Title 10—Energy--Volume 5

§ 21.1 Purpose.

The regulations in this part establish procedures and requirements for implementation of section 206 of the Energy Reorganization Act of 1974. That section requires any individual director or responsible officer of a firm constructing, owning, operating or supplying the components of any facility or activity which is licensed or otherwise regulated pursuant to the Atomic Energy Act of 1954, as amended, or the Energy Reorganization Act of 1974, who obtains information reasonably indicating: (a) That the facility, activity or basic component supplied to such facility or activity fails to comply with the Atomic Energy Act of 1954, as amended, or any applicable rule, regulation, order, or license of the Commission relating to substantial safety hazards or (b) that the facility, activity, or basic component supplied to such facility or activity contains defects, which could create a substantial safety hazard, to immediately notify the Commission of such failure to comply or such defect, unless he has actual knowledge that the Commission has been adequately informed of such defect or failure to comply.

§ 21.2 Scope.

(a) The regulations in this part apply, except as specifically provided otherwise in parts 31, 34, 35, 39, 40, 60, 61, 63, 70, or part 72 of this chapter, to:

(1) Each individual, partnership, corporation, or other entity applying for or holding a license or permit under the regulations in this chapter to possess, use, or transfer within the United States source material, byproduct material, special nuclear material, and/or spent fuel and high-level radioactive waste, or to construct, manufacture, possess, own, operate, or transfer within the United States, any production or utilization facility or independent spent fuel storage installation (ISFSI) or monitored retrievable storage installation (MRS); and each director and responsible officer of such a licensee;

(2) Each individual, corporation, partnership, or other entity doing business within the United States, and each director and responsible officer of such an organization, that constructs a production or utilization facility licensed for manufacture, construction, or operation under part 50, 52, or 53 of this chapter, an ISFSI for the storage of spent fuel licensed under part 72 of this chapter, an MRS for the storage of spent fuel or high-level radioactive waste under part 72 of this chapter, or a geologic repository for the disposal of high-level radioactive waste under part 60 or 63 of this chapter; or supplies basic components for a facility or activity licensed, other than for export, under part 30, 40, 50, 52, 53, 60, 61, 63, 70, 71, or 72 of this chapter;

(3) Each individual, corporation, partnership, or other entity doing business within the United States, and each director and responsible officer of such an organization, applying for a design certification rule under part 52 or 53 of this chapter; or supplying basic components with respect to that design certification, and each individual, corporation, partnership, or other entity doing business within the United States, and each director and responsible officer of such an organization, whose application for design certification has been granted under part 52 or 53 of this chapter, or who has supplied or is supplying basic components with respect to that design certification;

(4) Each individual, corporation, partnership, or other entity doing business within the United States, and each director and responsible officer of such an organization, applying for or holding a standard design approval under part 52 or 53 of this chapter; or supplying basic components with respect to a standard design approval under part 52 or 53 of this chapter;

(b) For persons licensed to construct a facility under either a construction permit issued under § 50.23 or § 53.1333 of this chapter or a combined license under part 52 or 53 of this chapter (for the period of construction until the date that the Commission makes the finding under § 52.103(g) or § 53.1452(g) of this chapter), or to manufacture a facility under part 52 or 53 of this chapter, evaluation of potential defects and failures to comply and reporting of defects and failures to comply under § 50.55(e) or § 53.605 of this chapter satisfies each person's evaluation, notification, and reporting obligation to report defects and failures to comply under this part and the responsibility of individual directors and responsible officers of these licensees to report defects under section 206 of the Energy Reorganization Act of 1974.

(c) For persons licensed to operate a nuclear power plant under part 50, 52, or 53 of this chapter, evaluation of potential defects and appropriate reporting of defects under § 50.72, § 50.73, § 53.1630, § 53.1640, or §§ 73.1200 and 73.1205 of this chapter, satisfies each person's evaluation, notification, and reporting obligation to report defects under this part, and the responsibility of individual directors and responsible officers of these licensees to report defects under Section 206 of the Energy Reorganization Act of 1974.

(d) Nothing in these regulations should be deemed to preclude either an individual, a manufacturer, or a supplier of a commercial grade item (as defined in § 21.3) not subject to the regulations in this part from reporting to the Commission, a known or suspected defect or failure to comply and, as authorized by law, the identity of anyone so reporting will be withheld from disclosure. NRC regional offices and headquarters will accept collect telephone calls from individuals who wish to speak to NRC representatives concerning nuclear safety-related problems. The location and telephone numbers of the four regions (answered during regular working hours), are listed in appendix D to part 20 of this chapter. The telephone numbers of the NRC Headquarters Operations Center (answered 24 hours a day—including holidays) are listed in appendix A to part 73 of this chapter.

(e) The regulations in this part apply in accordance with 10 CFR 76.60 to each individual, partnership, corporation, or other entity required to obtain a certificate of compliance or an approved compliance plan under part 76 of this chapter.

[56 FR 36089, July 31, 1991, as amended at 59 FR 14086, Mar. 25, 1994; 59 FR 48959, Sept. 23, 1994; 60 FR 48373, Sept. 19, 1995; 66 FR 55790, Nov. 2, 2001; 72 FR 49486, Aug. 28, 2007; 85 FR 65661, Oct. 16, 2020; 88 FR 15880, Mar. 14, 2023; 91 FR 15773, Mar. 30, 2026]

§ 21.3 Definitions.

Link to an amendment published at 91 FR 15774, Mar. 30, 2026.

As used in this part:

Basic component. (1)(i) When applied to nuclear power plants licensed under part 53 of this chapter, basic component means a safety-related structure, system, or component (SSC), or part thereof, and when applied to nuclear power plants licensed under part 50 or 52 of this chapter, basic component means an SSC, or part thereof, that affects its safety function necessary to assure:

(A) The integrity of the reactor coolant pressure boundary;

(B) The capability to shut down the reactor and maintain it in a safe-shutdown condition; or

(C) The capability to prevent or mitigate the consequences of accidents which could result in potential offsite exposures comparable to those referred to in § 50.34(a)(1), § 50.67(b)(2), or § 100.11 of this chapter, as applicable.

(ii) Basic components are items designed and manufactured under a quality assurance program complying with appendix B to part 50 of this chapter, or commercial grade items which have successfully completed the dedication process.

(2) When applied to standard design certifications and approvals under part 53 of this chapter, basic component means the design or procurement information approved or to be approved within the scope of the design certification or approval for a safety-related SSC, or part thereof. When applied to standard design certifications under subpart B of part 52 of this chapter and standard design approvals under part 52 of this chapter, basic component means the design or procurement information approved or to be approved within the scope of the design certification or approval for an SSC, or part thereof, that affects its safety function necessary to assure:

(i) The integrity of the reactor coolant pressure boundary;

(ii) The capability to shut down the reactor and maintain it in a safe-shutdown condition; or

(iii) The capability to prevent or mitigate the consequences of accidents which could result in potential offsite exposures comparable to those referred to in § 50.34(a)(1), § 50.67(b)(2), or § 100.11 of this chapter, as applicable.

(3) When applied to other facilities and other activities licensed under part 30, 40, 50 (other than nuclear power plants), 60, 61, 63, 70, 71, or 72 of this chapter, basic component means a structure, system, or component, or part thereof, that affects their safety function, that is directly procured by the licensee of a facility or activity subject to the regulations in this part and in which a defect or failure to comply with any applicable regulation in this chapter, order, or license issued by the Commission could create a substantial safety hazard.

(4) In all cases, basic component includes safety-related design, analysis, inspection, testing, fabrication, replacement of parts, or consulting services that are associated with the component hardware, design certification, design approval, or information in support of an early site permit application under part 52 or 53 of this chapter, whether these services are performed by the component supplier or others.

Commercial grade item. (1) When applied to nuclear power plants licensed under part 50 or 53 of this chapter, commercial grade item means an SSC, or part thereof that affects its safety function, that was not designed and manufactured as a basic component. Commercial grade items do not include items where the design and manufacturing process require in-process inspections and verifications to ensure that defects or failures to comply are identified and corrected (i.e., one or more critical characteristics of the item cannot be verified).

(2) When applied to facilities and activities licensed pursuant to part 30, 40, 50 (other than nuclear power plants), 60, 61, 63, 70, 71, or 72 of this chapter, commercial grade item means an item that is:

(i) Not subject to design or specification requirements that are unique to those facilities or activities;

(ii) Used in applications other than those facilities or activities; and

(iii) To be ordered from the manufacturer/supplier on the basis of specifications set forth in the manufacturer's published product description (for example, a catalog).

Commission means the Nuclear Regulatory Commission or its duly authorized representatives.

Constructing or construction means the analysis, design, manufacture, fabrication, placement, erection, installation, modification, inspection, or testing of a facility or activity which is subject to the regulations in this part and consulting services related to the facility or activity that are safety related.

Critical characteristics. When applied to nuclear power plants licensed under part 50, 52, or 53 of this chapter, critical characteristics are those important design, material, and performance characteristics of a commercial grade item that, once verified, will provide reasonable assurance that the item will perform its intended safety function.

Dedicating entity. When applied to nuclear power plants licensed under part 50, 52, or 53 of this chapter, dedicating entity means the organization that performs the dedication process. Dedication may be performed by the manufacturer of the item, a third-party dedicating entity, or the licensee itself. The dedicating entity, under § 21.21(c), is responsible for identifying and evaluating deviations, reporting defects and failures to comply for the dedicated item, and maintaining auditable records of the dedication process.

Dedication. (1) When applied to nuclear power plants licensed pursuant to part 30, 40, 50, 53, or 60 of this chapter, dedication is an acceptance process undertaken to provide reasonable assurance that a commercial grade item to be used as a basic component will perform its intended safety function and, in this respect, is deemed equivalent to an item designed and manufactured under a quality assurance program under appendix B to part 50 of this chapter. This assurance is achieved by identifying the critical characteristics of the item and verifying their acceptability by inspections, tests, or analyses performed by the purchaser or third-party dedicating entity after delivery, supplemented as necessary by one or more of the following: commercial grade surveys; product inspections or witness at holdpoints at the manufacturer's facility, and analysis of historical records for acceptable performance. In all cases, the dedication process must be conducted under the applicable provisions of appendix B to part 50. The process is considered complete when the item is designated for use as a basic component.

(2) When applied to facilities and activities licensed pursuant to part 30, 40, 50 (other than nuclear power plants), 60, 61, 63, 70, 71, or 72 of this chapter, dedication occurs after receipt when that item is designated for use as a basic component.

Defect means:

(1) A deviation in a basic component delivered to a purchaser for use in a facility or an activity subject to the regulations in this part if, on the basis of an evaluation, the deviation could create a substantial safety hazard;

(2) The installation, use, or operation of a basic component containing a defect as defined in this section;

(3) A deviation in a portion of a facility subject to the early site permit, standard design certification, standard design approval, construction permit, combined license or manufacturing licensing requirements of part 50, 52, or 53 of this chapter, provided the deviation could, on the basis of an evaluation, create a substantial safety hazard and the portion of the facility containing the deviation has been offered to the purchaser for acceptance;

(4) A condition or circumstance involving a basic component that could contribute to the exceeding of a safety limit, as defined in the technical specifications of a license for operation issued under part 50, 52, or 53 of this chapter; or

(5) An error, omission or other circumstance in a design certification, or standard design approval that, on the basis of an evaluation, could create a substantial safety hazard.

Deviation means a departure from the technical requirements included in a procurement document, or specified in early site permit information, a standard design certification or standard design approval.

Director means an individual, appointed or elected according to law, who is authorized to manage and direct the affairs of a corporation, partnership or other entity. In the case of an individual proprietorship, director means the individual.

Discovery means the completion of the documentation first identifying the existence of a deviation or failure to comply potentially associated with a substantial safety hazard within the evaluation procedures discussed in § 21.21(a).

Evaluation means the process of determining whether a particular deviation could create a substantial hazard or determining whether a failure to comply is associated with a substantial safety hazard.

Notification means the telephonic communication to the NRC Operations Center or written transmittal of information to the NRC Document Control Desk.

Operating or operation means the operation of a facility or the conduct of a licensed activity which is subject to the regulations in this part and consulting services related to operations that are safety related.

Procurement document means a contract that defines the requirements which facilities or basic components must meet in order to be considered acceptable by the purchaser.

Responsible officer means the president, vice-president or other individual in the organization of a corporation, partnership, or other entity who is vested with executive authority over activities subject to this part.

Substantial safety hazard means a loss of safety function to the extent that there is a major reduction in the degree of protection provided to public health and safety for any facility or activity licensed or otherwise approved or regulated by the NRC, other than for export, under part 30, 40, 50, 52, 53, 60, 61, 63, 70, 71, or 72 of this chapter.

Supplying or supplies means contractually responsible for a basic component used or to be used in a facility or activity which is subject to the regulations in this part.

[42 FR 28893, June 6, 1977; 42 FR 36803, July 18, 1977, as amended at 43 FR 48622, Oct. 19, 1978; 46 FR 58283, Dec. 1, 1981; 47 FR 57480, Dec. 27, 1982; 56 FR 36089, July 31, 1991; 59 FR 5519, Feb. 7, 1994; 60 FR 48373, Sept. 19, 1995; 61 FR 65171, Dec. 11, 1996; 64 FR 72000, Dec. 23, 1999; 66 FR 55790, Nov. 2, 2001; 72 FR 49486, Aug. 28, 2007; 84 FR 63567, Nov. 18, 2019; 91 FR 15774, Mar. 30, 2026]

§ 21.4 Interpretations.

Except as specifically authorized by the Commission in writing, no interpretation of the meaning of the regulations in this part by any officer or employee of the Commission other than a written interpretation by the General Counsel will be recognized to be binding upon the Commission. This section shall cease to have effect on January 8, 2027 unless the NRC determines that the cessation deadline should be extended to a date not more than 5 years in the future after offering the public an opportunity to provide input on the costs and benefits of this section and considering that input. The NRC will publish a document in the Federal Register announcing its determination and revising or removing this section accordingly.

[42 FR 28893, June 6, 1977, as amended at 90 FR 55628, Dec. 3, 2025]

§ 21.5 Communications.

Except where otherwise specified in this part, written communications and reports concerning the regulations in this part must be addressed to the NRC's Document Control Desk, and sent by mail to the U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; by hand delivery to the NRC's offices at 11555 Rockville Pike, Rockville, Maryland; or, where practicable, by electronic submission, for example, Electronic Information Exchange, or CD-ROM. Electronic submissions must be made in a manner that enables the NRC to receive, read, authenticate, distribute, and archive the submission, and process and retrieve it a single page at a time. Detailed guidance on making electronic submissions can be obtained by visiting the NRC's Web site at http://www.nrc.gov/site-help/e-submittals.html; by e-mail to MSHD.Resource@nrc.gov; or by writing the Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. The guidance discusses, among other topics, the formats the NRC can accept, the use of electronic signatures, and the treatment of nonpublic information. In the case of a licensee or permit holder, a copy of the communication must also be sent to the appropriate Regional Administrator at the address specified in appendix D to part 20 of this chapter.

[72 FR 49487, Aug. 28, 2007, as amended at 74 FR 62680, Dec. 1, 2009; 80 FR 74979, Dec. 1, 2015]

§ 21.6 Posting requirements.

(a)(1) Each individual, partnership, corporation, dedicating entity, or other entity subject to the regulations in this part shall post current copies of—

(i) The regulations in this part;

(ii) Section 206 of the Energy Reorganization Act of 1974; and

(iii) Procedures adopted pursuant to the regulations in this part.

(2) These documents must be posted in a conspicuous position on any premises within the United States where the activities subject to this part are conducted.

(b) If posting of the regulations in this part or the procedures adopted pursuant to the regulations in this part is not practicable, the licensee or firm subject to the regulations in this part may, in addition to posting section 206, post a notice which describes the regulations/procedures, including the name of the individual to whom reports may be made, and states where they may be examined.

(c) The effective date of this section has been deferred until January 6, 1978.

[42 FR 28893, June 6, 1977, as amended at 60 FR 48374, Sept. 19, 1995]

§ 21.7 Exemptions.

The Commission may, upon application of any interested person or upon its own initiative, grant such exemptions from the requirements of the regulations in this part as it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest. Suppliers of commercial grade items are exempt from the provisions of this part to the extent that they supply commercial grade items.

[42 FR 28893, June 6, 1977, as amended at 43 FR 48622, Oct. 19, 1978]

§ 21.8 Information collection requirements: OMB approval.

(a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150-0035.

(b) The approved information collection requirements contained in this part appear in §§ 21.7, 21.21 and 21.51.

[62 FR 52185, Oct. 6, 1997]

§ 21.21 Notification of failure to comply or existence of a defect and its evaluation.

(a) Each individual, corporation, partnership, dedicating entity, or other entity subject to the regulations in this part shall adopt appropriate procedures to—

(1) Evaluate deviations and failures to comply to identify defects and failures to comply associated with substantial safety hazards as soon as practicable, and, except as provided in paragraph (a)(2) of this section, in all cases within 60 days of discovery, in order to identify a reportable defect or failure to comply that could create a substantial safety hazard, were it to remain uncorrected, and

(2) Ensure that if an evaluation of an identified deviation or failure to comply potentially associated with a substantial safety hazard cannot be completed within 60 days from discovery of the deviation or failure to comply, an interim report is prepared and submitted to the Commission through a director or responsible officer or designated person as discussed in § 21.21(d)(5). The interim report should describe the deviation or failure to comply that is being evaluated and should also state when the evaluation will be completed. This interim report must be submitted in writing within 60 days of discovery of the deviation or failure to comply.

(3) Ensure that a director or responsible officer subject to the regulations of this part is informed as soon as practicable, and, in all cases, within the 5 working days after completion of the evaluation described in paragraphs (a)(1) or (a)(2) of this section if the manufacture, construction, or operation of a facility or activity, a basic component supplied for such facility or activity, or the design certification or design approval under part 52 or 53 of this chapter—

(i) Fails to comply with the Atomic Energy Act of 1954, as amended, or any applicable rule, regulation, order, or license of the Commission or standard design approval under part 52 or 53 of this chapter, relating to a substantial safety hazard, or

(ii) Contains a defect.

(b) If the deviation or failure to comply is discovered by a supplier of basic components, or services associated with basic components, and the supplier determines that it does not have the capability to perform the evaluation to determine if a defect exists, then the supplier must inform the purchasers or affected licensees within five working days of this determination so that the purchasers or affected licensees may evaluate the deviation or failure to comply, pursuant to § 21.21(a).

(c) A dedicating entity is responsible for—

(1) Identifying and evaluating deviations and reporting defects and failures to comply associated with substantial safety hazards for dedicated items; and

(2) Maintaining auditable records for the dedication process.

(d)(1) A director or responsible officer subject to the regulations of this part or a person designated under § 21.21(d)(5) must notify the Commission when he or she obtains information reasonably indicating a failure to comply or a defect affecting—

(i) The manufacture, construction or operation of a facility or an activity within the United States that is subject to the licensing requirements under parts part 30, 40, 50, 52, 53, 60, 61, 63, 70, 71, or 72 of this chapter and that is within his or her organization's responsibility; or

(ii) A basic component that is within his or her organization's responsibility and is supplied for a facility or an activity within the United States that is subject to the licensing, design certification, or approval requirements under part 30, 40, 50, 52, 53, 60, 61, 63, 70, 71, or 72 of this chapter.

(2) The notification to NRC of a failure to comply or of a defect under paragraph (d)(1) of this section and the evaluation of a failure to comply or a defect under paragraphs (a)(1) and (a)(2) of this section, are not required if the director or responsible officer has actual knowledge that the Commission has been notified in writing of the defect or the failure to comply.

(3) Notification required by paragraph (d)(1) of this section must be made as follows—

(i) Initial notification by facsimile, which is the preferred method of notification, to the NRC Operations Center at (301) 816-5151 or by telephone at (301) 816-5100 within two days following receipt of information by the director or responsible corporate officer under paragraph (a)(1) of this section, on the identification of a defect or a failure to comply. Verification that the facsimile has been received should be made by calling the NRC Operations Center. This paragraph does not apply to interim reports described in § 21.21(a)(2).

(ii) Written notification to the NRC at the address specified in § 21.5 within 30 days following receipt of information by the director or responsible corporate officer under paragraph (a)(3) of this section, on the identification of a defect or a failure to comply.

(4) The written report required by this paragraph shall include, but need not be limited to, the following information, to the extent known:

(i) Name and address of the individual or individuals informing the Commission.

(ii) Identification of the facility, the activity, or the basic component supplied for such facility or such activity within the United States which fails to comply or contains a defect.

(iii) Identification of the firm constructing the facility or supplying the basic component which fails to comply or contains a defect.

(iv) Nature of the defect or failure to comply and the safety hazard which is created or could be created by such defect or failure to comply.

(v) The date on which the information of such defect or failure to comply was obtained.

(vi) In the case of a basic component which contains a defect or fails to comply, the number and location of these components in use at, supplied for, being supplied for, or may be supplied for, manufactured, or being manufactured for one or more facilities or activities subject to the regulations in this part.

(vii) The corrective action which has been, is being, or will be taken; the name of the individual or organization responsible for the action; and the length of time that has been or will be taken to complete the action.

(viii) Any advice related to the defect or failure to comply about the facility, activity, or basic component that has been, is being, or will be given to purchasers or licensees.

(ix) In the case of an early site permit, the entities to whom an early site permit was transferred.

(5) The director or responsible officer may authorize an individual to provide the notification required by this paragraph, provided that, this shall not relieve the director or responsible officer of his or her responsibility under this paragraph.

(e) Individuals subject to this part may be required by the Commission to supply additional information related to a defect or failure to comply. Commission action to obtain additional information may be based on reports of defects from other reporting entities.

[42 FR 28893, June 6, 1977, as amended at 46 FR 58283, Dec. 1, 1981; 47 FR 57480, Dec. 27, 1982; 52 FR 31611, Aug. 21, 1987; 56 FR 36089, July 31, 1991; 59 FR 14086, Mar. 25, 1994; 60 FR 48374, Sept. 19, 1995; 66 FR 55790, Nov. 2, 2001; 67 FR 77652, Dec. 19, 2002; 72 FR 49487, Aug. 28, 2007; 91 FR 15775, Mar. 30, 2026]

§ 21.31 Procurement documents.

Each individual, corporation, partnership, dedicating entity, or other entity subject to the regulations in this part shall ensure that each procurement document for a facility, or a basic component issued by him, her or it on or after January 6, 1978, specifies, when applicable, that the provisions of 10 CFR part 21 apply.

[60 FR 48374, Sept. 19, 1995]

§ 21.41 Inspections.

Each individual, corporation, partnership, dedicating entity, or other entity subject to the regulations in this part shall permit the Commission to inspect records, premises, activities, and basic components as necessary to accomplish the purposes of this part.

[60 FR 48374, Sept. 19, 1995]

§ 21.51 Maintenance and inspection of records.

(a) Each individual, corporation, partnership, dedicating entity, or other entity subject to the regulations in this part shall prepare and maintain records necessary to accomplish the purposes of this part, specifically—

(1) Retain evaluations of all deviations and failures to comply for a minimum of five years after the date of the evaluation;

(2) Suppliers of basic components must retain any notifications sent to purchasers and affected licensees for a minimum of five years after the date of the notification.

(3) Suppliers of basic components must retain a record of the purchasers of basic components for 10 years after delivery of the basic component or service associated with a basic component.

(4) Applicants for standard design certification under subpart B of part 52 or under subpart H of part 53 of this chapter and others providing a design which is the subject of a design certification, during and following Commission adoption of a final design certification rule for that design, shall retain any notifications sent to purchasers and affected licensees for a minimum of 5 years after the date of the notification, and retain a record of the purchasers for 15 years after delivery of design which is the subject of the design certification rule or service associated with the design.

(5) Applicants for or holders of a standard design approval under subpart E of part 52 or under subpart H of part 53 of this chapter and others providing a design which is the subject of a design approval shall retain any notifications sent to purchasers and affected licensees for a minimum of 5 years after the date of the notification, and retain a record of the purchasers for 15 years after delivery of the design which is the subject of the design approval or service associated with the design.

(b) Each individual, corporation, partnership, dedicating entity, or other entity subject to the regulations in this part shall permit the Commission the opportunity to inspect records pertaining to basic components that relate to the identification and evaluation of deviations, and the reporting of defects and failures to comply, including (but not limited to) any advice given to purchasers or licensees on the placement, erection, installation, operation, maintenance, modification, or inspection of a basic component.

[56 FR 36090, July 31, 1991, as amended at 60 FR 48374, Sept. 19, 1995; 72 FR 49488, Aug. 28, 2007; 91 FR 15775, Mar. 30, 2026]

§ 21.61 Failure to notify.

(a) Any director or responsible officer of an entity (including dedicating entity) that is not otherwise subject to the deliberate misconduct provisions of this chapter but is subject to the regulations in this part who knowingly and consciously fails to provide the notice required as by § 21.21 shall be subject to a civil penalty equal to the amount provided by section 234 of the Atomic Energy Act of 1954, as amended.

(b) Any NRC licensee or applicant for a license (including an applicant for, or holder of, a permit), applicant for a design certification under part 52 or 53 of this chapter during the pendency of its application, applicant for a design certification after Commission adoption of a final design certification rule for that design, or applicant for or holder of a standard design approval under part 52 or 53 of this chapter subject to the regulations in this part who fails to provide the notice required by § 21.21, or otherwise fails to comply with the applicable requirements of this part shall be subject to a civil penalty as provided by Section 234 of the Atomic Energy Act of 1954, as amended.

(c) The dedicating entity, pursuant to § 21.21(c) of this part, is responsible for identifying and evaluating deviations, reporting defects and failures to comply for the dedicated item, and maintaining auditable records of the dedication process. NRC enforcement action can be taken for failure to identify and evaluate deviations, failure to report defects and failures to comply, or failure to maintain auditable records.

[60 FR 48374, Sept. 19, 1995, as amended at 72 FR 49488, Aug. 28, 2007; 91 FR 15775, Mar. 30, 2026]

§ 21.62 Criminal penalties.

(a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all the regulations in part 21 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section.

(b) The regulations in part 21 that are not issued under sections 161b, 161i, or 161o for the purposes of section 223 are as follows: §§ 21.1, 21.2, 21.3, 21.4 21.5, 21.7, 21.8, 21.61, and 21.62.

[57 FR 55071, Nov. 24, 1992]

§ 25.1 Purpose.

The regulations in this part establish procedures for granting, reinstating, extending, transferring, and terminating access authorizations of licensee personnel, licensee contractors or agents, and other persons (e.g., individuals involved in adjudicatory procedures as set forth in 10 CFR part 2, subpart I) who may require access to classified information.

[62 FR 17687, Apr. 11, 1997]

§ 25.3 Scope.

The regulations in this part apply to licensees, certificate holders, and others who may require access to classified information related to a license, certificate, an application for a license or certificate, or other activities as the Commission may determine.

[70 FR 32227, June 2, 2005]

§ 25.5 Definitions.

Access authorization means an administrative determination that an individual (including a consultant) who is employed by or an applicant for employment with the NRC, NRC contractors, agents, licensees and certificate holders, or other person designated by the Executive Director for Operations, is eligible for a security clearance for access to classified information.

Act means the Atomic Energy Act of 1954 (68 Stat. 919), as amended.

Certificate holder means a facility operating under the provisions of parts 71 or 76 of this chapter.

Classified information means either classified National Security Information, Restricted Data, or Formerly Restricted Data or any one of them. It is the generic term for information requiring protection in the interest of National Security whether classified under an Executive Order or the Atomic Energy Act.

Classified National Security Information means information that has been determined under E.O. 13526, as amended, or any predecessor or successor order to require protection against unauthorized disclosure and that is so designated.

Cognizant Security Agency (CSA) means agencies of the Executive Branch that have been authorized by E.O. 12829 to establish an industrial security program for the purpose of safeguarding classified information under the jurisdiction of those agencies when disclosed or released to U.S. industry. These agencies are the Department of Defense, the Department of Energy, the Central Intelligence Agency, and the Nuclear Regulatory Commission. A facility has a single CSA which exercises primary authority for the protection of classified information at the facility. The CSA for the facility provides security representation for other government agencies with security interests at the facility. The Secretary of Defense has been designated as Executive Agent for the National Industrial Security Program.

Commission means the Nuclear Regulatory Commission or its duly authorized representatives.

“L” access authorization means an access authorization granted by the Commission that is normally based on a Tier 3 (T3) investigation conducted by the Defense Counterintelligence and Security Agency (DCSA).

License means a license issued pursuant to part 50, 52, 53, 60, 63, 70, or 72 of this chapter.

Matter means documents or material.

National Security Information means information that has been determined pursuant to Executive Order 12958, as amended, or any predecessor order to require protection against unauthorized disclosure and that is so designated.

Need-to-know means a determination made by an authorized holder of classified information that a prospective recipient requires access to a specific classified information to perform or assist in a lawful and authorized governmental function under the cognizance of the Commission.

Person means (1) any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, government agency other than the Commission or the Department of Energy (DOE), except that the DOE shall be considered a person to the extent that its facilities are subject to the licensing and related regulatory authority of the Commission pursuant to section 202 of the Energy Reorganization Act of 1974 and sections 104, 105 and 202 of the Uranium Mill Tailings Radiation Control Act of 1978, any State or any political subdivision of, or any political entity within a State, any foreign government or nation or any political subdivision of any such government or nation, or other entity; and (2) any legal successor, representative, agent, or agency of the foregoing.

“Q” access authorization means an access authorization granted by the Commission normally based on a Tier 5 (T5) investigation conducted by the Defense Counterintelligence and Security Agency, the Federal Bureau of Investigation, or other U.S. Government agency that conducts personnel security investigations.

Restricted Data means all data concerning design, manufacture or utilization of atomic weapons, the production of special nuclear material, or the use of special nuclear material in the production of energy, but shall not include data declassified or removed from the Restricted Data category pursuant to section 142 of the Act.

Visit authorization letters (VAL) means a letter, generated by a licensee, certificate holder or other organization under the requirements of 10 CFR parts 25 and/or 95, verifying the need-to-know and access authorization of an individual from that organization who needs to visit another authorized facility for the purpose of exchanging or acquiring classified information related to the license.

[45 FR 14481, Mar. 5, 1980, as amended at 46 FR 58283, Dec. 1, 1981; 47 FR 38683, Sept. 2, 1982; 48 FR 24320, June 1, 1983; 50 FR 36984, Sept. 11, 1985; 55 FR 11574, Mar. 29, 1990; 62 FR 17687, Apr. 11, 1997; 64 FR 15647, Apr. 1, 1999; 70 FR 32227, June 2, 2005; 75 FR 73941, Nov. 30, 2010; 86 FR 43401, Aug. 9, 2021; 87 FR 45241, July 28, 2022; 91 FR 15775, Mar. 30, 2026]

§ 25.7 Interpretations.

Except as specifically authorized by the Commission in writing, no interpretation of the meaning of the regulations in this part by any officer or employee of the Commission other than a written interpretation by the General Counsel will be recognized to be binding upon the Commission. This section shall cease to have effect on January 8, 2027, unless the NRC determines that the cessation deadline should be extended to a date not more than 5 years in the future after offering the public an opportunity to provide input on the costs and benefits of this section and considering that input. The NRC will publish a document in the Federal Register announcing its determination and revising or removing this section accordingly.

[45 FR 14481, Mar. 5, 1980, as amended at 90 FR 55628, Dec. 3, 2025]

§ 25.8 Information collection requirements: OMB approval.

(a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150-0046.

(b) The approved information collection requirements contained in this part appear in §§ 25.11, 25.17, 25.21, 25.23, 25.25, 25.27, 25.29, 25.31, 25.33, and 25.35.

(c) This part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section. These information collection requirements and the control numbers under which they are approved are as follows:

(1) In §§ 25.17(b), 25.21(c), 25.27(a), 25.29, and 25.31, NRC Form 237 is approved under control number 3150-0050.

(2) In §§ 25.17(c), 25.21(c), 25.27(b), 25.29, and 25.31, the “Electronic Questionnaire for Investigations Processing (e-QIP), SF-86—Questionnaire for National Security Positions” is approved under control number 3206-0005.

(3) In § 25.21(b), NRC Form 354 is approved under control number 3150-0026.

(4) In § 25.33, NRC Form 136 is approved under control number 3150-0049.

(5) In § 25.35, NRC Form 277 is approved under control number 3150-0051.

[49 FR 19624, May 9, 1984, as amended at 57 FR 3720, Jan. 31, 1992; 62 FR 17687, Apr. 11, 1997; 62 FR 52185, Oct. 6, 1997; 87 FR 45241, July 28, 2022]

§ 25.9 Communications.

Except where otherwise specified, communications and reports concerning the regulations in this part should be addressed to the Director, Division of Facilities and Security, Mail Stop T7-D57, and sent either by mail to the U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; by hand delivery to the NRC's offices at 11555 Rockville Pike, Rockville, Maryland; or, where practicable, by electronic submission, for example, Electronic Information Exchange, or CD-ROM. Electronic submissions must be made in a manner that enables the NRC to receive, read, authenticate, distribute, and archive the submission, and process and retrieve it a single page at a time. Detailed guidance on making electronic submissions can be obtained by visiting the NRC's Web site at http://www.nrc.gov/site-help/e-submittals.html; by e-mail to MSHD.Resource@nrc.gov; or by writing the Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. The guidance discusses, among other topics, the formats the NRC can accept, the use of electronic signatures, and the treatment of nonpublic information.

[68 FR 58803, Oct. 10, 2003, as amended at 74 FR 62681, Dec. 1, 2009; 80 FR 74979, Dec. 1, 2015]

§ 25.11 Specific exemptions.

The NRC may, upon application by any interested person or upon its own initiative, grant exemptions from the requirements of the regulations of this part, that are—

(a) Authorized by law, will not present an undue risk to the public health and safety, and are consistent with the common defense and security; or

(b) Coincidental with one or more of the following:

(1) An application of the regulation in the particular circumstances conflicts with other NRC rules or requirements;

(2) An application of the regulation in the particular circumstances would not serve the underlying purpose of the rule or is not necessary to achieve the underlying purpose of the rule;

(3) When compliance would result in undue hardship or other costs that significantly exceed those contemplated when the regulation was adopted, or that significantly exceed those incurred by others similarly situated;

(4) When the exemption would result in benefit to the common defense and security that compensates for any decrease in the security that may result from the grant of the exemption;

(5) When the exemption would provide only temporary relief from the applicable regulation and the licensee or applicant has made good faith efforts to comply with the regulation;

(6) When there is any other material circumstance present that was not considered when the regulation was adopted that would be in the public interest to grant an exemption. If this condition is relied on exclusively for satisfying paragraph (b) of this section, the exemption may not be granted until the Executive Director for Operations has consulted with the Commission.

[64 FR 15647, Apr. 1, 1999]

§ 25.13 Maintenance of records.

(a) Each licensee or organization employing individuals approved for personnel security access authorization under this part, shall maintain records as prescribed within the part. These records are subject to review and inspection by CSA representatives during security reviews.

(b) Each record required by this part must be legible throughout the retention period specified by each Commission regulation. The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.

[45 FR 14481, Mar. 5, 1980, as amended at 53 FR 19245, May 27, 1988; 62 FR 17687, Apr. 11, 1997]

§ 25.15 Access permitted under “Q” or “L” access authorization.

(a) A “Q” access authorization permits an individual access on a need-to-know basis to (1) Secret and Confidential Restricted Data and (2) Secret and Confidential National Security Information including intelligence information, CRYPTO (i.e., cryptographic information) or other classified communications security (COMSEC) information.

(b) An “L” access authorization permits an individual access on a need-to-know basis to Confidential Restricted Data and Secret and Confidential National Security Information other than the categories specifically included in paragraph (a) of this section. In addition, access to certain Confidential COMSEC information is permitted as authorized by a National Communications Security Committee waiver dated February 14, 1985.

(c) Each employee of the Commission is processed for one of the two levels of access authorization. Licensees and other persons will furnish National Security Information and/or Restricted Data to a Commission employee on official business when the employee has the appropriate level of NRC access authorization and need-to-know. Some individuals are permitted to begin NRC employment without an access authorization. However, no NRC employee shall be permitted access to any classified information until the appropriate level of access authorization has been granted to that employee by NRC.

[45 FR 14481, Mar. 5, 1980, as amended at 47 FR 9195, Mar. 4, 1982; 50 FR 36984, Sept. 11, 1985]

§ 25.17 Approval for processing applicants for access authorization.

(a) Access authorizations must be requested for licensee employees or other persons (e.g., 10 CFR part 2, subpart I) who need access to classified information in connection with activities under part 50, 52, 53, 54, 60, 63, 70, 72, or 76 of this chapter.

(b) The request must be submitted to the facility CSA. If the NRC is the CSA, the procedures in § 25.17 (c) and (d) will be followed. If the NRC is not the CSA, the request will be submitted to the CSA in accordance with procedures established by the CSA. The NRC will be notified of the request by a letter that includes the name, Social Security number and level of access authorization.

(c) The request must include a completed personnel security packet (see § 25.17(d)) and request form (NRC Form 237) signed by a licensee, licensee contractor official, or other authorized person.

(d)(1) Each personnel security packet submitted must include the following completed forms:

(i) Electronic Questionnaire for Investigations Processing (e-QIP), SF-86 Questionnaire for National Security Positions;

(ii) Two standard fingerprint cards (FD-258);

(iii) Security Acknowledgment (NRC Form 176); and

(iv) Other related forms where specified in accompanying instructions (NRC Form 254).

(2) Only a Security Acknowledgment (NRC Form 176) need be completed by any person possessing an active access authorization, or who is being processed for an access authorization, by another Federal agency. The active or pending access authorization must be at an equivalent level to that required by the NRC and be based on an adequate investigation of not more than five years old.

(e) To avoid delays in processing requests for access authorizations, each security packet should be reviewed for completeness and correctness (including legibility of response on the forms) before submittal.

(f) The Defense Counterintelligence and Security Agency (DCSA) bills the NRC for the cost of each background investigation conducted in support of an application for access authorization (application). The combined cost of the DCSA investigation and the NRC's application processing overhead (NRC processing fee) are recovered through an access authorization fee imposed on applicants for access authorization.

(1) Each application for access authorization, renewal, or change in level must be accompanied by a remittance, payable to the U.S. Nuclear Regulatory Commission, which is equal to the NRC access authorization fee. This fee must be determined using the following formula: the DCSA investigation billing rates on the day the NRC receives the application + the NRC processing fee = the NRC access authorization fee. The NRC processing fee is determined by multiplying the DCSA investigation billing rate on the day the NRC receives the application by 90.2 percent (i.e., DCSA rate × 90.2 percent).

(2) Updated DCSA investigation billing rates are published periodically in a Federal Investigations Notice (FIN) issued by the DCSA's Federal Investigative Services. Copies of the current DCSA investigation billing rates schedule can be obtained by contacting the NRC's Personnel Security Branch, Division of Facilities Security, Office of Administration by email to Licensee_ Access_ Authorization_ Fee.Resource@nrc.gov

(3) The NRC's Information Access Authority Program (IAAP) is considered reimbursable work representing services provided to an organization for which the NRC is entitled payment. The NRC is authorized to receive and retain fees from licensees for services performed. The NRC's Office of the Chief Financial Officer periodically reviews the fees charged for IAAP and makes recommendations on revising those charges to reflect costs incurred by the NRC in providing those services. The reviews are performed using cost analysis techniques to determine the direct and indirect costs. Based on this review, the IAAP fees are adjusted to reflect the current cost for the program. IAAP requests for reciprocity will be charged a flat fee rate of $95.00 as referenced in paragraph (f)(4) of this section. This flat fee is aligned with the level of effort that has been expended by DCSA to process reciprocity requests, and accounts for inflation as well as recovery of the appropriate cost for conducting the investigations. Copies of the current NRC access authorization fee may be obtained by contacting the NRC's Personnel Security Branch, Division of Facilities and Security, Office of Administration by email at: Licensee_Access_ Authorization_Fee.Resource@nrc.gov. Any change in the NRC's access authorization fee will be applicable to each access authorization request received on or after the effective date of the DCSA's most recently published investigation billing rates schedule.

(4) Certain applications from individuals having current Federal access authorizations may be processed more expeditiously and at less cost because the Commission, at its discretion, may decide to accept the certification of access authorization and investigative data from other Federal Government agencies that grant personnel access authorizations.

(i) Applications for reciprocity will be processed at the NRC flat fee rate of $95 per request, as referenced in the following table:

The NRC application fee for an access authorization of type . . . | NRC fee rate

(A) NRC-L based on certification of comparable investigation 1 | $95

(B) NRC-Q based on certification of comparable investigation 2 | 95

1 If the NRC determines, based on its review of available data, that a Tier 3 investigation is necessary, the appropriate NRC-L fee will be assessed as shown in appendix A to this part before the conduct of the investigation.

2 If the NRC determines, based on its review of available data, that a Tier 5 investigation is necessary, the appropriate NRC-Q fee will be assessed as shown in appendix A to this part before the conduct of the investigation.

(ii) Applicants shall, in cases where reciprocity is not acceptable and it is necessary to perform a background investigation, be charged the appropriate fee referenced in appendix A to this part. Applicants shall calculate the access authorization fee according to the stated formula (i.e., DCSA rate × 90.2 percent).

[62 FR 17687, Apr. 11, 1997, as amended at 68 FR 62512, Nov. 5, 2003; 70 FR 32227, June 2, 2005; 72 FR 27411, May 16, 2007; 77 FR 26153, May 3, 2012; 77 FR 46258, Aug. 3, 2012; 86 FR 43401, Aug. 9, 2021; 86 FR 47209, Aug. 24, 2021; 87 FR 45241, July 28, 2022; 91 FR 15775, Mar. 30, 2026]

§ 25.19 Processing applications.

Each application for an access authorization or access authorization renewal must be submitted to the CSA. If the NRC is the CSA, the application and its accompanying fee must be submitted to the NRC Division of Facilities and Security. If necessary, the NRC Division of Facilities and Security may obtain approval from the appropriate Commission office exercising licensing or regulatory authority before processing the access authorization or access authorization renewal request. If the applicant is disapproved for processing, the NRC Division of Facilities and Security shall notify the submitter in writing and return the original application (security packet) and its accompanying fee.

[64 FR 15648, Apr. 1, 1999]

§ 25.21 Determination of initial and continued eligibility for access authorization.

(a) Following receipt by the CSA of the reports of the personnel security investigations, the record will be reviewed to determine that granting an access authorization or renewal of access authorization will not endanger the common defense and security and is clearly consistent with the national interest. If this determination is made, access authorization will be granted or renewed. If the NRC is the CSA, questions as to initial or continued eligibility will be determined in accordance with part 10 of chapter I. If another agency is the CSA, that agency will, under the requirements of the NISPOM, have established procedures at the facility to resolve questions as to initial or continued eligibility for access authorization. These questions will be determined in accordance with established CSA procedures already in effect for the facility.

(b) The CSA must be promptly notified of developments that bear on continued eligibility for access authorization throughout the period for which the authorization is active (e.g., persons who marry subsequent to the completion of a personnel security packet must report this change by submitting a completed NRC Form 354, “Data Report on Spouse” or equivalent CSA form).

(c)(1) Except as provided in paragraph (c)(2) of this section, an NRC “Q” access authorization must be renewed every five years from the date of issuance. Except as provided in paragraph (c)(2) of this section, an NRC “L” access authorization must be renewed every ten years from the date of issuance. An application for renewal must be submitted at least 120 days before the expiration of the five-year period for a “Q” access authorization and the ten-year period for an “L” access authorization, and must include:

(i) A statement by the licensee or other person that the individual continues to require access to classified National Security Information or Restricted Data; and

(ii) A personnel security packet as described in § 25.17(d).

(2) Renewal applications and the required paperwork are not required for individuals who have a current and active access authorization from another Federal agency and who are subject to a reinvestigation program by that agency that is determined by the NRC to meet the NRC's requirements. (The DOE Reinvestigation Program has been determined to meet the NRC's requirements.) For these individuals, the submission of the SF-86 by the licensee or other person to the other Government agency pursuant to their reinvestigation requirements will satisfy the NRC's renewal submission and paperwork requirements, even if less than five years have passed since the date of issuance or renewal of the NRC “Q” access authorization, or if less than 10 years have passed since the date of issuance or renewal of the NRC “L” access authorization. Any NRC access authorization continued in response to the provisions of this paragraph will, thereafter, not be due for renewal until the date set by the other Government agency for the next reinvestigation of the individual pursuant to the other agency's reinvestigation program. However, the period of time for the initial and each subsequent NRC “Q” renewal application to the NRC may not exceed seven years or, in the case of an NRC “L” renewal application, twelve years. Any individual who is subject to the reinvestigation program requirements of another Federal agency but, for administrative or other reasons, does not submit reinvestigation forms to that agency within seven years for a “Q” renewal or twelve years for an “L” renewal of the previous submission, shall submit a renewal application to the NRC using the forms prescribed in § 25.17(d) before the expiration of the seven-year period for a “Q” renewal or twelve-year period for an “L” renewal.

(3) If the NRC is not the CSA, reinvestigation program procedures and requirements will be set by the CSA.

[62 FR 17688, Apr. 11, 1997, as amended at 64 FR 15648, Apr. 1, 1999]

§ 25.23 Notification of grant of access authorization.

The determination to grant or renew access authorization will be furnished in writing to the licensee or organization that initiated the request. Upon receipt of the notification of original grant of access authorization, the licensee or organization shall obtain, as a condition for grant of access authorization and access to classified information, an executed “Classified Information Nondisclosure Agreement” (SF-312) from the affected individual. The SF-312 is an agreement between the United States and an individual who is cleared for access to classified information. An employee issued an initial access authorization shall execute a SF-312 before being granted access to classified information. The licensee or other organization shall forward the executed SF-312 to the CSA for retention. If the employee refuses to execute the SF-312, the licensee or other organization shall deny the employee access to classified information and submit a report to the CSA. The SF-312 must be signed and dated by the employee and witnessed. The employee's and witness' signatures must bear the same date. The individual shall also be given a security orientation briefing in accordance with § 95.33 of this chapter. Records of access authorization grant and renewal notification must be maintained by the licensee or other organization for three years after the access authorization has been terminated by the CSA. This information may also be furnished to other representatives of the Commission, to licensees, contractors, or other Federal agencies. Notifications of access authorization will not be given in writing to the affected individual except:

(a) In those cases when the determination was made as a result of a Personnel Security Hearing or by a Personnel Security Review Panel ; or

(b) When the individual also is the official designated by the licensee or other organization to whom written NRC notifications are forwarded.

[62 FR 17688, Apr. 11, 1997, as amended at 64 FR 15648, Apr. 1, 1999]

§ 25.25 Cancellation of requests for access authorization.

When a request for an individual's access authorization or renewal of an access authorization is withdrawn or canceled, the requestor shall notify the CSA immediately by telephone so that the single scope background investigation, national agency check with law and credit investigation, or other personnel security action may be discontinued. The requestor shall identify the full name and date of birth of the individual, the date of request, and the type of access authorization or access authorization renewal requested. The requestor shall confirm each telephone notification promptly in writing.

[64 FR 15648, Apr. 1, 1999]

§ 25.27 Reopening of cases in which requests for access authorizations are canceled.

(a) In conjunction with a new request for access authorization (NRC Form 237 or CSA equivalent) for individuals whose cases were previously canceled, new fingerprint cards (FD-257) in duplicate and a new Security Acknowledgment (NRC Form 176), or CSA equivalent, must be furnished to the CSA along with the request.

(b) Additionally, if 90 days or more have elapsed since the date of the last Questionnaire for National Security Positions (SF-86), or CSA equivalent, the individual must complete a personnel security packet (see § 25.17(d)). The CSA, based on investigative or other needs, may require a complete personnel security packet in other cases as well. A fee, equal to the amount paid for an initial request, will be charged only if a new or updating investigation by the NRC is required.

[62 FR 17689, Apr. 11, 1997, as amended at 64 FR 15648, Apr. 1, 1999]

§ 25.29 Reinstatement of access authorization.

(a) An access authorization can be reinstated provided that:

(1) No more than 24 months has lapsed since the date of termination of the clearance;

(2) There has been no break in employment with the employer since the date of termination of the clearance;

(3) There is no known adverse information;

(4) The most recent investigation must not exceed 5 years (Top Secret, Q) or 10 years (Secret, L); and

(5) The most recent investigation must meet or exceed the scope of the investigation required for the level of access authorization that is to be reinstated or granted.

(b) An access authorization can be reinstated at the same, or lower, level by submission of a CSA-designated form to the CSA. The employee may not have access to classified information until receipt of written confirmation of reinstatement and an up-to-date personnel security packet will be furnished with the request for reinstatement of an access authorization. A new Security Acknowledgement will be obtained in all cases. Where personnel security packets are not required, a request for reinstatement must state the level of access authorization to be reinstated and the full name and date of birth of the individual to establish positive identification. A fee, equal to the amount paid for an initial request, will be charged only if a new or updating investigation by the NRC is required.

[62 FR 17689, Apr. 11, 1997]

§ 25.31 Extensions and transfers of access authorizations.

(a) The NRC Division of Facilities and Security may, on request, extend the authorization of an individual who possesses an access authorization in connection with a particular employer or activity to permit access to classified information in connection with an assignment with another employer or activity.

(b) The NRC Division of Facilities and Security may, on request, transfer an access authorization when an individual's access authorization under one employer or activity is terminated, simultaneously with the individual being granted an access authorization for another employer or activity.

(c) Requests for an extension or transfer of an access authorization must state the full name of the person, date of birth, and level of access authorization. The Director, Division of Facilities and Security, may require a new personnel security packet (see § 25.17(c)) to be completed by the applicant. A fee, equal to the amount paid for an initial request, will be charged only if a new or updating investigation by the NRC is required.

(d) The date of an extension or transfer of access authorization may not be used to determine when a request for renewal of access authorization is required. Access authorization renewal requests must be timely submitted, in accordance with § 25.21(c).

[45 FR 14481, Mar. 5, 1980, as amended at 48 FR 24320, June 1, 1983; 57 FR 3721, Jan. 31, 1992; 62 FR 17689, Apr. 11, 1997; 64 FR 15648, Apr. 1, 1999]

§ 25.33 Termination of access authorizations.

(a) Access authorizations will be terminated when:

(1) An access authorization is no longer required;

(2) An individual is separated from the employment or the activity for which he or she obtained an access authorization for a period of 90 days or more; or

(3) An individual, pursuant to 10 CFR part 10 or other CSA-approved adjudicatory standards, is no longer eligible for an access authorization.

(b) A representative of the licensee or other organization that employs the individual whose access authorization will be terminated shall immediately notify the CSA when the circumstances noted in paragraph (a)(1) or (a)(2) of this section exist; inform the individual that his or her access authorization is being terminated, and the reason; and that he or she will be considered for reinstatement of an access authorization if he or she resumes work requiring the authorization.

(c) When an access authorization is to be terminated, a representative of the licensee or other organization shall conduct a security termination briefing of the individual involved, explain the Security Termination Statement (NRC Form 136 or CSA approved form) and have the individual complete the form. The representative shall promptly forward the original copy of the completed Security Termination Statement to CSA.

[62 FR 17689, Apr. 11, 1997, as amended at 64 FR 15649, Apr. 1, 1999]

§ 25.35 Classified visits.

(a) The number of classified visits must be held to a minimum. The licensee, certificate holder, applicant for a standard design certification under part 52 or 53 of this chapter (including an applicant after the Commission has adopted a final standard design certification rule under part 52 or 53 of this chapter), or other facility, or an applicant for or holder of a standard design approval under part 52 or 53 of this chapter shall determine that the visit is necessary and that the purpose of the visit cannot be achieved without access to, or disclosure of, classified information. All classified visits require advance notification to, and approval of, the organization to be visited. In urgent cases, visit information may be furnished by telephone and confirmed in writing.

(b) Representatives of the Federal Government, when acting in their official capacities as inspectors, investigators, or auditors, may visit a licensee, certificate holder, or other facility without furnishing advanced notification, provided these representatives present appropriate Government credentials upon arrival. Normally, however, Federal representatives will provide advance notification in the form of an NRC Form 277, “Request for Visit or Access Approval,” with the “need-to-know” certified by the appropriate NRC office exercising licensing or regulatory authority and verification of an NRC access authorization by the Division of Facilities and Security.

(c) The licensee, certificate holder, or others shall include the following information on all Visit Authorization Letters (VAL) which they prepare.

(1) Visitor's name, address, and telephone number and certification of the level of the facility security clearance;

(2) Name, date and place of birth, and citizenship of the individual intending to visit;

(3) Certification of the proposed visitor's personnel clearance and any special access authorizations required for the visit;

(4) Name of person(s) to be visited;

(5) Purpose and sufficient justification for the visit to allow for a determination of the necessity of the visit; and

(6) Date or period during which the VAL is to be valid.

(d) Classified visits may be arranged for a 12 month period. The requesting facility shall notify all places honoring these visit arrangements of any change in the individual's status that will cause the visit request to be canceled before its normal termination date.

(e) The responsibility for determining need-to-know in connection with a classified visit rests with the individual who will disclose classified information during the visit. The licensee, certificate holder or other facility shall establish procedures to ensure positive identification of visitors before the disclosure of any classified information.

[62 FR 17689, Apr. 11, 1997, as amended at 64 FR 15649, Apr. 1, 1999; 72 FR 49488, Aug. 28, 2007; 91 FR 15775, Mar. 30, 2026]

§ 25.37 Violations.

(a) An injunction or other court order may be obtained to prohibit a violation of any provision of:

(1) The Atomic Energy Act of 1954, as amended;

(2) Title II of the Energy Reorganization Act of 1974, as amended; or

(3) Any regulation or order issued under these Acts.

(b) National Security Information is protected under the requirements and sanctions of Executive Order 13526, as amended, or any predecessor or successor orders.

[48 FR 24320, June 1, 1983, as amended at 57 FR 55072, Nov. 24, 1992; 64 FR 15649, Apr. 1, 1999; 70 FR 32227, June 2, 2005; 75 FR 73941, Nov. 30, 2010]

§ 25.39 Criminal penalties.

(a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all the regulations in part 25 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section.

(b) The regulations in part 25 that are not issued under sections 161b, 161i, or 161o for the purposes of section 223 are as follows: §§ 25.1, 25.3, 25.5, 25.7, 25.8, 25.9, 25.11, 25.19, 25.25, 25.27, 25.29, 25.31, 25.37, and 25.39.

[57 FR 55072, Nov. 24, 1992]

§ 26.1 Purpose.

This part prescribes requirements and standards for the establishment, implementation, and maintenance of fitness-for-duty (FFD) programs.

§ 26.3 Scope.

(a) Licensees who are authorized to operate a nuclear power reactor under 10 CFR 50.57, and holders of a combined license under 10 CFR Part 52 after the Commission has made the finding under 10 CFR 52.103(g) shall comply with the requirements of this part, except for subpart K of this part. Licensees who receive their authorization to operate a nuclear power reactor under 10 CFR 50.57 after the date of publication of this final rule in the Federal Register and holders of a combined license under 10 CFR Part 52 after the Commission has made the finding under 10 CFR 52.103(g) shall implement the FFD program before the receipt of special nuclear material in the form of fuel assemblies.

(b) Licensees who are authorized to possess, use, or transport formula quantities of strategic special nuclear material (SSNM) under Part 70 of this chapter, and any corporation, firm, partnership, limited liability company, association, or other organization who obtains a certificate of compliance or an approved compliance plan under Part 76 of this chapter, only if the entity elects to engage in activities involving formula quantities of SSNM shall comply with the requirements of this part, except for subparts I and K of this part.

(c) Before the receipt of special nuclear material in the form of fuel assemblies, the following licensees and other entities shall comply with the requirements of this part, except for subpart I of this part; and, no later than the receipt of special nuclear material in the form of fuel assemblies, the following licensees and other entities shall comply with the requirements of this part:

(1) Combined license applicants (under Part 52 of this chapter) who have been issued a limited work authorization under § 50.10(e), if the limited work authorization authorizes the applicant to install the foundations, including the placement of concrete, for safety- and security-related structures, systems, and components (SSCs) under the limited work authorization;

(2) Combined license holders (under Part 52 of this chapter) before the Commission has made the finding under § 52.103(g);

(3) Construction permit applicants (under Part 50 of this chapter) who have been issued a limited work authorization under § 50.10(e), if the limited work authorization authorizes the applicant to install the foundations, including the placement of concrete, for safety- and security-related SSCs under the limited work authorization;

(4) Construction permit holders (under Part 50 of this chapter); and

(5) Early site permit holders who have been issued a limited work authorization under § 50.10(e), if the limited work authorization authorizes the early site permit holder to install the foundations, including the placement of concrete, for safety- and security-related SSCs under the limited work authorization.

(d) Contractor/vendors (C/Vs) who implement FFD programs or program elements, to the extent that the licensees and other entities specified in paragraphs (a) through (c) and (f) of this section rely on those C/V FFD programs or program elements to meet the requirements of this part, shall comply with the requirements of this part.

(e) This part does not apply to either spent fuel storage facility licensees or non-power production or utilization facility licensees who possess, use, or transport formula quantities of irradiated SSNM.

(f) No later than the start of construction activities, licensees and other entities that have applied for or have been issued a license under part 53 of this chapter, other than a manufacturing license (ML), must implement the requirements in subpart M of this part or all the requirements of this part except subparts K and M. Holders of an ML under part 53 of this chapter must implement the requirements in subpart M or all the requirements of this part except subparts K and M, before commencing activities that assemble a manufactured reactor.

[73 FR 17176, Mar. 31, 2008, as amended at 89 FR 106250, Dec. 30, 2024; 91 FR 15775, Mar. 30, 2026]

§ 26.4 FFD program applicability to categories of individuals.

(a) All persons who are granted unescorted access to nuclear power reactor protected areas by the licensees in § 26.3(a) and, as applicable, (c) and perform the following duties shall be subject to an FFD program that meets all of the requirements of this part, except subparts K and M of this part, and those persons who are granted unescorted access to either nuclear power reactor protected areas or remote facilities where safety-significant systems or components may be operated within the design basis of a licensed commercial nuclear plant, by the licensees and other entities in § 26.3(f) and perform the following duties must be subject to an FFD program that satisfies the requirements in subpart M of this part, unless the licensee or other entity subjects these individuals to an FFD program that satisfies all of the requirements of this part except for those requirements in subparts K and M:

(1) For persons who are granted unescorted access by the licensees in § 26.3(a) and, as applicable, (c), operating or onsite directing of the operation of systems and components that a risk-informed evaluation process has shown to be significant to public health and safety; for those persons who are granted unescorted access by the licensees and other entities in § 26.3(f), operating or directing of the operation of systems and components that a risk-informed evaluation process has shown to be significant to public health and safety;

(2) Performing health physics or chemistry duties required as a member of the onsite emergency response organization minimum shift complement;

(3) Performing the duties of a fire brigade member who is responsible for understanding the effects of fire and fire suppressants on safe shutdown capability;

(4) For persons who are granted unescorted access to nuclear power reactor protected areas by the licensees in § 26.3(a) and, as applicable, (c), performing maintenance or onsite directing of the maintenance of SSCs that a risk-informed evaluation process has shown to be significant to public health and safety; for those persons who are granted unescorted access to nuclear power reactor protected areas by the licensees and other entities in § 26.3(f), performing maintenance or directing of the maintenance of SSCs that a risk-informed evaluation process has shown to be significant to public health and safety; and

(5) Performing security duties as an armed security force officer, alarm station operator, response team leader, or watchman, hereinafter referred to as security personnel.

(b) All persons who are granted unescorted access to nuclear power reactor protected areas by the licensees in § 26.3(a) and, as applicable, (c) and who do not perform the duties described in paragraph (a) of this section shall be subject to an FFD program that meets all of the requirements of this part, except §§ 26.205 through 26.209 and subparts K and M of this part. All persons who are granted unescorted access to a facility licensed under part 53 of this chapter, and who do not perform or direct the performance of the duties described in paragraph (a) of this section, must be subject to the requirements in subpart M of this part, unless the licensee or other entity implements an FFD program that satisfies all of the requirements of this part, except §§ 26.205 through 26.209 and subparts K and M.

(c) All persons who are required by a licensee in § 26.3(a) and, as applicable, (c) to physically report to the licensee's Technical Support Center or Emergency Operations Facility by licensee emergency plans and procedures shall be subject to an FFD program that meets all of the requirements of this part, except §§ 26.205 through 26.209 and subparts K and M of this part. Also, for licensees or other entities in § 26.3(f), all persons without unescorted access to the facility who make decisions and/or direct actions regarding plant safety and security, and all persons who participate remotely in emergency response activities or physically report to the Technical Support Center or Emergency Operations Facility (or an equivalent facility), must be subject to an FFD program that satisfies all of the requirements described in subpart M of this part, unless the licensee or other entity implements an FFD program that satisfies all of the requirements of this part, except §§ 26.205 through 26.209 and subparts K and M.

(d) Any individual whose duties for the licensees and other entities in § 26.3(b) require him or her to have the following types of access or perform the following activities shall be subject to an FFD program that meets all of the requirements of this part, except subparts I and K of this part:

(1) All persons who are granted unescorted access to Category IA material;

(2) All persons who create or have access to procedures or records for safeguarding SSNM;

(3) All persons who measure Category IA material;

(4) All persons who transport or escort Category IA material; and

(5) All persons who guard Category IA material.

(e) When construction activities, as defined in § 26.5, begin, any individual whose duties for the licensees and other entities in § 26.3(c) require him or her to have the following types of access or perform the following activities at the location where the nuclear power plant will be constructed and operated shall be subject to an FFD program that meets all of the requirements of this part, except subparts I, K, and M of this part, and for any individual whose duties for the licensees and other entities in § 26.3(f) require him or her to have the following types of access, perform construction activities as defined in § 26.5, or perform the following activities must be subject to an FFD program as described in subpart M or an FFD program that satisfies all of the requirements of this part, except subparts I, K, and M:

(1) Serves as security personnel required by the NRC, until the licensees or other entities receive special nuclear material in the form of fuel assemblies, at which time individuals who serve as security personnel required by the NRC must meet the requirements applicable to security personnel in paragraph (a)(5) of this section;

(2) Performs quality assurance, quality control, or quality verification activities related to safety- or security-related construction activities;

(3) Based on a designation under § 26.406 by a licensee or other entity, monitors the fitness of the individuals specified in paragraph (f) of this section;

(4) Witnesses or determines inspections, tests, and analyses certification required under part 52 or 53 of this chapter;

(5) Supervises or manages the construction of safety- or security-related SSCs; or

(6) Directs, as defined in § 26.5, or implements the access authorization program, including—

(i) Having access to the information used by the licensee or other entity to make access authorization determinations, including information stored in electronic format;

(ii) Making access authorization determinations;

(iii) Issuing entry-control picture badges in accordance with access authorization determinations;

(iv) Conducting background investigations or psychological assessments used by the licensee or other entity to make access authorization determinations, except that he or she shall be subject to behavioral observation only when he or she is present at the location where the nuclear power plant will be constructed and operated, and licensees and other entities may rely on a local hospital or other organization that meets the requirements of 49 CFR Part 40, “Procedures for Department of Transportation Workplace Drug and Alcohol Testing Programs” to collect his or her specimens for drug and alcohol testing;

(v) Adjudicating reviews or appeals of access authorization determinations;

(vi) Auditing the access authorization program; or

(vii) Performing any of the activities or having any of the duties listed in paragraph (e)(6) of this section for any C/V upon whom the licensee's or other entity's access authorization program will rely.

(f) Any individual who is constructing or directing the construction of safety- or security-related SSCs shall be subject to an FFD program that meets the requirements of subpart K, or, if applicable, subpart M of this part, unless the licensee or other entity subjects these individuals to an FFD program that meets all of the requirements of this part, except for subparts I, K, and M of this part.

(g) All FFD program personnel who are involved in the day-to-day operations of the program, as defined by the procedures of the licensees and other entities in § 26.3(a) through (c), and, as applicable, (d) and whose duties require them to have the following types of access or perform the following activities shall be subject to an FFD program that meets all of the requirements of this part, except subparts I, K, and M of this part, and, at the licensee's or other entity's discretion, subpart C of this part. All personnel whose duties require them to have the following types of access or perform the following activities at facilities licensed under part 53 of this chapter must be subject to the requirements in subpart M or an FFD program that satisfies all of the requirements of this part, except subparts I, K, and M, and, at the licensee's or other entity's discretion, subpart C of this part:

(1) All persons who can link test results with the individual who was tested before an FFD policy violation determination is made, including, but not limited to the MRO;

(2) All persons who make determinations of fitness;

(3) All persons who make authorization decisions;

(4) All persons involved in selecting or notifying individuals for testing; and

(5) All persons involved in the collection or onsite testing of specimens.

(h) Individuals who have applied for authorization to have the types of access or perform the activities described in paragraphs (a) through (d) of this section shall be subject to §§ 26.31(c)(1), 26.35(b), 26.37, and 26.39, and the applicable requirements of subparts C, E through H, and M of this part.

(i) The following individuals are not subject to an FFD program under this part:

(1) Individuals who are not employed by a licensee or other entity in this part, who do not routinely provide FFD program services to a licensee or other entity in this part, and whose normal workplace is not at the licensee's or other entity's facility, but who may be called on to provide an FFD program service, including, but not limited to, collecting specimens for drug and alcohol testing, performing behavioral observation, or providing input to a determination of fitness. Such individuals may include, but are not limited to, hospital, employee assistance program (EAP) or substance abuse treatment facility personnel, or other medical professionals;

(2) NRC employees, law enforcement personnel, or offsite emergency fire and medical response personnel while responding on site;

(3) SSNM transporter personnel who are subject to U.S. Department of Transportation drug and alcohol FFD programs that require random testing for drugs and alcohol; and

(4) The FFD program personnel of a program that is regulated by another Federal agency or State on which a licensee or other entity relies to meet the requirements of this part, as permitted under §§ 26.4(j), 26.31(b)(2), and 26.405(e), if the FFD program personnel are not employed by the licensee or other entity and their normal workplace is not at the licensee's or other entity's facility.

(j) Individuals who are subject to this part and who are also subject to a program regulated by another Federal agency or State need be covered by only those elements of an FFD program that are not included in the Federal agency or State program, as long as all of the following conditions are met:

(1) The individuals are subject to pre-access (or pre-employment), random, for-cause, and post-event testing for the drugs and drug metabolites specified in § 26.31(d)(1) at or below the cutoff levels specified in § 26.163(a)(1) for initial drug testing and in § 26.163(b)(1) for confirmatory drug testing;

(2) The individuals are subject to pre-access (or pre-employment), random, for-cause, and post-event testing for alcohol at or below the cutoff levels specified in § 26.103(a) and breath specimens are subject to confirmatory testing, if required, with an EBT that meets the requirements specified in § 26.91;

(3) Urine specimens are tested for validity and the presence of drugs and drug metabolites at a Department of Health and Human Services (HHS)-certified laboratory, as defined in § 26.5;

(4) Training is provided to address the knowledge and abilities (KAs) listed in § 26.29(a)(1) through (a)(10); and

(5) Provisions are made to ensure that the testing agency or organization notifies the licensee or other entity granting authorization of any FFD policy violation.

[73 FR 17176, Mar. 31, 2008, as amended at 75 FR 73941, Nov. 30, 2010; 87 FR 71455, Nov. 22, 2022; 91 FR 15775, Mar. 30, 2026]

§ 26.5 Definitions.

Acute fatigue means fatigue from causes (e.g., restricted sleep, sustained wakefulness, task demands) occurring within the past 24 hours.

Adulterated specimen means a urine specimen that has been altered, as evidenced by test results showing either a substance that is not a normal constituent of urine or showing an abnormal concentration of an endogenous substance.

Alertness means the ability to remain awake and sustain attention.

Aliquot means a portion of a specimen that is used for testing. It is taken as a sample representing the whole specimen.

Analytical run means the process of testing a group of urine specimens for validity or for the presence of drugs and/or drug metabolites. For the purposes of defining the periods within which performance testing must be conducted by any licensee testing facility or HHS-certified laboratory that continuously processes specimens, an analytical run is defined as no more than an 8-hour period. For a facility that analyzes specimens in batches, an analytical run is defined as a group of specimens that are handled and tested together.

Authorization means that a licensee or other entity in § 26.3 has determined that an individual has met the requirements of this part to be granted or maintain the types of access or perform the duties specified in § 26.4(a) through (e), and, at the licensee's or other entity's discretion, § 26.4(f) or (g).

Best effort means documented actions that a licensee or other entity who is subject to subpart C of this part takes to obtain suitable inquiry and employment information in order to determine whether an individual may be granted authorization, when the primary source of information refuses or indicates an inability or unwillingness to provide the information within 3 business days of the request and the licensee or other entity relies on a secondary source to meet the requirement.

Biological marker means, for a part 53 licensee implementing subpart M of this part, an endogenous substance that is used to validate that the biological specimen collected for testing was produced by the donor.

Blood alcohol concentration (BAC) means the mass of alcohol in a volume of blood.

Calibrator means a solution of known concentration in the appropriate matrix that is used to define expected outcomes of a measurement procedure or to compare the response obtained with the response of a donor specimen or quality control sample. The concentration of the analyte of interest in the calibrator is known within limits ascertained during its preparation.

Cancelled test means the test result reported by the MRO to the licensee or other entity when a specimen has been reported to the MRO by the HHS-certified laboratory as an invalid result (for which the donor has no legitimate explanation), a specimen has been rejected for testing by the licensee testing facility or HHS-certified laboratory, or the retesting of a single specimen or the testing of Bottle B of a split specimen fails to reconfirm the original test result. For alcohol testing only, cancelled test means a test result that was not acceptable because testing did not meet the quality assurance and quality control requirements in § 26.91.

Carryover means the effect that occurs when a test result has been affected by a preceding sample or specimen during analysis.

Category IA material means SSNM that is directly usable in the manufacture of a nuclear explosive device, except if the material meets any of the following criteria:

(1) The dimensions are large enough (at least 2 meters in one dimension, greater than 1 meter in each of two dimensions, or greater than 25 centimeters in each of three dimensions) to preclude hiding the item on an individual;

(2) The total weight of an encapsulated item of SSNM is such that it cannot be carried inconspicuously by one person (i.e., at least 50 kilograms gross weight); or

(3) The quantity of SSNM (less than 0.05 formula kilograms) in each container requires protracted diversions to accumulate 5 formula kilograms.

Certifying Scientist means the individual at an HHS-certified laboratory responsible for verifying the chain of custody and scientific reliability of any test result reported by an HHS-certified laboratory.

Chain of custody means procedures to account for the integrity of each specimen or aliquot by tracking its handling and storage from the point of specimen collection to final disposition of the specimen and its aliquots. “Chain of custody” and “custody and control” are synonymous and may be used interchangeably.

Change as used in § 26.603(e) means an action that results in a modification of, addition to, or removal from the licensee's or other entity's FFD program.

Circadian variation in alertness and performance means the increases and decreases in alertness and cognitive/motor functioning caused by human physiological processes (e.g., body temperature, release of hormones) that vary on an approximately 24-hour cycle.

Collection site means a designated place where individuals present themselves for the purpose of providing a specimen of their urine, oral fluids, and/or breath to be analyzed for the presence of drugs or alcohol.

Collector means a person who is trained in the collection procedures of subpart E, instructs and assists a specimen donor at a collection site, and receives and makes an initial examination of the specimen(s) provided by the donor.

Commission means the U.S. Nuclear Regulatory Commission (NRC) or its duly authorized representatives.

Confirmatory drug or alcohol test means a second analytical procedure to identify the presence of alcohol or a specific drug or drug metabolite in a specimen. The purpose of a confirmatory test is to ensure the reliability and accuracy of an initial test result.

Confirmatory validity test means a second test performed on a different aliquot of the original urine specimen to further support a validity test result.

Confirmed test result means a test result that demonstrates that an individual has used drugs and/or alcohol in violation of the requirements of this part or has attempted to subvert the testing process by submitting an adulterated or substituted urine specimen. For drugs, adulterants, and substituted specimens, a confirmed test result is determined by the Medical Review Officer (MRO), after discussion with the donor subsequent to the MRO's receipt of a positive confirmatory drug test result from the HHS-certified laboratory and/or a confirmatory substituted or adulterated validity test result from the HHS-certified laboratory for that donor. For alcohol, a confirmed test result is based on a positive confirmatory alcohol test result from an evidential breath testing device (EBT) without MRO review of the test result.

Consortium/Third-party administrator (C/TPA) means a contractor/vendor that provides or coordinates one or more FFD program elements for a group of licensees or other entities, such as administering a collective random testing pool and random testing selections under § 26.607(b)(2)(vi), that otherwise could not be independently implemented by those licensees or other entities. A C/TPA also could provide access to, for example, the services of medical review officers, substance abuse experts, employee assistance programs, and HHS-certified laboratories under contract to perform drug testing.

Constructing or construction activities means, for the purposes of this part, the tasks involved in building a nuclear power plant that are performed at the location where the nuclear power plant will be constructed and operated. These tasks include fabricating, erecting, integrating, and testing safety- and security-related SSCs, and the installation of their foundations, including the placement of concrete. For a licensee or other entity described in § 26.3(f), construction is defined in § 53.020 of this chapter.

Contractor/vendor (C/V) means any company, or any individual not employed by a licensee or other entity specified in § 26.3(a) through (c) and (f), who is providing work or services to a licensee or other entity covered in § 26.3(a) through (c) and (f), either by contract, purchase order, oral agreement, or other arrangement.

Control means a sample used to evaluate whether an analytical procedure or test is operating within predefined tolerance limits.

Cumulative fatigue means the increase in fatigue over consecutive sleep-wake periods resulting from inadequate rest.

Cutoff level means the concentration or decision criteria established for designating and reporting a test result as positive, of questionable validity (referring to validity screening or initial validity test results from a licensee testing facility), or adulterated, substituted, dilute, or invalid (referring to initial or confirmatory test results from an HHS-certified laboratory).

Dilute specimen means a urine specimen with creatinine and specific gravity values that are lower than expected but are still within the physiologically producible ranges of human urine.

Directing means the exercise of control over a work activity by an individual who is directly involved in the execution of the work activity, and either makes technical decisions for that activity without subsequent technical review, or is ultimately responsible for the correct performance of that work activity.

Donor means the individual from whom a specimen is collected.

Eight (8)-hour shift schedule means a schedule that averages not more than 9 hours per workday over the entire shift cycle.

Employment action means a change in job responsibilities or removal from a job, or the employer-mandated implementation of a plan for substance abuse treatment in order to avoid a change in or removal from a job, because of the individual's use of drugs or alcohol.

Fatigue means the degradation in an individual's cognitive and motor functioning resulting from inadequate rest.

Federal custody and control form (Federal CCF) means any HHS-approved form, which has not expired, that is published in the Federal Register and is used to document the collection, custody, transport, and testing of a specimen.

Formula quantity means SSNM in any combination in a quantity of 5000 grams or more computed by the formula, grams = (grams contained U-235) + 2.5 (grams U-233 + grams plutonium). This class of material is sometimes referred to as a Category I quantity of material.

HHS-certified laboratory means a laboratory that is certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (the HHS Guidelines) at the time that testing of a specimen is performed for a licensee or other entity and performs that testing for a licensee or other entity in accordance with the HHS Guidelines, unless otherwise specified in this part.

Illegal drug means, for the purposes of this regulation, any drug that is included in Schedules I to V of section 202 of the Controlled Substances Act [21 U.S.C. 812], but not when used pursuant to a valid prescription or when used as otherwise authorized by law.

Illicit substance means a substance that causes impairment and possible addiction but is not an illegal drug as defined in this section.

Increased threat condition means an increase in the protective measure level, relative to the lowest protective measure level applicable to the site during the previous 60 days, as promulgated by an NRC Advisory.

Initial drug test means a test to differentiate “negative” specimens from those that require confirmatory drug testing.

Initial validity test means a first test used to determine whether a specimen is adulterated, dilute, substituted, or invalid, and may require confirmatory validity testing.

Invalid result means the result reported by an HHS-certified laboratory in accordance with the criteria established in § 26.161(f) when a positive, negative, adulterated, or substituted result cannot be established for a specific drug or specimen validity test.

Legal action means a formal action taken by a law enforcement authority or court of law, including an arrest, an indictment, the filing of charges, a conviction, or the mandated implementation of a plan for substance abuse treatment in order to avoid a permanent record of an arrest or conviction, in response to any of the following activities:

(1) The use, sale, or possession of illegal drugs;

(2) The abuse of legal drugs or alcohol; or

(3) The refusal to take a drug or alcohol test.

Licensee testing facility means a drug and specimen validity testing facility that is operated by a licensee or other entity who is subject to this part to perform tests of urine specimens.

Limit of detection (LOD) means the lowest concentration of an analyte that an analytical procedure can reliably detect, which could be significantly lower than the established cutoff levels.

Limit of quantitation (LOQ) means for quantitation assays, the lowest concentration at which the identity and concentration of the analyte can be accurately established.

Lot means a number of units of an item (e.g., drug test kits, reagents, quality control samples) manufactured from the same starting materials within a specified period of time for which the manufacturer states that the items have essentially the same performance characteristics and the same expiration date.

Maintenance means, for the purposes of § 26.4(a)(4), the following onsite maintenance activities: Modification, surveillance, post-maintenance testing, and corrective and preventive maintenance.

Medical Review Officer (MRO) means a licensed physician who is responsible for receiving laboratory results generated by a Part 26 drug testing program and who has the appropriate medical training to properly interpret and evaluate an individual's drug and validity test results together with his or her medical history and any other relevant biomedical information.

Nominal means the limited flexibility that is permitted in meeting a scheduled due date for completing a recurrent activity that is required under this part, such as the nominal 12-month frequency required for FFD refresher training in § 26.29(c)(2) and the nominal 12-month frequency required for certain audits in § 26.41(c)(1). Completing a recurrent activity at a nominal frequency means that the activity may be completed within a period that is 25 percent longer or shorter than the period required in this part. The next scheduled due date would be no later than the current scheduled due date plus the required frequency for completing the activity.

Other entity means any corporation, firm, partnership, limited liability company, association, C/V, or other organization who is subject to this part under § 26.3(a) through (c) and (f) but is not licensed by the NRC.

Oxidizing adulterant means a substance that acts alone or in combination with other substances to oxidize drugs or drug metabolites to prevent the detection of the drugs or drug metabolites, or a substance that affects the reagents in either the initial or confirmatory drug test. Examples of these agents include, but are not limited to, nitrites, pyridinium chlorochromate, chromium (VI), bleach, iodine/iodide, halogens, peroxidase, and peroxide.

Positive result means, for drug testing, the result reported by a licensee testing facility or HHS-certified laboratory when a specimen contains a drug or drug metabolite equal to or greater than the cutoff concentration. A result reported by an HHS-certified laboratory that a specimen contains a drug or drug metabolite below the cutoff concentration is also a positive result when the laboratory has conducted the special analysis permitted in § 26.163(a)(2). For alcohol testing, a positive result means the result reported by a collection site when the BAC indicated by testing a specimen is equal to or greater than the cutoff concentrations established in this part.

Potentially disqualifying FFD information means information demonstrating that an individual has—

(1) Violated a licensee's or other entity's FFD policy;

(2) Had authorization denied or terminated unfavorably under §§ 26.35(c)(2), 26.53(i), 26.63(d), 26.65(g), 26.67(c), 26.69(f), or 26.75(b) through (e);

(3) Used, sold, or possessed illegal drugs;

(4) Abused legal drugs or alcohol;

(5) Subverted or attempted to subvert a drug or alcohol testing program;

(6) Refused to take a drug or alcohol test;

(7) Been subjected to a plan for substance abuse treatment (except for self-referral); or

(8) Had legal action or employment action, as defined in this section, taken for alcohol or drug use.

Protected area has the same meaning as in § 73.2(g) of this chapter: An area encompassed by physical barriers and to which access is controlled.

Quality control sample means a sample used to evaluate whether an analytical procedure is operating within predefined tolerance limits. Calibrators, controls, negative samples, and blind performance test samples are collectively referred to as “quality control samples” and each is individually referred to as a “sample.”

Questionable validity means the results of validity screening or initial validity tests at a licensee testing facility indicating that a urine specimen may be adulterated, substituted, dilute, or invalid.

Reduction in FFD program effectiveness means, for a part 53 licensee or other entity implementing subpart M of this part, a change or series of changes to an element of the FFD program that reduces or eliminates the licensee's ability to satisfy or maintain site-specific FFD program performance when compared to historical site-specific performance, the licensee's fleet-level program performance, or industry performance.

Rejected for testing means the result reported to the MRO by a licensee testing facility or HHS-certified laboratory when no tests can be performed on a specimen.

Responsible Person means the person at the HHS-certified laboratory who assumes professional, organizational, educational, and administrative responsibility for the day-to-day management of the HHS-certified laboratory.

Reviewing official means an employee of a licensee or other entity specified in § 26.3(a) through (c) and (f), who is designated by the licensee or other entity to be responsible for reviewing and evaluating any potentially disqualifying FFD information about an individual, including, but not limited to, the results of a determination of fitness, as defined in § 26.189, in order to determine whether the individual may be granted or maintain authorization.

Safety-related structures, systems, and components (SSCs) means, for part 50 or 52 licensees and other entities described in § 26.3(a) through (d), those SSCs that are relied on to remain functional during and following design-basis events to ensure the integrity of the reactor coolant pressure boundary, the capability to shut down the reactor and maintain it in a safe shutdown condition, or the capability to prevent or mitigate the consequences of accidents that could result in potential offsite exposure comparable to the guidelines in § 50.34(a)(1) of this chapter. For part 53 licensees and other entities described in § 26.3(d) and (f), safety-related has the same meaning as that in § 53.020 of this chapter.

Security-related SSCs means, for the purposes of this part, those structures, systems, and components that the licensee will rely on to implement the licensee's physical security and safeguards contingency plans that either are required under part 73 of this chapter if the licensee is a construction permit applicant or holder or an early site permit holder, as described in § 26.3(c)(3) through (5), respectively, or are included in the licensee's application if the licensee is a combined license applicant or holder, as described in § 26.3(c)(1) and (2), respectively, or a licensee or other entity described in § 26.3(d) or (f).

Shift cycle means a series of consecutive work shifts and days off that is planned by the licensee or other entity to repeat regularly, thereby constituting a continuous shift schedule.

Special nuclear material (SNM) has the same meaning as that in § 70.4 of this chapter.

Standard means a reference material of known purity or a solution containing a reference material at a known concentration.

Strategic special nuclear material (SSNM) means uranium-235 (contained in uranium enriched to 20 percent or more in the uranium-235 isotope), uranium-233, or plutonium.

Substance abuse means the use, sale, or possession of illegal drugs, or the abuse of prescription and over-the-counter drugs, or the abuse of alcohol.

Substituted specimen means a specimen that has been submitted in place of the donor's urine, as evidenced by creatinine and specific gravity values that are outside the physiologically producible ranges of human urine.

Subversion and subvert the testing process mean a willful act to avoid being tested or to bring about an inaccurate drug or alcohol test result for oneself or others at any stage of the testing process (including selection and notification of individuals for testing, specimen collection, specimen analysis, and test result reporting), and adulterating, substituting, or otherwise causing a specimen to provide an inaccurate test result.

Supervises or manages means the exercise of control over a work activity by an individual who is not directly involved in the execution of the work activity, but who either makes technical decisions for that activity without subsequent technical review, or is ultimately responsible for the correct performance of that work activity.

Ten (10)-hour shift schedule means a schedule that averages more than 9 hours, but not more than 11 hours, per workday over the entire shift cycle.

Transporter means a general licensee, under 10 CFR 70.20(a), who is authorized to possess formula quantities of SSNM, in the regular course of carriage for another or storage incident thereto, and includes the driver or operator of any conveyance, and the accompanying guards or escorts.

Twelve (12)-hour shift schedule means a schedule that averages more than 11 hours, but not more than 12 hours, per workday over the entire shift cycle.

Unit outage means, for the purposes of this part, for electricity-generation units, that the reactor unit is disconnected from the electrical grid. Unit outage means, for the purposes of this part, for non-electricity-generation units, that the reactor unit is disconnected from the loads to which its output is supplied under normal operating conditions.

Validity screening test means a test to determine the need for initial validity testing of a urine specimen, using a non-instrumented test in which the endpoint result is obtained by visual evaluation (read by the human eye), or a test that is instrumented to the extent that results are machine-read.

Validity screening test lot means a group of validity screening tests that were made from the same starting material.

[73 FR 17176, Mar. 31, 2008, as amended at 81 FR 86909, Dec. 2, 2016; 83 FR 58464, Nov. 20, 2018; 87 FR 71455, Nov. 22, 2022; 91 FR 15776, Mar. 30, 2026]

§ 26.7 Interpretations.

Except as specifically authorized by the Commission in writing, no interpretation of the meaning of the regulations in this part by any officer or employee of the Commission other than a written interpretation by the General Counsel will be recognized to be binding on the Commission. This section shall cease to have effect on January 8, 2027, unless the NRC determines that the cessation deadline should be extended to a date not more than 5 years in the future after offering the public an opportunity to provide input on the costs and benefits of this section and considering that input. The NRC will publish a document in the Federal Register announcing its determination and revising or removing this section accordingly.

[73 FR 17176, Mar. 31, 2008, as amended at 90 FR 55628, Dec. 3, 2025]

§ 26.8 Information collection requirements: OMB approval.

(a) The NRC has submitted the information collection requirements contained in this part for approval by the Office of Management and Budget (OMB), as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150-0146.

(b) The approved information collection requirements contained in this part appear in §§ 26.9, 26.27, 26.29, 26.31, 26.33, 26.35, 26.37, 26.39, 26.41, 26.53, 26.55, 26.57, 26.59, 26.61, 26.63, 26.65, 26.67, 26.69, 26.75, 26.77, 26.85, 26.87, 26.89, 26.91, 26.93, 26.95, 26.97, 26.99, 26.101, 26.103, 26.107, 26.109, 26.111, 26.113, 26.115, 26.117, 26.119, 26.125, 26.127, 26.129, 26.135, 26.137, 26.139, 26.153, 26.157, 26.159, 26.163, 26.165, 26.167, 26.168, 26.169, 26.183, 26.185, 26.187, 26.189, 26.202, 26.203, 26.205, 26.207, 26.211, 26.401, 26.403, 26.405, 26.406, 26.407, 26.411, 26.413, 26.415, 26.417, 26.603, 26.605, 26.606, 26.607, 26.608, 26.609, 26.611, 26.613, 26.617, 26.619, 26.711, 26.713, 26.715, 26.717, 26.719, and 26.821.

[73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71456, Nov. 22, 2022; 91 FR 15777, Mar. 30, 2026]

§ 26.9 Specific exemptions.

Upon application of any interested person or on its own initiative, the Commission may grant such exemptions from the requirements of the regulations in this part as it determines are authorized by law and will not endanger life or property or the common defense and security, and are otherwise in the public interest.

§ 26.11 Communications.

Except where otherwise specified in this part, all communications, applications, and reports concerning the regulations in this part must be sent either by mail addressed to ATTN: NRC Document Control Desk, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; by hand delivery to the NRC's offices at 11555 Rockville Pike, Rockville, Maryland 20852-2738, between the hours of 8:15 a.m. and 4 p.m. eastern time; or, where practicable, by electronic submission, for example, via Electronic Information Exchange, e-mail, or CD-ROM. Electronic submissions must be made in a manner that enables the NRC to receive, read, authenticate, distribute, and archive the submission, and process and retrieve it a single page at a time. Detailed guidance on making electronic submissions can be obtained by visiting the NRC's Web site at http://www.nrc.gov/site-help/e-submittals.html; by e-mail to MSHD.Resource@nrc.gov; or by writing the Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. The guidance discusses, among other topics, the formats the NRC can accept, the use of electronic signatures, and the treatment of nonpublic information. Copies of all communications must be sent to the appropriate regional office and resident inspector (addresses for the NRC Regional Offices are listed in Appendix D to Part 20 of this chapter).

[73 FR 17176, Mar. 31, 2008, as amended at 74 FR 62681, Dec. 1, 2009; 80 FR 74979, Dec. 1, 2015; 88 FR 57878, Aug. 24, 2023]

§ 26.21 Fitness-for-duty program.

The licensees and other entities specified in § 26.3(a) through (c) and (f) (for those licensees and other entities that do not implement the requirements in subparts M and K of this part) shall establish, implement, and maintain FFD programs that, at a minimum, comprise the program elements contained in this subpart. The individuals specified in § 26.4(a) through (e) and (g), and, at the licensee's or other entity's discretion, § 26.4(f), and, if necessary, § 26.4(j) shall be subject to these FFD programs. Licensees and other entities may rely on the FFD program or program elements of a C/V, as defined in § 26.5, if the C/V's FFD program or program elements satisfy the applicable requirements of this part.

[91 FR 15777, Mar. 30, 2026]

§ 26.23 Performance objectives.

Fitness-for-duty programs must—

(a) Provide reasonable assurance that individuals are trustworthy and reliable as demonstrated by the avoidance of substance abuse;

(b) Provide reasonable assurance that individuals are not under the influence of any substance, legal or illegal, or mentally or physically impaired from any cause, which in any way adversely affects their ability to safely and competently perform their duties;

(c) Provide reasonable measures for the early detection of individuals who are not fit to perform the duties that require them to be subject to the FFD program;

(d) Provide reasonable assurance that the workplaces subject to this part are free from the presence and effects of illegal drugs and alcohol; and

(e) Provide reasonable assurance that the effects of fatigue and degraded alertness on individuals' abilities to safely and competently perform their duties are managed commensurate with maintaining public health and safety.

§ 26.25 [Reserved]

§ 26.27 Written policy and procedures.

(a) General. Each licensee and other entity shall establish, implement, and maintain written policies and procedures to meet the general performance objectives and applicable requirements of this part.

(b) Policy. The FFD policy statement must be clear, concise, and readily available, in its most current form, to all individuals who are subject to the policy. Methods of making the statement readily available include, but are not limited to, posting the policy in multiple work areas, providing individuals with brochures, or allowing individuals to print the policy from a computer. The policy statement must be written in sufficient detail to provide affected individuals with information on what is expected of them and what consequences may result from a lack of adherence to the policy. At a minimum, the written policy statement must—

(1) Describe the consequences of the following actions:

(i) The use, sale, or possession of illegal drugs on or off site;

(ii) The abuse of legal drugs and alcohol; and

(iii) The misuse of prescription and over-the-counter drugs;

(2) Describe the requirement that individuals who are notified that they have been selected for random testing must report to the collection site within the time period specified by the licensee or other entity;

(3) Describe the actions that constitute a refusal to provide a specimen for testing, the consequences of a refusal to test, as well as the consequences of subverting or attempting to subvert the testing process;

(4) Prohibit the consumption of alcohol, at a minimum—

(i) Within an abstinence period of 5 hours preceding the individual's arrival at the licensee's or other entity's facility, except as permitted in § 26.27(c)(3); and

(ii) During the period of any tour of duty;

(5) Convey that abstinence from alcohol for the 5 hours preceding any scheduled tour of duty is considered to be a minimum that is necessary, but may not be sufficient, to ensure that the individual is fit for duty;

(6) Address other factors that could affect FFD, such as mental stress, fatigue, or illness, and the use of prescription and over-the-counter medications that could cause impairment;

(7) Provide a description of any program that is available to individuals who are seeking assistance in dealing with drug, alcohol, fatigue, or other problems that could adversely affect an individual's ability to safely and competently perform the duties that require an individual to be subject to this subpart;

(8) Describe the consequences of violating the policy;

(9) Describe the individual's responsibility to report legal actions, as defined in § 26.5;

(10) Describe the responsibilities of managers, supervisors, and escorts to report FFD concerns; and

(11) Describe the individual's responsibility to report FFD concerns.

(c) Procedures. Each licensee and other entity shall prepare, implement, and maintain written procedures that describe the methods to be used in implementing the FFD policy and the requirements of this part. The procedures must—

(1) Describe the methods and techniques to be used in testing for drugs and alcohol, including procedures for protecting the privacy and other rights (including due process) of an individual who provides a specimen, procedures for protecting the integrity of the specimen, and procedures used to ensure that the test results are valid and attributable to the correct individual;

(2) Describe immediate and followup actions that will be taken, and the procedures to be used, in those cases in which individuals are determined to have—

(i) Been involved in the use, sale, or possession of illegal drugs;

(ii) Consumed alcohol to excess before the mandatory pre-work abstinence period, or consumed any alcohol during the mandatory pre-work abstinence period or while on duty, as determined by a test that measures BAC;

(iii) Attempted to subvert the testing process by adulterating or diluting specimens (in vivo or in vitro), substituting specimens, or by any other means;

(iv) Refused to provide a specimen for analysis; or

(v) Had legal action taken relating to drug or alcohol use, as defined in § 26.5;

(3) Describe the process that the licensee or other entity will use to ensure that individuals who are called in to perform an unscheduled working tour are fit for duty. At a minimum—

(i) The procedure must require the individual who is called in to state whether the individual considers himself or herself fit for duty and whether he or she has consumed alcohol within the pre-duty abstinence period stated in the policy;

(ii) If the individual has consumed alcohol within this period and the individual is called in for an unscheduled working tour, including an unscheduled working tour to respond to an emergency, the procedure must—

(A) Require a determination of fitness by breath alcohol analysis or other means;

(B) Permit the licensee or other entity to assign the individual to duties that require him or her to be subject to this subpart, if the results of the determination of fitness indicate that the individual is fit to safely and competently perform his or her duties;

(C) Prohibit the licensee or other entity from assigning the individual to duties that require him or her to be subject to this subpart, if the individual is not required to respond to an emergency and the results of the determination of fitness indicate that the individual may be impaired;

(D) State that consumption of alcohol during the 5-hour abstinence period required in paragraph (b)(4)(i) of this section may not by itself preclude a licensee or other entity from using individuals who are needed to respond to an emergency. However, if the determination of fitness indicates that an individual who has been called in for an unscheduled working tour to respond to an emergency may be impaired, the procedure must require the establishment of controls and conditions under which the individual who has been called in can perform work, if necessary; and

(E) State that no sanctions may be imposed on an individual who is called in to perform any unscheduled working tour for having consumed alcohol within the pre-duty abstinence period stated in the policy.

(iii) If the individual reports that he or she considers himself or herself to be unfit for duty for other reasons, including illness, fatigue, or other potentially impairing conditions, and the individual is called in, the procedure must require the establishment of controls and conditions under which the individual can perform work, if necessary;

(4) Describe the process to be followed if an individual's behavior raises a concern regarding the possible use, sale, or possession of illegal drugs on or off site; the possible possession or consumption of alcohol on site; or impairment from any cause which in any way could adversely affect the individual's ability to safely and competently perform his or her duties. The procedure must require that individuals who have an FFD concern about another individual's behavior shall contact the personnel designated in the procedures to report the concern.

(d) Review. The NRC may, at any time, review the written policy and procedures to assure that they meet the performance objectives and requirements of this part.

§ 26.29 Training.

(a) Training content. Licensees and other entities shall ensure that the individuals who are subject to this subpart have the following KAs:

(1) Knowledge of the policy and procedures that apply to the individual, the methods that will be used to implement them, and the consequences of violating the policy and procedures;

(2) Knowledge of the individual's role and responsibilities under the FFD program;

(3) Knowledge of the roles and responsibilities of others, such as the MRO and the human resources, FFD, and EAP staffs;

(4) Knowledge of the EAP services available to the individual;

(5) Knowledge of the personal and public health and safety hazards associated with abuse of illegal and legal drugs and alcohol;

(6) Knowledge of the potential adverse effects on job performance of prescription and over-the-counter drugs, alcohol, dietary factors, illness, mental stress, and fatigue;

(7) Knowledge of the prescription and over-the-counter drugs and dietary factors that have the potential to affect drug and alcohol test results;

(8) Ability to recognize illegal drugs and indications of the illegal use, sale, or possession of drugs;

(9) Ability to observe and detect performance degradation, indications of impairment, or behavioral changes; and

(10) Knowledge of the individual's responsibility to report an FFD concern and the ability to initiate appropriate actions, including referrals to the EAP and person(s) designated by the licensee or other entity to receive FFD concerns.

(b) Comprehensive examination. Individuals who are subject to this subpart shall demonstrate the successful completion of training by passing a comprehensive examination that addresses the KAs in paragraph (a) of this section. The examination must include a comprehensive random sampling of all KAs with questions that test each KA, including at least one question for each KA. The minimum passing score required must be 80 percent. Remedial training and testing are required for individuals who fail to answer correctly at least 80 percent of the test questions. The examination may be administered using a variety of media, including, but not limited to, hard-copy test booklets with separate answer sheets or computer-based questions.

(c) Training administration. Licensees and other entities shall ensure that individuals who are subject to this subpart are trained, as follows:

(1) Training must be completed before the licensee or other entity grants initial authorization, as defined in § 26.55, and must be current before the licensee or other entity grants an authorization update, as defined in § 26.57, or authorization reinstatement, as defined in § 26.59;

(2) Individuals shall complete refresher training on a nominal 12-month frequency, or more frequently where the need is indicated. Indications of the need for more frequent training include, but are not limited to, an individual's failure to properly implement FFD program procedures and the frequency, nature, or severity of problems discovered through audits or the administration of the program. Individuals who pass a comprehensive annual examination that meets the requirements in paragraph (b) of this section may forgo the refresher training; and

(3) Initial and refresher training may be delivered using a variety of media (including, but not limited to, classroom lectures, required reading, video, or computer-based training systems). The licensee or other entity shall monitor the completion of training and provide a qualified instructor or designated subject matter expert to answer questions during the course of training.

(d) Acceptance of training. Licensees and other entities may accept training of individuals who have been subject to another training program that meets the requirements of this section and who have, within the past 12 months, either had initial or refresher training, or have successfully passed a comprehensive examination that meets the requirements in paragraph (b) of this section.

§ 26.31 Drug and alcohol testing.

(a) General. To provide a means to deter and detect substance abuse, licensees and other entities who are subject to this part shall implement drug and alcohol testing programs for individuals who are subject to this subpart.

(b) Assuring the honesty and integrity of FFD program personnel. (1) Licensees and other entities who are subject to this subpart shall carefully select and monitor FFD program personnel, as defined in § 26.4(g), based on the highest standards of honesty and integrity, and shall implement measures to ensure that these standards are maintained. The measures must ensure that the honesty and integrity of these individuals are not compromised and that FFD program personnel are not subject to influence attempts attributable to personal relationships with any individuals who are subject to testing, an undetected or untreated substance abuse problem, or other factors. At a minimum, these measures must include the following considerations:

(i) Licensees and other entities shall complete appropriate background investigations, credit and criminal history checks, and psychological assessments of FFD program personnel before assignment to tasks directly associated with administration of the FFD program. The background investigations, credit and criminal history checks, and psychological assessments that are conducted to grant unescorted access authorization to individuals under a nuclear power plant licensee's access authorization program are acceptable to meet the requirements of this paragraph. The credit and criminal history checks and psychological assessments must be updated nominally every 5 years;

(ii) Individuals who have personal relationships with a donor may not perform any assessment or evaluation procedures, including, but not limited to, determinations of fitness. These personal relationships may include, but are not limited to, supervisors, coworkers within the same work group, and relatives of the donor;

(iii) Except if a directly observed collection is required, a collector who has a personal relationship with the donor may collect specimens from the donor only if the integrity of specimen collections in these instances is assured through the following means:

(A) The collection must be monitored by an individual who does not have a personal relationship with the donor and who is designated by the licensee or other entity for this purpose, including, but not limited to, security force or quality assurance personnel; and

(B) Individuals who are designated to monitor collections in these instances shall be trained to monitor specimen collections and the preparation of specimens for transfer or shipping under the requirements of this part;

(iv) If a specimen must be collected under direct observation, the collector or an individual who serves as the observer, as permitted under § 26.115(e), may not have a personal relationship with the donor; and

(v) FFD program personnel shall be subject to a behavioral observation program designed to assure that they continue to meet the highest standards of honesty and integrity. When an MRO and MRO staff are on site at a licensee's or other entity's facility, the MRO and MRO staff shall be subject to behavioral observation.

(2) Licensees and other entities may rely on a local hospital or other organization that meets the requirements of 49 CFR Part 40, “Procedures for Department of Transportation Workplace Drug and Alcohol Testing Programs” to collect specimens for drug and alcohol testing from the FFD program personnel listed in § 26.4(g).

(c) Conditions for testing. Licensees and other entities shall administer drug and alcohol tests to the individuals who are subject to this subpart under the following conditions:

(1) Pre-access. In order to grant initial, updated, or reinstated authorization to an individual, as specified in subpart C of this part;

(2) For cause. In response to an individual's observed behavior or physical condition indicating possible substance abuse or after receiving credible information that an individual is engaging in substance abuse, as defined in § 26.5;

(3) Post-event. As soon as practical after an event involving a human error that was committed by an individual who is subject to this subpart, where the human error may have caused or contributed to the event. The licensee or other entity shall test the individual(s) who committed the error(s), and need not test individuals who were affected by the event whose actions likely did not cause or contribute to the event. The individual(s) who committed the human error(s) shall be tested if the event resulted in—

(i) A significant illness or personal injury to the individual to be tested or another individual, which within 4 hours after the event is recordable under the Department of Labor standards contained in 29 CFR 1904.7, “General Recording Criteria,” and subsequent amendments thereto, and results in death, days away from work, restricted work, transfer to another job, medical treatment beyond first aid, loss of consciousness, or other significant illness or injury as diagnosed by a physician or other licensed health care professional, even if it does not result in death, days away from work, restricted work or job transfer, medical treatment beyond first aid, or loss of consciousness;

(ii) A radiation exposure or release of radioactivity in excess of regulatory limits; or

(iii) Actual or potential substantial degradations of the level of safety of the plant;

(4) Follow-up. As part of a follow-up plan to verify an individual's continued abstinence from substance abuse; and

(5) Random. On a statistically random and unannounced basis, so that all individuals in the population subject to testing have an equal probability of being selected and tested.

(d) General requirements for drug and alcohol testing—(1) Substances tested. At a minimum, licensees and other entities shall test for marijuana metabolite, cocaine metabolite, opioids (codeine, morphine, 6-acetylmorphine, hydrocodone, hydromorphone, oxycodone, and oxymorphone), amphetamines (amphetamine, methamphetamine, methylenedioxymethamphetamine, and methylenedioxyamphetamine), phencyclidine, and alcohol.

(i) In addition, licensees and other entities may consult with local law enforcement authorities, hospitals, and drug counseling services to determine whether other drugs with abuse potential are being used in the geographical locale of the facility and by the local workforce that may not be detected in the panel of drugs and drug metabolites specified in paragraph (d)(1) of this section.

(A) When appropriate, the licensee or other entity may add other drugs identified under paragraph (d)(1)(i) of this section to the panel of substances for testing, but only if the additional drugs are listed in Schedules I through V of section 202 of the Controlled Substances Act [21 U.S.C. 812].

(B) The licensee or other entity shall establish appropriate cutoff limits for these substances.

(C) The licensee or other entity shall establish rigorous testing procedures for these substances that are consistent with the intent of this part, so that the MRO can evaluate the use of these substances.

(D) The licensee or other entity may not conduct an analysis for any drug or drug metabolites except those identified in paragraph (d)(1) of this section unless the assay and cutoff levels to be used are certified in writing as scientifically sound and legally defensible by an independent, qualified forensic toxicologist who has no relationships with manufacturers of the assays or instruments to be used or the HHS-certified laboratory that will conduct the testing for the licensee or other entity, which could be construed as a potential conflict of interest. The forensic toxicologist may not be an employee of the licensee or entity, and shall either be a Diplomate of the American Board of Forensic Toxicology or currently holds, has held, or is eligible to hold, the position of Responsible Person at an HHS-certified laboratory. All new assays and cutoff levels must be properly validated consistent with established forensic toxicological standards before implementation. Certification of the assay and cutoff levels is not required if the HHS Guidelines are revised to authorize use of the assay in testing for the additional drug or drug metabolites and the licensee or other entity uses the cutoff levels established in the HHS Guidelines for the drug or drug metabolites, or if the licensee or other entity received written approval of the NRC to test for the additional drug or drug metabolites before April 30, 2008.

(ii) When conducting post-event, followup, and for-cause testing, as defined in § 26.31(c), licensees and other entities may test for any drugs listed on Schedules I through V of section 202 of the Controlled Substances Act [21 U.S.C. 812] that an individual is suspected of having abused, and may consider any drugs or metabolites so detected when determining appropriate action under subpart D of this part. If the drug or metabolites for which testing will be performed under this paragraph are not included in the FFD program's drug panel, the assay and cutoff levels to be used in testing for the additional drugs must be certified by a forensic toxicologist under paragraph (d)(1)(i)(D) of this section. Test results that fall below the established cutoff levels may not be considered when determining appropriate action under subpart D of this part, except if special analyses of the specimen is performed under § 26.163(a)(2) by the HHS-certified laboratory.

(iii) The licensee or other entity shall document the additional drug(s) for which testing will be performed in written policies and procedures in which the substances for which testing will be performed are described.

(2) Random testing. Random testing must—

(i) Be administered in a manner that provides reasonable assurance that individuals are unable to predict the time periods during which specimens will be collected. At a minimum, the FFD program shall—

(A) Take reasonable steps to either conceal from the workforce that collections will be performed during a scheduled collection period or create the appearance that specimens are being collected during a portion of each day on at least 4 days in each calendar week at each site. In the latter instance, the portions of each day and the days of the week must vary in a manner that cannot be predicted by donors; and

(B) Collect specimens on an unpredictable schedule, including weekends, backshifts, and holidays, and at various times during a shift;

(ii) At a minimum, be administered by the FFD program on a nominal weekly frequency;

(iii) Require individuals who are selected for random testing to report to the collection site as soon as reasonably practicable after notification, within the time period specified in the FFD program policy;

(iv) Ensure that all individuals in the population subject to testing have an equal probability of being selected and tested;

(v) Require that individuals who are off site when selected for testing, or who are on site and are not reasonably available for testing when selected, shall be tested at the earliest reasonable and practical opportunity when both the donor and collectors are available to collect specimens for testing and without prior notification to the individual that he or she has been selected for testing;

(vi) Provide that an individual completing a test is immediately eligible for another unannounced test; and

(vii) Ensure that the sampling process used to select individuals for random testing provides that the number of random tests performed annually is equal to at least 50 percent of the population that is subject to the FFD program.

(3) Drug testing. (i) Testing of urine specimens for drugs and validity, except validity screening and initial drug and validity tests performed by licensee testing facilities under paragraph (d)(3)(ii) of this section, must be performed in a laboratory that is certified by HHS for that purpose, consistent with its standards and procedures for certification. Urine specimens sent to HHS-certified laboratories must be subject to initial validity and initial drug testing by the laboratory. Oral fluid specimens sent to HHS-certified laboratories must be subject to initial drug testing by the laboratory. Specimens that yield positive initial drug test results or are determined by initial validity testing to be of questionable validity must be subject to confirmatory testing by the laboratory, except for invalid specimens that cannot be tested. Licensees and other entities shall ensure that laboratories report results for all specimens sent for testing, including blind performance test samples.

(ii) Licensees and other entities may conduct validity screening, initial validity, and initial drug tests of urine aliquots to determine which specimens are valid and negative and need no further testing, provided that the licensee's or other entity's staff possesses the necessary training and skills for the tasks assigned, the staff's qualifications are documented, and adequate quality controls for the testing are implemented.

(iii) At a minimum, licensees and other entities shall apply the cutoff levels specified in § 26.163(a)(1) for initial drug testing at either the licensee testing facility or HHS-certified laboratory, and in § 26.163(b)(1) for confirmatory drug testing at the HHS-certified laboratory. At their discretion, licensees and other entities may implement programs with lower cutoff levels in testing for drugs and drug metabolites.

(A) If a licensee or other entity implements lower cutoff levels, and the MRO determines that an individual has violated the FFD policy using the licensee's or other entity's more stringent cutoff levels, the individual shall be subject to all management actions and sanctions required by the licensee's or other entity's FFD policy and this part, as if the individual had a confirmed positive drug test result using the cutoff levels specified in this subpart. The licensee or other entity shall document the more stringent cutoff levels in any written policies and procedures in which cutoff levels for drug testing are described.

(B) The licensee or other entity shall uniformly apply the cutoff levels listed in § 26.163(a)(1) for initial drug testing and in § 26.163(b)(1) for confirmatory drug testing, or any more stringent cutoff levels implemented by the FFD program, to all tests performed under this part and equally to all individuals who are tested under this part, except as permitted in §§ 26.31(d)(1)(ii), 26.163(a)(2), and 26.165(c)(2).

(C) In addition, the scientific and technical suitability of any more stringent cutoff levels must be evaluated and certified, in writing, by a forensic toxicologist who meets the requirements set forth in § 26.31(d)(1)(i)(D). Certification of the more stringent cutoff levels is not required if the HHS Guidelines are revised to lower the cutoff levels for the drug or drug metabolites in Federal workplace drug testing programs and the licensee or other entity implements the cutoff levels published in the HHS Guidelines, or if the licensee or other entity received written approval of the NRC to test for lower cutoff levels before April 30, 2008.

(4) Alcohol testing. Initial tests for alcohol must be administered by breath or oral fluids analysis using alcohol analysis devices that meet the requirements of § 26.91(a). If the initial test shows a BAC of 0.02 percent or greater, a confirmatory test for alcohol must be performed. The confirmatory test must be performed with an EBT that meets the requirements of § 26.91(b).

(5) Medical conditions. (i) If an individual has a medical condition that makes collection of breath, oral fluids, or urine specimens difficult or hazardous, the MRO may authorize an alternative evaluation process, tailored to the individual case, to meet the requirements of this part for drug and alcohol testing. The alternative process must include measures to prevent subversion and achieve results that are comparable to those produced by urinalysis for drugs and breath analysis for alcohol.

(ii) If an individual requires medical attention, including, but not limited to, an injured worker in an emergency medical facility who is required to have a post-event test, treatment may not be delayed to conduct drug and alcohol testing.

(6) Limitations of testing. Specimens collected under NRC regulations may only be designated or approved for testing as described in this part and may not be used to conduct any other analysis or test without the written permission of the donor. Analyses and tests that may not be conducted include, but are not limited to, DNA testing, serological typing, or any other medical or genetic test used for diagnostic or specimen identification purposes.

[73 FR 17176, Mar. 31, 2008, as amended at 74 FR 38327, Aug. 3, 2009; 87 FR 71456, Nov. 22, 2022]

§ 26.33 Behavioral observation.

Licensees and other entities shall ensure that the individuals who are subject to this subpart are subject to behavioral observation. Behavioral observation must be performed by individuals who are trained under § 26.29 to detect behaviors that may indicate possible use, sale, or possession of illegal drugs; use or possession of alcohol on site or while on duty; or impairment from fatigue or any cause that, if left unattended, may constitute a risk to public health and safety or the common defense and security. Individuals who are subject to this subpart shall report any FFD concerns about other individuals to the personnel designated in the FFD policy.

§ 26.35 Employee assistance programs.

(a) Each licensee and other entity who is subject to this part shall maintain an EAP to strengthen the FFD program by offering confidential assessment, short-term counseling, referral services, and treatment monitoring to individuals who have problems that could adversely affect the individuals' abilities to safely and competently perform their duties. Employee assistance programs must be designed to achieve early intervention and provide for confidential assistance.

(b) Licensees and other entities need not provide EAP services to a C/V's employees, including those whose work location is a licensee's or other entity's facility, or to individuals who have applied for, but have not yet been granted, authorization under subpart C of this part.

(c) The EAP staff shall protect the identity and privacy of any individual (including those who have self-referred) seeking assistance from the EAP, except if the individual waives the right to privacy in writing or a determination is made that the individual's condition or actions pose or have posed an immediate hazard to himself or herself or others.

(1) Licensees and other entities may not require the EAP to routinely report the names of individuals who self-refer to the EAP or the nature of the assistance the individuals sought.

(2) If EAP personnel determine that an individual poses or has posed an immediate hazard to himself or herself or others, EAP personnel shall so inform FFD program management, and need not obtain a written waiver of the right to privacy from the individual. The individual conditions or actions that EAP personnel shall report to FFD program management include, but are not limited to, substantive reasons to believe that the individual—

(i) Is likely to commit self-harm or harm to others;

(ii) Has been impaired from using drugs or alcohol while in a work status and has a continuing substance abuse disorder that makes it likely he or she will be impaired while in a work status in the future; or

(iii) Has ever engaged in any acts that would be reportable under § 26.719(b)(1) through (b)(3).

(3) If a licensee or other entity receives a report from EAP personnel under paragraph (c)(2) of this section, the licensee or other entity must ensure that the requirements of §§ 26.69(d) and 26.77(b), or the procedures and actions required by § 26.606(b)(2)(vii) are implemented, as applicable.

[73 FR 17176, Mar. 31, 2008, as amended at 91 FR 15777, Mar. 30, 2026]

§ 26.37 Protection of information.

(a) Each licensee or other entity who is subject to this subpart who collects personal information about an individual for the purpose of complying with this part, shall establish, use, and maintain a system of files and procedures that protects the individual's privacy.

(b) Licensees and other entities shall obtain a signed consent that authorizes the disclosure of the personal information collected and maintained under this part before disclosing the personal information, except for disclosures to the following individuals:

(1) The subject individual or his or her representative, when the individual has designated the representative in writing for specified FFD matters;

(2) Assigned MROs and MRO staff;

(3) NRC representatives;

(4) Appropriate law enforcement officials under court order;

(5) A licensee's or other entity's representatives who have a need to have access to the information to perform their assigned duties under the FFD program, including determinations of fitness, FFD program audits, or some human resources functions;

(6) The presiding officer in a judicial or administrative proceeding that is initiated by the subject individual;

(7) Persons deciding matters under review in § 26.39; and

(8) Other persons pursuant to court order.

(c) Personal information that is collected under this subpart must be disclosed to other licensees and entities, including C/Vs, or their authorized representatives, who are legitimately seeking the information for authorization decisions as required by this part and who have obtained a signed release from the subject individual.

(d) Upon receipt of a written request by the subject individual or his or her designated representative, the FFD program, including but not limited to, the collection site, HHS-certified laboratory, substance abuse expert (SAE), or MRO, possessing such records shall promptly provide copies of all FFD records pertaining to the individual, including, but not limited to, records pertaining to a determination that the individual has violated the FFD policy, drug and alcohol test results, MRO reviews, determinations of fitness, and management actions pertaining to the subject individual. The licensee or other entity shall obtain records related to the results of any relevant laboratory certification, review, or revocation-of-certification proceedings from the HHS-certified laboratory and provide them to the subject individual on request.

(e) A licensee's or other entity's contracts with HHS-certified laboratories and C/Vs providing specimen collection services, and licensee testing facility procedures, must require test records to be maintained in confidence, except as provided in paragraphs (b), (c), and (d) of this section.

(f) This section does not authorize the licensee or other entity to withhold evidence of criminal conduct from law enforcement officials.

§ 26.39 Review process for fitness-for-duty policy violations.

(a) Each licensee and other entity who is subject to this subpart shall establish procedures for the review of a determination that an individual who they employ or who has applied for authorization has violated the FFD policy. The review procedure must provide for an objective and impartial review of the facts related to the determination that the individual has violated the FFD policy.

(b) The review procedure must provide notice to the individual of the grounds for the determination that the individual has violated the FFD policy, and must provide an opportunity for the individual to respond and submit additional relevant information.

(c) The review procedure must ensure that the individual who conducts the review is not associated with the administration of the FFD program [see the description of FFD program personnel in § 26.4(g)]. Individuals who conduct the review may be management personnel.

(d) If the review finds in favor of the individual, the licensee or other entity shall update the relevant records to reflect the outcome of the review and delete or correct all information the review found to be inaccurate.

(e) When a C/V is administering an FFD program on which licensees and other entities rely, and the C/V determines that its employee, subcontractor, or applicant has violated its FFD policy, the C/V shall ensure that the review procedure required in this section is provided to the individual. Licensees and other entities who rely on a C/V's FFD program need not provide the review procedure required in this section to a C/V's employee, subcontractor, or applicant when the C/V is administering its own FFD program and the FFD policy violation was determined under the C/V's program.

[75 FR 73941, Nov. 30, 2010]

§ 26.41 Audits and corrective action.

(a) General. Each licensee and other entity who is subject to this subpart is responsible for the continuing effectiveness of the FFD program, including FFD program elements that are provided by C/Vs, the FFD programs of any C/Vs that are accepted by the licensee or other entity, any FFD program services that are provided to the C/V by a subcontractor, and the programs of the HHS-certified laboratories on whom the licensee or other entity and its C/Vs rely. Each licensee and other entity shall ensure that these programs are audited and that corrective actions are taken to resolve any problems identified.

