ML22133A052

Response to SRM-M220323: Final Rule-Response to Public Comments for Fitness for Duty Drug Testing Requirements

ML22133A052
Person / Time
Issue date:	11/10/2022
From:	Office of Nuclear Material Safety and Safeguards, Office of Nuclear Reactor Regulation, Office of Nuclear Security and Incident Response
To:
Schneider, Stewart
Shared Package
ML22133A033	List: ML22133A034 ML22133A046 ML22133A052
References
Final Rule, Fitness for Duty, NRC-2009-0225, RIN 3150-AI67
Download: ML22133A052 (42)

Text

NRC Responses to Public Comments

Final Rule:

Fitness for Duty Drug Testing Requirements NRC-2009-0225; RIN 3150-AI67

U.S. Nuclear Regulatory Commission Office of Nuclear Security and Incident Response Office of Nuclear Material Safety and Safeguards Office of Nuclear Reactor Regulation

November 2022

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ii ABBREVIATIONS AND ACRONYMS

ADAMS Agencywide Documents Access and Management System

BOP behavioral observation program BPTS blind performance test sample

CCF custody and control form CFR Code of Federal Regulations

DOF determination of fitness DOL U.S. Department of Labor DOT U.S. Department of Transportation

EAP employee assistance program

FFD fitness-for-duty FR Federal Register

HHS U.S. Department of Health and Human Services

MDA methylenedioxyamphetamine MDEA methylenedioxyethylamphetamine MRO medical review officer

NLCP National Laboratory Certification Program NRC U.S. Nuclear Regulatory Commission

OF Oral/Fluid

SAE substance abuse expert

UA unescorted access UAA unescorted access authorization

iii U.S. NUCLEAR REGULATORY COMMISSION RESPONSE TO PUBLIC COMMENTS RECEIVED ON THE PROPOSED RULE ON FITNESS FOR DUTY DRUG TESTING REQUIREMENTS

Introduction

This document presents the U.S. Nuclear Regulatory Commissions (NRC) responses to written public comments received on the proposed rule, Fitness for Dut y Drug Testing Requirements, to revise Part 26 in title 10 of the Code of Federal Regulations (10 CFR), and Draft Regulatory Guide (DG)-5040, Urine Specimen Collection and Test Result Rev iew under 10 CFR Part 26, Fitness for Duty Program. The NRC published the proposed rule and DG-5040 in the Federal Register on September 16, 2019 (84 FR 48750), for public comment with a 75-day public comment period. The NRCs proposed rule would amend its regula tions that govern the fitness-for-duty (FFD) programs for certain licensees and other entitie s to more closely align the NRCs drug testing requirements with the updates made in 2008 (73 FR 71858 and corrected in 73 FR 75122) and 2017 (82 FR 7920) to the U.S. Department of He alth and Human Services (HHS) Mandatory Guidelines for Federal Workplace Drug Testing Programs (HHS Guidelines).

The proposed FFD drug testing requirements rule is available fr om the Federal e-Rulemaking Web site at https://www.regulations.gov (Docket ID No. NRC-2009-0225) and through the NRCs Agencywide Documents Access and Management System (ADAMS) under Accession No. ML19169A112.

In developing the final rule and supporting guidance, the NRC c onsidered all the comments provided in response to the proposed rule. If, as a result of its review of a public comment, the NRC changed the rule, the supporting statement of consideration s, or the supporting guidance, the NRCs response to the comment indicates where the change oc curred.

Overview of Public Comments

The NRC received 26 comment submissions on the proposed rule. Table 1 identifies these submissions. The NRC reviewed and annotated the comment submis sions to identify separate comments within each submission. Accordingly, a single submiss ion may have several individual comments associated with it. The NRC gave each indi vidual comment within a submission a unique identifier. The NRCs responses use this u nique identifier to identify which individual comments are addressed by each response. The annota ted versions of the comment submissions can be found at https://www.regulations.gov and ADAMS Accession No. ML20121A017.

1 Table 1: Comment Submissions on FFD Drug Testing Requirements Proposed Rule Comment ADAMS Submission Commenter Affiliation Submission Abbreviation1 Accession No.

Number 1 Anonymous-1 Private Citizen ANON1 ML19298B661 2 Braeden Clark Private Citizen BC ML19308B430 3 David Bonthron NextEra Energy NE ML19316E072 4 Johnny Rogers Private Citizen JR1 ML19338D258 5 Johnny Rogers Private Citizen JR2 ML19338D259 6 Johnny Rogers Private Citizen JR3 ML19338D260 7 Johnny Rogers Private Citizen JR4 ML19338D262 8 Johnny Rogers Private Citizen JR5 ML19338D263 9 Anonymous-2 Private Citizen ANON2 ML19338D245 10 Johnny Rogers Private Citizen JR6 ML19338D246 11 Johnny Rogers Private Citizen JR7 ML19338D247 12 Johnny Rogers Private Citizen JR8 ML19338D248 13 Johnny Rogers Private Citizen JR9 ML19338D249 14 Johnny Rogers Private Citizen JR10 ML19338D251 15 Johnny Rogers Private Citizen JR11 ML19338D252 16 Johnny Rogers Private Citizen JR12 ML19338D254 17 William Gross Nuclear Energy Institute NEI1 ML19338D255 18 Laura Shelton Drug and Alcohol Testing Industry Association DATIA ML19338D257 19 Megan Barry Private Citizen MB ML20017A342 20 John Nielsen Institute of Nuclear Power Operations INPO ML20017A343 21 Dolores Adams Exelon Nuclear EN1 ML20017A344 22 Joseph Chemistry Private Citizen JC ML20017A352 23 Mimi Estrada Private Citizen ME ML21144A288 24 William Gross Nuclear Energy Institute NEI2 ML21144A289 25 Maureen Gilday-Gulliford Energy Harbor EH ML21146A134 26 Mary Yerkes Exelon Nuclear EN2 ML21146A136

Public Meetings

On November 7, 2019, the NRC held a public meeting at NRC Headq uarters to discuss the FFD drug testing requirements proposed rule with external stakehold ers (see meeting summary at ADAMS Accession No. ML19336A003). The NRCs goal for conductin g this meeting was to explain the proposed rule and supporting guidance and answer qu estions to enable stakeholders to provide informed comments on the proposed rule.

1 The NRC has annotated the comments to identify individual comments. Some submissions contained multiple individual comments, and others contained only one. The individual comments are denoted within each annotated comment submission by the submission abbreviation and number (e.g., INPO-1, INPO-2). In some cases, the comment may be denoted as NEI1-CL1, NEI1-A1-1, or NEI1-A2-1. This refers to an NEI comment provided in the comment submission cover letter (CL), an NEI comment provided in the first attachment (A1), or an NEI comment provided in the second attachment (A2).

2 On April 13, 2021, the NRC held a virtual public meeting under the category of information meeting with a question and answer session to discuss the basi s for and obtain feedback on the proposed implementation schedule for the final rule (see me eting summary in ADAMS under Accession No. ML21096A015).

Comment Categorization

This comment response document separates the comments into the 25 categories identified below. Within each category, the NRC summarizes each comment a nd responds to the comment. In general, the NRC addresses each individual comment. However, when similar comments can be readily grouped together, the NRC has binned th ose comments and treated them as a single comment. The NRCs response addresses the bin ned comment. The annotated comment number or numbers appear in a parenthetical l ist at the end of each comment summary to provide a cross-reference aid to the reader.

The comment summaries are grouped in the following categories:

A. General Comments on the Proposed Rule B. Responses to Specific Requests for Comment C. FFD Program Applicability to Categories of Individuals D. Definitions E. Written Policy and Procedures F. Drug and Alcohol Testing G. Behavioral Observation H. Sanctions I. Management Actions Regarding Possible Impairment J. Preparing to Collect Specimens for Testing K. Urine Specimen Quantity L. Collecting a Urine Specimen Under Direct Observation M. Preparing Urine Specimens for Storage and Shipping N. Determining Shy Bladder O. Cutoff Levels for Validity Testing P. Blind Performance Testing Q. Determining a Fitness for Duty Policy Violation R. Substance Abuse Expert S. Determination of Fitness T. Other Comments U. Draft Regulatory Guide V. Draft Regulatory Analysis W. Information Collections X. Backfitting and Issue Finality Y. Cumulative Effects of Regulation

3 A. General Comments on the Proposed Rulemaking

Comment A-1: One commenter expressed concern that the proposed rule change s were not robust enough and requested the NRC to do more. (ANON1-1)

NRC Response: The comment contained no changes for consideration on the pro posed rule.

Accordingly, the NRC did not change the final rule in response to this comment.

Comment A-2: Four commenters expressed overall support for the proposed ru le. One commenter stated that the proposed changes to the FFD program a re very positive and should be implemented as soon as practical. Another commenter believe d that additional changes should also be considered for inclusion into the 10 CFR Part 26 rulemaking to enhance efficiencies while maintaining the continued reliability of the FFD program. A third commenter was pleased to see guidelines being proposed to enhance the abi lity of NRC licensees to identify individuals using illegal drugs, misusing legal drugs, or attempting to subvert the drug testing process. This commenter concluded that the proposed ru le change will aid in detection and ultimately lead to enhanced public safety. The fourth comm enter believed that drug testing helps to deter individuals from using drugs and therefore the p roposed rule will be beneficial.

(ANON2-CL10, ANON2-A10, NEI1-CL1, DATIA-1, ME-1)

NRC Response: The NRC agrees that this 10 CFR Part 26 final rule will enhan ce the ability of NRC licensees to identify individuals using illegal drugs, misu sing legal drugs, or attempting to subvert the drug testing process, thereby aiding in detection a nd ultimately lead to enhanced public safety. Regarding one commenters additional changes fo r consideration for inclusion in this rulemaking, the NRC responds to those changes in subsequen t comment responses.

