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| section_id ▼ | title_number | title_name | chapter | subchapter | part_number | part_name | subpart | subpart_name | section_number | section_heading | agency | authority | source_citation | amendment_citations | full_text |
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| 10:10:1.0.1.1.19.1.85.1 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | A | Subpart A—Administrative Provisions | § 26.1 Purpose. | NRC | This part prescribes requirements and standards for the establishment, implementation, and maintenance of fitness-for-duty (FFD) programs. | |||||
| 10:10:1.0.1.1.19.1.85.2 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | A | Subpart A—Administrative Provisions | § 26.3 Scope. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 89 FR 106250, Dec. 30, 2024] | (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 … | ||||
| 10:10:1.0.1.1.19.1.85.3 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | A | Subpart A—Administrative Provisions | § 26.4 FFD program applicability to categories of individuals. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 75 FR 73941, Nov. 30, 2010; 87 FR 71455, Nov. 22, 2022] | (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 subpart K of this part: (1) 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; (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) 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; 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 subpart K of this part. (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 requirement of this part, except §§ 26.205 through 26.209 and subpart K of this part. (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 subjec… | ||||
| 10:10:1.0.1.1.19.1.85.4 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | A | Subpart A—Administrative Provisions | § 26.5 Definitions. | NRC | [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] | 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. Blood alcohol concentration (BAC) means the mass of alcohol in a volume of blood. Calibrator means a solution of known concentration in the appro… | ||||
| 10:10:1.0.1.1.19.1.85.5 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | A | Subpart A—Administrative Provisions | § 26.7 Interpretations. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 90 FR 55628, Dec. 3, 2025] | 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. | ||||
| 10:10:1.0.1.1.19.1.85.6 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | A | Subpart A—Administrative Provisions | § 26.8 Information collection requirements: OMB approval. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71456, Nov. 22, 2022] | (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, 26.203, 26.205, 26.207, 26.211, 26.401, 26.403, 26.405, 26.406, 26.407, 26.411, 26.413, 26.415, 26.417, 26.711, 26.713, 26.715, 26.717, 26.719, and 26.821. | ||||
| 10:10:1.0.1.1.19.1.85.7 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | A | Subpart A—Administrative Provisions | § 26.9 Specific exemptions. | NRC | 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. | |||||
| 10:10:1.0.1.1.19.1.85.8 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | A | Subpart A—Administrative Provisions | § 26.11 Communications. | NRC | [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] | 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). | ||||
| 10:10:1.0.1.1.19.11.85.1 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | K | Subpart K—FFD Program for Construction | § 26.401 General. | NRC | (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. | |||||
| 10:10:1.0.1.1.19.11.85.10 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | K | Subpart K—FFD Program for Construction | § 26.417 Recordkeeping and reporting. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 88 FR 15880, Mar. 14, 2023] | (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. | ||||
| 10:10:1.0.1.1.19.11.85.11 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | K | Subpart K—FFD Program for Construction | § 26.419 Suitability and fitness evaluations. | NRC | 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. | |||||
| 10:10:1.0.1.1.19.11.85.2 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | K | Subpart K—FFD Program for Construction | § 26.403 Written policy and procedures. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 75 FR 73941, Nov. 30, 2010] | (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. | ||||
| 10:10:1.0.1.1.19.11.85.3 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | K | Subpart K—FFD Program for Construction | § 26.405 Drug and alcohol testing. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 75 FR 73941, Nov. 30, 2010; 87 FR 71463, Nov. 22, 2022] | (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… | ||||
| 10:10:1.0.1.1.19.11.85.4 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | K | Subpart K—FFD Program for Construction | § 26.406 Fitness monitoring. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 75 FR 73941, Nov. 30, 2010] | (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. | ||||