(b) FFD program. Each licensee and other entity who is subject to this subpart shall ensure that the entire FFD program is audited as needed, but no less frequently than nominally every 24 months. Licensees and other entities are responsible for determining the appropriate frequency, scope, and depth of additional auditing activities within the nominal 24-month period based on the review of FFD program performance, including, but not limited to, the frequency, nature, and severity of discovered problems, testing errors, personnel or procedural changes, and previous audit findings.

(c) C/Vs and HHS-certified laboratories. (1) FFD services that are provided to a licensee or other entity by C/V personnel who are off site or are not under the direct daily supervision or observation of the licensee's or other entity's personnel and HHS-certified laboratories must be audited on a nominal 12-month frequency.

(2) Audits of HHS-certified laboratories that are conducted for licensees and other entities who are subject to this subpart need not duplicate areas inspected in the most recent HHS certification inspection. However, the licensee and other entity shall review the HHS certification inspection records and reports to identify any areas in which the licensee or other entity uses services that the HHS certification inspection did not address. The licensee or other entity shall ensure that any such areas are audited on a nominal 12-month frequency. Licensees and other entities need not audit organizations and professionals who may provide an FFD program service to the licensee or other entity, but who are not routinely involved in providing services to a licensee's or other entity's FFD program, as specified in § 26.4(i)(1).

(d) Contracts. (1) The contracts of licensees and other entities with C/Vs and HHS-certified laboratories must reserve the right to audit the C/V, the C/V's subcontractors providing FFD program services, and the HHS-certified laboratories at any time, including at unannounced times, as well as to review all information and documentation that is reasonably relevant to the audits.

(2) Licensees' and other entities' contracts with C/Vs and HHS-certified laboratories must also permit the licensee or other entity to obtain copies of and take away any documents, including reviews and inspections pertaining to a laboratory's certification by HHS, and any other data that may be needed to assure that the C/V, its subcontractors, or the HHS-certified laboratory are performing their functions properly and that staff and procedures meet applicable requirements. In a contract with a licensee or other entity who is subject to this subpart, an HHS-certified laboratory may reasonably limit the use and dissemination of any documents copied or taken away by the licensee's or other entity's auditors in order to ensure the protection of proprietary information and donors' privacy.

(3) In addition, before awarding a contract, the licensee or other entity shall ensure completion of pre-award inspections and/or audits of the procedural aspects of the HHS-certified laboratory's drug-testing operations, except as provided in paragraph (g)(5) of this section.

(e) Conduct of audits. Audits must focus on the effectiveness of the FFD program or program element(s), as appropriate, and must be conducted by individuals who are qualified in the subject(s) being audited. The individuals performing the audit of the FFD program or program element(s) shall be independent from both the subject FFD program's management and from personnel who are directly responsible for implementing the FFD program.

(f) Audit results. The result of the audits, along with any recommendations, must be documented and reported to senior corporate and site management. Each audit report must identify conditions that are adverse to the proper performance of the FFD program, the cause of the condition(s), and recommended corrective actions. The licensee or other entity shall review the audit findings and take corrective actions, including re-auditing of the deficient areas where indicated, to preclude, within reason, repetition of the condition. The resolution of the audit findings and corrective actions must be documented.

(g) Sharing of audits. Licensees and other entities may jointly conduct audits, or may accept audits of C/Vs and HHS-certified laboratories that were conducted by other licensees and entities who are subject to this subpart, if the audit addresses the services obtained from the C/V or HHS-certified laboratory by each of the sharing licensees and other entities.

(1) Licensees and other entities shall review audit records and reports to identify any areas that were not covered by the shared or accepted audit.

(2) Licensees and other entities shall ensure that FFD program elements and services on which the licensee or entity relies are audited, if the program elements and services were not addressed in the shared audit.

(3) Sharing licensees and other entities need not re-audit the same C/V or HHS-certified laboratory for the same period of time.

(4) Each sharing licensee and other entity shall maintain a copy of the shared audit and HHS certification inspection records and reports, including findings, recommendations, and corrective actions.

(5) If an HHS-certified laboratory loses its certification, in whole or in part, a licensee or other entity is permitted to immediately use another HHS-certified laboratory that has been audited within the previous 12 months by another NRC licensee or entity who is subject to this subpart. Within 3 months after the change, the licensee or other entity shall ensure that an audit is completed of any areas that have not been audited by another licensee or entity who is subject to this subpart within the past 12 months.

[73 FR 17176, Mar. 31, 2008, as amended at 74 FR 38327, Aug. 3, 2009]

§ 26.51 Applicability.

The requirements in this subpart apply to the licensees and other entities identified in § 26.3(a), (b), and, as applicable, (c) for the categories of individuals in § 26.4(a) through (d), and, at the licensee's or other entity's discretion, in § 26.4(g) and, if necessary, § 26.4(j). The requirements in this subpart also apply to the licensees and other entities specified in § 26.3(c), as applicable, for the categories of individuals in § 26.4(e). At the discretion of a licensee or other entity in § 26.3(c), the requirements of this subpart also may be applied to the categories of individuals identified in § 26.4(f). In addition, the requirements in this subpart apply to the entities in § 26.3(d) to the extent that a licensee or other entity relies on the C/V to satisfy the requirements of this subpart. Certain requirements in this subpart also apply to the individuals specified in § 26.4(h). The requirements in this subpart apply to the FFD programs of licensees and other entities identified in § 26.3(f) that elect not to implement the requirements in subpart M of this part for the categories of individuals in § 26.4 and those licensees and other entities that elect to implement the requirements in § 26.605.

[91 FR 15777, Mar. 30, 2026]

§ 26.53 General provisions.

Link to an amendment published at 91 FR 15777, Mar. 30, 2026.

(a) In order to grant authorization to an individual, a licensee or other entity shall ensure that the requirements in this subpart have been met for either initial authorization, authorization update, authorization reinstatement, or authorization with potentially disqualifying FFD information, as applicable.

(b) For individuals who have previously held authorization under this part but whose authorization has since been favorably terminated, the licensee or other entity shall implement the requirements for either initial authorization, authorization update, or authorization reinstatement, based on the total number of days that the individual's authorization is interrupted, to include the day after the individual's last period of authorization was terminated and the intervening days until the day on which the licensee or other entity grants authorization to the individual. If potentially disqualifying FFD information is disclosed or discovered about an individual, licensees and other entities shall implement the applicable requirements in § 26.69 in order to grant or maintain an individual's authorization.

(c) The licensee or other entity shall ensure that an individual has met the applicable FFD training requirements in §§ 26.29 and 26.203(c) before granting authorization to the individual.

(d) Licensees and other entities who are seeking to grant authorization to an individual who is maintaining authorization under another FFD program that is implemented by a licensee or entity who is subject to this subpart may rely on the transferring FFD program to satisfy the requirements of this subpart. The individual may maintain his or her authorization if he or she continues to be subject to either the receiving FFD program or the transferring FFD program, or a combination of elements from both programs that collectively satisfy the applicable requirements of this part. The receiving FFD program shall ensure that the program elements to which the individual is subject under the transferring FFD program remain current.

(e) Licensees and other entities in § 26.3(a) through (c) and (f) may also rely on a C/V's FFD program or program elements when granting or maintaining the authorization of an individual who is or has been subject to the C/V's FFD program, if the C/V's program or program elements meet the applicable requirements of this part.

(1) A C/V's FFD program may grant and maintain an individual's authorization, as defined in § 26.5, under the C/V's FFD program. However, only a licensee or other entity in § 26.3(a) through (c) and (f) may grant or maintain an individual's authorization to have the types of access or perform the duties specified in § 26.4(a) through (e) and (g), and, at the licensee's or other entity's discretion, § 26.4(f).

(2) If a C/V's FFD program denies or unfavorably terminates an individual's authorization, and the individual is performing any duties for a licensee or other entity that are specified in § 26.4(a) through (e) and (g), or, at the licensee's or other entity's discretion, § 26.4(f), then the C/V shall inform the affected licensee or other entity of the denial or unfavorable termination. The licensee or other entity shall deny or unfavorably terminate the individual's authorization to perform those duties on the day that the licensee or other entity receives the information from the C/V, or implement the applicable process in § 26.69 to maintain the individual's authorization.

(3) If an individual is maintaining authorization under a C/V's FFD program, a licensee or other entity in § 26.3(a) through (c) and (f) may grant authorization to the individual to have the types of access and perform the duties specified in § 26.4(a) through (e) and (g), and, at the licensee's or other entity's discretion, § 26.4(f), and maintain his or her authorization, if the individual continues to be subject to either the receiving FFD program or a combination of elements from the receiving FFD program and the C/V's program that collectively satisfy the applicable requirements of this part. The receiving licensee's or other entity's FFD program shall ensure that the program elements to which the individual is subject under the C/V's FFD program remain current.

(f) Licensees and other entities who are seeking to grant authorization to an individual who has been subject to an FFD program under subpart K may not rely on that program or its program elements to meet the requirements of this subpart, except if the program or program element(s) of the FFD program for construction satisfy the applicable requirements of this part.

(g) The licensees and other entities specified in § 26.3(a) and, as applicable, (c), (d), and (f), shall identify any violation of any requirement of this part to any licensee who has relied on or intends to rely on the FFD program element that is determined to be in violation of this part.

(h) The licensees and other entities specified in § 26.3(a) and, as applicable, (c), (d), and (f), may not initiate any actions under this subpart without the knowledge and written consent of the subject individual. The individual may withdraw his or her consent at any time. If an individual withdraws his or her consent, the licensee or other entity may not initiate any elements of the authorization process specified in this subpart that were not in progress at the time the individual withdrew his or her consent, but shall complete and document any elements that are in progress at the time consent is withdrawn. The licensee or other entity shall record the individual's application for authorization; his or her withdrawal of consent; the reason given by the individual for the withdrawal, if any; and any pertinent information gathered from the elements that were completed (e.g., the results of pre-access drug tests, information obtained from the suitable inquiry). The licensee or other entity to whom the individual has applied for authorization shall inform the individual that—

(1) Withdrawal of his or her consent will withdraw the individual's current application for authorization under the licensee's or other entity's FFD program; and

(2) Other licensees and entities will have access to information documenting the withdrawal as a result of the information sharing that is required under this part.

(i) The licensees and other entities specified in § 26.3(a) and, as applicable, (c), (d), and (f), shall inform, in writing, any individual who is applying for authorization that the following actions related to providing and sharing the personal information required under this subpart are sufficient cause for denial or unfavorable termination of authorization:

(1) Refusal to provide written consent for the suitable inquiry;

(2) Refusal to provide or the falsification of any personal information required under this part, including, but not limited to, the failure to report any previous denial or unfavorable termination of authorization;

(3) Refusal to provide written consent for the sharing of personal information with other licensees or other entities required under this part; and

(4) Failure to report any legal actions, as defined in § 26.5.

[73 FR 17176, Mar. 31, 2008, as amended at 91 FR 15777, Mar. 30, 2026]

§ 26.55 Initial authorization.

(a) Before granting authorization to an individual who has never held authorization under this part or whose authorization has been interrupted for a period of 3 years or more and whose last period of authorization was terminated favorably, the licensee or other entity shall ensure that—

(1) A self-disclosure has been obtained and reviewed under the applicable requirements of § 26.61;

(2) A suitable inquiry has been completed under the applicable requirements of § 26.63;

(3) The individual has been subject to pre-access drug and alcohol testing under the applicable requirements of § 26.65; and

(4) The individual is subject to random drug and alcohol testing under the applicable requirements of § 26.67.

(b) If potentially disqualifying FFD information is disclosed or discovered, the licensee or other entity may not grant authorization to the individual, except under § 26.69.

§ 26.57 Authorization update.

(a) Before granting authorization to an individual whose authorization has been interrupted for more than 365 days but less than 3 years and whose last period of authorization was terminated favorably, the licensee or other entity shall ensure that—

(1) A self-disclosure has been obtained and reviewed under the applicable requirements of § 26.61;

(2) A suitable inquiry has been completed under the applicable requirements of § 26.63;

(3) The individual has been subject to pre-access drug and alcohol testing under the applicable requirements of § 26.65; and

(4) The individual is subject to random drug and alcohol testing under the applicable requirements of § 26.67.

(b) If potentially disqualifying FFD information is disclosed or discovered, the licensee or other entity may not grant authorization to the individual, except under § 26.69.

§ 26.59 Authorization reinstatement.

(a) In order to grant authorization to an individual whose authorization has been interrupted for a period of more than 30 days but no more than 365 days and whose last period of authorization was terminated favorably, the licensee or other entity shall ensure that—

(1) A self-disclosure has been obtained and reviewed under the applicable requirements of § 26.61;

(2) A suitable inquiry has been completed under the requirements of § 26.63 within 5 business days of reinstating authorization. If the suitable inquiry is not completed within 5 business days due to circumstances that are outside of the licensee's or other entity's control and the licensee or other entity is not aware of any potentially disqualifying information regarding the individual within the past 5 years, the licensee or other entity may maintain the individual's authorization for an additional 5 business days. If the suitable inquiry is not completed within 10 business days of reinstating authorization, the licensee or other entity shall administratively withdraw the individual's authorization until the suitable inquiry is completed;

(3) The individual has been subject to pre-access drug and alcohol testing under the applicable requirements of § 26.65; and

(4) The individual is subject to random drug and alcohol testing under the applicable requirements of § 26.67.

(b) If a licensee or other entity administratively withdraws an individual's authorization under paragraph (a)(2) of this section, and until the suitable inquiry is completed, the licensee or other entity may not record the administrative action to withdraw authorization as an unfavorable termination and may not disclose it in response to a suitable inquiry conducted under the provisions of § 26.63, a background investigation conducted under the provisions of this chapter, or any other inquiry or investigation. The individual may not be required to disclose the administrative action in response to requests for self-disclosure of potentially disqualifying FFD information, except if the individual's authorization was subsequently denied or terminated unfavorably by the licensee or other entity.

(c) Before granting authorization to an individual whose authorization has been interrupted for a period of no more than 30 days and whose last period of authorization was terminated favorably, the licensee or other entity shall ensure that—

(1) A self-disclosure has been obtained and reviewed under the applicable requirements of § 26.61;

(2) The individual has been subject to pre-access drug and alcohol testing under the applicable requirements of § 26.65, if the individual's authorization was interrupted for more than 5 days; and

(3) The individual is subject to random drug and alcohol testing under the applicable requirements of § 26.67.

(d) If potentially disqualifying FFD information is disclosed or discovered, the licensee or other entity may not grant authorization to the individual, except under § 26.69.

§ 26.61 Self-disclosure and employment history.

(a) Before granting authorization, the licensee or other entity shall ensure that a written self-disclosure and employment history has been obtained from the individual who is applying for authorization, except as follows:

(1) If an individual previously held authorization under this part, and the licensee or other entity has verified that the individual's last period of authorization was terminated favorably, and the individual has been subject to a behavioral observation program that includes arrest reporting, which meets the requirements of this part, throughout the period since the individual's last authorization was terminated, the granting licensee or other entity need not obtain the self-disclosure or employment history in order to grant authorization; and

(2) If the individual's last period of authorization was terminated favorably within the past 30 days, the licensee or other entity need not obtain the employment history.

(b) The written self-disclosure must—

(1) State whether the individual has—

(i) Violated a licensee's or other entity's FFD policy;

(ii) Had authorization denied or terminated unfavorably under §§ 26.35(c)(2), 26.53(i), 26.63(d), 26.65(g), 26.67(c), 26.69(f), or 26.75(b) through (e);

(iii) Used, sold, or possessed illegal drugs;

(iv) Abused legal drugs or alcohol;

(v) Subverted or attempted to subvert a drug or alcohol testing program;

(vi) Refused to take a drug or alcohol test;

(vii) Been subject to a plan for substance abuse treatment (except for self-referral); or

(viii) Had legal action or employment action, as defined in § 26.5, taken for alcohol or drug use;

(2) Address the specific type, duration, and resolution of any matter disclosed, including, but not limited to, the reason(s) for any unfavorable termination or denial of authorization; and

(3) Address the shortest of the following periods:

(i) The past 5 years;

(ii) Since the individual's eighteenth birthday; or

(iii) Since the individual's last period of authorization was terminated, if authorization was terminated favorably within the past 3 years.

(c) The individual shall provide a list of all employers, including the employer by whom the individual claims to have been employed on the day before he or she completes the employment history, if any, with dates of employment, for the shortest of the following periods:

(1) The past 3 years;

(2) Since the individual's eighteenth birthday; or

(3) Since authorization was last terminated, if authorization was terminated favorably within the past 3 years.

§ 26.63 Suitable inquiry.

(a) In order to grant authorization, licensees and other entities shall ensure that a suitable inquiry has been conducted, on a best effort basis, to verify the individual's self-disclosed information and determine whether any potentially disqualifying FFD information is available, except if all of the following conditions are met:

(1) The individual previously held authorization under this part;

(2) The licensee or other entity has verified that the individual's last period of authorization was terminated favorably; and

(3) The individual has been subject to a behavioral observation program that includes arrest reporting, which meets the requirements of this part, throughout the period of interruption.

(b) To meet the suitable inquiry requirement, licensees and other entities may rely on the information that other licensees and entities who are subject to this subpart have gathered for previous periods of authorization. Licensees and other entities may also rely on those licensees' and entities' determinations of fitness that were conducted under § 26.189, as well as their reviews and resolutions of potentially disqualifying FFD information, for previous periods of authorization.

(c) The licensee or other entity shall ensure that the suitable inquiry has been conducted, on a best effort basis, by questioning former employers, and the employer by whom the individual claims to have been employed on the day before he or she completes the employment history, if an employment history is required under § 26.61.

(1) For the claimed employment period, the suitable inquiry must ascertain the reason for termination, eligibility for rehire, and other information that could reflect on the individual's fitness to be granted authorization.

(2) If the claimed employment was military service, the licensee or other entity who is conducting the suitable inquiry shall request a characterization of service, reason for separation, and any disciplinary actions related to potentially disqualifying FFD information. If the individual's last duty station cannot provide this information, the licensee or other entity may accept a hand-carried copy of the DD 214 presented by the individual which on face value appears to be legitimate. The licensee or other entity may also accept a copy of a DD 214 provided by the custodian of military records.

(3) If a company, previous employer, or educational institution to whom the licensee or other entity has directed a request for information refuses to provide information or indicates an inability or unwillingness to provide information within 3 business days of the request, the licensee or other entity shall document this refusal, inability, or unwillingness in the licensee's or other entity's record of the investigation, and obtain a confirmation of employment or educational enrollment and attendance from at least one alternate source, with suitable inquiry questions answered to the best of the alternate source's ability. This alternate source may not have been previously used by the licensee or other entity to obtain information about the individual's character. If the licensee or other entity uses an alternate source because employer information is not forthcoming within 3 business days of the request, the licensee or other entity need not delay granting authorization to wait for any employer response, but shall evaluate and document the response if it is received.

(d) When any licensee or other entity in § 26.3(a) through (d) and (f) is legitimately seeking the information required for an authorization decision under this subpart and has obtained a signed release from the subject individual authorizing the disclosure of information, any licensee or other entity who is subject to this part shall disclose whether the subject individual's authorization was denied or terminated unfavorably as a result of a violation of an FFD policy and shall make available the information on which the denial or unfavorable termination of authorization was based, including, but not limited to, drug or alcohol test results, treatment and followup testing requirements or other results from a determination of fitness, and any other information that is relevant to an authorization decision.

(e) In conducting a suitable inquiry, a licensee or other entity may obtain information and documents by electronic means, including, but not limited to, telephone, facsimile, or e-mail. The licensee or other entity shall make a record of the contents of the telephone call and shall retain that record, and any documents or electronic files obtained electronically, under §§ 26.711 and 26.713(a), (b), and (c), as applicable.

(f) For individuals about whom no potentially disqualifying FFD information is known (or about whom potentially disqualifying FFD information is known, but it has been resolved by a licensee or other entity who is subject to this subpart) at the time at which the suitable inquiry is initiated, the licensee or other entity shall ensure that a suitable inquiry has been conducted as follows:

(1) Initial authorization. The period of the suitable inquiry must be the past 3 years or since the individual's eighteenth birthday, whichever is shorter. For the 1-year period immediately preceding the date on which the individual applies for authorization, the licensee or other entity shall ensure that the suitable inquiry has been conducted with every employer, regardless of the length of employment. For the remaining 2-year period, the licensee or other entity shall ensure that the suitable inquiry has been conducted with the employer by whom the individual claims to have been employed the longest within each calendar month, if the individual claims employment during the given calendar month.

(2) Authorization update. The period of the suitable inquiry must be the period since authorization was terminated. For the 1-year period immediately preceding the date on which the individual applies for authorization, the licensee or other entity shall ensure that the suitable inquiry has been conducted with every employer, regardless of the length of employment. For the remaining period since authorization was terminated, the licensee or other entity shall ensure that the suitable inquiry has been conducted with the employer by whom the individual claims to have been employed the longest within each calendar month, if the individual claims employment during the given calendar month.

(3) Authorization reinstatement after an interruption of more than 30 days. The period of the suitable inquiry must be the period since authorization was terminated. The licensee or other entity shall ensure that the suitable inquiry has been conducted with the employer by whom the individual claims to have been employed the longest within the calendar month, if the individual claims employment during the given calendar month.

[73 FR 17176, Mar. 31, 2008, as amended at 91 FR 15777, Mar. 30, 2026]

§ 26.65 Pre-access drug and alcohol testing.

(a) Purpose. This section contains pre-access testing requirements for granting authorization to an individual who either has never held authorization or whose last period of authorization was terminated favorably and about whom no potentially disqualifying FFD information has been discovered or disclosed that was not previously reviewed and resolved by a licensee or other entity under the requirements of this subpart.

(b) Accepting tests conducted within the past 30 days. If an individual has negative results from drug and alcohol tests that were conducted under the requirements of this part before the individual applied for authorization from the licensee or other entity, and the specimens for such testing were collected within the 30-day period preceding the day on which the licensee or other entity grants authorization to the individual, the licensee or other entity may rely on the results of those drug and alcohol tests to meet the requirements for pre-access testing in this section.

(c) Initial authorization and authorization update. Before granting authorization to an individual who has never held authorization or whose authorization has been interrupted for a period of more than 365 days, the licensee or other entity shall verify that the results of pre-access drug and alcohol tests, which must be performed within the 30-day period preceding the day the licensee or other entity grants authorization to the individual, are negative. The licensee or other entity need not conduct pre-access testing if—

(1) The individual previously held authorization under this part and has been subject to a drug and alcohol testing program that includes random testing and a behavioral observation program that includes arrest reporting, which both meet the requirements of this part, from the date the individual's last authorization was terminated through the date the individual is granted authorization; or

(2) The licensee or other entity relies on negative results from drug and alcohol tests that were conducted under the requirements of this part at any time before the individual applied for authorization, and the individual has remained subject to a drug and alcohol testing program that includes random testing and a behavioral observation program that includes arrest reporting, which both meet the requirements of this part, beginning on the date the drug and alcohol testing was conducted through the date the individual is granted authorization and thereafter.

(d) Authorization reinstatement after an interruption of more than 30 days. (1) To reinstate authorization for an individual whose authorization has been interrupted for a period of more than 30 days but no more than 365 days, except as permitted in paragraph (d)(2) of this section, the licensee or other entity shall—

(i) Verify that the individual has negative results from alcohol testing and collect a specimen for drug testing within the 30-day period preceding the day the licensee reinstates the individual's authorization; and

(ii) Verify that the drug test results are negative within 5 business days of specimen collection or administratively withdraw authorization until the drug test results are received.

(2) The licensee or other entity need not conduct pre-access testing of these individuals if—

(i) The individual previously held authorization under this part and has been subject to a drug and alcohol testing program that includes random testing and a behavioral observation program that includes arrest reporting, which both meet the requirements of this part, beginning on the date the individual's last authorization was terminated through the date the individual is granted authorization; or

(ii) The licensee or other entity relies on negative results from drug and alcohol tests that were conducted under the requirements of this part at any time before the individual applied for authorization, and the individual remains subject to a drug and alcohol testing program that includes random testing and a behavioral observation program that includes arrest reporting, which both meet the requirements of this part, beginning on the date the drug and alcohol testing was conducted through the date the individual is granted authorization.

(e) Authorization reinstatement after an interruption of 30 or fewer days. (1) The licensee or other entity need not conduct pre-access testing before granting authorization to an individual whose authorization has been interrupted for 5 or fewer days. In addition, the licensee or other entity need not conduct pre-access testing if the individual has been subject to a drug and alcohol testing program that includes random testing and a behavioral observation program that includes arrest reporting, which both meet the requirements of this part, from the date the individual's last authorization was terminated through the date the individual is granted authorization.

(2) In order to reinstate authorization for an individual whose authorization has been interrupted for a period of more than 5 days but not more than 30 days, except as permitted in paragraph (e)(1) of this section, the licensee or other entity shall take the following actions:

(i) The licensee or other entity shall subject the individual to random selection for pre-access drug and alcohol testing at a one-time probability that is equal to or greater than the normal testing rate specified in § 26.31(d)(2)(vii) calculated for a 30-day period;

(ii) If the individual is not selected for pre-access testing under paragraph (e)(2)(i) of this section, the licensee or other entity need not perform pre-access drug and alcohol tests; or

(iii) If the individual is selected for pre-access testing under this paragraph, the licensee or other entity shall—

(A) Verify that the individual has negative results from alcohol testing and collect a specimen for drug testing before reinstating authorization; and

(B) Verify that the drug test results are negative within 5 business days of specimen collection or administratively withdraw authorization until negative drug test results are received.

(f) Administrative withdrawal of authorization. If a licensee or other entity administratively withdraws an individual's authorization under paragraphs (d)(1)(ii) or (e)(2)(iii)(B) of this section, and until the drug test results are known, the licensee or other entity may not record the administrative action to withdraw authorization as an unfavorable termination. The individual may not be required to disclose the administrative action in response to requests for self-disclosure of potentially disqualifying FFD information, except if the individual's authorization was subsequently denied or terminated unfavorably by a licensee or entity. Immediately on receipt of negative test results, the licensee or other entity shall ensure that any matter that could link the individual to the temporary administrative action is eliminated from the donor's personnel record and other records.

(g) Sanctions. If an individual has confirmed positive, adulterated, or substituted test results from any drug, validity, or alcohol tests that may be required in this section, the licensee or other entity shall, at a minimum and as appropriate—

(1) Deny authorization to the individual, as required by § 26.75(b), (d), (e)(2), or (g);

(2) Terminate the individual's authorization, if it has been reinstated, under § 26.75(e)(1) or (f); or

(3) Grant authorization to the individual under § 26.69.

§ 26.67 Random drug and alcohol testing of individuals who have applied for authorization.

(a) When the licensee or other entity collects specimens from an individual for any pre-access testing that may be required under §§ 26.65 or 26.69, and thereafter, the licensee or other entity shall subject the individual to random testing under § 26.31(d)(2), except if—

(1) The licensee or other entity does not grant authorization to the individual; or

(2) The licensee or other entity relies on drug and alcohol tests that were conducted before the individual applied for authorization to meet the applicable requirements for pre-access testing. If the licensee or other entity relies on drug and alcohol tests that were conducted before the individual applied for authorization, the licensee or other entity shall subject the individual to random testing when the individual arrives at a licensee's or other entity's facility for in-processing and thereafter.

(b) If an individual is selected for one or more random tests after any applicable requirement for pre-access testing in §§ 26.65 or 26.69 has been met, the licensee or other entity may grant authorization before random testing is completed, if the individual has met all other applicable requirements for authorization.

(c) If an individual has confirmed positive, adulterated, or substituted test results from any drug, validity, or alcohol test required in this section, the licensee or other entity shall, at a minimum and as appropriate—

(1) Deny authorization to the individual, as required by § 26.75(b), (d), (e)(2), or (g);

(2) Terminate the individual's authorization, if it has been granted, as required by § 26.75(e)(1) or (f); or

(3) Grant authorization to the individual under § 26.69.

§ 26.69 Authorization with potentially disqualifying fitness-for-duty information.

(a) Purpose. This section defines the management actions that licensees and other entities who are subject to this subpart shall take to grant or maintain, at the licensee's or other entity's discretion, the authorization of an individual who is in the following circumstances:

(1) Potentially disqualifying FFD information within the past 5 years has been disclosed or discovered about the individual by any means, including, but not limited to, the individual's self-disclosure, the suitable inquiry, drug and alcohol testing, the administration of any FFD program under this part, a self-report of a legal action, behavioral observation, or other sources of information, including, but not limited to, any background investigation or credit and criminal history check conducted under the requirements of this chapter; and

(2) The potentially disqualifying FFD information has not been reviewed and favorably resolved by a previous licensee or other entity under this section.

(b) Authorization after a first confirmed positive drug or alcohol test result or a 5-year denial of authorization. The requirements in this paragraph apply to individuals whose authorization was denied or terminated unfavorably for a first violation of an FFD policy involving a confirmed positive drug or alcohol test result and individuals whose authorization was denied for 5 years under § 26.75(c), (d), (e)(2), or (f). To grant, and subsequently maintain, the individual's authorization, the licensee or other entity shall—

(1) Obtain and review a self-disclosure and employment history from the individual that addresses the shorter period of either the past 5 years or since the individual's last period of authorization was terminated, and verify that the self-disclosure does not contain any previously undisclosed potentially disqualifying FFD information before granting authorization;

(2) Complete a suitable inquiry with every employer by whom the individual claims to have been employed during the period addressed in the employment history obtained under paragraph (b)(1) of this section, and obtain and review any records that other licensees or entities who are subject to this part may have developed related to the unfavorable termination or denial of authorization;

(3) If the individual was subject to a 5-year denial of authorization under this part, verify that he or she has abstained from substance abuse for at least the past 5 years;

(4) Ensure that an SAE has conducted a determination of fitness and concluded that the individual is fit to safely and competently perform his or her duties.

(i) If the individual's authorization was denied or terminated unfavorably for a first confirmed positive drug or alcohol test result, ensure that clinically appropriate treatment and followup testing plans have been developed by an SAE before granting authorization;

(ii) If the individual was subject to a 5-year denial of authorization, ensure that any recommendations for treatment and followup testing from an SAE's determination of fitness are initiated before granting authorization; and

(iii) Verify that the individual is in compliance with, and successfully completes, any followup testing and treatment plans.

(5) Within 10 business days before granting authorization, perform a pre-access alcohol test, collect a specimen for drug testing under direct observation, and ensure that the individual is subject to random testing thereafter. Verify that the pre-access drug and alcohol test results are negative before granting authorization.

(6) If the individual's authorization was denied or terminated unfavorably for a first confirmed positive drug or alcohol test result and a licensee or other entity grants authorization to the individual, ensure that the individual is subject to unannounced testing at least quarterly for 3 calendar years after the date the individual is granted authorization. Both random and followup tests, as defined in § 26.31(c), satisfy this requirement. Verify that the individual has negative test results from a minimum of 15 tests distributed over the 3-year period, except as follows:

(i) If the individual does not continuously hold authorization during the 3-year period, the licensee or other entity shall ensure that at least one unannounced test is conducted in any quarter during which the individual holds authorization;

(ii) If the 15 tests are not completed within the 3-year period specified in this paragraph due to periods during which the individual does not hold authorization, the followup testing program may be extended up to 5 calendar years to complete the 15 tests;

(iii) If the individual does not hold authorization during the 5-year period a sufficient number of times or for sufficient periods of time to complete the 15 tests required in this paragraph, the licensee or other entity shall ensure that an SAE conducts a determination of fitness to assess whether further followup testing is required and implement the SAE's recommendations; and

(7) Verify that any drug and alcohol tests required in this paragraph, and any other drug and alcohol tests that are conducted under this part since authorization was terminated or denied, yield results indicating no further drug abuse, as determined by the MRO after review, or alcohol abuse, as determined by the result of confirmatory alcohol testing.

(c) Granting authorization with other potentially disqualifying FFD information. The requirements in this paragraph apply to an individual who has applied for authorization, and about whom potentially disqualifying FFD information has been discovered or disclosed that is not a first confirmed positive drug or alcohol test result or a 5-year denial of authorization. If potentially disqualifying FFD information is obtained about an individual by any means, including, but not limited to, the individual's self-disclosure, the suitable inquiry, the administration of any FFD program under this part, a self-report of a legal action, behavioral observation, or other sources of information, including, but not limited to, any background investigation or credit and criminal history check conducted under the requirements of this chapter, before granting authorization to the individual, the licensee or other entity shall—

(1) Obtain and review a self-disclosure and employment history that addresses the shortest of the following periods:

(i) The past 5 years;

(ii) Since the individual's eighteenth birthday; or

(iii) Since the individual's last period of authorization was terminated;

(2) Complete a suitable inquiry with every employer by whom the individual claims to have been employed during the period addressed in the employment history required under paragraph (c)(1) of this section. If the individual held authorization within the past 5 years, obtain and review any records that other licensees or entities who are subject to this part may have developed with regard to potentially disqualifying FFD information about the individual from the past 5 years;

(3) If the designated reviewing official determines that a determination of fitness is required, verify that a professional with the appropriate qualifications, as specified in § 26.189(a), has indicated that the individual is fit to safely and competently perform his or her duties;

(4) Ensure that the individual is in compliance with, or has completed, any plans for treatment and drug and alcohol testing from the determination of fitness, which may include the collection of a urine specimen under direct observation; and

(5) Verify that the results of pre-access drug and alcohol tests are negative before granting authorization, and that the individual is subject to random testing after the specimens have been collected for pre-access testing and thereafter.

(d) Maintaining authorization with other potentially disqualifying FFD information. If an individual is authorized when other potentially disqualifying FFD information is disclosed or discovered, in order to maintain the individual's authorization, the licensee or other entity shall—

(1) Ensure that the licensee's or other entity's designated reviewing official completes a review of the circumstances associated with the information;

(2) If the designated reviewing official concludes that a determination of fitness is required, verify that a professional with the appropriate qualifications, as specified in § 26.189(a), has indicated that the individual is fit to safely and competently perform his or her duties; and

(3) If the reviewing official determines that maintaining the individual's authorization is warranted, implement any recommendations for treatment and followup drug and alcohol testing from the determination of fitness, which may include the collection of urine specimens under direct observation, and ensure that the individual complies with and successfully completes the treatment plans.

(e) Accepting followup testing and treatment plans from another FFD program. Licensees and other entities may rely on followup testing, treatment plans, and determinations of fitness that meet the requirements of § 26.189 and were conducted under the FFD program of another licensee or entity who is subject to this subpart.

(1) If an individual leaves the FFD program in which a treatment and/or followup testing plan was required under paragraphs (b), (c), or (d) of this section, the licensee or other entity who imposed the treatment and/or followup testing plan shall ensure that information documenting the treatment and/or followup testing plan is identified to any subsequent licensee or other entity who seeks to grant authorization to the individual. If the individual is granted authorization by the same or another licensee or entity, the licensee or other entity who grants authorization to the individual shall ensure that any followup testing requirements are met and that the individual complies with any treatment plan, with accountability assumed by the granting licensee or other entity. If it is impractical for the individual to comply with a treatment plan that was developed under another FFD program because of circumstances that are outside of the individual's or licensee's or other entity's control (e.g., geographical distance, closure of a treatment facility), then the granting FFD program shall ensure that an SAE develops a comparable treatment plan, with accountability for monitoring the individual's compliance with the plan assumed by the granting licensee or other entity.

(2) If the previous licensee or other entity determined that the individual successfully completed any required treatment and followup testing, and the individual's last period of authorization was terminated favorably, the receiving licensee or entity may rely on the previous determination of fitness and no further review or followup is required.

(f) Sanctions. If an individual has confirmed positive, adulterated, or substituted test results from any drug, validity, or alcohol test required in this section, the licensee or other entity shall, at a minimum and as appropriate—

(1) Deny authorization to the individual, as required by § 26.75(b), (d), (e)(2), or (g); or

(2) Terminate the individual's authorization, if it has been granted, as required by § 26.75(e)(1) or (f).

[73 FR 17176, Mar. 31, 2008, as amended at 74 FR 38328, Aug. 3, 2009]

§ 26.71 Maintaining authorization.

(a) Individuals may maintain authorization under the following conditions:

(1) The individual complies with the licensee's or other entity's FFD policies and procedures, as described in § 26.27, including the responsibility to report any legal actions, as defined in § 26.5;

(2) The individual remains subject to a drug and alcohol testing program that meets the requirements of § 26.31, including random testing;

(3) The individual remains subject to a behavioral observation program that meets the requirements of § 26.33; and

(4) The individual successfully completes required FFD training on the schedule specified in § 26.29(c).

(b) If an authorized individual is not subject to an FFD program that meets the requirements of this section for more than 30 continuous days, then the licensee or other entity shall terminate the individual's authorization and the individual shall meet the requirements in this subpart, as applicable, to regain authorization.

§ 26.73 Applicability.

The requirements in this subpart apply to the licensees and other entities identified in § 26.3(a), (b), and, as applicable, (c) for the categories of individuals specified in § 26.4(a) through (d) and (g). The requirements in this subpart also apply to the licensees and other entities specified in § 26.3(c), as applicable, for the categories of individuals in § 26.4(e). At the discretion of a licensee or other entity in § 26.3(c), the requirements of this subpart also may be applied to the categories of individuals identified in § 26.4(f). In addition, the requirements in this subpart apply to the entities in § 26.3(d) to the extent that a licensee or other entity relies on the C/V to satisfy the requirements of this subpart. The regulations in this subpart also apply to the individuals specified in § 26.4(h) and (j), as appropriate. The requirements in this subpart apply to the FFD programs of licensees and other entities identified in § 26.3(f) that elect not to implement the requirements in subpart M of this part for the categories of individuals in § 26.4 and those licensees and other entities that elect to implement the requirements in § 26.605(b).

[91 FR 15778, Mar. 30, 2026]

§ 26.75 Sanctions.

(a) This section defines the minimum sanctions that licensees and other entities shall impose when an individual has violated the drug and alcohol provisions of an FFD policy. A licensee or other entity may impose more stringent sanctions, except as specified in paragraph (h) of this section.

(b) Any act or attempted act to subvert the testing process, including, but not limited to, refusing to provide a specimen and providing or attempting to provide a substituted or adulterated specimen, for any test required under § 26.31(c) must result in the immediate unfavorable termination of the individual's authorization and permanent denial of authorization thereafter.

(c) Any individual who is determined to have been involved in the sale, use, or possession of illegal drugs or the consumption of alcohol within a protected area of any nuclear power plant, within a facility that is licensed to possess or use formula quantities of SSNM, within a transporter's facility or vehicle, or while performing the duties that require the individual to be subject to this subpart shall immediately have his or her authorization unfavorably terminated and denied for a minimum of 5 years from the date of the unfavorable termination of authorization.

(d) Any individual who resigns or withdraws his or her application for authorization before authorization is terminated or denied for a first violation of the FFD policy involving a confirmed positive drug or alcohol test result shall immediately have his or her authorization denied for a minimum of 5 years from the date of termination or denial. If an individual resigns or withdraws his or her application for authorization before his or her authorization is terminated or denied for any violation of the FFD policy, the licensee or other entity shall record the resignation or withdrawal, the nature of the violation, and the minimum sanction that would have been required under this section had the individual not resigned or withdrawn his or her application for authorization.

(e) Lacking any other evidence to indicate the use, sale, or possession of illegal drugs or consumption of alcohol on site, a confirmed positive drug or alcohol test result must be presumed to be an indication of offsite drug or alcohol use in violation of the FFD policy.

(1) The first violation of the FFD policy involving a confirmed positive drug or alcohol test result must, at a minimum, result in the immediate unfavorable termination of the individual's authorization for at least 14 days from the date of the unfavorable termination.

(2) Any subsequent confirmed positive drug or alcohol test result, including during an assessment or treatment period, must result in the denial of authorization for a minimum of 5 years from the date of denial.

(f) Paragraph (e) of this section does not apply to the misuse of prescription and over-the-counter drugs, except if the MRO determines that misuse of the prescription or over-the-counter drug represents substance abuse. Sanctions for misuse of prescription and over-the-counter drugs must be sufficient to deter misuse of those substances.

(g) For individuals whose authorization was denied for 5 years under paragraphs (c), (d), (e)(2), or (f) of this section, any subsequent violation of the drug and alcohol provisions of an FFD policy must immediately result in permanent denial of authorization.

(h) A licensee or other entity may not terminate an individual's authorization and may not subject the individual to other administrative action based solely on a positive test result from any initial drug test, other than positive initial test results for marijuana or cocaine metabolites from a specimen that is reported to be valid on the basis of either validity screening or initial validity testing performed at a licensee testing facility, unless other evidence, including information obtained under the process set forth in § 26.189, indicates that the individual is impaired or might otherwise pose a safety hazard. The licensee or other entity may not terminate an individual's authorization or subject an individual to any other administrative action under this section based on the results of validity screening or initial validity testing performed at a licensee testing facility indicating that a specimen is of questionable validity.

(i) With respect to positive initial drug test results from a licensee testing facility for marijuana and cocaine metabolites from a valid specimen, licensee testing facility personnel may inform licensee or other entity management of the positive initial drug test result and the specific drugs or metabolites identified, and licensees or other entities may administratively withdraw the donor's authorization or take lesser administrative actions against the donor, provided that the licensee or other entity complies with the following conditions:

(1) For the drug for which action will be taken, at least 85 percent of the specimens that were determined to be positive as a result of initial drug tests at the licensee testing facility during the past 12-month data reporting period submitted to the NRC under § 26.717 were subsequently reported as positive by the HHS-certified laboratory as the result of confirmatory testing;

(2) There is no loss of compensation or benefits to the donor during the period of temporary administrative action;

(3) Immediately on receipt of a negative report from the HHS-certified laboratory or MRO, any matter that could link the donor to the temporary administrative action is eliminated from the donor's personnel record and other records; and

(4) Licensees and other entities may not disclose the temporary administrative action against an individual whose initial drug test result is not subsequently confirmed by the MRO as a violation of the FFD policy in response to a suitable inquiry conducted under the provisions of § 26.63, a background investigation conducted under the provisions of this chapter, or to any other inquiry or investigation.

(i) To ensure that no records are retained, access to the system of files and records must be provided to personnel who are conducting reviews, inquiries into allegations, or audits under the provisions of § 26.41, and to NRC inspectors.

(ii) The licensee or other entity shall provide the donor with a written statement that the records specified in §§ 26.713 and 26.715 have not been retained with respect to the temporary administrative action and shall inform the donor in writing that the temporary administrative action that was taken will not be disclosed and need not be disclosed by the individual in response to requests for self-disclosure of potentially disqualifying FFD information.

§ 26.77 Management actions regarding possible impairment.

(a) This section defines management actions that licensees and other entities who are subject to this subpart must take when an individual who is subject to this subpart shows indications that he or she may not be fit to safely and competently perform his or her duties.

(b) If an individual appears to be impaired or the individual's fitness is questionable, except as permitted under §§ 26.27(c)(3), 26.207, and 26.209, the licensee or other entity shall take immediate action to prevent the individual from performing the duties that require him or her to be subject to this subpart.

(1) If an observed behavior or physical condition creates a reasonable suspicion of possible substance abuse, the licensee or other entity shall perform drug and alcohol testing. The results must be negative before the individual returns to performing the duties that require the individual to be subject to this subpart. However, if the physical condition is the smell of alcohol with no other behavioral or physical indications of impairment, then only an alcohol test is required and the results must be negative before the individual returns to performing his or her duties.

(2) If a licensee or C/V who is subject to subpart I of this part is certain that the observed behavior or physical condition is the result solely of fatigue, the licensee or C/V shall ensure that a fatigue assessment is conducted under § 26.211. If the results of the fatigue assessment confirm that the observed behavior or physical condition is the result solely of fatigue, the licensee or C/V need not perform drug and alcohol tests or implement the determination of fitness process otherwise required by § 26.189.

(3) For other indications of possible impairment that do not create a reasonable suspicion of substance abuse (or fatigue, in the case of licensees and C/Vs who are subject to subpart I of this part), the licensee or other entity may permit the individual to return to performing his or her duties only after the impairing or questionable conditions are resolved and a determination of fitness indicates that the individual is fit to safely and competently perform his or her duties.

(c) If a licensee or other entity has a reasonable belief that an NRC employee or NRC contractor may be under the influence of any substance, or is otherwise unfit for duty, the licensee or other entity may not deny access but shall escort the individual. In any such instance, the licensee or other entity shall immediately notify the appropriate Regional Administrator by telephone, followed by written notification (e.g., e-mail or fax) to document the oral notification. If the Regional Administrator cannot be reached, the licensee or other entity shall notify the NRC Operations Center.

§ 26.81 Purpose and applicability.

This subpart contains requirements for collecting specimens for drug testing and conducting alcohol tests by or on behalf of the licensees and other entities in § 26.3(a) through (d) for the categories of individuals specified in § 26.4(a) through (d) and (g). At the discretion of a licensee or other entity in § 26.3(c), specimen collections and alcohol tests must be conducted either under this subpart for the individuals specified in § 26.4(e) and (f) or the licensee or other entity may rely on specimen collections and alcohol tests conducted under the requirements of 49 CFR part 40 for the individuals specified in § 26.4(e) and (f). The requirements of this subpart do not apply to specimen collections and alcohol tests that are conducted under the requirements of 49 CFR part 40, as permitted in this section and under §§ 26.4(j) and 26.31(b)(2) and subpart K of this part. The requirements in this subpart apply to the FFD programs of licensees and other entities identified in § 26.3(f) that elect not to implement the requirements in subpart M of this part for the categories of individuals in § 26.4 and those licensees and other entities that elect to implement the requirements in § 26.605.

[91 FR 15778, Mar. 30, 2026]

§ 26.83 Specimens to be collected.

Except as permitted under § 26.31(d)(5), licensees and other entities who are subject to this subpart shall—

(a) Collect either breath or oral fluids for initial tests for alcohol. Breath must be collected for confirmatory tests for alcohol; and

(b) Collect only urine specimens for both initial and confirmatory tests for drugs, unless the licensee or other entity establishes through its policy and procedures that an oral fluid specimen can be collected and tested for any of the observed specimen collection conditions under § 26.115(a)(1) through (3) and (5). For each observed collection condition under § 26.115(a)(1) through (3) and (5), the licensee or other entity shall always collect and test the same specimen type.

[73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71456, Nov. 22, 2022]

§ 26.85 Collector qualifications and responsibilities.

(a) Collector qualifications. Each collector shall be knowledgeable of the requirements of this part and the FFD policy and procedures of the licensee or other entity for whom collections are performed, and shall keep current on any changes to the collection procedures for each specimen the individual is qualified to collect under this part. Each collector shall receive qualification training that meets the requirements of this paragraph and demonstrate proficiency in applying the requirements of this paragraph before serving as a collector. At a minimum, qualification training must provide instruction on the following subjects:

(1) All steps necessary to complete a collection correctly and the proper completion and transmission of the Federal CCF;

(2) Methods to address “problem” collections, including, but not limited to:

(i) Inability to provide a specimen (e.g., “shy bladder” for a urine specimen, “shy lung” for a breath specimen, dry mouth for an oral fluid specimen); and

(ii) Attempts to tamper with a specimen;

(3) Operation of the particular specimen collection or alcohol testing device(s) (e.g., alcohol screening device (ASD), EBT, oral fluid) to be used, consistent with the most recent version of the manufacturers' instructions;

(4) How to correct problems in collections; and

(5) The collector's responsibility for maintaining the integrity of the specimen collection process, carefully ensuring the modesty and privacy of the donor, and avoiding any conduct or remarks that might be construed as accusatorial or otherwise offensive or inappropriate, and the specimen transfer process, if applicable.

(b) Alternative collectors. A medical professional, technologist, or technician may serve as a collector without meeting the collector qualification requirements in paragraphs (a) or (b) of this section, as applicable, only if all of the following conditions are met:

(1) A collector who meets the requirements of paragraph (a) of this section cannot reasonably be made available at the time the collection must occur;

(2) The individual is not employed by the licensee's or other entity's FFD program and his or her normal workplace is not at the licensee's or other entity's facility;

(3) The individual does not routinely provide FFD program services to the licensee or other entity;

(4) The individual is licensed or otherwise approved to practice in the jurisdiction in which the collection occurs; and

(5) The individual is provided with detailed, clearly-illustrated, written instructions for collecting specimens under this subpart and follows those instructions.

(c) Personnel available to testify at proceedings. The licensee or other entity shall ensure that qualified collection site personnel, when required, are available to testify in an administrative or disciplinary proceeding against an individual when that proceeding is based on positive drug or alcohol test results or adulterated or substituted test results from specimens collected by or under contract to the licensee or other entity.

(d) Files. Collection site personnel files must include each individual's resume of training and experience; certification or license, if any; references; job descriptions; records of performance evaluations and advancement; incident reports, if any; results of tests to establish employee competency for the position he or she holds, including, but not limited to, certification that collectors are proficient in administering alcohol tests consistent with the most recent manufacturer's instructions for the instruments and devices used; and appropriate data to support determinations of honesty and integrity conducted under § 26.31(b).

[73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71456, Nov. 22, 2022]

§ 26.87 Collection sites.

(a) Each FFD program must have one or more designated collection sites that have all necessary personnel, materials, equipment, facilities, and supervision to collect specimens for drug testing and to perform alcohol testing. Each collection site must provide for the collection, security, temporary storage, and shipping or transportation of specimens to a drug testing laboratory; the testing of specimens for alcohol; the security of specimen collection and testing devices; and test results. A properly equipped mobile facility that meets the requirements of this section is an acceptable collection site.

(b) Visual privacy must be provided to the donor and collector when viewing alcohol test results and during the collection of an oral fluid specimen for drug testing. The donor must be provided with individual privacy while submitting a urine specimen, except if a directly observed urine specimen collection is required. Unauthorized personnel may not be present for the specimen collection.

(c) Contracts for collection site services must permit representatives of the NRC, licensee, or other entity to conduct unannounced inspections and audits and to obtain all information and documentation that is reasonably relevant to the inspections and audits.

(d) Licensees and other entities shall take the following measures to prevent unauthorized access to the collection site that could compromise the integrity of the collection process or the specimens.

(1) Unauthorized personnel may not be permitted in any part of the designated collection site where specimens are collected or stored;

(2) A designated collection site must be secure. If a collection site is dedicated solely to specimen collection, it must be secure at all times. Methods of assuring security may include, but are not limited to, physical measures to control access, such as locked doors, alarms, or visual monitoring of the collection site when it is not occupied; and

(3) If a collection site cannot be dedicated solely to collecting specimens, the portion of the facility that is used for specimen collection must be secured and, during the time period during which a specimen is being collected, a sign must be posted to indicate that access is permitted only for authorized personnel.

(e) The following steps must be taken to deter the dilution and adulteration of urine specimens at the collection site:

(1) Agents that color any source of standing water in the stall or room in which the donor will provide a specimen, including, but not limited to, the toilet bowl or tank, must be placed in the source of standing water, so that the reservoirs of water are neither yellow nor colorless;

(2) There must be no other source of water (e.g., no shower or sink) in the enclosure where urination occurs, or the source of water must be rendered unusable; and

(3) Chemicals or products that could be used to contaminate or otherwise alter the specimen must be removed from the collection site or secured. The collector shall inspect the enclosure in which urination will occur before each collection to ensure that no materials are available that could be used to subvert the testing process.

(f) In the exceptional event that a designated collection site is inaccessible and there is an immediate requirement to collect a specimen for drug testing, including, but not limited to, an event investigation, then the licensee or other entity may use a public rest room, onsite rest room, or hospital examining room according to the following procedures:

(1) The facility must be secured by visual inspection to ensure that no unauthorized persons are present, and that undetected access (e.g., through a rear door not in the view of the collector) is impossible. Security during the collection may be maintained by restricting access to collection materials and specimens. In the case of a public rest room, a sign must be posted or an individual assigned to ensure that no unauthorized personnel are present during the entire collection procedure to avoid embarrassment of the donor and distraction of the collector.

(2) If practical when a urine specimen is to be collected, a water coloring agent that meets the requirements of § 26.87(e)(1) must be placed in the toilet bowl to be used by the donor and in any other accessible source of standing water, including, but not limited to, the toilet tank. The collector shall instruct the donor not to flush the toilet.

(3) A collector of the same gender as the donor shall accompany the donor into the area that will be used for a urine specimen collection , but remain outside of the stall, if it is a multi-stalled rest room, or outside of the door to the room, if it is a single rest room, in which the donor will provide the specimen. If a collector of the same gender is not available, the collector shall select a same-gender person to accompany the donor. This person shall be instructed on the collection procedures specified in this subpart and his or her identity must be documented on the Federal CCF.

(4) Once the collector has possession of the specimen, if the specimen is urine, the collector shall inspect the toilet bowl and area to ensure that there is no evidence of a subversion attempt and shall then flush the toilet, and for any specimen collected for drug testing, the collector shall instruct the donor to participate with the collector in completing the chain of custody procedures.

(5) If it is impractical to maintain continuous physical security of a collection site from the time a specimen for drug testing is presented until the sealed container is transferred for shipment, the specimen must remain under the direct control of an individual who is authorized by the licensee or other entity until the specimen is prepared for transfer, storage, or shipping, as required by § 26.117. The authorized individual shall be instructed on his or her responsibilities for maintaining custody and control of the specimen and his or her custody of the specimen must be documented on the Federal CCF .

[73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71457, Nov. 22, 2022]

§ 26.89 Preparing to collect specimens for testing.

(a) When an individual has been notified of a requirement for testing and does not appear at the collection site within the time period specified by FFD program procedures, the collector shall inform FFD program management that the individual has not reported for testing. FFD program management shall ensure that the necessary steps are taken to determine whether the individual's undue tardiness or failure to appear for testing constitutes a violation of the licensee's or other entity's FFD policy. If FFD program management determines that the undue tardiness or failure to report for testing represents an attempt to subvert the testing process, the licensee or other entity shall impose on the individual the sanctions in § 26.75(b). If FFD program management determines that the undue tardiness or failure to report does not represent a subversion attempt, the licensee or other entity may not impose sanctions but shall ensure that the individual is tested at the earliest reasonable and practical opportunity after locating the individual.

(b) Donors shall provide acceptable identification before testing.

(1) Acceptable identification includes photo-identification issued by a licensee or other entity who is subject to this part, or by the Federal, State, or local government. Licensees and other entities may not accept faxes or photocopies of identification.

(2) If the donor cannot produce acceptable identification before any testing that is required under this part other than pre-access testing, the collector shall proceed with the test and immediately inform FFD program management that the donor did not present acceptable identification. When so informed, FFD program management shall contact the individual's supervisor to verify in-person the individual's identity, or, if the supervisor is not available, take other steps to establish the individual's identity and determine whether the lack of identification was an attempt to subvert the testing process. The donor may not leave the collection site except under supervision until his or her identity has been established.

(3) If the donor is scheduled for pre-access testing and cannot produce acceptable identification, the collector may not proceed with the collection, and shall inform FFD program management that the individual did not present acceptable identification. When so informed, FFD program management will take the necessary steps to determine whether the lack of identification was an attempt to subvert the testing process.

(4) The collector shall explain the testing procedure to the donor, show the donor the form(s) to be used, and ask the donor to sign a consent-to-testing form. The donor may not be required to list prescription medications or over-the-counter preparations that he or she has recently used.

(c) The collector shall inform the donor that, if the donor refuses to cooperate in the specimen collection process (including, but not limited to, behaving in a confrontational manner that disrupts the testing process; admitting to the collector that he or she adulterated, diluted, or substituted the specimen; is found to have a device, such as a prosthetic appliance, the purpose of which is to interfere with providing an actual urine specimen; or leaving the collection site before all of the collection procedures are completed), it will be considered a refusal to test, and sanctions for subverting the testing process will be imposed under § 26.75(b). If the donor refuses to cooperate in the collection procedures, the collector shall inform FFD program management to obtain guidance on the actions to be taken.

(d) In order to promote the security of specimens, avoid distraction of the collector, and ensure against any confusion in the identification of specimens, a collector shall conduct only one collection procedure at any given time, except as described in § 26.109(b)(1). For the collection of specimen(s) for drug testing, the collection procedure is complete when the specimen container has been sealed with a tamper-evident seal, the seal has been dated and initialed, and the Federal CCF has been completed or when a refusal to test has been determined.

[73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71457, Nov. 22, 2022]

§ 26.91 Acceptable devices for conducting initial and confirmatory tests for alcohol and methods of use.

(a) Acceptable alcohol screening devices. Alcohol screening devices (ASDs), including devices that test specimens of oral fluids or breath, must be approved by the National Highway Traffic Safety Administration (NHTSA) and listed in the most current version of NHTSA's Conforming Products List (CPL) for such devices. An ASD that is listed in the NHTSA CPL may be used only for initial tests for alcohol, and may not be used for confirmatory tests.

(b) Acceptable evidential breath testing devices. Evidential breath testing devices listed in the NHTSA CPL for evidential devices that meet the requirements of paragraph (c) of this section must be used to conduct confirmatory alcohol tests, and may be used to conduct initial alcohol tests. Note that, among the devices listed in the CPL for EBTs, only those devices listed without an asterisk (*) may be used for confirmatory alcohol testing under this subpart.

(c) EBT capabilities. An EBT that is listed in the NHTSA CPL for evidential devices that has the following capabilities may be used for conducting initial alcohol tests and must be used for confirmatory alcohol tests under this subpart:

(1) Provides a printed result of each breath test;

(2) Assigns a unique number to each completed test, which the collector and donor can read before each test and which is printed on each copy of the test result;

(3) Prints, on each copy of the test result, the manufacturer's name for the device, its serial number, and the time of the test;

(4) Distinguishes alcohol from acetone at the 0.02 alcohol concentration level;

(5) Tests an air blank; and

(6) Permits performance of an external calibration check.

(d) Quality assurance and quality control of ASDs. (1) Licensees and other entities shall implement the most recent version of the quality assurance plan submitted to NHTSA for any ASD that is used for initial alcohol testing.

(2) Licensees and other entities may not use an ASD that fails the specified quality control checks or that has passed its expiration date.

(3) For ASDs that test breath specimens and meet EBT requirements for confirmatory testing, licensees and other entities shall also follow the device use and care requirements specified in paragraph (e) of this section.

(e) Quality assurance and quality control of EBTs. (1) Licensees and other entities shall implement the most recent version of the manufacturer's instructions for the use and care of the EBT consistently with the quality assurance plan submitted to NHTSA for the EBT, including performing external calibration checks no less frequently than at the intervals specified in the manufacturer's instructions.

(2) When conducting external calibration checks, licensees and other entities shall use only calibration devices appearing on NHTSA's CPL for “Calibrating Units for Breath Alcohol Tests.”

(3) If an EBT fails an external check of calibration, the licensee or other entity shall take the EBT out of service. The EBT may not be used again for alcohol testing under this subpart until it is repaired and passes an external calibration check.

(4) In order to ensure that confirmed positive alcohol test results are derived from an EBT that is calibrated, the licensee or other entity shall implement one of the following procedures:

(i) If an EBT fails any external check of calibration, cancel every confirmed positive test result that was obtained using the EBT from any tests that were conducted after the EBT passed the last external calibration check; or

(ii) After every confirmed positive test result obtained from using an EBT, conduct an external check of calibration of the EBT in the presence of the donor. If the EBT fails the external calibration check, cancel the donor's test result and conduct another initial and confirmatory test on a different EBT as soon as practicable.

(5) Inspection, maintenance, and calibration of the EBT must be performed by its manufacturer or a maintenance representative or other individual who is certified either by the manufacturer or by a State health agency or other appropriate State agency.

§ 26.93 Preparing for alcohol testing.

(a) Immediately before collecting a specimen for alcohol testing, the collector shall—

(1) Ask the donor whether he or she, in the past 15 minutes, has had anything to eat or drink, belched, or put anything into his or her mouth (including, but not limited to, a cigarette, breath mint, or chewing gum), and instruct the donor that he or she should avoid these activities during the collection process;

(2) If the donor states that he or she has not engaged in the activities listed in paragraph (a)(1) of this section, alcohol testing may proceed;

(3) If the donor states that he or she has engaged in any of the activities listed in paragraph (a)(1) of this section, inform the donor that a 15-minute waiting period is necessary to prevent an accumulation of mouth alcohol from leading to an artificially high reading;

(4) Explain that it is to the donor's benefit to avoid the activities listed in paragraph (a)(1) of this section during the collection process;

(5) Explain that the initial and confirmatory tests, if a confirmatory test is necessary, will be conducted at the end of the waiting period, even if the donor has not followed the instructions; and

(6) Document that the instructions were communicated to the donor.

(b) With the exception of the 15-minute waiting period, if necessary, the collector shall begin for-cause alcohol and/or drug testing as soon as reasonably practical after the decision is made that for-cause testing is required. When for-cause alcohol testing is required, alcohol testing may not be delayed by collecting a specimen for drug testing.

§ 26.95 Conducting an initial test for alcohol using a breath specimen.

(a) The collector shall perform the initial breath test as soon as practical after the donor indicates that he or she has not engaged in the activities listed in § 26.93(a)(1) or after the 15-minute waiting period has elapsed, if required.

(b) To perform the initial test, the collector shall—

(1) Select, or allow the donor to select, an individually wrapped or sealed mouthpiece from the testing materials;

(2) Open the individually wrapped or sealed mouthpiece in view of the donor and insert it into the device as required by the manufacturer's instructions;

(3) Instruct the donor to blow steadily and forcefully into the mouthpiece for at least 6 seconds or until the device indicates that an adequate amount of breath has been obtained;

(4) Show the donor the displayed or printed test result; and

(5) Ensure that the test result record can be associated with the donor and is maintained secure.

(c) Unless problems in administering the breath test require an additional collection, only one breath specimen may be collected for the initial test. If an additional collection(s) is required, the collector shall rely on the test result from the first successful collection to determine the need for confirmatory testing.

§ 26.97 Collecting oral fluid specimens for alcohol and drug testing.

(a) The collector, with the assistance of a virtual collection monitor as permitted under § 26.607(g)(2) if applicable, shall perform the oral fluid specimen collection consistent with the device manufacturer's instructions. The collector shall:

(1) Check the expiration date on the device and show it to the donor (the device may not be used after its expiration date);

(2) Open an individually wrapped or sealed package containing the device in the presence of the donor;

(3) Offer the donor the choice of using the device or having the collector use it. If the donor chooses to use it, instruct the donor to insert the device into his or her mouth and use it in the manner described by the device's manufacturer;

(4) If the donor chooses not to use the device, or in all cases when a new specimen collection is necessary because the device failed to activate, insert the device into the donor's mouth, and gather oral fluids in the manner described by the device's manufacturer (wear single-use examination or similar gloves while doing so and change them following each specimen collection); and

(5) When the device is removed from the donor's mouth, follow the manufacturer's instructions regarding necessary next steps to ensure that the device has activated.

(b) If all steps in paragraph (a) of this section could not be completed successfully (e.g., the device breaks, the device is dropped on the floor, the device fails to activate), the collector, with the assistance of a virtual collection monitor as permitted under § 26.607(g)(2) if applicable, shall:

(1) Discard the device and conduct a new specimen collection using a new device. The new device must be one that has been under the collector's control before the specimen collection;

(2) Record the reason for the new specimen collection;

(3) Offer the donor the choice of using the device or having the collector use it unless the donor, in the opinion of the collector, was responsible for the new specimen collection needing to be conducted. If the collector concludes that the donor was responsible, then the collector shall use the device to conduct the specimen collection; and

(4) Repeat the procedures in paragraph (a) of this section.

(c) If the second collection attempt in paragraph (b) of this section could not be completed, the collector shall—

(1) End the collection of oral fluids and document the reason(s) that the collection could not be completed; and

(2) Immediately conduct another specimen collection (i.e., initial test using an EBT for alcohol, or urine specimen collection for drug testing).

(d) For alcohol testing of oral fluids, the collector shall read the result displayed on the device no sooner than the device's manufacturer instructs. In all cases, the collector shall read the result within 15 minutes of the test. The collector shall then show the device and its reading to the donor, record the result, and record that an ASD was used.

(e) Devices, swabs, gloves, and other materials used in collecting oral fluids may not be re-used.

[73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71457, Nov. 22, 2022; 91 FR 15778, Mar. 30, 2026]

§ 26.99 Determining the need for a confirmatory test for alcohol.

(a) If the initial test result is less than 0.02 percent BAC, the collector shall declare the test result as negative.

(b) If the initial test result is 0.02 percent BAC or higher, the collector shall ensure that the time at which the test was concluded (i.e., the time at which the test result was known) is recorded and inform the donor that a confirmatory test for alcohol is required.

§ 26.101 Conducting a confirmatory test for alcohol.

(a) The confirmatory test must begin as soon as possible, but no more than 30 minutes after the conclusion of the initial test.

(b) To complete the confirmatory test, the collector shall—

(1) In the presence of the donor, conduct an air blank on the EBT before beginning the confirmatory test and show the result to the donor;

(2) Verify that the reading is 0.00. If the reading is 0.00, the test may proceed. If not, then conduct another air blank;

(3) If the reading on the second air blank is 0.00, the test may proceed. If the reading is greater than 0.00, take the EBT out of service and proceed with the test using another EBT. If an EBT is taken out of service for this reason, the EBT may not be used for further testing until it is found to be within tolerance limits on an external check of calibration;

(4) Open an individually wrapped or sealed mouthpiece in view of the donor and insert it into the device as required by the manufacturer's instructions;

(5) Read the unique test number displayed on the EBT, and ensure that the donor reads the same number;

(6) Instruct the donor to blow steadily and forcefully into the mouthpiece for at least 6 seconds or until the device indicates that an adequate amount of breath has been obtained; and

(7) Show the donor the result displayed on or printed by the EBT, record the result, and document the time at which the confirmatory test result was known.

(c) Unless there are problems in administering the breath test that require an additional collection, the collector shall collect only one breath specimen for the confirmatory test. If an additional collection(s) is required because of problems in administering the breath test, the collector shall rely on the breath specimen from the first successful collection to determine the confirmatory test result. Collection procedures may not require collectors to calculate an average or otherwise combine results from two or more breath specimens to determine the confirmatory test result.

(d) If an EBT that meets the requirements of § 26.91(b) and (c) was used for the initial alcohol test, the same EBT may be used for confirmatory testing.

§ 26.103 Determining a confirmed positive test result for alcohol.

(a) A confirmed positive test result for alcohol must be declared under any of the following conditions:

(1) When the result of the confirmatory test for alcohol is 0.04 percent BAC or higher;

(2) When the result of the confirmatory test for alcohol is 0.03 percent BAC or higher and the donor had been in a work status for at least 1 hour at the time the initial test was concluded (including any breaks for rest, lunch, dental/doctor appointments, etc.); or

(3) When the result of the confirmatory test for alcohol is 0.02 percent BAC or higher and the donor had been in a work status for at least 2 hours at the time the initial test was concluded (including any breaks for rest, lunch, dental/doctor appointments, etc.).

(b) When the result of the confirmatory test for alcohol is equal to or greater than 0.01 percent BAC but less than 0.02 percent BAC and the donor has been in a work status for 3 hours or more at the time the initial test was concluded (including any breaks for rest, lunch, dental/doctor appointments, etc.), the collector shall declare the test result as negative and inform FFD program management. The licensee or other entity shall prohibit the donor from performing any duties that require the individual to be subject to this subpart and may not return the individual to performing such duties until a determination of fitness indicates that the donor is fit to safely and competently perform his or her duties.

§ 26.105 Preparing for the collection of a specimen for drug testing.

(a) The collector shall ask the donor to remove any unnecessary outer garments, such as a coat or jacket, which might conceal items or substances that the donor could use to tamper with or adulterate his or her specimen. The collector shall ensure that all personal belongings such as a purse or briefcase remain with the outer garments outside of the room or stall in which the specimen is collected. The donor may retain his or her wallet.

(b) The collector shall also ask the donor to empty his or her pockets and display the items in them to enable the collector to identify items that the donor could use to adulterate or substitute his or her urine specimen. The donor shall permit the collector to make this observation. If the donor refuses to show the collector the items in his or her pockets, this is considered a refusal to test. If an item is found that appears to have been brought to the collection site with the intent to adulterate or substitute the specimen, the collector shall contact the MRO or FFD program manager to determine whether a directly observed collection is required. If the item appears to have been inadvertently brought to the collection site, the collector shall secure the item and continue with the normal collection procedure. If the collector identifies nothing that the donor could use to adulterate or substitute the specimen, the donor may place the items back into his or her pockets.

(c) The collector shall instruct the donor to wash and dry his or her hands before providing a specimen.

(d) After washing his or her hands, the donor shall remain in the presence of the collector and may not have access to any water fountain, faucet, soap dispenser, cleaning agent, or other materials that he or she could use to adulterate the specimen.

(e) The collector may select, or allow the donor to select, an individually wrapped or sealed urine specimen collection container from the collection kit materials or an oral fluid specimen collection device. Either the collector or the donor, with both present, shall unwrap or break the seal of the urine specimen collection container. With the exception of the collection container, the donor may not take anything from the collection kit into the room or stall used for urination.

[73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71457, Nov. 22, 2022]

§ 26.107 Collecting a urine specimen.

(a) The collector shall direct the donor to go into the room or stall used for urination, provide a specimen of the quantity that has been predetermined by the licensee or other entity, as defined in § 26.109(a), not flush the toilet, and return with the specimen as soon as the donor has completed the void.

(1) The donor shall provide his or her urine specimen in the privacy of a room, stall, or otherwise partitioned area (private area) that allows for individual privacy, except if a directly observed collection is required, as described in § 26.115;

(2) Except in the case of a directly observed collection, no one may go with the donor into the room or stall in which the donor will provide his or her specimen; and

(3) The collector may set a reasonable time limit for voiding.

(b)(1) The collector shall pay careful attention to the donor during the entire collection process, except as provided in § 26.109(b)(1), to observe any conduct that indicates an attempt to subvert the testing process (e.g., tampering with a specimen; having a substitute urine specimen in plain view; attempting to bring an adulterant, urine substitute, heating element, and/or temperature measurement device into the room, stall, or private area used for urination). If any such conduct is detected, the collector shall document a description of the conduct on the Federal CCF or through another documentation method consistent with the collection procedures of the licensee or other entity, and contact FFD program management to determine whether a directly observed collection is required, as described in § 26.115.

(2) If a hydration monitor is used to observe a donor during the § 26.109(b)(1) hydration process, this individual shall immediately inform the collector of any donor conduct that may indicate an attempt to subvert the testing process (e.g., donor leaves the collection site, donor refuses to follow instructions).

(c) After the donor has provided the urine specimen and submitted it to the collector, the donor shall be permitted to wash his or her hands. The collector shall inspect the toilet bowl and room or stall in which the donor voided to identify any evidence of a subversion attempt, and then flush the toilet.

(d) If a refusal to test is determined at any point during the specimen collection process, the collector shall do the following:

(1) Inform the donor that a refusal to test has been determined;

(2) Terminate the collection process;

(3) Document a description of the refusal to test on the Federal CCF or through another documentation method consistent with the collection procedures of the licensee or other entity;

(4) Discard any urine specimen(s) provided by the donor, unless the specimen was collected for a post-event test under § 26.31(c)(3); and

(5) Immediately inform the FFD program manager.

[73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71457, Nov. 22, 2022]

§ 26.109 Urine specimen quantity.

(a) Licensees and other entities who are subject to this subpart shall establish a predetermined quantity of urine that donors are requested to provide when submitting a specimen. At a minimum, the predetermined quantity must include 30 milliliters (mL) to ensure that a sufficient quantity of urine is available for initial and confirmatory validity and drug tests at an HHS-certified laboratory, and for retesting of an aliquot of the specimen if requested by the donor under § 26.165(b). The licensee's or other entity's predetermined quantity may include more than 30 mL, if the testing program follows split specimen procedures, tests for additional drugs, or performs initial testing at a licensee testing facility. Where collected specimens are to be split under the provisions of this subpart, the predetermined quantity must include an additional 15 mL.

(b) If the quantity of urine in the first specimen provided by the donor is less than 30 mL, the collector shall take the following steps:

(1) The collector shall encourage the donor to drink a reasonable amount of liquid (normally, 8 ounces of water every 30 minutes, but not to exceed a maximum of 40 ounces over 3 hours) until the donor provides a specimen of at least 30 mL. Alternatively, as specified in the licensee's or other entity's FFD program procedures, the collector may assign responsibility for monitoring a donor during the hydration process to another collector who meets the requirements in § 26.85(a) or to a hydration monitor. If another collector or hydration monitor is used, the collector:

(i) Shall explain the hydration process and acceptable donor behavior to the hydration monitor;

(ii) Shall record the name of the other collector or hydration monitor on the Federal CCF; and

(iii) May perform other collections while the donor is in the hydration process;

(2) The collector shall provide the donor with a separate collection container for each successive specimen. Once the donor provides a specimen of at least 30 mL, the collection must end. If the specimen quantity is at least 30 mL but is less than the licensee's or other entity's predetermined quantity, the licensee or other entity may not require the donor to provide additional specimens and may not impose any sanctions on the donor. If the donor provides a specimen of 30 mL or more, but the specimen quantity is less than the predetermined quantity, the collector shall forward the specimen to the HHS-certified laboratory for testing. If the donor provides a specimen of at least the predetermined quantity, the specimen may be processed under the FFD program's usual testing procedures;

(3) If the donor has not provided a specimen of at least 30 mL within 3 hours of the first unsuccessful attempt to provide a specimen of the predetermined quantity, the collector shall discontinue the collection and notify the FFD program manager or MRO to initiate the “shy bladder” procedures in § 26.119; and

(4) Neither the donor nor the collector may combine specimens. The collector shall discard specimens of less than 30 mL, except if there is reason to believe that the donor has diluted, adulterated, substituted, or otherwise tampered with the specimen, based on the collector's observations of the donor's behavior during the collection process or the specimen's characteristics, as specified in § 26.111. If the collector has a reason to believe that a specimen that is 15 mL or more, but less than 30 mL, has been diluted, adulterated, substituted, or altered, the collector shall prepare the suspect specimen for shipping to the HHS-certified laboratory and contact FFD program management to determine whether a directly observed collection is required, as described in § 26.115.

[73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71458, Nov. 22, 2022]

§ 26.111 Checking the acceptability of the urine specimen.

(a) Immediately after the donor provides the urine specimen to the collector, including specimens of less than 30 mL but equal to or greater than 15 mL, the collector shall measure the temperature of the specimen. The temperature-measuring device used must accurately reflect the temperature of the specimen and not contaminate the specimen. The time from urination to temperature measurement may not exceed 4 minutes. If the temperature of a urine specimen is outside the range of 90 °F to 100 °F (32 °C to 38 °C), that is a reason to believe the donor may have altered (e.g., adulterated or diluted) or substituted the specimen.

(b) Immediately after the donor provides a urine specimen, including specimens of less than 30 mL but equal to or greater than 15 mL, the collector shall also inspect the specimen to determine its color and clarity and look for any signs of contaminants or adulteration. The collector shall note any unusual findings on the Federal CCF or through another documentation method consistent with the collection procedures of the licensee or other entity.

(c) If there is reason to believe that the donor may have attempted to dilute, substitute, or adulterate the specimen based on specimen temperature or other observations made during the collection, the collector shall contact the FFD program manager, who may consult with the MRO, to determine whether the donor has attempted to subvert the testing process or whether other circumstances may explain the observations. The FFD program manager or MRO may require the donor to provide a second specimen as soon as possible under direct observation. In addition, the collector shall inform the donor that he or she may volunteer to submit a second specimen under direct observation to counter the reason to believe the donor may have altered (e.g., adulterated or diluted) or substituted the specimen.

(d) Any specimen of 15 mL or more that the collector suspects has been diluted, substituted, or adulterated, and any specimen of 15 mL or more that has been collected under direct observation under paragraph (c) of this section, must be sent directly to the HHS-certified laboratory for initial and, if required, confirmatory testing, and may not be subject to initial testing at a licensee testing facility.

(e) As much of the suspect specimen as possible must be preserved, except under the conditions described in § 26.107(d)(4).

[73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71458, Nov. 22, 2022]

§ 26.113 Splitting the urine specimen.

(a) Licensees and other entities may, but are not required to, use split-specimen methods of collection.

(b) If the urine specimen is to be split into two specimen bottles, hereinafter referred to as Bottle A and Bottle B, the collector shall take the following steps:

(1) The collector shall instruct the donor to urinate into a specimen container;

(2) The collector, in the presence of the donor and after determining specimen temperature as described in § 26.111(a), shall split the urine specimen. The collector shall pour 30 mL of urine into Bottle A and a minimum of 15 mL of urine into Bottle B. If the quantity of urine available for Bottle B is less than 15 mL, the collector shall pour the remaining urine into Bottle B and forward the specimens in Bottles A and B to the HHS-certified laboratory for drug and validity testing; and

(3) The collector shall ask the donor to observe the splitting of the urine specimen and to maintain visual contact with both specimen bottles until the Federal CCF(s) for both specimens are completed, the specimens are sealed, and the specimens and form(s) are prepared for secure storage or shipping.

(c) Licensees and other entities may use aliquots of the specimen collected for validity screening and initial validity and drug testing at the licensee testing facility, as permitted under § 26.31(d)(3)(ii), or to test for additional drugs, as permitted under § 26.31(d)(1)(i)(A), but only if sufficient urine is available for this testing after the specimen has been split into Bottle A and Bottle B.

§ 26.115 Collecting a urine specimen under direct observation.

(a) Procedures for collecting urine specimens must provide for the donor's privacy unless directed by this subpart or the MRO or FFD program manager determines that a directly observed collection is warranted. The following circumstances constitute the exclusive grounds for performing a directly observed collection:

(1) The donor has presented, at this or a previous collection, a urine specimen that the HHS-certified laboratory reported as being substituted, adulterated, or invalid to the MRO and the MRO reported to the licensee or other entity that there is no adequate medical explanation for the result;

(2) The donor has presented, at this collection, a urine specimen that falls outside the required temperature range;

(3) The collector, or the hydration monitor if one is used as permitted in § 26.109(b)(1), observes conduct by the donor indicating an attempt to subvert the testing process;

(4) A directly observed collection is required under § 26.69; or

(5) The donor requests a retest and either Bottle B or the single specimen is not available due to circumstances outside of the donor's control, as described in § 26.165(f)(2).

(b) Before collecting a urine specimen under direct observation, the collector shall obtain the agreement of the FFD program manager or MRO to obtain a urine specimen under direct observation. After obtaining agreement, the collector shall ensure that a specimen is collected under direct observation as soon as reasonably practicable.

(c) The collector shall explain to the donor the reason for direct observation of the collection under paragraph (a) of this section.

(d) The collector shall complete a new Federal CCF for the specimen that is obtained from the directly observed collection. The collector shall record that the collection was observed and the reason(s) for the directly observed collection on the form.

(e) The collector shall ensure that the observer is the same gender as the donor. A person of the opposite gender may not act as the observer under any conditions. The observer may be a different person from the collector and need not be a qualified collector. If the observer is not a qualified collector, the collector shall, in the presence of the donor, instruct the observer on the collection procedures in paragraph (f) of this section before proceeding with the directly observed collection.

(f) The individual who observes the collection shall follow these procedures:

(1) The observer shall instruct the donor to adjust his or her clothing to ensure that the area of the donor's body between the waist and knees is exposed;

(2) The observer shall watch the donor urinate into the collection container. Specifically, the observer shall watch the urine go from the donor's body into the collection container. A reflective mirror may be used to assist in observing the provision of the specimen only if the physical configuration of the room, stall, or private area used for urination is not sufficient to meet this direct observation requirement; the use of a video camera to assist in the observation process is not permitted;

(3) If the observer is not the collector, the observer may not touch or handle the collection container but shall maintain visual contact with the specimen until the donor hands the collection container to the collector; and

(4) If the observer is not the collector, the collector shall record the observer's name on the Federal CCF.

(g) If a donor declines to allow a directly observed collection that is required or permitted under this section, the donor's refusal constitutes an act to subvert the testing process, and the collector shall follow the procedures in § 26.107(d).

(h) If a collector learns that a directly observed collection should have been performed but was not, the collector shall inform the FFD program manager, or his or her designee. The FFD program manager or designee shall ensure that a directly observed collection is immediately performed.

[73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71458, Nov. 22, 2022]

§ 26.117 Preparing drug testing specimens for storage and shipping.

(a) Once the collector is presented with the specimen from the donor, both the donor and the collector shall keep the donor's specimen(s) in view at all times before the specimen(s) are sealed and labeled. If any specimen or aliquot is transferred to another container, the collector shall ask the donor to observe the transfer and sealing of the container with a tamper-evident seal.

(b) Both the collector and the donor shall be present (at the same time) during the procedures outlined in this section.

(c) The collector shall place an identification label securely on each container. The label must contain the date, the donor's specimen number, and any other identifying information provided or required by the FFD program. The collector shall also apply a tamper-evident seal on each container if it is separate from the label. The specimen bottle must be securely sealed to prevent undetected tampering.

(d) The donor shall initial the identification label(s) on the specimen bottle(s) for the purpose of certifying that the specimen was collected from him or her. The collector shall also ask the donor to read and sign a statement on the Federal CCF certifying that the specimen(s) identified as having been collected from the donor is, in fact, the specimen(s) that he or she provided.

(e) The collector shall complete the Federal CCF(s) and shall certify proper completion of the collection.

(f) The specimens and Federal CCFs must be packaged for transfer to the HHS-certified laboratory or to the licensee testing facility. If the specimens are not immediately prepared for transfer, they must be appropriately safeguarded during temporary storage.

(g) While any part of the chain of custody procedures is being performed, the specimens and custody documents must be under the control of the involved collector, except as provided in § 26.109(b)(1)(ii) for the Federal CCF. The collector may not leave the collection site during the interval between presentation of the specimen by the donor and securing of the specimens with identifying labels bearing the donor's specimen identification numbers and seals initialed by the donor. If the involved collector momentarily leaves his or her workstation, the sealed specimens and Federal CCFs must be secured or taken with him or her. If the collector is leaving for an extended period of time, the specimens must be packaged for transfer to the HHS-certified laboratory or the licensee testing facility and secured before the collector leaves the collection site.

(h) The specimen(s) sealed in a shipping container must be immediately transferred, appropriately safeguarded during temporary storage, or kept under the personal control of an authorized individual until transferred. These minimum procedures apply to the transfer of specimens to licensee testing facilities from collection sites (except where co-located) as well as to the shipping of specimens to HHS-certified laboratories. As an option, licensees and other entities may ship several specimens via courier in a locked or sealed shipping container.

(i) Collection site personnel shall ensure that a Federal CCF is packaged with its associated specimen bottle. Unless a collection site and a licensee testing facility are co-located, the sealed and labeled specimen bottles, with their associated Federal CCFs that are being transferred from the collection site to the drug testing laboratory must be placed in a second, tamper-evident shipping container. The second container must be designed to minimize the possibility of damage to the specimen during shipment (e.g., specimen boxes, shipping bags, padded mailers, or bulk insulated shipping containers with that capability), so that the contents of the shipping containers are no longer accessible without breaking a tamper-evident seal.

(j) Collection site personnel shall arrange to transfer the collected specimens to the HHS-certified laboratory or the licensee testing facility. Licensees and other entities shall take appropriate and prudent actions to minimize false negative results from specimen degradation. Urine specimens that have not shipped to the HHS-certified laboratory or the licensee testing facility within 24 hours of collection and any urine specimen that is suspected of having been substituted, adulterated, or tampered with in any way must be maintained cooled to not more than 6 °C (42.8 °F) until they are shipped to the HHS-certified laboratory. Oral fluid specimens shall be stored under the conditions specified by the oral fluid specimen collection device manufacturer. Specimens must be shipped from the collection site to the HHS-certified laboratory or the licensee testing facility as soon as reasonably practical but, except under unusual circumstances, the time between specimen shipment and receipt of the specimen at the licensee testing facility or HHS-certified laboratory should not exceed 2 business days.

(k) Couriers, express carriers, and postal service personnel do not have direct access to the Federal CCFs or the specimen bottles. Therefore, there is no requirement that such personnel document chain of custody on the Federal CCFs during transit. Custody accountability of the shipping containers during shipment must be maintained by a tracking system provided by the courier, express carrier, or postal service.

[73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71458, Nov. 22, 2022]

§ 26.119 Determining “shy” bladder.

(a) When a donor has not provided a specimen of at least 30 mL within the 3 hours permitted for urine collection, FFD program personnel shall direct the donor to obtain, within 5 business days, an evaluation from a licensed physician who is acceptable to the MRO and has expertise in the medical issues raised by the donor's failure to provide a sufficient specimen. The MRO may perform this evaluation if the MRO has the appropriate expertise.

(b) If another physician will perform the evaluation, the MRO shall provide the other physician with the following information and instructions:

(1) The donor was required to take a drug test, but was unable to provide a sufficient quantity of urine to complete the test;

(2) The potential consequences of refusing to take the required drug test; and

(3) The physician must agree to follow the requirements of paragraphs (c) through (f) of this section.

(c) The physician who conducts this evaluation shall make one of the following determinations:

(1) A medical condition has, or with a high degree of probability could have, precluded the donor from providing a sufficient amount of urine; or

(2) There is an inadequate basis for determining that a medical condition has, or with a high degree of probability could have, precluded the donor from providing a sufficient quantity of urine.

(d) For purposes of this section, a medical condition includes an ascertainable physiological condition (e.g., a urinary system dysfunction) or a medically documented pre-existing psychological disorder, but does not include unsupported assertions of “situational anxiety” or dehydration.

(e) The physician who conducts this evaluation shall provide a written statement of his or her determination and the basis for it to the MRO. This statement may not include detailed information on the donor's medical condition beyond what is necessary to explain the determination.

(f) If the physician who conducts this evaluation determines that the donor's medical condition is a serious and permanent or long-term disability that is highly likely to prevent the donor from providing a sufficient amount of urine for a very long or indefinite period of time, the physician shall set forth this determination and the reasons for it in the written statement to the MRO.

(g) The MRO shall seriously consider and assess the information provided by the physician in deciding whether the donor has a medical condition that has, or with a high degree of probability could have, precluded the donor from providing a sufficient amount of urine, as follows:

(1) If the MRO concurs with the physician's determination, then the MRO shall declare that the donor has not violated the FFD policy and the licensee or other entity shall take no further action with respect to the donor;

(2) If the MRO determines that the medical condition has not, or with a high degree of probability could not have, precluded the donor from providing a sufficient amount of urine, then the MRO shall declare that there has been a refusal to test; or

(3) If the MRO determines that the medical condition is highly likely to prevent the donor from providing a sufficient amount of urine for a very long or indefinite period of time, then the MRO shall authorize an alternative evaluation process, tailored to the individual case, for drug testing.

§ 26.121 Purpose.

This subpart contains requirements for facilities that are operated by licensees and other entities who are subject to this part to perform initial tests of urine specimens for validity, drugs, and drug metabolites. This subpart shall cease to have effect on January 8, 2027, unless the NRC determines that the cessation deadline should be extended to a date not more than 5 years in the future after offering the public an opportunity to provide input on the costs and benefits of this subpart and considering that input. The NRC will publish a document in the Federal Register announcing its determination and revising or removing this subpart accordingly.

[73 FR 17176, Mar. 31, 2008, as amended at 90 FR 55628, Dec. 3, 2025]

§ 26.123 Testing facility capabilities.

Each licensee testing facility shall have the capability, at the same premises, to perform either validity screening tests or initial validity tests or both, and initial drug tests for each drug and drug metabolite for which testing is conducted.

§ 26.125 Licensee testing facility personnel.

(a) Each licensee testing facility shall have one or more individuals who are responsible for day-to-day operations and supervision of the testing technicians. The designated individual(s) shall have at least a bachelor's degree in the chemical or biological sciences, medical technology, or equivalent. He or she shall also have training and experience in the theory and practice of the procedures used in the licensee testing facility, and a thorough understanding of quality control practices and procedures, the review, interpretation, and reporting of test results, and proper remedial actions to be taken in response to detection of abnormal test or quality control results.

(b) Other technicians or non-technical staff shall have the necessary training and skills for their assigned tasks. Technicians who perform urine specimen testing shall have documented proficiency in operating the testing instruments and devices used at the licensee testing facility.

(c) Licensee testing facility personnel files must include each individual's resume of training and experience; certification or license, if any; references; job descriptions; records of performance evaluations and advancement; incident reports, if any; results of tests that establish employee competency for the position he or she holds, including, but not limited to, certification that personnel are proficient in conducting testing in accordance with manufacturer's most recent instructions for the instruments and devices used and tests for color blindness; and appropriate data to support determinations of honesty and integrity required by this part.

§ 26.127 Procedures.

(a) Licensee testing facilities shall develop, implement, and maintain clear and well-documented procedures for accession, shipment, and testing of urine specimens.

(b) Written chain of custody procedures must describe the methods to be used to maintain control and accountability of specimens from receipt through completion of testing and reporting of results, during storage and shipping to the HHS-certified laboratory, and continuing until final disposition of the specimens.

(c) Licensee testing facilities shall develop, implement, and maintain written standard operating procedures for each assay performed for drug and specimen validity testing. If a licensee testing facility performs validity screening tests, the licensee testing facility shall develop, implement, and maintain written standard operating procedures for each test. The procedures must include, but are not limited to, detailed descriptions of—

(1) The principles of each test;

(2) Preparation of reagents, standards, and controls;

(3) Calibration procedures;

(4) Derivation of results;

(5) Linearity of the methods;

(6) Sensitivity of the methods;

(7) Cutoff values;

(8) Mechanisms for reporting results;

(9) Controls;

(10) Criteria for unacceptable specimens and results;

(11) Reagents and expiration dates; and

(12) References.

(d) Licensee testing facilities shall develop, implement, and maintain written procedures for instrument and test setup and normal operation, including the following:

(1) A schedule for checking critical operating characteristics for all instruments and validity screening tests;

(2) Tolerance limits for acceptable function checks; and

(3) Instructions for major troubleshooting and repair.

(e) Licensee testing facilities shall develop, implement, and maintain written procedures for remedial actions to be taken when systems, and instrumented and non-instrumented tests are out of acceptable limits or errors are detected. Each facility shall maintain documentation that these procedures are followed and that all necessary corrective actions are taken. In addition, each facility shall have systems in place to verify all stages of testing and reporting and to document the verification.

§ 26.129 Assuring specimen security, chain of custody, and preservation.

(a) Each licensee testing facility must be secure at all times. Each licensee or other entity shall have sufficient security measures in place to control access to the licensee testing facility and to ensure that no unauthorized personnel handle specimens or gain access to the licensee testing facility's processes or areas where records are stored. Access to these secured areas must be limited to specifically authorized individuals whose authorization is documented. All authorized visitors and maintenance and service personnel shall be escorted at all times while in the licensee testing facility.

(b) When specimens are received, licensee testing facility personnel shall inspect each package for evidence of possible tampering and shall compare information on the specimen containers within each package to the information on the accompanying Federal CCFs. Licensee testing facility personnel shall attempt to resolve any discrepancies identified in the information on specimen bottles or on the accompanying Federal CCFs. When resolving any discrepancies, licensee testing facility personnel shall obtain a memorandum for the record from the specimen collector involved in the discrepancy to document correction of the discrepancy. This memorandum must accompany the specimen(s) and Federal CCFs to the HHS-certified laboratory if the specimen(s) must be transferred.

(1) Indications of tampering with specimens in transit from the collection site, or at a licensee testing facility, must be reported to senior licensee or other entity management as soon as practical and no later than 8 hours after the indications are identified. In response to a report, licensee or other entity management personnel shall initiate an investigation to determine whether tampering has occurred.

(i) If the investigation determines that tampering has occurred, licensee or other entity management shall ensure that corrective actions are taken.

(ii) If there is reason to believe that the integrity or identity of a specimen is in question (as a result of tampering or discrepancies between the information on the specimen bottle and on the accompanying Federal CCFs that cannot be resolved), the licensee testing facility shall reject the specimen for testing. The licensee or other entity shall ensure that another collection occurs as soon as reasonably practical, except if a split specimen collection was performed, either the Bottle A or Bottle B seal remains intact, and the intact specimen contains at least 15 mL of urine. In this instance, the licensee testing facility shall forward the intact specimen for testing to the HHS-certified laboratory and may not conduct any testing at the licensee testing facility.

(2) The following are exclusive grounds requiring the MRO to cancel the testing of a donor's urine specimen and report a cancelled test result to the licensee or other entity:

(i) The Federal CCF does not contain information to identify the specimen collector and the collection site cannot provide conclusive evidence of the collector's identity;

(ii) The identification numbers on the specimen bottle seal(s) do not match the identification numbers on the Federal CCF;

(iii) A specimen bottle seal is broken or shows evidence of tampering and an intact specimen, as specified in paragraph (b)(1)(ii) of this section, does not exist;

(iv) The specimen appears to have leaked out of its sealed bottle and there is less than 15 mL remaining, and an intact specimen, as specified in paragraph (b)(1)(ii) of this section, does not exist; or

(v) As required under § 26.165(f)(2).

(c) The licensee testing facility shall retain specimen containers within the testing facility's accession area until all analyses have been completed. Testing facility personnel shall use aliquots of the specimen and licensee testing facility chain of custody forms, or other appropriate methods of tracking aliquot custody and control, when conducting validity screening and initial validity and drug tests. The original specimen bottles and the original Federal CCFs must remain in secure storage. Licensee testing facility personnel may discard specimens and aliquots as soon as practical after validity screening or initial validity tests have demonstrated that the specimen appears valid and initial test results for drugs and drug metabolites are negative.

(d) The licensee testing facility's procedure for tracking custody and control of specimens and aliquots must protect the identity of the donor, and provide documentation of the testing process and transfers of custody of the specimen and aliquots. Each time a specimen or aliquot is handled or transferred within the licensee testing facility, testing facility personnel shall document the date and purpose and every individual in the chain of custody must be identified.

(e) Urine specimens identified as positive or of questionable validity at a licensee testing facility must be shipped to an HHS-certified laboratory for testing as soon as reasonably practical.

(f) Licensee testing facility personnel shall take appropriate and prudent actions to minimize false negative results from specimen degradation. If validity screening or initial validity testing indicate that the specimen is of questionable validity, or initial drug test results are positive, or if a specimen has not been tested within 24 hours of receipt at the licensee testing facility, then the facility shall maintain the specimen cooled to not more than 6 °C (42.8 °F) until it is forwarded to the HHS-certified laboratory for further testing, if required. Split specimens in Bottle B that are associated with positive specimens or specimens of questionable validity in Bottle A must also be maintained cooled (as previously specified) until test results from the HHS-certified laboratory are known to be negative for Bottle A; until the MRO informs the licensee testing facility that Bottle B must be forwarded to an HHS-certified laboratory for testing; or until the specimen is moved to long-term, frozen storage, under § 26.135(c).

(g) Licensee testing facility personnel shall ensure that the original Federal CCF is packaged with its associated urine specimen bottle. Sealed and labeled specimen bottles, with their associated Federal CCFs, being transferred from the licensee testing facility to the HHS-certified laboratory must be placed in a second, tamper-evident shipping container designed to minimize the possibility of damage to the specimen during shipment (e.g., specimen boxes, padded mailers, or bulk insulated shipping containers with that capability) so that the contents of the shipping containers are no longer accessible without breaking a tamper-evident seal.

(h) Couriers, express carriers, and postal service personnel do not have direct access to the Federal CCFs or the specimen bottles. Therefore, such personnel are not required to document chain of custody on the Federal CCFs during transit. Custody accountability of the shipping containers during shipment must be maintained by a tracking system provided by the courier, express carrier, or postal service.

[78 FR 17176, Mar. 31, 2008, as amended at 87 FR 71459, Nov. 22, 2022]

§ 26.131 Cutoff levels for validity screening and initial validity tests.

(a) Each validity test result from the licensee testing facility must be based on performing either a validity screening test or an initial validity test, or both, on one or more aliquots of a urine specimen. The licensee testing facility shall forward any specimen that yields a questionable validity screening or initial validity test result to the HHS-certified laboratory for further testing. Licensee testing facilities need not perform validity screening tests before conducting initial validity tests of a specimen.

(b) At a minimum, the licensee testing facility shall test each urine specimen for creatinine, pH, and one or more oxidizing adulterants. Licensees and other entities may not specify more stringent cutoff levels for validity screening and initial validity tests than those specified in this section. If tests or observations indicate one or more of the following from either a validity screening test or an initial validity test, the licensee testing facility shall forward the specimen to the HHS-certified laboratory for additional testing:

(1) Creatinine is less than 20 milligrams (mg) per deciliter (dL);

(2) The pH of the specimen is either less than 4.5 or equal to or greater than 9, using either a colorimetric pH test with a dynamic range of 2 to 12 or pH meter that is capable of measuring pH to one decimal place (for initial validity tests), or colorimetric pH tests, dipsticks, and pH paper (for pH validity screening tests) that have a narrow dynamic range;

(3) Nitrite or other oxidant concentration is equal to or greater than 200 micrograms (mcg) per mL or equal to or greater than 200 mcg/mL nitrite-equivalents using either a nitrite colorimetric test or a general oxidant colorimetric test;

(4) The possible presence of an oxidizing adulterant (e.g., chromium (VI), pyridine (pyridinium chlorochromate)) is determined using either a general oxidant colorimetric test (with a cutoff equal to or greater than 50 mcg/mL chromium (VI)-equivalents) or a chromium (VI) colorimetric test (chromium (VI) concentration equal to or greater than 50 mcg/mL);

(5) The possible presence of halogen (e.g., bleach, iodine, fluoride) is determined using a general oxidant colorimetric test (with a cutoff equal to or greater than 200 mcg/mL nitrite-equivalents or equal to or greater than 50 mcg/mL chromium (VI)-equivalents), a halogen colorimetric test (halogen concentration equal to or greater than the limit of detection (LOD)), or the odor of the specimen;

(6) The possible presence of glutaraldehyde is determined using either an aldehyde test (aldehyde present) or the characteristic immunoassay response is observed on one or more drug immunoassay tests;

(7) The possible presence of a surfactant is determined by using a surfactant colorimetric test with a cutoff equal to or greater than 100 mcg/mL dodecylbenzene sulfonate-equivalent or a foam/shake test; or

(8) The specimen shows evidence of adulterants, including, but not limited to, the following:

(i) Abnormal physical characteristics;

(ii) Reactions or responses characteristic of an adulterant obtained during the validity screening or initial test; or

(iii) A possible unidentified interfering substance or adulterant, demonstrated by interference occurring on the immunoassay drug tests on two separate aliquots (i.e., valid immunoassay drug test results cannot be obtained).

§ 26.133 Cutoff levels for drugs and drug metabolites.

Subject to the provisions of § 26.31(d)(3)(iii), licensees and other entities may specify more stringent cutoff levels for drugs and drug metabolites than those in Table 1 to § 26.133 and, in such cases, may report initial test results for only the more stringent cutoff levels. Otherwise, the following cutoff levels must be used for initial testing of urine specimens to determine whether they are negative or positive for the indicated drugs and drug metabolites:

Table 1 to § 26.133—Urine, Initial Test Cutoff Levels for Drugs and Drug Metabolites

Drugs or drug metabolites | Cutoff level [nanograms (ng)/mL]

Marijuana metabolites | 50

Cocaine metabolites | 150

Opioids:

Codeine/Morphine 1 | 2,000

Hydrocodone/Hydromorphone | 300

Oxycodone/Oxymorphone | 100

6-acetylmorphine (6-AM) | 10

Phencyclidine (PCP) | 25

Amphetamines: 2

AMP/MAMP 3 | 500

MDMA 4/MDA 5 | 500

1 Morphine is the target analyte for codeine/morphine testing.

2 Either a single initial test kit or multiple initial test kits may be used provided the single test kit detects each target analyte independently at the specified cutoff.

3 Methamphetamine (MAMP) is the target analyte for amphetamine (AMP)/MAMP testing.

4 Methylenedioxymethamphetamine.

5 Methylenedioxyamphetamine.

[87 FR 71459, Nov. 22, 2022]

§ 26.135 Split specimens.

(a) If the FFD program follows split-specimen procedures, as described in § 26.113, the licensee testing facility shall analyze aliquots of the specimen for the licensee's or other entity's purposes as described in this part. Except as provided in paragraph (b) in this section, the licensee testing facility shall store Bottles A and B of the specimen in a secure manner until the facility has finished testing. If the initial validity and drug test results are negative and the specimen in Bottle A will not be forwarded to the HHS-certified laboratory, the licensee testing facility may discard both Bottle A and Bottle B. If any test results are positive or indicate that the specimen is of questionable validity, the licensee testing facility shall forward Bottle A to the HHS-certified laboratory for testing and shall retain Bottle B in secure storage, under the requirements of § 26.159(i), or may forward it to the HHS-certified laboratory for storage.

(b) If the MRO confirms any positive, adulterated, or substituted result for a specimen in Bottle A, based on the results of confirmatory testing at an HHS-certified laboratory, and the licensee testing facility has elected to retain Bottle B of the specimen, and the donor requests testing of the specimen in Bottle B, as permitted under § 26.165(b), the MRO shall ensure that Bottle B is forwarded to an HHS-certified laboratory other than the laboratory that tested the specimen in Bottle A, under the procedures specified in § 26.165(b).

(c) If the MRO confirms that the specimen in Bottle A is positive, adulterated, substituted, or invalid and the donor does not request that Bottle B be tested, the licensee or other entity shall ensure that Bottle B is maintained in long-term frozen storage (−20 °C (−4 °F) or less) for a minimum of 1 year. If a licensee testing facility elects to retain the specimen in Bottle B, rather than forwarding it to the HHS-certified laboratory with Bottle A, the licensee testing facility shall ensure proper storage conditions in the event of a prolonged power failure. After the end of 1 year, the licensee or other entity may discard Bottle B, with the exception that the licensee testing facility shall retain any specimens under legal challenge, or as requested by the NRC, until the specimen is no longer needed.

[73 FR 17176, Mar. 31, 2008, as amended at 79 FR 66602, Nov. 10, 2014]

§ 26.137 Quality assurance and quality control.

(a) Quality assurance program. Each licensee testing facility shall have a quality assurance program that encompasses all aspects of the testing process including, but not limited to, specimen acquisition, chain of custody, security and reporting of results, validity screening (if validity screening tests are performed), initial validity and drug testing, and validation of analytical procedures. Quality assurance procedures must be designed, implemented, and reviewed to monitor the conduct of each step of the process of validity testing and testing for drugs and drug metabolites.

(b) Performance testing and quality control requirements for validity screening tests. (1) Licensee testing facilities may rely on validity screening tests to determine the need for initial tests of specimen validity either at the licensee testing facility or HHS-certified laboratory. Licensees and other entities shall ensure that the HHS-certified laboratory is capable of conducting confirmatory testing for any adulterant for which the licensee testing facility conducts validity screening tests. Licensee testing facilities shall use only validity screening tests that meet the following criteria:

(i) Either the test, by lot number, has been placed on the Substance Abuse and Mental Health Services Administration (SAMHSA) list of point-of-collection tests that are approved for use in the Federal Workplace Drug Testing Program; or

(ii) Before using the test, the licensee or other entity has ensured that the validity screening test, by lot number, effectively identifies specimens of questionable validity by meeting the following performance testing and quality control requirements:

(A) The creatinine validity screening test must use a 20 mg/dL cutoff concentration;

(B) A pH specimen validity screening test must be able to determine if pH is less than 4.5 and if pH is equal to or greater than 9; and

(C) An oxidant validity screening test must be able to determine if an oxidant concentration is equal to or greater than a 200 mcg/mL nitrite-equivalent cutoff, and/or a chromium screening test must be able to determine concentrations equal to or greater than a 50 mcg/mL chromium(VI)-equivalent cutoff, and/or a halogen screening test must be able to determine the halogen concentration is equal to or greater than the LOD. Licensees and other entities who use validity screening tests for additional adulterants shall establish performance testing requirements to challenge the licensee testing facility and the HHS-certified laboratory for the additional validity screening test(s);

(D) The manufacturer has conducted validation studies to document the validity screening test's performance characteristics around each applicable cutoff specified in this section, using performance testing samples that have been formulated to challenge the validity screening test around the applicable cutoffs. These validation studies must demonstrate the validity screening test's ability to differentiate valid samples from those of questionable validity and the performance of the validity screening test(s) around the applicable cutoffs specified in this section; and

(E) The licensee testing facility shall submit three consecutive sets of performance testing samples to the manufacturer, using performance testing samples that have been formulated to challenge the validity screening test around the applicable cutoffs specified in this paragraph and whose formulation levels have been confirmed by an HHS-certified laboratory. For example, one set of performance testing samples used to challenge a creatinine validity screening test must include at least six samples formulated at different concentrations ranging from 0 to 20 mg/dL. A set of performance testing samples used to challenge a pH validity screening test must include at least six samples formulated with different pH levels that are equal to or less than 4.5, and six samples formulated with different pH levels that are equal to or greater than 9. And, a set of performance testing samples used to challenge an oxidizing adulterant validity screening test must include at least six samples to challenge each validity screening test used. The performance testing samples for oxidizing adulterants must contain nitrite and other oxidizing adulterant concentrations in a range of less than or equal to a 200 mcg/mL nitrite-equivalent cutoff to a 500 mcg/mL nitrite-equivalent cutoff; chromium samples formulated in a range less than or equal to a 50 mcg/mL chromium(VI)-equivalent cutoff to 100 mcg/mL chromium(VI)-equivalent cutoff; or halogen samples formulated in a concentration at or near the LOD and 25 percent above the LOD. The results of analyzing the three consecutive sets of performance test samples for each validity screening test (i.e., creatinine, pH, nitrite and general oxidants, chromium, or halogen) must demonstrate that the validity screening test, by lot number, correctly identified at least 90 percent of the total validity performance test challenges on each of three sets of performance testing samples, and, for each individual specimen validity screening test, the test, by lot number, correctly identified at least 90 percent of the validity performance test challenges on each of three sets of performance testing samples; and

(iii) After the licensee testing facility has placed a validity screening test in service, the licensee or other entity shall verify that the test, by lot number, remains on the SAMHSA-approved list. Or, if the SAMHSA-approved list is unavailable, the licensee or other entity shall ensure that the test continues to identify specimens of questionable validity, as demonstrated by documentation from the manufacturer that a set of validity screening tests from each lot in use by the licensee testing facility correctly identified at least 90 percent of the total validity test challenges on a set of performance testing samples, and, for each individual specimen validity screening test, that the test, by lot number, correctly identified at least 90 percent of the validity test challenges. This performance testing must be performed at a nominal annual frequency after the date on which the manufacturer completed the initial validation studies required under paragraph (b)(1)(ii)(D) of this section. The performance testing samples used must be formulated to challenge the validity screening test around the applicable cutoffs of this subpart.

(2) In addition, licensee testing facility personnel who perform the validity screening tests shall conduct quality control testing of validity screening tests as follows:

(i) At the beginning of any 8-hour period during which the licensee testing facility will perform validity screening tests, licensee testing facility personnel shall test a minimum of one quality control sample that is negative for each specific validity test to be performed (e.g., creatinine, pH, nitrites, chromium) during the 8-hour period, and one quality control sample that is formulated to challenge the validity screening test(s) around the cutoffs specified in this subpart for each specific validity test to be performed during the 8-hour period. The results of these quality control tests must be correct before any donor specimens may be tested.

(ii) After screening every ten donor specimens during the 8-hour period, licensee testing facility personnel shall also challenge each validity screening test with at least one quality control sample that is formulated to challenge the validity screening test(s) around the cutoffs specified in this subpart. If fewer than ten donor specimens were screened during the 8-hour period or the number of donor specimens tested exceeds a multiple of ten but is less than the next multiple of ten (e.g., 24 donor specimens, 48 donor specimens), licensee testing facility personnel shall challenge each validity screening test at the end of the 8-hour period during which the validity screening tests were performed.

(3) The licensee testing facility shall also submit at least one specimen out of every ten donor specimens that test negative using each validity screening test that the licensee testing facility uses to an HHS-certified laboratory as part of the licensee testing facility's quality assurance program.

(4) Licensee testing facilities shall store specimen validity tests as specified by the manufacturer's instructions and may not use such tests after the manufacturer's expiration date.

(c) Validity screening test results. If the results of a validity screening test indicate that the specimen is of questionable validity, the licensee testing facility may either perform initial validity testing or shall forward the specimen to the HHS-certified laboratory for further testing.

(d) Quality control requirements for performing initial validity tests. Licensees and other entities shall ensure that the HHS-certified laboratory is capable of conducting confirmatory testing for any adulterant for which the licensee testing facility conducts initial validity tests.

(1) Creatinine. Creatinine concentration must be measured to 1 decimal place. The initial creatinine test must have a control in the range of 3 to 20 mg/dL and a control in the range of 21 to 25 mg/dL.

(2) Requirements for performing initial pH tests are as follows:

(i) Colorimetric pH tests must have a dynamic range of 2 to 12 and pH meters must be capable of measuring pH to one decimal place.

(ii) An initial colorimetric pH test must have the following calibrators and controls:

(A) One calibrator at 3;

(B) One calibrator at 11;

(C) One control in the range of 2 to 2.8;

(D) One control in the range of 3.2 to 4;

(E) One control in the range of 4.5 to 9;

(F) One control in the range of 10 to 10.8; and

(G) One control in the range of 11.2 to 12.

(iii) If a pH screening test is not used, an initial pH meter test must have the following calibrators and controls:

(A) One calibrator at 4;

(B) One calibrator at 7;

(C) One calibrator at 10;

(D) One control in the range of 2 to 2.8;

(E) One control in the range of 3.2 to 4;

(F) One control in the range of 10 to 10.8; and

(G) One control in the range of 11.2 to 12.

(iv) If a pH screening test is used, an initial pH meter test must have the following calibrators and controls when the screening result indicates that the pH is below the lower decision point in use:

(A) One calibrator at 4;

(B) One calibrator at 7;

(C) One control in the range of 2 to 2.8; and

(D) One control in the range of 3.2 to 4.

(v) If a pH screening test is used, an initial pH meter test must have the following calibrators and controls when the screening test result indicates that the pH is above the upper decision point in use:

(A) One calibrator at 7;

(B) One calibrator at 10;

(C) One control in the range of 10 to 10.8; and

(D) One control in the range of 11.2 to 12.

(3) Oxidizing adulterants. Initial tests for oxidizing adulterants must include a calibrator at the appropriate cutoff concentration for the compound of interest, a control without the compound of interest (i.e., a certified negative control), and a control with at least one of the compounds of interest at a measurable concentration. For nitrite, the licensee testing facility shall have one control in the range of 200 to 400 mcg/mL, one control in the range of 500 to 625 mcg/mL, and a control without nitrite (i.e., a certified negative control).

(4) Other adulterants. Initial tests for other adulterants must include an appropriate calibrator, a control without the compound of interest (i.e., a certified negative control), and a control with the compound of interest at a measurable concentration.

(5) Each analytical run performed to conduct initial validity testing shall include at least one quality control sample.

(6) The licensee testing facility shall also submit at least one specimen out of every 10 donor specimens that test negative on the initial validity tests performed by the licensee testing facility to an HHS-certified laboratory as part of the licensee testing facility's quality assurance program.

(e) Quality control requirements for initial drug tests. (1) Any initial drug test performed by a licensee testing facility must use an immunoassay that meets the requirements of the Food and Drug Administration for commercial distribution. Licensee testing facilities may not use non-instrumented immunoassay testing devices that are pending HHS/SAMHSA review and approval for initial drug testing under this part. In addition, licensees and other entities may not take management actions on the basis of any drug test results obtained from non-instrumented devices that may be used for validity screening tests.

(2) Licensee testing facilities shall discard negative specimens or may pool them for use in the licensee testing facility's internal quality control program after certification by an HHS-certified laboratory that the specimens are negative and valid. Licensee testing facilities may not retain any information linking donors to specimens that are pooled for use in the internal quality control program.

(3) Licensee testing facilities may perform multiple initial drug tests for the same drug or drug class, provided that all tests meet the cutoffs and quality control requirements of this part. For example, a licensee testing facility may use immunoassay technique “A” for all drugs using the licensee's or other entity's cutoff levels, but specimens testing positive for amphetamines may also be tested using immunoassay technique “B” to eliminate any possible positives due to structural analogues; or, a valid analytical result cannot be obtained using immunoassay technique “A” and immunoassay technique “B” is used in an attempt to obtain a valid analytical result.

(4) Licensee testing facilities need not assess their false positive testing rates for drugs, because all specimens that test as positive on the initial tests for drugs and drug metabolites must be forwarded to an HHS-certified laboratory for initial and confirmatory testing.

(5) To ensure that the rate of false negative drug tests is kept to the minimum that the immunoassay technology supports, licensee testing facilities shall submit to the HHS-certified laboratory a minimum of 5 percent (or at least one) of the donor specimens screened as negative from every analytical run.

(6) A minimum of 10 percent of the total specimens in each analytical run of specimens to be initially tested for drugs and drug metabolites by the licensee testing facility must be quality control samples (i.e., calibrators and controls), which the licensee testing facility shall use for internal quality control purposes. (These samples are not forwarded to the HHS-certified laboratory for further testing, other than for performance testing of the samples.) Licensee testing facilities shall ensure that quality control samples that are positive for each drug and drug metabolite for which the FFD program conducts testing are included in at least one analytical run each calendar quarter. The quality control samples for each analytical run must include—

(i) At least one control certified by an HHS-certified laboratory to contain no drug or drug metabolite;

(ii) At least one positive control with the drug or drug metabolite targeted at 25 percent above the cutoff;

(iii) At least one positive control with the drug or drug metabolite targeted at 75 percent of the cutoff;

(iv) A sufficient number of calibrators to ensure and document the linearity of the assay method over time in the concentration area of the cutoff (after acceptable values are obtained for the known calibrators, those values will be used to calculate sample data); and

(7) Licensee testing facilities shall document the implementation of procedures to ensure that carryover does not contaminate the testing of a donor's specimen.

(f) Errors in testing. Each licensee testing facility shall investigate any testing errors or unsatisfactory performance discovered in the testing of quality control samples, in the testing of actual specimens, or through the processing of management reviews and/or MRO reviews, as well as any other errors or matters that could adversely reflect on the licensee testing facility's testing process.

(1) Whenever possible, the investigation must determine relevant facts and identify the root cause(s) of the testing or process error.

(2) The licensee testing facility shall take action to correct the cause(s) of any errors or unsatisfactory performance that are within the licensee testing facility's control.

(3) If false negative results are obtained in any analytical run from testing the quality control samples specified in paragraphs (b), (d), and (e) of this section at the licensee testing facility, the licensee testing facility shall forward all donor specimens from that analytical run to the HHS-certified laboratory for additional testing and implement corrective actions before resuming testing of donor specimens for the drug(s), drug metabolite(s), adulterant(s), or other specimen characteristics (i.e., creatinine, pH) associated with the quality control sample that yielded the false negative result(s).

(4) If a donor specimen that yielded negative validity or drug test results at the licensee testing facility yields positive, substituted, adulterated, or invalid results after confirmatory testing by the HHS-certified laboratory under paragraphs (b)(3), (d)(6), or (e)(5) of this section, the licensee or other entity shall implement corrective actions before resuming testing of donor specimens for the drug(s), drug metabolite(s), adulterant(s), or other specimen characteristics (i.e., creatinine, pH) associated with the donor specimen that yielded the false negative result(s). In addition to resolving any technical, methodological, or administrative errors in the licensee testing facility's testing process, the licensee or other entity may re-collect and test specimens from any donor whose test results from the licensee testing facility may have been inaccurate.

(5) A record of the investigative findings and the corrective actions taken, where applicable, must be dated and signed by the individuals who are responsible for the day-to-day management of the licensee testing facility and reported to appropriate levels of management.

(g) Accuracy. Volumetric pipettes and measuring devices must be certified for accuracy or be checked by gravimetric, colorimetric, or other verification procedure. Automatic pipettes and dilutors must be checked for accuracy and reproducibility before being placed in service, and periodically thereafter.

(h) Calibrators and controls. Calibrators and controls must be prepared using pure drug reference materials, stock standard solutions obtained from other laboratories, or standard solutions that are obtained from commercial manufacturers and are properly labeled as to content and concentration. Calibrators and controls may not be prepared from the same stock solution. The standards and controls must be labeled with the following dates: when received; when prepared or opened; when placed in service; and when scheduled for expiration.