B. Response to Specific Requests for Comment

In Section V of the Supplementary Information for the proposed rule, the NRC solicited stakeholder comment on seven topics pertaining to the rule. Th e following paragraphs restate these topics, summarize comments received from stakeholders, an d present the NRCs resolution of these comments.

B-1 Alignment with the HHS Guidelines

Two proposed changes in this rule would eliminate redundant pro visions in 10 CFR Part 26 that also appear in the HHS Guidelines (i.e., HHS-certified laborato ry personnel qualifications requirements in 10 CFR 26.155, Laboratory personnel, and HHS-certified laboratory procedures requirements specific to the HHS Guidelines in 10 CF R 26.157, Procedures).

Because the National Laboratory Certification Program (NLCP) in spection process verifies laboratory compliance with the HHS Guidelines, additional revie w and oversight by NRC licensees and other entities (e.g., of laboratory security requ irements) would be duplicative. The NRC is seeking comment on additional provisions in 10 CFR Part 26 that are consistent with the HHS Guidelines and could be eliminated from 10 CFR Part 26.

Comment B-1.1: One commenter agreed with the proposed changes to remove redu ndant provisions in 10 CFR Part 26 that also appear in the HHS Guidel ines, leading to duplicative

4 oversight. In addition, the commenter recommended two new chan ges for consideration by the NRC. First, the commenter suggested that as long as the HHS Gu idelines are followed, the NRC should remove the same-gender observed collection requireme nt in 10 CFR 26.115, which is included in Section 4.4(b) of the HHS Guidelines. Second, t he commenter stated that the NRC should eliminate the redundant requirements for Medical Rev iew Officer (MRO) specimen handling in 10 CFR Part 26. (ANON2-CL1, ANON2-A1)

NRC Response: The NRC disagrees. The NRC acknowledges that the HHS Guideli nes contain similar provisions regarding the same-gender collector requirement in 10 CFR 26.115(e) and the MRO specimen handling requirements in 10 CFR Part 26. However, NRC licensees and other entities are subject to the requirements in 10 CFR Pa rt 26 but are not required to comply with the HHS Guidelines. Because removing these require ments from 10 CFR Part 26 would completely eliminate these requirements for NRC licensees and other entities, the NRC will not remove these requirements.

As a result, the NRC did not change the final rule in response to this comment.

The NRC discusses the topic of t he same-gender observed collect ion requirement in 10 CFR 26.115(e) in the NRC Response to Comment L-1.

Comment B-1.2: One commenter recommended that the NRC establish a streamline d process other than rulemaking for nuclear facilities to adopt future HH S Guidelines upon issuance.

(NEI1-CL3, NEI1-AI-1)

NRC Response: The NRC disagrees. Streamlining the process to revise 10 CFR Part 26 whenever the HHS Guidelines change is outside the scope of this rulemaking.

Accordingly, the NRC did not change the final rule in response to this comment.

B-2 Special Analyses Testing

The proposed rule includes new requirements in 10 CFR 26.163(a) (2) for the special analyses testing of urine specimens for drugs and drug metabolites. The first would require special analyses testing of specimens with dilute validity test results when initial drug testing identifies a drug or drug metabolite within 40 percent of the testing cutoff level. Currently, special analyses testing of dilute specimens is optional. The second new requir ement would expand special analyses testing to specimens collected under direct observatio n as required by 10 CFR 26.115(a)(1) through (3) and new paragraph (a)(5). The NRC is seeking comment on whether special analyses testing should also apply to the testi ng of individuals that already have tested positive on a 10 CFR Part 26 test (i.e., denied unescort ed access authorization by 10 CFR 26.75(d) for a first or second drug testing positive res ult). Requiring special analyses testing in this case would add a level of assurance to follow-u p testing required by 10 CFR 26.69(b)(6), which is conducted to confirm continued abs tinence from illegal drug use and/or the misuse of legal drugs.

Comment B-2.1: One commenter supported applying special analyses testing for individuals that have already tested positive and indicated that it should be performed after the immunoassay and gas chromatography/m ass spectrometry (GC/MS) co nfirmation tests. The

5 commenter suggested that special analyses testing would identif y new drugs used and provide trends in drug use by different business departments and employ ee levels. (ANON2-CL2, ANON2-A2)

NRC Response: The NRC disagrees. The reasons the commenter provided for recommending that special analyses testing be applied to the te sting of specimens collected from individuals with a prior drug testing positive result do n ot apply as follows:

(1) Special analyses testing would not identify new drugs; it w ould only identify the drugs in the drug testing panel used by the licensee or other entity.

(2) Special analyses testing would not provide additional trans parency regarding the departments or employee levels where drug use is identified. T he NRC already collects information in the annual FFD program performance reports that licensees and other entities submit to the NRC under 10 CFR 26.717 and 26.417(b)(2). Perfor mance reports provide the employment type (i.e., licensee employee, contractor/vendor) and labor category (e.g.,

supervisor, reactor operator, security) of each individual with a positive test result.

Special analyses testing lowers the initial (i.e., immunoassay) and confirmatory (i.e., GC/MS) testing cutoff levels for existing substances in the drug testi ng panel used by the licensee or other entity. Lower testing cutoff levels increase the timefra me of detection after use of a drug, thereby increasing the likelihood of detecting drug use.

Accordingly, the NRC did not change the final rule in response to this comment.

Comment B-2.2: One commenter stated that if an individual had already tested positive, direct observation testing would be unnecessary because the individual had already tested positive.

The commenter supported using special analyses testing for rete sting a specimen.

(ANON2-CL3, ANON2-A3)

NRC Response: The NRC disagrees. As described in the proposed rule, the NR C would expand special analyses testing to specimens collected under di rect observation as required by 10 CFR 26.115(a)(1) through (3) and a new paragraph (a)(5). Sp ecimens collected under the conditions described in 10 CFR 26.115(a)(1) through (3) and (a) (5) would not have already tested positive, as stated by the commenter. Instead, the spec imens subject to special analyses testing would be collected under direct observation fo r the following reasons:

• The donor presents a specimen reported by an HHS-certified lab oratory as adulterated, substituted, or invalid, and the MRO determines that no adequat e medical explanation exists for the result and that another specimen should be colle cted from the donor;

• The donor provides a specimen that falls outside of the accept able temperature range specified in 10 CFR 26.111(a);

• Donor conduct during the collection process indicates an attem pt to dilute, substitute, or adulterate the specimen; or

6

• The MRO verifies that a specimen is positive, adulterated, or substituted; the donor requests that a retest of the specimen be performed at a second HHS-certified laboratory; but the specimen is not available for testing.

Accordingly, the NRC did not change the final rule in response to this comment.

Comment B-2.3: One commenter stated that if an individual reported a problem with illegal drug use, random drug testing should be directly observed, and special analyses testing performed on the specimens collected. (ANON2-CL4, ANON2-A4)

NRC Response: The NRC disagrees. This comment is beyond the scope of this rulemaking because the proposed rule did not include any changes to the ex clusive grounds for performing a directly observed collection in 10 CFR 26.115. As described below, appropriate mechanisms currently exist within 10 CFR Part 26 to address a situation wh ere an individual self-reports an illegal drug use problem to the licensee or other entity.

The commenters scenario most likely would apply to an individu al that already had been granted unescorted access (UA) or unescorted access authorizati on (UAA) by a licensee. In this instance, if the individual was an employee of the license e, they could utilize the Employee Assistance Program (EAP) that each FFD program must offer under 10 CFR 26.35. The EAP is designed to achieve early intervention and provide for confiden tial assistance. If the individual self-refers for assistance to the EAP, then the EAP is required to protect the identity and privacy of the individual except if the individual waives the right to privacy or the individuals condition or actions pose or have posed an immediate hazard to himself or he rself or others. If, however, the individual self-reports a problem outside the EAP, then the licensee or other entity would be required to disposition the situation under 10 CFR 26.69(d), M aintaining authorization with other potentially disqualifying FFD information. The definiti on of potentially disqualifying FFD information in 10 CFR 26.5 includes that an individual has use d illegal drugs. The licensee or other entity also may consider conducting for-cause testing und er 10 CFR 26.31(c)(2) based on receiving credible information that the individual is engaging in substance abuse. If on the other hand, the individual had not been granted UA or UAA by the lice nsee, but had already provided a specimen for pre-access testing required under 10 CFR 26.65, Pre-access drug and alcohol testing, or 10 CFR 26.69, Authorization with potentially disq ualifying fitness-for-duty information, and therefore would be subject to random testing, then the licensee would be required to evaluate the individuals disclosure under 10 CFR 2 6.69(c), Granting authorization with other potentially disqualifying FFD information.

The NRC did not propose changes to special analyses testing cri teria for random tests, however, a licensee or other entity may use lower testing cutof f levels for any condition for testing if they meet the requirements in 10 CFR 26.31(d)(3)(iii ).

Accordingly, the NRC did not change the final rule in response to this comment.

Comment B-2.4: One commenter indicated that special analyses testing will no t provide additional value for random and follow-up testing and asserted that special analyses testing would make it difficult to credit random tests for follow-up te sts. However, it is reasonable to conduct special analyses testing for the first observed test. (NEI1-A1-2)

7 NRC Response: The NRC disagrees, in part. The NRC sought comment on whethe r special analyses testing should also apply to follow-up tests conducted on individuals that previously tested positive on a 10 CFR Part 26 test and to whom a licensee or other entity subsequently granted unescorted access authorization. Special analyses test ing would provide additional value for follow-up tests because it lowers the testing cutoff levels for the substances in the drug testing panel used by the licensee or other entity. Use of low er testing cutoff levels increases the timeframe of detection after use of a drug, thereby increas ing the likelihood of detecting drug use.

However, the NRC agrees that because random tests would not be subject to the lower cutoff levels used in special analyses testing, the licensee or other entity could not take credit for a random test to meet the follow-up testing requirement (i.e., co unt a random test as meeting a follow-up testing requirement), as currently permitted in 10 CF R 26.69(b)(6).

