Risk-Informed, Technology-Inclusive Regulatory Framework for Advanced Reactors

Through this final rule, the NRC is establishing a technology- inclusive, risk-informed, and performance-based approach for the application of drug and alcohol testing and fatigue management requirements for facilities licensed under part 53. The requirements applicable to these applicants, licensees, and other entities are commensurate with the radiological consequences presented by the applicants' facilities and the operation of these facilities.\2\ The FFD framework consists of a two-tiered graded approach similar to that currently in part 26. This new FFD framework is established in subpart M, “Fitness-for-Duty Programs for Facilities Licensed Under Part 53,” of part 26.

\2\ The NRC uses the term “operation” in its part 26 discussion to focus on human performance, namely the necessity of individuals to operate, maintain, surveil, and protect the facility and respond to operational transients and unlikely event sequences.

The NRC is using operating experience to provide regulatory flexibility in the subpart M of part 26 framework to help support a licensee's or other entity's response to changes in societal drug use, drug testing technologies and processes, and FFD program performance. The flexibility also helps in FFD program implementation because of the wide variety of staff sizes anticipated at commercial nuclear plants licensed under part 53 and the geographically remote locations in which commercial nuclear plants may be sited.

The first-tier FFD program requirements apply to part 53 licensees and other entities of commercial nuclear plants that demonstrate compliance with Sec. 73.100(a)(1)(i), at their discretion, no later than the start of construction activities; licensees and other entities of facilities that do not demonstrate compliance with Sec. 73.100(a)(1)(i) no later than the start of construction activities; and holders of MLs who are assembling or performing non-operational testing of manufactured reactors. These requirements are provided in Sec. 26.605(a) and are essentially equivalent to those requirements in subpart K, “FFD Program for Construction,” of part 26 but have been supplemented by select requirements from subparts E, “Collecting Specimens for Testing,” and I, “Managing Fatigue,” of part 26, and the requirements in subparts A, “Administrative Provisions,” and O, “Inspection, Violations, and Penalties,” of part 26. The first-tier requirements involve policies, procedures, behavioral observation, fatigue management, drug and alcohol testing, determinations of fitness, appeals, training, sanctions, auditing, change control, evaluating FFD program performance, recordkeeping, and reporting. These

Sec. 26.605(a) FFD program requirements help deter individuals subject to this section from impairment from any cause, including drug use, alcohol misuse, and fatigue. These requirements also help licensees and other entities identify individuals using impairing substances and demonstrate compliance with Sec. 26.23, “Performance objectives.”

The second tier includes all the first-tier requirements, plus the more comprehensive set of FFD program requirements in current subparts C, “Granting and Maintaining Authorization,” D, “Management Actions and Sanctions to be Imposed,” H, “Determining Fitness-for-Duty Policy Violations and Determining Fitness,” and N, “Recordkeeping and Reporting Requirements,” of part 26. These requirements are provided in Sec. 26.605(b) and are applicable to licensees and other entities that demonstrate compliance with Sec. 73.100(a)(1)(i), if they do not choose to comply with Sec. 26.605(a). These licensees and other entities need to implement the FFD program before they begin construction. Section 26.605(b) also applies to holders of manufacturing licenses if they possess a separate license to load fuel into a manufactured reactor. These licensees must implement their FFD program no later than when they begin loading fuel into the reactor. These requirements also apply to licensees or other entities that do not demonstrate compliance with Sec. 73.100(a)(1)(i) that implement an FFD program under subpart M of part 26 before the loading of fuel onsite into a reactor vessel; before receiving a fueled manufactured reactor; or before operating, testing, performing maintenance of, or directing 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.

The second-tier requirements are based on the additional risk presented by nuclear reactor assembly, testing, fueling, and operation and the necessity for human actions in certain event sequences. The inclusion of the current part 26 requirements aligns part 53 FFD and AA program requirements with the current FFD and AA programs required for facilities licensed under parts 50 and 52. This approach ensures effective and consistent AA and FFD program implementation across the commercial nuclear power industry, thereby ensuring uniform requirements for individuals who may perform roles and responsibilities for multiple facilities regardless of facility licensure.

Regarding fatigue management requirements, work hour controls are required for personnel at utilization and manufacturing facilities in accordance with the existing scoping criteria in Sec. 26.4, “FFD program applicability to categories of individuals,” as revised in this final rule. The amended Sec. 26.4 also will be used to determine whether an individual is subject to drug and alcohol testing. The applicability of these scoping criteria for certain individuals (such as operators and maintenance personnel) will be determined by the licensee or other entity through its risk-informed evaluation process performed to assess the risk significance of the SSC upon which work is being performed or directed by the individual. These requirements also will be scaled based on the potential radiological consequences presented by the facility, as determined by whether the facility demonstrates compliance with Sec. 73.100(a)(1)(i). However, fatigue management will be applied to all individuals subject to the FFD program, similar to FFD program implementation by the current fleet of commercial nuclear plants because fatigue management is a proactive requirement designed to help prevent on-shift impairment through work hour scheduling and time off. The behavioral observation program (BOP) is the principal requirement to provide reasonable assurance that individuals on shift are not mentally or physically impaired due to fatigue, which in any way could adversely affect their ability to safely and competently perform their duties.

This final rule establishes subpart M of part 26 for facilities licensed under part 53, in lieu of subjecting all part 53 licensees to the same part 26 requirements that apply to facilities licensed under part 50 or 52, for four principal reasons. First, subpart M of part 26 applies FFD requirements in a risk-informed manner commensurate with the radiological consequences presented by facilities licensed under part 53 (i.e., whether a facility demonstrates compliance with Sec. 73.100(a)(1)(i)). This regulatory strategy is consistent with the current part 26, which provides a comprehensive set of deterministic requirements for licensees and other entities at facilities that are operating. This approach is also consistent with the current subpart K of part 26, which provides a more flexible framework for nuclear power reactors under construction.

Second, subpart M of part 26 enables a part 53 licensee or other entity to implement innovative drug testing technologies and behavior observation techniques while continuing to demonstrate compliance with the part 26 performance objective in Sec. 26.23(b) of providing reasonable assurance that individuals are not under the influence of any substance or mentally or physically impaired from any cause, which in any way adversely affects their ability to safely and competently perform assigned duties. These technologies include drug testing of oral fluid, urine, and hair specimens and non-invasive portal area screening instruments that passively test for drugs, alcohol, or both. Part of the basis to enable the use of innovative drug and alcohol testing technologies, should they become available, is to maintain FFD program effectiveness should the staff size at a part 53 commercial nuclear plant be small and challenge the effective implementation of the behavioral observation and drug and alcohol testing programs. Also, a commercial nuclear plant that is sited at a geographically remote location may present additional challenges not encountered by traditional LWR facilities licensed under part 50 or 52, such as: efficiency of postal services for shipping and controlling biological specimens; proximity to drug and alcohol collection facilities that are reasonably equivalent to that described in subpart E of part 26; availability of internet and cellular services to enable same-time discussions among the Medical Review Officer (MRO), donor, and laboratory; accessibility to substance abuse treatment services described in subpart H of part 26; and proximity to an MRO (or management and clinical staff) to evaluate potential impairment caused by fatigue and/or substance use or abuse, for-cause and post-event occurrences, and the individual's potential to return to duty.

A part 53 commercial nuclear plant that is sited in a geographically remote location and has a small staff size may present implementation challenges and the potential for small group dynamics to impact FFD program effectiveness. Particularly in isolated environments, psychological phenomena known as “groupthink” may take effect and could impact BOP effectiveness. For example, in circumstances where small staffs are drawn from the same small town and thereby have a potentially narrow experience base, it could be challenging to maintain a work environment in which personnel feel free to raise concerns without fear of retaliation, intimidation, harassment, or discrimination, and organizations may resultingly experience groupthink-like effects. Groupthink is particularly prevalent among cohesive and insulated

groups that experience high levels of decisional stress.\3\ Small staffs at part 53 commercial nuclear plants may therefore be more susceptible to groupthink if they are working in an isolated environment where decision-making pressures may be high.

\3\ See e.g., Irene W[aelig]r[oslash], Ragnar Rosness, and Stine Skaufel Kilska, “Human performance and safety in Arctic environments,” SINTEF (2018).

In small group dynamics, groupthink could have adverse effects on team decision-making, as studies show that individuals will be more hesitant to speak out against practices they deem unsafe for fear of deviating from group norms.\4\ Individuals may also be unaware of systematic biases in the group decision-making process and may then be less likely to scrutinize the potential risks of the group's decision or sufficiently contemplate alternative paths of action.\5\ Furthermore, the literature indicates that groups make riskier decisions than individuals acting alone due to the diffusion of responsibility among group members.\6\ This phenomenon is known as “the risky shift.” “Groupthink” and “the risky shift” may lead to group behaviors that render behavioral observation less effective. As such, alternative approaches to BOPs, such as the utilization of video- based surveillance by individuals separate from the onsite work unit, could serve to mitigate potential issues associated with groupthink. The incorporation of remote observation, performed by individuals physically separate from the site, could help to bring in independent and objective perspectives and help to break patterns of thought and communication that may result in groupthink.

\4\ See e.g., Russell Mannion and Carl Thompson, “Systematic biases in group decision-making: implications for patient safety,” International Journal for Quality I Health Care, Vol. 26, No. 6 (2014): 606-612 (arguing that small group dynamics in healthcare teams produce systematic biases in group decision-making because healthcare professionals may be reticent to vocalize concerns they have about quality of care).

\5\ See e.g., W[aelig]r[oslash], Rosness, and Kilska (arguing that groupthink leads teams to “develop shared rationalizations that bolster a proposed choice, rather than examining alternative options and identifying the risks associated with the proposed choice”). See also David Hofmann and Adam Stetzer, “A Cross-Level Investigation of Factors Influencing Unsafe Behaviors and Accidents,” Personnel Psychology, Vol. 49 (1996) (finding that in a study of fatal accidents involving offshore oil rigs, in the absence of standard operating procedures, workers “equated normal work methods (i.e., what everyone else does) with safe and/or ideal work methods,” revealing that the groupthink phenomena will further cement modes of work that do not reflect safety protocols in small groups that lack strong norms around workplace safety and tacitly reward short-cuts that prioritize efficiency over safety).

\6\ Mannion and Thompson, “Systematic biases in group decision- making: implications for patient safety,” International Journal for Quality I Health Care, Vol. 26, No. 6 (2014): 606-612.

Even without the influence of small group dynamics, there are other practical constraints to implementing FFD requirements, such as random drug and alcohol testing, among small staffs. Random testing is less effective when applied to small staff sizes because it may be easier for staff to communicate and predict when individuals will be subject to drug and alcohol testing. Furthermore, if a facility is sited in a remote location, program implementation could be challenged by the following factors: limited mail services to laboratories certified by the U.S. Department of Health and Human Services (HHS), availability of local clinical or medical options for treatment and determinations of fitness by an MRO or Substance Abuse Expert, and use of offsite drug and alcohol collection facilities.

The increased potential for small staff sizes to impact FFD policy compliance necessitates additional flexibilities be provided to implement various FFD program elements. The NRC is requiring that facilities with small staff sizes that cannot implement random drug and alcohol testing without predictability to use a consortium/third-party administrator (C/TPA) to include the workers from multiple licensees or other entities into a combined random testing pool under Sec. 26.607(b)(2)(vi). Use of a C/TPA significantly improves the effectiveness of the random testing programs of sites with small worker populations and ensures that individuals would not be able to predict whether random testing would be conducted in a given period of time. Use of C/TPAs is not new in Federally regulated testing, as the U.S. Department of Transportation has employed the use of C/TPAs in specific modal administrations, such as the Federal Motor Carrier Safety Administration under 49 CFR part 382, “Controlled Substances and Alcohol Use and Testing,” which, in part, covers independent owner- operator truck drivers that must be drug and alcohol tested. The U.S. Department of Transportation requirements in 49 CFR part 40, “Procedures for Transportation Workplace Drug and Alcohol Testing Programs,” also enable the use of C/TPAs to perform a variety of functions for employers, such operating random testing programs, and contracting with specimen collection sites and HHS-certified laboratories for services.

Another flexibility is in Sec. 26.607(g)(2), where the NRC is enabling the virtual collection of oral fluid specimens for drug and alcohol testing at facilities that must use a C/TPA to implement random testing under Sec. 26.607(b)(2)(vi). These sites have small staff sizes and could be in remote locations where accessing an in-person specimen collector might be difficult, untimely, and/or costly. Because all aspects of a virtual oral fluid collection are directly observed by the specimen collector, a video teleconference could accomplish many key elements of the collection process. The use of video teleconference technology also is not new to the NRC, as some clinicians complete other required evaluations using video teleconferencing technology, such as performing a psychological assessment under the personnel access authorization requirements in Sec. 73.56(e)(4) or a determination of fitness performed under Sec. 26.189(b) by a Substance Abuse Expert when potentially disqualifying FFD information is discovered about an individual that is subject to this part. In addition, existing Sec. 26.31(b)(1)(iii) enables the use of a monitor to assist a specimen collector in completing aspects of a urine collection when a trained collector is not able to complete the activity, and existing Sec. 26.109(b)(1) permits a hydration monitor to observe a donor during the shy bladder process in lieu of the collector conducting the activity. In both cases, the monitor must receive information from the collector on his or her responsibilities.

Also, the NRC is establishing a change control requirement to allow a licensee or other entity to change its subpart M of part 26 FFD program while ensuring that FFD program effectiveness is maintained.