| 10:10:1.0.1.1.19.11.85.5 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | K | Subpart K—FFD Program for Construction | § 26.407 Behavioral observation. | NRC | [75 FR 73941, Nov. 30, 2010] | 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. | ||||
| 10:10:1.0.1.1.19.11.85.6 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | K | Subpart K—FFD Program for Construction | § 26.409 Sanctions. | NRC | [75 FR 73941, Nov. 30, 2010] | 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. | ||||
| 10:10:1.0.1.1.19.11.85.7 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | K | Subpart K—FFD Program for Construction | § 26.411 Protection of information. | NRC | (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. | |||||
| 10:10:1.0.1.1.19.11.85.8 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | K | Subpart K—FFD Program for Construction | § 26.413 Review process. | NRC | 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. | |||||
| 10:10:1.0.1.1.19.11.85.9 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | K | Subpart K—FFD Program for Construction | § 26.415 Audits. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71463, Nov. 22, 2022] | (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. | ||||
| 10:10:1.0.1.1.19.13.85.1 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | N | Subpart N—Recordkeeping and Reporting Requirements | § 26.709 Applicability. | NRC | The requirements of this subpart apply to the FFD programs of licensees and other entities specified in § 26.3, except for FFD programs that are implemented under subpart K of this part. | |||||
| 10:10:1.0.1.1.19.13.85.2 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | N | Subpart N—Recordkeeping and Reporting Requirements | § 26.711 General provisions. | NRC | (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) and (d), 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) and (d), who has discovered the incorrect information, or develops new information, shall inform the reviewing officia… | |||||
| 10:10:1.0.1.1.19.13.85.3 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | N | Subpart N—Recordkeeping and Reporting Requirements | § 26.713 Recordkeeping requirements for licensees and other entities. | NRC | (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 violatio… | |||||
| 10:10:1.0.1.1.19.13.85.4 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | N | Subpart N—Recordkeeping and Reporting Requirements | § 26.715 Recordkeeping requirements for collection sites, licensee testing facilities, and laboratories certified by the Department of Health and Human Services. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71463, Nov. 22, 2022] | (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 … | ||||
| 10:10:1.0.1.1.19.13.85.5 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | N | Subpart N—Recordkeeping and Reporting Requirements | § 26.717 Fitness-for-duty program performance data. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 79 FR 66603, Nov. 10, 2014; 87 FR 71463, Nov. 22, 2022] | (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 a… | ||||
| 10:10:1.0.1.1.19.13.85.6 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | N | Subpart N—Recordkeeping and Reporting Requirements | § 26.719 Reporting requirements. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 75 FR 73942, Nov. 30, 2010; 88 FR 15880, Mar. 14, 2023] | (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 p… | ||||
| 10:10:1.0.1.1.19.14.85.1 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | O | Subpart O—Inspections, Violations, and Penalties | § 26.821 Inspections. | NRC | (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. | |||||
| 10:10:1.0.1.1.19.14.85.2 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | O | Subpart O—Inspections, Violations, and Penalties | § 26.823 Violations. | NRC | (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. | |||||
| 10:10:1.0.1.1.19.14.85.3 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | O | Subpart O—Inspections, Violations, and Penalties | § 26.825 Criminal penalties. | NRC | (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 Part 26 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, 26.823, and 26.825. | |||||
| 10:10:1.0.1.1.19.2.85.1 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | B | Subpart B—Program Elements | § 26.21 Fitness-for-duty program. | NRC | The licensees and other entities specified in § 26.3(a) through (c) 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 meet the applicable requirements of this part. | |||||
| 10:10:1.0.1.1.19.2.85.10 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | B | Subpart B—Program Elements | § 26.39 Review process for fitness-for-duty policy violations. | NRC | [75 FR 73941, Nov. 30, 2010] | (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. | ||||
| 10:10:1.0.1.1.19.2.85.11 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | B | Subpart B—Program Elements | § 26.41 Audits and corrective action. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 74 FR 38327, Aug. 3, 2009] | (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 aud… | ||||
