TCID 50 per dose.

[39 FR 44721, Dec. 27, 1974, as amended at 40 FR 20067, May 8, 1975; 40 FR 41089, Sept. 5, 1975; 43 FR 49529, Oct. 24, 1978; 48 FR 33472, July 22, 1983. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66784, 66786, Dec. 26, 1991; 72 FR 72564, Dec. 21, 2007]

§ 113.312 Rabies Vaccine, Live Virus.

Rabies Vaccine shall be prepared from virus-bearing cell cultures or embryonated chicken eggs. Only Master Seed Virus which has been established as pure, safe and immunogenic shall be used for preparing the production seed virus for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed Virus.

(a) The Master Seed Virus shall meet the applicable general requirements prescribed in § 113.300.

(1) Each lot of Master Seed Virus shall meet the special requirements prescribed in this section.

(2) Each lot of Master Seed Virus propagated in tissues or cells of avian origin shall be tested for pathogens by procedures prescribed in § 113.37.

(3) Each lot of Master Seed Virus propagated in primary cell cultures of mouse or hamster origin or brain tissues of mouse origin shall be tested for lymphocytic choriomeningitis (LCM) virus by the procedure prescribed in § 113.42. If LCM virus is detected, the Master Seed Virus is unsatisfactory.

(4) The Master Seed Virus shall be studied in each species of carnivore or domesticated wild animal for which the vaccine is specifically recommended to attempt to determine the fate of the vaccine virus. Results shall be considered in evaluating safety of vaccine virus.

(i) Obtain at least 10 unvaccinated animals, negative at 1:2 final serum dilution, of each species in which tests will be conducted. Divide each species into two groups of five animals.

(ii) For each species of animal, inject one group of five animals intramuscularly. Infiltrate a major nerve and the surrounding tissue in each of the five animals in the other group. Use 1.0 ml of high titer virus for each method of administration.

(iii) Observe all animals for signs of rabies until scheduled time to sacrifice. If animals show definite symptoms, sacrifice and check regional lymph nodes, brain, salivary glands, and kidney for rabies virus by injection of suckling mice (not more than 7 days of age). Tissues may be held frozen at −70 °C. until suckling mice are available. Inject each mouse in one litter intracerebrally with 0.02 ml of a ground tissue suspension from each organ. Observe mice each day for 21 days. If any mice die, determine if the deaths were due to rabies virus in the brain by a fluorescent antibody test.

(iv) Sacrifice animals that do not show signs of rabies according to the following schedule and check regional lymph nodes, brain, salivary glands, and kidney in suckling mice.

Route of injection | Days after injection | Number of animals

Intramuscularly | 15, 20, 25, 30, 35 | 1 each day.

Intraneurally | 3, 6, 9, 15, 30 | 1 each day.

(5) Each lot of Master Seed Virus shall be tested for safety in at least 10 unvaccinated serologically negative animals of each domestic species for which the vaccine is recommended.

(i) Each group of 10 animals shall be divided into 2 groups of 5 animals. For each species, inject one group intramuscularly with 10 doses of high titer virus.

(ii) Infiltrate a major nerve of each of the animals in the other group of 5 with 10 doses of the same high titer virus. For all species except dogs and cats, multiple injections along the cervical spine in the proximity to the nerve trunks emerging from the spinal cord may be used: Provided, That a 1-dose volume shall be injected into each of four or more sites bilaterally.

(iii) Observe all animals each day for 90 days.

(iv) If any animals show clinical signs of rabies, sacrifice the animal and check appropriate brain tissue for rabies virus by the fluorescent antibody test and by mouse injection.

(v) If rabies is confirmed, the lot of Master Seed Virus is unsatisfactory.

(b) The immunogenicity of vaccine prepared with virus at the highest passage of the Master Seed shall be established in each species for which the vaccine is recommended. Tests shall be conducted in accordance with a protocol filed with Animal and Plant Health Inspection Service before initiation of the tests. The vaccine shall be prepared using methods prescribed in the Outline of Production. If Rabies Vaccine is to be in combination with other fractions, the product tested shall include all fractions to be recommended.

(1) A geometric mean virus titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.

(2) The dose of vaccine to be used in the immunogenicity test shall be no more than the amount of rehydrated vaccine which, on the basis of previous titrations, has been diluted to the proposed minimum acceptable virus titer.

(3) Test animals shall be uniform and have no neutralizing antibodies to rabies as determined by serum-neutralization (SN) tests.

(i) Twenty-five or more animals shall be used as vaccinates. Each shall be injected intramuscularly at one site in the thigh with a dose of vaccine at the proposed minimum virus titer as specified in the filed Outline of Production.

(ii) Ten or more additional animals shall be held as controls.

(iii) On or about days 30, 90, 180, 270, and 365 postvaccination, all animals shall be bled and individual serums tested for neutralizing antibodies to rabies virus.

(iv) All surviving test animals of each species shall be challenged intramuscularly with virulent rabies virus furnished or approved by Animal and Plant Health Inspection Service 1 year after vaccination, except as provided in paragraphs (b)(4), (b)(5), and (b)(6) of this section. The challenged animals shall be observed each day for 90 days as prescribed in § 113.5(b). The brain of each test animal that dies following challenge shall be examined for rabies by the fluorescent antibody test or other method acceptable to Animal and Plant Health Inspection Service.

(v) Requirements for acceptance in challenge tests shall be death due to rabies in at least 80 percent of controls while at least 22 of 25 or 26 of 30 or a statistically equivalent number of the vaccinates remain well for a period of 90 days.

(4) An alternative to challenging all surviving test animals in accordance with paragraph (b)(3)(iv) of this section may be used when the test animals are of species other than carnivores. Vaccinates shall be challenged at 1 year postvaccination. These shall include five vaccinates with the lowest SN titers at the 270th-day bleeding, five vaccinates with the lowest SN titers at the 365th-day bleeding, and all vaccinates with SN titers below 1:10 by the mouse SN test or below 1:16 by the rapid-fluorescent-focus-inhibition test at any bleeding. At least five SN-negative controls of each species shall be challenged at the same time as the vaccinates. All SN titers shall be iterated to an endpoint. All of the challenged vaccinates must remain well for a period of 90 days, and at least 80 percent of the controls must die of rabies for a satisfactory test without further challenge. If one or more of the vaccinates die from rabies, all the remaining vaccinates, regardless of titer, along with the five controls shall be challenged. The cumulative results from the two challenges shall be evaluated for acceptance as specified in paragraph (b)(3)(v) of this section.

(5) An outline of Production change shall be made before authority for use of a new lot of Master Virus shall be granted by Animal and Plant Health Inspection Service.

(c) If more than 1 year duration of immunity is to be claimed, a duration of immunity test for the additional time shall be conducted and interpreted as prescribed in paragraph (b) of this section for the 1 year test. The test animals shall be monitored serologically at least every 180 days. The time of challenge may be adjusted accordingly.

(d) Test requirements for release: Each serial and each subserial shall meet the general requirements prescribed in § 113.300 and special requirements in this paragraph.

(1) Purity and safety tests. Final container samples of completed product from each serial or one subserial shall be tested.

(i) The test for pathogens, prescribed in § 113.37 shall be conducted on each serial or one subserial of avian origin. If necessary, neutralize the rabies virus with specific rabies antiserum.

(ii) A test for safety in three young seronegative animals of the most susceptible species for which the vaccine is recommended shall be conducted. Each shall be injected intramuscularly with 10 recommended doses of vaccine. If unfavorable reactions attributable to the product occur during a 28 day observation period, the serial is unsatisfactory.

(iii) If primary cell cultures of hamster origin or of mouse origin are used vaccine production, they shall be tested for LCM virus as prescribed in § 113.42. The cells shall be disrupted and undiluted cell fluids from each lot shall be tested.

(2) Virus titrations. Final container samples of completed product shall be tested for virus titer using the titration method used in paragraph (b)(1) of this section. To be eligible for release, each serial and each subserial shall have a virus titer sufficiently higher than the titer of the vaccine virus used in paragraph (b) of this section to assure that, when tested at any time within the expiration period, each serial and subserial shall have a virus titer equal to or greater than that used in the immunogenicity test.

(3) Young adult mice, each weighing 14 to 16 grams, shall be used as test animals when the virus in vaccine prepared with a low egg passage Flury Strain or high cell passage Street Alabama Dufferin Strain (HCP SAD) of rabies virus is titrated. At least 10 mice for each dilution shall be used.

(i) At least 10 mice shall be used for each dilution. Each shall be injected intracerebrally with 0.03 ml.

(ii) The injected young adult mice shall be observed each day for 14 days except when testing vaccines made with HCP SAD strain of rabies virus, in which case, the mice shall be observed each day for 21 days. Deaths and paralysis occurring subsequent to the fourth day post-injection shall be noted and the LD50 titer calculated by the Reed and Muench Method.

(iii) Virus titer requirements for release and at expiration date shall be determined for each vaccine on the basis of data available: Provided, That, the lowest titer permitted at expiration date when determined by this test shall be 10 3.0 LD50 per 0.03 ml.

(4) Suckling mice, 6 days of age or younger, shall be used as test animals when virus in vaccine prepared with a high egg passage Flury Strain of rabies virus is titrated.