Lastly, subpart M of part 26 consolidates the applicable FFD requirements by placing in one subpart all part 26 requirements (either new requirements or cross-references to existing part 26 requirements) for part 53 licensees and other entities. This should help licensees and other entities implement the requirements because it enables easy cross-reference to similar requirements in other subparts that are being implemented by non-part 53 licensees and entities subject to part 26. Understanding how other licensees or other entities implement similar FFD requirements may facilitate the sharing of operating experience in program implementation.

The use of innovative technologies and a risk-informed performance- based framework parallels the considerations presented in the Advanced Reactor Policy Statement. As stated in the policy statement, “[S]implified systems should facilitate operator comprehension, reliable system function, and more

straightforward engineering analysis.” Furthermore, these same attributes may reduce potential radiation exposures, help prevent the theft of nuclear materials, and use technology and design innovations. Should these components and systems be designed, implemented, and maintained to minimize reliance on human actions and leverage technology and innovation, then the robust and prescriptive FFD requirements in, for example, subparts B, “Program Elements,” and E of part 26 could be scaled to the part 53-licensed facility and its operation. This strategy is implemented in the subpart M of part 26 framework.

Even though current subpart K of part 26 provides a more flexible FFD program framework than the framework comprising all the subparts of part 26 except subparts I and K, subpart M of part 26 does not allow part 53 licensees and other entities to implement the requirements in subpart K. The principal reasons are that (without significant changes to subpart K that are outside the scope of this rulemaking): (1) subpart K does not apply to holders of MLs who assemble or test a reactor; (2) subpart K only applies during construction (and prior to the receipt of special nuclear material in the form of fuel assemblies), whereas subpart M applies during construction, operation, and decommissioning through implementation of the insider mitigation program (IMP) required by Sec. 73.55 or Sec. 73.100; (3) subpart K does not address training, authorization as defined in Sec. 26.5, and MRO performance; (4) subpart K does not expressly authorize the use of innovative drug and alcohol testing technologies; (5) subpart K does not describe the use of time-dependent alcohol limits or special analysis testing of urine specimens; and (6) subpart K has less rigor in the protection of worker rights and sensitive information than that required in subpart M.

Despite the differences between subparts K and M of part 26, the requirements in subpart M are essentially equivalent to many in subpart K that were implemented by the licensees of Vogtle Nuclear Station and V.C. Summer Nuclear Station when they were constructing four commercial nuclear power reactors and NRC inspection and operating experience evaluation determined that the use of subpart K contributed to adequately protecting the public health and safety and the common defense and security. Further, given the risk profile posed by facilities licensed under part 53 and the additional requirements in subpart M of part 26 that were developed from operating experience and other part 26 subparts (but are not included in subpart K of part 26), the NRC concludes that if licensees and other entities effectively implement the requirements in subpart M of part 26, then their FFD programs would provide reasonable assurance that individuals subject to this final rule are fit for duty and trustworthy and reliable. B. Changes to Part 26, Subparts A through E and I

Section 26.3(d) is the applicability paragraph for contractor/ vendors (C/Vs) who implement FFD programs or program elements, to the extent that the licensees and other entities specified in Sec. 26.3(a) through (c) rely on those C/V FFD programs or program elements to satisfy the requirements of part 26. This final rule amends Sec. 26.3(d) to address part 53 licensees and other entities in Sec. 26.3(f).

Section 26.3(f) places part 53 licensees or other entities within the scope of part 26. For licensees and other entities of a part 53 commercial nuclear plant, except a holder of an ML, the FFD program is required to be implemented no later than the start of construction activities. The holder of an ML needs to implement its FFD program before commencing activities that assemble a reactor.

Current Sec. 26.4 describes FFD program applicability to categories of individuals. These categories are based on the duties, responsibilities, and the types of access an individual may possess. The NRC is amending Sec. 26.4 to include licensees and other entities described in Sec. 26.3(f). The NRC expects that not all categories of individuals described in current Sec. 26.4 are applicable to all part 53 facilities. The NRC is establishing regulatory guidance in RG 5.99, “Fatigue Management for Nuclear Power Plant Personnel at Commercial Nuclear Plants Licensed Under 10 CFR part 53,” to help address program applicability to certain individuals.

This final rule amends Sec. 26.4(a)(1) and (a)(4) to account for the possibility that certain individuals may perform or direct the performance of operational and maintenance activities from a remote facility (for example, a remote-control station) for licensees or other entities licensed under part 53.

The framework of the current part 26 does not account for individuals who perform operating and maintenance duties at remote facilities. Although current Sec. 26.4(a)(1) does not limit the operating of applicable SSCs to onsite operating, Sec. 26.5 limits the definition of “Maintenance,” for the purposes of Sec. 26.4(a)(4), to include only “onsite maintenance activities.” In the 2008 part 26 final rule (73 FR 16966, March 31, 2008), the NRC explained that the work hour requirements apply to those individuals who perform maintenance activities within the licensee's owner-controlled area. Furthermore, regarding the direction of applicable operations and maintenance activities, current Sec. 26.4(a)(1) and (4) address only individuals who perform “onsite direction.”

Under this final rule's amendments to part 26, the limitation of “onsite” activities to those performed within the owner-controlled area still applies to facilities licensed under part 50 or 52. However, for licensees and other entities described in Sec. 26.3(f), the NRC is removing the “onsite” limitation to include activities performed both within the owner-controlled area as well as operations and maintenance duties performed at remote facilities where safety-significant systems and components are expected to be operated within the design basis of the commercial nuclear plant.

In the 2008 part 26 final rule, the purpose of limiting “directing” activities to those “directing” activities that are conducted onsite was to avoid requiring work hour controls for individuals performing incidental duties, consistent with Sec. 26.205(b)(5), from an offsite location in instances where those duties might be considered to be “directive” in nature. Under this final rule's amendments to part 26, the exclusion of incidental duties while calculating work hours is still applicable for licensees and other entities licensed under part 53. However, for these licensees and other entities, beyond instances of incidental duties, the direction of operations and maintenance activities associated with safety- significant SSCs, when performed at remote facilities, is considered in an equivalent fashion as direction performed at non-remote facilities, for the purposes of administering work hour controls.

Section 26.4(b) includes in an FFD program individuals who are granted unescorted access to the protected area of a facility licensed under part 53 and do not perform or direct the performance of the duties described in Sec. 26.4(a). This requirement contributes to the defense-in-depth regulatory framework that helps provide reasonable assurance that individuals who have unescorted access are fit for duty, trustworthy, and reliable. For example, through this final rule, the NRC is amending part 73 to require a part 53 licensee to subject individuals to

a series of reviews to help determine whether those individuals are trustworthy and reliable before granting them unescorted access to the facility's protected area.

Through this final rule, the NRC is amending Sec. 26.4(c) to include in an FFD program individuals who are assigned to physically report to the part 53 licensee's emergency response facility (or facilities) or participate remotely in emergency response activities, and individuals without unescorted access to the part 53 facility who, remotely or otherwise, make decisions and/or direct actions regarding plant safety or security. Part 53 commercial nuclear plants may be licensed for and rely upon offsite facilities to fulfill the role of a Technical Support Center or Emergency Operations Facility. Therefore, this final rule accounts for such offsite facilities or remotely performed activities. Further, the use of personnel to operate systems and components, maintain and surveil SSCs, and respond to plant conditions and security events may be different than those included in the Technical Support Center or Emergency Operations Facility team for power reactors currently licensed under part 50 or part 52.

For the individuals whose duties for the licensees and other entities in Sec. 26.3(c) require the individuals to have the types of access or perform the activities listed in Sec. 26.4(e)(1) through (6) at the location where the commercial nuclear plant will be constructed and operated, current Sec. 26.4(e) requires them to be subject to an FFD program that satisfies all the requirements of part 26 except subparts I and K. This final rule amends Sec. 26.4(e) to except subpart M as well as subparts I and K. This final rule also amends Sec. 26.4(e) to include in an FFD program the individuals whose duties for the licensees and other entities in Sec. 26.3(f) require the individuals to have the types of access or perform the activities listed in Sec. 26.4(e)(1) through (6) or perform construction activities as defined in Sec. 26.5.

This final rule revises Sec. 26.4(e)(4) to include in an FFD program individuals who witness or determine inspections, tests, and analyses certifications required under part 53 because current Sec. 26.4(e)(4) includes the individuals who perform the same duties under part 52.

This final rule amends Sec. 26.4(f) to require individuals who construct or direct the construction of safety- or security-related SSCs at facilities licensed under part 53 to be subject to an FFD program under subpart M of part 26 or an FFD program that demonstrates compliance with all of the requirements of part 26 except for subparts I, K, and M of part 26.

Section 26.4(g) is the applicability paragraph for FFD program personnel (e.g., the FFD manager, MRO, and technicians) and persons who perform AA determinations (e.g., the licensee- or other entity- designated Reviewing Official). This final rule amends this section to address part 53 licensed facilities. Specifically, a part 53 licensee or other entity will use FFD program personnel to implement its FFD program as well as other assigned individuals who are not involved in the day-to-day operations of the program to implement specific elements of its FFD program, such as the collection of a specimen for drug or alcohol testing. These individuals will be held accountable for program implementation, including consistent implementation of protections afforded to all individuals subject to the FFD program.

This final rule amends Sec. 26.4(h) to include subpart M of part 26.

Through this final rule, the NRC includes several new definitions in Sec. 26.5, “Definitions,” and amends some existing definitions. The NRC is adding a definition for “Biological marker.” The definition is consistent with “Biomarker” defined by the HHS in its Mandatory Guidelines for Federal Workplace Drug Testing (HHS Guidelines) using oral fluid as the biological specimen to be tested (84 FR 57554; October 25, 2019). However, the definition for Sec. 26.5 adds that the endogenous substance used to validate that the biological specimen “was produced by the donor” because subpart M of part 26 requires the MRO to evaluate any discrepant biological marker identified in a biological specimen collected from a donor.

The NRC is including a definition for the word “Change” as used in the Sec. 26.603(e), “FFD program change control,” process. The definition is consistent with the definition of “Change” for a part 50 or 52 licensee's emergency plans in Sec. 50.54(q)(1)(i).

The NRC is including a definition for “Consortium/Third-party administrator (C/TPA),” which is used in Sec. 26.607(b)(2)(vi), with respect to administering the random testing pool and random testing selections for licensees and other entities with facilities with small staff sizes. A C/TPA also could provide access to, for example, services of medical review officers, substance abuse experts, employee assistance programs, and HHS-certified laboratories under contract to perform drug testing. This definition is based, in part, on the Federal Motor Carrier Safety Administration regulations in 49 CFR part 382 and the U.S. Department of Transportation regulations in 49 CFR part 40.

The NRC is revising the definition of “Constructing or construction activities” to clarify that for licensees or other entities in Sec. 26.3(f), the definition of “Construction” is consistent with the definition in Sec. 53.020.

This final rule revises the definitions of “Contractor/vendor” (C/V) and “Other entity” to make them applicable to part 53 licensees. A holder of an ML under part 53 could be a C/V under the new C/V definition.

The NRC is including a definition for “Illicit substance” because this phrase is used in subpart M of part 26 and addresses substances that cause impairment and possible addiction but are not an “illegal drug” as defined in Sec. 26.5. This is based on operating experience where individuals have admitted to using common household, non-drug substances to achieve a high or satisfy an addiction. These common household items include, but are not limited to nitrous oxide, butane, propane, glue, paint vapors, lighter fluid, nail polish remover, degreasers, permanent markers, and methyl alcohol (which is found in hand sanitizer and mouthwash).

The NRC is including a definition for “Reduction in FFD program effectiveness” because this phrase, similar to the definition for “Change,” is used in Sec. 26.603(e). The definition is generally consistent with the definition of “Reduction in effectiveness” provided for emergency plans in Sec. 50.54(q)(1)(iv).

This final rule makes the current definition of “Reviewing official” applicable to those licenses and other entities in Sec. 26.3(f).

This final rule amends the current part 26 definition of “Safety- related structures, systems, and components” to use the NRC's definition in Sec. 53.020 for the part 53 licensees and other entities described in Sec. 26.3(d) and (f).

This final rule amends the definition of “Security-related SSCs” in Sec. 26.5 to make it applicable to a licensee or other entity described in Sec. 26.3(d) and (f).

The NRC is including a definition for “Special nuclear material” that refers to the definition in Sec. 70.4, “Definitions,” of part 70 to ensure consistency.

This final rule revises the definition of “Unit outage” to account for the potential use of commercial nuclear plants for purposes other than electricity generation.

This final rule amends Sec. 26.21, an applicability statement for part 26 FFD programs, to include licensees and other entities described in Sec. 26.3(f) that choose to implement an FFD program that implements all part 26 requirements, except those in subparts K and M of part 26.

This final rule amends Sec. 26.35(c)(3) to include a reference to Sec. 26.606(b)(2)(vii), which ensures that licensees and other entities take immediate action upon receiving notice from the employee assistance program (EAP) that an individual's condition or actions pose or have posed an immediate hazard to themselves or others.

This final rule amends Sec. 26.51, “Applicability,” to apply to licensees and other entities described in Sec. 26.3(f) that elect not to implement the requirements in subpart M of part 26 for the categories of individuals in Sec. 26.4 and those licensees and other entities that elect to implement the requirements in Sec. 26.605.

