(a) A licensee or other entity in § 26.3(f), at its discretion, may establish, implement, and maintain a fitness-for-duty (FFD) program that satisfies the requirements of this subpart for those categories of individuals in § 26.4, as applicable, and any person licensed to operate under part 53 of this chapter. If a licensee or other entity in § 26.3(f) does not elect to implement an FFD program that satisfies the requirements of this subpart, then those categories of individuals in § 26.4, as applicable, and any person licensed to operate under part 53 of this chapter must be subject to an FFD program that satisfies all requirements under this part, except for those requirements in subpart K and this subpart.

(b) A licensee or other entity in § 26.3(f) that elects to implement an FFD program that satisfies the requirements of this subpart, and that demonstrates compliance with § 73.100(a)(1)(i) of this chapter, must establish, implement, and maintain an FFD program under § 26.605(a) or (b).

(c) A licensee or other entity in § 26.3(f) that elects to implement an FFD program that satisfies the requirements of this subpart and does not demonstrate compliance with § 73.100(a)(1)(i) of this chapter must establish, implement, and maintain an FFD program under § 26.605(a) and (b).

(a) FFD program description. An applicant's description of the FFD program in its Final Safety Analysis Report, required by subpart H of part 53 of this chapter, must include—

(1) Whether the applicant demonstrates compliance with § 73.100(a)(1)(i) of this chapter;

(2) A statement whether the FFD program will be implemented pursuant to § 26.605(a) or (b) or § 26.605(a) and (b), or will satisfy all requirements under this part, except for the requirements in subpart K and this subpart;

(3) A discussion of the applicability of the FFD program to those individuals described in § 26.4 and how the program will be implemented offsite at a U.S. Nuclear Regulatory Commission (NRC)-licensed facility authorized to assemble or test a manufactured reactor, if applicable; and

(4) A description of the drug and alcohol testing and fitness determination process to be implemented through the licensee's or other entity's procedures, including the collection and testing facilities to be used, biological specimens to be collected and tested, and sanctions to be imposed for FFD policy violations.

(b) FFD program implementation and availability. For the licensees and other entities in § 26.3(f), other than the holder of a manufacturing license (ML), the FFD program must be maintained until the NRC's docketing of the license holder's certifications described in § 53.1070 of this chapter. For holders of an ML, the FFD program must be maintained until expiration of the ML.

(c)-(d) [Reserved]

(e) FFD program change control. (1) The licensee or other entity may make changes to its FFD program under this subpart if—

(i) The licensee or other entity performs and retains an analysis demonstrating that the changes do not reduce the effectiveness of the FFD program; or

(ii) The change was necessitated or justified by a change to this part, laboratory processes or procedures, or guidance issued by the U.S. Department of Health and Human Services (HHS) or NRC, as implemented by the licensee or other entity though its procedures.

(2) A licensee or other entity desiring to make a change that decreases FFD program effectiveness must implement a mitigating strategy so the FFD program, as revised, will continue to satisfy the performance objectives in § 26.23 and not result in a reduction in FFD program effectiveness.

(3) Except for phencyclidine, and notwithstanding paragraph (e)(1)(ii) of this section, the change control process may not be used to reduce the minimum panel of drugs to be tested in § 26.607(c)(1).

(4) The licensee must retain a record of each change made under this section for a period of at least 5 years from the date the change was implemented and summarize this change in its annual FFD performance report required by § 26.617(b)(2) or § 26.717, as applicable.

(a)(1) The licensee or other entity must establish, implement, and maintain an FFD program under this paragraph (a) before the start of—

(i) Construction activities as defined in § 26.5;

(ii) Activities performed under an ML that authorizes the assembly, non-operational testing, or both of a manufactured reactor; or

(iii) Activities described in paragraphs (a)(1)(i) and (ii) of this section.

(2) An FFD program under this paragraph (a) must—

(i) Apply to those individuals described in § 26.4, as applicable; and,

(ii) Implement the following requirements and subparts:

(A) Section 26.23, for performance objectives;

(B) Section 26.35, for employee assistance programs:

(1) For licensees and other entities who demonstrate compliance with § 73.100(a)(1)(i) of this chapter, § 26.35 must be implemented before the earliest occurrence of the following, as applicable: the loading of fuel onsite into a reactor vessel; receiving a fueled manufactured reactor; or individuals subject to this part operate, test, perform maintenance of, or direct the maintenance or surveillance of security-related equipment or equipment that a risk-informed evaluation process has shown to be significant to public health and safety; and