(i) Six to twelve mice shall be used for each dilution. Each shall be injected intracerebrally with 0.02 ml.

(ii) The injected suckling mice shall be observed each day for 21 days. Deaths and paralysis occurring subsequent to the fourth day post-injection shall be noted and the LD50 titer calculated by the Reed and Muench Method; and

(iii) Virus titer requirements for release and at expiration date shall be determined for each vaccine on the basis of data available: Provided, That, the lowest titer permitted at expiration date when determined by this test shall be 10 3.0 LD50 per 0.02 ml.

[39 FR 44721, Dec. 27, 1974, as amended at 40 FR 20067, May 8, 1975; 42 FR 6795, Feb. 4, 1977; 43 FR 49529, Oct. 24, 1978; 50 FR 20090, May 14, 1985; 50 FR 23797, June 6, 1985. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66784, 66786, Dec. 26, 1991; 61 FR 31823, June 21, 1996; 72 FR 72564, Dec. 21, 2007]

§ 113.313 Measles Vaccine.

Measles Vaccine shall be prepared from virus-bearing cell culture fluids. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed Virus.

(a) The Master Seed Virus shall meet the applicable general requirements prescribed in § 113.300. Each lot of Master Seed Virus shall meet the special requirements prescribed in this section.

(b) To detect virulent canine distemper virus, each of two canine distemper susceptible ferrets shall be injected with a sample of the Master Seed Virus equivalent to the amount of virus to be used in one dog dose and observed each day for 21 days. If undesirable reactions occur in either ferret, the lot of Master Seed Virus is unsatisfactory.

(c) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity. The selected virus dose from the lot of Master Seed Virus shall be established as follows:

(1) Twenty-five dogs, less than 12 weeks of age and free of measles antibody, shall be used as test animals (20 vaccinates and five controls). Blood samples shall be drawn from these animals and individual serum samples tested. The dogs shall be considered susceptible if the results are negative at a 1:2 final serum dilution in a varying serum-constant virus neutralization test with less than 500 ID50 of measles virus.

(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. Twenty dogs shall be vaccinated with a predetermined quantity of vaccine virus and the remaining five dogs held as unvaccinated controls. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.

(3) On the day of challenge, serum samples shall be obtained from each vaccinate and individually tested for antibody against canine distemper virus. For a valid test, each vaccinate shall be negative at a 1:4 final serum dilution in varying serum-constant virus neutralization test using less than 500 ID50 of canine distemper virus.

(4) At least 21 days postinoculation, the immunity of the vaccinates and controls shall be challenged by exposure to a uniform dose of aerosolized virulent canine distemper virus. All test dogs shall be observed daily for 21 days postchallenge.

(i) If at least 4 of the 5 controls do not die or show signs of distemper, including a temperature of 104.0 °F. or higher and at least 15 percent weight loss, the test is a No Test and may be repeated.

(ii) If at least 19 of the 20 vaccinates do not survive without showing a temperature of 104.0 °F. or higher and a weight loss exceeding 15 percent after day 8 postchallenge, the Master Seed Virus is unsatisfactory.

(5) When approved in advance by Animal and Plant Health Inspection Service, a sequential test procedure may be used in lieu of the 20 dog requirement. A beta value of 0.05 and a tolerance level of 0.78 shall be required.

(6) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.

(d) Test requirements for release: Each serial and subserial shall meet the general requirements prescribed in § 113.300 and the requirements in this paragraph. Final container samples of completed product shall be tested. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.

(1) Safety tests. The dog safety test prescribed in § 113.40 and the mouse safety test prescribed in § 113.33(a) shall be conducted.

(2) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the titration method used in paragraph (c)(2) of this section. To be eligible for release, each serial and each subserial shall have a virus titer sufficiently greater than the titer of the vaccine virus used in the immunogenicity test prescribed in paragraph (c) of this section to assure that when tested at any time within the expiration period, each serial and subserial shall have a virus titer of 10 0.7 greater than that used in the immunogenicity test but not less than 10 2.5 ID50 per dose.

[40 FR 53001, Nov. 14, 1975, as amended at 43 FR 49529, Oct. 24, 1978; 48 FR 33472, July 22, 1983. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66784, 66786, Dec. 26, 1991; 72 FR 72564, Dec. 21, 2007]

§ 113.314 Feline Calicivirus Vaccine.

Feline Calicivirus Vaccine shall be prepared from virus-bearing cell culture fluids. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed Virus.

(a) The Master Seed Virus shall meet the applicable general requirements prescribed in § 113.300.

(b) The Master Seed Virus shall be tested for chlamydial agents as prescribed in § 113.43.

(c) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity. The selected virus dose from the lot of Master Seed Virus shall be established as follows:

(1) Thirty feline calicivirus susceptible cats shall be used as test animals (20 vaccinates and 10 controls). Throat swabs shall be collected from each cat and individually tested on susceptible cell cultures for the presence of feline calicivirus. Blood samples shall be drawn and individual serum samples tested. The cats shall be considered suitable for use if all swabs are negative for virus isolation and if all serums are negative for calicivirus antibody at the 1:2 final dilution in a 50 percent plaque reduction test or other SN test of equal sensitivity.

(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. The 20 cats used as vaccinates shall be administered a predetermined quantity of vaccine virus by the method to be recommended on the label and the remaining 10 cats shall be held as controls. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used. If two doses are used, five replicate confirming titrations shall be conducted on each dose.

(3) Twenty-one or more days after the final dose of vaccine, the vaccinates and controls shall each be challenged intranasally with a minimum of 100,000 TCID50 or plaque forming units of virulent feline calicivirus furnished or approved by Animal and Plant Health Inspection Service and observed each day for 14 days postchallenge. The rectal temperature of each animal shall be taken and the presence or absence of clinical signs, particularly lesions on the oral mucosa, noted and recorded each day.

(i) If less than 8 of 10 controls show clinical signs of feline calicivirus infection other than fever, the test is a No Test and may be repeated.

(ii) If a significant difference in clinical signs cannot be demonstrated between vaccinates and controls using a scoring system approved by Animal and Plant Health Inspection Service and prescribed in the Outline of Production, the Master Seed Virus is unsatisfactory.

(4) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.

(d) Test requirements for release. Each serial and subserial shall meet the requirements prescribed in § 113.300 and in this paragraph. Final container samples of completed product shall be tested. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.

(1) Safety test. The mouse safety test prescribed in § 113.33(a) and the cat safety test prescribed in § 113.39(b) shall be conducted.

(2) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the titration method used in paragraph (c)(2) of this section. To be eligible for release, each serial and each subserial shall have a virus titer sufficiently greater than the titer of vaccine virus used in the immunogenicity test prescribed in paragraph (c) of this section to assure that when tested at any time within the expiration period, each serial and subserial shall have a virus titer of 10 0.7 greater than that used in the immunogenicity test but not less than 10 2.5 TCID50 or plaque forming units per dose.

[44 FR 58899, Oct. 12, 1979; 44 FR 63083, Nov. 2, 1979, as amended at 48 FR 33472, July 22, 1983. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66784, 66786, Dec. 26, 1991; 72 FR 72564, Dec. 21, 2007]

§ 113.315 Feline Rhinotracheitis Vaccine.

Feline Rhinotracheitis Vaccine shall be prepared from virus-bearing cell culture fluids. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed Virus.

(a) The Master Seed Virus shall meet the applicable general requirements prescribed in § 113.300.

(b) The Master Seed Virus shall be tested for chlamydial agents as prescribed in § 113.43.

(c) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity. The selected virus dose from the lot of Master Seed Virus shall be established as follows:

(1) Thirty feline rhinotracheitis susceptible cats shall be used as test animals (20 vaccinates and 10 controls). Throat swabs shall be collected from each cat and individually tested on susceptible cell cultures for the presence of feline rhinotracheitis virus. Blood samples shall be drawn and individual serum samples tested. The cats shall be considered suitable for use if all swabs are negative for virus isolation and if all serums are negative for feline rhinotracheitis virus antibody at the 1:2 final dilution in a 50 percent plaque reduction test or other SN test of equal sensitivity.

(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. The 20 cats used as vaccinates shall be administered a predetermined quantity of vaccine virus by the method to be recommended on the label and the remaining 10 cats shall be held as controls. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used. If two doses are used, five replicate confirming titrations shall be conducted on each dose.

(3) Twenty-one or more days after the final dose of vaccine, the vaccinates and controls shall each be challenged intranasally with a minimum of 100,000 TCID50 or plaque forming units of virulent feline rhinotracheitis virus furnished or approved by Animal and Plant Health Inspection Service and observed each day for 14 days post-challenge. The rectal temperature of each animal shall be taken and the presence of respiratory or other clinical signs of feline rhinotracheitis noted and recorded each day.

(i) If less than 8 of 10 controls show clinical signs of feline rhinotracheitis infection other than fever, the test is a No Test and may be repeated.

(ii) If a significant difference in clinical signs cannot be demonstrated between vaccinates and controls using a scoring system approved by Veterinary Services and prescribed in the Outline of Production, the Master Seed Virus is unsatisfactory.

(4) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.

(d) Test requirements for release. Each serial and subserial shall meet the requirements prescribed in § 113.300 and in this paragraph. Final container samples of completed product shall be tested. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.