[73 FR 17176, Mar. 31, 2008, as amended at 74 FR 38328, Aug. 3, 2009; 87 FR 71459, Nov. 22, 2022]

§ 26.139 Reporting initial validity and drug test results.

(a) The licensee testing facility shall report as negative all specimens that are valid on the basis of validity screening or initial validity tests, or both, and are negative on the initial tests for drugs and drug metabolites. Except as permitted under § 26.75(h), positive test results from initial drug tests at the licensee testing facility may not be reported to licensee or other entity management. In addition, the licensee testing facility may not report results from validity screening or initial validity testing indicating that a specimen is of questionable validity or positive initial drug test results from specimens that are of questionable validity.

(b) Except as provided in §§ 26.37 and 26.75(h), access to the results of initial tests must be limited to the licensee testing facility's staff, the MRO and MRO staff, the FFD program manager, and, when appropriate, EAP staff and the SAE.

(c) The licensee testing facility shall provide qualified personnel, when required, to testify in an administrative or disciplinary proceeding against an individual when that proceeding is based on urinalysis results reported by the licensee testing facility.

(d) The licensee testing facility shall prepare the information required for the annual report to the NRC, as required in § 26.717.

(e) The data in the annual report to the NRC must be presented for either the cutoff levels specified in this part, or for more stringent cutoff levels, if the FFD program uses more stringent cutoff levels for drugs and drug metabolites. If the FFD program tests for drugs and drug metabolites that are not specified in § 26.31(d)(1), the summary must also include the number of positive test results and the cutoff levels used for those drugs and drug metabolites.

(f) The designated FFD program official shall use the available information from the licensee testing facility's validity and drug test results, the results of quality control testing performed at the licensee testing facility, and the results from testing the quality control samples that the licensee testing facility submits to the HHS-certified laboratory to evaluate continued testing program effectiveness and detect any local trends in drugs of abuse that may require management action or FFD program adjustments. FFD program adjustments may include, but are not limited to, training enhancements, procedure changes, the expansion of the FFD program's drug panel to include additional drugs to be tested, or changes in the types of assays, validity screening tests, or instruments used.

§ 26.151 Purpose.

This subpart contains requirements for the HHS-certified laboratories that licensees and other entities use to perform testing under this part.

[87 FR 71459, Nov. 22, 2022]

§ 26.153 Using certified laboratories for testing specimens.

(a) Licensees and other entities who are subject to this part shall use only HHS-certified laboratories as defined in § 26.5.

(b) HHS-certified laboratories shall have the capability, at the same premises, to perform both initial and confirmatory tests for specimen validity and for each drug and drug metabolite for which the HHS-certified laboratory provides services to the licensee or other entity.

(c) An HHS-certified laboratory may not subcontract and shall perform all work with its own personnel and equipment unless otherwise authorized by the licensee or other entity.

(d) Licensees and other entities shall use only HHS-certified laboratories that agree to follow the same rigorous specimen testing, quality control, and chain of custody procedures when testing for more stringent cutoff levels as may be specified by licensees and other entities for the classes of drugs identified in this part, and for any other substances included in the licensees' or other entities' panels.

(e) Before awarding a contract to an HHS-certified laboratory, the licensee or other entity shall ensure that qualified personnel conduct a pre-award inspection and evaluation of the procedural aspects of the laboratory's drug testing operations. However, if an HHS-certified laboratory loses its certification, in whole or in part, a licensee or other entity may immediately begin using another HHS-certified laboratory that is being used by another licensee or entity who is subject to this part, as permitted by § 26.41(g)(5).

(f) All contracts between licensees or other entities who are subject to this part and HHS-certified laboratories must require the laboratory to implement all applicable requirements of this part. At a minimum, licensees' and other entities' contracts with HHS-certified laboratories must include the following requirements:

(1) Laboratory facilities shall comply with the applicable provisions of any State licensor requirements;

(2) The laboratory shall make available qualified personnel to testify in an administrative or disciplinary proceeding against an individual when that proceeding is based on urinalysis results reported by the HHS-certified laboratory;

(3) The laboratory shall maintain test records in confidence, consistent with the requirements of § 26.37, and use them with the highest regard for individual privacy.

(4) Consistent with the principles established in section 503 of Public Law 100-71, any employee of a licensee or other entity who is the subject of a drug test (or his or her representative designated under § 26.37(d)) shall, on written request, have access to the laboratory's records related to his or her validity and drug test and any records related to the results of any relevant certification, review, or revocation-of-certification proceedings;

(5) The laboratory may not enter into any relationship with the licensee's or other entity's MRO(s) that may be construed as a potential conflict of interest, including, but not limited to, the relationships described in § 26.183(b), and may not derive any financial benefit by having a licensee or other entity use a specific MRO; and

(6) The laboratory shall permit representatives of the NRC and any licensee or other entity using the laboratory's services to inspect the laboratory at any time, including unannounced inspections.

(g) If licensees or other entities use a form other than the current Federal CCF, licensees and other entities shall provide a memorandum to the laboratory explaining why a non-Federal CCF was used, but must ensure, at a minimum, that the form used contains all the required information on the Federal CCF.

[73 FR 17176, Mar. 31, 2008, as amended at 74 FR 38328, Aug. 3, 2009; 87 FR 71459, Nov. 22, 2022]

§ 26.155 [Reserved]

§ 26.157 Procedures.

(a) HHS-certified laboratories shall develop, implement, and maintain procedures specific to this part that document the accession, receipt, shipment, and testing of specimens.

(b) [Reserved]

[87 FR 71459, Nov. 22, 2022]

§ 26.159 Assuring specimen security, chain of custody, and preservation.

(a) The HHS-certified laboratories performing services for licensees and other entities under this part shall be secure at all times. Each laboratory shall have in place sufficient security measures to control access to the premises and to ensure that no unauthorized personnel handle specimens or gain access to the laboratory processes or areas where records are stored. Access to these secured areas must be limited to specially authorized individuals whose authorization is documented. All authorized visitors, and maintenance and service personnel, shall be escorted at all times in the laboratory, except personnel who are authorized to conduct inspections and audits on behalf of licensees, other entities, the NRC, or the HHS Secretary, and emergency personnel (including but not limited to firefighters and medical rescue teams).

(b) When a shipment of specimens is received, laboratory personnel shall inspect each package for evidence of possible tampering and shall compare information on specimen bottles within each package to the information on the accompanying Federal CCFs.

(1) Any direct evidence of tampering or discrepancies in the information on the specimen bottles and the Federal CCFs attached to the shipment must be reported to the licensee or other entity within 24 hours of the discovery and must be noted on the Federal CCFs for each specimen contained in the package. When notified, the licensee or other entity shall ensure that an investigation is initiated to determine whether tampering has occurred.

(i) If the investigation determines that tampering has occurred, the licensee or other entity shall ensure that corrective actions are taken.

(ii) If the licensee or other entity has reason to question the integrity and identity of the specimens, the laboratory shall reject the specimens for testing. The licensee or other entity shall ensure that another collection occurs as soon as reasonably practical, except if a split specimen collection was performed, either the Bottle A or Bottle B seal remains intact, and the intact specimen contains at least 15 mL of urine. In this instance, if the licensee testing facility has retained the specimen in Bottle B, the licensee testing facility shall forward the intact specimen for testing to the HHS-certified laboratory and may not conduct any testing at the licensee testing facility.

(2) The following are exclusive grounds requiring the MRO to cancel the testing of a donor's urine specimen and report a cancelled test to the licensee or other entity:

(i) The Federal CCF does not contain information to identify the specimen collector and the collection site cannot provide conclusive evidence of the collector's identity;

(ii) The identification numbers on the specimen bottle seal(s) do not match the identification numbers on the Federal CCF;

(iii) A specimen bottle seal is broken or shows evidence of tampering and an intact specimen, as specified in paragraph (b)(1)(ii) of this section, does not exist;

(iv) The specimen appears to have leaked out of its sealed bottle and there is less than 15 mL remaining, and an intact specimen, as specified in paragraph (b)(1)(ii) of this section, does not exist; or

(v) As required under § 26.165(f)(2).

(c) The HHS-certified laboratory shall retain specimen bottles within the laboratory's accession area until all analyses have been completed. Laboratory personnel shall use aliquots and laboratory internal chain of custody forms when conducting initial and confirmatory tests. The original specimen and the original Federal CCF must remain in secure storage.

(d) The laboratory's internal chain of custody form must allow for identification of the donor and documentation of the testing process and transfers of custody of the specimen.

(e) Each time a specimen is handled or transferred within the laboratory, laboratory personnel shall document the date and purpose on the chain of custody form and every individual in the chain shall be identified. Authorized technicians are responsible for each urine specimen or aliquot in their possession and shall sign and complete chain of custody forms for those specimens or aliquots as they are received.

(f) If a specimen is to be transferred to a second HHS-certified laboratory, laboratory personnel shall ensure that a copy of the Federal CCF is packaged with the aliquot of a single specimen or Bottle B of a split specimen, as appropriate. Sealed and labeled specimen bottles and aliquots, with their associated Federal CCFs , being transferred from one laboratory to another must be placed in a second, tamper-evident shipping container designed to minimize the possibility of damage to the specimen during shipment (e.g., specimen boxes, padded mailers, or bulk insulated shipping containers with that capability) so that the contents of the shipping containers are inaccessible without breaking a tamper-evident seal.

(g) Couriers, express carriers, and postal service personnel do not have direct access to the Federal CCFs or the specimen bottles. Therefore, such personnel are not required to document chain of custody on the Federal CCFs during transit. Custody accountability of the shipping containers during shipment must be maintained by a tracking system provided by the courier, express carrier, or postal service.

(h) Specimens that do not receive an initial test within 7 days of arrival at the laboratory must be placed in secure refrigeration units for short-term storage. Temperatures may not exceed 6 °C (42.8 °F). The laboratory shall ensure proper storage conditions in the event of a prolonged power failure.

(i) Long-term frozen storage at a temperature of −20 °C (−4 °F) or less ensures that positive, adulterated, substituted, and invalid urine specimens and Bottle B of a split specimen will be available for any necessary retests. Unless otherwise authorized in writing by the licensee or other entity, laboratories shall retain and place in properly secured long-term frozen storage all specimens reported as positive, adulterated, substituted, or invalid. At a minimum, such specimens must be stored for 1 year. Within this 1-year period, a licensee, other entity, or the NRC may ask the laboratory to retain the specimen for an additional period of time. If no retention request is received, the laboratory may discard the specimen at the end of 1 year. However, the laboratory shall retain any specimens under review or legal challenge until they are no longer needed.

(j) The laboratory shall discard a valid specimen that tests negative on initial or confirmatory drug tests or may pool such specimens for use in the laboratory's internal quality control program after certifying that the specimens are negative and valid. The laboratory may not retain any information linking donors to specimens that are pooled for use in the internal quality control program.

[73 FR 17176, Mar. 31, 2008, as amended at 79 FR 66602, Nov. 10, 2014; 87 FR 71460, Nov. 22, 2022]

§ 26.161 Cutoff levels for validity testing.

(a) Validity test results. Each validity test result for a specimen that the HHS-certified laboratory reports to the MRO as adulterated, substituted, dilute, or invalid must be based on performing an initial validity test on one aliquot and a confirmatory validity test on a second aliquot. Licensees and other entities shall ensure that the HHS-certified laboratory is capable of conducting, and conducts, confirmatory testing for at least one oxidizing adulterant and any other adulterants specified by the licensee's or other entity's testing program. If initial validity test results indicate that the specimen is valid under the criteria in paragraphs (c) through (f) of this section, the HHS-certified laboratory need not perform confirmatory validity testing of the specimen.

(b) Initial validity testing of urine. The HHS-certified laboratory shall perform initial validity testing of each specimen as follows:

(1) Determine the creatinine concentration;

(2) Determine the specific gravity of every specimen for which the creatinine concentration is less than 20 mg/dL;

(3) Determine the pH;

(4) Perform one or more initial validity tests for oxidizing adulterants; and

(5) Perform additional validity tests, the choice of which depends on the observed indicators or characteristics below, when the following conditions are observed:

(i) Abnormal physical characteristics;

(ii) Reactions or responses characteristic of an adulterant obtained during initial or confirmatory drug tests (e.g., non-recovery of internal standards, unusual response); or

(iii) Possible unidentified interfering substance or adulterant.

(c) Results indicating an adulterated specimen. The laboratory shall report a specimen as adulterated when the specimen yields any one or more of the following validity testing results:

(1) The pH is less than 3, or equal to or greater than 11, using either a pH meter or a colorimetric pH test for the initial test on the first aliquot and a pH meter for the confirmatory test on the second aliquot;

(2) The nitrite concentration is equal to or greater than 500 mcg/mL using either a nitrite colorimetric test or a general oxidant colorimetric test for the initial test on the first aliquot and a different confirmatory test (e.g., multi-wavelength spectrophotometry, ion chromatography, capillary electrophoresis) on the second aliquot;

(3) The presence of chromium (VI) is verified using either a general oxidant colorimetric test (with a cutoff equal to or greater than 50 mcg/mL chromium (VI)-equivalents) or a chromium (VI) colorimetric test (chromium (VI) concentration equal to or greater than 50 mcg/mL) for the initial test on the first aliquot and a different confirmatory test (e.g., multi-wavelength spectrophotometry, ion chromatography, atomic absorption spectrophotometry, capillary electrophoresis, inductively coupled plasma-mass spectrometry) with the chromium (VI) concentration equal to or greater than the LOQ of the confirmatory test on the second aliquot;

(4) The presence of halogen (e.g., bleach, iodine, fluoride) is verified using either a general oxidant colorimetric test (with a cutoff equal to or greater than 200 mcg/mL nitrite-equivalents or a cutoff equal to or greater than 50 mcg/mL chromium (VI)-equivalents) or a halogen colorimetric test (halogen concentration equal to or greater than the LOQ) for the initial test on the first aliquot and a different confirmatory test (e.g., multi-wavelength spectrophotometry, ion chromatography, inductively coupled plasma-mass spectrometry) with a specific halogen concentration equal to or greater than the LOQ of the confirmatory test on the second aliquot;

(5) The presence of glutaraldehyde is verified using either an aldehyde test (aldehyde present) or the specimen yields the characteristic immunoassay response on one or more drug immunoassay tests for the initial test on the first aliquot and a different confirmatory test (e.g., gas chromatography/mass spectrometry (GC/MS)) for the confirmatory test with the glutaraldehyde concentration equal to or greater than the LOQ of the analysis on the second aliquot;

(6) The presence of pyridine (pyridinium chlorochromate) is verified using either a general oxidant colorimetric test (with a cutoff equal to or greater than 200 mcg/mL nitrite-equivalents or a cutoff equal to or greater than 50 mcg/mL chromium (VI)-equivalents) or a chromium (VI) colorimetric test (chromium (VI) concentration equal to or greater than 50 mcg/mL) for the initial test on the first aliquot and a different confirmatory test (e.g., GC/MS) for the confirmatory test with the pyridine concentration equal to or greater than the LOQ of the analysis on the second aliquot;

(7) The presence of a surfactant is verified by using a surfactant colorimetric test with a cutoff equal to or greater than 100 mcg/mL dodecylbenzene sulfonate-equivalent for the initial test on the first aliquot and a different confirmatory test (e.g., multi-wavelength spectrophotometry) with a cutoff equal to or greater than 100 mcg/mL dodecylbenzene sulfonate equivalent on the second aliquot; or

(8) The presence of any other adulterant not specified in paragraphs (c)(3) through (c)(7) of this section is verified using an initial test on the first aliquot and a different confirmatory test on the second aliquot.

(d) Results indicating a substituted urine specimen. The laboratory shall report a specimen as substituted when the specimen's creatinine concentration is less than 2 mg/dL and its specific gravity is less than or equal to 1.0010, or equal to or greater than 1.0200, on both the initial and confirmatory creatinine tests (i.e., the same colorimetric test may be used to test both aliquots) and on both the initial and confirmatory specific gravity tests (i.e., a refractometer is used to test both aliquots) on two separate aliquots.

(e) Results indicating a dilute urine specimen. The laboratory shall report a specimen as dilute when the specimen's creatinine concentration is equal to or greater than 2 mg/dL but less than 20 mg/dL and its specific gravity is greater than 1.0010 but less than 1.0030 on a single aliquot.

(f) Results indicating an invalid specimen. The laboratory shall report a specimen as invalid when the laboratory obtains any one or more of the following validity testing results:

(1) Inconsistent creatinine concentration and specific gravity results are obtained (i.e., the creatinine concentration is less than 2 mg/dL on both the initial and confirmatory creatinine tests and the specific gravity is greater than 1.0010 but less than 1.0200 on the initial and/or confirmatory specific gravity test, the specific gravity is less than or equal to 1.0010 on both the initial and confirmatory specific gravity tests and the creatinine concentration is equal to or greater than 2 mg/dL on either or both the initial or confirmatory creatinine tests);

(2) The pH is equal to or greater than 3 and less than 4.5, or equal to or greater than 9 and less than 11, using either a colorimetric pH test or pH meter for the initial test and a pH meter for the confirmatory test on two separate aliquots;

(3) The nitrite concentration is equal to or greater than 200 mcg/mL using a nitrite colorimetric test, or equal to or greater than the equivalent of 200 mcg/mL nitrite using a general oxidant colorimetric test for both the initial test and the confirmatory test, or, using either initial test, the nitrite concentration is equal to or greater than 200 mcg/mL but less than 500 mcg/mL using a different confirmatory test (e.g., multi-wavelength spectrophotometry, ion chromatography, capillary electrophoresis) on two separate aliquots;

(4) The possible presence of chromium (VI) is determined using the same chromium (VI) colorimetric test with a cutoff equal to or greater than 50 mcg/mL chromium (VI) for both the initial test and the confirmatory test on two separate aliquots;

(5) The possible presence of a halogen (e.g., bleach, iodine, fluoride) is determined using the same halogen colorimetric test with a cutoff equal to or greater than the LOQ for both the initial test and the confirmatory test on two separate aliquots or relying on the odor of the specimen as the initial test;

(6) The possible presence of glutaraldehyde is determined using the same aldehyde test (aldehyde present) or the characteristic immunoassay response is observed on one or more drug immunoassay tests for both the initial test and the confirmatory test on two separate aliquots;

(7) The possible presence of an oxidizing adulterant is determined by using the same general oxidant colorimetric test (with cutoffs equal to or greater than 200 mcg/mL nitrite-equivalents, equal to or greater than 50 mcg/mL chromium (VI)-equivalents, or a halogen concentration equal to or greater than the LOQ) for both the initial test and the confirmatory test on two separate aliquots;

(8) The possible presence of a surfactant is determined using the same surfactant colorimetric test with a cutoff equal to or greater than 100 mcg/mL dodecylbenzene sulfonate-equivalent for both the initial test and the confirmatory test on two separate aliquots or a foam/shake test for the initial test;

(9) Interference occurs on the immunoassay drug tests on two separate aliquots (i.e., valid immunoassay drug test results cannot be obtained);

(10) Interference with the drug confirmation assay occurs on at least two separate aliquots of the specimen, and the laboratory is unable to identify the interfering substance;

(11) The physical appearance of the specimen indicates that testing may damage the laboratory's equipment; or

(12) The physical appearances of Bottles A and B (when a split specimen collection is used) are clearly different, and either the test result for Bottle A indicated it is an invalid specimen or the specimen in Bottle A was screened negative for drugs, or both.

(g) Additional testing by a second laboratory. If the presence of an interfering substance/adulterant is suspected that could make a test result invalid, but it cannot be identified (e.g., a new adulterant), laboratory personnel shall consult with the licensee's or other entity's MRO and, with the MRO's agreement, shall send the specimen to another HHS-certified laboratory that has the capability to identify the suspected substance.

(h) Validity test cutoff levels. Licensees and other entities may use more stringent cutoff levels for validity tests than those specified in this section only if the testing is performed at an HHS-certified laboratory.

[73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71460, Nov. 22, 2022]

§ 26.163 Cutoff levels for drugs and drug metabolites.

(a) Initial drug testing. (1) HHS-certified laboratories shall apply the following cutoff levels for initial testing of specimens to determine whether they are negative or positive for the indicated drugs and drug metabolites, except as specified in paragraph (a)(2) of this section or the licensee or other entity has established more stringent cutoff levels:

Table 1 to Paragraph (a)(1)—Urine, Initial Test Cutoff Levels for Drugs and Drug Metabolites

Drugs or drug metabolites | Cutoff level [nanograms (ng)/mL]

Marijuana metabolites | 50

Cocaine metabolites | 150

Opioids:

Codeine/Morphine 1 | 2,000

Hydrocodone/Hydromorphone | 300

Oxycodone/Oxymorphone | 100

6-acetylmorphine (6-AM) | 10

Phencyclidine (PCP) | 25

Amphetamines: 2

AMP/MAMP 3 | 500

MDMA 4/MDA 5 | 500

1 Morphine is the target analyte for codeine/morphine testing.

2 Either a single initial test kit or multiple initial test kits may be used provided the single test kit detects each target analyte independently at the specified cutoff.

3 Methamphetamine (MAMP) is the target analyte for amphetamine (AMP)/MAMP testing.

4 Methylenedioxymethamphetamine.

5 Methylenedioxyamphetamine.

Table 2 to Paragraph (a)(1)—Oral Fluid, Initial Test Cutoff Levels for Drugs and Drug Metabolites

Drugs or drug metabolites | Cutoff level 1 [nanograms (ng)/mL]

Marijuana (THC) 2 3 | 4

Cocaine/Benzoylecgonine | 15

Opioids:

Codeine/Morphine | 30

Hydrocodone/Hydromorphone | 30

Oxycodone/Oxymorphone | 30

6-acetylmorphine (6-AM) | 4 3

Phencyclidine (PCP) | 10

Amphetamines:

AMP/MAMP 4 | 50

MDMA/MDA 5 | 50

1 For grouped analytes (i.e., two or more analytes in the same drug class with the same initial test cutoff):

• Immunoassay: The test must be calibrated with one analyte from the group identified as the target analyte. The cross reactivity of the immunoassay to the other analyte(s) within the group must be 80 percent or greater; if not, separate immunoassays must be used for the analytes within the group.

• Alternative technology: Either one analyte or all analytes from the group must be used for calibration, depending on the technology. At least one analyte within the group must have a concentration equal to or greater than the initial test cutoff or, alternatively, the sum of the analytes present.

2 An immunoassay must be calibrated with the target analyte, delta-9-tetrahydrocannabinol (THC).

3 Alternate technology (THC and 6-AM): The confirmatory tests cutoff must be used for an alternate technology initial test that is specific for the target analyte (i.e., 2 ng/mL for THC, 2 ng/mL for 6-AM).

4 Amphetamine (AMP) and methamphetamine (MAMP).

5 Methylenedioxymethamphetamine (MDMA) and methylenedioxyamphetamine (MDA).

(2) HHS-certified laboratories shall conduct special analyses of specimens as follows:

(i) If initial validity testing indicates that a specimen is dilute, or if a specimen is collected under direct observation for any of the conditions specified in § 26.115(a)(1) through (3) or (a)(5), the laboratory shall compare the immunoassay responses of the specimen to the cutoff calibrator in each drug class tested;

(ii) If any immunoassay response is equal to or greater than 40 percent of the cutoff calibrator, the laboratory shall conduct confirmatory drug testing of the specimen to the LOQ for those drugs and/or drug metabolites; and

(iii) The laboratory shall report the numerical values obtained from this special analysis to the MRO.

(b) Confirmatory drug testing. (1) A specimen that is identified as positive on an initial drug test must be subject to confirmatory testing for the class(es) of drugs for which the specimen initially tested positive. The HHS-certified laboratory shall apply the confirmatory cutoff levels specified in this paragraph, except as permitted in paragraph (a)(2) of this section or the licensee or other entity has established more stringent cutoff levels.

Table 3 to Paragraph (b)(1)—Urine, Confirmatory Test Cutoff Levels for Drugs and Drug Metabolites

Drugs or drug metabolites | Cutoff level (ng/mL)

Marijuana metabolite 1 | 15

Cocaine metabolite 2 | 100

Opioids:

Morphine | 2,000

Codeine | 2,000

Hydrocodone | 100

Hydromorphone | 100

Oxycodone | 100

Oxymorphone | 100

6-acetylmorphine (6-AM) | 10

Phencyclidine (PCP) | 25

Amphetamines:

Amphetamine | 250

Methamphetamine 3 | 250

Methylenedioxymethamphetamine (MDMA) | 250

Methylenedioxyamphetamine (MDA) | 250

1 As delta-9-tetrahydrocannabinol-9-carboxylic acid (THCA).

2 As benzoylecgonine.

3 To be reported positive for methamphetamine, a specimen must also contain amphetamine at a concentration equal to or greater than 100 ng/mL.

Table 4 to Paragraph (b)(1)—Oral Fluid, Confirmatory Test Cutoff Levels for Drugs and Drug Metabolites

Drugs or drug metabolites | Cutoff level [nanograms (ng)/mL]

Marijuana (THC) | 2

Cocaine | 8

Benzoylecgonine | 8

Opioids:

Codeine | 15

Morphine | 15

Hydrocodone | 15

Hydromorphone | 15

Oxycodone | 15

Oxymorphone | 15

6-acetylmorphine (6-AM) | 2

Phencyclidine (PCP) | 10

Amphetamines:

Amphetamine | 25

Methamphetamine | 25

Methylenedioxymethamphetamine (MDMA) | 25

Methylenedioxyamphetamine (MDA) | 25

(2) Each confirmatory drug test must provide a quantitative result. When the concentration of a drug or metabolite exceeds the linear range of the standard curve, the laboratory may record the result as “exceeds the linear range of the test” or as “equal to or greater than <insert the value for the upper limit of the linear range>,” or may dilute an aliquot of the specimen to obtain an accurate quantitative result when the concentration is above the upper limit of the linear range.

[73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71460, Nov. 22, 2022]

§ 26.165 Testing split specimens and retesting single specimens.

(a) Testing split specimens. (1) If a specimen has been split into Bottle A and Bottle B at the collection site, and the specimen was not initially tested at a licensee testing facility, then the HHS-certified laboratory shall perform initial and confirmatory validity and drug testing, if required, of the specimen in Bottle A.

(2) If a specimen was initially tested at a licensee testing facility and positive or questionable validity test results were obtained, then the HHS-certified laboratory shall perform initial and confirmatory testing, if required, of the specimen in Bottle A.

(3) At the licensee's or other entity's discretion, Bottle B must either be forwarded to the HHS-certified laboratory or maintained in secure storage at the licensee testing facility, as required by § 26.135(a) and (c), as applicable. If the specimen in Bottle A is free of any evidence of drugs or drug metabolites, and is a valid specimen, then the licensee testing facility or HHS-certified laboratory may discard the specimens in Bottles A and B.

(b) Donor request to MRO for a retest of a single specimen or testing Bottle B of a split specimen. (1) For a confirmed positive, adulterated, or substituted result reported on a single specimen of 30 mL or more, or a specimen in Bottle A of a split specimen which the donor submitted to the licensee or other entity, a donor may request (through the MRO) that an aliquot from the single specimen or the split (Bottle B) specimen be tested by a second HHS-certified laboratory to verify the result reported by the first laboratory. For an invalid test result, a donor may not request that an aliquot from the single specimen or the split specimen in Bottle B be tested by a second HHS-certified laboratory.

(2) The MRO shall inform the donor that he or she may, within 3 business days of notification by the MRO of the confirmed positive, adulterated, or substituted test result, request the retesting of an aliquot of the single specimen or the testing of the Bottle B split specimen. The MRO shall provide the donor with specific instructions for making this request (i.e., providing telephone numbers or other contact information). The MRO shall have the ability to receive the donor's calls at all times during the 3-day period (e.g., by use of an answering machine with a “time stamp” feature when there is no one in the MRO's office to answer the phone). The donor's request may be oral or in writing. The MRO shall document in his or her records when (i.e., date and time) the request was received from the donor to retest an aliquot of the single specimen or to test the Bottle B split specimen.

(3) No entity, other than the MRO as permitted in § 26.185(l), may order the retesting of an aliquot of the single specimen or the testing of the Bottle B split specimen.

(4) If the donor has not requested a retest of an aliquot of a single specimen or a test of the split specimen (Bottle B) within 3 business days, the donor may present to the MRO information documenting that serious injury, illness, lack of actual notice of the confirmed test result, inability to contact the MRO (e.g., there was no one in the MRO's office and the answering machine was not working), or other circumstances unavoidably prevented the donor from making a timely request. If the MRO concludes from the donor's information that there was a legitimate reason for the donor's failure to contact the MRO within the 3 business days permitted, the MRO shall direct the retesting of an aliquot of the single specimen or the test of the split specimen (Bottle B) take place, as if the donor had made a timely request.

(5) As soon as reasonably practical and not more than 1 business day following the day of the donor's request, as permitted in paragraph (b)(3) or (b)(4) of this section, the MRO shall ensure that the HHS-certified laboratory forwards an aliquot of a single specimen, or that the HHS-certified laboratory (or licensee testing facility, as appropriate) forwards Bottle B of a split specimen, to a second HHS-certified laboratory that did not test the specimen in Bottle A.

(6) The HHS-certified laboratory that retests an aliquot of a single specimen or tests the specimen in Bottle B shall provide quantitative test results to the MRO and the MRO shall provide them to the donor.

(c) Retesting a specimen for drugs. (1) The second laboratory shall use its confirmatory drug test when retesting an aliquot of a single specimen or testing Bottle B of a split specimen for the drug(s) or drug metabolite(s) for which the first laboratory reported a positive result(s), including retesting specimens that have been subject to the special analysis permitted in § 26.163(a)(2).

(2) Because some drugs or drug metabolites may deteriorate during storage, the retest by the second laboratory is not subject to a specific drug cutoff level, but must provide data sufficient to reconfirm the presence of the drug(s) or drug metabolite(s) down to the assay's LOD.

(3) If the second laboratory fails to reconfirm the presence of the drug(s) or drug metabolite(s) for which the first laboratory reported a positive result(s), the second laboratory shall attempt to determine the reason for not reconfirming the first laboratory's findings by conducting specimen validity tests. The second laboratory shall conduct the same specimen validity tests it would conduct on a single specimen or the specimen in Bottle A of a split specimen.

(4) The second laboratory shall report all results to the licensee's or other entity's MRO.

(d) Retesting a specimen for adulterants. A second laboratory shall use the required confirmatory validity test and criteria in § 26.161(c) to reconfirm an adulterant result when retesting an aliquot from a single specimen or when testing Bottle B of a split specimen. The second laboratory may only conduct the confirmatory validity test needed to reconfirm the adulterant result reported by the first laboratory.

(e) Retesting a specimen for substitution. A second laboratory shall use its confirmatory creatinine and confirmatory specific gravity tests, when retesting an aliquot of a single specimen or testing Bottle B of a split specimen, to reconfirm that the creatinine concentration was less than 2 mg/dL and the specific gravity was less than or equal to 1.0010 or equal to or greater than 1.0200. The second laboratory may only conduct the confirmatory creatinine and specific gravity tests to reconfirm the substitution result reported by the first laboratory.

(f) Management actions and sanctions. (1) If the MRO confirms a positive, adulterated, or substituted test result(s) from the first HHS-certified laboratory and the donor requests testing of Bottle B of a split specimen or retesting of an aliquot from a single specimen, the licensee or other entity shall administratively withdraw the individual's authorization on the basis of the first confirmed positive, adulterated, or substituted test result until the results of testing Bottle B or retesting an aliquot of the single specimen are available and have been reviewed by the MRO. If the MRO reports that the results of testing Bottle B or retesting the aliquot of a single specimen reconfirm any of the original positive, adulterated, or substituted test result(s), the licensee or other entity shall impose the appropriate sanctions specified in subpart D. If the results of testing Bottle B or retesting the aliquot of a single specimen are negative, the MRO shall report a cancelled test result to the licensee or other entity, and the licensee and other entity—

(i) May not impose any sanctions on the individual;

(ii) Shall eliminate from the donor's personnel file and other records any matter that could link the individual to the temporary administrative action;

(iii) May not disclose the temporary administrative action in response to a suitable inquiry conducted under the provisions of § 26.63 or to any other inquiry or investigation required in this chapter. To ensure that no records have been retained, access to the system of files and records must be provided to personnel conducting reviews, inquiries into allegations, or audits under the provisions of § 26.41, or to NRC inspectors; and

(iv) Shall provide the tested individual with a written statement that the records specified in §§ 26.713 and 26.715 have not been retained and shall inform the individual in writing that the temporary administrative action that was taken will not be disclosed and need not be disclosed by the individual in response to requests for self-disclosure of potentially disqualifying FFD information.

(2) If a donor requests that Bottle B be tested or that an aliquot of the single specimen be retested, and either Bottle B or the single specimen are not available due to circumstances outside of the donor's control (including, but not limited to, circumstances in which there is an insufficient quantity of the single specimen or the specimen in Bottle B to permit retesting, either Bottle B or the original single specimen is lost in transit to the second HHS-certified laboratory, or Bottle B has been lost at the HHS-certified laboratory or licensee testing facility), the MRO shall cancel the test, report a cancelled test result to the licensee or other entity for the donor's specimen, and inform the licensee or other entity that another collection is required under direct observation as soon as reasonably practical. The donor shall receive no notice of the collection requirement before he or she is instructed to proceed to the collection site. The licensee or other entity shall continue to administratively withdraw the individual's authorization, as required by § 26.165(f)(1) until the results of the second specimen collection have been received by the MRO. The licensee or other entity shall eliminate from the donor's personnel and other records any matter that could link the donor to the original positive, adulterated, or substituted test result(s) and any temporary administrative action, and may not impose any sanctions on the donor for a cancelled test. If test results from the second specimen collected are positive, adulterated, or substituted and the MRO determines that the donor has violated the FFD policy, the licensee or other entity shall impose the appropriate sanctions specified in subpart D of this part, but may not consider the original confirmed positive, adulterated, or substituted test result that was reported as a cancelled test by the MRO under § 26.129(b)(2) or § 26.159(b)(2) in determining the appropriate sanctions.

[73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71461, Nov. 22, 2022]

§ 26.167 Quality assurance and quality control.

(a) Quality assurance program. Each HHS-certified laboratory shall have a quality assurance program that encompasses all aspects of the testing process, including, but not limited to, specimen accessioning, chain of custody, security and reporting of results, initial and confirmatory testing, certification of calibrators and controls, and validation of analytical procedures. The performance characteristics (e.g., accuracy, precision, LOD, limit of quantitation (LOQ), specificity) of each test must be validated and documented for each test. Validation of procedures must document that carryover does not affect the donor's specimen results. Periodic re-verification of analytical procedures is required. Quality assurance procedures must be designed, implemented, and reviewed to monitor the conduct of each step of the testing process.

(b) Calibrators and controls required. Each analytical run of specimens for which an initial or confirmatory validity test, or an initial or confirmatory drug test, is being performed must include the appropriate calibrators and controls.

(c) Quality control requirements for performing initial and confirmatory validity tests on urine. (1) Requirements for performing creatinine tests:

(i) The creatinine concentration must be measured to one decimal place on both the initial and the confirmatory creatinine tests;

(ii) The initial creatinine test must have a calibrator at 2 mg/dL;

(iii) The initial creatinine test must have a control in the range of 1 to 1.5 mg/dL, a control in the range of 3 to 20 mg/dL, and a control in the range of 21 to 25 mg/dL; and

(iv) The confirmatory creatinine test (performed on those specimens with a creatinine concentration less than 2 mg/dL on the initial test) must have a calibrator at 2 mg/dL, a control in the range of 1.0 to 1.5 mg/dL, and a control in the range of 3 to 4 mg/dL.

(2) Requirements for performing specific gravity tests:

(i) The refractometer must report and display the specific gravity to four decimal places, and must be interfaced with a laboratory information management system, or computer, and/or generate a hard copy or digital electronic display to document the numerical result;

(ii) The initial and confirmatory specific gravity tests must have a calibrator or control at 1.0000; and

(iii) The initial and confirmatory specific gravity tests must have the following controls:

(A) One control targeted at 1.0020;

(B) One control in the range of 1.0040 to 1.0180; and

(C) One control equal to or greater than 1.0200 but not greater than 1.0250.

(3) Requirements for performing pH tests:

(i) Colorimetric pH tests that have the dynamic range of 2 to 12 to support the 3 and 11 pH cutoffs and pH meters must be capable of measuring pH to one decimal place. Dipsticks, colorimetric pH tests, and pH paper that have a narrow dynamic range and do not support the 2 to 12 pH cutoffs may be used only to determine whether initial validity tests must be performed;

(ii) At a minimum, pH screening tests must have the following controls:

(A) One control below the lower decision point in use;

(B) One control between the decision points in use; and

(C) One control above the upper decision point in use;

(iii) If a pH screening test is not used, an initial pH meter test must have the following calibrators and controls:

(A) One calibrator at 4;

(B) One calibrator at 7;

(C) One calibrator at 10;

(D) One control in the range of 2 to 2.8;

(E) One control in the range of 3.2 to 4;

(F) One control in the range of 10 to 10.8; and

(G) One control in the range of 11.2 to 12;

(iv) If a pH screening test is used, an initial or confirmatory pH meter test must have the following calibrators and controls when the screening result indicates that the pH is below the lower decision point in use:

(A) One calibrator at 4;

(B) One calibrator at 7;

(C) One control in the range of 2 to 2.8; and

(D) One control in the range of 3.2 to 4;

(v) If a pH screening test is used, an initial or confirmatory pH meter test must have the following calibrators and controls when the screening result indicates that the pH is above the upper decision point in use:

(A) One calibrator at 7;

(B) One calibrator at 10;

(C) One control in the range of 10 to 10.8; and

(D) One control in the range of 11.2 to 12; and

(vi) An initial colorimetric pH test must have the following calibrators and controls:

(A) One calibrator at 3;

(B) One calibrator at 11;

(C) One control in the range of 2 to 2.8;

(D) One control in the range of 3.2 to 4;

(E) One control in the range of 4.5 to 9;

(F) One control in the range of 10 to 10.8;

(G) One control in the range of 11.2 to 12.

(4) Requirements for performing oxidizing adulterant tests:

(i) Initial tests for oxidizing adulterants must include a calibrator at the appropriate cutoff concentration for the compound of interest as specified in § 26.161(c) and (f), a control without the compound of interest (i.e., a certified negative control), and at least one control with one of the compounds of interest at a measurable concentration; and

(ii) A confirmatory test for a specific oxidizing adulterant must use a different analytical method than that used for the initial test. Each confirmatory analytical run must include a calibrator at the appropriate cutoff concentration for the compound of interest as specified in § 26.161(c) and (f), a control without the compound of interest (i.e., a certified negative control), and a control with the compound of interest at a measurable concentration.

(5) Requirements for performing nitrite tests: The initial and confirmatory nitrite tests must have a calibrator at the cutoff concentration, a control without nitrite (i.e., certified negative urine specimen), one control in the range of 200 to 400 mcg/mL, and one control in the range of 500 to 625 mcg/mL.

(6) Requirements for performing “other” adulterant tests:

(i) The initial and confirmatory tests for any “other” adulterant that may be identified in the future must satisfy the requirements in § 26.161(a);

(ii) The confirmatory test for “other” adulterants must use a different analytical principle or chemical reaction than that used for the initial test; and

(iii) The initial and confirmatory tests for “other” adulterants must include an appropriate calibrator, a control without the compound of interest (i.e., a certified negative control), and a control with the compound of interest at a measurable concentration.

(d) Quality control requirements for performing initial drug tests. (1) Any initial drug test of urine performed by an HHS-certified laboratory must use an immunoassay that meets the requirements of the Food and Drug Administration for commercial distribution. Non-instrumented immunoassay testing devices that are pending HHS/SAMHSA review and approval may not be used for initial drug testing under this part.

(2) HHS-certified laboratories may perform multiple initial drug tests for the same drug or drug class, provided that all tests meet the cutoffs and quality control requirements of this part. For example, an HHS-certified laboratory may use immunoassay technique “A” for all drugs using the licensee's or other entity's cutoff levels, but specimens testing positive for amphetamines may also be tested using immunoassay technique “B” to eliminate any possible positives due to structural analogues; or, a valid analytical result cannot be obtained using immunoassay technique “A” and immunoassay technique “B” is used in an attempt to obtain a valid analytical result.

(3) Quality control samples for each analytical run of specimens for initial testing must include—

(i) At least one control certified to contain no drug or drug metabolite;

(ii) At least one positive control with the drug or drug metabolite targeted at 25 percent above the cutoff;

(iii) At least one positive control with the drug or drug metabolite targeted at 75 percent of the cutoff;

(iv) A sufficient number of calibrators to ensure and document the linearity of the assay method over time in the concentration area of the cutoff (after acceptable values are obtained for the known calibrators, those values will be used to calculate sample data); and

(v) At least one control that appears to be a donor specimen to the laboratory analysts.

(4) A minimum of 10 percent of the total specimens in each analytical run must be quality control samples (i.e., calibrators and controls), as defined by paragraphs (d)(3)(i) through (iv) of this section.

(e) Quality control requirements for performing confirmatory drug tests. (1) Confirmatory tests for drugs and drug metabolites must be performed using gas chromatography/mass spectrometry (GC/MS) or other confirmatory test methodologies that HHS-certified laboratories are permitted to use in Federal workplace drug testing programs for this purpose.

(2) A minimum of 10 percent of the total specimens in each analytical run must be quality control samples (i.e., calibrators and controls).

(3) Each analytical run of specimens that are subjected to confirmatory testing must include—

(i) At least one control certified to contain no drug or drug metabolite;

(ii) A calibrator with its drug concentration at the cutoff;

(iii) At least one positive control with the drug or drug metabolite targeted at 25 percent above the cutoff; and

(iv) At least one control targeted at or below 40 percent of the cutoff.

(f) Errors in testing. The licensee or other entity shall ensure that the HHS-certified laboratory investigates any testing errors or unsatisfactory performance discovered in blind performance testing, as required under § 26.168, in the testing of actual specimens, or through the processing of reviews, as well as any other errors or matters that could adversely reflect on the testing process.

(1) Whenever possible, the investigation must determine relevant facts and identify the root cause(s) of the testing or process error. The licensee or other entity, and the HHS-certified laboratory, shall take action to correct the causes of any errors or unsatisfactory performance that are within each entity's control. Sufficient records shall be maintained to furnish evidence of activities affecting quality. The licensee or other entity shall assure that the cause of the condition is determined and that corrective action is taken to preclude repetition. The identification of the significant condition, the cause of the condition, and the corrective action taken shall be documented and reported to appropriate levels of management.

(2) If a false positive error occurs on a blind performance test sample or on a regular specimen, the licensee or other entity shall require the laboratory to take corrective action to minimize the occurrence of the particular error in the future. If there is reason to believe that the error could have been systematic, the licensee or other entity may also require review and re-analysis of previously run specimens.

(3) If a false positive error occurs on a blind performance test sample and the error is determined to be technical or methodological, the licensee or other entity shall instruct the laboratory to provide all quality control data from the batch or analytical run of specimens that included a false positive sample. In addition, the licensee or other entity shall require the laboratory to retest all specimens that analyzed as positive for that drug or metabolite, or as adulterated, substituted, dilute, or invalid in validity testing, from the time of final resolution of the error back to the time of the last satisfactory performance test cycle. This retesting must be documented by a statement signed by the laboratory's Responsible Person. The licensee or other entity and the NRC also may require an onsite review of the laboratory, which may be conducted unannounced during any hours of operation of the laboratory.

(g) Accuracy. Volumetric pipettes and measuring devices must be certified for accuracy or be checked by gravimetric, colorimetric, or other verification procedures. Automatic pipettes and dilutors must be checked for accuracy and reproducibility both before being placed in service and periodically thereafter.

(h) Calibrators and controls. Laboratory calibrators and controls must be prepared using pure drug reference materials, stock standard solutions obtained from other laboratories, or standard solutions that are obtained from commercial manufacturers and are properly labeled as to content and concentration. Calibrators and controls may not be prepared from the same stock solution. The standards and controls must be labeled with the following dates: when received; when prepared or opened; when placed in service; and when scheduled for expiration.

[73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71462, Nov. 22, 2022]

§ 26.168 Blind performance testing.

(a) Each licensee and other entity shall submit blind performance test samples to the HHS-certified laboratory.

(1) During the initial 90-day period of any contract with an HHS-certified laboratory (not including rewritten or renewed contracts), each licensee or other entity shall submit blind performance test samples to each HHS-certified laboratory with whom it contracts in the amount of at least 20 percent of the total number of specimens submitted (up to a maximum of 100 blind performance test samples) or 30 blind performance test samples, whichever is greater.

(2) Following the initial 90-day period, the number of blind performance test samples submitted per quarter must be a minimum of one percent of all specimens (up to a maximum of 100) or ten blind performance test samples, whichever is greater.

(3) Both during the initial 90-day period and quarterly thereafter, licensees and other entities should attempt to submit blind performance test samples at a frequency that corresponds to the submission frequency for other specimens.

(b) Approximately 60 percent of the blind performance test samples submitted to the laboratory must be positive for one or more drugs or drug metabolites per sample and submitted so that all of the drugs for which the FFD program is testing are included at least once each calendar quarter, except as follows:

(1) Licensees and other entities shall submit blind performance test samples that are positive for marijuana metabolite at least two times each quarter; and

(2) In at least two quarters each year, licensees and other entities shall submit an additional blind performance test sample that is positive for cocaine instead of the required sample that is positive for PCP.

(c) The positive blind performance test samples must be positive for only those drugs for which the FFD program is testing and formulated at concentrations established in paragraph (g)(2) of this section.

(d) To challenge the HHS-certified laboratory's ability to limit false negatives, approximately 10 percent of the blind performance test samples submitted to the laboratory each quarter must be formulated at the concentrations established in paragraph (g)(3) of this section.

(e) To challenge the HHS-certified laboratory's ability to determine specimen validity, the licensee or other entity shall submit blind performance test samples each quarter that are appropriately adulterated, diluted, or substituted, in the amount of 20 percent of the specimens submitted that quarter or at least three samples per quarter (one each that is adulterated, diluted, or substituted), whichever is greater. These samples must be formulated at the concentrations established in paragraphs (g)(4) through (g)(6) of this section.

(f) Approximately 10 percent of the blind performance test samples submitted to the laboratory each quarter must be negative, as specified in paragraph (g)(1) of this section.

(g) Licensees and other entities shall use only blind performance test samples that have been certified by the supplier to be—

(1) Negative. A negative blind performance test sample may not contain a measurable amount of a target drug analyte and must be certified by immunoassay and confirmatory testing;

(2) Drug positive. These samples must contain a measurable amount of the target drug or analyte in concentrations ranging between 150 and 200 percent of the initial cutoff values and be certified by immunoassay and confirmatory testing to contain one or more drug(s) or drug metabolite(s);

(3) A false negative challenge. This blind performance test sample must contain a measurable amount of the target drug or analyte in concentrations ranging between 130 and 155 percent of the initial cutoff values;

(4) Adulterated. The adulterated blind performance test sample must have a pH of less than or equal to 2, or greater than or equal to 12, or a nitrite or other oxidant concentration equal to or greater than 500 mcg/mL, equal to or greater than 50 mcg/mL chromium (VI)-equivalents, or a halogen concentration equal to or greater than the LOD. Blind performance test samples for other adulterants must have adulterant concentrations equal to or greater than (or equal to or less than, as appropriate) the initial cutoff levels used by the licensee's or other entity's HHS-certified laboratory;

(5) Dilute. The dilute blind performance test sample must contain a creatinine concentration that is equal to or greater than 5 mg/dL but less than 20 mg/dL, and the specific gravity must be greater than 1.0010 but less than 1.0030; or

(6) Substituted. The substituted blind performance test sample must contain less than 2 mg/dL of creatinine, and the specific gravity must be less than or equal to 1.0010, or equal to or greater than 1.0200.

(h) In order to ensure that blind performance test samples continue to meet the criteria set forth in paragraph (g) of this section, licensees and other entities shall—

(1) Ensure that all blind performance test sample lots are placed in service by the supplier only after confirmation by an HHS-certified laboratory;

(2) Ensure that the supplier provides the expiration date for each blind performance test sample to ensure that each sample will have the expected value when it is submitted to and tested by a laboratory; and

(3) At a minimum, require the supplier to check each open lot bi-monthly (i.e., every two months) to ensure that samples remaining in the lot do not fall below 130 percent of the initial cutoff test concentration established by the assay manufacturer. Thus, for example, a lot that was certified by an HHS-certified laboratory at 155 percent of the manufacturer's assay cutoff level, and was reported by the licensee's or other entity's HHS-certified laboratory to be at or above 130 percent of that standard is acceptable. A test that indicated a result below 130 percent of that standard would be unacceptable. Licensees and other entities shall discard blind performance test samples from any lot that is outside of these parameters and may not use any further samples from that lot.

(i) Licensees and other entities shall ensure that each blind performance test sample is indistinguishable to laboratory personnel from a donor's specimen, as follows:

(1) The licensee or other entity shall submit blind performance test samples to the laboratory using the same channels (i.e., from the licensee's or other entity's collection site or licensee testing facility, as appropriate) through which donors' specimens are sent to the laboratory;

(2) The collector and licensee testing facility personnel, as appropriate, shall use a Federal CCF, place fictional initials on the specimen bottles' labels/seals, and indicate for the MRO on the MRO's copy that the specimen is a blind performance test sample; and

(3) The licensee or other entity shall ensure that all blind performance test samples include split samples, when the FFD program includes split specimen procedures.

[73 FR 17176, Mar. 31, 2008, as amended at 81 FR 86909, Dec. 2, 2016; 87 FR 71462, Nov. 22, 2022]

§ 26.169 Reporting Results.

(a) The HHS-certified laboratory shall report test results to the licensee's or other entity's MRO within 5 business days after receiving the specimen from the licensee or other entity. Before reporting any test result to the MRO, the laboratory's Certifying Scientist shall certify the result as correct. The report must identify the substances for which testing was performed; the results of the validity and drug tests; the cutoff levels for each; any indications of tampering, adulteration, or substitution that may be present; the specimen identification number assigned by the licensee or other entity; and the specimen identification number assigned by the laboratory.

(b) If licensees or other entities specify cutoff levels for drugs or drug metabolites that are more stringent than those specified in this part, the laboratory need only conduct the more stringent tests and shall report the results of the initial and confirmatory tests only for the more stringent cutoff levels.

(c) The HHS-certified laboratory shall report as negative all specimens that are negative on the initial or confirmatory drug and validity tests. Specimens that test as positive, adulterated, substituted, dilute, or invalid on the confirmatory analysis must be reported to the MRO as positive for a specific drug(s) or drug metabolite(s), or as meeting the criteria for an adulterated, substituted, dilute, or invalid specimen.

(1) The laboratory shall report all positive, adulterated, substituted, dilute, and invalid test results for each specimen to the MRO. For example, a specimen may be both adulterated and positive for one or more specific drugs.

(2) For a specimen that has a positive test result, the laboratory shall provide numerical values if the MRO requests such information. The MRO's request for positive confirmatory test results may be either a general request covering all such results or a specific case-by-case request. The laboratory shall routinely provide quantitative values for confirmatory test results for morphine or codeine that are greater than or equal to 15,000 ng/mL, even if the MRO has not requested quantitative values for the test result.

(3) For a specimen that has an adulterated or substituted test result, the laboratory shall provide the MRO with the numerical values that support the reported result. The MRO may not disclose the numerical values to the licensee or other entity, except as permitted in § 26.37(b). If the numerical values for creatinine are below the LOD, the laboratory shall report to the MRO “creatinine: none detected” (i.e., substituted) along with the numerical values of the specific gravity test.

(4) For a specimen that has an invalid result, the laboratory shall contact the MRO and both will decide whether testing by another certified laboratory would be useful in being able to report a positive or adulterated result. This contact may occur through any secure electronic means (e.g., telephone, fax, e-mail). If no further testing is necessary, the laboratory shall report the invalid result to the MRO.

(5) When the concentration of a drug, metabolite, or adulterant exceeds the linear range of the standard curve, the laboratory may report to the MRO that the quantitative value “exceeds the linear range of the test,” that the quantitative value is “equal to or greater than <insert the value for the upper limit of the linear range>,” or may report an accurate quantitative value above the upper limit of the linear range that was obtained by diluting an aliquot of the specimen.

(d) The MRO and MRO staff may not disclose quantitative test results to a licensee or other entity, but shall report only whether the specimen was positive (and for which analyte), adulterated, substituted, dilute, invalid, or negative, except as permitted under § 26.37(b). This paragraph does not preclude either the HHS-certified laboratory or the MRO from providing program performance data, as required under § 26.717.

(e) The laboratory may transmit results to the MRO by various electronic means (e.g., teleprinters, facsimile, or computer) in a manner designed to ensure the confidentiality of the information. The laboratory may not provide results orally by telephone. The licensee or other entity, directly or through the HHS-certified laboratory, shall ensure the security of the data transmission and ensure only authorized access to any data transmission, storage, and retrieval system.

(f) For negative test results, the HHS-certified laboratory may fax, courier, mail, or electronically transmit a computer-generated electronic report and/or a legible image or copy of the completed Federal CCF to the MRO. However, for positive, adulterated, substituted, dilute, and invalid results, the laboratory shall fax, courier, mail, or electronically transmit a legible image or copy of the completed Federal CCF to the MRO.

(g) For a specimen that has a positive, adulterated, substituted, dilute, or invalid result, the laboratory shall retain the original Federal CCF and transmit to the MRO a copy of the original Federal CCF signed by a certifying scientist.

(h) The HHS-certified laboratory shall provide to the licensee's or other entity's official responsible for coordination of the FFD program an annual statistical summary of testing, which may not include any personal identifying information. To avoid sending data from which it is likely that information about a donor's test result can be readily inferred, the laboratory may not send a summary report if the licensee or other entity has fewer than 10 specimen test results in a 1-year period. The summary report must include test results that were reported within the year period. The laboratory shall send the summary report to the licensee or other entity within 14 calendar days after the end of the 1-year period covered by the report. The statistics must be presented either for the cutoff levels specified in this part or for any more stringent cutoff levels that the licensee or other entity may specify. The HHS-certified laboratory shall make available quantitative results for all specimens tested when requested by the NRC, licensee, or other entity for whom the laboratory is performing drug-testing services. If the FFD program tests for additional drugs beyond those listed in § 26.31(d), the summary must include drug test results for the additional drugs. The summary report must contain the following information:

(1) Total number of specimens received;

(2) Number of specimens reported as—

(i) Negative, and

(ii) Negative and dilute;

(3) Number of specimens reported as positive on confirmatory tests by drug or drug metabolite for which testing is conducted, including, but not limited to—

(i) Marijuana metabolite (as THCA);

(ii) Cocaine metabolite (as benzoylecgonine);

(iii) Opioids (total);

(A) Codeine;

(B) Morphine;

(C) 6-acetylmorphine (6-AM);

(D) Hydrocodone;

(E) Hydromorphone;

(F) Oxycodone; and

(G) Oxymorphone;

(iv) Phencyclidine (PCP);

(v) Amphetamines (total);

(A) Amphetamine;

(B) Methamphetamine;

(C) Methylenedioxymethamphetamine (MDMA); and

(D) Methylenedioxyamphetamine (MDA);

(4) Total number of specimens reported as adulterated;

(5) Total number of specimens reported as substituted;

(6) Total number of specimens reported as positive and dilute [including an indication as to whether the specimen was subject to the special analysis permitted in § 26.163(a)(2)];

(7) Total number of specimens reported as invalid; and

(8) Number of specimens reported as rejected for testing and the reason for the rejection.

[73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71462, Nov. 22, 2022]

§ 26.181 Purpose.

This subpart contains requirements for determining whether a donor has violated the FFD policy and for making a determination of fitness.

§ 26.183 Medical review officer.

(a) Qualifications. The MRO shall be knowledgeable of this part and of the FFD policies of the licensees and other entities for whom the MRO provides services. The MRO shall be a physician holding either a Doctor of Medicine or Doctor of Osteopathy degree who is licensed to practice medicine by any State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico. The MRO shall have passed an examination administered by a nationally-recognized MRO certification board or subspecialty board for medical practitioners in the field of medical review of Federally mandated drug tests.

(b) Relationships. The MRO may be an employee of the licensee or other entity or a contractor. However, the MRO may not be an employee or agent of, or have any financial interest in, an HHS-certified laboratory or a contracted operator of a licensee testing facility for whom the MRO reviews drug test results. Additionally, the MRO may not derive any financial benefit by having the licensee or other entity use a specific drug testing laboratory or licensee testing facility operating contractor and may not have any agreement with such parties that may be construed as a potential conflict of interest. Examples of relationships between laboratories and MROs that create conflicts of interest, or the appearance of such conflicts, include, but are not limited to—

(1) The laboratory employs an MRO who reviews test results produced by the laboratory;

(2) The laboratory has a contract or retainer with the MRO for the review of test results produced by the laboratory;

(3) The laboratory designates which MRO the licensee or other entity is to use, gives the licensee or other entity a slate of MROs from which to choose, or recommends certain MROs;

(4) The laboratory gives the licensee or other entity a discount or other incentive to use a particular MRO;

(5) The laboratory has its place of business co-located with that of an MRO or MRO staff who review test results produced by the laboratory; or

(6) The laboratory permits an MRO, or an MRO's organization, to have a financial interest in the laboratory.

(c) Responsibilities. The primary role of the MRO is to review and interpret positive, adulterated, substituted, invalid, and dilute test results obtained through the licensee's or other entity's testing program and to identify any evidence of subversion of the testing process. The MRO is also responsible for identifying any issues associated with collecting and testing specimens, and for advising and assisting FFD program management in planning and overseeing the overall FFD program.

(1) In carrying out these responsibilities, the MRO shall examine alternate medical explanations for any positive, adulterated, substituted, invalid, or dilute test result. This action may include, but is not limited to, conducting a medical interview with the donor, reviewing the donor's medical history, or reviewing any other relevant biomedical factors. The MRO shall review all medical records that the donor may make available when a positive, adulterated, substituted, invalid, or dilute test result could have resulted from responsible use of legally prescribed medication, a documented condition or disease state, or the demonstrated physiology of the donor.

(2) The MRO may only consider the results of tests of specimens that are collected and processed under this part, including the results of testing split specimens, in making his or her determination, as long as those split specimens have been stored and tested under the procedures described in this part.

(d) MRO staff. Individuals who provide administrative support to the MRO may be employees of a licensee or other entity, employees of the MRO, or employees of an organization with whom a licensee or other entity contracts for MRO services. Employees of a licensee or other entity who serve MRO staff functions may also perform other duties for the licensee or other entity and need not be under the direction of the MRO while performing those other duties.

(1) Direction of MRO staff activities. MROs shall be directly responsible for all administrative, technical, and professional activities of individuals who are serving MRO staff functions while they are performing those functions, and those functions must be under the MRO's direction.

(i) The duties of MRO staff must be maintained independent from any other activity or interest of a licensee or other entity, in order to protect the integrity of the MRO function and donors' privacy.

(ii) An MRO's responsibilities for directing MRO staff must include, but are not limited to, ensuring that—

(A) The procedures being performed by MRO staff meet NRC regulations and HHS' and professional standards of practice;

(B) Records and other donor personal information are maintained confidential by MRO staff and are not released to other individuals or entities, except as permitted under this part;

(C) Data transmission is secure; and

(D) Drug test results are reported to the licensee's or other entity's designated reviewing official only as required by this part.

(iii) The MRO may not delegate any of his or her responsibilities for directing MRO staff to any other individual or entity, except another MRO.

(2) MRO staff responsibilities. MRO staff may perform routine administrative support functions, including receiving test results, reviewing negative test results, and scheduling interviews for the MRO.

(i) The staff under the direction of the MRO may receive, review, and report negative test results to the licensee's or other entity's designated representative.

(ii) The staff reviews of positive, adulterated, substituted, invalid, and dilute test results must be limited to reviewing the Federal CCF to determine whether it contains any errors that may require corrective action and to ensure that it is consistent with the information on the MRO's copy. The staff may resolve errors in Federal CCFs that require corrective action(s), but shall forward the Federal CCFs to the MRO for review and approval of the resolution.

(iii) The staff may not conduct interviews with donors to discuss positive, adulterated, substituted, invalid, or dilute test results nor request medical information from a donor. Only the MRO may request and review medical information related to a positive, adulterated, substituted, or invalid test result or other matter from a donor.

(iv) Staff may not report nor discuss with any individuals other than the MRO and other MRO staff any positive, adulterated, substituted, invalid, or dilute test results received from the HHS-certified laboratory before those results have been reviewed and confirmed by the MRO. Any MRO staff discussions of confirmed positive, adulterated, substituted, invalid, or dilute test results must be limited to discussions only with the licensee's or other entity's FFD program personnel and may not reveal quantitative test results or any personal medical information about the donor that the MRO may have obtained in the course of reviewing confirmatory test results from the HHS-certified laboratory.

[73 FR 17176, Mar. 31, 2008, as amended at 83 FR 58464, Nov. 20, 2018; 87 FR 71462, Nov. 22, 2022]

§ 26.185 Determining a fitness-for-duty policy violation.

(a) MRO review required. A positive, adulterated, substituted, dilute, or invalid drug test result does not automatically identify an individual as having used drugs in violation of the NRC's regulations, or the licensee's or other entity's FFD policy, or as having attempted to subvert the testing process. An individual who has a detailed knowledge of possible alternate medical explanations is essential to the review of the results. The MRO shall review all positive, adulterated, substituted, and invalid test results from the HHS-certified laboratory to determine whether the donor has violated the FFD policy before reporting the results to the licensee's or other entity's designated representative.

(b) Reporting of initial test results prohibited. Neither the MRO nor MRO staff may report positive, adulterated, substituted, dilute, or invalid initial test results that are received from the HHS-certified laboratory to the licensee or other entity.

(c) Discussion with the donor. Before determining that a positive, adulterated, substituted, dilute, or invalid test result or other occurrence is an FFD policy violation and reporting it to the licensee or other entity, the MRO shall give the donor an opportunity to discuss the test result or other occurrence with the MRO, except as described in paragraph (d) of this section. After this discussion, if the MRO determines that a positive, adulterated, substituted, dilute, or invalid test result or other occurrence is an FFD policy violation, the MRO shall immediately notify the licensee's or other entity's designated representative.

(d) Donor unavailability. The MRO may determine that a positive, adulterated, substituted, dilute, or invalid test result or other occurrence is an FFD policy violation without having discussed the test result or other occurrence directly with the donor in the following three circumstances:

(1) The MRO has made and documented contact with the donor and the donor expressly declined the opportunity to discuss the test result or other occurrence that may constitute an FFD policy violation;

(2) A representative of the licensee or other entity, or an MRO staff member, has successfully made and documented contact with the donor and has instructed him or her to contact the MRO, and more than 1 business day has elapsed since the date on which the licensee's representative or MRO's staff member successfully contacted the donor; or

(3) The MRO, after making all reasonable efforts and documenting the dates and time of those efforts, has been unable to contact the donor. Reasonable efforts include, at a minimum, three attempts, spaced reasonably over a 24-hour period, to reach the donor at the day and evening telephone numbers listed on the Federal CCF.

(e) Additional opportunity for discussion. If the MRO determines that the donor has violated the FFD policy without having discussed the positive, adulterated, substituted, dilute, or invalid test result or other occurrence directly with the donor, the donor may, on subsequent notification of the MRO determination and within 30 days of that notification, present to the MRO information documenting the circumstances, including, but not limited to, serious illness or injury, which unavoidably prevented the donor from being contacted by the MRO or a representative of the licensee or other entity, or from contacting the MRO in a timely manner. On the basis of this information, the MRO may reopen the procedure for determining whether the donor's test result or other occurrence is an FFD policy violation and permit the individual to present information related to the issue. The MRO may modify the initial determination based on an evaluation of the information provided.

(f) Review of invalid specimens. (1) If the HHS-certified laboratory reports an invalid result, the MRO shall consult with the laboratory to determine whether additional testing by another HHS-certified laboratory may be useful in determining and reporting a positive or adulterated test result. If the MRO and the laboratory agree that further testing would be useful, the HHS-certified laboratory shall forward the specimen to a second laboratory for additional testing.

(2) If the MRO and the laboratory agree that further testing would not be useful and there is no technical explanation for the result, the MRO shall contact the donor and determine whether there is an acceptable medical explanation for the invalid result. If there is an acceptable medical explanation, the MRO shall report to the licensee or other entity that the test result is not an FFD policy violation, but that a negative test result was not obtained. If the medical reason for the invalid result is, in the opinion of the MRO, a temporary condition, the licensee or other entity shall collect a second urine specimen from the donor as soon as reasonably practical and rely on the MRO's review of the test results from the second collection. The second specimen collected for the purposes of this paragraph may not be collected under direct observation. If the medical reason for the invalid result would similarly affect the testing of another urine specimen, the MRO may authorize an alternative method for drug testing. Licensees and other entities may not impose sanctions for an invalid test result due to a medical condition.

(3) If the MRO and the laboratory agree that further testing would not be useful and there is no legitimate technical or medical explanation, and the invalid result is based on pH in the range of 9.0 to 9.5, the MRO shall consider whether there is evidence of elapsed time, exposure of the specimen to high temperature, or both that could account for the pH value. If an acceptable explanation exists for the invalid test result due to pH, based on objective and sufficient information, that elapsed time, high temperature, or both caused the high pH and donor action did not result in the invalid pH result, the MRO shall report a cancelled test result to the licensee or other entity, cancel the test result, and direct the licensee or other entity to collect a second urine specimen from the donor as soon as reasonably practicable. The second specimen collected may not be collected under direct observation.

(4) If the MRO and the laboratory agree that further testing would not be useful and there is no legitimate technical or medical explanation for the invalid test result, the MRO shall require that a second collection take place as soon as practical under direct observation. The licensee or other entity shall rely on the MRO's review of the test results from the directly observed collection.

(g) Review of dilute specimens. (1) If the HHS-certified laboratory reports that a specimen is dilute and that drugs or drug metabolites were detected in the specimen at or above the cutoff levels specified in this part or the licensee's or other entity's more stringent cutoff levels, and the MRO determines that there is no legitimate medical explanation for the presence of the drugs or drug metabolites in the specimen, and a clinical examination, if required under paragraph (g)(3) of this section, has been conducted, the MRO shall determine that the drug test results are positive and that the donor has violated the FFD policy.

(2) If the results of the special analysis testing required by § 26.163(a)(2) are positive, the MRO determines that there is no legitimate medical explanation for the presence of the drug(s) or drug metabolite(s) in the specimen, and a clinical examination, if required under paragraph (g)(3) of this section, has been conducted under paragraph (j) of this section, the MRO shall determine whether the positive and dilute specimen is a refusal to test. If the MRO does not have sufficient reason to believe that the positive and dilute specimen is a subversion attempt, he or she shall determine that the drug test results are positive and that the donor has violated the FFD policy. When determining whether the donor has diluted the specimen in a subversion attempt, the MRO shall also consider the following circumstances, if applicable:

(i) The donor has presented, at this or a previous collection, a urine specimen that the HHS-certified laboratory reported as being substituted, adulterated, or invalid to the MRO and the MRO determined that there is no adequate technical or medical explanation for the result;

(ii) The donor has presented a urine specimen of 30 mL or more that falls outside the required temperature range, even if a subsequent directly observed collection was performed; or

(iii) The collector observed conduct indicating an attempt to dilute the specimen.

(3) If the drugs detected in a dilute specimen are opioids (i.e., morphine and/or codeine), or if the drugs or metabolites detected indicate the use of prescription or over-the-counter medications, before determining that the donor has violated the FFD policy under paragraph (a) of this section, the MRO or his/her designee, who shall also be a licensed physician with knowledge of the clinical signs of drug abuse, shall conduct the clinical examination for abuse of these substances that is required in paragraph (j) of this section. An evaluation for clinical evidence of abuse is not required if the laboratory confirms the presence of 6-AM (i.e., the presence of this metabolite is proof of heroin use) in the dilute specimen.

(4) An MRO review is not required for specimens that the HHS-certified laboratory reports as negative and dilute. The licensee or other entity may not take any administrative actions or impose any sanctions on a donor who submits a negative and dilute specimen.

(h) Review of substituted specimens. (1) If the HHS-certified laboratory reports a specimen as substituted (i.e., the creatinine concentration is less than 2 mg/dL and the specific gravity is less than or equal to 1.0010 or equal to or greater than 1.0200), the MRO shall contact the donor and offer the donor an opportunity to provide a legitimate medical explanation for the substituted result. The burden of proof resides solely with the donor, who must provide legitimate medical evidence within 5 business days that he or she produced the specimen for which the HHS-certified laboratory reported a substituted result. Any medical evidence must be submitted through a physician who is experienced and qualified in the medical issues involved, as verified by the MRO. Claims of excessive hydration, or claims based on unsubstantiated personal characteristics, including, but not limited to, race, gender, diet, and body weight, are not acceptable evidence without medical studies which demonstrate that the donor did produce the laboratory result.

(2) If the MRO determines that there is no legitimate medical explanation for the substituted test result, the MRO shall report to the licensee or other entity that the specimen was substituted.

(3) If the MRO determines that there is a legitimate medical explanation for the substituted test result and no drugs or drug metabolites were detected in the specimen, the MRO shall report to the licensee or other entity that no FFD policy violation has occurred.

(i) Review of adulterated specimens. (1) If the HHS-certified laboratory reports a specimen as adulterated with a specific substance, the MRO shall contact the donor and offer the donor an opportunity to provide a legitimate medical explanation for the adulterated result. The burden of proof resides solely with the donor, who must provide legitimate medical evidence within 5 business days that he or she produced the adulterated result. Any medical evidence must be submitted through a physician experienced and qualified in the medical issues involved, as verified by the MRO.

(2) If the MRO determines there is no legitimate medical explanation for the adulterated test result, the MRO shall report to the licensee or other entity that the specimen is adulterated.

(3) If the MRO determines that there is a legitimate medical explanation for the adulterated test result and no drugs or drug metabolites were detected in the specimen, the MRO shall report to the licensee or other entity that no FFD policy violation has occurred.

(j) Review for opioids and prescription and over-the-counter medications. (1) If the MRO determines that there is no legitimate medical explanation for a positive confirmatory test result for opioids (i.e., morphine and/or codeine) and before the MRO determines that the test result is a violation of the FFD policy, the MRO or his/her designee, who shall also be a licensed physician with knowledge of the clinical signs of drug abuse, shall determine that there is clinical evidence, in addition to the positive confirmatory test result, that the donor has illegally used morphine and/or codeine. This requirement does not apply if the laboratory confirms the presence of 6-AM (i.e., the presence of this metabolite is proof of heroin use), or the morphine or codeine concentration is equal to or greater than 15,000 ng/mL and the donor does not present a legitimate medical explanation for the presence of morphine or codeine at or above this concentration. The MRO may not determine that the consumption of food products is a legitimate medical explanation for the presence of morphine or codeine at or above this concentration.

(2) If the MRO determines that there is no legitimate medical explanation for a positive confirmatory test result for drugs other than opioids that are commonly prescribed or included in over-the-counter preparations (e.g., benzodiazepines in the first case, barbiturates in the second) and are listed in the licensee's or other entity's panel of substances to be tested, the MRO shall determine whether there is clinical evidence, in addition to the positive confirmatory test result, of abuse of any of these substances or their derivatives.

(3) If the MRO determines that the donor has used another individual's prescription medication, including a medication containing opioids (i.e., morphine and/or codeine), and no clinical evidence of drug abuse is found, the MRO shall report to the licensee or other entity that the donor has misused a prescription medication. If the MRO determines that the donor has used another individual's prescription medication and clinical evidence of drug abuse is found, the MRO shall report to the licensee that the donor has violated the FFD policy.

(4) In determining whether a legitimate medical explanation exists for a positive confirmatory test result for opioids or prescription or over-the-counter medications, the MRO may consider the use of a medication from a foreign country. The MRO shall exercise professional judgment consistently with the following principles:

(i) There can be a legitimate medical explanation only with respect to a drug that is obtained legally in a foreign country;

(ii) There can be a legitimate medical explanation only with respect to a drug that has a legitimate medical use. Use of a drug of abuse (e.g., heroin, PCP) or any other substance that cannot be viewed as having a legitimate medical use can never be the basis for a legitimate medical explanation, even if the drug is obtained legally in a foreign country; and

(iii) Use of the drug can form the basis of a legitimate medical explanation only if it is used consistently with its proper and intended medical purpose.

(5) The MRO may not consider consumption of food products, supplements, or other preparations containing substances that may result in a positive confirmatory drug test result, including, but not limited to supplements containing hemp products or coca leaf tea, as a legitimate medical explanation for the presence of drugs or drug metabolites in the urine specimen above the cutoff levels specified in § 26.163 or a licensee's or other entity's more stringent cutoff levels.

(6) The MRO may not consider the use of any drug contained in Schedule I of section 202 of the Controlled Substances Act [21 U.S.C. 812] as a legitimate medical explanation for a positive confirmatory drug test result, even if the drug may be legally prescribed and used under State law.

(k) Results consistent with legitimate drug use. If the MRO determines that there is a legitimate medical explanation for a positive confirmatory drug test result, and that the use of a drug identified through testing was in the manner and at the dosage prescribed, and the results do not reflect a lack of reliability or trustworthiness, then the donor has not violated the licensee's or other entity's FFD policy. The MRO shall report to the licensee or other entity that no FFD policy violation has occurred. The MRO shall further evaluate the positive confirmatory test result and medical explanation to determine whether use of the drug and/or the medical condition poses a potential risk to public health and safety as a result of the individual being impaired while on duty. If the MRO determines that such a risk exists, he or she shall ensure that a determination of fitness is performed.

(l) Retesting authorized. Should the MRO question the accuracy or scientific validity of a positive, adulterated, substituted, or invalid test result, only the MRO is authorized to order retesting of an aliquot of the original specimen or the analysis of any split specimen (Bottle B) in order to determine whether the FFD policy has been violated. Retesting must be performed by a second HHS-certified laboratory. The MRO is also the only individual who may authorize a reanalysis of an aliquot of the original specimen or an analysis of any split specimen (Bottle B) in response to a request from the donor tested.

(m) Result scientifically insufficient. Based on the review of inspection and audit reports, quality control data, multiple specimens, and other pertinent results, the MRO may determine that a positive, adulterated, substituted or invalid test result is scientifically insufficient for further action and may declare that a drug or validity test result is not an FFD policy violation, but that a negative test result was not obtained. In this situation, the MRO may request retesting of the original specimen before making this decision. The MRO is neither expected nor required to request such retesting, unless in the sole opinion of the MRO, such retesting is warranted. The MRO may request that the reanalysis be performed by the same laboratory, or that an aliquot of the original specimen be sent for reanalysis to another HHS-certified laboratory. The licensee testing facility and the HHS-certified laboratory shall assist in this review process, as requested by the MRO, by making available the individual(s) responsible for day-to-day management of the licensee testing facility or the HHS-certified laboratory, or other individuals who are forensic toxicologists or who have equivalent forensic experience in urine drug testing, to provide specific consultation as required by the MRO.

(n) Evaluating results from a second laboratory. After a second laboratory tests an aliquot of a single specimen or the split (Bottle B) specimen, the MRO shall take the following actions if the second laboratory reports the following results:

(1) If the second laboratory reconfirms any positive test results, the MRO may report an FFD policy violation to the licensee or other entity;

(2) If the second laboratory reconfirms any adulterated, substituted, or invalid validity test results, the MRO may report an FFD policy violation to the licensee or other entity;

(3) If the second laboratory does not reconfirm the positive test results, the MRO shall report that no FFD policy violation has occurred; or

(4) If the second laboratory does not reconfirm the adulterated, substituted, or invalid validity test results, the MRO shall report that no FFD policy violation has occurred.

(o) Re-authorization after a first violation for a positive test result. The MRO is responsible for reviewing drug test results from an individual whose authorization was terminated or denied for a first violation of the FFD policy involving a confirmed positive drug test result and who is being considered for re-authorization. In order to determine whether subsequent positive confirmatory drug test results represent new drug use or remaining metabolites from the drug use that initially resulted in the FFD policy violation, the MRO shall request from the HHS-certified laboratory, and the laboratory shall provide, quantitation of the test results and other information necessary to make the determination. If the drug for which the individual first tested positive was marijuana and the confirmatory assay for delta-9-tetrahydrocannabinol-9-carboxylic acid yields a positive result, the MRO shall determine whether the confirmatory test result indicates further marijuana use since the first positive test result, or whether the test result is consistent with the level of delta-9-tetrahydrocannabinol-9-carboxylic acid that would be expected if no further marijuana use had occurred. If the test result indicates that no further marijuana use has occurred since the first positive test result, then the MRO shall declare the drug test result as negative.

(p) Time to complete MRO review. The MRO shall complete his or her review of positive, adulterated, substituted, and invalid test results and, in instances when the MRO determines that there is no legitimate medical explanation for the test result(s), notify the licensee's or other entity's designated representative within 10 business days of an initial positive, adulterated, substituted, or invalid test result. The MRO shall notify the licensee or other entity of the results of his or her review in writing and in a manner designed to ensure the confidentiality of the information.

[73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71462, Nov. 22, 2022]

§ 26.187 Substance abuse expert.

(a) Implementation. Any SAEs on whom licensees and other entities rely to make determinations of fitness under this part shall meet the requirements of this section. An MRO who meets the requirements of this section may serve as both an MRO and as an SAE.

(b) Credentials. An SAE shall have at least one of the following credentials:

(1) A licensed physician;

(2) A licensed or certified social worker;

(3) A licensed or certified psychologist;

(4) A licensed or certified employee assistance professional; or

(5) An alcohol and drug abuse counselor certified by the National Association of Alcoholism and Drug Abuse Counselors Certification Commission or by the International Certification Reciprocity Consortium/Alcohol and Other Drug Abuse.

(c) Basic knowledge. An SAE shall be knowledgeable in the following areas:

(1) Demonstrated knowledge of and clinical experience in the diagnosis and treatment of alcohol and controlled-substance abuse disorders;

(2) Knowledge of the SAE function as it relates to the public's interests in the duties performed by the individuals who are subject to this subpart; and

(3) Knowledge of this part and any changes thereto.

(d) Qualification training. SAEs shall receive qualification training on the following subjects:

(1) Background, rationale, and scope of this part;

(2) Key drug testing requirements of this part, including specimen collection, laboratory testing, MRO review, and problems in drug testing;

(3) Key alcohol testing requirements of this part, including specimen collection, the testing process, and problems in alcohol tests;

(4) SAE qualifications and prohibitions;

(5) The role of the SAE in making determinations of fitness and the return-to-duty process, including the initial evaluation, referrals for education and/or treatment, the followup evaluation, continuing treatment recommendations, and the followup testing plan;

(6) Procedures for SAE consultation and communication with licensees or other entities, MROs, and treatment providers;

(7) Reporting and recordkeeping requirements of this part; and

(8) Issues that SAEs confront in carrying out their duties under this part.

(e) Continuing education. During each 3-year period following completion of initial qualification training, the SAE shall complete continuing education consisting of at least 12 continuing professional education hours relevant to performing SAE functions.

(1) This continuing education must include material concerning new technologies, interpretations, recent guidance, rule changes, and other information about developments in SAE practice pertaining to this part, since the time the SAE met the qualification training requirements of this section.

(2) Continuing education activities must include documented assessment tools to assist in determining that the SAE has learned the material.

(f) Documentation. The SAE shall maintain documentation showing that he or she currently meets all requirements of this section. The SAE shall provide this documentation on request to NRC representatives, licensees, or other entities who are relying on or contemplating relying on the SAE's services, and to other individuals and entities, as required by § 26.37.

(g) Responsibilities and prohibitions. The SAE shall evaluate individuals who have violated the substance abuse provisions of an FFD policy and make recommendations concerning education, treatment, return to duty, followup drug and alcohol testing, and aftercare. The SAE is not an advocate for the licensee or other entity, or the individual. The SAE's function is to protect public health and safety and the common defense and security by professionally evaluating the individual and recommending appropriate education/treatment, follow-up tests, and aftercare.

(1) The SAE is authorized to make determinations of fitness in at least the following three circumstances:

(i) When potentially disqualifying FFD information has been identified regarding an individual who has applied for authorization under this part;

(ii) When an individual has violated the substance abuse provisions of a licensee's or other entity's FFD policy; and

(iii) When an individual may be impaired by alcohol, prescription or over-the-counter medications, or illegal drugs.

(2) After determining the best recommendation for assisting the individual, the SAE shall serve as a referral source to assist the individual's entry into an education and/or treatment program.

(i) To prevent the appearance of a conflict of interest, the SAE may not refer an individual requiring assistance to his or her private practice or to a person or organization from whom the SAE receives payment or in which the SAE has a financial interest. The SAE is precluded from making referrals to entities with whom the SAE is financially associated.

(ii) There are four exceptions to the prohibitions contained in the preceding paragraph. The SAE may refer an individual to any of the following providers of assistance, regardless of his or her relationship with them:

(A) A public agency (e.g., treatment facility) operated by a state, county, or municipality;

(B) A person or organization under contract to the licensee or other entity to provide alcohol or drug treatment and/or education services (e.g., the licensee's or other entity's contracted treatment provider);

(C) The sole source of therapeutically appropriate treatment under the individual's health insurance program (e.g., the single substance abuse in-patient treatment program made available by the individual's insurance coverage plan); or

(D) The sole source of therapeutically appropriate treatment reasonably available to the individual (e.g., the only treatment facility or education program reasonably located within the general commuting area).

[73 FR 17176, Mar. 31, 2008, as amended at 83 FR 58464, Nov. 20, 2018]

§ 26.189 Determination of fitness.

(a) A determination of fitness is the process entered when there are indications that an individual specified in § 26.4(a) through (e), and at the licensee's or other entity's discretion as specified in § 26.4(f) and (g), may be in violation of the licensee's or other entity's FFD policy or is otherwise unable to safely and competently perform his or her duties. A determination of fitness must be made by a licensed or certified professional who is appropriately qualified and has the necessary clinical expertise, as verified by the licensee or other entity, to evaluate the specific fitness issues presented by the individual. A professional called on by the licensee or other entity may not perform a determination of fitness regarding fitness issues that are outside of his or her specific areas of expertise. The types of professionals and the fitness issues for which they are qualified to make determinations of fitness include, but are not limited to, the following:

(1) An SAE who meets the requirements of § 26.187 may determine the fitness of an individual who may have engaged in substance abuse and shall determine an individual's fitness to be granted authorization following an unfavorable termination or denial of authorization under this part, but may not be qualified to assess the fitness of an individual who may have experienced mental illness, significant emotional stress, or other mental or physical conditions that may cause impairment but are unrelated to substance abuse, unless the SAE has additional qualifications for addressing those fitness issues;

(2) A clinical psychologist may determine the fitness of an individual who may have experienced mental illness, significant emotional stress, or cognitive or psychological impairment from causes unrelated to substance abuse, but may not be qualified to assess the fitness of an individual who may have a substance abuse disorder, unless the psychologist is also an SAE;

(3) A psychiatrist may determine the fitness of an individual who is taking psychoactive medications consistently with one or more valid prescription(s), but may not be qualified to assess potential impairment attributable to substance abuse, unless the psychiatrist has had specific training to diagnose and treat substance abuse disorders;

(4) A physician may determine the fitness of an individual who may be ill, injured, fatigued, taking medications in accordance with one or more valid prescriptions, or using over-the-counter medications, but may not be qualified to assess the fitness of an individual who may have a substance abuse disorder, unless the physician is also an SAE; and

(5) As a physician with specialized training, the MRO may determine the fitness of an individual who may have engaged in substance abuse or may be ill, injured, fatigued, taking medications under one or more valid prescriptions, and/or using over-the-counter medications, but may not be qualified to assess an individual's fitness to be granted authorization following an unfavorable termination or denial of authorization under this part, unless the MRO is also an SAE.

(b) A determination of fitness must be made in at least the following circumstances:

(1) When there is an acceptable medical explanation for a positive, adulterated, substituted, or invalid test result, but there is a basis for believing that the individual could be impaired while on duty;

(2) Before making return-to-duty recommendations after an individual's authorization has been terminated unfavorably or denied under a licensee's or other entity's FFD policy;

(3) Before an individual is granted authorization when potentially disqualifying FFD information is identified that has not previously been evaluated by another licensee or entity who is subject to this subpart; and

(4) When potentially disqualifying FFD information is otherwise identified and the licensee's or other entity's reviewing official concludes that a determination of fitness is warranted under § 26.69.

(c) A determination of fitness that is conducted for cause (i.e., because of observed behavior or a physical condition) must be conducted through face-to-face interaction between the subject individual and the professional making the determination. Electronic means of communication may not be used.

(1) If there is neither conclusive evidence of an FFD policy violation nor a significant basis for concern that the individual may be impaired while on duty, then the individual must be determined to be fit for duty.

(2) If there is no conclusive evidence of an FFD policy violation but there is a significant basis for concern that the individual may be impaired while on duty, then the subject individual must be determined to be unfit for duty. This result does not constitute a violation of this part nor of the licensee's or other entity's FFD policy, and no sanctions may be imposed. However, the professional who made the determination of fitness shall consult with the licensee's or other entity's management personnel to identify the actions required to ensure that any possible limiting condition does not represent a threat to workplace or public health and safety. Licensee or other entity management personnel shall implement the required actions. When appropriate, the subject individual may also be referred to the EAP.

(d) Neither the individual nor licensees and other entities may seek a second determination of fitness if a determination of fitness under this part has already been performed by a qualified professional employed by or under contract to the licensee or other entity. After the initial determination of fitness has been made, the professional may modify his or her evaluation and recommendations based on new or additional information from other sources including, but not limited to, the subject individual, another licensee or entity, or staff of an education or treatment program. Unless the professional who made the initial determination of fitness is no longer employed by or under contract to the licensee or other entity, only that professional is authorized to modify the evaluation and recommendations. When reasonably practicable, licensees and other entities shall assist in arranging for consultation between the new professional and the professional who is no longer employed by or under contract to the licensee or other entity, to ensure continuity and consistency in the recommendations and their implementation.

§ 26.201 Applicability.

(a) The requirements in this subpart, with the exception of § 26.202, apply to the licensees and other entities identified in § 26.3(a); if applicable, (c), (d), and (f), for licensees and other entities not implementing the requirements in subparts K and M. For the licensees and other entities to whom the requirements in this subpart, with the exception of § 26.202, apply, the requirements in §§ 26.203 and 26.211 apply to the individuals identified in § 26.4(a) through (c). In addition, the requirements in § 26.205 through § 26.209 apply to the individuals identified in § 26.4(a).

(b) The requirements in this subpart, with the exception of § 26.203, apply to the licensees or other entities identified in § 26.3(f) implementing this subpart under § 26.605. For these licensees and other entities, the requirements in §§ 26.202 and 26.211 apply to the individuals identified in § 26.4(a) through (c) and any person licensed to operate under 10 CFR part 53; and the requirements in §§ 26.205 through 26.209 apply to the individuals identified in § 26.4(a).

[91 FR 15778, Mar. 30, 2026]

§ 26.202 General provisions for facilities licensed under 10 CFR part 53.

(a) Policy. Licensees must establish a policy for the management of fatigue for all individuals who are subject to the licensee's FFD program and incorporate it into the written policy required in § 26.606(a).

(b) Procedures. In addition to the procedures required in § 26.606(b), licensees must develop, implement, and maintain procedures that—

(1) Describe the process to be followed when any individual identified in § 26.4(a) through (c) makes a self-declaration that he or she is not fit to safely and competently perform his or her duties for any part of a working tour as a result of fatigue. The procedure must—

(i) Describe the individual's and licensee's rights and responsibilities related to self-declaration;

(ii) Describe requirements for establishing controls and conditions under which an individual may be permitted or required to perform work after that individual declares that he or she is not fit due to fatigue; and

(iii) Describe the process to be followed if the individual disagrees with the results of a fatigue assessment that is required under § 26.211(a)(2);

(2) Describe the process for implementing the controls required under § 26.205 for the individuals who are performing the duties listed in § 26.4(a);

(3) Describe the process to be followed in conducting fatigue assessments under § 26.211; and

(4) Describe the disciplinary actions that the licensee may impose on an individual following a fatigue assessment, and the conditions and considerations for taking those disciplinary actions.

(c) Training and assessments. Licensees must include the following KAs in the content of the training and trainee assessments required in § 26.608:

(1) Knowledge of the contributors to worker fatigue, circadian variations in alertness and performance, indications and risk factors for common sleep disorders, shiftwork strategies for obtaining adequate rest, and the effective use of fatigue countermeasures; and

(2) Ability to identify symptoms of worker fatigue and contributors to decreased alertness in the workplace.

(d) Recordkeeping. Licensees must retain the following records for at least 3 years or until the completion of all related legal proceedings, whichever is later:

(1) Records of work hours for individuals who are subject to the work hour controls in § 26.205;

(2) For licensees implementing the requirements of § 26.205(d)(3), records of shift schedules and shift cycles, or, for licensees implementing the requirements of § 26.205(d)(7), records of shift schedules and records showing the beginning and end times and dates of all averaging periods, of individuals who are subject to the work hour controls in § 26.205;

(3) The documentation of waivers that is required in § 26.207(a)(4), including the bases for granting the waivers;

(4) The documentation of work hour reviews that is required in § 26.205(e)(3) and (e)(4); and

(5) The documentation of fatigue assessments that is required in § 26.211(g).

(e) Reporting. Licensees must include the following information in a standard format in the annual FFD program performance report required under § 26.617(b)(2):

(1) A summary for each nuclear power plant site of all instances during the previous calendar year when the licensee waived one or more of the work hour controls specified in § 26.205(d)(1) through (d)(5)(i) and (d)(7) for individuals described in § 26.4(a). The summary must include only those waivers under which work was performed. If it was necessary to waive more than one work hour control during any single extended work period, the summary of instances must include each of the work hour controls that were waived during the period. For each category of individuals specified in § 26.4(a), the licensee must report—

(i) The number of instances when each applicable work hour control specified in § 26.205(d)(1)(i) through (iii), (d)(2)(i) and (ii), (d)(3)(i) through (v), and (d)(7) was waived for individuals not working on outage activities;

(ii) The number of instances when each applicable work hour control specified in § 26.205(d)(1)(i) through (iii), (d)(2)(i) and (ii), (d)(3)(i) through (v), (d)(4), (d)(5)(i), and (d)(7) was waived for individuals working on outage activities; and

(iii) A summary that shows the distribution of waiver use among the individuals applicable within each category of individuals identified in § 26.4(a) (e.g., a table that shows the number of individuals who received only one waiver during the reporting period, the number of individuals who received a total of two waivers during the reporting period).

(2) A summary of corrective actions, if any, resulting from the analyses of these data, including fatigue assessments.

(f) Audits. Licensees must audit the management of worker fatigue under § 26.615.

[91 FR 15778, Mar. 30, 2026]

§ 26.203 General provisions.

(a) Policy. Licensees shall establish a policy for the management of fatigue for all individuals who are subject to the licensee's FFD program and incorporate it into the written policy required in § 26.27(b).

(b) Procedures. In addition to the procedures required in § 26.27(c), licensees shall develop, implement, and maintain procedures that—

(1) Describe the process to be followed when any individual identified in § 26.4(a) through (c) makes a self-declaration that he or she is not fit to safely and competently perform his or her duties for any part of a working tour as a result of fatigue. The procedure must—

(i) Describe the individual's and licensee's rights and responsibilities related to self-declaration;

(ii) Describe requirements for establishing controls and conditions under which an individual may be permitted or required to perform work after that individual declares that he or she is not fit due to fatigue; and

(iii) Describe the process to be followed if the individual disagrees with the results of a fatigue assessment that is required under § 26.211(a)(2);

(2) Describe the process for implementing the controls required under § 26.205 for the individuals who are performing the duties listed in § 26.4(a);

(3) Describe the process to be followed in conducting fatigue assessments under § 26.211; and

(4) Describe the disciplinary actions that the licensee may impose on an individual following a fatigue assessment, and the conditions and considerations for taking those disciplinary actions.

(c) Training and examinations. Licensees shall add the following KAs to the content of the training that is required in § 26.29(a) and the comprehensive examination required in § 26.29(b):

(1) Knowledge of the contributors to worker fatigue, circadian variations in alertness and performance, indications and risk factors for common sleep disorders, shiftwork strategies for obtaining adequate rest, and the effective use of fatigue countermeasures; and

(2) Ability to identify symptoms of worker fatigue and contributors to decreased alertness in the workplace.

(d) Recordkeeping. Licensees shall retain the following records for at least 3 years or until the completion of all related legal proceedings, whichever is later:

(1) Records of work hours for individuals who are subject to the work hour controls in § 26.205;

(2) For licensees implementing the requirements of § 26.205(d)(3), records of shift schedules and shift cycles, or, for licensees implementing the requirements of § 26.205(d)(7), records of shift schedules and records showing the beginning and end times and dates of all averaging periods, of individuals who are subject to the work hour controls in § 26.205;

(3) The documentation of waivers that is required in § 26.207(a)(4), including the bases for granting the waivers;

(4) The documentation of work hour reviews that is required in § 26.205(e)(3) and (e)(4); and

(5) The documentation of fatigue assessments that is required in § 26.211(g).

(e) Reporting. Licensees shall include the following information in a standard format in the annual FFD program performance report required under § 26.717:

(1) A summary for each nuclear power plant site of all instances during the previous calendar year when the licensee waived one or more of the work hour controls specified in § 26.205(d)(1) through (d)(5)(i) and (d)(7) for individuals described in § 26.4(a). The summary must include only those waivers under which work was performed. If it was necessary to waive more than one work hour control during any single extended work period, the summary of instances must include each of the work hour controls that were waived during the period. For each category of individuals specified in § 26.4(a), the licensee shall report:

(i) The number of instances when each applicable work hour control specified in § 26.205(d)(1)(i) through (d)(1)(iii), (d)(2)(i) and (d)(2)(ii), (d)(3)(i) through (d)(3)(v), and (d)(7) was waived for individuals not working on outage activities;

(ii) The number of instances when each applicable work hour control specified in § 26.205(d)(1)(i) through (d)(1)(iii), (d)(2)(i) and (d)(2)(ii), (d)(3)(i) through (d)(3)(v), (d)(4) and (d)(5)(i), and (d)(7) was waived for individuals working on outage activities; and

(iii) A summary that shows the distribution of waiver use among the individuals within each category of individuals identified in § 26.4(a) (e.g., a table that shows the number of individuals who received only one waiver during the reporting period, the number of individuals who received a total of two waivers during the reporting period).

(2) A summary of corrective actions, if any, resulting from the analyses of these data, including fatigue assessments.

(f) Audits. Licensees shall audit the management of worker fatigue as required by § 26.41.

[73 FR 17176, Mar. 31, 2008, as amended at 76 FR 43548, July 21, 2011]

§ 26.205 Work hours.

(a) Individuals subject to work hour controls. Any individual who performs duties identified in § 26.4(a)(1) through (a)(5) shall be subject to the requirements of this section.

(b) Calculating work hours. For the purposes of this section, a licensee shall calculate the work hours of individuals who are subject to this section as the amount of time the individuals perform duties for the licensee. Except as permitted by paragraphs (b)(1) through (b)(5) of this section, the calculated work hours must include all time performing duties for the licensee, including all within-shift break times and rest periods during which there are no reasonable opportunities or accommodations appropriate for restorative sleep.

(1) Shift turnover. Licensees may exclude shift turnover from the calculation of an individual's work hours. Shift turnover includes only those activities that are necessary to safely transfer information and responsibilities between two or more individuals between shifts. Shift turnover activities may include, but are not limited to, discussions of the status of plant equipment, and the status of ongoing activities, such as extended tests of safety systems and components. Licensees may not exclude work hours worked during turnovers between individuals within a shift period due to rotations or relief within a shift. Activities that licensees may not exclude from work hours calculations also include, but are not limited to, shift holdovers to cover for late arrivals of incoming shift members; early arrivals of individuals for meetings, training, or pre-shift briefings for special evolutions; and holdovers for interviews needed for event investigations.

(2) Within-shift break and rest periods. Licensees may exclude from the calculation of an individual's work hours only that portion of a break or rest period during which there is a reasonable opportunity and accommodations for restorative sleep (e.g., a nap).

(3) Beginning or resuming duties subject to work hour controls. If an individual begins or resumes performing for the licensee any of the duties listed in § 26.4(a) during the calculation period, the licensee shall include in the calculation of the individual's work hours all work hours worked for the licensee, including hours worked performing duties that are not listed in § 26.4(a), and control the individual's work hours under the requirements of paragraph (d) of this section.

(4) Unannounced emergency preparedness exercises and drills. Licensees may exclude from the calculation of an individual's work hours the time the individual works unscheduled work hours for the purpose of participating in the actual conduct of an unannounced emergency preparedness exercise or drill.

(5) Incidental duties performed off site. Licensees may exclude from the calculation of an individual's work hours unscheduled work performed off site (e.g., technical assistance provided by telephone from an individual's home), provided the total duration of the work does not exceed a nominal 30 minutes during any single break period. For the purposes of compliance with the minimum break requirements of § 26.205(d)(2), and the minimum days off requirements of § 26.205(d)(3) through (d)(5) or the maximum average work hours requirements of § 26.205(d)(7), such duties do not constitute work periods, work shifts, or hours worked.

(c) Work hours scheduling. Licensees shall schedule the work hours of individuals who are subject to this section consistent with the objective of preventing impairment from fatigue due to the duration, frequency, or sequencing of successive shifts.

(d) Work hour controls. Licensees shall control the work hours of individuals who are subject to this section.

(1) Except as permitted in § 26.207, licensees shall ensure that any individual's work hours do not exceed the following limits:

(i) 16 work hours in any 24-hour period;

(ii) 26 work hours in any 48-hour period; and

(iii) 72 work hours in any 7-day period.

(2) Licensees shall ensure that individuals have, at a minimum, the rest breaks specified in this paragraph. For the purposes of this subpart, a break is defined as an interval of time that falls between successive work periods, during which the individual does not perform any duties for the licensee other than one period of shift turnover at either the beginning or end of a shift but not both. Except as permitted in § 26.207, licensees shall ensure that individuals have, at a minimum—

(i) A 10-hour break between successive work periods or an 8-hour break between successive work periods when a break of less than 10 hours is necessary to accommodate a crew's scheduled transition between work schedules or shifts; and

(ii) A 34-hour break in any 9-day period.

(3) Licensees shall either ensure that individuals have, at a minimum, the number of days off specified in this paragraph, or comply with the requirements for maximum average workhours in § 26.205(d)(7). For the purposes of this section, a day off is defined as a calendar day during which an individual does not start a work shift. For the purposes of calculating the average number of days off required in this paragraph, the duration of the shift cycle may not exceed 6 weeks.

(i) Individuals who are working 8-hour shift schedules shall have at least 1 day off per week, averaged over the shift cycle;

(ii) Individuals who are working 10-hour shift schedules shall have at least 2 days off per week, averaged over the shift cycle;

(iii) Individuals who are working 12-hour shift schedules while performing the duties described in § 26.4(a)(1) through (a)(3) shall have at least 2.5 days off per week, averaged over the shift cycle;

(iv) Individuals who are working 12-hour shift schedules while performing the duties described in § 26.4(a)(4) shall have at least 2 days off per week, averaged over the shift cycle; and

(v) Individuals who are working 12-hour shift schedules while performing the duties described in § 26.4(a)(5) shall have at least 3 days off per week, averaged over the shift cycle.

(4) During the first 60 days of a unit outage, licensees need not meet the requirements of § 26.205(d)(3) or (d)(7) for individuals specified in § 26.4(a)(1) through (a)(4), while those individuals are working on outage activities. However, the licensee shall ensure that the individuals specified in § 26.4(a)(1) through (a)(3) have at least 3 days off in each successive (i.e., non-rolling) 15-day period and that the individuals specified in § 26.4(a)(4) have at least 1 day off in any 7-day period;

(5) During the first 60 days of a unit outage, security system outage, or increased threat condition, licensees shall control the hours worked by individuals specified in § 26.4(a)(5) as follows:

(i) During the first 60 days of a unit outage or a planned security system outage, licensees need not meet the requirements of § 26.205(d)(3) or (d)(7). However, licensees shall ensure that these individuals have at least 4 days off in each successive (i.e., non-rolling) 15-day period; and

(ii) During the first 60 days of an unplanned security system outage or increased threat condition, licensees need not meet the requirements of § 26.205(d)(3), (d)(5)(i), or (d)(7).

(6) The 60-day periods in paragraphs (d)(4) and (d)(5) of this section may be extended for each individual in 7-day increments for each non-overlapping 7-day period the individual has worked not more than 48 hours during the unit or security system outage or increased threat condition, as applicable.

(7) Licensees may, as an alternative to complying with the minimum days off requirements in § 26.205(d)(3), comply with the requirements for maximum average work hours in this paragraph.

(i) Individuals may not work more than a weekly average of 54 hours, calculated using an averaging period of up to six (6) weeks, which advances by 7 consecutive calendar days at the finish of every averaging period.

(ii) For purposes of this section, when an individual's work shift starts at the end of a calendar day and concludes during the next calendar day, the licensee shall either consider the hours worked during that entire shift as if they were all worked on the day the shift started, or attribute the hours to the calendar days on which the hours were actually worked.

(iii) Each licensee shall state, in its FFD policy and procedures required by either §§ 26.27 and 26.203(a) and (b) or §§ 26.202(a) and (b) and 26.606, the work hour counting system in paragraph (d)(7)(ii) of this section the licensee is using.

(8) Each licensee shall state, in its FFD policy and procedures required by either §§ 26.27 and 26.203(a) and (b) or §§ 26.202(a) and (b) and 26.606, the requirements with which the licensee is complying: the minimum days off requirements in paragraph (d)(3) of this section or maximum average work hours requirements in paragraph (d)(7) of this section.

(e) Reviews. Licensees shall evaluate the effectiveness of their control of work hours of individuals who are subject to this section. Licensees shall conduct the reviews once per calendar year. If any plant or security system outages or increased threat conditions occurred since the licensee completed the most recent review, the licensee shall include in the review an evaluation of the control of work hours during the outages or increased threat conditions. Licensees shall complete the review within 30 days of the end of the review period. Licensees shall—

(1) Review the actual work hours and performance of individuals who are subject to this section for consistency with the requirements of § 26.205(c). At a minimum, this review must address—

(i) Individuals whose actual hours worked during the review period exceeded an average of 54 hours per week in any shift cycle while the individuals' work hours are subject to the requirements of § 26.205(d)(3) or in any averaging period of up to 6 weeks, using the same averaging period durations that the licensee uses to control the individuals' work hours, while the individuals' work hours are subject to the requirements of § 26.205(d)(7);

(ii) Individuals who were granted more than one waiver during the review period; and

(iii) Individuals who were assessed for fatigue under § 26.211 during the review period.

(2) Review individuals' hours worked and the waivers under which work was performed to evaluate staffing adequacy for all jobs subject to the work hour controls of this section;

(3) Document the methods used to conduct the review and the results of the review; and

(4) Record, trend, and correct, under the licensee's corrective action program, any problems identified in maintaining control of work hours consistent with the specific requirements and performance objectives of this part.

[73 FR 17176, Mar. 31, 2008, as amended at 76 FR 43548, July 21, 2011; 91 FR 15779, Mar. 30, 2026]

§ 26.207 Waivers and exceptions.

(a) Waivers. Licensees may grant a waiver of one or more of the work hour controls in § 26.205(d)(1) through (d)(5)(i) and (d)(7), as follows:

(1) To grant a waiver, the licensee shall meet both of the following requirements:

(i) An operations shift manager determines that the waiver is necessary to mitigate or prevent a condition adverse to safety, or a security shift manager determines that the waiver is necessary to maintain site security, or a site senior-level manager with requisite signature authority makes either determination; and

(ii) A supervisor assesses the individual face-to-face and determines that there is reasonable assurance that the individual will be able to safely and competently perform his or her duties during the additional work period for which the waiver will be granted. The supervisor performing the assessment shall be trained as required by either §§ 26.29 and 26.203(c) or §§ 26.202(c) and 26.608 and shall be qualified to direct the work to be performed by the individual. If there is no supervisor on site who is qualified to direct the work, the assessment may be performed by a supervisor who is qualified to provide oversight of the work to be performed by the individual. At a minimum, the assessment must address the potential for acute and cumulative fatigue considering the individual's work history for at least the past 14 days, the potential for circadian degradations in alertness and performance considering the time of day for which the waiver will be granted, the potential for fatigue-related degradations in alertness and performance to affect risk-significant functions, and whether any controls and conditions must be established under which the individual will be permitted to perform work. For licensees and other entities in § 26.3(f), the assessment may be performed remotely using electronic communications. In such instances, the assessment must be supported by someone who is present in-person with the individual whose alertness may be impaired, and that supporting person must be trained under the requirements of either §§ 26.29 and 26.203(c) or §§ 26.202(c) and 26.608.

(2) To the extent practicable, licensees shall rely on the granting of waivers only to address circumstances that could not have been reasonably controlled;

(3) Licensees shall ensure that the timing of the face-to-face supervisory assessment that is required by paragraph (a)(1)(ii) of this section supports a valid assessment of the potential for worker fatigue during the time the individual will be performing work under the waiver. Licensees may not perform the face-to-face assessment more than 4 hours before the individual begins performing any work under the waiver; and

(4) Licensees shall document the bases for individual waivers. The documented basis for a waiver must include a description of the circumstances that necessitate the waiver, a statement of the scope of work and time period for which the waiver is approved, and the bases for the determinations required in paragraphs (a)(1)(i) and (ii) of this section.

(b) Force-on-force tactical exercises. For the purposes of compliance with the minimum days off requirements of § 26.205(d)(3) or the maximum average work hours requirements of § 26.205(d)(7), licensees may exclude shifts worked by security personnel during the actual conduct of NRC-evaluated force-on-force tactical exercises when calculating the individual's number of days off or hours worked, as applicable.

(c) Common defense and security. When informed in writing by the NRC that the requirements of § 26.205, or any subset thereof, are waived for security personnel to ensure the common defense and security, licensees need not meet the specified requirements of § 26.205 for the duration of the period defined by the NRC.

(d) Plant emergencies. Licensees need not meet the requirements of § 26.205(c) and (d) during declared emergencies, as defined in the licensee's emergency plan.

[73 FR 17176, Mar. 31, 2008, as amended at 76 FR 43549, July 21, 2011; 91 FR 15779, Mar. 30, 2026]

§ 26.209 Self-declarations.

(a) If an individual is performing, or being assessed for, work under a waiver of one or more of the requirements contained in § 26.205(d)(1) through (d)(5)(i) and (d)(7) and declares that, due to fatigue, he or she is unable to safely and competently perform his or her duties, the licensee shall immediately stop the individual from performing any duties listed in § 26.4(a), except if the individual is required to continue performing those duties under other requirements of this chapter. If the subject individual must continue performing the duties listed in § 26.4(a) until relieved, the licensee shall immediately take action to relieve the individual.

(b) Following a self-declaration, as described in paragraph (a) of this section, the licensee—

(1) May reassign the individual to duties other than those listed in § 26.4(a), but only if the results of a fatigue assessment, conducted under the requirements of § 26.211, indicate that the individual is fit to safely and competently perform those other duties; and

(2) Shall permit or require the individual to take a break of at least 10 hours before the individual returns to performing any duties listed in § 26.4(a).

[73 FR 17176, Mar. 31, 2008, as amended at 76 FR 43549, July 21, 2011]

§ 26.211 Fatigue assessments.

(a) Licensees shall ensure that fatigue assessments are conducted under the following conditions:

(1) For-cause. In addition to any other test or determination of fitness that may be required under §§ 26.31(c), 26.77, 26.607(b), and 26.619, a fatigue assessment must be conducted in response to an observed condition of impaired individual alertness creating a reasonable suspicion that an individual is not fit to safely and competently perform his or her duties, except if the condition is observed during an individual's break period. If the observed condition is impaired alertness with no other behaviors or physical conditions creating a reasonable suspicion of possible substance abuse, then the licensee need only conduct a fatigue assessment. If the licensee has reason to believe that the observed condition is not due to fatigue, the licensee need not conduct a fatigue assessment;

(2) Self-declaration. A fatigue assessment must be conducted in response to an individual's self-declaration to his or her supervisor that he or she is not fit to safely and competently perform his or her duties for any part of a working tour because of fatigue, except if, following the self-declaration, the licensee permits or requires the individual to take a rest break of at least 10 hours before the individual returns to duty;

(3) Post-event. A fatigue assessment must be conducted in response to events requiring post-event drug and alcohol testing as specified in § 26.31(c) or post-event tests in § 26.607(b)(4). Licensees may not delay necessary medical treatment in order to conduct a fatigue assessment; and

(4) Followup. If a fatigue assessment was conducted for cause or in response to a self-declaration, and the licensee returns the individual to duty following a break of less than 10 hours in duration, the licensee shall reassess the individual for fatigue as well as the need to implement controls and conditions before permitting the individual to resume performing any duties.

(b) Only supervisors and FFD program personnel who are trained under either §§ 26.29 and 26.203(c) or §§ 26.202(c) and 26.608 may conduct a fatigue assessment. The fatigue assessment must be conducted face-to-face with the individual whose alertness may be impaired. For licensees and other entities in § 26.3(f), a fatigue assessment may be performed remotely using electronic communications. In such instances, the fatigue assessment must be supported by someone who is present in-person with the individual whose alertness may be impaired, and that supporting person must be trained in accordance with the requirements of either §§ 26.29 and 26.203(c) or §§ 26.202(c) and 26.608.

(1) In the case of a fatigue assessment conducted for cause, the individual who observed the condition of impaired alertness may not conduct the fatigue assessment.

(2) In the case of a post-event fatigue assessment, the individual who conducts the fatigue assessment may not have—

(i) Performed or directed (on site) the work activities during which the event occurred;

(ii) Performed, within 24 hours before the event occurred, a fatigue assessment of the individuals who were performing or directing (on site) the work activities during which the event occurred; and

(iii) Evaluated or approved a waiver of one or more of the limits specified in § 26.205(d)(1) through (d)(5)(i) and (d)(7) for any of the individuals who were performing or directing (on site) the work activities during which the event occurred, if the event occurred while such individuals were performing work under that waiver.

(c) A fatigue assessment must provide the information necessary for management decisions and actions in response to the circumstance that initiated the assessment.

(1) At a minimum, the fatigue assessment must address the following factors:

(i) Acute fatigue;

(ii) Cumulative fatigue; and

(iii) Circadian variations in alertness and performance.

(2) Individuals shall provide complete and accurate information that may be required by the licensee to address the factors listed in paragraph (c)(1) of this section. Licensees shall limit any inquiries to obtaining from the subject individual only the personal information that may be necessary to assess the factors listed in paragraph (c)(1) of this section.

(d) The licensee may not conclude that fatigue has not or will not degrade the individual's ability to safely and competently perform his or her duties solely on the basis that the individual's work hours have not exceeded any of the limits specified in § 26.205(d)(1), the individual has had the minimum breaks required in § 26.205(d)(2) or minimum days off required in § 26.205(d)(3) through (d)(5), as applicable, or the individual's hours worked have not exceeded the maximum average number of hours worked in § 26.205(d)(7).

(e) Following a fatigue assessment, the licensee shall determine and implement the controls and conditions, if any, that are necessary to permit the individual to resume performing duties for the licensee, including the need for a break.

(f) Licensees shall document the results of any fatigue assessments conducted, the circumstances that necessitated the fatigue assessment, and any controls and conditions that were implemented.

(g) Licensees shall also prepare an annual summary for each nuclear power plant site of instances of fatigue assessments that were conducted during the previous calendar year for any individual identified in § 26.4(a) through (c). Each summary must include—

(1) The conditions under which each fatigue assessment was conducted (i.e., self-declaration, for cause, post-event, followup);

(2) A statement of whether or not the individual was working on outage activities at the time of the self-declaration or condition resulting in the fatigue assessment;

(3) The category of duties the individual was performing, if the individual was performing the duties described in § 26.4(a)(1) through (a)(5) at the time of the self-declaration or condition resulting in the fatigue assessment; and

(4) The management actions, if any, resulting from each fatigue assessment.

[73 FR 17176, Mar. 31, 2008, as amended at 76 FR 43549, July 21, 2011; 91 FR 15779, Mar. 30, 2026]

§ 26.401 General.

(a) At the licensee's or other entity's discretion, a licensee or other entity in § 26.3(c) may establish, implement, and maintain an FFD program that meets the requirements of this subpart to apply to the individuals specified in § 26.4(f). If a licensee or other entity in § 26.3(c) does not elect to implement an FFD program that meets the requirements of this subpart, the individuals specified in § 26.4(f) shall be subject to an FFD program that meets the requirements of subparts A through H, N, and O of this part.

(b) Entities who intend to implement an FFD program under this subpart shall submit a description of the FFD program and its implementation as part of the license, permit, or limited work authorization application.

(c) Nothing in this subpart prohibits the licensees and other entities in § 26.3(c) from subjecting the individuals in § 26.4(f) to an FFD program that meets all of the requirements of this part or FFD program elements that meet all of the applicable requirements of this part.

§ 26.403 Written policy and procedures.

(a) Licensees and other entities who implement an FFD program under this subpart shall ensure that a clear, concise, written FFD policy statement is provided to individuals who are subject to the program. The policy statement must be written in sufficient detail to provide affected individuals with information on what is expected of them and what consequences may result from a lack of adherence to the policy.

(b) Licensees and other entities shall develop, implement, and maintain written procedures that address the following topics:

(1) The methods and techniques to be used in testing for drugs and alcohol, including procedures for protecting the privacy of an individual who provides a specimen, procedures for protecting the integrity of the specimen, and procedures used to ensure that the test results are valid and attributable to the correct individual;

(2) The immediate and followup actions that will be taken, and the procedures to be used, in those cases in which individuals who are subject to the FFD program are determined to have—

(i) Been involved in the use, sale, or possession of illegal drugs;

(ii) Consumed alcohol to excess before or while constructing or directing the construction of safety- or security-related SSCs, as determined by a test that accurately measures BAC;

(iii) Attempted to subvert the testing process by adulterating or diluting specimens (in vivo or in vitro), substituting specimens, or by any other means;

(iv) Refused to provide a specimen for analysis; or

(v) Had legal action taken relating to drug or alcohol use.

(3) The process to be followed if an individual's behavior or condition raises a concern regarding the possible use, sale, or possession of illegal drugs on or off site; the possible use or possession of alcohol while constructing or directing the construction of safety- or security-related SSCs; or impairment from any cause which in any way could adversely affect the individual's ability to safely and competently perform his or her duties.

[73 FR 17176, Mar. 31, 2008, as amended at 75 FR 73941, Nov. 30, 2010]

§ 26.405 Drug and alcohol testing.

(a) To provide means to deter and detect substance abuse, licensees and other entities who implement an FFD program under this subpart shall perform drug and alcohol testing that complies with the requirements of this section.

(b) If the licensee or other entity elects to impose random testing for drugs and alcohol on the individuals identified in § 26.4(f), random testing must—

(1) Be administered in a manner that provides reasonable assurance that individuals are unable to predict the time periods during which specimens will be collected;

(2) Require individuals who are selected for random testing to report to the collection site as soon as reasonably practicable after notification, within the time period specified in the FFD program policy;

(3) Ensure that all individuals in the population that is subject to random testing on a given day have an equal probability of being selected and tested; and

(4) Provide that an individual completing a test is immediately eligible for another random test.

(c) Individuals identified in § 26.4(f) shall be subject to drug and alcohol testing under the following conditions:

(1) Pre-assignment. Before assignment to construct or direct the construction of safety- or security-related SSCs;

(2) For-cause. In response to an individual's observed behavior or physical condition indicating possible substance abuse or after receiving credible information that an individual is engaging in substance abuse, as defined in § 26.5;

(3) Post-accident. As soon as practical after an event involving a human error that was committed by an individual specified in § 26.4(f), where the human error may have caused or contributed to the accident. The licensee or other entity shall test the individual(s) who committed the error(s), and need not test individuals who were affected by the event but whose actions likely did not cause or contribute to the event. The individual(s) who committed the human error(s) shall be tested if the event resulted in—

(i) A significant illness or personal injury to the individual to be tested or another individual, which within 4 hours after the event is recordable under the Department of Labor standards contained in 29 CFR 1904.7, and subsequent amendments thereto, and results in death, days away from work, restricted work, transfer to another job, medical treatment beyond first aid, loss of consciousness, or other significant illness or injury as diagnosed by a physician or other licensed health care professional, even if it does not result in death, days away from work, restricted work or job transfer, medical treatment beyond first aid, or loss of consciousness; or

(ii) Significant damage, during construction, to any safety-or security-related SSC; and

(4) Followup. As part of a followup plan to verify an individual's continued abstinence from substance abuse.