The NRC did not propose nor request comment on whether an indiv idual with a first or second confirmed positive drug test result under 10 CFR Part 26 should be subject to special analyses testing for the pre-access test conducted under 10 CFR 26.69(b). As a result, this comment is beyond the scope of this rulemaking.

Accordingly, the NRC did not change the final rule in response to this comment.

B-3 Provide Flexibility to Conduct Specimen Validity Testing

Section 26.31(d)(1)(i)(D) permits a licensee or other entity to utilize lower cutoff levels and drug testing assays without forensic toxicologist review if the HHS Guidelines are revised to authorize use of the assay and testing cutoff levels. However, 10 CFR 26.161(h) prohibits licensees and other entities from using more stringent cutoff levels for vali dity tests. The NRC is seeking comment on whether 10 CFR 26.161(h) should be revised to provid e a licensee or other entity with the option to conduct additional specimen validity tests a nd/or to utilize lower cutoff levels if the HHS Guidelines are revised in the future to include such te sting.

Comment B-3.1: Two commenters responded to the request for comment on provid ing flexibility to conduct specimen validity testing. The first co mmenter supported providing licensees and other entities with the option to use lower cutof f levels to conduct specimen validity testing. The commenter also suggested that licensees and other entities be provided with flexibility to use different forms of testing such as hair testing. In this case, the integrity and accountability of the program should be within NLCP Audit p arameters. This must be checked and accounted for so there is not mis-representation at any level.

The second commenter stated that providing the option to conduc t additional specimen validity tests may result in an inconsistent approach across the industr y and preferred a streamlined approach to adopt future updates to the HHS Guidelines. (ANON2 -CL5, ANON2-A5, NEI1-A1-3)

NRC Response: The NRC agrees, in part. Licensees and other entities should be provided with the option to utilize lower cutoff levels for existing specimen validity tests performed under Part 26, as long as those cutoff levels are consistent with the current HHS Guidelines. Affording licensees and other entities with the flexibility to use lower cutoff levels to perform validity testing

8 is consistent with the testing principle that the NRC establish ed in 10 CFR 26.31(d)(1)(i)(D) for drug testing. Section 26.31(d)(1)(i)(D) permits a licensee or other entity to use lower cutoff levels to test for drugs specified in Part 26 and does not requ ire the review of the cutoff levels by a forensic toxicologist if the cutoff levels are consistent wit h the current HHS Guidelines.

Providing a licensee or other entity with flexibility to adopt improvements in the existing validity tests performed under 10 CFR Part 26 is consistent with a key g oal of this rulemaking: enhance the methods for detecting subversion attempts. The NRC acknowl edges that providing the option to use lower cutoff levels for existing validity tests m ay result in variability among some licensees and other entities in the performance of such tests, but this approach is consistent with existing practice for drug testing and was consistent with the optional use of special analyses testing under 10 CFR 26.163(a)(2) until the final rule mandated such testing.

Accordingly, the final rule has been revised in 10 CFR 26.161(h ) to read, Validity test cutoff levels. Licensees and other entities may use more stringent cutoff l evels for validity tests than those specified in this section only if the testing is performe d at an HHS-certified laboratory.

The NRC disagrees that flexibility should be provided to collect and test specimens other than urine as an acceptable alternative to the current validity test s performed under 10 CFR Part 26.

This comment is beyond the scope of this rulemaking.

B-4 Effective Date of the Final Rule

If the proposed rule is finalized, the NRC anticipates providin g a 60-day implementation period from the date that the final rule is published in the Federal Register. The effective date of the final rule and the compliance date for licensees and other enti ties would be 60 days after the date that the final rule is published in the Federal Register. The NRC is seeking comment on whether this implementation time period is appropriate based on the proposed rule changes.

Comment B-4.1: Two commenters disagreed with the proposed effective date of 60 days after the publication date of the final rule. The first commenter ar gued that the proposed 60-day timeframe did not provide sufficient time to understand the new requirements and completely communicate them to all departments and sections. The commente r recommended at least 120 days and noted that this timeframe is still very aggressive.

The second commenter stated that licensees will need approximat ely 12 months to fully and effectively implement the new program utilizing established pro cedures. The commenter explained that once the rule is issued, licensees will need to evaluate change management plan items to include procedures, union/lab contracts, computer systems, and training.

The second commenter also recommended that the NRC clarify that during the transition period, any program may accept and rely on another programs FF D-related information as long as the information being shared is compliant with the sharing p rograms current 10 CFR Part 26 processes. (ANON2-CL6, ANON2-A6, NEI1-A1-4, NEI2-1, EH-1, EN2-1)

NRC Response: The information provided by the two commenters was insufficie nt to support a change to the proposed 60-day implementation timeframe to compl y with the final rule changes.

However, the public provided substantive information during the April 13, 2021, public meeting on the Cumulative Effects of Regulation (CER) for this rule to justify additional implementation

9 time (see meeting summary in ADAMS under Accession No. ML21096A 015). Specifically, an industry stakeholder stated that an implementation timeframe of 1 year was more appropriate than 60 days because of operational challenges posed to a licen sees FFD program staff before, during, and after Spring (February to May) and Fall (Au gust to November) refueling outages at operating nuclear power reactors. The licensees of some power reactor sites also impose training and system change blackout periods 2 months bef ore, during, and 2 months after reactor outages. This industry stakeholder also describe d additional challenges in meeting the 60-day implementation timeframe due to updates to the FFD t raining system used by the industry, licensee information technology system changes, and t he ongoing impacts of the Coronavirus Disease 2019 pandemic such as the remote work statu s of some staff. Three comment submissions received after the public comment period cl osed affirmed the stakeholder feedback presented at the CER public meeting on the implementat ion timeframe.

Accordingly, the NRC revised the compliance deadline to be 1 ye ar from the date that the final rule is published in the Federal Register. Because licensees and other entities can implement the new requirements before the 1-year deadline, licensees and other entities that do so should inform the NRC of their implementation date through their 10 CF R 26.717 annual FFD program performance reports.

The NRC disagrees with the second commenters request to clarif y that during the implementation period of the final rule, any program may accept and rely on another programs FFD-related information as long as the information being shared is compliant with the sharing programs current 10 CFR Part 26 processes. No change is neces sary because the existing requirements in 10 CFR Part 26 permit the sharing of informatio n. For example, to grant authorization, licensees and other entities shall ensure that a suitable inquiry has been conducted under § 26.63, Suitable inquiry, to verify an indiv iduals self-disclosed information and to determine whether any potentially disqualifying FFD info rmation is available. A suitable inquiry can involve licensees sharing information about an indi vidual collected under 10 CFR Part 26. Accordingly, no changes were made to the final rule as a result of this request.

B-5 Direct Observation of Specimen Collection

The proposed rule retained the requirement for direct observati on during the collection of a second sample when there are indications of a subversion attemp t during the initial collection.

The NRC is seeking comment on whet her there are any effective alternatives to direct observation that will assist in preventing subversion of the dr ug testing process.

Comment B-5.1: One commenter responded that a direct observation collection is the only way to ensure the integrity of the specimen collected from the donor and that there were no effective alternatives. The commenter further stated that the highest integrity of the procedure must be maintained between the observer and donor (i.e., no con flicts of interest, no harassment, and no bribery). (ANON2-CL7, ANON2-A7)

Another commenter offered that an oral fluid specimen collectio n is an effective alternative to collecting a urine specimen under direct observation. The comm enter also suggested that an oral fluid specimen should be considered if a donor is unable t o provide the minimum quantity of urine on the initial attempt and that 10 CFR Part 26 should sta te that industry can adopt and

10 implement the HHS Guidelines for oral fluid testing within thei r programs without submitting exemptions or awaiting rulemaking. (NEI1-A1-5)

NRC Response: 8The NRC agrees that collecting an oral fluid specimen under direct observation of the specimen collector is equivalent to and equa lly effective as collecting a urine specimen from a donor under the observed collections conditions in 10 CFR 26.115(a)(1) through (3) and a new paragraph (a)(5). The NRC basis for this decision is the HHS issuance of the Mandatory Guidelines for Federal Workplace Drug Testing Program-Oral/Fluid (2019 HHS OF Guidelines) on October 25, 2019 (84 FR 57554). The 2019 HHS OF Guidelines became effective on January 1, 2020. The 2019 HHS OF Guideline s relied on the technical basis of the acceptability of oral fluid as an alternative spec imen in the Federal employee workplace drug testing program that was presented in the propos ed revisions to the HHS Guidelines published on May 15, 2015 (80 FR 28101).

Under the conditions permitted in the final rule, the testing o f an oral fluid specimen is equally effective in identifying the same substances tested in urine. Oral fluid is tested at an HHS-certified laboratory, with the same HHS inspection and oversigh t process used for urine specimen testing laboratories. Each oral fluid specimen is col lected under the direct observation of the specimen collector.

Although the NRC is permitting a licensee or other entity to co llect a urine or oral fluid specimen under specified direct observation conditions, each specimen ch osen has advantages and disadvantages. The intent of the flexibility offered by the ch anges in the final rule is to provide the licensee or other entity with the ability to collect and te st the appropriate specimen for the collection condition encountered. The following discussion des cribes how both collection methods can detect attempts to subvert the testing process.