(1) Safety test. The mouse safety test prescribed in § 113.33(a) and the cat safety test prescribed in § 113.39(b) shall be conducted.

(2) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the titration method used in paragraph (c)(2) of this section. To be eligible for release, each serial and each subserial shall have a virus titer sufficiently greater than the titer of vaccine virus used in the immunogenicity test prescribed in paragraph (c) of this section to assure that when tested at any time within the expiration period, each serial and subserial shall have a virus titer of 10 0.7 greater than that used in the immunogenicity test but not less than 10 2.5 TCID50 or plaque forming units per dose.

[44 FR 58899, Oct. 12, 1979, as amended at 48 FR 33472, July 22, 1983. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66784, 66786, Dec. 26, 1991; 72 FR 72564, Dec. 21, 2007]

§ 113.316 Canine Parainfluenza Vaccine.

Canine Parainfluenza Vaccine shall be prepared from virus-bearing cell culture fluids. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for preparing seeds for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed.

(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.300 and the requirements in this section.

(b) Each lot of Master Seed shall be tested for immunogenicity. The selected virus dose shall be established as follows:

(1) Twenty-five canine parainfluenza susceptible dogs (20 vaccinates and 5 controls) shall be used as test animals. Nasal swabs shall be collected from each dog on the day the first dose of vaccine is administered and individually tested on susceptible cell cultures for the presence of canine parainfluenza virus. Blood samples shall also be drawn and individual serum samples tested for neutralizing antibody. Dogs shall be considered susceptible if all swabs are negative for virus isolation and if all serums are negative for canine parainfluenza antibody at a 1:2 final dilution in a constant virus-varying serum neutralization test using 50 to 300 TCID50 of canine parainfluenza virus.

(2) A geometric mean titer of vaccine produced at the highest passage from the Master Seed shall be established before the immunogenicity test is conducted. The 20 dogs used as vaccinates shall be administered a predetermined quantity of vaccine virus. Five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used to confirm the dosage administered. If two doses are used, five replicate confirming titrations shall be conducted on each dose.

(3) Three to 4 weeks after the final dose of vaccine, all dogs shall be bled for serum antibodies and nasal swabs shall be collected for canine parainfluenza virus isolation. On the same day, all vaccinates and controls shall be challenged with canine parainfluenza virus furnished or approved by Animal and Plant Health Inspection Service.

(4) The rectal temperature of each dog shall be taken and the presence of respiratory or other clinical signs of canine parainfluenza virus infection noted and recorded each day for 14 consecutive days postchallenge. Nasal swabs shall be collected from each dog each day for at least 10 consecutive days postchallenge. Individual swabs shall be tested for virus isolation by culture in canine parainfluenza virus susceptible cells for at least 7 days. Results shall be evaluated according to the following criteria:

(i) If five of five controls have not remained seronegative at a final serum dilution of 1:2 during the prechallenge period, the test is a No Test and may be repeated.

(ii) If more than one vaccinate shows febrile response, respiratory or other clinical signs of canine parainfluenza virus infection; or, if less than 19 of 20 vaccinates show serum neutralization titers of 1:4 or greater; or, if there is not a significant reduction in virus isolation rate in vaccinates when compared with controls, the Master Seed is unsatisfactory.

(5) An Outline of Production change shall be made before authority for use of a new lot of Master Seed shall be granted by Animal and Plant Health Inspection Service.

(c) Test requirements for release. Each serial and subserial shall meet the applicable general requirements prescribed in § 113.300 and the requirements in this paragraph. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.

(1) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the titration method used in paragraph (b)(2) of this section. To be eligible for release, each serial and each subserial shall have a virus titer sufficiently greater than the titer of vaccine virus used in the immunogenicity test prescribed in paragraph (b) of this section to assure that, when tested at any time within the expiration period, each serial and subserial shall have a virus titer at least 10 0.7 greater than that used in the immunogenicity test but not less than 10 2.5 TCID50 per dose.

(2) [Reserved]

[50 FR 436, Jan. 4, 1985. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66784, 66786, Dec. 26, 1991; 72 FR 72564, Dec. 21, 2007]

§ 113.317 Parvovirus Vaccine (Canine).

Parvovirus Vaccine recommended for use in dogs shall be prepared from virus-bearing cell culture fluids. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for preparing seeds for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed.

(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.300 and the requirements in this section.

(b) The Master Seed shall be tested for reversion to virulence in dogs using a method acceptable to Animal and Plant Health Inspection Service. If a significant increase in virulence is seen within five backpassages, the Master Seed is unsatisfactory.

(c) Each lot of Master Seed shall be tested for immunogenicity. The selected virus dose shall be established as follows:

(1) Twenty-five canine parvovirus susceptible dogs (20 vaccinates and 5 controls) shall be used as test animals. Blood samples drawn from each dog shall be individually tested for neutralizing antibody against canine parvovirus to determine susceptibility. Dogs shall be considered susceptible if there is no neutralization at a 1:2 final serum dilution in a constant virus-varying serum neutralization test in cell culture using 50 to 300 TCID50 of canine parvovirus.

(2) A geometric mean titer of the vaccine produced at the highest passage from the Master Seed shall be established before the immunogenicity test is conducted. The 20 dogs used as vaccinates shall be administered a predetermined quantity of vaccine virus by the method recommended on the label. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used. If two doses are used, five replicate confirming titrations shall be conducted on each dose.

(3) Fourteen days or more after the final dose of vaccine the vaccinates and the controls shall be challenged with virulent canine parvovirus furnished or approved by Animal and Plant Health Inspection Service and the dogs observed each day for 14 days. Rectal temperature, blood lymphocyte count, and feces for viral detection shall be taken from each dog each day for at least 10 days postchallenge and the presence or absence of clinical signs noted and recorded each day.

(i) The immunogenicity of the Master Seed shall be evaluated on the following criteria of infection: temperature ≥103.4 °F; lymphopenia of ≥50 percent of prechallenge normal; clinical signs such as diarrhea, mucus in feces, or blood in feces; and viral hemagglutinins at a level of ≥1:64 in a 1:5 dilution of feces or a test of equal sensitivity. If at least 80 percent of the controls do not show at least three of the four criteria of infection during the observation period, the test is a No Test and may be repeated.

(ii) If at least 19 of the 20 vaccinates do not survive the observation period without showing more than one criterion of infection described in paragraph (c)(3)(i), of this section, the Master Seed is unsatisfactory.

(4) An Outline of Production change shall be made before authority for use of a new lot of Master Seed shall be granted by Animal and Plant Health Inspection Service.

(d) Test requirements for release. Each serial and subserial shall meet the applicable general requirements prescribed in § 113.300 and the requirements in this paragraph. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.

(1) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the titration method used in paragraph (c)(2) of this section. To be eligible for release, each serial and each subserial shall have a virus titer sufficiently greater than the titer of vaccine used in the immunogenicity test in paragraph (c) of this section to assure that, when tested at any time within the expiration period, each serial and subserial shall have a virus titer of 10 0.7 greater than that used in the immunogenicity test, but not less than 10 2.5 ID50 per dose.

[50 FR 436, Jan. 4, 1985. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66784, 66786, Dec. 26, 1991; 72 FR 72564, Dec. 21, 2007]

§ 113.318 Pseudorabies Vaccine.

Pseudorabies Vaccine shall be prepared from virus-bearing cell culture fluids. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for preparing seeds for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed.

(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.300 and the requirements in this section.

(b) Each lot of Master Seed shall be tested for immunogenicity. The selected virus dose shall be established as follows:

(1) Twenty-five pseudorabies susceptible pigs (20 vaccinates and 5 controls) of the youngest age for which the vaccine is recommended, shall be used as test animals. Blood samples shall be taken from each pig and the serums inactivated and individually tested for neutralizing antibody against pseudorabies virus. Pigs shall be considered susceptible if there is no neutralization at a 1:2 final serum dilution in a constant virus-varying serum neutralization test using 50 to 300 TCID50 pseudorabies virus.

(2) A geometric mean titer of the vaccine produced at the highest passage from the Master Seed shall be established before the immunogenicity test is conducted. The 20 pigs used as vaccinates shall be administered a predetermined quantity of vaccine virus by the method recommended on the label. To confirm the dosage administered, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.

(3) Fourteen to 28 days postvaccination, the vaccinates and controls shall be challenged with virulent pseudorabies virus furnished or approved by Animal and Plant Health Inspection Service and observed each day for 14 days.

(i) If at least four of the five controls do not develop severe central nervous system signs or die, the test is a No Test and may be repeated.

(ii) If at least 19 of the 20 vaccinates in a valid test do not remain free of signs of pseudorabies, the Master Seed is unsatisfactory.

(4) An Outline of Production change shall be made before authority for use of a new lot of Master Seed shall be granted by Animal and Plant Health Inspection Service.

(c) Test requirements for release. Each serial and subserial shall meet the applicable general requirements prescribed in § 113.300 and the requirements in this paragraph.

