ML21148A173: Difference between revisions

From kanterella
Jump to navigation Jump to search
(StriderTol Bot insert)
 
(StriderTol Bot change)
 
Line 17: Line 17:


=Text=
=Text=
{{#Wiki_filter:}}
{{#Wiki_filter:THIS PRELIMINARY RULE LANGUAGE AND ACCOMPANYING DISCUSSION IS BEING RELEASED TO SUPPORT INTERACTIONS WITH STAKEHOLDERS AND THE ADVISORY COMMITTEE ON REACTOR SAFEGUARDS (ACRS). THIS LANGUAGE HAS NOT BEEN SUBJECT TO COMPLETE NRC MANAGEMENT OR LEGAL REVIEW, AND ITS CONTENTS SHOULD NOT BE INTERPRETED AS OFFICIAL AGENCY POSITIONS.
THE NRC STAFF PLANS TO CONTINUE WORKING ON THE CONCEPTS AND DETAILS PROVIDED IN THIS DOCUMENT AND WILL CONTINUE TO PROVIDE OPPORTUNITIES FOR PUBLIC PARTICIPATION AS PART OF THE RULEMAKING ACTIVITIES.
THE STAFF IS PRIMARILY SEEKING INSIGHTS REGARDING THE CONCEPTS IN THIS PRELIMINARY LANGUAGE AND SECONDARILY SEEKING INSIGHTS RELATED TO DETAILS SUCH AS NUMERICAL VALUES FOR VARIOUS CRITERIA. WHILE THE NRC WILL CONSIDER ALL COMMENTS RECEIVED IN FURTHER DEVELOPING THE PRELIMINARY LANGUAGE, IT WILL NOT PROVIDE WRITTEN RESPONSES TO THOSE COMMENTS. ONCE THE PROPOSED RULE IS ISSUED IN THE FEDERAL REGISTER, THE PUBLIC WILL HAVE AN ADDITIONAL OPPORTUNITY TO PROVIDE COMMENTS AND THE AGENCY WILL RESPOND IN WRITING TO ALL PUBLIC COMMENTS ON THE PROPOSED RULE WHEN ISSUING A FINAL RULE.
PART 26 - Fitness for Duty - PRELIMINARY RULE LANGUAGE                                                      December 2021 10 CFR Part 26, FITNESS FOR DUTY PROGRAMS Summary Statements The staff is proposing a risk-informed, performance-based approach for the application of drug and alcohol testing and fatigue management requirements for facilities licensed under Part 53.
Applicants that meet the criterion in § 53.830(a)(2)(i) of the preliminary proposed rule text would be able to implement a fitness for duty (FFD) program described in proposed new Part 26, subpart M, Fitness for Duty Programs for Facilities Licensed Under Part 53, that is similar to the requirements applied to research and test reactors. For example, drug and alcohol testing would not be required; however, other Part 26 requirements like behavioral observation and a performance monitoring program would be required.
Applicants that do not meet the criterion would be subject to an alternate FFD program that is also prescribed in subpart M, or an FFD program that implements all Part 26 requirements, except for those requirements in 10 CFR Part 26, subparts K, FFD Program for Construction, or M.
With regards to fatigue management requirements, work hour controls would be required for personnel at operating facilities in accordance with the existing scoping criteria (10 CFR 26.4). The applicability of these scoping criteria for certain individuals (such as operators and maintenance personnel) would rely on the risk evaluation performed by a given applicant, and the determined risk significance of the work being performed by a given individual.
The NRC proposes that the new subpart M apply FFD requirements to facilities licensed under Part 53, in lieu of just including Part 53 licensees in the category of licensees with facilities licensed under 10 CFR Part 50 or 52, for four principal reasons. First, subpart M would apply FFD requirements in a risk-informed, performance-based manner commensurate with the radiological risk 1
 
consequences presented by facilities licensed under Part 53. This regulatory strategy is consistent with that already in Part 26; however, the proposal accounts for advanced reactor designs that may present very low radiological risk when compared to that of a traditional light water reactor licensed under Part 50 or 52. Second, subpart M would enable a Part 53 licensee to implement innovative drug testing technologies while continuing to provide reasonable assurance that individuals can safely and competently perform assigned duties and responsibilities. Third, subpart M would consolidate the applicable FFD requirements. This should help stakeholders understand the proposed framework and facilitate early involvement and comment on preliminary proposed rule text. This approach also could help licensees implement the requirements. Lastly, the framework is performance-based. FFD performance monitoring is proposed where the licensee must assess its FFD performance against site-specific, FFD program, and generic industry performance. Also, a change control process is proposed to allow a licensee to change its FFD program while ensuring that FFD program effectiveness is maintained. These four reasons are consistent with the NRC white paper, Risk-Informed and Performance-Based Human-System Considerations for Advanced Reactors, and the Commissions Policy Statement on the Regulation of Advanced Reactors.
2
 
Preliminary Proposed Language Black text is existing language in Part 26                                        Discussion Red text is preliminary proposed rule language Subpart A - Administrative Provisions
§ 26.3 Scope                                                            Proposed § 26.3(f) places Part 53 licensees or other
..                                                                    entities within the scope of Part 26. Note that Part 26 (f) Before construction, licensees and other entities that have    uses the terminology licensees and other entities as applied for or have been issued a license under Part 53, Licensing    defined in § 26.5.
and Regulation of Advanced Nuclear Reactors, shall implement the requirements in subpart M or all the requirements of this part except  The FFD framework for facilities licensed under Part 53 subparts K and M. Licensees and other entities who have received a      does not allow Part 53 licensees to implement the manufacturing license under Part 53 must implement the                  requirements in subpart K, FFD program for construction.
requirements in subpart M or all the requirements of this part, except  The principal reasons are that subpart K (1) would not subparts K and M, before the loading of nuclear fuel in a reactor      apply to manufacturing licensees who fabricate and fuel a vessel module.                                                          reactor vessel module; (2) only applies during construction, whereas subpart M applies during construction and operation; (3) does not address training, authorization, and Medical Review Officer performance; (4) has less rigor in the protection of worker rights and sensitive information; and (5) is not consistent with recent Commission position on the use of performance-based regulations.
§ 26.4 FFD program applicability to categories of individuals          Section 26.4 is very specific as to its applicability to (a) All persons who are granted unescorted access to nuclear        individuals who perform certain duties and responsibilities power reactor protected areas by the licensees in § 26.3(a) and, as    or who are afforded certain types of access to protected applicable, (c) and perform the following duties shall be subject to an areas, materials, or information. This section would be FFD program that meets all of the requirements of this part, except    revised to account for the types of individuals working at a subpart K of this part, and those persons who are granted unescorted    facility licensed under Part 53 who must be subject to an access to nuclear power reactor protected areas by the licensees and    FFD program. The NRC expects that not all categories of other entities in § 26.3(f) and perform the following duties shall be  individuals described in this section would be applicable to subject to an FFD program that meets the requirements in subpart M,    all Part 53 facilities, but the proposed changes cover all unless the licensee or other entity subjects these individuals to an    individuals currently within the scope of consideration.
FFD program that meets all of the requirements of this part except for those requirements in subparts K and M.                                Paragraph (a) - This is the applicability paragraph for certain individuals during reactor operation. This 3
 
paragraph is an example of how a licensee makes a risk-informed determination whether to apply its FFD program to the categories of individuals in this paragraph.
(1) Operating or onsite directing of the operation of systems and Paragraph (1) - For Part 53 applicants, this existing components that a risk-informed evaluation process has shown to be    scoping criterion will ensure that Certified Operators, as significant to public health and safety;                              defined in § 26.5 below, and NRC-licensed reactor operators are subject to fatigue management controls, including work hour controls, when the actions they are performing are risk-significant.
In the accompanying NRC guidance under development, the staff is considering offering flexibility in the application of current work hour controls for reactor operators at Part 53 sites in cases where those licensees can demonstrate, through their risk-informed evaluation process, that operator actions are not relied upon to protect the public health and safety or the environment. The NRC plans to ensure that its guidance will be informed by the criteria listed in § 53.755(a).
Additionally, in some instances, work hour controls may only be applicable during certain operations evolutions that are determined to be significant to public health and safety. For example, a plants risk-informed evaluation could determine that plant safety during the startup of a facility relies on manual action, while periods of normal operation do not. In such instances, operators would need to be subject to work hour controls during the startup period; however, during periods of normal operation, where plant safety can be achieved via automated safety systems and other design features of the plant, operators would not be subject to work hours restrictions.
Applicants that intend to not apply work hour controls to operators during any period while the plant is operating 4
 
would need to provide sufficient justification in their risk-informed evaluations.
Additionally, for facilities licensed under Part 53 that perform operations activities from a remote facility (for example, a remote control room/station/console), such a remote facility would be considered to be an extension of the site for the purposes of considering onsite directing throughout § 26.4(a).
(2) Performing health physics or chemistry duties required as a    Paragraphs (2) and (3) - For certain advanced reactor member of the onsite emergency response organization minimum            designs, it may be the case that there will be no shift complement;                                                      individuals who perform these duties.
(3) Performing the duties of a fire brigade member who is responsible for understanding the effects of fire and fire suppressants on safe shutdown capability; (4) Performing maintenance or onsite directing of the              Paragraph (4) - This duty, as written, scopes in personnel maintenance of SSCs that a risk-informed evaluation process has        performing work on equipment non-safety-related but shown to be significant to public health and safety; and                safety significant or relied upon to meet certain criteria (including maintenance work on automated instrumentation and controls, passive systems, etc.).
For instance, workers responsible for conducting surveillance tests required by plant Technical Specifications would need to be under work hours controls. It should be noted that the current Part 26 guidance pertaining to the interpretation of maintenance limits the applicability of this criterion to maintenance activities that change the state or condition of the SSC.
This guidance may need to be revised to incorporate other maintenance activities (for example, non-destructive examination) that will be relied upon to provide a basis for operability of SSCs important to safety.
5
 
In instances where applicants intend to not apply work hour controls to individuals performing maintenance activities, those applicants would need to provide sufficient justification in their risk-informed evaluations.
Additionally, for facilities licensed under Part 53 that maintain or control equipment that is important to safety at a remote facility (for example, a remote control room or control station/console), such a remote facility would be considered to be an extension of the site for the purposes of considering onsite direction.
(5) Performing security duties as an armed security force officer, Paragraph (5) - Part 53 sites that require security alarm station operator, response team leader, or watchman,              personnel would need to ensure that work hour controls hereinafter referred to as security personnel.                          are administered for those personnel.
(b) All persons who are granted unescorted access to nuclear      Paragraph (b) - This is the applicability paragraph for power reactor protected areas by the licensees in § 26.3(a) and, as    individuals who have access to the protected area. This applicable, (c) and who do not perform the duties described in          requirement helps ensure the defense-in-depth regulatory paragraph (a) of this section shall be subject to an FFD program that  framework that provides reasonable assurance that meets all of the requirements of this part, except §§ 26.205 through    individuals who have unescorted access are trustworthy 26.209 and subpart K of this part. All persons who are granted          and reliable. For example, this requirement helps mitigate unescorted access to a facility licensed under Part 53, and who do not  the insider threat.
perform the duties described in § 26.4(a), shall be subject to the requirements in subpart M of this part, unless the licensee or other entity implements an FFD program that meets all of the requirements of this part, except §§ 26.205 through 26.209 and subparts K and M.
(c) All persons who are required by a licensee in § 26.3(a) and,  Paragraph (c) - This is the applicability paragraph for as applicable, (c) to physically report to the licensees Technical    those individuals who are assigned to the EOF or TSC Support Center (TSC) or Emergency Operations Facility (EOF) by          and those that direct or conduct activities remotely. Note licensee emergency plans and procedures shall be subject to an FFD      that Part 53 facilities may be remotely operated or rely on program that meets all of the requirement of this part, except          other facilities to fulfill the traditional role of a TSC or EOF;
§§ 26.205 through 26.209 and subpart K of this part. For licensees in  therefore, new text is proposed to account for other
§ 26.3(f), all persons who are assigned by the licensee to participate  facilities or remotely performed activities. Further, the use remotely and make decisions or direct actions regarding plant safety    of personnel to operate, maintain, surveil, and respond to 6
 
and security, and all persons who are assigned by the licensee to          adverse plant conditions and/or security events may be participate remotely in emergency response activities or physically        different than those traditionally included in the TSC or report to the TSC or EOF (or an equivalent facility), shall be subject to  EOF team.
an FFD program that meets all of the requirements described in subpart M of this part, unless the licensee or other entity implements an FFD program that meets all of the requirements of this part, except
§§ 26.205 through 26.209 and subparts K and M.
(d) []
(e) When construction activities, as defined in § 26.5, begin, any    Paragraph (e) - This is the applicability paragraph for individual whose duties for the licensees and other entities in            construction. Note that Part 26 already defines
§ 26.3(c) require him or her to have the following types of access or      construction. The NRC will assess and align this perform the following activities at the location where the nuclear          definition, if necessary, with the Part 53 definition of power plant will be constructed and operated shall be subject to an        construction.
FFD program that meets all of the requirements of this part, except subparts I, K, and M of this part, and for any individual whose duties for the licensees and other entities in § 26.3(f) require him or her to the have the following types of access, perform construction activities as defined in § 26.5, or perform the following activities shall be subject to an FFD program as described in subpart M of this part or an FFD program that meets all of the requirements of this part, except subparts I, K, and M:
(1) Serves as security personnel []
(2) Performs quality assurance, quality control, or quality            Paragraph (e)(2) - The NRC is proposing a revision to the verification activities related to safety- or security-related construction term safety-related as provided in § 26.5 below.
activities; (3) Based on a designation under § 26.406 by a licensee or other entity, monitors the fitness of the individuals specified in paragraph (f) of this section; (4) Witnesses or determines inspections, tests, and analyses          Paragraph (e)(4) - Applicability statement.
certification required under Parts 52 or 53 of this chapter; (5) Supervises or manages the construction of safety- or security-    Paragraph (e)(5) - The reference to safety-related SSCs related SSCs or the construction of SSCs that a risk-informed              is being removed to more generalize this scoping language. This terminology may change for Part 53 7
 
evaluation process has shown to be significant to public health and        licensed facilities; this may cause a conforming change to safety; or                                                                  this paragraph.
(6) Directs, as defined in § 26.5, or implements the access authorization program, including
[]
(f) Any individual who is constructing or directing the construction    Paragraph (f) - This is the applicability paragraph for those of safety- or security-related SSCs activities as defined in § 26.5 shall  individuals who construct or direct the construction of be subject to an FFD program that meets the requirements of subpart        commercial power reactors licensed under Part 50 or 52 K, or, if applicable, subpart M of this part, unless the licensee or other  in the current Part 26 rule. Since the definition of entity subjects these individuals to an FFD program that meets all of      construction in § 26.5 may change for Part 53 licensed the requirements of this part, except for subparts I, K, and M.            facilities, this provision may also need to change. Also, the use of terminology such as safety-related may change for Part 53 licensed facilities; this may cause a conforming change to this paragraph.
(g) All FFD program personnel who are involved in the day-to-day      Paragraph (g) - This is the applicability paragraph for FFD operations of the program, as defined by the procedures of the              program personnel (e.g., the FFD manager, Medical licensees and other entities in § 26.3(a) through (c), and, as              Review Officer, and technicians) and persons who applicable, (d) and whose duties require them to have the following        perform access authorization determinations (e.g., the types of access or perform the following activities shall be subject to    licensee-designated Reviewing Official). A Part 53 an FFD program that meets all of the requirements of this part, except      licensee would use FFD program personnel to implement subparts I, and K, and M of this part, and, at the licensees or other      the FFD program and assigned individuals to implement entitys discretion, subpart C of this part. All personnel described,      the Part 26 FFD program. However, since the staff is who have the types of access and perform those duties and                  proposing a risk-informed FFD program based on the responsibilities described in this paragraph at facilities licensed under  requirements in subpart K, the prescriptive requirements Part 53, shall be subject to the requirements in subpart M or an FFD        in Subpart B would no longer be required for licensees or program that meets all of the requirements of this part, except            other entities who implement the requirements in subpart subparts I, K, and M of this part, and, at the licensees or other entitys M.
discretion, subpart C of this part.
(1) All persons who . . .
8
 
(h) Individuals who have applied for authorization to have the          Paragraph (h) - This is the applicability paragraph for types of access or perform the activities described in paragraphs (a)        individuals who have applied for authorization when through (d) of this section shall be subject to §§ 26.31(c)(1), 26.35(b),    authorization becomes applicable before reactor 26.37, 26.39, and the applicable requirements of subparts C, and E            operation. The regulatory concept of authorization is through H, and, if applicable M, of this part.                                necessary immediately before and during commercial power plant operation.
§ 26.5 Definitions Certified Operator means an individual certified under the              The NRC is proposing a new category of individuals provisions of §§ 53.770 through 53.779 to manipulate a control of a          called Certified Operators. The FFD program would facility. Certified operators are not licensed by the Commission.            apply to these individuals. Although the definition is provided here, the NRC may elect to instead reference the definition of Certified Operator in Part 53.
Change as used in § 26.603(e) means an action that results in a        The NRC is proposing a definition for the word change as modification of, addition to, or removal from, the licensees or other        it is used on the § 26.603(e), FFD program change entitys FFD program.                                                        control, process. The proposed definition is consistent with that being proposed for the amended security requirements in the NRCs draft proposed decommissioning rule.
Contractor/vendor (C/V) means any company, or any individual            This proposed amendment makes the definition of not employed by a licensee or other entity specified in § 26.3(a)            contractor/vendor applicable to Part 53 licensees.
through (c) and (f), who is providing work or services to a licensee or other entity covered in § 26.3(a) through (c) and (f), either by contract, purchase order, oral agreement, or other arrangement.
Other entity means any corporation, firm, partnership, limited          This proposed amendment makes the definition of other liability company, association, C/V, or other organization who is            entity applicable to Part 53 licensees.
subject to this part under § 26.3(a) through (c) and (f), but is not licensed by the NRC.
Questionable validity means the results of validity screening or        The risk-informed approach being proposed for FFD initial validity tests at a licensee testing facility indicating that a urine programs for Part 53 licensees would not preclude Part 53 specimen may be adulterated, substituted, dilute, or invalid. For a          licensee use of alternative testing methodologies or Part 53 licensee, Questionable validity means the results of validity        alternative biological specimens (such as oral fluid) for screening or initial validity tests that a biological specimen obtained      drug testing as long as FFD program effectiveness does from an individual pursuant to subpart M may be adulterated,                  not diminish - see the proposed FFD performance substituted, dilute, or invalid.                                              monitoring and review program in § 26.603(b)(3) and the FFD change control process in § 26.603(b)(4).
9
 
Reduction in FFD program effectiveness means a change or            The NRC is proposing a definition for reduction in FFD series of changes to an element of the FFD program that reduces or        program effectiveness because this phrase is used in eliminates the licensees ability to meet or maintain site-specific FFD  proposed requirement § 26.603(e). The proposed program performance when compared to historical site-specific            definition is generally consistent with that being proposed performance, the licensees fleet-level program performance, or          for the amended security requirements in the NRCs generic industry performance.                                            proposed decommissioning rule, Regulatory Improvements for Production and Utilization Facilities Transitioning to Decommissioning (NRC-2015-0070; RIN 3150-AJ59). The Commissions markup of the proposed rule and its approval for publication can be viewed in a Staff Requirements Memorandum at Agencywide Documents and Management System (ADAMS)
Accession No. ML21307A046.
The NRC may propose a definition of FFD program because external stakeholders may have a different understanding of this phrase than the NRC. Typically, FFD program was that FFD program implemented by a licensee for a specific NRC-licensed facility. However, over time, companies have acquired additional NRC-licensed facilities, establishing a fleet of nuclear power plants. Some of these companies then have elected to implement one common FFD program for all its NRC-licensed facilities even if these facilities are not co-located. The NRC expects that facilities licensed under Part 53 may be owned and operated in a similar manner.
Reviewing official means an employee of a licensee or other        This proposed amendment makes the Reviewing official entity specified in § 26.3(a) through (c), and (f) who is designated by  definition applicable to Part 53 licensees.
the licensee or other entity to be responsible for reviewing and evaluating any potentially disqualifying FFD information about an individual, including, but not limited to, the results of a determination of fitness, as defined in § 26.189, in order to determine whether the individual may be granted or maintain authorization.
Safety-related structures, systems, and components (SSCs)          The current Part 26 definition for safety-related would mean, for licensees and other entities described in § 26.3(a) - (d) and  not be applicable to licensees under Part 53. Therefore, for the purposes of this part, those SSCs that are relied on to remain    Part 26 would use the Part 53 proposed definition for 10
 
functional during and following design basis events to ensure the        licensees described in § 26.3(f). The NRC staff plans to integrity of the reactor coolant pressure boundary, the capability to    issue regulatory guidance to describe this term in Part 53 shut down the reactor and maintain it in a safe shutdown condition, or and Part 26.
the capability to prevent or mitigate the consequences of accidents that could result in potential offsite exposure comparable to the guidelines in § 50.34(a)(1). For licensees and other entities described in § 26.3(d) and (f), safety-related has the meaning provided in
§ 53.020.
Security-related SSCs mean, for the purposes of this part, those          The NRC staff is assessing whether the Part 26 definition structures, systems, and components that the licensee will rely on to    of security-related needs to be further changed. The implement the licensee's physical security and safeguards                proposed amendment would, at minimum, make this contingency plans that either are required under Part 73 of this          definition applicable to Part 53 licensees.
chapter if the licensee is a construction permit applicant or holder or an early site permit holder, as described in § 26.3(c)(3) through (c)(5),
respectively, or are included in the licensee's application if the licensee is a combined license applicant or holder, as described in
§ 26.3(c)(1) and (c)(2), respectively, or a licensee or other entity described in § 26.3(d) and (f).
Subpart M  Fitness for Duty Programs for Facilities Licensed Under Part 53.
§ 26.601 Applicability.                                                  This proposed section makes subpart M applicable to Part At the licensee's or other entity's discretion, a licensee or other  53 licensees, at their discretion.
entity in § 26.3(f) may establish, implement, and maintain an FFD program that meets the requirements of this subpart for the individuals specified in § 26.602. If a licensee or other entity in
§ 26.3(f) does not elect to implement an FFD program that meets the requirements of this subpart, then the individuals specified in § 26.602 shall be subject to an FFD program that meets all Part 26 requirements, except for those requirements in subparts K and M.
§ 26.602 FFD program applicability to categories of individuals.          This proposed section requires Part 53 licensees and The requirements of this subpart apply to those categories of        other entities to apply subpart M to those individuals individuals in § 26.4, as applicable, and any Certified Operator, as      described in § 26.4, as applicable.
defined in § 26.5, as designated by the licensee or other entity.
§ 26.603 General provisions.
(a) FFD Program Description. As required by §§ 53.1245(e)(3),        Paragraph (a) - The proposed Part 53 framework would
[53.1266], 53.1275(y), and 53.1289(a)(24) of subpart H of Part 53, the require an applicant to provide a description of its FFD program within its application for a license. This 11
 
applicants description of the FFD program in its final safety analysis    description must be clear and contain certain information report must include                                                      to inform the NRC of its plans. This description requirement is based on the requirements of
                                                                          §§ 26.401(b),52.79(a)(44), and proposed rule language in
                                                                          § 53.1275(y) and supplemented by sub-paragraphs (a)(1)-(5) to account for operating experience during the construction of light water reactors.
(1) A summary of the analysis performed under paragraph (c)(2)        Paragraph (a)(1) - This paragraph requires a summary of this section, if performed, including the assumptions, methodology,    description of the analysis performed to assess the risk-conclusion, and references;                                                informed determination criterion for FFD programs. This description could be the same evaluated for security programs.
(2) A statement whether the FFD program will be implemented          Paragraph (a)(2) - This statement makes clear what FFD pursuant to §§ 26.604 or 26.605, or will meet all Part 26 requirements,    program the licensee would implement. This except for the requirements in subparts K and M;                          determination would be dependent on the risk-informed determination criterion. The licensee or other entity may choose to implement all Part 26 requirements, except those in subparts K and M.
(3) A discussion of the applicability of the FFD program to those    Paragraph (a)(3) - This description informs the NRC of individuals described in § 26.602 and how the program will be              the applicability of the FFD program to individuals who implemented offsite at an NRC-licensed facility authorized to              perform safety or security significant activities, including fabricate, construct, and/or test a nuclear reactor module, if            the situation where the licensees risk-informed evaluation applicable;                                                                process has shown that the duties and responsibilities performed by the individual would be significant to public health and safety. The NRC staff continues to evaluate the applicability of FFD programs to a facility licensed to fabricate, construct, and/or test a nuclear reactor module offsite from the NRC-licensed site for commercial power reactor operation.
(4) A description of the drug and alcohol testing and fitness        Paragraph (a)(4) - This description enables the NRCs determination process to be implemented by the licensees or other        and publics understanding of FFD program entitys procedures, including the collection and testing facilities to be 12
 
used, biological specimens to be collected, and sanctions to be        implementation, specifically how drug and alcohol testing imposed upon a confirmed FFD policy violation; and                      would be conducted.
(5) A summary of the FFD performance monitoring and review        Paragraph (a)(5) - This description is designed to inform program, including expected measures and metrics required by            the NRC and public of those FFD performance measures paragraph (d)(1) of this section.                                      that the licensee would use upon implementation of its FFD program.
(b) FFD Program Implementation and Availability. For the          Paragraph (b) - This requirement establishes when the licensees and other entities in § 26.4(f), the FFD program shall be    FFD program must be implemented and the longevity of established, implemented, and maintained before the start of            the FFD - this proposal is consistent the current FFD construction, as defined in § 26.5, and during reactor operation and    framework and includes the requirement that an FFD until the NRCs docketing of the license holders certifications        program would not be applicable during decommissioning described in §§ 50.82(a)(1) or 52.110(a). For licensees that have      of the Part 53 licensed facility. The current Part 26 been issued a manufacturing license, the FFD program shall be          framework requires the implementation of an FFD established, implemented, and maintained before the loading of          program for the construction of commercial nuclear power nuclear fuel into the reactor vessel module and until expiration of the reactor facilities licensed under Parts 50 and/or 52. Then, manufacturing license.                                                  as construction nears completion, the licensee or other entity is required to implement all Part 26 requirements, except those in Subpart K, because the radiological risk consequences begin to increase. However, the current FFD framework does not apply to a facility where its licensee has submitted its certifications under 10 CFR 50.82 or 52.110(a), which places the facility in decommissioning (either SAFSTOR or dismantlement).
The NRC describes decommissioning at https://www.nrc.gov/waste/decommissioning.html.
The NRC is still evaluating how to describe the milestone when the FFD program would need to be initiated to support the loading of fuel into the reactor vessel module at the manufacturing facility. For example, the NRC staff position is that the FFD program be implemented before individuals at the manufacturing facility begin assembling or directing the assembly of those SSCs that a risk-informed evaluation process has shown to be significant 13
 