(2) For licensees and other entities that do not demonstrate compliance with § 73.100(a)(1)(i) of this chapter, § 26.35 must be implemented before the start of activities performed under an ML that allows the assembly, non-operational testing, or both, of a manufactured reactor;

(C) Section 26.603, for general provisions;

(D) Section 26.606, for written policy and procedures;

(E) Section 26.607, for drug and alcohol testing;

(F) Section 26.608, for FFD program training;

(G) Section 26.609, for behavioral observation;

(H) Section 26.610, for sanctions;

(I) Section 26.611, for protection of information;

(J) Section 26.613, for the appeals process;

(K) Section 26.615, for audits;

(L) Section 26.617, for recordkeeping, reporting, and FFD program performance;

(M) Section 26.619, for suitability and fitness determinations;

(N) Subpart A, for administrative provisions;

(O) Subpart I, for managing fatigue, in the case of holders of an ML that allows the assembly, non-operational testing, or both of a manufactured reactor; and

(P) Subpart O, for inspections, violations, and penalties.

(b)(1) Except for a licensee or other entity that demonstrates compliance with § 73.100(a)(1)(i) of this chapter and elects to implement an FFD program that satisfies the requirements of this paragraph (b), for which its FFD program must be established, implemented, and maintained no later than the start of construction activities, as defined in § 26.5, and except for holders of manufacturing licenses if they possess a separate license to load fuel into a manufactured reactor, for which its FFD program under this paragraph (b) must be established, implemented, and maintained no later than the start of the loading of fuel into the reactor, the licensee or other entity must establish, implement, and maintain an FFD program under this paragraph (b) before the earliest occurrence of the following, as applicable:

(i) The loading of fuel onsite into a reactor vessel;

(ii) Receiving a fueled manufactured reactor; and

(iii) Individuals subject to this part operate, test, perform maintenance of, or direct the maintenance or surveillance of security-related equipment or equipment that a risk-informed evaluation process has shown to be significant to public health and safety.

(2) An FFD program under this paragraph (b) must—

(i) Apply to those individuals described in § 26.4, as applicable; and

(ii) Implements the following requirements and subparts:

(A) Section 26.23, for performance objectives;

(B) Section 26.35, for employee assistance programs;

(C) Section 26.603, for general provisions;

(D) Section 26.606, for written policy and procedures;

(E) Section 26.607, for drug and alcohol testing;

(F) Section 26.608, for FFD program training;

(G) Section 26.609, for behavioral observation;

(H) Section 26.611, for protection of information;

(I) Section 26.613, for the appeals process;

(J) Section 26.615, for audits;

(K) Subpart A, for administrative provisions;

(L) Subpart C, for granting and maintaining authorization;

(M) Subpart D, for management actions and sanctions to be imposed;

(N) Subpart H, for determining fitness-for-duty Policy violations and determining fitness, unless using the Mandatory Guidelines for Federal Workplace Drug Testing Programs (the HHS Guidelines) for Medical Review Officer (MRO) evaluation of drug test results, and determining fitness;

(O) Subpart I, for managing fatigue;

(P) Subpart N, for recordkeeping and reporting requirements; and

(Q) Subpart O, for inspections, violations, and penalties.

(a) Licensees and other entities that implement an FFD program under this subpart must ensure that—

(1) A written FFD policy statement is provided to each individual who is subject to the program before the individual is subject to drug and alcohol testing.

(2) The FFD policy statement describes the performance objectives in § 26.23.

(3) The FFD policy statement describes the minimum days off requirements in § 26.205(d)(3) or maximum average work hours requirements in § 26.205(d)(7).

(4) The FFD policy statement must be written in sufficient detail to provide affected individuals with information on what is expected of them and what consequences may result from a lack of adherence to the policy, including those elements described in paragraph (b) of this section, sanctions required under this part, and required medical/clinical treatment and follow-up testing for FFD policy violations.

(5) The FFD policy statement describes the individual's responsibilities to report for work in a physiological and psychological condition that enables the safe and competent performance of assigned duties and responsibilities and inform a licensee- or other entity-designated representative when the individual determines that this cannot be accomplished.

(6) The FFD policy statement must prohibit the consumption of alcohol, at a minimum, within an abstinence period of 5 hours preceding the individual's arrival at the licensee's or other entity's facility.

(7) The FFD policy statement must convey that abstinence from alcohol for the 5 hours preceding any scheduled tour of duty is considered to be a minimum that is necessary, but may not be sufficient, to ensure that the individual is fit for duty.