| 10:10:1.0.1.1.19.2.85.2 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | B | Subpart B—Program Elements | § 26.23 Performance objectives. | NRC | 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. | |||||
| 10:10:1.0.1.1.19.2.85.3 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | B | Subpart B—Program Elements | § 26.25 [Reserved] | NRC | ||||||
| 10:10:1.0.1.1.19.2.85.4 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | B | Subpart B—Program Elements | § 26.27 Written policy and procedures. | NRC | (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, suc… | |||||
| 10:10:1.0.1.1.19.2.85.5 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | B | Subpart B—Program Elements | § 26.29 Training. | NRC | (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 percen… | |||||
| 10:10:1.0.1.1.19.2.85.6 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | B | Subpart B—Program Elements | § 26.31 Drug and alcohol testing. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 74 FR 38327, Aug. 3, 2009; 87 FR 71456, Nov. 22, 2022] | (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 … | ||||
| 10:10:1.0.1.1.19.2.85.7 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | B | Subpart B—Program Elements | § 26.33 Behavioral observation. | NRC | 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. | |||||
| 10:10:1.0.1.1.19.2.85.8 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | B | Subpart B—Program Elements | § 26.35 Employee assistance programs. | NRC | (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 r… | |||||
| 10:10:1.0.1.1.19.2.85.9 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | B | Subpart B—Program Elements | § 26.37 Protection of information. | NRC | (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… | |||||
| 10:10:1.0.1.1.19.3.85.1 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | C | Subpart C—Granting and Maintaining Authorization | § 26.51 Applicability. | NRC | 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 meet the requirements of this subpart. Certain requirements in this subpart also apply to the individuals specified in § 26.4(h). | |||||
| 10:10:1.0.1.1.19.3.85.10 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | C | Subpart C—Granting and Maintaining Authorization | § 26.69 Authorization with potentially disqualifying fitness-for-duty information. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 74 FR 38328, Aug. 3, 2009] | (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 obta… | ||||
| 10:10:1.0.1.1.19.3.85.11 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | C | Subpart C—Granting and Maintaining Authorization | § 26.71 Maintaining authorization. | NRC | (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. | |||||
| 10:10:1.0.1.1.19.3.85.2 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | C | Subpart C—Granting and Maintaining Authorization | § 26.53 General provisions. | NRC | (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 curren… | |||||
| 10:10:1.0.1.1.19.3.85.3 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | C | Subpart C—Granting and Maintaining Authorization | § 26.55 Initial authorization. | NRC | (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. | |||||
| 10:10:1.0.1.1.19.3.85.4 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | C | Subpart C—Granting and Maintaining Authorization | § 26.57 Authorization update. | NRC | (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. | |||||
| 10:10:1.0.1.1.19.3.85.5 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | C | Subpart C—Granting and Maintaining Authorization | § 26.59 Authorization reinstatement. | NRC | (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… | |||||
| 10:10:1.0.1.1.19.3.85.6 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | C | Subpart C—Granting and Maintaining Authorization | § 26.61 Self-disclosure and employment history. | NRC | (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 t… | |||||
| 10:10:1.0.1.1.19.3.85.7 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | C | Subpart C—Granting and Maintaining Authorization | § 26.63 Suitable inquiry. | NRC | (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 indivi… | |||||
| 10:10:1.0.1.1.19.3.85.8 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | C | Subpart C—Granting and Maintaining Authorization | § 26.65 Pre-access drug and alcohol testing. | NRC | (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 und… | |||||
| 10:10:1.0.1.1.19.3.85.9 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | C | Subpart C—Granting and Maintaining Authorization | § 26.67 Random drug and alcohol testing of individuals who have applied for authorization. | NRC | (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. | |||||
| 10:10:1.0.1.1.19.4.85.1 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | D | Subpart D—Management Actions and Sanctions To Be Imposed | § 26.73 Applicability. | NRC | 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 meet the requirements of this subpart. The regulations in this subpart also apply to the individuals specified in § 26.4(h) and (j), as appropriate. | |||||