• Urine specimen collections are valuable in identifying subvers ion attempts. Collecting a urine specimen under direct observation requires the donor, in the presence of a same-gender observer, to remove his or her clothing between the wais t and knees. This clothing removal process has revealed cheating paraphernalia, d efinitive proof of a donors attempt to subvert the testing process. An NRC analysi s of FFD program performance data submitted under §§ 26.717 and 26.417(b)(2) det ermined that the two most likely subversion determination scenarios are either a don or refuses to provide a second urine specimen under direct observation, or the donors second observed urine specimen tests positive for a drug and the donors initial unob served urine specimen tests negative for that drug. The collection and testing of a donors two urine specimens, the first unobserved and second observed, also provides the MRO with contemporaneous information on the physical characteristics of the specimens that can be used to inform a subversion determination. For example, in rare instances when both the unobserved and observed specimens provided by a donor test negative for drugs, the MROs comparison of the physical characteristics of the two specimens has identified medically impossible differences in specimen tempera ture, pH, creatinine, and specific gravity test results that have resulted in subversion determinations. The removal of a donors clothing from waist to knees, the collecti on of a second urine specimen under the direct observation of the collector, and the testing of the same biological specimen in a contemporaneous testing event has prov ided conclusive evidence of subversion attempts. The existing observed urine c ollection process has

11 proven effective in identifying subversion attempts and urine d rug testing has been successfully conducted by licensees and other entities under 10 CFR Part 26 since 1990.

• Oral fluid specimen collections would not be expected to ident ify subversion attempts.

Collecting an oral fluid specimen is always performed under the direct observation of the collector and does not require a same-gender collector (i.e., t he donor does not remove his or her clothing from the waist to the knees). It is possib le that a donor could retain cheating paraphernalia used during the provision of the initial unobserved urine specimen because clothing is not removed. If the licensee or o ther entity suspects that a donor may be in possession of subversion paraphernalia, then the licensee or other entity can consider taking additional action to identify the pa raphernalia before collecting an oral fluid specimen. In the absence of any identifiable sub version paraphernalia, the licensee or other entity could then conduct an oral fluid speci men collection to meet an observed collection requirement.

The window of detection for drugs and drug metabolites in urine is somewhat longer than in oral fluid. However, this difference is immaterial under the condit ions that oral fluid testing is permitted in the final rule. Oral fluid drug testing is permit ted for collection conditions warranted by information suggesting a possible subversion attempt. Indiv iduals that attempt to subvert the drug testing process do so because of recent use of one or more of the substances included in the drug-testing panel used by the licensee or other entity. S imply put, it is unlikely that a donor would risk a permanent denial of unescorted access under § 26.7 5, Sanctions, for an identified subversion attempt unless they likely would test positive on dr ug testing. As a result, the NRC believes that oral fluid and urine specimen testing likely woul d be equally effective in identifying recent drug use. It is notable that identifying any given subs tance through drug testing is dependent on the chemical properties of the substance, the rete ntion of that particular substance in the human body, frequency of use, and the genetic makeup of the user, which impacts drug metabolism rates. These complexities apply to uri ne and oral fluid specimen testing.

Another difference between urine and oral fluid drug testing is the volume of the biological specimen needed for testing. An oral fluid specimen collection device must obtain a minimum of 1 milliliter (mL) of the donors saliva, whereas urine drug testing requires a volume of 30 to 45 mL. This volume difference must be taken into account by li censees and other entities choosing to use oral fluid testing because sufficient specimen volume must be available to support retesting of a specimen should a donor request specimen retesting following a positive test result under § 26.165.

The oral fluid collection process requires fewer steps to compl ete, and therefore may take less time to complete than for a urine specimen. The stability of o ral fluid specimens also may be better than urine specimens because oral fluid specimen collect ion devices contain a stability buffer, which may reduce the necessity for refrigeration under certain collection and specimen handling conditions.

For each of the directly observed collection conditions in § 26.115(a)(1) through (3) and a new paragraph (a)(5), a licensee or other entity must always collec t either urine or oral fluid specimens. For example, a licensee could continue to collect a urine specimen under every

12 10 CFR 26.115(a)(2) directly observed collection condition when the initial urine specimen provided is outside the acceptable temperature range, but could choose to collect an oral fluid specimen under every 10 CFR 26.115(a)(1) directly observed coll ection condition after an invalid urine specimen test result without a legitimate medical explanation. The required special analyses testing provisions included in the final rule under 10 CFR 26.163(a)(2) apply to the specimens collected under direct observation in 10 CFR 26.163(a )(2) regardless of the specimen that is tested (i.e., both for urine and oral fluid).

As a result of including oral fluid specimen collection and tes ting under specified direct observation conditions in the final rule, the NRC revised the f ollowing sections in the final rule:

• 10 CFR 26.5, Definitions (HHS-certified laboratory);

• 10 CFR 26.31, Drug and alcohol testing;

• 10 CFR 26.83, Specimens to be collected;

• 10 CFR 26.85, Collector qualifications and responsibilities;

• 10 CFR 26.87, Collection sites;

• 10 CFR 26.89, Preparing to collect specimens for testing;

• 10 CFR 26.97, Conducting an initial test for alcohol using a specimen of oral fluids;

• 10 CFR 26.105, Prepare for urine collection;

• 10 CFR 26.117, Prepare urine specimens for storage and shippi ng;

• 10 CFR 26.151, Purpose;

• 10 CFR 26.153, Using certified laboratories for testing urine specimens;

• 10 CFR 26.161, Cutoff levels for validity testing;

• 10 CFR 26.163, Cutoff levels for drugs and drug metabolites;

• 10 CFR 26.167, Quality assurance and quality control;

• 10 CFR 26.169, Reporting results; and

• 10 CFR 26.405, Drug and alcohol testing (FFD program for con struction).

The commenters request to revise 10 CFR Part 26 to permit the collection of an oral fluid specimen in the instance where a donor is unable to provide the minimum quantity of urine on the initial collection attempt (i.e., a shy bladder) is beyond the scope of this rulemaking because the NRC did not propose, nor request comment on, the use of ora l fluid specimens when a donor is unable to provide the minimum quantity of urine on the initial collection attempt.

B-6 2017 HHS GuidelinesNew Test Analytes

On January 23, 2017, HHS issued its latest revision of the Mand atory Guidelines for Federal Workplace Drug Testing Programs Using Urine Specimens (82 FR 79 20). Subpart C, Urine Drug and Specimen Validity Tests, of the 2017 HHS Guidelines w as revised to include additional initial and confirmatory test analytes for certain o pioids; specifically, hydrocodone, hydromorphone, oxycodone, and oxymorphone. The NRC is seeking comment on whether 10 CFR 26.31(d)(1) and 26.405(d) should be revised to identify hydrocodone, hydromorphone, oxycodone, and oxymorphone test substances, and whether 10 CFR 26.133 and 26.163(a)(1) and (b)(1) should be revised to require initial and confirmator y testing of these drugs at the cutoff levels recommended in the 2017 HHS Guidelines.

13 Comment B-6.1: Three commenters expressed support for expanding the 10 CFR P art 26 drug testing panel to include the four opioids added to the 201 7 HHS Guidelines (i.e., hydrocodone, hydromorphone, oxycodone, and oxymorphone). One commenter stated that adopting this expanded drug testing panel will provide gre ater reassurances that persons with authorization to access licensed facilities are fit for du ty. Another commenter expressly endorsed the cutoff levels recommended in the 2017 HHS Guidelin es for these drugs.

(ANON2-CL8, ANON2-A8, NEI1-A1-6, DATIA-2)

NRC Response: The NRC agrees. The NRC evaluated detection changes followin g implementation of drug testing under the 2017 HHS Guidelines on safety-sensitive worker populations analogous to the individuals subject to 10 CFR Part 26. The U.S. Department of Transportation (DOT) began drug testing under the 2017 HHS Guid elines on January 1, 2018 (82 FR 52229; November 13, 2017). The NRC assessment of DOT te st results data for 2018 identified a significant increase in the number of testing viol ations for opioid positive test results.

The NRC analyzed drug testing data from the three modal adminis trations most comparable to the population tested under 10 CFR Part 26 (Federal Aviation Ad ministration (FAA), Federal Rail Administration (FRA), and Federal Transit Administration ( FTA)). The opioid positive testing violation rate for FAA increased from 0.0196 percent in 2017 to 0.0652 percent in 2018 (233-percent increase), for FRA from 0.0322 percent in 2017 to 0.0904 percent in 2018 (181-percent increase), and for FTA from 0.0349 percent in 2017 to 0.1623 percent in 2018 (365-percent increase). These increases in testing violations demonstrated both the effectiveness of the 2017 HHS Guidelines expanded opioid testin g panel and also the prevalence of illicit use of these substances in analogous work er populations to those tested under 10 CFR Part 26.

Most FFD programs already require individuals to report the use of any substance (e.g., prescription drug, over-the-counter substance) with prod uct labeling or use information indicating a potential impairing impact on performance, whereby an assessment would be conducted by the MRO to ensure that the individual can safety p erform assigned job activities.

Required testing for the four additional opioids in the 2017 HH S Guidelines also will likely increase the level of compliance in reporting the use of these impairing substances to the FFD program consistent with the FFD program prescription drug polic y. This change is likely because of the uniform testing for these substances, as well as the consequence for identifying individuals violating the FFD policy and the minimum sanctions that apply under 10 CFR 26.75 for positive test results.

Accordingly, the NRC revised 10 CFR 26.31(d)(1), 26.133, 26.163 (a)(1) and (b)(1),

26.169(h)(3), 26.185(j), and 26.405(d) in the final rule to ali gn with the 2017 HHS Guidelines by adding testing for hydrocodone, hydromorphone, oxycodone, and o xymorphone.

Comment B-6.2: One commenter expressed concern with the increasing number of individuals being placed into follow-up testing programs because of the opi oid epidemic. The commenter asserted that a select few of the nuclear facilities have expan ded their panels to address the opioid crisis. The commenter also stated that these facilities place individuals into the follow-up program for the purpose of monitoring abstinence from opiate ad diction: However, when the individual in the follow-up program travels to another utility; they are not monitored for the substance for which they were placed in the follow-up program; as these programs have not expanded the panel and have no provision to test for the abused opiate. Therefore, the

14 commenter declared that industry is currently ill equipped to monitor the problem because of the significant gap in the follow-up programs ability to detec t on going opiate abuse.

The commenter recommended that the rule include language that a ddresses the opiate epidemic and includes provisions for collection and testing und er every FFD test condition.