to public health and safety, such as those associated with an inspection, test, analysis and acceptance criteria (ITAAC) and will be used in the reactor vessel module.
Are there other milestones that should be considered?
The staff requests feedback on this topic.
(c) Criterion and Analysis for an FFD Program. (1) Criterion. The  Paragraph (c) - This is a new requirement detailing the criterion to be used for the analysis in § 26.603(c)(2) shall be the    use of the criterion to determine which FFD program criterion in 10 CFR 53.830(a)(2)(i).                                    described in Subpart M (i.e., § 26.604 or § 26.605) a Part 53 licensee may establish, implement, and maintain unless it elects to implement all requirements in Part 26, except those in Subpart M. The requirement in paragraph (c)(2) explains the analysis to be conducted in the licensees or other entitys evaluation of the criterion.
Specifically, the FFD criterion is equivalent to that used in
                                                                        § 53.830(a)(2)(i). And, the analysis requirement is based on the equivalent provision in Part 53.
(2) Analysis. In order for a licensee or other entity to implement Paragraph (c)(2). The applicant may conduct this an FFD program under § 26.604, the licensee or other entity must        analysis to assess whether it could implement the FFD perform a site-specific analysis to demonstrate that the criterion in  program described in § 26.604. If the licensee finds that
§ 26.603(c)(1) is met. The licensee or other entity must maintain the  its facility and operation does not meet the criterion, (or, at analysis until permanent cessation of operations under § 53.XXX of      their discretion, if the criterion is satisfied) the applicant this chapter.                                                          must implement the FFD program described in
                                                                        § 26.605 or one that meets all Part 26 requirements, except those in subparts K and M.
(d) FFD Performance Monitoring and Review. A licensee or other    Paragraph (d) - This is a new requirement based on the entity must establish performance measures and associated              NRCs Reactor Oversight Process. A performance thresholds as described in § 26.603(d)(1) and monitor the              monitoring and review program is proposed to be effectiveness of its FFD program against these performance              consistent with a performance-based and risk-informed measures and thresholds, in a manner sufficient to provide              regulatory framework. This program is also required reasonable assurance that individuals subject to the program can        because the subpart M requirements are not prescriptive, safely and competently perform assigned duties and responsibilities    and they enable program implementation and change and are trustworthy and reliable to maintain the types of access        based on consequences and human performance. Since making them subject to this subpart.                                    FFD programs under subpart M may be site specific (e.g.,
14
 
using oral fluid instead of using urine for drug testing), this helps provide reasonable assurance that the FFD program would remain effective as determined by an evaluation against site-specific and industry metrics and averages, as well as qualitative considerations. This requirement helps enable performance-based and risk-informed NRC inspections.
(1) The performance monitoring and review program shall be            Paragraph (d)(1) - This paragraph requires the licensee documented and maintained and include the following program              or other entity to monitor its own performance through the elements:                                                                establishment of their own performance measures and (i) Performance Measures. Performance measures must be                thresholds designed to initiate corrective actions. The identified and designed to monitor FFD program performance in a          NRC staff is developing a draft proposed regulatory guide manner sufficient to provide reasonable assurance that the 10 CFR        to provide guidance on the types of performance 26.23 performance objectives are met.                                    measures that the licensee should consider and one set of measures that the NRC finds acceptable - where applicable, guidance would be based on and conform to that already implemented under the NRCs Reactor Oversight Process. The measures are both qualitative and qualitative (discussed below) and should be based on year-to-year site-specific performance and site performance compared to industry performance.
Additionally, if the FFD program applies to more than one NRC-licensed site, a site-to-site comparison within the FFD program should be performed. Prescriptive thresholds are not proposed by the NRC. Licensees and other entities currently subject to Part 26 already must annually report FFD performance data to the NRCno change would be proposed for current facilities. This information is docketed, publicly available, and displayed on the NRCs external website.
(A) If the licensee or other entity is subject to the requirements in Paragraph (d)(1)(i)(A) - The program must include the
§ 26.604, then the monitoring program must include a performance          periodic assessment of the behavioral observation measure for the effectiveness of the behavioral observation program.      program for a licensee or other entity that does not implement drug and alcohol testing. This requirement is 15
 
necessary to provide reasonable assurance that individuals are performing their duties and responsibilities safely and competently and not acting in a manner that may adversely affect, either directly or indirectly, the licensees capability to prevent significant core damage and spent fuel sabotage.
(B) If the licensee or other entity is subject to the requirements in Paragraph (d)(1)(i)(B) - FFD performance data
§ 26.604 and has implemented a drug testing program at its                associated with pre-access and random testing and discretion, or is subject to the requirements of § 26.605, then the        subversion attempts in the commercial nuclear industry monitoring program must include performance measures for the pre-          subject to Part 26 is well established and publicly access and random positive testing rates, and subversion attempts;        available. From this data, a licensee or other entity may make reasonably equivalent comparisons to other operating commercial nuclear facilities, based on, for example, megawatts-electric of the facility and number of individuals subject to the FFD program. Other considerations such as geographic location, use of laboratories and collection facilities, and conduct of large maintenance activities (such as refueling or engineering design changes) could also be used to inform the program. The NRC acknowledges that there may be cases where the existing FFD performance data generated by the current large light-water reactor fleet may not be directly applicable to a facility licensed under Part 53 For example, this could occur if the Part 53 facility maintains a very small licensee employee workforce. The NRC staff intends to address this issue in a draft regulatory guide and is working to complete a technical study on FFD performance monitoring.
(ii) Monitoring Program. Assessments must be conducted as            Paragraph (d)(1)(ii) - This paragraph states that the data is received. Monitoring must enable year-to-year comparisons for      licensee or other entity must evaluate FFD data as it is the site and when data is available against FFD program and industry      received. This is important because the licensee or other performance.                                                              entity is required under paragraph (d)(1)(i)(B) to monitor subversions. Operating experience indicates that some sites have very few subversion attempts, therefore, for these sites, the licensee- or other entity-established 16
 
threshold could be quite low, such that a single or few occurrences could initiate corrective actions.
(iii) Thresholds. Licensee- or other entity-specific thresholds for Paragraph (d)(1)(iii) - This paragraph regarding its site-specific performance measures must be established and used      thresholds introduces the concept of maintaining FFD to facilitate corrective actions to maintain FFD program performance. program effectiveness. This terminology is proposed Initial thresholds must be based on FFD performance data from            because it implements a performance-based regulatory comparable facilities subject to part 26, FFD program information if      strategy where the license or other entity must initially the program has more than one site subject to part 26, and generic        establish a level of performance that is representative of industry FFD performance data. Licensees and other entities must re-      other facilities in its FFD program and the FFD evaluate their performance measures and thresholds every two years        performance of comparable facilities subject to Part 26.
and adjust their performance measures and thresholds to maintain          Since NRC oversight has demonstrated that FFD FFD program effectiveness based on historical site-specific,              performance in the industry has met and continues to licensees fleet-level program performance, and comparable industry      meet the FFD performance objectives in § 26.23, that performance or any identified areas for improvement.                      level of historical FFD performance (e.g., number of FFD policy violations per site per year) when combined with the 10 CFR defense-in-depth regulatory framework, contributes to the protection of public health and safety, common defense and security, and protection of the environment. The proposed FFD change control process and NRC inspection of the FFD program and its annual and biennial reports will help provide assurance that measures and thresholds are not adjusted over time in a manner that lessens the effectiveness of the FFD program. The phrase reduction in FFD program effectiveness is a proposed definition in § 26.5.
(iv) Quantitative and Qualitative Reviews. The performance          Paragraph (d)(1)(iv) - This paragraph regarding monitoring and review program shall include a documented review of        quantitative and qualitative reviews lists those elements the elements in § 26.603(d)(1)(i)-(iii) and the following elements.      within the FFD program for which the NRC staff believes would be difficult for the licensee or other entities to establish quantitative performance measures, because there are very few data points in which to establish an effective monitoring program. However, since these listed elements involve multi-step processes, detailed 17
 
procedures, and human performance, a qualitative review (i.e., audit) can be performed to evaluate performance.
(A) Appeals Process. The review must include a documented          Paragraph (d)(1)(iv)(A) - This paragraph requires the assessment of the licensees or other entitys implementation of the  licensee to monitor whether the FFD program is affording protections described in §§ 26.606(b)(1), 26.611, and 26.613.          appropriate protections (protection of sensitive information, protection of privacy, due process, etc.) to individuals subject to the FFD program.
(B) Laboratory Test Results and Medical Review Officer            Paragraph (d)(1)(iv)(B) - The NRC proposes that Performance. The review must include a documented assessment          laboratory test results and Medical Review Officer (MRO) whether the actions taken by the Medical Review Officer met the        performance be included in the biennial program review requirements in § 26.185 based on the laboratory test results reported for three reasons: (1) this is a worker protection under § 26.169.                                                        consideration that the drug testing program is resulting in outcomes consistent laboratory test results; (2) this review provides a performance-based assessment of both the laboratory and MRO; and (3) this review facilitates actions to improve laboratory performance and/or MRO training under § 26.607(l)(2).
(C) Change Control Process. The review must include a              Paragraph (d)(1)(iv)(C) - The NRC staff proposes that the documented assessment of the changes made under § 26.603(e) to        change control process be included in the biennial provided assurance that the summation of program changes have not      program review to help ensure that changes implemented resulted in a reduction in FFD program effectiveness.                  over the life of the facility do not result in an unevaluated decrease in program effectiveness. The use of the word summation in this requirement is to require a holistic assessment of all changes because the proposed change control process in § 26.603(e) focuses only on a particular change being pursued for implementation and not a retrospective analysis of the potential aggregated effect of all changes on program effectiveness.
(2) Corrective Actions. Corrective actions shall be implemented to Paragraph (d)(2) - This provision helps ensure that address when FFD performance meets a licensee-established              corrective actions would be effective.
performance threshold or to resolve a finding resulting from a 18
 
qualitative review or audit in a manner that restores performance and corrects root and/or contributing causes.
(3) Program Review Periodicity. The documented review in        Paragraph (d)(3) - The licensee must monitor, periodically
§ 26.603(d)(1)(iv) shall be conducted biennially to assess and modify assess, and document its FFD performance monitoring licensee or other entity implementation of its FFD program. This      program - this report is not required to be submitted to the documented review must demonstrate that the performance              NRC. This report may summarize the results/findings measures and thresholds are appropriate based on site- and FFD        obtained from the reviews conducted in § 26.603(d)(i)(iv).
program-specific historical performance, and informed by industry    All Part 26 licensees must annually submit FFD performance.                                                          performance data to this NRC (10 CFR 26.417(b)(2) and 26.717). Two principal outcomes result from this effort:
(1) the licensee lessons learned would contribute to their own performance assessment to maintain program effectiveness and (2) the NRC is informed of FFD performance and can then aggregate industry data for use in licensee performance monitoring and review programs.
(i) Identified program weaknesses must be summarized in the      Paragraph (d)(3)(i) - This provision helps ensure that the annual reporting requirement described in § 26.617.                  NRC is informed of FFD program weaknesses to facilitate regulatory oversight, if necessary. The reference to § 26.617 enables the licensee to use the pre-existing and free, NRC-developed, electronic reporting system designed to minimize regulatory burden and enhance reporting consistency (https://www.nrc.gov/site-help/e-submittals.html). This enhances consistency across the industry and supports NRC aggregation of data. As proposed in § 26.617 and as currently required in § 26.719, all licensees and other entities subject to Part 26 would be required to submit FFD performance data to the NRC before March 1 for the previous calendar year.
(https://www.nrc.gov/reactors/operating/ops-experience/fitness-for-duty-programs/submit-ffd-reports.html)
(ii) The program review must be completed and approved by the    Paragraph (d)(3)(ii) - This provision helps ensure that the licensee or other entity before November 15 of every even year, and  review is periodically performed because of the flexibilities 19
 
corrective actions implemented before May 15 of the following year. afforded in the Part 53 FFD framework and the annual reporting of FFD performance data to the NRC. The November 15th date provides assurance of completion and informs NRC oversight, and implementing corrective actions within the next 6 months supports a possible full year of implementation prior to the next biennial FFD performance review.
(e) FFD Program Change Control. The licensee or other entity shall  Paragraph (e) - This section is based on § 50.54(p) and establish, implement, and maintain a change control process that    (q), the change control processes for security and meets the following requirements                                  emergency plans respectively. The staff proposes a change control process for Part 26 for two reasons. First, there must be change control for the assessment for the FFD criterion, which establishes the minimum FFD program that must be implemented, because if this assessment changes, then the licensees FFD program may change. Second, the requirements in subpart M are objective and performance based. Since this regulatory approach focuses on desired results (e.g., individuals are fit for duty and trustworthy and reliable) and measurable outcomes (e.g., performance measures and thresholds that demonstrate the FFD program is maintaining effectiveness), respectively, rather than prescriptive processes, techniques, or procedures, the licensee or other entity is essentially free to implement its own methods to achieve the desired results or measurable outcomes. In this case, the change control process helps provide assurance that FFD program changes do not result in a reduction in FFD program effectiveness and that a documented history is maintain should FFD program effectiveness unknowingly decreases (1) The licensee or other entity may make changes to its FFD  Paragraph (e)(1) - As will be further described in draft program under this subpart without prior NRC approval only if:      guidance, the following are types of changes a licensee or other entity may make: (1) If HHS determines that the societal risk posed by a particular drug or drug metabolite 20
 
(i) the licensee or other entity performs and retains an analysis  does not warrant its testing in its Mandatory Guidelines for demonstrating that the changes do not reduce the effectiveness of the    Federal Workplace Drug Testing Programs (HHS FFD program or                                                          Guidelines) because it is no longer used in society or (ii) the change was necessitated or justified by a change to Part  does not cause an impairing condition of concern, then 26 or laboratory processes or procedures, including the full panel of    the change is justified. (2) If HHS changes its laboratory drugs, drug metabolites, and cutoffs, implemented to maintain their      validity testing to account for a change in adulteration U.S. Department of Health and Human Services (HHS) laboratory          techniques, HHS may revise its validity testing certification.                                                          requirements, this change is justified.
(2) A licensee or other entity desiring to make a change that      Paragraph (e)(2) - If a change reduces FFD program decreases FFD program effectiveness must submit an application for      effectiveness, then NRC approval is required. As will be amendment to its license, in addition to the filing requirements in      described in draft guidance, the following are examples
§§ 53.YY and 53.ZZ. The request must include a detailed description      where a change may represent a reduction in program of the change, the reason for the change, and the use of any            effectiveness. (1) If the licensee elects to reduce the mitigating strategy needed to provide reasonable assurance that if the  severity of its established sanction for an FFD policy change is approved, the FFD program, as revised, will continue to        violation; this change can reduce FFD program meet the performance objectives in § 26.23.                              effectiveness because the deterrent value of the sanction would be reduced. (2) If the licensee elects to reduce the number of individuals onsite and subject to the FFD program; this change could reduce the effectiveness of the behavioral observation and, if applicable, random testing programs. (3) If the licensee elects to change its supplier of oral fluid test kits and the testing accuracy decreases, cutoffs increase, or panel of drugs to be tested decreased from that tested previously; these types of changes could represent a reduction in program effectiveness.
(3) The credited technical analysis used to justify meeting the    Paragraph (e)(3) - This requirement provides assurance risk-informed determination criterion of this section must be            that changes to the facility, its operation, personnel, maintained, including updates to reflect changes made pursuant to        safeguards, etc., are managed and evaluated to prevent
§ 26.603(e) to the staffing, FFD programs, or offsite support            unanticipated change to the justification used to assess resources described in the analysis, to show that the facility and its  the FFD criteria.
operation continues to meet the risk-informed determination criteria, if applicable.
21
 
(4) The licensee shall retain a record of each change made under    Paragraph (e)(4) - Records shall be maintained in a this section for a period of at least five years from the date the change manner similar to records maintained for § 50.54(p) and was implemented and summarize this change in its annual FFD              (q) changes. Five years is based on the current NRC performance report required by § 26.617(b)(2).                            practice to conduct triennial inspections of the FFD program.
§ 26.604 FFD program requirements for facilities that meet the FFD criterion (a) FFD Program. Licensees and other entities with an analysis as described in § 26.603(c)(2) that demonstrates the criterion in
§ 26.603(c)(1) is met, may elect to establish, implement, and maintain an FFD program under this section. That FFD program must contain the following elements:
(1) applies to those individuals described in § 26.602, as applicable; (2) implements the program elements and requirements described in in § 26.603; and, (3) implements the following requirements and subparts in this part:
(i) § 26.23, Performance objectives (ii) § 26.606, Written policies and procedures, (a) and, if applicable (b)
(iii) § 26.608, FFD program training (iv) § 26.609, Behavioral observation (v) § 26.610, Sanctions (vi) § 26.611, Protection of information (vii) § 26.613, Review process (viii) § 26.615, Audits (ix) § 26.617, Recordkeeping and reporting (x) § 26.619, Suitability and fitness determinations (xi) Subpart AAdministrative Provisions (xii) Subpart OInspections, Violations, and Penalties
§ 26.605 FFD program requirements for facilities that do not meet        Section 26.605 is written for a Part 53 licensee that does the FFD criterion                                                        not meet the FFD criterion in § 26.603(c) and a Part 53 (a) Licensees and other entities implementing § 26.604, at their    licensee that meets the FFD criterion yet elects to discretion, and licensees and other entities that implement an FFD        implement this section. This section also applies to the program under this subpart must establish, implement, and maintain        holder of a Part 53 manufacturing license that allows the 22
 
an FFD program under this section during either construction            fabrication and fueling of a reactor vessel module.
activities as defined in § 26.5, or during activities performed under a However, the proposed FFD requirements will only be manufacturing license that allows the assembly and fueling of a        applicable to those individuals who assemble and direct reactor vessel module, as applicable. That FFD program must contain    the assembly of the reactor vessel module and its SSCs, the following elements:                                                and those individuals who conduct QA/QV activities for (1) applies for those individuals described in § 26.602, as        the assembly of the reactor vessel module at the applicable;                                                            manufacturing licensees fabrication facility.
(2) implements the program elements and requirements described in in § 26.603;                                              An FFD program under § 26.605 is commensurate with (3) implements the following requirements and subparts in this    the risk of a reactor facility licensed under Part 53 that part                                                                  uses plant technologies, engineered features, and (i) § 26.23, Performance objectives                                controls that are applied in an integrated defense-in-depth (ii) § 26.606, Written policy and procedures                      manner to provide reasonable assurance that the facility (iii) § 26.607, Drug and alcohol testing                          construction and operation would not result in radiological (iv) § 26.608, FFD program training                                consequences inimical to public health or safety. Such a (v) § 26.609, Behavioral observation                              facility presents a risk profile much lower than that of a (vi) § 26.610, Sanctions                                          traditional commercial light water reactor power plant. For (vii) § 26.611, Protection of information                          example, advanced reactors would meet (1) the safety (viii) § 26.613, Review process                                    criteria of §§ 53.210 and 53.220, (2) the safety functions (ix) § 26.615, Audits                                              of § 53.230, (3) the requirements associated with defense (x) § 26.617, Recordkeeping and reporting                          in depth, as described under § 53.250, and (4) the (xi) § 26.619, Suitability and fitness evaluations; and            analysis of licensing basis events in accordance with (xii) Subpart AAdministrative Provisions                          § 53.450. These facilities may also use SSCs that (xiii) Subpart IFatigue Management                                function through inherent characteristics or have (xiv) Subpart OInspections, Violations, and Penalties            engineered protections against human failures (e.g.,
system misalignments). Meeting these licensing and design requirements provides assurance that a reactor licensed under Part 53 presents a radiological risk that enables the establishment of an objective, risk-informed, and performance-based FFD regulatory framework that was developed from the existing FFD program requirements detailed in subpart K of Part 26.
Paragraphs (a)(1) - (3) establish the FFD program requirements during construction and decommissioning.
As mentioned above, the requirements listed on this 23
 
paragraph are based on the current requirements in subpart K, FFD Program for Construction.
Similar to the requirements in § 26.604, the Part 53 licensee implementing this section must be subject to the minimum requirements needed to make Part 26 applicable to a Part 53 licensee, establish the regulatory framework, protect workers, and support NRC licensing and oversight.
(b) Licensees and other entities implementing § 26.604, at their Paragraph (b) - An FFD program under § 26.605(b) is discretion, and licensees and other entities that implement an FFD    based on the risk presented by the facility as the licensee program under this subpart, before the loading of fuel onsite into a  readies it for commercial nuclear power plant operation.
reactor vessel; before receiving a reactor vessel module loaded with  These requirements must be implemented immediately fuel; or before operating, testing, performing maintenance of, or    before operation (i.e., a consequential change in reactor directing the maintenance or surveillance of security-related        core reactivity) and other significant activities that affect equipment or equipment that a risk-informed evaluation process has    the design, operation, or maintenance of the licensed shown to be significant to public health and safety, shall establish, facility. This operational milestone is similar to that of implement, and maintain an FFD program that                          initial core loading currently used in, for example, §§ 50.54(a)(1), 50.55a(f)(4)(i), 50.71(h)(1), 50.120, Part 50 (1) applies to those individuals described in § 26.602, as      appendix E, 52.99(a) and (c), 52.103(a) and (e). At this applicable.                                                          operational milestone, the Part 53 licensee must implement an FFD program that (1) provides assurance (2) implements the program elements and requirements            that the facility would be operated and maintained in a described in § 26.603(a)-(e); and                                    manner in which it was designed and licensed and (2) implements regulatory requirements that seamlessly (3) Implements the following requirements and subparts          integrate the FFD program with the rest of the commercial (i) § 26.23, Performance objectives                              nuclear industry regarding, in part, FFD policy violations, (ii) § 26.606, Written policy and procedures                    sanctions, authorization determinations, fatigue (iii) § 26.607, Drug and alcohol testing                        management, records, and reports. This assurance is (iv) § 26.608, FFD program training                              obtained by requiring the implementation of subparts C, (v) § 26.609, Behavioral observation                            D, H, I, and N.
(vi) § 26.611, Protection of information (vii) § 26.613, Review process                                  Additional language is being included among the (viii) § 26.615, Audits                                          requirements in Paragraph (b) to apply FFD controls (ix) Subpart AAdministrative Provisions                        (including fatigue management) to individuals who may be 24
 
(x) Subpart CGranting and Maintaining Authorization                loading fuel into a pre-fabricated module at an offsite (xi) Subpart DManagement Actions and Sanctions to be              facility.
Imposed (xii) Subpart HDetermining Fitness-for-Duty Policy Violations      Also, similar to Paragraph 26.4(a)(6), additional language and Determining Fitness                                                is included in these requirements to address FFD needs (xiii) Subpart IFatigue Management                                in instances where individuals, likely at an offsite facility, (xiv) Subpart NRecordkeeping and Reporting Requirements            would be installing components into a pre-fabricated (xiv) Subpart OInspections, Violations, and Penalties.            nuclear reactor module, and where those component are located such that the licensee would be unable to perform inspection, test, analysis, and acceptance criteria (ITAAC) examination or otherwise to identify potential latent human error in installation. The NRC staff finds that certain passive SSCs (for example, a component - such as a fusible link - internal to the reactor module designed to melt at a particular temperature setpoint to trigger an actuation mechanism) could be included in a design in such a way that those components are relied upon for safe operation but cannot be inspected for proper installation, configuration, or operation after-the-fact. In such instances, the safety-significance of correctly-performed installation could warrant the application of FFD requirements on the individual(s) performing the installation of such a component.
§ 26.606 Written policy and procedures.                                Section 26.606 is based on § 26.403, Written policy and (a) Licensees and other entities that implement an FFD program      procedures.
under this subpart shall ensure that (1) A written FFD policy statement is provided to each individual  Paragraph (a)(1) - This requirement is based on who is subject to the program before the individual is subject to      § 26.403(a), except that the phrase clear, concise was behavioral observation and/or drug and alcohol testing under this part. removed because it is not defined. To enhance protections afforded to individuals a new requirement is also proposed that the policy must be provided to individuals before being subject to behavioral observation and any FFD program drug and alcohol test; this new requirement helps ensure that individuals know what is expected of them prior to being subject to the FFD program and possibly entering the NRC-licensed facility.
25
 
(2) The FFD policy statement describes the performance              Paragraph (a)(2) - This requirement is proposed to help objectives in § 26.23.                                                      ensure that the FFD programs of all licensees required to meet in Part 26 have the same performance objectives.
(3) The FFD policy statement must be written in sufficient detail to Paragraph (a)(3) - This requirement is based on provide affected individuals with information on what is expected of        § 26.403(a), with additional clarity provided on what the them and what consequences may result from a lack of adherence to          policy statement must include. This protects the worker the policy, including those elements described in paragraph (b) of this    and enhances consistency.
section, Part 26-required sanctions, and required medical/clinical treatment and follow-up testing for FFD policy violations.
(b) Licensees and other entities shall establish, implement, and    Paragraph (b) - This requirement is based on § 26.403(b).
maintain written procedures that address the following topics:              Minor changes were made to apply to a Part 53 FFD program.
(1) If implementing a drug and alcohol testing program under this    Paragraph (b)(1) - This requirement is based subpart,                                                                    § 26.403(b)(1) to clarify program processes (e.g.,
(i) the methods and techniques to be used in collecting, testing,    collecting, testing, shipping, and temporary storage of shipping, and temporarily storing biological specimens for drugs and        biological specimens) that licensees and other entities alcohol testing, and                                                        must detail in its procedures because alternative testing (ii) procedures for protecting the privacy of an individual who      methods are enabled by subpart M.
provides a specimen, protecting the integrity of the specimen, and ensuring that the test results are valid and attributable to the correct individual.
(2) The immediate and followup actions that will be taken, and the  Paragraph (b)(2) - This requirement is based on procedures to be used, in those cases in which individuals who are          § 26.403(b)(2) and helps ensure the effectiveness of the subject to the FFD program:                                                FFD program and its consistent implementation. It also helps inform individuals subject to Part 26 of FFD program requirements.
(i) Have been involved in the use, sale, or possession of illegal or Paragraph (b)(2)(i) is based on § 26.403(b)(2)(i) except illicit substances;                                                        that the phrase illicit substances was added to include individuals who use, sell, or possess legal substances in a manner inconsistent with federal or state law, or can cause impairment while at the NRC-licensed facility.
26
 
(ii) Are impaired by any substance or the consumption of alcohol    Paragraph (b)(2)(ii) is based on § 26.403(b)(2)(ii) except as determined by behavioral observation or a test that measures          that it was revised to remove the phrases to excess. and blood alcohol concentration;                                              accurately, because these phrases are not defined.
Alcohol impairment can be determined by behavioral observation and by whether the individuals BAC meets or exceeds the alcohol limits in §§ 26.99, 26.101, and 26.103. The phrase by any substance was added based on operating experience. The phrase before or while constructing or directing construction was removed because § 26.606 applies during construction, operation, and decommissioning. The term behavioral observation was added because impairment can be visibly or audibly observed in an individual and individuals are trained in behavioral observation. The behavioral observation program requirement is provided in § 26.609, with training requirement provided in § 26.608.
(iii) If drug and alcohol testing is conducted, attempted to subvert Paragraphs (b)(2)(iii) is based on § 26.403(b)(2)(iii),
the testing process by adulterating or diluting specimens (in vivo or in  except the phrase if drug and alcohol testing is vitro), substituting specimens, or by any other means;                    conducted was added to address the licensee who implements § 26.604.
(iv) If drug and alcohol testing is conducted, refused to provide a  Paragraph (b)(2)(iv) is based on § 26.403(b)(2)(iv), except specimen for analysis or follow instructions provided by FFD program      the phrase or follow the instructions provided by FFD personnel;                                                                program personnel which is based on § 26.89(c) and the phrase if drug and alcohol testing is conducted were added to address the licensee who implements § 26.604.
(v) Had legal action taken relating to drug or alcohol use; or      Paragraphs (b)(2)(v) is based on § 26.403(b)(2)(v).
(vi) Demonstrated character or actions indicating that the          Paragraph (b)(2)(vi) is proposed to gather information for individual cannot be trusted or relied upon to perform those duties and  the insider threat program. This also helps to align the responsibilities or maintain access to NRC-licensed facilities or        Part 26 behavioral observation program with the sensitive information.                                                    behavioral observation program implemented under proposed Part 53 requirement § 73.120.
27
 