| 10:10:1.0.1.1.19.4.85.2 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | D | Subpart D—Management Actions and Sanctions To Be Imposed | § 26.75 Sanctions. | NRC | (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… | |||||
| 10:10:1.0.1.1.19.4.85.3 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | D | Subpart D—Management Actions and Sanctions To Be Imposed | § 26.77 Management actions regarding possible impairment. | NRC | (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 reso… | |||||
| 10:10:1.0.1.1.19.5.85.1 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | E | Subpart E—Collecting Specimens for Testing | § 26.81 Purpose and applicability. | NRC | 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 paragraph and under §§ 26.4(j) and 26.31(b)(2) and Subpart K. | |||||
| 10:10:1.0.1.1.19.5.85.10 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | E | Subpart E—Collecting Specimens for Testing | § 26.99 Determining the need for a confirmatory test for alcohol. | NRC | (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. | |||||
| 10:10:1.0.1.1.19.5.85.11 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | E | Subpart E—Collecting Specimens for Testing | § 26.101 Conducting a confirmatory test for alcohol. | NRC | (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… | |||||
| 10:10:1.0.1.1.19.5.85.12 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | E | Subpart E—Collecting Specimens for Testing | § 26.103 Determining a confirmed positive test result for alcohol. | NRC | (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. | |||||
| 10:10:1.0.1.1.19.5.85.13 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | E | Subpart E—Collecting Specimens for Testing | § 26.105 Preparing for the collection of a specimen for drug testing. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71457, Nov. 22, 2022] | (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 pres… | ||||
| 10:10:1.0.1.1.19.5.85.14 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | E | Subpart E—Collecting Specimens for Testing | § 26.107 Collecting a urine specimen. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71457, Nov. 22, 2022] | (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 … | ||||
| 10:10:1.0.1.1.19.5.85.15 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | E | Subpart E—Collecting Specimens for Testing | § 26.109 Urine specimen quantity. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71458, Nov. 22, 2022] | (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 th… | ||||
| 10:10:1.0.1.1.19.5.85.16 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | E | Subpart E—Collecting Specimens for Testing | § 26.111 Checking the acceptability of the urine specimen. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71458, Nov. 22, 2022] | (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 … | ||||
| 10:10:1.0.1.1.19.5.85.17 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | E | Subpart E—Collecting Specimens for Testing | § 26.113 Splitting the urine specimen. | NRC | (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. | |||||
| 10:10:1.0.1.1.19.5.85.18 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | E | Subpart E—Collecting Specimens for Testing | § 26.115 Collecting a urine specimen under direct observation. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71458, Nov. 22, 2022] | (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 ob… | ||||
| 10:10:1.0.1.1.19.5.85.19 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | E | Subpart E—Collecting Specimens for Testing | § 26.117 Preparing drug testing specimens for storage and shipping. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71458, Nov. 22, 2022] | (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 … | ||||
| 10:10:1.0.1.1.19.5.85.2 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | E | Subpart E—Collecting Specimens for Testing | § 26.83 Specimens to be collected. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71456, Nov. 22, 2022] | 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. | ||||
| 10:10:1.0.1.1.19.5.85.20 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | E | Subpart E—Collecting Specimens for Testing | § 26.119 Determining “shy” bladder. | NRC | (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-t… | |||||
| 10:10:1.0.1.1.19.5.85.3 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | E | Subpart E—Collecting Specimens for Testing | § 26.85 Collector qualifications and responsibilities. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71456, Nov. 22, 2022] | (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 coll… | ||||
| 10:10:1.0.1.1.19.5.85.4 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | E | Subpart E—Collecting Specimens for Testing | § 26.87 Collection sites. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71457, Nov. 22, 2022] | (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 … | ||||
| 10:10:1.0.1.1.19.5.85.5 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | E | Subpart E—Collecting Specimens for Testing | § 26.89 Preparing to collect specimens for testing. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71457, Nov. 22, 2022] | (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 super… | ||||