(d) At a minimum, licensees and other entities shall test specimens for marijuana metabolite, cocaine metabolite, opioids (codeine, morphine, 6-acetylmorphine, hydrocodone, hydromorphone, oxycodone, and oxymorphone), amphetamines (amphetamine, methamphetamine, methylenedioxymethamphetamine, and methylenedioxyamphetamine), phencyclidine, and alcohol at the cutoff levels specified in this part, or comparable cutoff levels if specimens other than urine are collected for drug testing. Urine specimens collected for drug testing must be subject to validity testing that includes testing for adulterants.

(e) The specimen collection and drug and alcohol testing procedures of FFD programs under this subpart must protect the donor's privacy and the integrity of the specimen, and implement stringent quality controls to ensure that test results are valid and attributable to the correct individual. At the licensee's or other entity's discretion, specimen collections and alcohol testing may be conducted at a local hospital or other facility under the specimen collection and alcohol testing requirements of 49 CFR Part 40 and subsequent amendments thereto.

(f) Testing of urine specimens for drugs and validity, except validity screening and initial drug and validity tests that may be performed by licensee testing facilities, must be performed in a laboratory that is certified by HHS for that purpose, consistent with its standards and procedures for certification. Any initial drug test performed by a licensee or other entity subject to this subpart must use an immunoassay that meets the requirements of the Food and Drug Administration for commercial distribution. Urine specimens that yield positive, adulterated, substituted, or invalid initial validity or drug test results must be subject to confirmatory testing by the HHS-certified laboratory, except for invalid specimens that cannot be tested. Other specimens that yield positive initial drug test results must be subject to confirmatory testing by a laboratory that meets stringent quality control requirements that are comparable to those required for certification by the HHS.

(g) Licensees and other entities shall provide for an MRO review of positive, adulterated, substituted, and invalid confirmatory drug and validity test results to determine whether the donor has violated the FFD policy, before reporting the results to the individual designated by the licensee or other entity to perform the suitability and fitness evaluations required under § 26.419.

[73 FR 17176, Mar. 31, 2008, as amended at 75 FR 73941, Nov. 30, 2010; 87 FR 71463, Nov. 22, 2022]

§ 26.406 Fitness monitoring.

(a) The requirements in this section apply only if a licensee or other entity does not elect to subject the individuals specified in § 26.4(f) to random testing for drugs and alcohol under § 26.405(b).

(b) Licensees and other entities shall implement a fitness monitoring program to deter substance abuse and detect indications of possible use, sale, or possession of illegal drugs; use or possession of alcohol while constructing or directing the construction of safety- or security-related SSCs; or impairment from any cause that if left unattended may result in a risk to public health and safety or the common defense and security.

(c) Licensees and other entities shall establish procedures that monitors shall follow in response to the indications and actions specified in paragraph (b) of this section and train the monitors to implement the program.

(d) Licensees and other entities shall ensure that the fitness of individuals specified in § 26.4(f) is monitored effectively while the individuals are constructing or directing the construction of safety- and security-related SSCs, commensurate with the potential risk to public health and safety and the common defense and security imposed by the construction activity. To achieve this objective, licensees and other entities shall consider the number and placement of monitors required, the necessary ratio of monitors to individuals specified in § 26.4(f), and the frequency with which the individuals specified in § 26.4(f) shall be monitored while constructing or directing the construction of each safety- or security-related SSC.

[73 FR 17176, Mar. 31, 2008, as amended at 75 FR 73941, Nov. 30, 2010]

§ 26.407 Behavioral observation.

While the individuals specified in § 26.4(f) are constructing or directing the construction of safety- or security-related SSCs, licensees and other entities shall ensure that these individuals are subject to behavioral observation, except if the licensee or other entity has implemented a fitness monitoring program under § 26.406.

[75 FR 73941, Nov. 30, 2010]

§ 26.409 Sanctions.

Licensees and other entities who implement an FFD program under this subpart shall establish sanctions for FFD policy violations that, at a minimum, prohibit the individuals specified in § 26.4(f) from being assigned to construct or direct the construction of safety- or security-related SSCs unless or until the licensee or other entity determines that the individual's condition or behavior does not pose a potential risk to public health and safety or the common defense and security.

[75 FR 73941, Nov. 30, 2010]

§ 26.411 Protection of information.

(a) Licensees and other entities who collect personal information about an individual for the purpose of complying with this subpart shall establish and maintain a system of files and procedures to protect the personal information. FFD programs must maintain and use such records with the highest regard for individual privacy.

(b) Licensees and other entities shall obtain a signed consent that authorizes the disclosure of the personal information collected and maintained under this subpart before disclosing the personal information, except for disclosures to the individuals and entities specified in § 26.37(b)(1) through (b)(6), (b)(8), and persons deciding matters under review in § 26.413.

§ 26.413 Review process.

Licensees and other entities who implement an FFD program under this subpart shall establish and implement procedures for the review of a determination that an individual in § 26.4(f) has violated the FFD policy. The procedure must provide for an objective and impartial review of the facts related to the determination that the individual has violated the FFD policy.

§ 26.415 Audits.

(a) Licensees and other entities who implement an FFD program under this subpart shall ensure that audits are performed to assure the continuing effectiveness of the FFD program, including FFD program elements that are provided by C/Vs, and the FFD programs of C/Vs that are accepted by the licensee or other entity.

(b) Each licensee and other entity shall ensure that these programs are audited at a frequency that assures their continuing effectiveness and that corrective actions are taken to resolve any problems identified. Licensees and entities may conduct joint audits, or accept audits of C/Vs conducted by others, so long as the audit addresses the relevant C/Vs' services.

(c) Licensees and other entities need not audit HHS-certified laboratories or the specimen collection and alcohol testing services that meet the requirements of 49 CFR Part 40, “Procedures for Department of Transportation Workplace Drug and Alcohol Testing Programs”, on which licensees and other entities may rely to meet the drug and alcohol testing requirements of this subpart.

[73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71463, Nov. 22, 2022]

§ 26.417 Recordkeeping and reporting.

(a) Licensees and other entities who implement FFD programs under this subpart shall ensure that records pertaining to the administration of the program, which may be stored and archived electronically, are maintained so that they are available for NRC inspection purposes and for any legal proceedings resulting from the administration of the program.

(b) Licensees and other entities shall make the following reports:

(1) Reports to the NRC Operations Center by telephone within 24 hours after the licensee or other entity discovers any intentional act that casts doubt on the integrity of the FFD program and any programmatic failure, degradation, or discovered vulnerability of the FFD program that may permit undetected drug or alcohol use or abuse by individuals who are subject to this subpart. These events must be reported under this subpart, rather than under the provisions of 10 CFR 73.1200; and

(2) Annual program performance reports for the FFD program.

[73 FR 17176, Mar. 31, 2008, as amended at 88 FR 15880, Mar. 14, 2023]

§ 26.419 Suitability and fitness evaluations.

Licensees and other entities who implement FFD programs under this subpart shall develop, implement, and maintain procedures for evaluating whether to assign individuals to construct safety- and security-related SSCs. These procedures must provide reasonable assurance that the individuals are fit to safely and competently perform their duties, and are trustworthy and reliable, as demonstrated by the avoidance of substance abuse.

§ 26.601 Applicability.

(a) A licensee or other entity in § 26.3(f), at its discretion, may establish, implement, and maintain a fitness-for-duty (FFD) program that satisfies the requirements of this subpart for those categories of individuals in § 26.4, as applicable, and any person licensed to operate under part 53 of this chapter. If a licensee or other entity in § 26.3(f) does not elect to implement an FFD program that satisfies the requirements of this subpart, then those categories of individuals in § 26.4, as applicable, and any person licensed to operate under part 53 of this chapter must be subject to an FFD program that satisfies all requirements under this part, except for those requirements in subpart K and this subpart.

(b) A licensee or other entity in § 26.3(f) that elects to implement an FFD program that satisfies the requirements of this subpart, and that demonstrates compliance with § 73.100(a)(1)(i) of this chapter, must establish, implement, and maintain an FFD program under § 26.605(a) or (b).

(c) A licensee or other entity in § 26.3(f) that elects to implement an FFD program that satisfies the requirements of this subpart and does not demonstrate compliance with § 73.100(a)(1)(i) of this chapter must establish, implement, and maintain an FFD program under § 26.605(a) and (b).

§ 26.603 General provisions.

(a) FFD program description. An applicant's description of the FFD program in its Final Safety Analysis Report, required by subpart H of part 53 of this chapter, must include—

(1) Whether the applicant demonstrates compliance with § 73.100(a)(1)(i) of this chapter;

(2) A statement whether the FFD program will be implemented pursuant to § 26.605(a) or (b) or § 26.605(a) and (b), or will satisfy all requirements under this part, except for the requirements in subpart K and this subpart;

(3) A discussion of the applicability of the FFD program to those individuals described in § 26.4 and how the program will be implemented offsite at a U.S. Nuclear Regulatory Commission (NRC)-licensed facility authorized to assemble or test a manufactured reactor, if applicable; and

(4) A description of the drug and alcohol testing and fitness determination process to be implemented through the licensee's or other entity's procedures, including the collection and testing facilities to be used, biological specimens to be collected and tested, and sanctions to be imposed for FFD policy violations.

(b) FFD program implementation and availability. For the licensees and other entities in § 26.3(f), other than the holder of a manufacturing license (ML), the FFD program must be maintained until the NRC's docketing of the license holder's certifications described in § 53.1070 of this chapter. For holders of an ML, the FFD program must be maintained until expiration of the ML.

(c)-(d) [Reserved]

(e) FFD program change control. (1) The licensee or other entity may make changes to its FFD program under this subpart if—

(i) The licensee or other entity performs and retains an analysis demonstrating that the changes do not reduce the effectiveness of the FFD program; or

(ii) The change was necessitated or justified by a change to this part, laboratory processes or procedures, or guidance issued by the U.S. Department of Health and Human Services (HHS) or NRC, as implemented by the licensee or other entity though its procedures.

(2) A licensee or other entity desiring to make a change that decreases FFD program effectiveness must implement a mitigating strategy so the FFD program, as revised, will continue to satisfy the performance objectives in § 26.23 and not result in a reduction in FFD program effectiveness.

(3) Except for phencyclidine, and notwithstanding paragraph (e)(1)(ii) of this section, the change control process may not be used to reduce the minimum panel of drugs to be tested in § 26.607(c)(1).

(4) The licensee must retain a record of each change made under this section for a period of at least 5 years from the date the change was implemented and summarize this change in its annual FFD performance report required by § 26.617(b)(2) or § 26.717, as applicable.

§ 26.605 FFD program requirements.

(a)(1) The licensee or other entity must establish, implement, and maintain an FFD program under this paragraph (a) before the start of—

(i) Construction activities as defined in § 26.5;

(ii) Activities performed under an ML that authorizes the assembly, non-operational testing, or both of a manufactured reactor; or

(iii) Activities described in paragraphs (a)(1)(i) and (ii) of this section.

(2) An FFD program under this paragraph (a) must—

(i) Apply to those individuals described in § 26.4, as applicable; and,

(ii) Implement the following requirements and subparts:

(A) Section 26.23, for performance objectives;

(B) Section 26.35, for employee assistance programs:

(1) For licensees and other entities who demonstrate compliance with § 73.100(a)(1)(i) of this chapter, § 26.35 must be implemented before the earliest occurrence of the following, as applicable: the loading of fuel onsite into a reactor vessel; receiving a fueled manufactured reactor; or individuals subject to this part operate, test, perform maintenance of, or direct the maintenance or surveillance of security-related equipment or equipment that a risk-informed evaluation process has shown to be significant to public health and safety; and

(2) For licensees and other entities that do not demonstrate compliance with § 73.100(a)(1)(i) of this chapter, § 26.35 must be implemented before the start of activities performed under an ML that allows the assembly, non-operational testing, or both, of a manufactured reactor;

(C) Section 26.603, for general provisions;

(D) Section 26.606, for written policy and procedures;

(E) Section 26.607, for drug and alcohol testing;

(F) Section 26.608, for FFD program training;

(G) Section 26.609, for behavioral observation;

(H) Section 26.610, for sanctions;

(I) Section 26.611, for protection of information;

(J) Section 26.613, for the appeals process;

(K) Section 26.615, for audits;

(L) Section 26.617, for recordkeeping, reporting, and FFD program performance;

(M) Section 26.619, for suitability and fitness determinations;

(N) Subpart A, for administrative provisions;

(O) Subpart I, for managing fatigue, in the case of holders of an ML that allows the assembly, non-operational testing, or both of a manufactured reactor; and

(P) Subpart O, for inspections, violations, and penalties.

(b)(1) Except for a licensee or other entity that demonstrates compliance with § 73.100(a)(1)(i) of this chapter and elects to implement an FFD program that satisfies the requirements of this paragraph (b), for which its FFD program must be established, implemented, and maintained no later than the start of construction activities, as defined in § 26.5, and except for holders of manufacturing licenses if they possess a separate license to load fuel into a manufactured reactor, for which its FFD program under this paragraph (b) must be established, implemented, and maintained no later than the start of the loading of fuel into the reactor, the licensee or other entity must establish, implement, and maintain an FFD program under this paragraph (b) before the earliest occurrence of the following, as applicable:

(i) The loading of fuel onsite into a reactor vessel;

(ii) Receiving a fueled manufactured reactor; and

(iii) Individuals subject to this part operate, test, perform maintenance of, or direct the maintenance or surveillance of security-related equipment or equipment that a risk-informed evaluation process has shown to be significant to public health and safety.

(2) An FFD program under this paragraph (b) must—

(i) Apply to those individuals described in § 26.4, as applicable; and

(ii) Implements the following requirements and subparts:

(A) Section 26.23, for performance objectives;

(B) Section 26.35, for employee assistance programs;

(C) Section 26.603, for general provisions;

(D) Section 26.606, for written policy and procedures;

(E) Section 26.607, for drug and alcohol testing;

(F) Section 26.608, for FFD program training;

(G) Section 26.609, for behavioral observation;

(H) Section 26.611, for protection of information;

(I) Section 26.613, for the appeals process;

(J) Section 26.615, for audits;

(K) Subpart A, for administrative provisions;

(L) Subpart C, for granting and maintaining authorization;

(M) Subpart D, for management actions and sanctions to be imposed;

(N) Subpart H, for determining fitness-for-duty Policy violations and determining fitness, unless using the Mandatory Guidelines for Federal Workplace Drug Testing Programs (the HHS Guidelines) for Medical Review Officer (MRO) evaluation of drug test results, and determining fitness;

(O) Subpart I, for managing fatigue;

(P) Subpart N, for recordkeeping and reporting requirements; and

(Q) Subpart O, for inspections, violations, and penalties.

§ 26.606 Written policy and procedures.

(a) Licensees and other entities that implement an FFD program under this subpart must ensure that—

(1) A written FFD policy statement is provided to each individual who is subject to the program before the individual is subject to drug and alcohol testing.

(2) The FFD policy statement describes the performance objectives in § 26.23.

(3) The FFD policy statement describes the minimum days off requirements in § 26.205(d)(3) or maximum average work hours requirements in § 26.205(d)(7).

(4) The FFD policy statement must be written in sufficient detail to provide affected individuals with information on what is expected of them and what consequences may result from a lack of adherence to the policy, including those elements described in paragraph (b) of this section, sanctions required under this part, and required medical/clinical treatment and follow-up testing for FFD policy violations.

(5) The FFD policy statement describes the individual's responsibilities to report for work in a physiological and psychological condition that enables the safe and competent performance of assigned duties and responsibilities and inform a licensee- or other entity-designated representative when the individual determines that this cannot be accomplished.

(6) The FFD policy statement must prohibit the consumption of alcohol, at a minimum, within an abstinence period of 5 hours preceding the individual's arrival at the licensee's or other entity's facility.

(7) The FFD policy statement must convey that abstinence from alcohol for the 5 hours preceding any scheduled tour of duty is considered to be a minimum that is necessary, but may not be sufficient, to ensure that the individual is fit for duty.

(b) Licensees and other entities must establish, implement, and maintain written procedures that address the following topics:

(1) For the drug and alcohol testing program under this subpart:

(i) The methods and techniques to collect and test for drugs and alcohol and for the shipping and temporary storage of biological specimens used for drug testing at HHS-certified laboratories;

(ii) The urine specimen volumes, techniques for split specimen collections, and the acceptability of a urine specimen as described in § 26.111 or as described in the HHS Guidelines;

(iii) Protecting the privacy of an individual who provides a specimen, protecting the integrity of the specimen, and ensuring that the test results are valid and attributable to the correct individual; and

(iv) If the licensee or other entity elects to use the HHS Guidelines, the name of the specific HHS Guideline and revision being implemented by the licensee or other entity and a description of the specific sections in the guideline that are being implemented in the procedure, including specimen collections, drug testing, and evaluation of test results.

(2) The immediate and follow-up actions that will be taken, and the procedures to be used, in those cases in which individuals who are subject to the FFD program:

(i) Have been involved in the use, sale, or possession of illegal substances, illegal drugs, or illicit substances;

(ii) Are impaired by any illegal substances, illegal drugs, or illicit substances or the consumption of alcohol as determined by behavioral observation or a test that measures blood alcohol concentration;

(iii) Attempted to subvert the testing process by adulterating or diluting specimens (in vivo or in vitro), substituting specimens, or by any other means;

(iv) Refused to provide a specimen for analysis or follow instructions provided by FFD program personnel;

(v) Had legal action taken relating to drug or alcohol use;

(vi) Demonstrated character or actions indicating that the individual cannot be trusted or relied upon to perform those duties and responsibilities or maintain access to NRC-licensed facilities, special nuclear material (SNM), or sensitive information; or

(vii) Have a condition or have taken actions that pose or have posed an immediate hazard to themselves or others, as notified by EAP personnel under § 26.35(c)(2).

(3) The process, including the duties and responsibilities of FFD program personnel, to be followed if an individual's behavior or condition raises a concern regarding the possible use, sale, or possession of illegal drugs on- or offsite; the possible use or possession of alcohol on the NRC-licensed facility; impairment from any cause that in any way could adversely affect the individual's ability to safely and competently perform the individual's duties; or the receipt of credible information indicating that the individual cannot be trusted or relied on to perform those duties and responsibilities making the individual subject to this part.

(4) Operation and oversight of any onsite or offsite collection facility.

(5) The fatigue management requirements in § 26.202(b) and either § 26.205(d)(3) or (7).

(6) Measures to prevent subversion of drug and alcohol tests conducted onsite and offsite.

§ 26.607 Drug and alcohol testing.

Licensees and other entities must perform drug and alcohol testing that complies with the following requirements—

(a) Split specimens. Split specimen collections of oral fluid or urine must be used for the test conditions described in paragraph (b) of this section. Testing of the split specimen (specimen B) requires the donor's permission unless ordered by the MRO to resolve an invalid test result obtained for specimen A.

(b) Test conditions. Individuals identified in § 26.4 must be subject to drug and alcohol testing under the following conditions:

(1) Pre-access. A pre-access test must be conducted for drugs and alcohol before performing or directing the conduct of roles and responsibilities making the individual subject to this subpart or being granted unescorted access to the protected areas of the NRC-licensed facility. A pre-access test must have been conducted no more than 14 days before the individual is granted unescorted access.

(2) Random. Random testing for drugs and alcohol must—

(i) Be administered in a manner that provides reasonable assurance that individuals are unable to predict the time periods during which specimens will be collected;

(ii) Require individuals who are selected for random testing to report to the onsite collection site as soon as reasonably practicable after notification, within the time period specified in the FFD program procedure;

(iii) Ensure that all individuals in the population that is subject to random testing on a given day have an equal probability of being selected and tested;

(iv) Ensure that an individual completing a test is immediately eligible for another random test; and

(v) Ensure that the sampling process used to select individuals for random testing provides that the number of random tests performed annually is equal to at least 50 percent of the population that is subject to the FFD program at the NRC-licensed site.

(vi) If the number of individuals subject to random testing at an NRC-licensed site is such that paragraph (b)(2)(v) of this section cannot be implemented without predictable outcomes, the licensee must use a consortium/third-party administrator to manage the random testing pool and make selections for testing throughout the year.

(3) For-cause. For-cause drug and alcohol tests must be conducted onsite in response to an individual's observed behavior or physical condition indicating possible substance abuse, as defined in § 26.5. A for-cause drug test, alcohol test, or both, must be conducted onsite after receiving credible information either that an individual is engaging in substance abuse or in response to a portal area screening test result under paragraph (j) of this section.

(4) Post-event. A post-event test for drugs and alcohol must be conducted—

(i) As soon as practical after an event involving a human error that was committed by an individual specified in § 26.4, where the human error may have caused or contributed to the event. This test must be conducted onsite unless the individual requires offsite medical care. The licensee or other entity must test the individual(s) who committed or directed the error and need not test individuals who were affected by the event and whose actions likely did not cause or contribute to the event. The licensee or other entity must describe in its procedures what constitutes a human error.

(ii) Within 4 hours of an event unless immediate medical intervention precludes the conduct of the test on the individual(s) who caused or contributed to the accident(s), if the event results in—

(A) An illness or personal injury to any individual which results in death, days away from work, restricted work, transfer to another job, medical treatment beyond first aid, loss of consciousness, or other significant illness or injury, as diagnosed by a licensee- or other entity-designated physician or other licensed health care professional, even if the illness or injury does not result in death, days away from work, restricted work or job transfer, medical treatment beyond first aid, or loss of consciousness; or

(B) Damage to any safety- or security-related structures, systems, and components; and

(5) Follow-up. An individual subject to this part who has violated the FFD policy for substance use or abuse, or the sale, use, or possession of illegal drugs must be subject to a follow-up series of tests for drugs, alcohol, or both to verify an individual's continued abstinence from substance abuse.

(c) Urine and oral fluid specimens. (1) All urine or oral fluid specimens must be tested for the substances listed in § 26.31(d)(1), except as allowed by § 26.603(e)(3). All urine specimens must be subject to validity testing as specified in either this part or the HHS Guidelines. All oral fluid specimens may be subject to validity testing, including a biological marker, as specified in either this part or the HHS Guidelines.

(2) For the use of urine as the biological specimen to be tested, the following requirements must be implemented—

(i) Section 26.115, for collecting a urine specimen under direct observation;

(ii) Section 26.119, for determining “shy” bladder; and

(iii) Section 26.163, for cutoff levels for drugs and drug metabolites.

(3) For alcohol testing onsite, the following requirements must be implemented—

(i) Section 26.91, for acceptable devices for conducting initial and confirmatory tests for alcohol and methods of use;

(ii) Section 26.93, for preparing for alcohol testing;

(iii) Section 26.95, for conducting an initial test for alcohol using a breath specimen;

(iv) Section 26.97, for collecting oral fluid specimens for alcohol and drug testing;

(v) Section 26.99, for determining the need for a confirmatory test for alcohol;

(vi) Section 26.101, for conducting a confirmatory test for alcohol; and,

(vii) Section 26.103, for determining a confirmed positive test result for alcohol.

(4) For all test conditions in paragraph (b) of this section and for MRO-directed tests under § 26.185, drug testing must be performed at an HHS-certified laboratory for the specific biological specimen to be tested. Only HHS-certified laboratory test results from urine and oral fluid specimens may be used for the issuance of a sanction required under this part. The licensee or other entity must establish and maintain a contract with a primary and a back-up HHS-certified laboratory (with a different Certifying Scientist) for the specimen(s) to be tested. These contracts must stipulate that the laboratories are subject to inspection or audit by the licensee or other entity and that records and documents must be provided and/or able to be photocopied and removed from the premises to support the inspection or audit.

(d) Privacy and integrity. The specimen collection and drug and alcohol testing procedures of FFD programs must protect the donor's privacy and the integrity of the specimen and implement quality controls to ensure that test results are valid and attributable to the correct individual.

(e) Offsite collection facilities. At the licensee's or other entity's discretion, except for those specimens that must be collected onsite under paragraphs (b)(3) and (4) of this section, specimen collections and alcohol testing may be conducted at a local hospital or other facility licensed to conduct specimen collections and perform alcohol testing and audited by the State or a State-designated entity. The licensee or other entity must audit these facilities, if used, before their initial use and then on a biennial basis to confirm that the facility procedures are comparable to those described in subpart E of this part or the HHS Guidelines for urine and oral fluid.

(f) Initial testing. A licensee or other entity subject to this subpart performing an initial test must use an immunoassay, or an alternative technology as specified in the HHS Guidelines for the specific biological specimen that is to be tested. Specimens that yield positive, positive and dilute, adulterated, substituted, or invalid initial validity or drug test results or discrepant biological markers must be subject to confirmatory testing by an HHS-certified laboratory, certified for that biological specimen, except for invalid specimens that cannot be tested.

(g) Oral fluid testing. (1) If the licensee or other entity elects to use oral fluid for drug or alcohol testing, the collection, packaging, temporary storage, and shipment of an oral fluid specimen to an HHS-certified laboratory for drug testing, or the collection of an oral fluid specimen for alcohol testing must be performed in accordance with licensee- or other entity-established procedures based either on the requirements in this part or the procedures in HHS Guidelines identified by the licensee or other entity in § 26.606(b)(1)(iv). The oral fluid device must not expire before the date of the collection of the specimen for testing. The drugs, drug metabolites, initial and confirmatory testing cutoffs, and biological markers, if applicable, must be those established by the HHS Guidelines for oral fluid testing and the alcohol cutoffs in this part or, if not established by the HHS Guidelines or this part for the panel of drugs and drug metabolites to be tested, as determined and documented by a forensic toxicologist review conducted pursuant to § 26.31(d)(1)(i)(D).

(2) The virtual collection of oral fluid specimens for drug and alcohol testing is only permitted for sites that must use a C/TPA to implement random testing under paragraph (b)(2)(vi) of this section. For a licensee or other entity to utilize a virtual oral fluid specimen collection process, the following must apply or should be considered, as applicable:

(i) The specimen collector completing the virtual collection must meet the requirements in § 26.85.

(ii) The oral fluid specimen collection process must be completed as described under §§ 26.97 and 26.99.

(iii) An individual other than the donor (i.e., a virtual collection monitor) may be needed in the location where the specimen collection is to be performed to assist the virtual collector in completing activities, performing observations, or both.

(iv) If a virtual collection monitor is used to assist the specimen collector in completing an oral fluid specimen collection, then the virtual specimen collector must explain the collection process to the monitor and provide instruction to the monitor on required activities to be performed during the collection process. The monitor's name must be recorded on the Federal custody and control form (Federal CCF) for drug testing specimens, or an analogous document for alcohol testing.

(v) Video teleconference communication method(s) must provide sufficient visual and aural clarity to complete the process and ensure that a donor is not able to subvert the testing process.

(vi) Collection kit materials must be maintained in a secure fashion until the virtual collector initiates the virtual collection process with the donor.

(vii) The licensee or other entity's written FFD procedures must describe in detail the virtual collection process and when and how it is to be implemented.

(viii) The virtual collection procedure must address problem collections, such as the video teleconference becomes inoperable during the collection process or the donor is unable to provide an oral fluid specimen of sufficient quantity to complete the specimen collection process for drug or alcohol testing.

(ix) The virtual collection procedure must include steps to collect a breath specimen using an evidential breath testing device (EBT) if the oral fluid specimen test result under § 26.99(b) requires a confirmatory testing for alcohol under § 26.101. At a minimum, a donor with an oral fluid specimen test result requiring confirmatory testing for alcohol must be removed from duty pending additional testing.

(h) [Reserved]

(i) Hair testing. The testing of hair specimens may only be used to inform a licensee's or other entity's determination of whether the individual is trustworthy and reliable under the test condition in paragraph (b)(1) of this section to supplement the information gained from a pre-access test using oral fluid or urine as the test specimen and must be conducted at an HHS-certified laboratory certified to test hair specimens.

(1) If used, this process must be described in the licensee's or other entity's FFD policy and described in detail in its procedure. The panel of drugs and drug metabolites to be evaluated must only include those listed as Schedule I or II of section 202 of the Controlled Substances Act [21 U.S.C. 812]. The collection, packaging, and temporary storage of a hair specimen and shipment of the specimen to an HHS-certified laboratory must be conducted in accordance with the HHS Guidelines. The licensee- or other entity-designated FFD program personnel must conduct the collection, packaging, temporary storage, shipping, and custody and control of the specimen.

(2) Before the licensee or other entity begins to conduct hair testing, the initial and confirmatory testing cutoffs must be the cutoffs established by the HHS Guidelines for hair testing or, if not established by the HHS Guidelines or this part, as determined by a forensic toxicologist review conducted pursuant to § 26.31(d)(1)(i)(D).

(3) Confirmed positive test results must be considered potentially disqualifying FFD information until proven otherwise by a review under § 26.613. Sanctions under this subpart must not be issued for any FFD policy violation involving a drug test using a hair specimen unless the licensee or other entity determines that the individual has attempted to subvert the testing process, as defined in § 26.5, for the hair test.

(j) Portal area screening. A non-invasive testing instrument may be used to screen individuals for drugs, drug metabolites, and alcohol before the individuals' entry into or exit from a protected or vital area.

(1) The instrument must be operated in accordance with the manufacturer's specifications. If screening detects the presence of any drug, drug metabolite, or alcohol at or above the instrument set point, the individual screened by the instrument must be subject to for-cause testing under paragraph (b)(3) of this section.

(2) Annually, the licensee or other entity must verify the accuracy of the portal area screening test for each substance with any positive results. If at least 85 percent of the positive portal area screening test results for a substance in the past 12 months do not subsequently confirm positive on for-cause testing performed under paragraph (j)(1) of this section, the licensee or other entity cannot continue to use the screening test for the particular substance until such time as corrective actions have been implemented to improve the testing accuracy.

(3) A sanction under this part may not be issued to an individual based solely on a portal area screening instrument detection that drugs or alcohol exceed the instrument's established setpoint.

(k) Blood testing. The testing of blood specimens may only be conducted under the order of the licensee- or other entity-designated MRO for a valid medical reason as confirmed by the MRO pursuant to § 26.31(d)(5). This specimen must be subject to testing by a laboratory that satisfies quality control requirements that are comparable to those required for certification by the HHS.

(l) Federal custody and control form. For the collection and packaging of urine, oral fluid, and hair specimens for drug testing, the licensee or other entity must use a Federal CCF.

(m) Medical Review Officer. Licensees or other entities must—

(1) Require their designated MRO to review positive, positive and dilute, adulterated, substituted, and invalid confirmatory drug and validity test results to determine whether the donor has violated the FFD policy. The review must be completed before reporting the results to the individual designated by the licensee or other entity to assess authorization or perform the suitability and fitness determinations required under § 26.619, or, if required, that are described in subpart H of this part.

(2) Require their MRO to satisfy the requirements in § 26.183 and, prior to conducting any activities under this part, attend and pass a medical- or clinical-based training session to improve his/her knowledge of MRO duties and responsibilities, drug and alcohol testing processes and procedures, and evaluation of drug testing results. This training session must be conducted by a nationally recognized MRO training and certification organization that has been assessed by the licensee's or other entity's FFD program personnel to include the technical elements an MRO must implement under § 26.185. An MRO who performed the duties and responsibilities in §§ 26.185 and 26.187 for at least 3 continuous years in the last 10 years prior to being hired or contracted by the licensee or other entity satisfies the requirements in this paragraph (m)(2).

(3) Require their MRO to attend a medical- or clinical-based training session at least every 5 years to improve his/her knowledge of changes in drug and alcohol testing processes and procedures and evaluation of drug testing results.

(4) Require their MRO to determine whether a biological specimen is positive, positive and dilute, adulterated, substituted, or invalid by implementing the requirements in § 26.185 or the HHS Guidelines through the licensee's or other entity's procedures.

(i) If § 26.185 or the HHS Guidelines, as used by the licensee or other entity in its procedures, are insufficient to make this determination, then guidance issued by a State agency in the State in which the NRC-licensed facility is located, Federal agencies, or nationally recognized MRO training and certification organizations may be used to inform an MRO determination.

(ii) An MRO need not review alcohol test results, including positive confirmatory alcohol test results determined by an EBT under paragraphs (c)(3)(vi) and (vii) of this section.

(5) Require their MRO to determine and approve the use of oral fluid or urine as an alternative biological specimen when the donor cannot provide a specimen for testing. This determination and the retest must be documented and completed as soon as reasonably practicable.

(6) Require the MRO to review all specimen test results associated with drug-related FFD policy violations. This review includes split specimens and all specimens taken to resolve a discrepant condition, such as a possible subversion attempt, impairment without a known cause, or a donor-requested or MRO-directed re-test. To resolve a discrepant condition, the MRO is authorized to test a specimen for a biological marker, adulterants, or additional drugs.

(n) Limitations of screening and testing. Specimens collected under NRC regulations may only be designated or approved for screening and testing as described in this part and may not be used to conduct any other analysis or test without the written permission of the donor. Analyses, screens, and tests that may not be conducted include, but are not limited to, DNA testing, serological typing, or any other medical or genetic test used for diagnostic or specimen identification purposes. No biological specimens may be passively sampled and analyzed in a manner different than described in this subpart.

(o) Specimen collectors. All onsite specimen collections, except a collection by a portal area screening instrument in paragraph (j) of this section, must be conducted by licensee- or other entity-designated and -trained personnel.

§ 26.608 FFD program training.

(a) FFD program training. (1) Individuals must be trained in the FFD policy and procedure, including fatigue management, and their FFD program responsibilities. Individuals who collect specimens for testing must also be trained in specimen collector duties and responsibilities, including, at a minimum, specimen collection, custody and control, identification and response to subversion attempts, and privacy. For licensees and other entities of commercial nuclear plants, the FFD program training program must use a systems approach to training as defined in § 53.725 of this chapter and described in § 53.830 of this chapter for those individuals in § 26.4.

(2) FFD program training must include training on the behavioral observation program. The behavioral observation program training must include the detection of physiological behaviors or conditions that may indicate—

(i) Possible use, sale, or possession of illegal drugs or illicit drugs, or substance abuse on- or offsite;

(ii) Use or possession of alcohol onsite or use while on duty offsite;

(iii) Impairment from fatigue or any cause that, if left unattended, could result in inattentiveness or human errors; and

(iv) Any individual's inability to safely and competently perform assigned duties and responsibilities or act in a trustworthy and reliable manner while having access to protected areas, SNM, or sensitive information.

(3) Training must explain that an individual's FFD policy violation will—

(i) Subject the individual to an FFD program-required sanction designed to preclude recurrence of an FFD policy violation;

(ii) Contribute to the licensee's or other entity's assessment of whether the individual can be trusted and relied upon to safely and competently perform the assigned duties and responsibilities making the individual subject to this subpart;

(iii) Be used to inform the licensee's or other entity's insider mitigation and access authorization programs under § 73.55, § 73.56, § 73.100, or § 73.120 of this chapter; and

(iv) Be used to inform other NRC licensees and other entities subject to this part when FFD program information is requested to support authorization determinations under subpart C of this part or § 73.56 or § 73.120 of this chapter.

(b) Training and assessments. Training and a trainee assessment must be conducted before pre-access testing, and FFD program refresher training and trainee assessments must be conducted on a nominal 24-month frequency, or more frequently where the need is indicated. Indications of the need for more frequent training include, but are not limited to, an individual's failure to properly implement FFD program procedures and the frequency, nature, or severity of problems discovered through audits or the administration of the program.

(c) Training program review. The licensee or other entity must periodically evaluate its FFD training program and revise it as appropriate to reflect industry experience as well as applicable changes to the regulations in this part, the HHS Guidelines, if used, and specimen collection and testing processes implemented by the licensee or other entity.

§ 26.609 Behavioral observation.

(a) Licensees and other entities must ensure that the individuals who are subject to this subpart are subject to behavioral observation and that behavioral observation is performed by all individuals subject to this subpart.

(b) Licensees and other entities must require all individuals subject to the FFD program to report to the licensee- or other entity-designated representative any onsite or offsite behaviors or activities by individuals subject to this part that may constitute an unreasonable risk to the safety or security of the NRC-licensed facility or SNM or may cause harm to others. This reporting must include any information relating to character or reputation of the individual indicating that the individual cannot be trusted or relied upon to perform those duties and responsibilities or maintain access to NRC-licensed facilities, SNM, or sensitive information that makes them subject to this part.

(c) Behavioral observation must be performed visually, in-person, and, when necessary, remotely by live video and audible streaming and capture, to observe the behavior of individuals in the workforce subject to the requirements in this subpart.

(d) Not withstanding paragraph (c) of this section, for a reactor facility where individual task loading does not allow for the effective conduct of behavior observation in addition to assigned operational tasks, the licensee or other entity must implement a live video and audible streaming and capture system to conduct behavioral observation of persons licensed to operate under part 53 of this chapter who manipulate the controls of any commercial nuclear plant licensed under part 53.

§ 26.610 Sanctions.

(a) Licensees and other entities that implement an FFD program under this subpart must establish sanctions for FFD policy violations that, at a minimum, prohibit the individuals specified in § 26.4 from being assigned to perform or direct those duties and responsibilities or maintaining authorization making them subject to this subpart.

(b) The severity of the sanction must escalate with the number of occurrences and severity of the FFD policy violation. The sanction must be long enough to act as a deterrent and, if the individual is retained as a licensee employee or contractor/vendor, facilitate the individual to complete counseling or treatment. The sanctions must include an immediate unfavorable termination of the individual's authorization as follows:

(1) A minimum 14-day denial of access for a first violation of the FFD policy involving a confirmed positive drug or alcohol test result;

(2) A minimum 3-year denial of access for a second violation of the FFD policy involving a confirmed positive drug or alcohol test result;

(3) A minimum 5-year denial of access for any individual who is determined to have been involved in the sale, use, or possession of illegal drugs or the consumption of alcohol within a protected area of any facility licensed under part 53 of this chapter or within a transporter's facility or vehicle used in the conveyance of formula quantities of strategic SNM while the individual is subject to this subpart; and

(4) A permanent denial of access for a third violation of the FFD policy involving a confirmed positive drug or alcohol test result or a subversion attempt of any drug or alcohol test or screening process.

§ 26.611 Protection of information.

(a) Licensees and other entities that collect personal information about an individual for the purpose of complying with this subpart must establish and maintain a system of files and procedures to prevent unauthorized disclosure.

(b) Licensees and other entities must obtain a signed consent that documents the individual's acceptance of being subject to the FFD program and authorizes the disclosure of the personal information collected and maintained under this subpart, except for disclosures to the individuals and entities specified in § 26.37(b)(1) through (6) and (8), and persons deciding matters under review in § 26.613. This signed and dated consent must be obtained before making the individual subject to the FFD program.

§ 26.613 Appeals process.

Licensees and other entities that implement an FFD program under this subpart must establish and implement procedures for the review of a determination that an individual in § 26.4 has violated the FFD policy. The procedure must provide for an objective and impartial review of the facts related to the determination that the individual has violated the FFD policy and a schedule for the completion of the review.

§ 26.615 Audits.

(a) Licensees and other entities that implement an FFD program under this subpart must audit their programs at a frequency that ensures the continuing effectiveness of their FFD program, FFD program elements that are provided by C/Vs, and the FFD programs of C/Vs that are accepted by the licensee or other entity. Corrective actions must be taken as soon as reasonably practicable to resolve any problems identified in an audit and preclude recurrence.

(b) The subject matter, scope, and frequency of audits must be revised as necessary to improve or maintain program performance based on annual FFD program performance data reviews performed under § 26.617(d) and unsatisfactory performance or programmatic weaknesses identified under § 26.617(b)(3) and (e).

(c) Licensees and other entities may conduct joint audits or accept audits of C/Vs so long as the audit addresses the relevant services of the C/Vs.

(d) Licensees and other entities must audit HHS-certified laboratories unless the licensee's or other entity's panel of drugs and drug metabolites to be tested is equivalent to the panel by which the laboratory is certified by HHS or is subject to the standards and procedures for drug testing and evaluation used by the laboratory under the HHS Guidelines. Licensees and other entities must audit any hospital or other facility licensed by the State (or State-designated entity) if used to conduct specimen collections and perform alcohol testing under this part on a biennial basis to confirm that the facility procedures are comparable to those described in subpart E of this part, for urine and oral fluid.

§ 26.617 Recordkeeping, reporting, and FFD program performance.

(a) Licensees and other entities that implement FFD programs under this subpart must ensure that records pertaining to the administration of their program, which may be stored and archived electronically, are maintained so that they are available for NRC inspection purposes and for any legal proceedings resulting from the administration of the program. Records pertaining to the administration of the FFD program and FFD performance data required by § 26.717 must be retained until license termination.

(b) Licensees and other entities must make the following reports:

(1) Reports to the NRC Operations Center by telephone within 24 hours after the licensee or other entity discovers any intentional act that casts doubt on the integrity of the FFD program and any programmatic failure, degradation, or discovered vulnerability of the FFD program that may permit undetected drug or alcohol use or abuse by individuals who are subject to this subpart. These events must be reported under this subpart, rather than under the provisions of § 73.1200 of this chapter;

(2) Annual FFD program performance data under § 26.717(b) for each FFD program subject to this subpart. Licensees and other entities must submit FFD program performance data (for January through December) to the NRC annually, before March 1 of the following year and must use unexpired NRC-provided forms for the electronic submission of FFD information to the NRC; and

(3) Reports on drug and alcohol testing errors within 30 days of completing an investigation of any testing errors or unsatisfactory performance, discovered at an HHS-certified laboratory or through the processing of appeals under § 26.613, or errors or matters that could adversely reflect on the integrity of the random selection or random testing process. The reports must describe the incident and any corrective actions taken or planned.

(c) Licensees and other entities subject to this subpart must describe in sufficient detail to support an authorization determination, an individual's FFD policy violation (while protecting privacy information under § 26.611) and FFD program weakness to NRC, licensees, and other entities subject to this part when requested to support authorization determinations under subpart C of this part or § 73.120 of this chapter, as applicable, or to support licensee or other entity performance monitoring.

(d) Licensees and other entities must analyze FFD program performance data at least annually and take appropriate actions to correct any identified program weakness.

(e) Licensees and other entities must document, trend, and correct non-reportable indicators of FFD programmatic weaknesses under the licensee's or other entity's corrective action program, but may not track or trend drug and alcohol test results in a manner that would permit the identification of any individuals.

§ 26.619 Suitability and fitness determinations.

Licensees and other entities that implement FFD programs under this subpart must develop, implement, and maintain procedures for evaluating whether to assign individuals to perform or direct those duties and responsibilities making them subject to this subpart. A suitability or fitness determination conducted for cause must be performed face-to-face. A suitability or fitness determination conducted for cause may be performed remotely using electronic communications that provide sufficient visual and aural clarity to complete the assessment. A fitness determination may be supported by someone who is present in-person with the individual being assessed only during for-cause drug and alcohol testing determinations under § 26.607(b)(3) and fatigue assessments performed under § 26.211(a)(1). The supporting person must be trained in accordance with the requirements of either § 26.29 or § 26.608.

§ 26.709 Applicability.

(a) The requirements of this subpart apply to the FFD programs of licensees and other entities specified in § 26.3(a) through (d), except for FFD programs that are implemented under subpart K of this part.

(b) The requirements in this subpart apply to the FFD programs of licensees and other entities specified in § 26.3(f) that elect not to implement the requirements in subpart M or elect to implement the requirements in § 26.605(b).

[91 FR 15786, Mar. 30, 2026]

§ 26.711 General provisions.

(a) Each licensee and other entity shall maintain records and submit certain reports to the NRC. Records that are required by the regulations in this part must be retained for the period specified by the appropriate regulation. If a retention period is not otherwise specified, these records must be retained until the Commission terminates the facility's license, certificate, or other regulatory approval.

(b) All records may be stored and archived electronically, provided that the method used to create the electronic records meets the following criteria:

(1) Provides an accurate representation of the original records;

(2) Prevents the alteration of any archived information and/or data once it has been committed to storage; and

(3) Permits easy retrieval and re-creation of the original records.

(c) The licensees and other entities specified in § 26.3(a) and, as applicable, (c), (d), and (f), shall inform each individual of his or her right to review information about the individual that is collected and maintained under this part to assure its accuracy. Licensees and other entities shall provide the individual with an opportunity to correct any inaccurate or incomplete information that is documented by licensees and other entities about the individual.

(d) Licensees and other entities shall ensure that only correct and complete information about individuals is retained and shared with other licensees and entities. If, for any reason, the shared information used for determining an individual's eligibility for authorization under this part changes or new information is developed about the individual, licensees and other entities shall correct or augment the shared information contained in the records. If the changed or developed information has implications for adversely affecting an individual's eligibility for authorization, a licensee and other entity specified in § 26.3(a) and, as applicable, (c), (d), and (f), who has discovered the incorrect information, or develops new information, shall inform the reviewing official of any FFD program under which the individual is maintaining authorization of the updated information on the day of discovery. The reviewing official shall evaluate the information and take appropriate actions, which may include denial or unfavorable termination of the individual's authorization.

[73 FR 17176, Mar. 31, 2008, as amended at 91 FR 15786, Mar. 30, 2026]

§ 26.713 Recordkeeping requirements for licensees and other entities.

(a) Each licensee and other entity who is subject to this subpart shall retain the following records for at least 5 years after the licensee or other entity terminates or denies an individual's authorization or until the completion of all related legal proceedings, whichever is later:

(1) Records of self-disclosures, employment histories, and suitable inquiries that are required under §§ 26.55, 26.57, 26.59, and 26.69 that result in the granting of authorization;

(2) Records pertaining to the determination of a violation of the FFD policy and related management actions;

(3) Documentation of the granting and termination of authorization; and

(4) Records of any determinations of fitness conducted under § 26.189, including any recommendations for treatment and followup testing plans.

(b) Each licensee and other entity who is subject to this subpart shall retain the following records for at least 3 years or until the completion of all related legal proceedings, whichever is later:

(1) Records of FFD training and examinations conducted under § 26.29; and

(2) Records of audits, audit findings, and corrective actions taken under § 26.41.

(c) Licensees and other entities shall ensure the retention and availability of records pertaining to any 5-year denial of authorization under § 26.75(c), (d), or (e)(2) and any permanent denial of authorization under § 26.75(b) and (g) for at least 40 years or until, on application, the NRC determines that the records are no longer needed.

(d) Licensees and other entities shall retain any superseded versions of the written FFD policy and procedures required under §§ 26.27, 26.39, and 26.203(b) for at least 5 years or until completion of all legal proceedings related to an FFD violation that may have occurred under the policy and procedures, whichever is later.

(e) Licensees and other entities shall retain written agreements for the provision of services under this part for the life of the agreement or until completion of all legal proceedings related to an FFD policy violation that involved those services, whichever is later.

(f) Licensees and other entities shall retain records of the background investigations, credit and criminal history checks, and psychological assessments of FFD program personnel, conducted under § 26.31(b)(1)(i), for the length of the individual's employment by or contractual relationship with the licensee or other entity, or until the completion of all related legal proceedings, whichever is later.

(g) If a licensee's or other entity's FFD program includes tests for drugs in addition to those specified in this part, as permitted under § 26.31(d)(1), or uses more stringent cutoff levels than those specified in this part, as permitted under § 26.31(d)(3), the licensee or other entity shall retain documentation certifying the scientific and technical suitability of the assays and cutoff levels used, as required under § 26.31(d)(1)(i) and (d)(3)(iii)(C), respectively, for the time the FFD program follows these practices or until the completion of all related legal proceedings, whichever is later.

§ 26.715 Recordkeeping requirements for collection sites, licensee testing facilities, and laboratories certified by the Department of Health and Human Services.

(a) Collection sites providing services to licensees and other entities who are subject to this subpart, licensee testing facilities, and HHS-certified laboratories shall maintain and make available documentation of all aspects of the testing process for at least 2 years or until the completion of all legal proceedings related to a determination of an FFD violation, whichever is later. This 2-year period may be extended on written notification by the NRC or by any licensee or other entity for whom services are being provided.

(b) Documentation that must be retained includes, but is not limited to, the following:

(1) Personnel files, including training records, for all individuals who have been authorized to have access to specimens, but are no longer under contract to or employed by the collection site or licensee testing facility;

(2) Chain of custody documents (other than forms recording specimens with negative test results and no FFD violations or anomalies, which may be destroyed after appropriate summary information has been recorded for program administration purposes);

(3) Quality assurance and quality control records;

(4) Superseded procedures;

(5) All test data (including calibration curves and any calculations used in determining test results);

(6) Test reports;

(7) Records pertaining to performance testing;

(8) Records pertaining to the investigation of testing errors or unsatisfactory performance discovered in quality control or blind performance testing, in the testing of actual specimens, or through the processing of appeals and MRO reviews, as well as any other errors or matters that could adversely reflect on the integrity of the testing process, investigation findings, and corrective actions taken, where applicable;

(9) Performance records on certification inspections;

(10) Records of preventative maintenance on licensee testing facility instruments;

(11) Records that summarize any test results that the MRO determined to be scientifically insufficient for further action;

(12) Either printed or electronic copies of computer-generated data;

(13) Records that document the dates, times of entry and exit, escorts, and purposes of entry of authorized visitors, maintenance personnel, and service personnel who have accessed secured areas of licensee testing facilities and HHS-certified laboratories; and

(14) Records of the inspection, maintenance, and calibration of EBTs.

[73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71463, Nov. 22, 2022]

§ 26.717 Fitness-for-duty program performance data.

(a) Licensees and other entities shall collect and compile FFD program performance data for each FFD program that is subject to this subpart.

(b) The FFD program performance data must include the following information:

(1) The random testing rate;

(2) Drugs for which testing is conducted and cutoff levels, including results of tests using lower cutoff levels, tests for drugs not included in the HHS panel, and any special analyses of dilute specimens permitted under § 26.163(a)(2);

(3) Populations tested (i.e., licensee or other entity employees, C/Vs);

(4) Number of tests administered and results of those tests sorted by population tested (i.e., licensee or other entity employees, C/Vs);

(5) Conditions under which the tests were performed, as defined in § 26.31(c);

(6) Substances identified;

(7) Number of subversion attempts by type;

(8) Summary of management actions; and

(9) The information required under § 26.203(e)(1) and (e)(2).

(c) Licensees and other entities who have a licensee-approved FFD program shall analyze the data at least annually and take appropriate actions to correct any identified program weaknesses. Records of the data, analyses, and corrective actions taken must be retained for at least 3 years or until the completion of any related legal proceedings, whichever is later.

(d) Any licensee or other entity who terminates an individual's authorization or takes administrative action on the basis of the results of a positive initial drug test for marijuana or cocaine shall also report these test results in the annual summary by processing stage (i.e., initial testing at the licensee testing facility, testing at the HHS-certified laboratory, and MRO determinations). The report must also include the number of terminations and administrative actions taken against individuals for the reporting period.

(e) Licensees and other entities shall submit the FFD program performance data (for January through December) to the NRC annually, before March 1 of the following year.

(f) Licensees and other entities may submit the FFD program performance data in a consolidated report, as long as the report presents the data separately for each site.

(g) Each C/V who maintains a licensee-approved drug and alcohol testing program is subject to the reporting requirements of this section and shall submit the required information either directly to the NRC or through the licensees or other entities to whom the C/V provided services during the year. Licensees, other entities, and C/Vs shall share information to ensure that the information is reported completely and is not duplicated in reports submitted to the NRC.

[73 FR 17176, Mar. 31, 2008, as amended at 79 FR 66603, Nov. 10, 2014; 87 FR 71463, Nov. 22, 2022]

§ 26.719 Reporting requirements.

(a) Required reports. Each licensee and entity who is subject to this subpart shall inform the NRC of significant violations of the FFD policy, significant FFD program failures, and errors in drug and alcohol testing. These events must be reported under this section, rather than under the provisions of 10 CFR 73.1200.

(b) Significant FFD policy violations or programmatic failures. The following significant FFD policy violations and programmatic failures must be reported to the NRC Operations Center by telephone within 24 hours after the licensee or other entity discovers the violation:

(1) The use, sale, distribution, possession, or presence of illegal drugs, or the consumption or presence of alcohol within a protected area;

(2) Any acts by any person licensed under 10 CFR part 55 to operate a power reactor, as well as any acts by SSNM transporters, FFD program personnel, or any supervisory personnel who are authorized under this part, if such acts—

(i) Involve the use, sale, or possession of a controlled substance;

(ii) Result in a determination that the individual has violated the licensee's or other entity's FFD policy (including subversion as defined in § 26.5); or

(iii) Involve the consumption of alcohol within a protected area or while performing the duties that require the individual to be subject to the FFD program;

(3) Any intentional act that casts doubt on the integrity of the FFD program; and

(4) Any programmatic failure, degradation, or discovered vulnerability of the FFD program that may permit undetected drug or alcohol use or abuse by individuals within a protected area, or by individuals who are assigned to perform duties that require them to be subject to the FFD program.

(c) Drug and alcohol testing errors. (1) Within 30 days of completing an investigation of any testing errors or unsatisfactory performance discovered in performance testing at either a licensee testing facility or an HHS-certified laboratory, in the testing of quality control or actual specimens, or through the processing of reviews under § 26.39 and MRO reviews under § 26.185, as well as any other errors or matters that could adversely reflect on the integrity of the random selection or testing process, the licensee or other entity shall submit to the NRC a report of the incident and corrective actions taken or planned. If the error involves an HHS-certified laboratory, the NRC shall ensure that HHS is notified of the finding.

(2) If a false positive error occurs on a blind performance test sample submitted to an HHS-certified laboratory, the licensee or other entity shall notify the NRC within 24 hours after discovery of the error.

(3) If a false negative error occurs on a quality assurance check of validity screening tests, as required in § 26.137(b), the licensee or other entity shall notify the NRC within 24 hours after discovery of the error.

(d) Indicators of programmatic weaknesses. Licensees and other entities shall document, trend, and correct non-reportable indicators of FFD programmatic weaknesses under the licensee's or other entity's corrective action program, but may not track or trend drug and alcohol test results in a manner that would permit the identification of any individuals.

[73 FR 17176, Mar. 31, 2008, as amended at 75 FR 73942, Nov. 30, 2010; 88 FR 15880, Mar. 14, 2023]

§ 26.821 Inspections.

(a) Each licensee and other entity who is subject to this part shall permit duly authorized NRC representatives to inspect, copy, or take away copies of its records and to inspect its premises, activities, and personnel as may be necessary to accomplish the purposes of this part.

(b) Written agreements between licensees or other entities and their C/Vs must clearly show that—

(1) The licensee or other entity is responsible to the NRC for maintaining an effective FFD program under this part; and

(2) Duly authorized NRC representatives may inspect, copy, or take away copies of any licensee's, other entity's, or C/V's documents, records, and reports related to implementation of the licensee's or other entity's FFD program under the scope of the contracted activities.

§ 26.823 Violations.

(a) An injunction or other court order may be obtained to prohibit a violation of any provision of—

(1) The Atomic Energy Act of 1954, as amended;

(2) Title II of the Energy Reorganization Act of 1974; or

(3) Any regulation or order issued under these Acts.

(b) A court order may be obtained for the payment of a civil penalty imposed under section 234 of the Atomic Energy Act of 1954, for violations of—

(1) Section 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Act;

(2) Section 206 of the Energy Reorganization Act of 1974;

(3) Any rule, regulation, or order issued under these sections;

(4) Any term, condition, or limitation of any license issued under these sections; or

(5) Any provisions for which a license may be revoked under section 186 of the Atomic Energy Act of 1954.

§ 26.825 Criminal penalties.

(a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For the purposes of section 223, all of the regulations in Part 26 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section.

(b) The regulations in this part that are not issued under sections 161b, 161i, or 161o for the purposes of section 223 are as follows: §§ 26.1, 26.3, 26.5, 26.7, 26.8, 26.9, 26.11, 26.51, 26.81, 26.121, 26.151, 26.181, 26.201, 26.601, 26.823, and 26.825.

[73 FR 17176, Mar. 31, 2008, as amended at 91 FR 15786, Mar. 30, 2026]

§ 30.1 Scope.

This part prescribes rules applicable to all persons in the United States governing domestic licensing of byproduct material under the Atomic Energy Act of 1954, as amended (68 Stat. 919), and under title II of the Energy Reorganization Act of 1974 (88 Stat. 1242), and exemptions from the domestic licensing requirements permitted by Section 81 of the Act. This part also gives notice to all persons who knowingly provide to any licensee, applicant, certificate of registration holder, contractor, or subcontractor, components, equipment, materials, or other goods or services, that relate to a licensee's, applicant's or certificate of registration holder's activities subject to this part, that they may be individually subject to NRC enforcement action for violation of § 30.10.

[63 FR 1895, Jan. 13, 1998]

§ 30.2 Resolution of conflict.

The requirements of this part are in addition to, and not in substitution for, other requirements of this chapter. In any conflict between the requirements in this part and a specific requirement in another part of the regulations in this chapter, the specific requirement governs.

[30 FR 8185, June 26, 1965]

§ 30.3 Activities requiring license.

(a) Except as provided in paragraphs (b)(2), (b)(3), (c)(2), and (c)(3) of this section and for persons exempt as provided in this part and part 150 of this chapter, no person shall manufacture, produce, transfer, receive, acquire, own, possess, or use byproduct material except as authorized in a specific or general license issued in accordance with the regulations in this chapter.

(b)(1) The requirements, including provisions that are specific to licensees, in this part and parts 19, 20, 21, and 71 of this chapter, as well as the additional requirements for specific broad scope, industrial radiography, irradiator, or well logging uses in 10 CFR parts 33, 34, 36, or 39, respectively, shall apply to Government agencies or Federally recognized Indian Tribes on November 30, 2007, when conducting activities under the authority provided by paragraphs (b)(2) and (b)(3) of this section.

(2) A specifically licensed Government agency or Federally recognized Indian Tribe that possesses and uses accelerator-produced radioactive material or discrete sources of radium-226 for which a license amendment is required to authorize the activities in paragraph (a) of this section, may continue to use these materials for uses permitted under this part until the date of the NRC's final licensing determination, provided that the licensee submits an amendment application on or before June 2, 2008.

(3) A Government agency or Federally recognized Indian Tribe that possesses and uses accelerator-produced radioactive material or discrete sources of radium-226 for which a specific license is required in paragraph (a) of this section, may continue to use such material for uses permitted under this part until the date of the NRC's final licensing determination provided that the agency or Indian Tribe submits an application for a license authorizing activities involving these materials on or before December 1, 2008.

(c)(1) The requirements, including provisions that are specific to licensees in this part and parts 19, 20, 21, and 71 of this chapter, as well as the additional requirements for specific broad scope, industrial radiography, irradiator, or well logging uses in 10 CFR parts 33, 34, 36, or 39, respectively, shall apply to all persons, other than those included in paragraph (b)(1) of this section, on August 8, 2009, or earlier as noticed by the NRC, when conducting activities under the authority provided by paragraphs (c)(2) and (c)(3) of this section.

(2) Except as provided in paragraph (b)(2) of this section, all other licensees, who possess and use accelerator-produced radioactive material or discrete sources of radium-226 for which a license amendment is required to authorize the activities in paragraph (a) of this section, may continue to use these materials for uses permitted under this part until the date of the NRC's final licensing determination, provided that the person submits an amendment application within 6 months from the waiver expiration date of August 7, 2009 or within 6 months from the date of an earlier termination of the waiver as noticed by the NRC, whichever date is earlier.

(3) Except as provided in paragraph (b)(3) of this section, all other persons, who possess and use accelerator-produced radioactive material or discrete sources of radium-226 for which a specific license is required in paragraph (a) of this section, may continue to use such material for uses permitted under this part until the date of the NRC's final licensing determination, provided that the person submits a license application within 12 months from the waiver expiration date of August 7, 2009 or within 12 months from the date of an earlier termination of the waiver as noticed by the NRC, whichever date is earlier.

(d) If a person or licensee is required to file an application for a license or amendment in accordance with paragraphs (b)(2), (b)(3), (c)(2), and (c)(3) of this section, but does not file for the license or amendment within the required time, the authority provided by paragraphs (b)(2), (b)(3), (c)(2), and (c)(3) of this section to receive or use the accelerator-produced radioactive material or discrete sources of radium-226 shall expire with respect to the person's or licensee's authority to receive and use such byproduct material. This authority shall not expire with respect to the responsibility of the person or licensee regarding the possession of such byproduct material, the decommissioning (including financial assurance) of facilities, or the disposal of such byproduct material.

[72 FR 55924, Oct. 1, 2007]

§ 30.4 Definitions.

Accelerator-produced radioactive material means any material made radioactive by a particle accelerator.

Act means the Atomic Energy Act of 1954 (68 Stat. 919), including any amendments thereto;

Agreement State means any state with which the Atomic Energy Commission or the Nuclear Regulatory Commission has entered into an effective agreement under subsection 274b. of the Act. Non-agreement State means any other State;

Alert means events may occur, are in progress, or have occurred that could lead to a release of radioactive material but that the release is not expected to require a response by offsite response organizations to protect persons offsite.

Byproduct material means—

(1) Any radioactive material (except special nuclear material) yielded in, or made radioactive by, exposure to the radiation incident to the process of producing or using special nuclear material;

(2)(i) Any discrete source of radium-226 that is produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity; or

(ii) Any material that—

(A) Has been made radioactive by use of a particle accelerator; and

(B) Is produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity; and

(3) Any discrete source of naturally occurring radioactive material, other than source material, that—

(i) The Commission, in consultation with the Administrator of the Environmental Protection Agency, the Secretary of Energy, the Secretary of Homeland Security, and the head of any other appropriate Federal agency, determines would pose a threat similar to the threat posed by a discrete source of radium-226 to the public health and safety or the common defense and security; and

(ii) Before, on, or after August 8, 2005, is extracted or converted after extraction for use in a commercial, medical, or research activity.

Commencement of construction means taking any action defined as “construction” or any other activity at the site of a facility subject to the regulations in this part that has a reasonable nexus to:

(1) Radiological health and safety; or

(2) Common defense and security.

Commission means the Nuclear Regulatory Commission and its duly authorized representatives;

Consortium means an association of medical use licensees and a PET radionuclide production facility in the same geographical area that jointly own or share in the operation and maintenance cost of the PET radionuclide production facility that produces PET radionuclides for use in producing radioactive drugs within the consortium for noncommercial distributions among its associated members for medical use. The PET radionuclide production facility within the consortium must be located at an educational institution or a Federal facility or a medical facility.

Construction means the installation of foundations, or in-place assembly, erection, fabrication, or testing for any structure, system, or component of a facility or activity subject to the regulations in this part that are related to radiological safety or security. The term “construction” does not include:

(1) Changes for temporary use of the land for public recreational purposes;

(2) Site exploration, including necessary borings to determine foundation conditions or other preconstruction monitoring to establish background information related to the suitability of the site, the environmental impacts of construction or operation, or the protection of environmental values;

(3) Preparation of the site for construction of the facility, including clearing of the site, grading, installation of drainage, erosion and other environmental mitigation measures, and construction of temporary roads and borrow areas;

(4) Erection of fences and other access control measures that are not related to the safe use of, or security of, radiological materials subject to this part;

(5) Excavation;

(6) Erection of support buildings (e.g., construction equipment storage sheds, warehouse and shop facilities, utilities, concrete mixing plants, docking and unloading facilities, and office buildings) for use in connection with the construction of the facility;

(7) Building of service facilities (e.g., paved roads, parking lots, railroad spurs, exterior utility and lighting systems, potable water systems, sanitary sewerage treatment facilities, and transmission lines);

(8) Procurement or fabrication of components or portions of the proposed facility occurring at other than the final, in-place location at the facility; or

(9) Taking any other action that has no reasonable nexus to:

(i) Radiological health and safety, or

(ii) Common defense and security.

Curie means that amount of radioactive material which disintegrates at the rate of 37 billion atoms per second;

Cyclotron means a particle accelerator in which the charged particles travel in an outward spiral or circular path. A cyclotron accelerates charged particles at energies usually in excess of 10 megaelectron volts and is commonly used for production of short half-life radionuclides for medical use.

Decommission means to remove a facility or site safely from service and reduce residual radioactivity to a level that permits—

(1) Release of the property for unrestricted use and termination of the license; or

(2) Release of the property under restricted conditions and termination of the license.

Dentist means an individual licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice dentistry.

Department and Department of Energy means the Department of Energy established by the Department of Energy Organization Act (Pub. L. 95-91, 91 Stat. 565, 42 U.S.C. 7101 et seq.) to the extent that the Department, or its duly authorized representatives, exercises functions formerly vested in the U.S. Atomic Energy Commission, its Chairman, members, officers and components and transferred to the U.S. Energy Research and Development Administration and to the Administrator thereof pursuant to sections 104 (b), (c) and (d) of the Energy Reorganization Act of 1974 (Pub. L. 93-438, 88 Stat. 1233 at 1237, 42 U.S.C. 5814) and retransferred to the Secretary of Energy pursuant to section 301(a) of the Department of Energy Organization Act (Pub. L. 95-91, 91 Stat. 565 at 577-578, 42 U.S.C. 7151).

Discrete source means a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.

Effective dose equivalent means the sum of the products of the dose equivalent to the organ or tissue and the weighting factors applicable to each of the body organs or tissues that are irradiated. Weighting factors are: 0.25 for gonads, 0.15 for breast, 0.12 for red bone marrow, 0.12 for lungs, 0.03 for thyroid, 0.03 for bone surface, and 0.06 for each of the other five organs receiving the highest dose equivalent.

Government agency means any executive department, commission, independent establishment, corporation, wholly or partly owned by the United States of America which is an instrumentality of the United States, or any board, bureau, division, service, office, officer, authority, administration, or other establishment in the executive branch of the Government;

License, except where otherwise specified means a license for by-product material issued pursuant to the regulations in this part and parts 31 through 36 and 39 of this chapter;

Medical use means the intentional internal or external administration of byproduct material or the radiation therefrom to patients or human research subjects under the supervision of an authorized user as defined in 10 CFR part 35.

Microcurie means that amount of radioactive material which disintegrates at the rate of 37 thousand atoms per second;

Millicurie means that amount of radioactive material which disintegrates at the rate of 37 million atoms per second;

Particle accelerator means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of 1 megaelectron volt. For purposes of this definition, accelerator is an equivalent term.

Person means: (1) Any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, Government agency other than the Commission or the Department, except that the Department shall be considered a person within the meaning of the regulations in this part to the extent that its facilities and activities are subject to the licensing and related regulatory authority of the Commission pursuant to section 202 of the Energy Reorganization Act of 1974 (88 Stat. 1244), any State or any political subdivision of or any political entity within a State, any foreign government or nation or any political subdivision of any such government or nation, or other entity; and (2) any legal successor, representative, agent, or agency of the foregoing;

Physician means a medical doctor or doctor of osteopathy licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to prescribe drugs in the practice of medicine;

Podiatrist means an individual licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice podiatry.

Principal activities, as used in this part, means activities authorized by the license which are essential to achieving the purpose(s) for which the license was issued or amended. Storage during which no licensed material is accessed for use or disposal and activities incidental to decontamination or decommissioning are not principal activities.

Production facility means production facility as defined in the regulations contained in part 50 of this chapter;

Research and development means: (1) Theoretical analysis, exploration, or experimentation; or (2) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials and processes. “Research and development” as used in this part and parts 31 through 35 does not include the internal or external administration of byproduct material, or the radiation therefrom, to human beings;

Sealed source means any byproduct material that is encased in a capsule designed to prevent leakage or escape of the byproduct material;

Site area emergency means events may occur, are in progress, or have occurred that could lead to a significant release of radioactive material and that could require a response by offsite response organizations to protect persons offsite.

Source material means source material as defined in the regulations contained in part 40 of this chapter;

Special nuclear material means special nuclear material as defined in the regulations contained in part 70 of this chapter;

United States, when used in a geographical sense, includes Puerto Rico and all territories and possessions of the United States;

Utilization facility means a utilization facility as defined in the regulations contained in part 50 or 53 of this chapter.

[30 FR 8185, June 26, 1965]

Editorial Note:For Federal Register citations affecting § 30.4, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

§ 30.5 Interpretations.

Except as specifically authorized by the Commission in writing, no interpretation of the meaning of the regulations in this part and parts 31 through 36 and 39 by any officer or employee of the Commission other than a written interpretation by the General Counsel will be recognized to be binding upon the Commission. This section shall cease to have effect on January 8, 2027, unless the NRC determines that the cessation deadline should be extended to a date not more than 5 years in the future after offering the public an opportunity to provide input on the costs and benefits of this section and considering that input. The NRC will publish a document in the Federal Register announcing its determination and revising or removing this section accordingly.

[30 FR 8185, June 26, 1965, as amended at 43 FR 6921, Feb. 17, 1978; 52 FR 8241, Mar. 17, 1987; 58 FR 7736, Feb. 9, 1993; 90 FR 55628, Dec. 3, 2025]

§ 30.6 Communications.

(a) Unless otherwise specified or covered under the regional licensing program as provided in paragraph (b) of this section, any communication or report concerning the regulations in parts 30 through 37 and 39 of this chapter and any application filed under these regulations may be submitted to the Commission as follows:

(1) By mail addressed: ATTN: Document Control Desk, Director, Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

(2) By hand delivery to the NRC's offices at 11555 Rockville Pike, Rockville, Maryland.

(3) Where practicable, by electronic submission, for example, via Electronic Information Exchange, or CD-ROM. Electronic submissions must be made in a manner that enables the NRC to receive, read, authenticate, distribute, and archive the submission, and process and retrieve it a single page at a time. Detailed guidance on making electronic submissions can be obtained by visiting the NRC's Web site at http://www.nrc.gov/site-help/e-submittals.html; by e-mail to MSHD.Resource@nrc.gov; or by writing the Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. The guidance discusses, among other topics, the formats the NRC can accept, the use of electronic signatures, and the treatment of nonpublic information.

(b) The Commission has delegated to the four Regional Administrators licensing authority for selected parts of its decentralized licensing program for nuclear materials as described in paragraph (b)(1) of this section. Any communication, report, or application covered under this licensing program must be submitted to the appropriate Regional Administrator. The Administrators' jurisdictions and mailing addresses are listed in paragraph (b)(2) of this section.

(1) The delegated licensing program includes authority to issue, renew, amend, cancel, modify, suspend, or revoke licenses for nuclear materials issued pursuant to 10 CFR parts 30 through 36, 39, 40, and 70 to all persons for academic, medical, and industrial uses, with the following exceptions:

(i) Activities in the fuel cycle and special nuclear material in quantities sufficient to constitute a critical mass in any room or area. This exception does not apply to license modifications relating to termination of special nuclear material licenses that authorize possession of larger quantities when the case is referred for action from NRC's Headquarters to the Regional Administrators.

(ii) Health and safety design review of sealed sources and devices and approval, for licensing purposes, of sealed sources and devices.

(iii) Processing of source material for extracting of metallic compounds (including Zirconium, Hafnium, Tantalum, Titanium, Niobium, etc.).

(iv) Distribution of products containing radioactive material under §§ 32.11 through 32.30 and 40.52 of this chapter to persons exempt from licensing requirements.

(v) New uses or techniques for use of byproducts, source, or special nuclear material.

(2) Submissions. (i) Region I. The regional licensing program involves all Federal facilities in the region and non-Federal licensees in the following Region I non-Agreement States and the District of Columbia: Connecticut, Delaware, and Vermont. All mailed or hand-delivered inquiries, communications, and applications for a new license or an amendment, renewal, or termination request of an existing license specified in paragraph (b)(1) of this section must use the following address: U.S. Nuclear Regulatory Commission, Region I, 475 Allendale Road, Suite 102, King of Prussia, PA 19406-1415; where email is appropriate it should be addressed to RidsRgn1MailCenter.Resource@nrc.gov.

(ii) Region II. The regional licensing program involves all Federal facilities in the region and non-Federal licensees in the following Region II non-Agreement States and territories: West Virginia, Puerto Rico, and the Virgin Islands. All mailed or hand-delivered inquiries, communications, and applications for a new license or an amendment, renewal, or termination request of an existing license specified in paragraph (b)(1) of this section must use the following address: U.S. Nuclear Regulatory Commission, Region I, 475 Allendale Road, Suite 102, King of Prussia, PA 19406-1415; where email is appropriate it should be addressed to RidsRgn1MailCenter.Resource@nrc.gov.

(iii) Region III. (A) The regional licensing program for mining and milling involves all Federal facilities in the region, and non-Federal licensees in the Region III non-Agreement States of Indiana, Michigan, Missouri and the Region III Agreement States of Minnesota, Wisconsin, and Iowa. All mailed or hand-delivered inquiries, communications, and applications for a new license or an amendment, renewal, or termination request of an existing license specified in paragraph (b)(1) of this section must use the following address: U.S. Nuclear Regulatory Commission, Region III, Material Licensing Section, 2443 Warrenville Road, Suite 210, Lisle, IL 60532-4352; where e-mail is appropriate it should be addressed to RidsRgn3MailCenter.Resource@nrc.gov.

(B) Otherwise, the regional licensing program involves all Federal facilities in the region and non-Federal licensees in the Region III non-Agreement States of Indiana, Michigan, and Missouri. All mailed or hand-delivered inquiries, communications, and applications for a new license or an amendment, renewal, or termination request of an existing license specified in paragraph (b)(1) of this section must use the following address: U.S. Nuclear Regulatory Commission, Region III, Material Licensing Section, 2443 Warrenville Road, Suite 210, Lisle, IL 60532-4352; where e-mail is appropriate it should be addressed to RidsRgn3MailCenter.Resource@nrc.gov.

(iv) Region IV. (A) The regional licensing program for mining and milling involves all Federal facilities in the region, and non-Federal licensees in the Region IV non-Agreement States and territory of Alaska, Hawaii, Idaho, Montana, South Dakota, Wyoming and Guam and Region IV Agreement States of Oregon, California, Nevada, New Mexico, Louisiana, Mississippi, Arkansas, Oklahoma, Kansas, Nebraska, and North Dakota. All mailed or hand-delivered inquiries, communications, and applications for a new license or an amendment, renewal, or termination request of an existing license specified in paragraph (b)(1) of this section must use the following address: U.S. Nuclear Regulatory Commission, Region IV, Division of Nuclear Materials Safety, 1600 E. Lamar Blvd., Arlington, TX 76011-4511; where email is appropriate, it should be addressed to RidsRgn4MailCenter@nrc.gov.

(B) Otherwise, the regional licensing program involves all Federal facilities in the region and non-Federal licensees in the following Region IV non-Agreement States and territory: Alaska, Hawaii, Idaho, Montana, South Dakota, Wyoming, and Guam. All mailed or hand-delivered inquiries, communications, and applications for a new license or an amendment, renewal, or termination request of an existing license specified in paragraph (b)(1) of this section must use the following address: U.S. Nuclear Regulatory Commission, Region IV, Division of Nuclear Materials Safety, 1600 E. Lamar Blvd., Arlington, TX 76011-4511; where email is appropriate, it should be addressed to RidsRgn4MailCenter@nrc.gov.

Editorial Note:For Federal Register citations affecting § 30.6, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

§ 30.7 Employee protection.

(a) Discrimination by a Commission licensee, an applicant for a Commission license, or a contractor or subcontractor of a Commission licensee or applicant against an employee for engaging in certain protected activities is prohibited. Discrimination includes discharge and other actions that relate to compensation, terms, conditions, or privileges of employment. The protected activities are established in section 211 of the Energy Reorganization Act of 1974, as amended, and in general are related to the administration or enforcement of a requirement imposed under the Atomic Energy Act or the Energy Reorganization Act.

(1) The protected activities include but are not limited to:

(i) Providing the Commission or his or her employer information about alleged violations of either of the statutes named in paragraph (a) introductory text of this section or possible violations of requirements imposed under either of those statutes;

(ii) Refusing to engage in any practice made unlawful under either of the statutes named in paragraph (a) introductory text or under these requirements if the employee has identified the alleged illegality to the employer;

(iii) Requesting the Commission to institute action against his or her employer for the administration or enforcement of these requirements;

(iv) Testifying in any Commission proceeding, or before Congress, or at any Federal or State proceeding regarding any provision (or proposed provision) of either of the statutes named in paragraph (a) introductory text.

(v) Assisting or participating in, or is about to assist or participate in, these activities.

(2) These activities are protected even if no formal proceeding is actually initiated as a result of the employee assistance or participation.

(3) This section has no application to any employee alleging discrimination prohibited by this section who, acting without direction from his or her employer (or the employer's agent), deliberately causes a violation of any requirement of the Energy Reorganization Act of 1974, as amended, or the Atomic Energy Act of 1954, as amended.

(b) Any employee who believes that he or she has been discharged or otherwise discriminated against by any person for engaging in protected activities specified in paragraph (a)(1) of this section may seek a remedy for the discharge or discrimination through an administrative proceeding in the Department of Labor. The administrative proceeding must be initiated within 180 days after an alleged violation occurs. The employee may do this by filing a complaint alleging the violation with the Department of Labor, Employment Standards Administration, Wage and Hour Division. The Department of Labor may order reinstatement, back pay, and compensatory damages.

(c) A violation of paragraphs (a), (e), or (f) of this section by a Commission licensee, an applicant for a Commission license, or a contractor or subcontractor of a Commission licensee or applicant may be grounds for—

(1) Denial, revocation, or suspension of the license.

(2) Imposition of a civil penalty on the licensee, applicant, or a contractor or subcontractor of the licensee or applicant.

(3) Other enforcement action.

(d) Actions taken by an employer, or others, which adversely affect an employee may be predicated upon nondiscriminatory grounds. The prohibition applies when the adverse action occurs because the employee has engaged in protected activities. An employee's engagement in protected activities does not automatically render him or her immune from discharge or discipline for legitimate reasons or from adverse action dictated by nonprohibited considerations.

(e)(1) Each specific licensee, each applicant for a specific license, and each general licensee subject to part 19 shall prominently post the revision of NRC Form 3, “Notice to Employees,” referenced in 10 CFR 19.11(e)(1).

(2) The posting of NRC Form 3 must be at locations sufficient to permit employees protected by this section to observe a copy on the way to or from their place of work. Premises must be posted not later than 30 days after an application is docketed and remain posted while the application is pending before the Commission, during the term of the license, and for 30 days following license termination.

(3) Copies of NRC Form 3 may be obtained by writing to the Regional Administrator of the appropriate U.S. Nuclear Regulatory Commission Regional Office listed in appendix D to part 20 of this chapter, via email to Forms.Resource@nrc.gov, or by visiting the NRC's online library at http://www.nrc.gov/reading-rm/doc-collections/forms/.

(f) No agreement affecting the compensation, terms, conditions, or privileges of employment, including an agreement to settle a complaint filed by an employee with the Department of Labor pursuant to section 211 of the Energy Reorganization Act of 1974, as amended, may contain any provision which would prohibit, restrict, or otherwise discourage an employee from participating in protected activity as defined in paragraph (a)(1) of this section including, but not limited to, providing information to the NRC or to his or her employer on potential violations or other matters within NRC's regulatory responsibilities.

[58 FR 52408, Oct. 8, 1993, as amended at 60 FR 24551, May 9, 1995; 61 FR 6764, Feb. 22, 1996; 68 FR 58803, Oct. 10, 2003; 72 FR 63973, Nov. 14, 2007; 73 FR 30458, May 28, 2008; 79 FR 66603, Nov. 10, 2014; 83 FR 58465, Nov. 20, 2018]

§ 30.8 Information collection requirements: OMB approval.

(a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150-0017.

(b) The approved information collection requirements contained in this part appear in §§ 30.9, 30.11, 30.15, 30.19, 30.20, 30.32, 30.34, 30.35, 30.36, 30.37, 30.38, 30.41, 30.50, 30.51, 30.55, and appendices A, C, D, and E to this part.

(c) This part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section. These information collection requirements and the control numbers under which they are approved are as follows:

(1) In §§ 30.32 and 30.37, NRC Form 313 is approved under control number 3150-0120.

(2) In § 30.36, NRC Form 314 is approved under control number 3150-0028.

(3) In § 30.34, DOC/NRC Forms AP-1, AP-A, and associated forms are approved under control number 0694-0135.

[49 FR 19625, May 9, 1984, as amended at 59 FR 61780, Dec. 2, 1994; 62 FR 52186, Oct. 6, 1997; 62 FR 63639, Dec. 2, 1997; 63 FR 29541, June 1, 1998; 67 FR 67099, Nov. 4, 2002; 73 FR 78604, Dec. 23, 2008; 77 FR 43689, July 25, 2012]

§ 30.9 Completeness and accuracy of information.

(a) Information provided to the Commission by an applicant for a license or by a licensee or information required by statute or by the Commission's regulations, orders, or license conditions to be maintained by the applicant or the licensee shall be complete and accurate in all material respects.

(b) Each applicant or licensee shall notify the Commission of information identified by the applicant or licensee as having for the regulated activity a significant implication for public health and safety or common defense and security. An applicant or licensee violates this paragraph only if the applicant or licensee fails to notify the Commission of information that the applicant or licensee has identified as having a significant implication for public health and safety or common defense and security. Notification shall be provided to the Administrator of the appropriate Regional Office within two working days of identifying the information. This requirement is not applicable to information which is already required to be provided to the Commission by other reporting or updating requirements.

[52 FR 49371, Dec. 31, 1987]

§ 30.10 Deliberate misconduct.

(a) Any licensee, certificate of registration holder, applicant for a license or certificate of registration, employee of a licensee, certificate of registration holder or applicant; or any contractor (including a supplier or consultant), subcontractor, employee of a contractor or subcontractor of any licensee or certificate of registration holder or applicant for a license or certificate of registration, who knowingly provides to any licensee, applicant, certificate holder, contractor, or subcontractor, any components, equipment, materials, or other goods or services that relate to a licensee's, certificate holder's or applicant's activities in this part, may not:

(1) Engage in deliberate misconduct that causes or would have caused, if not detected, a licensee, certificate of registration holder, or applicant to be in violation of any rule, regulation, or order; or any term, condition, or limitation of any license issued by the Commission; or

(2) Deliberately submit to the NRC, a licensee, certificate of registration holder, an applicant, or a licensee's, certificate holder's or applicant's, contractor or subcontractor, information that the person submitting the information knows to be incomplete or inaccurate in some respect material to the NRC.

(b) A person who violates paragraph (a)(1) or (a)(2) of this section may be subject to enforcement action in accordance with the procedures in 10 CFR part 2, subpart B.

(c) For the purposes of paragraph (a)(1) of this section, deliberate misconduct by a person means an intentional act or omission that the person knows:

(1) Would cause a licensee, certificate of registration holder or applicant to be in violation of any rule, regulation, or order; or any term, condition, or limitation, of any license issued by the Commission; or

(2) Constitutes a violation of a requirement, procedure, instruction, contract, purchase order, or policy of a licensee, certificate of registration holder, applicant, contractor, or subcontractor.

[63 FR 1896, Jan. 13, 1998]

§ 30.11 Specific exemptions.

(a) The Commission may, upon application of any interested person or upon its own initiative, grant such exemptions from the requirements of the regulations in this part and parts 31 through 36 and 39 of this chapter as it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest.

(b) Any licensee's activities are exempt from the requirements of this part to the extent that its activities are licensed under the requirements of part 72 of this chapter.

(c) The Department of Energy is exempt from the requirements of this part to the extent that its activities are subject to the requirements of part 60 or 63 of this chapter.

(d) Except as specifically provided in part 61 of this chapter, any licensee is exempt from the requirements of this part to the extent that its activities are subject to the requirements of part 61 of this chapter.

[37 FR 5746, Mar. 21, 1972, as amended at 39 FR 26279, July 18, 1974; 40 FR 8784, Mar. 3, 1975; 43 FR 6921, Feb. 21, 1978; 45 FR 65530, Oct. 3, 1980; 46 FR 13979, Feb. 25, 1981; 47 FR 57480, Dec. 27, 1982; 52 FR 8241, Mar. 17, 1987; 58 FR 7736, Feb. 9, 1993; 66 FR 51838, Oct. 11, 2001; 66 FR 55790, Nov. 2, 2001]

§ 30.12 Persons using byproduct material under certain Department of Energy and Nuclear Regulatory Commission contracts.

Link to an amendment published at 91 FR 63145, Oct. 5, 2026.

Except to the extent that Department facilities or activities of the types subject to licensing pursuant to section 202 of the Energy Reorganization Act of 1974 are involved, any prime contractor of the Department is exempt from the requirements for a license set forth in sections 81 and 82 of the Act and from the regulations in this part to the extent that such contractor, under his prime contract with the Department manufactures, produces, transfers, receives, acquires, owns, possesses, or uses byproduct material for:

(a) The performance of work for the Department at a United States Government-owned or controlled site, including the transportation of byproduct material to or from such site and the performance of contract services during temporary interruptions of such transportation;

(b) Research in, or development, manufacture, storage, testing or transportation of, atomic weapons or components thereof; or

(c) The use or operation of nuclear reactors or other nuclear devices in a United States Government-owned vehicle or vessel.

In addition to the foregoing exemptions and subject to the requirement for licensing of Department facilities and activities pursuant to section 202 of the Energy Reorganization Act of 1974, any prime contractor or subcontractor of the Department or the Commission is exempt from the requirements for a license set forth in sections 81 and 82 of the Act and from the regulations in this part to the extent that such prime contractor or subcontractor manufacturers, produces, transfers, receives, acquires, owns, possesses, or uses byproduct material under his prime contract or subcontract when the Commission determines that the exemption of the prime contractor or subcontractor is authorized by law; and that, under the terms of the contract or subcontract, there is adequate assurance that the work thereunder can be accomplished without undue risk to the public health and safety.

[40 FR 8784, Mar. 3, 1975, as amended at 43 FR 6921, Feb. 17, 1978]

§ 30.13 Carriers.

Common and contract carriers, freight forwarders, warehousemen, and the U.S. Postal Service are exempt from the regulations in this part and parts 31 through 37 and 39 of this chapter and the requirements for a license set forth in section 81 of the Act to the extent that they transport or store byproduct material in the regular course of carriage for another or storage incident thereto.

[78 FR 17006, Mar. 19, 2013]

§ 30.14 Exempt concentrations.

(a) Except as provided in paragraphs (c) and (d) of this section, any person is exempt from the requirements for a license set forth in section 81 of the Act and from the regulations in this part and parts 31 through 36 and 39 of this chapter to the extent that such person receives, possesses, uses, transfers, owns or acquires products or materials containing byproduct material in concentrations not in excess of those listed in § 30.70.

(b) This section shall not be deemed to authorize the import of byproduct material or products containing byproduct material.

(c) A manufacturer, processor, or producer of a product or material is exempt from the requirements for a license set forth in section 81 of the Act and from the regulations in this part and parts 31 through 36 and 39 of this chapter to the extent that this person transfers byproduct material contained in a product or material in concentrations not in excess of those specified in § 30.70 and introduced into the product or material by a licensee holding a specific license issued by the Commission expressly authorizing such introduction. This exemption does not apply to the transfer of byproduct material contained in any food, beverage, cosmetic, drug, or other commodity or product designed for ingestion or inhalation by, or application to, a human being.

(d) No person may introduce byproduct material into a product or material knowing or having reason to believe that it will be transferred to persons exempt under this section or equivalent regulations of an Agreement State, except in accordance with a license issued under § 32.11 of this chapter.

[30 FR 8185, June 26, 1965, as amended at 40 FR 8785, Mar. 3, 1975; 43 FR 6921, Feb. 17, 1978; 52 FR 8241, Mar. 17, 1987; 58 FR 7736, Feb. 9, 1993; 72 FR 58486, Oct. 16, 2007]

§ 30.15 Certain items containing byproduct material.

(a) Except for persons who apply byproduct material to, or persons who incorporate byproduct material into, the following products, or persons who initially transfer for sale or distribution the following products containing byproduct material, any person is exempt from the requirements for a license set forth in section 81 of the Act and from the regulations in parts 20 and 30 through 36 and 39 of this chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires the following products:

(1) Timepieces or hands or dials containing not more than the following specified quantities of byproduct material and not exceeding the following specified levels of radiation:

(i) 25 millicuries of tritium per timepiece,

(ii) 5 millicuries of tritium per hand,

(iii) 15 millicuries of tritium per dial (bezels when used shall be considered as part of the dial),

(iv) 100 microcuries of promethium 147 per watch or 200 microcuries of promethium 147 per any other timepiece,

(v) 20 microcuries of promethium 147 per watch hand or 40 microcuries of promethium 147 per other timepiece hand,

(vi) 60 microcuries of promethium 147 per watch dial or 120 microcuries of promethium 147 per other timepiece dial (bezels when used shall be considered as part of the dial),

(vii) The levels of radiation from hands and dials containing promethium 147 will not exceed, when measured through 50 milligrams per square centimeter of absorber:

(A) For wrist watches, 0.1 millirad per hour at 10 centimeters from any surface,

(B) For pocket watches, 0.1 millirad per hour at 1 centimeter from any surface,

(C) For any other timepiece, 0.2 millirad per hour at 10 centimeters from any surface.

(viii) 0.037 megabecquerel (1 microcurie) of radium-226 per timepiece in intact timepieces manufactured prior to November 30, 2007.

(2)(i) Static elimination devices which contain, as a sealed source or sources, byproduct material consisting of a total of not more than 18.5 MBq (500 µCi) of polonium-210 per device.

(ii) Ion generating tubes designed for ionization of air that contain, as a sealed source or sources, byproduct material consisting of a total of not more than 18.5 MBq (500 µCi) of polonium-210 per device or of a total of not more than 1.85 GBq (50 mCi) of hydrogen-3 (tritium) per device.

(iii) Such devices authorized before October 23, 2012 for use under the general license then provided in § 31.3 and equivalent regulations of Agreement States and manufactured, tested, and labeled by the manufacturer in accordance with the specifications contained in a specific license issued by the Commission.

(3) Balances of precision containing not more than 1 millicurie of tritium per balance or not more than 0.5 millicurie of tritium per balance part manufactured before December 17, 2007.

(4) [Reserved]

(5) Marine compasses containing not more than 750 millicuries of tritium gas and other marine navigational instruments containing not more than 250 millicuries of tritium gas manufactured before December 17, 2007.

(6) [Reserved]

(7) Ionization chamber smoke detectors containing not more than 1 microcurie (µCi) of americium-241 per detector in the form of a foil and designed to protect life and property from fires.

(8) Electron tubes: Provided, That each tube does not contain more than one of the following specified quantities of byproduct material:

(i) 150 millicuries of tritium per microwave receiver protector tube or 10 millicuries of tritium per any other electron tube;

(ii) 1 microcurie of cobalt-60;

(iii) 5 microcuries of nickel-63;

(iv) 30 microcuries of krypton-85;

(v) 5 microcuries of cesium-137;

(vi) 30 microcuries of promethium-147;

And provided further, That the levels of radiation from each electron tube containing byproduct material do not exceed 1 millirad per hour at 1 centimeter from any surface when measured through 7 milligrams per square centimeter of absorber. 1

1 For purposes of this paragraph “electron tubes” include spark gap tubes, power tubes, gas tubes including glow lamps, receiving tubes, microwave tubes, indicator tubes, pickup tubes, radiation detection tubes, and any other completely sealed tube that is designed to conduct or control electrical currents.

(9) Ionizing radiation measuring instruments containing, for purposes of internal calibration or standardization, one or more sources of byproduct material: Provided, That;

(i) Each source contains no more than one exempt quantity set forth in § 30.71, Schedule B, and

(ii) Each instrument contains no more than 10 exempt quantities. For purposes of this paragraph (a)(9), an instrument's source(s) may contain either one type or different types of radionuclides and an individual exempt quantity may be composed of fractional parts of one or more of the exempt quantities in § 30.71, Schedule B, provided that the sum of such fractions shall not exceed unity.

(iii) For purposes of this paragraph (a)(9), 0.05 microcurie of americium-241 is considered an exempt quantity under § 30.71, Schedule B.

(10) [Reserved]

(b) Any person who desires to apply byproduct material to, or to incorporate byproduct material into, the products exempted in paragraph (a) of this section, or who desires to initially transfer for sale or distribution such products containing byproduct material, should apply for a specific license pursuant to § 32.14 of this chapter, which license states that the product may be distributed by the licensee to persons exempt from the regulations pursuant to paragraph (a) of this section.

[31 FR 5316, Apr. 2, 1966]

Editorial Note:For Federal Register citations affecting § 30.15, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

§ 30.18 Exempt quantities.

(a) Except as provided in paragraphs (c) through (e) of this section, any person is exempt from the requirements for a license set forth in section 81 of the Act and from the regulations in parts 30 through 34, 36, and 39 of this chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires byproduct material in individual quantities, each of which does not exceed the applicable quantity set forth in § 30.71, Schedule B.

(b) Any person, who possesses byproduct material received or acquired before September 25, 1971, under the general license then provided in § 31.4 of this chapter or similar general license of a State, is exempt from the requirements for a license set forth in section 81 of the Act and from the regulations in parts 30 through 34, 36 and 39 of this chapter to the extent that this person possesses, uses, transfers, or owns byproduct material.

(c) This section does not authorize for purposes of commercial distribution the production, packaging, repackaging, or transfer of byproduct material or the incorporation of byproduct material into products intended for commercial distribution.

(d) No person may, for purposes of commercial distribution, transfer byproduct material in the individual quantities set forth in § 30.71 Schedule B, knowing or having reason to believe that such quantities of byproduct material will be transferred to persons exempt under this section or equivalent regulations of an Agreement State, except in accordance with a license issued under § 32.18 of this chapter, which license states that the byproduct material may be transferred by the licensee to persons exempt under this section or the equivalent regulations of an Agreement State.

(e) No person may, for purposes of producing an increased radiation level, combine quantities of byproduct material covered by this exemption so that the aggregate quantity exceeds the limits set forth in § 30.71, Schedule B, except for byproduct material combined within a device placed in use before May 3, 1999, or as otherwise permitted by the regulations in this part.

[35 FR 6427, Apr. 22, 1970, as amended at 36 FR 16898, Aug. 26, 1971; 43 FR 6921, Feb. 17, 1978; 52 FR 8241, Mar. 17, 1987; 58 FR 7736, Feb. 9, 1993; 72 FR 55925, Oct. 1, 2007; 72 FR 58486, Oct. 16, 2007]

§ 30.19 Self-luminous products containing tritium, krypton-85, or promethium-147.

(a) Except for persons who manufacture, process, produce, or initially transfer for sale or distribution self-luminous products containing tritium, krypton-85, or promethium-147, and except as provided in paragraph (c) of this section, any person is exempt from the requirements for a license set forth in section 81 of the Act and from the regulations in parts 20 and 30 through 36 and 39 of this chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires tritium, krypton-85, or promethium-147 in self-luminous products manufactured, processed, produced, or initially transferred in accordance with a specific license issued pursuant to § 32.22 of this chapter, which license authorizes the initial transfer of the product for use under this section.

(b) Any person who desires to manufacture, process, or produce, or initially transfer for sale or distribution self-luminous products containing tritium, krypton-85, or promethium-147 for use under paragraph (a) of this section, should apply for a license under § 32.22 of this chapter and for a certificate of registration in accordance with § 32.210 of this chapter.

(c) The exemption in paragraph (a) of this section does not apply to tritium, krypton-85, or promethium-147 used in products primarily for frivolous purposes or in toys or adornments.

[34 FR 9026, June 6, 1969, as amended at 40 FR 8785, Mar. 3, 1975; 43 FR 6921, Feb. 17, 1978; 52 FR 8241, Mar. 17, 1987; 58 FR 7736, Feb. 9, 1993; 77 FR 43689, July 25, 2012]

§ 30.20 Gas and aerosol detectors containing byproduct material.

(a) Except for persons who manufacture, process, produce, or initially transfer for sale or distribution gas and aerosol detectors containing byproduct material, any person is exempt from the requirements for a license set forth in section 81 of the Act and from the regulations in parts 19, 20, 21, and 30 through 36 and 39 of this chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires byproduct material in gas and aerosol detectors designed to protect health, safety, or property, and manufactured, processed, produced, or initially transferred in accordance with a specific license issued under § 32.26 of this chapter, which license authorizes the initial transfer of the product for use under this section. This exemption also covers gas and aerosol detectors manufactured or distributed before November 30, 2007, in accordance with a specific license issued by a State under comparable provisions to § 32.26 of this chapter authorizing distribution to persons exempt from regulatory requirements.

(b) Any person who desires to manufacture, process, or produce gas and aerosol detectors containing byproduct material, or to initially transfer such products for use under paragraph (a) of this section, should apply for a license under § 32.26 of this chapter and for a certificate of registration in accordance with § 32.210 of this chapter.

[77 FR 43689, July 25, 2012]

§ 30.21 Radioactive drug: Capsules containing carbon-14 urea for “in vivo” diagnostic use for humans.

(a) Except as provided in paragraphs (b) and (c) of this section, any person is exempt from the requirements for a license set forth in Section 81 of the Act and from the regulations in this part and part 35 of this chapter provided that such person receives, possesses, uses, transfers, owns, or acquires capsules containing 37 kBq (1 µCi) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process) each, for “in vivo” diagnostic use for humans.

(b) Any person who desires to use the capsules for research involving human subjects shall apply for and receive a specific license pursuant to part 35 of this chapter.

(c) Any person who desires to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution such capsules shall apply for and receive a specific license pursuant to § 32.21 of this chapter.

(d) Nothing in this section relieves persons from complying with applicable FDA, other Federal, and State requirements governing receipt, administration, and use of drugs.

[62 FR 63640, Dec. 2, 1997]

§ 30.22 Certain industrial devices.

(a) Except for persons who manufacture, process, produce, or initially transfer for sale or distribution industrial devices containing byproduct material designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing an ionized atmosphere, any person is exempt from the requirements for a license set forth in section 81 of the Act and from the regulations in parts 19, 20, 21, 30 through 36, and 39 of this chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires byproduct material, in these certain detecting, measuring, gauging, or controlling devices and certain devices for producing an ionized atmosphere, and manufactured, processed, produced, or initially transferred in accordance with a specific license issued under § 32.30 of this chapter, which license authorizes the initial transfer of the device for use under this section. This exemption does not cover sources not incorporated into a device, such as calibration and reference sources.

(b) Any person who desires to manufacture, process, produce, or initially transfer for sale or distribution industrial devices containing byproduct material for use under paragraph (a) of this section, should apply for a license under § 32.30 of this chapter and for a certificate of registration in accordance with § 32.210 of this chapter.

[77 FR 43689, July 25, 2012]

§ 30.31 Types of licenses.

Licenses for byproduct material are of two types: General and specific.

(a) The Commission issues a specific license to a named person who has filed an application for the license under the provisions of this part and parts 32 through 36, and 39.

(b) A general license is provided by regulation, grants authority to a person for certain activities involving byproduct material, and is effective without the filing of an application with the Commission or the issuance of a licensing document to a particular person. However, registration with the Commission may be required by the particular general license.

[65 FR 79187, Dec. 18, 2000]

§ 30.32 Application for specific licenses.

(a) A person may file an application on NRC Form 313, “Application for Material License,” in accordance with the instructions in § 30.6 of this chapter. Information contained in previous applications, statements or reports filed with the Commission or the Atomic Energy Commission may be incorporated by reference, provided that the reference is clear and specific.

(b) The Commission may at any time after the filing of the original application, and before the expiration of the license, require further statements in order to enable the Commission to determine whether the application should be granted or denied or whether a license should be modified or revoked.

(c) Each application shall be signed by the applicant or licensee or a person duly authorized to act for and on his behalf.

(d) An application for license filed pursuant to the regulations in this part and parts 32 through 35 of this chapter will be considered also as an application for licenses authorizing other activities for which licenses are required by the Act, provided that the application specifies the additional activities for which licenses are requested and complies with regulations of the Commission as to applications for such licenses.

(e) Each application for a byproduct material license, other than a license exempted from part 170 of this chapter, shall be accompanied by the fee prescribed in § 170.31 of this chapter. No fee will be required to accompany an application for renewal or amendment of a license, except as provided in § 170.31 of this chapter.

(f) An application for a license to receive and possess byproduct material for the conduct of any activity which the Commission has determined pursuant to subpart A of part 51 of this chapter will significantly affect the quality of the environment shall be filed at least 9 months prior to commencement of construction of the plant or facility in which the activity will be conducted and shall be accompanied by any Environmental Report required pursuant to subpart A of part 51 of this chapter.

(g)(1) Except as provided in paragraphs (g)(2), (3), and (4) of this section, an application for a specific license to use byproduct material in the form of a sealed source or in a device that contains the sealed source must either—

(i) Identify the source or device by manufacturer and model number as registered with the Commission under § 32.210 of this chapter, with an Agreement State, or for a source or a device containing radium-226 or accelerator-produced radioactive material with a State under provisions comparable to § 32.210 of this chapter; or

(ii) Contain the information identified in § 32.210(c) of this chapter.

(2) For sources or devices manufactured before October 23, 2012 that are not registered with the Commission under § 32.210 of this chapter or with an Agreement State, and for which the applicant is unable to provide all categories of information specified in § 32.210(c) of this chapter, the application must include:

(i) All available information identified in § 32.210(c) of this chapter concerning the source, and, if applicable, the device; and

(ii) Sufficient additional information to demonstrate that there is reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property. Such information must include a description of the source or device, a description of radiation safety features, the intended use and associated operating experience, and the results of a recent leak test.

(3) For sealed sources and devices allowed to be distributed without registration of safety information in accordance with § 32.210(g)(1) of this chapter, the applicant may supply only the manufacturer, model number, and radionuclide and quantity.

(4) If it is not feasible to identify each sealed source and device individually, the applicant may propose constraints on the number and type of sealed sources and devices to be used and the conditions under which they will be used, in lieu of identifying each sealed source and device.

(h) As provided by § 30.35, certain applications for specific licenses filed under this part and parts 32 through 35 of this chapter must contain a proposed decommissioning funding plan or a certification of financial assurance for decommissioning. In the case of renewal applications submitted before July 27, 1990, this submittal may follow the renewal application but must be submitted on or before July 27, 1990.

(i)(1) Each application to possess radioactive materials in unsealed form, on foils or plated sources, or sealed in glass in excess of the quantities in § 30.72, “Schedule C—Quantities of Radioactive Materials Requiring Consideration of the Need for an Emergency Plan for Responding to a Release,” must contain either:

(i) An evaluation showing that the maximum dose to a person offsite due to a release of radioactive materials would not exceed 1 rem effective dose equivalent or 5 rems to the thyroid; or

(ii) An emergency plan for responding to a release of radioactive material.

(2) One or more of the following factors may be used to support an evaluation submitted under paragraph (i)(1)(i) of this section:

(i) The radioactive material is physically separated so that only a portion could be involved in an accident;

(ii) All or part of the radioactive material is not subject to release during an accident because of the way it is stored or packaged;

(iii) The release fraction in the respirable size range would be lower than the release fraction shown § 30.72 due to the chemical or physical form of the material;

(iv) The solubility of the radioactive material would reduce the dose received;

(v) Facility design or engineered safety features in the facility would cause the release fraction to be lower than shown in § 30.72;

(vi) Operating restrictions or procedures would prevent a release fraction as large as that shown in § 30.72; or

(vii) Other factors appropriate for the specific facility.

(3) An emergency plan for responding to a release of radioactive material submitted under paragraph (i)(1)(ii) of this section must include the following information:

(i) Facility description. A brief description of the licensee's facility and area near the site.

(ii) Types of accidents. An identification of each type of radio-active materials accident for which protective actions may be needed.

(iii) Classification of accidents. A classification system for classifying accidents as alerts or site area emergencies.

(iv) Detection of accidents. Identification of the means of detecting each type of accident in a timely manner.

(v) Mitigation of consequences. A brief description of the means and equipment for mitigating the consequences of each type of accident, including those provided to protect workers onsite, and a description of the program for maintaining the equipment.

(vi) Assessment of releases. A brief description of the methods and equipment to assess releases of radioactive materials.

(vii) Responsibilities. A brief description of the responsibilities of licensee personnel should an accident occur, including identification of personnel responsible for promptly notifying offsite response organizations and the NRC; also responsibilities for developing, maintaining, and updating the plan.

(viii) Notification and coordination. A commitment to and a brief description of the means to promptly notify offsite response organizations and request offsite assistance, including medical assistance for the treatment of contaminated injured onsite workers when appropriate. A control point must be established. The notification and coordination must be planned so that unavailability of some personnel, parts of the facility, and some equipment will not prevent the notification and coordination. The licensee shall also commit to notify the NRC operations center immediately after notification of the appropriate offsite response organizations and not later than one hour after the licensee declares an emergency. 1

1 These reporting requirements do not supersede or release licensees of complying with the requirements under the Emergency Planning and Community Right-to-Know Act of 1986, Title III, Pub. L. 99-499 or other state or federal reporting requirements.

(ix) Information to be communicated. A brief description of the types of information on facility status, radioactive releases, and recommended protective actions, if necessary, to be given to offsite response organizations and to the NRC.

(x) Training. A brief description of the frequency, performance objectives and plans for the training that the licensee will provide workers on how to respond to an emergency including any special instructions and orientation tours the licensee would offer to fire, police, medical and other emergency personnel. The training shall familiarize personnel with site-specific emergency procedures. Also, the training shall thoroughly prepare site personnel for their responsibilities in the event of accident scenarios postulated as most probable for the specific site, including the use of team training for such scenarios.

(xi) Safe shutdown. A brief description of the means of restoring the facility to a safe condition after an accident.

(xii) Exercises. Provisions for conducting quarterly communications checks with offsite response organizations and biennial onsite exercises to test response to simulated emergencies. Quarterly communications checks with offsite response organizations must include the check and update of all necessary telephone numbers. The licensee shall invite offsite response organizations to participate in the biennial exercises. Participation of offsite response organizations in biennial exercises although recommended is not required. Exercises must use accident scenarios postulated as most probable for the specific site and the scenarios shall not be known to most exercise participants. The licensee shall critique each exercise using individuals not having direct implementation responsibility for the plan. Critiques of exercises must evaluate the appropriateness of the plan, emergency procedures, facilities, equipment, training of personnel, and overall effectiveness of the response. Deficiencies found by the critiques must be corrected.

(xiii) Hazardous chemicals. A certification that the applicant has met its responsibilities under the Emergency Planning and Community Right-to-Know Act of 1986, title III, Pub. L. 99-499, if applicable to the applicant's activities at the proposed place of use of the byproduct material.

(4) The licensee shall allow the offsite response organizations expected to respond in case of an accident 60 days to comment on the licensee's emergency plan before submitting it to NRC. The licensee shall provide any comments received within the 60 days to the NRC with the emergency plan.

(j) An application from a medical facility, educational institution, or Federal facility to produce Positron Emission Tomography (PET) radioactive drugs for noncommercial transfer to licensees in its consortium authorized for medical use under part 35 of this chapter or equivalent Agreement State requirements shall include:

(1) A request for authorization for the production of PET radionuclides or evidence of an existing license issued under part 30 of this chapter or Agreement State requirements for a PET radionuclide production facility within its consortium from which it receives PET radionuclides.

(2) Evidence that the applicant is qualified to produce radioactive drugs for medical use by meeting one of the criteria in § 32.72(a)(2) of this chapter.

(3) Identification of individual(s) authorized to prepare the PET radioactive drugs if the applicant is a pharmacy, and documentation that each individual meets the requirements of an authorized nuclear pharmacist as specified in § 32.72(b)(2) of this chapter.

(4) Information identified in § 32.72(a)(3) of this chapter on the PET drugs to be noncommercially transferred to members of its consortium.

[30 FR 8185, June 26, 1965, as amended at 36 FR 145, Jan. 6, 1971; 37 FR 5747, Mar. 21, 1972; 43 FR 6922, Feb. 17, 1978; 49 FR 9403, Mar. 12, 1984; 49 FR 27924, July 9, 1984; 52 FR 27786, July 24, 1987; 53 FR 24044, June 27, 1988; 54 FR 14060, Apr. 7, 1989; 68 FR 58004, Oct. 10, 2003; 72 FR 55925, Oct. 1, 2007; 73 FR 63570, Oct. 24, 2008; 77 FR 43689, July 25, 2012; 79 FR 58671, Sept. 30, 2014; 88 FR 80949, Nov. 21, 2023]

§ 30.33 General requirements for issuance of specific licenses.

(a) An application for a specific license will be approved if:

(1) The application is for a purpose authorized by the Act;

(2) The applicant's proposed equipment and facilities are adequate to protect health and minimize danger to life or property;

(3) The applicant is qualified by training and experience to use the material for the purpose requested in such manner as to protect health and minimize danger to life or property;

(4) The applicant satisfies any special requirements contained in parts 32 through 37 and 39 of this chapter; and

(5) In the case of an application for a license to receive and possess byproduct material for the conduct of any activity which the NRC determines will significantly affect the quality of the environment, the Director, Office of Nuclear Material Safety and Safeguards or his/her designee, before commencement of construction of the plant or facility in which the activity will be conducted, on the basis of information filed and evaluations made pursuant to subpart A of part 51 of this chapter, has concluded, after weighing the environmental, economic, technical, and other benefits against environmental costs and considering available alternatives, that the action called for is the issuance of the proposed license, with any appropriate conditions to protect environmental values. Commencement of construction prior to such conclusion shall be grounds for denial of a license to receive and possess byproduct material in such plant or facility. Commencement of construction as defined in § 30.4 may include non-construction activities if the activity has a reasonable nexus to radiological safety and security.

(b) Upon a determination that an application meets the requirements of the Act, and the regulations of the Commission, the Commission will issue a specific license authorizing the possession and use of byproduct material (Form NRC 374, “Byproduct Material License”).

[30 FR 8185, June 26, 1965, as amended at 36 FR 12731, July 7, 1971; 37 FR 5747, Mar. 21, 1972; 39 FR 26279, July 18, 1974; 43 FR 6922, Feb. 17, 1978; 49 FR 9403, Mar. 12, 1984; 52 FR 8241, Mar. 17, 1987; 58 FR 7736, Feb. 9, 1993; 73 FR 5717, Jan. 31, 2008; 76 FR 56962, Sept. 15, 2011; 78 FR 17006, Mar. 19, 2013]

§ 30.34 Terms and conditions of licenses.

(a) Each license issued pursuant to the regulations in this part and the regulations in parts 31 through 36 and 39 of this chapter shall be subject to all the provisions of the Act, now or hereafter in effect, and to all valid rules, regulations and orders of the Commission.

(b)(1) No license issued or granted pursuant to the regulations in this part and parts 31 through 36, and 39 nor any right under a license shall be transferred, assigned or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of any license to any person, unless the Commission shall, after securing full information, find that the transfer is in accordance with the provisions of the Act and shall give its consent in writing.

(2) An application for transfer of license must include:

(i) The identity, technical and financial qualifications of the proposed transferee; and

(ii) Financial assurance for decommissioning information required by § 30.35.

(c) Each person licensed by the Commission pursuant to the regulations in this part and parts 31 through 36 and 39 shall confine his possession and use of the byproduct material to the locations and purposes authorized in the license. Except as otherwise provided in the license, a license issued pursuant to the regulations in this part and parts 31 through 36 and 39 of this chapter shall carry with it the right to receive, acquire, own, and possess byproduct material. Preparation for shipment and transport of byproduct material shall be in accordance with the provisions of part 71 of this chapter.

(d) Each license issued pursuant to the regulations in this part and parts 31 through 36 and 39 shall be deemed to contain the provisions set forth in section 183b.-d., inclusive, of the Act, whether or not these provisions are expressly set forth in the license.

(e) The Commission may incorporate, in any license issued pursuant to the regulations in this part and parts 31 through 36 and 39, at the time of issuance, or thereafter by appropriate rule, regulation or order, such additional requirements and conditions with respect to the licensee's receipt, possession, use and transfer of byproduct material as it deems appropriate or necessary in order to:

(1) Promote the common defense and security;

(2) Protect health or to minimize danger to life or property;

(3) Protect restricted data;

(4) Require such reports and the keeping of such records, and to provide for such inspections of activities under the license as may be necessary or appropriate to effectuate the purposes of the Act and regulations thereunder.

(f) Licensees required to submit emergency plans by § 30.32(i) shall follow the emergency plan approved by the Commission. The licensee may change the approved without Commission approval only if the changes do not decrease the effectiveness of the plan. The licensee shall furnish the change to the appropriate NRC Regional Office specified in § 30.6 and to affected offsite response organizations within six months after the change is made. Proposed changes that decrease, or potentially decrease, the effectiveness of the approved emergency plan may not be implemented without prior application to and prior approval by the Commission.

(g) Each licensee preparing technetium-99m radiopharmaceuticals from molybdenum-99/technetium-99m generators or rubidium-82 from strontium-82/rubidium-82 generators shall test the generator eluates for molybdenum-99 breakthrough or strontium-82 and strontium-85 contamination, respectively, in accordance with § 35.204 of this chapter. The licensee shall record the results of each test and retain each record for 3 years after the record is made. The licensee shall report the results of any test that exceeds the permissible concentration listed in § 35.204(a) of this chapter at the time of generator elution, in accordance with § 35.3204 of this chapter.

(h)(1) Each general licensee that is required to register by § 31.5(c)(13) of this chapter and each specific licensee shall notify the appropriate NRC Regional Administrator, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy under any chapter of title 11 (Bankruptcy) of the United States Code by or against:

(i) The licensee;

(ii) An entity (as that term is defined in 11 U.S.C. 101(15) controlling the licensee or listing the license or licensee as property of the estate; or

(iii) An affiliate (as that term is defined in 11 U.S.C. 101(2)) of the licensee.

(2) This notification must indicate:

(i) The bankruptcy court in which the petition for bankruptcy was filed; and

(ii) The date of the filing of the petition.

(i) Security requirements for portable gauges. Each portable gauge licensee shall use a minimum of two independent physical controls that form tangible barriers to secure portable gauges from unauthorized removal, whenever portable gauges are not under the control and constant surveillance of the licensee.

(j)(1) Authorization under § 30.32(j) to produce Positron Emission Tomography (PET) radioactive drugs for noncommercial transfer to medical use licensees in its consortium does not relieve the licensee from complying with applicable FDA, other Federal, and State requirements governing radioactive drugs.

(2) Each licensee authorized under § 30.32(j) to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium shall:

(i) Satisfy the labeling requirements in § 32.72(a)(4) of this chapter for each PET radioactive drug transport radiation shield and each syringe, vial, or other container used to hold a PET radioactive drug intended for noncommercial distribution to members of its consortium.

(ii) Possess and use instrumentation to measure the radioactivity of the PET radioactive drugs intended for noncommercial distribution to members of its consortium and meet the procedural, radioactivity measurement, instrument test, instrument check, and instrument adjustment requirements in § 32.72(c) of this chapter.

(3) A licensee that is a pharmacy authorized under § 30.32(j) to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium shall require that any individual that prepares PET radioactive drugs shall be:

(i) an authorized nuclear pharmacist that meets the requirements in § 32.72(b)(2) of this chapter, or

(ii) an individual under the supervision of an authorized nuclear pharmacist as specified in § 35.27 of this chapter.

(4) A pharmacy, authorized under § 30.32(j) to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium that allows an individual to work as an authorized nuclear pharmacist, shall meet the requirements of § 32.72(b)(5) of this chapter.

(k) As required by the Additional Protocol, each specific licensee authorized to possess and use byproduct material shall file with the Commission location information described in § 75.11 of this chapter on DOC/NRC Forms AP-1 and associated forms. The licensee shall also permit verification of this information by the International Atomic Energy Agency (IAEA) and shall take other action as may be necessary to implement the US/IAEA Safeguards Agreement, as described in part 75 of this chapter.

[30 FR 8185, June 26, 1965, as amended at 38 FR 33969, Dec. 10, 1973; 43 FR 6922, Feb. 17, 1978; 48 FR 32328, July 15, 1983; 52 FR 1295, Jan. 12, 1987; 52 FR 8241, Mar. 17, 1987; 53 FR 19245, May 27, 1988; 53 FR 23383, June 22, 1988; 54 FR 14061, Apr. 7, 1989; 58 FR 7736, Feb. 9, 1993; 59 FR 61780, Dec. 2, 1994; 65 FR 79187, Dec. 18, 2000; 70 FR 2009, Jan. 12, 2005; 72 FR 55926, Oct. 1, 2007; 73 FR 63570, Oct. 24, 2008; 73 FR 78604, Dec. 23, 2008; 74 FR 7785, Feb. 20, 2009; 76 FR 35564, June 17, 2011; 77 FR 39905, July 6, 2012; 79 FR 58671, Sept. 30, 2014; 83 FR 33101, July 16, 2018]

§ 30.35 Financial assurance and recordkeeping for decommissioning.