(b) Licensees and other entities must establish, implement, and maintain written procedures that address the following topics:

(1) For the drug and alcohol testing program under this subpart:

(i) The methods and techniques to collect and test for drugs and alcohol and for the shipping and temporary storage of biological specimens used for drug testing at HHS-certified laboratories;

(ii) The urine specimen volumes, techniques for split specimen collections, and the acceptability of a urine specimen as described in § 26.111 or as described in the HHS Guidelines;

(iii) Protecting the privacy of an individual who provides a specimen, protecting the integrity of the specimen, and ensuring that the test results are valid and attributable to the correct individual; and

(iv) If the licensee or other entity elects to use the HHS Guidelines, the name of the specific HHS Guideline and revision being implemented by the licensee or other entity and a description of the specific sections in the guideline that are being implemented in the procedure, including specimen collections, drug testing, and evaluation of test results.

(2) The immediate and follow-up actions that will be taken, and the procedures to be used, in those cases in which individuals who are subject to the FFD program:

(i) Have been involved in the use, sale, or possession of illegal substances, illegal drugs, or illicit substances;

(ii) Are impaired by any illegal substances, illegal drugs, or illicit substances or the consumption of alcohol as determined by behavioral observation or a test that measures blood alcohol concentration;

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

(iv) Refused to provide a specimen for analysis or follow instructions provided by FFD program personnel;

(v) Had legal action taken relating to drug or alcohol use;

(vi) Demonstrated character or actions indicating that the individual cannot be trusted or relied upon to perform those duties and responsibilities or maintain access to NRC-licensed facilities, special nuclear material (SNM), or sensitive information; or

(vii) Have a condition or have taken actions that pose or have posed an immediate hazard to themselves or others, as notified by EAP personnel under § 26.35(c)(2).

(3) The process, including the duties and responsibilities of FFD program personnel, to be followed if an individual's behavior or condition raises a concern regarding the possible use, sale, or possession of illegal drugs on- or offsite; the possible use or possession of alcohol on the NRC-licensed facility; impairment from any cause that in any way could adversely affect the individual's ability to safely and competently perform the individual's duties; or the receipt of credible information indicating that the individual cannot be trusted or relied on to perform those duties and responsibilities making the individual subject to this part.

(4) Operation and oversight of any onsite or offsite collection facility.

(5) The fatigue management requirements in § 26.202(b) and either § 26.205(d)(3) or (7).

(6) Measures to prevent subversion of drug and alcohol tests conducted onsite and offsite.

Licensees and other entities must perform drug and alcohol testing that complies with the following requirements—

(a) Split specimens. Split specimen collections of oral fluid or urine must be used for the test conditions described in paragraph (b) of this section. Testing of the split specimen (specimen B) requires the donor's permission unless ordered by the MRO to resolve an invalid test result obtained for specimen A.

(b) Test conditions. Individuals identified in § 26.4 must be subject to drug and alcohol testing under the following conditions:

(1) Pre-access. A pre-access test must be conducted for drugs and alcohol before performing or directing the conduct of roles and responsibilities making the individual subject to this subpart or being granted unescorted access to the protected areas of the NRC-licensed facility. A pre-access test must have been conducted no more than 14 days before the individual is granted unescorted access.

(2) Random. Random testing for drugs and alcohol must—

(i) Be administered in a manner that provides reasonable assurance that individuals are unable to predict the time periods during which specimens will be collected;

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

(iii) Ensure that all individuals in the population that is subject to random testing on a given day have an equal probability of being selected and tested;

(iv) Ensure that an individual completing a test is immediately eligible for another random test; and

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

(vi) If the number of individuals subject to random testing at an NRC-licensed site is such that paragraph (b)(2)(v) of this section cannot be implemented without predictable outcomes, the licensee must use a consortium/third-party administrator to manage the random testing pool and make selections for testing throughout the year.

(3) For-cause. For-cause drug and alcohol tests must be conducted onsite in response to an individual's observed behavior or physical condition indicating possible substance abuse, as defined in § 26.5. A for-cause drug test, alcohol test, or both, must be conducted onsite after receiving credible information either that an individual is engaging in substance abuse or in response to a portal area screening test result under paragraph (j) of this section.

(4) Post-event. A post-event test for drugs and alcohol must be conducted—

(i) As soon as practical after an event involving a human error that was committed by an individual specified in § 26.4, where the human error may have caused or contributed to the event. This test must be conducted onsite unless the individual requires offsite medical care. The licensee or other entity must test the individual(s) who committed or directed the error and need not test individuals who were affected by the event and whose actions likely did not cause or contribute to the event. The licensee or other entity must describe in its procedures what constitutes a human error.