(3) The process to be followed if an individuals behavior or      Paragraph (b)(3) - This requirement is based on condition raises a concern regarding: the possible use, sale, or          § 26.403(b)(3) and is designed to help ensure that when possession of illegal drugs on or off site; the possible use or          individuals may be in violation of the FFD policy, they are possession of alcohol on the NRC-licensed facility; impairment from      removed from the duties and responsibilities making them any cause which in any way could adversely affect the individuals        subject to Part 26. The § 26.403(b)(3) phrase while ability to safely and competently perform his or her duties; or the      constructing or directing the construction of safety- or receipt of credible information indicating that the individual cannot be  security-related SSCs was replaced with on the NRC-trusted or relied on to perform those duties and responsibilities        licensed facility because this provision applies during making the individual subject to this part.                              construction and operation and this would apply to holders of an NRC manufacturing license.
The requirement regarding credible information is proposed to help address the insider threat.
§ 26.607 Drug and alcohol testing.                                        Section 26.607(a) - These requirements are based on the (a)(1) To provide means to deter and detect substance abuse,        requirements in § 26.405(a) and changes are proposed licensees and other entities implementing § 26.604, at their discretion,  commensurate with the risk consequences presented by a and licensees and other entities implementing § 26.605 shall perform      Part 53 licensed facility. For § 26.607(a)(2), a split drug and alcohol testing that complies with the following                specimen need not be taken when using a point of requirements                                                            collection testing and assessment device is use for a screening test conducted for random testing, because if (2) Split specimen collections of oral fluid or urine must be used  the individual screens positive, invalid, dilute, adulterated, for the test conditions described in paragraph (b) of this section. A    or substituted, the individual is subject to an immediate re-split specimen collection need not be used if the licensee or other      collection (i.e., another drug test) using a device approved entity elects to use a point of collection testing and assessment        for use for validity, if required, initial, and confirmatory devise for a screening test conducted during random testing under        drug testing at an HHS-certified laboratory.
§ 26.605(b)(2) and (i).
(b) Individuals identified in § 26.602 shall be subject to drug and Paragraph (b) - These test conditions are based on alcohol testing under the following conditions:                          § 26.405(c) with the except of the random testing provisions in § 26.607(b)(2) which are based on
                                                                          § 26.405(b).
(1) Pre- access. Before performing or directing the conduct of      Paragraph (b)(1) - This requirement is based on roles and responsibilities making the individual subject to this subpart  § 26.405(c)(1); however it was revised to remove or being granted unescorted access to the protected area of the          construct or direct the construction of safety- or security-NRC-licensed facility;                                                    related SSCs because for licensees or other entities under 28
 
Part 53, the pre-assignment/access test condition applies to construction, operation, and decommissioning to help inform a licensees or other entity of whether the individual can be trusted and relied upon to perform those duties and responsibilities making the individual subject to subpart M.
(2) Random Testing. Random testing for drugs and alcohol              Paragraph (b)(2) - This requirement is based on must                                                                      § 26.405(b). Random testing must be conducted by a licensee or other entity who does not meet the FFD criterion, and may be conducted at the licensees discretion for those licensees and other entities that do meet the FFD criterion. This provision is different than that in § 26.405(b) because § 26.406, Fitness monitoring may not be performed in lieu of random testing for a Part 53 licensee.
(i) Be administered in a manner that provides reasonable              Paragraph (b)(2)(i) - This requirement based on assurance that individuals are unable to predict the time periods          § 26.405(b)(1) helps ensure that individuals do not know during which specimens will be collected;                                  when they would be subject to a random test.
(ii) Require individuals who are selected for random testing to        Paragraph (b)(2)(ii) - This requirement based on report to the collection site as soon as reasonably practicable after      § 26.405(b)(2) helps ensure that individuals would be notification, within the time period specified in the FFD program          subject to a timely test and that the test result would be a procedure;                                                                  good indication of the drugs, drug metabolites, and alcohol concentration(s) in the individual with access to the NRC-licensed facility prior to the time of test.
(iii) Ensure that all individuals in the population that is subject to Paragraph (b)(2)(iii) - This requirement based on random testing on a given day have an equal probability of being            § 26.405(b)(3) helps ensure that random testing is equally selected and tested; and                                                    applied to all individuals.
(iv) Ensure that an individual completing a test is immediately        Paragraph (b)(2)(iv) - This requirement based on eligible for another random test.                                          § 26.405(b)(4) helps ensure that there are no breaks in the random testing program providing an opportunity for the individual to illicitly use substances that may cause impairment.
29
 
(v) Ensure that the sampling process used to select individuals for  Paragraph (b)(2)(v) - This requirement is not in subpart K; random testing provides that the number of random tests performed          the requirement is from § 26.31(d)(2)(vii) which annually is equal to at least 50 percent for licensee employees and 50    establishes the random testing rate for the population of percent for contractor/vendors at the NRC-licensed site.                  individuals subject to testing. Based on operating experience, a 50 percent random testing rate provides reasonable assurance of public health and safety and the common defense and security, by providing sufficient detection and deterrence. However, operating experience demonstrates that the contractor/vendor population is tested at rate lower than 50 percent, even though this population results in the majority of all FFD policy violations. Furthermore, the proposed framework enables the use of immunoassay point of collection testing and assessment (POCTA) devices for the conduct of random testing. In order to maintain program effectiveness (e.g.,
the detection and deterrent value of random testing does not substantially decrease with the use of a POCTA device) the random testing rates for both populations (licensee employees and contractor/vendors) must remain at or above 50 percent. The NRC staff has commenced a study to assess the effectiveness of a 50 percent random testing rate when there is a large transient worker population that may be onsite for only a short period of time. Information from this study would be used to inform proposed Paragraph (b)(2)(v).
(3) For-cause. In response to an individual's observed behavior      Paragraph (b)(3) - This for-cause testing requirement is or physical condition indicating possible substance abuse or after        equivalent to that used in current FFD programs receiving credible information that an individual is engaging in          implementing § 26.405(c)(2).
substance abuse, as defined in § 26.5; (4) Post-accident. (i) As soon as practical after an accident        Paragraph (b)(4) - This post-accident testing requirement involving a human error that was committed by an individual specified      is from § 26.405(c)(3). It is essentially equivalent to that in § 26.602, where the human error may have caused or contributed          used in current FFD programs. However, for Part 53 to the accident, the licensee or other entity shall test the individual(s) licensees, the staff proposes that the post-accident testing 30
 
who committed or directed the error(s). The licensee or other entity        language be amended to clearly require testing under two need not test individuals who were affected by the accident and            conditions: sub-paragraph (i) human errors that result in whose actions likely did not cause or contribute to the accident. The      accidents and sub-paragraph (ii) accidents that result in licensee or other entity shall describe in its procedures what              adverse health consequences. Editorial changes are also constitutes a human error and accident.                                    proposed (e.g., replace the word event with accident).
(ii) A post-accident test shall be conducted within 4-hours of an    The NRC proposes that the licensee or other entity define accident unless immediate medical intervention precludes the conduct        in its procedures the terms human error and accident.
of the test, on the individual(s) who caused or contributed to the          Although this Part 26 requirement is based on an accident if the accident results in                                        Occupational Safety and Health Administration (OSHA) provisions that enables post-incident drug testing (OSHA Memorandum, Kim Stille, Acting Director, Enforcement Programs, October 11, 2018, 29 CFR 1904.35(b)(1)(iv)),
the reference to OSHA was removed based on operating experience learned from program implementation.
(A) An illness or personal injury to the individual(s) who caused or Paragraph (b)(4)(ii)(A) - This requirement is from contributed to the event or another individual which results in death,      § 26.405(c)(3)(i). The staff removed the word significant days away from work, restricted work, transfer to another job, medical      as used in significant illness or personal injury because treatment beyond first aid, loss of consciousness, or other significant    the requirement describes what illnesses or injuries are illness or injury, as diagnosed by a licensee- or other entity-            covered.
designated physician or other licensed health care professional, even if it does not result in death, days away from work, restricted work or job transfer, medical treatment beyond first aid, or loss of consciousness; or (B) Damage to any safety- or security-related SSC.                  Paragraph (b)(4)(ii)(B) - This requirement from
                                                                            § 26.405(c)(3)(ii) was changed based on operating experience to remove the word significant because this term is not defined; NRC may propose guidance on what constitutes damage or leave it to the licensee to define.
Also, the term construction was removed because this provision applies during construction and operation. Note that § 26.5 defines safety-related SSCs and security-related SSCs, if these definitions change, then a conforming change may be provided to this requirement.
31
 
(iii) The conduct of a post-accident test for an accident involving Paragraph (b)(4)(iii) - This is a new requirement proposed human error, if conducted within 4 hours of the accident, satisfies the  to clearly state that the human error post-accident test (§ post-accident test requirement in paragraph (b)(4)(ii) of this section;  26.607(b)(4)(i)) can meet the requirement for the conduct and                                                                      of a health consequence-based post-accident test
(§ 26.607(b)(4)(ii)). Two tests on a particular individual for a single event should never be conducted.
(5) Followup. As part of a followup plan to verify an individual's  Paragraph (b)(5) - This requirement is based on continued abstinence from substance abuse.                              § 26.405(c)(4).
(c) At a minimum, the following requirements shall be met          Paragraph (c) - This requirement is based on § 26.405(d) and ensures that drug testing is technology inclusive.
Specifically, the provisions enable the use of alternative testing technologies.
(1) For the use of urine as the biological specimen to be tested,  Paragraph (c)(1) - This requirement is based on the following requirements shall be implemented                        § 26.405(d) but was modified to apply to directly reference (i) § 26.115, Collecting a urine specimen under direct              the drugs, drug metabolites, and cutoffs that are observation;                                                            applicable to NRC-licensees subject to Part 26. Instead
    § 26.119, Determining shy bladder;                                of the general non-specific statement of drugs and drug (ii) § 26.161, Cutoff levels for validity testing, and              metabolites in § 26.405(d). Section 26.607(c)(1) refers to (iii) § 26.163, Cutoff levels for drugs and drug metabolites.      § 26.161, Cutoff levels for validity testing, and § 26.163, Cutoff levels for drugs and drug metabolites, for validity testing and the specific drugs and drug metabolites for urine testing, respectively. Sections §§ 26.115 and 26.119 are required for program effectiveness and as a worker protection. On September 16, 2021, the NRC staff provided the Commission a draft Final Rule that recommends changes to Part 26 drug testing requirements. This draft Final Rule (RIN 3150-AI67; NRC-2009-0225; SECY-21-0082) can be viewed on the NRCs website at ADAMS Accession No. ML21111A017.
If the Commission approves this Final Rule package, conforming changes may be necessary in the proposed FFD requirements for Part 53 licensees.
32
 
(2) For alcohol testing, the following requirements shall be        Paragraph (c)(2) - This ensures that the Part 53 licensee implemented                                                              or other entity implements an alcohol testing program that (i) § 26.91, Acceptable devices for conducting initial and          is consistent with that implemented by other NRC confirmatory tests for alcohol and methods of use;                        licensees or other entities subject to Part 26. This is a (ii) § 26.93, Preparing for alcohol testing;                        program effectiveness and worker protection (iii) § 26.95, Conducting an initial test for alcohol using a breath consideration.
specimen; (iv) § 26.97, Conducting an initial test for alcohol using a specimen of oral fluids; (v) § 26.99, Determining the need for a confirmatory test for alcohol; (vi) §26.101, Conducting a confirmatory test for alcohol; and, (vii) §26.103 Determining a confirmed positive test result for alcohol.
(3) For all test conditions in paragraph (b) of this section and    Paragraph (c)(3) - This requirement is from § 26.405(f) but MRO-directed tests under § 26.185, drug testing must be performed        was modified to apply to facilities licensed under Part 53.
at an HHS-certified laboratory for the specific biological specimen to    For all current FFD programs, confirmatory drug testing be tested. Only HHS-certified laboratory test results using urine or      must be performed at a laboratory certified by the U.S.
oral fluid may be used for the issuance of a Part 26-required sanction. Department of Health and Human Services; this too would The licensee or other entity must establish and maintain a contract      be applied to Part 53 licensees. Wording is proposed to with a primary and back-up HHS-certified laboratory (with a different    enable the testing of alternative biological specimens and Certifying Scientist) for the specimen(s) to be tested.                  to ensure that the licensee or other entity has a secondary (back-up) HHS-certified laboratory should additional testing be directed by the MRO or problems occur with the primary laboratory. The back-up laboratory may be of the same corporate entity but at a different location using a different Certifying Scientist. This is an operating experience lesson learned.
(d) Licensees and other entities may add drugs and drug              Paragraph (d) - This requirement is not from subpart K, metabolites to their panel of drugs and drug metabolites to be tested if  but from subpart B, Program Elements. Similar to the requirements in § 26.31(d)(1)(i) are met.                            current FFD programs, this preliminary proposed requirement enables a Part 53 licensee or other entity to add or remove drugs or drug metabolites from its panel of drugs to be tested. This is important for two reasons.
33
 
First, a licensee or other entity may desire to align with the HHS recommendation should HHS add a new drug to their recommended panel of drugs to be tested because it may improve FFD program effectiveness. Second, aligning with the HHS drug panel also benefits protections afforded to workers because HHS National Laboratory Certification Program evaluation of the laboratory processes (and its blind performance testing program) would be those same processes used for a biological specimen submitted by the licensee or other entity drug.
As currently proposed, should a licensee or other entity desire to add or remove a drug or drug metabolite from its panel of drugs, then it would implement the FFD change control process in §26.603(e); for these types of changes based on HHS recommendations, NRC review and approval would not be necessary.
(e) The specimen collection and drug and alcohol testing              Paragraph (e) - This requirement is from § 26.405(e),
procedures of FFD programs under this subpart must protect the            except the word stringent was removed from the phrase donor's privacy and the integrity of the specimen and implement            stringent quality controls, because the word stringent is quality controls to ensure that test results are valid and attributable to not defined.
the correct individual.
(f) At the licensee's or other entity's discretion, specimen          Paragraph (f) - Similar to paragraph (e) above, this collections and alcohol testing may be conducted at a local hospital or    requirement is from § 26.405(e), yet an audit requirement other facility licensed and audited by the State (or State-designated      is proposed to ensure that the collection facility entity) to conduct specimen collections and perform alcohol testing.      procedures are comparable to those in Part 26, subpart E, The licensee or other entity shall audit these facilities, if used, on a  Collecting Specimens for Testing, including the biennial basis to provide reasonable assurance that the facility          prevention of subversion attempts. This is a program procedures are comparable to those described in subpart E of this          effectiveness and worker protection consideration.
part for urine and oral fluid. The licensee or other entity must establish measures to help prevent subversion of the drug and/or          The subpart K reference to the U.S. Department of alcohol test onsite or offsite.                                            Transportation drug and alcohol collection and testing requirements in 49 CFR Part 40 was removed based on operating experience.
34
 
(g) Any initial drug test performed by a licensee or other entity      Paragraph (g) - This requirement is from § 26.405(f) and subject to this subpart must use an immunoassay, or a testing              was modified for a facility licensed under Part 53 process implemented under the licensees or other entitys change          implementing an FFD program that may implement control process under § 26.603(e), that meets the requirements of the      alternative biological specimen testing. For example, the U.S. Food and Drug Administration (FDA) for commercial distribution.        phrase or better testing process enables a licensee to Specimens that yield positive, adulterated, substituted, or invalid initial use its change control process in § 26.603(e) to evaluate validity or drug test results must be subject to confirmatory testing by    and document a change to its collection and analysis the HHS-certified laboratory, certified for that biological specimen,      procedures to enable the use of a better or perhaps more except for invalid specimens that cannot be tested.                        cost-effective collection and/or testing technology.
(h) If the licensee or other entity elects to use oral fluid for drug  Paragraph (h) - A licensee or other entity implementing testing, the collection, packaging, temporary storage, and shipment of      subpart K, FFD programs for construction, may implement an oral fluid specimen to an HHS-certified laboratory must be              a drug testing program using oral fluid. The paragraph (h) performed in accordance with the instructions provided with the oral        requirement enables a Part 53 licensee to use oral fluid as fluid collection kit or on the manufacturers website. The kit must have    a biological specimen for testing. Also, oral fluid testing received premarket approval from the FDA and must not expire                may currently be conducted under direction of an MRO as before laboratory testing. All site processes shall be conducted by        enabled in § 26.31(d)(5). HHS has issued guidelines on licensee- or other entity-designated FFD program personnel. The            the use of oral fluid and urine as drug testing matrices and drugs, drug metabolites, and initial and confirmatory testing cutoffs      has determined that these test methods are comparable.
shall be comparable to those established for urine testing in this part    These guidelines may be viewed at as determined by a documented forensic toxicologist review                  https://www.samhsa.gov/workplace/resources.
conducted pursuant to § 26.31(d)(1)(i)(D).
(i) Point of collection testing and assessment. (1) If the licensee    Paragraph (i)(1) - (3) - Under subpart K, a licensee or or other entity elects to use a point of collection testing and            other entity is not precluded from using a point of assessment device, then it may only be used for random drug and/or          collection testing and assessment (POCTA) device for alcohol testing using urine or oral fluid as the test specimen and only    initial drug and alcohol testing. Using the proposed for screening. A forensic toxicologist must review and document their      framework, subpart M enables the use of POCTA for only evaluation that the validity, accuracy, and precision of the device for    oral fluid and urine specimens and only for random alcohol and/or all the drugs and drug metabolites listed in §§ 26.161      testing. This test methodology is acceptable because the and 26.163 is comparable to the performance achieved by initial            individuals subject to testing have already been subject to testing conducted using a similar technology at an HHS-certified            pre-access/pre-assignment drug and alcohol testing and laboratory before its use.                                                  were evaluated by the licensee or other entity and found (2) If the performance of the point of collection testing and          to be acceptable to perform those duties and assessment device used for random testing is not comparable to that        responsibilities making them subject to Part 26. The achieved from initial testing conducted by an HHS-certified laboratory      confidence afforded by a licensee or other entity pre-35
 
as determined by the forensic toxicologist, then the licensee or other access drug screening, hiring, and implementing NRC entity must propose a mitigating strategy to maintain program          regulations to grant, restore, or maintain unescorted effectiveness to the NRC and obtain NRC approval under                access to the NRC-licensed facility or sensitive
§ 26.603(e)(2) before its use.                                        information helps provide assurance that reasonable reductions in accuracy and precision of the POCTA device would not be averse to the overall effectiveness of the FFD program. Furthermore, the individual is required to take FFD training (§ 26.608) and is subject to behavioral observation (§ 26.609).
The proposed requirements enable licensees and other entities to use POCTA devices if their evaluation demonstrates that its use does not reduce program effectiveness. The device would typically provide a visual indication (e.g., color or a highlighted line) to reveal whether a drug or drug metabolite exceeded its initial test cutoff as listed in § 26.163(a), or as found to be comparable by the § 26.603 change control process.
Many devices also test for adulterants and subversion attempts and this would be required for the forensic toxicologists assessment of comparable equivalency to the urine specimen drug testing program.
It would be the licensees or other entitys responsibility to demonstrate that its intended use of a POTCA device is comparable to testing conducted by an HHS-certified laboratory. A comparable analysis is considered acceptable because both test processes (point of collection testing device and initial testing at a laboratory) provide an indication (above a pre-established setpoint) whether the individual may possibly be impaired, may be using an illegal drug, may have a concentration of a drug or drug metabolite indicative of illicit use, or may indicate that the specimen is adulterated or subverted. From this initial test, if any initial test cutoff is exceeded, additional (i.e., confirmatory) testing is required at the HHS-certified 36
 
laboratory under § 26.607(i)(3). A finding that the devise is comparable is also based on the fact that accuracy, precision, and repeatability are not requirements in Part 26 for any drug test.
(3) If the use of a point of collection testing and assessment      Paragraph (i)(3) provides the immediate actions for the device indicates a test result that exceeds the initial test cutoff and/or licensees and other entity to ensure that the individual is indicates that the specimen is invalid or the individual subverted the    removed from all activities making him/her subject to the drug or alcohol test, the individual must be immediately removed from      rule and is immediately subject to a drug test that provides duties, responsibilities, and access making him/her subject to this        quantified confirmatory test results from which an FFD subpart, and subject to an immediate drug/alcohol test using the          policy violation may be issued. Paragraph (i)(3) also alcohol testing process in paragraph (c)(2) of this section for a          requires that if the individual screens position on a positive alcohol screen and either oral fluid or urine by a collection kit POTCA device, a second specimen must be obtained by that is not a point of collection testing and assessment device for a      the individual to facilitate validity (if required), initial, and positive drug, drug metabolite, adulterated, substituted, or invalid drug  confirmatory testing be conducted at an HHS certified screen, that enables validity, if required, initial, and confirmatory      laboratory.
testing by an HHS-certified laboratory.
(j) Blood Testing. The testing of blood specimens may only be        Paragraph (j) - Using a blood specimen for drug testing is conducted under the order of the licensee- or other entity-designated      currently allowed in Part 26, but only for certain medical Medical Review Officer for a valid medical reason as confirmed by the      conditions as determined by the MRO, § 26.31(d)(5).
Medical Review Officer pursuant to § 26.31(d)(5). This testing must        However, the requirement is clarified to ensure that a be subject to testing by a laboratory that meets quality control          licensee- or other entity-designated MRO is used and not requirements that are comparable to those required for certification by    one designated by a 3rd party. This MRO requirement is the HHS (e.g., a hospital certified by the State, Commonwealth, or        important because subpart M, like subpart K, enables the territory).                                                                use of a hospital for the collection of biological specimen for drug and alcohol testing. A medical doctor or MRO, who is not familiar with Part 26 requirements, may not implement a review required by Part 26.
(k) Custody and Control Form. For the collection of urine and oral  Paragraph (k) - This requirement to use an Office of fluid specimens, the licensee and other entity must use a custody and      Management and Budget approved and valid federal control form approved by the U.S. Office of Management Budget. For        custody and control form is based on current Part 26 the use of a point of collection testing and assessment device, the        requirements. Since subpart M enables the use of point licensee or other entity shall implement a licensee or other entity        of collection testing and assessment devices for random approved and maintained procedure that ensures the reliability of the      testing, the licensee or other entity must implement a 37
 
tracking, handling, and storage of a specimen from the point of          process/procedure that ensures the specimen collected is specimen collection to final disposition of the specimen and the        uniquely assigned to the donor.
reliability of an identification system to uniquely assign the specimen to the donor.
(l) Medical Review Officer. Licensees or other entities shall (1) Require their designated Medical Review Officer (MRO) to        Paragraph (l)(1). This provision is based on § 26.405(g).
review positive, adulterated, substituted, invalid, and dilute confirmatory drug and validity test results to determine whether the donor has violated the FFD policy for urine and oral fluid specimens.
The review must be completed before reporting the results to the individual designated by the licensee or other entity to perform the suitability and fitness evaluations required under § 26.619, or, if required, that are described in subpart H of this part.
(2) Require their MRO to meet the requirements in § 26.183 and,    Paragraph (l)(2) - This helps ensure that MRO reviews are prior to conducting any activities under this part, to attend and pass a consistent with those at other NRC-licensed facilities medical- or clinical-based training session to improve his/her          subject to Part 26 and that the MRO has and maintains knowledge of MRO duties and responsibilities, drug and alcohol          knowledge of drug collection, testing and evaluation. This testing processes and procedures, and evaluation of drug testing        is necessary because of the flexibilities afforded to Part 53 results. This training session must be conducted by a nationally-        licensees or other entities to collect, test, and assess recognized MRO training and certification organization that has been    alternative biological specimens for the presence of drugs assessed by the NRC to include § 26.185 requirements. The MRO            or drug metabolites.
must also attend a medical- or clinical-based training session on a triennial basis to improve his/her knowledge of changes in drug and alcohol testing processes/procedures and evaluation of drug testing results.
(3) Require their MRO to determine whether a biological            Paragraph (l)(3) - This helps ensure that MRO decisions specimen is positive, adulterated, substituted, invalid, or dilute by    are informed with appropriate regulatory requirements and implementing the requirements in § 26.185. If § 26.185 is insufficient  medical- or clinically-based information. Section 26.185 is to make this determination, the guidance issued by State (in which the  a requirement in Part 26, subpart H, that MROs must NRC-licensed facility resides) or Federal agencies or nationally        follow while assessing drug test results to ensure recognized MRO training and certification organizations may be used      consistency, program effectiveness, and worker to inform an MRO determination.                                          protection.
(4) Require their MRO to determine and approve the use of oral fluid or urine as an alternative biological specimen when the donor cannot provide a specimen for testing. This determination and the 38
 
retest shall be completed as soon as reasonably practicable and documented.
(m) Limitations of testing. Specimens collected under NRC                Paragraph (m) - This requirement is based on regulations may only be designated or approved for testing as                  § 26.31(d)(6) and is a worker protection consideration.
described in this part and may not be used to conduct any other analysis or test without the written permission of the donor. Analyses and tests that may not be conducted include, but are not limited to, DNA testing, serological typing, or any other medical or genetic test used for diagnostic or specimen identification purposes. No biological specimens may be collected and or tested in a manner different than described in this subpart.
§ 26.608 FFD Program Training                                                  The preliminary proposed rule text for the FFD training (a) FFD Program Training. (1) Individuals must be trained in the        program in subpart M does not use the prescriptive FFD policy and procedure and their FFD program responsibilities.              training requirements in § 26.29, Training, and modeled These responsibilities include reporting for work, either on or offsite, in    on the framework presented in 10 CFR 50.120, Training a physiological and psychological condition that enables the safe and          and qualification of nuclear power plant personnel.
competent performance of assigned duties and responsibilities and informing licensee- or other entity-designated individual when the            Paragraph (a)(1). The proposed text makes clear that the individual determines that this cannot be accomplished.                        training shall include the individuals responsibility to not only report FFD concerns about others but to report for work fit for duty and to inform a licensee-or other-designated individual that he/she cannot or may not be able to safely and competently perform assigned duties and responsibilities.
(2) FFD program training must include training on the behavioral        Paragraph (a)(2) - This proposed requirement is based, in observation program (BOP). The BOP training must include the                  part, on § 26.33, Behavioral observation, and includes a detection of physiological or physiological behaviors or conditions that      training element and the security-related behavioral may indicate                                                                  observation requirements in § 73.120. The inclusion of (i) possible use, sale, or possession of illegal drugs or illicit drugs, elements from § 26.33 and § 73.120 is necessary or substance abuse on or off site;                                            because § 26.608 applies during construction, operation, (ii) use or possession of alcohol on site or use while on duty off      and decommissioning. The specific § 73.120 element is site;                                                                          in § 26.608(a)(2)(iv) since drug and alcohol impairment (iii) impairment from fatigue or any cause that, if left unattended,    could result in aberrant behavior or changes in behavior could result in inattentiveness or human errors; and                          indicative of the individual not being trustworthy or reliable. The phrase or illicit drug or substance abuse is 39
 