(a)(1) Each applicant for a specific license authorizing the possession and use of unsealed byproduct material of half-life greater than 120 days and in quantities exceeding 10 5 times the applicable quantities set forth in appendix B to part 30 shall submit a decommissioning funding plan as described in paragraph (e) of this section. The decommissioning funding plan must also be submitted when a combination of isotopes is involved if R divided by 10 5 is greater than 1 (unity rule), where R is defined here as the sum of the ratios of the quantity of each isotope to the applicable value in appendix B to part 30.

(2) Each holder of, or applicant for, any specific license authorizing the possession and use of sealed sources or plated foils of half-life greater than 120 days and in quantities exceeding 10 12 times the applicable quantities set forth in appendix B to part 30 (or when a combination of isotopes is involved if R, as defined in § 30.35(a)(1), divided by 10 12 is greater than 1), shall submit a decommissioning funding plan as described in paragraph (e) of this section. The decommissioning funding plan must be submitted to NRC by December 2, 2005.

(b) Each applicant for a specific license authorizing possession and use of byproduct material of half-life greater than 120 days and in quantities specified in paragraph (d) of this section shall either—

(1) Submit a decommissioning funding plan as described in paragraph (e) of this section; or

(2) Submit a certification that financial assurance for decommissioning has been provided in the amount prescribed by paragraph (d) of this section using one of the methods described in paragraph (f) of this section. For an applicant, this certification may state that the appropriate assurance will be obtained after the application has been approved and the license issued but before the receipt of licensed material. If the applicant defers execution of the financial instrument until after the license has been issued, a signed original of the financial instrument obtained to satisfy the requirements of paragraph (f) of this section must be submitted to NRC before receipt of licensed material. If the applicant does not defer execution of the financial instrument, the applicant shall submit to NRC, as part of the certification, a signed original of the financial instrument obtained to satisfy the requirements of paragraph (f) of this section.

(c)(1) Each holder of a specific license issued on or after July 27, 1990, which is of a type described in paragraph (a) or (b) of this section, shall provide financial assurance for decommissioning in accordance with the criteria set forth in this section.

(2) Each holder of a specific license issued before July 27, 1990, and of a type described in paragraph (a) of this section shall submit a decommissioning funding plan as described in paragraph (e) of this section or a certification of financial assurance for decommissioning in an amount at least equal to $1,125,000 in accordance with the criteria set forth in this section. If the licensee submits the certification of financial assurance rather than a decommissioning funding plan, the licensee shall include a decommissioning funding plan in any application for license renewal.

(3) Each holder of a specific license issued before July 27, 1990, and of a type described in paragraph (b) of this section shall submit, on or before July 27, 1990, a decommissioning funding plan as described, in paragraph (e) of this section, or a certification of financial assurance for decommissioning in accordance with the criteria set forth in this section.

(4) Any licensee who has submitted an application before July 27, 1990, for renewal of license in accordance with § 30.37 shall provide financial assurance for decommissioning in accordance with paragraphs (a) and (b) of this section. This assurance must be submitted when this rule becomes effective November 24, 1995.

(5) Waste collectors and waste processors, as defined in 10 CFR part 20, Appendix G, must provide financial assurance in an amount based on a decommissioning funding plan as described in paragraph (e) of this section. The decommissioning funding plan must include the cost of disposal of the maximum amount (curies) of radioactive material permitted by license, and the cost of disposal of the maximum quantity, by volume, of radioactive material which could be present at the licensee's facility at any time, in addition to the cost to remediate the licensee's site to meet the license termination criteria of 10 CFR part 20. The decommissioning funding plan must be submitted by December 2, 2005.

(6) If, in surveys made under 10 CFR 20.1501(a), residual radioactivity in the facility and environment, including the subsurface, is detected at levels that would, if left uncorrected, prevent the site from meeting the 10 CFR 20.1402 criteria for unrestricted use, the licensee must submit a decommissioning funding plan within one year of when the survey is completed.

(d) Table of required amounts of financial assurance for decommissioning by quantity of material. Licensees required to submit the $1,125,000 amount must do so by December 2, 2004. Licensees required to submit the $113,000 or $225,000 amount must do so by June 2, 2005. Licensees having possession limits exceeding the upper bounds of this table must base financial assurance on a decommissioning funding plan.

Greater than 10 4 but less than or equal to 10 5 times the applicable quantities of appendix B to part 30 in unsealed form. (For a combination of isotopes, if R, as defined in § 30.35(a)(1), divided by 10 4 is greater than 1 but R divided by 10 5 is less than or equal to 1) | $1,125,000

Greater than 10 3 but less than or equal to 10 4 times the applicable quantities of appendix B to part 30 in unsealed form. (For a combination of isotopes, if R, as defined in § 30.35(a)(1), divided by 10 3 is greater than 1 but R divided by 10 4 is less than or equal to 1) | 225,000

Greater than 10 10 but less than or equal to 10 12 times the applicable quantities of appendix B to part 30 in sealed sources or plated foils. (For a combination of isotopes, if R, as defined in § 30.35(a)(1), divided by 10 10 is greater than, 1, but R divided by 10 12 is less than or equal to 1) | 113,000

(e)(1) Each decommissioning funding plan must be submitted for review and approval and must contain —

(i) A detailed cost estimate for decommissioning, in an amount reflecting:

(A) The cost of an independent contractor to perform all decommissioning activities;

(B) The cost of meeting the 10 CFR 20.1402 criteria for unrestricted use, provided that, if the applicant or licensee can demonstrate its ability to meet the provisions of 10 CFR 20.1403, the cost estimate may be based on meeting the 10 CFR 20.1403 criteria;

(C) The volume of onsite subsurface material containing residual radioactivity that will require remediation to meet the criteria for license termination; and

(D) An adequate contingency factor.

(ii) Identification of and justification for using the key assumptions contained in the DCE;

(iii) A description of the method of assuring funds for decommissioning from paragraph (f) of this section, including means for adjusting cost estimates and associated funding levels periodically over the life of the facility;

(iv) A certification by the licensee that financial assurance for decommissioning has been provided in the amount of the cost estimate for decommissioning; and

(v) A signed original of the financial instrument obtained to satisfy the requirements of paragraph (f) of this section (unless a previously submitted and accepted financial instrument continues to cover the cost estimate for decommissioning).

(2) At the time of license renewal and at intervals not to exceed 3 years, the decommissioning funding plan must be resubmitted with adjustments as necessary to account for changes in costs and the extent of contamination. If the amount of financial assurance will be adjusted downward, this can not be done until the updated decommissioning funding plan is approved. The decommissioning funding plan must update the information submitted with the original or prior approved plan, and must specifically consider the effect of the following events on decommissioning costs:

(i) Spills of radioactive material producing additional residual radioactivity in onsite subsurface material;

(ii) Waste inventory increasing above the amount previously estimated;

(iii) Waste disposal costs increasing above the amount previously estimated;

(iv) Facility modifications;

(v) Changes in authorized possession limits;

(vi) Actual remediation costs that exceed the previous cost estimate;

(vii) Onsite disposal; and

(viii) Use of a settling pond.

(f) The financial instrument must include the licensee's name, license number, and docket number, and the name, address, and other contact information of the issuer, and, if a trust is used, the trustee. When any of the foregoing information changes, the licensee must, within 30 days, submit financial instruments reflecting such changes. The financial instrument submitted must be a signed original or signed original duplicate, except where a copy of the signed original is specifically permitted. Financial assurance for decommissioning must be provided by one or more of the following methods:

(1) Prepayment. Prepayment is the deposit before the start of operation into an account segregated from licensee assets and outside the licensee's administrative control of cash or liquid assets such that the amount of funds would be sufficient to pay decommissioning costs. Prepayment must be made into a trust account, and the trustee and the trust must be acceptable to the Commission.

(2) A surety method, insurance, or other guarantee method. These methods guarantee that decommissioning costs will be paid. A surety method may be in the form of a surety bond, or letter of credit. A parent company guarantee of funds for decommissioning costs based on a financial test may be used if the guarantee and test are as contained in Appendix A to this part. For commercial corporations that issue bonds, a guarantee of funds by the applicant or licensee for decommissioning costs based on a financial test may be used if the guarantee and test are as contained in Appendix C to this part. For commercial companies that do not issue bonds, a guarantee of funds by the applicant or licensee for decommissioning costs may be used if the guarantee and test are as contained in Appendix D to this part. For nonprofit entities, such as colleges, universities, and nonprofit hospitals, a guarantee of funds by the applicant or licensee may be used if the guarantee and test are as contained in Appendix E to this part. Except for an external sinking fund, a parent company guarantee or a guarantee by the applicant or licensee may not be used in combination with any other financial methods used to satisfy the requirements of this section. A guarantee by the applicant or licensee may not be used in any situation where the applicant or licensee has a parent company holding majority control of the voting stock of the company. Any surety method or insurance used to provide financial assurance for decommissioning must contain the following conditions:

(i) The surety method or insurance must be open-ended or, if written for a specified term, such as five years, must be renewed automatically unless 90 days or more prior to the renewal date, the issuer notifies the Commission, the beneficiary, and the licensee of its intention not to renew. The surety method or insurance must also provide that the full face amount be paid to the beneficiary automatically prior to the expiration without proof of forfeiture if the licensee fails to provide a replacement acceptable to the Commission within 30 days after receipt of notification of cancellation.

(ii) The surety method or insurance must be payable to a trust established for decommissioning costs. The trustee and trust must be acceptable to the Commission. An acceptable trustee includes an appropriate State or Federal government agency or an entity which has the authority to act as a trustee and whose trust operations are regulated and examined by a Federal or State agency.

(iii) The surety method or insurance must remain in effect until the Commission has terminated the license.

(3) An external sinking fund in which deposits are made at least annually, coupled with a surety method, insurance, or other guarantee method, the value of which may decrease by the amount being accumulated in the sinking fund. An external sinking fund is a fund established and maintained by setting aside funds periodically in an account segregated from licensee assets and outside the licensee's administrative control in which the total amount of funds would be sufficient to pay decommissioning costs at the time termination of operation is expected. An external sinking fund must be in the form of a trust. If the other guarantee method is used, no surety or insurance may be combined with the external sinking fund. The surety, insurance, or other guarantee provisions must be as stated in paragraph (f)(2) of this section.

(4) In the case of Federal, State, or local government licensees, a statement of intent containing a cost estimate for decommissioning or an amount based on the table in paragraph (d) of this section, and indicating that funds for decommissioning will be obtained when necessary.

(5) When a government entity is assuming custody and ownership of a site, an arrangement that is deemed acceptable by such government entity.

(g) Each person licensed under this part or parts 32 through 36 and 39 of this chapter shall keep records of information important to the decommissioning of a facility in an identified location until the site is released for unrestricted use. Before licensed activities are transferred or assigned in accordance with § 30.34(b), licensees shall transfer all records described in this paragraph to the new licensee. In this case, the new licensee will be responsible for maintaining these records until the license is terminated. If records important to the decommissioning of a facility are kept for other purposes, reference to these records and their locations may be used. Information the Commission considers important to decommissioning consists of—

(1) Records of spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment, or site. These records may be limited to instances when contamination remains after any cleanup procedures or when there is reasonable likelihood that contaminants may have spread to inaccessible areas as in the case of possible seepage into porous materials such as concrete. These records must include any known information on identification of involved nuclides, quantities, forms, and concentrations.

(2) As-built drawings and modifications of structures and equipment in restricted areas where radioactive materials are used and/or stored, and of locations of possible inaccessible contamination such as buried pipes which may be subject to contamination. If required drawings are referenced, each relevant document need not be indexed individually. If drawings are not available, the licensee shall substitute appropriate records of available information concerning these areas and locations.

(3) Except for areas containing only sealed sources (provided the sources have not leaked or no contamination remains after any leak) or byproduct materials having only half-lives of less than 65 days, a list contained in a single document and updated every 2 years, of the following:

(i) All areas designated and formerly designated restricted areas as defined in 10 CFR 20.1003 (For requirements prior to January 1, 1994, see 10 CFR 20.3 as contained in the CFR edition revised as of January 1, 1993.);

(ii) All areas outside of restricted areas that require documentation under § 30.35(g)(1).

(iii) All areas outside of restricted areas where current and previous wastes have been buried as documented under 10 CFR 20.2108; and

(iv) All areas outside of restricted areas that contain material such that, if the license expired, the licensee would be required to either decontaminate the area to meet the criteria for decommissioning in 10 CFR part 20, subpart E, or apply for approval for disposal under 10 CFR 20.2002.

(4) Records of the cost estimate performed for the decommissioning funding plan or of the amount certified for decommissioning, and records of the funding method used for assuring funds if either a funding plan or certification is used.

(h) In providing financial assurance under this section, each licensee must use the financial assurance funds only for decommissioning activities and each licensee must monitor the balance of funds held to account for market variations. The licensee must replenish the funds, and report such actions to the NRC, as follows:

(1) If, at the end of a calendar quarter, the fund balance is below the amount necessary to cover the cost of decommissioning, but is not below 75 percent of the cost, the licensee must increase the balance to cover the cost, and must do so within 30 days after the end of the calendar quarter.

(2) If, at any time, the fund balance falls below 75 percent of the amount necessary to cover the cost of decommissioning, the licensee must increase the balance to cover the cost, and must do so within 30 days of the occurrence.

(3) Within 30 days of taking the actions required by paragraph (h)(1) or (h)(2) of this section, the licensee must provide a written report of such actions to the Director, Office of Nuclear Material Safety and Safeguards , and state the new balance of the fund.

[53 FR 24044, June 27, 1988, as amended at 56 FR 23471, May 21, 1991; 58 FR 39633, July 26, 1993; 58 FR 67659, Dec. 22, 1993; 58 FR 68730, Dec. 29, 1993; 59 FR 1618, Jan. 12, 1994; 60 FR 38238, July 26, 1995; 61 FR 24673, May 16, 1996; 62 FR 39090, July 21, 1997; 63 FR 29541, June 1, 1998; 68 FR 57335, Oct. 3, 2003; 76 FR 35564, June 17, 2011]

§ 30.36 Expiration and termination of licenses and decommissioning of sites and separate buildings or outdoor areas.

(a) Each specific license expires at the end of the day on the expiration date stated in the license, unless the licensee has filed an application for renewal under § 30.37 not less than 30 days before the expiration date stated in the existing license. If an application for renewal has been filed at least 30 days before the expiration date stated in the existing license, the existing license expires at the end of the day on which the Commission makes a final determination to deny the renewal application or, if the determination states an expiration date, the expiration date stated in the determination.

(b) Each specific license revoked by the Commission expires at the end of the day on the date of the Commission's final determination to revoke the license, or on the expiration date stated in the determination, or as otherwise provided by Commission Order.

(c) Each specific license continues in effect, beyond the expiration date if necessary, with respect to possession of byproduct material until the Commission notifies the licensee in writing that the license is terminated. During this time, the licensee shall—

(1) Limit actions involving byproduct material to those related to decommissioning; and

(2) Continue to control entry to restricted areas until they are suitable for release in accordance with NRC requirements.

(d) Within 60 days of the occurrence of any of the following, consistent with the administrative directions in § 30.6, each licensee shall provide notification to the NRC in writing of such occurrence, and either begin decommissioning its site, or any separate building or outdoor area that contains residual radioactivity so that the building or outdoor area is suitable for release in accordance with NRC requirements, or submit within 12 months of notification a decommissioning plan, if required by paragraph (g)(1) of this section, and begin decommissioning upon approval of that plan if—

(1) The license has expired pursuant to paragraph (a) or (b) of this section; or

(2) The licensee has decided to permanently cease principal activities, as defined in this part, at the entire site or in any separate building or outdoor area that contains residual radioactivity such that the building or outdoor area is unsuitable for release in accordance with NRC requirements; or

(3) No principal activities under the license have been conducted for a period of 24 months; or

(4) No principal activities have been conducted for a period of 24 months in any separate building or outdoor area that contains residual radioactivity such that the building or outdoor area is unsuitable for release in accordance with NRC requirements.

(e) Coincident with the notification required by paragraph (d) of this section, the licensee shall maintain in effect all decommissioning financial assurances established by the licensee pursuant to § 30.35 in conjunction with a license issuance or renewal or as required by this section. The amount of the financial assurance must be increased, or may be decreased, as appropriate, to cover the detailed cost estimate for decommissioning established pursuant to paragraph (g)(4)(v) of this section.

(1) Any licensee who has not provided financial assurance to cover the detailed cost estimate submitted with the decommissioning plan shall do so when this rule becomes effective November 24, 1995.

(2) Following approval of the decommissioning plan, a licensee may reduce the amount of the financial assurance as decommissioning proceeds and radiological contamination is reduced at the site with the approval of the Commission.

(f) The Commission may grant a request to extend the time periods established in paragraph (d) if the Commission determines that this relief is not detrimental to the public health and safety and is otherwise in the public interest. The request must be submitted no later than 30 days before notification pursuant to paragraph (d) of this section. The schedule for decommissioning set forth in paragraph (d) of this section may not commence until the Commission has made a determination on the request.

(g)(1) A decommissioning plan must be submitted if required by license condition or if the procedures and activities necessary to carry out decommissioning of the site or separate building or outdoor area have not been previously approved by the Commission and these procedures could increase potential health and safety impacts to workers or to the public, such as in any of the following cases:

(i) Procedures would involve techniques not applied routinely during cleanup or maintenance operations;

(ii) Workers would be entering areas not normally occupied where surface contamination and radiation levels are significantly higher than routinely encountered during operation;

(iii) Procedures could result in significantly greater airborne concentrations of radioactive materials than are present during operation; or

(iv) Procedures could result in significantly greater releases of radioactive material to the environment than those associated with operation.

(2) The Commission may approve an alternate schedule for submittal of a decommissioning plan required pursuant to paragraph (d) of this section if the Commission determines that the alternative schedule is necessary to the effective conduct of decommissioning operations and presents no undue risk from radiation to the public health and safety and is otherwise in the public interest.

(3) Procedures such as those listed in paragraph (g)(1) of this section with potential health and safety impacts may not be carried out prior to approval of the decommissioning plan.

(4) The proposed decommissioning plan for the site or separate building or outdoor area must include:

(i) A description of the conditions of the site or separate building or outdoor area sufficient to evaluate the acceptability of the plan;

(ii) A description of planned decommissioning activities;

(iii) A description of methods used to ensure protection of workers and the environment against radiation hazards during decommissioning;

(iv) A description of the planned final radiation survey; and

(v) An updated detailed cost estimate for decommissioning, comparison of that estimate with present funds set aside for decommissioning, and a plan for assuring the availability of adequate funds for completion of decommissioning.

(vi) For decommissioning plans calling for completion of decommissioning later than 24 months after plan approval, the plan shall include a justification for the delay based on the criteria in paragraph (i) of this section.

(5) The proposed decommissioning plan will be approved by the Commission if the information therein demonstrates that the decommissioning will be completed as soon as practicable and that the health and safety of workers and the public will be adequately protected.

(h)(1) Except as provided in paragraph (i) of this section, licensees shall complete decommissioning of the site or separate building or outdoor area as soon as practicable but no later than 24 months following the initiation of decommissioning.

(2) Except as provided in paragraph (i) of this section, when decommissioning involves the entire site, the licensee shall request license termination as soon as practicable but no later than 24 months following the initiation of decommissioning.

(i) The Commission may approve a request for an alternative schedule for completion of decommissioning of the site or separate building or outdoor area, and license termination if appropriate, if the Commission determines that the alternative is warranted by consideration of the following:

(1) Whether it is technically feasible to complete decommissioning within the allotted 24-month period;

(2) Whether sufficient waste disposal capacity is available to allow completion of decommissioning within the allotted 24-month period;

(3) Whether a significant volume reduction in wastes requiring disposal will be achieved by allowing short-lived radionuclides to decay;

(4) Whether a significant reduction in radiation exposure to workers can be achieved by allowing short-lived radionuclides to decay; and

(5) Other site-specific factors which the Commission may consider appropriate on a case-by-case basis, such as the regulatory requirements of other government agencies, lawsuits, groundwater treatment activities, monitored natural groundwater restoration, actions that could result in more environmental harm than deferred cleanup, and other factors beyond the control of the licensee.

(j) As the final step in decommissioning, the licensee shall—

(1) Certify the disposition of all licensed material, including accumulated wastes, by submitting a completed NRC Form 314 or equivalent information; and

(2) Conduct a radiation survey of the premises where the licensed activities were carried out and submit a report of the results of this survey, unless the licensee demonstrates in some other manner that the premises are suitable for release in accordance with the criteria for decommissioning in 10 CFR part 20, subpart E. The licensee shall, as appropriate—

(i) Report levels of gamma radiation in units of millisieverts (microroentgen) per hour at one meter from surfaces, and report levels of radioactivity, including alpha and beta, in units of megabecquerels (disintegrations per minute or microcuries) per 100 square centimeters—removable and fixed—for surfaces, megabecquerels (microcuries) per milliliter for water, and becquerels (picocuries) per gram for solids such as soils or concrete; and

(ii) Specify the survey instrument(s) used and certify that each instrument is properly calibrated and tested.

(k) Specific licenses, including expired licenses, will be terminated by written notice to the licensee when the Commission determines that:

(1) Byproduct material has been properly disposed;

(2) Reasonable effort has been made to eliminate residual radioactive contamination, if present; and

(3)(i) A radiation survey has been performed which demonstrates that the premises are suitable for release in accordance with the criteria for decommissioning in 10 CFR part 20, subpart E; or

(ii) Other information submitted by the licensee is sufficient to demonstrate that the premises are suitable for release in accordance with the criteria for decommissioning in 10 CFR part 20, subpart E.

(4) Records required by § 30.51 (d) and (f) have been received.

[59 FR 36034, July 15, 1994, as amended at 60 FR 38238, July 26, 1995; 61 FR 1114, Jan. 16, 1996; 61 FR 24673, May 16, 1996; 61 FR 29637, June 12, 1996; 62 FR 39090, July 21, 1997; 73 FR 42673, July 23, 2008; 81 FR 86909, Dec. 2, 2016]

§ 30.37 Application for renewal of licenses.

Application for renewal of a specific license must be filed on NRC Form 313 and in accordance with § 30.32.

[75 FR 73942, Nov. 30, 2010]

§ 30.38 Application for amendment of licenses and registration certificates.

Applications for amendment of a license must be filed in accordance with § 30.32 and must specify the respects in which the licensee desires its license to be amended and the grounds for the amendment. Applications for amendment of sealed source and device registration certificates must be filed in accordance with § 32.210 of this chapter and any other applicable provisions and must specify the respects in which the certificate holder desires its certificate to be amended and the grounds for the amendment.

[77 FR 43690, July 25, 2012]

§ 30.39 Commission action on applications to renew or amend.

In considering an application to renew or amend a license or to amend a sealed source or device registration certificate, the Commission will apply the applicable criteria set forth in § 30.33 and parts 32 through 36 and 39 of this chapter.

[77 FR 43690, July 25, 2012]

§ 30.41 Transfer of byproduct material.

(a) No licensee shall transfer byproduct material except as authorized pursuant to this section.

(b) Except as otherwise provided in his license and subject to the provisions of paragraphs (c) and (d) of this section, any licensee may transfer byproduct material:

(1) To the Department;

(2) To the agency in any Agreement State which regulates radioactive material pursuant to an agreement under section 274 of the Act;

(3) To any person exempt from the licensing requirements of the Act and regulations in this part, to the extent permitted under such exemption;

(4) To any person in an Agreement State, subject to the jurisdiction of that State, who has been exempted from the licensing requirements and regulations of that State, to the extent permitted under such exemption;

(5) To any person authorized to receive such byproduct material under terms of a specific license or a general license or their equivalents issued by the Atomic Energy Commission, the Commission, or an Agreement State;

(6) To a person abroad pursuant to an export license issued under part 110 of this chapter; or

(7) As otherwise authorized by the Commission in writing.

(c) Before transferring byproduct material to a specific licensee of the Commission or an Agreement State or to a general licensee who is required to register with the Commission or with an Agreement State prior to receipt of the byproduct material, the licensee transferring the material shall verify that the transferee's license authorizes the receipt of the type, form, and quantity of byproduct material to be transferred.

(d) The following methods for the verification required by paragraph (c) of this section are acceptable:

(1) The transferor may have in his possession, and read, a current copy of the transferee's specific license or registration certificate;

(2) The transferor may have in his possession a written certification by the transferee that he is authorized by license or registration certificate to receive the type, form, and quantity of byproduct material to be transferred, specifying the license or registration certificate number, issuing agency and expiration date;

(3) For emergency shipments the transferor may accept oral certification by the transferee that he is authorized by license or registration certificate to receive the type, form, and quantity of byproduct material to be transferred, specifying the license or registration certificate number, issuing agency and expiration date: Provided, That the oral certification is confirmed in writing within 10 days;

(4) The transferor may obtain other sources of information compiled by a reporting service from official records of the Commission or the licensing agency of an Agreement State as to the identity of licensees and the scope and expiration dates of licenses and registration; or

(5) When none of the methods of verification described in paragraphs (d)(1) to (4) of this section are readily available or when a transferor desires to verify that information received by one of such methods is correct or up-to-date, the transferor may obtain and record confirmation from the Commission or the licensing agency of an Agreement State that the transferee is licensed to receive the byproduct material.

[38 FR 33969, Dec. 10, 1973, as amended at 40 FR 8785, Mar. 3, 1975; 43 FR 6922, Feb. 17, 1978]

§ 30.50 Reporting requirements.

(a) Immediate report. Each licensee shall notify the NRC as soon as possible but not later than 4 hours after the discovery of an event that prevents immediate protective actions necessary to avoid exposures to radiation or radioactive materials that could exceed regulatory limits or releases of licensed material that could exceed regulatory limits (events may include fires, explosions, toxic gas releases, etc.).

(b) Twenty-four hour report. Each licensee shall notify the NRC within 24 hours after the discovery of any of the following events involving licensed material:

(1) An unplanned contamination event that:

(i) Requires access to the contaminated area, by workers or the public, to be restricted for more than 24 hours by imposing additional radiological controls or by prohibiting entry into the area;

(ii) Involves a quantity of material greater than five times the lowest annual limit on intake specified in appendix B of §§ 20.1001-20.2401 of 10 CFR part 20 for the material; and

(iii) Has access to the area restricted for a reason other than to allow isotopes with a half-life of less than 24 hours to decay prior to decontamination.

(2) An event in which equipment is disabled or fails to function as designed when:

(i) The equipment is required by regulation or license condition to prevent releases exceeding regulatory limits, to prevent exposures to radiation and radioactive materials exceeding regulatory limits, or to mitigate the consequences of an accident;

(ii) The equipment is required to be available and operable when it is disabled or fails to function; and

(iii) No redundant equipment is available and operable to perform the required safety function.

(3) An event that requires unplanned medical treatment at a medical facility of an individual with spreadable radioactive contamination on the individual's clothing or body.

(4) An unplanned fire or explosion damaging any licensed material or any device, container, or equipment containing licensed material when:

(i) The quantity of material involved is greater than five times the lowest annual limit on intake specified in appendix B of §§ 20.1001-20.2401 of 10 CFR part 20 for the material; and

(ii) The damage affects the integrity of the licensed material or its container.

(c) Preparation and submission of reports. Reports made by licensees in response to the requirements of this section must be made as follows:

(1) Licensees shall make reports required by paragraphs (a) and (b) of this section by telephone to the NRC Headquarters Operations Center at the numbers specified in appendix A to part 73 of this chapter. To the extent that the information is available at the time of notification, the information provided in these reports must include:

(i) The caller's name and call back telephone number;

(ii) A description of the event, including date and time;

(iii) The exact location of the event;

(iv) The isotopes, quantities, and chemical and physical form of the licensed material involved; and

(v) Any personnel radiation exposure data available.

(2) Written report. Each licensee who makes a report required by paragraph (a) or (b) of this section shall submit a written follow-up report within 30 days of the initial report. Written reports prepared pursuant to other regulations may be submitted to fulfill this requirement if the reports contain all of the necessary information and the appropriate distribution is made. These written reports must be sent to the NRC using an appropriate method listed in § 30.6(a); and a copy must be sent to the appropriate NRC Regional office listed in appendix D to part 20 of this chapter. The reports must include the following:

(i) A description of the event, including the probable cause and the manufacturer and model number (if applicable) of any equipment that failed or malfunctioned;

(ii) The exact location of the event;

(iii) The isotopes, quantities, and chemical and physical form of the licensed material involved;

(iv) Date and time of the event;

(v) Corrective actions taken or planned and the results of any evaluations or assessments; and

(vi) The extent of exposure of individuals to radiation or to radioactive materials without identification of individuals by name.

(3) The provisions of this section do not apply to licensees subject to the notification requirements in § 50.72 or § 53.1630 of this chapter. They do apply to those licensees under part 50 of this chapter possessing material licensed under this part, who are not subject to the notification requirements in § 50.72 of this chapter.

[56 FR 40767, Aug. 16, 1991, as amended at 59 FR 14086, Mar. 25, 1994; 68 FR 58804, Oct. 10, 2003; 85 FR 65661, Oct. 16, 2020; 91 FR 15786, Mar. 30, 2026]

§ 30.51 Records.

(a) Each person who receives byproduct material pursuant to a license issued pursuant to the regulations in this part and parts 31 through 36 of this chapter shall keep records showing the receipt, transfer, and disposal of the byproduct material as follows:

(1) The licensee shall retain each record of receipt of byproduct material as long as the material is possessed and for three years following transfer or disposal of the material.

(2) The licensee who transferred the material shall retain each record of transfer for three years after each transfer unless a specific requirement in another part of the regulations in this chapter dictates otherwise.

(3) The licensee who disposed of the material shall retain each record of disposal of byproduct material until the Commission terminates each license that authorizes disposal of the material.

(b) The licensee shall retain each record that is required by the regulations in this part and parts 31 through 36 of this chapter or by license condition for the period specified by the appropriate regulation or license condition. If a retention period is not otherwise specified by regulation or license condition, the record must be retained until the Commission terminates each license that authorizes the activity that is subject to the recordkeeping requirement.

(c)(1) Records which must be maintained pursuant to this part and parts 31 through 36 of this chapter may be the original or a reproduced copy or microform if such reproduced copy or microform is duly authenticated by authorized personnel and the microform is capable of producing a clear and legible copy after storage for the period specified by Commission regulations. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.

(2) If there is a conflict between the Commission's regulations in this part and parts 31 through 36 and 39 of this chapter, license condition, or other written Commission approval or authorization pertaining to the retention period for the same type of record, the retention period specified in the regulations in this part and parts 31 through 36 and 39 of this chapter for such records shall apply unless the Commission, pursuant to § 30.11, has granted a specific exemption from the record retention requirements specified in the regulations in this part or parts 31 through 36 and 39 of this chapter.

(d) Prior to license termination, each licensee authorized to possess radioactive material with a half-life greater than 120 days, in an unsealed form, shall forward the following records to the appropriate NRC Regional Office:

(1) Records of disposal of licensed material made under §§ 20.2002 (including burials authorized before January 28, 1981 1 ), 20.2003, 20.2004, 20.2005; and

1 A previous § 20.304 permitted burial of small quantities of licensed materials in soil before January 28, 1981, without specific Commission authorization. See § 20.304 contained in the 10 CFR, parts 0 to 199, edition revised as of January 1, 1981.

(2) Records required by § 20.2103(b)(4).

(e) If licensed activities are transferred or assigned in accordance with § 30.34(b), each licensee authorized to possess radioactive material, with a half-life greater than 120 days, in an unsealed form, shall transfer the following records to the new licensee and the new licensee will be responsible for maintaining these records until the license is terminated:

(1) Records of disposal of licensed material made under §§ 20.2002 (including burials authorized before January 28, 1981 1), 20.2003, 20.2004, 20.2005; and

(2) Records required by § 20.2103(b)(4).

(f) Prior to license termination, each licensee shall forward the records required by § 30.35(g) to the appropriate NRC Regional Office.

[41 FR 18301, May 5, 1976, as amended at 43 FR 6922, Feb. 17, 1978; 52 FR 8241, Mar. 17, 1987; 53 FR 19245, May 27, 1988; 58 FR 7736, Feb. 9, 1993; 61 FR 24673, May 16, 1996]

§ 30.52 Inspections.

(a) Each licensee shall afford to the Commission at all reasonable times opportunity to inspect byproduct material and the premises and facilities wherein byproduct material is used or stored.

(b) Each licensee shall make available to the Commission for inspection, upon reasonable notice, records kept by him pursuant to the regulations in this chapter.

[30 FR 8185, June 26, 1965]

§ 30.53 Tests.

Each licensee shall perform, or permit the Commission to perform, such tests as the Commission deems appropriate or necessary for the administration of the regulations in this part and parts 31 through 36 and 39 of this chapter, including tests of:

(a) Byproduct material;

(b) Facilities wherein byproduct material is utilized or stored;

(c) Radiation detection and monitoring instruments; and

(d) Other equipment and devices used in connection with the utilization or storage of byproduct material.

[30 FR 8185, June 26, 1965, as amended at 43 FR 6922, Feb. 17, 1978; 52 FR 8241, Mar. 17, 1987; 58 FR 7736, Feb. 9, 1993]

§ 30.55 Tritium reports.

(a)-(b) [Reserved]

(c) Except as specified in paragraph (d) of this section, each licensee who is authorized to possess tritium shall report promptly to the appropriate NRC Regional Office listed in appendix D of part 20 of this chapter by telephone and telegraph, mailgram, or facsimile any incident in which an attempt has been made or is believed to have been made to commit a theft or unlawful diversion of more than 10 curies of such material at any one time or more than 100 curies of such material in any one calendar year. The initial report shall be followed within a period of fifteen (15) days by a written report submitted to the appropriate NRC Regional Office which sets forth the details of the incident and its consequences. Copies of such written report shall be sent to the Director, Office of Nuclear Material Safety and Safeguards , using an appropriate method listed in § 30.6(a). Subsequent to the submission of the written report required by this paragraph, the licensee shall promptly inform the Office of Nuclear Material Safety and Safeguards by means of a written report of any substantive additional information, which becomes available to the licensee, concerning an attempted or apparent theft or unlawful diversion of tritium.

(d) The reports described in this section are not required for tritium possessed pursuant to a general license provided in part 31 of this chapter or for tritium contained in spent fuel.

[37 FR 9208, May 6, 1972, as amended at 38 FR 1271, Jan. 11, 1973; 38 FR 2330, Jan. 24, 1973; 41 FR 16446, Apr. 19, 1976; 43 FR 6922, Feb. 17, 1978; 46 FR 55085, Nov. 6, 1981; 49 FR 24707, June 15, 1984; 52 FR 31611, Aug. 21, 1987; 68 FR 58804, Oct. 10, 2003; 73 FR 5718, Jan. 31, 2008]

§ 30.61 Modification and revocation of licenses and registration certificates.

(a) The terms and conditions of each license and registration certificate issued under the regulations in this part and parts 31 through 36 and 39 of this chapter shall be subject to amendment, revision, or modification by reason of amendments to the Act, or by reason of rules, regulations, and orders issued in accordance with the terms of the Act.

(b) Any license or registration certificate may be revoked, suspended, or modified, in whole or in part, for any material false statement in the application or in any statement of fact required under section 182 of the Act, or because of conditions revealed by such application or statement of fact or any report, record, or inspection or other means that would warrant the Commission to refuse to grant a license or registration certificate on an original application, or for violation of, or failure to observe any of the terms and provisions of the Act or of any rule, regulation, or order of the Commission.

(c) Except in cases of willfulness or those in which the public health, interest, or safety requires otherwise, no license or registration certificate shall be modified, suspended, or revoked unless, before the institution of proceedings therefor, facts or conduct that may warrant such action shall have been called to the attention of the licensee or certificate holder in writing and the licensee or certificate holder shall have been given an opportunity to demonstrate or achieve compliance with all lawful requirements.

[77 FR 43690, July 25, 2012]

§ 30.62 Right to cause the withholding or recall of byproduct material.

The Commission may cause the withholding or recall of byproduct material from any licensee who is not equipped to observe or fails to observe such safety standards to protect health as may be established by the Commission, or who uses such materials in violation of law or regulation of the Commission, or in a manner other than as disclosed in the application therefor or approved by the Commission.

[30 FR 8185, June 26, 1965, as amended at 40 FR 8785, Mar. 3, 1975]

§ 30.63 Violations.

(a) The Commission may obtain an injunction or other court order to prevent a violation of the provisions of—

(1) The Atomic Energy Act of 1954, as amended;

(2) Title II of the Energy Reorganization Act of 1974, as amended; or

(3) A regulation or order issued pursuant to those Acts.

(b) The Commission may obtain a court order for the payment of a civil penalty imposed under section 234 of the Atomic Energy Act:

(1) For violations of—

(i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Atomic Energy Act of 1954, as amended;

(ii) Section 206 of the Energy Reorganization Act;

(iii) Any rule, regulation, or order issued pursuant to the sections specified in paragraph (b)(1)(i) of this section;

(iv) Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(i) of this section.

(2) For any violation for which a license may be revoked under section 186 of the Atomic Energy Act of 1954, as amended.

[57 FR 55072, Nov. 24, 1992]

§ 30.64 Criminal penalties.

(a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all the regulations in part 30 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section.

(b) The regulations in part 30 that are not issued under sections 161b, 161i, or 161o for the purposes of section 223 are as follows: §§ 30.1, 30.2, 30.4, 30.5, 30.6, 30.8, 30.11, 30.12, 30.13, 30.15, 30.31, 30.32, 30.33, 30.37, 30.38, 30.39, 30.61, 30.62, 30.63, 30.64, 30.70, 30.71, and 30.72.

[57 FR 55072, Nov. 24, 1992, as amended at 73 FR 42673, July 23, 2008]

§ 30.70 Schedule A—Exempt concentrations.

[See footnotes at end of this table]

Element (atomic number) | Isotope | Col. I | Col. II

Gas concentration µCi/ml 1 | Liquid and solid concentration µCi/ml 2

Antimony (51) | Sb 122 | 3 × 10−4

Sb 124 | 2 × 10−4

Sb 125 | 1 × 10−3

Argon (18) | A 37 | 1 × 10−3

A 41 | 4 × 10−7

Arsenic (33) | As 73 | 5 × 10−3

As 74 | 5 × 10−4

As 76 | 2 × 10−4

As 77 | 8 × 10−4

Barium (56) | Ba 131 | 2 × 10−3

Ba 140 | 3 × 10−4

Beryllium (4) | Be 7 | 2 × 10−2

Bismuth (83) | Bi 206 | 4 × 10−4

Bromine (35) | Br 82 | 4 × 10−7 | 3 × 10−3

Cadmium (48) | Cd 109 | 2 × 10−3

Cd 115m | 3 × 10−4

Cd 115 | 3 × 10−4

Calcium (20) | Ca 45 | 9 × 10−5

Ca 47 | 5 × 10−4

Carbon (6) | C 14 | 1 × 10−6 | 8 × 10−3

Cerium (58) | Ce 141 | 9 × 10−4

Ce 143 | 4 × 10−4

Ce 144 | 1 × 10−4

Cesium (55) | Cs 131 | 2 × 10−2

Cs 134m | 6 × 10−2

Cs 134 | 9 × 10−5

Chlorine (17) | Cl 38 | 9 × 10−7 | 4 × 10−3

Chromium (24) | Cr 51 | 2 × 10−2

Cobalt (27) | Co 57 | 5 × 10−3

Co 58 | 1 × 10−3

Co 60 | 5 × 10−4

Copper (29) | Cu 64 | 3 × 10−3

Dysprosium (66) | Dy 165 | 4 × 10−3

Dy 166 | 4 × 10−4

Erbium (68) | Er 169 | 9 × 10−4

Er 171 | 1 × 10−3

Europium (63) | Eu 152 | 6 × 10−4

(T/2 = 9.2 Hrs)

Eu 155 | 2 × 10−3

Fluorine (9) | F 18 | 2 × 10−6 | 8 × 10−3

Gadolinium (64) | Gd 153 | 2 × 10−3

Gd 159 | 8 × 10−4

Gallium (31) | Ga 72 | 4 × 10−4

Germanium (32) | Ge 71 | 2 × 10−2

Gold (79) | Au 196 | 2 × 10−3

Au 198 | 5 × 10−4

Au 199 | 2 × 10−3

Hafnium (72) | Hf 181 | 7 × 10−4

Hydrogen (1) | H 3 | 5 × 10−6 | 3 × 10−2

Indium (49) | In 113m | 1 × 10−2

In 114m | 2 × 10−4

Iodine (53) | I 126 | 3 × 10−9 | 2 × 10−5

I 131 | 3 × 10−9 | 2 × 10−5

I 132 | 8 × 10−8 | 6 × 10−4

I 133 | 1 × 10−8 | 7 × 10−5

I 134 | 2 × 10−7 | 1 × 10−3

Iridium (77) | Ir 190 | 2 × 10−3

Ir 192 | 4 × 10−4

Ir 194 | 3 × 10−4

Iron (26) | Fe 55 | 8 × 10−3

Fe 59 | 6 × 10−4

Krypton (36) | Kr 85m | 1 × 10−6

Kr 85 | 3 × 10−6

Lanthanum (57) | La 140 | 2 × 10−4

Lead (82) | Pb 203 | 4 × 10−3

Lutetium (71) | Lu 177 | 1 × 10−3

Manganese (25) | Mn 52 | 3 × 10−4

Mn 54 | 1 × 10−3

Mn 56 | 1 × 10−3

Mercury (80) | Hg 197m | 2 × 10−3

Hg 197 | 3 × 10−3

Hg 203 | 2 × 10−4

Molybdenum (42) | Mo 99 | 2 × 10−3

Neodymium (60) | Nd 147 | 6 × 10−4

Nd 149 | 3 × 10−3

Nickel (28) | Ni 65 | 1 × 10−3

Niobium (Columbium) (41) | Nb 95 | 1 × 10−3

Nb 97 | 9 × 10−3

Osmium (76) | Os 185 | 7 × 10−4

Os 191m | 3 × 10−2

Os 191 | 2 × 10−3

Os 193 | 6 × 10−4

Palladium (46) | Pd 103 | 3 × 10−3

Pd 109 | 9 × 10−4

Phosphorus (15) | P 32 | 2 × 10−4

Platinum (78) | Pt 191 | 1 × 10−3

Pt 193m | 1 × 10−2

Pt 197m | 1 × 10−2

Pt 197 | 1 × 10−3

Potassium (19) | K 42 | 3 × 10−3

Praseodymium (59) | Pr 142 | 3 × 10−4

Pr 143 | 5 × 10−4

Promethium (61) | Pm 147 | 2 × 10−3

Pm 149 | 4 × 10−4

Rhenium (75) | Re 183 | 6 × 10−3

Re 186 | 9 × 10−4

Re 188 | 6 × 10−4

Rhodium (45) | Rh 103m | 1 × 10−1

Rh 105 | 1 × 10−3

Rubidium (37) | Rb 86 | 7 × 10−4

Ruthenium (44) | Ru 97 | 4 × 10−4

Ru 103 | 8 × 10−4

Ru 105 | 1 × 10−3

Ru 106 | 1 × 10−4

Samarium (62) | Sm 153 | 8 × 10−4

Scandium (21) | Sc 46 | 4 × 10−4

Sc 47 | 9 × 10−4

Sc 48 | 3 × 10−4

Selenium (34) | Se 75 | 3 × 10−3

Silicon (14) | Si 31 | 9 × 10−3

Silver (47) | Ag 105 | 1 × 10−3

Ag 110m | 3 × 10−4

Ag 111 | 4 × 10−4

Sodium (11) | Na 24 | 2 × 10−3

Strontium (38) | Sr 85 | 1 × 10−4

Sr 89 | 1 × 10−4

Sr 91 | 7 × 10−4

Sr 92 | 7 × 10−4

Sulfur (16) | S 35 | 9 × 10−8 | 6 × 10−4

Tantalum (73) | Ta 182 | 4 × 10−4

Technetium (43) | Tc 96m | 1 × 10−1

Tc 96 | 1 × 10−3

Tellurium (52) | Te 125m | 2 × 10−3

Te 127m | 6 × 10−4

Te 127 | 3 × 10−3

Te 129m | 3 × 10−4

Te 131m | 6 × 10−4

Te 132 | 3 × 10−4

Terbium (65) | Tb 160 | 4 × 10−4

Thallium (81) | Tl 200 | 4 × 10−3

Tl 201 | 3 × 10−3

Tl 202 | 1 × 10−3

Tl 204 | 1 × 10−3

Thulium (69) | Tm 170 | 5 × 10−4

Tm 171 | 5 × 10−3

Tin (50) | Sn 113 | 9 × 10−4

Sn 125 | 2 × 10−4

Tungsten (Wolfram) (74) | W 181 | 4 × 10−3

W 187 | 7 × 10−4

Vanadium (23) | V 48 | 3 × 10−4

Xenon (54) | Xe 131m | 4 × 10−6

Xe 133 | 3 × 10−6

Xe 135 | 1 × 10−6

Ytterbium (70) | Yb 175 | 1 × 10−3

Yttrium (39) | Y 90 | 2 × 10−4

Y 91m | 3 × 10−2

Y 91 | 3 × 10−4

Y 92 | 6 × 10−4

Y 93 | 3 × 10−4

Zinc (30) | Zn 65 | 1 × 10−3

Zn 69m | 7 × 10−4

Zn 69 | 2 × 10−2

Zirconium (40) | Zr 95 | 6 × 10−4

Zr 97 | 2 × 10−4

Beta and/or gamma emitting byproduct material not listed above with half-life less than 3 years | 1 × 10−10 | 1 × 10−6

Footnotes to Schedule A:

1 Values are given only for those materials normally used as gases.

2 µCi/gm for solids.

Note 1: Many radioisotopes disintegrate into isotopes which are also radioactive. In expressing the concentrations in Schedule A, the activity stated is that of the parent isotope and takes into account the daughters.

Note 2: For purposes of § 30.14 where there is involved a combination of isotopes, the limit for the combination should be derived as follows:

Determine for each isotope in the product the ratio between the concentration present in the product and the exempt concentration established in Schedule A for the specific isotope when not in combination. The sum of such ratios may not exceed “1” (i.e., unity).

Example:

[30 FR 8185, June 26, 1965, as amended at 35 FR 3982, Mar. 3, 1970; 38 FR 29314, Oct. 24, 1973; 59 FR 5520, Feb. 7, 1994]

§ 30.71 Schedule B.

Link to an amendment published at 91 FR 63145, Oct. 5, 2026.

Byproduct material | Microcuries

Antimony 122 (Sb 122) | 100

Antimony 124 (Sb 124) | 10

Antimony 125 (Sb 125) | 10

Arsenic 73 (As 73) | 100

Arsenic 74 (As 74) | 10

Arsenic 76 (As 76) | 10

Arsenic 77 (As 77) | 100

Barium 131 (Ba 131) | 10

Barium 133 (Ba 133) | 10

Barium 140 (Ba 140) | 10

Bismuth 210 (Bi 210) | 1

Bromine 82 (Br 82) | 10

Cadmium 109 (Cd 109) | 10

Cadmium 115m (Cd 115m) | 10

Cadmium 115 (Cd 115) | 100

Calcium 45 (Ca 45) | 10

Calcium 47 (Ca 47) | 10

Carbon 14 (C 14) | 100

Cerium 141 (Ce 141) | 100

Cerium 143 (Ce 143) | 100

Cerium 144 (Ce 144) | 1

Cesium 129 (Cs 129) | 100

Cesium 131 (Cs 131) | 1,000

Cesium 134m (Cs 134m) | 100

Cesium 134 (Cs 134) | 1

Cesium 135 (Cs 135) | 10

Cesium 136 (Cs 136) | 10

Cesium 137 (Cs 137) | 10

Chlorine 36 (C1 36) | 10

Chlorine 38 (Cl 38) | 10

Chromium 51 (Cr 51) | 1,000

Cobalt 57 (Co 57) | 100

Cobalt 58m (Co 58m) | 10

Cobalt 58 (Co 58) | 10

Cobalt 60 (Co 60) | 1

Copper 64 (Cu 64) | 100

Dysprosium 165 (Dy 165) | 10

Dysprosium 166 (Dy 166) | 100

Erbium 169 (Er 169) | 100

Erbium 171 (Er 171) | 100

Europium 152 9.2 h (Eu 152 9.2 h) | 100

Europium 152 13 yr (Eu 152 13 yr) | 1

Europium 154 (Eu 154) | 1

Europium 155 (Eu 155) | 10

Fluorine 18 (F 18) | 1,000

Gadolinium 153 (Gd 153) | 10

Gadolinium 159 (Gd 159) | 100

Gallium 67 (Ga 67) | 100

Gallium 72 (Ga 72) | 10

Germanium 68 (Ge 68) | 10

Germanium 71 (Ge 71) | 100

Gold 195 (Au 195) | 10

Gold 198 (Au 198) | 100

Gold 199 (Au 199) | 100

Hafnium 181 (Hf 181) | 10

Holmium 166 (Ho 166) | 100

Hydrogen 3 (H 3) | 1,000

Indium 111 (In 111) | 100

Indium 113m (In 113m) | 100

Indium 114m (In 114m) | 10

Indium 115m (In 115m) | 100

Indium 115 (In 115) | 10

Iodine 123 (I 123) | 100

Iodine 125 (I 125) | 1

Iodine 126 (I 126) | 1

Iodine 129 (I 129) | 0.1

Iodine 131 (I 131) | 1

Iodine 132 (I 132) | 10

Iodine 133 (I 133) | 1

Iodine 134 (I 134) | 10

Iodine 135 (I 135) | 10

Iridium 192 (Ir 192) | 10

Iridium 194 (Ir 194) | 100

Iron 52 (Fe 52) | 10

Iron 55 (Fe 55) | 100

Iron 59 (Fe 59) | 10

Krypton 85 (Kr 85) | 100

Krypton 87 (Kr 87) | 10

Lanthanum 140 (La 140) | 10

Lutetium 177 (Lu 177) | 100

Manganese 52 (Mn 52) | 10

Manganese 54 (Mn 54) | 10

Manganese 56 (Mn 56) | 10

Mercury 197m (Hg 197m) | 100

Mercury 197 (Hg 197) | 100

Mercury 203 (Hg 203) | 10

Molybdenum 99 (Mo 99) | 100

Neodymium 147 (Nd 147) | 100

Neodymium 149 (Nd 149) | 100

Nickel 59 (Ni 59) | 100

Nickel 63 (Ni 63) | 10

Nickel 65 (Ni 65) | 100

Niobium 93m (Nb 93m) | 10

Niobium 95 (Nb 95) | 10

Niobium 97 (Nb 97) | 10

Osmium 185 (Os 185) | 10

Osmium 191m (Os 191m) | 100

Osmium 191 (Os 191) | 100

Osmium 193 (Os 193) | 100

Palladium 103 (Pd 103) | 100

Palladium 109 (Pd 109) | 100

Phosphorus 32 (P 32) | 10

Platinum 191 (Pt 191) | 100

Platinum 193m (Pt 193m) | 100

Platinum 193 (Pt 193) | 100

Platinum 197m (Pt 197m) | 100

Platinum 197 (Pt 197) | 100

Polonium 210 (Po 210) | 0.1

Potassium 42 (K 42) | 10

Potassium 43 (K 43) | 10

Praseodymium 142 (Pr 142) | 100

Praseodymium 143 (Pr 143) | 100

Promethium 147 (Pm 147) | 10

Promethium 149 (Pm 149) | 10

Rhenium 186 (Re 186) | 100

Rhenium 188 (Re 188) | 100

Rhodium 103m (Rh 103m) | 100

Rhodium 105 (Rh 105) | 100

Rubidium 81 (Rb 81) | 10

Rubidium 86 (Rb 86) | 10

Rubidium 87 (Rb 87) | 10

Ruthenium 97 (Ru 97) | 100

Ruthenium 103 (Ru 103) | 10

Ruthenium 105 (Ru 105) | 10

Ruthenium 106 (Ru 106) | 1

Samarium 151 (Sm 151) | 10

Samarium 153 (Sm 153) | 100

Scandium 46 (Sc 46) | 10

Scandium 47 (Sc 47) | 100

Scandium 48 (Sc 48) | 10

Selenium 75 (Se 75) | 10

Silicon 31 (Si 31) | 100

Silver 105 (Ag 105) | 10

Silver 110m (Ag 110m) | 1

Silver 111 (Ag 111) | 100

Sodium 22 (Na 22) | 10

Sodium 24 (Na 24) | 10

Strontium 85 (Sr 85) | 10

Strontium 89 (Sr 89) | 1

Strontium 90 (Sr 90) | 0.1

Strontium 91 (Sr 91) | 10

Strontium 92 (Sr 92) | 10

Sulphur 35 (S 35) | 100

Tantalum 182 (Ta 182) | 10

Technetium 96 (Tc 96) | 10

Technetium 97m (Tc 97m) | 100

Technetium 97 (Tc 97) | 100

Technetium 99m (Tc 99m) | 100

Technetium 99 (Tc 99) | 10

Tellurium 125m (Te 125m) | 10

Tellurium 127m (Te 127m) | 10

Tellurium 127 (Te 127) | 100

Tellurium 129m (Te 129m) | 10

Tellurium 129 (Te 129) | 100

Tellurium 131m (Te 131m) | 10

Tellurium 132 (Te 132) | 10

Terbium 160 (Tb 160) | 10

Thallium 200 (Tl 200) | 100

Thallium 201 (Tl 201) | 100

Thallium 202 (Tl 202) | 100

Thallium 204 (Tl 204) | 10

Thulium 170 (Tm 170) | 10

Thulium 171 (Tm 171) | 10

Tin 113 (Sn 113) | 10

Tin 125 (Sn 125) | 10

Tungsten 181 (W 181) | 10

Tungsten 185 (W 185) | 10

Tungsten 187 (W 187) | 100

Vanadium 48 (V 48) | 10

Xenon 131m (Xe 131m) | 1,000

Xenon 133 (Xe 133) | 100

Xenon 135 (Xe 135) | 100

Ytterbium 175 (Yb 175) | 100

Yttrium 87 (Y 87) | 10

Yttrium 88 (Y 88) | 10

Yttrium 90 (Y 90) | 10

Yttrium 91 (Y 91) | 10

Yttrium 92 (Y 92) | 100

Yttrium 93 (Y 93) | 100

Zinc 65 (Zn 65) | 10

Zinc 69m (Zn 69m) | 100

Zinc 69 (Zn 69) | 1,000

Zirconium 93 (Zr 93) | 10

Zirconium 95 (Zr 95) | 10

Zirconium 97 (Zr 97) | 10

Any byproduct material not listed above other than alpha emitting byproduct material | 0.1

[35 FR 6427, Apr. 22, 1970, as amended at 36 FR 16898, Aug. 26, 1971; 59 FR 5519, Feb. 7, 1994; 72 FR 55926, Oct. 1, 2007]

§ 30.72 Schedule C—Quantities of radioactive materials requiring consideration of the need for an emergency plan for responding to a release.

Radioactive material 1 | Release fraction | Quantity (curies)

Actinium-228 | 0.001 | 4,000

Americium-241 | .001 | 2

Americium-242 | .001 | 2

Americium-243 | .001 | 2

Antimony-124 | .01 | 4,000

Antimony-126 | .01 | 6,000

Barium-133 | .01 | 10,000

Barium-140 | .01 | 30,000

Bismuth-207 | .01 | 5,000

Bismuth-210 | .01 | 600

Cadmium-109 | .01 | 1,000

Cadmium-113 | .01 | 80

Calcium-45 | .01 | 20,000

Californium-252 | .001 | 9 (20 mg)

Carbon-14 (non-carbon dioxide) | .01 | 50,000

Cerium-141 | .01 | 10,000

Cerium-144 | .01 | 300

Cesium-134 | .01 | 2,000

Cesium-137 | .01 | 3,000

Chlorine-36 | .5 | 100

Chromium-51 | .01 | 300,000

Cobalt-60 | .001 | 5,000

Copper-64 | .01 | 200,000

Curium-242 | .001 | 60

Curium-243 | .001 | 3

Curium-244 | .001 | 4

Curium-245 | .001 | 2

Europium-152 | .01 | 500

Europium-154 | .01 | 400

Europium-155 | .01 | 3,000

Germanium-68 | .01 | 2,000

Gadolinium-153 | .01 | 5,000

Gold-198 | .01 | 30,000

Hafnium-172 | .01 | 400

Hafnium-181 | .01 | 7,000

Holmium-166m | .01 | 100

Hydrogen-3 | .5 | 20,000

Iodine-125 | .5 | 10

Iodine-131 | .5 | 10

Indium-114m | .01 | 1,000

Iridium-192 | .001 | 40,000

Iron-55 | .01 | 40,000

Iron-59 | .01 | 7,000

Krypton-85 | 1.0 | 6,000,000

Lead-210 | .01 | 8

Manganese-56 | .01 | 60,000

Mercury-203 | .01 | 10,000

Molybdenum-99 | .01 | 30,000

Neptunium-237 | .001 | 2

Nickel-63 | .01 | 20,000

Niobium-94 | .01 | 300

Phosphorus-32 | .5 | 100

Phosphorus-33 | .5 | 1,000

Polonium-210 | .01 | 10

Potassium-42 | .01 | 9,000

Promethium-145 | .01 | 4,000

Promethium-147 | .01 | 4,000

Radium-226 | 0.001 | 100

Ruthenium-106 | .01 | 200

Samarium-151 | .01 | 4,000

Scandium-46 | .01 | 3,000

Selenium-75 | .01 | 10,000

Silver-110m | .01 | 1,000

Sodium-22 | .01 | 9,000

Sodium-24 | .01 | 10,000

Strontium-89 | .01 | 3,000

Strontium-90 | .01 | 90

Sulfur-35 | .5 | 900

Technitium-99 | .01 | 10,000

Technitium-99m | .01 | 400,000

Tellurium-127m | .01 | 5,000

Tellurium-129m | .01 | 5,000

Terbium-160 | .01 | 4,000

Thulium-170 | .01 | 4,000

Tin-113 | .01 | 10,000

Tin-123 | .01 | 3,000

Tin-126 | .01 | 1,000

Titanium-44 | .01 | 100

Vanadium-48 | .01 | 7,000

Xenon-133 | 1.0 | 900,000

Yttrium-91 | .01 | 2,000

Zinc-65 | .01 | 5,000

Zirconium-93 | .01 | 400

Zirconium-95 | .01 | 5,000

Any other beta-gamma emitter | .01 | 10,000

Mixed fission products | .01 | 1,000

Mixed corrosion products | .01 | 10,000

Contaminated equipment beta-gamma | .001 | 10,000

Irradiated material, any form other than solid noncombustible | .01 | 1,000

Irradiated material, solid noncombustible | .001 | 10,000

Mixed radioactive waste, beta-gamma | .01 | 1,000

Packaged mixed waste, beta-gamma 4 | .001 | 10,000

Any other alpha emitter | .001 | 2

Contaminated equipment, alpha | .0001 | 20

Packaged waste, alpha 4 | .0001 | 20

Combinations of radioactive materials listed above 1

1 For combinations of radioactive materials, consideration of the need for an emergency plan is required if the sum of the ratios of the quantity of each radioactive material authorized to the quantity listed for that material in Schedule C exceeds one.

2 Waste packaged in Type B containers does not require an emergency plan.

[54 FR 14061, Apr. 7, 1989, as amended at 61 FR 9902, Mar. 12, 1996; 72 FR 55926, Oct. 1, 2007]

§ 31.1 Purpose and scope.

This part establishes general licenses for the possession and use of byproduct material and a general license for ownership of byproduct material. Specific provisions of 10 CFR Part 30 are applicable to general licenses established by this part. These provisions are specified in § 31.2 or in the particular general license.

[65 FR 79187, Dec. 18, 2000]

§ 31.2 Terms and conditions.

The general licenses provided in this part are subject to the general provisions of Part 30 of this chapter (§§ 30.1 through 30.10), the provisions of §§ 30.14(d), 30.34(a) to (e), 30.41, 30.50 to 30.53, 30.61 to 30.63, and Parts 19, 20, and 21, of this chapter 1 unless indicated otherwise in the specific provision of the general license.

1 Attention is directed particularly to the provisions of Part 20 of this chapter concerning labeling of containers.

[65 FR 79187, Dec. 18, 2000]

§ 31.3 [Reserved]

§ 31.4 Information collection requirements: OMB approval.

(a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150-0016.

(b) The approved information collection requirements contained in this part appear in §§ 31.5, 31.8, 31.11, and 31.12.

(c) This part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section. These information collection requirements and the control numbers under which they are approved are as follows:

(1) In § 31.11. NRC Form 483 is approved under control number 3150-0038.

(2) [Reserved]

[62 FR 52186, Oct. 6, 1997, as amended at 67 FR 67099, Nov. 4, 2002; 72 FR 55926, Oct. 1, 2007]

§ 31.5 Certain detecting, measuring, gauging, or controlling devices and certain devices for producing light or an ionized atmosphere. 2

2 Persons possessing byproduct material in devices under a general license in § 31.5 before January 15, 1975, may continue to possess, use, or transfer that material in accordance with the labeling requirements of § 31.5 in effect on January 14, 1975.

(a) A general license is hereby issued to commercial and industrial firms and research, educational and medical institutions, individuals in the conduct of their business, and Federal, State or local government agencies to acquire, receive, possess, use or transfer, in accordance with the provisions of paragraphs (b), (c) and (d) of this section, byproduct material contained in devices designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing light or an ionized atmosphere.

(b)(1) The general license in paragraph (a) of this section applies only to byproduct material contained in devices which have been manufactured or initially transferred and labeled in accordance with the specifications contained in—

(i) A specific license issued under § 32.51 of this chapter; or

(ii) An equivalent specific license issued by an Agreement State; or

(iii) An equivalent specific license issued by a State with provisions comparable to § 32.51 of this chapter.

(2) The devices must have been received from one of the specific licensees described in paragraph (b)(1) of this section or through a transfer made under paragraph (c)(9) of this section.

(c) Any person who acquires, receives, possesses, uses or transfers byproduct material in a device pursuant to the general license in paragraph (a) of this section:

(1) Shall assure that all labels affixed to the device at the time of receipt and bearing a statement that removal of the label is prohibited are maintained thereon and shall comply with all instructions and precautions provided by such labels;

(2) Shall assure that the device is tested for leakage of radioactive material and proper operation of the on-off mechanism and indicator, if any, at no longer than six-month intervals or at such other intervals as are specified in the label; however:

(i) Devices containing only krypton need not be tested for leakage of radioactive material, and

(ii) Devices containing only tritium or not more than 100 microcuries of other beta and/or gamma emitting material or 10 microcuries of alpha emitting material and devices held in storage in the original shipping container prior to initial installation need not be tested for any purpose;

(3) Shall assure that the tests required by paragraph (c)(2) of this section and other testing, installation, servicing, and removal from installation involving the radioactive materials, its shielding or containment, are performed:

(i) In accordance with the instructions provided by the labels; or

(ii) By a person holding a specific license pursuant to parts 30 and 32 of this chapter or from an Agreement State to perform such activities;

(4) Shall maintain records showing compliance with the requirements of paragraphs (c)(2) and (c)(3) of this section. The records must show the results of tests. The records also must show the dates of performance of, and the names of persons performing, testing, installing, servicing, and removing from the installation radioactive material and its shielding or containment. The licensee shall retain these records as follows:

(i) Each record of a test for leakage or radioactive material required by paragraph (c)(2) of this section must be retained for three years after the next required leak test is performed or until the sealed source is transferred or disposed of.

(ii) Each record of a test of the on-off mechanism and indicator required by paragraph (c)(2) of this section must be retained for three years after the next required test of the on-off mechanism and indicator is performed or until the sealed source is transferred or disposed of.

(iii) Each record that is required by paragraph (c)(3) of this section must be retained for three years from the date of the recorded event or until the device is transferred or disposed of.

(5) Shall immediately suspend operation of the device if there is a failure of, or damage to, or any indication of a possible failure of or damage to, the shielding of the radioactive material or the on-off mechanism or indicator, or upon the detection of 185 bequerel (0.005 microcurie) or more removable radioactive material. The device may not be operated until it has been repaired by the manufacturer or other person holding a specific license to repair such devices that was issued under parts 30 and 32 of this chapter or by an Agreement State. The device and any radioactive material from the device may only be disposed of by transfer to a person authorized by a specific license to receive the byproduct material in the device or as otherwise approved by the Commission. A report containing a brief description of the event and the remedial action taken; and, in the case of detection of 0.005 microcurie or more removable radioactive material or failure of or damage to a source likely to result in contamination of the premises or the environs, a plan for ensuring that the premises and environs are acceptable for unrestricted use, must be furnished to the Director, Office of Nuclear Material Safety and Safeguards, ATTN: GLTS, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 within 30 days. Under these circumstances, the criteria set out in § 20.1402 of this chapter, “Radiological criteria for unrestricted use,” may be applicable, as determined by the Commission on a case-by-case basis;

(6) Shall not abandon the device containing byproduct material;

(7) Shall not export the device containing byproduct material except in accordance with part 110 of this chapter;

(8)(i) Shall transfer or dispose of the device containing byproduct material only by export as provided by paragraph (c)(7) of this section, by transfer to another general licensee as authorized in paragraph (c)(9) of this section, or to a person authorized to receive the device by a specific license issued under parts 30 and 32 of this chapter, or part 30 of this chapter that authorizes waste collection, or equivalent regulations of an Agreement State, or as otherwise approved under paragraph (c)(8)(iii) of this section.

(ii) Shall, within 30 days after the transfer of a device to a specific licensee or export, furnish a report to the Director, Office of Nuclear Material Safety and Safeguards , ATTN: Document Control Desk/GLTS, using an appropriate method listed in § 30.6(a) of this chapter. The report must contain—

(A) The identification of the device by manufacturer's (or initial transferor's) name, model number, and serial number;

(B) The name, address, and license number of the person receiving the device (license number not applicable if exported); and

(C) The date of the transfer.

(iii) Shall obtain written NRC approval before transferring the device to any other specific licensee not specifically identified in paragraph (c)(8)(i) of this section; however, a holder of a specific license may transfer a device for possession and use under its own specific license without prior approval, if, the holder:

(A) Verifies that the specific license authorizes the possession and use, or applies for and obtains an amendment to the license authorizing the possession and use;

(B) Removes, alters, covers, or clearly and unambiguously augments the existing label (otherwise required by paragraph (c)(1) of this section) so that the device is labeled in compliance with § 20.1904 of this chapter; however the manufacturer, model number, and serial number must be retained;

(C) Obtains the manufacturer's or initial transferor's information concerning maintenance that would be applicable under the specific license (such as leak testing procedures); and

(D) Reports the transfer under paragraph (c)(8)(ii) of this section.

(9) Shall transfer the device to another general licensee only if—

(i) The device remains in use at a particular location. In this case, the transferor shall give the transferee a copy of this section, a copy of § 31.2, 30.51, 20.2201, and 20.2202 of this chapter, and any safety documents identified in the label of the device. Within 30 days of the transfer, the transferor shall report to the Director, Office of Nuclear Material Safety and Safeguards , ATTN: Document Control Desk/GLTS, using an appropriate method listed in § 30.6(a) of this chapter—

(A) The manufacturer's (or initial transferor's) name;

(B) The model number and the serial number of the device transferred;

(C) The transferee's name and mailing address for the location of use; and

(D) The name, title, and phone number of the responsible individual identified by the transferee in accordance with paragraph (c)(12) of this section to have knowledge of and authority to take actions to ensure compliance with the appropriate regulations and requirements; or

(ii) The device is held in storage by an intermediate person in the original shipping container at its intended location of use prior to initial use by a general licensee.

(10) Shall comply with the provisions of §§ 20.2201, and 20.2202 of this chapter for reporting radiation incidents, theft or loss of licensed material, but shall be exempt from the other requirements of parts 19, 20, and 21, of this chapter.

(11) Shall respond to written requests from the Nuclear Regulatory Commission to provide information relating to the general license within 30 calendar days of the date of the request, or other time specified in the request. If the general licensee cannot provide the requested information within the allotted time, it shall, within that same time period, request a longer period to supply the information by providing the Director, Office of Nuclear Material Safety and Safeguards , by an appropriate method listed in § 30.6(a) of this chapter, a written justification for the request.

(12) Shall appoint an individual responsible for having knowledge of the appropriate regulations and requirements and the authority for taking required actions to comply with appropriate regulations and requirements. The general licensee, through this individual, shall ensure the day-to-day compliance with appropriate regulations and requirements. This appointment does not relieve the general licensee of any of its responsibility in this regard.

(13)(i) Shall register, in accordance with paragraphs (c)(13)(ii) and (iii) of this section, devices containing at least 370 megabecquerels (10 millicuries) of cesium-137, 3.7 megabecquerels (0.1 millicurie) of strontium-90, 37 megabecquerels (1 millicurie) of cobalt-60, 3.7 megabecquerels (0.1 millicurie) of radium-226, or 37 megabecquerels (1 millicurie) of americium-241 or any other transuranic (i.e., element with atomic number greater than uranium (92)), based on the activity indicated on the label. Each address for a location of use, as described under paragraph (c)(13)(iii)(D) of this section, represents a separate general licensee and requires a separate registration and fee.

(ii) If in possession of a device meeting the criteria of paragraph (c)(13)(i) of this section, shall register these devices annually with the Commission and shall pay the fee required by § 170.31 of this chapter. Registration must be done by verifying, correcting, and/or adding to the information provided in a request for registration received from the Commission. The registration information must be submitted to the NRC within 30 days of the date of the request for registration or as otherwise indicated in the request. In addition, a general licensee holding devices meeting the criteria of paragraph (c)(13)(i) of this section is subject to the bankruptcy notification requirement in § 30.34(h) of this chapter.

(iii) In registering devices, the general licensee shall furnish the following information and any other information specifically requested by the Commission—

(A) Name and mailing address of the general licensee.

(B) Information about each device: the manufacturer (or initial transferor), model number, serial number, the radioisotope and activity (as indicated on the label).

(C) Name, title, and telephone number of the responsible person designated as a representative of the general licensee under paragraph (c)(12) of this section.

(D) Address or location at which the device(s) are used and/or stored. For portable devices, the address of the primary place of storage.

(E) Certification by the responsible representative of the general licensee that the information concerning the device(s) has been verified through a physical inventory and checking of label information.

(F) Certification by the responsible representative of the general licensee that they are aware of the requirements of the general license.

(iv) Persons generally licensed by an Agreement State with respect to devices meeting the criteria in paragraph (c)(13)(i) of this section are not subject to registration requirements if the devices are used in areas subject to NRC jurisdiction for a period less than 180 days in any calendar year. The Commission will not request registration information from such licensees.

(14) Shall report changes to the mailing address for the location of use (including change in name of general licensee) to the Director, Office of Nuclear Material Safety and Safeguards, ATTN: GLTS, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 within 30 days of the effective date of the change. For a portable device, a report of address change is only required for a change in the device's primary place of storage.

(15) May not hold devices that are not in use for longer than 2 years. If devices with shutters are not being used, the shutter must be locked in the closed position. The testing required by paragraph (c)(2) of this section need not be performed during the period of storage only. However, when devices are put back into service or transferred to another person, and have not been tested within the required test interval, they must be tested for leakage before use or transfer and the shutter tested before use. Devices kept in standby for future use are excluded from the two-year time limit if the general licensee performs quarterly physical inventories of these devices while they are in standby.

(d) The general license in paragraph (a) of this section does not authorize the manufacture or import of devices containing byproduct material.

[39 FR 43532, Dec. 16, 1974, as amended at 40 FR 8785, Mar. 3, 1975; 40 FR 14085, Mar. 28, 1975; 42 FR 25721, May 19, 1977; 42 FR 28896, June 6, 1977; 43 FR 6922, Feb. 17, 1978; 53 FR 19246, May 27, 1988; 56 FR 23471, May 21, 1991; 56 FR 61352, Dec. 3, 1991; 58 FR 67659, Dec. 22, 1993; 64 FR 42275, Aug. 4, 1999; 65 FR 79188, Dec. 18, 2000; 68 FR 58804, Oct. 10, 2003; 72 FR 55926, Oct. 1, 2007; 72 FR 58486, Oct. 16, 2007; 73 FR 5718, Jan. 31, 2008; 73 FR 42673, July 23, 2008]

§ 31.6 General license to install devices generally licensed in § 31.5.

Any person who holds a specific license issued by an Agreement State authorizing the holder to manufacture, install, or service a device described in § 31.5 within such Agreement State is hereby granted a general license to install and service such device in any non-Agreement State and a general license to install and service such device in offshore waters, as defined in § 150.3(f) of this chapter: Provided, That:

(a) [Reserved]

(b) The device has been manufactured, labeled, installed, and serviced in accordance with applicable provisions of the specific license issued to such person by the Agreement State.

(c) Such person assures that any labels required to be affixed to the device under regulations of the Agreement State which licensed manufacture of the device bear a statement that removal of the label is prohibited.

[30 FR 8189, June 26, 1965, as amended at 30 FR 10947, Aug. 24, 1965; 39 FR 43533, Dec. 16, 1974; 46 FR 44151, Sept. 3, 1981]

§ 31.7 Luminous safety devices for use in aircraft.

(a) A general license is hereby issued to own, receive, acquire, possess, and use tritium or promethium-147 contained in luminous safety devices for use in aircraft, provided each device contains not more than 10 curies of tritium or 300 millicuries of promethium-147 and that each device has been manufactured, assembled or initially transferred in accordance with a license issued under the provisions of § 32.53 of this chapter or manufactured or assembled in accordance with a specific license issued by an Agreement State which authorizes manufacture or assembly of the device for distribution to persons generally licensed by the Agreement State.

(b) Persons who own, receive, acquire, possess or use luminous safety devices pursuant to the general license in this section are exempt from the requirements of parts 19, 20, and 21, of this chapter, except that they shall comply with the provisions of §§ 20.2201, and 20.2202 of this chapter.

(c) This general license does not authorize the manufacture, assembly, repair or import of luminous safety devices containing tritium or promethium-147.

(d) This general license does not authorize the export of luminous safety devices containing tritium or promethium-147.

(e) This general license does not authorize the ownership, receipt, acquisition, possession or use of promethium-147 contained in instrument dials.

[30 FR 8189, June 26, 1965, as amended at 33 FR 6463, Apr. 27, 1968; 38 FR 22220, Aug. 17, 1973; 42 FR 28896, June 6, 1977; 43 FR 6922, Feb. 17, 1978; 56 FR 23471, May 21, 1991; 56 FR 61352, Dec. 3, 1991; 58 FR 67659, Dec. 22, 1993]

§ 31.8 Americium-241 and radium-226 in the form of calibration or reference sources.

(a) A general license is issued to those persons listed in this section to own, receive, acquire, possess, use, and transfer, in accordance with the provisions of paragraphs (b) and (c) of this section, americium-241 or radium-226 in the form of calibration or reference sources:

(1) Any person in a non-Agreement State who holds a specific license issued under this chapter which authorizes receipt, possession, use, and transfer of byproduct material, source material, or special nuclear material; and

(2) Any Government agency, as defined in § 30.4 of this chapter, which holds a specific license issued under this chapter which authorizes it to receive, possess, use, and transfer byproduct material, source material, or special nuclear material.

(b) The general license in paragraph (a) of this section applies only to calibration or reference sources which have been manufactured or initially transferred in accordance with the specifications contained in a specific license issued under § 32.57 of this chapter or in accordance with the specifications contained in a specific license issued to the manufacturer by an Agreement State which authorizes manufacture of the sources for distribution to persons generally licensed by the Agreement State, or in accordance with a specific license issued by a State with comparable provisions to § 32.57.

(c) The general license in paragraph (a) of this section is subject to the provisions of §§ 30.14(d), 30.34 (a) to (e), and 30.50 to 30.63 of this chapter, and to the provisions of parts 19, 20, and 21, of this chapter. In addition, persons who own, receive, acquire, possess, use, and transfer one or more calibration or reference sources under this general license:

(1) Shall not possess at any one time, at any one location of storage or use, more than 0.185 megabecquerel (5 microcuries) of americium-241 or 0.185 megabecquerel (5 microcuries) of radium-226 in such sources;

(2) Shall not receive, possess, use, or transfer a source unless the source, or the storage container, bears a label which includes the following statement or a substantially similar statement which contains the information called for in the following statement: 1

1 Sources generally licensed under this section before January 19, 1975, may bear labels authorized by the regulations in effect on January 1, 1975. Sources containing radium-226 generally licensed under this section and manufactured before November 30, 2007 shall be labeled in accordance with the applicable State regulations at the time of manufacture or import.

The receipt, possession, use, and transfer of this source, Model XX, Serial No. XX, are subject to a general license and the regulations of the United States Nuclear Regulatory Commission or of a State with which the Commission has entered into an agreement for the exercise of regulatory authority. Do not remove this label.

CAUTION—RADIOACTIVE MATERIAL—THIS SOURCE CONTAINS AMERICIUM-241 [or RADIUM-226, as appropriate]. DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE. (Name of manufacturer or initial transferor)

(3) Shall not transfer, abandon, or dispose of a source except by transfer to a person authorized by a license issued under this chapter or by an Agreement State to receive the source.

(4) Shall store a source, except when the source is being used, in a closed container adequately designed and constructed to contain americium-241 or radium-226 which might otherwise escape during storage.

(5) Shall not use a source for any purpose other than the calibration of radiation detectors or the standardization of other sources.

(d) This general license does not authorize the manufacture or import of calibration or reference sources containing americium-241 or radium-226.

(e) This general license does not authorize the export of calibration or reference sources containing americium-241 or radium-226.

[72 FR 55927, Oct. 1, 2007]

§ 31.9 General license to own byproduct material.

A general license is hereby issued to own byproduct material without regard to quantity. Notwithstanding any other provision of this chapter, a general licensee under this paragraph is not authorized to manufacture, produce, transfer, receive, possess, use, import or export byproduct material, except as authorized in a specific license.

[30 FR 8189, June 26, 1965]

§ 31.10 General license for strontium 90 in ice detection devices.

(a) A general license is hereby issued to own, receive, acquire, possess, use, and transfer strontium 90 contained in ice detection devices, provided each device contains not more than fifty microcuries of strontium 90 and each device has been manufactured or initially transferred in accordance with the specifications contained in a license issued pursuant to § 32.61 of this chapter or in accordance with the specifications contained in a specific license issued to the manufacturer by an Agreement State which authorizes manufacture of the ice detection devices for distribution to persons generally licensed by the Agreement State.

(b) Persons who own, receive, acquire, possess, use, or transfer strontium 90 contained in ice detection devices pursuant to the general license in paragraph (a) of this section:

(1) Shall, upon occurrence of visually observable damage, such as a bend or crack or discoloration from overheating, to the device, discontinue use of the device until it has been inspected, tested for leakage and repaired by a person holding a specific license pursuant to part 30 or 32 of this chapter or from an Agreement State to manufacture or service such devices; or shall dispose of the device pursuant to the provisions of § 20.2001.

(2) Shall assure that all labels affixed to the device at the time of receipt, and which bear a statement which prohibits removal of the labels, are maintained thereon;

(3) Are exempt from the requirements of parts 19, 20, and 21, of this chapter except that such persons shall comply with the provisions of §§ 20.2001, 20.2201, and 20.2202 of this chapter.

(c) The general license does not authorize the manufacture, assembly, disassembly, repair, or import of strontium 90 in ice detection devices.

[30 FR 9905, Aug. 10, 1965, as amended at 38 FR 22220, Aug. 17, 1973; 40 FR 8785, Mar. 3, 1975; 42 FR 28896, June 6, 1977; 43 FR 6922, Feb. 17, 1978; 56 FR 23471, May 21, 1991; 56 FR 61352, Dec. 3, 1991; 58 FR 67659, Dec. 22, 1993]

§ 31.11 General license for use of byproduct material for certain in vitro clinical or laboratory testing.

(a) A general license is hereby issued to any physician, veterinarian in the practice of veterinary medicine, clinical laboratory or hospital to receive, acquire, possess, transfer, or use, for any of the following stated tests, in accordance with the provisions of paragraphs (b), (c), (d), (e), and (f) of this section, the following byproduct materials in prepackaged units:

(1) Iodine-125, in units not exceeding 10 microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of byproduct material, or the radiation therefrom, to human beings or animals.

(2) Iodine-131, in units not exceeding 10 microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of byproduct material, or the radiation therefrom, to human beings or animals.

(3) Carbon-14, in units not exceeding 10 microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of byproduct material, or the radiation therefrom, to human beings or animals.

(4) Hydrogen-3 (tritium), in units not exceeding 50 microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of byproduct material, or the radiation therefrom, to human beings or animals.

(5) Iron-59, in units not exceeding 20 microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of byproduct material, or the radiation therefrom, to human beings, or animals.

(6) Selenium-75, in units not exceeding 10 microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of byproduct material, or the radiation therefrom, to human beings or animals.

(7) Mock Iodine-125 reference or calibration sources, in units not exceeding 0.05 microcurie of iodine-129 and 0.005 microcurie of americium-241 each for use in in vitro clinical or laboratory tests not involving internal or external administration of byproduct material, or the radiation therefrom, to human beings or animals.

(8) Cobalt-57, in units not exceeding 0.37 megabecquerel (10 microcuries) each for use in in vitro clinical or laboratory tests not involving internal or external administration of byproduct material, or the radiation therefrom, to human beings or animals.

(b) A person shall not receive, acquire, possess, use, or transfer byproduct material under the general license established by paragraph (a) of this section unless that person:

(1) Has filed NRC Form 483, “Registration Certificate—In Vitro Testing with Byproduct Material Under General License,” with the Director, Office of Nuclear Material Safety and Safeguards , by an appropriate method listed in § 30.6(a) of this chapter, and has received from the Commission a validated copy of NRC Form 483 with a registration number assigned; or

(2) Has a license that authorizes the medical use of byproduct material that was issued under part 35 of this chapter.

(c) A person who receives, acquires, possesses, or uses byproduct material pursuant to the general license established by paragraph (a) of this section shall comply with the following:

(1) The general licensee shall not possess at any one time, under the general license in paragraph (a) of this section, at any one location of storage or use, a total amount of iodine-125, iodine-131, selenium-75, cobalt-57 and/or iron-59 in excess of 7.4 megabecquerels (200 microcuries).

(2) The general licensee shall store the byproduct material, until used, in the original shipping container or in a container providing equivalent radiation protection.

(3) The general licensee shall use the byproduct material only for the uses authorized by paragraph (a) of this section.

(4) The general licensee shall not transfer the byproduct material except by transfer to a person authorized to receive it by a license pursuant to this chapter or from an Agreement State, nor transfer the byproduct material in any manner other than in the unopened, labeled shipping container as received from the supplier.

(5) The general licensee shall dispose of the Mock Iodine-125 reference or calibration sources described in paragraph (a)(7) of this section as required by § 20.2001.

(d) The general licensee shall not receive, acquire, possess, or use byproduct material pursuant to paragraph (a) of this section:

(1) Except as prepackaged units which are labeled in accordance with the provisions of a specific license issued under the provisions of § 32.71 of this chapter or in accordance with the provisions of a specific license issued by an Agreement State, or before November 30, 2007, and the provisions of a specific license issued by a State with comparable provisions to § 32.71 that authorize manufacture and distribution of iodine-125, iodine-131, carbon-14, hydrogen-3 (tritium), selenium-75, iron-59, cobalt-57, or Mock Iodine-125 for distribution to persons generally licensed by the Agreement State or the State with comparable provisions to § 32.71.

(2) Unless the following statement, or a substantially similar statement which contains the information called for in the following statement, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package: 1

1 Labels authorized by the regulations in effect on September 26, 1979, may be used until one year from September 27, 1979.

This radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians in the practice of veterinary medicine, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of the U.S. Nuclear Regulatory Commission or of a State with which the Commission has entered into an agreement for the exercise of regulatory authority.

(Name of Manufacturer)

(e) The registrant possessing or using byproduct materials under the general license of paragraph (a) of this section shall report in writing to the Director, Office of Nuclear Material Safety and Safeguards , any changes in the information furnished by him in the ”Registration Certificate—In Vitro Testing With Byproduct Material Under General License.” Form NRC-483. The report shall be furnished within 30 days after the effective date of such change.

(f) Any person using byproduct material pursuant to the general license of paragraph (a) of this section is exempt from the requirements of parts 19, 20, and 21, of this chapter with respect to byproduct materials covered by that general license, except that such persons using the Mock Iodine-125 described in paragraph (a)(7) of this section shall comply with the provisions of §§ 20.2001, 20.2201, and 20.2202.

[33 FR 16553, Nov. 14, 1968]

Editorial Note:For Federal Register citations affecting § 31.11, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

§ 31.12 General license for certain items and self-luminous products containing radium-226.

(a) A general license is hereby issued to any person to acquire, receive, possess, use, or transfer, in accordance with the provisions of paragraphs (b), (c), and (d) of this section, radium-226 contained in the following products manufactured prior to November 30, 2007.

(1) Antiquities originally intended for use by the general public. For the purposes of this paragraph, antiquities mean products originally intended for use by the general public and distributed in the late 19th and early 20th centuries, such as radium emanator jars, revigators, radium water jars, radon generators, refrigerator cards, radium bath salts, and healing pads.

(2) Intact timepieces containing greater than 0.037 megabecquerel (1 microcurie), nonintact timepieces, and timepiece hands and dials no longer installed in timepieces.

(3) Luminous items installed in air, marine, or land vehicles.

(4) All other luminous products, provided that no more than 100 items are used or stored at the same location at any one time.

(5) Small radium sources containing no more than 0.037 megabecquerel (1 microcurie) of radium-226. For the purposes of this paragraph, “small radium sources” means discrete survey instrument check sources, sources contained in radiation measuring instruments, sources used in educational demonstrations (such as cloud chambers and spinthariscopes), electron tubes, lightning rods, ionization sources, static eliminators, or as designated by the NRC.

(b) Persons who acquire, receive, possess, use, or transfer byproduct material under the general license issued in paragraph (a) of this section are exempt from the provisions of 10 CFR parts 19, 20, and 21, and § 30.50 and 30.51 of this chapter, to the extent that the receipt, possession, use, or transfer of byproduct material is within the terms of the general license; provided, however, that this exemption shall not be deemed to apply to any such person specifically licensed under this chapter.

(c) Any person who acquires, receives, possesses, uses, or transfers byproduct material in accordance with the general license in paragraph (a) of this section:

(1) Shall notify the NRC should there be any indication of possible damage to the product so that it appears it could result in a loss of the radioactive material. A report containing a brief description of the event, and the remedial action taken, must be furnished to the Director of the Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 within 30 days.

(2) Shall not abandon products containing radium-226. The product, and any radioactive material from the product, may only be disposed of according to § 20.2008 of this chapter or by transfer to a person authorized by a specific license to receive the radium-226 in the product or as otherwise approved by the NRC.

(3) Shall not export products containing radium-226 except in accordance with part 110 of this chapter.

(4) Shall dispose of products containing radium-226 at a disposal facility authorized to dispose of radioactive material in accordance with any Federal or State solid or hazardous waste law, including the Solid Waste Disposal Act, as authorized under the Energy Policy Act of 2005, by transfer to a person authorized to receive radium-226 by a specific license issued under part 30 of this chapter, or equivalent regulations of an Agreement State, or as otherwise approved by the NRC.

(5) Shall respond to written requests from the NRC to provide information relating to the general license within 30 calendar days of the date of the request, or other time specified in the request. If the general licensee cannot provide the requested information within the allotted time, it shall, within that same time period, request a longer period to supply the information by providing the Director of the Office of Nuclear Material Safety and Safeguards, by an appropriate method listed in § 30.6(a) of this chapter, a written justification for the request.

(d) The general license in paragraph (a) of this section does not authorize the manufacture, assembly, disassembly, repair, or import of products containing radium-226, except that timepieces may be disassembled and repaired.

[72 FR 55927, Oct. 1, 2007]

§§ 31.13-31.20 [Reserved]

§ 31.21 Maintenance of records.

Each record required by this part must be legible throughout the retention period specified by each Commission regulation. The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, specifications, must include all pertinent information such as letters, stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records. This section shall cease to have effect on January 8, 2027, unless the NRC determines that the cessation deadline should be extended to a date not more than 5 years in the future after offering the public an opportunity to provide input on the costs and benefits of this section and considering that input. The NRC will publish a document in the Federal Register announcing its determination and revising or removing this section accordingly.

[53 FR 19246, May 27, 1988. Redesignated at 72 FR 55927, Oct. 1, 2007, as amended at 90 FR 55628, Dec. 3, 2025]

§ 31.22 Violations.

(a) The Commission may obtain an injunction or other court order to prevent a violation of the provisions of—

(1) The Atomic Energy Act of 1954, as amended;

(2) Title II of the Energy Reorganization Act of 1974, as amended; or

(3) A regulation or order issued pursuant to those Acts.

(b) The Commission may obtain a court order for the payment of a civil penalty imposed under section 234 of the Atomic Energy Act:

(1) For violations of—

(i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Atomic Energy Act of 1954, as amended;

(ii) Section 206 of the Energy Reorganization Act;

(iii) Any rule, regulation, or order issued pursuant to the sections specified in paragraph (b)(1)(i) of this section;

(iv) Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(i) of this section.

(2) For any violation for which a license may be revoked under section 186 of the Atomic Energy Act of 1954, as amended.

[57 FR 55072, Nov. 24, 1992. Redesignated at 72 FR 55927, Oct. 1, 2007]

§ 31.23 Criminal penalties.

(a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all the regulations in part 31 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section.

(b) The regulations in part 31 that are not issued under sections 161b, 161i, or 161o for the purposes of section 223 are as follows: §§ 31.1, 31.2, 31.4, 31.9, 31.22, and 31.23.

[57 FR 55073, Nov. 24, 1992. Redesignated at 72 FR 55927, Oct. 1, 2007, and amended at 77 FR 43690, July 25, 2012]

§ 32.1 Purpose and scope.

(a)(1) This part prescribes requirements for the issuance of specific licenses to persons who manufacture or initially transfer items containing byproduct material for sale or distribution to:

(i) Persons exempted from the licensing requirements of part 30 of this chapter, or equivalent regulations of an Agreement State, or

(ii) Persons generally licensed under part 31 of this chapter or equivalent regulations of an Agreement State.

(iii) Persons licensed under part 35 of this chapter.

(2) This part prescribes requirements for the issuance of specific licenses to persons who introduce byproduct material into a product or material owned by or in the possession of a licensee or another, and regulations governing holders of such licenses.

(3) This part prescribes certain requirements governing holders of licenses to manufacture or distribute items containing byproduct material.

(4) This part describes procedures and prescribes requirements for the issuance of certificates of registration (covering radiation safety information about a product) to manufacturers or initial transferors of sealed sources or devices containing sealed sources.

(b) The provisions and requirements of this part are in addition to, and not in substitution for, other requirements of this chapter. In particular, the provisions of part 30 of this chapter apply to applications, licenses and certificates of registration subject to this part, and the provisions of part 37 of this chapter apply to applications and licenses subject to this part.

(c)(1) The requirements in this part, including provisions that are specific to licensees, shall apply to Government agencies and Federally recognized Indian Tribes with respect to accelerator-produced radioactive material or discrete sources of radium-226 on November 30, 2007 except that the agency or Tribe may continue to manufacture or initially transfer items containing accelerator-produced radioactive material or discrete sources of radium-226 for sale or distribution to persons exempted from the licensing requirements of part 30 of this chapter, and to persons generally licensed under part 31 of this chapter, and radioactive drugs and sources and devices to medical use licensees, until the date of the NRC's final licensing determination, provided that the agency or Tribe submits a new license application for these activities on or before December 1, 2008 or an amendment application for these activities on or before June 2, 2008.

(2) The requirements in this part, including provisions that are specific to licensees, shall apply to all persons other than those included in paragraph (c)(1) of this section with respect to accelerator-produced radioactive material or discrete sources of radium-226 on August 8, 2009, or earlier as noticed by the NRC, except that these persons may continue to manufacture or initially transfer items containing accelerator-produced radioactive material or discrete sources of radium-226 for sale or distribution to persons exempted from the licensing requirements of part 30 of this chapter, and to persons generally licensed under part 31 of this chapter, and to sell or manufacture radioactive drugs and sources and devices to medical use licensees until the date of the NRC's final licensing determination, provided that the person submits a license application within 12 months from the waiver expiration date of August 7, 2009 or within 12 months from the date of an earlier termination of the waiver as noticed by the NRC, whichever is earlier; or that the person submits an amendment request within 6 months from the waiver expiration date of August 7, 2009 or within 6 months from the date of an earlier termination of the waiver as noticed by the NRC, whichever date is earlier.

[30 FR 8192, June 26, 1965, as amended at 52 FR 27786, July 24, 1987; 63 FR 1896, Jan. 13, 1998; 72 FR 55928, Oct. 1, 2007; 77 FR 43690, July 25, 2012; 78 FR 17006, Mar. 19, 2013; 80 FR 74979, Dec. 1, 2015]

§ 32.2 Definitions.

As used in this part:

Committed dose for the purposes of this part means the radiation dose that will accumulate over time as a result of retention in the body of radioactive material. Committed dose is a generic term for internal dose and must be calculated by summing the projected dose over the 50 years after intake for all irradiated organs or tissues multiplying the doses to individual organs and tissues by applicable tissue weighting factors.

Dose commitment means the total radiation dose to a part of the body that will result from retention in the body of radioactive material. For purposes of estimating the dose commitment, it is assumed that from the time of intake the period of exposure to retained material will not exceed 50 years.

Lot Tolerance Percent Defective means, expressed in percent defective, the poorest quality in an individual inspection lot that should be accepted.

Nationally tracked source is a sealed source containing a quantity equal to or greater than Category 1 or Category 2 levels of any radioactive material listed in Appendix E to part 20 of this Chapter. In this context a sealed source is defined as radioactive material that is sealed in a capsule or closely bonded, in a solid form and which is not exempt from regulatory control. It does not mean material encapsulated solely for disposal, or nuclear material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. Category 1 nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the Category 1 threshold. Category 2 nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the Category 2 threshold but less than the Category 1 threshold.

Sealed Source and Device Registry means the national registry that contains all the registration certificates, generated by both the NRC and the Agreement States, that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product.

[34 FR 6653, Apr. 18, 1969, as amended at 39 FR 22129, June 20, 1974; 71 FR 65708, Nov. 8, 2006; 77 FR 43690, July 25, 2012]

§ 32.3 Maintenance of records.

Each record required by this part must be legible throughout the retention period specified by each Commission regulation. The record may be the original or a reproduced copy of a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records. This section shall cease to have effect on January 8, 2027, unless the NRC determines that the cessation deadline should be extended to a date not more than 5 years in the future after offering the public an opportunity to provide input on the costs and benefits of this section and considering that input. The NRC will publish a document in the Federal Register announcing its determination and revising or removing this section accordingly.

[53 FR 19246, May 27, 1988, as amended at 90 FR 55629, Dec. 3, 2025]

§ 32.8 Information collection requirements: OMB approval.

(a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150-0001.

(b) The approved information collection requirements contained in this part appear in §§ 32.11, 32.12, 32.14, 32.15, 32.16, 32.18, 32.19, 32.20, 32.21, 32.21a, 32.22, 32.23, 32.25, 32.26, 32.27, 32.29, 32.30, 32.31, 32.32, 32.51, 32.51a, 32.52, 32.53, 32.54, 32.55, 32.56, 32.57, 32.58, 32.61, 32.62, 32.71, 32.72, 32.74, 32.201, 32.210, and 32.211.

(c) This part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section. These information collection requirements and the control numbers under which they are approved are as follows:

(1) In § 32.11, NRC Form 313 is approved under control number 3150-0120.

(2) [Reserved]

[49 FR 19625, May 9, 1984, as amended at 59 FR 61780, Dec. 2, 1994; 62 FR 52186, Oct. 6, 1997; 62 FR 63640, Dec. 2, 1997; 71 FR 65708, Nov. 8, 2006; 72 FR 58486, Oct. 16, 2007; 77 FR 43691, July 25, 2012]

§ 32.11 Introduction of byproduct material in exempt concentrations into products or materials, and transfer of ownership or possession: Requirements for license.

An application for a specific license on Form NRC-313 authorizing the introduction of byproduct material into a product or material owned by or in the possession of the licensee or another and the transfer of ownership or possession of the product or material containing the byproduct material will be approved if the applicant:

(a) Satisfies the general requirements specified in § 30.33 of this chapter; provided, however, that the requirements of § 30.33(a)(2) and (3) do not apply to an application for a license to introduce byproduct material into a product or material owned by or in the possession of the licensee or another and the transfer of ownership or possession of the product or material containing the byproduct material, if the possession and use of the byproduct material to be introduced is authorized by a license issued by an Agreement State;

(b) Provides a description of the product or material into which the byproduct material will be introduced, intended use of the byproduct material and the product or material into which it is introduced, method of introduction, initial concentration of the byproduct material in the product or material, control methods to assure that no more than the specified concentration is introduced into the product or material, estimated time interval between introduction and transfer of the product or material, and estimated concentration of the radioisotopes in the product or material at the time of transfer; and

(c) Provides reasonable assurance that the concentrations of byproduct material at the time of transfer will not exceed the concentrations in § 30.70 of this chapter, that reconcentration of the byproduct material in concentrations exceeding those in § 30.70 is not likely, that use of lower concentrations is not feasible, and that the product or material is not likely to be incorporated in any food, beverage, cosmetic, drug or other commodity or product designed for ingestion or inhalation by, or application to, a human being.

[30 FR 8192, June 26, 1965, as amended at 49 FR 19625, May 9, 1984; 72 FR 58487, Oct. 16, 2007]

§ 32.12 Same: Records and material transfer reports.

(a) Each person licensed under § 32.11 shall maintain records of transfer of byproduct material and file a report with the Director of the Office of Nuclear Material Safety and Safeguards by an appropriate method listed in § 30.6(a) of this chapter, including in the address: ATTN: Document Control Desk/Exempt Distribution.

(1) The report must clearly identify the specific licensee submitting the report and include the license number of the specific licensee.

(2) The report must indicate that the byproduct material is transferred for use under § 30.14 of this chapter or equivalent regulations of an Agreement State.

(b) The report must identify the:

(1) Type and quantity of each product or material into which byproduct material has been introduced during the reporting period;

(2) Name and address of the person who owned or possessed the product or material, into which byproduct material has been introduced, at the time of introduction;

(3) The type and quantity of radionuclide introduced into each product or material; and

(4) The initial concentrations of the radionuclide in the product or material at time of transfer of the byproduct material by the licensee.

(c)(1) The licensee shall file the report, covering the preceding calendar year, on or before January 31 of each year. In its first report after December 17, 2007, the licensee shall separately include data for transfers in prior years not previously reported to the Commission or to an Agreement State.

(2) Licensees who permanently discontinue activities authorized by the license issued under § 32.11 shall file a report for the current calendar year within 30 days after ceasing distribution.

(d) If no transfers of byproduct material have been made under § 32.11 during the reporting period, the report must so indicate.

(e) The licensee shall maintain the record of a transfer for one year after the transfer is included in a report to the Commission.

[72 FR 58487, Oct. 16, 2007, as amended at 73 FR 5719, Jan. 31, 2008; 73 FR 42673, July 23, 2008]

§ 32.13 Same: Prohibition of introduction.

No person may introduce byproduct material into a product or material knowing or having reason to believe that it will be transferred to persons exempt under § 30.14 of this chapter or equivalent regulations of an Agreement State, except in accordance with a license issued under § 32.11.

[72 FR 58487, Oct. 16, 2007]

§ 32.14 Certain items containing byproduct material; requirements for license to apply or initially transfer.

An application for a specific license to apply byproduct material to, or to incorporate byproduct material into, the products specified in § 30.15 of this chapter or to initially transfer for sale or distribution such products containing byproduct material for use pursuant to § 30.15 of this chapter will be approved if:

(a) The applicant satisfies the general requirements specified in § 30.33 of this chapter;

(b) The applicant submits sufficient information regarding the product pertinent to evaluation of the potential radiation exposure, including:

(1) Chemical and physical form and maximum quantity of byproduct material in each product;

(2) Details of construction and design of each product;

(3) The method of containment or binding of the byproduct material in the product;

(4) Except for electron tubes and ionization chamber smoke detectors and timepieces containing promethium-147 or tritium in the form of gaseous tritium light sources, procedures for and results of prototype testing to demonstrate that the byproduct material will not become detached from the product and that the byproduct material will not be released to the environment under the most severe conditions likely to be encountered in normal use of the product;

(5) In the case of ionizing radiation measuring instruments and timepieces containing tritium in the form of paint, quality control procedures to be followed in the fabrication of production lots of the product and the quality control standards the product will be required to meet;

(6) The proposed method of labeling or marking each unit, except timepieces or hands or dials containing tritium or promethium-147, and its container with the identification of the manufacturer or initial transferor of the product and the byproduct material in the product;

(7) For products for which limits on levels of radiation are specified in § 30.15 of this chapter, the radiation level and the method of measurement;

(8) Any additional information, including experimental studies and tests, required by the Commission to facilitate a determination of the safety of the product.

(c) Each product will contain no more than the quantity of byproduct material specified for that product in § 30.15 of this chapter. The levels of radiation from each product containing byproduct material will not exceed the limits specified for that product in § 30.15 of this chapter.

(d) The Commission determines that the byproduct material is properly contained in the product under the most severe conditions that are likely to be encountered in normal use and handling.

[31 FR 5316, Apr. 2, 1966, as amended at 34 FR 6652, Apr. 18, 1969; 43 FR 6922, Feb. 17, 1978; 63 FR 32971, June 17, 1998; 72 FR 58487, Oct. 16, 2007; 77 FR 43691, July 25, 2012]

§ 32.15 Same: Quality assurance, prohibition of transfer, and labeling.

(a) Each person licensed under § 32.14 for products for which quality control procedures are required shall:

(1) Maintain quality assurance systems in the manufacture of the part or product, or the installation of the part into the product, in a manner sufficient to provide reasonable assurance that the safety-related components of the distributed products are capable of performing their intended functions;

(2) Subject inspection lots to acceptance sampling procedures, by procedures specified in the license issued under § 32.14, to provide at least 95 percent confidence that the Lot Tolerance Percent Defective of 5.0 percent will not be exceeded; and

(3) Visually inspect each unit in inspection lots. Any unit which has an observable physical defect that could adversely affect containment of the byproduct material must be considered a defective unit.

(b) No person licensed under § 32.14 shall transfer to other persons for use under § 30.15 of this chapter or equivalent regulations of an Agreement State:

(1) Any part or product tested and found defective under the criteria and procedures specified in the license issued under § 32.14, unless the defective part or product has been repaired or reworked, retested, and found by an independent inspector to meet the applicable acceptance criteria; or

(2) Any part or product contained within any lot that has been sampled and rejected as a result of the procedures in paragraph (a)(2) of this section, unless:

(i) A procedure for defining sub-lot size, independence, and additional testing procedures is contained in the license issued under § 32.14; and

(ii) Each individual sub-lot is sampled, tested, and accepted in accordance with the procedures specified in paragraphs (a)(2) and (b)(2)(i) of this section and any other criteria that may be required as a condition of the license issued under § 32.14.

(c) [Reserved]

(d) Each person licensed under § 32.14 for products for which quality control procedures are required shall:

(1) Label or mark each unit, except timepieces or hands or dials containing tritium or promethium-147, and its container so that the manufacturer or initial transferor of the product and the byproduct material in the product can be identified.

(2) For ionization chamber smoke detectors, label or mark each detector and its point-of-sale package so that:

(i) Each detector has a durable, legible, readily visible label or marking on the external surface of the detector containing:

(A) The following statement: “CONTAINS RADIOACTIVE MATERIAL”;

(B) The name of the radionuclide (“americium-241” or “Am-241”) and the quantity of activity; and

(C) An identification of the person licensed under § 32.14 to transfer the detector for use under § 30.15(a)(7) of this chapter or equivalent regulations of an Agreement State.

(ii) The labeling or marking specified in paragraph (d)(2)(i) of this section is located where it will be readily visible when the detector is removed from its mounting.

(iii) The external surface of the point-of-sale package has a legible, readily visible label or marking containing:

(A) The name of the radionuclide and quantity of activity;

(B) An identification of the person licensed under § 32.14 to transfer the detector for use under § 30.15(a)(7) or equivalent regulations of an Agreement State; and

(C) The following or a substantially similar statement: “THIS DETECTOR CONTAINS RADIOACTIVE MATERIAL. THE PURCHASER IS EXEMPT FROM ANY REGULATORY REQUIREMENTS.”

(iv) Each detector and point-of-sale package is provided with such other information as may be required by the Commission.

[31 FR 5317, Apr. 2, 1966, as amended at 34 FR 6652, Apr. 18, 1969; 39 FR 22129, June 20, 1974; 43 FR 6922, Feb. 17, 1978; 72 FR 58487, Oct. 16, 2007; 73 FR 42673, July 23, 2008; 77 FR 43691, July 25, 2012; 86 FR 43402, Aug. 9, 2021]

§ 32.16 Certain items containing byproduct material: Records and reports of transfer.

(a) Each person licensed under § 32.14 shall maintain records of all transfers of byproduct material and file a report with the Director of the Office of Nuclear Material Safety and Safeguards by an appropriate method listed in § 30.6(a) of this chapter, including in the address: ATTN: Document Control Desk/Exempt Distribution.

(1) The report must clearly identify the specific licensee submitting the report and include the license number of the specific licensee.

(2) The report must indicate that the products are transferred for use under § 30.15 of this chapter, giving the specific paragraph designation, or equivalent regulations of an Agreement State.

(b) The report must include the following information on products transferred to other persons for use under § 30.15 or equivalent regulations of an Agreement State:

(1) A description or identification of the type of each product and the model number(s), if applicable;

(2) For each radionuclide in each type of product and each model number, if applicable, the total quantity of the radionuclide; and

(3) The number of units of each type of product transferred during the reporting period by model number, if applicable.

(c)(1) The licensee shall file the report, covering the preceding calendar year, on or before January 31 of each year. In its first report after December 17, 2007, the licensee shall separately include data for transfers in prior years not previously reported to the Commission.

(2) Licensees who permanently discontinue activities authorized by the license issued under § 32.14 shall file a report for the current calendar year within 30 days after ceasing distribution.

(d) If no transfers of byproduct material have been made under § 32.14 during the reporting period, the report must so indicate.

(e) The licensee shall maintain the record of a transfer for one year after the transfer is included in a report to the Commission.

[72 FR 58487, Oct. 16, 2007, as amended at 73 FR 5719, Jan. 31, 2008; 73 FR 42673, July 23, 2008]

§ 32.18 Manufacture, distribution and transfer of exempt quantities of byproduct material: Requirements for license.

An application for a specific license to manufacture, process, produce, package, repackage, or transfer quantities of byproduct material for commercial distribution to persons exempt pursuant to § 30.18 of this chapter or the equivalent regulations of an Agreement State will be approved if:

(a) The applicant satisfies the general requirements specified in § 30.33 of this chapter: Provided, however, That the requirements of § 30.33(a) (2) and (3) of this chapter do not apply to an application for a license to transfer byproduct material manufactured, processed, produced, packaged, or repackaged pursuant to a license issued by an Agreement State;

(b) The byproduct material is not contained in any food, beverage, cosmetic, drug, or other commodity designed for ingestion or inhalation by, or application to, a human being;

(c) The byproduct material is in the form of processed chemical elements, compounds, or mixtures, tissue samples, bioassay samples, counting standards, plated or encapsulated sources, or similar substances, identified as radioactive and to be used for its radioactive properties, but is not incorporated into any manufactured or assembled commodity, product, or device intended for commercial distribution; and

(d) The applicant submits copies of prototype labels and brochures and the Commission approves such labels and brochures.

[35 FR 6428, Apr. 22, 1970, as amended at 43 FR 6922, Feb. 17, 1978]

§ 32.19 Same: Conditions of licenses.

Each license issued under § 32.18 is subject to the following conditions:

(a) No more than 10 exempt quantities set forth in § 30.71, Schedule B of this chapter shall be sold or transferred in any single transaction. For purposes of this requirement, an individual exempt quantity may be composed of fractional parts of one or more of the exempt quantities in § 30.71, Schedule B of this chapter, provided that the sum of such fractions shall not exceed unity.

(b) Each quantity of byproduct material set forth in § 30.71, Schedule B of this chapter shall be separately and individually packaged. No more than 10 such packaged exempt quantities shall be contained in any outer package for transfer to persons exempt pursuant to § 30.18 of this chapter. The outer package shall be such that the dose rate at the external surface of the package does not exceed 0.5 millirem per hour.

(c) The immediate container of each quantity or separately packaged fractional quantity of byproduct material shall bear a durable, legible label which (1) identifies the radioisotope and the quantity of radioactivity, and (2) bears the words “Radioactive Material.”

(d) In addition to the labeling information required by paragraph (c) of this section, the label affixed to the immediate container, or an accompanying brochure, shall also (1) state that the contents are exempt from NRC or Agreement State licensing requirements; (2) bear the words “Radioactive Material—Not for Human Use—Introduction Into Foods, Beverages, Cosmetics, Drugs, or Medicinals, or Into Products Manufactured for Commercial Distribution is Prohibited—Exempt Quantities Should Not be Combined”; and (3) set forth appropriate additional radiation safety precautions and instructions relating to the handling, use, storage, and disposal of the radioactive material.

[35 FR 6428, Apr. 22, 1970]

§ 32.20 Same: Records and material transfer reports.

(a) Each person licensed under § 32.18 shall maintain records of transfer of material identifying, by name and address, each person to whom byproduct material is transferred for use under § 30.18 of this chapter or the equivalent regulations of an Agreement State and stating the kinds, quantities, and physical form of byproduct material transferred.

(b) The licensee shall file a summary report with the Director of the Office of Nuclear Material Safety and Safeguards by an appropriate method listed in § 30.6(a) of this chapter, including in the address: ATTN: Document Control Desk/Exempt Distribution.

(1) The report must clearly identify the specific licensee submitting the report and include the license number of the specific licensee.

(2) The report must indicate that the materials are transferred for use under § 30.18 or equivalent regulations of an Agreement State.

(c) For each radionuclide in each physical form, the report shall indicate the total quantity of each radionuclide and the physical form, transferred under the specific license.

(d)(1) The licensee shall file the report, covering the preceding calendar year, on or before January 31 of each year. In its first report after December 17, 2007, the licensee shall separately include the total quantity of each radionuclide transferred for transfers in prior years not previously reported to the Commission.

(2) Licensees who permanently discontinue activities authorized by the license issued under § 32.18 shall file a report for the current calendar year within 30 days after ceasing distribution.

(e) If no transfers of byproduct material have been made under § 32.18 during the reporting period, the report must so indicate.

(f) The licensee shall maintain the record of a transfer for one year after the transfer is included in a summary report to the Commission.

[72 FR 58488, Oct. 16, 2007, as amended at 73 FR 5719, Jan. 31, 2008; 73 FR 42673, July 23, 2008]

§ 32.21 Radioactive drug: Manufacture, preparation, or transfer for commercial distribution of capsules containing carbon-14 urea each for “in vivo” diagnostic use for humans to persons exempt from licensing; Requirements for a license.

(a) An application for a specific license to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution capsules containing 37 kBq (1 µCi) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process) each for “in vivo” diagnostic use, to persons exempt from licensing under § 30.21 of this chapter or the equivalent regulations of an Agreement State will be approved if:

(1) The applicant satisfies the general requirements specified in § 30.33 of this chapter, provided that the requirements of § 30.33(a) (2) and (3) of this chapter do not apply to an application for a license to transfer byproduct material manufactured, prepared, processed, produced, packaged, or repackaged pursuant to a license issued by an Agreement State;

(2) The applicant meets the requirements under § 32.72(a)(2) of this part;

(3) The applicant provides evidence that each capsule contains 37 kBq (1 µCi) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process);

(4) The carbon-14 urea is not contained in any food, beverage, cosmetic, drug (except as described in this section) or other commodity designed for ingestion or inhalation by, or topical application to, a human being;

(5) The carbon-14 urea is in the form of a capsule, identified as radioactive, and to be used for its radioactive properties, but is not incorporated into any manufactured or assembled commodity, product, or device intended for commercial distribution; and

(6) The applicant submits copies of prototype labels and brochures and the NRC approves these labels and brochures.

(b) Nothing in this section relieves the licensee from complying with applicable FDA, other Federal, and State requirements governing drugs.

[62 FR 63640, Dec. 2, 1997, as amended at 66 FR 64738, Dec. 14, 2001]

§ 32.21a Same: Conditions of license.

Each license issued under § 32.21 of this part is subject to the following conditions:

(a) The immediate container of the capsule(s) must bear a durable, legible label which:

(1) Identifies the radioisotope, the physical and chemical form, the quantity of radioactivity of each capsule at a specific date; and

(2) Bears the words “Radioactive Material.”

(b) In addition to the labeling information required by paragraph (a) of this section, the label affixed to the immediate container, or an accompanying brochure also must:

(1) State that the contents are exempt from NRC or Agreement State licensing requirements; and

(2) Bears the words “Radioactive Material. For “In Vivo” Diagnostic Use Only. This Material Is Not To Be Used for Research Involving Human Subjects and Must Not Be Introduced into Foods, Beverages, Cosmetics, or Other Drugs or Medicinals, or into Products Manufactured for Commercial Distribution. This Material May Be Disposed of in Ordinary Trash.”

[62 FR 63640, Dec. 2, 1997]

§ 32.22 Self-luminous products containing tritium, krypton-85 or promethium-147: Requirements for license to manufacture, process, produce, or initially transfer.

(a) An application for a specific license to manufacture, process, or produce self-luminous products containing tritium, krypton-85, or promethium-147, or to initially transfer such products for use pursuant to § 30.19 of this chapter or equivalent regulations of an Agreement State, will be approved if:

(1) The applicant satisfies the general requirements specified in § 30.33 of this chapter: Provided, however, That the requirements of § 30.33(a) (2) and (3) do not apply to an application for a license to transfer tritium, krypton-85, or promethium-147 in self-luminous products manufactured, processed, or produced pursuant to a license issued by an Agreement State.

(2) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, and conditions of handling, storage, use, and disposal of the self-luminous product to demonstrate that the product will meet the safety criteria set forth in § 32.23. The information should include:

(i) A description of the product and its intended use or uses.

(ii) The type and quantity of byproduct material in each unit.

(iii) Chemical and physical form of the byproduct material in the product and changes in chemical and physical form that may occur during the useful life of the product.

(iv) Solubility in water and body fluids of the forms of the byproduct material identified in paragraphs (a)(2) (iii) and (xii) of this section.

(v) Details of construction and design of the product as related to containment and shielding of the byproduct material and other safety features under normal and severe conditions of handling, storage, use, and disposal of the product.

(vi) Maximum external radiation levels at 5 and 25 centimeters from any external surface of the product, averaged over an area not to exceed 10 square centimeters, and the method of measurement.

(vii) Degree of access of human beings to the product during normal handling and use.

(viii) Total quantity of byproduct material expected to be distributed in the product annually.

(ix) The expected useful life of the product.

(x) The proposed method of labeling or marking each unit with identification of the manufacturer or initial transferor of the product and the byproduct material in the product.

(xi) Procedures for prototype testing of the product to demonstrate the effectiveness of the containment, shielding, and other safety features under both normal and severe conditions of handling, storage, use, and disposal of the product.

(xii) Results of the prototype testing of the product, including any change in the form of the byproduct material contained in the product, the extent to which the byproduct material may be released to the environment, any increase in external radiation levels, and any other changes in safety features.

(xiii) The estimated external radiation doses and dose commitments relevant to the safety criteria in § 32.23 and the basis for such estimates.

(xiv) A determination that the probabilities with respect to the doses referred to in § 32.23(d) meet the criteria of that paragraph.

(xv) Quality control procedures to be followed in the fabrication of production lots of the product and the quality control standards the product will be required to meet.

(xvi) Any additional information, including experimental studies and tests, required by the Commission.

(3)(i) The Commission determines that the product meets the safety criteria in § 32.23; and

(ii) The product has been evaluated by the NRC and registered in the Sealed Source and Device Registry.

(b) Notwithstanding the provisions of paragraph (a) of this section, the Commission may deny an application for a specific license under this section if the end uses of the product cannot be reasonably foreseen.

[34 FR 9026, June 6, 1969, as amended at 43 FR 6923, Feb. 17, 1978; 77 FR 43691, July 25, 2012]

§ 32.23 Same: Safety criteria.