This final rule amends Sec. 26.53(e), (e)(1) and (3), and (g) through (i), which are general provisions for granting and maintaining authorization, to apply to licensees and other entities described in Sec. 26.3(f).

This final rule amends Sec. 26.63(d), a suitable inquiry requirement, to apply to licensees and other entities described in Sec. 26.3(f).

This final rule amends Sec. 26.73, the applicability statement for subpart D of part 26, to apply to licensees and other entities described in Sec. 26.3(f) that elect not to implement the requirements in subpart M of part 26 for the categories of individuals in Sec. 26.4 and those licensees and other entities that elect to implement the requirements in Sec. 26.605(b).

This final rule amends Sec. 26.81, the purpose and applicability statement for subpart E of part 26, to apply to licensees and other entities described in Sec. 26.3(f) that elect not to implement the requirements in subpart M of part 26 for the categories of individuals in Sec. 26.4 and those licensees and other entities that implement Sec. 26.605(a) or (b). The subpart E requirements to be implemented are listed in Sec. 26.607(c)(2)(i) and (ii), and (c)(3).

This final rule revises Sec. 26.97(a) and (b) to enable the virtual collection of oral fluid specimens for drug and alcohol testing, as permitted under Sec. 26.607(g)(2).

This final rule amends Sec. 26.201, the applicability statement for subpart I of part 26, to apply to licensees and other entities described in Sec. 26.3(f). Also, the applicability statement is divided into two paragraphs for clarity.

The NRC is adding Sec. 26.202, “General provisions for facilities licensed under part 53,” for licensees or other entities described in Sec. 26.3(f) that elect to implement the requirements in subpart I of part 26 in accordance with Sec. 26.605. Section 26.202 establishes requirements equivalent to those in current Sec. 26.203, “General provisions,” which is applicable to parts 50 and 52 licensees. The NRC is adding the separate Sec. 26.202 because Sec. 26.203 refers to various requirements under subpart B of part 26, which are not applicable to facilities licensed under part 53 that implement subpart M of part 26.

Additionally, Sec. 26.202(c), “Training and assessments,” unlike Sec. 26.203(c), “Training and examinations,” does not include a comprehensive examination requirement because trainee assessment is conducted as part of a SAT that would be required under the FFD program training requirements in Sec. 26.608.

Changes in Sec. Sec. 26.205, 26.207, and 26.211 add references to new requirements in subparts I and M of part 26 that are applicable specifically to licensees and other entities in Sec. 26.3(f). The NRC is not changing the specific provisions for work hour requirements in current Sec. 26.205(d). However, as addressed in the discussion of changes to Sec. 26.4(a), whether a licensee or other entity under part 26 needs to implement work hour controls for certain individuals or groups is dependent, in part, on determinations reached by that licensee's risk-informed evaluation process.

Changes to Sec. Sec. 26.207(a)(1)(ii) and 26.211(b) allow licensees and other entities in Sec. 26.3(f) to perform face-to-face assessments to support the approval of work hour control waivers and the conduct of fatigue assessments, respectively, using electronic communications. These changes allow supervisors to conduct such assessments from a remote location under appropriate circumstances. Such remotely conducted assessments need to be supported by someone who is present in-person with the individual being assessed and who is trained in accordance with the requirements of either Sec. Sec. 26.29 and 26.203(c), or Sec. Sec. 26.608 and 26.202(c). The reasoning for these changes and the associated need for in-person support to augment electronic communications is addressed further in the preamble discussion of Sec. 26.619. C. Requirements for Part 26, Subpart M

This final rule adds a new subpart M to part 26 that provides alternative FFD requirements for part 53 licensees and other entities.

Section 26.601 describes which entities can implement subpart M. Section 26.601(a) makes subpart M of part 26 applicable to part 53 licensees and other entities, at their discretion. If a licensee or other entity in Sec. 26.3(f) does not elect to implement an FFD program that demonstrates compliance with the requirements of subpart M, then the individuals specified in Sec. 26.4 will be subject to an FFD program that demonstrates compliance with all part 26 requirements, except for those requirements in subparts K and M.

For a licensee or other entity in Sec. 26.3(f) that elects to implement an FFD program that satisfies the requirements of subpart M, Sec. 26.601(b) and (c) describes which provisions of subpart M apply. Under Sec. 26.601(b), a licensee or other entity that demonstrates compliance with Sec. 73.100(a)(1)(i) has the option to implement an FFD program under either Sec. 26.605(a) or (b). Under Sec. 26.601(c), if a licensee or other entity elects to implement an FFD program under subpart M but does not demonstrate compliance with Sec. 73.100(a)(1)(i), then that licensee or other entity must implement an FFD program under both Sec. 26.605(a) and (b).

Section 26.603(a) requires an applicant to provide a description of its FFD program and its implementation within its application for a license. This requirement is equivalent to the existing requirements in Sec. Sec. 26.401(b) and 52.79(a)(44). The entities required to submit these FFD program descriptions are certain applicants that comply with the part 53 application requirements in subpart H. In subpart H, Sec. 53.1309(a)(6) requires an applicant for a CP to provide a description of its FFD program in its PSAR. Under Sec. Sec. 53.1279(b)(4), 53.1369(x), and 53.1416(a)(24), this final rule requires an applicant for an ML, OL, and COL, respectively, to provide a description of its FFD program in its FSAR.

Unlike an application for a license, a description of an FFD program does not receive NRC review for possible approval. The applicant provides the NRC with information about the applicant's proposed FFD program to inform the NRC's inspection program and to demonstrate that the FFD program will be effectively implemented before a licensee or other entity commences any activity making individuals at the NRC-licensed facility subject to the FFD program.

Section 26.603(a)(1) requires the applicant to state whether it demonstrates compliance with Sec. 73.100(a)(1)(i), which is necessary to

understand FFD program applicability under Sec. 26.605(a) and (b).

Section 26.603(a)(2) requires the applicant to state what FFD program it plans to implement under subpart M (i.e., Sec. 26.605(a), Sec. 26.605(b), or Sec. 26.605(a) and (b)), or the existing FFD program (i.e., all parts of part 26, except for subpart K and M).

Section 26.603(a)(3) requires a discussion that informs the NRC of the applicability of the applicant's FFD program to individuals who perform safety- or security-significant activities. This description should summarize any key differences between the staff at the site and any remote facility and the categories of individuals in Sec. 26.4. The principal purpose of providing this description is to inform the NRC of any substantial differences in the applicability of the FFD program to the categories of individuals in Sec. 26.4.

Section 26.603(a)(4) requires 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. This process includes how individuals who test positive for a drug or alcohol will be evaluated before being afforded unescorted access to the protected area to perform or direct those duties or responsibilities making them subject to the FFD program.

Section 26.603(b) establishes the longevity of a license's or other entity's FFD program. Unlike the current part 26 regulations, Sec. 26.603(b) expressly states that an FFD program is not applicable during decommissioning of a part 53 facility for licensees and other entities specified in Sec. 26.3(f). However, holders of an operating or combined license should be aware that the physical protection program regulations in Sec. 73.55, “Requirements for physical protection of licensed activities in nuclear power reactors against radiological sabotage,” and Sec. 73.100 include a requirement for the implementation of an IMP, even during decommissioning. Section 26.603(b) also requires the holder of an ML under part 53 to maintain its FFD program until expiration of the ML.

In Sec. 26.603(e), this final rule implements a change control requirement for subpart M of part 26 FFD programs. Requiring licensees and other entities to demonstrate compliance with certain requirements before implementing changes to their FFD programs is necessary for two primary reasons. First, compliance with Sec. 73.100(a)(1)(i) determines which FFD program requirements may be implemented. If a licensee makes changes to its facility that impact the licensee's ability to comply with Sec. 73.100(a)(1)(i), then the set of applicable FFD program requirements under Sec. 26.605 may change and would need to be documented under Sec. 26.603(e). Second, FFD program implementation may change periodically in response to societal changes in substance abuse. Change control therefore relies on the licensee or other entity maintaining its procedures in a manner that details how its FFD program is to be implemented while incorporating changes, with documentation that justifies the changes to support audits and NRC inspection.

Section 26.603(e)(1) permits the licensee or other entity to implement changes to its FFD program if it performs and retains an analysis demonstrating that the change does not reduce the effectiveness of the FFD program or the change was necessitated or justified by a change to part 26, laboratory processes, or guidance issued by the HHS or NRC. The change control requirement enables flexibility in program implementation should the NRC or HHS change its drug testing procedures (as implemented by the licensee or other entity through its procedures) in response to changes in societal substance abuse or drug testing technologies.

The change control requirement was developed from the change control requirements in Sec. 50.54(p) and (q)--the change control requirements for security and emergency plans, respectively. However, unlike these two requirements, the NRC does not review and approve a licensee's or other entity's FFD program or its implementing procedures, and the FFD program is not licensing-basis information as described in Sec. 53.1300.

Section 26.603(e)(2) requires that if a change reduces FFD program effectiveness, then the licensee must implement a mitigating strategy so the FFD program, as revised, will continue to demonstrate compliance with the performance objectives in Sec. 26.23 and not result in a reduction in FFD program effectiveness.

Section 26.603(e)(3) prohibits, with one exception, the use of the change control process to reduce the minimum panel of drugs to be tested and references the drugs listed in Sec. 26.607(c)(1). Section 26.607(c)(1) references current Sec. 26.31(d)(1), which states that, at a minimum, licensees and other entities shall test for marijuana metabolite, cocaine metabolite, opioids (codeine, morphine, 6- acetylmorphine, hydrocodone, hydromorphone, oxycodone, and oxymorphone), amphetamines (amphetamine, methamphetamine, methylenedioxymethamphetamine, and methylenedioxyamphetamine), phencyclidine, and alcohol. The testing of these drugs and drug metabolites, except phencyclidine, and alcohol is necessary for the FFD program to remain effective. Also, there is no subpart M of part 26 requirement stating that this panel of drugs and drug metabolites needs to consist of only scheduled drugs.\7\ This flexibility accounts for the situation where an impairing substance becomes prevalent in society and a licensee or other entity elects to add the substance to their panel of substances to be tested prior to it being scheduled by the Drug Enforcement Administration.

\7\ The Drug Enforcement Administration classifies drugs, substances, and certain chemicals used to make drugs into five (5) distinct categories, depending upon the drug's acceptable medical use and the drug's abuse or dependency potential. These categories appear as Schedules I through V of section 202 of the Controlled Substances Act (21 U.S.C. 812). Schedule I drugs have a high potential for abuse, have no currently accepted medical uses in treatment in the United States, and lack accepted safety for use under medical supervision. At the other end of the classification scheme, Schedule V drugs have the least potential for abuse among the five categories of drugs, have a currently accepted medical use in treatment in the United States, and abuse of the drug may lead to limited physical dependence or psychological dependence. For more information, see https://www.dea.gov/drug-information/drug-scheduling.

The exception in Sec. 26.603(e)(3) is that, should HHS elect to remove phencyclidine from the panel of drugs and drug metabolites to be tested, a licensee or other entity could make this change in its FFD program without resulting in a reduction in FFD program effectiveness. This outcome is justified based on the very infrequent occurrence rate of FFD policy violations due to phencyclidine use since 2010. However, if HHS proposes to remove a class of drugs from the panel of drugs to be tested that is listed in Sec. 26.31(d)(1), except for phencyclidine, then a licensee or other entity may not make a similar change to its panel of drugs to be tested, because this change would be a reduction in FFD program effectiveness even with a mitigative strategy implemented.

Changes in the HHS panel of drugs and drug metabolites to be tested could potentially shift from one metabolite to a different metabolite for the same drug. Should HHS issue such a change to its panel, this is not expected to result in a reduction in FFD program effectiveness because HHS would be

targeting a more effective metabolite for identifying an existing drug already being tested in its panel. This situation could occur as HHS gathers more operating experience from Federal Government implementation of its HHS Guidelines, or data generated by drug testing laboratories and Federally mandated drug testing programs required by Federal agencies such as the NRC and U.S. Departments of Transportation, Energy, and Defense.

Section 26.603(e)(4) requires that change control records be maintained for a 5-year record retention period based on the current NRC practice to conduct triennial inspections of licensees' and other entities' FFD programs. This affords the NRC an opportunity to review the licensee's or other entity's determination that FFD program changes have not reduced the effectiveness of their FFD program. Licensees and other entities are also required to summarize each change made under Sec. 26.603(e) in their annual FFD performance reports required by Sec. 26.617(b)(2) or Sec. 26.717, as applicable.

Section 26.605 establishes requirements in a graded manner similar to the regulatory framework established by the requirements in subparts A through I, N, O, and K of part 26. This graded approach consists of less prescriptive FFD program requirements in Sec. 26.605(a) and more robust program requirements in Sec. 26.605(b).

The FFD programs under Sec. 26.605(a) and (b) include FFD program elements similar to those in subpart B of part 26, but the new requirements are less prescriptive, enabling more flexibility in program implementation like that offered in subpart K of part 26. For example, the requirements in subpart B of part 26 are explicit requirements for, in part, the collection and testing of urine specimens. Subpart B of part 26 does not enable the use of oral fluid for drug testing, except under very limited situations as described in subpart E of part 26, or the use of hair specimens, unlike Sec. 26.605. Section 26.605 requires drug and alcohol testing based on either the requirements in part 26 or the HHS Guidelines. The principal benefits of the Sec. 26.605 FFD program are that it provides a regulatory framework that is consistent with the radiological consequences for a facility that demonstrates compliance with Sec. 73.100(a)(1)(i), and affords flexibilities in the conduct of drug and alcohol testing.