(iv) an individuals inability to safely and competently perform    from operating experience that demonstrates individuals assigned duties and responsibilities or act in a trustworthy and reliable have reported to work under the influence of over-the-manner while having access to protected areas, NRC-licensed              counter drugs or chemical substances that can cause material, or sensitive information.                                      impairment.
(3) Training must explain that an individuals FFD policy violation  Paragraph (a)(3) - This requirement helps ensure that will                                                                    individuals subject to the FFD program understand that (i) subject the individual to an FFD program-required sanction      FFD policy violations would result in an FFD program designed to preclude recurrence of an FFD policy violation;              sanction and that program information learned or (ii) contribute to the licensees or other entitys assessment of    generated by FFD program implementation would be whether the individual can be trusted and relied upon to safely and      used to aid licensee or other entity authorization competently perform the assigned duties and responsibilities making      determinations and be shared, as requested, with other him or her subject to this subpart;                                      licensees or other entities subject to Parts 26 and 73.
(iii) be used to inform the licensees or other entitys access      This requirement is therefore a worker protection authorization and insider mitigation programs under Part 73, if          consideration (because the worker would understand how applicable; and,                                                          FFD program information would be used) and a program (iv) be used to inform other NRC licensees and other entities        effectiveness requirement because it helps ensure that subject to Part 26 when FFD program information is requested to          Part 26 and 73 implementation by other licensees or other support authorization determinations under Part 26, subpart C, or        entities are informed with information on an individuals
§§ 73.56 or 73.120.                                                      ability to follow licensee instructions and safely and competently perform assigned duties and responsibilities in a trustworthy and reliable manner.
(b) Training Periodicity. Training must be conducted before pre-    Paragraph (b) - This is a worker protection requirement.
access/pre-assignment testing and refresher training must be              The periodicity is based on § 50.120, Training and conducted periodically.                                                  qualification of nuclear power plant personnel.
(c) Training Review. The FFD training program must be                Paragraph (c) - The periodicity is based on § 50.120, periodically evaluated and revised as appropriate to reflect industry    Training and qualification of nuclear power plant experience as well as applicable changes to the regulations in this      personnel.
part and specimen collection and testing processes implemented by the licensee or other entity.
§ 26.609 Behavioral observation.                                          Section 26.609 is based on the behavioral observation (a) Licensees and other entities shall ensure that the individuals  program (BOP) requirements in § 26.33 Behavioral who are subject to this subpart are subject to behavioral observation    observation, but is provided for separately in subpart M because § 26.609 applies during construction, operation, 40
 
and that behavioral observation is performed by all individuals subject    and decommissioning for all licensees and other entities to this subpart.                                                          subject to subpart M. The principle behavioral observation (b) Licensees and other entities shall require all individuals      requirement is to observe individuals, and report if human subject to the FFD program to report to the licensee- or other entity-    performance concerns are identified and this is an designated official behaviors or activities by individuals subject to this element in §§ 26.33 and 26.407. Additionally, paragraph part, that occur on or offsite, that may constitute an unreasonable risk  (c) includes elements from the behavioral observation to the safety or security of the NRC-licensed facility or materials or    program required by the access authorization program may cause harm to individuals. This reporting must include any            described in § 73.120.
information relating to character or reputation indicating that the observed individual cannot be trusted or relied upon to perform those      Section 26.33 use of the phrase FFD concerns was duties and responsibilities or maintain access to NRC-licensed            replaced with behaviors or activities, on or offsite, that facilities or sensitive information.                                      may constitute an unreasonable risk to the safety and (c) Behavioral observation shall be performed visually, in-person    security of the licensees facility, including character or or remotely by video, to observe the behavior of individuals in the        reputation indicating that the observed individual cannot workforce subject to the requirements in this subpart, and to detect      be trusted or relied upon to perform those duties and and promptly report to plant supervision aberrant behavior or changes      responsibilities or maintain access to NRC-licensed in behavior that might adversely reflect on an individuals fitness or    facilities or sensitive information.
trustworthiness and reliability.
The NRC staff intends to propose regulatory guidance for behavioral observation that would include examples of behaviors, activities, character, or reputation that should be reported to license- or other entity-designated persons.
These examples may include, but are not limited to: sale, use, or possession of illegal drugs; threats to cause harm to facilities or people; threats to aid or abet a threat to the facility, people, NRC-licensed material, or sensitive information.
§ 26.610 Sanctions.                                                        Section 26.610 is based on § 26.409, Sanctions. The Licensees and other entities that implement an FFD program          wording was modified to align with the Part 53 FFD under this subpart shall establish sanctions for FFD policy violations    program. For example, the phrase unless or until the that, at a minimum, prohibit the individuals specified in § 26.602 from    licensee or other entity determines that the individual's being assigned to perform or direct those duties and responsibilities      condition or behavior does not pose a potential risk to making them applicable to this subpart. The severity of the sanction      public health and safety or the common defense and must escalate with the number of occurrences and severity of the          security, was removed because a sanction must be FFD policy violation, with a permanent denial of access to the NRC-        administered for an FFD policy violation to help deter future FFD policy violations (i.e., positive drug tests, 41
 
licensed facility for three FFD policy violations or any subversion      subversions, and impairment while working at the NRC-attempt.                                                                licensed facility) and a sanction facilitates counseling, training, rehabilitation, and/or treatment prior to the licensee reinstating the individuals access to the facility.
The last sentence states that the sanction must account for the severity of the FFD policy violation (this is partly based on § 26.75(b) and (c)) and the number of FFD policy violations (this is partly based on § 26.75(e)(1) and (2) and (g).
§ 26.611 Protection of information.
(a) Licensees and other entities that collect personal information  Paragraph 26.611(a) is based on § 26.411, Protection of about an individual for the purpose of complying with this subpart      information. The phrase FFD programs must maintain shall establish and maintain a system of files and procedures to        and use such records with the highest regard for protect the personal information.                                        individual privacy, was removed because the term highest regard for individual privacy is not defined.
(b) Licensees and other entities shall obtain a signed consent that Paragraph (b) - This requires that the consent-to-test shall documents the individuals acceptance of being subject to the FFD        be signed by the individual before making him or her program and authorizes the disclosure of the personal information        subject to the FFD program. This proposal is to enhance collected and maintained under this subpart, except for disclosures to  an individuals knowledge of why he or she is being tested the individuals and entities specified in § 26.37(b)(1) through (b)(6),  and what the drug and alcohol testing information would (b)(8), and persons deciding matters under review in § 26.613. This      be used for by the licensee or other entity before the Part signed and dated consent shall be obtained before making the            26-required test. This is a worker protection individual subject to the FFD program.                                  enhancement.
§ 26.613 Review process.                                                Section 26.613 is based on the requirements in subpart K, Licensees and other entities that implement an FFD program          § 26.413, Review process. The wording was modified to under this subpart shall establish and implement procedures for the      align with the Part 53 FFD program. The phrase review review of a determination that an individual in § 26.602 has violated    process is consistent with that of an appeals process.
the FFD policy. The procedure must provide for an objective and impartial review of the facts related to the determination that the individual has violated the FFD policy.
§ 26.615 Audits                                                          Section 26.615 is based on § 26.415, Audits.
(a) Licensees and other entities that implement an FFD program under this subpart shall ensure that audits are performed to ensure the continuing effectiveness of the FFD program, including FFD 42
 
program elements that are provided by C/Vs, and the FFD programs of C/Vs that are accepted by the licensee or other entity.
(b) Each licensee and other entity shall ensure that FFD program      Paragraph (b) - This would require licensee and other elements that are not part of the FFD program performance and              entities to revise their audit program based on the results monitoring review described in § 26.603(d) are audited at a frequency      of its FFD performance monitoring program.
that ensures their continuing effectiveness and that corrective actions are taken to resolve any problems identified. The subject matter,          A non-prescriptive and performance-based audit program scope, and frequency of audits must be revised as necessary to              that would be implemented to supplement the FFD improve or maintain program performance based on findings resulting        performance monitoring requirement is consistent with from licensee or other entity implementation of its FFD performance        NRC generic efforts to establish performance-based and monitoring and review program in § 26.603(d).                              risk-informed regulatory requirements. For comparison purposes only, the NRC staff notes that Part 50 requires auditing four times: twice for security plans in §§ 50.34(c)(3) and 50.54(p)(4) and then in Criteria XVII and XVIII of Part 50, Appendix B, quality assurance program requirements.
(c) Licensees and entities may conduct joint audits or accept          Paragraph (c) - This requirement is based on § 26.415(b).
audits of C/Vs so long as the audit addresses the relevant C/Vs' services.
(d) Licensees and other entities need not audit HHS-certified          Paragraph (d) - This requirement is based on § 26.415(c);
laboratories if their panel of drugs and drug metabolites to be tested is  however, it was revised to remove its reference to 49 CFR equivalent to that by which the laboratory is certified by HHS.            Part 40, "Procedures for Department of Transportation Licensees and other entities shall audit any hospital or other facility    Workplace Drug and Alcohol Testing Programs" (65 FR licensed by the State (or State-designated entity) if used to conduct      41944; August 9, 2001) and to align with the Part 53 FFD specimen collections and perform alcohol testing under this part on a      program. Additionally, an audit requirement is proposed biennial basis to provide reasonable assurance that the facility            to ensure that collection facility procedures are procedures are comparable to those described in subpart E,                  comparable to that required in Part 26.
Collecting Specimens for Testing, for urine and oral fluid, of this part.
§ 26.617 Recordkeeping and reporting                                        Section 26.617 is based on the requirements in § 26.417, (a) Licensees and other entities that implement FFD programs          Recordkeeping and reporting. However, if the Part 53 under this subpart shall ensure that records pertaining to the              facility operates under an FFD program described in administration of the program, which may be stored and archived            § 26.605, the licensee must implement subpart N electronically, are maintained so that they are available for NRC          Recordkeeping and Reporting Requirements, which would inspection purposes and for any legal proceedings resulting from the        align with the requirements placed on other licensees and 43
 
administration of the program. FFD performance data required by          other entities subject to Part 26, namely those facilities
§ 26.617 shall be retained until license termination.                    licensed under Parts 50, 52, and 70. This is necessary to support consistent FFD program performance (b) Licensees and other entities shall make the following reports:  assessments by licensees, NRC oversight, and NRC-required authorization requirements.
(1) Reports to the NRC Operations Center by telephone within        Paragraph (b)(1) - This requirement parallels the reporting 24 hours after the licensee or other entity discovers any intentional act requirements in § 26.417, Recordkeeping and reporting.
that casts doubt on the integrity of the FFD program and any              The wording was modified to align with a Part 53 FFD programmatic failure, degradation, or discovered vulnerability of the    program.
FFD program that may permit undetected drug or alcohol use or abuse by individuals who are subject to this subpart. These events must be reported under this subpart, rather than under the provisions of § 73.71; and (2) Annual program performance reports for the FFD program,          Paragraph (b)(2). This paragraph is based on the annual including the FFD program performance data listed in § 26.717(b), as      program performance requirement in § 26.417, applicable. Licensees and other entities shall submit FFD program        Recordkeeping and reporting. However, the performance data (for January through December) to the NRC                requirement was modified to apply to the Part 53 FFD annually, before March 1 of the following year and shall use NRC          program and to clarify the reporting period and milestone.
Forms 890, Single Positive Test Form, and 891, Annual Reporting for Drug and Alcohol Tests.                                                  A new requirement is proposed that licensees must use the NRC electronic reporting forms. This is necessary to account for the flexibilities in drug testing afforded to Part 53 licensees and to ensure consistent operating experience data in the advance reactor, Category I fuel cycle facility, and existing light water reactor communities.
Operating experience has demonstrated that 100 percent of all current licensees subject to Part 26 use the NRCs forms and its electronic reporting system to annually report FFD performance data to the NRC. The use of this system informs licensee audits and correctives and represent a low burden to complete, store, and submit.
Use of the forms should also enhance the subpart M FFD performance monitoring program, and NRC oversight because it aids consistency and clarity of reported data.
The NRC staff finds that the use of Form 891, Annual 44
 
Reporting Form for Drugs and Alcohol, should also aid the licensees biennial FFD program performance review required by § 26.603(b)(3) because much of the data on this form is applicable to a performance monitoring program.
(c) Licensees and other entities subject to this subpart shall      Paragraph (c) - This requirement helps ensure that describe in sufficient detail an individuals FFD policy violation (while FFD-related information is shared within the commercial protecting privacy information under § 26.611) and FFD program            nuclear industry. This helps ensure that individuals who weakness to NRC licensees and other entities subject to Part 26          become employed by another NRC-licensed facility when requested to support authorization determinations under with        subject to FFD (10 CFR Part 26, subpart C) and access Part 26, Subpart C, or § 73.56, or to support licensee or other entity    (10 CFR 73.56) authorization requirements complete their performance monitoring.                                                  licensee-administered NRC-required sanctions and implementation of drug and/or alcohol abuse treatment plans before the restoration of authorization.
§ 26.619 Suitability and fitness determinations                          Section 26.619 is based on § 26.419, Suitability and Licensees and other entities that implement FFD programs under      fitness determinations.
this subpart shall develop, implement, and maintain procedures for evaluating whether to assign individuals to perform or direct those duties and responsibilities making them subject to this subpart. These procedures must provide reasonable assurance that the individuals are fit to safely and competently perform their duties, and are trustworthy and reliable, as demonstrated by the avoidance of substance abuse.
NOTE: The proposed amendments in the following sections are conforming and enable Part 53 FFD programs.
Subpart B  Program Elements
§ 26.21 Fitness-for-duty program.                                        This section is amended to apply to licensees and other (a) The licensees and other entities specified in § 26.3(a) through  entities described § 26.3(f) should they chose to (c) shall establish, implement, and maintain FFD []                      implement an FFD program that implements all Part 26 (b) The licensees and other entities specified in § 26.3(f) that do  requirements, except those in subpart M. Also, the not implement the requirements in subpart M, shall implement the          applicability statement is proposed to be split into two requirements in this subpart.                                            smaller paragraphs for clarity.
Subpart C  Granting and Maintaining Authorization
§ 26.51 Applicability                                                    This section is amended to apply to licensees and other entities described § 26.3(f). Also, the applicability 45
 
(a) The requirements in this subpart apply to the licensees and        statement is proposed to be split into two smaller other entities identified in § 26.3(a), (b), and, as applicable, (c) for the paragraphs for clarity.
categories of individuals in § 26.4(a) through (d), and, at the licensee's or other entity's discretion, in § 26.4(g) and, if necessary,
§ 26.4(j) . . .
(b) The requirements in this subpart apply to the FFD programs of licensees and other entities identified in § 26.3(f) for the categories of individuals in § 26.602 that elect not to implement the requirements in subpart M and those licensees and other entities that elect to implement the requirements in § 26.605.
§ 26.53 General provisions.                                                  Section 26.53(e) and (e)(1) and (3), (g) - (i) are amended to apply to licensees and other entities described (e) Licensees and other entities in § 26.3(a) through (c), and, if      § 26.3(f).
applicable, (f) may also rely on a C/Vs FFD program []
(1) A C/Vs FFD program may grant and maintain an individuals authorization, as defined in § 26.5, under the C/Vs FFD program.
However, only a licensee or other entity in § 26.3(a) through (c), and if applicable, (f) may grant or maintain []
(3) If an individual is maintaining authorization under a C/Vs FFD program, a licensee or other entity in § 26.3(a) through (c), and if applicable, (f) may grant authorization []
(g) The licensees and other entities specified in § 26.3(a) and, as applicable, (c), and (d), and (f) shall identify any violation []
(h) The licensees and other entities specified in § 26.3(a) and, as applicable, (c), and (d), and (f) []
(i) The licensees and other entities specified in § 26.3(a) and, as applicable, (c), and (d), and (f) shall inform, in writing, any individual who is applying for []
§ 26.63 Suitable inquiry                                                    This section is amended to apply to licensees and other entities described § 26.3(f).
(d) When any licensee or other entity in § 26.3(a) through (d),
and, if applicable, (f) is legitimately seeking the information []
46
 
Subpart DManagement Actions and Sanctions To Be Imposed
§ 26.73 Applicability.                                                      This section is amended to apply to licensees and other (a) The requirements in this subpart apply to the licensees and        entities described § 26.3(f). Also, the applicability other entities identified in § 26.3(a), (b), and, as applicable, (c) for the statement is proposed to be split into two smaller categories of individuals specified in § 26.4(a) through (d) and (g) []    paragraphs for clarity.
(b) The requirements in this subpart apply to the FFD programs of licensees and other entities identified in § 26.3(f) for the categories of individuals in § 26.602 that elect not to implement the requirements in subpart M and those licensees and other entities that elect to implement the requirements in § 26.605.
Subpart ECollecting Specimens for Testing
§ 26.81 Purpose and applicability.                                          This section is amended to apply to licensees and other (a) This subpart contains requirements for collecting specimens        entities described § 26.3(f). Also, the applicability for drug testing and conducting alcohol tests by or on behalf of the        statement is proposed to be split into two smaller licensees and other entities in § 26.3(a) through (d) for the categories    paragraphs for clarity.
of individuals specified in § 26.4(a) through (d) and (g) []
(b) The requirements in this subpart apply to the FFD programs of licensees and other entities identified in § 26.3(f) for the categories of individuals in § 26.602 that elect not to implement the requirements in subpart M and those licensees and other entities that elect to implement the requirements in § 26.605.
Subpart IManaging Fatigue
§ 26.201 Applicability.                                                      This section is amended to apply to licensees and other (a) The requirements in this subpart, with the exception of            entities described § 26.3(f). Also, the applicability
§ 26.202, apply to the licensees and other entities identified in            statement is proposed to be split into two smaller
§ 26.3(a); if applicable, (c) and (d); and (f), for licensees and other      paragraphs for clarity.
entities not implementing the requirements in subpart M. For these licensees and other entities, the requirements in §§ 26.203 and 26.211 apply to the individuals identified in § 26.4 (a) through (c). In addition, the requirements in § 26.205 through § 26.209 apply to the individuals identified in § 26.4(a).
(b) The requirements in this subpart, with the exception of
§ 26.203, apply to the licensees or other entities identified in § 26.3(f) implementing this subpart in accordance with § 26.605. For these licensees and other entities, the requirements in §§ 26.202 and 47
 
26.211 apply to the individuals identified in § 26.4 (a) through (c) and, as applicable, any Certified Operator; and the requirements in
§ 26.205 through § 26.209 apply to the individuals identified in
§ 26.4(a).
§ 26.202 General provisions for acilities licensed under Part 53          This section is based on § 26.203, General provisions, (a) Policy. Licensees shall establish a policy for the management    as applied to licensees or other entities described in of fatigue for all individuals who are subject to the licensees FFD      § 26.3(f). The amendments to the requirements are program and incorporate it into the written policy required in            proposed because the § 26.203 general provisions refer
§ 26.606(a).                                                              to various requirements (26.2X, 26.3X, or 26.4X, under (b) Procedures. In addition to the procedures required in            subpart B of Part 26), which would not be applicable to
§ 26.606(b), licensees shall develop, implement, and maintain              facilities licensed under Part 53 that implement subpart M, procedures that                                                          given that the new requirements in subpart M replace the (1) Describe the process to be followed when any individual          subpart B requirements applied to sites licensed under identified in § 26.4(a) through (c) makes a self-declaration that he or    Part 50 and Part 52.
she is not fit to safely and competently perform his or her duties for any part of a working tour as a result of fatigue. The procedure          The proposed requirements in Section 26.202 are must                                                                      essentially identical to the existing provisions listed in (i) Describe the individuals and licensees rights and              § 26.203, with the exception of the revised references to responsibilities related to self-declaration;                              account for the newly developed sections in subpart M.
(ii) Describe requirements for establishing controls and conditions under which an individual may be permitted or required to perform          This approach would also allow the NRC to work after that individual declares that he or she is not fit due to      reconsider/revise general provisions for facilities licensed fatigue; and                                                              under Part 53, as appropriate, based on feedback (iii) Describe the process to be followed if the individual disagrees received during the period when we are receiving with the results of a fatigue assessment that is required under            input/comment period from public stakeholders.
§ 26.211(a)(2);
(2) Describe the process for implementing the controls required under § 26.205 for the individuals who are performing the duties listed in § 26.4(a);
(3) Describe the process to be followed in conducting fatigue assessments under § 26.211; and (4) Describe the disciplinary actions that the licensee may impose on an individual following a fatigue assessment, and the conditions and considerations for taking those disciplinary actions.
(c) Training and examinations. Licensees shall add the following      Paragraph (c) - The staff proposed to not include a KAs to the content of the training that is required in § 26.608:          comprehensive training requirement for licensees and 48
 
(1) Knowledge of the contributors to worker fatigue, circadian      other entities described in § 26.3(f).
variations in alertness and performance, indications and risk factors for common sleep disorders, shiftwork strategies for obtaining adequate rest, and the effective use of fatigue countermeasures; and (2) Ability to identify symptoms of worker fatigue and contributors to decreased alertness in the workplace.
(d) Recordkeeping. Licensees shall retain the following records for at least 3 years or until the completion of all related legal proceedings, whichever is later:
(1) Records of work hours for individuals who are subject to the work hour controls in § 26.205; (2) For licensees implementing the requirements of
§ 26.205(d)(3), records of shift schedules and shift cycles, or, for licensees implementing the requirements of § 26.205(d)(7), records of shift schedules and records showing the beginning and end times and dates of all averaging periods, of individuals who are subject to the work hour controls in § 26.205; (3) The documentation of waivers that is required in
§ 26.207(a)(4), including the bases for granting the waivers; (4) The documentation of work hour reviews that is required in
§ 26.205(e)(3) and (e)(4); and (5) The documentation of fatigue assessments that is required in
§ 26.211(g).
(e) Reporting. Licensees shall include the following information in a standard format in the annual FFD program performance report required under § 26.617:
(1) A summary for each nuclear power plant site of all instances during the previous calendar year when the licensee waived one or more of the work hour controls specified in § 26.205(d)(1) through (d)(5)(i) and (d)(7) for individuals described in § 26.4(a). The summary must include only those waivers under which work was performed. If it was necessary to waive more than one work hour control during any single extended work period, the summary of instances must include each of the work hour controls that were waived during the period. For each category of individuals specified in § 26.4(a), the licensee shall report:
49
 
(i) The number of instances when each applicable work hour control specified in § 26.205(d)(1)(i) through (d)(1)(iii), (d)(2)(i) and (d)(2)(ii), (d)(3)(i) through (d)(3)(v), and (d)(7) was waived for individuals not working on outage activities; (ii) The number of instances when each applicable work hour control specified in § 26.205(d)(1)(i) through (d)(1)(iii), (d)(2)(i) and (d)(2)(ii), (d)(3)(i) through (d)(3)(v), (d)(4) and (d)(5)(i), and (d)(7) was waived for individuals working on outage activities; and (iii) A summary that shows the distribution of waiver use among the individuals applicable within each category of individuals identified in § 26.4(a) (e.g., a table that shows the number of individuals who received only one waiver during the reporting period, the number of individuals who received a total of two waivers during the reporting period).
(2) A summary of corrective actions, if any, resulting from the analyses of these data, including fatigue assessments.
(f) Audits. Licensees shall audit the management of worker fatigue as required by § 26.615.
§ 26.205 Work Hours                                                          Overall, the specific provisions for Work Hours requirements are not being changed. However, as (d) Work hour controls. Licensees shall control the work hours of        addressed in the discussion of § 26.4(a) requirements individuals who are subject to this section.                                  above, whether or not a licensee under Part 26 would need to implement work hour controls would be
[]                                                                          dependent on determinations reached by that licensees risk-informed evaluation process. (See discussion above for more details)
(7) Licensees may, as an alternative to complying with the              Paragraphs (7) and (8) - The proposed revisions update minimum days off requirements in § 26.205(d)(3), comply with the              the references, which currently refer to requirements requirements for maximum average work hours in this paragraph.                under subpart B that would not be applicable to facilities licensed under Part 53, given that the new requirements
[]                                                                          in subpart M replace the subpart B requirements for facilities licensed under Part 53.
(iii) Each licensee shall state, in its FFD policy and procedures required by § 26.27 and or § 26.606(a), in addition to § 26.203(a) and 50
 
(b), the work hour counting system in § 26.205(d)(7)(ii) the licensee is using.
[]
(8) Each licensee shall state, in its FFD policy and procedures required by § 26.27 and or § 26.606(a), in addition to § 26.203(a) and (b), the requirements with which the licensee is complying: the minimum days off requirements in § 26.205(d)(3) or maximum average work hours requirements in § 26.205(d)(7).
[]
§ 26.207 Waivers and exceptions.                                          The proposed revisions update the references, which (a) Waivers. Licensees may grant a waiver of one or more of the      currently refer to requirements under subpart B that would work hour controls in § 26.205(d)(1) through (d)(5)(i) and (d)(7), as      not be applicable to facilities licensed under Part 53, given follows:                                                                  that the new requirements in subpart M replace the subpart B requirements for facilities licensed under
[]                                                                        Part 53.
(1) To grant a waiver, the licensee shall meet both of the following requirements:
[]
(ii) A supervisor assesses the individual face to face and          Paragraph(a)(1)(ii) - The proposed revisions update the determines that there is reasonable assurance that the individual will    references, which currently refer to requirements under be able to safely and competently perform his or her duties during the    subpart B that would not be applicable to facilities additional work period for which the waiver will be granted. The          licensed under Part 53, given that the new requirements supervisor performing the assessment shall be trained as required by      in subpart M replace the subpart B requirements for
§ 26.29 or § 26.608, and in addition to § 26.202(c) or 26.203(c), and      facilities licensed under Part 53.
shall be qualified [...]
§ 26.211 Fatigue assessments.                                              The revisions proposed update the references, which (a) Licensees shall ensure that fatigue assessments are              currently point to requirements under subpart B that would conducted under the following conditions:                                  not be applicable to facilities licensed under Part 53, given (1) For cause. In addition to any other test or determination of    that the new requirements in subpart M replace the fitness that may be required under §§ 26.31(c), and 26.77, and 51
 
26.607(c), a fatigue assessment must be conducted in response to an      subpart B requirements for facilities licensed under observed condition of impaired individual alertness creating a            Part 53.
reasonable suspicion that an individual is not fit to safely and competently perform his or her duties []
(3) Post-event. A fatigue assessment must be conducted in response to events requiring post-event drug and alcohol testing as specified in § 26.31(c) or § 26.607(c). Licensees may not delay necessary medical treatment in order to conduct a fatigue assessment; and
[]
(b) Only supervisors and FFD program personnel who are trained under either §§ 26.29 and 26.203(c) or 26.608 and 26.202(c) may conduct a fatigue assessment. The fatigue assessment must be conducted face to face with the individual whose alertness may be impaired.
Subpart NRecordkeeping and Reporting Requirements
§ 26.709 Applicability.                                                  Section 26.709. This proposed change makes subpart N (a) The requirements of this subpart apply to the FFD programs      applicable to facilities licensed under Part 53.
of licensees and other entities specified in § 26.3, except for FFD programs that are implemented under subpart K of this part.
(b) The requirements in this subpart apply to the FFD programs of licensees and other entities identified in § 26.3(f) that elect not to implement the requirements in subpart M and those licensees and other entities that elect to implement the requirements detailed in
§ 26.605.
§ 26.711 General provisions.
(c) The licensees and other entities specified in § 26.3(a) and, as Paragraphs (c) and (d) - These proposed changes make applicable, (c), and (d), and (f) shall inform each individual []        this section applicable to licensees or other entities (d) Licensees and other entities shall ensure that only correct and described in § 26.3(f).
complete information about individuals [. . .] a licensee and other 52
 
entity specified in § 26.3(a) and, as applicable, (c), and (d), and (f) who has discovered the incorrect information []
53}}

Latest revision as of 12:37, 19 January 2022

Rulemaking: Proposed Rule: Discussion Table for Preliminary Rule Language for the Part 53 Rulemaking: Part 26 - Fitness for Duty Programs
ML21148A173
Person / Time
Issue date: 12/31/2021
From: Robert Beall
NRC/NMSS/DREFS/RRPB
To:
Beall, Robert
Shared Package
ML20289A534 List:
References
10 CFR Part 26, 10 CFR Part 53, NRC-2019-0062, RIN 3150-AK31
Download: ML21148A173 (53)
v • d • e


Text

THIS PRELIMINARY RULE LANGUAGE AND ACCOMPANYING DISCUSSION IS BEING RELEASED TO SUPPORT INTERACTIONS WITH STAKEHOLDERS AND THE ADVISORY COMMITTEE ON REACTOR SAFEGUARDS (ACRS). THIS LANGUAGE HAS NOT BEEN SUBJECT TO COMPLETE NRC MANAGEMENT OR LEGAL REVIEW, AND ITS CONTENTS SHOULD NOT BE INTERPRETED AS OFFICIAL AGENCY POSITIONS.