(ii) Within 4 hours of an event unless immediate medical intervention precludes the conduct of the test on the individual(s) who caused or contributed to the accident(s), if the event results in—

(A) An illness or personal injury to any individual which results in death, days away from work, restricted work, transfer to another job, medical treatment beyond first aid, loss of consciousness, or other significant illness or injury, as diagnosed by a licensee- or other entity-designated physician or other licensed health care professional, even if the illness or injury does not result in death, days away from work, restricted work or job transfer, medical treatment beyond first aid, or loss of consciousness; or

(B) Damage to any safety- or security-related structures, systems, and components; and

(5) Follow-up. An individual subject to this part who has violated the FFD policy for substance use or abuse, or the sale, use, or possession of illegal drugs must be subject to a follow-up series of tests for drugs, alcohol, or both to verify an individual's continued abstinence from substance abuse.

(c) Urine and oral fluid specimens. (1) All urine or oral fluid specimens must be tested for the substances listed in § 26.31(d)(1), except as allowed by § 26.603(e)(3). All urine specimens must be subject to validity testing as specified in either this part or the HHS Guidelines. All oral fluid specimens may be subject to validity testing, including a biological marker, as specified in either this part or the HHS Guidelines.

(2) For the use of urine as the biological specimen to be tested, the following requirements must be implemented—

(i) Section 26.115, for collecting a urine specimen under direct observation;

(ii) Section 26.119, for determining “shy” bladder; and

(iii) Section 26.163, for cutoff levels for drugs and drug metabolites.

(3) For alcohol testing onsite, the following requirements must be implemented—

(i) Section 26.91, for acceptable devices for conducting initial and confirmatory tests for alcohol and methods of use;

(ii) Section 26.93, for preparing for alcohol testing;

(iii) Section 26.95, for conducting an initial test for alcohol using a breath specimen;

(iv) Section 26.97, for collecting oral fluid specimens for alcohol and drug testing;

(v) Section 26.99, for determining the need for a confirmatory test for alcohol;

(vi) Section 26.101, for conducting a confirmatory test for alcohol; and,

(vii) Section 26.103, for determining a confirmed positive test result for alcohol.

(4) For all test conditions in paragraph (b) of this section and for MRO-directed tests under § 26.185, drug testing must be performed at an HHS-certified laboratory for the specific biological specimen to be tested. Only HHS-certified laboratory test results from urine and oral fluid specimens may be used for the issuance of a sanction required under this part. The licensee or other entity must establish and maintain a contract with a primary and a back-up HHS-certified laboratory (with a different Certifying Scientist) for the specimen(s) to be tested. These contracts must stipulate that the laboratories are subject to inspection or audit by the licensee or other entity and that records and documents must be provided and/or able to be photocopied and removed from the premises to support the inspection or audit.

(d) Privacy and integrity. The specimen collection and drug and alcohol testing procedures of FFD programs must protect the donor's privacy and the integrity of the specimen and implement quality controls to ensure that test results are valid and attributable to the correct individual.

(e) Offsite collection facilities. At the licensee's or other entity's discretion, except for those specimens that must be collected onsite under paragraphs (b)(3) and (4) of this section, specimen collections and alcohol testing may be conducted at a local hospital or other facility licensed to conduct specimen collections and perform alcohol testing and audited by the State or a State-designated entity. The licensee or other entity must audit these facilities, if used, before their initial use and then on a biennial basis to confirm that the facility procedures are comparable to those described in subpart E of this part or the HHS Guidelines for urine and oral fluid.

(f) Initial testing. A licensee or other entity subject to this subpart performing an initial test must use an immunoassay, or an alternative technology as specified in the HHS Guidelines for the specific biological specimen that is to be tested. Specimens that yield positive, positive and dilute, adulterated, substituted, or invalid initial validity or drug test results or discrepant biological markers must be subject to confirmatory testing by an HHS-certified laboratory, certified for that biological specimen, except for invalid specimens that cannot be tested.

(g) Oral fluid testing. (1) If the licensee or other entity elects to use oral fluid for drug or alcohol testing, the collection, packaging, temporary storage, and shipment of an oral fluid specimen to an HHS-certified laboratory for drug testing, or the collection of an oral fluid specimen for alcohol testing must be performed in accordance with licensee- or other entity-established procedures based either on the requirements in this part or the procedures in HHS Guidelines identified by the licensee or other entity in § 26.606(b)(1)(iv). The oral fluid device must not expire before the date of the collection of the specimen for testing. The drugs, drug metabolites, initial and confirmatory testing cutoffs, and biological markers, if applicable, must be those established by the HHS Guidelines for oral fluid testing and the alcohol cutoffs in this part or, if not established by the HHS Guidelines or this part for the panel of drugs and drug metabolites to be tested, as determined and documented by a forensic toxicologist review conducted pursuant to § 26.31(d)(1)(i)(D).