Section 26.605(a) applies to part 53 licensees and other entities of commercial nuclear plants that demonstrate compliance with Sec. 73.100(a)(1)(i), at their discretion (no later than the start of construction activities as defined in Sec. 26.5); licensees and other entities of commercial nuclear plants that do not demonstrate compliance with Sec. 73.100(a)(1)(i) (no later than the start of construction activities as defined in Sec. 26.5); and holders of MLs before the start of activities performed under an ML that allows the assembly, non-operational testing, or both, of a manufactured reactor. The timing element of the applicability statement of Sec. 26.605(a) is equivalent to that for an LWR licensee or other entity who is performing those same activities at a facility licensed under part 50 or 52 and helps provide assurance that those individuals who assemble, test, or perform construction activities as defined in Sec. 26.5 or direct these activities are fit for duty and trustworthy and reliable. This is important because assembly and non-operational testing of a manufactured reactor and the construction and testing of SSCs required for facility operation require, in part, adherence to procedures, possible implementation of unique and precise assembly techniques, and quality assurance and controls. Additionally, SSCs within a manufactured reactor may not be accessible, testable, or available for quality assurance and verification after the reactor is assembled. This requirement also addresses solo-assembly activities that may cause latent failures and passive SSCs located internal to a reactor (for example, a fusible link designed to melt at a particular temperature to trigger an actuation mechanism) that are relied upon for safe operation but cannot be inspected or tested for proper installation, configuration, or operation after installation. A Sec. 26.605(a) FFD program for these types of activities is equivalent to the FFD program applicable to the assembly of the reactor vessel internals and testing of the SSCs internal to the reactor at an LWR licensed under part 50 or 52.

Section 26.605(a) requires the holder of an ML to implement its FFD program no later than the start of activities that assemble a reactor, non-operational testing of a manufactured reactor, or both. The holder of the ML should establish in its procedures when reactor assembly commences and what constitutes assembly. For example, the FFD program does not need to be implemented for the receipt, storage, inspection, and staging of components and systems used to assemble (i.e., build or fabricate) the reactor because this is not a current requirement for LWR facilities licensed under part 50 or 52. Furthermore, the NRC currently does not require that an FFD program be applied to the assembly or manufacturing of components (or basic components as defined in Sec. 21.3), or systems that were fabricated or assembled outside the footprint of a commercial power reactor, and this regulatory position also applies to a manufacturing facility.

Section 26.605(b) also contains timing requirements for implementing FFD programs under that paragraph. Licensees and other entities that demonstrate compliance with Sec. 73.100(a)(1)(i) and elect to implement FFD programs that satisfy the requirements of Sec. 26.605(b) must establish, implement, and maintain the program no later than the start of construction activities. Holders of MLs that also possess a separate license to load fuel into a manufactured reactor must establish, implement, and maintain the program no later than the start of reactor fuel load. For all other licensees and other entities implementing an FFD program under Sec. 26.605(b), they must establish, implement, and maintain the program before the earliest of the loading of fuel onsite into a reactor vessel; receiving a fueled manufactured reactor; or individuals subject to part 26 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.

These entities must establish, implement, and maintain an FFD program that implements all the requirements in Sec. 26.605(a), except Sec. Sec. 26.610, “Sanctions”; 26.617, “Recordkeeping, reporting, and FFD program performance”; and 26.619, “Suitability and fitness determinations”; plus additional requirements due to the increased radiological consequences presented by a part 53 commercial nuclear plant as the licensee readies it for operation. These additional requirements include those in subparts C, D, H, and N of part 26, some of which replace Sec. Sec. 26.610, 26.617, and 26.619.

Section 26.605(b) also enables the licensee or other entity to better integrate its facility with the LWR fleet and Category I fuel cycle facilities because subparts C, D, and H of part 26 are required. These subparts are required, in part, because it is expected that: (1) individuals will be able to work at any part 50, 52, or 53 commercial nuclear plant and will possess a nuclear safety culture and desirable

qualifications, skills, expertise, or services; and (2) licensees and other entities of facilities licensed under parts 50, 52, and 70 may venture to construct or operate a facility licensed under part 53. Therefore, the implementation of these subparts helps ensure that all individuals subject to part 26, whether under subpart M, subpart K, or all subparts except M and K, are subject to FFD programs that provide reasonable assurance that the individuals are fit for duty, trustworthy, and reliable.

Section 26.606, “Written policy and procedures,” requires licensees and other entities to implement and maintain an FFD policy and procedures for their FFD programs. This section establishes requirements equivalent to those in current Sec. 26.403, “Written policy and procedures,” of subpart K. However, a principal difference is that Sec. 26.606 is written to enable the drug testing of urine, oral fluid, and hair specimens.

Section 26.606(a)(1) requires each licensee and other entity to provide a written FFD policy statement to individuals subject to the FFD program before the individuals are subjected to any FFD program drug and alcohol test. This is a protection measure afforded to individuals subject to the FFD program to help ensure that they know what is expected of them before being subject to the FFD program and potential consequences should they violate the FFD policy or procedures. This requirement also contributes to safety and security because understanding FFD program responsibilities may enhance an individual's safety culture or the individual may self-select out of the licensee's or other entity's hiring process.

Section 26.606(a)(2) requires that the FFD policy statement describe the performance objectives in Sec. 26.23, which are the same FFD program performance objectives required for facilities licensed under parts 50, 52, or 70. Having a standard performance outcome based on a licensee or other entity satisfying the Sec. 26.23 performance objectives enhances consistency in FFD program implementation across all entities subject to part 26. It also generates confidence that individuals subject to part 26 will safely and competently perform their duties and responsibilities and use NRC-licensed materials in a manner that will protect the public health and safety and common defense and security.

Section 26.606(a)(3) requires that the FFD policy statement describe the licensee's or other entity's implementation of the minimum days off requirements in Sec. 26.205(d)(3) or maximum average work hours requirements in Sec. 26.205(d)(7).

Section 26.606(a)(4) requires the FFD policy statement 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 Sec. 26.603(b), part 26-required sanctions, and required medical/ clinical treatment and follow-up testing for FFD policy violations. This requirement is equivalent to Sec. 26.403(a) of subpart K but includes an additional description of what the policy statement must include. For example, the policy describes the NRC-required sanctions to help deter substance abuse and required medical/clinical treatment and follow-up testing for FFD policy violations. This provision provides a protection measure by helping the individual get the assistance they need and help ensure that the individual refrains from substance abuse.

Section 26.606(a)(5) requires that the FFD policy statement describe 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.

Section 26.606(a)(6) requires that 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.

Section 26.606(a)(7) requires that 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.

Section 26.606(b) requires licensees and other entities implementing an FFD program in accordance with subpart M of part 26 to establish, implement, and maintain written procedures for their FFD programs. This requirement is equivalent to that in Sec. 26.403(b) of subpart K.

Section 26.606(b)(1) establishes requirements for the licensee or other entity to develop and maintain written procedures for its drug and alcohol testing program. This provision is equivalent to the requirements in current Sec. 26.403(b)(1) of subpart K, but Sec. 26.606(b)(1)(i) through (iv) requires additional clarity and specificity that licensees and other entities must detail in their procedures to address new testing methods in subpart M of part 26 that are not permitted under the current part 26 framework. Clarity and specificity in procedural instructions support consistent program implementation, which protects all individuals subject to the program.

Section 26.606(b)(1)(iv) requires that if the licensee or other entity elects to use the HHS Guidelines for the conduct of drug testing, the FFD program procedures must include 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, including specimen collections, drug testing, laboratory procedures, and evaluation of test results. This requirement helps ensure the following: the validity and accuracy of drug testing because the specimens are subject to laboratory testing that has been certified by the HHS; protection of worker rights equivalent to the privacy, information, and due process protections afforded to Federal workers under the HHS Guidelines because the HHS Guidelines are used in the Federally mandated drug testing programs; consistency in program implementation because all individuals subject to the FFD program are subject to the same collection, testing, and evaluation processes; and FFD program effectiveness because the effectiveness of the HHS Guidelines have been verified by HHS's National Laboratory Certification Program (NLCP). Detailed procedures will enhance MRO and FFD program personnel reviews of individual test results because instructions will be provided for, in part, the evaluation of specific test results (e.g., positive, negative, biological markers), the conduct of additional testing for invalid or dilute specimens, and the assessment of subversion attempts (e.g., adulterated or substituted). This benefits FFD program effectiveness and helps prevent misunderstanding of program requirements and processes.

Section 26.606(b)(2) requires licensees and other entities to include in their written procedures the immediate and follow-up actions that will be taken, and the procedures that will be used, in certain situations specified in Sec. 26.606(b)(2)(i) through (vi). Section 26.606(b)(2) is equivalent to the requirements in current Sec. 26.403(b)(2), which provides the same requirement under an FFD program for construction for part 50 or 52 licensees and other entities. This helps ensure the effectiveness of the FFD program and its consistent implementation, because part 53 licensed facilities will be

implementing procedures to address the same requirements and with individuals who understand what is expected of them no matter what part 53 facility they were assigned.

The situation specified in Sec. 26.606(b)(2)(i) arises when individuals subject to the FFD program have been involved in the use, sale, or possession of illegal substances, illegal drugs, or illicit substances. This provision is equivalent to current Sec. 26.403(b)(2)(i), except that the phrase “illegal drugs” is replaced with “illegal substances, illegal drugs, or illicit substances.” Illegal substances include legal substances used in a manner inconsistent with Federal or State law.

The situation specified in Sec. 26.606(b)(2)(ii) arises when individuals who are subject to the FFD program are impaired by any substance or the consumption of alcohol as determined by behavioral observation or a test that measures blood alcohol concentration, as defined in Sec. 26.5. Except for a few differences, this provision is equivalent to current Sec. 26.403(b)(2)(ii) of subpart K. The NRC does not include the phrases “to excess” and “accurately” in Sec. 26.606(b)(2)(ii). Subpart M of part 26 is a performance-based framework that focuses on impaired human performance, and for alcohol, impairment is determined by blood alcohol concentrations exceeding the limits in Sec. 26.103, “Determining a confirmed positive test result for alcohol,” using an evidential breath testing device (EBT) for alcohol (not whether an individual drank “to excess”).

The NRC is including the phrase “illegal substances, illegal drugs, and illicit substances” in Sec. 26.606(b)(2)(ii) based on operating experience and the terminology in current Sec. 26.23(b). There are far more substances that may cause impairment than those designated by the Drug Enforcement Administration as controlled substances (i.e., those that appear on Schedules I through V of section 202 of the Controlled Substances Act), and alcohol. The phrase “before or while constructing or directing construction of safety- or security- related SSCs” in current Sec. 26.403(b)(2)(ii) is not included in Sec. 26.606(b)(2)(ii) because Sec. 26.606 applies during construction, operation, and decommissioning, if applicable. The NRC is including the term “behavioral observation” in Sec. 26.606(b)(2)(ii) because impairment can be visibly or audibly observed in an individual, and individuals subject to subpart M of part 26 will be trained in behavioral observation under Sec. 26.608.

The situation specified in Sec. 26.606(b)(2)(iii) arises when individuals attempt to subvert the testing process by adulterating or diluting specimens (in vivo or in vitro), substituting specimens, or by any other means. This provision is equivalent to current Sec. 26.403(b)(2)(iii). The purpose underlying this requirement has increased in significance since issuance of the 2008 part 26 final rule because subversion attempts have accounted for about one-third of all drug testing violations of the FFD policy every year since 2016.

The situation specified in Sec. 26.606(b)(2)(iv) arises when individuals refuse to provide a specimen for analysis or refuse to follow instructions provided by FFD program personnel. Except for one difference, this provision is equivalent to current Sec. 26.403(b)(2)(iv). The NRC is including the phrase “or follow the instructions provided by FFD program personnel” based on an existing requirement in Sec. 26.89(c) that the collector must inform the donor that if the donor refuses to cooperate in the specimen collection process, then such refusal will be considered a refusal to test and sanctions for subverting the testing process will be imposed.

The situation specified in Sec. 26.606(b)(2)(v) arises when individuals who are subject to an FFD program had legal action taken relating to drug or alcohol use. This requirement is equivalent to current Sec. 26.403(b)(2)(v).

The situation specified in Sec. 26.606(b)(2)(vi) is when individuals subject to an FFD program demonstrate 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, SNM, or sensitive information. This includes character traits beyond those attributed to drug or alcohol use. This requirement helps ensure that the licensee or other entity will implement an FFD program designed to demonstrate compliance with the Sec. 26.23(c) performance objective that FFD programs must 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.” An individual who is not trustworthy and reliable is not fit to perform or direct the performance of those duties and responsibilities or be afforded those types of access that make the individual subject to an FFD program.

This requirement also helps to align the subpart M of part 26 BOP with the BOP implemented under Sec. 73.56(f) and Sec. 73.120 and the purpose of the IMP as described in Sec. 73.55(b)(9) and Sec. 73.100(b)(10).\8\ The demonstrated character and actions of an individual can indicate whether the individual can be trusted and relied upon to safely and competently perform assigned duties and responsibilities or be afforded those types of access making the individual subject to the FFD program. This holds true for any demonstrated adverse character indication or action on- or offsite.

\8\ The IMP must monitor the initial and continuing trustworthiness and reliability of individuals granted or retaining unescorted AA to a protected or vital area and implement defense-in- depth methodologies to minimize the potential for an insider to adversely affect, either directly or indirectly, the licensee's capability to protect against radiological sabotage.