(JR6-1)

NRC Response: The NRC agrees. See the NRC Response to Comment B-6.1, which discusses the NRCs decision to expand the drug testing panel t o include the four semi-synthetic opioids included in the 2017 HHS Guidelines (i.e., hydrocodone, hydromorphone, oxycodone, and oxymorphone). See also the NRC R esponse to Comment F-2, which addresses, in part, a comment on follow-up testing f or individuals identified as having abused opioids.

B-7 Methylenedioxyethylamphetamine

The 2008 HHS Guidelines adds methy lenedioxyethylamphetamine (MDEA) as a confirmatory analyte to the drug testing panel in Section 3.4. However, whe n the HHS revised the mandatory guidelines in 2017, HHS removed MDEA from Section 3.4 stating t hat [t]he Department has evaluated the comments and has removed MDEA from the Guidelines (i.e., MDEA is no longer included as an authorized drug in Section 3.4). The number of positive MDEA specimens reported by HHS-certified laboratories (i.e., information provi ded to the Department through the NLCP) does not support testing all specimens for MDEA in federa l workplace drug testing programs (82 FR 7920, 7923; January 23, 2017). The NRC is not proposing to adopt the 2008 HHS Guidelines addition of MDEA as a confirmatory test analyte at this time. As a result, the NRC is also proposing to add methylenedioxyamphetamine (MDA) to the initial testing panel to fully align with the Ecstasy drugs testing panel in the 2017 guidelines. The NRC is seeking comment on these changes.

Comment B-7.1: Two commenters responded to the specific request for comment on whether MDEA and MDA testing is needed. One commenter disagreed and st ated that MDEA should be included in the drug testing panel because not testing for this substance would provide an opportunity for drug use in a sensitive position.

The second commenter favored aligning with the 2017 HHS Guideli nes, which does not include MDEA, even though Ecstasy drugs have not been a prevalent iss ue in the industry. However, the commenter recommended that if blind specimen testing remain s a requirement, then the NRC should consider eliminating the testing of drugs that are n ot prevalent issues in the industry. (ANON2-CL9, ANON2-A9, NEI1-A1-7)

NRC Response: The NRC disagrees, in part. The 2017 HHS Guidelines establis hed the appropriate minimum testing standard for the drugs and drug met abolites to be tested in the specimens collected from individuals subject to testing under 1 0 CFR Part 26. The 2017 HHS Guidelines (82 FR 7923) stated that HHS understands that MDA a nd some other analytes also have a low incidence but believes that continued testing for th ese analytes is warranted in a deterrent program. In particular, inclusion of MDA as an initi al and confirmatory test analyte is warranted because, in addition to being a drug of abuse, it is a metabolite of MDEA and MDMA. The NRC agrees with this HHS position.

15 Further, 10 CFR 26.31(d)(2) provides flexibility to licensees a nd other entities to consult with local law enforcement authorities, hospitals, and drug counseli ng services to determine whether other drugs with abuse potential are being used in the geograph ical locale of the facility and by the local workforce that may not be detected in the standard te sting panel under 10 CFR 26.31(d)(1). When appropriate, a licensee or other enti ty may add other drugs to the testing panel, but only if the additional drugs are listed in S chedules I through V of section 202 of the Controlled Substances Act [21 U.S.C. 812]. MDEA is a Sc hedule I substance. The licensee or other entity must also inform the NRC under 10 CFR 26.717(b)(2) that it is testing for the additional drugs. The NRC has not received information fro m any licensee or other entity that testing for Ecstasy drugs has been performed under a 10 CF R Part 26 testing program.

Therefore, no basis exists to evaluate the commenters position regarding the prevalence of Ecstasy drugs in the industry, but changes in substance abuse t rends do occur over time and testing for substances in the amphetamines drug class supports a deterrent testing program.

The commenters requested change to the blind performance test sample (BPTS) requirements in 10 CFR 26.168 is beyond the scope of this rulemaking because the NRC did not propose changes to, nor request comment on, the blind performance test sample requirements.

Additional discussion on this topic is provided under NRC respo nse to Comment P-1.

Accordingly, the NRC did not change the final rule in response to these comments.

C. FFD Program Applicability to Categories of Individuals

The following comments pertain to 10 CFR 26.4, FFD program app licability to categories of individuals.

C-1 Hydration monitors

Comment C-1.1: Several commenters responded to the proposed new activity in 10 CFR 26.4(g)(6) of monitoring a donor during the hydration pr ocess as an activity that would require the monitor to be designated as FFD program personnel u nder 10 CFR Part 26. Two commenters recommended deleting the proposed new activity. The commenters explained that 10 CFR 26.31, Drug and alcohol testing, permits an individual that is not designated as FFD program personnel to monitor more significant collection proces ses while only receiving training on the activities to be performed. One commenter also referenc ed the observation process in 10 CFR 26.115, Collecting a urine specimen under direct observ ation, for the same reason.

To ensure proper completion of required activities, the comment ers suggested that the rule be modified to include instructions to the hydration monitor on ob servation responsibilities.

In contrast, another commenter requested that FFD authorization personnel be considered acceptable for monitoring the hydration process because FFD pro gram personnel would not be available after hours or on weekends. The commenter stated tha t the main difference between FFD program personnel and FFD authorization personnel is that F FD authorization personnel are not subject to psychological testing during qualification f or the position. However, FFD authorization personnel receive the psychological test if they have UAA or UA, which most of them do. In addition, personnel performing FFD authorization a ctivities are subject to random

16 testing and must complete annual FFD behavioral observation pro gram (BOP) training.

(NEI1-A1-8, EN1-1, INPO-1)

NRC Response: The NRC agrees that persons monitoring a donor during the hyd ration process need not be designated as FFD program personnel because 10 CFR Part 26 already permits three comparable or more significant observation activi ties already permitted to be performed without such a restriction:

(1) Monitoring the collection of a specimen when a donor and co llector have a personal relationship (10 CFR 26.31(b)(1)(iii));

(2) Observing a donor provide a urine specimen under direct obs ervation when a same-gender collector is not available (10 CFR 26.115(e) and (f)); and

(3) In the exceptional event that a designated collection site is inaccessible, an immediate requirement exists to collect a urine specimen (e.g., post-even t test), and a same-gender collector is not available to stand outside the area to be used for the specimen collection (10 CFR 26.87(f)(3)).

In these three instances, the individual observing the collecti on process must receive training or instruction on the applicable collection procedures to be permi tted to perform the observation activity. Use of a hydration monitor also requires instruction to be provided to the individual, as specified in proposed rule 10 CFR 26.109(b)(1)(i), which would require the original collector to explain the hydration process and acceptable donor behavior to the hydration monitor.

Accordingly, the NRC modified the final rule and RG 5.89 as fol lows:

• Removed proposed 10 CFR 26.4(g)(6), which read as follows: A ll persons monitoring a donor during the hydration process described in 10 CFR 26.109(b );

• Revised proposed 10 CFR 26.109(b)(1) to replace the phrase or to a hydration monitor who meets the requirements in 10 CFR 26.4(g)(6) with or to a hydration monitor; and

• Revised guidance in Section C.1.A.(2) of RG 5.89 to replace th e text or to use hydration monitors (10 CFR 26.4(g)(6)) with or also use hydration monit ors.

C-2 Infrequently performed activities

Comment C-2.1: One commenter requested that the NRC revise 10 CFR 26.4(g) to c larify that an individual infrequently performing an activity described in 10 CFR 26.4(g), such as a security officer conducting a specimen collection (e.g., a back shift ra ndom test, or a for-cause or a post-event test), not be considered FFD program personnel. The commenter noted confusion among some licensees on this issue. (JR2-1)

NRC Response: The commenters request to revise 10 CFR 26.4(g) to clarify t hat an individual infrequently performing an activity described in 10 CFR 26.4(g) not be considered FFD program personnel is outside the scope of this rulemaking because the N RC did not propose changes to, nor request comment on, this provision in 10 CFR 26.4(g).

17 However, 10 CFR 26.4(g) does require the licensee or other enti ty to identify in its procedures the individuals involved in the day-to-day operations of the FF D program. If an individual infrequently performing duties listed in 10 CFR 26.4(g) is not identified in the procedures as FFD program personnel, then the individual is not considered FFD pr ogram personnel.

Accordingly, the NRC did not change the final rule in response to this comment.

C-3 Remote collections

Comment C-3.1: One commenter asserted that the remote collection requirement s in 10 CFR 26.4(h)(2) are not clearly denoted, and expressed concer n that as a result, licensees may choose to define which personnel may provide specimens at a remote collection site for drug and alcohol testing. The commenter stated, Licensee comp anys increasingly are placing demands on FFD program personnel to accommodate remote collecti on conditions that would allow the licensee to meet the definition of critical group, th ereby requiring placement in the FFD program. The commenter recommended that the NRC provide guida nce to ensure a clear understanding of this issue. (JR3-1)

NRC Response: The NRC disagrees. The regulations in 10 CFR Part 26 permit specimens to be collected at a location other than a designated collection s ite meeting the requirements in 10 CFR 26.87, which is what the NRC believes the commenter is r eferring to by using the term remote collection. However, under 10 CFR 26.31(b)(2), a lice nsee or other entity is permitted to collect specimens for drug and alcohol testing at a local ho spital or other organization that meets the requirements in 49 CFR Part 40, Procedures for Depar tment of Transportation Workplace Drug and Alcohol Testing Programs, but only for indi viduals identified as FFD program personnel in 10 CFR 26.4(g).

Section 26.4, FFD program applicability to category of individ uals, does not contain a paragraph (h)(2). The comment appears to be referring to parag raph (i), which immediately follows 10 CFR 26.4(h) and includes a subparagraph (2). Howeve r, 10 CFR 26.4(i) describes the individuals that are not subject to an FFD program under 10 CFR Part 26. Therefore, the commenters description of the issue is inconsistent with the r equirements in 10 CFR Part 26.