(2) The virtual collection of oral fluid specimens for drug and alcohol testing is only permitted for sites that must use a C/TPA to implement random testing under paragraph (b)(2)(vi) of this section. For a licensee or other entity to utilize a virtual oral fluid specimen collection process, the following must apply or should be considered, as applicable:

(i) The specimen collector completing the virtual collection must meet the requirements in § 26.85.

(ii) The oral fluid specimen collection process must be completed as described under §§ 26.97 and 26.99.

(iii) An individual other than the donor (i.e., a virtual collection monitor) may be needed in the location where the specimen collection is to be performed to assist the virtual collector in completing activities, performing observations, or both.

(iv) If a virtual collection monitor is used to assist the specimen collector in completing an oral fluid specimen collection, then the virtual specimen collector must explain the collection process to the monitor and provide instruction to the monitor on required activities to be performed during the collection process. The monitor's name must be recorded on the Federal custody and control form (Federal CCF) for drug testing specimens, or an analogous document for alcohol testing.

(v) Video teleconference communication method(s) must provide sufficient visual and aural clarity to complete the process and ensure that a donor is not able to subvert the testing process.

(vi) Collection kit materials must be maintained in a secure fashion until the virtual collector initiates the virtual collection process with the donor.

(vii) The licensee or other entity's written FFD procedures must describe in detail the virtual collection process and when and how it is to be implemented.

(viii) The virtual collection procedure must address problem collections, such as the video teleconference becomes inoperable during the collection process or the donor is unable to provide an oral fluid specimen of sufficient quantity to complete the specimen collection process for drug or alcohol testing.

(ix) The virtual collection procedure must include steps to collect a breath specimen using an evidential breath testing device (EBT) if the oral fluid specimen test result under § 26.99(b) requires a confirmatory testing for alcohol under § 26.101. At a minimum, a donor with an oral fluid specimen test result requiring confirmatory testing for alcohol must be removed from duty pending additional testing.

(h) [Reserved]

(i) Hair testing. The testing of hair specimens may only be used to inform a licensee's or other entity's determination of whether the individual is trustworthy and reliable under the test condition in paragraph (b)(1) of this section to supplement the information gained from a pre-access test using oral fluid or urine as the test specimen and must be conducted at an HHS-certified laboratory certified to test hair specimens.

(1) If used, this process must be described in the licensee's or other entity's FFD policy and described in detail in its procedure. The panel of drugs and drug metabolites to be evaluated must only include those listed as Schedule I or II of section 202 of the Controlled Substances Act [21 U.S.C. 812]. The collection, packaging, and temporary storage of a hair specimen and shipment of the specimen to an HHS-certified laboratory must be conducted in accordance with the HHS Guidelines. The licensee- or other entity-designated FFD program personnel must conduct the collection, packaging, temporary storage, shipping, and custody and control of the specimen.

(2) Before the licensee or other entity begins to conduct hair testing, the initial and confirmatory testing cutoffs must be the cutoffs established by the HHS Guidelines for hair testing or, if not established by the HHS Guidelines or this part, as determined by a forensic toxicologist review conducted pursuant to § 26.31(d)(1)(i)(D).

(3) Confirmed positive test results must be considered potentially disqualifying FFD information until proven otherwise by a review under § 26.613. Sanctions under this subpart must not be issued for any FFD policy violation involving a drug test using a hair specimen unless the licensee or other entity determines that the individual has attempted to subvert the testing process, as defined in § 26.5, for the hair test.

(j) Portal area screening. A non-invasive testing instrument may be used to screen individuals for drugs, drug metabolites, and alcohol before the individuals' entry into or exit from a protected or vital area.

(1) The instrument must be operated in accordance with the manufacturer's specifications. If screening detects the presence of any drug, drug metabolite, or alcohol at or above the instrument set point, the individual screened by the instrument must be subject to for-cause testing under paragraph (b)(3) of this section.

(2) Annually, the licensee or other entity must verify the accuracy of the portal area screening test for each substance with any positive results. If at least 85 percent of the positive portal area screening test results for a substance in the past 12 months do not subsequently confirm positive on for-cause testing performed under paragraph (j)(1) of this section, the licensee or other entity cannot continue to use the screening test for the particular substance until such time as corrective actions have been implemented to improve the testing accuracy.