(2) Virus titer requirements. Final container samples of completed product shall be titrated by the method used in paragraph (b)(2) of this section. To be eligible for release, each serial and subserial shall have a virus titer sufficiently greater than the titer of the vaccine used in the immunogenicity test prescribed in paragraph (b) of this section to assure that, when tested at any time within the expiration period, each serial and subserial shall have a virus titer at least 10. 0.7 greater than that used in the immunogenicity test, but not less than 10 2.5 TCID50 per dose.

[50 FR 437, Jan. 4, 1985. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66784, 66786, Dec. 26, 1991; 72 FR 72564, Dec. 21, 2007]

§§ 113.319-113.324 [Reserved]

§ 113.325 Avian Encephalomyelitis Vaccine.

Avian Encephalomyelitis Vaccine shall be prepared from virus-bearing tissues or fluids from embryonated chicken eggs. Only Master Seed Virus which has been established as pure, safe, and immunogenic in accordance with the requirements in paragraphs (a), (b), and (c) of this section shall be used for preparing the production seed virus for vaccine production. All serials shall be prepared from the first through the fifth passage from the Master Seed Virus.

(a) The Master Seed Virus shall meet the applicable requirements prescribed in § 113.300 and the requirements prescribed in this section.

(b) Each lot of Master Seed Virus shall be tested for pathogens by the chicken embryo inoculation test prescribed in § 113.37, except that, if the test is a No Test because of a vaccine virus override, the test may be repeated and if the repeat test is inconclusive for the same reason, the chicken inoculation test prescribed in § 113.36 may be conducted and the virus judged accordingly.

(c) Each lot of Master Seed Virus shall be tested for immunogenicity and the selected virus dose to be used shall be established as follows:

(1) Avian encephalomyelitis susceptible chickens, all of the same age (eight weeks or older) and from the same source, shall be used. Twenty or more chickens shall be used as vaccinates for each method of administration recommended on the label. Ten additional chickens of the same age and from the same source shall be held as unvaccinated controls.

(2) A geometric mean titer of the vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. Each vaccinate shall receive a predetermined quantity of vaccine virus. Five replicate virus titrations shall be conducted on an aliquot of the vaccine virus to confirm the amount of virus administered to each chicken used in the test. At least three appropriate (not to exceed tenfold) dilutions shall be used and the test conducted as follows:

(i) For each dilution, inoculate at least 10 embryos, 5 or 6 days old, in the yolk sac with 0.2 ml each. Twenty similar embryos obtained from the same source shall be kept as uninoculated negative controls. Disregard all deaths during the first 48 hours post-inoculation.

(ii) Eggs for each dilution shall be kept in separate containers and allowed to hatch. Sufficient precaution shall be taken to assure that chickens from each dilution remain separated. To be a valid test, at least 75 percent of the uninoculated eggs shall hatch.

(iii) On the third day after normal hatching time, count all unhatched eggs and all dead, paralyzed and ataxic chickens as positive evidence of viral infection.

(iv) A satisfactory titration shall have at least one dilution with between 50 and 100 percent positives and at least one dilution with between 50 and 0 percent positives.

(v) Calculate the EID50 by the Spearman-Karber or Reed-Muench method.

(3) At least 21 days post-vaccination, the vaccinates and the controls shall be challenged intracerebrally with a virulent avian encephalomyelitis virus and observed each day for 21 days.

(4) If at least 80 percent of the controls do not show signs of avian encephalomyelitis or die, the test is a No Test and may be repeated. If at least 19 of 20, or 27 of 30, or 36 of 40 of the vaccinates in each group do not remain free from clinical signs of avian encephalomyelitis during the observation period, the Master Seed Virus is unsatisfactory.

(5) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.

(d) After a lot of Master Seed Virus has been established as prescribed in paragraphs (a), (b), and (c) of this section, each serial and subserial shall meet the applicable requirements in § 113.300 and the requirements prescribed in this paragraph.

(1) Final container samples from each serial shall be tested for pathogens by the chicken embryo inoculation test prescribed in § 113.37, except that, if the test is a No Test because of a vaccine virus override, the chicken inoculation test prescribed in § 113.36 may be conducted and the vaccine judged accordingly.

(2) Safety test. Final container samples of completed product shall be tested for safety as follows:

(i) At least 25 AE susceptible birds (6 to 10 weeks of age) shall be vaccinated with the equivalent of 10 doses by each of all routes recommended on the label and be observed each day for 21 days.

(ii) If unfavorable reactions attributable to the biological product occur during the observation period, the serial is unsatisfactory. If unfavorable reactions occur which are not attributable to the product, the test shall be declared a No Test and repeated, except that, if the test is not repeated, the serial shall be unsatisfactory.

(3) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the titration method used in paragraph (c)(2) of this section. To be eligible for release, each serial and each subserial shall have a virus titer sufficiently greater than the titer of vaccine virus used in the immunogenicity test prescribed in paragraph (c) of this section to assure that when tested at any time within the expiration period, each serial and subserial shall have a virus titer of 10 0.7 greater than that used in such immunogenicity test but not less than 10 .5 EID50 per dose.

[39 FR 44723, Dec. 27, 1974, as amended at 40 FR 18405, Apr. 28, 1975; 40 FR 41089, Sept. 5, 1975; 42 FR 43617, Aug. 30, 1977; 48 FR 33473, July 22, 1983. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66784, 66786, Dec. 26, 1991; 72 FR 72564, Dec. 21, 2007; 79 FR 55969, Sept. 18, 2014]

§ 113.326 Avian Pox Vaccine.

Fowl Pox Vaccine and Pigeon Pox Vaccine shall be prepared from virus-bearing cell culture fluids or embryonated chicken eggs. Only Master Seed Virus which has been established as pure, safe, and immunogenic in accordance with the requirements in paragraphs (a), (b), and (c) of this section shall be used for preparing the production seed virus for vaccine production. All serials shall be prepared from the first through the fifth passage from the Master Seed Virus.

(a) The Master Seed Virus shall meet the applicable requirements prescribed in § 113.300 except paragraph (c) of this section and shall meet the requirements prescribed in this section.

(b) Each lot of Master Seed Virus shall be tested for pathogens by the chicken inoculation test prescribed in § 113.36.

(c) Each lot of Master Seed Virus shall be tested for immunogenicity and the selected virus dose to be used shall be established as follows:

(1) Fowl pox susceptible birds all of the same age and from the same source, shall be used as test birds. Twenty or more birds shall be used as vaccinates for each method of administration recommended on the label. Ten additional birds of the same age and from the same source as the vaccinates shall be held as unvaccinated controls.

(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. Each vaccinate shall receive a predetermined quantity of vaccine virus. Five replicate virus titrations shall be conducted on an aliquot of the vaccine virus to confirm the amount of virus administered to each bird used in the test. At least three appropriate (not to exceed tenfold) dilutions shall be used and the test conducted as follows:

(i) For each dilution, inoculate at least five embryos, 9 to 11 days old, on the chorioallantoic membrane with at least 0.2 ml each. Disregard all deaths during the first 24 hours post-inoculation. To be a valid test, at least four embryos in each dilution shall remain viable beyond 24 hours.

(ii) Examine the surviving embryos for evidence of infection 5 to 7 days post-inoculation.

(iii) A satisfactory titration shall have at least one dilution with between 50 and 100 percent positives and at least one dilution with between 50 and 0 percent positives.

(iv) Calculate the EID50 by the Spearman-Karber or Reed-Muench method.

(3) Fourteen to twenty-one days post-vaccination, all vaccinates and controls shall be challenged by the wing web method and observed each day for 10 days. If the wing web method was used for vaccination, the opposite wing shall be used for challenge. Challenge virus shall be provided or approved by Animal and Plant Health Inspection Service.

(4) If at least 90 percent of the controls do not develop fowl pox during the observation period, the test is a No Test and may be repeated. If at least 19 of 20, or 27 of 30, or 36 of 40 of the vaccinates in each group do not remain free from clinical signs of fowl pox during the observation period, the Master Seed Virus is unsatisfactory.

(5) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.

(d) After a lot of Master Seed Virus has been established as prescribed in paragraphs (a), (b), and (c) of this section, each serial and subserial shall meet the requirements in § 113.36, in § 113.300 except paragraph (c), and in this paragraph.

(1) Safety test. Final container samples of completed product from each serial shall be tested. Vaccines recommended for use in birds 10 days of age or younger shall be tested in accordance with paragraphs (d)(1)(i), (ii), and (iii) of this section.

(i) Each of 25 susceptible birds 5 days of age or younger, properly identified and obtained from the same source and hatch, shall be vaccinated with the equivalent of 10 doses of vaccine by each of all routes recommended on the label and observed each day for 14 days. Severe clinical signs or death shall be counted as failures. Two-stage sequential testing may be conducted if the first test (which then becomes stage one) has three failures.

(ii) The results shall be evaluated according to the following table:

Cumulative Totals

Stage | Number of birds | Failures for satisfactory serials | Failures for unsatisfactory serials

1 | 25 | 2 or less | 4 or more.

2 | 50 | 5 or less | 6 or more.

(iii) If unfavorable reactions occur which are not attributable to the product, the test shall be declared a No Test and may be repeated or, in lieu thereof, the serial declared unsatisfactory.