| 10:10:1.0.1.1.19.5.85.6 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | E | Subpart E—Collecting Specimens for Testing | § 26.91 Acceptable devices for conducting initial and confirmatory tests for alcohol and methods of use. | NRC | (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… | |||||
| 10:10:1.0.1.1.19.5.85.7 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | E | Subpart E—Collecting Specimens for Testing | § 26.93 Preparing for alcohol testing. | NRC | (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. | |||||
| 10:10:1.0.1.1.19.5.85.8 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | E | Subpart E—Collecting Specimens for Testing | § 26.95 Conducting an initial test for alcohol using a breath specimen. | NRC | (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. | |||||
| 10:10:1.0.1.1.19.5.85.9 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | E | Subpart E—Collecting Specimens for Testing | § 26.97 Collecting oral fluid specimens for alcohol and drug testing. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71457, Nov. 22, 2022] | (a) To perform the initial specimen collection, 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 the 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 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 collec… | ||||
| 10:10:1.0.1.1.19.6.85.1 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | F | Subpart F—Licensee Testing Facilities | § 26.121 Purpose. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 90 FR 55628, Dec. 3, 2025] | 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. | ||||
| 10:10:1.0.1.1.19.6.85.10 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | F | Subpart F—Licensee Testing Facilities | § 26.139 Reporting initial validity and drug test results. | NRC | (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 s… | |||||
| 10:10:1.0.1.1.19.6.85.2 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | F | Subpart F—Licensee Testing Facilities | § 26.123 Testing facility capabilities. | NRC | 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. | |||||
| 10:10:1.0.1.1.19.6.85.3 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | F | Subpart F—Licensee Testing Facilities | § 26.125 Licensee testing facility personnel. | NRC | (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. | |||||
| 10:10:1.0.1.1.19.6.85.4 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | F | Subpart F—Licensee Testing Facilities | § 26.127 Procedures. | NRC | (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 nece… | |||||
| 10:10:1.0.1.1.19.6.85.5 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | F | Subpart F—Licensee Testing Facilities | § 26.129 Assuring specimen security, chain of custody, and preservation. | NRC | [78 FR 17176, Mar. 31, 2008, as amended at 87 FR 71459, Nov. 22, 2022] | (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 resul… | ||||
| 10:10:1.0.1.1.19.6.85.6 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | F | Subpart F—Licensee Testing Facilities | § 26.131 Cutoff levels for validity screening and initial validity tests. | NRC | (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) con… | |||||
| 10:10:1.0.1.1.19.6.85.7 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | F | Subpart F—Licensee Testing Facilities | § 26.133 Cutoff levels for drugs and drug metabolites. | NRC | [87 FR 71459, Nov. 22, 2022] | 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 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. | ||||
| 10:10:1.0.1.1.19.6.85.8 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | F | Subpart F—Licensee Testing Facilities | § 26.135 Split specimens. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 79 FR 66602, Nov. 10, 2014] | (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 … | ||||
| 10:10:1.0.1.1.19.6.85.9 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | F | Subpart F—Licensee Testing Facilities | § 26.137 Quality assurance and quality control. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 74 FR 38328, Aug. 3, 2009; 87 FR 71459, Nov. 22, 2022] | (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 n… | ||||
| 10:10:1.0.1.1.19.7.85.1 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | G | Subpart G—Laboratories Certified by the Department of Health and Human Services | § 26.151 Purpose. | NRC | [87 FR 71459, Nov. 22, 2022] | This subpart contains requirements for the HHS-certified laboratories that licensees and other entities use to perform testing under this part. | ||||
| 10:10:1.0.1.1.19.7.85.10 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | G | Subpart G—Laboratories Certified by the Department of Health and Human Services | § 26.168 Blind performance testing. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 81 FR 86909, Dec. 2, 2016; 87 FR 71462, Nov. 22, 2022] | (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… | ||||