(3) A sanction under this part may not be issued to an individual based solely on a portal area screening instrument detection that drugs or alcohol exceed the instrument's established setpoint.

(k) Blood testing. The testing of blood specimens may only be conducted under the order of the licensee- or other entity-designated MRO for a valid medical reason as confirmed by the MRO pursuant to § 26.31(d)(5). This specimen must be subject to testing by a laboratory that satisfies quality control requirements that are comparable to those required for certification by the HHS.

(l) Federal custody and control form. For the collection and packaging of urine, oral fluid, and hair specimens for drug testing, the licensee or other entity must use a Federal CCF.

(m) Medical Review Officer. Licensees or other entities must—

(1) Require their designated MRO to review positive, positive and dilute, adulterated, substituted, and invalid confirmatory drug and validity test results to determine whether the donor has violated the FFD policy. The review must be completed before reporting the results to the individual designated by the licensee or other entity to assess authorization or perform the suitability and fitness determinations required under § 26.619, or, if required, that are described in subpart H of this part.

(2) Require their MRO to satisfy the requirements in § 26.183 and, prior to conducting any activities under this part, attend and pass a medical- or clinical-based training session to improve his/her knowledge of MRO duties and responsibilities, drug and alcohol testing processes and procedures, and evaluation of drug testing results. This training session must be conducted by a nationally recognized MRO training and certification organization that has been assessed by the licensee's or other entity's FFD program personnel to include the technical elements an MRO must implement under § 26.185. An MRO who performed the duties and responsibilities in §§ 26.185 and 26.187 for at least 3 continuous years in the last 10 years prior to being hired or contracted by the licensee or other entity satisfies the requirements in this paragraph (m)(2).

(3) Require their MRO to attend a medical- or clinical-based training session at least every 5 years to improve his/her knowledge of changes in drug and alcohol testing processes and procedures and evaluation of drug testing results.

(4) Require their MRO to determine whether a biological specimen is positive, positive and dilute, adulterated, substituted, or invalid by implementing the requirements in § 26.185 or the HHS Guidelines through the licensee's or other entity's procedures.

(i) If § 26.185 or the HHS Guidelines, as used by the licensee or other entity in its procedures, are insufficient to make this determination, then guidance issued by a State agency in the State in which the NRC-licensed facility is located, Federal agencies, or nationally recognized MRO training and certification organizations may be used to inform an MRO determination.

(ii) An MRO need not review alcohol test results, including positive confirmatory alcohol test results determined by an EBT under paragraphs (c)(3)(vi) and (vii) of this section.

(5) Require their MRO to determine and approve the use of oral fluid or urine as an alternative biological specimen when the donor cannot provide a specimen for testing. This determination and the retest must be documented and completed as soon as reasonably practicable.

(6) Require the MRO to review all specimen test results associated with drug-related FFD policy violations. This review includes split specimens and all specimens taken to resolve a discrepant condition, such as a possible subversion attempt, impairment without a known cause, or a donor-requested or MRO-directed re-test. To resolve a discrepant condition, the MRO is authorized to test a specimen for a biological marker, adulterants, or additional drugs.

(n) Limitations of screening and testing. Specimens collected under NRC regulations may only be designated or approved for screening and testing as described in this part and may not be used to conduct any other analysis or test without the written permission of the donor. Analyses, screens, and tests that may not be conducted include, but are not limited to, DNA testing, serological typing, or any other medical or genetic test used for diagnostic or specimen identification purposes. No biological specimens may be passively sampled and analyzed in a manner different than described in this subpart.

(o) Specimen collectors. All onsite specimen collections, except a collection by a portal area screening instrument in paragraph (j) of this section, must be conducted by licensee- or other entity-designated and -trained personnel.

(a) FFD program training. (1) Individuals must be trained in the FFD policy and procedure, including fatigue management, and their FFD program responsibilities. Individuals who collect specimens for testing must also be trained in specimen collector duties and responsibilities, including, at a minimum, specimen collection, custody and control, identification and response to subversion attempts, and privacy. For licensees and other entities of commercial nuclear plants, the FFD program training program must use a systems approach to training as defined in § 53.725 of this chapter and described in § 53.830 of this chapter for those individuals in § 26.4.