An applicant for a license under § 32.22 shall demonstrate that the product is designed and will be manufactured so that:

(a) In normal use and disposal of a single exempt unit, it is unlikely that the external radiation dose in any one year, or the dose commitment resulting from the intake of radioactive material in any one year, to a suitable sample of the group of individuals expected to be most highly exposed to radiation or radioactive material from the product will exceed the dose to the appropriate organ as specified in Column I of the table in § 32.24 of this part.

(b) In normal handling and storage of the quantities of exempt units likely to accumulate in one location during marketing, distribution, installation, and servicing of the product, it is unlikely that the external radiation dose in any one year, or the dose commitment resulting from the intake of radioactive material in any one year, to a suitable sample of the group of individuals expected to be most highly exposed to radiation or radioactive material from the product will exceed the dose to the appropriate organ as specified in Column II of the table in § 32.24.

(c) It is unlikely that there will be a significant reduction in the effectiveness of the containment, shielding, or other safety features of the product from wear and abuse likely to occur in normal handling and use of the product during its useful life.

(d) 1 In use and disposal of a single exempt unit, or in handling and storage of the quantities of exempt units likely to accumulate in one location during marketing, distribution, installation, and servicing of the product, the probability is low that the containment, shielding, or other safety features of the product would fail under such circumstances that a person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in Column III of the table in § 32.24, and the probability is negligible that a person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in Column IV of the table in § 32.24.

1 It is the intent of this paragraph that as the magnitude of the potential dose increases above that permitted under normal conditions, the probability that any individual will receive such a dose must decrease. The probabilities have been expressed in general terms to emphasize the approximate nature of the estimates which are to be made. The following values may be used as guides in estimating compliance with the criteria:

Low—not more than one such failure per year for each 10,000 exempt units distributed.

Negligible—not more than one such failure per year for each 1 million exempt units distributed.

[34 FR 9027, June 6, 1969]

§ 32.24 Same: Table of organ doses.

Part of body | Column I (rem) | Column II (rem) | Column III (rem) | Column IV (rem)

Whole body; head and trunk: active blood-forming organs; gonads: or lens of eye | 0.001 | 0.01 | 0.5 | 15

Hands and forearms; feet and ankles; localized areas of skin averaged over areas no larger than 1 square centimeter | 0.015 | 0.15 | 7.5 | 200

Other organs | 0.003 | 0.03 | 1.5 | 50

[34 FR 9329, June 13, 1969]

§ 32.25 Conditions of licenses issued under § 32.22: Quality control, labeling, and reports of transfer.

Each person licensed under § 32.22 shall:

(a) Carry out adequate control procedures in the manufacture of the product to assure that each production lot meets the quality control standards approved by the Commission;

(b) Label or mark each unit so that the manufacturer, processor, producer, or initial transferor of the product and the byproduct material in the product can be identified; and

(c) Maintain records of all transfers and file a report with the Director of the Office of Nuclear Material Safety and Safeguards by an appropriate method listed in § 30.6(a) of this chapter, including in the address: ATTN: Document Control Desk/Exempt Distribution.

(1) The report must clearly identify the specific licensee submitting the report and include the license number of the specific licensee.

(2) The report must indicate that the products are transferred for use under § 30.19 of this chapter or equivalent regulations of an Agreement State.

(3) The report must include the following information on products transferred to other persons for use under § 30.19 or equivalent regulations of an Agreement State:

(i) A description or identification of the type of each product and the model number(s);

(ii) For each radionuclide in each type of product and each model number, the total quantity of the radionuclide;

(iii) The number of units of each type of product transferred during the reporting period by model number.

(4)(i) The licensee shall file the report, covering the preceding calendar year, on or before January 31 of each year. In its first report after December 17, 2007, the licensee shall separately include data for transfers in prior years not previously reported to the Commission.

(ii) Licensees who permanently discontinue activities authorized by the license issued under § 32.22 shall file a report for the current calendar year within 30 days after ceasing distribution.

(5) If no transfers of byproduct material have been made under § 32.22 during the reporting period, the report must so indicate.

(6) The licensee shall maintain the record of a transfer for one year after the transfer is included in a report to the Commission.

[34 FR 9027, June 6, 1969, as amended at 43 FR 6923, Feb. 17, 1978; 48 FR 12334, Mar. 24, 1983; 68 FR 58804, Oct. 10, 2003; 72 FR 58488, Oct. 16, 2007; 73 FR 5719, Jan. 31, 2008; 73 FR 42673, July 23, 2008]

§ 32.26 Gas and aerosol detectors containing byproduct material: Requirements for license to manufacture, process, produce, or initially transfer.

An application for a specific license to manufacture, process, or produce gas and aerosol detectors containing byproduct material and designed to protect health, safety, or property, or to initially transfer such products for use under § 30.20 of this chapter or equivalent regulations of an Agreement State, will be approved if:

(a) The applicant satisfies the general requirements specified in § 30.33 of this chapter: Provided, however, That the requirements of § 30.33(a) (2) and (3) do not apply to an application for a license to transfer byproduct material in gas and aerosol detectors manufactured, processed or produced pursuant to a license issued by an Agreement State.

(b) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, and conditions of handling, storage, use, and disposal of the gas and aerosol detector to demonstrate that the product will meet the safety criteria set forth in § 32.27. The information should include:

(1) A description of the product and its intended use or uses;

(2) The type and quantity of byproduct material in each unit;

(3) Chemical and physical form of the byproduct material in the product and changes in chemical and physical form that may occur during the useful life of the product;

(4) Solubility in water and body fluids of the forms of the byproduct material identified in paragraphs (b) (3) and (12) of this section;

(5) Details of construction and design of the product as related to containment and shielding of the byproduct material and other safety features under normal and severe conditions of handling, storage, use, and disposal of the product;

(6) Maximum external radiation levels at 5 and 25 centimeters from any external surface of the product, averaged over an area not to exceed 10 square centimeters, and the method of measurement;

(7) Degree of access of human beings to the product during normal handling and use;

(8) Total quantity of byproduct material expected to be distributed in the product annually;

(9) The expected useful life of the product;

(10) The proposed methods of labeling or marking the detector and its point-of-sale package to satisfy the requirements of § 32.29(b);

(11) Procedures for prototype testing of the product to demonstrate the effectiveness of the containment, shielding, and other safety features under both normal and severe conditions of handling, storage, use, and disposal of the product;

(12) Results of the prototype testing of the product, including any change in the form of the byproduct material contained in the product, the extent to which the byproduct material may be released to the environment, any increase in external radiation levels, and any other changes in safety features;

(13) The estimated external radiation doses and dose commitments relevant to the safety criteria in § 32.27 and the basis for such estimates;

(14) A determination that the probabilities with respect to the doses referred to in § 32.27(c) meet the criteria of that paragraph;

(15) Quality control procedures to be followed in the fabrication of production lots of the product and the quality control standards the product will be required to meet; and

(16) Any additional information, including experimental studies and tests, required by the Commission.

(c)(1) The Commission determines that the product meets the safety criteria in § 32.27; and

(2) The product has been evaluated by the NRC and registered in the Sealed Source and Device Registry.

[34 FR 6653, Apr. 18, 1969, as amended at 43 FR 6923, Feb. 17, 1978; 45 FR 38342, June 9, 1980; 77 FR 43691, July 25, 2012]

§ 32.27 Same: Safety criteria.

An applicant for a license under § 32.26 shall demonstrate that the product is designed and will be manufactured so that:

(a) In normal use and disposal of a single exempt unit, and in normal handling and storage of the quantities of exempt units likely to accumulate in one location during marketing, distribution, installation, and servicing of the product, it is unlikely that the external radiation dose in any one year, or the dose commitment resulting from the intake of radioactive material in any one year, to a suitable sample of the group of individuals expected to be most highly exposed to radiation or radioactive material from the product will exceed the dose to the appropriate organ as specified in Column I of the table in § 32.28.

(b) It is unlikely that there will be a significant reduction in the effectiveness of the containment, shielding, or other safety features of the product from wear and abuse likely to occur in normal handling and use of the product during its useful life.

(c) In use and disposal of a single exempt unit and in handling and storage of the quantities of exempt units likely to accumulate in one location during marketing, distribution, installation, and servicing of the product, the probability is low that the containment, shielding, or other safety features of the product would fail under such circumstances that a person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in Column II of the table in § 32.28, and the probability is negligible that a person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in Column III of the table in § 32.28. 1

1 It is the intent of this paragraph that as the magnitude of the potential dose increases above that permitted under normal conditions, the probability that any individual will receive such a dose must decrease. The probabilities have been expressed in general terms to emphasize the approximate nature of the estimates which are to be made. The following values may be used as guides in estimating compliance with the criteria:

Low—not more than one such failure per year for each 10,000 exempt units distributed.

Negligible—not more than one such failure per year for each one million exempt units distributed.

[34 FR 6654, Apr. 18, 1969]

§ 32.28 Same: Table of organ doses.

Part of body | Column I (rem) | Column II (rem) | Column III (rem)

Whole body; head and trunk; active blood-forming organs; gonads; or lens of eye | 0.005 | 0.5 | 15

Hands and forearms; feet and ankles; localized areas of skin averaged over areas no larger than 1 square centimeter | 0.075 | 7.5 | 200

Other organs | 0.015 | 1.5 | 50

[34 FR 6654, Apr. 18, 1969]

§ 32.29 Conditions of licenses issued under § 32.26: Quality control, labeling, and reports of transfer.

Each person licensed under § 32.26 shall:

(a) Carry out adequate control procedures in the manufacture of the product to assure that each production lot meets the quality control standards approved by the Commission;

(b) Label or mark each detector and its point-of-sale package so that:

(1) Each detector has a durable, legible, readily visible label or marking on the external surface of the detector containing:

(i) The following statement: “CONTAINS RADIOACTIVE MATERIAL”;

(ii) The name of the radionuclide and quantity of activity; and

(iii) An identification of the person licensed under § 32.26 to transfer the detector for use pursuant to § 30.20 of this chapter or equivalent regulations of an Agreement State.

(2) The labeling or marking specified in paragraph (b)(1) of this section is located where its will be readily visible when the detector is removed from its mounting.

(3) The external surface of the point-of-sale package has a legible, readily visible label or marking containing:

(i) The name of the radionuclide and quantity of activity;

(ii) An identification of the person licensed under § 32.26 to transfer the detector for use pursuant to § 30.20 of this chapter or equivalent regulations of an Agreement State; and

(iii) The following or a substantially similar statement:

THIS DETECTOR CONTAINS RADIOACTIVE MATERIAL AND HAS BEEN MANUFACTURED IN COMPLIANCE WITH U.S. NRC SAFETY CRITERIA IN 10 CFR 32.27. THE PURCHASER IS EXEMPT FROM ANY REGULATORY REQUIREMENTS.

(4) Each detector and point-of-sale package is provided with such other information as may be required by the Commission; and

(c) Maintain records of all transfers and file a report with the Director of the Office of Nuclear Material Safety and Safeguards by an appropriate method listed in § 30.6(a) of this chapter, including in the address: ATTN: Document Control Desk/Exempt Distribution.

(1) The report must clearly identify the specific licensee submitting the report and include the license number of the specific licensee.

(2) The report must indicate that the products are transferred for use under § 30.20 of this chapter or equivalent regulations of an Agreement State.

(3) The report must include the following information on products transferred to other persons for use under § 30.20 or equivalent regulations of an Agreement State:

(i) A description or identification of the type of each product and the model number(s);

(ii) For each radionuclide in each type of product and each model number, the total quantity of the radionuclide;

(iii) The number of units of each type of product transferred during the reporting period by model number.

(4)(i) The licensee shall file the report, covering the preceding calendar year, on or before January 31 of each year. In its first report after December 17, 2007, the licensee shall separately include data for transfers in prior years not previously reported to the Commission.

(ii) Licensees who permanently discontinue activities authorized by the license issued under § 32.26 shall file a report for the current calendar year within 30 days after ceasing distribution.

(5) If no transfers of byproduct material have been made under § 32.26 during the reporting period, the report must so indicate.

(6) The licensee shall maintain the record of a transfer for one year after the transfer is included in a report to the Commission.

[34 FR 6654, Apr. 18, 1969, as amended at 43 FR 6923, Feb. 17, 1978; 45 FR 38342, June 9, 1980; 48 FR 12334, Mar. 24, 1983; 72 FR 58488, Oct. 16, 2007; 73 FR 5719, Jan. 31, 2008; 73 FR 42673, July 23, 2008]

§ 32.30 Certain industrial devices containing byproduct material: Requirements for license to manufacture, process, produce, or initially transfer.

An application for a specific license to manufacture, process, produce, or initially transfer for sale or distribution devices containing byproduct material for use under § 30.22 of this chapter or equivalent regulations of an Agreement State will be approved if:

(a) The applicant satisfies the general requirements of § 30.33 of this chapter: However, the requirements of § 30.33(a)(2) and (3) do not apply to an application for a license to transfer byproduct material in such industrial devices manufactured, processed, or produced under a license issued by an Agreement State;

(b) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, and conditions of handling, storage, use, and disposal of the industrial devices to demonstrate that the device will meet the safety criteria set forth in § 32.31. The information should include:

(1) A description of the device and its intended use or uses;

(2) The type and quantity of byproduct material in each unit;

(3) Chemical and physical form of the byproduct material in the device and changes in chemical and physical form that may occur during the useful life of the device;

(4) Solubility in water and body fluids of the forms of the byproduct material identified in paragraphs (b)(3) and (b)(12) of this section;

(5) Details of construction and design of the device as related to containment and shielding of the byproduct material and other safety features under normal and severe conditions of handling, storage, use, and disposal of the device;

(6) Maximum external radiation levels at 5 and 30 centimeters from any external surface of the device, averaged over an area not to exceed 10 square centimeters, and the method of measurement;

(7) Degree of access of human beings to the device during normal handling and use;

(8) Total quantity of byproduct material expected to be distributed in the devices annually;

(9) The expected useful life of the device;

(10) The proposed methods of labeling or marking the device and its point-of-sale package to satisfy the requirements of § 32.32(b);

(11) Procedures for prototype testing of the device to demonstrate the effectiveness of the containment, shielding, and other safety features under both normal and severe conditions of handling, storage, use, and disposal of the device;

(12) Results of the prototype testing of the device, including any change in the form of the byproduct material contained in the device, the extent to which the byproduct material may be released to the environment, any increase in external radiation levels, and any other changes in safety features;

(13) The estimated external radiation doses and committed doses resulting from the intake of byproduct material in any one year relevant to the safety criteria in § 32.31 and the basis for these estimates;

(14) A determination that the probabilities with respect to the doses referred to in § 32.31(a)(4) meet the criteria of that paragraph;

(15) Quality control procedures to be followed in the fabrication of production lots of the devices and the quality control standards the devices will be required to meet; and

(16) Any additional information, including experimental studies and tests, required by the Commission.

(c)(1) The Commission determines that the device meets the safety criteria in § 32.31.

(2) The device is unlikely to be routinely used by members of the general public in a non-occupational environment.

(3) The device has been registered in the Sealed Source and Device Registry.

[77 FR 43691, July 25, 2012]

§ 32.31 Certain industrial devices containing byproduct material: Safety criteria.

(a) An applicant for a license under § 32.30 shall demonstrate that the device is designed and will be manufactured so that:

(1) In normal use, handling, and storage of the quantities of exempt units likely to accumulate in one location, including during marketing, distribution, installation, and servicing of the device, it is unlikely that the external radiation dose in any one year, or the committed dose resulting from the intake of radioactive material in any one year, to a suitable sample of the group of individuals expected to be most highly exposed to radiation or radioactive material from the device will exceed 200 µSv (20 mrem).

(2) It is unlikely that the external radiation dose in any one year, or the committed dose resulting from the intake of radioactive material in any one year, to a suitable sample of the group of individuals expected to be most highly exposed to radiation or radioactive material from disposal of the quantities of units likely to accumulate in the same disposal site will exceed 10 µSv (1 mrem).

(3) It is unlikely that there will be a significant reduction in the effectiveness of the containment, shielding, or other safety features of the device from wear and abuse likely to occur in normal handling and use of the device during its useful life.

(4) In use, handling, storage, and disposal of the quantities of exempt units likely to accumulate in one location, including during marketing, distribution, installation, and servicing of the device, the probability is low that the containment, shielding, or other safety features of the device would fail under such circumstances that a person would receive an external radiation dose or committed dose in excess of 5 mSv (500 mrem), and the probability is negligible that a person would receive an external radiation dose or committed dose of 100 mSv (10 rem) or greater. 1

1 It is the intent of this paragraph that as the magnitude of the potential dose increases above that permitted under normal conditions, the probability that any individual will receive such a dose must decrease. The probabilities have been expressed in general terms to emphasize the approximate nature of the estimates that are to be made. The following values may be used as guides in estimating compliance with the criteria: Low—not more than one such failure/incident per year for each 10,000 exempt units distributed. Negligible—not more than one such failure/incident per year for each one million exempt units distributed.

(b) An applicant for a license under § 32.30 shall demonstrate that, even in unlikely scenarios of misuse, including those resulting in direct exposure to the unshielded source removed from the device for 1,000 hours at an average distance of 1 meter and those resulting in dispersal and subsequent intake of 10−4 of the quantity of byproduct material (or in the case of tritium, an intake of 10 percent), a person will not receive an external radiation dose or committed dose in excess of 100 mSv (10 rem), and, if the unshielded source is small enough to fit in a pocket, that the dose to localized areas of skin averaged over areas no larger than 1 square centimeter from carrying the unshielded source in a pocket for 80 hours will not exceed 2 Sv (200 rem).

[77 FR 43692, July 25, 2012]

§ 32.32 Conditions of licenses issued under § 32.30: Quality control, labeling, and reports of transfer.

Each person licensed under § 32.30 shall:

(a) Carry out adequate control procedures in the manufacture of the device to ensure that each production lot meets the quality control standards approved by the Commission;

(b) Label or mark each device and its point-of-sale package so that:

(1) Each item has a durable, legible, readily visible label or marking on the external surface of the device containing:

(i) The following statement: “CONTAINS RADIOACTIVE MATERIAL”;

(ii) The name of the radionuclide(s) and quantity(ies) of activity;

(iii) An identification of the person licensed under § 32.30 to transfer the device for use under § 30.22 of this chapter or equivalent regulations of an Agreement State; and

(iv) Instructions and precautions necessary to assure safe installation, operation, and servicing of the device (documents such as operating and service manuals may be identified in the label and used to provide this information).

(2) The external surface of the point-of-sale package has a legible, readily visible label or marking containing:

(i) The name of the radionuclide and quantity of activity;

(ii) An identification of the person licensed under § 32.30 to transfer the device for use under § 30.22 of this chapter or equivalent regulations of an Agreement State; and

(iii) The following or a substantially similar statement: “THIS DEVICE CONTAINS RADIOACTIVE MATERIAL AND HAS BEEN MANUFACTURED IN COMPLIANCE WITH U.S. NUCLEAR REGULATORY COMMISSION SAFETY CRITERIA IN 10 CFR 32.31. THE PURCHASER IS EXEMPT FROM ANY REGULATORY REQUIREMENTS.”

(3) Each device and point-of-sale package contains such other information as may be required by the Commission; and

(c) Maintain records of all transfers and file a report with the Director of the Office of Nuclear Material Safety and Safeguards by an appropriate method listed in § 30.6(a) of this chapter, including in the address: ATTN: Document Control Desk/Exempt Distribution.

(1) The report must clearly identify the specific licensee submitting the report and include the license number of the specific licensee.

(2) The report must indicate that the devices are transferred for use under § 30.22 of this chapter or equivalent regulations of an Agreement State.

(3) The report must include the following information on devices transferred to other persons for use under § 30.22 or equivalent regulations of an Agreement State:

(i) A description or identification of the type of each device and the model number(s);

(ii) For each radionuclide in each type of device and each model number, the total quantity of the radionuclide; and

(iii) The number of units of each type of device transferred during the reporting period by model number.

(4)(i) The licensee shall file the report, covering the preceding calendar year, on or before January 31 of each year.

(ii) Licensees who permanently discontinue activities authorized by the license issued under § 32.30 shall file a report for the current calendar year within 30 days after ceasing distribution.

(5) If no transfers of byproduct material have been made under § 32.30 during the reporting period, the report must so indicate.

(6) The licensee shall maintain the record of a transfer for a period of one year after the transfer is included in a report to the Commission.

[77 FR 43692, July 25, 2012]

§ 32.51 Byproduct material contained in devices for use under § 31.5; requirements for license to manufacture, or initially transfer.

(a) An application for a specific license to manufacture, or initially transfer devices containing byproduct material to persons generally licensed under § 31.5 of this chapter or equivalent regulations of an Agreement State will be approved if:

(1) The applicant satisfies the general requirements of § 30.33 of this chapter;

(2) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control, labels, proposed uses, installation, servicing, leak testing, operating and safety instructions, and potential hazards of the device to provide reasonable assurance that:

(i) The device can be safely operated by persons not having training in radiological protection;

(ii) Under ordinary conditions of handling, storage, and use of the device, the byproduct material contained in the device will not be released or inadvertently removed from the device, and it is unlikely that any person will receive in 1 year a dose in excess of 10 percent of the annual limits specified in § 20.1201(a) of this chapter; and

(iii) Under accident conditions (such as fire and explosion) associated with handling, storage and use of the device, it is unlikely that any person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in Column IV of the table in § 32.24.

(3) Each device bears a durable, legible, clearly visible label or labels approved by the Commission which contain in a clearly identified and separate statement:

(i) Instructions and precautions necessary to assure safe installation, operation, and servicing of the device (documents such as operating and service manuals may be identified in the label and used to provide this information);

(ii) The requirements, or lack of requirement, for leak testing, or for testing any on-off mechanism and indicator, including the maximum time interval for such testing, and the identification of radioactive material by isotope, quantity of radioactivity, and date of determination of the quantity; and

(iii) The information called for in the following statement in the same or substantially similar form: 1

1 Devices licensed under § 32.51 prior to January 19, 1975 may bear labels authorized by the regulations in effect on January 1, 1975.

The receipt, possession, use, and transfer of this device Model ____ 2, Serial No.___ 2, are subject to a general license or the equivalent and the regulations of the U.S. NRC or of a State with which the NRC has entered into an agreement for the exercise of regulatory authority. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited.

2 The model, serial number, and the name of the manufacturer, or initial transferor may be omitted from this label provided the information is elsewhere specified in labeling affixed to the device.

CAUTION—RADIOACTIVE MATERIAL (Name of manufacturer, or initial transferor) 2

(4) Each device having a separable source housing that provides the primary shielding for the source also bears, on the source housing, a durable label containing the device model number and serial number, the isotope and quantity, the words, “Caution-Radioactive Material,” the radiation symbol described in § 20.1901 of this chapter, and the name of the manufacturer or initial distributor.

(5) Each device meeting the criteria of § 31.5(c)(13)(i) of this chapter, bears a permanent (e.g., embossed, etched, stamped, or engraved) label affixed to the source housing if separable, or the device if the source housing is not separable, that includes the words, “Caution-Radioactive Material,” and, if practicable, the radiation symbol described in § 20.1901 of this chapter.

(6) The device has been registered in the Sealed Source and Device Registry.

(b) In the event the applicant desires that the device be required to be tested at intervals longer than six months, either for proper operation of the on-off mechanism and indicator, if any, or for leakage of radioactive material or for both, he shall include in this application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the device or similar devices, and by design features which have a significant bearing on the probability or consequences of leakage of radioactive material from the device or failure of the on-off mechanism and indicator. In determining the acceptable interval for the test for leakage of radioactive material, the Commission will consider information which includes, but is not limited to:

(1) Primary containment (source capsule);

(2) Protection of primary containment;

(3) Method of sealing containment;

(4) Containment construction materials;

(5) Form of contained radioactive material;

(6) Maximum temperature withstood during prototype tests;

(7) Maximum pressure withstood during prototype tests;

(8) Maximum quantity of contained radioactive material;

(9) Radiotoxicity of contained radioactive material; and

(10) Operating experience with identical devices or similarly designed and constructed devices.

(c) In the event the applicant desires that the general licensee under § 31.5 of this chapter, or under equivalent regulations of an Agreement State, be authorized to install the device, collect the sample to be analyzed by a specific licensee for leakage of radioactive material, service the device, test the on-off mechanism and indicator, or remove the device from installation, the applicant shall include in the application written instructions to be followed by the general licensee, estimated calendar quarter doses associated with such activity or activities, and the bases for these estimates. The submitted information must demonstrate that performance of this activity or activities by an individual untrained in radiological protection, in addition to other handling, storage, and use of devices under the general license, is unlikely to cause that individual to receive a dose in excess of 10 percent of the annual limits specified in § 20.1201(a) of this chapter.

[39 FR 43533, Dec. 16, 1974, as amended at 40 FR 8785, Mar. 3, 1975; 42 FR 25721, May 19, 1977; 43 FR 6923, Feb. 17, 1978; 58 FR 67660, Dec. 22, 1993; 59 FR 5520, Feb. 7, 1994; 65 FR 79189, Dec. 18, 2000; 77 FR 43693, July 25, 2012]

§ 32.51a Same: Conditions of licenses.

(a) If a device containing byproduct material is to be transferred for use under the general license contained in § 31.5 of this chapter, each person that is licensed under § 32.51 shall provide the information specified in this paragraph to each person to whom a device is to be transferred. This information must be provided before the device may be transferred. In the case of a transfer through an intermediate person, the information must also be provided to the intended user prior to initial transfer to the intermediate person. The required information includes—

(1) A copy of the general license contained in § 31.5 of this chapter; if paragraphs (c)(2) through (4) or (c)(13) of § 31.5 do not apply to the particular device, those paragraphs may be omitted.

(2) A copy of §§ 31.2, 30.51, 20.2201, and 20.2202 of this chapter;

(3) A list of the services that can only be performed by a specific licensee;

(4) Information on acceptable disposal options including estimated costs of disposal; and

(5) An indication that NRC's policy is to issue high civil penalties for improper disposal.

(b) If byproduct material is to be transferred in a device for use under an equivalent general license of an Agreement State, each person that is licensed under § 32.51 shall provide the information specified in this paragraph to each person to whom a device is to be transferred. This information must be provided before the device may be transferred. In the case of a transfer through an intermediate person, the information must also be provided to the intended user prior to initial transfer to the intermediate person. The required information includes—

(1) A copy of the Agreement State's regulations equivalent to §§ 31.5, 31.2, 30.51, 20.2201, and 20.2202 of this chapter or a copy of §§ 31.5, 31.2, 30.51, 20.2201, and 20.2202 of this chapter. If a copy of the NRC regulations is provided to a prospective general licensee in lieu of the Agreement State's regulations, it shall be accompanied by a note explaining that use of the device is regulated by the Agreement State; if certain paragraphs of the regulations do not apply to the particular device, those paragraphs may be omitted.

(2) A list of the services that can only be performed by a specific licensee;

(3) Information on acceptable disposal options including estimated costs of disposal; and

(4) The name or title, address, and phone number of the contact at the Agreement State regulatory agency from which additional information may be obtained.

(c) An alternative approach to informing customers may be proposed by the licensee for approval by the Commission.

(d) Each device that is transferred after February 19, 2002 must meet the labeling requirements in § 32.51(a)(3) through (5).

(e) If a notification of bankruptcy has been made under § 30.34(h) or the license is to be terminated, each person licensed under § 32.51 shall provide, upon request, to the NRC and to any appropriate Agreement State, records of final disposition required under § 32.52(c).

[65 FR 79189, Dec. 18, 2000; 65 FR 80991, Dec. 22, 2000]

§ 32.52 Same: material transfer reports and records.

Each person licensed under § 32.51 to initially transfer devices to generally licensed persons shall comply with the requirements of this section.

(a) The person shall report to the Director, Office of Nuclear Material Safety and Safeguards , ATTN: GLTS, by an appropriate method listed in § 30.6(a) of this chapter, all transfers of such devices to persons for use under the general license in § 31.5 of this chapter and all receipts of devices from persons licensed under § 31.5 of this chapter. The report must be submitted on a quarterly basis on NRC Form 653—“Transfers of Industrial Devices Report” or in a clear and legible report containing all of the data required by the form.

(1) The required information for transfers to general licensees includes—

(i) The identity of each general licensee by name and mailing address for the location of use; if there is no mailing address for the location of use, an alternate address for the general licensee shall be submitted along with information on the actual location of use.

(ii) The name, title, and phone number of the person identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with the appropriate regulations and requirements;

(iii) The date of transfer;

(iv) The type, model number, and serial number of the device transferred; and

(v) The quantity and type of byproduct material contained in the device.

(2) If one or more intermediate persons will temporarily possess the device at the intended place of use before its possession by the user, the report must include the same information for both the intended user and each intermediate person, and clearly designate the intermediate person(s).

(3) For devices received from a § 31.5 general licensee, the report must include the identity of the general licensee by name and address, the type, model number, and serial number of the device received, the date of receipt, and, in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor.

(4) If the licensee makes changes to a device possessed by a § 31.5 general licensee, such that the label must be changed to update required information, the report must identify the general licensee, the device, and the changes to information on the device label.

(5) The report must cover each calendar quarter, must be filed within 30 days of the end of the calendar quarter, and must clearly indicate the period covered by the report.

(6) The report must clearly identify the specific licensee submitting the report and include the license number of the specific licensee.

(7) If no transfers have been made to or from persons generally licensed under § 31.5 of this chapter during the reporting period, the report must so indicate.

(b) The person shall report all transfers of devices to persons for use under a general license in an Agreement State's regulations that are equivalent to § 31.5 of this chapter and all receipts of devices from general licensees in the Agreement State's jurisdiction to the responsible Agreement State agency. The report must be submitted on Form 653—“Transfers of Industrial Devices Report” or in a clear and legible report containing all of the data required by the form.

(1) The required information for transfers to general licensees includes—

(i) The identity of each general licensee by name and mailing address for the location of use; if there is no mailing address for the location of use, an alternate address for the general licensee shall be submitted along with information on the actual location of use.

(ii) The name, title, and phone number of the person identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with the appropriate regulations and requirements;

(iii) The date of transfer;

(iv) The type, model number, and serial number of the device transferred; and

(v) The quantity and type of byproduct material contained in the device.

(2) If one or more intermediate persons will temporarily possess the device at the intended place of use before its possession by the user, the report must include the same information for both the intended user and each intermediate person, and clearly designate the intermediate person(s).

(3) For devices received from a general licensee, the report must include the identity of the general licensee by name and address, the type, model number, and serial number of the device received, the date of receipt, and, in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor.

(4) If the licensee makes changes to a device possessed by a general licensee, such that the label must be changed to update required information, the report must identify the general licensee, the device, and the changes to information on the device label.

(5) The report must cover each calendar quarter, must be filed within 30 days of the end of the calendar quarter, and must clearly indicate the period covered by the report.

(6) The report must clearly identify the specific licensee submitting the report and must include the license number of the specific licensee.

(7) If no transfers have been made to or from a particular Agreement State during the reporting period, this information shall be reported to the responsible Agreement State agency upon request of the agency.

(c) The person shall maintain all information concerning transfers and receipts of devices that supports the reports required by this section. Records required by this paragraph must be maintained for a period of 3 years following the date of the recorded event.

[65 FR 79189, Dec. 18, 2000, as amended at 68 FR 58805, Oct. 10, 2003; 73 FR 5719, Jan. 31, 2008]

§ 32.53 Luminous safety devices for use in aircraft: Requirements for license to manufacture, assemble, repair or initially transfer.

An application for a specific license to manufacture, assemble, repair or initially transfer luminous safety devices containing tritium or promethium-147 for use in aircraft, for distribution to persons generally licensed under § 31.7 of this chapter, will be approved if:

(a) The applicant satisfies the general requirements specified in § 30.33 of this chapter;

(b) The applicant submits sufficient information regarding each device pertinent to evaluation of the potential radiation exposure, including:

(1) Chemical and physical form and maximum quantity of tritium or promethium-147 in each device;

(2) Details of construction and design;

(3) Details of the method of binding or containing the tritium or promethium-147;

(4) Procedures for and results of prototype testing to demonstrate that the tritium or promethium-147 will not be released to the environment under the most severe conditions likely to be encountered in normal use;

(5) Quality assurance procedures to be followed that are sufficient to ensure compliance with § 32.55;

(6) Any additional information, including experimental studies and tests, required by the Commission to facilitate a determination of the safety of the device.

(c) Each device will contain no more than 10 curies of tritium or 300 millicuries of promethium-147. The levels of radiation from each device containing promethium-147 will not exceed 0.5 millirad per hour at 10 centimeters from any surface when measured through 50 milligrams per square centimeter of absorber.

(d) The Commission determines that:

(1) The method of incorporation and binding of the tritium or promethium-147 in the device is such that the tritium or promethium-147 will not be released under the most severe conditions which are likely to be encountered in normal use and handling of the device;

(2) The tritium or promethium-147 is incorporated or enclosed so as to preclude direct physical contact by any person with it;

(3) The device is so designed that it cannot easily be disassembled; and

(4) Prototypes of the device have been subjected to and have satisfactorily passed the tests required by paragraph (e) of this section.

(e) The applicant shall subject at least five prototypes of the device to tests as follows:

(1) The devices are subjected to tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment of tritium or promethium-147, such as temperature, moisture, absolute pressure, water immersion, vibration, shock, and weathering.

(2) The devices are inspected for evidence of physical damage and for loss of tritium or promethium-147, after each stage of testing, using methods of inspection adequate for determining compliance with the criteria in paragraph (e)(3) of this section.

(3) Device designs are rejected for which the following has been detected for any unit:

(i) A leak resulting in a loss of 0.1 percent or more of the original amount of tritium or promethium-147 from the device; or

(ii) Surface contamination of tritium or promethium-147 on the device of more than 2,200 disintegrations per minute per 100 square centimeters of surface area; or

(iii) Any other evidence of physical damage.

(f) The device has been registered in the Sealed Source and Device Registry.

[30 FR 8192, June 26, 1965, as amended at 33 FR 6463, Apr. 27, 1968; 43 FR 6923, Feb. 17, 1978; 77 FR 43693, July 25, 2012]

§ 32.54 Same: Labeling of devices.

(a) A person licensed under § 32.53 to manufacture, assemble, or initially transfer devices containing tritium or promethium-147 for distribution to persons generally licensed under § 31.7 of this chapter shall, except as provided in paragraph (b) of this section, affix to each device a label containing the radiation symbol prescribed by § 20.1901 of this chapter, such other information as may be required by the Commission including disposal instructions when appropriate, and the following or a substantially similar statement which contains the information called for in the following statement: 1

1 Devices licensed under § 32.53 prior to January 19, 1975 may bear labels authorized by the regulations in effect on January 1, 1975.

The receipt, possession, use, and transfer of this device, Model* _______, Serial No.* ___, containing ______ (Identity and quantity of radioactive material) are subject to a general license or the equivalent and the regulations of the U.S. NRC or of a State with which the NRC has entered into an agreement for the exercise of regulatory authority. Do not remove this label.

CAUTION—RADIOACTIVE MATERIAL (Name of manufacturer, assembler, or initial transferor.)*

*The model, serial number, and name of manufacturer, assembler, or initial transferor may be omitted from this label provided they are elsewhere specified in labeling affixed to the device.

(b) If the Commission determines that it is not feasible to affix a label to the device containing all the information called for in paragraph (a) of this section, it may waive the requirements of that paragraph and require in lieu thereof that:

(1) A label be affixed to the device identifying:

(i) The manufacturer, assembler, or initial transferor; and

(ii) The type of radioactive material; and

(2) A leaflet bearing the following information be enclosed in or accompany the container in which the device is shipped:

(i) The name of the manufacturer, assembler, or initial transferor,

(ii) The type and quantity of radioactive material,

(iii) The model number,

(iv) A statement that the receipt, possession, use, and transfer of the device are subject to a general license or the equivalent and the regulations of the U.S. NRC or of an Agreement State, and

(v) Such other information as may be required by the Commission, including disposal instructions when appropriate.

[33 FR 16331, Nov. 7, 1968, as amended at 40 FR 8785, Mar. 3, 1975; 43 FR 6923, Feb. 17, 1978; 63 FR 39483, July 23, 1998]

§ 32.55 Same: Quality assurance, prohibition of transfer.

(a) Each person licensed under § 32.53 shall visually inspect each device and shall reject any that has an observable physical defect that could adversely affect containment of the tritium or promethium-147.

(b) Each person licensed under § 32.53 shall:

(1) Maintain quality assurance systems in the manufacture of the luminous safety device in a manner sufficient to provide reasonable assurance that the safety-related components of the distributed devices are capable of performing their intended functions; and

(2) Subject inspection lots to acceptance sampling procedures, by procedures specified in paragraph (c) of this section and in the license issued under § 32.53, to provide at least 95 percent confidence that the Lot Tolerance Percent Defective of 5.0 percent will not be exceeded.

(c) The licensee shall subject each inspection lot to:

(1) Tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment of tritium or promethium-147, such as absolute pressure and water immersion.

(2) Inspection for evidence of physical damage, containment failure, or for loss of tritium or promethium-147 after each stage of testing, using methods of inspection adequate for applying the following criteria for defective:

(i) A leak resulting in a loss of 0.1 percent or more of the original amount of tritium or promethium-147 from the device;

(ii) Levels of radiation in excess of 5 microgray (0.5 millirad) per hour at 10 centimeters from any surface when measured through 50 milligrams per square centimeter of absorber, if the device contains promethium-147; and

(iii) Any other criteria specified in the license issued under § 32.53.

(d) No person licensed under § 32.53 shall transfer to persons generally licensed under § 31.7 of this chapter, or under an equivalent general license of an Agreement State:

(1) Any luminous safety device tested and found defective under any condition of a license issued under § 32.53, or paragraph (b) of this section, unless the defective luminous safety device has been repaired or reworked, retested, and determined by an independent inspector to meet the applicable acceptance criteria; or

(2) Any luminous safety device contained within any lot that has been sampled and rejected as a result of the procedures in paragraph (b)(2) of this section, unless:

(i) A procedure for defining sub-lot size, independence, and additional testing procedures is contained in the license issued under § 32.53; and

(ii) Each individual sub-lot is sampled, tested, and accepted in accordance with paragraphs (b)(2) and (d)(2)(i) of this section and any other criteria that may be required as a condition of the license issued under § 32.53.

[77 FR 43693, July 25, 2012]

§ 32.56 Same: Material transfer reports.

(a) Each person licensed under § 32.53 shall file an annual report with the Director, Office of Nuclear Material Safety and Safeguards , ATTN: Document Control Desk/GLTS, by an appropriate method listed in § 30.6(a) of this chapter, which must state the total quantity of tritium or promethium-147 transferred to persons generally licensed under § 31.7 of this chapter. The report must identify each general licensee by name, state the kinds and numbers of luminous devices transferred, and specify the quantity of tritium or promethium-147 in each kind of device. Each report must cover the year ending June 30 and must be filed within thirty (30) days thereafter. If no transfers have been made to persons generally licensed under § 31.7 of this chapter during the reporting period, the report must so indicate.

(b) Each person licensed under § 32.53 shall report annually all transfers of devices to persons for use under a general license in an Agreement State's regulations that are equivalent to § 31.7 of this chapter to the responsible Agreement State agency. The report must state the total quantity of tritium or promethium-147 transferred, identify each general licensee by name, state the kinds and numbers of luminous devices transferred, and specify the quantity of tritium or promethium-147 in each kind of device. If no transfers have been made to a particular Agreement State during the reporting period, this information must be reported to the responsible Agreement State agency upon request of the agency.

[77 FR 43694, July 25, 2012]

§ 32.57 Calibration or reference sources containing americium-241 or radium-226: Requirements for license to manufacture or initially transfer.

An application for a specific license to manufacture or initially transfer calibration or reference sources containing americium-241 or radium-226, for distribution to persons generally licensed under § 31.8 of this chapter, will be approved if:

(a) The applicant satisfies the general requirements of § 30.33 of this chapter;

(b) The applicant submits sufficient information regarding each type of calibration or reference source pertinent to evaluation of the potential radiation exposure, including:

(1) Chemical and physical form and maximum quantity of americium 241 or radium-226 in the source;

(2) Details of construction and design;

(3) Details of the method of incorporation and binding of the americium-241 or radium-226 in the source;

(4) Procedures for and results of prototype testing of sources, which are designed to contain more than 0.005 microcurie of americium-241 or radium-226, to demonstrate that the americium-241 or radium-226 contained in each source will not be released or be removed from the source under normal conditions of use;

(5) Details of quality control procedures to be followed in manufacture of the source;

(6) Description of labeling to be affixed to the source or the storage container for the source;

(7) Any additional information, including experimental studies and tests, required by the Commission to facilitate a determination of the safety of the source.

(c) Each source will contain no more than 5 microcuries of americium-241 or radium-226.

(d) The Commission determines, with respect to any type of source containing more than 0.005 microcurie of americium-241 or radium-226, that:

(1) The method of incorporation and binding of the americium-241 or radium-226 in the source is such that the americium-241 or radium-226 will not be released or be removed from the source under normal conditions of use and handling of the source; and

(2) The source has been subjected to and has satisfactorily passed appropriate tests required by paragraph (e) of this section.

(e) The applicant shall subject at least five prototypes of each source that is designed to contain more than 0.185 kilobecquerel (0.005 microcurie) of americium-241 or radium-226 to tests as follows:

(1) The initial quantity of radioactive material deposited on each source is measured by direct counting of the source.

(2) The sources are subjected to tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment or binding of americium-241 or radium-226, such as physical handling, moisture, and water immersion.

(3) The sources are inspected for evidence of physical damage and for loss of americium-241 or radium-226, after each stage of testing, using methods of inspection adequate for determining compliance with the criteria in paragraph (e)(4) of this section.

(4) Source designs are rejected for which the following has been detected for any unit: Removal of more than 0.185 kilobecquerel (0.005 microcurie) of americium-241 or radium-226 from the source or any other evidence of physical damage.

[30 FR 8192, June 26, 1965, as amended at 43 FR 6923, Feb. 17, 1978; 72 FR 55928, Oct. 1, 2007; 73 FR 42674, July 23, 2008; 77 FR 43694, July 25, 2012]

§ 32.58 Same: Labeling of devices.

Each person licensed under § 32.57 shall affix to each source, or storage container for the source, a label which shall contain sufficient information relative to safe use and storage of the source and shall include the following statement or a substantially similar statement which contains the information called for in the following statement: 1

1 Sources licensed under § 32.57 before January 19, 1975, may bear labels authorized by the regulations in effect on January 1, 1975.

The receipt, possession, use, and transfer of this source, Model, Serial No., are subject to a general license and the regulations of the United States Nuclear Regulatory Commission or of a State with which the Commission has entered into an agreement for the exercise of regulatory authority. Do not remove this label.

CAUTION-RADIOACTIVE MATERIAL-THIS SOURCE CONTAINS AMERICIUM-241 (or RADIUM-226). DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE (Name of manufacturer or initial transferor)

[72 FR 55929, Oct. 1, 2007]

§ 32.59 Same: Leak testing of each source.

Each person licensed under § 32.57 shall perform a dry wipe test upon each source containing more than 3.7 kilobecquerels (0.1 microcurie) of americium-241 or radium-226 before transferring the source to a general licensee under § 31.8 of this chapter or under equivalent regulations of an Agreement State. This test must be performed by wiping the entire radioactive surface of the source with a filter paper with the application of moderate finger pressure. The radioactivity on the filter paper must be measured using methods capable of detecting 0.185 kilobecquerel (0.005 microcurie) of americium-241 or radium-226. If a source has been shown to be leaking or losing more than 0.185 kilobecquerel (0.005 microcurie) of americium-241 or radium-226 by the methods described in this section, the source must be rejected and must not be transferred to a general licensee under § 31.8 of this chapter, or equivalent regulations of an Agreement State.

[77 FR 43694, July 25, 2012]

§ 32.60 [Reserved]

§ 32.61 Ice detection devices containing strontium-90; requirements for license to manufacture or initially transfer.

An application for a specific license to manufacture or initially transfer ice detection devices containing strontium-90 for distribution to persons generally licensed under § 31.10 of this chapter will be approved if:

(a) The applicant satisfies the general requirements specified in § 30.33 of this chapter;

(b) The applicant submits sufficient information regarding each type of device pertinent to evaluation of the potential radiation exposure, including:

(1) Chemical and physical form and maximum quantity of strontium-90 in the device;

(2) Details of construction and design of the source of radiation and its shielding;

(3) Radiation profile of a prototype device;

(4) Procedures for and results of prototype testing of devices to demonstrate that the strontium-90 contained in each device will not be released or be removed from the device under the most severe conditions likely to be encountered in normal handling and use;

(5) Details of quality control procedures to be followed in manufacture of the device;

(6) Description of labeling to be affixed to the device;

(7) Instructions for handling and installation of the device;

(8) Any additional information, including experimental studies and tests, required by the Commission to facilitate a determination of the safety of the device;

(c) Each device will contain no more than 50 microcuries of strontium-90 in an insoluble form;

(d) Each device will bear durable, legible labeling which includes the radiation caution symbol prescribed by § 20.1901(a) of this chapter, a statement that the device contains strontium-90 and the quantity thereof, instructions for disposal and statements that the device may be possessed pursuant to a general license, that the manufacturer or civil authorities should be notified if the device is found, that removal of the labeling is prohibited and that disassembly and repair of the device may be performed only by a person holding a specific license to manufacture or service such devices;

(e) The Commission determines that:

(1) The method of incorporation and binding of the strontium-90 in the device is such that the strontium-90 will not be released from the device under the most severe conditions which are likely to be encountered in normal use and handling of the device;

(2) The strontium-90 is incorporated or enclosed so as to preclude direct physical contact by any individual with it and is shielded so that no individual will receive a radiation exposure to a major portion of his body in excess of 0.5 rem in a year under ordinary circumstances of use;

(3) The device is so designed that it cannot be easily disassembled;

(4) Prototypes of the device have been subjected to and have satisfactorily passed the tests required by paragraph (f) of this section.

(5) Quality control procedures have been established to satisfy the requirements of § 32.62.

(f) The applicant shall subject at least five prototypes of the device to tests as follows:

(1) The devices are subjected to tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment of strontium-90, such as temperature, moisture, absolute pressure, water immersion, vibration, shock, and weathering.

(2) The devices are inspected for evidence of physical damage and for loss of strontium-90 after each stage of testing, using methods of inspection adequate for determining compliance with the criteria in paragraph (f)(3) of this section.

(3) Device designs are rejected for which the following has been detected for any unit:

(i) A leak resulting in a loss of 0.1 percent or more of the original amount of strontium-90 from the device; or

(ii) Surface contamination of strontium-90 on the device of more than 2,200 disintegrations per minute per 100 square centimeters of surface area; or

(iii) Any other evidence of physical damage.

(g) The device has been registered in the Sealed Source and Device Registry.

[30 FR 9905, Aug. 10, 1965, as amended at 43 FR 6923, Feb. 17, 1978; 56 FR 23472, May 21, 1991; 58 FR 67660, Dec. 22, 1993; 77 FR 43694, July 25, 2012]

§ 32.62 Same: Quality assurance; prohibition of transfer.

(a) Each person licensed under § 32.61 shall visually inspect each device and shall reject any which has an observable physical defect that could affect containment of the strontium-90.

(b) Each person licensed under § 32.61 shall test each device for possible loss of strontium-90 or for contamination by wiping with filter paper an area of at least 100 square centimeters on the outside surface of the device, or by wiping the entire surface area if it is less than 100 square centimeters. The detection on the filter paper of more than 2,200 disintegrations per minute of radioactive material per 100 square centimeters of surface wiped shall be cause for rejection of the tested device.

(c) Each person licensed under § 32.61 shall:

(1) Maintain quality assurance systems in the manufacture of the ice detection device containing strontium-90 in a manner sufficient to provide reasonable assurance that the safety-related components of the distributed devices are capable of performing their intended functions; and

(2) Subject inspection lots to acceptance sampling procedures, by procedures specified in paragraph (d) of this section and in the license issued under § 32.61, to provide at least 95 percent confidence that the Lot Tolerance Percent Defective of 5.0 percent will not be exceeded.

(d) Each person licensed under § 32.61 shall subject each inspection lot to:

(1) Tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could possibly affect the effective containment of strontium-90, such as absolute pressure and water immersion.

(2) Inspection for evidence of physical damage, containment failure, or for loss of strontium-90 after each stage of testing, using methods of inspection adequate to determine compliance with the following criteria for defective: A leak resulting in a loss of 0.1 percent or more of the original amount of strontium-90 from the device and any other criteria specified in the license issued under § 32.61.

(e) No person licensed under § 32.61 shall transfer to persons generally licensed under § 31.10 of this chapter, or under an equivalent general license of an Agreement State:

(1) Any ice detection device containing strontium-90 tested and found defective under the criteria specified in a license issued under § 32.61, unless the defective ice detection device has been repaired or reworked, retested, and determined by an independent inspector to meet the applicable acceptance criteria; or

(2) Any ice detection device containing strontium-90 contained within any lot that has been sampled and rejected as a result of the procedures in paragraph (c)(2) of this section, unless:

(i) A procedure for defining sub-lot size, independence, and additional testing procedures is contained in the license issued under § 32.61; and

(ii) Each individual sub-lot is sampled, tested, and accepted in accordance with paragraphs (c)(2) and (e)(2)(i) of this section and any other criteria as may be required as a condition of the license issued under § 32.61.

[30 FR 9905, Aug. 10, 1965, as amended at 39 FR 22130, June 20, 1974; 39 FR 26397, July 19, 1974; 43 FR 6923, Feb. 17, 1978; 77 FR 43694, July 25, 2012]

§ 32.71 Manufacture and distribution of byproduct material for certain in vitro clinical or laboratory testing under general license.

An application for a specific license to manufacturer or distribute byproduct material for use under the general license of § 31.11 of this chapter will be approved if:

(a) The applicant satisfies the general requirements specified in § 30.33 of this chapter.

(b) The byproduct material is to be prepared for distribution in prepackaged units of:

(1) Iodine-125 in units not exceeding 10 microcuries each.

(2) Iodine-131 in units not exceeding 10 microcuries each.

(3) Carbon-14 in units not exceeding 10 microcuries each.

(4) Hydrogen-3 (tritium) in units not exceeding 50 microcuries each.

(5) Iron-59 in units not exceeding 20 microcuries each.

(6) Selenium-75 in units not exceeding 10 microcuries each.

(7) Mock Iodine-125 in units not exceeding 0.05 microcurie of iodine-129 and 0.005 microcurie of americium-241 each.

(8) Cobalt-57 in units not exceeding 0.37 megabecquerel (10 microcuries) each.

(c) Each prepackaged unit bears a durable, clearly visible label:

(1) Identifying the radioactive contents as to chemical form and radionuclide, and indicating that the amount of radioactivity does not exceed 0.37 megabecquerel (10 microcuries) of iodine-131, iodine-125, selenium-75, or carbon-14; 1.85 megabecquerels (50 microcuries) of hydrogen-3 (tritium); or 0.74 megabecquerel (20 microcuries) of iron-59; or Mock Iodine-125 in units not exceeding 1.85 kilobecquerels (0.05 microcurie) of iodine-129 and 0.185 kilobecquerel (0.005 microcurie) of americium-241 each; or cobalt-57 in units not exceeding 0.37 megabecquerel (10 microcuries); and

(2) Displaying the radiation caution symbol described in § 20.1901(a) of this chapter and the words, “Caution, Radioactive Material”, and “Not for Internal or External Use in Humans or Animals.”

(d) The following statement, or a substantially similar statement which contains the information called for in the following statement, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package: 1

1 Labels authorized by the regulations in effect on September 26, 1979, may be used until one year from September 27, 1979.

The radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians in the practice of veterinary medicine, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of the U.S. Nuclear Regulatory Commission or of a State with which the Commission has entered into an agreement for the exercise of regulatory authority.

(Name of Manufacturer)

(e) The label affixed to the unit, or the leaflet or brochure which accompanies the package, contains adequate information as to the precautions to be observed in handling and storing such byproduct material. In the case of the Mock Iodine-125 reference or calibration source, the information accompanying the source must also contain directions to the licensee regarding the waste disposal requirements set out in § 20.2001.

[33 FR 16553, Nov. 14, 1968, as amended at 38 FR 34110, Dec. 11, 1973; 39 FR 26148, July 17, 1974; 40 FR 8786, Mar. 3, 1975; 42 FR 21604, Apr. 28, 1977; 42 FR 26987, May 26, 1977; 44 FR 50325, Aug. 28, 1979; 56 FR 23472, May 21, 1991; 58 FR 67660, Dec. 22, 1993; 72 FR 55929, Oct. 1, 2007]

§ 32.72 Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing byproduct material for medical use under part 35.

(a) An application for a specific license to manufacture, prepare, or transfer for commercial distribution radioactive drugs containing byproduct material for use by persons authorized pursuant to part 35 of this chapter will be approved if:

(1) The applicant satisfies the general requirements specified in 10 CFR 30.33;

(2) The applicant submits evidence that the applicant is at least one of the following:

(i) Registered with the U.S. Food and Drug Administration (FDA) as the owner or operator of a drug establishment that engages in the manufacture, preparation, propagation, compounding, or processing of a drug under 21 CFR 207.17(a);

(ii) Registered or licensed with a state agency as a drug manufacturer;

(iii) Licensed as a pharmacy by a State Board of Pharmacy;

(iv) Operating as a nuclear pharmacy within a Federal medical institution; or

(v) A Positron Emission Tomography (PET) drug production facility registered with a State agency.

(3) The applicant submits information on the radionuclide; the chemical and physical form; the maximum activity per vial, syringe, generator, or other container of the radioactive drug; and the shielding provided by the packaging to show it is appropriate for the safe handling and storage of the radioactive drugs by medical use licensees; and

(4) The applicant commits to the following labeling requirements:

(i) A label is affixed to each transport radiation shield, whether it is constructed of lead, glass, plastic, or other material, of a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words “CAUTION, RADIOACTIVE MATERIAL” or “DANGER, RADIOACTIVE MATERIAL”; the name of the radioactive drug or its abbreviation; and the quantity of radioactivity at a specified date and time. For radioactive drugs with a half life greater than 100 days, the time may be omitted.

(ii) A label is affixed to each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words “CAUTION, RADIOACTIVE MATERIAL” or “DANGER, RADIOACTIVE MATERIAL” and an identifier that ensures that the syringe, vial, or other container can be correlated with the information on the transport radiation shield label.

(b) A licensee described by paragraph (a)(2)(iii) or (iv) of this section:

(1) May prepare radioactive drugs for medical use, as defined in 10 CFR 35.2, provided that the radioactive drug is prepared by either an authorized nuclear pharmacist, as specified in paragraphs (b)(2) and (b)(4) of this section, or an individual under the supervision of an authorized nuclear pharmacist as specified in 10 CFR 35.27.

(2) May allow a pharmacist to work as an authorized nuclear pharmacist if:

(i) This individual qualifies as an authorized nuclear pharmacist as defined in 10 CFR 35.2,

(ii) This individual meets the requirements specified in § 35.55(b) and 35.59 of this chapter, and the licensee has received an approved license amendment identifying this individual as an authorized nuclear pharmacist; or

(iii) This individual is designated as an authorized nuclear pharmacist in accordance with paragraph (b)(4) of this section.

(3) The actions authorized in paragraphs (b)(1) and (b)(2) of this section are permitted in spite of more restrictive language in license conditions.

(4) May designate a pharmacist (as defined in § 35.2 of this chapter) as an authorized nuclear pharmacist if:

(i) The individual was a nuclear pharmacist preparing only radioactive drugs containing accelerator-produced radioactive material, and

(ii) The individual practiced at a pharmacy at a Government agency or Federally recognized Indian Tribe before November 30, 2007 or at all other pharmacies before August 8, 2009, or an earlier date as noticed by the NRC.

(5) Shall provide to the Commission:

(i) A copy of each individual's certification by a specialty board whose certification process has been recognized by the Commission or an Agreement State as specified in § 35.55(a) of this chapter; or

(ii) The Commission or Agreement State license, or

(iii) Commission master materials licensee permit, or

(iv) The permit issued by a licensee or Commission master materials permittee of broad scope or the authorization from a commercial nuclear pharmacy authorized to list its own authorized nuclear pharmacist, or

(v) Documentation that only accelerator-produced radioactive materials were used in the practice of nuclear pharmacy at a Government agency or Federally recognized Indian Tribe before November 30, 2007 or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC; and

(vi) A copy of the State pharmacy licensure or registration, no later than 30 days after the date that the licensee allows, under paragraphs (b)(2)(i) and (b)(2)(iii) of this section, the individual to work as an authorized nuclear pharmacist.

(c) A licensee shall possess and use instrumentation to measure the radioactivity of radioactive drugs. The licensee shall have procedures for use of the instrumentation. The licensee shall measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha-, beta-, or photon-emitting radioactive drugs prior to transfer for commercial distribution. In addition, the licensee shall:

(1) Perform tests before initial use, periodically, and following repair, on each instrument for accuracy, linearity, and geometry dependence, as appropriate for the use of the instrument; and make adjustments when necessary; and

(2) Check each instrument for constancy and proper operation at the beginning of each day of use.

(d) A licensee shall satisfy the labeling requirements in paragraph (a)(4) of this section.

(e) Nothing in this section relieves the licensee from complying with applicable FDA, other Federal, and State requirements governing radioactive drugs.

[59 FR 61780, Dec. 2, 1994; 59 FR 65244, Dec. 19, 1994, as amended at 60 FR 324, Jan. 4, 1995; 67 FR 20370, Apr. 24, 2002; 67 FR 62872, Oct. 9, 2002; 67 FR 77652, Dec. 19, 2002; 71 FR 15007, Mar. 27, 2006; 72 FR 45150, Aug. 13, 2007; 72 FR 55929, Oct. 1, 2007; 83 FR 33101, July 16, 2018; 88 FR 57878, Aug. 24, 2023]

§ 32.74 Manufacture and distribution of sources or devices containing byproduct material for medical use.

(a) An application for a specific license to manufacture and distribute sources and devices containing byproduct material to persons licensed under part 35 of this chapter for use as a calibration, transmission, or reference source or for the uses listed in §§ 35.400, 35.500, 35.600, and 35.1000 of this chapter will be approved if:

(1) The applicant satisfies the general requirements in § 30.33 of this chapter;

(2) The applicant submits sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including:

(i) The byproduct material contained, its chemical and physical form, and amount;

(ii) Details of design and construction of the source or device;

(iii) Procedures for, and results of, prototype tests to demonstrate that the source or device will maintain its integrity under stresses likely to be encountered in normal use and accidents;

(iv) For devices containing byproduct material, the radiation profile of a prototype device;

(v) Details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests;

(vi) Procedures and standards for calibrating sources and devices;

(vii) Legend and methods for labeling sources and devices as to their radioactive content;

(viii) Instructions for handling and storing the source or device from the radiation safety standpoint; these instructions are to be included on a durable label attached to the source or device or attached to a permanent storage container for the source or device: Provided, That instructions which are too lengthy for such label may be summarized on the label and printed in detail on a brochure which is referenced on the label;

(3) The label affixed to the source or device, or to the permanent storage container for the source or device, contains information on the radionuclide, quantity and date of assay, and a statement that the U.S. Nuclear Regulatory Commission has approved distribution of the (name of source or device) to persons licensed to use byproduct material identified in §§ 35.65, 35.400, 35.500, and 35.600 as appropriate, and to persons who hold an equivalent license issued by an Agreement State. However, labels worded in accordance with requirements that were in place on March 30, 1987 may be used until March 30, 1989.

(4) The source or device has been registered in the Sealed Source and Device Registry.

(b)(1) In the event the applicant desires that the source or device be required to be tested for leakage of radioactive material at intervals longer than six months, he shall include in his application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the source or device or similar sources or devices and by design features that have a significant bearing on the probability or consequences of leakage of radioactive material from the source.

(2) In determining the acceptable interval for test of leakage of radioactive material, the Commission will consider information that includes, but is not limited to:

(i) Primary containment (source capsule);

(ii) Protection of primary containment;

(iii) Method of sealing containment;

(iv) Containment construction materials;

(v) Form of contained radioactive material;

(vi) Maximum temperature withstood during prototype tests;

(vii) Maximum pressure withstood during prototype tests;

(viii) Maximum quantity of contained radioactive material;

(ix) Radiotoxicity of contained radioactive material;

(x) Operating experience with identical sources or devices or similarly designed and constructed sources or devices.

(c) If an application is filed pursuant to paragraph (a) of this section on or before October 15, 1974, for a license to manufacture and distribute a source or device that was distributed commercially on or before August 16, 1974, the applicant may continue the distribution of such source or device to group licensees until the Commission issues the license or notifies the applicant otherwise.

[39 FR 26149, July 17, 1974, as amended at 51 FR 36967, Oct. 16, 1986; 62 FR 59276, Nov. 3, 1997; 67 FR 20370, Apr. 24, 2002; 71 FR 15008, Mar. 27, 2006; 72 FR 45150, Aug. 13, 2007; 77 FR 43695, July 25, 2012]

§ 32.201 Serialization of nationally tracked sources.

Each licensee who manufactures a nationally tracked source after February 6, 2007 shall assign a unique serial number to each nationally tracked source. Serial numbers must be composed only of alpha-numeric characters.

[71 FR 65709, Nov. 8, 2006]

§ 32.210 Registration of product information.

(a) Any manufacturer or initial distributor of a sealed source or device containing a sealed source may submit a request to the NRC for evaluation of radiation safety information about its product and for its registration.

(b) The request for review must be sent to the NRC's Office of Nuclear Material Safety and Safeguards, ATTN: SSDR by an appropriate method listed in § 30.6(a) of this chapter.

(c) The request for review of a sealed source or a device must include sufficient information about the design, manufacture, prototype testing, quality control program, labeling, proposed uses and leak testing and, for a device, the request must also include sufficient information about installation, service and maintenance, operating and safety instructions, and its potential hazards, to provide reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property.

(d) The NRC normally evaluates a sealed source or a device using radiation safety criteria in accepted industry standards. If these standards and criteria do not readily apply to a particular case, the NRC formulates reasonable standards and criteria with the help of the manufacturer or distributor. The NRC shall use criteria and standards sufficient to ensure that the radiation safety properties of the device or sealed source are adequate to protect health and minimize danger to life and property. Subpart A of this part includes specific criteria that apply to certain exempt products and subpart B includes specific criteria applicable to certain generally licensed devices. Subpart C includes specific provisions that apply to certain specifically licensed items.

(e) After completion of the evaluation, the Commission issues a certificate of registration to the person making the request. The certificate of registration acknowledges the availability of the submitted information for inclusion in an application for a specific license proposing use of the product, or concerning use under an exemption from licensing or general license as applicable for the category of certificate.

(f) The person submitting the request for evaluation and registration of safety information about the product shall manufacture and distribute the product in accordance with—

(1) The statements and representations, including quality control program, contained in the request; and

(2) The provisions of the registration certificate.

(g) Authority to manufacture or initially distribute a sealed source or device to specific licensees may be provided in the license without the issuance of a certificate of registration in the following cases:

(1) Calibration and reference sources containing no more than:

(i) 37 MBq (1 mCi), for beta and/or gamma emitting radionuclides; or

(ii) 0.37 MBq (10 µCi), for alpha emitting radionuclides; or

(2) The intended recipients are qualified by training and experience and have sufficient facilities and equipment to safely use and handle the requested quantity of radioactive material in any form in the case of unregistered sources or, for registered sealed sources contained in unregistered devices, are qualified by training and experience and have sufficient facilities and equipment to safely use and handle the requested quantity of radioactive material in unshielded form, as specified in their licenses; and

(i) The intended recipients are licensed under part 33 of this chapter or comparable provisions of an Agreement State; or

(ii) The recipients are authorized for research and development; or

(iii) The sources and devices are to be built to the unique specifications of the particular recipient and contain no more than 740 GBq (20 Ci) of tritium or 7.4 GBq (200 mCi) of any other radionuclide.

(h) After the certificate is issued, the Commission may conduct an additional review as it determines is necessary to ensure compliance with current regulatory standards. In conducting its review, the Commission will complete its evaluation in accordance with criteria specified in this section. The Commission may request such additional information as it considers necessary to conduct its review and the certificate holder shall provide the information as requested.

[52 FR 27786, July 24, 1987, as amended at 60 FR 24551, May 9, 1995; 68 FR 58805, Oct. 10, 2003; 73 FR 5719, Jan. 31, 2008; 77 FR 43695, July 25, 2012]

§ 32.211 Inactivation of certificates of registration of sealed sources and devices.

(a) A certificate holder who no longer manufactures or initially transfers any of the sealed source(s) or device(s) covered by a particular certificate issued by the Commission shall request inactivation of the registration certificate. Such a request must be made to the NRC's Office of Nuclear Material Safety and Safeguards, ATTN: SSDR by an appropriate method listed in § 30.6(a) of this chapter and must normally be made no later than two years after initial distribution of all of the source(s) or device(s) covered by the certificate has ceased. However, if the certificate holder determines that an initial transfer was in fact the last initial transfer more than two years after that transfer, the certificate holder shall request inactivation of the certificate within 90 days of this determination and briefly describe the circumstances of the delay.

(b) If a distribution license is to be terminated in accordance with § 30.36 of this chapter, the licensee shall request inactivation of its registration certificates associated with that distribution license before the Commission will terminate the license. Such a request for inactivation of certificate(s) must indicate that the license is being terminated and include the associated specific license number.

(c) A specific license to manufacture or initially transfer a source or device covered only by an inactivated certificate no longer authorizes the licensee to initially transfer such sources or devices for use. Servicing of devices must be in accordance with any conditions in the certificate, including in the case of an inactive certificate.

[77 FR 43695, July 25, 2012]

§ 32.301 Violations.

(a) The Commission may obtain an injunction or other court order to prevent a violation of the provisions of—

(1) The Atomic Energy Act of 1954, as amended;

(2) Title II of the Energy Reorganization Act of 1974, as amended; or

(3) A regulation or order issued pursuant to those Acts.

(b) The Commission may obtain a court order for the payment of a civil penalty imposed under section 234 of the Atomic Energy Act:

(1) For violations of—

(i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Atomic Energy Act of 1954, as amended;

(ii) Section 206 of the Energy Reorganization Act;

(iii) Any rule, regulation, or order issued pursuant to the sections specified in paragraph (b)(1)(i) of this section;

(iv) Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(i) of this section.

(2) For any violation for which a license may be revoked under section 186 of the Atomic Energy Act of 1954, as amended.

[57 FR 55073, Nov. 24, 1992]

§ 32.303 Criminal penalties.

(a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all the regulations in part 32 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section.

(b) The regulations in part 32 that are not issued under subsections 161b, 161i, or 161o for the purposes of section 223 are as follows: §§ 32.1, 32.2, 32.8, 32.11, 32.14, 32.18, 32.21, 32.22, 32.23, 32.24, 32.26, 32.27, 32.28, 32.30, 32.31, 32.51, 32.53, 32.57, 32.61, 32.71, 32.72, 32.74, 32.301, and 32.303.

[57 FR 55073, Nov. 24, 1992, as amended at 59 FR 61781, Dec. 2, 1994; 73 FR 42674, July 23, 2008; 77 FR 43696, July 25, 2012]

§ 33.1 Purpose and scope.

This part prescribes requirements for the issuance of specific licenses of broad scope for byproduct material (“broad licenses”) and certain regulations governing holders of such licenses. The provisions and requirements of this part are in addition to, and not in substitution for, other requirements of this chapter. In particular, the provisions of parts 30 and 37 of this chapter apply to applications and licenses subject to this part.

[78 FR 17006, Mar. 19, 2013]

§ 33.8 Information collection requirements: OMB approval.

(a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150-0015.

(b) The approved information collection requirements contained in this part appear in §§ 33.12, 33.13, 33.14 and 33.15.

(c) This part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section. These information collection requirements and the control numbers under which they are approved are as follows:

(1) In § 33.12, NRC Form 313 is approved under control number 3150-0120.

(2) [Reserved]

[49 FR 19625, May 9, 1984, as amended at 62 FR 52186, Oct. 6, 1997; 67 FR 67099, Nov. 4, 2002]

§ 33.11 Types of specific licenses of broad scope.

(a) A “Type A specific license of broad scope” is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of the byproduct material specified in the license, but not exceeding quantities specified in the license, for purposes authorized by the Act. The quantities specified are usually in the multicurie range.

(b) A “Type B specific license of broad scope” is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of byproduct material specified in § 33.100, Schedule A, of this part for purposes authorized by the Act. The possession limit for a Type B broad license, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in § 33.100, Schedule A, Column I. If two or more radionuclides are possessed thereunder, the possession limit for each is determined as follows: For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified in § 33.100, Schedule A, Column I, for that radionuclide. The sum of the ratios for all radionuclides possessed under the license shall not exceed unity.

(c) A “Type C specific license of broad scope” is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of byproduct material specified in § 33.100, Schedule A, for purposes authorized by the Act. The possession limit for a Type C broad license, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in § 33.100, Schedule A, Column II. If two or more radionuclides are possessed thereunder, the possession limit is determined for each as follows: For each radionuclide determine the ratio of the quantity possessed to the applicable quantity specified in § 33.100, Schedule A, Column II, for that radionuclide. The sum of the ratios for all radionuclides possessed under the license shall not exceed unity.

(Sec. 161, as amended, Pub. L. 83-703, 68 Stat. 948 (42 U.S.C. 2201); sec. 201, as amended, Pub. L. 93-438, 88 Stat. 1243 (42 U.S.C. 5841))

[33 FR 14579, Sept. 28, 1968, as amended at 43 FR 6923, Feb. 17, 1978]

§ 33.12 Applications for specific licenses of broad scope.

A person may file an application for specific license of broad scope on NRC Form 313, “Application for Material License,” in accordance with the provisions of § 30.32 of this chapter.

[68 FR 58805, Oct. 10, 2003]

§ 33.13 Requirements for the issuance of a Type A specific license of broad scope.

An application for a Type A specific license of broad scope will be approved if:

(a) The applicant satisfies the general requirements specified in § 30.33 of this chapter;

(b) The applicant has engaged in a reasonable number of activities involving the use of byproduct material; and

(c) The applicant has established administrative controls and provisions relating to organization and management, procedures, record keeping, material control, and accounting and management review that are necessary to assure safe operations, including:

(1) The establishment of a radiation safety committee composed of such persons as a radiological safety officer, a representative of management, and persons trained and experienced in the safe use of radioactive materials;

(2) The appointment of a radiological safety officer who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiological safety matters; and

(3) The establishment of appropriate administrative procedures to assure:

(i) Control of procurement and use of byproduct material;

(ii) Completion of safety evaluations of proposed uses of byproduct material which take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures; and

(iii) Review, approval, and recording by the radiation safety committee of safety evaluations of proposed uses prepared in accordance with paragraph (c)(3)(ii) of this section prior to use of the byproduct material.

§ 33.14 Requirements for the issuance of a Type B specific license of broad scope.

An application for a Type B specific license of broad scope will be approved if:

(a) The applicant satisfies the general requirements specified in § 30.33 of this chapter; and

(b) The applicant has established administrative controls and provisions relating to organization and management, procedures, record keeping, material control and accounting, and management review that are necessary to assure safe operations, including:

(1) The appointment of a radiological safety officer who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiological safety matters; and

(2) The establishment of appropriate administrative procedures to assure:

(i) Control of procurement and use of byproduct material;

(ii) Completion of safety evaluations of proposed uses of byproduct material which take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures; and

(iii) Review, approval, and recording by the radiological safety officer of safety evaluations of proposed uses prepared in accordance with paragraph (b)(2)(ii) of this section prior to use of the byproduct material.

§ 33.15 Requirements for the issuance of a Type C specific license of broad scope.

An application for a Type C specific license of broad scope will be approved if:

(a) The applicant satisfies the general requirements specified in § 30.33 of this chapter; and

(b) The applicant submits a statement that byproduct material will be used only by, or under the direct supervision of, individuals who have received:

(1) A college degree at the bachelor level, or equivalent training and experience, in the physical or biological sciences or in engineering; and

(2) At least 40 hours of training and experience in the safe handling of radioactive materials, and in the characteristics of ionizing radiation, units of radiation dose and quantities, radiation detection instrumentation, and biological hazards of exposure to radiation appropriate to the type and forms of byproduct material to be used; and

(c) The applicant has established administrative controls and provisions relating to procurement of byproduct material, procedures, record keeping, material control and accounting, and management review necessary to assure safe operations.

§ 33.16 Application for other specific licenses.

An application filed pursuant to part 30 of this chapter for a specific license other than one of broad scope will be considered by the Commission as an application for a specific license of broad scope under this part if the requirements of the applicable sections of this part are satisfied.

§ 33.17 Conditions of specific licenses of broad scope.

(a) Unless specifically authorized pursuant to other parts of this chapter, persons licensed under this part shall not:

(1) Conduct tracer studies in the environment involving direct release of byproduct material;

(2) Receive, acquire, own, possess, use, transfer, or import devices containing 100,000 curies or more of byproduct material in sealed sources used for irradiation of materials;

(3) Conduct activities for which a specific license issued by the Commission under part 32, 34, or 35 of this chapter is required; or

(4) Add or cause the addition of byproduct material to any food, beverage, cosmetic, drug, or other product designed for ingestion or inhalation by, or application to, a human being.

(b) Each Type A specific license of broad scope issued under this part shall be subject to the condition that byproduct material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's radiation safety committee.

(c) Each Type B specific license of broad scope issued under this part shall be subject to the condition that byproduct material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's radiological safety officer.

(d) Each Type C specific license of broad scope issued under this part shall be subject to the condition that byproduct material possessed under the license may only be used by, or under the direct supervision of, individuals who satisfy the requirements of § 33.15 of this part.

§ 33.21 Violations.

(a) The Commission may obtain an injunction or other court order to prevent a violation of the provisions of—

(1) The Atomic Energy Act of 1954, as amended;

(2) Title II of the Energy Reorganization Act of 1974, as amended; or

(3) A regulation or order issued pursuant to those Acts.

(b) The Commission may obtain a court order for the payment of a civil penalty imposed under section 234 of the Atomic Energy Act:

(1) For violations of—

(i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Atomic Energy Act of 1954, as amended;

(ii) Section 206 of the Energy Reorganization Act;

(iii) Any rule, regulation, or order issued pursuant to the sections specified in paragraph (b)(1)(i) of this section;

(iv) Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(i) of this section.

(2) For any violation for which a license may be revoked under section 186 of the Atomic Energy Act of 1954, as amended.

[57 FR 55073, Nov. 24, 1992]

§ 33.23 Criminal penalties.

(a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all the regulations in part 33 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section.

(b) The regulations in part 33 that are not issued under sections 161b, 161i, or 161o for the purposes of section 223 are as follows: §§ 33.1, 33.8, 33.11, 33.12, 33.13, 33.14, 33.15, 33.16, 33.21, 33.23 and 33.100.

[57 FR 55073, Nov. 24, 1992]

§ 33.100 Schedule A.

Byproduct material | Col. I curies | Col. II curies

Antimony-122 | 1 | 0.01

Antimony-124 | 1 | .01

Antimony-125 | 1 | .01

Arsenic-73 | 10 | .1

Arsenic-74 | 1 | .01

Arsenic-76 | 1 | .01

Arsenic-77 | 10 | .1

Barium-131 | 10 | .1

Barium-140 | 1 | .01

Beryllium-7 | 10 | 0.1

Bismuth-210 | .1 | .001

Bromine-82 | 10 | .1

Cadmium-109 | 1 | .01

Cadmium-115m | 1 | .01

Cadmium-115 | 10 | .1

Calcium-45 | 1 | .01

Calcium-47 | 10 | .1

Carbon-14 | 100 | 1.

Cerium-141 | 10 | .1

Cerium-143 | 10 | .1

Cerium-144 | .1 | .001

Cesium-131 | 100 | 1.

Cesium-134m | 100 | 1.

Cesium-134 | .1 | .001

Cesium-135 | 1 | .01

Cesium-136 | 10 | .1

Cesium-137 | .1 | .001

Chlorine-36 | 1 | .01

Chlorine-38 | 100 | 1.

Chromium-51 | 100 | 1.

Cobalt-57 | 10 | 0.1

Cobalt-58m | 100 | 1.

Cobalt-58 | 1 | .01

Cobalt-60 | .1 | .001

Copper-64 | 10 | .1

Dysprosium-165 | 100 | 1.

Dysprosium-166 | 10 | .1

Erbium-169 | 10 | .1

Erbium-171 | 10 | .1

Europium-152 9.2 h | 10 | .1

Europium-152 13 y | .1 | .001

Europium-154 | .1 | .001

Europium-155 | 1 | .01

Fluorine-18 | 100 | 1.

Gadolinium-153 | 1 | .01

Gadolinium-159 | 10 | .1

Gallium-72 | 10 | .1

Germanium-71 | 100 | 1

Gold-198 | 10 | .1

Gold-199 | 10 | .1

Hafnium-181 | 1 | .01

Holmium-166 | 10 | .1

Hydrogen-3 | 100 | 1

Indium-113m | 100 | 1

Indium-114m | 1 | .01

Indium-115m | 100 | 1

Indium-115 | 1 | .01

Iodine-125 | .1 | .001

Iodine-126 | .1 | .001

Iodine-129 | .1 | .01

Iodine-131 | .1 | .001

Iodine-132 | 10 | .1

Iodine-133 | 1 | .01

Iodine-134 | 10 | .1

Iodine-135 | 1 | .01

Iridium-192 | 1 | .01

Iridium-194 | 10 | .1

Iron-55 | 10 | .1

Iron-59 | 1 | .01

Krypton-85 | 100 | 1

Krypton-87 | 10 | .1

Lanthanum-140 | 1 | .01

Lutetium-177 | 10 | .1

Manganese-52 | 1 | .01

Manganese-54 | 1 | .01

Manganese-56 | 10 | .1

Mercury-197m | 10 | .1

Mercury-197 | 10 | .1

Mercury-203 | 1 | .01

Molybdenum-99 | 10 | .1

Neodymium-147 | 10 | .1

Neodymium-149 | 10 | .1

Nickel-59 | 10 | .1

Nickel-63 | 1 | .01

Nickel-65 | 10 | .1

Niobium-93m | 1 | .01

Niobium-95 | 1 | .01

Niobium-97 | 100 | 1.

Osmium-185 | 1 | .01

Osmium-191m | 100 | 1.

Osmium-191 | 10 | .1

Osmium-193 | 10 | .1

Palladium-103 | 10 | .1

Palladium-109 | 10 | .1

Phosphorus-32 | 1 | .01

Platinum-191 | 10 | .1

Platinum-193m | 100 | 1.

Platinum-193 | 10 | .1

Platinum-197m | 100 | 1

Platinum-197 | 10 | .1

Polonium-210 | .01 | .0001

Potassium-42 | 1 | .01

Praseodymium-142 | 10 | .1

Praseodymium-143 | 10 | .1

Promethium-147 | 1 | .01

Promethium-149 | 10 | .1

Radium-226 | 0.01 | 0.0001

Rhenium-186 | 10 | .1

Rhenium-188 | 10 | .1

Rhodium-103m | 1,000 | 10.

Rhodium-105 | 10 | .1

Rubidium-86 | 1 | .01

Rubidium-87 | 1 | .01

Ruthenium-97 | 100 | 1.

Ruthenium-103 | 1 | .01

Ruthenium-105 | 10 | .1

Ruthenium-106 | .1 | .001

Samarium-151 | 1 | .01

Samarium-153 | 10 | .1

Scandium-46 | 1 | .01

Scandium-47 | 10 | .1

Scandium-48 | 1 | .01

Selenium-75 | 1 | .01

Silicon-31 | 10 | .1

Silver-105 | 1 | .01

Silver-110m | .1 | .001

Silver-111 | 10 | .1

Sodium-22 | 0.1 | 0.001

Sodium-24 | 1 | .01

Strontium-85m | 1,000 | 10.

Strontium-85 | 1 | .01

Strontium-89 | 1 | .01

Strontium-90 | .01 | .0001

Strontium-91 | 10 | .1

Strontium-92 | 10 | .1

Sulphur-35 | 10 | .1

Tantalum-182 | 1 | .01

Technetium-96 | 10 | .1

Technetium-97m | 10 | .1

Technetium-97 | 10 | .1

Technetium-99m | 100 | 1.

Technetium-99 | 1 | .01

Tellurium-125m | 1 | .01

Tellurium-127m | 1 | .01

Tellurium-127 | 10 | .1

Tellurium-129m | 1 | .01

Tellurium-129 | 100 | 1

Tellurium-131m | 10 | .1

Tellurium-132 | 1 | .01

Terbium-160 | 1 | .01

Thallium-200 | 10 | .1

Thallium-201 | 10 | .1

Thallium-202 | 10 | .1

Thallium-204 | 1 | .01

Thulium-170 | 1 | .01

Thulium-171 | 1 | .01

Tin-113 | 1 | .01

Tin-125 | 1 | .01

Tungsten-181 | 1 | .01

Tungsten-185 | 1 | .01

Tungsten-187 | 10 | .1

Vanadium-48 | 1 | .01

Xenon-131m | 1,000 | 10.

Xenon-133 | 100 | 1.

Xenon-135 | 100 | 1.

Ytterbium-175 | 10 | .1

Yttrium-90 | 1 | .01

Yttrium-91 | 1 | .01

Yttrium-92 | 10 | .1

Yttrium-93 | 1 | .01

Zinc-65 | 1 | .01

Zinc-69m | 10 | .1

Zinc-69 | 100 | 1.

Zirconium-93 | 1 | .01

Zirconium-95 | 1 | .01

Zirconium-97 | 1 | .01

Any byproduct material other than alpha emitting byproduct material not listed above | .1 | .001

(Sec. 201, Pub. L. 93-438; 88 Stat. 1242 (42 U.S.C. 5841))

[33 FR 14579, Sept. 28, 1968, as amended at 72 FR 55930, Oct. 1, 2007]

§ 34.1 Purpose and scope.

This part prescribes requirements for the issuance of licenses for the use of sealed sources containing byproduct material and radiation safety requirements for persons using these sealed sources in industrial radiography. The provisions and requirements of this part are in addition to, and not in substitution for, other requirements of this chapter. In particular, the requirements and provisions of parts 19, 20, 21, 30, 37, 71, 150, 170, and 171 of this chapter apply to applications and licenses subject to this part. This rule does not apply to medical uses of byproduct material.

[78 FR 17006, Mar. 19, 2013]

§ 34.3 Definitions.

ALARA (acronym for “as low as is reasonably achievable”) means making every reasonable effort to maintain exposures to radiation as far below the dose limits specified in 10 CFR part 20 as is practical consistent with the purpose for which the licensed activity is undertaken, taking into account the state of technology, the economics of improvements in relation to state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed materials in the public interest.

Annual refresher safety training means a review conducted or provided by the licensee for its employees on radiation safety aspects of industrial radiography. The review may include, as appropriate, the results of internal inspections, new procedures or equipment, new or revised regulations, accidents or errors that have been observed, and should also provide opportunities for employees to ask safety questions.

Associated equipment means equipment that is used in conjunction with a radiographic exposure device to make radiographic exposures that drives, guides, or comes in contact with the source, (e.g., guide tube, control tube, control (drive) cable, removable source stop, “J” tube and collimator when it is used as an exposure head.

Becquerel (Bq) means one disintegration per second.

Certifying Entity means an independent certifying organization meeting the requirements in appendix A of this part or an Agreement State meeting the requirements in appendix A, parts II and III of this part.

Collimator means a radiation shield that is placed on the end of the guide tube or directly onto a radiographic exposure device to restrict the size of the radiation beam when the sealed source is cranked into position to make a radiographic exposure.

Control (drive) cable means the cable that is connected to the source assembly and used to drive the source to and from the exposure location.

Control drive mechanism means a device that enables the source assembly to be moved to and from the exposure device.

Control tube means a protective sheath for guiding the control cable. The control tube connects the control drive mechanism to the radiographic exposure device.

Exposure head means a device that locates the gamma radiography sealed source in the selected working position. (An exposure head is also known as a source stop.)

Field station means a facility where licensed material may be stored or used and from which equipment is dispatched.

Gray means the SI unit of absorbed dose. One gray is equal to an absorbed dose of 1 Joule/kilogram. It is also equal to 100 rads.

Guide tube (Projection sheath) means a flexible or rigid tube (i.e., “J” tube) for guiding the source assembly and the attached control cable from the exposure device to the exposure head. The guide tube may also include the connections necessary for attachment to the exposure device and to the exposure head.

Hands-on experience means experience in all of those areas considered to be directly involved in the radiography process.

Independent certifying organization means an independent organization that meets all of the criteria of appendix A to this part.

Industrial radiography (radiography) means an examination of the structure of materials by nondestructive methods, utilizing ionizing radiation to make radiographic images.

Lay-barge radiography means industrial radiography performed on any water vessel used for laying pipe.

Offshore platform radiography means industrial radiography conducted from a platform over a body of water.

Permanent radiographic installation means an enclosed shielded room, cell, or vault, not located at a temporary jobsite, in which radiography is performed.

Practical Examination means a demonstration through practical application of the safety rules and principles in industrial radiography including use of all appropriate equipment and procedures.

Radiation Safety Officer for industrial radiography means an individual with the responsibility for the overall radiation safety program on behalf of the licensee and who meets the requirements of § 34.42.

Radiographer means any individual who performs or who, in attendance at the site where the sealed source or sources are being used, personally supervises industrial radiographic operations and who is responsible to the licensee for assuring compliance with the requirements of the Commission's regulations and the conditions of the license.

Radiographer certification means written approval received from a certifying entity stating that an individual has satisfactorily met certain established radiation safety, testing, and experience criteria.

Radiographer's assistant means any individual who under the direct supervision of a radiographer, uses radiographic exposure devices, sealed sources or related handling tools, or radiation survey instruments in industrial radiography.

Radiographic exposure device (also called a camera, or a projector) means any instrument containing a sealed source fastened or contained therein, in which the sealed source or shielding thereof may be moved, or otherwise changed, from a shielded to unshielded position for purposes of making a radiographic exposure.

Radiographic operations means all activities associated with the presence of radioactive sources in a radiographic exposure device during use of the device or transport (except when being transported by a common or contract transport), to include surveys to confirm the adequacy of boundaries, setting up equipment and any activity inside restricted area boundaries.

S-tube means a tube through which the radioactive source travels when inside a radiographic exposure device.

Sealed source means any byproduct material that is encased in a capsule designed to prevent leakage or escape of the byproduct material.

Shielded position means the location within the radiographic exposure device or source changer where the sealed source is secured and restricted from movement.

Sievert means the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sieverts is equal to the absorbed dose in grays multiplied by the quality factor (1 Sv = 100 rems).

Source assembly means an assembly that consists of the sealed source and a connector that attaches the source to the control cable. The source assembly may also include a stop ball used to secure the source in the shielded position.

Source changer means a device designed and used for replacement of sealed sources in radiographic exposure devices, including those also used for transporting and storage of sealed sources.

Storage area means any location, facility, or vehicle which is used to store or to secure a radiographic exposure device, a storage container, or a sealed source when it is not in use and which is locked or has a physical barrier to prevent accidental exposure, tampering with, or unauthorized removal of the device, container, or source.

Storage container means a container in which sealed sources are secured and stored.

Temporary jobsite means a location where radiographic operations are conducted and where licensed material may be stored other than those location(s) of use authorized on the license.

Underwater radiography means industrial radiography performed when the radiographic exposure device and/or related equipment are beneath the surface of the water.

§ 34.5 Interpretations.

Except as specifically authorized by the Commission in writing, no interpretation of the meaning of the regulations in this part by any officer or employee of the Commission, other than a written interpretation by the General Counsel, will be recognized to be binding upon the Commission. This section shall cease to have effect on January 8, 2027, unless the NRC determines that the cessation deadline should be extended to a date not more than 5 years in the future after offering the public an opportunity to provide input on the costs and benefits of this section and considering that input. The NRC will publish a document in the Federal Register announcing its determination and revising or removing this section accordingly.

[62 FR 28963, May 28, 1997, as amended at 90 FR 55629, Dec. 3, 2025]

§ 34.8 Information collection requirements: OMB approval.

(a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may nor conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150-0007.

(b) The approved information collection requirements contained in this part appear in §§ 34.13, 34.20, 34.25, 34.27, 34.29, 34.31, 34.33, 34.35, 34.41, 34.42, 34.43, 34.45, 34.47, 34.49, 34.61, 34.63, 34.65, 34.67, 34.69, 34.71, 34.73, 34.75, 34.79, 34.81, 34.83, 34.85, 34.87, 34.89, 34.101, 34.111, and appendix A.

(c) This part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section. The information collection requirements and the control numbers under which it is approved are as follows:

(1) In § 34.11, NRC Form 313 is approved under control number 3150-0120.

(2) [Reserved]

[62 FR 52186, Oct. 6, 1997, as amended at 75 FR 73942, Nov. 30, 2010; 85 FR 65662, Oct. 16, 2020]

§ 34.11 Application for a specific license.

A person may file an application for specific license for use of sealed sources in industrial radiography on NRC Form 313, “Application for Material License,” in accordance with the provisions of § 30.32 of this chapter.

[68 FR 58805, Oct. 10, 2003]

§ 34.13 Specific license for industrial radiography.

An application for a specific license for the use of licensed material in industrial radiography will be approved if the applicant meets the following requirements:

(a) The applicant satisfies the general requirements specified in § 30.33 of this chapter for byproduct material, as appropriate, and any special requirements contained in this part.

(b) The applicant submits an adequate program for training radiographers and radiographers' assistants that meets the requirements of § 34.43.

(1) After May 28, 1999, a license applicant need not describe its initial training and examination program for radiographers in the subjects outlined in § 34.43(g).

(2) From June 27, 1997 to May 28, 1999 a license applicant may affirm that all individuals acting as industrial radiographers will be certified in radiation safety by a certifying entity before commencing duty as radiographers. This affirmation substitutes for a description of its initial training and examination program for radiographers in the subjects outlined in § 34.43(g).

(c) The applicant submits procedures for verifying and documenting the certification status of radiographers and for ensuring that the certification of individuals acting as radiographers remains valid.

(d) The applicant submits written operating and emergency procedures as described in § 34.45.

(e) The applicant submits a description of a program for inspections of the job performance of each radiographer and radiographers' assistant at intervals not to exceed 6 months as described in § 34.43(e).

(f) The applicant submits a description of the applicant's overall organizational structure as it applies to the radiation safety responsibilities in industrial radiography, including specified delegation of authority and responsibility.

(g) The applicant identifies and lists the qualifications of the individual(s) designated as the RSO (§ 34.42) and potential designees responsible for ensuring that the licensee's radiation safety program is implemented in accordance with approved procedures.

(h) If an applicant intends to perform leak testing of sealed sources or exposure devices containing depleted uranium (DU) shielding, the applicant must describe the procedures for performing and the qualifications of the person(s) authorized to do the leak testing. If the applicant intends to analyze its own wipe samples, the application must include a description of the procedures to be followed. The description must include the—

(1) Instruments to be used;

(2) Methods of performing the analysis; and

(3) Pertinent experience of the person who will analyze the wipe samples.

(i) If the applicant intends to perform “in-house” calibrations of survey instruments the applicant must describe methods to be used and the relevant experience of the person(s) who will perform the calibrations. All calibrations must be performed according to the procedures described and at the intervals prescribed in § 34.25.

(j) The applicant identifies and describes the location(s) of all field stations and permanent radiographic installations.

(k) The applicant identifies the locations where all records required by this part and other parts of this chapter will be maintained.

§ 34.20 Performance requirements for industrial radiography equipment.

Equipment used in industrial radiographic operations must meet the following minimum criteria:

(a)(1) Each radiographic exposure device, source assembly or sealed source, and all associated equipment must meet the requirements specified in American National Standards Institute, N432-1980 “Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography,” (published as NBS Handbook 136, issued January 1981). This publication has been approved for incorporation by reference by the Director of the Federal Register in accordance with 5 U.S.C. 552(a)and 1 CFR part 51. This publication may be purchased from the American National Standards Institute, Inc., 25 West 43rd Street, New York, New York 10036; Telephone: (212) 642-4900. Copies of the document are available for inspection at the Nuclear Regulatory Commission Library, 11545 Rockville Pike, Rockville, Maryland 20852. A copy of the document is also on file 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) Engineering analysis may be submitted by an applicant or licensee to demonstrate the applicability of previously performed testing on similar individual radiography equipment components. Upon review, the Commission may find this an acceptable alternative to actual testing of the component pursuant to the above referenced standard.

(b) In addition to the requirements specified in paragraph (a) of this section, the following requirements apply to radiographic exposure devices, source changers, source assemblies and sealed sources.

(1) The licensee shall ensure that each radiographic exposure device has attached to it a durable, legible, clearly visible label bearing the—

(i) Chemical symbol and mass number of the radionuclide in the device;

(ii) Activity and the date on which this activity was last measured;

(iii) Model (or product code) and serial number of the sealed source;

(iv) Manufacturer's identity of the sealed source; and

(v) Licensee's name, address, and telephone number.

(2) Radiographic exposure devices intended for use as Type B transport containers must meet the applicable requirements of 10 CFR part 71.

(3) Modification of radiographic exposure devices, source changers, and source assemblies and associated equipment is prohibited, unless the design of any replacement component,including source holder, source assembly, controls or guide tubes would not compromise the design safety features of the system.

(c) In addition to the requirements specified in paragraphs (a) and (b) of this section, the following requirements apply to radiographic exposure devices, source assemblies, and associated equipment that allow the source to be moved out of the device for radiographic operations or to source changers.

(1) The coupling between the source assembly and the control cable must be designed in such a manner that the source assembly will not become disconnected if cranked outside the guide tube. The coupling must be such that it cannot be unintentionally disconnected under normal and reasonably foreseeable abnormal conditions.

(2) The device must automatically secure the source assembly when it is cranked back into the fully shielded position within the device. This securing system may only be released by means of a deliberate operation on the exposure device.

(3) The outlet fittings, lock box, and drive cable fittings on each radiographic exposure device must be equipped with safety plugs or covers which must be installed during storage and transportation to protect the source assembly from water, mud, sand or other foreign matter.

(4)(i) Each sealed source or source assembly must have attached to it or engraved on it, a durable, legible, visible label with the words: “DANGER—RADIOACTIVE.”

(ii) The label may not interfere with the safe operation of the exposure device or associated equipment.

(5) The guide tube must be able to withstand a crushing test that closely approximates the crushing forces that are likely to be encountered during use, and be able to withstand a kinking resistance test that closely approximates the kinking forces that are likely to be encountered during use.

(6) Guide tubes must be used when moving the source out of the device.

(7) An exposure head or similar device designed to prevent the source assembly from passing out of the end of the guide tube must be attached to the outermost end of the guide tube during industrial radiography operations.

(8) The guide tube exposure head connection must be able to withstand the tensile test for control units specified in ANSI N432-1980.

(9) Source changers must provide a system for ensuring that the source will not be accidentally withdrawn from the changer when connecting or disconnecting the drive cable to or from a source assembly.

(d) All radiographic exposure devices and associated equipment in use after January 10, 1996, must comply with the requirements of this section.

(e) Notwithstanding paragraph (a)(1) of this section, equipment used in industrial radiographic operations need not comply with § 8.9.2(c) of the Endurance Test in American National Standards Institute N432-1980, if the prototype equipment has been tested using a torque value representative of the torque that an individual using the radiography equipment can realistically exert on the lever or crankshaft of the drive mechanism.

[62 FR 28963, May 28, 1997, as amended at 69 FR 18803, Apr. 9, 2004; 77 FR 39906, July 6, 2012]

§ 34.21 Limits on external radiation levels from storage containers and source changers.

The maximum exposure rate limits for storage containers and source changers are 2 millisieverts (200 millirem) per hour at any exterior surface, and 0.1 millisieverts (10 millirem) per hour at 1 meter from any exterior surface with the sealed source in the shielded position.

§ 34.23 Locking of radiographic exposure devices, storage containers and source changers.

(a) Each radiographic exposure device must have a lock or outer locked container designed to prevent unauthorized or accidental removal of the sealed source from its shielded position. The exposure device and/or its container must be kept locked (and if a keyed-lock, with the key removed at all times) when not under the direct surveillance of a radiographer or a radiographer's assistant except at permanent radiographic installations as stated in § 34.51. In addition, during radiographic operations the sealed source assembly must be secured in the shielded position each time the source is returned to that position.

(b) Each sealed source storage container and source changer must have a lock or outer locked container designed to prevent unauthorized or accidental removal of the sealed source from its shielded position. Storage containers and source changers must be kept locked (and if a keyed-lock, with the key removed at all times) when containing sealed sources except when under the direct surveillance of a radiographer or a radiographer's assistant.

§ 34.25 Radiation survey instruments.

(a) The licensee shall keep sufficient calibrated and operable radiation survey instruments at each location where radioactive material is present to make the radiation surveys required by this part and by 10 CFR part 20 of this chapter. Instrumentation required by this section must be capable of measuring a range from 0.02 millisieverts (2 millirems) per hour through 0.01 sievert (1 rem) per hour.

(b) The licensee shall have each radiation survey instrument required under paragraph (a) of this section calibrated—

(1) At intervals not to exceed 6 months and after instrument servicing, except for battery changes;

(2) For linear scale instruments, at two points located approximately one-third and two-thirds of full-scale on each scale; for logarithmic scale instruments, at mid-range of each decade, and at two points of at least one decade; and for digital instruments, at 3 points between 0.02 and 10 millisieverts (2 and 1000 millirems) per hour; and

(3) So that an accuracy within plus or minus 20 percent of the calibration source can be demonstrated at each point checked.

(c) The licensee shall maintain records of the results of the instrument calibrations in accordance with § 34.65.

§ 34.27 Leak testing and replacement of sealed sources.

(a) The replacement of any sealed source fastened to or contained in a radiographic exposure device and leak testing of any sealed source must be performed by persons authorized to do so by the NRC or an Agreement State.

(b) The opening, repair, or modification of any sealed source must be performed by persons specifically authorized to do so by the Commission or an Agreement State.

(c) Testing and recordkeeping requirements. (1) Each licensee who uses a sealed source shall have the source tested for leakage at intervals not to exceed 6 months. The leak testing of the source must be performed using a method approved by the Commission or by an Agreement State. The wipe sample should be taken from the nearest accessible point to the sealed source where contamination might accumulate. The wipe sample must be analyzed for radioactive contamination. The analysis must be capable of detecting the presence of 185 Bq (0.005 microcurie) of radioactive material on the test sample and must be performed by a person specifically authorized by the Commission or an Agreement State to perform the analysis.

(2) The licensee shall maintain records of the leak tests in accordance with § 34.67.

(3) Unless a sealed source is accompanied by a certificate from the transferor that shows that it has been leak tested within 6 months before the transfer, it may not be used by the licensee until tested for leakage. Sealed sources that are in storage and not in use do not require leak testing, but must be tested before use or transfer to another person if the interval of storage exceeds 6 months.

(d) Any test conducted pursuant to paragraph (c) of this section which reveals the presence of 185 Bq (0.005 microcurie) or more of removable radioactive material must be considered evidence that the sealed source is leaking. The licensee shall immediately withdraw the equipment involved from use and shall have it decontaminated and repaired or disposed of in accordance with Commission regulations. A report must be filed with the Director, Office of Nuclear Material Safety and Safeguards , by an appropriate method listed in § 30.6(a) of this chapter, the report to be filed within 5 days of any test with results that exceed the threshold in this paragraph (d), and to describe the equipment involved, the test results, and the corrective action taken. A copy of the report must be sent to the Administrator of the appropriate Nuclear Regulatory Commission's Regional Office listed in appendix D of 10 CFR part 20 of this chapter “Standards for Protection Against Radiation.”

(e) Each exposure device using depleted uranium (DU) shielding and an “S” tube configuration must be tested for DU contamination at intervals not to exceed 12 months. The analysis must be capable of detecting the presence of 185 Bq (0.005 microcuries) of radioactive material on the test sample and must be performed by a person specifically authorized by the Commission or an Agreement State to perform the analysis. Should such testing reveal the presence of 185 Bq (0.005 microcuries) or more of removable DU contamination, the exposure device must be removed from use until an evaluation of the wear on the S-tube has been made. Should the evaluation reveal that the S-tube is worn through, the device may not be used again. DU shielded devices do not have to be tested for DU contamination while in storage and not in use. Before using or transferring such a device however, the device must be tested for DU contamination if the interval of storage exceeded 12 months. A record of the DU leak-test must be made in accordance with § 34.67. Licensees will have until June 27, 1998, to comply with the DU leak-testing requirements of this paragraph.

[62 FR 28963, May 28, 1997, as amended at 63 FR 37061, July 9, 1998; 67 FR 77652, Dec. 19, 2002; 68 FR 58805, Oct. 10, 2003; 73 FR 5719, Jan. 31, 2008]

§ 34.29 Quarterly inventory.

(a) Each licensee shall conduct a quarterly physical inventory to account for all sealed sources and for devices containing depleted uranium received and possessed under this license.

(b) The licensee shall maintain records of the quarterly inventory in accordance with § 34.69.

§ 34.31 Inspection and maintenance of radiographic exposure devices, transport and storage containers, associated equipment, source changers, and survey instruments.

(a) The licensee shall perform visual and operability checks on survey meters, radiographic exposure devices, transport and storage containers, associated equipment and source changers before use on each day the equipment is to be used to ensure that the equipment is in good working condition, that the sources are adequately shielded, and that required labeling is present. Survey instrument operability must be performed using check sources or other appropriate means. If equipment problems are found, the equipment must be removed from service until repaired.

(b) Each licensee shall have written procedures for:

(1) Inspection and routine maintenance of radiographic exposure devices, source changers, associated equipment, transport and storage containers, and survey instruments at intervals not to exceed 3 months or before the first use thereafter to ensure the proper functioning of components important to safety. Replacement components shall meet design specifications. If equipment problems are found, the equipment must be removed from service until repaired.

(2) Inspection and maintenance necessary to maintain the Type B packaging used to transport radioactive materials. The inspection and maintenance program must include procedures to assure that Type B packages are shipped and maintained in accordance with the certificate of compliance or other approval.

(c) Records of equipment problems and of any maintenance performed under paragraphs (a) and (b) of this section must be made in accordance with § 34.73.

§ 34.33 Permanent radiographic installations.

(a) Each entrance that is used for personnel access to the high radiation area in a permanent radiographic installation must have either:

(1) An entrance control of the type described in § 20.1601(a)(1) of this chapter that reduces the radiation level upon entry into the area, or

(2) Both conspicuous visible and audible warning signals to warn of the presence of radiation. The visible signal must be actuated by radiation whenever the source is exposed. The audible signal must be actuated when an attempt is made to enter the installation while the source is exposed.

(b) The alarm system must be tested for proper operation with a radiation source each day before the installation is used for radiographic operations. The test must include a check of both the visible and audible signals. Entrance control devices that reduce the radiation level upon entry (designated in paragraph (a)(1) of this section) must be tested monthly. If an entrance control device or an alarm is operating improperly, it must be immediately labeled as defective and repaired within 7 calendar days. The facility may continue to be used during this 7-day period, provided the licensee implements the continuous surveillance requirements of § 34.51 and uses an alarming ratemeter. Test records for entrance controls and audible and visual alarm must be maintained in accordance with § 34.75.

§ 34.35 Labeling, storage, and transportation.

(a) The licensee may not use a source changer or a container to store licensed material unless the source changer or the storage container has securely attached to it a durable, legible, and clearly visible label bearing the standard trefoil radiation caution symbol conventional colors, i.e., magenta, purple or black on a yellow background, having a minimum diameter of 25 mm, and the wording

CAUTION* RADIOACTIVE MATERIAL NOTIFY CIVIL AUTHORITIES (or “NAME OF COMPANY”) *____ or “DANGER”

(b) The licensee may not transport licensed material unless the material is packaged, and the package is labeled, marked, and accompanied with appropriate shipping papers in accordance with regulations set out in 10 CFR part 71.

(c) Locked radiographic exposure devices and storage containers must be physically secured to prevent tampering or removal by unauthorized personnel. The licensee shall store licensed material in a manner which will minimize danger from explosion or fire.

(d) The licensee shall lock and physically secure the transport package containing licensed material in the transporting vehicle to prevent accidental loss, tampering, or unauthorized removal of the licensed material from the vehicle.

§ 34.41 Conducting industrial radiographic operations.

(a) Whenever radiography is performed at a location other than a permanent radiographic installation, the radiographer must be accompanied by at least one other qualified radiographer or an individual who has at a minimum met the requirements of § 34.43(c). The additional qualified individual shall observe the operations and be capable of providing immediate assistance to prevent unauthorized entry. Radiography may not be performed if only one qualified individual is present.

(b) All radiographic operations conducted at locations of use authorized on the license must be conducted in a permanent radiographic installation, unless specifically authorized by the Commission.

(c) A licensee may conduct lay-barge, offshore platform, or underwater radiography only if procedures have been approved by the Commission or by an Agreement State.

(d) Licensees will have until June 27, 1998, to meet the requirements for having two qualified individuals present at locations other than a permanent radiographic installation as specified in paragraph (a) of this section.

[62 FR 28963, May 28, 1997, as amended at 63 FR 37061, July 9, 1998]

§ 34.42 Radiation Safety Officer for industrial radiography.

The RSO shall ensure that radiation safety activities are being performed in accordance with approved procedures and regulatory requirements in the daily operation of the licensee's program.

(a) The minimum qualifications, training, and experience for RSOs for industrial radiography are as follows:

(1) Completion of the training and testing requirements of § 34.43(a);

(2) 2000 hours of hands-on experience as a qualified radiographer in industrial radiographic operations; and

(3) Formal training in the establishment and maintenance of a radiation protection program.

(b) The Commission will consider alternatives when the RSO has appropriate training and/or experience in the field of ionizing radiation, and in addition, has adequate formal training with respect to the establishment and maintenance of a radiation safety protection program.

(c) The specific duties and authorities of the RSO include, but are not limited to:

(1) Establishing and overseeing all operating, emergency, and ALARA procedures as required by 10 CFR part 20 of this chapter, and reviewing them regularly to ensure that the procedures in use conform to current 10 CFR part 20 procedures, conform to other NRC regulations and to the license conditions.

(2) Overseeing and approving all phases of the training program for radiographic personnel, ensuring that appropriate and effective radiation protection practices are taught;

(3) Ensuring that required radiation surveys and leak tests are performed and documented in accordance with the regulations, including any corrective measures when levels of radiation exceed established limits;

(4) Ensuring that personnel monitoring devices are calibrated and used properly by occupationally-exposed personnel, that records are kept of the monitoring results, and that timely notifications are made as required by § 20.2203 of this chapter; and

(5) Ensuring that operations are conducted safely and to assume control for instituting corrective actions including stopping of operations when necessary.

(d) Licensees will have until June 27, 1999, to meet the requirements of paragraph (a) or (b) of this section.

[62 FR 28963, May 28, 1997, as amended at 63 FR 37061, July 9, 1998]

§ 34.43 Training.

(a) The licensee may not permit any individual to act as a radiographer until the individual—

(1) Has received training in the subjects in paragraph (g) of this section, in addition to a minimum of 2 months of on-the-job training, and is certified through a radiographer certification program by a certifying entity in accordance with the criteria specified in appendix A of this part. (An independent organization that would like to be recognized as a certifying entity shall submit its request to the Director, Office of Nuclear Material Safety and Safeguards, by an appropriate method listed in § 30.6(a) of this chapter.); or

(2) The licensee may, until June 27, 1999, allow an individual who has not met the requirements of paragraph (a)(1) of this section, to act as a radiographer after the individual has received training in the subjects outlined in paragraph (g) of this section and demonstrated an understanding of these subjects by successful completion of a written examination that was previously submitted to and approved by the Commission.

(b) In addition, the licensee may not permit any individual to act as a radiographer until the individual—

(1) Has received copies of and instruction in the requirements described in NRC regulations contained in this part; in §§ 30.7, 30.9, and 30.10 of this chapter; in the applicable sections of 10 CFR parts 19 and 20, of this chapter, in applicable DOT regulations as referenced in 10 CFR part 71, in the NRC license(s) under which the radiographer will perform industrial radiography, and the licensee's operating and emergency procedures;

(2) Has demonstrated understanding of the licensee's license and operating and emergency procedures by successful completion of a written or oral examination covering this material.

(3) Has received training in the use of the licensee's radiographic exposure devices, sealed sources, in the daily inspection of devices and associated equipment, and in the use of radiation survey instruments.

(4) Has demonstrated understanding of the use of radiographic exposure devices, sources, survey instruments and associated equipment described in paragraphs (b)(1) and (b)(3) of this section by successful completion of a practical examination covering this material.

(c) The licensee may not permit any individual to act as a radiographer's assistant until the individual—

(1) Has received copies of and instruction in the requirements described in NRC regulations contained in this part, in §§ 30.7, 30.9, and 30.10 of this chapter, in the applicable sections of 10 CFR parts 19 and 20 of this chapter, in applicable DOT regulations as referenced in 10 CFR part 71, in the NRC license(s) under which the radiographer's assistant will perform industrial radiography, and the licensee's operating and emergency procedures;

(2) Has developed competence to use, under the personal supervision of the radiographer, the radiographic exposure devices, sealed sources, associated equipment, and radiation survey instruments that the assistant will use; and

(3) Has demonstrated understanding of the instructions provided under (c)(1) of this section by successfully completing a written test on the subjects covered and has demonstrated competence in the use of hardware described in (c)(2) of this section by successful completion of a practical examination on the use of such hardware.

(d) The licensee shall provide annual refresher safety training for each radiographer and radiographer's assistant at intervals not to exceed 12 months.

(e) Except as provided in paragraph (e)(4), the RSO or designee shall conduct an inspection program of the job performance of each radiographer and radiographer's assistant to ensure that the Commission's regulations, license requirements, and the applicant's operating and emergency procedures are followed. The inspection program must:

(1) Include observation of the performance of each radiographer and radiographer's assistant during an actual industrial radiographic operation, at intervals not to exceed 6 months; and

(2) Provide that, if a radiographer or a radiographer's assistant has not participated in an industrial radiographic operation for more than 6 months since the last inspection, the radiographer must demonstrate knowledge of the training requirements of § 34.43(b)(3) and the radiographer's assistant must re-demonstrate knowledge of the training requirements of § 34.43(c)(2) by a practical examination before these individuals can next participate in a radiographic operation.

(3) The Commission may consider alternatives in those situations where the individual serves as both radiographer and RSO.

(4) In those operations where a single individual serves as both radiographer and RSO, and performs all radiography operations, an inspection program is not required.

(f) The licensee shall maintain records of the above training to include certification documents, written and practical examinations, refresher safety training and inspections of job performance in accordance with § 34.79.

(g) The licensee shall include the following subjects required in paragraph (a) of this section:

(1) Fundamentals of radiation safety including—

(i) Characteristics of gamma radiation;

(ii) Units of radiation dose and quantity of radioactivity;

(iii) Hazards of exposure to radiation;

(iv) Levels of radiation from licensed material; and

(v) Methods of controlling radiation dose (time, distance, and shielding);

(2) Radiation detection instruments including—

(i) Use, operation, calibration, and limitations of radiation survey instruments;

(ii) Survey techniques; and

(iii) Use of personnel monitoring equipment;

(3) Equipment to be used including—

(i) Operation and control of radiographic exposure equipment, remote handling equipment, and storage containers, including pictures or models of source assemblies (pigtails).

(ii) Storage, control, and disposal of licensed material; and

(iii) Inspection and maintenance of equipment.

(4) The requirements of pertinent Federal regulations; and

(5) Case histories of accidents in radiography.

(h) Licensees will have until June 27, 1998, to comply with the additional training requirements specified in paragraphs (b)(1) and (c)(1) of this section.

(i) Licensees will have until June 27, 1999 to comply with the certification requirements specified in paragraph (a)(1) of this section. Records of radiographer certification maintained in accordance with § 34.79(a) provide appropriate affirmation of certification requirements specified in paragraph (a)(1) of this section.

[62 FR 28963, May 28, 1997, as amended at 63 FR 37061, July 9, 1998; 68 FR 58805, Oct. 10, 2003, 73 FR 5720, Jan. 31, 2008]

§ 34.45 Operating and emergency procedures.

(a) Operating and emergency procedures must include, as a minimum, instructions in the following:

(1) Appropriate handling and use of licensed sealed sources and radiographic exposure devices so that no person is likely to be exposed to radiation doses in excess of the limits established in 10 CFR part 20 of this chapter “Standards for Protection Against Radiation”;

(2) Methods and occasions for conducting radiation surveys;

(3) Methods for controlling access to radiographic areas;

(4) Methods and occasions for locking and securing radiographic exposure devices, transport and storage containers and sealed sources;

(5) Personnel monitoring and the use of personnel monitoring equipment;

(6) Transporting sealed sources to field locations, including packing of radiographic exposure devices and storage containers in the vehicles, placarding of vehicles when needed, and control of the sealed sources during transportation (refer to 49 CFR parts 171-173);

(7) The inspection, maintenance, and operability checks of radiographic exposure devices, survey instruments, transport containers, and storage containers;

(8) Steps that must be taken immediately by radiography personnel in the event a pocket dosimeter is found to be off-scale or an alarm ratemeter alarms unexpectedly.

(9) The procedure(s) for identifying and reporting defects and noncompliance, as required by 10 CFR part 21 of this chapter;

(10) The procedure for notifying proper persons in the event of an accident;

(11) Minimizing exposure of persons in the event of an accident;

(12) Source recovery procedure if licensee will perform source recovery;

(13) Maintenance of records.

(b) The licensee shall maintain copies of current operating and emergency procedures in accordance with §§ 34.81 and 34.89.

§ 34.46 Supervision of radiographers' assistants.

Whenever a radiographer's assistant uses radiographic exposure devices, associated equipment or sealed sources or conducts radiation surveys required by § 34.49(b) to determine that the sealed source has returned to the shielded position after an exposure, the assistant shall be under the personal supervision of a radiographer. The personal supervision must include:

(a) The radiographer's physical presence at the site where the sealed sources are being used;

(b) The availability of the radiographer to give immediate assistance if required; and

(c) The radiographer's direct observation of the assistant's performance of the operations referred to in this section.

§ 34.47 Personnel monitoring.

(a) The licensee may not permit any individual to act as a radiographer or a radiographer's assistant unless, at all times during radiographic operations, each individual wears, on the trunk of the body, a direct reading dosimeter, an operating alarm ratemeter, and a personnel dosimeter. At permanent radiography installations where other appropriate alarming or warning devices are in routine use, the wearing of an alarming ratemeter is not required.

(1) Pocket dosimeters must have a range from zero to 2 millisieverts (200 millirems) and must be recharged at the start of each shift. Electronic personal dosimeters may only be used in place of ion-chamber pocket dosimeters.

(2) Each personnel dosimeter must be assigned to and worn only by one individual.

(3) Film badges must be replaced at least monthly and all other personnel dosimeters that require replacement must be replaced at least quarterly. All personnel dosimeters must be evaluated at least quarterly or promptly after replacement, whichever is more frequent.

(b) Direct reading dosimeters such as pocket dosimeters or electronic personal dosimeters, must be read and the exposures recorded at the beginning and end of each shift, and records must be maintained in accordance with § 34.83.

(c) Pocket dosimeters, or electronic personal dosimeters, must be checked at periods not to exceed 12 months for correct response to radiation, and records must be maintained in accordance with § 34.83. Acceptable dosimeters must read within plus or minus 20 percent of the true radiation exposure.

(d) If an individual's pocket chamber is found to be off-scale, or if his or her electronic personal dosimeter reads greater than 2 millisieverts (200 millirems), and the possibility of radiation exposure cannot be ruled out as the cause, the individual's personnel dosimeter that requires processing must be sent for processing and evaluation within 24 hours. For personnel dosimeters that do not require processing, evaluation of the dosimeter must be started within 24 hours. In addition, the individual may not resume work associated with licensed material use until a determination of the individual's radiation dose has been made. This determination must be made by the RSO or the RSO's designee. The results of this determination must be included in the records maintained in accordance with § 34.83.

(e) If the personnel dosimeter that is required by paragraph (a) of this section is lost or damaged, the worker shall cease work immediately until a replacement personnel dosimeter meeting the requirements in paragraph (a) is provided and the exposure is calculated for the time period from issuance to loss or damage of the personnel dosimeter. The results of the calculated exposure and the time period for which the personnel dosimeter was lost or damaged must be included in the records maintained in accordance with § 34.83.

(f) Dosimetry results must be retained in accordance with § 34.83.