THE NRC STAFF PLANS TO CONTINUE WORKING ON THE CONCEPTS AND DETAILS PROVIDED IN THIS DOCUMENT AND WILL CONTINUE TO PROVIDE OPPORTUNITIES FOR PUBLIC PARTICIPATION AS PART OF THE RULEMAKING ACTIVITIES.

THE STAFF IS PRIMARILY SEEKING INSIGHTS REGARDING THE CONCEPTS IN THIS PRELIMINARY LANGUAGE AND SECONDARILY SEEKING INSIGHTS RELATED TO DETAILS SUCH AS NUMERICAL VALUES FOR VARIOUS CRITERIA. WHILE THE NRC WILL CONSIDER ALL COMMENTS RECEIVED IN FURTHER DEVELOPING THE PRELIMINARY LANGUAGE, IT WILL NOT PROVIDE WRITTEN RESPONSES TO THOSE COMMENTS. ONCE THE PROPOSED RULE IS ISSUED IN THE FEDERAL REGISTER, THE PUBLIC WILL HAVE AN ADDITIONAL OPPORTUNITY TO PROVIDE COMMENTS AND THE AGENCY WILL RESPOND IN WRITING TO ALL PUBLIC COMMENTS ON THE PROPOSED RULE WHEN ISSUING A FINAL RULE.

PART 26 - Fitness for Duty - PRELIMINARY RULE LANGUAGE December 2021 10 CFR Part 26, FITNESS FOR DUTY PROGRAMS Summary Statements The staff is proposing a risk-informed, performance-based approach for the application of drug and alcohol testing and fatigue management requirements for facilities licensed under Part 53.

Applicants that meet the criterion in § 53.830(a)(2)(i) of the preliminary proposed rule text would be able to implement a fitness for duty (FFD) program described in proposed new Part 26, subpart M, Fitness for Duty Programs for Facilities Licensed Under Part 53, that is similar to the requirements applied to research and test reactors. For example, drug and alcohol testing would not be required; however, other Part 26 requirements like behavioral observation and a performance monitoring program would be required.

Applicants that do not meet the criterion would be subject to an alternate FFD program that is also prescribed in subpart M, or an FFD program that implements all Part 26 requirements, except for those requirements in 10 CFR Part 26, subparts K, FFD Program for Construction, or M.

With regards to fatigue management requirements, work hour controls would be required for personnel at operating facilities in accordance with the existing scoping criteria (10 CFR 26.4). The applicability of these scoping criteria for certain individuals (such as operators and maintenance personnel) would rely on the risk evaluation performed by a given applicant, and the determined risk significance of the work being performed by a given individual.

The NRC proposes that the new subpart M apply FFD requirements to facilities licensed under Part 53, in lieu of just including Part 53 licensees in the category of licensees with facilities licensed under 10 CFR Part 50 or 52, for four principal reasons. First, subpart M would apply FFD requirements in a risk-informed, performance-based manner commensurate with the radiological risk 1

consequences presented by facilities licensed under Part 53. This regulatory strategy is consistent with that already in Part 26; however, the proposal accounts for advanced reactor designs that may present very low radiological risk when compared to that of a traditional light water reactor licensed under Part 50 or 52. Second, subpart M would enable a Part 53 licensee to implement innovative drug testing technologies while continuing to provide reasonable assurance that individuals can safely and competently perform assigned duties and responsibilities. Third, subpart M would consolidate the applicable FFD requirements. This should help stakeholders understand the proposed framework and facilitate early involvement and comment on preliminary proposed rule text. This approach also could help licensees implement the requirements. Lastly, the framework is performance-based. FFD performance monitoring is proposed where the licensee must assess its FFD performance against site-specific, FFD program, and generic industry performance. Also, a change control process is proposed to allow a licensee to change its FFD program while ensuring that FFD program effectiveness is maintained. These four reasons are consistent with the NRC white paper, Risk-Informed and Performance-Based Human-System Considerations for Advanced Reactors, and the Commissions Policy Statement on the Regulation of Advanced Reactors.

2

Preliminary Proposed Language Black text is existing language in Part 26 Discussion Red text is preliminary proposed rule language Subpart A - Administrative Provisions

§ 26.3 Scope Proposed § 26.3(f) places Part 53 licensees or other

.. entities within the scope of Part 26. Note that Part 26 (f) Before construction, licensees and other entities that have uses the terminology licensees and other entities as applied for or have been issued a license under Part 53, Licensing defined in § 26.5.

and Regulation of Advanced Nuclear Reactors, shall implement the requirements in subpart M or all the requirements of this part except The FFD framework for facilities licensed under Part 53 subparts K and M. Licensees and other entities who have received a does not allow Part 53 licensees to implement the manufacturing license under Part 53 must implement the requirements in subpart K, FFD program for construction.

requirements in subpart M or all the requirements of this part, except The principal reasons are that subpart K (1) would not subparts K and M, before the loading of nuclear fuel in a reactor apply to manufacturing licensees who fabricate and fuel a vessel module. reactor vessel module; (2) only applies during construction, whereas subpart M applies during construction and operation; (3) does not address training, authorization, and Medical Review Officer performance; (4) has less rigor in the protection of worker rights and sensitive information; and (5) is not consistent with recent Commission position on the use of performance-based regulations.

§ 26.4 FFD program applicability to categories of individuals Section 26.4 is very specific as to its applicability to (a) All persons who are granted unescorted access to nuclear individuals who perform certain duties and responsibilities power reactor protected areas by the licensees in § 26.3(a) and, as or who are afforded certain types of access to protected applicable, (c) and perform the following duties shall be subject to an areas, materials, or information. This section would be FFD program that meets all of the requirements of this part, except revised to account for the types of individuals working at a subpart K of this part, and those persons who are granted unescorted facility licensed under Part 53 who must be subject to an access to nuclear power reactor protected areas by the licensees and FFD program. The NRC expects that not all categories of other entities in § 26.3(f) and perform the following duties shall be individuals described in this section would be applicable to subject to an FFD program that meets the requirements in subpart M, all Part 53 facilities, but the proposed changes cover all unless the licensee or other entity subjects these individuals to an individuals currently within the scope of consideration.

FFD program that meets all of the requirements of this part except for those requirements in subparts K and M. Paragraph (a) - This is the applicability paragraph for certain individuals during reactor operation. This 3

paragraph is an example of how a licensee makes a risk-informed determination whether to apply its FFD program to the categories of individuals in this paragraph.

(1) Operating or onsite directing of the operation of systems and Paragraph (1) - For Part 53 applicants, this existing components that a risk-informed evaluation process has shown to be scoping criterion will ensure that Certified Operators, as significant to public health and safety; defined in § 26.5 below, and NRC-licensed reactor operators are subject to fatigue management controls, including work hour controls, when the actions they are performing are risk-significant.

In the accompanying NRC guidance under development, the staff is considering offering flexibility in the application of current work hour controls for reactor operators at Part 53 sites in cases where those licensees can demonstrate, through their risk-informed evaluation process, that operator actions are not relied upon to protect the public health and safety or the environment. The NRC plans to ensure that its guidance will be informed by the criteria listed in § 53.755(a).

Additionally, in some instances, work hour controls may only be applicable during certain operations evolutions that are determined to be significant to public health and safety. For example, a plants risk-informed evaluation could determine that plant safety during the startup of a facility relies on manual action, while periods of normal operation do not. In such instances, operators would need to be subject to work hour controls during the startup period; however, during periods of normal operation, where plant safety can be achieved via automated safety systems and other design features of the plant, operators would not be subject to work hours restrictions.

Applicants that intend to not apply work hour controls to operators during any period while the plant is operating 4

would need to provide sufficient justification in their risk-informed evaluations.

Additionally, for facilities licensed under Part 53 that perform operations activities from a remote facility (for example, a remote control room/station/console), such a remote facility would be considered to be an extension of the site for the purposes of considering onsite directing throughout § 26.4(a).

(2) Performing health physics or chemistry duties required as a Paragraphs (2) and (3) - For certain advanced reactor member of the onsite emergency response organization minimum designs, it may be the case that there will be no shift complement; individuals who perform these duties.

(3) Performing the duties of a fire brigade member who is responsible for understanding the effects of fire and fire suppressants on safe shutdown capability; (4) Performing maintenance or onsite directing of the Paragraph (4) - This duty, as written, scopes in personnel maintenance of SSCs that a risk-informed evaluation process has performing work on equipment non-safety-related but shown to be significant to public health and safety; and safety significant or relied upon to meet certain criteria (including maintenance work on automated instrumentation and controls, passive systems, etc.).

For instance, workers responsible for conducting surveillance tests required by plant Technical Specifications would need to be under work hours controls. It should be noted that the current Part 26 guidance pertaining to the interpretation of maintenance limits the applicability of this criterion to maintenance activities that change the state or condition of the SSC.

This guidance may need to be revised to incorporate other maintenance activities (for example, non-destructive examination) that will be relied upon to provide a basis for operability of SSCs important to safety.

5

In instances where applicants intend to not apply work hour controls to individuals performing maintenance activities, those applicants would need to provide sufficient justification in their risk-informed evaluations.

Additionally, for facilities licensed under Part 53 that maintain or control equipment that is important to safety at a remote facility (for example, a remote control room or control station/console), such a remote facility would be considered to be an extension of the site for the purposes of considering onsite direction.

(5) Performing security duties as an armed security force officer, Paragraph (5) - Part 53 sites that require security alarm station operator, response team leader, or watchman, personnel would need to ensure that work hour controls hereinafter referred to as security personnel. are administered for those personnel.

(b) All persons who are granted unescorted access to nuclear Paragraph (b) - This is the applicability paragraph for power reactor protected areas by the licensees in § 26.3(a) and, as individuals who have access to the protected area. This applicable, (c) and who do not perform the duties described in requirement helps ensure the defense-in-depth regulatory paragraph (a) of this section shall be subject to an FFD program that framework that provides reasonable assurance that meets all of the requirements of this part, except §§ 26.205 through individuals who have unescorted access are trustworthy 26.209 and subpart K of this part. All persons who are granted and reliable. For example, this requirement helps mitigate unescorted access to a facility licensed under Part 53, and who do not the insider threat.

perform the duties described in § 26.4(a), shall be subject to the requirements in subpart M of this part, unless the licensee or other entity implements an FFD program that meets all of the requirements of this part, except §§ 26.205 through 26.209 and subparts K and M.

(c) All persons who are required by a licensee in § 26.3(a) and, Paragraph (c) - This is the applicability paragraph for as applicable, (c) to physically report to the licensees Technical those individuals who are assigned to the EOF or TSC Support Center (TSC) or Emergency Operations Facility (EOF) by and those that direct or conduct activities remotely. Note licensee emergency plans and procedures shall be subject to an FFD that Part 53 facilities may be remotely operated or rely on program that meets all of the requirement of this part, except other facilities to fulfill the traditional role of a TSC or EOF;

§§ 26.205 through 26.209 and subpart K of this part. For licensees in therefore, new text is proposed to account for other

§ 26.3(f), all persons who are assigned by the licensee to participate facilities or remotely performed activities. Further, the use remotely and make decisions or direct actions regarding plant safety of personnel to operate, maintain, surveil, and respond to 6

and security, and all persons who are assigned by the licensee to adverse plant conditions and/or security events may be participate remotely in emergency response activities or physically different than those traditionally included in the TSC or report to the TSC or EOF (or an equivalent facility), shall be subject to EOF team.

an FFD program that meets all of the requirements described in subpart M of this part, unless the licensee or other entity implements an FFD program that meets all of the requirements of this part, except

§§ 26.205 through 26.209 and subparts K and M.

(d) []

(e) When construction activities, as defined in § 26.5, begin, any Paragraph (e) - This is the applicability paragraph for individual whose duties for the licensees and other entities in construction. Note that Part 26 already defines

§ 26.3(c) require him or her to have the following types of access or construction. The NRC will assess and align this perform the following activities at the location where the nuclear definition, if necessary, with the Part 53 definition of power plant will be constructed and operated shall be subject to an construction.

FFD program that meets all of the requirements of this part, except subparts I, K, and M of this part, and for any individual whose duties for the licensees and other entities in § 26.3(f) require him or her to the have the following types of access, perform construction activities as defined in § 26.5, or perform the following activities shall be subject to an FFD program as described in subpart M of this part or an FFD program that meets all of the requirements of this part, except subparts I, K, and M:

(1) Serves as security personnel []

(2) Performs quality assurance, quality control, or quality Paragraph (e)(2) - The NRC is proposing a revision to the verification activities related to safety- or security-related construction term safety-related as provided in § 26.5 below.

activities; (3) Based on a designation under § 26.406 by a licensee or other entity, monitors the fitness of the individuals specified in paragraph (f) of this section; (4) Witnesses or determines inspections, tests, and analyses Paragraph (e)(4) - Applicability statement.

certification required under Parts 52 or 53 of this chapter; (5) Supervises or manages the construction of safety- or security- Paragraph (e)(5) - The reference to safety-related SSCs related SSCs or the construction of SSCs that a risk-informed is being removed to more generalize this scoping language. This terminology may change for Part 53 7

evaluation process has shown to be significant to public health and licensed facilities; this may cause a conforming change to safety; or this paragraph.

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

[]

(f) Any individual who is constructing or directing the construction Paragraph (f) - This is the applicability paragraph for those of safety- or security-related SSCs activities as defined in § 26.5 shall individuals who construct or direct the construction of be subject to an FFD program that meets the requirements of subpart commercial power reactors licensed under Part 50 or 52 K, or, if applicable, subpart M of this part, unless the licensee or other in the current Part 26 rule. Since the definition of entity subjects these individuals to an FFD program that meets all of construction in § 26.5 may change for Part 53 licensed the requirements of this part, except for subparts I, K, and M. facilities, this provision may also need to change. Also, the use of terminology such as safety-related may change for Part 53 licensed facilities; this may cause a conforming change to this paragraph.

(g) All FFD program personnel who are involved in the day-to-day Paragraph (g) - This is the applicability paragraph for FFD operations of the program, as defined by the procedures of the program personnel (e.g., the FFD manager, Medical licensees and other entities in § 26.3(a) through (c), and, as Review Officer, and technicians) and persons who applicable, (d) and whose duties require them to have the following perform access authorization determinations (e.g., the types of access or perform the following activities shall be subject to licensee-designated Reviewing Official). A Part 53 an FFD program that meets all of the requirements of this part, except licensee would use FFD program personnel to implement subparts I, and K, and M of this part, and, at the licensees or other the FFD program and assigned individuals to implement entitys discretion, subpart C of this part. All personnel described, the Part 26 FFD program. However, since the staff is who have the types of access and perform those duties and proposing a risk-informed FFD program based on the responsibilities described in this paragraph at facilities licensed under requirements in subpart K, the prescriptive requirements Part 53, shall be subject to the requirements in subpart M or an FFD in Subpart B would no longer be required for licensees or program that meets all of the requirements of this part, except other entities who implement the requirements in subpart subparts I, K, and M of this part, and, at the licensees or other entitys M.

discretion, subpart C of this part.

(1) All persons who . . .

8

(h) Individuals who have applied for authorization to have the Paragraph (h) - This is the applicability paragraph for types of access or perform the activities described in paragraphs (a) individuals who have applied for authorization when through (d) of this section shall be subject to §§ 26.31(c)(1), 26.35(b), authorization becomes applicable before reactor 26.37, 26.39, and the applicable requirements of subparts C, and E operation. The regulatory concept of authorization is through H, and, if applicable M, of this part. necessary immediately before and during commercial power plant operation.

§ 26.5 Definitions Certified Operator means an individual certified under the The NRC is proposing a new category of individuals provisions of §§ 53.770 through 53.779 to manipulate a control of a called Certified Operators. The FFD program would facility. Certified operators are not licensed by the Commission. apply to these individuals. Although the definition is provided here, the NRC may elect to instead reference the definition of Certified Operator in Part 53.

Change as used in § 26.603(e) means an action that results in a The NRC is proposing a definition for the word change as modification of, addition to, or removal from, the licensees or other it is used on the § 26.603(e), FFD program change entitys FFD program. control, process. The proposed definition is consistent with that being proposed for the amended security requirements in the NRCs draft proposed decommissioning rule.

Contractor/vendor (C/V) means any company, or any individual This proposed amendment makes the definition of not employed by a licensee or other entity specified in § 26.3(a) contractor/vendor applicable to Part 53 licensees.

through (c) and (f), who is providing work or services to a licensee or other entity covered in § 26.3(a) through (c) and (f), either by contract, purchase order, oral agreement, or other arrangement.

Other entity means any corporation, firm, partnership, limited This proposed amendment makes the definition of other liability company, association, C/V, or other organization who is entity applicable to Part 53 licensees.

subject to this part under § 26.3(a) through (c) and (f), but is not licensed by the NRC.

Questionable validity means the results of validity screening or The risk-informed approach being proposed for FFD initial validity tests at a licensee testing facility indicating that a urine programs for Part 53 licensees would not preclude Part 53 specimen may be adulterated, substituted, dilute, or invalid. For a licensee use of alternative testing methodologies or Part 53 licensee, Questionable validity means the results of validity alternative biological specimens (such as oral fluid) for screening or initial validity tests that a biological specimen obtained drug testing as long as FFD program effectiveness does from an individual pursuant to subpart M may be adulterated, not diminish - see the proposed FFD performance substituted, dilute, or invalid. monitoring and review program in § 26.603(b)(3) and the FFD change control process in § 26.603(b)(4).

9

Reduction in FFD program effectiveness means a change or The NRC is proposing a definition for reduction in FFD series of changes to an element of the FFD program that reduces or program effectiveness because this phrase is used in eliminates the licensees ability to meet or maintain site-specific FFD proposed requirement § 26.603(e). The proposed program performance when compared to historical site-specific definition is generally consistent with that being proposed performance, the licensees fleet-level program performance, or for the amended security requirements in the NRCs generic industry performance. proposed decommissioning rule, Regulatory Improvements for Production and Utilization Facilities Transitioning to Decommissioning (NRC-2015-0070; RIN 3150-AJ59). The Commissions markup of the proposed rule and its approval for publication can be viewed in a Staff Requirements Memorandum at Agencywide Documents and Management System (ADAMS)

Accession No. ML21307A046.

The NRC may propose a definition of FFD program because external stakeholders may have a different understanding of this phrase than the NRC. Typically, FFD program was that FFD program implemented by a licensee for a specific NRC-licensed facility. However, over time, companies have acquired additional NRC-licensed facilities, establishing a fleet of nuclear power plants. Some of these companies then have elected to implement one common FFD program for all its NRC-licensed facilities even if these facilities are not co-located. The NRC expects that facilities licensed under Part 53 may be owned and operated in a similar manner.

Reviewing official means an employee of a licensee or other This proposed amendment makes the Reviewing official entity specified in § 26.3(a) through (c), and (f) who is designated by definition applicable to Part 53 licensees.

the licensee or other entity to be responsible for reviewing and evaluating any potentially disqualifying FFD information about an individual, including, but not limited to, the results of a determination of fitness, as defined in § 26.189, in order to determine whether the individual may be granted or maintain authorization.

Safety-related structures, systems, and components (SSCs) The current Part 26 definition for safety-related would mean, for licensees and other entities described in § 26.3(a) - (d) and not be applicable to licensees under Part 53. Therefore, for the purposes of this part, those SSCs that are relied on to remain Part 26 would use the Part 53 proposed definition for 10

functional during and following design basis events to ensure the licensees described in § 26.3(f). The NRC staff plans to integrity of the reactor coolant pressure boundary, the capability to issue regulatory guidance to describe this term in Part 53 shut down the reactor and maintain it in a safe shutdown condition, or and Part 26.

the capability to prevent or mitigate the consequences of accidents that could result in potential offsite exposure comparable to the guidelines in § 50.34(a)(1). For licensees and other entities described in § 26.3(d) and (f), safety-related has the meaning provided in

§ 53.020.

Security-related SSCs mean, for the purposes of this part, those The NRC staff is assessing whether the Part 26 definition structures, systems, and components that the licensee will rely on to of security-related needs to be further changed. The implement the licensee's physical security and safeguards proposed amendment would, at minimum, make this contingency plans that either are required under Part 73 of this definition applicable to Part 53 licensees.

chapter if the licensee is a construction permit applicant or holder or an early site permit holder, as described in § 26.3(c)(3) through (c)(5),

respectively, or are included in the licensee's application if the licensee is a combined license applicant or holder, as described in

§ 26.3(c)(1) and (c)(2), respectively, or a licensee or other entity described in § 26.3(d) and (f).

Subpart M Fitness for Duty Programs for Facilities Licensed Under Part 53.

§ 26.601 Applicability. This proposed section makes subpart M applicable to Part At the licensee's or other entity's discretion, a licensee or other 53 licensees, at their discretion.

entity in § 26.3(f) may establish, implement, and maintain an FFD program that meets the requirements of this subpart for the individuals specified in § 26.602. If a licensee or other entity in

§ 26.3(f) does not elect to implement an FFD program that meets the requirements of this subpart, then the individuals specified in § 26.602 shall be subject to an FFD program that meets all Part 26 requirements, except for those requirements in subparts K and M.

§ 26.602 FFD program applicability to categories of individuals. This proposed section requires Part 53 licensees and The requirements of this subpart apply to those categories of other entities to apply subpart M to those individuals individuals in § 26.4, as applicable, and any Certified Operator, as described in § 26.4, as applicable.

defined in § 26.5, as designated by the licensee or other entity.

§ 26.603 General provisions.

(a) FFD Program Description. As required by §§ 53.1245(e)(3), Paragraph (a) - The proposed Part 53 framework would

[53.1266], 53.1275(y), and 53.1289(a)(24) of subpart H of Part 53, the require an applicant to provide a description of its FFD program within its application for a license. This 11

applicants description of the FFD program in its final safety analysis description must be clear and contain certain information report must include to inform the NRC of its plans. This description requirement is based on the requirements of

§§ 26.401(b),52.79(a)(44), and proposed rule language in

§ 53.1275(y) and supplemented by sub-paragraphs (a)(1)-(5) to account for operating experience during the construction of light water reactors.

(1) A summary of the analysis performed under paragraph (c)(2) Paragraph (a)(1) - This paragraph requires a summary of this section, if performed, including the assumptions, methodology, description of the analysis performed to assess the risk-conclusion, and references; informed determination criterion for FFD programs. This description could be the same evaluated for security programs.

(2) A statement whether the FFD program will be implemented Paragraph (a)(2) - This statement makes clear what FFD pursuant to §§ 26.604 or 26.605, or will meet all Part 26 requirements, program the licensee would implement. This except for the requirements in subparts K and M; determination would be dependent on the risk-informed determination criterion. The licensee or other entity may choose to implement all Part 26 requirements, except those in subparts K and M.

(3) A discussion of the applicability of the FFD program to those Paragraph (a)(3) - This description informs the NRC of individuals described in § 26.602 and how the program will be the applicability of the FFD program to individuals who implemented offsite at an NRC-licensed facility authorized to perform safety or security significant activities, including fabricate, construct, and/or test a nuclear reactor module, if the situation where the licensees risk-informed evaluation applicable; process has shown that the duties and responsibilities performed by the individual would be significant to public health and safety. The NRC staff continues to evaluate the applicability of FFD programs to a facility licensed to fabricate, construct, and/or test a nuclear reactor module offsite from the NRC-licensed site for commercial power reactor operation.

(4) A description of the drug and alcohol testing and fitness Paragraph (a)(4) - This description enables the NRCs determination process to be implemented by the licensees or other and publics understanding of FFD program entitys procedures, including the collection and testing facilities to be 12

used, biological specimens to be collected, and sanctions to be implementation, specifically how drug and alcohol testing imposed upon a confirmed FFD policy violation; and would be conducted.

(5) A summary of the FFD performance monitoring and review Paragraph (a)(5) - This description is designed to inform program, including expected measures and metrics required by the NRC and public of those FFD performance measures paragraph (d)(1) of this section. that the licensee would use upon implementation of its FFD program.

(b) FFD Program Implementation and Availability. For the Paragraph (b) - This requirement establishes when the licensees and other entities in § 26.4(f), the FFD program shall be FFD program must be implemented and the longevity of established, implemented, and maintained before the start of the FFD - this proposal is consistent the current FFD construction, as defined in § 26.5, and during reactor operation and framework and includes the requirement that an FFD until the NRCs docketing of the license holders certifications program would not be applicable during decommissioning described in §§ 50.82(a)(1) or 52.110(a). For licensees that have of the Part 53 licensed facility. The current Part 26 been issued a manufacturing license, the FFD program shall be framework requires the implementation of an FFD established, implemented, and maintained before the loading of program for the construction of commercial nuclear power nuclear fuel into the reactor vessel module and until expiration of the reactor facilities licensed under Parts 50 and/or 52. Then, manufacturing license. as construction nears completion, the licensee or other entity is required to implement all Part 26 requirements, except those in Subpart K, because the radiological risk consequences begin to increase. However, the current FFD framework does not apply to a facility where its licensee has submitted its certifications under 10 CFR 50.82 or 52.110(a), which places the facility in decommissioning (either SAFSTOR or dismantlement).