(iv) Vaccines not recommended for use in birds 10 days of age or younger shall be tested for safety as follows: Each of twenty-five 3- to 5-week-old, fowl-pox susceptible birds shall be vaccinated with the equivalent of 10 doses of vaccine by each of all routes recommended on the label and observed each day for 14 days. If any of the birds show severe clinical signs of disease or death during the observation period due to causes attributable to the product, the serial is unsatisfactory. If unfavorable reactions occur which are not attributable to the product, the test shall be declared a No Test and may be repeated or, in lieu thereof, the serial declared unsatisfactory.

(2) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the titration method used in paragraph (c)(2) of this section. To be eligible for release, each serial and each subserial shall have a virus titer sufficiently greater than the titer of vaccine virus used in the immunogenicity test prescribed in paragraph (c) of this section to assure that when tested at any time within the expiration period, each serial and subserial shall have a virus titer of 10 0.7 greater than that used in such immunogenicity test but not less than 10 2.0 EID50 per dose.

[39 FR 44724, Dec. 27, 1974, as amended at 40 FR 18406, Apr. 28, 1975; 40 FR 41089, Sept. 5, 1975; 44 FR 33051, June 8, 1979; 48 FR 33473, July 22, 1983. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66784, 66786, Dec. 26, 1991; 72 FR 72564, Dec. 21, 2007]

§ 113.327 Bronchitis Vaccine.

Bronchitis Vaccine shall be prepared from virus-bearing cell culture fluids or embryonated chicken eggs. Only Master Seed Virus which has been established as pure, safe, and immunogenic in accordance with the requirements in paragraphs (a), (b), and (c) of this section shall be used for preparing the production seed virus for vaccine production. All serials shall be prepared from the first through the fifth passage from the Master Seed Virus.

(a) The Master Seed Virus shall meet the applicable requirements prescribed in § 113.300 and the requirements prescribed in this section.

(b) Each lot of Master Seed Virus shall be tested for pathogens by the chicken embryo inoculation test prescribed in § 113.37, except that, if the test is a No Test because of a vaccine virus override, the test may be repeated and if the repeat test is a No Test for the same reason, the chicken inoculation test prescribed in § 113.36 may be conducted and the virus judged accordingly.

(c) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity and the selected virus dose to be used shall be established as follows:

(1) Bronchitis susceptible chickens, all of the same age and from the same source, shall be used in the virus-recovery test. For each method of administration recommended on the label for each serotype against which protection is claimed, twenty or more chickens shall be used as vaccinates. Ten additional chickens for each serotype against which protection is claimed shall be held as unvaccinated controls.

(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity tests are conducted. Each vaccinate shall receive a predetermined quantity of vaccine virus. Five replicate virus titrations shall be conducted on an aliquot of the vaccine virus to confirm the amount of virus administered to each chicken used in such tests. At least three approved (not to exceed tenfold) dilutions shall be used and the test conducted as follows;

(i) For each dilution, inject at least five embryos, 9 to 11 days old, in the allantoic cavity with 0.1 ml each. Deaths occurring during the first 24 hours shall be disregarded, but at least four viable embryos in each dilution shall survive beyond 24 hours of a valid test. After 5 to 8 days incubation, examine the surviving embryos for evidence of infection.

(ii) A satisfactory titration shall have at least one dilution with between 50 and 100 percent positives and at least one dilution with between 50 and 0 percent positives.

(iii) Calculate the EID50 by the Spearman-Karber or Reed-Muench method.

(3) Twenty-one to twenty-eight days post-vaccination, all vaccinates and controls shall be challenged by eye-drop with virulent bronchitis virus. A separate set of vaccinates and controls shall be used for each serotype against which protection is claimed. Each challenge virus shall be approved or provided by Animal and Plant Health Inspection Service and shall titer at least 10 4.0 EID50 per ml.

(i) Tracheal swabs shall be taken once, 5 days post-challenge, from each control and vaccinate. Each swab shall be placed in a test tube containing 3 ml of tryptose phosphate broth and antibiotics. The tube and swab shall be swirled thoroughly and if they are to be stored, be immediately frozen and be stored at below −40 °C. pending egg evaluation. For each chicken swab, at least five chicken embryos 9 to 11 days old shall be inoculated in the allantoic cavity with 0.2 ml each of broth from each tube.

(ii) All embryos surviving the third day post-inoculation shall be used in the evaluation, except that, if a swab is not represented by at least four embryos, the test of that swab is invalid and the results a No Test. A tracheal swab shall be positive for virus recovery when any of the embryos in a valid test show typical infectious bronchitis virus lesions, such as but not limited to, stunting, curling, kidney urates, clubbed down, or death during the 4 to 7 day post-inoculation period. If less than 20 percent of the embryos which survive the third day post-inoculation die during the 4 to 7 day post-inoculation period and show no gross lesions typical of infectious bronchitis, they may be disregarded.

(iii) If less than 90 percent of the controls are positive for virus recovery, the test is a No Test and may be repeated.

(iv) If less than 90 percent of the vaccinates are negative for virus recovery, the Master Seed Virus is unsatisfactory.

(4) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.

(d) After a lot of Master Seed Virus has been established as prescribed in paragraphs (a), (b), and (c) of this section, each serial and subserial shall meet the applicable requirements in § 113.300 and the requirements prescribed in this paragraph, except that, if the vaccine contains more than one virus type, bulk samples taken from each type prior to mixing shall be used in the virus identity tests prescribed in § 113.300(c). The additional requirements in this paragraph shall also be met.

(1) Final container samples from each serial shall be tested for pathogens by the chicken embryo inoculation test prescribed in § 113.37, except that, if the test is a No Test because of a vaccine virus override, the chicken inoculation test prescribed in § 113.36 may be conducted and the vaccine judged accordingly.

(2) Safety test. Final container samples of completed product shall be tested to determine safety for use in bronchitis susceptible young chickens.

(i) Twenty-five susceptible chickens, 5 days of age or younger, properly identified and obtained from the same source and hatch, shall be vaccinated by the eye-drop method with the equivalent of 10 doses of vaccine and observed each day for 21 days post-vaccination. Severe respiratory signs or death shall be counted as failures. Two-stage sequential testing may be conducted if the first test (which then becomes stage one) has three failures.

(ii) The results shall be evaluated according to the following table:

Cumulative Totals

Stage | Number of chickens | Failures for satisfactory serials | Failures for unsatisfactory serials

1 | 25 | 2 or less | 4 or more.

2 | 50 | 5 or less | 6 or more.

If unfavorable reactions occur which are not attributable to the product, the test shall be declared a No Test and repeated or, in lieu thereof, the serial declared unsatisfactory.

(3) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the procedure prescribed in paragraph (c)(2) of this section and in this paragraph.

(i) The Newcastle disease virus fraction of combined Newcastle-Bronchitis Vaccines shall be neutralized prior to titration of the bronchitis virus fraction. Equal parts of heat-inactivated Newcastle disease antiserum shall be mixed with each appropriate serial ten-fold dilution of the vaccine. After inactivation, embryos shall be injected with 0.2 ml each and results calculated as a 0.1 ml dose to allow for serum dilution of the vaccine. The allantoic fluids, tested as prescribed in § 113.34 shall not show hemagglutinating activity in the lowest dilution used in the titration.

(ii) Each bronchitis virus type shall be harvested separately and a sample of bulk harvested material shall be collected prior to mixing with the other virus type(s). Each sample shall contain not less than the minimum virus titer stated in the filed Outline of Production.

(iii) To be eligible for release, each serial and each subserial shall have a virus titer sufficiently greater than the titer of vaccine virus used in the immunogenicity test prescribed in paragraph (c) of this section to assure that when tested at any time within the expiration period, each serial and subserial shall have a virus titer of 10 0.7 greater than that used in such immunogenicity test but not less than 10 2.0 EID50 per dose.

[39 FR 44724, Dec. 27, 1974, as amended at 40 FR 18406, Apr. 28, 1975; 40 FR 41089, Sept. 5, 1975; 42 FR 43617, Aug. 30, 1977; 48 FR 33473, July 22, 1983. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66784, 66786, Dec. 26, 1991; 64 FR 43045, Aug. 9, 1999; 72 FR 72564, Dec. 21, 2007]

§ 113.328 Fowl Laryngotracheitis Vaccine.

Fowl Laryngotracheitis Vaccine shall be prepared from virus-bearing cell culture fluids or embryonated chicken eggs. Only Master Seed Virus which has been established as pure, safe, and immunogenic in accordance with the requirements in paragraphs (a), (b), and (c) of this section shall be used for preparing the production seed virus for vaccine production. All serials shall be prepared from the first through the fifth passage from the Master Seed Virus.

(a) The Master Seed Virus shall meet the applicable requirements prescribed in § 113.300 and the requirements prescribed in this section.

(b) Each lot of Master Seed Virus shall be tested for pathogens by the chicken embryo inoculation test prescribed in § 113.37, except that, if the test is a No Test because of vaccine virus override, the test may be repeated and if the repeat test is a No Test for the same reason, the chicken inoculation test prescribed in § 113.36 may be conducted and the virus judged accordingly. Each lot shall also be tested for safety as follows:

(1) Each of at least ten 3 to 4 week old susceptible chickens obtained from the same source and hatch as those used in the immunogenicity test prescribed in paragraph (c) of this section shall be injected intratracheally with 0.2 ml of the virus as used in the vaccine and the chickens observed each day for 14 days.