(g) Each alarm ratemeter must—

(1) Be checked to ensure that the alarm functions properly (sounds) before using at the start of each shift;

(2) Be set to give an alarm signal at a preset dose rate of 5 mSv/hr (500 mrem/hr); with an accuracy of plus or minus 20 percent of the true radiation dose rate;

(3) Require special means to change the preset alarm function; and

(4) Be calibrated at periods not to exceed 12 months for correct response to radiation. The licensee shall maintain records of alarm ratemeter calibrations in accordance with § 34.83.

[62 FR 28963, May 28, 1997, as amended at 65 FR 63751, Oct. 24, 2000; 85 FR 15351, Mar. 18, 2020]

§ 34.49 Radiation surveys.

The licensee shall:

(a) Conduct surveys with a calibrated and operable radiation survey instrument that meets the requirements of § 34.25.

(b) Using a survey instrument meeting the requirements of paragraph (a) of this section, conduct a survey of the radiographic exposure device and the guide tube after each exposure when approaching the device or the guide tube. The survey must determine that the sealed source has returned to its shielded position before exchanging films, repositioning the exposure head, or dismantling equipment.

(c) Conduct a survey of the radiographic exposure device with a calibrated radiation survey instrument any time the source is exchanged and whenever a radiographic exposure device is placed in a storage area (as defined in § 34.3), to ensure that the sealed source is in its shielded position.

(d) Maintain records in accordance with § 34.85.

§ 34.51 Surveillance.

During each radiographic operation the radiographer, or the other individual present, as required by § 34.41, shall maintain continuous direct visual surveillance of the operation to protect against unauthorized entry into a high radiation area, as defined in 10 CFR part 20 of this chapter, except at permanent radiographic installations where all entryways are locked and the requirements of § 34.33 are met.

§ 34.53 Posting.

All areas in which industrial radiography is being performed must be conspicuously posted as required by § 20.1902(a) and (b) of this chapter. Exceptions listed in § 20.1903 of this chapter do not apply to industrial radiographic operations.

[62 FR 28963, May 28, 1997, as amended at 66 FR 64738, Dec. 14, 2001]

§ 34.61 Records of the specific license for industrial radiography.

Each licensee shall maintain a copy of its license, license conditions, documents incorporated by reference, and amendments to each of these items until superseded by new documents approved by the Commission, or until the Commission terminates the license.

§ 34.63 Records of receipt and transfer of sealed sources.

(a) Each licensee shall maintain records showing the receipts and transfers of sealed sources and devices using DU for shielding and retain each record for 3 years after it is made.

(b) These records must include the date, the name of the individual making the record, radionuclide, number of becquerels (curies) or mass (for DU), and manufacturer, model, and serial number of each sealed source and/or device, as appropriate.

§ 34.65 Records of radiation survey instruments.

Each licensee shall maintain records of the calibrations of its radiation survey instruments that are required under § 34.25 and retain each record for 3 years after it is made.

§ 34.67 Records of leak testing of sealed sources and devices containing depleted uranium.

Each licensee shall maintain records of leak test results for sealed sources and for devices containing DU. The results must be stated in units of becquerels (microcuries). The licensee shall retain each record for 3 years after it is made or until the source in storage is removed.

§ 34.69 Records of quarterly inventory.

(a) Each licensee shall maintain records of the quarterly inventory of sealed sources and of devices containing depleted uranium as required by § 34.29 and retain each record for 3 years after it is made.

(b) The record must include the date of the inventory, name of the individual conducting the inventory, radionuclide, number of becquerels (curies) or mass (for DU) in each device, location of sealed source and/or devices, and manufacturer, model, and serial number of each sealed source and/or device, as appropriate.

§ 34.71 Utilization logs.

(a) Each licensee shall maintain utilization logs showing for each sealed source the following information:

(1) A description, including the make, model, and serial number of the radiographic exposure device or transport or storage container in which the sealed source is located;

(2) The identity and signature of the radiographer to whom assigned; and

(3) The plant or site where used and dates of use, including the dates removed and returned to storage.

(b) The licensee shall retain the logs required by paragraph (a) of this section for 3 years after the log is made.

§ 34.73 Records of inspection and maintenance of radiographic exposure devices, transport and storage containers, associated equipment, source changers, and survey instruments.

(a) Each licensee shall maintain records specified in § 34.31 of equipment problems found in daily checks and quarterly inspections of radiographic exposure devices, transport and storage containers, associated equipment, source changers, and survey instruments; and retain each record for 3 years after it is made.

(b) The record must include the date of check or inspection, name of inspector, equipment involved, any problems found, and what repair and/or maintenance, if any, was done.

§ 34.75 Records of alarm system and entrance control checks at permanent radiographic installations.

Each licensee shall maintain records of alarm system and entrance control device tests required under § 34.33 and retain each record for 3 years after it is made.

§ 34.79 Records of training and certification.

Each licensee shall maintain the following records (of training and certification) for 3 years after the record is made:

(a) Records of training of each radiographer and each radiographer's assistant. The record must include radiographer certification documents and verification of certification status, copies of written tests, dates of oral and practical examinations, and names of individuals conducting and receiving the oral and practical examinations; and

(b) Records of annual refresher safety training and semi-annual inspections of job performance for each radiographer and each radiographer's assistant. The records must list the topics discussed during the refresher safety training, the dates the annual refresher safety training was conducted, and names of the instructors and attendees. For inspections of job performance, the records must also include a list showing the items checked and any non-compliances observed by the RSO.

§ 34.81 Copies of operating and emergency procedures.

Each licensee shall maintain a copy of current operating and emergency procedures until the Commission terminates the license. Superseded material must be retained for 3 years after the change is made.

§ 34.83 Records of personnel monitoring procedures.

Each licensee shall maintain the following exposure records specified in § 34.47:

(a) Direct reading dosimeter readings and yearly operability checks required by § 34.47 (b) and (c) for 3 years after the record is made.

(b) Records of alarm ratemeter calibrations for 3 years after the record is made.

(c) Personnel dosimeter results until the Commission terminates the license.

(d) Records of estimates of exposures as a result of: off-scale personal direct reading dosimeters, or lost or damaged personnel dosimeters until the Commission terminates the license.

[62 FR 28963, May 28, 1997, as amended at 65 FR 63752, Oct. 24, 2000; 85 FR 15351, Mar. 18, 2020]

§ 34.85 Records of radiation surveys.

Each licensee shall maintain a record of each exposure device survey conducted before the device is placed in storage as specified in § 34.49(c), if that survey is the last one performed in the workday. Each record must be maintained for 3 years after it is made.

§ 34.87 Form of records.

Each record required by this part must be legible throughout the specified retention period. The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of reproducing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records, such as letters, drawings, and specifications, must include all pertinent information, such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records. This section shall cease to have effect on January 8, 2027, unless the NRC determines that the cessation deadline should be extended to a date not more than 5 years in the future after offering the public an opportunity to provide input on the costs and benefits of this section and considering that input. The NRC will publish a document in the Federal Register announcing its determination and revising or removing this section accordingly.

[62 FR 28963, May 28, 1997, as amended at 90 FR 55629, Dec. 3, 2025]

§ 34.89 Location of documents and records.

(a) Each licensee shall maintain copies of records required by this part and other applicable parts of this chapter at the location specified in § 34.13(k).

(b) Each licensee shall also maintain copies of the following documents and records sufficient to demonstrate compliance at each applicable field station and each temporary jobsite;

(1) The license authorizing the use of licensed material;

(2) A copy of 10 CFR parts 19, 20, and 34 of NRC regulations;

(3) Utilization records for each radiographic exposure device dispatched from that location as required by § 34.71.

(4) Records of equipment problems identified in daily checks of equipment as required by § 34.73(a);

(5) Records of alarm system and entrance control checks required by § 34.75, if applicable;

(6) Records of direct reading dosimeters such as pocket dosimeter and/or electronic personal dosimeters readings as required by § 34.83;

(7) Operating and emergency procedures required by § 34.81;

(8) Evidence of the latest calibration of the radiation survey instruments in use at the site, as required by § 34.65;

(9) Evidence of the latest calibrations of alarm ratemeters and operability checks of pocket dosimeters and/or electronic personal dosimeters as required by § 34.83;

(10) Latest survey records required by § 34.85;

(11) The shipping papers for the transportation of radioactive materials required by § 71.5 of this chapter; and

(12) When operating under reciprocity pursuant to § 150.20 of this chapter, a copy of the Agreement State license authorizing the use of licensed materials.

§ 34.101 Notifications.

(a) In addition to the reporting requirements specified in § 30.50 and under other sections of this chapter, such as § 21.21, each licensee shall send a written report to the NRC's Office of Nuclear Material Safety and Safeguards, by an appropriate method listed in § 30.6(a) of this chapter, within 30 days of the occurrence of any of the following incidents involving radiographic equipment:

(1) Unintentional disconnection of the source assembly from the control cable;

(2) Inability to retract the source assembly to its fully shielded position and secure it in this position; or

(3) Failure of any component (critical to safe operation of the device) to properly perform its intended function;

(b) The licensee shall include the following information in each report submitted under paragraph (a) of this section, and in each report of overexposure submitted under 10 CFR 20.2203 which involves failure of safety components of radiography equipment:

(1) A description of the equipment problem;

(2) Cause of each incident, if known;

(3) Name of the manufacturer and model number of equipment involved in the incident;

(4) Place, date, and time of the incident;

(5) Actions taken to establish normal operations;

(6) Corrective actions taken or planned to prevent recurrence; and

(7) Qualifications of personnel involved in the incident.

(c) Any licensee conducting radiographic operations or storing radioactive material at any location not listed on the license for a period in excess of 180 days in a calendar year, shall notify the appropriate NRC regional office listed in § 30.6(b)(2) of this chapter prior to exceeding the 180 days.

[62 FR 28963, May 28, 1997, as amended at 67 FR 3585, Jan. 25, 2002; 68 FR 58805, Oct. 10, 2003; 73 FR 5720, Jan. 31, 2008; 83 FR 30287, June 28, 2018]

§ 34.111 Applications for exemptions.

The Commission may, upon application of any interested person or upon its own initiative, grant an exemption from the requirements of the regulations in this part if it determines the exemption is authorized by law and would not endanger life or property or the common defense and security and is otherwise in the public interest. This section shall cease to have effect on January 8, 2027, unless the NRC determines that the cessation deadline should be extended to a date not more than 5 years in the future after offering the public an opportunity to provide input on the costs and benefits of this section and considering that input. The NRC will publish a document in the Federal Register announcing its determination and revising or removing this section accordingly.

[62 FR 28963, May 28, 1997, as amended at 90 FR 55629, Dec. 3, 2025]

§ 34.121 Violations.

(a) The Commission may obtain an injunction or other court order to prevent a violation of the provisions of—

(1) The Atomic Energy Act of 1954, as amended;

(2) Title II of the Energy Reorganization Act of 1974, as amended; or

(3) A regulation or order issued pursuant to these Acts.

(b) The Commission may obtain a court order for the payment of a civil penalty imposed under Section 234 of the Atomic Energy Act;

(1) For violations of—

(i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Atomic Energy Act of 1954, as amended;

(ii) Section 206 of the Energy Reorganization Act;

(iii) Any rule, regulation, or order issued pursuant to the sections specified in paragraph (b)(1)(i) of this section.

(iv) Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(i) of this section.

(2) For any violation for which a license may be revoked under section 186 of the Atomic Energy Act of 1954, as amended.

§ 34.123 Criminal penalties.

(a) Section 223 of the Atomic Energy Act of 1952, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under one or more of §§ 161b, 161i, or 161o of the Act. For purposes of Section 223, all the regulations in 10 CFR part 34 are issued under one or more of §§ 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section.

(b) The regulations in 10 CFR part 34 that are not issued under sections 161b, 161i, or 161o for the purposes of Section 223 are as follows: §§ 34.1, 34.3, 34.5, 34.8, 34.11, 34.13, 34.111, 34.121, 34.123.

§ 35.1 Purpose and scope.

This part contains the requirements and provisions for the medical use of byproduct material and for issuance of specific licenses authorizing the medical use of this material. These requirements and provisions provide for the radiation safety of workers, the general public, patients, and human research subjects. The requirements and provisions of this part are in addition to, and not in substitution for, others in this chapter. The requirements and provisions of parts 19, 20, 21, 30, 37, 71, 170, and 171 of this chapter apply to applicants and licensees subject to this part unless specifically exempted.

[78 FR 17006, Mar. 19, 2013]

§ 35.2 Definitions.

Address of use means the building or buildings that are identified on the license and where byproduct material may be received, prepared, used, or stored.

Agreement State means any State with which the Commission or the Atomic Energy Commission has entered into an effective agreement under subsection 274b of the Atomic Energy Act of 1954, as amended.

Area of use means a portion of an address of use that has been set aside for the purpose of receiving, preparing, using, or storing byproduct material.

Associate Radiation Safety Officer means an individual who—

(1) Meets the requirements in §§ 35.50 and 35.59; and

(2) Is currently identified as an Associate Radiation Safety Officer for the types of use of byproduct material for which the individual has been assigned duties and tasks by the Radiation Safety Officer on—

(i) A specific medical use license issued by the Commission or an Agreement State; or

(ii) A medical use permit issued by a Commission master material licensee.

Authorized medical physicist means an individual who—

(1) Meets the requirements in §§ 35.51(a) and 35.59; or

(2) Is identified as an authorized medical physicist or teletherapy physicist on—

(i) A specific medical use license issued by the Commission or Agreement State;

(ii) A medical use permit issued by a Commission master material licensee;

(iii) A permit issued by a Commission or Agreement State broad scope medical use licensee; or

(iv) A permit issued by a Commission master material license broad scope medical use permittee.

Authorized nuclear pharmacist means a pharmacist who—

(1) Meets the requirements in §§ 35.55(a) and 35.59; or

(2) Is identified as an authorized nuclear pharmacist on—

(i) A specific license issued by the Commission or Agreement State that authorizes medical use or the practice of nuclear pharmacy;

(ii) A permit issued by a Commission master material licensee that authorizes medical use or the practice of nuclear pharmacy;

(iii) A permit issued by a Commission or Agreement State broad scope medical use licensee that authorizes medical use or the practice of nuclear pharmacy; or

(iv) A permit issued by a Commission master material license broad scope medical use permittee that authorizes medical use or the practice of nuclear pharmacy; or

(3) Is identified as an authorized nuclear pharmacist by a commercial nuclear pharmacy that has been authorized to identify authorized nuclear pharmacists; or

(4) Is designated as an authorized nuclear pharmacist in accordance with § 32.72(b)(4).

Authorized user means a physician, dentist, or podiatrist who—

(1) Meets the requirements in §§ 35.59 and 35.190(a), 35.290(a), 35.390(a), 35.392(a), 35.394(a), 35.490(a), 35.590(a), or 35.690(a); or

(2) Is identified as an authorized user on—

(i) A Commission or Agreement State license that authorizes the medical use of byproduct material;

(ii) A permit issued by a Commission master material licensee that is authorized to permit the medical use of byproduct material;

(iii) A permit issued by a Commission or Agreement State specific licensee of broad scope that is authorized to permit the medical use of byproduct material; or

(iv) A permit issued by a Commission master material license broad scope permittee that is authorized to permit the medical use of byproduct material.

Brachytherapy means a method of radiation therapy in which sources are used to deliver a radiation dose at a distance of up to a few centimeters by surface, intracavitary, intraluminal, or interstitial application.

Brachytherapy source means a radioactive source or a manufacturer-assembled source train or a combination of these sources that is designed to deliver a therapeutic dose within a distance of a few centimeters.

Client's address means the area of use or a temporary job site for the purpose of providing mobile medical service in accordance with § 35.80.

Cyclotron means a particle accelerator in which the charged particles travel in an outward spiral or circular path. A cyclotron accelerates charged particles at energies usually in excess of 10 megaelectron volts and is commonly used for production of short half-life radionuclides for medical use.

Dedicated check source means a radioactive source that is used to assure the constant operation of a radiation detection or measurement device over several months or years.

Dentist means an individual licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice dentistry.

High dose-rate remote afterloader, as used in this part, means a brachytherapy device that remotely delivers a dose rate in excess of 12 gray (1200 rads) per hour at the point or surface where the dose is prescribed.

Low dose-rate remote afterloader, as used in this part, means a brachytherapy device that remotely delivers a dose rate of less than or equal to 2 gray (200 rads) per hour at the point or surface where the dose is prescribed.

Management means the chief executive officer or other individual having the authority to manage, direct, or administer the licensee's activities, or those persons' delegate or delegates.

Manual brachytherapy, as used in this part, means a type of brachytherapy in which the brachytherapy sources (e.g., seeds, ribbons) are manually placed topically on or inserted either into the body cavities that are in close proximity to a treatment site or directly into the tissue volume.

Medical event means an event that meets the criteria in § 35.3045(a) or (b).

Medical institution means an organization in which more than one medical discipline is practiced.

Medical use means the intentional internal or external administration of byproduct material or the radiation from byproduct material to patients or human research subjects under the supervision of an authorized user.

Medium dose-rate remote afterloader, as used in this part, means a brachytherapy device that remotely delivers a dose rate of greater than 2 gray (200 rads) per hour, but less than or equal to 12 gray (1200 rads) per hour at the point or surface where the dose is prescribed.

Mobile medical service means the transportation of byproduct material to and its medical use at the client's address.

Ophthalmic physicist means an individual who—

(1) Meets the requirements in §§ 35.433(a)(2) and 35.59; and

(2) Is identified as an ophthalmic physicist on a—

(i) Specific medical use license issued by the Commission or an Agreement State;

(ii) Permit issued by a Commission or Agreement State broad scope medical use licensee;

(iii) Medical use permit issued by a Commission master material licensee; or

(iv) Permit issued by a Commission master material licensee broad scope medical use permittee.

Output means the exposure rate, dose rate, or a quantity related in a known manner to these rates from a brachytherapy source or a teletherapy, remote afterloader, or gamma stereotactic radiosurgery unit for a specified set of exposure conditions.

Patient intervention means actions by the patient or human research subject, whether intentional or unintentional, such as dislodging or removing treatment devices or prematurely terminating the administration.

Pharmacist means an individual licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice pharmacy.

Physician means a medical doctor or doctor of osteopathy licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to prescribe drugs in the practice of medicine.

Podiatrist means an individual licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice podiatry.

Positron Emission Tomography (PET) radionuclide production facility is defined as a facility operating a cyclotron or accelerator for the purpose of producing PET radionuclides.

Preceptor means an individual who provides, directs, or verifies training and experience required for an individual to become an authorized user, an authorized medical physicist, an authorized nuclear pharmacist, a Radiation Safety Officer, or an Associate Radiation Safety Officer.

Prescribed dosage means the specified activity or range of activity of unsealed byproduct material as documented—

(1) In a written directive; or

(2) In accordance with the directions of the authorized user for procedures performed pursuant to §§ 35.100 and 35.200.

Prescribed dose means—

(1) For gamma stereotactic radiosurgery, the total dose as documented in the written directive;

(2) For teletherapy, the total dose and dose per fraction as documented in the written directive;

(3) For manual brachytherapy, either the total source strength and exposure time or the total dose, as documented in the written directive; or

(4) For remote brachytherapy afterloaders, the total dose and dose per fraction as documented in the written directive.

Pulsed dose-rate remote afterloader, as used in this part, means a special type of remote afterloading brachytherapy device that uses a single source capable of delivering dose rates in the “high dose-rate” range, but—

(1) Is approximately one-tenth of the activity of typical high dose-rate remote afterloader sources; and

(2) Is used to simulate the radiobiology of a low dose-rate treatment by inserting the source for a given fraction of each hour.

Radiation Safety Officer means an individual who—

(1) Meets the requirements in §§ 35.50(a) or (c)(1) and 35.59; or

(2) Is identified as a Radiation Safety Officer on—

(i) A specific medical use license issued by the Commission or Agreement State; or

(ii) A medical use permit issued by a Commission master material licensee.

Sealed source means any byproduct material that is encased in a capsule designed to prevent leakage or escape of the byproduct material.

Sealed Source and Device Registry means the national registry that contains all the registration certificates, generated by both NRC and the Agreement States, that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product.

Stereotactic radiosurgery means the use of external radiation in conjunction with a stereotactic guidance device to very precisely deliver a therapeutic dose to a tissue volume.

Structured educational program means an educational program designed to impart particular knowledge and practical education through interrelated studies and supervised training.

Teletherapy, as used in this part, means a method of radiation therapy in which collimated gamma rays are delivered at a distance from the patient or human research subject.

Temporary job site means a location where mobile medical services are conducted other than those location(s) of use authorized on the license.

Therapeutic dosage means a dosage of unsealed byproduct material that is intended to deliver a radiation dose to a patient or human research subject for palliative or curative treatment.

Therapeutic dose means a radiation dose delivered from a source containing byproduct material to a patient or human research subject for palliative or curative treatment.

Treatment site means the anatomical description of the tissue intended to receive a radiation dose, as described in a written directive.

Type of use means use of byproduct material under §§ 35.100, 35.200, 35.300, 35.400, 35.500, 35.600, or 35.1000.

Unit dosage means a dosage prepared for medical use for administration as a single dosage to a patient or human research subject without any further manipulation of the dosage after it is initially prepared.

Written directive means an authorized user's written order for the administration of byproduct material or radiation from byproduct material to a specific patient or human research subject, as specified in § 35.40.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19324, Apr. 21, 2003; 69 FR 55737, Sept. 16, 2004; 70 FR 16361, Mar. 30, 2005; 71 FR 15008, Mar. 27, 2006; 72 FR 45151, Aug. 13, 2007; 72 FR 55930, Oct. 1, 2007; 83 FR 33102, July 16, 2018]

§ 35.5 Maintenance of records.

Each record required by this part must be legible throughout the specified retention period. The record may be the original, a reproduced copy, or a microform if the copy or microform is authenticated by authorized personnel and the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, and specifications must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records. This section shall cease to have effect on January 8, 2027, unless the NRC determines that the cessation deadline should be extended to a date not more than 5 years in the future after offering the public an opportunity to provide input on the costs and benefits of this section and considering that input. The NRC will publish a document in the Federal Register announcing its determination and revising or removing this section accordingly.

[67 FR 20370, Apr. 24, 2002, as amended at 90 FR 55629, Dec. 3, 2025]

§ 35.6 Provisions for the protection of human research subjects.

(a) A licensee may conduct research involving human research subjects only if it uses the byproduct materials specified on its license for the uses authorized on its license.

(b) If the research is conducted, funded, supported, or regulated by another Federal agency that has implemented the Federal Policy for the Protection of Human Subjects (Federal Policy), the licensee shall, before conducting research—

(1) Obtain review and approval of the research from an “Institutional Review Board,” as defined and described in the Federal Policy; and

(2) Obtain “informed consent,” as defined and described in the Federal Policy, from the human research subject.

(c) If the research will not be conducted, funded, supported, or regulated by another Federal agency that has implemented the Federal Policy, the licensee shall, before conducting research, apply for and receive a specific amendment to its NRC medical use license. The amendment request must include a written commitment that the licensee will, before conducting research—

(1) Obtain review and approval of the research from an “Institutional Review Board,” as defined and described in the Federal Policy; and

(2) Obtain “informed consent”, as defined and described in the Federal Policy, from the human research subject.

(d) Nothing in this section relieves licensees from complying with the other requirements in this part.

[67 FR 20370, Apr. 24, 2002; 67 FR 62872, Oct. 9, 2002]

§ 35.7 FDA, other Federal, and State requirements.

Nothing in this part relieves the licensee from complying with applicable FDA, other Federal, and State requirements governing radioactive drugs or devices.

§ 35.8 Information collection requirements: OMB approval.

(a) The Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501et seq.). The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has approved the information collection requirements in this part under control number 3150-0010.

(b) The approved information collection requirements contained in this part appear in §§ 35.6, 35.12, 35.13, 35.14, 35.19, 35.24, 35.26, 35.27, 35.40, 35.41, 35.50, 35.51, 35.55, 35.60, 35.61, 35.63, 35.67, 35.69, 35.70, 35.75, 35.80, 35.92, 35.190, 35.204, 35.290, 35.310, 35.315, 35.390, 35.392, 35.394, 35.396, 35.404, 35.406, 35.410, 35.415, 35.432, 35.433, 35.490, 35.491, 35.590, 35.604, 35.605, 35.610, 35.615, 35.630, 35.632, 35.633, 35.635, 35.642, 35.643, 35.645, 35.647, 35.652, 35.655, 35.690, 35.1000, 35.2024, 35.2026, 35.2040, 35.2041, 35.2060, 35.2061, 35.2063, 35.2067, 35.2070, 35.2075, 35.2080, 35.2092, 35.2204, 35.2310, 35.2404, 35.2406, 35.2432, 35.2433, 35.2605, 35.2610, 35.2630, 35.2632, 35.2642, 35.2643, 35.2645, 35.2647, 35.2652, 35.2655, 35.3045, 35.3047, 35.3067, and 35.3204.

(c) This part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section. These information collection requirements and the control numbers under which they are approved are as follows:

(1) In § 35.12, NRC Form 313, including NRC Form 313A, which licensees may use to provide supplemental information, is approved under control number 3150-0120.

(2) [Reserved]

[67 FR 20370, Apr. 24, 2002, as amended at 71 FR 15008, Mar. 27, 2006; 83 FR 33102, July 16, 2018]

§ 35.10 Implementation.

(a) A Government agency or a Federally recognized Indian Tribe that possesses and uses accelerator-produced radioactive material or discrete sources of radium-226 for which a specific medical use license is required by the Atomic Energy Act of 1954, as amended, must comply with the requirements of this part, including provisions that are specific to licensees, on November 30, 2007. All other persons who possess and use accelerator-produced radioactive material or discrete sources of radium-226 for which a specific medical use license is required, must comply with the requirements of this part, including provisions that are specific to licensees, on August 8, 2009, or earlier as noticed by the NRC.

(b)-(c) [Reserved]

(d) If a license condition exempted a licensee from a provision of Part 35 on October 24, 2002, then the license condition continues to exempt the licensee from the requirements in the corresponding provision of §§ 35.1-35.4002.

(e) When a requirement in this part differs from the requirement in an existing license condition, the requirement in this part shall govern.

(f) A licensee shall continue to comply with any license condition that requires it to implement procedures required by §§ 35.610, 35.642, 35.643, and 35.645 until there is a license amendment or renewal that modifies the license condition.

[67 FR 20370, Apr. 24, 2002, as amended at 71 FR 15008, Mar. 27, 2006; 72 FR 55930, Oct. 1, 2007]

§ 35.11 License required.

(a) A person may manufacture, produce, acquire, receive, possess, prepare, use, or transfer byproduct material for medical use only in accordance with a specific license issued by the Commission or an Agreement State, or as allowed in paragraph (b) or (c) of this section.

(b) A specific license is not needed for an individual who—

(1) Receives, possesses, uses, or transfers byproduct material in accordance with the regulations in this chapter under the supervision of an authorized user as provided in § 35.27, unless prohibited by license condition; or

(2) Prepares unsealed byproduct material for medical use in accordance with the regulations in this chapter under the supervision of an authorized nuclear pharmacist or authorized user as provided in § 35.27, unless prohibited by license condition.

(c)(1) A Government agency or a Federally recognized Indian Tribe, that possesses and uses accelerator-produced radioactive material or discrete sources of radium-226 for which a specific medical use license is required in paragraph (a) of this section, may continue to use such materials for medical uses until the date of the NRC's final licensing determination, provided that the person submits a medical use license application on or before December 1, 2008.

(2) Except as provided in paragraph (c)(1) of this section, all other persons, who possess and use accelerator-produced radioactive material or discrete sources of radium-226 for which a specific medical use license is required in paragraph (a) of this section, may continue to use this type of material for medical uses permitted under this part until the date of the NRC's final licensing determination, provided that the person submits a medical use license application within 12 months from the waiver expiration date of August 7, 2009 or within 12 months from the date of an earlier termination of the waiver as noticed by the NRC, whichever date is earlier.

[67 FR 20370, Apr. 24, 2002, as amended at 72 FR 55930, Oct. 1, 2006]

§ 35.12 Application for license, amendment, or renewal.

(a) An application must be signed by the applicant's or licensee's management.

(b) An application for a license for medical use of byproduct material as described in §§ 35.100, 35.200, 35.300, 35.400, 35.500, 35.600, and 35.1000 must be made by—

(1) Filing an original NRC Form 313, “Application for Material License,” that includes the facility diagram, equipment, and training and experience qualifications of the Radiation Safety Officer, Associate Radiation Safety Officer(s), authorized user(s), authorized medical physicist(s), ophthalmic physicist(s), and authorized nuclear pharmacist(s); and

(2) Submitting procedures required by §§ 35.610, 35.642, 35.643, and 35.645, as applicable.

(c) A request for a license amendment or renewal must be made by—

(1) Submitting an original of either—

(i) NRC Form 313, “Application for Material License”; or

(ii) A letter containing all information required by NRC Form 313; and

(2) Submitting procedures required by §§ 35.610, 35.642, 35.643, and 35.645, as applicable.

(d) In addition to the requirements in paragraphs (b) and (c) of this section, an application for a license or amendment for medical use of byproduct material as described in § 35.1000 must also include:

(1) Any additional aspects of the medical use of the material that are applicable to radiation safety that are not addressed in, or differ from, subparts A through C, L, and M of this part;

(2) Identification of and commitment to follow the applicable radiation safety program requirements in subparts D through H of this part that are appropriate for the specific § 35.1000 medical use;

(3) Any additional specific information on—

(i) Radiation safety precautions and instructions;

(ii) Methodology for measurement of dosages or doses to be administered to patients or human research subjects; and

(iii) Calibration, maintenance, and repair of instruments and equipment necessary for radiation safety; and

(4) Any other information requested by the Commission in its review of the application.

(e) An applicant that satisfies the requirements specified in § 33.13 of this chapter may apply for a Type A specific license of broad scope.

[67 FR 20370, Apr. 24, 2002; 67 FR 62872, Oct. 9, 2002; 83 FR 33102, July 16, 2018]

§ 35.13 License amendments.

A licensee shall apply for and must receive a license amendment—

(a) Before it receives, prepares, or uses byproduct material for a type of use that is permitted under this part, but is not authorized on the licensee's current license issued under this part; except that—

(1) A Government agency or a Federally recognized Indian Tribe licensee who possesses and uses accelerator-produced radioactive material or discrete sources of radium-226 may continue to use such material for medical uses permitted under this part until the date of the NRC's final licensing determination, provided that the licensee submits an amendment application on or before June 2, 2008.

(2) Except as provided in paragraph (a)(1) of this section, all other licensees who possess and use accelerator-produced radioactive material or discrete sources of radium-226 may continue to use those materials for medical uses permitted under this part until the date of the NRC's final licensing determination, provided that the person submits a medical use license amendment request within 6 months from the waiver expiration date of August 7, 2009 or within 6 months from the date of an earlier termination of the waiver as noticed by the NRC, whichever date is earlier.

(b) Before it permits anyone to work as an authorized user, authorized medical physicist, ophthalmic physicist, or authorized nuclear pharmacist under the license, except—

(1) For an authorized user, an individual who meets the requirements in §§ 35.59 and 35.190(a), 35.290(a), 35.390(a), 35.392(a), 35.394(a), 35.490(a), 35.590(a), and 35.690(a);

(2) For an authorized nuclear pharmacist, an individual who meets the requirements in §§ 35.55(a) and 35.59;

(3) For an authorized medical physicist, an individual who meets the requirements in §§ 35.51(a) and 35.59;

(4) An individual who is identified as an authorized user, an authorized nuclear pharmacist, authorized medical physicist, or an ophthalmic physicist—

(i) On a Commission or Agreement State license or other equivalent permit or license recognized by NRC that authorizes the use of byproduct material in medical use or in the practice of nuclear pharmacy;

(ii) On a permit issued by a Commission or Agreement State specific license of broad scope that is authorized to permit the use of byproduct material in medical use or in the practice of nuclear pharmacy;

(iii) On a permit issued by a Commission master material licensee that is authorized to permit the use of byproduct material in medical use or in the practice of nuclear pharmacy; or

(iv) By a commercial nuclear pharmacy that has been authorized to identify authorized nuclear pharmacists;

(c) Before it changes Radiation Safety Officers, except as provided in § 35.24(c);

(d) Before it permits anyone to work as an Associate Radiation Safety Officer, or before the Radiation Safety Officer assigns duties and tasks to an Associate Radiation Safety Officer that differ from those for which this individual is authorized on the license;

(e) Before it receives byproduct material in excess of the amount or in a different form, or receives a different radionuclide than is authorized on the license;

(f) Before it adds to or changes the areas of use identified in the application or on the license, including areas used in accordance with either § 35.100 or § 35.200 if the change includes addition or relocation of either an area where PET radionuclides are produced or a PET radioactive drug delivery line from the PET radionuclide/PET radioactive drug production area. Other areas of use where byproduct material is used only in accordance with either § 35.100 or § 35.200 are exempt;

(g) Before it changes the address(es) of use identified in the application or on the license;

(h) Before it revises procedures required by §§ 35.610, 35.642, 35.643, and 35.645, as applicable, where such revision reduces radiation safety; and

(i) Before it receives a sealed source from a different manufacturer or of a different model number than authorized by its license unless the sealed source is used for manual brachytherapy, is listed in the Sealed Source and Device Registry, and is in a quantity and for an isotope authorized by the license.

[67 FR 20370, Apr. 24, 2002, as amended at 71 FR 15008, Mar. 27, 2006; 72 FR 55930, Oct. 1, 2007; 83 FR 33102, July 16, 2018; 87 FR 68031, Nov. 14, 2022]

§ 35.14 Notifications.

(a) A licensee shall provide the Commission, no later than 30 days after the date that the licensee permits an individual to work under the provisions of § 35.13(b) as an authorized user, authorized medical physicist, ophthalmic physicist, or authorized nuclear pharmacist—

(1) A copy of the board certification and, as appropriate, verification of completion of:

(i) Training for the authorized medical physicist under § 35.51(c);

(ii) Any additional case experience required in § 35.390(b)(1)(ii)(G) for an authorized user under § 35.300; or

(iii) Device specific training in § 35.690(c) for the authorized user under § 35.600; or

(2) A copy of the Commission or Agreement State license, the permit issued by a Commission master material licensee, the permit issued by a Commission or Agreement State licensee of broad scope, the permit issued by a Commission master material license broad scope permittee, or documentation that only accelerator-produced radioactive materials, discrete sources of radium-226, or both, were used for medical use or in the practice of nuclear pharmacy at a Government agency or Federally recognized Indian Tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC for each individual whom the licensee permits to work under the provisions of this section.

(b) A licensee shall notify the Commission no later than 30 days after:

(1) An authorized user, an authorized nuclear pharmacist, a Radiation Safety Officer, an Associate Radiation Safety Officer, an authorized medical physicist, or ophthalmic physicist permanently discontinues performance of duties under the license or has a name change;

(2) The licensee permits an individual qualified to be a Radiation Safety Officer under §§ 35.50 and 35.59 to function as a temporary Radiation Safety Officer and to perform the functions of a Radiation Safety Officer in accordance with § 35.24(c);

(3) The licensee's mailing address changes;

(4) The licensee's name changes, but the name change does not constitute a transfer of control of the license as described in § 30.34(b) of this chapter;

(5) The licensee has added to or changed the areas of use identified in the application or on the license where byproduct material is used in accordance with either § 35.100 or § 35.200 if the change does not include addition or relocation of either an area where PET radionuclides are produced or a PET radioactive drug delivery line from the PET radionuclide/PET radioactive drug production area; or

(6) The licensee obtains a sealed source for use in manual brachytherapy from a different manufacturer or with a different model number than authorized by its license for which it did not require a license amendment as provided in § 35.13(i). The notification must include the manufacturer and model number of the sealed source, the isotope, and the quantity per sealed source.

(c) The licensee shall send the documents required in this section to the appropriate address identified in § 30.6 of this chapter.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 58805, Oct. 10, 2003; 70 FR 16361, Mar. 30, 2005; 71 FR 15008, Mar. 27, 2006; 72 FR 55931, Oct. 1, 2007; 83 FR 33103, July 16, 2018]

§ 35.15 Exemptions regarding Type A specific licenses of broad scope.

A licensee possessing a Type A specific license of broad scope for medical use, issued under Part 33 of this chapter, is exempt from—

(a) The provisions of § 35.12(d) regarding the need to file an amendment to the license for medical use of byproduct material, as described in § 35.1000;

(b) The provisions of § 35.13(b);

(c) The provisions of § 35.13(f) regarding additions to or changes in the areas of use at the addresses identified in the application or on the license;

(d) The provisions of § 35.14(a);

(e) The provisions of § 35.14(b)(1) for an authorized user, an authorized nuclear pharmacist, an authorized medical physicist, or an ophthalmic physicist;

(f) The provisions of § 35.14(b)(5).

(g) The provisions of § 35.49(a).

[67 FR 20370, Apr. 24, 2002, as amended at 72 FR 55931, Oct. 1, 2007; 83 FR 33103, July 16, 2018]

§ 35.18 License issuance.

(a) The Commission shall issue a license for the medical use of byproduct material if—

(1) The applicant has filed NRC Form 313 “Application for Material License” in accordance with the instructions in § 35.12;

(2) The applicant has paid any applicable fee as provided in Part 170 of this chapter;

(3) The Commission finds the applicant equipped and committed to observe the safety standards established by the Commission in this Chapter for the protection of the public health and safety; and

(4) The applicant meets the requirements of Part 30 of this chapter.

(b) The Commission shall issue a license for mobile medical service if the applicant:

(1) Meets the requirements in paragraph (a) of this section; and

(2) Assures that individuals or human research subjects to whom unsealed byproduct material or radiation from implants containing byproduct material will be administered may be released following treatment in accordance with § 35.75.

§ 35.19 Specific exemptions.

The Commission may, upon application of any interested person or upon its own initiative, grant exemptions from the regulations in this part that it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest. This section shall cease to have effect on January 8, 2027, unless the NRC determines that the cessation deadline should be extended to a date not more than 5 years in the future after offering the public an opportunity to provide input on the costs and benefits of this section and considering that input. The NRC will publish a document in the Federal Register announcing its determination and revising or removing this section accordingly.

[67 FR 20370, Apr. 24, 2002, as amended at 90 FR 55629, Dec. 3, 2025]

§ 35.24 Authority and responsibilities for the radiation protection program.

(a) In addition to the radiation protection program requirements of § 20.1101 of this chapter, a licensee's management shall approve in writing—

(1) Requests for a license application, renewal, or amendment before submittal to the Commission;

(2) Any individual before allowing that individual to work as an authorized user, authorized nuclear pharmacist, or authorized medical physicist; and

(3) Radiation protection program changes that do not require a license amendment and are permitted under § 35.26;

(b) A licensee's management shall appoint a Radiation Safety Officer who agrees, in writing, to be responsible for implementing the radiation protection program. The licensee, through the Radiation Safety Officer, shall ensure that radiation safety activities are being performed in accordance with licensee-approved procedures and regulatory requirements. A licensee's management may appoint, in writing, one or more Associate Radiation Safety Officers to support the Radiation Safety Officer. The Radiation Safety Officer, with written agreement of the licensee's management, must assign the specific duties and tasks to each Associate Radiation Safety Officer. These duties and tasks are restricted to the types of use for which the Associate Radiation Safety Officer is listed on a license. The Radiation Safety Officer may delegate duties and tasks to the Associate Radiation Safety Officer but shall not delegate the authority or responsibilities for implementing the radiation protection program.

(c) For up to 60 days each year, a licensee may permit an individual qualified to be a Radiation Safety Officer, under §§ 35.50 and 35.59, to function as a temporary Radiation Safety Officer and to perform the functions of a Radiation Safety Officer, as provided in paragraph (g) of this section, if the licensee takes the actions required in paragraphs (b), (e), (g), and (h) of this section and notifies the Commission in accordance with § 35.14(b).

(d) A licensee may simultaneously appoint more than one temporary Radiation Safety Officer in accordance with paragraph (c) of this section, if needed to ensure that the licensee has a temporary Radiation Safety Officer that satisfies the requirements to be a Radiation Safety Officer for each of the different types of uses of byproduct material permitted by the license.

(e) A licensee shall establish the authority, duties, and responsibilities of the Radiation Safety Officer in writing.

(f) Licensees that are authorized for two or more different types of uses of byproduct material under Subparts E, F, and H of this part, or two or more types of units under Subpart H of this part, shall establish a Radiation Safety Committee to oversee all uses of byproduct material permitted by the license. The Committee must include an authorized user of each type of use permitted by the license, the Radiation Safety Officer, a representative of the nursing service, and a representative of management who is neither an authorized user nor a Radiation Safety Officer. The Committee may include other members the licensee considers appropriate.

(g) A licensee shall provide the Radiation Safety Officer sufficient authority, organizational freedom, time, resources, and management prerogative, to—

(1) Identify radiation safety problems;

(2) Initiate, recommend, or provide corrective actions;

(3) Stop unsafe operations; and,

(4) Verify implementation of corrective actions.

(h) A licensee shall retain a record of actions taken under paragraphs (a), (b), and (e) of this section in accordance with § 35.2024.

[67 FR 20370, Apr. 24, 2002, as amended at 83 FR 33103, July 16, 2018]

§ 35.26 Radiation protection program changes.

(a) A licensee may revise its radiation protection program without Commission approval if—

(1) The revision does not require a license amendment under § 35.13;

(2) The revision is in compliance with the regulations and the license ;

(3) The revision has been reviewed and approved by the Radiation Safety Officer and licensee management; and

(4) The affected individuals are instructed on the revised program before the changes are implemented.

(b) A licensee shall retain a record of each change in accordance with § 35.2026.

§ 35.27 Supervision.

(a) A licensee that permits the receipt, possession, use, or transfer of byproduct material by an individual under the supervision of an authorized user, as allowed by § 35.11(b)(1), shall—

(1) In addition to the requirements in § 19.12 of this chapter, instruct the supervised individual in the licensee's written radiation protection procedures, written directive procedures, regulations of this chapter, and license conditions with respect to the use of byproduct material; and

(2) Require the supervised individual to follow the instructions of the supervising authorized user for medical uses of byproduct material, written radiation protection procedures established by the licensee, written directive procedures, regulations of this chapter, and license conditions with respect to the medical use of byproduct material.

(b) A licensee that permits the preparation of byproduct material for medical use by an individual under the supervision of an authorized nuclear pharmacist or physician who is an authorized user, as allowed by § 35.11(b)(2), shall—

(1) In addition to the requirements in § 19.12 of this chapter, instruct the supervised individual in the preparation of byproduct material for medical use, as appropriate to that individual's involvement with byproduct material; and

(2) Require the supervised individual to follow the instructions of the supervising authorized user or authorized nuclear pharmacist regarding the preparation of byproduct material for medical use, written radiation protection procedures established by the licensee, the regulations of this chapter, and license conditions.

(c) A licensee that permits supervised activities under paragraphs (a) and (b) of this section is responsible for the acts and omissions of the supervised individual.

§ 35.40 Written directives.

(a) A written directive must be dated and signed by an authorized user before the administration of I-131 sodium iodide greater than 1.11 megabecquerels (MBq) (30 microcuries (µCi)), any therapeutic dosage of unsealed byproduct material or any therapeutic dose of radiation from byproduct material.

(1) If, because of the emergent nature of the patient's condition, a delay in order to provide a written directive would jeopardize the patient's health, an oral directive is acceptable. The information contained in the oral directive must be documented as soon as possible in writing in the patient's record. A written directive must be prepared within 48 hours of the oral directive.

(b) The written directive must contain the patient or human research subject's name and the following information—

(1) For any administration of quantities greater than 1.11 MBq (30 µCi) of sodium iodide I-131: the dosage;

(2) For an administration of a therapeutic dosage of unsealed byproduct material other than sodium iodide I-131: the radioactive drug, dosage, and route of administration;

(3) For gamma stereotactic radiosurgery: the total dose, treatment site, and values for the target coordinate settings per treatment for each anatomically distinct treatment site;

(4) For teletherapy: the total dose, dose per fraction, number of fractions, and treatment site;

(5) For high dose-rate remote afterloading brachytherapy: The radionuclide, treatment site, dose per fraction, number of fractions, and total dose;

(6) For permanent implant brachytherapy:

(i) Before implantation: The treatment site, the radionuclide, and the total source strength; and

(ii) After implantation but before the patient leaves the post-treatment recovery area: The treatment site, the number of sources implanted, the total source strength implanted, and the date; or

(7) For all other brachytherapy, including low, medium, and pulsed dose rate remote afterloaders:

(i) Before implantation: The treatment site, radionuclide, and dose; and

(ii) After implantation but before completion of the procedure: The radionuclide; treatment site; number of sources; total source strength and exposure time (or the total dose); and date.

(c)(1) A written revision to an existing written directive may be made if the revision is dated and signed by an authorized user before the administration of the dosage of unsealed byproduct material, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the next fractional dose.

(2) If, because of the patient's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive is acceptable. The oral revision must be documented as soon as possible in the patient's record. A revised written directive must be signed by the authorized user within 48 hours of the oral revision.

(d) The licensee shall retain a copy of the written directive in accordance with § 35.2040.

[67 FR 20370, Apr. 24, 2002; 67 FR 62872, Oct. 9, 2002; 68 FR 75389, Dec. 31, 2003; 83 FR 33103, July 16, 2018]

§ 35.41 Procedures for administrations requiring a written directive.

(a) For any administration requiring a written directive, the licensee shall develop, implement, and maintain written procedures to provide high confidence that:

(1) The patient's or human research subject's identity is verified before each administration; and

(2) Each administration is in accordance with the written directive.

(b) At a minimum, the procedures required by paragraph (a) of this section must address the following items that are applicable to the licensee's use of byproduct material—

(1) Verifying the identity of the patient or human research subject;

(2) Verifying that the administration is in accordance with the treatment plan, if applicable, and the written directive;

(3) Checking both manual and computer-generated dose calculations;

(4) Verifying that any computer-generated dose calculations are correctly transferred into the consoles of therapeutic medical units authorized by §§ 35.600 or 35.1000;

(5) Determining if a medical event, as defined in § 35.3045, has occurred; and

(6) Determining, for permanent implant brachytherapy, within 60 calendar days from the date the implant was performed, the total source strength administered outside of the treatment site compared to the total source strength documented in the post-implantation portion of the written directive, unless a written justification of patient unavailability is documented.

(c) A licensee shall retain a copy of the procedures required under paragraph (a) in accordance with § 35.2041.

[67 FR 20370, Apr. 24, 2002, as amended at 72 FR 45151, Aug. 13, 2007; 83 FR 33104, July 16, 2018]

§ 35.49 Suppliers for sealed sources or devices for medical use.

For medical use, a licensee may only use—

(a) Sealed sources or devices manufactured, labeled, packaged, and distributed in accordance with a license issued under 10 CFR Part 30 and 10 CFR 32.74 of this chapter or equivalent requirements of an Agreement State;

(b) Sealed sources or devices non-commercially transferred from a Part 35 licensee or an Agreement State medical use licensee.

(c) Teletherapy sources manufactured and distributed in accordance with a license issued under 10 CFR Part 30 or the equivalent requirements of an Agreement State.

[67 FR 20370, Apr. 24, 2002, as amended at 71 FR 15008, Mar. 27, 2006]

§ 35.50 Training for Radiation Safety Officer and Associate Radiation Safety Officer.

Except as provided in § 35.57, the licensee shall require an individual fulfilling the responsibilities of the Radiation Safety Officer or an individual assigned duties and tasks as an Associate Radiation Safety Officer as provided in § 35.24 to be an individual who—

(a) Is certified by a specialty board whose certification process has been recognized by the Commission or an Agreement State and who meets the requirements in paragraph (d) of this section. The names of board certifications that have been recognized by the Commission or an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:

(1)(i) Hold a bachelor's or graduate degree from an accredited college or university in physical science or engineering or biological science with a minimum of 20 college credits in physical science;

(ii) Have 5 or more years of professional experience in health physics (graduate training may be substituted for no more than 2 years of the required experience) including at least 3 years in applied health physics; and

(iii) Pass an examination administered by diplomates of the specialty board, which evaluates knowledge and competence in radiation physics and instrumentation, radiation protection, mathematics pertaining to the use and measurement of radioactivity, radiation biology, and radiation dosimetry; or

(2)(i) Hold a master's or doctor's degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university;

(ii) Have 2 years of full-time practical training and/or supervised experience in medical physics—

(A) Under the supervision of a medical physicist who is certified in medical physics by a specialty board recognized by the Commission or an Agreement State; or

(B) In clinical nuclear medicine facilities providing diagnostic or therapeutic services under the direction of physicians who meet the requirements for authorized users in §§ 35.57, 35.290, or 35.390; and

(iii) Pass an examination, administered by diplomates of the specialty board, that assesses knowledge and competence in clinical diagnostic radiological or nuclear medicine physics and in radiation safety; or

(b)(1) Has completed a structured educational program consisting of both:

(i) 200 hours of classroom and laboratory training in the following areas—

(A) Radiation physics and instrumentation;

(B) Radiation protection;

(C) Mathematics pertaining to the use and measurement of radioactivity;

(D) Radiation biology; and

(E) Radiation dosimetry; and

(ii) One year of full-time radiation safety experience under the supervision of the individual identified as the Radiation Safety Officer on a Commission or an Agreement State license or permit issued by a Commission master material licensee that authorizes similar type(s) of use(s) of byproduct material. An Associate Radiation Safety Officer may provide supervision for those areas for which the Associate Radiation Safety Officer is authorized on a Commission or an Agreement State license or permit issued by a Commission master material licensee. The full-time radiation safety experience must involve the following—

(A) Shipping, receiving, and performing related radiation surveys;

(B) Using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and instruments used to measure radionuclides;

(C) Securing and controlling byproduct material;

(D) Using administrative controls to avoid mistakes in the administration of byproduct material;

(E) Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures;

(F) Using emergency procedures to control byproduct material; and

(G) Disposing of byproduct material; and

(2) This individual must obtain a written attestation, signed by a preceptor Radiation Safety Officer or Associate Radiation Safety Officer who has experience with the radiation safety aspects of similar types of use of byproduct material for which the individual is seeking approval as a Radiation Safety Officer or an Associate Radiation Safety Officer. The written attestation must state that the individual has satisfactorily completed the requirements in paragraphs (b)(1) and (d) of this section, and is able to independently fulfill the radiation safety-related duties as a Radiation Safety Officer or as an Associate Radiation Safety Officer for a medical use license; or

(c)(1) Is a medical physicist who has been certified by a specialty board whose certification process has been recognized by the Commission or an Agreement State under § 35.51(a), has experience with the radiation safety aspects of similar types of use of byproduct material for which the licensee seeks the approval of the individual as Radiation Safety Officer or an Associate Radiation Safety Officer, and meets the requirements in paragraph (d) of this section; or

(2) Is an authorized user, authorized medical physicist, or authorized nuclear pharmacist identified on a Commission or an Agreement State license, a permit issued by a Commission master material licensee, a permit issued by a Commission or an Agreement State licensee of broad scope, or a permit issued by a Commission master material license broad scope permittee, has experience with the radiation safety aspects of similar types of use of byproduct material for which the licensee seeks the approval of the individual as the Radiation Safety Officer or Associate Radiation Safety Officer, and meets the requirements in paragraph (d) of this section; or

(3) Has experience with the radiation safety aspects of the types of use of byproduct material for which the individual is seeking simultaneous approval both as the Radiation Safety Officer and the authorized user on the same new medical use license or new medical use permit issued by a Commission master material licensee. The individual must also meet the requirements in paragraph (d) of this section.

(d) Has training in the radiation safety, regulatory issues, and emergency procedures for the types of use for which a licensee seeks approval. This training requirement may be satisfied by completing training that is supervised by a Radiation Safety Officer, an Associate Radiation Safety Officer, authorized medical physicist, authorized nuclear pharmacist, or authorized user, as appropriate, who is authorized for the type(s) of use for which the licensee is seeking approval.

[83 FR 33104, July 16, 2018, as amended at 86 FR 43402, Aug. 9, 2021]

§ 35.51 Training for an authorized medical physicist.

Except as provided in § 35.57, the licensee shall require the authorized medical physicist to be an individual who—

(a) Is certified by a specialty board whose certification process has been recognized by the Commission or an Agreement State and who meets the requirements in paragraph (c) of this section. The names of board certifications that have been recognized by the Commission or an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:

(1) Hold a master's or doctor's degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university;

(2) Have 2 years of full-time practical training and/or supervised experience in medical physics—

(i) Under the supervision of a medical physicist who is certified in medical physics by a specialty board whose certification process has been recognized under this section by the Commission or an Agreement State; or

(ii) In clinical radiation facilities providing high-energy, external beam therapy (photons and electrons with energies greater than or equal to 1 million electron volts) and brachytherapy services under the direction of physicians who meet the requirements in § 35.57, 35.490, or 35.690; and

(3) Pass an examination, administered by diplomates of the specialty board, that assesses knowledge and competence in clinical radiation therapy, radiation safety, calibration, quality assurance, and treatment planning for external beam therapy, brachytherapy, and stereotactic radiosurgery; or

(b)(1) Holds a master's or doctor's degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university; and has completed 1 year of full-time training in medical physics and an additional year of full-time work experience under the supervision of an individual who meets the requirements for an authorized medical physicist for the type(s) of use for which the individual is seeking authorization. This training and work experience must be conducted in clinical radiation facilities that provide high-energy, external beam therapy (photons and electrons with energies greater than or equal to 1 million electron volts) and brachytherapy services and must include:

(i) Performing sealed source leak tests and inventories;

(ii) Performing decay corrections;

(iii) Performing full calibration and periodic spot checks of external beam treatment units, stereotactic radiosurgery units, and remote afterloading units as applicable; and

(iv) Conducting radiation surveys around external beam treatment units, stereotactic radiosurgery units, and remote afterloading units as applicable; and

(2) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (b)(1) and (c) of this section, and is able to independently fulfill the radiation safety-related duties as an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status. The written attestation must be signed by a preceptor authorized medical physicist who meets the requirements in § 35.51, § 35.57, or equivalent Agreement State requirements for an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status.

(c) Has training for the type(s) of use for which authorization is sought that includes hands-on device operation, safety procedures, clinical use, and the operation of a treatment planning system. This training requirement may be satisfied by satisfactorily completing either a training program provided by the vendor or by training supervised by an authorized medical physicist authorized for the type(s) of use for which the individual is seeking authorization.

[67 FR 20370, Apr. 24, 2002; 67 FR 62872, Oct. 9, 2002, as amended at 70 FR 16362, Mar. 30, 2005; 71 FR 15008, Mar. 27, 2006; 74 FR 33904, July 14, 2009; 83 FR 33105, July 16, 2018]

§ 35.55 Training for an authorized nuclear pharmacist.

Except as provided in § 35.57, the licensee shall require the authorized nuclear pharmacist to be a pharmacist who—

(a) Is certified by a specialty board whose certification process has been recognized by the Commission or an Agreement State. The names of board certifications that have been recognized by the Commission or an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:

(1) Have graduated from a pharmacy program accredited by the Accreditation Council for Pharmacy Education (ACPE) (previously named the American Council on Pharmaceutical Education) or have passed the Foreign Pharmacy Graduate Examination Committee (FPGEC) examination;

(2) Hold a current, active license to practice pharmacy;

(3) Provide evidence of having acquired at least 4000 hours of training/experience in nuclear pharmacy practice. Academic training may be substituted for no more than 2000 hours of the required training and experience; and

(4) Pass an examination in nuclear pharmacy administered by diplomates of the specialty board, that assesses knowledge and competency in procurement, compounding, quality assurance, dispensing, distribution, health and safety, radiation safety, provision of information and consultation, monitoring patient outcomes, research and development; or

(b)(1) Has completed 700 hours in a structured educational program consisting of both:

(i) 200 hours of classroom and laboratory training in the following areas—

(A) Radiation physics and instrumentation;

(B) Radiation protection;

(C) Mathematics pertaining to the use and measurement of radioactivity;

(D) Chemistry of byproduct material for medical use; and

(E) Radiation biology; and

(ii) Supervised practical experience in a nuclear pharmacy involving—

(A) Shipping, receiving, and performing related radiation surveys;

(B) Using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and, if appropriate, instruments used to measure alpha- or beta-emitting radionuclides;

(C) Calculating, assaying, and safely preparing dosages for patients or human research subjects;

(D) Using administrative controls to avoid medical events in the administration of byproduct material; and

(E) Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures; and

(2) Has obtained written attestation, signed by a preceptor authorized nuclear pharmacist, that the individual has satisfactorily completed the requirements in paragraph (b)(1) of this section and is able to independently fulfill the radiation safety-related duties as an authorized nuclear pharmacist.

[67 FR 20370, Apr. 24, 2002, as amended at 70 FR 16362, Mar. 30, 2005; 83 FR 33105, July 16, 2018; 86 FR 43402, Aug. 9, 2021]

§ 35.57 Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist.

(a)(1) An individual identified on a Commission or an Agreement State license or a permit issued by a Commission or an Agreement State broad scope licensee or master material license permit or by a master material license permittee of broad scope as a Radiation Safety Officer, a teletherapy or medical physicist, an authorized medical physicist, a nuclear pharmacist or an authorized nuclear pharmacist on or before January 14, 2019 need not comply with the training requirements of § 35.50, § 35.51, or § 35.55, respectively, except the Radiation Safety Officers and authorized medical physicists identified in this paragraph must meet the training requirements in § 35.50(d) or § 35.51(c), as appropriate, for any material or uses for which they were not authorized prior to this date.

(2) Any individual certified by the American Board of Health Physics in Comprehensive Health Physics; American Board of Radiology; American Board of Nuclear Medicine; American Board of Science in Nuclear Medicine; Board of Pharmaceutical Specialties in Nuclear Pharmacy; American Board of Medical Physics in radiation oncology physics; Royal College of Physicians and Surgeons of Canada in nuclear medicine; American Osteopathic Board of Radiology; or American Osteopathic Board of Nuclear Medicine on or before October 24, 2005, need not comply with the training requirements of § 35.50 to be identified as a Radiation Safety Officer or as an Associate Radiation Safety Officer on a Commission or an Agreement State license or Commission master material license permit for those materials and uses that these individuals performed on or before October 24, 2005.

(3) Any individual certified by the American Board of Radiology in therapeutic radiological physics, Roentgen ray and gamma ray physics, x-ray and radium physics, or radiological physics, or certified by the American Board of Medical Physics in radiation oncology physics, on or before October 24, 2005, need not comply with the training requirements for an authorized medical physicist described in § 35.51, for those materials and uses that these individuals performed on or before October 24, 2005.

(4) A Radiation Safety Officer, a medical physicist, or a nuclear pharmacist, who used only accelerator-produced radioactive materials, discrete sources of radium-226, or both, for medical uses or in the practice of nuclear pharmacy at a Government agency or Federally recognized Indian Tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC, need not comply with the training requirements of § 35.50, § 35.51 or § 35.55, respectively, when performing the same uses. A nuclear pharmacist, who prepared only radioactive drugs containing accelerator-produced radioactive materials, or a medical physicist, who used only accelerator-produced radioactive materials, at the locations and during the time period identified in this paragraph, qualifies as an authorized nuclear pharmacist or an authorized medical physicist, respectively, for those materials and uses performed before these dates, for the purposes of this chapter.

(b)(1) Physicians, dentists, or podiatrists identified as authorized users for the medical use of byproduct material on a license issued by the Commission or an Agreement State, a permit issued by a Commission master material licensee, a permit issued by a Commission or an Agreement State broad scope licensee, or a permit issued by a Commission master material license broad scope permittee on or before January 14, 2019, who perform only those medical uses for which they were authorized on or before that date need not comply with the training requirements of subparts D through H of this part.

(2) Physicians, dentists, or podiatrists not identified as authorized users for the medical use of byproduct material on a license issued by the Commission or an Agreement State, a permit issued by a Commission master material licensee, a permit issued by a Commission or an Agreement State broad scope licensee, or a permit issued in accordance with a Commission master material broad scope license on or before October 24, 2005, need not comply with the training requirements of subparts D through H of this part for those materials and uses that these individuals performed on or before October 24, 2005, as follows:

(i) For uses authorized under § 35.100 or § 35.200, or oral administration of sodium iodide I-131 requiring a written directive for imaging and localization purposes, a physician who was certified on or before October 24, 2005, in nuclear medicine by the American Board of Nuclear Medicine; diagnostic radiology by the American Board of Radiology; diagnostic radiology or radiology by the American Osteopathic Board of Radiology; nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or American Osteopathic Board of Nuclear Medicine in nuclear medicine;

(ii) For uses authorized under § 35.300, a physician who was certified on or before October 24, 2005, by the American Board of Nuclear Medicine; the American Board of Radiology in radiology, therapeutic radiology, or radiation oncology; nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or the American Osteopathic Board of Radiology after 1984;

(iii) For uses authorized under § 35.400 or § 35.600, a physician who was certified on or before October 24, 2005, in radiology, therapeutic radiology or radiation oncology by the American Board of Radiology; radiation oncology by the American Osteopathic Board of Radiology; radiology, with specialization in radiotherapy, as a British “Fellow of the Faculty of Radiology” or “Fellow of the Royal College of Radiology”; or therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; and

(iv) For uses authorized under § 35.500, a physician who was certified on or before October 24, 2005, in radiology, diagnostic radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology; nuclear medicine by the American Board of Nuclear Medicine; diagnostic radiology or radiology by the American Osteopathic Board of Radiology; or nuclear medicine by the Royal College of Physicians and Surgeons of Canada.

(3) Physicians, dentists, or podiatrists who used only accelerator-produced radioactive materials, discrete sources of radium-226, or both, for medical uses performed at a Government agency or Federally recognized Indian Tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC, need not comply with the training requirements of subparts D through H of this part when performing the same medical uses. A physician, dentist, or podiatrist, who used only accelerator-produced radioactive materials, discrete sources of radium-226, or both, for medical uses at the locations and time period identified in this paragraph, qualifies as an authorized user for those materials and uses performed before these dates, for the purposes of this chapter.

(c) Individuals who need not comply with training requirements as described in this section may serve as preceptors for, and supervisors of, applicants seeking authorization on NRC licenses for the same uses for which these individuals are authorized.

[70 FR 16363, Mar. 30, 2005, as amended at 72 FR 55931, Oct. 1, 2007; 74 FR 33905, July 14, 2009; 83 FR 33105, July 16, 2018; 86 FR 43402, Aug. 9, 2021; 86 FR 47209, Aug. 24, 2021]

§ 35.59 Recentness of training.

The training and experience specified in Subparts B, D, E, F, G, and H of this part must have been obtained within the 7 years preceding the date of application or the individual must have had related continuing education and experience since the required training and experience was completed.

[71 FR 15008, Mar. 27, 2006]

§ 35.60 Possession, use, and calibration of instruments used to measure the activity of unsealed byproduct material.

(a) For direct measurements performed in accordance with § 35.63, a licensee shall possess and use instrumentation to measure the activity of unsealed byproduct material before it is administered to each patient or human research subject.

(b) A licensee shall calibrate the instrumentation required in paragraph (a) of this section in accordance with nationally recognized standards or the manufacturer's instructions.

(c) A licensee shall retain a record of each instrument calibration required by this section in accordance with § 35.2060.

§ 35.61 Calibration of survey instruments.

(a) A licensee shall calibrate the survey instruments used to show compliance with this part and 10 CFR Part 20 before first use, annually, and following a repair that affects the calibration. A licensee shall—

(1) Calibrate all scales with readings up to 10 mSv (1000 mrem) per hour with a radiation source;

(2) Calibrate two separated readings on each scale or decade that will be used to show compliance; and

(3) Conspicuously note on the instrument the date of calibration.

(b) A licensee may not use survey instruments if the difference between the indicated exposure rate and the calculated exposure rate is more than 20 percent.

(c) A licensee shall retain a record of each survey instrument calibration in accordance with § 35.2061.

§ 35.63 Determination of dosages of unsealed byproduct material for medical use.

(a) A licensee shall determine and record the activity of each dosage before medical use.

(b) For a unit dosage, this determination must be made by—

(1) Direct measurement of radioactivity; or

(2) A decay correction, based on the activity or activity concentration determined by—

(i) A manufacturer or preparer licensed under § 32.72 of this chapter or equivalent Agreement State requirements; or

(ii) An NRC or Agreement State licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by FDA; or

(iii) A PET radioactive drug producer licensed under § 30.32(j) of this chapter or equivalent Agreement State requirements.

(c) For other than unit dosages, this determination must be made by—

(1) Direct measurement of radioactivity;

(2) Combination of measurement of radioactivity and mathematical calculations; or

(3) Combination of volumetric measurements and mathematical calculations, based on the measurement made by:

(i) A manufacturer or preparer licensed under § 32.72 of this chapter or equivalent Agreement State requirements; or

(ii) A PET radioactive drug producer licensed under § 30.32(j) of this chapter or equivalent Agreement State requirements.

(d) Unless otherwise directed by the authorized user, a licensee may not use a dosage if the dosage does not fall within the prescribed dosage range or if the dosage differs from the prescribed dosage by more than 20 percent.

(e) A licensee shall retain a record of the dosage determination required by this section in accordance with § 35.2063.

[67 FR 20370, Apr. 24, 2002, as amended at 72 FR 55931, Oct. 1, 2007]

§ 35.65 Authorization for calibration, transmission, and reference sources.

(a) Any person authorized by § 35.11 for medical use of byproduct material may receive, possess, and use any of the following byproduct material for check, calibration, transmission, and reference use:

(1) Sealed sources, not exceeding 1.11 GBq (30 mCi) each, manufactured and distributed by a person licensed under § 32.74 of this chapter or equivalent Agreement State regulations;

(2) Sealed sources, not exceeding 1.11 GBq (30 mCi) each, redistributed by a licensee authorized to redistribute the sealed sources manufactured and distributed by a person licensed under § 32.74 of this chapter or equivalent Agreement State regulations, providing the redistributed sealed sources are in the original packaging and shielding and are accompanied by the manufacturer's approved instructions;

(3) Any byproduct material with a half-life not longer than 120 days in individual amounts not to exceed 0.56 GBq (15 mCi);

(4) Any byproduct material with a half-life longer than 120 days in individual amounts not to exceed the smaller of 7.4 MBq (200 µCI) or 1000 times the quantities in appendix B of part 30 of this chapter; or

(5) Technetium-99m in amounts as needed.

(b) Byproduct material in sealed sources authorized by this provision shall not be:

(1) Used for medical use as defined in § 35.2 except in accordance with the requirements in § 35.500; or

(2) Combined (i.e., bundled or aggregated) to create an activity greater than the maximum activity of any single sealed source authorized under this section.

(c) A licensee using calibration, transmission, and reference sources in accordance with the requirements in paragraph (a) or (b) of this section need not list these sources on a specific medical use license.

[83 FR 33106, July 16, 2018]

§ 35.67 Requirements for possession of sealed sources and brachytherapy sources.

(a) A licensee in possession of any sealed source or brachytherapy source shall follow the radiation safety and handling instructions supplied by the manufacturer.

(b) A licensee in possession of a sealed source shall—

(1) Test the source for leakage before its first use unless the licensee has a certificate from the supplier indicating that the source was tested within 6 months before transfer to the licensee; and

(2) Test the source for leakage at intervals not to exceed 6 months or at other intervals approved by the Commission or an Agreement State in the Sealed Source and Device Registry.

(c) To satisfy the leak test requirements of this section, the licensee shall measure the sample so that the leak test can detect the presence of 185 Bq (0.005 µCi) of radioactive material in the sample.

(d) A licensee shall retain leak test records in accordance with § 35.2067(a).

(e) If the leak test reveals the presence of 185 Bq (0.005 µCi) or more of removable contamination, the licensee shall—

(1) Immediately withdraw the sealed source from use and store, dispose, or cause it to be repaired in accordance with the requirements in parts 20 and 30 of this chapter; and

(2) File a report within 5 days of the leak test in accordance with § 35.3067.

(f) A licensee need not perform a leak test on the following sources:

(1) Sources containing only byproduct material with a half-life of less than 30 days;

(2) Sources containing only byproduct material as a gas;

(3) Sources containing 3.7 MBq (100 µCi) or less of beta or gamma-emitting material or 0.37 MBq (10 µCi) or less of alpha-emitting material;

(4) Seeds of iridium-192 encased in nylon ribbon; and

(5) Sources stored and not being used. However, the licensee shall test each such source for leakage before any use or transfer unless it has been leak tested within 6 months before the date of use or transfer.

(g) A licensee in possession of sealed sources or brachytherapy sources, except for gamma stereotactic radiosurgery sources, shall conduct a semi-annual physical inventory of all such sources in its possession. The licensee shall retain each inventory record in accordance with § 35.2067(b).

§ 35.69 Labeling of vials and syringes.

Each syringe and vial that contains unsealed byproduct material must be labeled to identify the radioactive drug. Each syringe shield and vial shield must also be labeled unless the label on the syringe or vial is visible when shielded.

§ 35.70 Surveys of ambient radiation exposure rate.

(a) In addition to the surveys required by Part 20 of this chapter, a licensee shall survey with a radiation detection survey instrument at the end of each day of use. A licensee shall survey all areas where unsealed byproduct material requiring a written directive was prepared for use or administered.

(b) A licensee does not need to perform the surveys required by paragraph (a) of this section in an area(s) where patients or human research subjects are confined when they cannot be released under § 35.75.

(c) A licensee shall retain a record of each survey in accordance with § 35.2070.

§ 35.75 Release of individuals containing unsealed byproduct material or implants containing byproduct material.

(a) A licensee may authorize the release from its control of any individual who has been administered unsealed byproduct material or implants containing byproduct material if the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed 5 mSv (0.5 rem). 1

1 The current revision of NUREG-1556, Vol. 9, “Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Licenses” describes methods for calculating doses to other individuals and contains tables of activities not likely to cause doses exceeding 5 mSv (0.5 rem).

(b) A licensee shall provide the released individual, or the individual's parent or guardian, with instructions, including written instructions, on actions recommended to maintain doses to other individuals as low as is reasonably achievable if the total effective dose equivalent to any other individual is likely to exceed 1 mSv (0.1 rem). If the total effective dose equivalent to a nursing infant or child could exceed 1 mSv (0.1 rem) assuming there were no interruption of breast-feeding, the instructions must also include—

(1) Guidance on the interruption or discontinuation of breast-feeding; and

(2) Information on the potential consequences, if any, of failure to follow the guidance.

(c) A licensee shall maintain a record of the basis for authorizing the release of an individual in accordance with § 35.2075(a).

(d) The licensee shall maintain a record of instructions provided to a breast-feeding female in accordance with § 35.2075(b).

[67 FR 20370, Apr. 24, 2002, as amended at 70 FR 16363, Mar. 30, 2005; 72 FR 45151, Aug. 13, 2007]

§ 35.80 Provision of mobile medical service.

(a) A licensee providing mobile medical service shall—

(1) Obtain a letter signed by the management of each client for which services are rendered that permits the use of byproduct material at the client's address and clearly delineates the authority and responsibility of the licensee and the client;

(2) Check instruments used to measure the activity of unsealed byproduct material for proper function before medical use at each client's address or on each day of use, whichever is more frequent. At a minimum, the check for proper function required by this paragraph must include a constancy check;

(3) Check survey instruments for proper operation with a dedicated check source before use at each client's address; and

(4) Before leaving a client's address, survey all areas of use to ensure compliance with the requirements in Part 20 of this chapter.

(b) A mobile medical service may not have byproduct material delivered from the manufacturer or the distributor to the client unless the client has a license allowing possession of the byproduct material. Byproduct material delivered to the client must be received and handled in conformance with the client's license.

(c) A licensee providing mobile medical services shall retain the letter required in paragraph (a)(1) and the record of each survey required in paragraph (a)(4) of this section in accordance with § 35.2080(a) and (b), respectively.

§ 35.92 Decay-in-storage.

(a) A licensee may hold byproduct material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if it—

(1) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding; and

(2) Removes or obliterates all radiation labels, except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee.

(b) A licensee shall retain a record of each disposal permitted under paragraph (a) of this section in accordance with § 35.2092.

[67 FR 20370, Apr. 24, 2002, as amended at 72 FR 45151, Aug. 13, 2007]

§ 35.100 Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required.

Except for quantities that require a written directive under § 35.40(b), a licensee may use any unsealed byproduct material prepared for medical use for uptake, dilution, or excretion studies that is—

(a) Obtained from:

(1) A manufacturer or preparer licensed under § 32.72 of this chapter or equivalent Agreement State requirements; or

(2) A PET radioactive drug producer licensed under § 30.32(j) of this chapter or equivalent Agreement State requirements; or

(b) Excluding production of PET radionuclides, prepared by:

(1) An authorized nuclear pharmacist;

(2) A physician who is an authorized user and who meets the requirements specified in §§ 35.290, or 35.390 and 35.290(c)(1)(ii)(G); or

(3) An individual under the supervision, as specified in § 35.27, of the authorized nuclear pharmacist in paragraph (b)(1) of this section or the physician who is an authorized user in paragraph (b)(2) of this section; or

(c) Obtained from and prepared by an NRC or Agreement State licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by FDA; or

(d) Prepared by the licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an Investigational New Drug (IND) protocol accepted by FDA.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19324, Apr. 21, 2003; 71 FR 15009, Mar. 27, 2006; 72 FR 55931, Oct. 1, 2007]

§ 35.190 Training for uptake, dilution, and excretion studies.

Except as provided in § 35.57, the licensee shall require an authorized user of unsealed byproduct material for the uses authorized under § 35.100 to be a physician who—

(a) Is certified by a medical specialty board whose certification process has been recognized by the Commission or an Agreement State. The names of board certifications that have been recognized by the Commission or an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:

(1) Complete 60 hours of training and experience in basic radionuclide handling techniques and radiation safety applicable to the medical use of unsealed byproduct material for uptake, dilution, and excretion studies as described in paragraphs (c)(1)(i) through (c)(1)(ii)(F) of this section; and

(2) Pass an examination, administered by diplomates of the specialty board, that assesses knowledge and competence in radiation safety, radionuclide handling, and quality control; or

(b) Is an authorized user under §§ 35.290, 35.390, or equivalent Agreement State requirements; or

(c)(1) Has completed 60 hours of training and experience, including a minimum of 8 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed byproduct material for uptake, dilution, and excretion studies. The training and experience must include—

(i) Classroom and laboratory training in the following areas—

(A) Radiation physics and instrumentation;

(B) Radiation protection;

(C) Mathematics pertaining to the use and measurement of radioactivity;

(D) Chemistry of byproduct material for medical use; and

(E) Radiation biology; and

(ii) Work experience, under the supervision of an authorized user who meets the requirements in §§ 35.57, 35.190, 35.290, 35.390, or equivalent Agreement State requirements, involving—

(A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(B) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

(C) Calculating, measuring, and safely preparing patient or human research subject dosages;

(D) Using administrative controls to prevent a medical event involving the use of unsealed byproduct material;

(E) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; and

(F) Administering dosages of radioactive drugs to patients or human research subjects; and

(2) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraph (c)(1) of this section and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under § 35.100. The attestation must be obtained from either:

(i) A preceptor authorized user who meets the requirements in § 35.57, § 35.190, § 35.290, or § 35.390, or equivalent Agreement State requirements; or

(ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in § 35.57, § 35.190, § 35.290, or § 35.390, or equivalent Agreement State requirements, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in paragraph (c)(1) of this section.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19324, Apr. 21, 2003; 69 FR 55738, Sept. 16, 2004; 70 FR 16363, Mar. 30, 2005; 71 FR 15009, Mar. 27, 2006; 72 FR 45151, Aug. 13, 2007; 74 FR 33905, July 14, 2009; 83 FR 33106, July 16, 2018]

§ 35.200 Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required.

Except for quantities that require a written directive under § 35.40(b), a licensee may use any unsealed byproduct material prepared for medical use for imaging and localization studies that is—

(a) Obtained from:

(1) A manufacturer or preparer licensed under § 32.72 of this chapter or equivalent Agreement State requirements; or

(2) A PET radioactive drug producer licensed under § 30.32(j) of this chapter or equivalent Agreement State requirements; or

(b) Excluding production of PET radionuclides, prepared by:

(1) An authorized nuclear pharmacist;

(2) A physician who is an authorized user and who meets the requirements specified in § 35.290, or 35.390 and 35.290(c)(1)(ii)(G); or

(3) An individual under the supervision, as specified in § 35.27, of the authorized nuclear pharmacist in paragraph (b)(1) of this section or the physician who is an authorized user in paragraph (b)(2) of this section;

(c) Obtained from and prepared by an NRC or Agreement State licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by FDA; or

(d) Prepared by the licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an Investigational New Drug (IND) protocol accepted by FDA.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19324, Apr. 21, 2003; 71 FR 15009, Mar. 27, 2006; 72 FR 55932, Oct. 1, 2007]

§ 35.204 Permissible molybdenum-99, strontium-82, and strontium-85 concentrations.

(a) A licensee may not administer to humans a radiopharmaceutical that contains:

(1) More than 0.15 kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m (0.15 microcurie of molybdenum-99 per millicurie of technetium-99m); or

(2) More than 0.02 kilobecquerel of strontium-82 per megabecquerel of rubidium-82 chloride injection (0.02 microcurie of strontium-82 per millicurie of rubidium-82 chloride); or more than 0.2 kilobecquerel of strontium-85 per megabecquerel of rubidium-82 chloride injection (0.2 microcurie of strontium-85 per millicurie of rubidium-82).

(b) A licensee that uses molybdenum-99/technetium-99m generators for preparing a technetium-99m radiopharmaceutical shall measure the molybdenum-99 concentration in each eluate from a generator to demonstrate compliance with paragraph (a) of this section.

(c) A licensee that uses a strontium-82/rubidium-82 generator for preparing a rubidium-82 radiopharmaceutical shall, before the first patient use of the day, measure the concentration of radionuclides strontium-82 and strontium-85 to demonstrate compliance with paragraph (a) of this section.

(d) If a licensee is required to measure the molybdenum-99 concentration or strontium-82 and strontium-85 concentrations, the licensee shall retain a record of each measurement in accordance with § 35.2204.

(e) The licensee shall report any measurement that exceeds the limits in paragraph (a) of this section at the time of generator elution, in accordance with § 35.3204.

[67 FR 20370, Apr. 24, 2002, as amended at 72 FR 55932, Oct. 1, 2007; 83 FR 33107, July 16, 2018]

§ 35.290 Training for imaging and localization studies.

Except as provided in § 35.57, the licensee shall require an authorized user of unsealed byproduct material for the uses authorized under § 35.200 to be a physician who—

(a) Is certified by a medical specialty board whose certification process has been recognized by the Commission or an Agreement State. The names of board certifications that have been recognized by the Commission or an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:

(1) Complete 700 hours of training and experience in basic radionuclide handling techniques and radiation safety applicable to the medical use of unsealed byproduct material for imaging and localization studies as described in paragraphs (c)(1)(i) through (c)(1)(ii)(G) of this section; and

(2) Pass an examination, administered by diplomates of the specialty board, which assesses knowledge and competence in radiation safety, radionuclide handling, and quality control; or

(b) Is an authorized user under § 35.390 and meets the requirements in § 35.290(c)(1)(ii)(G), or equivalent Agreement State requirements; or

(c)(1) Has completed 700 hours of training and experience, including a minimum of 80 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed byproduct material for imaging and localization studies. The training and experience must include, at a minimum—

(i) Classroom and laboratory training in the following areas—

(A) Radiation physics and instrumentation;

(B) Radiation protection;

(C) Mathematics pertaining to the use and measurement of radioactivity;

(D) Chemistry of byproduct material for medical use;

(E) Radiation biology; and

(ii) Work experience, under the supervision of an authorized user who meets the requirements in § 35.57, § 35.290, or §§ 35.390 and 35.290(c)(1)(ii)(G), or equivalent Agreement State requirements. An authorized nuclear pharmacist who meets the requirements in § 35.55 or § 35.57 may provide the supervised work experience for paragraph (c)(1)(ii)(G) of this section. Work experience must involve—

(A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(B) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

(C) Calculating, measuring, and safely preparing patient or human research subject dosages;

(D) Using administrative controls to prevent a medical event involving the use of unsealed byproduct material;

(E) Using procedures to safely contain spilled radioactive material and using proper decontamination procedures;

(F) Administering dosages of radioactive drugs to patients or human research subjects; and

(G) Eluting generator systems appropriate for preparation of radioactive drugs for imaging and localization studies, measuring and testing the eluate for radionuclidic purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs; and

(2) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraph (c)(1) of this section and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under §§ 35.100 and 35.200. The attestation must be obtained from either:

(i) A preceptor authorized user who meets the requirements in § 35.57, § 35.290, or §§ 35.390 and 35.290(c)(1)(ii)(G), or equivalent Agreement State requirements; or

(ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in § 35.57, § 35.290, or §§ 35.390 and 35.290(c)(1)(ii)(G), or equivalent Agreement State requirements, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in paragraph (c)(1) of this section.

[67 FR 20370, Apr. 24, 2002, as amended at 70 FR 16364, Mar. 30, 2005; 71 FR 15009, Mar. 27, 2006; 72 FR 45151, Aug. 13, 2007; 74 FR 33905, July 14, 2009; 83 FR 33107, July 16, 2018]

§ 35.300 Use of unsealed byproduct material for which a written directive is required.

A licensee may use any unsealed byproduct material identified in § 35.390(b)(1)(ii)(G) prepared for medical use and for which a written directive is required that is—

(a) Obtained from:

(1) A manufacturer or preparer licensed under § 32.72 of this chapter or equivalent Agreement State requirements; or

(2) A PET radioactive drug producer licensed under § 30.32(j) of this chapter or equivalent Agreement State requirements; or

(b) Excluding production of PET radionuclides, prepared by:

(1) An authorized nuclear pharmacist;

(2) A physician who is an authorized user and who meets the requirements specified in §§ 35.290, 35.390, or

(3) An individual under the supervision, as specified in § 35.27, of the authorized nuclear pharmacist in paragraph (b)(1) of this section or the physician who is an authorized user in paragraph (b)(2) of this section; or

(c) Obtained from and prepared by an NRC or Agreement State licensee for use in research in accordance with an Investigational New Drug (IND) protocol accepted by FDA; or

(d) Prepared by the licensee for use in research in accordance with an Investigational New Drug (IND) protocol accepted by FDA.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19324, Apr. 21, 2003; 71 FR 15009, Mar. 27, 2006; 72 FR 55932, Oct. 1, 2007; 83 FR 33107, July 16, 2018]

§ 35.310 Safety instruction.

In addition to the requirements of § 19.12 of this chapter,

(a) A licensee shall provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects who cannot be released under § 35.75. To satisfy this requirement, the instruction must be commensurate with the duties of the personnel and include—

(1) Patient or human research subject control;

(2) Visitor control, including—

(i) Routine visitation to hospitalized individuals in accordance with § 20.1301(a)(1) of this chapter; and

(ii) Visitation authorized in accordance with § 20.1301(c) of this chapter;

(3) Contamination control;

(4) Waste control; and

(5) Notification of the Radiation Safety Officer, or his or her designee, and an authorized user if the patient or the human research subject has a medical emergency or dies.

(b) A licensee shall retain a record of individuals receiving instruction in accordance with § 35.2310.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19324, Apr. 21, 2003]

§ 35.315 Safety precautions.

(a) For each patient or human research subject who cannot be released under § 35.75, a licensee shall—

(1) Quarter the patient or the human research subject either in—

(i) A private room with a private sanitary facility; or

(ii) A room, with a private sanitary facility, with another individual who also has received therapy with unsealed byproduct material and who also cannot be released under § 35.75;

(2) Visibly post the patient's or the human research subject's room with a “Radioactive Materials” sign.

(3) Note on the door or in the patient's or human research subject's chart where and how long visitors may stay in the patient's or the human research subject's room; and

(4) Either monitor material and items removed from the patient's or the human research subject's room to determine that their radioactivity cannot be distinguished from the natural background radiation level with a radiation detection survey instrument set on its most sensitive scale and with no interposed shielding, or handle the material and items as radioactive waste.

(b) A licensee shall notify the Radiation Safety Officer, or his or her designee, and an authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19325, Apr. 21, 2003]

§ 35.390 Training for use of unsealed byproduct material for which a written directive is required.

Except as provided in § 35.57, the licensee shall require an authorized user of unsealed byproduct material for the uses authorized under § 35.300 to be a physician who—

(a) Is certified by a medical specialty board whose certification process has been recognized by the Commission or an Agreement State and who meets the requirements in paragraphs (b)(1)(ii)(G) of this section. The names of board certifications that have been recognized by the Commission or an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit web page. To be recognized, a specialty board shall require all candidates for certification to:

(1) Successfully complete residency training in a radiation therapy or nuclear medicine training program or a program in a related medical specialty. These residency training programs must include 700 hours of training and experience as described in paragraphs (b)(1)(i) through (b)(1)(ii)(E) of this section. Eligible training programs must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of the American Osteopathic Association; and

(2) Pass an examination, administered by diplomates of the specialty board, which tests knowledge and competence in radiation safety, radionuclide handling, quality assurance, and clinical use of unsealed byproduct material for which a written directive is required; or

(b)(1) Has completed 700 hours of training and experience, including a minimum of 200 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed byproduct material requiring a written directive. The training and experience must include—

(i) Classroom and laboratory training in the following areas—

(A) Radiation physics and instrumentation;

(B) Radiation protection;

(C) Mathematics pertaining to the use and measurement of radioactivity;

(D) Chemistry of byproduct material for medical use; and

(E) Radiation biology; and

(ii) Work experience, under the supervision of an authorized user who meets the requirements in §§ 35.57, 35.390, or equivalent Agreement State requirements. A supervising authorized user, who meets the requirements in § 35.390(b), must also have experience in administering dosages in the same dosage category or categories (i.e., § 35.390(b)(1)(ii)(G)) as the individual requesting authorized user status. The work experience must involve—

(A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(B) Performing quality control procedures on instruments used to determine the activity of dosages, and performing checks for proper operation of survey meters;

(C) Calculating, measuring, and safely preparing patient or human research subject dosages;

(D) Using administrative controls to prevent a medical event involving the use of unsealed byproduct material;

(E) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures;

(F) [Reserved]

(G) Administering dosages of radioactive drugs to patients or human research subjects from the three categories in this paragraph. Radioactive drugs containing radionuclides in categories not included in this paragraph are regulated under § 35.1000. This work experience must involve a minimum of three cases in each of the following categories for which the individual is requesting authorized user status—

(1) Oral administration of less than or equal to 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131, for which a written directive is required;

(2) Oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131; 2

2 Experience with at least three cases in Category (G)(2) also satisfies the requirement in Category (G)(1).

(3) Parenteral administration of any radioactive drug that contains a radionuclide that is primarily used for its electron emission, beta radiation characteristics, alpha radiation characteristics, or photon energy of less than 150 keV, for which a written directive is required; and

(2) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraph (b)(1) of this section and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under § 35.300 for which the individual is requesting authorized user status. The attestation must be obtained from either:

(i) A preceptor authorized user who meets the requirements in § 35.57, § 35.390, or equivalent Agreement State requirements and has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status; or

(ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in § 35.57, § 35.390, or equivalent Agreement State requirements, has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in paragraph (b)(1) of this section.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 75389, Dec. 31, 2003; 70 FR 16364, Mar. 30, 2005; 71 FR 15009, Mar. 27, 2006; 74 FR 33905, July 14, 2009; 83 FR 33107, July 16, 2018; 85 FR 65662, Oct. 16, 2020]

§ 35.392 Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries).

Except as provided in § 35.57, the licensee shall require an authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 Gigabecquerels (33 millicuries), to be a physician who—

(a) Is certified by a medical specialty board whose certification process includes all of the requirements in paragraphs (c)(1) and (2) of this section and whose certification process has been recognized by the Commission or an Agreement State. The names of board certifications that have been recognized by the Commission or an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit web page; or

(b) Is an authorized user under § 35.390 for uses listed in § 35.390(b)(1)(ii)(G)(1) or (2), § 35.394, or equivalent Agreement State requirements; or

(c)(1) Has successfully completed 80 hours of classroom and laboratory training, applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive. The training must include—

(i) Radiation physics and instrumentation;

(ii) Radiation protection;

(iii) Mathematics pertaining to the use and measurement of radioactivity;

(iv) Chemistry of byproduct material for medical use; and

(v) Radiation biology; and

(2) Has work experience, under the supervision of an authorized user who meets the requirements in §§ 35.57, 35.390, 35.392, 35.394, or equivalent Agreement State requirements. A supervising authorized user who meets the requirements in § 35.390(b) must also have experience in administering dosages as specified in §§ 35.390(b)(1)(ii)(G)(1) or 35.390(b)(1)(ii)(G)(2). The work experience must involve—

(i) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(ii) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

(iii) Calculating, measuring, and safely preparing patient or human research subject dosages;

(iv) Using administrative controls to prevent a medical event involving the use of byproduct material;

(v) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; and

(vi) Administering dosages to patients or human research subjects, that includes at least 3 cases involving the oral administration of less than or equal to 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131; and

(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (c)(1) and (2) of this section, and is able to independently fulfill the radiation safety-related duties as an authorized user for oral administration of less than or equal to 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131 for medical uses authorized under § 35.300. The attestation must be obtained from either:

(i) A preceptor authorized user who meets the requirements in § 35.57, § 35.390, § 35.392, § 35.394, or equivalent Agreement State requirements and has experience in administering dosages as specified in § 35.390(b)(1)(ii)(G)(1) or (2); or

(ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in § 35.57, § 35.390, § 35.392, § 35.394, or equivalent Agreement State requirements, has experience in administering dosages as specified in § 35.390(b)(1)(ii)(G)(1) or (2), and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in paragraphs (c)(1) and (2) of this section.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 75389, Dec. 31, 2003; 70 FR 16364, Mar. 30, 2005; 71 FR 15009, Mar. 27, 2006; 74 FR 33905, July 14, 2009; 83 FR 33108, July 16, 2018]

§ 35.394 Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries).

Except as provided in § 35.57, the licensee shall require an authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 Gigabecquerels (33 millicuries), to be a physician who—

(a) Is certified by a medical specialty board whose certification process includes all of the requirements in paragraphs (c)(1) and (2) of this section, and whose certification has been recognized by the Commission or an Agreement State. The names of board certifications that have been recognized by the Commission or an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit web page; or

(b) Is an authorized user under § 35.390 for uses listed in § 35.390(b)(1)(ii)(G)(2) or equivalent Agreement State requirements; or

(c)(1) Has successfully completed 80 hours of classroom and laboratory training, applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive. The training must include—

(i) Radiation physics and instrumentation;

(ii) Radiation protection;

(iii) Mathematics pertaining to the use and measurement of radioactivity;

(iv) Chemistry of byproduct material for medical use; and

(v) Radiation biology; and

(2) Has work experience, under the supervision of an authorized user who meets the requirements in §§ 35.57, 35.390, 35.394, or equivalent Agreement State requirements. A supervising authorized user, who meets the requirements in § 35.390(b), must also have experience in administering dosages as specified in § 35.390(b)(1)(ii)(G)(2). The work experience must involve—

(i) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(ii) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

(iii) Calculating, measuring, and safely preparing patient or human research subject dosages;

(iv) Using administrative controls to prevent a medical event involving the use of byproduct material;

(v) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; and

(vi) Administering dosages to patients or human research subjects, that includes at least 3 cases involving the oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131; and

(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (c)(1) and (2) of this section, and is able to independently fulfill the radiation safety-related duties as an authorized user for oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131 for medical uses authorized under § 35.300. The attestation must be obtained from either:

(i) A preceptor authorized user who meets the requirements in § 35.57, § 35.390, § 35.394, or equivalent Agreement State requirements, and has experience in administering dosages as specified in § 35.390(b)(1)(ii)(G)(2); or

(ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in § 35.57, § 35.390, § 35.394, or equivalent Agreement State requirements, has experience in administering dosages as specified in § 35.390(b)(1)(ii)(G)(2), and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in paragraphs (c)(1) and (2) of this section.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 75389, Dec. 31, 2003; 70 FR 16365, Mar. 30, 2005; 71 FR 15010, Mar. 27, 2006; 74 FR 33905, July 14, 2009; 83 FR 33108, July 16, 2018]

§ 35.396 Training for the parenteral administration of unsealed byproduct material requiring a written directive.

(a) Except as provided in § 35.57, the licensee shall require an authorized user for the parenteral administration requiring a written directive, to be a physician who—

(1) Is an authorized user under § 35.390 for uses listed in § 35.390(b)(1)(ii)(G)(3), or equivalent Agreement State requirements; or

(2) Is an authorized user under § 35.490, § 35.690, or equivalent Agreement State requirements, and who meets the requirements in paragraph (b) of this section; or

(3) Is certified by a medical specialty board whose certification process has been recognized by the Commission or an Agreement State under § 35.490 or § 35.690, and who meets the requirements in paragraph (b) of this section.

(b) The physician—

(1) Has successfully completed 80 hours of classroom and laboratory training, applicable to parenteral administrations listed in § 35.390(b)(1)(ii)(G)(3). The training must include—

(i) Radiation physics and instrumentation;

(ii) Radiation protection;

(iii) Mathematics pertaining to the use and measurement of radioactivity;

(iv) Chemistry of byproduct material for medical use; and

(v) Radiation biology; and

(2) Has work experience, under the supervision of an authorized user who meets the requirements in § 35.57, § 35.390, § 35.396, or equivalent Agreement State requirements, in the parenteral administrations listed in § 35.390(b)(1)(ii)(G)(3). A supervising authorized user who meets the requirements in § 35.390, § 35.396, or equivalent Agreement State requirements, must have experience in administering dosages in the same category or categories as the individual requesting authorized user status. The work experience must involve—

(i) Ordering, receiving, and unpacking radioactive materials safely, and performing the related radiation surveys;

(ii) Performing quality control procedures on instruments used to determine the activity of dosages, and performing checks for proper operation of survey meters;

(iii) Calculating, measuring, and safely preparing patient or human research subject dosages;

(iv) Using administrative controls to prevent a medical event involving the use of unsealed byproduct material;

(v) Using procedures to contain spilled byproduct material safely, and using proper decontamination procedures; and

(vi) Administering dosages to patients or human research subjects, that include at least three cases of the parenteral administrations as specified in § 35.390(b)(1)(ii)(G)(3); and

(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (b)(1) and (2) of this section, and is able to independently fulfill the radiation safety-related duties as an authorized user for the parenteral administration of unsealed byproduct material requiring a written directive. The attestation must be obtained from either:

(i) A preceptor authorized user who meets the requirements in § 35.57, § 35.390, § 35.396, or equivalent Agreement State requirements. A preceptor authorized user who meets the requirements in § 35.390, § 35.396, or equivalent Agreement State requirements, must have experience in administering dosages in the same category or categories as the individual requesting authorized user status; or

(ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in § 35.57, § 35.390, § 35.396, or equivalent Agreement State requirements, has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in paragraphs (b)(1) and (2) of this section.

[83 FR 33108, July 16, 2018]

§ 35.400 Use of sources for manual brachytherapy.

A licensee must use only brachytherapy sources:

(a) Approved in the Sealed Source and Device Registry for manual brachytherapy medical use. The manual brachytherapy sources may be used for manual brachytherapy uses that are not explicitly listed in the Sealed Source and Device Registry, but must be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry; or

(b) In research to deliver therapeutic doses for medical use in accordance with an active Investigational Device Exemption (IDE) application accepted by the U.S. Food and Drug Administration provided the requirements of § 35.49(a) are met.

[83 FR 33109, July 16, 2018]

§ 35.404 Surveys after source implant and removal.

(a) Immediately after implanting sources in a patient or a human research subject, the licensee shall make a survey to locate and account for all sources that have not been implanted.

(b) Immediately after removing the last temporary implant source from a patient or a human research subject, the licensee shall make a survey of the patient or the human research subject with a radiation detection survey instrument to confirm that all sources have been removed.

(c) A licensee shall retain a record of the surveys required by paragraphs (a) and (b) of this section in accordance with § 35.2404.

§ 35.406 Brachytherapy sources accountability.

(a) A licensee shall maintain accountability at all times for all brachytherapy sources in storage or use.

(b) As soon as possible after removing sources from a patient or a human research subject, a licensee shall return brachytherapy sources to a secure storage area.

(c) A licensee shall maintain a record of the brachytherapy source accountability in accordance with § 35.2406.

§ 35.410 Safety instruction.

In addition to the requirements of § 19.12 of this chapter,

(a) The licensee shall provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects who are receiving brachytherapy and cannot be released under § 35.75. To satisfy this requirement, the instruction must be commensurate with the duties of the personnel and include the—

(1) Size and appearance of the brachytherapy sources;

(2) Safe handling and shielding instructions;

(3) Patient or human research subject control;

(4) Visitor control, including both:

(i) Routine visitation of hospitalized individuals in accordance with § 20.1301(a)(1) of this chapter; and

(ii) Visitation authorized in accordance with § 20.1301(c) of this chapter; and

(5) Notification of the Radiation Safety Officer, or his or her designee, and an authorized user if the patient or the human research subject has a medical emergency or dies.

(b) A licensee shall retain a record of individuals receiving instruction in accordance with § 35.2310.

§ 35.415 Safety precautions.

(a) For each patient or human research subject who is receiving brachytherapy and cannot be released under § 35.75, a licensee shall—

(1) Not quarter the patient or the human research subject in the same room as an individual who is not receiving brachytherapy;

(2) Visibly post the patient's or human research subject's room with a “Radioactive Materials” sign; and

(3) Note on the door or in the patient's or human research subject's chart where and how long visitors may stay in the patient's or human research subject's room.

(b) A licensee shall have applicable emergency response equipment available near each treatment room to respond to a source—

(1) Dislodged from the patient; and

(2) Lodged within the patient following removal of the source applicators.

(c) A licensee shall notify the Radiation Safety Officer, or his or her designee, and an authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.

§ 35.432 Calibration measurements of brachytherapy sources.

(a) Before the first medical use of a brachytherapy source on or after October 24, 2002, a licensee shall have—

(1) Determined the source output or activity using a dosimetry system that meets the requirements of § 35.630(a);

(2) Determined source positioning accuracy within applicators; and

(3) Used published protocols currently accepted by nationally recognized bodies to meet the requirements of paragraphs (a)(1) and (a)(2) of this section.

(b) Instead of a licensee making its own measurements as required in paragraph (a) of this section, the licensee may use measurements provided by the source manufacturer or by a calibration laboratory accredited by the American Association of Physicists in Medicine that are made in accordance with paragraph (a) of this section.

(c) A licensee shall mathematically correct the outputs or activities determined in paragraph (a) of this section for physical decay at intervals consistent with 1 percent physical decay.

(d) A licensee shall retain a record of each calibration in accordance with § 35.2432.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19325, Apr. 21, 2003]

§ 35.433 Strontium-90 sources for ophthalmic treatments.

(a) Licensees who use strontium-90 for ophthalmic treatments must ensure that certain activities as specified in paragraph (b) of this section are performed by either:

(1) An authorized medical physicist; or

(2) An individual who:

(i) is identified as an ophthalmic physicist on a specific medical use license issued by the Commission or an Agreement State; permit issued by a Commission or Agreement State broad scope medical use licensee; medical use permit issued by a Commission master material licensee; or permit issued by a Commission master material licensee broad scope medical use permittee; and

(ii) holds a master's or doctor's degree in physics, medical physics, other physical sciences, engineering, or applied mathematics from an accredited college or university; and

(iii) has successfully completed 1 year of full-time training in medical physics and an additional year of full-time work experience under the supervision of a medical physicist; and

(iv) Has documented training in:

(A) The creation, modification, and completion of written directives;

(B) Procedures for administrations requiring a written directive; and

(C) Performing the calibration measurements of brachytherapy sources as detailed in § 35.432.

(b) The individuals who are identified in paragraph (a) of this section must:

(1) Calculate the activity of each strontium-90 source that is used to determine the treatment times for ophthalmic treatments. The decay must be based on the activity determined under § 35.432; and

(2) Assist the licensee in developing, implementing, and maintaining written procedures to provide high confidence that the administration is in accordance with the written directive. These procedures must include the frequencies that the individual meeting the requirements in paragraph (a) of this section will observe treatments, review the treatment methodology, calculate treatment time for the prescribed dose, and review records to verify that the administrations were in accordance with the written directives.

(c) Licensees must retain a record of the activity of each strontium-90 source in accordance with § 35.2433.

[83 FR 33109, July 16, 2018]

§ 35.457 Therapy-related computer systems.

The licensee shall perform acceptance testing on the treatment planning system of therapy-related computer systems in accordance with published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testing must include, as applicable, verification of:

(a) The source-specific input parameters required by the dose calculation algorithm;

(b) The accuracy of dose, dwell time, and treatment time calculations at representative points;

(c) The accuracy of isodose plots and graphic displays; and

(d) The accuracy of the software used to determine sealed source positions from radiographic images.

§ 35.490 Training for use of manual brachytherapy sources.

Except as provided in § 35.57, the licensee shall require an authorized user of a manual brachytherapy source for the uses authorized under § 35.400 to be a physician who—

(a) Is certified by a medical specialty board whose certification process has been recognized by the Commission or an Agreement State. The names of board certifications that have been recognized by the Commission or an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:

(1) Successfully complete a minimum of 3 years of residency training in a radiation oncology program approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association; and

(2) Pass an examination, administered by diplomates of the specialty board, that tests knowledge and competence in radiation safety, radionuclide handling, treatment planning, quality assurance, and clinical use of manual brachytherapy; or

(b)(1) Has completed a structured educational program in basic radionuclide handling techniques applicable to the use of manual brachytherapy sources that includes—

(i) 200 hours of classroom and laboratory training in the following areas—

(A) Radiation physics and instrumentation;

(B) Radiation protection;

(C) Mathematics pertaining to the use and measurement of radioactivity; and

(D) Radiation biology; and

(ii) 500 hours of work experience, under the supervision of an authorized user who meets the requirements in § 35.57, § 35.490, or equivalent Agreement State requirements, at a medical facility authorized to use byproduct materials under § 35.400, involving—

(A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(B) Checking survey meters for proper operation;

(C) Preparing, implanting, and removing brachytherapy sources;

(D) Maintaining running inventories of material on hand;

(E) Using administrative controls to prevent a medical event involving the use of byproduct material;

(F) Using emergency procedures to control byproduct material; and

(2) Has completed 3 years of supervised clinical experience in radiation oncology, under an authorized user who meets the requirements in §§ 35.57, 35.490, or equivalent Agreement State requirements, as part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by paragraph (b)(1)(ii) of this section; and

(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (b)(1) and (2) of this section and is able to independently fulfill the radiation safety-related duties as an authorized user of manual brachytherapy sources for the medical uses authorized under § 35.400. The attestation must be obtained from either:

(i) A preceptor authorized user who meets the requirements in § 35.57, § 35.490, or equivalent Agreement State requirements; or

(ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in § 35.57, § 35.490, or equivalent Agreement State requirements, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in paragraphs (b)(1) and (2) of this section.

[67 FR 20370, Apr. 24, 2002, as amended at 70 FR 16366, Mar. 30, 2005; 71 FR 15010, Mar. 27, 2006; 74 FR 33906, July 14, 2009; 83 FR 33109, July 16, 2018; 85 FR 65662, Oct. 16, 2020]

§ 35.491 Training for ophthalmic use of strontium-90.

Except as provided in § 35.57, the licensee shall require the authorized user of strontium-90 for ophthalmic radiotherapy to be a physician who—

(a) Is an authorized user under § 35.490 or equivalent Agreement State requirements; or

(b)(1) Has completed 24 hours of classroom and laboratory training applicable to the medical use of strontium-90 for ophthalmic radiotherapy. The training must include—

(i) Radiation physics and instrumentation;

(ii) Radiation protection;

(iii) Mathematics pertaining to the use and measurement of radioactivity; and

(iv) Radiation biology; and

(2) Supervised clinical training in ophthalmic radiotherapy under the supervision of an authorized user at a medical institution, clinic, or private practice that includes the use of strontium-90 for the ophthalmic treatment of five individuals. This supervised clinical training must involve—

(i) Examination of each individual to be treated;

(ii) Calculation of the dose to be administered;

(iii) Administration of the dose; and

(iv) Follow up and review of each individual's case history; and

(3) Has obtained written attestation, signed by a preceptor authorized user who meets the requirements in § 35.57, § 35.490, § 35.491, or equivalent Agreement State requirements, that the individual has satisfactorily completed the requirements in paragraphs (b)(1) and (2) of this section and is able to independently fulfill the radiation safety-related duties as an authorized user of strontium-90 for ophthalmic use.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19326, Apr. 21, 2003; 71 FR 15011, Mar. 27, 2006; 74 FR 33906, July 14, 2009; 83 FR 33109, July 16, 2018]

§ 35.500 Use of sealed sources and medical devices for diagnosis.

(a) A licensee must use only sealed sources that are not in medical devices for diagnostic medical uses if the sealed sources are approved in the Sealed Source and Device Registry for diagnostic medicine. The sealed sources may be used for diagnostic medical uses that are not explicitly listed in the Sealed Source and Device Registry but must be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry.

(b) A licensee must only use medical devices containing sealed sources for diagnostic medical uses if both the sealed sources and medical devices are approved in the Sealed Source and Device Registry for diagnostic medical uses. The diagnostic medical devices may be used for diagnostic medical uses that are not explicitly listed in the Sealed Source and Device Registry but must be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry.

(c) Sealed sources and devices for diagnostic medical uses may be used in research in accordance with an active Investigational Device Exemption (IDE) application accepted by the U.S. Food and Drug Administration provided the requirements of § 35.49(a) are met.

[83 FR 33110, July 16, 2018]

§ 35.590 Training for use of sealed sources and medical devices for diagnosis.

Except as provided in § 35.57, the licensee shall require the authorized user of a diagnostic sealed source or a device authorized under § 35.500 to be a physician, dentist, or podiatrist who—

(a) Is certified by a specialty board whose certification process includes all of the requirements in paragraphs (c) and (d) of this section and whose certification has been recognized by the Commission or an Agreement State. The names of board certifications that have been recognized by the Commission or an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit web page; or

(b) Is an authorized user for uses listed in § 35.200 or equivalent Agreement State requirements; or

(c) Has completed 8 hours of classroom and laboratory training in basic radionuclide handling techniques specifically applicable to the use of the device. The training must include—

(1) Radiation physics and instrumentation;

(2) Radiation protection;

(3) Mathematics pertaining to the use and measurement of radioactivity; and

(4) Radiation biology; and

(d) Has completed training in the use of the device for the uses requested.

[83 FR 33110, July 16, 2018]

§ 35.600 Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit.

(a) A licensee must only use sealed sources:

(1) Approved and as provided for in the Sealed Source and Device Registry in photon emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units to deliver therapeutic doses for medical uses: or

(2) In research involving photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units in accordance with an active Investigational Device Exemption (IDE) application accepted by the U.S. Food and Drug Administration provided the requirements of § 35.49(a) are met.

(b) A licensee must use photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units:

(1) Approved in the Sealed Source and Device Registry to deliver a therapeutic dose for medical use. These devices may be used for therapeutic medical treatments that are not explicitly provided for in the Sealed Source and Device Registry, but must be used in accordance with radiation safety conditions and limitations described in the Sealed Source and Device Registry; or

(2) In research in accordance with an active Investigational Device Exemption (IDE) application accepted by the FDA provided the requirements of § 35.49(a) are met.

[83 FR 33110, July 16, 2018]

§ 35.604 Surveys of patients and human research subjects treated with a remote afterloader unit.

(a) Before releasing a patient or a human research subject from licensee control, a licensee shall survey the patient or the human research subject and the remote afterloader unit with a portable radiation detection survey instrument to confirm that the source(s) has been removed from the patient or human research subject and returned to the safe shielded position.

(b) A licensee shall retain a record of these surveys in accordance with § 35.2404.

§ 35.605 Installation, maintenance, adjustment, and repair.

(a) Only a person specifically licensed by the Commission or an Agreement State shall install, maintain, adjust, or repair a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit that involves work on the source(s) shielding, the source(s) driving unit, or other electronic or mechanical component that could expose the source(s), reduce the shielding around the source(s), or compromise the radiation safety of the unit or the source(s).

(b) Except for low dose-rate remote afterloader units, only a person specifically licensed by the Commission or an Agreement State shall install, replace, relocate, or remove a sealed source or source contained in other remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units.

(c) For a low dose-rate remote afterloader unit, only a person specifically licensed by the Commission or an Agreement State or an authorized medical physicist shall install, replace, relocate, or remove a sealed source(s) contained in the unit.

(d) A licensee shall retain a record of the installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units in accordance with § 35.2605.

§ 35.610 Safety procedures and instructions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

(a) A licensee shall—

(1) Secure the unit, the console, the console keys, and the treatment room when not in use or unattended;

(2) Permit only individuals approved by the authorized user, Radiation Safety Officer, or authorized medical physicist to be present in the treatment room during treatment with the source(s);

(3) Prevent dual operation of more than one radiation producing device in a treatment room if applicable; and

(4) Develop, implement, and maintain written procedures for responding to an abnormal situation when the operator is unable to place the source(s) in the shielded position, or remove the patient or human research subject from the radiation field with controls from outside the treatment room. These procedures must include—

(i) Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions;

(ii) The process for restricting access to and posting of the treatment area to minimize the risk of inadvertent exposure; and

(iii) The names and telephone numbers of the authorized users, the authorized medical physicist, and the Radiation Safety Officer to be contacted if the unit or console operates abnormally.

(b) A copy of the procedures required by paragraph (a)(4) of this section must be physically located at the unit console.

(c) A licensee shall post instructions at the unit console to inform the operator of—

(1) The location of the procedures required by paragraph (a)(4) of this section; and

(2) The names and telephone numbers of the authorized users, the authorized medical physicist, and the Radiation Safety Officer to be contacted if the unit or console operates abnormally.

(d)(1) Prior to the first use for patient treatment of a new unit or an existing unit with a manufacturer upgrade that affects the operation and safety of the unit, a licensee shall ensure that vendor operational and safety training is provided to all individuals who will operate the unit. The vendor operational and safety training must be provided by the device manufacturer or by an individual certified by the device manufacturer to provide the operational and safety training.

(2) A licensee shall provide operational and safety instructions initially and at least annually to all individuals who operate the unit at the facility, as appropriate to the individual's assigned duties. The instructions shall include instruction in—

(i) The procedures identified in paragraph (a)(4) of this section; and

(ii) The operating procedures for the unit.

(e) A licensee shall ensure that operators, authorized medical physicists, and authorized users participate in drills of the emergency procedures, initially and at least annually.

(f) A licensee shall retain a record of individuals receiving instruction required by paragraph (d) of this section, in accordance with § 35.2310.

(g) A licensee shall retain a copy of the procedures required by paragraphs (a)(4) and (d)(2)(ii) of this section in accordance with § 35.2610.

[67 FR 20370, Apr. 24, 2002, as amended at 83 FR 33110, July 16, 2018]

§ 35.615 Safety precautions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

(a) A licensee shall control access to the treatment room by a door at each entrance.

(b) A licensee shall equip each entrance to the treatment room with an electrical interlock system that will—

(1) Prevent the operator from initiating the treatment cycle unless each treatment room entrance door is closed;

(2) Cause the source(s) to be shielded when an entrance door is opened; and

(3) Prevent the source(s) from being exposed following an interlock interruption until all treatment room entrance doors are closed and the source(s) on-off control is reset at the console.

(c) A licensee shall require any individual entering the treatment room to assure, through the use of appropriate radiation monitors, that radiation levels have returned to ambient levels.

(d) Except for low-dose remote afterloader units, a licensee shall construct or equip each treatment room with viewing and intercom systems to permit continuous observation of the patient or the human research subject from the treatment console during irradiation.

(e) For licensed activities where sources are placed within the patient's or human research subject's body, a licensee shall only conduct treatments which allow for expeditious removal of a decoupled or jammed source.

(f) In addition to the requirements specified in paragraphs (a) through (e) of this section, a licensee shall—

(1) For medium dose-rate and pulsed dose-rate remote afterloader units, require—

(i) An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who has been trained in the operation and emergency response for the unit to be physically present during the initiation of all patient treatments involving the unit; and

(ii) An authorized medical physicist and either an authorized user or an individual, under the supervision of an authorized user, who has been trained to remove the source applicator(s) in the event of an emergency involving the unit, to be immediately available during continuation of all patient treatments involving the unit.

(2) For high dose-rate remote afterloader units, require—

(i) An authorized user and an authorized medical physicist to be physically present during the initiation of all patient treatments involving the unit; and

(ii) An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who has been trained in the operation and emergency response for the unit, to be physically present during continuation of all patient treatments involving the unit.

(3) For gamma stereotactic radiosurgery units, require an authorized user and an authorized medical physicist to be physically present throughout all patient treatments involving the unit.

(4) Notify the Radiation Safety Officer, or his/her designee, and an authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.

(g) A licensee shall have applicable emergency response equipment available near each treatment room to respond to a source—

(1) Remaining in the unshielded position; or

(2) Lodged within the patient following completion of the treatment.

§ 35.630 Dosimetry equipment.

(a) Except for low dose-rate remote afterloader sources where the source output or activity is determined by the manufacturer, a licensee shall have a calibrated dosimetry system available for use. To satisfy this requirement, one of the following two conditions must be met.

(1) The system must have been calibrated using a system or source traceable to the National Institute of Standards and Technology (NIST) and published protocols accepted by nationally recognized bodies; or by a calibration laboratory accredited by the American Association of Physicists in Medicine (AAPM). The calibration must have been performed within the previous 2 years and after any servicing that may have affected system calibration; or

(2) The system must have been calibrated within the previous 4 years. Eighteen to thirty months after that calibration, the system must have been intercompared with another dosimetry system that was calibrated within the past 24 months by NIST or by a calibration laboratory accredited by the AAPM. The results of the intercomparison must indicate that the calibration factor of the licensee's system had not changed by more than 2 percent. The licensee may not use the intercomparison result to change the calibration factor. When intercomparing dosimetry systems to be used for calibrating sealed sources for therapeutic units, the licensee shall use a comparable unit with beam attenuators or collimators, as applicable, and sources of the same radionuclide as the source used at the licensee's facility.

(b) The licensee shall have a dosimetry system available for use for spot-check output measurements, if applicable. To satisfy this requirement, the system may be compared with a system that has been calibrated in accordance with paragraph (a) of this section. This comparison must have been performed within the previous year and after each servicing that may have affected system calibration. The spot-check system may be the same system used to meet the requirement in paragraph (a) of this section.

(c) The licensee shall retain a record of each calibration, intercomparison, and comparison in accordance with § 35.2630.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19326, Apr. 21, 2003]

§ 35.632 Full calibration measurements on teletherapy units.

(a) A licensee authorized to use a teletherapy unit for medical use shall perform full calibration measurements on each teletherapy unit—

(1) Before the first medical use of the unit; and

(2) Before medical use under the following conditions:

(i) Whenever spot-check measurements indicate that the output differs by more than 5 percent from the output obtained at the last full calibration corrected mathematically for radioactive decay;

(ii) Following replacement of the source or following reinstallation of the teletherapy unit in a new location;

(iii) Following any repair of the teletherapy unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and

(3) At intervals not exceeding 1 year.

(b) To satisfy the requirement of paragraph (a) of this section, full calibration measurements must include determination of—

(1) The output within ±3 percent for the range of field sizes and for the distance or range of distances used for medical use;

(2) The coincidence of the radiation field and the field indicated by the light beam localizing device;

(3) The uniformity of the radiation field and its dependence on the orientation of the useful beam;

(4) Timer accuracy and linearity over the range of use;

(5) On-off error; and

(6) The accuracy of all distance measuring and localization devices in medical use.

(c) A licensee shall use the dosimetry system described in § 35.630(a) to measure the output for one set of exposure conditions. The remaining radiation measurements required in paragraph (b)(1) of this section may be made using a dosimetry system that indicates relative dose rates.

(d) A licensee shall make full calibration measurements required by paragraph (a) of this section in accordance with published protocols accepted by nationally recognized bodies.

(e) A licensee shall mathematically correct the outputs determined in paragraph (b)(1) of this section for physical decay for intervals not exceeding 1 month for cobalt-60, 6 months for cesium-137, or at intervals consistent with 1 percent decay for all other nuclides.

(f) Full calibration measurements required by paragraph (a) of this section and physical decay corrections required by paragraph (e) of this section must be performed by the authorized medical physicist.

(g) A licensee shall retain a record of each calibration in accordance with § 35.2632.

§ 35.633 Full calibration measurements on remote afterloader units.