| 10:10:1.0.1.1.19.7.85.11 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | G | Subpart G—Laboratories Certified by the Department of Health and Human Services | § 26.169 Reporting Results. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71462, Nov. 22, 2022] | (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 codein… | ||||
| 10:10:1.0.1.1.19.7.85.2 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | G | Subpart G—Laboratories Certified by the Department of Health and Human Services | § 26.153 Using certified laboratories for testing specimens. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 74 FR 38328, Aug. 3, 2009; 87 FR 71459, Nov. 22, 2022] | (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 administrat… | ||||
| 10:10:1.0.1.1.19.7.85.3 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | G | Subpart G—Laboratories Certified by the Department of Health and Human Services | § 26.155 [Reserved] | NRC | ||||||
| 10:10:1.0.1.1.19.7.85.4 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | G | Subpart G—Laboratories Certified by the Department of Health and Human Services | § 26.157 Procedures. | NRC | [87 FR 71459, Nov. 22, 2022] | (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] | ||||
| 10:10:1.0.1.1.19.7.85.5 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | G | Subpart G—Laboratories Certified by the Department of Health and Human Services | § 26.159 Assuring specimen security, chain of custody, and preservation. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 79 FR 66602, Nov. 10, 2014; 87 FR 71460, Nov. 22, 2022] | (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 int… | ||||
| 10:10:1.0.1.1.19.7.85.6 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | G | Subpart G—Laboratories Certified by the Department of Health and Human Services | § 26.161 Cutoff levels for validity testing. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71460, Nov. 22, 2022] | (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… | ||||
| 10:10:1.0.1.1.19.7.85.7 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | G | Subpart G—Laboratories Certified by the Department of Health and Human Services | § 26.163 Cutoff levels for drugs and drug metabolites. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71460, Nov. 22, 2022] | (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 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 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 Methylenedioxymetha… | ||||
| 10:10:1.0.1.1.19.7.85.8 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | G | Subpart G—Laboratories Certified by the Department of Health and Human Services | § 26.165 Testing split specimens and retesting single specimens. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71461, Nov. 22, 2022] | (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 … | ||||
| 10:10:1.0.1.1.19.7.85.9 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | G | Subpart G—Laboratories Certified by the Department of Health and Human Services | § 26.167 Quality assurance and quality control. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71462, Nov. 22, 2022] | (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 interface… | ||||
| 10:10:1.0.1.1.19.8.85.1 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | H | Subpart H—Determining Fitness-for-Duty Policy Violations and Determining Fitness | § 26.181 Purpose. | NRC | This subpart contains requirements for determining whether a donor has violated the FFD policy and for making a determination of fitness. | |||||
| 10:10:1.0.1.1.19.8.85.2 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | H | Subpart H—Determining Fitness-for-Duty Policy Violations and Determining Fitness | § 26.183 Medical review officer. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 83 FR 58464, Nov. 20, 2018; 87 FR 71462, Nov. 22, 2022] | (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 la… | ||||
| 10:10:1.0.1.1.19.8.85.3 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | H | Subpart H—Determining Fitness-for-Duty Policy Violations and Determining Fitness | § 26.185 Determining a fitness-for-duty policy violation. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71462, Nov. 22, 2022] | (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 … | ||||
| 10:10:1.0.1.1.19.8.85.4 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | H | Subpart H—Determining Fitness-for-Duty Policy Violations and Determining Fitness | § 26.187 Substance abuse expert. | NRC | [73 FR 17176, Mar. 31, 2008, as amended at 83 FR 58464, Nov. 20, 2018] | (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 … | ||||
| 10:10:1.0.1.1.19.8.85.5 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | H | Subpart H—Determining Fitness-for-Duty Policy Violations and Determining Fitness | § 26.189 Determination of fitness. | NRC | (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 me… | |||||
| 10:10:1.0.1.1.19.9.85.1 | 10 | Energy | I | 26 | PART 26—FITNESS FOR DUTY PROGRAMS | I | Subpart I—Managing Fatigue | § 26.201 Applicability. | NRC | The requirements in this subpart apply to the licensees and other entities identified in § 26.3(a), and, if applicable, (c) and (d). 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). |
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