(2) If more than 20 percent of the chickens die during the observation period, the virus is unsatisfactory.

(c) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity and the selected virus dose to be used shall be established as follows:

(1) Fowl laryngotracheitis susceptible chickens all of the same age and from the same source shall be used. Twenty or more chickens shall be used as vaccinates for each method of administration recommended on the label. Ten additional chickens of the same age and from the same source shall be held as unvaccinated controls.

(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. Each vaccinate shall receive a predetermined quantity of vaccine virus. Five replicate virus titrations shall be conducted on an aliquot of the vaccine virus to confirm the amount of virus administered to each chicken used in the test. At least three appropriate (not to exceed tenfold) dilutions shall be used for vaccine of chicken embryo origin and the test conducted as follows:

(i) For each dilution, inject at least five embryos, 9 to 11 days old, on the chorioallantoic membrane with 0.2 ml each. Disregard all deaths during the first 24 hours post-injection. To be a valid test, at least four embryos in each dilution shall remain viable beyond 24 hours.

(ii) Examine the surviving embryos for evidence of infection 5 to 8 days post-injection.

(iii) A satisfactory titration shall have at least one dilution with between 50 and 100 percent positives and at least one dilution with between 50 and 0 percent positives.

(iv) Calculate the EID50 by the Spearman-Karber or Reed-Muench method.

(3) Tissue culture origin vaccine may be titrated by a tissue culture method approved by Animal and Plant Health Inspection Service and written into the filed Outline of Productions.

(4) Ten to fourteen days post-vaccination, all vaccinates and controls shall be challenged intratracheally or in the orbital sinus with infectious fowl laryngotracheitis virus and observed each day for 10 days. Challenge virus shall be provided or approved by Animal and Plant Health Inspection Service.

(5) If at least 80 percent of the controls do not die or show clinical signs of fowl laryngotracheitis during the observation period, the test is a No Test and may be repeated. If at least 19 of 20, 27 of 30, or 36 of 40 of the vaccinates in each group do not remain free of clinical signs of fowl laryngotracheitis during the observation period, the Master Seed Virus is unsatisfactory.

(6) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.

(d) After a lot of Master Seed Virus has been established as prescribed in paragraphs (a), (b), and (c) of this section, each serial and subserial shall meet the applicable requirements in § 113.300 and the requirements prescribed in this paragraph.

(1) Final container samples from each serial shall be tested for pathogens by the chicken embryo inoculation test prescribed in § 113.37, except that, if the test is a No Test because of a vaccine virus override, the chicken inoculation test prescribed in § 113.36 may be conducted and the vaccine judged accordingly.

(2) Safety test. Final container samples of completed product from each serial of modified live virus vaccine shall be tested for safety as provided in this paragraph. Live virus vaccine not prepared with modified live virus shall be tested for safety as provided in the filed Outline of Production.

(i) Twenty-five 3 to 4 week old laryngotracheitis susceptible chickens shall be injected intratracheally with 0.2 ml of vaccine rehydrated at the rate of 30 ml for 1,000 doses. Chickens shall be observed each day for 14 days. Deaths shall be counted as failures. Two-stage sequential testing may be conducted if the first test (which then becomes stage one) has five, six, or seven failures.

(ii) The results shall be evaluated according to the following table:

Cumulative Totals

Stage | Number of chickens | Failures for satisfactory serials | Failures for unsatisfactory serials

1 | 25 | 4 or less | 8 or more.

2 | 50 | 10 or less | 11 or more.

(iii) If unfavorable reactions occur which are not attributable to the product, the test shall be declared a No Test and repeated or in lieu thereof, the serial declared unsatisfactory.

(3) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the titration method provided in paragraphs (c)(2) or (3) of this section. To be eligible for release, each serial and each subserial shall have a virus titer sufficiently greater than the titer of vaccine virus used in the immunogenicity test prescribed in paragraph (c) of this section to assure that when tested at any time within the expiration period, each serial and subserial shall have a virus titer of 10 0.7 greater than that used in such immunogenicity test but not less than 10 2.5 EID50 per dose for chicken embryo origin vaccine and 10 2.0 EID50 or 10 2.5 TCID50 per dose for tissue culture origin vaccine.

[39 FR 44726, Dec. 27, 1974, as amended at 40 FR 18407, Apr. 28, 1975; 40 FR 41089, Sept. 5, 1975; 41 FR 44359, Oct. 8, 1976; 42 FR 43617, Aug. 30, 1977; 48 FR 33473, July 22, 1983. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66784, 66786, Dec. 26, 1991; 72 FR 72564, Dec. 21, 2007]

§ 113.329 Newcastle Disease Vaccine.

Newcastle Disease Vaccine shall be prepared from virus-bearing cell culture fluids or embryonated chicken eggs. Only Master Seed Virus which has been established as pure, safe, and immunogenic in accordance with the requirements in paragraphs (a), (b), and (c) of this section shall be used for preparing the production seed virus for vaccine production. All serials shall be prepared from the first through the fifth passage from the Master Seed Virus.

(a) The Master Seed Virus shall meet the applicable requirements prescribed in § 113.300, except § 113.34, and the requirements prescribed in this section.

(b) Each lot of Master Seed Virus shall be tested for pathogens by the chicken embryo inoculation test prescribed in § 113.37, except that, if the test is a No Test because of a vaccine virus override, the test may be repeated and if the repeat test is a No Test for the same reason, the chicken inoculation test prescribed in § 113.36 may be conducted and the virus judged accordingly.

(c) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity and the selected virus dose to be used shall be established as follows:

(1) Newcastle Disease susceptible chickens, all of the same age and from the same source, shall be used. Twenty or more chickens shall be used as vaccinates for each method of administration recommended on the label. Ten additional chickens of the same age and from the same source shall be held as unvaccinated controls.

(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. Each vaccinate shall receive a predetermined quantity of vaccine virus. Five replicate virus titrations shall be conducted on an aliquot of the vaccine virus to confirm the amount of virus administered to each chicken used in the test. At least three appropriate (not to exceed tenfold) dilutions shall be used and the test conducted as follows:

(i) For each dilution, inject at least five embryos, 9 to 11 days old, in the allantoic cavity with at least 0.1 ml each. Disregard all deaths during the first 24 hours post-injection. To be a valid test, at least four embryos in each dilution shall remain viable beyond 24 hours.

(ii) Examine the surviving embryos for evidence of infection 5 to 7 days post-injection.

(iii) A satisfactory titration shall have at least one dilution with between 50 and 100 percent positives and at least one dilution with between 50 and 0 percent positives.

(iv) Calculate the EID50 by the Spearman-Karber or Reed-Muench method.

(3) Twenty to twenty-eight days postvaccination, all vaccinates and controls shall be challenged intramuscularly with at least 10 4.0 EID50 of virus per chicken and observed each day for 14 days. Challenge virus shall be provided or approved by Animal and Plant Health Inspection Service.

(4) If at least 90 percent of the controls do not develop clinical signs of Newcastle disease during the observation period, the test is a No Test and may be repeated. If at least 19 of 20, or 27 of 30, or 36 of 40 of the vaccinates in each group do not remain free from clinical signs of Newcastle disease during the observation period, the Master Seed Virus is unsatisfactory.

(5) A strain identity test acceptable to Animal and Plant Health Inspection Service shall be conducted.

(6) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.

(d) After a lot of Master Seed Virus has been established as prescribed in paragraphs (a), (b), and (c) of this section, each serial and subserial shall meet the applicable requirements in § 113.300, except § 113.34, and the requirements prescribed in this paragraph.

(1) Final container samples from each serial shall be tested for pathogens by the chicken embryo inoculation test prescribed in § 113.37, except that, if the test is a No Test because of a vaccine virus override, the chicken inoculation test prescribed in § 113.36 may be conducted and the vaccine judged accordingly.

(2) Safety test: Final container samples of completed product from each serial shall be tested to determine whether the vaccine is safe for use in susceptible young chickens. Vaccines recommended for use in chickens 10 days of age or younger shall be tested in accordance with paragraphs (d)(2)(i), (ii), and (iii) of this section.

(i) Twenty-five susceptible chickens, 5 days of age or younger, properly identified and obtained from the same source and hatch, shall be vaccinated by the eye drop method with the equivalent of 10 doses of vaccine and the chickens observed each day for 21 days. Severe respiratory signs or death shall be counted as failures. Two-stage sequential testing may be conducted if the first test (which then becomes stage one) has 3 failures.

(ii) The results shall be evaluated according to the following table:

Cumulative Totals

Stage | Number of chickens | Failures for satisfactory serials | Failures for unsatisfactory serials

1 | 25 | 2 or less | 4 or more.

2 | 50 | 5 or less | 6 or more.

(iii) If unfavorable reactions occur which are not attributable to the product, the test shall be declared a No Test and may be repeated.

(iv) Vaccines not recommended for use in chickens 10 days of age or younger shall be tested for safety as follows:

Each of twenty-five 3 to 5 week old Newcastle disease susceptible chickens shall be vaccinated as recommended on the label with the equivalent of ten doses and observed each day for 21 days. If any of the birds show severe clinical signs of disease or death during the observation period due to causes attributable to the product, the serial is unsatisfactory.