Accordingly, the NRC did not change the final rule in response to this comment.

D. Definitions

The following comments pertain to 10 CFR 26.5, Definitions.

D-1 Federal custody and control form

Comment D-1.1: One commenter requested that the NRC clarify the proposed new definition for the term Federal custody and control form (Federal CCF). Specifically, the commenter recommended that the NRC revise the proposed phrase any HHS ap proved form, which has not expired with the phrase any HHS-approved form or equivale nt form, which has not expired and add the sentence: Expired custody and control fo rms may be used if covered by an active memorandum for the record. (NEI1-A1-9)

18 NRC Response: The NRC disagrees. The term Federal custody and control form is spec ific to forms approved by HHS. Section 26.153(g) already provides a licensee or other entity with the ability to use a form other than the current Federal CCF, a s long as the form contains all of the required information on the Federal CCF and provides the HH S-certified laboratory with a memorandum explaining why a non-Federal form was used.

Accordingly, the NRC did not change the final rule in response to this comment.

D-2 Lot

Comment D-2.1: One commenter asserted that the blind performance testing req uirement in 10 CFR 26.168(h)(1) does not limit a blind performance test sam ple (BPTS) supplier to certify a lot for only 6 months. Instead, the commenter asserted that th e requirement is that any lot certified by the supplier be for a period of no more than 6 mon ths. The commenter requested the following three definitions be added to 10 CFR 26.5 to impr ove the clarify of the rule:

• Lot (blind specimen) - A controlled and numbered batch prepare d by a provider of Blind Specimens that meets specific Part 26 testing parameters for a drug type, metabolite, adulterant, etc. that must be tested and confirmed by an HHS-ce rtified lab as part of the providers specimen certification process.

• Open Lot - A controlled and numbered batch that meets specific Part 26 testing parameters, and sufficient quantity remains to be tested and co nfirmed by an HHS-certified lab as part of the providers specimen certificat ion process.

• Closed Lot - A controlled and numbered batch that previously m et specific Part 26 testing parameters, but there is no longer sufficient quantity to support the providers specimen certification process. (INPO-3)

NRC Response: The NRC disagrees. Before this rulemaking, 10 CFR 26.168(h)( 1) stated that all blind performance test sample lots are placed in service b y the supplier only after confirmation by an HHS-certified laboratory, and for no more th an 6 months. The final rule eliminates the 6 month in service time limitation for a BPTS lot. In the proposed rule, the NRC proposed eliminating the in-service limit based on feedback tha t sample lots can remain viable for much longer than 6 months (e.g., 2 years) and because the 2 008 HHS Guidelines did not impose an in-service time limit on BPTS lots.

In the proposed rule, the NRC proposed a new definition in 10 C FR 26.5 for the term lot, which would mean a number of units of an item (e.g., drug test kits, reagents, quality control samples) manufactured from the same starting materials within a specific period of time for which the manufacturer states that the items have essentially the same pe rformance characteristics and the same expiration date. The final rule includes this new de finition of lot. The existing definition in 10 CFR 26.5 for Quality control sample is a sa mple used to evaluate whether an analytical procedure is operating within predefined tolerance l imits. Calibrators, controls, negative samples, and blind performance test samples are collec tively referred to as quality control samples and each is individually referred to as a sam ple.

19 Section 26.168(h)(2) requires the BPTS supplier to provide an e xpiration date on each BPTS to ensure that the expected value is received when the licensee or other entity submits the specimen for testing to an HHS-certified laboratory. Under 10 CFR 26.168(h)(3), the BPTS manufacturer must test each open lot every 2 months to ensure t hat samples remaining in the lot do not fall below 130 percent of the initial cutoff test co ncentration established by the assay manufacturer. A test result below 130 percent of that standard is unacceptable and licensees and other entities must discard any BPTS from any lot that is o utside of the acceptable parameters in 10 CFR 26.168. The testing performed under 10 CF R 26.168(h)(3) ensures that each BPTS provided to a licensee or other entity meets the form ulation requirements under 10 CFR 26.168(g) for the duration of the time period that the B PTS supplier has specified on the BPTS.

In addition, the proposed definitions provided by the commenter would use the term batch in a manner inconsistent with the existing rule. The term batch i s specific to the testing of specimens at the same time. In 10 CFR Part 26, the term batch is used under the quality assurance and quality control requirements in 10 CFR 26.167(f)( 3) and in the 10 CFR 26.5 definition of analytical run. The analytical run definitio n states, in part, that an analytical run is defined as no more than an 8-hour period. For a facility th at analyzes specimens in batches, an analytical run is defined as a group of specimens that are h andled and tested together. In contrast, the proposed use of the term batch by the commenter would be equivalent to the term lot, which the final rule defines in 10 CFR 26.5 as a n umber of units of an item (e.g., drug test kits, reagents, quality control samples) manufactured from the same starting materials within a specified period of time for which the manufacturer st ates that the items have essentially the same performance characteristics and the same e xpiration date.

Accordingly, the NRC did not change the final rule in response to this comment.

D-3 Potentially disqualifying FFD information

Comment D-3.1: One commenter asserted that the current definition of Potent ially disqualifying FFD information needed to be amended to address marijuana legalized by state law. The commenter suggested to include the statement (Includ ing controlled substances determined to be illegal under federal law, such as marijuana, but deemed legal under state law) after the current definition of Used, sold, or possessed illegal drugs. (NEI1-A1-10)

NRC Response: The NRC disagrees. The definition of illegal drug in 10 CF R 26.5 means, for purposes of 10 CFR Part 26, any drug that is included in S chedules I to V of section 202 of the Controlled Substances Act [21 U.S.C. 812], but not when use d pursuant to a valid prescription or when used as otherwise authorized by law. Mar ijuana is a Schedule I drug, which means it has no currently accepted medical use in treatm ent in the United States[and t]here is a lack of accepted safety for use of the drug or othe r substance under medical supervision. So, no valid prescription can be written for a S chedule I drug under Federal law.

In addition, 10 CFR 26.185(j)(6) states, The MRO may not consi der the use of any drug contained in Schedule I of section 202 of the Controlled Substa nces Act [21 U.S.C. 812] as a legitimate medical explanation for a positive confirmatory drug test result, even if the drug may be legally prescribed and used under State law.

20 As a result, the NRC did not change the final rule in response to this comment.

Comment D-3.2: One commenter requested that the current definition of Poten tially disqualifying FFD information be revised to remove (except fo r self-referral) from the statement (7) Been subjected to a plan for substance abuse tre atment (except for self-referral). The basis for the request was that the current sta tement is in conflict with two other elements in the existing definition: (3) Used, sold, or posse ssed illegal drugs and (4) Abused legal drugs or alcohol. (NEI1-A1-11)

NRC Response: The NRC disagrees. The NRC did not propose changes to, nor r equest comment on, the definition of the term Potentially disqualifyi ng FFD information in 10 CFR 26.5. As a result, this comment is beyond the scope of this rulemaking.

However, under 10 CFR 26.35(c), the employee assistance program (EAP) staff shall protect the identity and privacy of any individual (including those who have self-referred) seeking assistance from the EAP, except if the individual waives the ri ght to privacy in writing or EAP personnel determine that the individuals condition or actions pose or have posed an immediate hazard to himself or herself or others. In the latter situatio n, 10 CFR 26.35(c) requires EAP personnel to inform FFD program management that the individual s condition or actions pose or have posed an immediate hazard to himself or herself or others and need not obtain a written waiver of the right to privacy from the individual. The indivi dual conditions or actions that EAP personnel shall report to FFD program management include, but a re not limited to, substantive reasons to believe that the individual has been impaired from u sing drugs or alcohol while in a work status and has a continuing substance abuse disorder that makes it likely he or she will be impaired while in a work status in the future, or has ever enga ged in any acts that would be reportable under 10 CFR 26.719(b)(1) through (b)(3).

Removing except self-referral from the Potentially disqualif ying FFD information definition could be chilling to an individual seeking assistance from the EAP, which exists to provide early intervention and provide for confidential assistance, except as noted above. In the 2008 Part 26 final rule statement of considerations (73 FR 17026), the Commi ssion stated:

[T]he EAP provides an important means to detect and achieve ear ly resolution of developing substance abuse and other problems, which if left un treated could have the potential to adversely affect an individuals ability to safely and competently perform his or her duties. The knowledge or percep tion among individuals who are subject to the rule that self-referrals to the EAP will be reported to management and will routinely result in the loss of authorization represents a significant barrier to the effectiveness of the EA P element of FFD programs. Therefore, an individuals use of the licensees o r other entitys EAP must remain confidential, except in very limited circumstan ces.

Accordingly, the NRC did not change the final rule in response to this comment.

21 D-4 Rejected for testing

Comment D-4.1: One commenter requested that the proposed new definition for rejected for testing be modified for clarity. The commenter suggested that the definition read as the result reported to the MRO by a licensee testing facility or HHS-certi fied laboratory when a fatal flaw disqualifies a specimen or, any of the required testing cannot be performed on a specimen.

(NEI1-A1-12)

NRC Response: The NRC disagrees. The term fatal flaw is not used in 10 C FR Part 26, although the term is used in the 2008 and 2017 HHS Guidelines ( Subpart O - Criteria for Rejecting a Specimen for Testing, Section 15.1). Instead, 10 C FR Part 26 specifies the exclusive grounds requiring the MRO to cancel the testing of a donors urine specimen under 10 CFR 26.129(b)(2) for tests performed at licensee testing fac ilities, and under 10 CFR 26.159(b)(2) for tests performed at HHS-certified labora tories. The NRC added the definition of rejected for testing because, in part, that is the term used by the laboratory in its communication to the licensee or other entity. Under the HHS G uidelines, if an HHS-certified laboratory identifies a fatal flaw, then the laboratory will re port on the Federal CCF that the specimen was rejected for testing and the reason for the report ed result.