(a) A licensee authorized to use a remote afterloader unit for medical use shall perform full calibration measurements on each unit—

(1) Before the first medical use of the unit;

(2) Before medical use under the following conditions:

(i) Following replacement of the source or following reinstallation of the unit in a new location outside the facility; and

(ii) Following any repair of the unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and

(3) At intervals not exceeding 1 quarter for high dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader units with sources whose half-life exceeds 75 days; and

(4) At intervals not exceeding 1 year for low dose-rate remote afterloader units.

(b) To satisfy the requirement of paragraph (a) of this section, full calibration measurements must include, as applicable, determination of:

(1) The output within ±5 percent;

(2) Source positioning accuracy to within ±1 millimeter;

(3) Source retraction with backup battery upon power failure;

(4) Length of the source transfer tubes;

(5) Timer accuracy and linearity over the typical range of use;

(6) Length of the applicators; and

(7) Function of the source transfer tubes, applicators, and transfer tube-applicator interfaces.

(c) A licensee shall use the dosimetry system described in § 35.630(a) to measure the output.

(d) A licensee shall make full calibration measurements required by paragraph (a) of this section in accordance with published protocols accepted by nationally recognized bodies.

(e) In addition to the requirements for full calibrations for low dose-rate remote afterloader units in paragraph (b) of this section, a licensee shall perform an autoradiograph of the source(s) to verify inventory and source(s) arrangement at intervals not exceeding 1 quarter.

(f) For low dose-rate remote afterloader units, a licensee may use measurements provided by the source manufacturer that are made in accordance with paragraphs (a) through (e) of this section.

(g) A licensee shall mathematically correct the outputs determined in paragraph (b)(1) of this section for physical decay at intervals consistent with 1 percent physical decay.

(h) Full calibration measurements required by paragraph (a) of this section and physical decay corrections required by paragraph (g) of this section must be performed by the authorized medical physicist.

(i) A licensee shall retain a record of each calibration in accordance with § 35.2632.

§ 35.635 Full calibration measurements on gamma stereotactic radiosurgery units.

(a) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform full calibration measurements on each unit—

(1) Before the first medical use of the unit;

(2) Before medical use under the following conditions—

(i) Whenever spot-check measurements indicate that the output differs by more than 5 percent from the output obtained at the last full calibration corrected mathematically for radioactive decay;

(ii) Following replacement of the sources or following reinstallation of the gamma stereotactic radiosurgery unit in a new location; and

(iii) Following any repair of the gamma stereotactic radiosurgery unit that includes removal of the sources or major repair of the components associated with the source assembly; and

(3) At intervals not exceeding 1 year, with the exception that relative helmet factors need only be determined before the first medical use of a helmet and following any damage to a helmet.

(b) To satisfy the requirement of paragraph (a) of this section, full calibration measurements must include determination of—

(1) The output within ±3 percent;

(2) Relative helmet factors;

(3) Isocenter coincidence;

(4) Timer accuracy and linearity over the range of use;

(5) On-off error;

(6) Trunnion centricity;

(7) Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off;

(8) Helmet microswitches;

(9) Emergency timing circuits; and

(10) Stereotactic frames and localizing devices (trunnions).

(c) A licensee shall use the dosimetry system described in § 35.630(a) to measure the output for one set of exposure conditions. The remaining radiation measurements required in paragraph (b)(1) of this section may be made using a dosimetry system that indicates relative dose rates.

(d) A licensee shall make full calibration measurements required by paragraph (a) of this section in accordance with published protocols accepted by nationally recognized bodies.

(e) A licensee shall mathematically correct the outputs determined in paragraph (b)(1) of this section at intervals not exceeding 1 month for cobalt-60 and at intervals consistent with 1 percent physical decay for all other radionuclides.

(f) Full calibration measurements required by paragraph (a) of this section and physical decay corrections required by paragraph (e) of this section must be performed by the authorized medical physicist.

(g) A licensee shall retain a record of each calibration in accordance with § 35.2632.

§ 35.642 Periodic spot-checks for teletherapy units.

(a) A licensee authorized to use teletherapy units for medical use shall perform output spot-checks on each teletherapy unit once in each calendar month that include determination of—

(1) Timer accuracy, and timer linearity over the range of use;

(2) On-off error;

(3) The coincidence of the radiation field and the field indicated by the light beam localizing device;

(4) The accuracy of all distance measuring and localization devices used for medical use;

(5) The output for one typical set of operating conditions measured with the dosimetry system described in § 35.630(b); and

(6) The difference between the measurement made in paragraph (a)(5) of this section and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay).

(b) A licensee shall perform measurements required by paragraph (a) of this section in accordance with written procedures established by the authorized medical physicist. That individual need not actually perform the spot-check measurements.

(c) A licensee shall have the authorized medical physicist review the results of each spot-check within 15 days. The authorized medical physicist shall notify the licensee as soon as possible in writing of the results of each spot-check.

(d) A licensee authorized to use a teletherapy unit for medical use shall perform safety spot-checks of each teletherapy facility once in each calendar month and after each source installation to assure proper operation of—

(1) Electrical interlocks at each teletherapy room entrance;

(2) Electrical or mechanical stops installed for the purpose of limiting use of the primary beam of radiation (restriction of source housing angulation or elevation, carriage or stand travel and operation of the beam on-off mechanism);

(3) Source exposure indicator lights on the teletherapy unit, on the control console, and in the facility;

(4) Viewing and intercom systems;

(5) Treatment room doors from inside and outside the treatment room; and

(6) Electrically assisted treatment room doors with the teletherapy unit electrical power turned off.

(e) If the results of the checks required in paragraph (d) of this section indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

(f) A licensee shall retain a record of each spot-check required by paragraphs (a) and (d) of this section, and a copy of the procedures required by paragraph (b), in accordance with § 35.2642.

§ 35.643 Periodic spot-checks for remote afterloader units.

(a) A licensee authorized to use a remote afterloader unit for medical use shall perform spot-checks of each remote afterloader facility and on each unit—

(1) Before the first use of a high dose-rate, medium dose-rate, or pulsed dose-rate remote afterloader unit on a given day;

(2) Before each patient treatment with a low dose-rate remote afterloader unit; and

(3) After each source installation.

(b) A licensee shall perform the measurements required by paragraph (a) of this section in accordance with written procedures established by the authorized medical physicist. That individual need not actually perform the spot check measurements.

(c) A licensee shall have the authorized medical physicist review the results of each spot-check within 15 days. The authorized medical physicist shall notify the licensee as soon as possible in writing of the results of each spot-check.

(d) To satisfy the requirements of paragraph (a) of this section, spot-checks must, at a minimum, assure proper operation of—

(1) Electrical interlocks at each remote afterloader unit room entrance;

(2) Source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility;

(3) Viewing and intercom systems in each high dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader facility;

(4) Emergency response equipment;

(5) Radiation monitors used to indicate the source position;

(6) Timer accuracy;

(7) Clock (date and time) in the unit's computer; and

(8) Decayed source(s) activity in the unit's computer.

(e) If the results of the checks required in paragraph (d) of this section indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

(f) A licensee shall retain a record of each check required by paragraph (d) of this section and a copy of the procedures required by paragraph (b) of this section in accordance with § 35.2643.

§ 35.645 Periodic spot-checks for gamma stereotactic radiosurgery units.

(a) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform spot-checks of each gamma stereotactic radiosurgery facility and on each unit—

(1) Monthly;

(2) Before the first use of the unit on a given day; and

(3) After each source installation.

(b) A licensee shall—

(1) Perform the measurements required by paragraph (a) of this section in accordance with written procedures established by the authorized medical physicist. That individual need not actually perform the spot check measurements.

(2) Have the authorized medical physicist review the results of each spot-check within 15 days. The authorized medical physicist shall notify the licensee as soon as possible in writing of the results of each spot-check.

(c) To satisfy the requirements of paragraph (a)(1) of this section, spot-checks must, at a minimum—

(1) Assure proper operation of—

(i) Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off;

(ii) Helmet microswitches;

(iii) Emergency timing circuits; and

(iv) Stereotactic frames and localizing devices (trunnions).

(2) Determine—

(i) The output for one typical set of operating conditions measured with the dosimetry system described in § 35.630(b);

(ii) The difference between the measurement made in paragraph (c)(2)(i) of this section and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay);

(iii) Source output against computer calculation;

(iv) Timer accuracy and linearity over the range of use;

(v) On-off error; and

(vi) Trunnion centricity.

(d) To satisfy the requirements of paragraphs (a)(2) and (a)(3) of this section, spot-checks must assure proper operation of—

(1) Electrical interlocks at each gamma stereotactic radiosurgery room entrance;

(2) Source exposure indicator lights on the gamma stereotactic radiosurgery unit, on the control console, and in the facility;

(3) Viewing and intercom systems;

(4) Timer termination;

(5) Radiation monitors used to indicate room exposures; and

(6) Emergency off buttons.

(e) A licensee shall arrange for the repair of any system identified in paragraph (c) of this section that is not operating properly as soon as possible.

(f) If the results of the checks required in paragraph (d) of this section indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

(g) A licensee shall retain a record of each check required by paragraphs (c) and (d) and a copy of the procedures required by paragraph (b) of this section in accordance with § 35.2645.

§ 35.647 Additional technical requirements for mobile remote afterloader units.

(a) A licensee providing mobile remote afterloader service shall—

(1) Check survey instruments before medical use at each address of use or on each day of use, whichever is more frequent; and

(2) Account for all sources before departure from a client's address of use.

(b) In addition to the periodic spot-checks required by § 35.643, a licensee authorized to use mobile afterloaders for medical use shall perform checks on each remote afterloader unit before use at each address of use. At a minimum, checks must be made to verify the operation of—

(1) Electrical interlocks on treatment area access points;

(2) Source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility;

(3) Viewing and intercom systems;

(4) Applicators, source transfer tubes, and transfer tube-applicator interfaces;

(5) Radiation monitors used to indicate room exposures;

(6) Source positioning (accuracy); and

(7) Radiation monitors used to indicate whether the source has returned to a safe shielded position.

(c) In addition to the requirements for checks in paragraph (b) of this section, a licensee shall ensure overall proper operation of the remote afterloader unit by conducting a simulated cycle of treatment before use at each address of use.

(d) If the results of the checks required in paragraph (b) of this section indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

(e) A licensee shall retain a record of each check required by paragraph (b) of this section in accordance with § 35.2647.

§ 35.652 Radiation surveys.

(a) In addition to the survey requirement in § 20.1501 of this chapter, a person licensed under this subpart shall make surveys to ensure that the maximum radiation levels and average radiation levels from the surface of the main source safe with the source(s) in the shielded position do not exceed the levels stated in the Sealed Source and Device Registry.

(b) The licensee shall make the survey required by paragraph (a) of this section at installation of a new source and following repairs to the source(s) shielding, the source(s) driving unit, or other electronic or mechanical component that could expose the source, reduce the shielding around the source(s), or compromise the radiation safety of the unit or the source(s).

(c) A licensee shall retain a record of the radiation surveys required by paragraph (a) of this section in accordance with § 35.2652.

§ 35.655 Full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units.

(a) A licensee shall have each teletherapy unit and gamma stereotactic radiosurgery unit fully inspected and serviced during each source replacement to assure proper functioning of the source exposure mechanism and other safety components. The interval between each full-inspection servicing shall not exceed 5 years for each teletherapy unit and shall not exceed 7 years for each gamma stereotactic radiosurgery unit.

(b) This inspection and servicing may only be performed by persons specifically licensed to do so by the Commission or an Agreement State.

(c) A licensee shall keep a record of the inspection and servicing in accordance with § 35.2655.

[67 FR 20370, Apr. 24, 2002, as amended at 83 FR 33110, July 16, 2018]

§ 35.657 Therapy-related computer systems.

The licensee shall perform acceptance testing on the treatment planning system of therapy-related computer systems in accordance with published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testing must include, as applicable, verification of:

(a) The source-specific input parameters required by the dose calculation algorithm;

(b) The accuracy of dose, dwell time, and treatment time calculations at representative points;

(c) The accuracy of isodose plots and graphic displays;

(d) The accuracy of the software used to determine sealed source positions from radiographic images; and

(e) The accuracy of electronic transfer of the treatment delivery parameters to the treatment delivery unit from the treatment planning system.

§ 35.690 Training for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

Except as provided in § 35.57, the licensee shall require an authorized user of a sealed source for a use authorized under § 35.600 to be a physician who—

(a) Is certified by a medical specialty board whose certification process has been recognized by the Commission or an Agreement State and who meets the requirements in paragraph (c) of this section. The names of board certifications that have been recognized by the Commission or an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:

(1) Successfully complete a minimum of 3 years of residency training in a radiation therapy program approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association; and

(2) Pass an examination, administered by diplomates of the specialty board, which tests knowledge and competence in radiation safety, radionuclide handling, treatment planning, quality assurance, and clinical use of stereotactic radiosurgery, remote afterloaders and external beam therapy; or

(b)(1) Has completed a structured educational program in basic radionuclide techniques applicable to the use of a sealed source in a therapeutic medical unit that includes—

(i) 200 hours of classroom and laboratory training in the following areas—

(A) Radiation physics and instrumentation;

(B) Radiation protection;

(C) Mathematics pertaining to the use and measurement of radioactivity; and

(D) Radiation biology; and

(ii) 500 hours of work experience, under the supervision of an authorized user who meets the requirements in § 35.57, § 35.690, or equivalent Agreement State requirements, at a medical facility that is authorized to use byproduct materials in § 35.600, involving—

(A) Reviewing full calibration measurements and periodic spot-checks;

(B) Preparing treatment plans and calculating treatment doses and times;

(C) Using administrative controls to prevent a medical event involving the use of byproduct material;

(D) Implementing emergency procedures to be followed in the event of the abnormal operation of the medical unit or console;

(E) Checking and using survey meters; and

(F) Selecting the proper dose and how it is to be administered; and

(2) Has completed 3 years of supervised clinical experience in radiation therapy, under an authorized user who meets the requirements in §§ 35.57, 35.690, or equivalent Agreement State requirements, as part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by paragraph (b)(1)(ii) of this section; and

(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (b)(1) and (2) and (c) of this section; and is able to independently fulfill the radiation safety-related duties as an authorized user of each type of therapeutic medical unit for which the individual is requesting authorized user status. The attestation must be obtained from either:

(i) A preceptor authorized user who meets the requirements in § 35.57, § 35.690, or equivalent Agreement State requirements for the type(s) of therapeutic medical unit for which the individual is requesting authorized user status; or

(ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in § 35.57, § 35.690, or equivalent Agreement State requirements, for the type(s) of therapeutic medical unit for which the individual is requesting authorized user status, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in paragraphs (b)(1) and (2) of this section.

(c) Has received training in device operation, safety procedures, and clinical use for the type(s) of use for which authorization is sought. This training requirement may be satisfied by satisfactory completion of a training program provided by the vendor for new users or by receiving training supervised by an authorized user or authorized medical physicist, as appropriate, who is authorized for the type(s) of use for which the individual is seeking authorization.

[67 FR 20370, Apr. 24, 2002, as amended at 70 FR 16366, Mar. 30, 2005; 71 FR 15011, Mar. 27, 2006; 74 FR 33906, July 14, 2009; 83 FR 33110, July 16, 2018; 85 FR 65662, Oct. 16, 2020]

§ 35.1000 Other medical uses of byproduct material or radiation from byproduct material.

A licensee may use byproduct material or a radiation source approved for medical use which is not specifically addressed in subparts D through H of this part if—

(a) The applicant or licensee has submitted the information required by § 35.12(b) through (d); and

(b) The applicant or licensee has received written approval from the Commission in a license or license amendment and uses the material in accordance with the regulations and specific conditions the Commission considers necessary for the medical use of the material.

§ 35.2024 Records of authority and responsibilities for radiation protection programs.

(a) A licensee shall retain a record of actions taken by the licensee's management in accordance with § 35.24(a) for 5 years. The record must include a summary of the actions taken and a signature of licensee management.

(b) The licensee shall retain a copy of both authority, duties, and responsibilities of the Radiation Safety Officer as required by § 35.24(e), and a signed copy of each Radiation Safety Officer's agreement to be responsible for implementing the radiation safety program, as required by § 35.24(b), for the duration of the license. The records must include the signature of the Radiation Safety Officer and licensee management.

(c) For each Associate Radiation Safety Officer appointed under § 35.24(b), the licensee shall retain, for 5 years after the Associate Radiation Safety Officer is removed from the license, a copy of the written document appointing the Associate Radiation Safety Officer signed by the licensee's management.

[67 FR 20370, Apr. 24, 2002, as amended at 83 FR 33111, July 16, 2018]

§ 35.2026 Records of radiation protection program changes.

A licensee shall retain a record of each radiation protection program change made in accordance with § 35.26(a) for 5 years. The record must include a copy of the old and new procedures; the effective date of the change; and the signature of the licensee management that reviewed and approved the change.

§ 35.2040 Records of written directives.

A licensee shall retain a copy of each written directive as required by § 35.40 for 3 years.

§ 35.2041 Records for procedures for administrations requiring a written directive

A licensee shall retain a copy of the procedures required by § 35.41(a) for the duration of the license.

§ 35.2060 Records of calibrations of instruments used to measure the activity of unsealed byproduct material.

A licensee shall maintain a record of instrument calibrations required by § 35.60 for 3 years. The records must include the model and serial number of the instrument, the date of the calibration, the results of the calibration, and the name of the individual who performed the calibration.

§ 35.2061 Records of radiation survey instrument calibrations.

A licensee shall maintain a record of radiation survey instrument calibrations required by § 35.61 for 3 years. The record must include the model and serial number of the instrument, the date of the calibration, the results of the calibration, and the name of the individual who performed the calibration.

§ 35.2063 Records of dosages of unsealed byproduct material for medical use.

(a) A licensee shall maintain a record of dosage determinations required by § 35.63 for 3 years.

(b) The record must contain—

(1) The radiopharmaceutical;

(2) The patient's or human research subject's name, or identification number if one has been assigned;

(3) The prescribed dosage, the determined dosage, or a notation that the total activity is less than 1.1 MBq (30 µCi);

(4) The date and time of the dosage determination; and

(5) The name of the individual who determined the dosage.

§ 35.2067 Records of leaks tests and inventory of sealed sources and brachytherapy sources.

(a) A licensee shall retain records of leak tests required by § 35.67(b) for 3 years. The records must include the model number, and serial number if one has been assigned, of each source tested; the identity of each source by radionuclide and its estimated activity; the results of the test; the date of the test; and the name of the individual who performed the test.

(b) A licensee shall retain records of the semi-annual physical inventory of sealed sources and brachytherapy sources required by § 35.67(g) for 3 years. The inventory records must contain the model number of each source, and serial number if one has been assigned, the identity of each source by radionuclide and its nominal activity, the location of each source, and the name of the individual who performed the inventory.

§ 35.2070 Records of surveys for ambient radiation exposure rate.

A licensee shall retain a record of each survey required by § 35.70 for 3 years. The record must include the date of the survey, the results of the survey, the instrument used to make the survey, and the name of the individual who performed the survey.

§ 35.2075 Records of the release of individuals containing unsealed byproduct material or implants containing byproduct material.

(a) A licensee shall retain a record of the basis for authorizing the release of an individual in accordance with § 35.75, if the total effective dose equivalent is calculated by—

(1) Using the retained activity rather than the activity administered;

(2) Using an occupancy factor less than 0.25 at 1 meter;

(3) Using the biological or effective half-life; or

(4) Considering the shielding by tissue.

(b) A licensee shall retain a record that the instructions required by § 35.75(b) were provided to a breast-feeding female if the radiation dose to the infant or child from continued breast-feeding could result in a total effective dose equivalent exceeding 5 mSv (0.5 rem).

(c) The records required by paragraphs (a) and (b) of this section must be retained for 3 years after the date of release of the individual.

§ 35.2080 Records of mobile medical services.

(a) A licensee shall retain a copy of each letter that permits the use of byproduct material at a client's address, as required by § 35.80(a)(1). Each letter must clearly delineate the authority and responsibility of the licensee and the client and must be retained for 3 years after the last provision of service.

(b) A licensee shall retain the record of each survey required by § 35.80(a)(4) for 3 years. The record must include the date of the survey, the results of the survey, the instrument used to make the survey, and the name of the individual who performed the survey.

§ 35.2092 Records of decay-in-storage.

A licensee shall maintain records of the disposal of licensed materials, as required by § 35.92, for 3 years. The record must include the date of the disposal, the survey instrument used, the background radiation level, the radiation level measured at the surface of each waste container, and the name of the individual who performed the survey.

§ 35.2204 Records of molybdenum-99, strontium-82, and strontium-85 concentrations.

A licensee shall maintain a record of the molybdenum-99 concentration or strontium-82 and strontium-85 concentration tests required by § 35.204(b) and (c) for 3 years. The record must include:

(a) For each measured elution of technetium-99m, the ratio of the measures expressed as kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m (or microcuries of molybdenum per millicurie of technetium), the time and date of the measurement, and the name of the individual who made the measurement; or

(b) For each measured elution of rubidium-82, the ratio of the measures expressed as kilobecquerel of strontium-82 per megabecquerel of rubidium-82 (or microcuries of strontium-82 per millicurie of rubidium), kilobecquerel of strontium-85 per megabecquerel of rubidium-82 (or microcuries of strontium-85 per millicurie of rubidium), the time and date of the measurement, and the name of the individual who made the measurement.

[72 FR 55932, Oct. 1, 2007]

§ 35.2310 Records of safety instruction.

A licensee shall maintain a record of safety instructions required by §§ 35.310 and 35.410 and the operational and safety instructions required by § 35.610 for 3 years. The record must include a list of the topics covered, the date of the instruction, the name(s) of the attendee(s), and the name(s) of the individual(s) who provided the instruction.

[83 FR 33111, July 16, 2018]

§ 35.2404 Records of surveys after source implant and removal.

A licensee shall maintain a record of the surveys required by §§ 35.404 and 35.604 for 3 years. Each record must include the date and results of the survey, the survey instrument used, and the name of the individual who made the survey.

§ 35.2406 Records of brachytherapy source accountability.

(a) A licensee shall maintain a record of brachytherapy source accountability required by § 35.406 for 3 years.

(b) For temporary implants, the record must include—

(1) The number and activity of sources removed from storage, the time and date they were removed from storage, the name of the individual who removed them from storage, and the location of use; and

(2) The number and activity of sources returned to storage, the time and date they were returned to storage, and the name of the individual who returned them to storage.

(c) For permanent implants, the record must include—

(1) The number and activity of sources removed from storage, the date they were removed from storage, and the name of the individual who removed them from storage;

(2) The number and activity of sources not implanted, the date they were returned to storage, and the name of the individual who returned them to storage; and

(3) The number and activity of sources permanently implanted in the patient or human research subject.

§ 35.2432 Records of calibration measurements of brachytherapy sources.

(a) A licensee shall maintain a record of the calibrations of brachytherapy sources required by § 35.432 for 3 years after the last use of the source.

(b) The record must include—

(1) The date of the calibration;

(2) The manufacturer's name, model number, and serial number for the source and the instruments used to calibrate the source;

(3) The source output or activity;

(4) The source positioning accuracy within the applicators; and

(5) The name of the individual, the source manufacturer, or the calibration laboratory that performed the calibration.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19326, Apr. 21, 2003]

§ 35.2433 Records of decay of strontium-90 sources for ophthalmic treatments.

(a) A licensee shall maintain a record of the activity of a strontium-90 source required by § 35.433 for the life of the source.

(b) The record must include—

(1) The date and initial activity of the source as determined under § 35.432; and

(2) For each decay calculation, the date and the source activity as determined under § 35.433.

§ 35.2605 Records of installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

A licensee shall retain a record of the installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units as required by § 35.605 for 3 years. For each installation, maintenance, adjustment and repair, the record must include the date, description of the service, and name(s) of the individual(s) who performed the work.

§ 35.2610 Records of safety procedures.

A licensee shall retain a copy of the procedures required by §§ 35.610(a)(4) and (d)(2) until the licensee no longer possesses the remote afterloader, teletherapy unit, or gamma stereotactic radiosurgery unit.

§ 35.2630 Records of dosimetry equipment used with remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

(a) A licensee shall retain a record of the calibration, intercomparison, and comparisons of its dosimetry equipment done in accordance with § 35.630 for the duration of the license.

(b) For each calibration, intercomparison, or comparison, the record must include—

(1) The date;

(2) The manufacturer's name, model numbers and serial numbers of the instruments that were calibrated, intercompared, or compared as required by paragraphs (a) and (b) of § 35.630;

(3) The correction factor that was determined from the calibration or comparison or the apparent correction factor that was determined from an intercomparison; and

(4) The names of the individuals who performed the calibration, intercomparison, or comparison.

§ 35.2632 Records of teletherapy, remote afterloader, and gamma stereotactic radiosurgery full calibrations.

(a) A licensee shall maintain a record of the teletherapy unit, remote afterloader unit, and gamma stereotactic radiosurgery unit full calibrations required by §§ 35.632, 35.633, and 35.635 for 3 years.

(b) The record must include—

(1) The date of the calibration;

(2) The manufacturer's name, model number, and serial number of the teletherapy, remote afterloader, and gamma stereotactic radiosurgery unit(s), the source(s), and the instruments used to calibrate the unit(s);

(3) The results and an assessment of the full calibrations;

(4) The results of the autoradiograph required for low dose-rate remote afterloader units; and

(5) The signature of the authorized medical physicist who performed the full calibration.

§ 35.2642 Records of periodic spot-checks for teletherapy units.

(a) A licensee shall retain a record of each periodic spot-check for teletherapy units required by § 35.642 for 3 years.

(b) The record must include—

(1) The date of the spot-check;

(2) The manufacturer's name, model number, and serial number of the teletherapy unit, source and instrument used to measure the output of the teletherapy unit;

(3) An assessment of timer linearity and constancy;

(4) The calculated on-off error;

(5) A determination of the coincidence of the radiation field and the field indicated by the light beam localizing device;

(6) The determined accuracy of each distance measuring and localization device;

(7) The difference between the anticipated output and the measured output;

(8) Notations indicating the operability of each entrance door electrical interlock, each electrical or mechanical stop, each source exposure indicator light, and the viewing and intercom system and doors; and

(9) The name of the individual who performed the periodic spot-check and the signature of the authorized medical physicist who reviewed the record of the spot-check.

(c) A licensee shall retain a copy of the procedures required by § 35.642(b) until the licensee no longer possesses the teletherapy unit.

§ 35.2643 Records of periodic spot-checks for remote afterloader units.

(a) A licensee shall retain a record of each spot-check for remote afterloader units required by § 35.643 for 3 years.

(b) The record must include, as applicable—

(1) The date of the spot-check;

(2) The manufacturer's name, model number, and serial number for the remote afterloader unit and source;

(3) An assessment of timer accuracy;

(4) Notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom systems, and clock and decayed source activity in the unit's computer; and

(5) The name of the individual who performed the periodic spot-check and the signature of the authorized medical physicist who reviewed the record of the spot-check.

(c) A licensee shall retain a copy of the procedures required by § 35.643(b) until the licensee no longer possesses the remote afterloader unit.

§ 35.2645 Records of periodic spot-checks for gamma stereotactic radiosurgery units.

(a) A licensee shall retain a record of each spot-check for gamma stereotactic radiosurgery units required by § 35.645 for 3 years.

(b) The record must include—

(1) The date of the spot-check;

(2) The manufacturer's name, model number, and serial number for the gamma stereotactic radiosurgery unit and the instrument used to measure the output of the unit;

(3) An assessment of timer linearity and accuracy;

(4) The calculated on-off error;

(5) A determination of trunnion centricity;

(6) The difference between the anticipated output and the measured output;

(7) An assessment of source output against computer calculations;

(8) Notations indicating the operability of radiation monitors, helmet microswitches, emergency timing circuits, emergency off buttons, electrical interlocks, source exposure indicator lights, viewing and intercom systems, timer termination, treatment table retraction mechanism, and stereotactic frames and localizing devices (trunnions); and

(9) The name of the individual who performed the periodic spot-check and the signature of the authorized medical physicist who reviewed the record of the spot-check.

(c) A licensee shall retain a copy of the procedures required by § 35.645(b) until the licensee no longer possesses the gamma stereotactic radiosurgery unit.

§ 35.2647 Records of additional technical requirements for mobile remote afterloader units.

(a) A licensee shall retain a record of each check for mobile remote afterloader units required by § 35.647 for 3 years.

(b) The record must include—

(1) The date of the check;

(2) The manufacturer's name, model number, and serial number of the remote afterloader unit;

(3) Notations accounting for all sources before the licensee departs from a facility;

(4) Notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom system, applicators, source transfer tubes, and transfer tube applicator interfaces, and source positioning accuracy; and

(5) The signature of the individual who performed the check.

§ 35.2652 Records of surveys of therapeutic treatment units.

(a) A licensee shall maintain a record of radiation surveys of treatment units made in accordance with § 35.652 for the duration of use of the unit.

(b) The record must include—

(1) The date of the measurements;

(2) The manufacturer's name, model number and serial number of the treatment unit, source, and instrument used to measure radiation levels;

(3) Each dose rate measured around the source while the unit is in the off position and the average of all measurements; and

(4) The signature of the individual who performed the test.

§ 35.2655 Records of full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units.

(a) A licensee shall maintain a record of the full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units required by § 35.655 for the duration of the use of the unit.

(b) The record must contain—

(1) The inspector's radioactive materials license number;

(2) The date of inspection;

(3) The manufacturer's name and model number and serial number of both the treatment unit and source;

(4) A list of components inspected and serviced, and the type of service; and

(5) The signature of the inspector.

[67 FR 20370, Apr. 24, 2002, as amended at 83 FR 33111, July 16, 2018]

§ 35.3045 Report and notification of a medical event.

(a) A licensee shall report any event as a medical event, except for an event that results from patient intervention, in which—

(1) The administration of byproduct material or radiation from byproduct material, except permanent implant brachytherapy, results in—

(i) A dose that differs from the prescribed dose or dose that would have resulted from the prescribed dosage by more than 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin; and

(A) The total dose delivered differs from the prescribed dose by 20 percent or more;

(B) The total dosage delivered differs from the prescribed dosage by 20 percent or more or falls outside the prescribed dosage range; or

(C) The fractionated dose delivered differs from the prescribed dose for a single fraction, by 50 percent or more.

(ii) A dose that exceeds 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin from any of the following—

(A) An administration of a wrong radioactive drug containing byproduct material or the wrong radionuclide for a brachytherapy procedure;

(B) An administration of a radioactive drug containing byproduct material by the wrong route of administration;

(C) An administration of a dose or dosage to the wrong individual or human research subject;

(D) An administration of a dose or dosage delivered by the wrong mode of treatment; or

(E) A leaking sealed source.

(iii) A dose to the skin or an organ or tissue other than the treatment site that exceeds by:

(A) 0.5 Sv (50 rem) or more the expected dose to that site from the procedure if the administration had been given in accordance with the written directive prepared or revised before administration; and

(B) 50 percent or more the expected dose to that site from the procedure if the administration had been given in accordance with the written directive prepared or revised before administration.

(2) For permanent implant brachytherapy, the administration of byproduct material or radiation from byproduct material (excluding sources that were implanted in the correct site but migrated outside the treatment site) that results in—

(i) The total source strength administered differing by 20 percent or more from the total source strength documented in the post-implantation portion of the written directive;

(ii) The total source strength administered outside of the treatment site exceeding 20 percent of the total source strength documented in the post-implantation portion of the written directive; or

(iii) An administration that includes any of the following:

(A) The wrong radionuclide;

(B) The wrong individual or human research subject;

(C) Sealed source(s) implanted directly into a location discontiguous from the treatment site, as documented in the post-implantation portion of the written directive; or

(D) A leaking sealed source resulting in a dose that exceeds 0.5 Sv (50 rem) to an organ or tissue.

(b) A licensee shall report any event resulting from intervention of a patient or human research subject in which the administration of byproduct material or radiation from byproduct material results or will result in unintended permanent functional damage to an organ or a physiological system, as determined by a physician.

(c) The licensee shall notify by telephone the NRC Operations Center 3 no later than the next calendar day after discovery of the medical event.

3 The commercial telephone number of the NRC Operations Center is (301) 816-5100.

(d) By an appropriate method listed in § 30.6(a) of this chapter, the licensee shall submit a written report to the appropriate NRC Regional Office listed in § 30.6 of this chapter within 15 days after discovery of the medical event.

(1) The written report must include—

(i) The licensee's name;

(ii) The name of the prescribing physician;

(iii) A brief description of the event;

(iv) Why the event occurred;

(v) The effect, if any, on the individual(s) who received the administration;

(vi) What actions, if any, have been taken or are planned to prevent recurrence; and

(vii) Certification that the licensee notified the individual (or the individual's responsible relative or guardian), and if not, why not.

(2) The report may not contain the individual's name or any other information that could lead to identification of the individual.

(e) The licensee shall provide notification of the event to the referring physician and also notify the individual who is the subject of the medical event no later than 24 hours after its discovery, unless the referring physician personally informs the licensee either that he or she will inform the individual or that, based on medical judgment, telling the individual would be harmful. The licensee is not required to notify the individual without first consulting the referring physician. If the referring physician or the affected individual cannot be reached within 24 hours, the licensee shall notify the individual as soon as possible thereafter. The licensee may not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the medical event, because of any delay in notification. To meet the requirements of this paragraph, the notification of the individual who is the subject of the medical event may be made instead to that individual's responsible relative or guardian. If a verbal notification is made, the licensee shall inform the individual, or appropriate responsible relative or guardian, that a written description of the event can be obtained from the licensee upon request. The licensee shall provide such a written description if requested.

(f) Aside from the notification requirement, nothing in this section affects any rights or duties of licensees and physicians in relation to each other, to individuals affected by the medical event, or to that individual's responsible relatives or guardians.

(g) A licensee shall:

(1) Annotate a copy of the report provided to the NRC with the:

(i) Name of the individual who is the subject of the event; and

(ii) Identification number or if no other identification number is available, the social security number of the individual who is the subject of the event; and

(2) Provide a copy of the annotated report to the referring physician, if other than the licensee, no later than 15 days after the discovery of the event.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 58805, Oct. 10, 2003; 76 FR 72085, Nov. 22, 2011; 83 FR 33111, July 16, 2018; 85 FR 33530, June 2, 2020]

§ 35.3047 Report and notification of a dose to an embryo/fetus or a nursing child.

(a) A licensee shall report any dose to an embryo/fetus that is greater than 50 mSv (5 rem) dose equivalent that is a result of an administration of byproduct material or radiation from byproduct material to a pregnant individual unless the dose to the embryo/fetus was specifically approved, in advance, by the authorized user.

(b) A licensee shall report any dose to a nursing child that is a result of an administration of byproduct material to a breast-feeding individual that—

(1) Is greater than 50 mSv (5 rem) total effective dose equivalent; or

(2) Has resulted in unintended permanent functional damage to an organ or a physiological system of the child, as determined by a physician.

(c) The licensee shall notify by telephone the NRC Operations Center no later than the next calendar day after discovery of a dose to the embryo/fetus or nursing child that requires a report in paragraphs (a) or (b) in this section.

(d) By an appropriate method listed in § 30.6(a) of this chapter, the licensee shall submit a written report to the appropriate NRC Regional Office listed in § 30.6 of this chapter within 15 days after discovery of a dose to the embryo/fetus or nursing child that requires a report in paragraphs (a) or (b) in this section.

(1) The written report must include—

(i) The licensee's name;

(ii) The name of the prescribing physician;

(iii) A brief description of the event;

(iv) Why the event occurred;

(v) The effect, if any, on the embryo/fetus or the nursing child;

(vi) What actions, if any, have been taken or are planned to prevent recurrence; and

(vii) Certification that the licensee notified the pregnant individual or mother (or the mother's or child's responsible relative or guardian), and if not, why not.

(2) The report must not contain the individual's or child's name or any other information that could lead to identification of the individual or child.

(e) The licensee shall provide notification of the event to the referring physician and also notify the pregnant individual or mother, both hereafter referred to as the mother, no later than 24 hours after discovery of an event that would require reporting under paragraph (a) or (b) of this section, unless the referring physician personally informs the licensee either that he or she will inform the mother or that, based on medical judgment, telling the mother would be harmful. The licensee is not required to notify the mother without first consulting with the referring physician. If the referring physician or mother cannot be reached within 24 hours, the licensee shall make the appropriate notifications as soon as possible thereafter. The licensee may not delay any appropriate medical care for the embryo/fetus or for the nursing child, including any necessary remedial care as a result of the event, because of any delay in notification. To meet the requirements of this paragraph, the notification may be made to the mother's or child's responsible relative or guardian instead of the mother. If a verbal notification is made, the licensee shall inform the mother, or the mother's or child's responsible relative or guardian, that a written description of the event can be obtained from the licensee upon request. The licensee shall provide such a written description if requested.

(f) A licensee shall:

(1) Annotate a copy of the report provided to the NRC with the:

(i) Name of the pregnant individual or the nursing child who is the subject of the event; and

(ii) Identification number or if no other identification number is available, the social security number of the individual who is the subject of the event; and

(2) Provide a copy of the annotated report to the referring physician, if other than the licensee, no later than 15 days after the discovery of the event.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 58805, Oct. 10, 2003; 85 FR 33530, June 2, 2020]

§ 35.3067 Report of a leaking source.

A licensee shall file a report within 5 days if a leak test required by § 35.67 reveals the presence of 185 Bq (0.005 µCi) or more of removable contamination. The report must be filed with the appropriate NRC Regional Office listed in § 30.6 of this chapter, by an appropriate method listed in § 30.6(a) of this chapter, with a copy to the Director, Office of Nuclear Material Safety and Safeguards. The written report must include the model number and serial number, if assigned, of the leaking source; the radionuclide and its estimated activity; the results of the test; the date of the test; and the action taken.

[73 FR 5720, Jan. 31, 2008]

§ 35.3204 Report and notification for an eluate exceeding permissible molybdenum-99, strontium-82, and strontium-85 concentrations.

(a) The licensee shall notify by telephone the NRC Operations Center and the distributor of the generator within 7 calendar days after discovery that an eluate exceeded the permissible concentration listed in § 35.204(a) at the time of generator elution. The telephone report to the NRC must include the manufacturer, model number, and serial number (or lot number) of the generator; the results of the measurement; the date of the measurement; whether dosages were administered to patients or human research subjects, when the distributor was notified, and the action taken.

(b) By an appropriate method listed in § 30.6(a) of this chapter, the licensee shall submit a written report to the appropriate NRC Regional Office listed in § 30.6 of this chapter within 30 calendar days after discovery of an eluate exceeding the permissible concentration at the time of generator elution. The written report must include the action taken by the licensee; the patient dose assessment; the methodology used to make this dose assessment if the eluate was administered to patients or human research subjects; and the probable cause and an assessment of failure in the licensee's equipment, procedures or training that contributed to the excessive readings if an error occurred in the licensee's breakthrough determination; and the information in the telephone report as required by paragraph (a) of this section.

[83 FR 33111, July 16, 2018]

§ 35.4001 Violations.

(a) The Commission may obtain an injunction or other court order to prevent a violation of the provisions of—

(1) The Atomic Energy Act of 1954, as amended;

(2) Title II of the Energy Reorganization Act of 1974, as amended; or

(3) A regulation or order issued under those Acts.

(b) The Commission may obtain a court order for the payment of a civil penalty imposed under Section 234 of the Atomic Energy Act:

(1) For violations of—

(i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Atomic Energy Act of 1954, as amended;

(ii) Section 206 of the Energy Reorganization Act;

(iii) Any rule, regulation, or order issued under the sections specified in paragraph (b)(1)(i) of this section;

(iv) Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(i) of this section.

(2) For any violation for which a license may be revoked under Section 186 of the Atomic Energy Act of 1954, as amended.

§ 35.4002 Criminal penalties.

(a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of Section 223, all the regulations in 10 CFR part 35 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section.

(b) The regulations in 10 CFR part 35 that are not issued under subsections 161b, 161i, or 161o for the purposes of Section 223 are as follows: §§ 35.1, 35.2, 35.7, 35.8, 35.12, 35.15, 35.18, 35.19, 35.65, 35.100, 35.200, 35.300, 35.4001, and 35.4002.

§ 36.1 Purpose and scope.

(a) This part contains requirements for the issuance of a license authorizing the use of sealed sources containing radioactive materials in irradiators used to irradiate objects or materials using gamma radiation. This part also contains radiation safety requirements for operating irradiators. The requirements of this part are in addition to other requirements of this chapter. In particular, the provisions of parts 19, 20, 21, 30, 37, 71, 170, and 171 of this chapter apply to applications and licenses subject to this part. Nothing in this part relieves the licensee from complying with other applicable Federal, State and local regulations governing the siting, zoning, land use, and building code requirements for industrial facilities.

(b) The regulations in this part apply to panoramic irradiators that have either dry or wet storage of the radioactive sealed sources and to underwater irradiators in which both the source and the product being irradiated are under water. Irradiators whose dose rates exceed 5 grays (500 rads) per hour at 1 meter from the radioactive sealed sources in air or in water, as applicable for the irradiator type, are covered by this part.

(c) The regulations in this part do not apply to self-contained dry-source-storage irradiators (those in which both the source and the area subject to irradiation are contained within a device and are not accessible by personnel), medical radiology or teletherapy, radiography (the irradiation of materials for nondestructive testing purposes), gauging, or open-field (agricultural) irradiations.

[58 FR 7728, Feb. 9, 1993, as amended at 78 FR 17007, Mar. 19, 2013]

§ 36.2 Definitions.

Annually means either (1) at intervals not to exceed 1 year or (2) once per year, at about the same time each year (plus or minus 1 month).

Commencement of construction means taking any action defined as “construction” or any other activity at the site of a facility subject to the regulations in this part that has a reasonable nexus to:

(1) Radiological health and safety; or

(2) Common defense and security.

Construction means the installation of foundations, or in-place assembly, erection, fabrication, or testing for any structure, system, or component of a facility or activity subject to the regulations in this part that are related to radiological safety or security. The term “construction” does not include:

(1) Changes for temporary use of the land for public recreational purposes;

(2) Site exploration, including necessary borings to determine foundation conditions or other preconstruction monitoring to establish background information related to the suitability of the site, the environmental impacts of construction or operation, or the protection of environmental values;

(3) Preparation of the site for construction of the facility, including clearing of the site, grading, installation of drainage, erosion and other environmental mitigation measures, and construction of temporary roads and borrow areas;

(4) Erection of fences and other access control measures that are not related to the safe use of, or security of, radiological materials subject to this part;

(5) Excavation;

(6) Erection of support buildings (e.g., construction equipment storage sheds, warehouse and shop facilities, utilities, concrete mixing plants, docking and unloading facilities, and office buildings) for use in connection with the construction of the facility;

(7) Building of service facilities (e.g., paved roads, parking lots, railroad spurs, exterior utility and lighting systems, potable water systems, sanitary sewerage treatment facilities, and transmission lines);

(8) Procurement or fabrication of components or portions of the proposed facility occurring at other than the final, in-place location at the facility; or

(9) Taking any other action that has no reasonable nexus to:

(i) Radiological health and safety, or

(ii) Common defense and security.

Doubly encapsulated sealed source means a sealed source in which the radioactive material is sealed within a capsule and that capsule is sealed within another capsule.

Irradiator means a facility that uses radioactive sealed sources for the irradiation of objects or materials and in which radiation dose rates exceeding 5 grays (500 rads) per hour exist at 1 meter from the sealed radioactive sources in air or water, as applicable for the irradiator type, but does not include irradiators in which both the sealed source and the area subject to irradiation are contained within a device and are not accessible to personnel.

Irradiator operator means an individual who has successfully completed the training and testing described in § 36.51 and is authorized by the terms of the license to operate the irradiator without a supervisor present.

Panoramic dry-source-storage irradiator means an irradiator in which the irradiations occur in air in areas potentially accessible to personnel and in which the sources are stored in shields made of solid materials. The term includes beam-type dry-source-storage irradiators in which only a narrow beam of radiation is produced for performing irradiations.

Panoramic irradiator means an irradiator in which the irradiations are done in air in areas potentially accessible to personnel. The term includes beam-type irradiators.

Panoramic wet-source-storage irradiator means an irradiator in which the irradiations occur in air in areas potentially accessible to personnel and in which the sources are stored under water in a storage pool.

Pool irradiator means any irradiator at which the sources are stored or used in a pool of water including panoramic wet-source-storage irradiators and underwater irradiators.

Product conveyor system means a system for moving the product to be irradiated to, from, and within the area where irradiation takes place.

Radiation room means a shielded room in which irradiations take place. Underwater irradiators do not have radiation rooms.

Radiation safety officer means an individual with responsibility for the overall radiation safety program at the facility.

Sealed source means any byproduct material that is used as a source of radiation and is encased in a capsule designed to prevent leakage or escape of the byproduct material.

Seismic area means any area where the probability of a horizontal acceleration in rock of more than 0.3 times the acceleration of gravity in 250 years is greater than 10 percent, as designated by the U.S. Geological Survey.

Underwater irradiator means an irradiator in which the sources always remain shielded under water and humans do not have access to the sealed sources or the space subject to irradiation without entering the pool.

[58 FR 7728, Feb. 9, 1993, as amended at 76 FR 56963, Sept. 15, 2011]

§ 36.5 Interpretations.

Except as specifically authorized by the Commission in writing, no interpretation of the meaning of the regulations in this part by any officer or employee of the Commission, other than a written interpretation by the General Counsel, will be recognized to be binding upon the Commission. This section shall cease to have effect on January 8, 2027, unless the NRC determines that the cessation deadline should be extended to a date not more than 5 years in the future after offering the public an opportunity to provide input on the costs and benefits of this section and considering that input. The NRC will publish a document in the Federal Register announcing its determination and revising or removing this section accordingly.

[58 FR 7728, Feb. 9, 1993, as amended at 90 FR 55629, Dec. 3, 2025]

§ 36.8 Information collection requirements: OMB approval.

(a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150-0158.

(b) The approved information collection requirements contained in this part appear in §§ 36.11, 36.13, 36.17, 36.19, 36.21, 36.53, 36.69, 36.81, and 36.83.

(c) This part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section. These information collection requirements and the control numbers under which they are approved are as follows:

(1) In § 36.11, NRC Form 313 is approved under control number 3150-0120.

(2) [Reserved]

[58 FR 7728, Feb. 9, 1993, as amended at 62 FR 52187, Oct. 6, 1997]

§ 36.11 Application for a specific license.

A person, as defined in § 30.4 of this chapter, may file an application for a specific license authorizing the use of sealed sources in an irradiator on Form NRC 313, “Application for Material License.” Each application for a license, other than a license exempted from part 170 of this chapter, must be accompanied by the fee prescribed in § 170.31 of this chapter. The application and one copy must be sent to the appropriate NRC Regional Office listed in appendix D to part 20 of this chapter.

§ 36.13 Specific licenses for irradiators.

The Commission will approve an application for a specific license for the use of licensed material in an irradiator if the applicant meets the requirements contained in this section.

(a) The applicant shall satisfy the general requirements specified in §§ 30.33(a)(1)-(4) and 30.33(b) of this chapter and the requirements contained in this part.

(b) The application must describe the training provided to irradiator operators including—

(1) Classroom training;

(2) On-the-job or simulator training;

(3) Safety reviews;

(4) Means employed by the applicant to test each operator's understanding of the Commission's regulations and licensing requirements and the irradiator operating and emergency procedures; and

(5) Minimum training and experience of personnel who may provide training.

(c) The application must include an outline of the written operating and emergency procedures listed in § 36.53 that describes the radiation safety aspects of the procedures.

(d) The application must describe the organizational structure for managing the irradiator, specifically the radiation safety responsibilities and authorities of the radiation safety officer and those management personnel who have important radiation safety responsibilities or authorities. In particular, the application must specify who, within the management structure, has the authority to stop unsafe operations. The application must also describe the training and experience required for the position of radiation safety officer.

(e) The application must include a description of the access control systems required by § 36.23, the radiation monitors required by § 36.29, the method of detecting leaking sources required by § 36.59 including the sensitivity of the method, and a diagram of the facility that shows the locations of all required interlocks and radiation monitors.

(f) If the applicant intends to perform leak testing of dry-source-storage sealed sources, the applicant shall establish procedures for leak testing and submit a description of these procedures to the Commission. The description must include the—

(1) Instruments to be used;

(2) Methods of performing the analysis; and

(3) Pertinent experience of the individual who analyzes the samples.

(g) If licensee personnel are to load or unload sources, the applicant shall describe the qualifications and training of the personnel and the procedures to be used. If the applicant intends to contract for source loading or unloading at its facility, the loading or unloading must be done by an organization specifically authorized by the Commission or an Agreement State to load or unload irradiator sources.

(h) The applicant shall describe the inspection and maintenance checks, including the frequency of the checks required by § 36.61.

[58 FR 7728, Feb. 9, 1993, as amended at 76 FR 56963, Sept. 15, 2011]

§ 36.15 Commencement of construction.

Commencement of construction of a new irradiator may not occur prior to the submission to the NRC of both an application for a license for the irradiator and the fee required by § 170.31 of this chapter. Any activities undertaken prior to the issuance of a license are entirely at the risk of the applicant and have no bearing on the issuance of a license with respect to the requirements of the Atomic Energy Act of 1954 (Act), as amended, and rules, regulations, and orders issued under the Act. Commencement of construction as defined in § 36.2 may include non-construction activities if the activity has a reasonable nexus to radiological safety and security.

[76 FR 56963, Sept. 15, 2011]

§ 36.17 Applications for exemptions.

(a) The Commission may, upon application of any interested person or upon its own initiative, grant any exemptions from the requirements in this part that it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest. This paragraph (a) shall cease to have effect on January 8, 2027, unless the NRC determines that the cessation deadline should be extended to a date not more than 5 years in the future after offering the public an opportunity to provide input on the costs and benefits of this paragraph (a) and considering that input. The NRC will publish a document in the Federal Register announcing its determination and revising or removing this paragraph (a) accordingly.

(b) Any application for a license or for amendment of a license authorizing use of a teletherapy-type unit for irradiation of materials or objects may include proposed alternatives for the requirements of this part. The Commission will approve the proposed alternatives if the applicant provides adequate rationale for the proposed alternatives and demonstrates that they are likely to provide an adequate level of safety for workers and the public.

[58 FR 7728, Feb. 9, 1993, as amended at 90 FR 55629, Dec. 3, 2025]

§ 36.19 Request for written statements.

(a) After the filing of the original application, the Commission may request further information necessary to enable the Commission to determine whether the application should be granted or denied.

(b) Each license is issued with the condition that the licensee will, at any time before expiration of the license, upon the Commission's request, submit written statements to enable the Commission to determine whether the license should be modified, suspended, or revoked.

§ 36.21 Performance criteria for sealed sources.

(a) Requirements. Sealed sources installed after July 1, 1993:

(1) Must have a certificate of registration issued under 10 CFR 32.210;

(2) Must be doubly encapsulated;

(3) Must use radioactive material that is as nondispersible as practical and that is as insoluble as practical if the source is used in a wet-source-storage or wet-source-change irradiator;

(4) Must be encapsulated in a material resistant to general corrosion and to localized corrosion, such as 316L stainless steel or other material with equivalent resistance if the sources are for use in irradiator pools; and

(5) In prototype testing of the sealed source, must have been leak tested and found leak-free after each of the tests described in paragraphs (b) through (g) of this section.

(b) Temperature. The test source must be held at −40 °C for 20 minutes, 600 °C for 1 hour, and then be subjected to a thermal shock test with a temperature drop from 600 °C to 20 °C within 15 seconds.

(c) Pressure. The test source must be twice subjected for at least 5 minutes to an external pressure (absolute) of 2 million newtons per square meter.

(d) Impact. A 2-kilogram steel weight, 2.5 centimeters in diameter, must be dropped from a height of 1 meter onto the test source.

(e) Vibration. The test source must be subjected 3 times for 10 minutes each to vibrations sweeping from 25 hertz to 500 hertz with a peak amplitude of 5 times the acceleration of gravity. In addition, each test source must be vibrated for 30 minutes at each resonant frequency found.

(f) Puncture. A 50-gram weight and pin, 0.3-centimeter pin diameter, must be dropped from a height of 1 meter onto the test source.

(g) Bend. If the length of the source is more than 15 times larger than the minimum cross-sectional dimension, the test source must be subjected to a force of 2000 newtons at its center equidistant from two support cylinders, the distance between which is 10 times the minimum cross-sectional dimension of the source.

§ 36.23 Access control.

(a) Each entrance to a radiation room at a panoramic irradiator must have a door or other physical barrier to prevent inadvertent entry of personnel if the sources are not in the shielded position. Product conveyor systems may serve as barriers as long as they reliably and consistently function as a barrier. It must not be possible to move the sources out of their shielded position if the door or barrier is open. Opening the door or barrier while the sources are exposed must cause the sources to return promptly to their shielded position. The personnel entrance door or barrier must have a lock that is operated by the same key used to move the sources. The doors and barriers must not prevent any individual in the radiation room from leaving.

(b) In addition, each entrance to a radiation room at a panoramic irradiator must have an independent backup access control to detect personnel entry while the sources are exposed. Detection of entry while the sources are exposed must cause the sources to return to their fully shielded position and must also activate a visible and audible alarm to make the individual entering the room aware of the hazard. The alarm must also alert at least one other individual who is onsite of the entry. That individual shall be trained on how to respond to the alarm and prepared to promptly render or summon assistance.

(c) A radiation monitor must be provided to detect the presence of high radiation levels in the radiation room of a panoramic irradiator before personnel entry. The monitor must be integrated with personnel access door locks to prevent room access when radiation levels are high. Attempted personnel entry while the monitor measures high radiation levels, must activate the alarm described in paragraph (b) of this section. The monitor may be located in the entrance (normally referred to as the maze) but not in the direct radiation beam.

(d) Before the sources move from their shielded position in a panoramic irradiator, the source control must automatically activate conspicuous visible and audible alarms to alert people in the radiation room that the sources will be moved from their shielded position. The alarms must give individuals enough time to leave the room before the sources leave the shielded position.

(e) Each radiation room at a panoramic irradiator must have a clearly visible and readily accessible control that would allow an individual in the room to make the sources return to their fully shielded position.

(f) Each radiation room of a panoramic irradiator must contain a control that prevents the sources from moving from the shielded position unless the control has been activated and the door or barrier to the radiation room has been closed within a preset time after activation of the control.

(g) Each entrance to the radiation room of a panoramic irradiator and each entrance to the area within the personnel access barrier of an underwater irradiator must be posted as required by 10 CFR 20.1902. Radiation postings for panoramic irradiators must comply with the posting requirements of 10 CFR 20.1902, except that signs may be removed, covered, or otherwise made inoperative when the sources are fully shielded.

(h) If the radiation room of a panoramic irradiator has roof plugs or other movable shielding, it must not be possible to operate the irradiator unless the shielding is in its proper location. This requirement may be met by interlocks that prevent operation if shielding is not placed properly or by an operating procedure requiring inspection of shielding before operating.

(i) Underwater irradiators must have a personnel access barrier around the pool which must be locked to prevent access when the irradiator is not attended. Only operators and facility management may have access to keys to the personnel access barrier. There must be an intrusion alarm to detect unauthorized entry when the personnel access barrier is locked. Activation of the intrusion alarm must alert an individual (not necessarily onsite) who is prepared to respond or summon assistance.

[58 FR 7728, Feb. 9, 1993, as amended at 63 FR 39483, July 23, 1998]

§ 36.25 Shielding.

(a) The radiation dose rate in areas that are normally occupied during operation of a panoramic irradiator may not exceed 0.02 millisievert (2 millirems) per hour at any location 30 centimeters or more from the wall of the room when the sources are exposed. The dose rate must be averaged over an area not to exceed 100 square centimeters having no linear dimension greater than 20 cm. Areas where the radiation dose rate exceeds 0.02 millisievert (2 millirems) per hour must be locked, roped off, or posted.

(b) The radiation dose at 30 centimeters over the edge of the pool of a pool irradiator may not exceed 0.02 millisievert (2 millirems) per hour when the sources are in the fully shielded position.

(c) The radiation dose rate at 1 meter from the shield of a dry-source-storage panoramic irradiator when the source is shielded may not exceed 0.02 millisievert (2 millirems) per hour and at 5 centimeters from the shield may not exceed 0.2 millisievert (20 millirems) per hour.

§ 36.27 Fire protection.

(a) The radiation room at a panoramic irradiator must have heat and smoke detectors. The detectors must activate an audible alarm. The alarm must be capable of alerting a person who is prepared to summon assistance promptly. The sources must automatically become fully shielded if a fire is detected.

(b) The radiation room at a panoramic irradiator must be equipped with a fire extinguishing system capable of extinguishing a fire without the entry of personnel into the room. The system for the radiation room must have a shut-off valve to control flooding into unrestricted areas.

§ 36.29 Radiation monitors.

(a) Irradiators with automatic product conveyor systems must have a radiation monitor with an audible alarm located to detect loose radioactive sources that are carried toward the product exit. If the monitor detects a source, an alarm must sound and product conveyors must stop automatically. The alarm must be capable of alerting an individual in the facility who is prepared to summon assistance. Underwater irradiators in which the product moves within an enclosed stationary tube are exempt from the requirements of this paragraph.

(b) Underwater irradiators that are not in a shielded radiation room must have a radiation monitor over the pool to detect abnormal radiation levels. The monitor must have an audible alarm and a visible indicator at entrances to the personnel access barrier around the pool. The audible alarm may have a manual shut-off. The alarm must be capable of alerting an individual who is prepared to respond promptly.

§ 36.31 Control of source movement.

(a) The mechanism that moves the sources of a panoramic irradiator must require a key to actuate. Actuation of the mechanism must cause an audible signal to indicate that the sources are leaving the shielded position. Only one key may be in use at any time, and only operators or facility management may possess it. The key must be attached to a portable radiation survey meter by a chain or cable. The lock for source control must be designed so that the key may not be removed if the sources are in an unshielded position. The door to the radiation room must require the same key.

(b) The console of a panoramic irradiator must have a source position indicator that indicates when the sources are in the fully shielded position, when they are in transit, and when the sources are exposed.

(c) The control console of a panoramic irradiator must have a control that promptly returns the sources to the shielded position.

(d) Each control for a panoramic irradiator must be clearly marked as to its function.

§ 36.33 Irradiator pools.

(a) For licenses initially issued after July 1, 1993, irradiator pools must either:

(1) Have a water-tight stainless steel liner or a liner metallurgically compatible with other components in the pool; or

(2) Be constructed so that there is a low likelihood of substantial leakage and have a surface designed to facilitate decontamination. In either case, the licensee shall have a method to safely store the sources during repairs of the pool.

(b) For licenses initially issued after July 1, 1993, irradiator pools must have no outlets more than 0.5 meter below the normal low water level that could allow water to drain out of the pool. Pipes that have intakes more than 0.5 meter below the normal low water level and that could act as siphons must have siphon breakers to prevent the siphoning of pool water.

(c) A means must be provided to replenish water losses from the pool.

(d) A visible indicator must be provided in a clearly visible location to indicate if the pool water level is below the normal low water level or above the normal high water level.

(e) Irradiator pools must be equipped with a purification system designed to be capable of maintaining the water during normal operation at a conductivity of 20 microsiemens per centimeter or less and with a clarity so that the sources can be seen clearly.

(f) A physical barrier, such as a railing or cover, must be used around or over irradiator pools during normal operation to prevent personnel from accidentally falling into the pool. The barrier may be removed during maintenance, inspection, and service operations.

(g) If long-handled tools or poles are used in irradiator pools, the radiation dose rate on the handling areas of the tools may not exceed 0.02 millisievert (2 millirems) per hour.

§ 36.35 Source rack protection.

If the product to be irradiated moves on a product conveyor system, the source rack and the mechanism that moves the rack must be protected by a barrier or guides to prevent products and product carriers from hitting or touching the rack or mechanism.

§ 36.37 Power failures.

(a) If electrical power at a panoramic irradiator is lost for longer than 10 seconds, the sources must automatically return to the shielded position.

(b) The lock on the door of the radiation room of a panoramic irradiator may not be deactivated by a power failure.

(c) During a power failure, the area of any irradiator where sources are located may be entered only when using an operable and calibrated radiation survey meter.

§ 36.39 Design requirements.

Irradiators whose construction begins after July 1, 1993, must meet the design requirements of this section.

(a) Shielding. For panoramic irradiators, the licensee shall design shielding walls to meet generally accepted building code requirements for reinforced concrete and design the walls, wall penetrations, and entranceways to meet the radiation shielding requirements of § 36.25. If the irradiator will use more than 2 × 10 17 becquerels (5 million curies) of activity, the licensee shall evaluate the effects of heating of the shielding walls by the irradiator sources.

(b) Foundations. For panoramic irradiators, the licensee shall design the foundation, with consideration given to soil characteristics, to ensure it is adequate to support the weight of the facility shield walls.

(c) Pool integrity. For pool irradiators, the licensee shall design the pool to assure that it is leak resistant, that it is strong enough to bear the weight of the pool water and shipping casks, that a dropped cask would not fall on sealed sources, that all outlets or pipes meet the requirements of § 36.33(b), and that metal components are metallurgically compatible with other components in the pool.

(d) Water handling system. For pool irradiators, the licensee shall verify that the design of the water purification system is adequate to meet the requirements of § 36.33(e). The system must be designed so that water leaking from the system does not drain to unrestricted areas without being monitored.

(e) Radiation monitors. For all irradiators, the licensee shall evaluate the location and sensitivity of the monitor to detect sources carried by the product conveyor system as required by § 36.29(a). The licensee shall verify that the product conveyor is designed to stop before a source on the product conveyor would cause a radiation overexposure to any person. For pool irradiators, if the licensee uses radiation monitors to detect contamination under § 36.59(b), the licensee shall verify that the design of radiation monitoring systems to detect pool contamination includes sensitive detectors located close to where contamination is likely to concentrate.

(f) Source rack. For pool irradiators, the licensee shall verify that there are no crevices on the source or between the source and source holder that would promote corrosion on a critical area of the source. For panoramic irradiators, the licensee shall determine that source rack drops due to loss of power will not damage the source rack and that source rack drops due to failure of cables (or alternate means of support) will not cause loss of integrity of sealed sources. For panoramic irradiators, the licensee shall review the design of the mechanism that moves the sources to assure that the likelihood of a stuck source is low and that, if the rack sticks, a means exists to free it with minimal risk to personnel.

(g) Access control. For panoramic irradiators, the licensee shall verify from the design and logic diagram that the access control system will meet the requirements of § 36.23.

(h) Fire protection. For panoramic irradiators, the licensee shall verify that the number, location, and spacing of the smoke and heat detectors are appropriate to detect fires and that the detectors are protected from mechanical and radiation damage. The licensee shall verify that the design of the fire extinguishing system provides the necessary discharge patterns, densities, and flow characteristics for complete coverage of the radiation room and that the system is protected from mechanical and radiation damage.

(i) Source return. For panoramic irradiators, the licensee shall verify that the source rack will automatically return to the fully shielded position if offsite power is lost for more than 10 seconds.

(j) Seismic. For panoramic irradiators to be built in seismic areas, the licensee shall design the reinforced concrete radiation shields to retain their integrity in the event of an earthquake by designing to the seismic requirements of an appropriate source such as American Concrete Institute Standard ACI 318-89, “Building Code Requirements for Reinforced Concrete,” Chapter 21, “Special Provisions for Seismic Design,” or local building codes, if current.

(k) Wiring. For panoramic irradiators, the licensee shall verify that electrical wiring and electrical equipment in the radiation room are selected to minimize failures due to prolonged exposure to radiation.

§ 36.41 Construction monitoring and acceptance testing.

The requirements of this section must be met for irradiators whose construction begins after July 1, 1993. The requirements must be met prior to loading sources.

(a) Shielding. For panoramic irradiators, the licensee shall monitor the construction of the shielding to verify that its construction meets design specifications and generally accepted building code requirements for reinforced concrete.

(b) Foundations. For panoramic irradiators, the licensee shall monitor the construction of the foundations to verify that their construction meets design specifications.

(c) Pool integrity. For pool irradiators, the licensee shall verify that the pool meets design specifications and shall test the integrity of the pool. The licensee shall verify that outlets and pipes meet the requirements of § 36.33(b).

(d) Water handling system. For pool irradiators, the licensee shall verify that the water purification system, the conductivity meter, and the water level indicators operate properly.

(e) Radiation monitors. For all irradiators, the licensee shall verify the proper operation of the monitor to detect sources carried on the product conveyor system and the related alarms and interlocks required by § 36.29(a). For pool irradiators, the licensee shall verify the proper operation of the radiation monitors and the related alarm if used to meet § 36.59(b). For underwater irradiators, the licensee shall verify the proper operation of the over-the-pool monitor, alarms, and interlocks required by § 36.29(b).

(f) Source rack. For panoramic irradiators, the licensee shall test the movement of the source racks for proper operation prior to source loading; testing must include source rack lowering due to simulated loss of power. For all irradiators with product conveyor systems, the licensee shall observe and test the operation of the conveyor system to assure that the requirements in § 36.35 are met for protection of the source rack and the mechanism that moves the rack; testing must include tests of any limit switches and interlocks used to protect the source rack and mechanism that moves the rack from moving product carriers.

(g) Access control. For panoramic irradiators, the licensee shall test the completed access control system to assure that it functions as designed and that all alarms, controls, and interlocks work properly.

(h) Fire protection. For panoramic irradiators, the licensee shall test the ability of the heat and smoke detectors to detect a fire, to activate alarms, and to cause the source rack to automatically become fully shielded. The licensee shall test the operability of the fire extinguishing system.

(i) Source return. For panoramic irradiators, the licensee shall demonstrate that the source racks can be returned to their fully shielded positions without offsite power.

(j) Computer systems. For panoramic irradiators that use a computer system to control the access control system, the licensee shall verify that the access control system will operate properly if offsite power is lost and shall verify that the computer has security features that prevent an irradiator operator from commanding the computer to override the access control system when it is required to be operable.

(k) Wiring. For panoramic irradiators, the licensee shall verify that the electrical wiring and electrical equipment that were installed meet the design specifications.

§ 36.51 Training.

(a) Before an individual is permitted to operate an irradiator without a supervisor present, the individual must be instructed in:

(1) The fundamentals of radiation protection applied to irradiators (including the differences between external radiation and radioactive contamination, units of radiation dose, NRC dose limits, why large radiation doses must be avoided, how shielding and access controls prevent large doses, how an irradiator is designed to prevent contamination, the proper use of survey meters and personnel dosimeters, other radiation safety features of an irradiator, and the basic function of the irradiator);

(2) The requirements of parts 19 and 36 of NRC regulations that are relevant to the irradiator;

(3) The operation of the irradiator;

(4) Those operating and emergency procedures listed in § 36.53 that the individual is responsible for performing; and

(5) Case histories of accidents or problems involving irradiators.

(b) Before an individual is permitted to operate an irradiator without a supervisor present, the individual shall pass a written test on the instruction received consisting primarily of questions based on the licensee's operating and emergency procedures that the individual is responsible for performing and other operations necessary to safely operate the irradiator without supervision.

(c) Before an individual is permitted to operate an irradiator without a supervisor present, the individual must have received on-the-job training or simulator training in the use of the irradiator as described in the license application. The individual shall also demonstrate the ability to perform those portions of the operating and emergency procedures that he or she is to perform.

(d) The licensee shall conduct safety reviews for irradiator operators at least annually. The licensee shall give each operator a brief written test on the information. Each safety review must include, to the extent appropriate, each of the following—

(1) Changes in operating and emergency procedures since the last review, if any;

(2) Changes in regulations and license conditions since the last review, if any;

(3) Reports on recent accidents, mistakes, or problems that have occurred at irradiators, if any;

(4) Relevant results of inspections of operator safety performance;

(5) Relevant results of the facility's inspection and maintenance checks; and

(6) A drill to practice an emergency or abnormal event procedure.

(e) The licensee shall evaluate the safety performance of each irradiator operator at least annually to ensure that regulations, license conditions, and operating and emergency procedures are followed. The licensee shall discuss the results of the evaluation with the operator and shall instruct the operator on how to correct any mistakes or deficiencies observed.

(f) Individuals who will be permitted unescorted access to the radiation room of the irradiator or the area around the pool of an underwater irradiator, but who have not received the training required for operators and the radiation safety officer, shall be instructed and tested in any precautions they should take to avoid radiation exposure, any procedures or parts of procedures listed in § 36.53 that they are expected to perform or comply with, and their proper response to alarms required in this part. Tests may be oral.

(g) Individuals who must be prepared to respond to alarms required by §§ 36.23(b), 36.23(i), 36.27(a), 36.29(a), 36.29(b), and 36.59(b) shall be trained and tested on how to respond. Each individual shall be retested at least once a year. Tests may be oral.

§ 36.53 Operating and emergency procedures.

(a) The licensee shall have and follow written operating procedures for—

(1) Operation of the irradiator, including entering and leaving the radiation room;

(2) Use of personnel dosimeters;

(3) Surveying the shielding of panoramic irradiators;

(4) Monitoring pool water for contamination while the water is in the pool and before release of pool water to unrestricted areas;

(5) Leak testing of sources;

(6) Inspection and maintenance checks required by § 36.61;

(7) Loading, unloading, and repositioning sources, if the operations will be performed by the licensee; and

(8) Inspection of movable shielding required by § 36.23(h), if applicable.

(b) The licensee shall have and follow emergency or abnormal event procedures, appropriate for the irradiator type, for—

(1) Sources stuck in the unshielded position;

(2) Personnel overexposures;

(3) A radiation alarm from the product exit portal monitor or pool monitor;

(4) Detection of leaking sources, pool contamination, or alarm caused by contamination of pool water;

(5) A low or high water level indicator, an abnormal water loss, or leakage from the source storage pool;

(6) A prolonged loss of electrical power;

(7) A fire alarm or explosion in the radiation room;

(8) An alarm indicating unauthorized entry into the radiation room, area around pool, or another alarmed area;

(9) Natural phenomena, including an earthquake, a tornado, flooding, or other phenomena as appropriate for the geographical location of the facility; and

(10) The jamming of automatic conveyor systems.

(c) The licensee may revise operating and emergency procedures without Commission approval only if all of the following conditions are met:

(1) The revisions do not reduce the safety of the facility,

(2) The revisions are consistent with the outline or summary of procedures submitted with the license application,

(3) The revisions have been reviewed and approved by the radiation safety officer, and

(4) The users or operators are instructed and tested on the revised procedures before they are put into use.

§ 36.55 Personnel monitoring.

(a) Irradiator operators shall wear a personnel dosimeter while operating a panoramic irradiator or while in the area around the pool of an underwater irradiator. The personnel dosimeter must be capable of detecting high energy photons in the normal and accident dose ranges. Each personnel dosimeter must be assigned to and worn by only one individual. Film badges must be replaced at least monthly and all other personnel dosimeters that require replacement must be replaced at least quarterly. All personnel dosimeters must be evaluated at least quarterly or promptly after replacement, whichever is more frequent.

(b) Other individuals who enter the radiation room of a panoramic irradiator shall wear a dosimeter, which may be a pocket dosimeter. For groups of visitors, only two people who enter the radiation room are required to wear dosimeters. If pocket dosimeters are used to meet the requirements of this paragraph, a check of their response to radiation must be done at least annually. Acceptable dosimeters must read within plus or minus 30 percent of the true radiation dose.

[58 FR 7728, Feb. 9, 1993, as amended at 65 FR 63752, Oct. 24, 2000; 85 FR 15351, Mar. 18, 2020]

§ 36.57 Radiation surveys.

(a) A radiation survey of the area outside the shielding of the radiation room of a panoramic irradiator must be conducted with the sources in the exposed position before the facility starts to operate. A radiation survey of the area above the pool of pool irradiators must be conducted after the sources are loaded but before the facility starts to operate. Additional radiation surveys of the shielding must be performed at intervals not to exceed 3 years and before resuming operation after addition of new sources or any modification to the radiation room shielding or structure that might increase dose rates.

(b) If the radiation levels specified in § 36.25 are exceeded, the facility must be modified to comply with the requirements in § 36.25.

(c) Portable radiation survey meters must be calibrated at least annually to an accuracy of ±20 percent for the gamma energy of the sources in use. The calibration must be done at two points on each scale or, for digital instruments, at one point per decade over the range that will be used. Portable radiation survey meters must be of a type that does not saturate and read zero at high radiation dose rates.

(d) Water from the irradiator pool, other potentially contaminated liquids, and sediments from pool vacuuming must be monitored for radioactive contamination before release to unrestricted areas. Radioactive concentrations must not exceed those specified in 10 CFR part 20, table 2, column 2 or table 3 of appendix B, “Annual Limits on Intake (ALIs) and Derived Air Concentrations (DACs) of Radionuclides for Occupational Exposure; Effluent Concentrations; Concentrations for Release to Sewerage.”

(e) Before releasing resins for unrestricted use, they must be monitored before release in an area with a background level less than 0.5 microsievert (0.05 millirem) per hour. The resins may be released only if the survey does not detect radiation levels above background radiation levels. The survey meter used must be capable of detecting radiation levels of 0.5 microsievert (0.05 millirem) per hour.

§ 36.59 Detection of leaking sources.

(a) Each dry-source-storage sealed source must be tested for leakage at intervals not to exceed 6 months using a leak test kit or method approved by the Commission or an Agreement State. In the absence of a certificate from a transferor that a test has been made within the 6 months before the transfer, the sealed source may not be used until tested. The test must be capable of detecting the presence of 200 becquerels (0.005 microcurie) of radioactive material and must be performed by a person approved by the Commission or an Agreement State to perform the test.

(b) For pool irradiators, sources may not be put into the pool unless the licensee tests the sources for leaks or has a certificate from a transferor that leak test has been done within the 6 months before the transfer. Water from the pool must be checked for contamination each day the irradiator operates. The check may be done either by using a radiation monitor on a pool water circulating system or by analysis of a sample of pool water. If a check for contamination is done by analysis of a sample of pool water, the results of the analysis must be available within 24 hours. If the licensee uses a radiation monitor on a pool water circulating system, the detection of above normal radiation levels must activate an alarm. The alarm set-point must be set as low as practical, but high enough to avoid false alarms. The licensee may reset the alarm set-point to a higher level if necessary to operate the pool water purification system to clean up contamination in the pool if specifically provided for in written emergency procedures.

(c) If a leaking source is detected, the licensee shall arrange to remove the leaking source from service and have it decontaminated, repaired, or disposed of by an NRC or Agreement State licensee that is authorized to perform these functions. The licensee shall promptly check its personnel, equipment, facilities, and irradiated product for radioactive contamination. No product may be shipped until the product has been checked and found free of contamination. If a product has been shipped that may have been inadvertently contaminated, the licensee shall arrange to locate and survey that product for contamination. If any personnel are found to be contaminated, decontamination must be performed promptly. If contaminated equipment, facilities, or products are found, the licensee shall arrange to have them decontaminated or disposed of by an NRC or Agreement State licensee that is authorized to perform these functions. If a pool is contaminated, the licensee shall arrange to clean the pool until the contamination levels do not exceed the appropriate concentration in table 2, column 2, appendix B to part 20. (See 10 CFR 30.50 for reporting requirements.)

[58 FR 7728, Feb. 9, 1993, as amended at 58 FR 67660, Dec. 22, 1993]

§ 36.61 Inspection and maintenance.

(a) The licensee shall perform inspection and maintenance checks that include, as a minimum, each of the following at the frequency specified in the license or license application:

(1) Operability of each aspect of the access control system required by § 36.23.

(2) Functioning of the source position indicator required by § 36.31(b).

(3) Operability of the radiation monitor for radioactive contamination in pool water required by § 36.59(b) using a radiation check source, if applicable.

(4) Operability of the over-pool radiation monitor at underwater irradiators as required by § 36.29(b).

(5) Operability of the product exit monitor required by § 36.29(a).

(6) Operability of the emergency source return control required by § 36.31(c).

(7) Leak-tightness of systems through which pool water circulates (visual inspection).

(8) Operability of the heat and smoke detectors and extinguisher system required by § 36.27 (but without turning extinguishers on).

(9) Operability of the means of pool water replenishment required by § 36.33(c).

(10) Operability of the indicators of high and low pool water levels required by § 36.33(d).

(11) Operability of the intrusion alarm required by § 36.23(i), if applicable.

(12) Functioning and wear of the system, mechanisms, and cables used to raise and lower sources.

(13) Condition of the barrier to prevent products from hitting the sources or source mechanism as required by § 36.35.

(14) Amount of water added to the pool to determine if the pool is leaking.

(15) Electrical wiring on required safety systems for radiation damage.

(16) Pool water conductivity measurements and analysis as required by § 36.63(b).

(b) Malfunctions and defects found during inspection and maintenance checks must be repaired without undue delay.

§ 36.63 Pool water purity.

(a) Pool water purification system must be run sufficiently to maintain the conductivity of the pool water below 20 microsiemens per centimeter under normal circumstances. If pool water conductivity rises above 20 microsiemens per centimeter, the licensee shall take prompt actions to lower the pool water conductivity and shall take corrective actions to prevent future recurrences.

(b) The licensee shall measure the pool water conductivity frequently enough, but no less than weekly, to assure that the conductivity remains below 20 microsiemens per centimeter. Conductivity meters must be calibrated at least annually.

§ 36.65 Attendance during operation.

(a) Both an irradiator operator and at least one other individual, who is trained on how to respond and prepared to promptly render or summon assistance if the access control alarm sounds, shall be present onsite:

(1) Whenever the irradiator is operated using an automatic product conveyor system; and

(2) Whenever the product is moved into or out of the radiation room when the irradiator is operated in a batch mode.

(b) At a panoramic irradiator at which static irradiations (no movement of the product) are occurring, a person who has received the training on how to respond to alarms described in § 36.51(g) must be onsite.

(c) At an underwater irradiator, an irradiator operator must be present at the facility whenever the product is moved into or out of the pool. Individuals who move the product into or out of the pool of an underwater irradiator need not be qualified as irradiator operators; however, they must have received the training described in § 36.51 (f) and (g). Static irradiations may be performed without a person present at the facility.

§ 36.67 Entering and leaving the radiation room.

(a) Upon first entering the radiation room of a panoramic irradiator after an irradiation, the irradiator operator shall use a survey meter to determine that the source has returned to its fully shielded position. The operator shall check the functioning of the survey meter with a radiation check source prior to entry.

(b) Before exiting from and locking the door to the radiation room of a panoramic irradiator prior to a planned irradiation, the irradiator operator shall:

(1) Visually inspect the entire radiation room to verify that no one else is in it; and

(2) Activate a control in the radiation room that permits the sources to be moved from the shielded position only if the door to the radiation room is locked within a preset time after setting the control.

(c) During a power failure, the area around the pool of an underwater irradiator may not be entered without using an operable and calibrated radiation survey meter unless the over-the-pool monitor required by § 36.29(b) is operating with backup power.

§ 36.69 Irradiation of explosive or flammable materials.

(a) Irradiation of explosive material is prohibited unless the licensee has received prior written authorization from the Commission. Authorization will not be granted unless the licensee can demonstrate that detonation of the explosive would not rupture the sealed sources, injure personnel, damage safety systems, or cause radiation overexposures of personnel.

(b) Irradiation of more than small quantities of flammable material (flash point below 140 °F) is prohibited in panoramic irradiators unless the licensee has received prior written authorization from the Commission. Authorization will not be granted unless the licensee can demonstrate that a fire in the radiation room could be controlled without damage to sealed sources or safety systems and without radiation overexposures of personnel.

§ 36.81 Records and retention periods.

The licensee shall maintain the following records at the irradiator for the periods specified.

(a) A copy of the license, license conditions, documents incorporated into a license by reference, and amendments thereto until superseded by new documents or until the Commission terminates the license for documents not superseded.

(b) Records of each individual's training, tests, and safety reviews provided to meet the requirements of § 36.51 (a), (b), (c), (d), (f), and (g) until 3 years after the individual terminates work.

(c) Records of the annual evaluations of the safety performance of irradiator operators required by § 36.51(e) for 3 years after the evaluation.

(d) A copy of the current operating and emergency procedures required by § 36.53 until superseded or the Commission terminates the license. Records of the radiation safety officer's review and approval of changes in procedures as required by § 36.53(c)(3) retained for 3 years from the date of the change.

(e) Evaluations of personnel dosimeters required by § 36.55 until the Commission terminates the license.

(f) Records of radiation surveys required by § 36.57 for 3 years from the date of the survey.

(g) Records of radiation survey meter calibrations required by § 36.57 and pool water conductivity meter calibrations required by § 36.63(b) until 3 years from the date of calibration.

(h) Records of the results of leak tests required by § 36.59(a) and the results of contamination checks required by § 36.59(b) for 3 years from the date of each test.

(i) Records of inspection and maintenance checks required by § 36.61 for 3 years.

(j) Records of major malfunctions, significant defects, operating difficulties or irregularities, and major operating problems that involve required radiation safety equipment for 3 years after repairs are completed.

(k) Records of the receipt, transfer and disposal, of all licensed sealed sources as required by §§ 30.51 and 30.41.

(l) Records on the design checks required by § 36.39 and the construction control checks as required by § 36.41 until the license is terminated. The records must be signed and dated. The title or qualification of the person signing must be included.

(m) Records related to decommissioning of the irradiator as required by § 30.35(g).

[58 FR 7728, Feb. 9, 1993, as amended at 65 FR 63752, Oct. 24, 2000]

§ 36.83 Reports.

(a) In addition to the reporting requirements in other parts of NRC regulations, the licensee shall report the following events if not reported under other parts of NRC regulations:

(1) Source stuck in an unshielded position.

(2) Any fire or explosion in a radiation room.

(3) Damage to the source racks.

(4) Failure of the cable or drive mechanism used to move the source racks.

(5) Inoperability of the access control system.

(6) Detection of radiation source by the product exit monitor.

(7) Detection of radioactive contamination attributable to licensed radioactive material.

(8) Structural damage to the pool liner or walls.

(9) Abnormal water loss or leakage from the source storage pool.

(10) Pool water conductivity exceeding 100 microsiemens per centimeter.

(b) The report must include a telephone report within 24 hours as described in § 30.50(c)(1), and a written report within 30 days as described in § 30.50(c)(2).

§ 36.91 Violations.

(a) The Commission may obtain an injunction or other court order to prevent a violation of the provisions of—

(1) The Atomic Energy Act of 1954, as amended;

(2) Title II of the Energy Reorganization Act of 1974, as amended; or

(3) A regulation or order issued pursuant to those Acts.

(b) The Commission may obtain a court order for the payment of a civil penalty imposed under section 234 of the Atomic Energy Act:

(1) For violations of—

(i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Atomic Energy Act of 1954, as amended;

(ii) Section 206 of the Energy Reorganization Act;

(iii) Any rule, regulation, or order issued pursuant to the sections specified in paragraph (b)(1)(i) of this section;

(iv) Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(i) of this section.

(2) For any violation for which a license may be revoked under section 186 of the Atomic Energy Act of 1954, as amended.

§ 36.93 Criminal penalties.

(a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all the regulations in part 36 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section.

(b) The regulations in part 36 that are not issued under sections 161b, 161i, or 161o for the purposes of section 223 are as follows: §§ 36.1, 36.2, 36.5, 36.8, 36.11, 36.13, 36.17, 36.19, 36.91, and 36.93.

§ 37.1 Purpose.

This part has been established to provide the requirements for the physical protection program for any licensee that possesses an aggregated category 1 or category 2 quantity of radioactive material listed in Appendix A to this part. These requirements provide reasonable assurance of the security of category 1 or category 2 quantities of radioactive material by protecting these materials from theft or diversion. Specific requirements for access to material, use of material, transfer of material, and transport of material are included. No provision of this part authorizes possession of licensed material.

§ 37.3 Scope.

(a) Subparts B and C of this part apply to any person who, under the regulations in this chapter, possesses or uses at any site, an aggregated category 1 or category 2 quantity of radioactive material.

(b) Subpart D of this part applies to any person who, under the regulations of this chapter:

(1) Transports or delivers to a carrier for transport in a single shipment, a category 1 or category 2 quantity of radioactive material; or

(2) Imports or exports a category 1 or category 2 quantity of radioactive material; the provisions only apply to the domestic portion of the transport.

§ 37.5 Definitions.

As used in this part:

Access control means a system for allowing only approved individuals to have unescorted access to the security zone and for ensuring that all other individuals are subject to escorted access.

Act means the Atomic Energy Act of 1954 (68 Stat. 919), including any amendments thereto.

Aggregated means accessible by the breach of a single physical barrier that would allow access to radioactive material in any form, including any devices that contain the radioactive material, when the total activity equals or exceeds a category 2 quantity of radioactive material.

Agreement State means any state with which the Atomic Energy Commission or the U.S. Nuclear Regulatory Commission has entered into an effective agreement under subsection 274b. of the Act. Non-agreement State means any other State.

Approved individual means an individual whom the licensee has determined to be trustworthy and reliable for unescorted access in accordance with subpart B of this part and who has completed the training required by § 37.43(c).

Background investigation means the investigation conducted by a licensee or applicant to support the determination of trustworthiness and reliability.

Becquerel (Bq) means one disintegration per second.

Byproduct material means—

(1) Any radioactive material (except special nuclear material) yielded in, or made radioactive by, exposure to the radiation incident to the process of producing or using special nuclear material;

(2) The tailings or wastes produced by the extraction or concentration of uranium or thorium from ore processed primarily for its source material content, including discrete surface wastes resulting from uranium solution extraction processes. Underground ore bodies depleted by these solution extraction operations do not constitute “byproduct material” within this definition;

(3)(i) Any discrete source of radium-226 that is produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity; or

(ii) Any material that—

(A) Has been made radioactive by use of a particle accelerator; and

(B) Is produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity; and

(4) Any discrete source of naturally occurring radioactive material, other than source material, that—

(i) The Commission, in consultation with the Administrator of the Environmental Protection Agency, the Secretary of Energy, the Secretary of Homeland Security, and the head of any other appropriate Federal agency, determines would pose a threat similar to the threat posed by a discrete source of radium-226 to the public health and safety or the common defense and security; and

(ii) Before, on, or after August 8, 2005, is extracted or converted after extraction for use in a commercial, medical, or research activity.

Carrier means a person engaged in the transportation of passengers or property by land or water as a common, contract, or private carrier, or by civil aircraft.

Category 1 quantity of radioactive material means a quantity of radioactive material meeting or exceeding the category 1 threshold in Table 1 of Appendix A to this part. This is determined by calculating the ratio of the total activity of each radionuclide to the category 1 threshold for that radionuclide and adding the ratios together. If the sum is equal to or exceeds 1, the quantity would be considered a category 1 quantity. Category 1 quantities of radioactive material do not include the radioactive material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet.

Category 2 quantity of radioactive material means a quantity of radioactive material meeting or exceeding the category 2 threshold but less than the category 1 threshold in Table 1 of Appendix A to this part. This is determined by calculating the ratio of the total activity of each radionuclide to the category 2 threshold for that radionuclide and adding the ratios together. If the sum is equal to or exceeds 1, the quantity would be considered a category 2 quantity. Category 2 quantities of radioactive material do not include the radioactive material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet.

Commission means the U.S. Nuclear Regulatory Commission or its duly authorized representatives.

Curie means that amount of radioactive material which disintegrates at the rate of 37 billion atoms per second.

Diversion means the unauthorized movement of radioactive material subject to this part to a location different from the material's authorized destination inside or outside of the site at which the material is used or stored.

Escorted access means accompaniment while in a security zone by an approved individual who maintains continuous direct visual surveillance at all times over an individual who is not approved for unescorted access.

Fingerprint orders means the orders issued by the U.S. Nuclear Regulatory Commission or the legally binding requirements issued by Agreement States that require fingerprints and criminal history records checks for individuals with unescorted access to category 1 and category 2 quantities of radioactive material or safeguards information-modified handling.

Government agency means any executive department, commission, independent establishment, corporation, wholly or partly owned by the United States of America which is an instrumentality of the United States, or any board, bureau, division, service, office, officer, authority, administration, or other establishment in the executive branch of the Government.

License, except where otherwise specified, means a license for byproduct material issued pursuant to the regulations in parts 30 through 36 and 39 of this chapter;

License issuing authority means the licensing agency that issued the license, i.e. the U.S. Nuclear Regulatory Commission or the appropriate agency of an Agreement State;

Local law enforcement agency (LLEA) means a public or private organization that has been approved by a federal, state, or local government to carry firearms and make arrests, and is authorized and has the capability to provide an armed response in the jurisdiction where the licensed category 1 or category 2 quantity of radioactive material is used, stored, or transported.

Lost or missing licensed material means licensed material whose location is unknown. It includes material that has been shipped but has not reached its destination and whose location cannot be readily traced in the transportation system.

Mobile device means a piece of equipment containing licensed radioactive material that is either mounted on wheels or casters, or otherwise equipped for moving without a need for disassembly or dismounting; or designed to be hand carried. Mobile devices do not include stationary equipment installed in a fixed location.

Movement control center means an operations center that is remote from transport activity and that maintains position information on the movement of radioactive material, receives reports of attempted attacks or thefts, provides a means for reporting these and other problems to appropriate agencies and can request and coordinate appropriate aid.

No-later-than arrival time means the date and time that the shipping licensee and receiving licensee have established as the time at which an investigation will be initiated if the shipment has not arrived at the receiving facility. The no-later-than-arrival time may not be more than 6 hours after the estimated arrival time for shipments of category 2 quantities of radioactive material.

Person means—

(1) Any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, Government agency other than the Commission or the DOE (except that the Department shall be considered a person within the meaning of the regulations in 10 CFR chapter I to the extent that its facilities and activities are subject to the licensing and related regulatory authority of the Commission under section 202 of the Energy Reorganization Act of 1974 (88 Stat. 1244), the Uranium Mill Tailings Radiation Control Act of 1978 (92 Stat. 3021), the Nuclear Waste Policy Act of 1982 (96 Stat. 2201), and section 3(b)(2) of the Low-Level Radioactive Waste Policy Amendments Act of 1985 (99 Stat. 1842), any State or any political subdivision of or any political entity within a State, any foreign government or nation or any political subdivision of any such government or nation, or other entity; and

(2) Any legal successor, representative, agent, or agency of the foregoing.

Reviewing official means the individual who shall make the trustworthiness and reliability determination of an individual to determine whether the individual may have, or continue to have, unescorted access to the category 1 or category 2 quantities of radioactive materials that are possessed by the licensee.

Sabotage means deliberate damage, with malevolent intent, to a category 1 or category 2 quantity of radioactive material, a device that contains a category 1 or category 2 quantity of radioactive material, or the components of the security system.

Safe haven means a readily recognizable and readily accessible site at which security is present or from which, in the event of an emergency, the transport crew can notify and wait for the local law enforcement authorities.

Security zone means any temporary or permanent area determined and established by the licensee for the physical protection of category 1 or category 2 quantities of radioactive material.

State means a State of the United States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands.

Telemetric position monitoring system means a data transfer system that captures information by instrumentation and/or measuring devices about the location and status of a transport vehicle or package between the departure and destination locations.

Trustworthiness and reliability are characteristics of an individual considered dependable in judgment, character, and performance, such that unescorted access to category 1 or category 2 quantities of radioactive material by that individual does not constitute an unreasonable risk to the public health and safety or security. A determination of trustworthiness and reliability for this purpose is based upon the results from a background investigation.

Unescorted access means solitary access to an aggregated category 1 or category 2 quantity of radioactive material or the devices that contain the material.

United States, when used in a geographical sense, includes Puerto Rico and all territories and possessions of the United States.

§ 37.7 Communications.

Except where otherwise specified or covered under the regional licensing program as provided in § 30.6(b) of this chapter, all communications and reports concerning the regulations in this part may be sent as follows:

(a) By mail addressed to: ATTN: Document Control Desk; Director, Office of Nuclear Reactor Regulation; or Director, Office of Nuclear Material Safety and Safeguards, as appropriate, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001;

(b) By hand delivery to the NRC's offices at 11555 Rockville Pike, Rockville, Maryland 20852;

(c) Where practicable, by electronic submission, for example, Electronic Information Exchange, or CD-ROM. Electronic submissions must be made in a manner that enables the NRC to receive, read, authenticate, distribute, and archive the submission, and process and retrieve it a single page at a time. Detailed guidance on making electronic submissions can be obtained by visiting the NRC's Web site at http://www.nrc.gov/site-help/e-submittals.html; by email to MSHD.Resource@nrc.gov; or by writing the Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. The guidance discusses, among other topics, the formats the NRC can accept, the use of electronic signatures, and the treatment of nonpublic information.

[78 FR 17007, Mar. 19, 2013, as amended at 79 FR 75740, Dec. 19, 2014; 80 FR 74979, Dec. 1, 2015; 83 FR 58722, Nov. 21, 2018; 84 FR 65644, Nov. 29, 2019]

§ 37.9 Interpretations.

Except as specifically authorized by the Commission in writing, no interpretations of the meaning of the regulations in this part by any officer or employee of the Commission other than a written interpretation by the General Counsel will be recognized as binding upon the Commission. This section shall cease to have effect on January 8, 2027, unless the NRC determines that the cessation deadline should be extended to a date not more than 5 years in the future after offering the public an opportunity to provide input on the costs and benefits of this section and considering that input. The NRC will publish a document in the Federal Register announcing its determination and revising or removing this section accordingly.

[78 FR 17007, Mar. 19, 2013, as amended at 90 FR 55630, Dec. 3, 2025]

§ 37.11 Specific exemptions.

(a) The Commission may, upon application of any interested person or upon its own initiative, grant such exemptions from the requirements of the regulations in this part as it determines are authorized by law and will not endanger life or property or the common defense and security, and are otherwise in the public interest.

(b) Any licensee's NRC-licensed activities are exempt from the requirements of subparts B and C of this part to the extent that its activities are included in a security plan required by part 73 of this chapter.

(c) A licensee that possesses radioactive waste that contains category 1 or category 2 quantities of radioactive material is exempt from the requirements of subparts B, C, and D of this part. Except that any radioactive waste that contains discrete sources, ion-exchange resins, or activated material that weighs less than 2,000 kg (4,409 lbs) is not exempt from the requirements of this part. The licensee shall implement the following requirements to secure the radioactive waste:

(1) Use continuous physical barriers that allow access to the radioactive waste only through established access control points;

(2) Use a locked door or gate with monitored alarm at the access control point;

(3) Assess and respond to each actual or attempted unauthorized access to determine whether an actual or attempted theft, sabotage, or diversion occurred; and

(4) Immediately notify the LLEA and request an armed response from the LLEA upon determination that there was an actual or attempted theft, sabotage, or diversion of the radioactive waste that contains category 1 or category 2 quantities of radioactive material.

§ 37.13 Information collection requirements: OMB approval.

(a) The U.S. Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB has approved the information collection requirements contained in this part under control number 3150-0214.

(b) The approved information collection requirements contained in this part appear in §§ 37.11, 37.21, 37.23, 37.25, 37.27, 37.29, 37.31, 37.33, 37.41, 37.43, 37.45, 37.49, 37.51, 37.55, 37.57, 37.71, 37.75, 37.77, 37.79, and 37.81.

§ 37.21 Personnel access authorization requirements for category 1 or category 2 quantities of radioactive material.

(a) General. (1) Each licensee that possesses an aggregated quantity of radioactive material at or above the category 2 threshold shall establish, implement, and maintain its access authorization program in accordance with the requirements of this subpart.

(2) An applicant for a new license and each licensee that would become newly subject to the requirements of this subpart upon application for modification of its license shall implement the requirements of this subpart, as appropriate, before taking possession of an aggregated category 1 or category 2 quantity of radioactive material.

(3) Any licensee that has not previously implemented the Security Orders or been subject to the provisions of this subpart B shall implement the provisions of this subpart B before aggregating radioactive material to a quantity that equals or exceeds the category 2 threshold.

(b) General performance objective. The licensee's access authorization program must ensure that the individuals specified in paragraph (c)(1) of this section are trustworthy and reliable.

(c) Applicability. (1) Licensees shall subject the following individuals to an access authorization program:

(i) Any individual whose assigned duties require unescorted access to category 1 or category 2 quantities of radioactive material or to any device that contains the radioactive material; and

(ii) Reviewing officials.

(2) Licensees need not subject the categories of individuals listed in § 37.29(a)(1) through (13) to the investigation elements of the access authorization program.

(3) Licensees shall approve for unescorted access to category 1 or category 2 quantities of radioactive material only those individuals with job duties that require unescorted access to category 1 or category 2 quantities of radioactive material.

(4) Licensees may include individuals needing access to safeguards information-modified handling under part 73 of this chapter in the access authorization program under this subpart B.

§ 37.23 Access authorization program requirements.

(a) Granting unescorted access authorization. (1) Licensees shall implement the requirements of this subpart for granting initial or reinstated unescorted access authorization.

(2) Individuals who have been determined to be trustworthy and reliable shall also complete the security training required by § 37.43(c) before being allowed unescorted access to category 1 or category 2 quantities of radioactive material.

(b) Reviewing officials. (1) Reviewing officials are the only individuals who may make trustworthiness and reliability determinations that allow individuals to have unescorted access to category 1 or category 2 quantities of radioactive materials possessed by the licensee.

(2) Each licensee shall name one or more individuals to be reviewing officials. After completing the background investigation on the reviewing official, the licensee shall provide under oath or affirmation, a certification that the reviewing official is deemed trustworthy and reliable by the licensee. Provide oath or affirmation certifications to the Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, ATTN: Source Management and Protection Branch. The fingerprints of the named reviewing official must be taken by a law enforcement agency, Federal or State agencies that provide fingerprinting services to the public, or commercial fingerprinting services authorized by a State to take fingerprints. The licensee shall recertify that the reviewing official is deemed trustworthy and reliable every 10 years in accordance with § 37.25(c).

(3) Reviewing officials must be permitted to have unescorted access to category 1 or category 2 quantities of radioactive materials or access to safeguards information or safeguards information-modified handling, if the licensee possesses safeguards information or safeguards information-modified handling.

(4) Reviewing officials cannot approve other individuals to act as reviewing officials.

(5) A reviewing official does not need to undergo a new background investigation before being named by the licensee as the reviewing official if:

(i) The individual has undergone a background investigation that included fingerprinting and an FBI criminal history records check and has been determined to be trustworthy and reliable by the licensee; or

(ii) The individual is subject to a category listed in § 37.29(a).

(c) Informed consent. (1) Licensees may not initiate a background investigation without the informed and signed consent of the subject individual. This consent must include authorization to share personal information with other individuals or organizations as necessary to complete the background investigation. Before a final adverse determination, the licensee shall provide the individual with an opportunity to correct any inaccurate or incomplete information that is developed during the background investigation. Licensees do not need to obtain signed consent from those individuals that meet the requirements of § 37.25(b). A signed consent must be obtained prior to any reinvestigation.

(2) The subject individual may withdraw his or her consent at any time. Licensees shall inform the individual that:

(i) If an individual withdraws his or her consent, the licensee may not initiate any elements of the background investigation that were not in progress at the time the individual withdrew his or her consent; and

(ii) The withdrawal of consent for the background investigation is sufficient cause for denial or termination of unescorted access authorization.

(d) Personal history disclosure. Any individual who is applying for unescorted access authorization shall disclose the personal history information that is required by the licensee's access authorization program for the reviewing official to make a determination of the individual's trustworthiness and reliability. Refusal to provide, or the falsification of, any personal history information required by this subpart is sufficient cause for denial or termination of unescorted access.

(e) Determination basis. (1) The reviewing official shall determine whether to permit, deny, unfavorably terminate, maintain, or administratively withdraw an individual's unescorted access authorization based on an evaluation of all of the information collected to meet the requirements of this subpart.

(2) The reviewing official may not permit any individual to have unescorted access until the reviewing official has evaluated all of the information collected to meet the requirements of this subpart and determined that the individual is trustworthy and reliable. The reviewing official may deny unescorted access to any individual based on information obtained at any time during the background investigation.

(3) The licensee shall document the basis for concluding whether or not there is reasonable assurance that an individual is trustworthy and reliable.

(4) The reviewing official may terminate or administratively withdraw an individual's unescorted access authorization based on information obtained after the background investigation has been completed and the individual granted unescorted access authorization.

(5) Licensees shall maintain a list of persons currently approved for unescorted access authorization. When a licensee determines that a person no longer requires unescorted access or meets the access authorization requirement, the licensee shall remove the person from the approved list as soon as possible, but no later than 7 working days, and take prompt measures to ensure that the individual is unable to have unescorted access to the material.

(f) Procedures. Licensees shall develop, implement, and maintain written procedures for implementing the access authorization program. The procedures must include provisions for the notification of individuals who are denied unescorted access. The procedures must include provisions for the review, at the request of the affected individual, of a denial or termination of unescorted access authorization. The procedures must contain a provision to ensure that the individual is informed of the grounds for the denial or termination of unescorted access authorization and allow the individual an opportunity to provide additional relevant information.

(g) Right to correct and complete information. (1) Prior to any final adverse determination, licensees shall provide each individual subject to this subpart with the right to complete, correct, and explain information obtained as a result of the licensee's background investigation. Confirmation of receipt by the individual of this notification must be maintained by the licensee for a period of 1 year from the date of the notification.

(2) If, after reviewing his or her criminal history record, an individual believes that it is incorrect or incomplete in any respect and wishes to change, correct, update, or explain anything in the record, the individual may initiate challenge procedures. These procedures include direct application by the individual challenging the record to the law enforcement agency that contributed the questioned information or a direct challenge as to the accuracy or completeness of any entry on the criminal history record to the Federal Bureau of Investigation, Criminal Justice Information Services (CJIS) Division, ATTN: SCU, Mod. D-2, 1000 Custer Hollow Road, Clarksburg, WV 26306 as set forth in 28 CFR 16.30 through 16.34. In the latter case, the Federal Bureau of Investigation (FBI) will forward the challenge to the agency that submitted the data, and will request that the agency verify or correct the challenged entry. Upon receipt of an official communication directly from the agency that contributed the original information, the FBI Identification Division makes any changes necessary in accordance with the information supplied by that agency. Licensees must provide at least 10 days for an individual to initiate action to challenge the results of an FBI criminal history records check after the record being made available for his or her review. The licensee may make a final adverse determination based upon the criminal history records only after receipt of the FBI's confirmation or correction of the record.

(h) Records. (1) The licensee shall retain documentation regarding the trustworthiness and reliability of individual employees for 3 years from the date the individual no longer requires unescorted access to category 1 or category 2 quantities of radioactive material.

(2) The licensee shall retain a copy of the current access authorization program procedures as a record for 3 years after the procedure is no longer needed. If any portion of the procedure is superseded, the licensee shall retain the superseded material for 3 years after the record is superseded.

(3) The licensee shall retain the list of persons approved for unescorted access authorization for 3 years after the list is superseded or replaced.

[78 FR 17007, Mar. 19, 2013, as amended at 80 FR 45843, Aug. 3, 2015; 83 FR 30287, June 28, 2018; 84 FR 63567, Nov. 18, 2019]

§ 37.25 Background investigations.

(a) Initial investigation. Before allowing an individual unescorted access to category 1 or category 2 quantities of radioactive material or to the devices that contain the material, licensees shall complete a background investigation of the individual seeking unescorted access authorization. The scope of the investigation must encompass at least the 7 years preceding the date of the background investigation or since the individual's eighteenth birthday, whichever is shorter. The background investigation must include at a minimum:

(1) Fingerprinting and an FBI identification and criminal history records check in accordance with § 37.27;

(2) Verification of true identity. Licensees shall verify the true identity of the individual who is applying for unescorted access authorization to ensure that the applicant is who he or she claims to be. A licensee shall review official identification documents (e.g., driver's license; passport; government identification; certificate of birth issued by the state, province, or country of birth) and compare the documents to personal information data provided by the individual to identify any discrepancy in the information. Licensees shall document the type, expiration, and identification number of the identification document, or maintain a photocopy of identifying documents on file in accordance with § 37.31. Licensees shall certify in writing that the identification was properly reviewed, and shall maintain the certification and all related documents for review upon inspection;

(3) Employment history verification. Licensees shall complete an employment history verification, including military history. Licensees shall verify the individual's employment with each previous employer for the most recent 7 years before the date of application;

(4) Verification of education. Licensees shall verify that the individual participated in the education process during the claimed period;

(5) Character and reputation determination. Licensees shall complete reference checks to determine the character and reputation of the individual who has applied for unescorted access authorization. Unless other references are not available, reference checks may not be conducted with any person who is known to be a close member of the individual's family, including but not limited to the individual's spouse, parents, siblings, or children, or any individual who resides in the individual's permanent household. Reference checks under this subpart must be limited to whether the individual has been and continues to be trustworthy and reliable;

(6) The licensee shall also, to the extent possible, obtain independent information to corroborate that provided by the individual (e.g., seek references not supplied by the individual); and

(7) If a previous employer, educational institution, or any other entity with which the individual claims to have been engaged fails to provide information or indicates an inability or unwillingness to provide information within a time frame deemed appropriate by the licensee but at least after 10 business days of the request or if the licensee is unable to reach the entity, the licensee shall document the refusal, unwillingness, or inability in the record of investigation; and attempt to obtain the information from an alternate source.

(b) Grandfathering. (1) Individuals who have been determined to be trustworthy and reliable for unescorted access to category 1 or category 2 quantities of radioactive material under the Fingerprint Orders may continue to have unescorted access to category 1 and category 2 quantities of radioactive material without further investigation. These individuals shall be subject to the reinvestigation requirement.

(2) Individuals who have been determined to be trustworthy and reliable under the provisions of part 73 of this chapter or the security orders for access to safeguards information, safeguards information-modified handling, or risk-significant material may have unescorted access to category 1 and category 2 quantities of radioactive material without further investigation. The licensee shall document that the individual was determined to be trustworthy and reliable under the provisions of part 73 of this chapter or a security order. Security order, in this context, refers to any order that was issued by the NRC that required fingerprints and an FBI criminal history records check for access to safeguards information, safeguards information-modified handling, or risk significant material such as special nuclear material or large quantities of uranium hexafluoride. These individuals shall be subject to the reinvestigation requirement.

(c) Reinvestigations. Licensees shall conduct a reinvestigation every 10 years for any individual with unescorted access to category 1 or category 2 quantities of radioactive material. The reinvestigation shall consist of fingerprinting and an FBI identification and criminal history records check in accordance with § 37.27. The reinvestigations must be completed within 10 years of the date on which these elements were last completed.

§ 37.27 Requirements for criminal history records checks of individuals granted unescorted access to category 1 or category 2 quantities of radioactive material.

(a) General performance objective and requirements. (1) Except for those individuals listed in § 37.29 and those individuals grandfathered under § 37.25(b), each licensee subject to the provisions of this subpart shall fingerprint each individual who is to be permitted unescorted access to category 1 or category 2 quantities of radioactive material. Licensees shall transmit all collected fingerprints to the Commission for transmission to the FBI. The licensee shall use the information received from the FBI as part of the required background investigation to determine whether to grant or deny further unescorted access to category 1 or category 2 quantities of radioactive materials for that individual.

(2) The licensee shall notify each affected individual that his or her fingerprints will be used to secure a review of his or her criminal history record, and shall inform him or her of the procedures for revising the record or adding explanations to the record.

(3) Fingerprinting is not required if a licensee is reinstating an individual's unescorted access authorization to category 1 or category 2 quantities of radioactive materials if:

(i) The individual returns to the same facility that granted unescorted access authorization within 365 days of the termination of his or her unescorted access authorization; and

(ii) The previous access was terminated under favorable conditions.

(4) Fingerprints do not need to be taken if an individual who is an employee of a licensee, contractor, manufacturer, or supplier has been granted unescorted access to category 1 or category 2 quantities of radioactive material, access to safeguards information, or safeguards information-modified handling by another licensee, based upon a background investigation conducted under this subpart, the Fingerprint Orders, or part 73 of this chapter. An existing criminal history records check file may be transferred to the licensee asked to grant unescorted access in accordance with the provisions of § 37.31(c).

(5) Licensees shall use the information obtained as part of a criminal history records check solely for the purpose of determining an individual's suitability for unescorted access authorization to category 1 or category 2 quantities of radioactive materials, access to safeguards information, or safeguards information-modified handling.

(b) Prohibitions. (1) Licensees may not base a final determination to deny an individual unescorted access authorization to category 1 or category 2 quantities of radioactive material solely on the basis of information received from the FBI involving:

(i) An arrest more than 1 year old for which there is no information of the disposition of the case; or

(ii) An arrest that resulted in dismissal of the charge or an acquittal.

(2) Licensees may not use information received from a criminal history records check obtained under this subpart in a manner that would infringe upon the rights of any individual under the First Amendment to the Constitution of the United States, nor shall licensees use the information in any way that would discriminate among individuals on the basis of race, religion, national origin, gender, or age.

(c) Procedures for processing of fingerprint checks. (1) For the purposes of complying with this subpart, licensees shall use an appropriate method listed in § 37.7 to submit to the U.S. Nuclear Regulatory Commission, Director, Division of Physical and Cyber Security Policy, 11545 Rockville Pike, ATTN: Criminal History Program/Mail Stop T-07D04M, Rockville, MD 20852, one completed, legible standard fingerprint card (Form FD-258, ORIMDNRCOOOZ), electronic fingerprint scan or, where practicable, other fingerprint record for each individual requiring unescorted access to category 1 or category 2 quantities of radioactive material. Copies of these forms may be obtained by emailing MAILSVS.Resource@nrc.gov. Guidance on submitting electronic fingerprints can be found at https://www.nrc.gov/security/chp.html.

(2) Fees for the processing of fingerprint checks are due upon application. Licensees shall submit payment made payable to the U.S. Nuclear Regulatory Commission. The payments are to be made in U.S. funds using the electronic payment methods accepted at www.Pay.gov. For guidance on making electronic payments, contact the Division of Physical and Cyber Security Policy by emailing Crimhist.Resource@nrc.gov. Combined payment for multiple applications is acceptable. The Commission publishes the amount of the fingerprint check application fee on the NRC's public website. (To find the current fee amount, go to the Licensee Criminal History Records Checks & Firearms Background Check information page at https://www.nrc.gov/security/chp.html and see the link for How do I determine how much to pay for the request?)

(3) The Commission will forward to the submitting licensee all data received from the FBI as a result of the licensee's application(s) for criminal history records checks.

[78 FR 17007, Mar. 19, 2013, as amended at 80 FR 74979, Dec. 1, 2015; 84 FR 63567, Nov. 18, 2019; 86 FR 43402, Aug. 9, 2021; 89 FR 51810, June 20, 2024]

§ 37.29 Relief from fingerprinting, identification, and criminal history records checks and other elements of background investigations for designated categories of individuals permitted unescorted access to certain radioactive materials.

(a) Fingerprinting, and the identification and criminal history records checks required by section 149 of the Atomic Energy Act of 1954, as amended, and other elements of the background investigation are not required for the following individuals prior to granting unescorted access to category 1 or category 2 quantities of radioactive materials:

(1) An employee of the Commission or of the Executive Branch of the U.S. Government who has undergone fingerprinting for a prior U.S. Government criminal history records check;

(2) A Member of Congress;

(3) An employee of a member of Congress or Congressional committee who has undergone fingerprinting for a prior U.S. Government criminal history records check;

(4) The Governor of a State or his or her designated State employee representative;

(5) Federal, State, or local law enforcement personnel;

(6) State Radiation Control Program Directors and State Homeland Security Advisors or their designated State employee representatives;

(7) Agreement State employees conducting security inspections on behalf of the NRC under an agreement executed under section 274.i. of the Atomic Energy Act;

(8) Representatives of the International Atomic Energy Agency (IAEA) engaged in activities associated with the U.S./IAEA Safeguards Agreement who have been certified by the NRC;

(9) Emergency response personnel who are responding to an emergency;

(10) Commercial vehicle drivers for road shipments of category 1 and category 2 quantities of radioactive material;

(11) Package handlers at transportation facilities such as freight terminals and railroad yards;

(12) Any individual who has an active Federal security clearance, provided that he or she makes available the appropriate documentation. Written confirmation from the agency/employer that granted the Federal security clearance or reviewed the criminal history records check must be provided to the licensee. The licensee shall retain this documentation for a period of 3 years from the date the individual no longer requires unescorted access to category 1 or category 2 quantities of radioactive material; and

(13) Any individual employed by a service provider licensee for which the service provider licensee has conducted the background investigation for the individual and approved the individual for unescorted access to category 1 or category 2 quantities of radioactive material. Written verification from the service provider must be provided to the licensee. The licensee shall retain the documentation for a period of 3 years from the date the individual no longer requires unescorted access to category 1 or category 2 quantities of radioactive material.

(b) Fingerprinting, and the identification and criminal history records checks required by section 149 of the Atomic Energy Act of 1954, as amended, are not required for an individual who has had a favorably adjudicated U.S. Government criminal history records check within the last 5 years, under a comparable U.S. Government program involving fingerprinting and an FBI identification and criminal history records check provided that he or she makes available the appropriate documentation. Written confirmation from the agency/employer that reviewed the criminal history records check must be provided to the licensee. The licensee shall retain this documentation for a period of 3 years from the date the individual no longer requires unescorted access to category 1 or category 2 quantities of radioactive material. These programs include, but are not limited to:

(1) National Agency Check;

(2) Transportation Worker Identification Credentials (TWIC) under 49 CFR part 1572;

(3) Bureau of Alcohol, Tobacco, Firearms, and Explosives background check and clearances under 27 CFR part 555;

(4) Health and Human Services security risk assessments for possession and use of select agents and toxins under 42 CFR part 73;

(5) Hazardous Material security threat assessment for hazardous material endorsement to commercial drivers license under 49 CFR part 1572; and

(6) Customs and Border Protection's Free and Secure Trade (FAST) Program.

[78 FR 17007, Mar. 19, 2013, as amended at 79 FR 58671, Sept. 30, 2014]

§ 37.31 Protection of information.

(a) Each licensee who obtains background information on an individual under this subpart shall establish and maintain a system of files and written procedures for protection of the record and the personal information from unauthorized disclosure.

(b) The licensee may not disclose the record or personal information collected and maintained to persons other than the subject individual, his or her representative, or to those who have a need to have access to the information in performing assigned duties in the process of granting or denying unescorted access to category 1 or category 2 quantities of radioactive material, safeguards information, or safeguards information-modified handling. No individual authorized to have access to the information may disseminate the information to any other individual who does not have a need to know.

(c) The personal information obtained on an individual from a background investigation may be provided to another licensee:

(1) Upon the individual's written request to the licensee holding the data to disseminate the information contained in his or her file; and

(2) The recipient licensee verifies information such as name, date of birth, social security number, gender, and other applicable physical characteristics.

(d) The licensee shall make background investigation records obtained under this subpart available for examination by an authorized representative of the NRC to determine compliance with the regulations and laws.

(e) The licensee shall retain all fingerprint and criminal history records (including data indicating no record) received from the FBI, or a copy of these records if the individual's file has been transferred, on an individual for 3 years from the date the individual no longer requires unescorted access to category 1 or category 2 quantities of radioactive material.

§ 37.33 Access authorization program review.

(a) Each licensee shall be responsible for the continuing effectiveness of the access authorization program. Each licensee shall ensure that access authorization programs are reviewed to confirm compliance with the requirements of this subpart and that comprehensive actions are taken to correct any noncompliance that is identified. The review program shall evaluate all program performance objectives and requirements. Each licensee shall periodically (at least annually) review the access program content and implementation.

(b) The results of the reviews, along with any recommendations, must be documented. Each review report must identify conditions that are adverse to the proper performance of the access authorization program, the cause of the condition(s), and, when appropriate, recommend corrective actions, and corrective actions taken. The licensee shall review the findings and take any additional corrective actions necessary to preclude repetition of the condition, including reassessment of the deficient areas where indicated.

(c) Review records must be maintained for 3 years.

§ 37.41 Security program.

(a) Applicability. (1) Each licensee that possesses an aggregated category 1 or category 2 quantity of radioactive material shall establish, implement, and maintain a security program in accordance with the requirements of this subpart.

(2) An applicant for a new license and each licensee that would become newly subject to the requirements of this subpart upon application for modification of its license shall implement the requirements of this subpart, as appropriate, before taking possession of an aggregated category 1 or category 2 quantity of radioactive material.

(3) Any licensee that has not previously implemented the Security Orders or been subject to the provisions of subpart C shall provide written notification to the NRC regional office specified in § 30.6 of this chapter at least 90 days before aggregating radioactive material to a quantity that equals or exceeds the category 2 threshold.

(b) General performance objective. Each licensee shall establish, implement, and maintain a security program that is designed to monitor and, without delay, detect, assess, and respond to an actual or attempted unauthorized access to category 1 or category 2 quantities of radioactive material.