The NRC describes decommissioning at https://www.nrc.gov/waste/decommissioning.html.

The NRC is still evaluating how to describe the milestone when the FFD program would need to be initiated to support the loading of fuel into the reactor vessel module at the manufacturing facility. For example, the NRC staff position is that the FFD program be implemented before individuals at the manufacturing facility begin assembling or directing the assembly of those SSCs that a risk-informed evaluation process has shown to be significant 13

to public health and safety, such as those associated with an inspection, test, analysis and acceptance criteria (ITAAC) and will be used in the reactor vessel module.

Are there other milestones that should be considered?

The staff requests feedback on this topic.

(c) Criterion and Analysis for an FFD Program. (1) Criterion. The Paragraph (c) - This is a new requirement detailing the criterion to be used for the analysis in § 26.603(c)(2) shall be the use of the criterion to determine which FFD program criterion in 10 CFR 53.830(a)(2)(i). described in Subpart M (i.e., § 26.604 or § 26.605) a Part 53 licensee may establish, implement, and maintain unless it elects to implement all requirements in Part 26, except those in Subpart M. The requirement in paragraph (c)(2) explains the analysis to be conducted in the licensees or other entitys evaluation of the criterion.

Specifically, the FFD criterion is equivalent to that used in

§ 53.830(a)(2)(i). And, the analysis requirement is based on the equivalent provision in Part 53.

(2) Analysis. In order for a licensee or other entity to implement Paragraph (c)(2). The applicant may conduct this an FFD program under § 26.604, the licensee or other entity must analysis to assess whether it could implement the FFD perform a site-specific analysis to demonstrate that the criterion in program described in § 26.604. If the licensee finds that

§ 26.603(c)(1) is met. The licensee or other entity must maintain the its facility and operation does not meet the criterion, (or, at analysis until permanent cessation of operations under § 53.XXX of their discretion, if the criterion is satisfied) the applicant this chapter. must implement the FFD program described in

§ 26.605 or one that meets all Part 26 requirements, except those in subparts K and M.

(d) FFD Performance Monitoring and Review. A licensee or other Paragraph (d) - This is a new requirement based on the entity must establish performance measures and associated NRCs Reactor Oversight Process. A performance thresholds as described in § 26.603(d)(1) and monitor the monitoring and review program is proposed to be effectiveness of its FFD program against these performance consistent with a performance-based and risk-informed measures and thresholds, in a manner sufficient to provide regulatory framework. This program is also required reasonable assurance that individuals subject to the program can because the subpart M requirements are not prescriptive, safely and competently perform assigned duties and responsibilities and they enable program implementation and change and are trustworthy and reliable to maintain the types of access based on consequences and human performance. Since making them subject to this subpart. FFD programs under subpart M may be site specific (e.g.,

14

using oral fluid instead of using urine for drug testing), this helps provide reasonable assurance that the FFD program would remain effective as determined by an evaluation against site-specific and industry metrics and averages, as well as qualitative considerations. This requirement helps enable performance-based and risk-informed NRC inspections.

(1) The performance monitoring and review program shall be Paragraph (d)(1) - This paragraph requires the licensee documented and maintained and include the following program or other entity to monitor its own performance through the elements: establishment of their own performance measures and (i) Performance Measures. Performance measures must be thresholds designed to initiate corrective actions. The identified and designed to monitor FFD program performance in a NRC staff is developing a draft proposed regulatory guide manner sufficient to provide reasonable assurance that the 10 CFR to provide guidance on the types of performance 26.23 performance objectives are met. measures that the licensee should consider and one set of measures that the NRC finds acceptable - where applicable, guidance would be based on and conform to that already implemented under the NRCs Reactor Oversight Process. The measures are both qualitative and qualitative (discussed below) and should be based on year-to-year site-specific performance and site performance compared to industry performance.

Additionally, if the FFD program applies to more than one NRC-licensed site, a site-to-site comparison within the FFD program should be performed. Prescriptive thresholds are not proposed by the NRC. Licensees and other entities currently subject to Part 26 already must annually report FFD performance data to the NRCno change would be proposed for current facilities. This information is docketed, publicly available, and displayed on the NRCs external website.

(A) If the licensee or other entity is subject to the requirements in Paragraph (d)(1)(i)(A) - The program must include the

§ 26.604, then the monitoring program must include a performance periodic assessment of the behavioral observation measure for the effectiveness of the behavioral observation program. program for a licensee or other entity that does not implement drug and alcohol testing. This requirement is 15

necessary to provide reasonable assurance that individuals are performing their duties and responsibilities safely and competently and not acting in a manner that may adversely affect, either directly or indirectly, the licensees capability to prevent significant core damage and spent fuel sabotage.

(B) If the licensee or other entity is subject to the requirements in Paragraph (d)(1)(i)(B) - FFD performance data

§ 26.604 and has implemented a drug testing program at its associated with pre-access and random testing and discretion, or is subject to the requirements of § 26.605, then the subversion attempts in the commercial nuclear industry monitoring program must include performance measures for the pre- subject to Part 26 is well established and publicly access and random positive testing rates, and subversion attempts; available. From this data, a licensee or other entity may make reasonably equivalent comparisons to other operating commercial nuclear facilities, based on, for example, megawatts-electric of the facility and number of individuals subject to the FFD program. Other considerations such as geographic location, use of laboratories and collection facilities, and conduct of large maintenance activities (such as refueling or engineering design changes) could also be used to inform the program. The NRC acknowledges that there may be cases where the existing FFD performance data generated by the current large light-water reactor fleet may not be directly applicable to a facility licensed under Part 53 For example, this could occur if the Part 53 facility maintains a very small licensee employee workforce. The NRC staff intends to address this issue in a draft regulatory guide and is working to complete a technical study on FFD performance monitoring.

(ii) Monitoring Program. Assessments must be conducted as Paragraph (d)(1)(ii) - This paragraph states that the data is received. Monitoring must enable year-to-year comparisons for licensee or other entity must evaluate FFD data as it is the site and when data is available against FFD program and industry received. This is important because the licensee or other performance. entity is required under paragraph (d)(1)(i)(B) to monitor subversions. Operating experience indicates that some sites have very few subversion attempts, therefore, for these sites, the licensee- or other entity-established 16

threshold could be quite low, such that a single or few occurrences could initiate corrective actions.

(iii) Thresholds. Licensee- or other entity-specific thresholds for Paragraph (d)(1)(iii) - This paragraph regarding its site-specific performance measures must be established and used thresholds introduces the concept of maintaining FFD to facilitate corrective actions to maintain FFD program performance. program effectiveness. This terminology is proposed Initial thresholds must be based on FFD performance data from because it implements a performance-based regulatory comparable facilities subject to part 26, FFD program information if strategy where the license or other entity must initially the program has more than one site subject to part 26, and generic establish a level of performance that is representative of industry FFD performance data. Licensees and other entities must re- other facilities in its FFD program and the FFD evaluate their performance measures and thresholds every two years performance of comparable facilities subject to Part 26.

and adjust their performance measures and thresholds to maintain Since NRC oversight has demonstrated that FFD FFD program effectiveness based on historical site-specific, performance in the industry has met and continues to licensees fleet-level program performance, and comparable industry meet the FFD performance objectives in § 26.23, that performance or any identified areas for improvement. level of historical FFD performance (e.g., number of FFD policy violations per site per year) when combined with the 10 CFR defense-in-depth regulatory framework, contributes to the protection of public health and safety, common defense and security, and protection of the environment. The proposed FFD change control process and NRC inspection of the FFD program and its annual and biennial reports will help provide assurance that measures and thresholds are not adjusted over time in a manner that lessens the effectiveness of the FFD program. The phrase reduction in FFD program effectiveness is a proposed definition in § 26.5.

(iv) Quantitative and Qualitative Reviews. The performance Paragraph (d)(1)(iv) - This paragraph regarding monitoring and review program shall include a documented review of quantitative and qualitative reviews lists those elements the elements in § 26.603(d)(1)(i)-(iii) and the following elements. within the FFD program for which the NRC staff believes would be difficult for the licensee or other entities to establish quantitative performance measures, because there are very few data points in which to establish an effective monitoring program. However, since these listed elements involve multi-step processes, detailed 17

procedures, and human performance, a qualitative review (i.e., audit) can be performed to evaluate performance.

(A) Appeals Process. The review must include a documented Paragraph (d)(1)(iv)(A) - This paragraph requires the assessment of the licensees or other entitys implementation of the licensee to monitor whether the FFD program is affording protections described in §§ 26.606(b)(1), 26.611, and 26.613. appropriate protections (protection of sensitive information, protection of privacy, due process, etc.) to individuals subject to the FFD program.

(B) Laboratory Test Results and Medical Review Officer Paragraph (d)(1)(iv)(B) - The NRC proposes that Performance. The review must include a documented assessment laboratory test results and Medical Review Officer (MRO) whether the actions taken by the Medical Review Officer met the performance be included in the biennial program review requirements in § 26.185 based on the laboratory test results reported for three reasons: (1) this is a worker protection under § 26.169. consideration that the drug testing program is resulting in outcomes consistent laboratory test results; (2) this review provides a performance-based assessment of both the laboratory and MRO; and (3) this review facilitates actions to improve laboratory performance and/or MRO training under § 26.607(l)(2).

(C) Change Control Process. The review must include a Paragraph (d)(1)(iv)(C) - The NRC staff proposes that the documented assessment of the changes made under § 26.603(e) to change control process be included in the biennial provided assurance that the summation of program changes have not program review to help ensure that changes implemented resulted in a reduction in FFD program effectiveness. over the life of the facility do not result in an unevaluated decrease in program effectiveness. The use of the word summation in this requirement is to require a holistic assessment of all changes because the proposed change control process in § 26.603(e) focuses only on a particular change being pursued for implementation and not a retrospective analysis of the potential aggregated effect of all changes on program effectiveness.

(2) Corrective Actions. Corrective actions shall be implemented to Paragraph (d)(2) - This provision helps ensure that address when FFD performance meets a licensee-established corrective actions would be effective.

performance threshold or to resolve a finding resulting from a 18

qualitative review or audit in a manner that restores performance and corrects root and/or contributing causes.

(3) Program Review Periodicity. The documented review in Paragraph (d)(3) - The licensee must monitor, periodically

§ 26.603(d)(1)(iv) shall be conducted biennially to assess and modify assess, and document its FFD performance monitoring licensee or other entity implementation of its FFD program. This program - this report is not required to be submitted to the documented review must demonstrate that the performance NRC. This report may summarize the results/findings measures and thresholds are appropriate based on site- and FFD obtained from the reviews conducted in § 26.603(d)(i)(iv).

program-specific historical performance, and informed by industry All Part 26 licensees must annually submit FFD performance. performance data to this NRC (10 CFR 26.417(b)(2) and 26.717). Two principal outcomes result from this effort:

(1) the licensee lessons learned would contribute to their own performance assessment to maintain program effectiveness and (2) the NRC is informed of FFD performance and can then aggregate industry data for use in licensee performance monitoring and review programs.

(i) Identified program weaknesses must be summarized in the Paragraph (d)(3)(i) - This provision helps ensure that the annual reporting requirement described in § 26.617. NRC is informed of FFD program weaknesses to facilitate regulatory oversight, if necessary. The reference to § 26.617 enables the licensee to use the pre-existing and free, NRC-developed, electronic reporting system designed to minimize regulatory burden and enhance reporting consistency (https://www.nrc.gov/site-help/e-submittals.html). This enhances consistency across the industry and supports NRC aggregation of data. As proposed in § 26.617 and as currently required in § 26.719, all licensees and other entities subject to Part 26 would be required to submit FFD performance data to the NRC before March 1 for the previous calendar year.

(https://www.nrc.gov/reactors/operating/ops-experience/fitness-for-duty-programs/submit-ffd-reports.html)

(ii) The program review must be completed and approved by the Paragraph (d)(3)(ii) - This provision helps ensure that the licensee or other entity before November 15 of every even year, and review is periodically performed because of the flexibilities 19

corrective actions implemented before May 15 of the following year. afforded in the Part 53 FFD framework and the annual reporting of FFD performance data to the NRC. The November 15th date provides assurance of completion and informs NRC oversight, and implementing corrective actions within the next 6 months supports a possible full year of implementation prior to the next biennial FFD performance review.

(e) FFD Program Change Control. The licensee or other entity shall Paragraph (e) - This section is based on § 50.54(p) and establish, implement, and maintain a change control process that (q), the change control processes for security and meets the following requirements emergency plans respectively. The staff proposes a change control process for Part 26 for two reasons. First, there must be change control for the assessment for the FFD criterion, which establishes the minimum FFD program that must be implemented, because if this assessment changes, then the licensees FFD program may change. Second, the requirements in subpart M are objective and performance based. Since this regulatory approach focuses on desired results (e.g., individuals are fit for duty and trustworthy and reliable) and measurable outcomes (e.g., performance measures and thresholds that demonstrate the FFD program is maintaining effectiveness), respectively, rather than prescriptive processes, techniques, or procedures, the licensee or other entity is essentially free to implement its own methods to achieve the desired results or measurable outcomes. In this case, the change control process helps provide assurance that FFD program changes do not result in a reduction in FFD program effectiveness and that a documented history is maintain should FFD program effectiveness unknowingly decreases (1) The licensee or other entity may make changes to its FFD Paragraph (e)(1) - As will be further described in draft program under this subpart without prior NRC approval only if: guidance, the following are types of changes a licensee or other entity may make: (1) If HHS determines that the societal risk posed by a particular drug or drug metabolite 20

(i) the licensee or other entity performs and retains an analysis does not warrant its testing in its Mandatory Guidelines for demonstrating that the changes do not reduce the effectiveness of the Federal Workplace Drug Testing Programs (HHS FFD program or Guidelines) because it is no longer used in society or (ii) the change was necessitated or justified by a change to Part does not cause an impairing condition of concern, then 26 or laboratory processes or procedures, including the full panel of the change is justified. (2) If HHS changes its laboratory drugs, drug metabolites, and cutoffs, implemented to maintain their validity testing to account for a change in adulteration U.S. Department of Health and Human Services (HHS) laboratory techniques, HHS may revise its validity testing certification. requirements, this change is justified.

(2) A licensee or other entity desiring to make a change that Paragraph (e)(2) - If a change reduces FFD program decreases FFD program effectiveness must submit an application for effectiveness, then NRC approval is required. As will be amendment to its license, in addition to the filing requirements in described in draft guidance, the following are examples

§§ 53.YY and 53.ZZ. The request must include a detailed description where a change may represent a reduction in program of the change, the reason for the change, and the use of any effectiveness. (1) If the licensee elects to reduce the mitigating strategy needed to provide reasonable assurance that if the severity of its established sanction for an FFD policy change is approved, the FFD program, as revised, will continue to violation; this change can reduce FFD program meet the performance objectives in § 26.23. effectiveness because the deterrent value of the sanction would be reduced. (2) If the licensee elects to reduce the number of individuals onsite and subject to the FFD program; this change could reduce the effectiveness of the behavioral observation and, if applicable, random testing programs. (3) If the licensee elects to change its supplier of oral fluid test kits and the testing accuracy decreases, cutoffs increase, or panel of drugs to be tested decreased from that tested previously; these types of changes could represent a reduction in program effectiveness.

(3) The credited technical analysis used to justify meeting the Paragraph (e)(3) - This requirement provides assurance risk-informed determination criterion of this section must be that changes to the facility, its operation, personnel, maintained, including updates to reflect changes made pursuant to safeguards, etc., are managed and evaluated to prevent

§ 26.603(e) to the staffing, FFD programs, or offsite support unanticipated change to the justification used to assess resources described in the analysis, to show that the facility and its the FFD criteria.

operation continues to meet the risk-informed determination criteria, if applicable.

21

(4) The licensee shall retain a record of each change made under Paragraph (e)(4) - Records shall be maintained in a this section for a period of at least five years from the date the change manner similar to records maintained for § 50.54(p) and was implemented and summarize this change in its annual FFD (q) changes. Five years is based on the current NRC performance report required by § 26.617(b)(2). practice to conduct triennial inspections of the FFD program.

§ 26.604 FFD program requirements for facilities that meet the FFD criterion (a) FFD Program. Licensees and other entities with an analysis as described in § 26.603(c)(2) that demonstrates the criterion in

§ 26.603(c)(1) is met, may elect to establish, implement, and maintain an FFD program under this section. That FFD program must contain the following elements:

(1) applies to those individuals described in § 26.602, as applicable; (2) implements the program elements and requirements described in in § 26.603; and, (3) implements the following requirements and subparts in this part:

(i) § 26.23, Performance objectives (ii) § 26.606, Written policies and procedures, (a) and, if applicable (b)

(iii) § 26.608, FFD program training (iv) § 26.609, Behavioral observation (v) § 26.610, Sanctions (vi) § 26.611, Protection of information (vii) § 26.613, Review process (viii) § 26.615, Audits (ix) § 26.617, Recordkeeping and reporting (x) § 26.619, Suitability and fitness determinations (xi) Subpart AAdministrative Provisions (xii) Subpart OInspections, Violations, and Penalties

§ 26.605 FFD program requirements for facilities that do not meet Section 26.605 is written for a Part 53 licensee that does the FFD criterion not meet the FFD criterion in § 26.603(c) and a Part 53 (a) Licensees and other entities implementing § 26.604, at their licensee that meets the FFD criterion yet elects to discretion, and licensees and other entities that implement an FFD implement this section. This section also applies to the program under this subpart must establish, implement, and maintain holder of a Part 53 manufacturing license that allows the 22

an FFD program under this section during either construction fabrication and fueling of a reactor vessel module.

activities as defined in § 26.5, or during activities performed under a However, the proposed FFD requirements will only be manufacturing license that allows the assembly and fueling of a applicable to those individuals who assemble and direct reactor vessel module, as applicable. That FFD program must contain the assembly of the reactor vessel module and its SSCs, the following elements: and those individuals who conduct QA/QV activities for (1) applies for those individuals described in § 26.602, as the assembly of the reactor vessel module at the applicable; manufacturing licensees fabrication facility.

(2) implements the program elements and requirements described in in § 26.603; An FFD program under § 26.605 is commensurate with (3) implements the following requirements and subparts in this the risk of a reactor facility licensed under Part 53 that part uses plant technologies, engineered features, and (i) § 26.23, Performance objectives controls that are applied in an integrated defense-in-depth (ii) § 26.606, Written policy and procedures manner to provide reasonable assurance that the facility (iii) § 26.607, Drug and alcohol testing construction and operation would not result in radiological (iv) § 26.608, FFD program training consequences inimical to public health or safety. Such a (v) § 26.609, Behavioral observation facility presents a risk profile much lower than that of a (vi) § 26.610, Sanctions traditional commercial light water reactor power plant. For (vii) § 26.611, Protection of information example, advanced reactors would meet (1) the safety (viii) § 26.613, Review process criteria of §§ 53.210 and 53.220, (2) the safety functions (ix) § 26.615, Audits of § 53.230, (3) the requirements associated with defense (x) § 26.617, Recordkeeping and reporting in depth, as described under § 53.250, and (4) the (xi) § 26.619, Suitability and fitness evaluations; and analysis of licensing basis events in accordance with (xii) Subpart AAdministrative Provisions § 53.450. These facilities may also use SSCs that (xiii) Subpart IFatigue Management function through inherent characteristics or have (xiv) Subpart OInspections, Violations, and Penalties engineered protections against human failures (e.g.,

system misalignments). Meeting these licensing and design requirements provides assurance that a reactor licensed under Part 53 presents a radiological risk that enables the establishment of an objective, risk-informed, and performance-based FFD regulatory framework that was developed from the existing FFD program requirements detailed in subpart K of Part 26.

Paragraphs (a)(1) - (3) establish the FFD program requirements during construction and decommissioning.

As mentioned above, the requirements listed on this 23

paragraph are based on the current requirements in subpart K, FFD Program for Construction.

Similar to the requirements in § 26.604, the Part 53 licensee implementing this section must be subject to the minimum requirements needed to make Part 26 applicable to a Part 53 licensee, establish the regulatory framework, protect workers, and support NRC licensing and oversight.

(b) Licensees and other entities implementing § 26.604, at their Paragraph (b) - An FFD program under § 26.605(b) is discretion, and licensees and other entities that implement an FFD based on the risk presented by the facility as the licensee program under this subpart, before the loading of fuel onsite into a readies it for commercial nuclear power plant operation.

reactor vessel; before receiving a reactor vessel module loaded with These requirements must be implemented immediately fuel; or before operating, testing, performing maintenance of, or before operation (i.e., a consequential change in reactor directing the maintenance or surveillance of security-related core reactivity) and other significant activities that affect equipment or equipment that a risk-informed evaluation process has the design, operation, or maintenance of the licensed shown to be significant to public health and safety, shall establish, facility. This operational milestone is similar to that of implement, and maintain an FFD program that initial core loading currently used in, for example, §§ 50.54(a)(1), 50.55a(f)(4)(i), 50.71(h)(1), 50.120, Part 50 (1) applies to those individuals described in § 26.602, as appendix E, 52.99(a) and (c), 52.103(a) and (e). At this applicable. operational milestone, the Part 53 licensee must implement an FFD program that (1) provides assurance (2) implements the program elements and requirements that the facility would be operated and maintained in a described in § 26.603(a)-(e); and manner in which it was designed and licensed and (2) implements regulatory requirements that seamlessly (3) Implements the following requirements and subparts integrate the FFD program with the rest of the commercial (i) § 26.23, Performance objectives nuclear industry regarding, in part, FFD policy violations, (ii) § 26.606, Written policy and procedures sanctions, authorization determinations, fatigue (iii) § 26.607, Drug and alcohol testing management, records, and reports. This assurance is (iv) § 26.608, FFD program training obtained by requiring the implementation of subparts C, (v) § 26.609, Behavioral observation D, H, I, and N.

(vi) § 26.611, Protection of information (vii) § 26.613, Review process Additional language is being included among the (viii) § 26.615, Audits requirements in Paragraph (b) to apply FFD controls (ix) Subpart AAdministrative Provisions (including fatigue management) to individuals who may be 24

(x) Subpart CGranting and Maintaining Authorization loading fuel into a pre-fabricated module at an offsite (xi) Subpart DManagement Actions and Sanctions to be facility.

Imposed (xii) Subpart HDetermining Fitness-for-Duty Policy Violations Also, similar to Paragraph 26.4(a)(6), additional language and Determining Fitness is included in these requirements to address FFD needs (xiii) Subpart IFatigue Management in instances where individuals, likely at an offsite facility, (xiv) Subpart NRecordkeeping and Reporting Requirements would be installing components into a pre-fabricated (xiv) Subpart OInspections, Violations, and Penalties. nuclear reactor module, and where those component are located such that the licensee would be unable to perform inspection, test, analysis, and acceptance criteria (ITAAC) examination or otherwise to identify potential latent human error in installation. The NRC staff finds that certain passive SSCs (for example, a component - such as a fusible link - internal to the reactor module designed to melt at a particular temperature setpoint to trigger an actuation mechanism) could be included in a design in such a way that those components are relied upon for safe operation but cannot be inspected for proper installation, configuration, or operation after-the-fact. In such instances, the safety-significance of correctly-performed installation could warrant the application of FFD requirements on the individual(s) performing the installation of such a component.

§ 26.606 Written policy and procedures. Section 26.606 is based on § 26.403, Written policy and (a) Licensees and other entities that implement an FFD program procedures.

under this subpart shall ensure that (1) A written FFD policy statement is provided to each individual Paragraph (a)(1) - This requirement is based on who is subject to the program before the individual is subject to § 26.403(a), except that the phrase clear, concise was behavioral observation and/or drug and alcohol testing under this part. removed because it is not defined. To enhance protections afforded to individuals a new requirement is also proposed that the policy must be provided to individuals before being subject to behavioral observation and any FFD program drug and alcohol test; this new requirement helps ensure that individuals know what is expected of them prior to being subject to the FFD program and possibly entering the NRC-licensed facility.

25

(2) The FFD policy statement describes the performance Paragraph (a)(2) - This requirement is proposed to help objectives in § 26.23. ensure that the FFD programs of all licensees required to meet in Part 26 have the same performance objectives.

(3) The FFD policy statement must be written in sufficient detail to Paragraph (a)(3) - This requirement is based on provide affected individuals with information on what is expected of § 26.403(a), with additional clarity provided on what the them and what consequences may result from a lack of adherence to policy statement must include. This protects the worker the policy, including those elements described in paragraph (b) of this and enhances consistency.

section, Part 26-required sanctions, and required medical/clinical treatment and follow-up testing for FFD policy violations.

(b) Licensees and other entities shall establish, implement, and Paragraph (b) - This requirement is based on § 26.403(b).

maintain written procedures that address the following topics: Minor changes were made to apply to a Part 53 FFD program.

(1) If implementing a drug and alcohol testing program under this Paragraph (b)(1) - This requirement is based subpart, § 26.403(b)(1) to clarify program processes (e.g.,

(i) the methods and techniques to be used in collecting, testing, collecting, testing, shipping, and temporary storage of shipping, and temporarily storing biological specimens for drugs and biological specimens) that licensees and other entities alcohol testing, and must detail in its procedures because alternative testing (ii) procedures for protecting the privacy of an individual who methods are enabled by subpart M.

provides a specimen, protecting the integrity of the specimen, and ensuring that the test results are valid and attributable to the correct individual.

(2) The immediate and followup actions that will be taken, and the Paragraph (b)(2) - This requirement is based on procedures to be used, in those cases in which individuals who are § 26.403(b)(2) and helps ensure the effectiveness of the subject to the FFD program: FFD program and its consistent implementation. It also helps inform individuals subject to Part 26 of FFD program requirements.

(i) Have been involved in the use, sale, or possession of illegal or Paragraph (b)(2)(i) is based on § 26.403(b)(2)(i) except illicit substances; that the phrase illicit substances was added to include individuals who use, sell, or possess legal substances in a manner inconsistent with federal or state law, or can cause impairment while at the NRC-licensed facility.

26

(ii) Are impaired by any substance or the consumption of alcohol Paragraph (b)(2)(ii) is based on § 26.403(b)(2)(ii) except as determined by behavioral observation or a test that measures that it was revised to remove the phrases to excess. and blood alcohol concentration; accurately, because these phrases are not defined.

Alcohol impairment can be determined by behavioral observation and by whether the individuals BAC meets or exceeds the alcohol limits in §§ 26.99, 26.101, and 26.103. The phrase by any substance was added based on operating experience. The phrase before or while constructing or directing construction was removed because § 26.606 applies during construction, operation, and decommissioning. The term behavioral observation was added because impairment can be visibly or audibly observed in an individual and individuals are trained in behavioral observation. The behavioral observation program requirement is provided in § 26.609, with training requirement provided in § 26.608.