Accordingly, the NRC did not change the final rule in response to this comment.

D-5 Substance abuse

Comment D-5.1: One commenter requested that the NRC consider amending the cu rrent definition of substance abuse to specifically include control led substances, such as marijuana, which has been deemed legal under State law. (NEI1-A1-13)

NRC Response: The NRC disagrees. The NRC did not propose changes to, nor r equest comment on, the 10 CFR 26.5 definition of substance abuse, wh ich means the use, sale, or possession of illegal drugs, or the abuse of prescription and o ver-the-counter drugs, or alcohol abuse of alcohol. As a result, this comment is beyond the sco pe of this rulemaking.

Accordingly, the NRC did not change the final rule in response to this comment.

See also the NRC Response to Comment D-3.1, which discusses the 10 CFR 26.5 definition of illegal drugs.

E. Written Policy and Procedures

The following comments pertain to 10 CFR 26.27, Written policy and procedures.

Comment E-1: 5-hour prohibition for the use of impairing substances. One commenter suggested that the current requirement in 10 CFR 26.27(b)(4) th at prohibits the consumption of alcohol within an abstinence period of 5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> preceding the in dividuals arrival at the facility, should apply to any substance with known impairing qualities. In particular, the commenter was concerned that there are additional substances with intoxicatin g effects greater than or equal to alcohol. Some examples given included prescription opiates, in halant substances, benzodiazepines, sedatives, and sleep aids. To address this co ncern, the commenter recommended that while naming every impairing substance may not serve the purpose, it would

22 be more efficacious to stipulate that any impairing substance ingested within 5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> of reporting, is prohibited, including alcohol. (JR4-1)

NRC Response: The NRC disagrees. The NRC did not propose changes to, nor r equest comment on, the 5-hour abstinence period for alcohol use. As a result, this comment is beyond the scope of this rulemaking.

The NRC does not support establishing a specific abstinence per iod to prohibit the use of other potentially impairing substances by an individual subject to a Part 26 FFD program. For example, the complexity of the time periods in which impairment may result from use of prescription or over-the-counter (OTC) drugs, makes establishin g such an abstinence period impractical. However, 10 CFR Part 26 does not prohibit a licen see or other entity from establishing such a policy.

The requirements in 10 CFR Part 26 establish a robust framework to mitigate potential impairing effects of prescription and OTC medication use. Each licensee and other entity must implement a behavioral observation program under 10 CFR 26.33 to train in dividuals in detecting behaviors that may indicate impairment from any cause that may constitute a risk to public health and safety or the common defense and security, and to take action u nder 10 CFR 26.77 to address possible impairment. Section 26.27(b) requires the establishme nt of an FFD policy to address the factors that could cause impairment, such as the use of pre scription and OTC medications, and to describe the consequences to an individual for the misus e of those substances. Section 26.29 requires initial and annual training for each individual on prescription and OTC drugs and dietary factors that have the potential to affect drug and alco hol test results, and the ability to observe and detect performance degradation, indications of impa irment, or behavioral changes.

Accordingly, the NRC did not change the final rule in response to this comment.

F. Drug and Alcohol Testing

The following comments pertain to 10 CFR 26.31, Drug and alcoh ol testing.

F-1 Post-event testing criteria

Comment F-1.1: One commenter indicated that the 10 CFR 26.31(c)(3)(i) criter ion to conduct post-event testing after an event resulting in illness or inj ury determined to be reportable under 29 CFR 1904.7, General recording criteria, of the U.S. Depart ment of Labor (DOL) is difficult to implement. The requirement to conduct post-event testing withi n 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> after the event is determined to be recordable to DOL is confusing because it may take 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> or longer after the event occurs to determine that it is recordable to DOL. In this situation, the commenter questioned whether post-event testing makes sense. (JR5-1)

NRC Response: The NRC did not propose changes to, nor request comment on, t he post-event testing criteria in 10 CFR 26.31(c)(3)(i). As a result, this comment is beyond the scope of this rulemaking. However, the commenters request could inform future considerations by the NRC.

Accordingly, the NRC did not change the final rule in response to this comment.

23 Comment F-1.2: One commenter stated that the 10 CFR 26.31(c)(3)(iii) criteri a requiring post-event testing to be conducted for substantial degradation to the of level of safety of the plant, has been frequently debated and suggested that the degr adations of plant safety that generally may compromise general safety and security may be a more appropriate testing criteria. (JR5-2)

NRC Response: The NRC did not propose changes to, nor request comment on, t he post-event testing criteria in 10 CFR 26.31(c)(3)(iii). As a result, this comment is beyond the scope of this rulemaking. However, the commenters request could inf orm future considerations by the NRC.

Accordingly, the NRC did not change the final rule in response to this comment.

F-2 Follow-up testing plan

Comment F-2: One commenter requested that personnel in the follow-up testi ng program for a specific substance under one licensee or other entitys FFD tes ting program to verify abstinence from substance abuse continue to be monitored through follow-up testing for the applicable substance if they change employment within the industry. The c ommenter indicated that follow-up testing has worked well when it applies to the standa rd panel of drugs tested for under 10 CFR Part 26, but it has not adapted to the opioid epidemic. Few sites utilize expanded testing panel testing for opioids and therefore variability exi sts on whether a subsequent licensee or other entity will continue to monitor abstinence fo r an addiction issue. (JR6-2)

NRC Response: The NRC disagrees, in part. Under 10 CFR 26.69(e), Accepting followup testing and treatment plans from another FFD program, a licensee or other entity may rely on the follow-up testing, treatment plan, and determination of fitness for an individual if compliant with 10 CFR 26.189 and conducted under the 10 CFR Part 26 FFD progra m of another licensee or other entity. The licensee or other entity who imposed a treat ment plan, follow-up testing plan, or both, must ensure that the information documenting the plan( s) is identified to any subsequent licensee or other entity who seeks to grant authoriz ation to an individual, which is the case described by the commenter. If it is impractical for the individual to comply with a treatment plan that was developed under another FFD program bec ause of circumstances outside of the individuals or licensees or other entitys con trol (e.g., geographical distance, closure of a treatment facility), then the granting FFD program must ensure that a substance abuse expert (SAE) develops a comparable treatment plan, with a ccountability for monitoring the individuals compliance with the plan assumed by the granti ng licensee or other entity. If the previous licensee or other entity determined that the individua l successfully completed any required treatment and follow-up testing, and the individuals last period of authorization was terminated favorably, the receiving licensee or entity may rely on the previous determination of fitness and no further review or follow-up is required.

However, under 10 CFR 26.69(b), Authorization after a first co nfirmed positive drug or alcohol test result or a 5-year denial of authorization, a licensee or other entity is required to:

(1) ensure that an SAE has conducted a determination of fitness and concluded that the individual is fit to safely and competently perform his or her duties; (2) ensure that any recommendations for treatment and follow-up testing be initiate d before granting authorization;

24 (3) conduct a minimum number of follow-up tests over a specifie d period of time; and (4) verify compliance and successful completion of any treatment and follo w-up testing.

The NRC Response to Comment B-6.1 describes the changes made in the final rule to expand the drug testing panel to include four semi-synthetic opioids i n the 2017 HHS Guidelines (i.e., hydromorphone, hydrocodone, oxycodone, and oxymorphone). These drug testing panel changes apply under all conditions of testing under 10 CFR Part 26 and address, in part, the request of the commenter.

F-3 Random testing collector availability

Comment F-3: One commenter requested that the random testing requirement i n 10 CFR 26.31(d)(2)(v) pertaining to individuals who are off-or on-site and not reasonably available for testing when selected, be revised to clarify ava ilability of the collector performing in a collector capacity. The commenter requested that the phr ase when both the donor and collectors are available to collect specimens for testing and w ithout prior notification to the individual be replaced with when collection personnel are sch eduled to perform collections and the donor is available for testing and without prior notificati on to the donor. (NEI1-A1-14)

NRC Response: The NRC did not propose changes to, nor request comment on, t he random testing requirements in 10 CFR 26.31(d)(2)(v). As a result, th is comment is beyond the scope of this rulemaking.

Accordingly, the NRC did not change the final rule in response to this comment.

G. Behavioral Observation

The following comment pertains to 10 CFR 26.33, Behavioral observation.

Comment G-1: Program elements. One commenter requested that the NRC revise the behavior observation program requirements in 10 CFR 26.33 to ad d detecting behaviors indicative of mental illness, as well as impairment from any su bstance (e.g., inhalants, household substances). Currently, a behavioral observation pro gram must detect behaviors that may indicate possible use, s ale or possession of illegal d rugs or use or possession of alcohol on site or while on duty. (JR1-1)

NRC Response: The NRC disagrees. The NRC did not propose changes to, nor r equest comment on, the behavioral observation requirements in 10 CFR 2 6.33. As a result, this comment is beyond the scope of this rulemaking.

The behavioral observation program requirements in 10 CFR 26.33 include the statement or impairment from fatigue or any cause that, if left unattended, may constitute a risk to public health and safety or the common defense and security. This st atement covers the topics of the commenters request. However, the commenters request could in form future considerations by the NRC.

Accordingly, the NRC did not change the final rule in response to this comment.

25 H. Sanctions

The following comments pertain to 10 CFR 26.75, Sanctions.

Comment H-1: Denial period for first positive result of illegal drug use. One commenter requested that 10 CFR 26.75 be revised in the final rule. The commenter stated that the minimum denial of authorization for a period of 14 days for a f irst positive test result for a legal substance (e.g., alcohol) must not be the same as that for a fi rst positive test result for an illegal substance (e.g., cocaine). Instead, the commenter recommended increasing the minimum denial of authorization to 5 years for a first positive test re sult for an illegal drug. (NE-1)

NRC Response: The NRC disagrees. The NRC did not propose changes to, nor r equest comment on, the sanctions in 10 CFR 26.75. As a result, this c omment is beyond the scope of this rulemaking. The NRC addressed this subject in the initial 10 CFR Part 26 final rule (June 7, 1989; 54 FR 24477). Further, under 10 CFR 26.75(a), a licensee or other entity may impose a more stringent sanction (except as specified in 10 CFR 26.75(h)). The 10 CFR 26.717 annual FFD program performance data reported to t he NRC by licensees and other entities indicates that some licensees and other entities institute a sanction far greater than 14 days for a first positive test result.