The phrase “character or actions” is used in Sec. 26.606(b)(2)(vi) to focus on observed examples that indicate an individual subject to subpart M of part 26 may not be fit for duty or trustworthy and reliable. Character traits include but are not limited to personality, temperament, honesty, carelessness, apathy, psychosis, and commitment to safety culture. Assessment of an individual's character should consider the potential for changes in these traits when compared to a previous baseline. Actions include a physical or verbal demonstration of a character trait that could call into question an individual's fitness, trustworthiness, or reliability. For example, the individual does something physically, verbally, or in writing (e.g., falsifying records, driving while impaired, or harming or threatening to harm oneself, others, or property) that compels another individual to conclude that the observed individual cannot be trusted or relied upon. Unlike the background investigation and reviews of “character and reputation” in Sec. 73.56(d)(6) and (k)(1)(v) and Sec. 73.120, which are principally retrospective reviews of an individual and may be based on third-party information (i.e., information from individuals not subject to NRC requirements), the “character or action” focus of Sec. 26.606(b)(2)(vi) is a present observation of an individual subject to the FFD program and performed by an individual who is also subject to the FFD program. Whether the information is received from an individual subject to the FFD program or someone who is not subject to the FFD program, the licensee or other entity will need to review this information (i.e., determine if the information and its source are credible) to determine whether the individual should maintain authorization.

Section 26.606(b)(3) requires licensees and other entities to address in their

procedures the process, including the duties and responsibilities of FFD program personnel, to be followed if an individual's behavior or condition raises an FFD concern. This provision also requires a process to be conducted when credible information is received by the licensee or other entity that the individual is not fit for duty, trustworthy, and reliable.

With a few exceptions, Sec. 26.606(b)(3) is equivalent to current Sec. 26.403(b)(3). Instead of the phrase “while constructing or directing the construction of safety- or security-related SSCs” in current Sec. 26.403(b)(3), the NRC uses “on the NRC-licensed facility” in Sec. 26.606(b)(3), because this provision applies during commercial nuclear plant construction, operation, and decommissioning, if applicable, in addition to holders of an ML as described in Sec. 26.3(f). The requirement that the roles and responsibilities of FFD program personnel be described was developed from current Sec. Sec. 26.4(g) and 26.31(b) and operating experience, which has demonstrated that clear job descriptions help ensure that individuals know who is designated by the licensee or other entity to make decisions regarding FFD program implementation and who can be approached when physiological or psychological help is needed. This is principally a protection consideration afforded to individuals subject to the FFD program.

The requirement also includes two conditions not found in current Sec. 26.403(b) that clarify the initiation of the fitness determination process should an individual's behavior or condition raise an FFD concern. The phrase, “impairment from any cause that in any way could adversely affect the individual's ability to safely and competently perform the individual's duties,” reflects the Sec. 26.23(b) performance objective. The condition, “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,” reflects the Sec. 26.23(a) performance objective. In either case, as required by Sec. 26.23(c), the FFD program must 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.

Section 26.606(b)(4) requires licensees and other entities to have written procedures that address the operation and oversight of onsite and offsite collection facilities. This requirement is equivalent to current Sec. Sec. 26.403(b) and 26.405(e) and is developed from Sec. 26.41(b), which states that each licensee and other entity who is subject to subpart B of part 26, shall ensure that the entire FFD program is audited, which is part of a licensee's or other entity's oversight of the facility, and Sec. 26.87(a), which states that 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. Having procedures for the operation and oversight of onsite and offsite collection facilities enhances consistency in program implementation, protects individuals subject to testing, and accounts for the flexibilities afforded in the types of biological specimens that may be collected under an FFD program subject to subpart M of part 26. Section 26.606(b)(4), when used with the audit requirement in Sec. 26.615, helps maintain FFD program effectiveness and prevent subversion attempts at facilities that may not be under the direct day-to-day oversight of FFD program personnel.

Section 26.606(b)(5) requires licensees and other entities to have written procedures that address the fatigue management requirements in Sec. 26.202(b), “Procedures,” and either Sec. 26.205(d)(3) or (d)(7).

Section 26.606(b)(6) requires licensees and other entities to have written procedures that provide measures to prevent subversion of drug and alcohol tests conducted onsite and offsite. This requirement was developed from Sec. 26.27(c)(1).

Section 26.607, “Drug and alcohol testing,” establishes drug and alcohol testing requirements for licensees and other entities implementing Sec. 26.605. Except for a few differences, Sec. 26.607 is equivalent to current Sec. 26.405, which requires licenses and other entities implementing an FFD program under subpart K of part 26 to have a drug and alcohol testing program that demonstrates compliance with the requirements in Sec. 26.405(b) through (g). The differences are commensurate with the risk consequences presented by a part 53- licensed facility as compared to a part 50 or 52 nuclear power plant. These requirements improve flexibility in the conduct of drug and alcohol testing while maintaining protections afforded to individuals subject to the FFD program.

Section 26.607(a) requires licensees and other entities to obtain a split specimen for all drug tests using oral fluid or urine for all test conditions in Sec. 26.607(b) and (j). Neither current subpart K nor current subparts B or E of part 26 require a split specimen. However, many of the LWR fleet use split specimens for drug testing and commercially available drug screening products use a split specimen technique. Since publication of the 2008 part 26 final rule, the HHS has issued guidelines for urine and oral fluid specimen testing that require split specimen collections. The U.S. Department of Transportation regulations under 49 CFR part 40 also require split specimen collections for urine and oral fluid. The proposed HHS Guidelines for hair testing also require split specimen collections.

The required use of a split specimen process protects the individual because, upon a donor-alleged discrepant or questionable test result, the donor may provide permission to test the split specimen (specimen B) in an effort to refute the laboratory test results for specimen A. The requirement also enables the MRO to direct laboratory testing of specimen B if specimen A were invalid; though the NRC expects specimens becoming invalid at the laboratory to be a rare occurrence as testing will be conducted by HHS-certified laboratories. If a specimen is determined to be invalid, the occurrence would warrant further investigation by the MRO and laboratory to identify the cause. This protocol is equivalent to the special analysis testing in current Sec. 26.163(a)(2) for dilute specimens and specimens collected under most directly observed collection conditions in that additional laboratory analysis is performed because of a questionable test result.

If a split specimen is tested by an HHS-certified laboratory, then the test result from specimen B must be used as part of the determination for an FFD policy violation as required by Sec. 26.185(n), “Evaluating results from a second laboratory.” However, this is not to say that the test results from specimen A should be discarded. Since the HHS-certified laboratory should report all test results from all specimens tested to the MRO, like the information described in Sec. 26.169, “Reporting results,” test result differences between specimens A and B can be used to inform the MRO as to what should be reported to the licensee or other entity to either facilitate medical or clinical assistance for the individual, inform an FFD-policy violation determination, or both.

Section 26.607(a) states that split specimen collections of oral fluid or urine must be used for the test conditions described in Sec. 26.607(b). In addition, 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.

Section 26.607(b) requires the licensee or other entity to subject individuals identified in Sec. 26.202 to drug and alcohol testing under the five conditions listed in Sec. 26.607(b)(1) through (5). Section 26.607(b) is equivalent to current Sec. 26.405(c).

Section 26.607(b)(1) requires pre-access testing similar to current Sec. 26.405(c)(1), which requires testing before assignment to construct or direct the construction of safety- or security-related SSCs. Unlike current Sec. 26.405(c)(1), the requirement does not include the phrase, “construct or direct the construction of safety- or security-related SSCs,” because, for licensees or other entities under part 53, the pre-access test condition applies to construction, operation, and decommissioning, if applicable, to help inform a licensee's or other entity's authorization determination. The requirement also uses “pre-access” instead of “pre-assignment,” which is used in current Sec. 26.405(c)(1).

A pre-access test requires the collection of an oral fluid or a urine specimen no more than 14 days before the individual is granted unescorted access. Although this change has roots in the 2008 part 26 final rule, which reduced the period within which pre-access testing must be performed from 60 days to 30 days or less, the 14-day requirement is based on two lessons learned from operating experience.

First, the 14-day period is a large enough window of time to collect the specimen and evaluate test results because licensees or other entities typically receive laboratory test results within 5 business days of laboratory receipt of the biological specimen. At the same time, the 14-day period is small enough to help ensure that the test results are representative of the individual's recent drug use before being granted authorization.

Second, the NRC does not expect licensees and other entities licensed under part 53 to have the large and periodic influxes of individuals (either licensee employees or C/Vs) that LWRs have to support facility operation, maintenance, engineering design changes, or nuclear refueling. Therefore, these licensees or other entities will not be periodically challenged to in-take a large workforce within the 14-day pre-access testing window.

Section 26.607(b)(2) requires the licensee or other entity to conduct random drug and alcohol testing of all individuals subject to the FFD program. With notable exceptions, this requirement is equivalent to current Sec. 26.405(b). Section 26.405(b) gives licensees and other entities that implement an FFD program subject to subpart K of part 26 the option to impose random drug and alcohol testing. Section 26.607(b)(2) does not offer that option because subpart M of part 26, unlike subpart K, does not allow a licensee or other entity to implement a fitness monitoring program under current Sec. 26.406 instead of a random testing program. The principal reasons for not allowing this flexibility are that no licensee or other entity has ever implemented a fitness monitoring program (i.e., there is no operating or regulatory experience on which to judge the effectiveness of a fitness monitoring program), and the subpart M framework already uses behavioral observation to help ensure FFD program effectiveness. Supplementing the Sec. 26.609 BOP with an additional observation technique (i.e., the fitness monitoring program) would not result in a level of deterrence or detection equivalent to that which will be obtained through behavioral observation and random drug and alcohol testing.

Section 26.607(b)(2)(i) through (v) provides specific requirements for the conduct of a random testing program. These paragraphs are equivalent to Sec. 26.405(b)(1) through (4), although with a few differences. The similar provisions are in Sec. 26.607(b)(2)(i), (b)(2)(iii), and (b)(2)(iv).

The differing provisions include Sec. 26.607(b)(2)(ii), which refers to an “FFD program procedure” instead of the reference to an “FFD program policy” in Sec. 26.405(b)(2) because procedures contain the instructions that implement FFD program requirements, but the FFD policy need not contain specific instructions. Section 26.607(b)(2)(ii) also requires individuals who are selected for random testing to report to the onsite collection site, as opposed to the collection site in Sec. 26.405(b)(2), because alcohol metabolism necessitates a timely alcohol test. This change is also being implemented because the NRC expects that part 53 licensees and other entities may use a combination of onsite (for random, for-cause, and post-event testing) and offsite (for pre-access, post-event, and follow-up testing) collection facilities for drug and alcohol testing and may have to afford reasonable accommodation to certain individuals, which would add complexity in the licensee's or other entity's procedurally determined time period in which an individual must report to the collection facility.

Another difference from Sec. 26.405(b) is Sec. 26.607(b)(2)(v), which establishes the random testing rate for the population of individuals subject to testing. Subpart K of part 26 does not establish a random testing rate. The new requirement is equivalent to current Sec. 26.31(d)(2)(vii), which requires 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.

Section 26.607(b)(3) requires for-cause testing equivalent to that used in current FFD programs implementing Sec. 26.405(c)(2). The NRC is requiring for-cause testing, like random testing, to be conducted onsite to ensure that the test is conducted as soon as reasonably practicable. This is an important consideration when for-cause testing for alcohol or using oral fluid for drug screening or testing because human metabolism continually lowers the concentrations of the drugs, drug metabolites, and alcohol perhaps to concentrations lower than the initial or confirmatory testing cutoffs. Additionally, for facilities that are sited in geographically remote locations, an offsite collection facility might be too far away or not readily accessible.

Section 26.607(b)(4) requires post-event testing in a manner equivalent to current Sec. 26.405(c)(3), with a few adjustments. For part 53 licensees or other entities, the NRC is requiring post-event testing under two conditions: events involving human errors that may have caused or contributed to the events (Sec. 26.607(b)(4)(i)), and events not involving human error that result in adverse health consequences or damage to any safety- or security-related SSC (Sec. 26.607(b)(4)(ii)). The word “significant” is not used in Sec. 26.607(b)(4)(ii)(A) to describe the “illness or personal injury” as used in Sec. 26.405(c)(3)(i) because Sec. 26.607(b)(4)(ii)(A) describes which illnesses or injuries are covered. Section 26.607(b)(4)(ii)(B), unlike Sec. 26.405(c)(3)(ii), does not use the word “significant” to describe the damage to safety- or security- related SSCs because any damage to safety- or security-related SSCs requires testing within four hours of the event unless immediate medical intervention precludes the conduct of the test on the individual(s) who caused or contributed to the event. Section 26.607(b)(4)(ii)(B) also does not use the word “construction” as in Sec. 26.405(c)(3)(ii) because Sec. 26.607(b)(4) applies to construction, operation, and decommissioning, if applicable.

Section 26.607(b)(4)(i) requires the licensee or other entity to define in its procedures the term “human error.” This term may take on various meanings

and it is not defined in the current or final rule, so the licensee or other entity is required to describe or define this term to help ensure consistent implementation of subpart M of part 26 and that the post- event test condition is consistently applied to all individuals subject to the FFD program. The Sec. 26.405(c)(3)(i) requirement that “the event is recordable under the Department of Labor standards contained in 29 CFR 1904.7, and subsequent amendments thereto,” is not carried over to Sec. 26.607(b)(4). Instead, the NRC is prescribing the post- event test conditions in Sec. 26.607(b)(4), in part so they will not change unless the NRC amends the requirement.