(iii) If drug and alcohol testing is conducted, attempted to subvert Paragraphs (b)(2)(iii) is based on § 26.403(b)(2)(iii),

the testing process by adulterating or diluting specimens (in vivo or in except the phrase if drug and alcohol testing is vitro), substituting specimens, or by any other means; conducted was added to address the licensee who implements § 26.604.

(iv) If drug and alcohol testing is conducted, refused to provide a Paragraph (b)(2)(iv) is based on § 26.403(b)(2)(iv), except specimen for analysis or follow instructions provided by FFD program the phrase or follow the instructions provided by FFD personnel; program personnel which is based on § 26.89(c) and the phrase if drug and alcohol testing is conducted were added to address the licensee who implements § 26.604.

(v) Had legal action taken relating to drug or alcohol use; or Paragraphs (b)(2)(v) is based on § 26.403(b)(2)(v).

(vi) Demonstrated character or actions indicating that the Paragraph (b)(2)(vi) is proposed to gather information for individual cannot be trusted or relied upon to perform those duties and the insider threat program. This also helps to align the responsibilities or maintain access to NRC-licensed facilities or Part 26 behavioral observation program with the sensitive information. behavioral observation program implemented under proposed Part 53 requirement § 73.120.

27

(3) The process to be followed if an individuals behavior or Paragraph (b)(3) - This requirement is based on condition raises a concern regarding: the possible use, sale, or § 26.403(b)(3) and is designed to help ensure that when possession of illegal drugs on or off site; the possible use or individuals may be in violation of the FFD policy, they are possession of alcohol on the NRC-licensed facility; impairment from removed from the duties and responsibilities making them any cause which in any way could adversely affect the individuals subject to Part 26. The § 26.403(b)(3) phrase while ability to safely and competently perform his or her duties; or the constructing or directing the construction of safety- or receipt of credible information indicating that the individual cannot be security-related SSCs was replaced with on the NRC-trusted or relied on to perform those duties and responsibilities licensed facility because this provision applies during making the individual subject to this part. construction and operation and this would apply to holders of an NRC manufacturing license.

The requirement regarding credible information is proposed to help address the insider threat.

§ 26.607 Drug and alcohol testing. Section 26.607(a) - These requirements are based on the (a)(1) To provide means to deter and detect substance abuse, requirements in § 26.405(a) and changes are proposed licensees and other entities implementing § 26.604, at their discretion, commensurate with the risk consequences presented by a and licensees and other entities implementing § 26.605 shall perform Part 53 licensed facility. For § 26.607(a)(2), a split drug and alcohol testing that complies with the following specimen need not be taken when using a point of requirements collection testing and assessment device is use for a screening test conducted for random testing, because if (2) Split specimen collections of oral fluid or urine must be used the individual screens positive, invalid, dilute, adulterated, for the test conditions described in paragraph (b) of this section. A or substituted, the individual is subject to an immediate re-split specimen collection need not be used if the licensee or other collection (i.e., another drug test) using a device approved entity elects to use a point of collection testing and assessment for use for validity, if required, initial, and confirmatory devise for a screening test conducted during random testing under drug testing at an HHS-certified laboratory.

§ 26.605(b)(2) and (i).

(b) Individuals identified in § 26.602 shall be subject to drug and Paragraph (b) - These test conditions are based on alcohol testing under the following conditions: § 26.405(c) with the except of the random testing provisions in § 26.607(b)(2) which are based on

§ 26.405(b).

(1) Pre- access. Before performing or directing the conduct of Paragraph (b)(1) - This requirement is based on roles and responsibilities making the individual subject to this subpart § 26.405(c)(1); however it was revised to remove or being granted unescorted access to the protected area of the construct or direct the construction of safety- or security-NRC-licensed facility; related SSCs because for licensees or other entities under 28

Part 53, the pre-assignment/access test condition applies to construction, operation, and decommissioning to help inform a licensees or other entity of whether the individual can be trusted and relied upon to perform those duties and responsibilities making the individual subject to subpart M.

(2) Random Testing. Random testing for drugs and alcohol Paragraph (b)(2) - This requirement is based on must § 26.405(b). Random testing must be conducted by a licensee or other entity who does not meet the FFD criterion, and may be conducted at the licensees discretion for those licensees and other entities that do meet the FFD criterion. This provision is different than that in § 26.405(b) because § 26.406, Fitness monitoring may not be performed in lieu of random testing for a Part 53 licensee.

(i) Be administered in a manner that provides reasonable Paragraph (b)(2)(i) - This requirement based on assurance that individuals are unable to predict the time periods § 26.405(b)(1) helps ensure that individuals do not know during which specimens will be collected; when they would be subject to a random test.

(ii) Require individuals who are selected for random testing to Paragraph (b)(2)(ii) - This requirement based on report to the collection site as soon as reasonably practicable after § 26.405(b)(2) helps ensure that individuals would be notification, within the time period specified in the FFD program subject to a timely test and that the test result would be a procedure; good indication of the drugs, drug metabolites, and alcohol concentration(s) in the individual with access to the NRC-licensed facility prior to the time of test.

(iii) Ensure that all individuals in the population that is subject to Paragraph (b)(2)(iii) - This requirement based on random testing on a given day have an equal probability of being § 26.405(b)(3) helps ensure that random testing is equally selected and tested; and applied to all individuals.

(iv) Ensure that an individual completing a test is immediately Paragraph (b)(2)(iv) - This requirement based on eligible for another random test. § 26.405(b)(4) helps ensure that there are no breaks in the random testing program providing an opportunity for the individual to illicitly use substances that may cause impairment.

29

(v) Ensure that the sampling process used to select individuals for Paragraph (b)(2)(v) - This requirement is not in subpart K; random testing provides that the number of random tests performed the requirement is from § 26.31(d)(2)(vii) which annually is equal to at least 50 percent for licensee employees and 50 establishes the random testing rate for the population of percent for contractor/vendors at the NRC-licensed site. individuals subject to testing. Based on operating experience, a 50 percent random testing rate provides reasonable assurance of public health and safety and the common defense and security, by providing sufficient detection and deterrence. However, operating experience demonstrates that the contractor/vendor population is tested at rate lower than 50 percent, even though this population results in the majority of all FFD policy violations. Furthermore, the proposed framework enables the use of immunoassay point of collection testing and assessment (POCTA) devices for the conduct of random testing. In order to maintain program effectiveness (e.g.,

the detection and deterrent value of random testing does not substantially decrease with the use of a POCTA device) the random testing rates for both populations (licensee employees and contractor/vendors) must remain at or above 50 percent. The NRC staff has commenced a study to assess the effectiveness of a 50 percent random testing rate when there is a large transient worker population that may be onsite for only a short period of time. Information from this study would be used to inform proposed Paragraph (b)(2)(v).

(3) For-cause. In response to an individual's observed behavior Paragraph (b)(3) - This for-cause testing requirement is or physical condition indicating possible substance abuse or after equivalent to that used in current FFD programs receiving credible information that an individual is engaging in implementing § 26.405(c)(2).

substance abuse, as defined in § 26.5; (4) Post-accident. (i) As soon as practical after an accident Paragraph (b)(4) - This post-accident testing requirement involving a human error that was committed by an individual specified is from § 26.405(c)(3). It is essentially equivalent to that in § 26.602, where the human error may have caused or contributed used in current FFD programs. However, for Part 53 to the accident, the licensee or other entity shall test the individual(s) licensees, the staff proposes that the post-accident testing 30

who committed or directed the error(s). The licensee or other entity language be amended to clearly require testing under two need not test individuals who were affected by the accident and conditions: sub-paragraph (i) human errors that result in whose actions likely did not cause or contribute to the accident. The accidents and sub-paragraph (ii) accidents that result in licensee or other entity shall describe in its procedures what adverse health consequences. Editorial changes are also constitutes a human error and accident. proposed (e.g., replace the word event with accident).

(ii) A post-accident test shall be conducted within 4-hours of an The NRC proposes that the licensee or other entity define accident unless immediate medical intervention precludes the conduct in its procedures the terms human error and accident.

of the test, on the individual(s) who caused or contributed to the Although this Part 26 requirement is based on an accident if the accident results in Occupational Safety and Health Administration (OSHA) provisions that enables post-incident drug testing (OSHA Memorandum, Kim Stille, Acting Director, Enforcement Programs, October 11, 2018, 29 CFR 1904.35(b)(1)(iv)),

the reference to OSHA was removed based on operating experience learned from program implementation.

(A) An illness or personal injury to the individual(s) who caused or Paragraph (b)(4)(ii)(A) - This requirement is from contributed to the event or another individual which results in death, § 26.405(c)(3)(i). The staff removed the word significant days away from work, restricted work, transfer to another job, medical as used in significant illness or personal injury because treatment beyond first aid, loss of consciousness, or other significant the requirement describes what illnesses or injuries are illness or injury, as diagnosed by a licensee- or other entity- covered.

designated physician or other licensed health care professional, even if it does not result in death, days away from work, restricted work or job transfer, medical treatment beyond first aid, or loss of consciousness; or (B) Damage to any safety- or security-related SSC. Paragraph (b)(4)(ii)(B) - This requirement from

§ 26.405(c)(3)(ii) was changed based on operating experience to remove the word significant because this term is not defined; NRC may propose guidance on what constitutes damage or leave it to the licensee to define.

Also, the term construction was removed because this provision applies during construction and operation. Note that § 26.5 defines safety-related SSCs and security-related SSCs, if these definitions change, then a conforming change may be provided to this requirement.

31

(iii) The conduct of a post-accident test for an accident involving Paragraph (b)(4)(iii) - This is a new requirement proposed human error, if conducted within 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> of the accident, satisfies the to clearly state that the human error post-accident test (§ post-accident test requirement in paragraph (b)(4)(ii) of this section; 26.607(b)(4)(i)) can meet the requirement for the conduct and of a health consequence-based post-accident test

(§ 26.607(b)(4)(ii)). Two tests on a particular individual for a single event should never be conducted.

(5) Followup. As part of a followup plan to verify an individual's Paragraph (b)(5) - This requirement is based on continued abstinence from substance abuse. § 26.405(c)(4).

(c) At a minimum, the following requirements shall be met Paragraph (c) - This requirement is based on § 26.405(d) and ensures that drug testing is technology inclusive.

Specifically, the provisions enable the use of alternative testing technologies.

(1) For the use of urine as the biological specimen to be tested, Paragraph (c)(1) - This requirement is based on the following requirements shall be implemented § 26.405(d) but was modified to apply to directly reference (i) § 26.115, Collecting a urine specimen under direct the drugs, drug metabolites, and cutoffs that are observation; applicable to NRC-licensees subject to Part 26. Instead

§ 26.119, Determining shy bladder; of the general non-specific statement of drugs and drug (ii) § 26.161, Cutoff levels for validity testing, and metabolites in § 26.405(d). Section 26.607(c)(1) refers to (iii) § 26.163, Cutoff levels for drugs and drug metabolites. § 26.161, Cutoff levels for validity testing, and § 26.163, Cutoff levels for drugs and drug metabolites, for validity testing and the specific drugs and drug metabolites for urine testing, respectively. Sections §§ 26.115 and 26.119 are required for program effectiveness and as a worker protection. On September 16, 2021, the NRC staff provided the Commission a draft Final Rule that recommends changes to Part 26 drug testing requirements. This draft Final Rule (RIN 3150-AI67; NRC-2009-0225; SECY-21-0082) can be viewed on the NRCs website at ADAMS Accession No. ML21111A017.

If the Commission approves this Final Rule package, conforming changes may be necessary in the proposed FFD requirements for Part 53 licensees.

32

(2) For alcohol testing, the following requirements shall be Paragraph (c)(2) - This ensures that the Part 53 licensee implemented or other entity implements an alcohol testing program that (i) § 26.91, Acceptable devices for conducting initial and is consistent with that implemented by other NRC confirmatory tests for alcohol and methods of use; licensees or other entities subject to Part 26. This is a (ii) § 26.93, Preparing for alcohol testing; program effectiveness and worker protection (iii) § 26.95, Conducting an initial test for alcohol using a breath consideration.

specimen; (iv) § 26.97, Conducting an initial test for alcohol using a specimen of oral fluids; (v) § 26.99, Determining the need for a confirmatory test for alcohol; (vi) §26.101, Conducting a confirmatory test for alcohol; and, (vii) §26.103 Determining a confirmed positive test result for alcohol.

(3) For all test conditions in paragraph (b) of this section and Paragraph (c)(3) - This requirement is from § 26.405(f) but MRO-directed tests under § 26.185, drug testing must be performed was modified to apply to facilities licensed under Part 53.

at an HHS-certified laboratory for the specific biological specimen to For all current FFD programs, confirmatory drug testing be tested. Only HHS-certified laboratory test results using urine or must be performed at a laboratory certified by the U.S.

oral fluid may be used for the issuance of a Part 26-required sanction. Department of Health and Human Services; this too would The licensee or other entity must establish and maintain a contract be applied to Part 53 licensees. Wording is proposed to with a primary and back-up HHS-certified laboratory (with a different enable the testing of alternative biological specimens and Certifying Scientist) for the specimen(s) to be tested. to ensure that the licensee or other entity has a secondary (back-up) HHS-certified laboratory should additional testing be directed by the MRO or problems occur with the primary laboratory. The back-up laboratory may be of the same corporate entity but at a different location using a different Certifying Scientist. This is an operating experience lesson learned.

(d) Licensees and other entities may add drugs and drug Paragraph (d) - This requirement is not from subpart K, metabolites to their panel of drugs and drug metabolites to be tested if but from subpart B, Program Elements. Similar to the requirements in § 26.31(d)(1)(i) are met. current FFD programs, this preliminary proposed requirement enables a Part 53 licensee or other entity to add or remove drugs or drug metabolites from its panel of drugs to be tested. This is important for two reasons.

33

First, a licensee or other entity may desire to align with the HHS recommendation should HHS add a new drug to their recommended panel of drugs to be tested because it may improve FFD program effectiveness. Second, aligning with the HHS drug panel also benefits protections afforded to workers because HHS National Laboratory Certification Program evaluation of the laboratory processes (and its blind performance testing program) would be those same processes used for a biological specimen submitted by the licensee or other entity drug.

As currently proposed, should a licensee or other entity desire to add or remove a drug or drug metabolite from its panel of drugs, then it would implement the FFD change control process in §26.603(e); for these types of changes based on HHS recommendations, NRC review and approval would not be necessary.

(e) The specimen collection and drug and alcohol testing Paragraph (e) - This requirement is from § 26.405(e),

procedures of FFD programs under this subpart must protect the except the word stringent was removed from the phrase donor's privacy and the integrity of the specimen and implement stringent quality controls, because the word stringent is quality controls to ensure that test results are valid and attributable to not defined.

the correct individual.

(f) At the licensee's or other entity's discretion, specimen Paragraph (f) - Similar to paragraph (e) above, this collections and alcohol testing may be conducted at a local hospital or requirement is from § 26.405(e), yet an audit requirement other facility licensed and audited by the State (or State-designated is proposed to ensure that the collection facility entity) to conduct specimen collections and perform alcohol testing. procedures are comparable to those in Part 26, subpart E, The licensee or other entity shall audit these facilities, if used, on a Collecting Specimens for Testing, including the biennial basis to provide reasonable assurance that the facility prevention of subversion attempts. This is a program procedures are comparable to those described in subpart E of this effectiveness and worker protection consideration.

part for urine and oral fluid. The licensee or other entity must establish measures to help prevent subversion of the drug and/or The subpart K reference to the U.S. Department of alcohol test onsite or offsite. Transportation drug and alcohol collection and testing requirements in 49 CFR Part 40 was removed based on operating experience.

34

(g) Any initial drug test performed by a licensee or other entity Paragraph (g) - This requirement is from § 26.405(f) and subject to this subpart must use an immunoassay, or a testing was modified for a facility licensed under Part 53 process implemented under the licensees or other entitys change implementing an FFD program that may implement control process under § 26.603(e), that meets the requirements of the alternative biological specimen testing. For example, the U.S. Food and Drug Administration (FDA) for commercial distribution. phrase or better testing process enables a licensee to Specimens that yield positive, adulterated, substituted, or invalid initial use its change control process in § 26.603(e) to evaluate validity or drug test results must be subject to confirmatory testing by and document a change to its collection and analysis the HHS-certified laboratory, certified for that biological specimen, procedures to enable the use of a better or perhaps more except for invalid specimens that cannot be tested. cost-effective collection and/or testing technology.

(h) If the licensee or other entity elects to use oral fluid for drug Paragraph (h) - A licensee or other entity implementing testing, the collection, packaging, temporary storage, and shipment of subpart K, FFD programs for construction, may implement an oral fluid specimen to an HHS-certified laboratory must be a drug testing program using oral fluid. The paragraph (h) performed in accordance with the instructions provided with the oral requirement enables a Part 53 licensee to use oral fluid as fluid collection kit or on the manufacturers website. The kit must have a biological specimen for testing. Also, oral fluid testing received premarket approval from the FDA and must not expire may currently be conducted under direction of an MRO as before laboratory testing. All site processes shall be conducted by enabled in § 26.31(d)(5). HHS has issued guidelines on licensee- or other entity-designated FFD program personnel. The the use of oral fluid and urine as drug testing matrices and drugs, drug metabolites, and initial and confirmatory testing cutoffs has determined that these test methods are comparable.

shall be comparable to those established for urine testing in this part These guidelines may be viewed at as determined by a documented forensic toxicologist review https://www.samhsa.gov/workplace/resources.

conducted pursuant to § 26.31(d)(1)(i)(D).

(i) Point of collection testing and assessment. (1) If the licensee Paragraph (i)(1) - (3) - Under subpart K, a licensee or or other entity elects to use a point of collection testing and other entity is not precluded from using a point of assessment device, then it may only be used for random drug and/or collection testing and assessment (POCTA) device for alcohol testing using urine or oral fluid as the test specimen and only initial drug and alcohol testing. Using the proposed for screening. A forensic toxicologist must review and document their framework, subpart M enables the use of POCTA for only evaluation that the validity, accuracy, and precision of the device for oral fluid and urine specimens and only for random alcohol and/or all the drugs and drug metabolites listed in §§ 26.161 testing. This test methodology is acceptable because the and 26.163 is comparable to the performance achieved by initial individuals subject to testing have already been subject to testing conducted using a similar technology at an HHS-certified pre-access/pre-assignment drug and alcohol testing and laboratory before its use. were evaluated by the licensee or other entity and found (2) If the performance of the point of collection testing and to be acceptable to perform those duties and assessment device used for random testing is not comparable to that responsibilities making them subject to Part 26. The achieved from initial testing conducted by an HHS-certified laboratory confidence afforded by a licensee or other entity pre-35

as determined by the forensic toxicologist, then the licensee or other access drug screening, hiring, and implementing NRC entity must propose a mitigating strategy to maintain program regulations to grant, restore, or maintain unescorted effectiveness to the NRC and obtain NRC approval under access to the NRC-licensed facility or sensitive

§ 26.603(e)(2) before its use. information helps provide assurance that reasonable reductions in accuracy and precision of the POCTA device would not be averse to the overall effectiveness of the FFD program. Furthermore, the individual is required to take FFD training (§ 26.608) and is subject to behavioral observation (§ 26.609).

The proposed requirements enable licensees and other entities to use POCTA devices if their evaluation demonstrates that its use does not reduce program effectiveness. The device would typically provide a visual indication (e.g., color or a highlighted line) to reveal whether a drug or drug metabolite exceeded its initial test cutoff as listed in § 26.163(a), or as found to be comparable by the § 26.603 change control process.

Many devices also test for adulterants and subversion attempts and this would be required for the forensic toxicologists assessment of comparable equivalency to the urine specimen drug testing program.

It would be the licensees or other entitys responsibility to demonstrate that its intended use of a POTCA device is comparable to testing conducted by an HHS-certified laboratory. A comparable analysis is considered acceptable because both test processes (point of collection testing device and initial testing at a laboratory) provide an indication (above a pre-established setpoint) whether the individual may possibly be impaired, may be using an illegal drug, may have a concentration of a drug or drug metabolite indicative of illicit use, or may indicate that the specimen is adulterated or subverted. From this initial test, if any initial test cutoff is exceeded, additional (i.e., confirmatory) testing is required at the HHS-certified 36

laboratory under § 26.607(i)(3). A finding that the devise is comparable is also based on the fact that accuracy, precision, and repeatability are not requirements in Part 26 for any drug test.

(3) If the use of a point of collection testing and assessment Paragraph (i)(3) provides the immediate actions for the device indicates a test result that exceeds the initial test cutoff and/or licensees and other entity to ensure that the individual is indicates that the specimen is invalid or the individual subverted the removed from all activities making him/her subject to the drug or alcohol test, the individual must be immediately removed from rule and is immediately subject to a drug test that provides duties, responsibilities, and access making him/her subject to this quantified confirmatory test results from which an FFD subpart, and subject to an immediate drug/alcohol test using the policy violation may be issued. Paragraph (i)(3) also alcohol testing process in paragraph (c)(2) of this section for a requires that if the individual screens position on a positive alcohol screen and either oral fluid or urine by a collection kit POTCA device, a second specimen must be obtained by that is not a point of collection testing and assessment device for a the individual to facilitate validity (if required), initial, and positive drug, drug metabolite, adulterated, substituted, or invalid drug confirmatory testing be conducted at an HHS certified screen, that enables validity, if required, initial, and confirmatory laboratory.

testing by an HHS-certified laboratory.

(j) Blood Testing. The testing of blood specimens may only be Paragraph (j) - Using a blood specimen for drug testing is conducted under the order of the licensee- or other entity-designated currently allowed in Part 26, but only for certain medical Medical Review Officer for a valid medical reason as confirmed by the conditions as determined by the MRO, § 26.31(d)(5).

Medical Review Officer pursuant to § 26.31(d)(5). This testing must However, the requirement is clarified to ensure that a be subject to testing by a laboratory that meets quality control licensee- or other entity-designated MRO is used and not requirements that are comparable to those required for certification by one designated by a 3rd party. This MRO requirement is the HHS (e.g., a hospital certified by the State, Commonwealth, or important because subpart M, like subpart K, enables the territory). use of a hospital for the collection of biological specimen for drug and alcohol testing. A medical doctor or MRO, who is not familiar with Part 26 requirements, may not implement a review required by Part 26.

(k) Custody and Control Form. For the collection of urine and oral Paragraph (k) - This requirement to use an Office of fluid specimens, the licensee and other entity must use a custody and Management and Budget approved and valid federal control form approved by the U.S. Office of Management Budget. For custody and control form is based on current Part 26 the use of a point of collection testing and assessment device, the requirements. Since subpart M enables the use of point licensee or other entity shall implement a licensee or other entity of collection testing and assessment devices for random approved and maintained procedure that ensures the reliability of the testing, the licensee or other entity must implement a 37

tracking, handling, and storage of a specimen from the point of process/procedure that ensures the specimen collected is specimen collection to final disposition of the specimen and the uniquely assigned to the donor.

reliability of an identification system to uniquely assign the specimen to the donor.

(l) Medical Review Officer. Licensees or other entities shall (1) Require their designated Medical Review Officer (MRO) to Paragraph (l)(1). This provision is based on § 26.405(g).

review positive, adulterated, substituted, invalid, and dilute confirmatory drug and validity test results to determine whether the donor has violated the FFD policy for urine and oral fluid specimens.

The review must be completed before reporting the results to the individual designated by the licensee or other entity to perform the suitability and fitness evaluations required under § 26.619, or, if required, that are described in subpart H of this part.

(2) Require their MRO to meet the requirements in § 26.183 and, Paragraph (l)(2) - This helps ensure that MRO reviews are prior to conducting any activities under this part, to attend and pass a consistent with those at other NRC-licensed facilities medical- or clinical-based training session to improve his/her subject to Part 26 and that the MRO has and maintains knowledge of MRO duties and responsibilities, drug and alcohol knowledge of drug collection, testing and evaluation. This testing processes and procedures, and evaluation of drug testing is necessary because of the flexibilities afforded to Part 53 results. This training session must be conducted by a nationally- licensees or other entities to collect, test, and assess recognized MRO training and certification organization that has been alternative biological specimens for the presence of drugs assessed by the NRC to include § 26.185 requirements. The MRO or drug metabolites.

must also attend a medical- or clinical-based training session on a triennial basis to improve his/her knowledge of changes in drug and alcohol testing processes/procedures and evaluation of drug testing results.

(3) Require their MRO to determine whether a biological Paragraph (l)(3) - This helps ensure that MRO decisions specimen is positive, adulterated, substituted, invalid, or dilute by are informed with appropriate regulatory requirements and implementing the requirements in § 26.185. If § 26.185 is insufficient medical- or clinically-based information. Section 26.185 is to make this determination, the guidance issued by State (in which the a requirement in Part 26, subpart H, that MROs must NRC-licensed facility resides) or Federal agencies or nationally follow while assessing drug test results to ensure recognized MRO training and certification organizations may be used consistency, program effectiveness, and worker to inform an MRO determination. protection.

(4) Require their MRO to determine and approve the use of oral fluid or urine as an alternative biological specimen when the donor cannot provide a specimen for testing. This determination and the 38

retest shall be completed as soon as reasonably practicable and documented.

(m) Limitations of testing. Specimens collected under NRC Paragraph (m) - This requirement is based on regulations may only be designated or approved for testing as § 26.31(d)(6) and is a worker protection consideration.

described in this part and may not be used to conduct any other analysis or test without the written permission of the donor. Analyses and tests that may not be conducted include, but are not limited to, DNA testing, serological typing, or any other medical or genetic test used for diagnostic or specimen identification purposes. No biological specimens may be collected and or tested in a manner different than described in this subpart.

§ 26.608 FFD Program Training The preliminary proposed rule text for the FFD training (a) FFD Program Training. (1) Individuals must be trained in the program in subpart M does not use the prescriptive FFD policy and procedure and their FFD program responsibilities. training requirements in § 26.29, Training, and modeled These responsibilities include reporting for work, either on or offsite, in on the framework presented in 10 CFR 50.120, Training a physiological and psychological condition that enables the safe and and qualification of nuclear power plant personnel.

competent performance of assigned duties and responsibilities and informing licensee- or other entity-designated individual when the Paragraph (a)(1). The proposed text makes clear that the individual determines that this cannot be accomplished. training shall include the individuals responsibility to not only report FFD concerns about others but to report for work fit for duty and to inform a licensee-or other-designated individual that he/she cannot or may not be able to safely and competently perform assigned duties and responsibilities.

(2) FFD program training must include training on the behavioral Paragraph (a)(2) - This proposed requirement is based, in observation program (BOP). The BOP training must include the part, on § 26.33, Behavioral observation, and includes a detection of physiological or physiological behaviors or conditions that training element and the security-related behavioral may indicate observation requirements in § 73.120. The inclusion of (i) possible use, sale, or possession of illegal drugs or illicit drugs, elements from § 26.33 and § 73.120 is necessary or substance abuse on or off site; because § 26.608 applies during construction, operation, (ii) use or possession of alcohol on site or use while on duty off and decommissioning. The specific § 73.120 element is site; in § 26.608(a)(2)(iv) since drug and alcohol impairment (iii) impairment from fatigue or any cause that, if left unattended, could result in aberrant behavior or changes in behavior could result in inattentiveness or human errors; and indicative of the individual not being trustworthy or reliable. The phrase or illicit drug or substance abuse is 39

(iv) an individuals inability to safely and competently perform from operating experience that demonstrates individuals assigned duties and responsibilities or act in a trustworthy and reliable have reported to work under the influence of over-the-manner while having access to protected areas, NRC-licensed counter drugs or chemical substances that can cause material, or sensitive information. impairment.