(3) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the titration method used in paragraph (c)(2) of this section. To be eligible for release, each serial and each subserial shall have a virus titer per dose sufficiently greater than the titer of vaccine virus used in the immunogenicity test prescribed in paragraph (c) of this section to assure that when tested at any time within the expiration period, each serial and subserial shall have a virus titer of 10 0.7 greater than that used in the immunogenicity test but not less than 10 5.5 EID50 per dose.

[39 FR 44727, Dec. 27, 1974, as amended at 40 FR 18407, Apr. 28, 1975; 40 FR 23721, June 2, 1975; 40 FR 41090, Sept. 5, 1975; 42 FR 43618, Aug. 30, 1977; 48 FR 33473, July 22, 1983. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66784, 66786, Dec. 26, 1991; 72 FR 72564, Dec. 21, 2007]

§ 113.330 Marek's Disease Vaccines.

Marek's disease vaccine shall be prepared from virus-bearing tissue culture cells. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine production.

(a) The Master Seed Virus shall meet the applicable requirements prescribed in § 113.300, and the requirements prescribed in this section. The identity test required in § 113.300(c) shall be conducted in a serotype-specific manner by a method acceptable to APHIS. Each lot of Master Seed Virus shall also be tested for pathogens by the chicken embryo inoculation test prescribed in § 113.37, except that, if the test is a No Test because of a vaccine virus override, the chicken inoculation test prescribed in § 113.36 may be conducted and the virus judged accordingly.

(b) Safety test. The Master Seed Virus shall be nonpathogenic for chickens as determined by the following procedure:

(1) Specific pathogen free chickens or embryos, negative for Marek's disease virus antibodies, and from the same source, shall be isolated into the following groups:

(i) Group 1. At least 50 test subjects shall be inoculated with 10 times as much viable virus as will be contained in one dose of vaccine, by the route recommended for vaccination.

(ii) Group 2. At least 50 test subjects shall be injected with a very virulent Marek's disease virus provided or approved by APHIS, at a dosage level that will cause gross lesions of Marek's disease in at least 80 per cent of the chickens within 50 days.

(iii) Group 3. Fifty uninoculated controls. For in ovo studies, this group should receive a sham inoculation of diluent.

(iv) Group 4. For studies evaluating Serotype 1 Master Seed Viruses, a group of 50 uninoculated control chickens shall be housed in contact with the group 1 vaccinated chickens.

(2) At least 40 chickens in each group shall survive to 5 days of age. All chickens that die shall be necropsied and examined for lesions of Marek's disease and cause of death. The test shall be judged according to the following criteria:

(i) At 50 days of age, the remaining chickens in group 2 shall be killed and examined for gross lesions of Marek's disease. If at least 80 percent of this group do not develop Marek's disease, the test is a No Test and may be repeated.

(ii) At 120 days of age, the remaining chickens in groups 1, 3, and 4 shall be weighed, killed, and necropsied. If less than 30 of the chickens in group 3 survive the 120 day period, or if any of the chickens in group 3 have gross lesions of Marek's disease at necropsy, the test is declared a No Test. If less than 30 chickens in groups 1 and 4 survive the 120 day period; or if any of the chickens in groups 1 and 4 have gross lesions of Marek's disease at necropsy; or if the average body weight of the chickens in groups 1 or 4 is significantly (statistically) different from the average in group 3 at the end of the 120 days, the lot of Master Seed Virus is unsatisfactory.

(3) For tests involving in ovo inoculation, hatchability results shall also be reported for each group.

(c) Immunogenicity. Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity at the highest passage level allowed for the product, and the virus dose to be used shall be established as follows:

(1) Specific pathogen free chickens or embryos, negative for Marek's disease antibodies, and from the same source, shall be isolated into the following groups:

(i) Group 1. A minimum of 35 test subjects shall be inoculated with the vaccine, using the recommended route, at 1 day of age for chicks or 18 days of embryonation for embryos. The dose used shall be established by 5 replicate virus titrations conducted by a cell culture system or other titration method acceptable to APHIS.

(ii) Group 2. A minimum of 35 nonvaccinated test subjects shall be held as challenge controls.

(iii) Group 3. A minimum of 25 nonvaccinated test subjects shall be held as nonchallenge controls.

(iv) Group 4. Except for studies evaluating vaccines which contain only a Serotype 3 virus as the Marek's disease fraction, a minimum of 35 chicks shall be vaccinated at 1 day of age with a licensed Serotype 3 vaccine, in order to document the severity of the very virulent challenge.

(2) At least 30 chickens in groups 1, 2, and 4, and at least 20 chickens in group 3, shall survive to 5 days of age. All chickens in groups 1, 2, and 4 shall be challenged at 5 days of age in the following manner:

(i) For studies evaluating vaccines which contain only a Serotype 3 virus as the Marek's disease fraction, groups 1 and 2 shall be inoculated with a standard virulent challenge virus provided or approved by APHIS.

(ii) For all other Marek's disease vaccines, groups 1, 2, and 4 shall be inoculated with a very virulent challenge virus provided or approved by APHIS.

(3) All chickens shall be observed until 7 weeks of age, necropsied, and examined for grossly observable lesions consistent with Marek's disease. All chickens dying before the end of the 7 week observation period shall be necropsied and evaluated for gross lesions of Marek's disease. Any chickens not so examined shall be scored as positive for Marek's disease.

(4) For a valid test, at least 80 percent of the chickens in group 2 must develop grossly observable lesions, none of the chickens in group 3 shall develop grossly observable lesions, and (when included) greater than 20 percent of the chickens in group 4 must develop grossly observable lesions.

(5) For a valid test to be considered satisfactory, at least 80 percent of the chickens in group 1 must remain free of grossly observable lesions. The appropriate product claim resulting from a satisfactory test would be to aid in the prevention of Marek's disease, for vaccines containing only a Serotype 3 virus as the Marek's disease fraction, or to aid in the prevention of very virulent Marek's disease, for all other vaccines.

(d) Test requirements for release. Each serial and subserial shall meet the applicable requirements prescribed in § 113.300. The identity test required in § 113.300(c) shall be conducted in a serotype-specific manner by a method acceptable to APHIS. Final container samples of completed product shall also meet the requirements in paragraphs (d) (1), (2), and (3) of this section. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.

(1) Purity test. The chicken embryo inoculation test prescribed in § 113.37 shall be conducted, except that, if the test is a No Test because of a vaccine virus override, the chicken inoculation test prescribed in § 113.36 may be conducted and the virus judged accordingly.

(2) Safety test. At least 25 one-day-old, specific pathogen free chickens shall be injected, by the subcutaneous route, with the equivalent of 10 chicken doses of virus (vaccine concentrated 10X). The chickens shall be observed each day for 21 days. Chickens dying during the period shall be examined, cause of death determined, and the results recorded.

(i) If at least 20 chickens do not survive the observation period, the test is a No Test.

(ii) If lesions of any disease or cause of death are directly attributable to the vaccine, the serial is unsatisfactory.

(iii) If less than 20 chicks survive the observation period and there are no deaths or lesions attributable to the vaccine, the test may be repeated one time, Provided, that if the test is not repeated, the serial shall be declared unsatisfactory.

(3) Potency test. The samples shall be titrated using a cell culture system or other titration method acceptable to APHIS. For vaccines composed of more than one Marek's disease virus serotype, each fraction shall be titrated in a serotype-specific manner.

(i) Samples of desiccated vaccine shall be incubated at 37 °C for 3 days before preparation for use in the potency test. Samples of desiccated or frozen vaccine shall be reconstituted in diluent according to the label recommendations, and held in an ice bath at 0 °C to 4 °C for 2 hours prior to use in the potency test.

(ii) For a serial or subserial to be eligible for release, each serotype contained in the vaccine shall have a virus titer per dose which is at least 3 times greater than the number of plaque forming units (pfu) used in the immunogenicity test prescribed in paragraph (c) of this section, but not less than 1000 pfu per dose.

(iii) When tested (without the pretest incubation of desiccated products) at any time within the expiration period, each serotype contained in the vaccine shall have a virus titer per dose which is at least 2 times the number of pfu used in the immunogenicity test, but not less than 750 pfu per dose.

[61 FR 33841, July 1, 1996]

§ 113.331 Bursal Disease Vaccine.

Bursal Disease Vaccine shall be prepared from virus-bearing cell culture fluids or embryonated chicken eggs. Only Master Seed Virus which has been established as pure, safe, and immunogenic in accordance with the requirements in paragraphs (a), (b), and (c) of this section shall be used for preparing the production seed virus for vaccine production. All serials shall be prepared from the first through the fifth passage from the Master Seed Virus.

(a) The Master Seed Virus shall meet the applicable requirements prescribed in § 113.300 and the requirements prescribed in this section.

(b) Each lot of Master Seed Virus shall be tested for pathogens by the chicken embryo inoculation test prescribed in § 113.37, except that, if the test is a No Test because of a vaccine virus override, the chicken inoculation test prescribed in § 113.36 may be conducted and the virus judged accordingly. Each lot of Master Seed Virus used in the preparation of modified live virus vaccines shall also be nonpathogenic to chickens as determined by the following procedures:

(1) Each of twenty-five 1-day-old bursal disease susceptible chickens (vaccinates) shall be injected subcutaneously with 10 times the recommended dose of vaccine virus and observed for 21 days. Fifteen chickens of the same source and hatch shall be kept isolated as controls.