Section 26.607(b)(5) requires follow-up testing. This requirement is equivalent to current Sec. 26.405(c)(4), although Sec. 26.607(b)(5) further describes follow-up testing. This final rule describes follow-up testing as part of a series of tests for drugs, alcohol, or both, which are performed after an individual subject to part 26 has violated the FFD policy on substance use or abuse, or the sale, use, or possession of illegal drugs. Follow-up testing will be used to verify an individual's continued abstinence from substance abuse. This final rule does not include a reference to a follow-up plan as in Sec. 26.405(c)(4) because the intent of a follow-up plan is to conduct a series of drug tests, alcohol tests, or both, to verify continuing abstinence from substance abuse. Nevertheless, individuals who violate an FFD policy on substance use or abuse, or the sale, use, or possession of illegal drugs, should have a follow-up plan that includes a definition of “abstinence” from the medical professional prescribing the plan.

Section 26.607(c) provides additional testing requirements. This requirement is equivalent to Sec. 26.405(d) and requires implementation of select requirements from current subpart E of part 26. The requirements govern directly observed collections, shy bladder situations, special analysis testing, and alcohol testing. These requirements are necessary to maintain FFD program effectiveness equivalent to that currently implemented by the LWR fleet.

Section 26.607(c)(1) requires validity testing and establishes the minimum panel of drugs and drug metabolites to be tested. This panel is the same as those in Sec. Sec. 26.31(d)(1) and 26.405(d) because, based on operating experience from LWR FFD program implementation, this panel has been determined to contribute to a licensee or other entity satisfying the FFD performance objectives in Sec. 26.23(a) through (d).

Section 26.405(d) requires that urine specimens collected for drug testing be subject to validity testing. Like Sec. 26.405(d), Sec. 26.607(c)(1) requires validity testing of urine specimens. Oral fluid specimens could also be subject to validity testing, including a biological marker, as specified in either part 26 or the HHS Guidelines.

Section 26.607(c)(2) includes requirements that already exist in the part 26 framework that provide protections for individuals subject to the FFD program and contribute to testing effectiveness when collecting and assessing a urine specimen. Specifically, current Sec. 26.115, “Collecting a urine specimen under direct observation,” describes the exclusive grounds for performing a directly observed collection and the process to be followed to protect the privacy of the individual. Section 26.119, “Determining `shy' bladder,” establishes the process to be followed when a donor is not able to produce a sufficient amount of urine for testing, and Sec. 26.163(a)(2) requires special analysis testing when a specimen is dilute to help prevent a subversion attempt.

Section 26.607(c)(3) requires implementation of all the current alcohol testing requirements in Sec. 26.91, “Acceptable devices for conducting initial and confirmatory tests for alcohol and methods of use,” through Sec. 26.103, “Determining a confirmed positive test result for alcohol.” Using the same alcohol testing framework for parts 50, 52, 70, and 53 licensees and other entities provides for regulatory consistency, protections for individuals subject to the FFD program (e.g., the quality controls and verification applied to the EBT), and FFD program effectiveness (e.g., accuracy of test results). For alcohol testing, unlike drug testing, there is a preponderance of evidence that correlates blood alcohol concentrations to impairment and intoxication. Furthermore, FFD performance data has demonstrated that the time-dependent alcohol cutoffs in Sec. 26.103 have increased the detection of individuals who are under the influence of alcohol. For these reasons, the current alcohol requirements in part 26 are required for FFD programs under subpart M.

Section 26.607(c)(4) establishes additional testing requirements. This is equivalent to current Sec. 26.405(f) for facilities licensed under part 53 for the conduct of drug testing. Unlike Sec. 26.405(f), Sec. 26.607(c)(4) does not reference validity screening and initial drug and validity tests at licensee testing facilities. Another minor difference between Sec. 26.405(f) and Sec. 26.607(c)(4) reflects the requirement in subpart M of part 26 to use an HHS-certified laboratory for all biological specimens collected and not just for urine specimens.

Consistent with Sec. 26.405(f), Sec. 26.607(c)(4) requires the use of an HHS-certified laboratory for all test conditions listed in Sec. 26.607(b), MRO-directed tests, and the testing of a split specimen. Further, HHS-certified laboratory test results using urine or oral fluid are required for the issuance of an FFD policy violation and part 26-required sanction.

All drug testing needs to be performed at an HHS-certified laboratory to help ensure FFD program effectiveness and to protect the donor from a false positive test result and an unwarranted FFD policy violation. The donor will be protected because laboratory procedures for specimen accessioning, testing, custody and control, and evaluation of test results and the training and qualification of laboratory personnel are evaluated by HHS as part of the NLCP. This provides assurance that the drug testing results are accurate and attributed to the donor. Hair specimens may also be pre-access tested for drugs as described in Sec. 26.607(i) and positive test results may only be used as potentially disqualifying information for a licensee's or other entity's authorization determination (i.e., used to assess the fitness, trustworthiness, and reliability of the individual). A positive hair test result may not be used for the administration of an FFD policy violation and sanction, except as provided for in Sec. Sec. 26.607(i)(3) and 26.610(b)(4) for attempts to subvert the testing process, as defined in Sec. 26.5.

There are three phrases or requirements in Sec. 26.405(f) that the NRC is not using in Sec. 26.607(c)(4). The first is the phrase, “consistent with its standards and procedures for certification,” regarding the operation of an HHS-certified laboratory, because the laboratory would not be HHS-certified if it were not following “its standards and procedures for certification.” The second is the requirement that urine specimens that yield positive, adulterated, substituted, or invalid initial validity or drug test results must be subject to confirmatory testing by the HHS-certified laboratory, except for invalid specimens that cannot be tested. This requirement is not used because, under subpart M of part 26, licensees or other entities are required to use an HHS-certified laboratory. For a laboratory to be HHS-certified, it must follow the HHS Guidelines and include

procedures that describe when a specimen cannot be tested. Lastly, the Sec. 26.405(f) requirement that other specimens that yield positive initial drug test results must be subject to confirmatory testing by a laboratory that demonstrates compliance with stringent quality control requirements that are comparable to those required for certification by the HHS, is not used because subpart M of part 26 requires the use of an HHS-certified laboratory.

Section 26.607(c)(4) requires the licensee or other entity to contract with a primary and backup HHS-certified laboratory. This provision helps ensure that specimens are processed and tested to maintain FFD program effectiveness should the primary laboratory be unable to perform specimen testing. This helps maintain protections afforded to individuals subject to the FFD program (e.g., should the donor or MRO request testing of the split specimen, a different laboratory could be used). This requirement also states that the primary and backup laboratories must have a different certifying scientist. Having a back-up HHS-certified laboratory and a different certifying scientist benefits the program and donor because the drug testing instruments, technicians, and certifying scientist are independent of the primary laboratory testing and review process. The back-up HHS-certified laboratory may be of the same corporate entity as the primary laboratory.

Section 26.607(c)(4) also states that the laboratory is 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. This requirement is equivalent to current Sec. 26.41(d), except that laboratories are not able to limit the use and dissemination of documents copied or taken from the laboratory by a licensee or other entity. This is necessary to ensure the continuing effectiveness of FFD programs, because NLCP findings and audit results could adversely impact FFD program effectiveness. Pertinent information includes and should not be limited to NLCP-identified weaknesses (e.g., custody and control, accessioning, instrumentation, procedures, training, supervision, review of test results, and resolution of previously identified corrective actions) that may impact the effectiveness of FFD programs.

Section 26.607(d) helps protect the donor from mistakes made during the drug and alcohol testing processes and helps ensure FFD program effectiveness. This final rule requires the licensee or other entity to protect the individual's privacy and the integrity of the specimen and to implement quality controls to ensure that test results are valid and attributable to the correct individual. This requirement is equivalent to the first sentence of current Sec. 26.405(e), except that the word “stringent” was removed from the phrase “stringent quality controls,” because the word “stringent” is not defined.

Section 26.607(e) describes the requirements for licensees and other entities that use offsite collection facilities. Consistent with current Sec. 26.405(e), a licensee or other entity will be able to conduct specimen collections and alcohol testing at a local hospital or other facility, except for those specimens that must be collected onsite under Sec. 26.607(b)(3) and (4). Unlike Sec. 26.405(e), Sec. 26.607(e) does not restrict licensees and other entities to use hospitals and other facilities that meet the U.S. Department of Transportation requirements in 49 CFR part 40 because subpart M of part 26 is intended to provide flexibilities beyond those in the current part 26 framework. Licensees and other entities may use these Department of Transportation requirements to inform their procedures under Sec. 26.606(b)(1) as long as the procedures do not conflict with the requirements in part 26 or the HHS Guidelines.

Section 26.607(e) also requires licensees and other entities to audit offsite collection facilities before their use and biennially to confirm that the facility procedures are comparable to those described in subpart E of part 26 or the HHS Guidelines for urine and oral fluid. This requirement is based on current Sec. 26.41(a) and (b). The Sec. 26.607(e) audit requirement is a program effectiveness consideration because offsite collection facilities may not require vigilance of their collectors (e.g., identification of subversion attempts), diligence in the protection of worker rights (e.g., privacy and specimen custody and control), or procedural compliance.

The offsite facility used by a licensee or other entity under Sec. 26.607(e) must be licensed to conduct specimen collections and perform alcohol testing, and be audited, by the State or a State-designated entity. This requirement helps provide assurance of adequate collection facility performance and may help reduce the burden on the licensee or other entity and the collection facility. Crediting a State audit (or State licensure, oversight, or regulation) is established in Sec. Sec. 26.4(i)(4) and (j), 26.91(e)(5), 26.153(f)(1), and 26.183(a).

Section 26.607(f) provides the requirements for initial drug testing. This provision is equivalent to Sec. 26.405(f) except to account for the testing of urine and oral fluid specimens under subpart M of part 26. The 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. Examples of alternative technologies include liquid or gas chromatography and mass spectrometry. Another difference from Sec. 26.405(f) is changing the word “urine” in Sec. 26.405(f) to “biological specimens” in Sec. 26.607(f). Lastly, Sec. 26.607(f) includes the phrase “discrepant biological marker” as a drug screening result that must be analyzed by an HHS-certified laboratory and evaluated by the MRO to help inform the MRO's determination of a subversion attempt.

Section 26.607(g) enables a part 53 licensee to use oral fluid as a biological specimen for testing. This requirement is equivalent to Sec. 26.31(d)(5), which enables the MRO to conduct drug and alcohol testing using alternative methods, and Sec. 26.405, which does not preclude the use of oral fluid specimens for FFD programs that implement subpart K of part 26 requirements. In order to provide assurance that drug testing is effective and protects the worker, Sec. 26.607(g) requires that the licensee's or other entity's procedures incorporate the HHS Guidelines or the requirements in part 26 for the conduct of urine or oral fluid testing.

Section 26.607(g) requires that the oral fluid device must not expire before the date of the collection of the specimen. Also, 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 drug testing and the alcohol cutoffs in part 26. If they are not established by the HHS Guidelines or this part for the paneled drugs and drug metabolites, then they will be determined and documented by a forensic toxicologist review under Sec. 26.31(d)(1)(i)(D).

Section 26.607(g)(2) permits the virtual collection of oral fluid specimens for drug and alcohol testing but only at facilities that must use a consortium/third-party administrator to implement random testing under Sec. 26.607(b)(2)(vi). A virtual collection monitor is permitted in the location where the specimen collection is to be performed to assist the virtual collector, such as by completing Federal custody and control form (Federal CCF) paperwork; observing activities outside the viewable area of the video

teleconference equipment to ensure that the donor does not attempt to subvert the testing process; providing information to the virtual collector if/when requested; and ensuring that the oral fluid specimen(s) once packaged for shipping are secured until picked up for transportation to the HHS-certified laboratory.

Section 26.607(i) enables the collection of hair specimens for drug testing to supplement pre-access testing of urine or oral fluid specimens. Hair testing is a new feature in the part 26 framework. The NRC is permitting the use of hair testing for only Schedule I or II drugs or their metabolites to inform a licensee's or other entity's determination whether the individual is trustworthy and reliable. For example, if an individual stated no prior use of illegal drugs, a pre- access hair test could be performed to ascertain the validity of the individual's statement. However, if the HHS-certified laboratory reports a positive test result, an FFD policy violation may not be administered. This laboratory information must be treated as potentially disqualifying FFD information, unless the individual is determined to have attempted to subvert the testing process, in which case a permanent denial of authorization must be issued under Sec. 26.610(b)(4). To provide assurance of testing effectiveness and protections afforded to individuals subject to the FFD program, Sec. 26.607(i) requires that an HHS-certified laboratory must be used to test the hair specimen. The forensic toxicologist review is necessary if the panel of drug or drug metabolites to be tested and their cutoffs are not established by HHS or part 26 for hair.