(2) FFD program training must include training on the behavioral observation program. The behavioral observation program training must include the detection of physiological behaviors or conditions that may indicate—

(i) Possible use, sale, or possession of illegal drugs or illicit drugs, or substance abuse on- or offsite;

(ii) Use or possession of alcohol onsite or use while on duty offsite;

(iii) Impairment from fatigue or any cause that, if left unattended, could result in inattentiveness or human errors; and

(iv) Any individual's inability to safely and competently perform assigned duties and responsibilities or act in a trustworthy and reliable manner while having access to protected areas, SNM, or sensitive information.

(3) Training must explain that an individual's FFD policy violation will—

(i) Subject the individual to an FFD program-required sanction designed to preclude recurrence of an FFD policy violation;

(ii) Contribute to the licensee's or other entity's assessment of whether the individual can be trusted and relied upon to safely and competently perform the assigned duties and responsibilities making the individual subject to this subpart;

(iii) Be used to inform the licensee's or other entity's insider mitigation and access authorization programs under § 73.55, § 73.56, § 73.100, or § 73.120 of this chapter; and

(iv) Be used to inform other NRC licensees and other entities subject to this part when FFD program information is requested to support authorization determinations under subpart C of this part or § 73.56 or § 73.120 of this chapter.

(b) Training and assessments. Training and a trainee assessment must be conducted before pre-access testing, and FFD program refresher training and trainee assessments must be conducted on a nominal 24-month frequency, or more frequently where the need is indicated. Indications of the need for more frequent training include, but are not limited to, an individual's failure to properly implement FFD program procedures and the frequency, nature, or severity of problems discovered through audits or the administration of the program.

(c) Training program review. The licensee or other entity must periodically evaluate its FFD training program and revise it as appropriate to reflect industry experience as well as applicable changes to the regulations in this part, the HHS Guidelines, if used, and specimen collection and testing processes implemented by the licensee or other entity.

(a) Licensees and other entities must ensure that the individuals who are subject to this subpart are subject to behavioral observation and that behavioral observation is performed by all individuals subject to this subpart.

(b) Licensees and other entities must require all individuals subject to the FFD program to report to the licensee- or other entity-designated representative any onsite or offsite behaviors or activities by individuals subject to this part that may constitute an unreasonable risk to the safety or security of the NRC-licensed facility or SNM or may cause harm to others. This reporting must include any information relating to character or reputation of the individual indicating that the individual cannot be trusted or relied upon to perform those duties and responsibilities or maintain access to NRC-licensed facilities, SNM, or sensitive information that makes them subject to this part.

(c) Behavioral observation must be performed visually, in-person, and, when necessary, remotely by live video and audible streaming and capture, to observe the behavior of individuals in the workforce subject to the requirements in this subpart.

(d) Not withstanding paragraph (c) of this section, for a reactor facility where individual task loading does not allow for the effective conduct of behavior observation in addition to assigned operational tasks, the licensee or other entity must implement a live video and audible streaming and capture system to conduct behavioral observation of persons licensed to operate under part 53 of this chapter who manipulate the controls of any commercial nuclear plant licensed under part 53.

(a) Licensees and other entities that implement an FFD program under this subpart must establish sanctions for FFD policy violations that, at a minimum, prohibit the individuals specified in § 26.4 from being assigned to perform or direct those duties and responsibilities or maintaining authorization making them subject to this subpart.

(b) The severity of the sanction must escalate with the number of occurrences and severity of the FFD policy violation. The sanction must be long enough to act as a deterrent and, if the individual is retained as a licensee employee or contractor/vendor, facilitate the individual to complete counseling or treatment. The sanctions must include an immediate unfavorable termination of the individual's authorization as follows:

(1) A minimum 14-day denial of access for a first violation of the FFD policy involving a confirmed positive drug or alcohol test result;

(2) A minimum 3-year denial of access for a second violation of the FFD policy involving a confirmed positive drug or alcohol test result;

(3) A minimum 5-year denial of access for any individual who is determined to have been involved in the sale, use, or possession of illegal drugs or the consumption of alcohol within a protected area of any facility licensed under part 53 of this chapter or within a transporter's facility or vehicle used in the conveyance of formula quantities of strategic SNM while the individual is subject to this subpart; and

(4) A permanent denial of access for a third violation of the FFD policy involving a confirmed positive drug or alcohol test result or a subversion attempt of any drug or alcohol test or screening process.

(a) Licensees and other entities that collect personal information about an individual for the purpose of complying with this subpart must establish and maintain a system of files and procedures to prevent unauthorized disclosure.