(i) Seventeen days postvaccination, each of five controls shall be administered at least 10 2.0 EID50 of a virulent bursal disease virus by eye-drop, isolated, and used as positive controls. The remaining controls shall be used as negative controls.

(ii) If the vaccinates do not remain free of clinical signs of bursal disease, the Master Seed Virus is unsatisfactory. If unfavorable reactions which are not attributable to the Master Seed Virus occur in more than two of the vaccinates, the test shall be declared a No Test and may be repeated.

(iii) Twenty-one days postvaccination, the vaccinates and the controls shall be necropsied and examined for gross lesions of bursal disease. If more than two of the vaccinates have such lesions, the Master Seed Virus is unsatisfactory, except that, if any of the negative controls or less than four of the positive controls have such lesions, the test is a No Test and may be repeated. For purposes of this test, gross lesions shall include obvious pathological processes and/or obvious reduction in size of the bursa from normal.

(2) Each of thirty-five 3- to 4-week-old bursal disease susceptible chickens (vaccinates) shall be vaccinated with approximately one minimum protective dose of vaccine virus as determined in paragraph (c) of this section. Each of 10 chickens of the same source and hatch shall be administered at least 10 2.0 EID50 of a virulent bursal disease virus by eye-drop, isolated, and used as positive controls. Also, each of 20 additional chickens of the same source and hatch shall be isolated and held as negative controls.

(i) Three or four days postvaccination, 10 of the vaccinates, the 10 positive controls, and 10 of the negative controls shall be necropsied and examined for gross lesions of bursal disease. If any of the vaccinates have such lesions, the Master Seed Virus is unsatisfactory, except that, if any of the negative controls or less than 8 of the positive controls have such lesions, the test is a No Test and may be repeated. For purposes of this test, gross lesions shall include peri-bursal edema and/or edema and/or macroscopic hemorrhage in the bursal tissue.

(ii) Fourteen days post-vaccination, the remaining vaccinates and negative controls shall be necropsied and examined for obvious bursal atrophy. If any of the vaccinates have such atrophy, the Master Seed Virus is unsatisfactory, except that, if any of the negative controls have such atrophy, the test is a No Test and may be repeated.

(c) Each lot of Master Seed Virus shall be tested for immunogenicity and the selected virus dose to be used shall be established as follows:

(1) Bursal Disease susceptible chickens, all of the same age (3 weeks or younger) and from the same source, shall be used. Twenty or more chickens shall be used as vaccinates for each method of administration recommended on the label. Ten additional chickens of the same age and from the same source shall be held as unvaccinated controls.

(2) A geometric mean titer of the vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. Each vaccinate shall receive a predetermined quantity of vaccine virus. Five replicate virus titrations shall be conducted on an aliquot of the vaccine virus to confirm the amount of virus administered to each chicken used in the test. At least three appropriate (not to exceed tenfold) dilutions shall be used to conduct the titrations by a method acceptable to Animal and Plant Health Inspection Service.

(3) When the test chickens are 28 to 35 days of age but not less than 14 days postvaccination, each vaccinate and each control shall be challenged by eye-drop with a virulent bursal disease virus provided or approved by Animal and Plant Health Inspection Service.

(i) Three to five days postchallenge, all vaccinates and controls shall be necropsied and examined for gross lesions of bursal disease as described in paragraph (b)(2)(i) of this section.

(ii) If at least 19 of 20, or 27 of 30, or 36 of 40 vaccinates in each group are not free from such lesions, the Master Seed Virus is unsatisfactory, except that, if less than 90 percent of the controls have such lesions, the test is a No Test and may be repeated.

(4) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.

(d) After a lot of Master Seed Virus has been established as prescribed in paragraphs (a), (b), and (c) of this section, each serial and subserial shall meet the applicable requirements in § 113.300 and the requirements prescribed in this paragraph.

(1) Tests for pathogens. Final container samples from each serial shall be tested for pathogens by the chicken embryo inoculation test prescribed in § 113.37, except that, if the test is a No Test because of a vaccine virus override, the chicken inoculation test prescribed in § 113.36 may be conducted and the serial judged accordingly.

(2) Safety tests. (i) Final container samples of completed product from each serial shall be tested to determine whether the vaccine is safe as follows:

(A) For vaccines intended for parenteral administration, each of twenty-five 1-day-old bursal disease susceptible chickens shall be vaccinated with the equivalent of 10 doses by subcutaneous injection.

(B) For vaccines intended for drinking water administration, each of twenty-five 4- to 5-week-old bursal disease susceptible chickens shall be vaccinated orally with the equivalent of 10 doses.

(C) Ten chickens of the same source and hatch shall be maintained in isolation as negative controls. The vaccinates and controls shall be observed each day for 21 days.

(ii) If unfavorable reactions which are attributable to the biological product occur during the observation period, the serial is unsatisfactory. If unfavorable reactions occur in more than one of the controls or if unfavorable reactions which are not attributable to the biological product occur in more than two of the vaccinates, the test shall be declared a No Test and repeated, except that, if the test is not repeated, the serial shall be unsatisfactory.

(3) Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the titration method used in paragraph (c)(2) of this section. To be eligible for release, each serial and each subserial shall have a virus titer sufficiently greater than the titer of vaccine virus used in the immunogenicity test prescribed in paragraph (c) of this section to assure that when tested at any time within the expiration period, each serial and subserial shall have a virus titer of 10 0.7 times greater than that used in such immunogenicity test, but not less than 10 2.0 titration units (PFU or ID50's) per dose.

[44 FR 60263, Oct. 19, 1979, as amended at 44 FR 67087, Nov. 23, 1979; 48 FR 33473, July 22, 1983. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66784, 66786, Dec. 26, 1991; 64 FR 43045, Aug. 9, 1999; 72 FR 72564, Dec. 21, 2007]

§ 113.332 Tenosynovitis Vaccine.

Tenosynovitis Vaccine shall be prepared from virus-bearing cell culture fluids or embryonated chicken eggs.

Only Master Seed which has been established as pure, safe, and immunogenic shall be used for preparing seeds for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed.

(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.300, except (a)(3)(ii) and (c), and the special requirements in this section.

(b) Each lot of Master Seed shall be tested for:

(1) Pathogens by the chicken inoculation test prescribed in § 113.36.

(2) Lymphoid leukosis virus contamination as follows:

(i) Each of at least 10 3-week-old or older lymphoid leukosis free chickens from the same source and hatch shall be injected intra-muscularly with an amount of Master Seed equal to 100 label doses of vaccine. At least 15 chickens of the same source and hatch shall be used as controls; 5 or more shall be unvaccinated and serve as negative controls; 5 or more shall be injected with subgroup A lymphoid leukosis virus; and 5 or more with subgroup B lymphoid leukosis virus. Each group of control chickens shall be held isolated from each other and from the vaccinates.

(ii) Twenty-one to 28 days postinoculation, blood samples shall be taken from each chicken and the serum separated using a technique conducive to virus preservation. These serums shall be used as inocula in the complement fixation for avian lymphoid leukosis (COFAL) test prescribed in § 113.31.

(iii) Serums from the vaccinates shall be tested separately, but serums within each control group may be pooled. A valid test shall have positive COFAL reactions from each virus inoculated group and negative reactions from the uninoculated controls. If any of the chickens injected with the Master Seed have positive COFAL test reactions in a valid test, the Master Seed is unsatisfactory.

(3) Identity using the following agar gel immunodiffusion test. The undiluted Master Seed may be used as test antigen or the Master Seed may be inoculated onto the chorioallantoic membrane (CAM) of fully susceptible chicken embryos and the infected CAMs ground and used as antigen. A known tenosynovitis antiserum and a known tenosynovitis antigen shall be used in the test. A precipitin line shall form between the test antigen and the known antiserum in the center well which shows identity with the line formed between the antiserum and the known antigen, or the Master Seed is unsatisfactory.

(4) Safety using the following chicken test:

(i) For vaccines intended for use in chickens less than 14 days of age, Master Seed equal to 10 label doses shall be administered subcutaneously to each of 25 1-day-old tenosynovitis susceptible chickens.

(ii) For vaccines intended for use only in chickens 14 days of age or older, Master Seed equal to 10 label doses shall be administered subcutaneously to each of 25 4-week-old or older tenosynovitis susceptible chickens.

(iii) The vaccinates shall be observed each day for 21 days. If unfavorable reactions occur which are attributable to the vaccine, the Master Seed is unsatisfactory. If unfavorable reactions occur which are not attributable to the vaccine, the test is a No Test and may be repeated.

(c) Each lot of Master Seed shall be tested for immunogenicity. The selected virus dose shall be established as follows:

(1) Tenosynovitis susceptible chickens, of the same age and from the same source shall be used as test birds. Vaccines intended for use in very young chickens shall be administered to chickens of the youngest age for which the vaccine is recommended. Vaccines intended for use in older chickens shall be administered to 4-week-old or older chickens. Twenty or more vaccinates shall be used for each method of administration recommended on the label. Ten or more chickens shall be held as unvaccinated controls.