Section 26.607(j) enables the use of portal area screening instruments to test for drugs, alcohol, or both, should these types of screening tests become available for use. This technology could substantially contribute to a licensee or other entity satisfying the Sec. 26.23 performance objectives by helping ensure that all individuals who arrive at the NRC-licensed facility to perform or direct those duties and responsibilities or maintain those types of access making them subject to the FFD program are fit for duty and deterred from arriving onsite in a physiological condition that may be adverse to safety and security. Additionally, screening could be conducted when individuals exit the NRC-licensed facility to provide assurance that substance abuse had not occurred onsite (see Sec. 26.23(d)). The screening instrument could be electronically linked to temporarily prevent ingress or egress and could automatically inform licensee- or other entity-designated officials of the portal area alarm. The use of portal area screening technologies may also represent cost savings because, for NRC-licensed facilities that have small staff sizes or are geographically remote, passive drug and alcohol screening technologies could be an innovative alternative to a random testing program, although the license or other entity would need to request and receive an exemption.

Section 26.607(j) also provides that if the portal area screening instrument detects a substance that exceeds the instrument's established setpoint, the individual then must be for-cause tested under Sec. 26.607(b)(3) for drugs, alcohol, or both, depending on the screening test result received. A portal area screening test result is to be considered credible use information, which strengthens the effectiveness of a licensee's or other entity's BOP. The requirements do not allow an individual to be rescreened by the portal area screening instrument following an initial screening detection that exceeded an established setpoint in order to prevent a subversion attempt. To ensure the accuracy of any portal area screening testing performed by a licensee or other entity, a performance-based approach must be used to verify the continuing accuracy of the testing for each substance tested by the instrument. A portal area screening test can be used so long as the accuracy of the test result for a specific substance is confirmed by the resultant for-cause testing performed on an oral fluid or urine specimen for drugs, oral fluid or breath specimen for alcohol, or both. If a portal area screening result for a specific drug or drug metabolite is confirmed by drug testing performed at an HHS-certified laboratory, or oral fluid or breath alcohol testing for at least 85 percent of the specimens testing positive on portal area screening in the past 12-month data reporting period for a specific substance, the portal area screening test for that substance can continue to be used. This performance-based measure balances the use of the technology with the protection afforded to individuals from unnecessary testing. If these instruments and alcohol screening devices have the capability, they could also be used to determine the true identity of individuals to facilitate the implementation of the FFD BOP, which may be very practicable at facilities that operate with small staff sizes.

Section 26.607(k) enables the use of a blood specimen for drug, alcohol, or other testing for certain medical conditions as determined by the licensee- or other entity-designated MRO. This requirement is equivalent to current Sec. 26.31(d)(5). The use of a licensee- or other entity-designated MRO and not one designated by a third party, such as an MRO employed by an offsite specimen collection facility, is important because the MRO must be familiar with the subpart M of part 26 requirements. To help ensure testing effectiveness and protect the worker, the blood test needs to be conducted by a laboratory that demonstrates compliance with quality control requirements that are comparable to those required for certification by the HHS, such as a hospital or clinic certified by the State, Commonwealth, or territory.

Section 26.607(l) requires licensee and other entities to use a Federal custody and control form (Federal CCF) as defined in Sec. 26.5 for the collection and packaging of hair, oral fluid, and urine specimens for drug testing. This requirement is based on the Federal CCF documentation requirements in current subpart E of part 26 because subpart K of part 26 does not require the use of a Federal CCF under Sec. 26.117(e).

Section 26.607(m) establishes requirements for the licensee- or other entity-designated MRO. Section 26.607(m)(1) is equivalent to Sec. 26.405(g), however, the word “designated” is added to the first sentence to clarify that the MRO is designated by the licensee or other entity, and not by a third party. As stated with regard to Sec. 26.607(k), this change clarifies that it is the licensee's or other entity's responsibility, through their designated MRO, to determine whether an individual is fit for duty and trustworthy and reliable. This is consistent with the description of FFD program personnel in current Sec. 26.31(b) and helps provide FFD program effectiveness and protections to individuals subject to the FFD program. The paragraph was also modified from Sec. 26.405(g) to address the determinations of FFD policy violations and fitness required by subpart H for a part 53 licensee or other entity that implements the FFD program described in Sec. 26.605(b).

Section 26.607(m)(2) helps ensure that MRO reviews are consistent with those MRO reviews conducted at other NRC-licensed facilities subject to part 26 and that the MRO maintains knowledge of drug collection, testing processes and procedures, and evaluation of testing results.

The NRC is also requiring that if an MRO performed the duties and responsibilities in Sec. Sec. 26.185 and 26.187 for at least three continuous years in the last 10 years prior to being hired or contracted by the licensee or other

entity, then the MRO would not need to repeat the initial training and examination requirements. The basis for 3 years is that the MRO has experienced three annual cycles of evaluating drug and alcohol test results, contributed to the annual FFD program performance data reported to the NRC, experienced a refueling or maintenance outage, understood the duties and responsibilities of individuals subject to the FFD program to make informed determinations of fitness, demonstrated a safety culture that helps ensure FFD program effectiveness, and been subject to NRC inspection. The basis for 10 years is the relatively long periods between significant changes to part 26 and the HHS Guidelines.

Section 26.607(m)(3) requires that the MRO attend a medical- or clinical-based training session every 5 years. This requirement was developed, in part, from section 13.1 of the HHS Guidelines for the testing of urine and oral fluid specimens and 49 CFR 40.121 of the U.S. Department of Transportation's requirements. The NRC did not include an examination requirement as part of this refresher training requirement because it could limit the types of trainings that MROs may attend. The new requirement is justified to maintain currency on changes in societal drug use, forensic toxicology, determinations of fitness, and other part 26 technical areas necessary to perform required responsibilities as an MRO performing services under subpart M of part 26.

Section 26.607(m)(4) requires the MRO to evaluate drug testing results by implementing the requirements in Sec. 26.185 or the HHS Guidelines through the licensee's or other entity's procedures. This requirement helps ensure FFD program effectiveness and enhances consistency across the commercial nuclear industry for the evaluation of drug testing results. This also helps protect individuals because they are subject to the same evaluation criteria. If Sec. 26.185 provides insufficient information for an MRO to make a determination on a drug testing result (including adulterant and discrepant biological markers), the guidance issued by a State agency in the State in which the NRC-licensed facility is located, Federal agency, or nationally recognized MRO training and certification organization may be used to inform an MRO determination. This provision ensures that the MRO has the flexibility to inform their evaluation of the drug testing results and fitness determination, if necessary, considering the drug- and alcohol-related flexibilities afforded in subpart M of part 26.

The Sec. 26.607(m)(4)(ii) requirement also states that an MRO need not review alcohol test results, including positive confirmatory alcohol test results determined by an EBT under Sec. 26.607(c)(3)(vi) and (vii), which are equivalent to the current requirements in Sec. Sec. 26.101 and 26.103, respectively. Section 26.607(c)(3)(i) requires the use of an EBT under Sec. 26.91, which ensures that confirmatory alcohol test results are precise and accurate to issue FFD policy violations.

Section 26.607(m)(5) requires the licensee- or other entity- designated MRO to determine and approve the use of oral fluid or urine as an alternative biological specimen when the donor cannot provide a requested specimen for testing. This requirement is equivalent to Sec. 26.31(d)(5), which enables the use of an alternative specimen collection if a medical condition makes the collection of the biological specimen difficult. This determination and the retest must be completed as soon as reasonably practicable and documented to support recordkeeping, auditing, and NRC inspection.

Section 26.607(m)(6) requires that the MRO review all specimen test results associated with a drug-related FFD policy violation. This 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 retest. To resolve a discrepant condition, the MRO is authorized to test a specimen for a biological marker, adulterants, or additional drugs. The broad scope of this MRO evaluation is necessary because of the variety of different screening and testing methods that may have been associated with the FFD policy violation. All information learned from the conduct of part 26 drug and alcohol testing should be used in the evaluation of an individual's trustworthiness and reliability, issuance of a sanction, and development of a follow-up treatment and testing plan, if administered.

Section 26.607(n) is equivalent to current Sec. 26.31(d)(6) and establishes limits on the screening and testing of biological specimens. This is a protection consideration afforded to individuals subject to the FFD program and was not provided in subpart K of part 26. This requirement states that 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 and tests that may not be conducted include, but are not limited to, deoxyribonucleic acid (i.e., DNA) testing, serological typing, or any other medical or genetic test used for diagnostic or specimen identification purposes.

The NRC is requiring that no biological specimens may be passively sampled and analyzed in a manner different than described in subpart M of part 26 to ensure workers are protected from non-consensual passive screening. The subpart M framework enables passive detection of drugs and alcohol, whereas passive detection is not afforded in subparts A through I, N, and O of part 26.

Section 26.607(o) is equivalent to current Sec. Sec. 26.31(b)(1)(iii)(A) and 26.89 and requires that all specimen collections be conducted by a licensee- or other entity-designated and -trained individual. For subpart M of part 26, this includes onsite specimen collections, except a collection by a portal area screening instrument in Sec. 26.607(j).

Section 26.608 requires licensees and other entities to provide FFD program training to individuals subject to the FFD program. The performance-based Sec. 26.608 requirement was developed from the prescriptive training requirements in current Sec. 26.29 and modeled on current Sec. 50.120 and the requirements in Sec. Sec. 53.725 and 53.830 because there is no training requirement in subpart K of part 26.

Section 26.608(a)(1) requires an FFD training program that includes the licensee's or other entity's FFD policies and procedures, including fatigue management, and the individuals' 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 individuals specified in Sec. 26.4, a licensee or other entity of a commercial nuclear plant is required to use a SAT, as defined in Sec. 53.725(c)(13). These requirements are based on requirements in Sec. 26.29(a)(2), (3), (9), and (10).

Section 26.608(a)(2) requires training on the BOP. This requirement is based on Sec. Sec. 26.29(a)(8), (9), and (10), and 26.33. The provision requires individuals to be trained in the detection of behaviors or conditions that may indicate the use of illegal drugs, as in the current Sec. 26.33 BOP requirements, and also the use of illicit drugs and substance abuse onsite and offsite. Also, in reference to impairment from fatigue or any cause if left

unattended, the phrase in Sec. 26.33, “may constitute a risk to public health and safety or the common defense and security,” is replaced in Sec. 26.608(a)(2)(iii) with “could result in inattentiveness or human errors,” because subpart M of part 26 is focused, in part, on ensuring individuals are fit for duty to perform or direct the performance of assigned duties and responsibilities safely and competently.

Section 26.608(a)(2)(iv) focuses on training to inform individuals that they are responsible for their own conduct, as well as observing others. Specifically, individuals will be trained to recognize when they feel unable to safely and competently perform assigned duties and responsibilities, as well as to recognize when others appear unable to safety and competently perform assigned duties and responsibilities or act in an untrustworthy and unreliable manner. The training requirement and the self-reporting requirement in Sec. 26.606(a)(5) are in the interest of safety and security because the individual is proactively announcing that assistance may be necessary. This is consistent with the performance objectives in Sec. 26.23(b) and (c), where certain behavior or stress conditions may be indicative of an individual not being fit for duty, trustworthy, and reliable.

Section 26.608(a)(3) helps ensure that individuals subject to the FFD program understand that FFD policy violations result in an FFD program sanction and that program information learned or generated by FFD program implementation will be used to aid licensee or other entity authorization determinations and be shared, as requested, with other licensees or other entities subject to parts 26 and 73. This requirement is equivalent to Sec. 26.29(a)(1). Section 26.608(a)(3) is a protection measure afforded to individuals subject to the FFD program because they will understand that licensees and other entities subject to parts 26 and 73 will be informed of, in part, an individual's character, reputation, and ability to follow policies, procedures, and instructions to safely and competently perform assigned duties and responsibilities in a trustworthy and reliable manner. FFD-related information includes drug and alcohol testing results (not quantitative testing values), issuance of any sanctions, FFD determinations regarding trustworthiness and reliability, testing programs, treatment, and other remedial or corrective action.

Section 26.608(b) requires individuals to be trained on the FFD program and to receive a trainee assessment before pre-access testing. Section 26.608(b) also requires that FFD program refresher training and trainee assessments be conducted on a nominal 24-month frequency or more frequently if the need is indicated. These requirements are similar to Sec. 26.29(c)(1). However, Sec. 26.608(b) was developed from the SAT-based training requirements in Sec. 50.120 and training elements from the annual FFD program refresher training requirements in Sec. 26.29(c)(2). A trainee assessment is the same as in currently required SAT-based training programs.

Section 26.608(c) requires licensees and other entities to periodically evaluate their FFD training programs and revise them as appropriate. This training focus is not required by subpart K of part 26 or Sec. 26.29 but addresses the flexibilities afforded in subpart M of part 26. This section is equivalent to Sec. 50.120(b)(3).

Section 26.609 requires the implementation of a BOP. The requirement is equivalent to that in Sec. Sec. 26.33 and 26.407, “Behavioral observation,” and applies during construction, operation, and decommissioning, if applicable. Because subpart M of part 26 applies during decommissioning through a licensee's IMP, Sec. 26.609(a) and (b) were developed, in part, from new Sec. 73.100(b)(9) and current Sec. Sec. 73.55(b)(9) and 73.56(f) to help ensure consistency in the conduct of behavioral observation whether conducted for FFD or security purposes.