(3) Training must explain that an individuals FFD policy violation Paragraph (a)(3) - This requirement helps ensure that will individuals subject to the FFD program understand that (i) subject the individual to an FFD program-required sanction FFD policy violations would result in an FFD program designed to preclude recurrence of an FFD policy violation; sanction and that program information learned or (ii) contribute to the licensees or other entitys assessment of generated by FFD program implementation would be whether the individual can be trusted and relied upon to safely and used to aid licensee or other entity authorization competently perform the assigned duties and responsibilities making determinations and be shared, as requested, with other him or her subject to this subpart; licensees or other entities subject to Parts 26 and 73.

(iii) be used to inform the licensees or other entitys access This requirement is therefore a worker protection authorization and insider mitigation programs under Part 73, if consideration (because the worker would understand how applicable; and, FFD program information would be used) and a program (iv) be used to inform other NRC licensees and other entities effectiveness requirement because it helps ensure that subject to Part 26 when FFD program information is requested to Part 26 and 73 implementation by other licensees or other support authorization determinations under Part 26, subpart C, or entities are informed with information on an individuals

§§ 73.56 or 73.120. ability to follow licensee instructions and safely and competently perform assigned duties and responsibilities in a trustworthy and reliable manner.

(b) Training Periodicity. Training must be conducted before pre- Paragraph (b) - This is a worker protection requirement.

access/pre-assignment testing and refresher training must be The periodicity is based on § 50.120, Training and conducted periodically. qualification of nuclear power plant personnel.

(c) Training Review. The FFD training program must be Paragraph (c) - The periodicity is based on § 50.120, periodically evaluated and revised as appropriate to reflect industry Training and qualification of nuclear power plant experience as well as applicable changes to the regulations in this personnel.

part and specimen collection and testing processes implemented by the licensee or other entity.

§ 26.609 Behavioral observation. Section 26.609 is based on the behavioral observation (a) Licensees and other entities shall ensure that the individuals program (BOP) requirements in § 26.33 Behavioral who are subject to this subpart are subject to behavioral observation observation, but is provided for separately in subpart M because § 26.609 applies during construction, operation, 40

and that behavioral observation is performed by all individuals subject and decommissioning for all licensees and other entities to this subpart. subject to subpart M. The principle behavioral observation (b) Licensees and other entities shall require all individuals requirement is to observe individuals, and report if human subject to the FFD program to report to the licensee- or other entity- performance concerns are identified and this is an designated official behaviors or activities by individuals subject to this element in §§ 26.33 and 26.407. Additionally, paragraph part, that occur on or offsite, that may constitute an unreasonable risk (c) includes elements from the behavioral observation to the safety or security of the NRC-licensed facility or materials or program required by the access authorization program may cause harm to individuals. This reporting must include any described in § 73.120.

information relating to character or reputation indicating that the observed individual cannot be trusted or relied upon to perform those Section 26.33 use of the phrase FFD concerns was duties and responsibilities or maintain access to NRC-licensed replaced with behaviors or activities, on or offsite, that facilities or sensitive information. may constitute an unreasonable risk to the safety and (c) Behavioral observation shall be performed visually, in-person security of the licensees facility, including character or or remotely by video, to observe the behavior of individuals in the reputation indicating that the observed individual cannot workforce subject to the requirements in this subpart, and to detect be trusted or relied upon to perform those duties and and promptly report to plant supervision aberrant behavior or changes responsibilities or maintain access to NRC-licensed in behavior that might adversely reflect on an individuals fitness or facilities or sensitive information.

trustworthiness and reliability.

The NRC staff intends to propose regulatory guidance for behavioral observation that would include examples of behaviors, activities, character, or reputation that should be reported to license- or other entity-designated persons.

These examples may include, but are not limited to: sale, use, or possession of illegal drugs; threats to cause harm to facilities or people; threats to aid or abet a threat to the facility, people, NRC-licensed material, or sensitive information.

§ 26.610 Sanctions. Section 26.610 is based on § 26.409, Sanctions. The Licensees and other entities that implement an FFD program wording was modified to align with the Part 53 FFD under this subpart shall establish sanctions for FFD policy violations program. For example, the phrase unless or until the that, at a minimum, prohibit the individuals specified in § 26.602 from licensee or other entity determines that the individual's being assigned to perform or direct those duties and responsibilities condition or behavior does not pose a potential risk to making them applicable to this subpart. The severity of the sanction public health and safety or the common defense and must escalate with the number of occurrences and severity of the security, was removed because a sanction must be FFD policy violation, with a permanent denial of access to the NRC- administered for an FFD policy violation to help deter future FFD policy violations (i.e., positive drug tests, 41

licensed facility for three FFD policy violations or any subversion subversions, and impairment while working at the NRC-attempt. licensed facility) and a sanction facilitates counseling, training, rehabilitation, and/or treatment prior to the licensee reinstating the individuals access to the facility.

The last sentence states that the sanction must account for the severity of the FFD policy violation (this is partly based on § 26.75(b) and (c)) and the number of FFD policy violations (this is partly based on § 26.75(e)(1) and (2) and (g).

§ 26.611 Protection of information.

(a) Licensees and other entities that collect personal information Paragraph 26.611(a) is based on § 26.411, Protection of about an individual for the purpose of complying with this subpart information. The phrase FFD programs must maintain shall establish and maintain a system of files and procedures to and use such records with the highest regard for protect the personal information. individual privacy, was removed because the term highest regard for individual privacy is not defined.

(b) Licensees and other entities shall obtain a signed consent that Paragraph (b) - This requires that the consent-to-test shall documents the individuals acceptance of being subject to the FFD be signed by the individual before making him or her program and authorizes the disclosure of the personal information subject to the FFD program. This proposal is to enhance collected and maintained under this subpart, except for disclosures to an individuals knowledge of why he or she is being tested the individuals and entities specified in § 26.37(b)(1) through (b)(6), and what the drug and alcohol testing information would (b)(8), and persons deciding matters under review in § 26.613. This be used for by the licensee or other entity before the Part signed and dated consent shall be obtained before making the 26-required test. This is a worker protection individual subject to the FFD program. enhancement.

§ 26.613 Review process. Section 26.613 is based on the requirements in subpart K, Licensees and other entities that implement an FFD program § 26.413, Review process. The wording was modified to under this subpart shall establish and implement procedures for the align with the Part 53 FFD program. The phrase review review of a determination that an individual in § 26.602 has violated process is consistent with that of an appeals process.

the FFD policy. The procedure must provide for an objective and impartial review of the facts related to the determination that the individual has violated the FFD policy.

§ 26.615 Audits Section 26.615 is based on § 26.415, Audits.

(a) Licensees and other entities that implement an FFD program under this subpart shall ensure that audits are performed to ensure the continuing effectiveness of the FFD program, including FFD 42

program elements that are provided by C/Vs, and the FFD programs of C/Vs that are accepted by the licensee or other entity.

(b) Each licensee and other entity shall ensure that FFD program Paragraph (b) - This would require licensee and other elements that are not part of the FFD program performance and entities to revise their audit program based on the results monitoring review described in § 26.603(d) are audited at a frequency of its FFD performance monitoring program.

that ensures their continuing effectiveness and that corrective actions are taken to resolve any problems identified. The subject matter, A non-prescriptive and performance-based audit program scope, and frequency of audits must be revised as necessary to that would be implemented to supplement the FFD improve or maintain program performance based on findings resulting performance monitoring requirement is consistent with from licensee or other entity implementation of its FFD performance NRC generic efforts to establish performance-based and monitoring and review program in § 26.603(d). risk-informed regulatory requirements. For comparison purposes only, the NRC staff notes that Part 50 requires auditing four times: twice for security plans in §§ 50.34(c)(3) and 50.54(p)(4) and then in Criteria XVII and XVIII of Part 50, Appendix B, quality assurance program requirements.

(c) Licensees and entities may conduct joint audits or accept Paragraph (c) - This requirement is based on § 26.415(b).

audits of C/Vs so long as the audit addresses the relevant C/Vs' services.

(d) Licensees and other entities need not audit HHS-certified Paragraph (d) - This requirement is based on § 26.415(c);

laboratories if their panel of drugs and drug metabolites to be tested is however, it was revised to remove its reference to 49 CFR equivalent to that by which the laboratory is certified by HHS. Part 40, "Procedures for Department of Transportation Licensees and other entities shall audit any hospital or other facility Workplace Drug and Alcohol Testing Programs" (65 FR licensed by the State (or State-designated entity) if used to conduct 41944; August 9, 2001) and to align with the Part 53 FFD specimen collections and perform alcohol testing under this part on a program. Additionally, an audit requirement is proposed biennial basis to provide reasonable assurance that the facility to ensure that collection facility procedures are procedures are comparable to those described in subpart E, comparable to that required in Part 26.

Collecting Specimens for Testing, for urine and oral fluid, of this part.

§ 26.617 Recordkeeping and reporting Section 26.617 is based on the requirements in § 26.417, (a) Licensees and other entities that implement FFD programs Recordkeeping and reporting. However, if the Part 53 under this subpart shall ensure that records pertaining to the facility operates under an FFD program described in administration of the program, which may be stored and archived § 26.605, the licensee must implement subpart N electronically, are maintained so that they are available for NRC Recordkeeping and Reporting Requirements, which would inspection purposes and for any legal proceedings resulting from the align with the requirements placed on other licensees and 43

administration of the program. FFD performance data required by other entities subject to Part 26, namely those facilities

§ 26.617 shall be retained until license termination. licensed under Parts 50, 52, and 70. This is necessary to support consistent FFD program performance (b) Licensees and other entities shall make the following reports: assessments by licensees, NRC oversight, and NRC-required authorization requirements.

(1) Reports to the NRC Operations Center by telephone within Paragraph (b)(1) - This requirement parallels the reporting 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after the licensee or other entity discovers any intentional act requirements in § 26.417, Recordkeeping and reporting.

that casts doubt on the integrity of the FFD program and any The wording was modified to align with a Part 53 FFD programmatic failure, degradation, or discovered vulnerability of the program.

FFD program that may permit undetected drug or alcohol use or abuse by individuals who are subject to this subpart. These events must be reported under this subpart, rather than under the provisions of § 73.71; and (2) Annual program performance reports for the FFD program, Paragraph (b)(2). This paragraph is based on the annual including the FFD program performance data listed in § 26.717(b), as program performance requirement in § 26.417, applicable. Licensees and other entities shall submit FFD program Recordkeeping and reporting. However, the performance data (for January through December) to the NRC requirement was modified to apply to the Part 53 FFD annually, before March 1 of the following year and shall use NRC program and to clarify the reporting period and milestone.

Forms 890, Single Positive Test Form, and 891, Annual Reporting for Drug and Alcohol Tests. A new requirement is proposed that licensees must use the NRC electronic reporting forms. This is necessary to account for the flexibilities in drug testing afforded to Part 53 licensees and to ensure consistent operating experience data in the advance reactor, Category I fuel cycle facility, and existing light water reactor communities.

Operating experience has demonstrated that 100 percent of all current licensees subject to Part 26 use the NRCs forms and its electronic reporting system to annually report FFD performance data to the NRC. The use of this system informs licensee audits and correctives and represent a low burden to complete, store, and submit.

Use of the forms should also enhance the subpart M FFD performance monitoring program, and NRC oversight because it aids consistency and clarity of reported data.

The NRC staff finds that the use of Form 891, Annual 44

Reporting Form for Drugs and Alcohol, should also aid the licensees biennial FFD program performance review required by § 26.603(b)(3) because much of the data on this form is applicable to a performance monitoring program.

(c) Licensees and other entities subject to this subpart shall Paragraph (c) - This requirement helps ensure that describe in sufficient detail an individuals FFD policy violation (while FFD-related information is shared within the commercial protecting privacy information under § 26.611) and FFD program nuclear industry. This helps ensure that individuals who weakness to NRC licensees and other entities subject to Part 26 become employed by another NRC-licensed facility when requested to support authorization determinations under with subject to FFD (10 CFR Part 26, subpart C) and access Part 26, Subpart C, or § 73.56, or to support licensee or other entity (10 CFR 73.56) authorization requirements complete their performance monitoring. licensee-administered NRC-required sanctions and implementation of drug and/or alcohol abuse treatment plans before the restoration of authorization.

§ 26.619 Suitability and fitness determinations Section 26.619 is based on § 26.419, Suitability and Licensees and other entities that implement FFD programs under fitness determinations.

this subpart shall develop, implement, and maintain procedures for evaluating whether to assign individuals to perform or direct those duties and responsibilities making them subject to this subpart. These procedures must provide reasonable assurance that the individuals are fit to safely and competently perform their duties, and are trustworthy and reliable, as demonstrated by the avoidance of substance abuse.

NOTE: The proposed amendments in the following sections are conforming and enable Part 53 FFD programs.

Subpart B Program Elements

§ 26.21 Fitness-for-duty program. This section is amended to apply to licensees and other (a) The licensees and other entities specified in § 26.3(a) through entities described § 26.3(f) should they chose to (c) shall establish, implement, and maintain FFD [] implement an FFD program that implements all Part 26 (b) The licensees and other entities specified in § 26.3(f) that do requirements, except those in subpart M. Also, the not implement the requirements in subpart M, shall implement the applicability statement is proposed to be split into two requirements in this subpart. smaller paragraphs for clarity.

Subpart C Granting and Maintaining Authorization

§ 26.51 Applicability This section is amended to apply to licensees and other entities described § 26.3(f). Also, the applicability 45

(a) The requirements in this subpart apply to the licensees and statement is proposed to be split into two smaller other entities identified in § 26.3(a), (b), and, as applicable, (c) for the paragraphs for clarity.

categories of individuals in § 26.4(a) through (d), and, at the licensee's or other entity's discretion, in § 26.4(g) and, if necessary,

§ 26.4(j) . . .

(b) The requirements in this subpart apply to the FFD programs of licensees and other entities identified in § 26.3(f) for the categories of individuals in § 26.602 that elect not to implement the requirements in subpart M and those licensees and other entities that elect to implement the requirements in § 26.605.

§ 26.53 General provisions. Section 26.53(e) and (e)(1) and (3), (g) - (i) are amended to apply to licensees and other entities described (e) Licensees and other entities in § 26.3(a) through (c), and, if § 26.3(f).

applicable, (f) may also rely on a C/Vs FFD program []

(1) A C/Vs FFD program may grant and maintain an individuals authorization, as defined in § 26.5, under the C/Vs FFD program.

However, only a licensee or other entity in § 26.3(a) through (c), and if applicable, (f) may grant or maintain []

(3) If an individual is maintaining authorization under a C/Vs FFD program, a licensee or other entity in § 26.3(a) through (c), and if applicable, (f) may grant authorization []

(g) The licensees and other entities specified in § 26.3(a) and, as applicable, (c), and (d), and (f) shall identify any violation []

(h) The licensees and other entities specified in § 26.3(a) and, as applicable, (c), and (d), and (f) []

(i) The licensees and other entities specified in § 26.3(a) and, as applicable, (c), and (d), and (f) shall inform, in writing, any individual who is applying for []

§ 26.63 Suitable inquiry This section is amended to apply to licensees and other entities described § 26.3(f).

(d) When any licensee or other entity in § 26.3(a) through (d),

and, if applicable, (f) is legitimately seeking the information []

46

Subpart DManagement Actions and Sanctions To Be Imposed

§ 26.73 Applicability. This section is amended to apply to licensees and other (a) The requirements in this subpart apply to the licensees and entities described § 26.3(f). Also, the applicability other entities identified in § 26.3(a), (b), and, as applicable, (c) for the statement is proposed to be split into two smaller categories of individuals specified in § 26.4(a) through (d) and (g) [] paragraphs for clarity.

(b) The requirements in this subpart apply to the FFD programs of licensees and other entities identified in § 26.3(f) for the categories of individuals in § 26.602 that elect not to implement the requirements in subpart M and those licensees and other entities that elect to implement the requirements in § 26.605.

Subpart ECollecting Specimens for Testing

§ 26.81 Purpose and applicability. This section is amended to apply to licensees and other (a) This subpart contains requirements for collecting specimens entities described § 26.3(f). Also, the applicability for drug testing and conducting alcohol tests by or on behalf of the statement is proposed to be split into two smaller licensees and other entities in § 26.3(a) through (d) for the categories paragraphs for clarity.

of individuals specified in § 26.4(a) through (d) and (g) []

(b) The requirements in this subpart apply to the FFD programs of licensees and other entities identified in § 26.3(f) for the categories of individuals in § 26.602 that elect not to implement the requirements in subpart M and those licensees and other entities that elect to implement the requirements in § 26.605.

Subpart IManaging Fatigue

§ 26.201 Applicability. This section is amended to apply to licensees and other (a) The requirements in this subpart, with the exception of entities described § 26.3(f). Also, the applicability

§ 26.202, apply to the licensees and other entities identified in statement is proposed to be split into two smaller

§ 26.3(a); if applicable, (c) and (d); and (f), for licensees and other paragraphs for clarity.

entities not implementing the requirements in subpart M. For these licensees and other entities, the requirements in §§ 26.203 and 26.211 apply to the individuals identified in § 26.4 (a) through (c). In addition, the requirements in § 26.205 through § 26.209 apply to the individuals identified in § 26.4(a).

(b) The requirements in this subpart, with the exception of

§ 26.203, apply to the licensees or other entities identified in § 26.3(f) implementing this subpart in accordance with § 26.605. For these licensees and other entities, the requirements in §§ 26.202 and 47

26.211 apply to the individuals identified in § 26.4 (a) through (c) and, as applicable, any Certified Operator; and the requirements in

§ 26.205 through § 26.209 apply to the individuals identified in

§ 26.4(a).

§ 26.202 General provisions for acilities licensed under Part 53 This section is based on § 26.203, General provisions, (a) Policy. Licensees shall establish a policy for the management as applied to licensees or other entities described in of fatigue for all individuals who are subject to the licensees FFD § 26.3(f). The amendments to the requirements are program and incorporate it into the written policy required in proposed because the § 26.203 general provisions refer

§ 26.606(a). to various requirements (26.2X, 26.3X, or 26.4X, under (b) Procedures. In addition to the procedures required in subpart B of Part 26), which would not be applicable to

§ 26.606(b), licensees shall develop, implement, and maintain facilities licensed under Part 53 that implement subpart M, procedures that given that the new requirements in subpart M replace the (1) Describe the process to be followed when any individual subpart B requirements applied to sites licensed under identified in § 26.4(a) through (c) makes a self-declaration that he or Part 50 and Part 52.

she is not fit to safely and competently perform his or her duties for any part of a working tour as a result of fatigue. The procedure The proposed requirements in Section 26.202 are must essentially identical to the existing provisions listed in (i) Describe the individuals and licensees rights and § 26.203, with the exception of the revised references to responsibilities related to self-declaration; account for the newly developed sections in subpart M.

(ii) Describe requirements for establishing controls and conditions under which an individual may be permitted or required to perform This approach would also allow the NRC to work after that individual declares that he or she is not fit due to reconsider/revise general provisions for facilities licensed fatigue; and under Part 53, as appropriate, based on feedback (iii) Describe the process to be followed if the individual disagrees received during the period when we are receiving with the results of a fatigue assessment that is required under input/comment period from public stakeholders.

§ 26.211(a)(2);

(2) Describe the process for implementing the controls required under § 26.205 for the individuals who are performing the duties listed in § 26.4(a);

(3) Describe the process to be followed in conducting fatigue assessments under § 26.211; and (4) Describe the disciplinary actions that the licensee may impose on an individual following a fatigue assessment, and the conditions and considerations for taking those disciplinary actions.

(c) Training and examinations. Licensees shall add the following Paragraph (c) - The staff proposed to not include a KAs to the content of the training that is required in § 26.608: comprehensive training requirement for licensees and 48

(1) Knowledge of the contributors to worker fatigue, circadian other entities described in § 26.3(f).

variations in alertness and performance, indications and risk factors for common sleep disorders, shiftwork strategies for obtaining adequate rest, and the effective use of fatigue countermeasures; and (2) Ability to identify symptoms of worker fatigue and contributors to decreased alertness in the workplace.

(d) Recordkeeping. Licensees shall retain the following records for at least 3 years or until the completion of all related legal proceedings, whichever is later:

(1) Records of work hours for individuals who are subject to the work hour controls in § 26.205; (2) For licensees implementing the requirements of

§ 26.205(d)(3), records of shift schedules and shift cycles, or, for licensees implementing the requirements of § 26.205(d)(7), records of shift schedules and records showing the beginning and end times and dates of all averaging periods, of individuals who are subject to the work hour controls in § 26.205; (3) The documentation of waivers that is required in

§ 26.207(a)(4), including the bases for granting the waivers; (4) The documentation of work hour reviews that is required in

§ 26.205(e)(3) and (e)(4); and (5) The documentation of fatigue assessments that is required in

§ 26.211(g).

(e) Reporting. Licensees shall include the following information in a standard format in the annual FFD program performance report required under § 26.617:

(1) A summary for each nuclear power plant site of all instances during the previous calendar year when the licensee waived one or more of the work hour controls specified in § 26.205(d)(1) through (d)(5)(i) and (d)(7) for individuals described in § 26.4(a). The summary must include only those waivers under which work was performed. If it was necessary to waive more than one work hour control during any single extended work period, the summary of instances must include each of the work hour controls that were waived during the period. For each category of individuals specified in § 26.4(a), the licensee shall report:

49

(i) The number of instances when each applicable work hour control specified in § 26.205(d)(1)(i) through (d)(1)(iii), (d)(2)(i) and (d)(2)(ii), (d)(3)(i) through (d)(3)(v), and (d)(7) was waived for individuals not working on outage activities; (ii) The number of instances when each applicable work hour control specified in § 26.205(d)(1)(i) through (d)(1)(iii), (d)(2)(i) and (d)(2)(ii), (d)(3)(i) through (d)(3)(v), (d)(4) and (d)(5)(i), and (d)(7) was waived for individuals working on outage activities; and (iii) A summary that shows the distribution of waiver use among the individuals applicable within each category of individuals identified in § 26.4(a) (e.g., a table that shows the number of individuals who received only one waiver during the reporting period, the number of individuals who received a total of two waivers during the reporting period).

(2) A summary of corrective actions, if any, resulting from the analyses of these data, including fatigue assessments.

(f) Audits. Licensees shall audit the management of worker fatigue as required by § 26.615.

§ 26.205 Work Hours Overall, the specific provisions for Work Hours requirements are not being changed. However, as (d) Work hour controls. Licensees shall control the work hours of addressed in the discussion of § 26.4(a) requirements individuals who are subject to this section. above, whether or not a licensee under Part 26 would need to implement work hour controls would be

[] dependent on determinations reached by that licensees risk-informed evaluation process. (See discussion above for more details)

(7) Licensees may, as an alternative to complying with the Paragraphs (7) and (8) - The proposed revisions update minimum days off requirements in § 26.205(d)(3), comply with the the references, which currently refer to requirements requirements for maximum average work hours in this paragraph. under subpart B that would not be applicable to facilities licensed under Part 53, given that the new requirements

[] in subpart M replace the subpart B requirements for facilities licensed under Part 53.

(iii) Each licensee shall state, in its FFD policy and procedures required by § 26.27 and or § 26.606(a), in addition to § 26.203(a) and 50

(b), the work hour counting system in § 26.205(d)(7)(ii) the licensee is using.

[]

(8) Each licensee shall state, in its FFD policy and procedures required by § 26.27 and or § 26.606(a), in addition to § 26.203(a) and (b), the requirements with which the licensee is complying: the minimum days off requirements in § 26.205(d)(3) or maximum average work hours requirements in § 26.205(d)(7).

[]

§ 26.207 Waivers and exceptions. The proposed revisions update the references, which (a) Waivers. Licensees may grant a waiver of one or more of the currently refer to requirements under subpart B that would work hour controls in § 26.205(d)(1) through (d)(5)(i) and (d)(7), as not be applicable to facilities licensed under Part 53, given follows: that the new requirements in subpart M replace the subpart B requirements for facilities licensed under

[] Part 53.

(1) To grant a waiver, the licensee shall meet both of the following requirements:

[]

(ii) A supervisor assesses the individual face to face and Paragraph(a)(1)(ii) - The proposed revisions update the determines that there is reasonable assurance that the individual will references, which currently refer to requirements under be able to safely and competently perform his or her duties during the subpart B that would not be applicable to facilities additional work period for which the waiver will be granted. The licensed under Part 53, given that the new requirements supervisor performing the assessment shall be trained as required by in subpart M replace the subpart B requirements for

§ 26.29 or § 26.608, and in addition to § 26.202(c) or 26.203(c), and facilities licensed under Part 53.

shall be qualified [...]

§ 26.211 Fatigue assessments. The revisions proposed update the references, which (a) Licensees shall ensure that fatigue assessments are currently point to requirements under subpart B that would conducted under the following conditions: not be applicable to facilities licensed under Part 53, given (1) For cause. In addition to any other test or determination of that the new requirements in subpart M replace the fitness that may be required under §§ 26.31(c), and 26.77, and 51

26.607(c), a fatigue assessment must be conducted in response to an subpart B requirements for facilities licensed under observed condition of impaired individual alertness creating a Part 53.

reasonable suspicion that an individual is not fit to safely and competently perform his or her duties []

(3) Post-event. A fatigue assessment must be conducted in response to events requiring post-event drug and alcohol testing as specified in § 26.31(c) or § 26.607(c). Licensees may not delay necessary medical treatment in order to conduct a fatigue assessment; and

[]

(b) Only supervisors and FFD program personnel who are trained under either §§ 26.29 and 26.203(c) or 26.608 and 26.202(c) may conduct a fatigue assessment. The fatigue assessment must be conducted face to face with the individual whose alertness may be impaired.

Subpart NRecordkeeping and Reporting Requirements

§ 26.709 Applicability. Section 26.709. This proposed change makes subpart N (a) The requirements of this subpart apply to the FFD programs applicable to facilities licensed under Part 53.

of licensees and other entities specified in § 26.3, except for FFD programs that are implemented under subpart K of this part.

(b) The requirements in this subpart apply to the FFD programs of licensees and other entities identified in § 26.3(f) that elect not to implement the requirements in subpart M and those licensees and other entities that elect to implement the requirements detailed in

§ 26.605.

§ 26.711 General provisions.

(c) The licensees and other entities specified in § 26.3(a) and, as Paragraphs (c) and (d) - These proposed changes make applicable, (c), and (d), and (f) shall inform each individual [] this section applicable to licensees or other entities (d) Licensees and other entities shall ensure that only correct and described in § 26.3(f).

complete information about individuals [. . .] a licensee and other 52

entity specified in § 26.3(a) and, as applicable, (c), and (d), and (f) who has discovered the incorrect information []

53

Retrieved from "https://kanterella.com/w/index.php?title=ML21148A173&oldid=3409796"