(b) Licensees and other entities must obtain a signed consent that documents the individual's acceptance of being subject to the FFD program and authorizes the disclosure of the personal information collected and maintained under this subpart, except for disclosures to the individuals and entities specified in § 26.37(b)(1) through (6) and (8), and persons deciding matters under review in § 26.613. This signed and dated consent must be obtained before making the individual subject to the FFD program.

Licensees and other entities that implement an FFD program under this subpart must establish and implement procedures for the review of a determination that an individual in § 26.4 has violated the FFD policy. The procedure must provide for an objective and impartial review of the facts related to the determination that the individual has violated the FFD policy and a schedule for the completion of the review.

(a) Licensees and other entities that implement an FFD program under this subpart must audit their programs at a frequency that ensures the continuing effectiveness of their FFD program, FFD program elements that are provided by C/Vs, and the FFD programs of C/Vs that are accepted by the licensee or other entity. Corrective actions must be taken as soon as reasonably practicable to resolve any problems identified in an audit and preclude recurrence.

(b) The subject matter, scope, and frequency of audits must be revised as necessary to improve or maintain program performance based on annual FFD program performance data reviews performed under § 26.617(d) and unsatisfactory performance or programmatic weaknesses identified under § 26.617(b)(3) and (e).

(c) Licensees and other entities may conduct joint audits or accept audits of C/Vs so long as the audit addresses the relevant services of the C/Vs.

(d) Licensees and other entities must audit HHS-certified laboratories unless the licensee's or other entity's panel of drugs and drug metabolites to be tested is equivalent to the panel by which the laboratory is certified by HHS or is subject to the standards and procedures for drug testing and evaluation used by the laboratory under the HHS Guidelines. Licensees and other entities must audit any hospital or other facility licensed by the State (or State-designated entity) if used to conduct specimen collections and perform alcohol testing under this part on a biennial basis to confirm that the facility procedures are comparable to those described in subpart E of this part, for urine and oral fluid.

(a) Licensees and other entities that implement FFD programs under this subpart must ensure that records pertaining to the administration of their program, which may be stored and archived electronically, are maintained so that they are available for NRC inspection purposes and for any legal proceedings resulting from the administration of the program. Records pertaining to the administration of the FFD program and FFD performance data required by § 26.717 must be retained until license termination.

(b) Licensees and other entities must make the following reports:

(1) Reports to the NRC Operations Center by telephone within 24 hours after the licensee or other entity discovers any intentional act that casts doubt on the integrity of the FFD program and any programmatic failure, degradation, or discovered vulnerability of the FFD program that may permit undetected drug or alcohol use or abuse by individuals who are subject to this subpart. These events must be reported under this subpart, rather than under the provisions of § 73.1200 of this chapter;

(2) Annual FFD program performance data under § 26.717(b) for each FFD program subject to this subpart. Licensees and other entities must submit FFD program performance data (for January through December) to the NRC annually, before March 1 of the following year and must use unexpired NRC-provided forms for the electronic submission of FFD information to the NRC; and

(3) Reports on drug and alcohol testing errors within 30 days of completing an investigation of any testing errors or unsatisfactory performance, discovered at an HHS-certified laboratory or through the processing of appeals under § 26.613, or errors or matters that could adversely reflect on the integrity of the random selection or random testing process. The reports must describe the incident and any corrective actions taken or planned.

(c) Licensees and other entities subject to this subpart must describe in sufficient detail to support an authorization determination, an individual's FFD policy violation (while protecting privacy information under § 26.611) and FFD program weakness to NRC, licensees, and other entities subject to this part when requested to support authorization determinations under subpart C of this part or § 73.120 of this chapter, as applicable, or to support licensee or other entity performance monitoring.

(d) Licensees and other entities must analyze FFD program performance data at least annually and take appropriate actions to correct any identified program weakness.

(e) Licensees and other entities must document, trend, and correct non-reportable indicators of FFD programmatic weaknesses under the licensee's or other entity's corrective action program, but may not track or trend drug and alcohol test results in a manner that would permit the identification of any individuals.

Licensees and other entities that implement FFD programs under this subpart must develop, implement, and maintain procedures for evaluating whether to assign individuals to perform or direct those duties and responsibilities making them subject to this subpart. A suitability or fitness determination conducted for cause must be performed face-to-face. A suitability or fitness determination conducted for cause may be performed remotely using electronic communications that provide sufficient visual and aural clarity to complete the assessment. A fitness determination may be supported by someone who is present in-person with the individual being assessed only during for-cause drug and alcohol testing determinations under § 26.607(b)(3) and fatigue assessments performed under § 26.211(a)(1). The supporting person must be trained in accordance with the requirements of either § 26.29 or § 26.608.