Under the FFD program, the purpose of the BOP is to help ensure that individuals subject to the FFD program are fit for duty and trustworthy and reliable to perform or direct those duties and responsibilities and maintain those types of access that make the individual subject to the FFD program. This assurance is accomplished by requiring each individual subject to subpart M of part 26 to be subject to behavioral observation, and by requiring all individuals to perform behavioral observation of others and report FFD concerns to the licensee- or other entity-designated representative(s). The intent of the BOP requirement is not to require that all individuals be observed at all times by others; NRC-licensed operators, maintenance professionals, security officers, and others routinely perform solo operations periodically throughout the day. However, individuals must be subject to observation while they are performing or directing the performance of duties and responsibilities or maintaining the types of access making them subject to the FFD program. Observing behavior only at the beginning of a work shift is not sufficient to ascertain whether an individual is fit for duty, trustworthy, and reliable. Impairing substances may have a delayed effect between use (e.g., ingestion of a controlled substance) and the onset of physiological or psychological effects, and fatigue accumulates with time. Behavior must be continually observed throughout the work shift to detect any changes from baseline human performance characteristics, including mental or physical health and mannerisms, or any activities that may indicate that the individual is not trustworthy and reliable.

Section 26.609(a) differs from Sec. Sec. 26.33 and 26.407 in that it places the responsibility for performing behavioral observation on “all individuals subject to this subpart,” rather than only those “individuals specified in Sec. 26.4(f) [who] are constructing or directing the construction of safety- or security-related SSCs” in Sec. 26.407 or “individuals who are trained under Sec. 26.29 to detect behaviors” in Sec. 26.33 to improve clarity.

Section 26.609(b) requires 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. The NRC is requiring this description of reportable conduct because an individual's activities (e.g., use of illegal substances) and communications (e.g., hate speech or threats of violence) offsite are a direct indication of the individual's fitness, trustworthiness, and reliability and must be evaluated as to whether authorization should be granted or maintained. Section 26.609(b) includes a description of this conduct instead of the Sec. 26.33 undefined phrase, “FFD concerns,” to enhance the clarity of the requirement. This BOP reporting requirement includes 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. This better aligns with the Sec. 73.120 BOP requirement, which states that each person subject to behavioral observation must communicate to the licensee or applicant observed behaviors or activities of individuals that may constitute an unreasonable risk to the health and safety of the public and common defense and security. Section 26.609(a) and (b) were written broadly

to include offsite conduct that the reporting individual considers serious enough to call into question the character or reputation of the subject individual.

Section 26.609(c) requires that licensees and other entities perform behavioral observation visually, in-person, and, when necessary, remotely by live video and audible streaming and capture. This requirement was developed from the security observation requirements in Sec. 73.55(e)(7)(i)(B) and (C), (h)(2)(v), and (i)(2) and (i)(5)(ii). Conducting an in-person observation of another individual is the preferred method to ascertain whether the observed individual can safely and competently perform assigned duties and responsibilities. When in-person observations are not feasible (e.g., during solo operations), the requirement enables the use of video monitoring. This is addressed, for example, in Sec. 26.609(d) regarding NRC-licensed operator manipulation of reactor controls. Additionally, certain duties (such as maintenance activities performed by a single worker outside of a control room) may not present an opportunity for video monitoring; in these situations, behavioral observation should be conducted on a sampling basis (i.e., a planned observation of the work activity) as outlined in a licensee's or other entity's FFD program.

In situations involving small staff sizes, facilities sited in geographically remote locations, or both, additional observers enhance the effectiveness of a BOP. Technological developments in automated safety and security systems may enable licensees or other entities to reduce staff sizes to 10 to 40 percent of the staff size of an LWR facility licensed under part 50 or 52. Smaller staff sizes may translate into more solo operations, less teamwork, fewer peer checks, or infrequent management oversight of field activities, leading to fewer behavioral observations. Therefore, a licensee or other entity may have fewer opportunities to observe whether individuals are fit for duty. Enabling video and audible streaming and capture to enhance the BOP is consistent with the security-related behavioral observation requirement in Sec. 73.120(c)(2)(ii), which also enables video conferencing or other acceptable electronic means promoting face-to- face interaction for those individuals working remotely.

Section 26.609(d) requires that licensees or other entities perform behavioral observation of NRC-licensed operators who manipulate the controls of any commercial nuclear plant licensed under part 53, remotely by live video and audible streaming capture for those part 53 facilities where individual task loading does not allow for the effective conduct of behavior observation in addition to assigned operational tasks. The purpose of this paragraph is similar to that of Sec. 26.609(c), where the possibility of in-person observation is significantly diminished because of solo operations or because the facility may only require a minimum staff size onsite.

Section 26.610(a) is similar to Sec. 26.409, “Sanctions,” and requires the licensee or other entity to establish sanctions for FFD policy violations that, at a minimum, prohibit the individuals specified in Sec. 26.4 from being assigned to perform or direct those duties and responsibilities or maintaining authorization making them subject to subpart M of part 26. To be consistent with Sec. 26.75, “Sanctions,” the severity of the sanction as described in Sec. 26.610(b) escalates with the number of occurrences and severity of the FFD policy violation. The sanction is long enough to help deter future FFD policy violations and facilitate counseling and treatment before the licensee reinstates the individual's access to the facility.

Equivalent to Sec. 26.75(c), Sec. 26.610(b)(3) also requires a minimum 5-year denial of access to the NRC-licensed facility for certain violations of the FFD policy within the protected area of a commercial nuclear plant and by an individual or individuals who are the operators of the conveyance to transport or use formula quantities of strategic SNM. Equivalent to Sec. 26.75(b), Sec. 26.610(b)(4) requires a permanent denial of authorization be issued for any subversion attempt.

Section 26.611 protects information collected from FFD program implementation and is equivalent to current Sec. 26.411, “Protection of information.” The protected information includes, but is not limited to, privacy and medical information. Section 26.611 does not include the Sec. 26.411 requirement that FFD programs must maintain and use the personal information with the highest regard for individual privacy because such a requirement is unnecessary in light of the Sec. 26.611(a) requirement that licensees and other entities must establish and maintain a system of files and procedures to prevent unauthorized disclosure.

Section 26.611(b), although equivalent to Sec. 26.411(b), requires licensees and other entities to have all individuals sign a consent to be subject to the FFD program before subjecting the individual to the FFD program (e.g., before being subject to a pre-access test in Sec. 26.607(b)(1), unlike Sec. 26.411(b)). The purpose of this requirement is to enhance protections afforded to individuals subject to the FFD program and their knowledge of, in part, why they are subject to drug and alcohol testing, behavioral observation, information collection, MRO reviews, and other FFD program elements. Like the consent required by Sec. 26.411(b), the consent authorizes disclosure of the collected information. Consent is not needed for disclosures to the individuals and entities specified in Sec. 26.37(b)(1) through (b)(6), (b)(8), and persons deciding matters under review in Sec. 26.613, “Appeals process.”

Section 26.613 is equivalent to Sec. 26.413, “Review process.” The title was changed to an appeal process to clarify that Sec. 26.613 is the process implemented when an individual elects to appeal a licensee or other entity determination that the individual had violated the FFD policy. The provision also requires that the process include a schedule for the completion of the review of the determination that the individual had violated the FFD policy. The NRC is establishing this requirement because operating experience demonstrates that workers may not be protected from a continuous review process that does not result in an outcome.

Section 26.615 requires licensees and other entities to perform audits of the FFD program. The section is similar to Sec. 26.415, “Audits.” Under Sec. 26.615(a), audits are performed at a frequency that ensures the FFD program's continuing effectiveness. Corrective actions will be taken as soon as reasonably practicable to resolve any problems identified and preclude recurrence. Section 26.615(b) requires the subject matter, scope, and frequency of audits to be revised as necessary to improve or maintain FFD program performance based on annual FFD program performance data reviews performed under Sec. 26.617(d) and unsatisfactory performance or programmatic weaknesses identified under Sec. 26.617(b)(3) and (e).

Section 26.615(c) is equivalent to Sec. 26.415(b) and enables licensees and other entities to conduct joint audits or accept audits of C/Vs so long as the audit addresses the relevant services of the C/ Vs.

Section 26.615(d) is equivalent to Sec. 26.415(c) by establishing requirements for the auditing of HHS-certified laboratories. Unlike Sec. 26.415(c), the new requirement does not contain a reference to the U.S. Department of Transportation drug and alcohol testing requirements. This broadens the regulatory flexibility afforded to a

licensee or other entity in that they may use an offsite collection or testing facility that does not meet the Department of Transportation requirements.

Section 26.615(d) states that licensees and other entities need not audit an HHS-certified laboratory if 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. The NRC affords this flexibility because the NRC is aware that HHS desires to streamline changes in its guidelines to its panel of drugs and drug metabolites to be tested. Therefore, if a licensee or other entity elects to implement the HHS Guidelines in its procedures and maintains the minimum panel of drugs and drug metabolites to be tested as required by subpart M of part 26, a licensee or other entity may still use (and not audit) the HHS- certified laboratory because the Sec. 26.603(e) change control process maintains FFD program effectiveness.

To help ensure FFD program effectiveness, Sec. 26.615(d) also requires that collection facility procedures are comparable to those required in subpart E of part 26, including a requirement that the offsite facility's specimen collection and testing procedures are audited on a biennial basis, which is also a protection consideration afforded to individuals subject to the FFD program. Conducting this audit on a biennial basis is equivalent to that required in Sec. 26.41(b) and helps ensure that the specimen collection process at the facility remains effective.

Section 26.617 establishes recordkeeping, reporting, and FFD program performance requirements similar to those in current Sec. 26.417. However, Sec. 26.617 requires retention of records pertaining to administration of the FFD program and FFD performance data required by Sec. 26.717 until license termination, which is based on current Sec. 26.711(a) because Sec. 26.417 does not provide for a retention period.

Section 26.617(b)(1) is identical to the reporting requirements in Sec. 26.417(b)(1) regarding the licensee's or other entity's FFD program.

Section 26.617(b)(2) requires the reporting of annual (i.e., January through December) FFD program performance data for each FFD program subject to subpart M. Licensees and other entities must submit the program performance data to the NRC before March 1 of the following year. This reporting is equivalent to the annual program performance requirement in Sec. 26.417(b)(1), and the March 1 due date is based on the reporting deadline in Sec. 26.717(e). Licensees and other entities are required to report FFD performance information using NRC-provided forms (e.g., new NRC Forms 893, “Single Positive Test Form, 10 CFR part 26, subpart M FFD Program” and 894, “Annual Reporting Form, 10 CFR part 26, subpart M FFD Program”).

Section 26.617(b)(3) requires the reporting of drug and alcohol testing errors to the NRC 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 Sec. 26.613, or matters that could adversely reflect on the integrity of the random selection or random testing process. Licensees and other entities must describe in the reports the incident and any corrective actions taken or planned.

Section 26.617(c) requires that FFD-related information be shared within the commercial nuclear industry when requested to support authorization determinations. This requirement helps individuals seeking employment by another NRC-licensed facility subject to subpart C of part 26, complete their NRC-required sanctions and licensee- administered or -directed drug and/or alcohol abuse treatment plans before the restoration of authorization by a licensee or other entity. Information sharing may also enhance FFD program effectiveness because FFD-related lessons learned from, for example, substance testing, subversion attempts, and laboratory and MRO performance must be shared when requested.

Section 26.617(d) requires licensees and other entities to analyze FFD program performance data at least annually and take appropriate actions to correct any identified program weakness.

Section 26.617(e) requires licensees and other entities to document, trend, and correct non-reportable indicators of FFD programmatic weaknesses under the licensee or other entity's corrective action program. However, to protect individual privacy, drug and alcohol test results may not be tracked in a manner that would permit the identification of any individuals.

Section 26.619 requires licensees or other entities to establish a process to evaluate individuals when their fitness or trustworthiness and reliability are in question. Section 26.619 is equivalent to Sec. 26.419, “Suitability and fitness determinations,” but, unlike Sec. 26.419, applies during the construction and operation phases. Also, Sec. 26.619 requires that a suitability or fitness determination conducted for cause be conducted face-to-face. This requirement is based on current Sec. 26.189(c); however, unlike Sec. 26.189(c), Sec. 26.619 does not prohibit augmenting determinations via electronic means of communication (i.e., provides sufficient visual and aural clarity to complete the process). Instead, Sec. 26.619 explicitly permits determinations to be performed via electronic means and explains when a trained individual must be present in-person with the individual being assessed (i.e., only to assist in completing for-cause drug and alcohol testing determinations and fatigue assessments).

In considering the current restriction on the use of electronic means of communication for determinations of fitness conducted for cause, the NRC finds that since publication of the 2008 part 26 final rule, there have been developments in using electronic means of communication (i.e., videoconferencing) as an alternative to conducting face-to-face interactions. To address these considerations, the NRC contracted the Pacific Northwest National Laboratory (PNNL), DOE, to study whether a medical and mental health assessment via electronic communication could be an acceptable alternative to an in-person, face- to-face assessment.\9\ Based on this study, if electronic means were to be used to conduct a face-to-face assessment, an in-person element would still be integral to the assessment process. However, under certain circumstances, face-to-face determinations and assessments conducted as part of an FFD program for an entity licensed under part 53 (i.e., those determinations and assessments performed in accordance with Sec. 26.619, Sec. 26.207, or Sec. 26.211) may be augmented via electronic communications. Such remotely conducted determinations and assessments are required to be conducted with someone who is present in-person with the individual being assessed and who is trained in accordance with the requirements of either Sec. 26.29 and Sec. 26.203(c) or Sec. 26.608 and Sec. 26.202(c). Permitting the use of electronic communications helps ensure FFD program effectiveness, especially in instances where the part 53 commercial nuclear plant is sited in a geographically remote location, when the facility has a small staff size, and when an urgent determination is required.

\9\ PNNL, Technical Letter Report, “The Use of Electronic Communications to Perform Determinations of Fitness,” dated August 2017.