Accordingly, the NRC did not change the final rule in response to this comment.

Comment H-2: Use of other intoxicating agents. One commenter requested that the conditions requiring a 5-year denial under 10 CFR 26.75 be expanded to inc lude the abuse of any intoxicating substance (e.g., solvents, computer cleaners) and any prescription drug with the sole intent of producing a high to alter consciousness. The co mmenter reasoned that these conditions should be added because they both jeopardize safety and security. Currently, a 5-year denial of authorization sanction is required for the sa le, use or possession of illegal drugs or the consumption of alcohol within a protected area o r while performing duties that require the individual to be subject to 10 CFR Part 26. (JR7-1)

NRC Response: The NRC did not propose changes to, nor request comment on, t he sanctions in 10 CFR 26.75. As a result, this comment is beyond the scope of this rulemaking. However, the commenters request could inform future considerations by t he NRC.

Part 26 does not prohibit a licensee from establishing a sancti on under its FFD policy for abuse of an intoxicating substance.

Accordingly, the NRC did not change the final rule in response to this comment.

I. Management Actions Regarding Possible Impairment

The following comments pertain to 10 CFR 26.77, Management act ions regarding possible impairment.

Comment I-1: Assessing impairment. One commenter requested that the NRC consider language that clearly allows for drug and alcohol testing to el iminate the possibility that drugs and alcohol are playing a role in the behavior. Impairment may not be observed, but behavior

26 that may deviate significantly from the individuals recognized customary character or practice necessitates a drug and alcohol screen. A negative finding on a drug and alcohol screen will eliminate the possibility that drugs or alcohol are playing a r ole in the observed behavior. Once this factor is eliminated, other contributing factors such as m ental or physical health may be considered. The commenter stated that there have been notewort hy cases where behaviors were reported as odd or irregular only to find that, following a drug and alcohol screen, prescription drug abuse, alcohol abuse, or a combination of the two was the contributing cause.

In other cases, mental illness was detected, resulting in the n eed for treatment. In each of these cases, there was no demonstrated impairment. Drug and alcohol screens are a vital data point in a process of next steps in reaching a decision concerning th e need for a full determination of fitness. (JR8-1)

NRC Response: The NRC disagrees. The NRC did not propose changes to, nor r equest comment on, the management actions regarding possible impairmen t described in 10 CFR 26.77. As a result, this comment is beyond the scope of this rulemaking.

Under 10 CFR 26.77(b)(1), if an observed behavior or physical c ondition creates a reasonable suspicion of possible substance abuse, then the licensee or oth er entity must perform drug and alcohol testing, unless the physical condition is the smell of alcohol with no other behavioral or physical indications of impairment, in which case only alcohol testing is required.

Under 10 CFR 26.77(b)(3), a licensee or other entity must perfo rm a determination of fitness for other indications of possible impairment that do not create a reasonable suspicion of substance abuse (or fatigue, in the case of licensees and [contractor/ven dors] who are subject to subpart I of this part). The determination of fitness requirement under 10 CFR 26.189(a) specifies that the determination of fitness must be made by a licensed or cer tified professional who is appropriately qualified and has the necessary expertise to ev aluate the specific fitness issues presented by the individual. Section 26.189(a)(5) also states, If there is no conclusive evidence of an FFD policy violation but there is a significant basis for concern that the individual may be impaired while on duty, then the subject individual must be determined to be unfit for duty. [T]he professional who made the determination of fitnes s shall consult with the licensees or other entitys management personnel to identify t he actions required to ensure that any possible limiting condition does not represent a threat to workplace or public health and safety. Licensee or other entity management personnel shall im plement the required actions.

When appropriate, the subject individual may also be referred t o the EAP.

Accordingly, the NRC did not change the final rule in response to this comment.

J. Preparing to Collect Specimens for Testing

The following comments pertain to 10 CFR 26.89, Preparing to c ollect specimens for testing.

Comment J-1: Use of the terms label and seal. One commenter requested that the term tamper-evident tape used in proposed rule 10 CFR 26.89(d) be replaced with the term a tamper-evident seal. This change would ensure consistency wit h the term that is currently used in 10 CFR 26.117(c). (NEI1-A1-15)

27 NRC Response: The NRC agrees.

Accordingly, the NRC has corrected the inconsistency in 10 CFR 26.89(d) of the proposed rule by replacing the term tamper-evident tape with the phrase a tamper-evident seal.

K. Urine Specimen Quantity

The following comments pertain to 10 CFR 26.109, Urine specime n quantity.

K-1 Hydration monitor being a collector

Comment K-1: One commenter stated that the new requirement in proposed rul e section 10 CFR 26.109(b)(1), that a hydration monitor be a collector, i s unnecessary and an administrative burden. To address this concern, the commenter recommended the following two changes:

First, create a new 10 CFR 26.31(b)(1)(vi) that states, When a donor is unable to provide an acceptable specimen of 30 mL, they are encouraged to follow the hydration process in 10 CFR 26.109(b). During the hydration period, a donor may be under the observation of a hydration monitor as follows: (A) The donor must be continuous ly monitored by an individual who does not have a personal relationship with the donor; (B) I ndividuals who are assigned to monitor donors during a hydration period shall be provided inst ructions on the monitoring process and control the donors access to any fluids, and contr ol the hydration process in accordance with 10 CFR 26.109(b); and (C) The hydration monitor shall be responsible for documenting the hydration process in accordance with program pr ocedures.

Second, replace the phrase a hydration monitor who meets the r equirements in 10 CFR 26.4(g)(6) with a hydration monitor who meets the requ irements in 10 CFR 26.31(b)(1)(vi) in proposed rule 10 CFR 26.109(b)(1). (NEI1-A1-16)

NRC Response: The NRC disagrees, in part. The proposed requirement in 10 CFR 26.109(b)(1) stated that the collector may assign respo nsibility for monitoring a donor during the hydration process to another collector who meets the requirements in 10 CFR 26.85(a) or to a hydration monitor who meets the require ments in 10 CFR 26.4(g)(6).

Under the proposed rule, a hydration monitor would not need to be a collector but would need to be FFD program personnel.

In the final rule, the NRC eliminated the 10 CFR 26.4(g)(6) pro posed requirement that a hydration monitor be designated as FFD program personnel (see N RC Response to Comment C-1). Therefore, the commenters request to include requiremen ts for a hydration monitor in 10 CFR 26.31(b)(1), the section of Part 26 that describes how a licensee or other entity will assure the honesty and integrity of FFD program personnel, is n ot applicable.

However, in terms of the content of the commenters proposed 10 CFR 26.31(b)(1)(vi), the proposed and final rules under 10 CFR 26.109(b)(1)(i) do requir e the specimen collector to explain the hydration process and acceptable donor behavior to the hydration monitor. The NRC agrees that the hydration monitor should not have a persona l relationship with the donor,

28 as is described in Section 1.A.(6) of DG-5040, which states tha t the collector should verbally confirm that the hydration monitor does not have a personal rel ationship with the donor(s).

Accordingly, the NRC did not change the final rule in response to this comment.

K-2 Adding information to the CCF remarks line and CCF control

Comment K-2.1: One commenter requested that the proposed 10 CFR 26.109(b)(1)(i i) requirement that the original specimen collector record the na me of the other collector or hydration monitor on the Federal CCF and then provide the Feder al CCF to that individual for the duration of the hydration process be deleted. The comment er stated that there is insufficient room on the Federal CCF to record the name and tha t it is both unnecessary and inconsistent with other 10 CFR Part 26 collection provisions th at permit the use of a monitor, but do not require the individuals name to be recorded on the Fede ral CCF. The commenter pointed out that the only instance when the name of an individu al is recorded on the Federal CCF is for a directly observed collection. Further, the commen ter stated that the Federal CCF should remain with the original collector and not be provided t o the hydration monitor or other collector during the hydration process. (NEI1-A1-17, NEI1-A1-1 8)

NRC Response: The NRC disagrees, in part. As noted by the commenter, 10 CFR 26.115(f)(4) is the only requirement where the name of a n observer must be recorded on the Federal CCF if someone other than a collector observes a specimen provided under direct observation. In the other circumstance described by the commenter under 10 CFR 26.31(b)(1)(iii), if a donor and the collector have a pe rsonal relationship, the collection must be monitored by an individual who does not have a personal relationship with the donor, but the rule is silent on documenting the monitors name on the CCF. The difference between these two collection circumstances is that under 10 CFR 26.31(b )(1)(iii), the specimen collector retains their responsibilities during the collection process, w hereas under 10 CFR 26.115(f)(4),

the individual observing the donor is solely performing the ass igned duty.

Under the proposed rule, the collector is permitted to transfer the responsibility to observe a donor during the hydration process to another collector or indi vidual instructed on the required responsibilities (i.e., a hydration monitor). In this situatio n, the original collector is not performing the observation activity and therefore it is appropr iate to document the name of the individual (i.e., hydration monitor or second collector) on the Federal CCF, as required under proposed 10 CFR 26.109(b)(1)(ii). Documenting the name of the hydration monitor or a second collector on the Federal CCF is a donor protection, is a limite d amount of text to write on the Federal CCF, and supports NRC inspection for compliance with 10 CFR Part 26 collection requirements. However, the NRC does agree that only limited sp ace exists on the Federal CCF to record more extensive comments on the specimen collection (s ee NRC Response to Comment U-1.3).

The NRC agrees that is it unnecessary for another specimen coll ector or hydration monitor to be provided with the Federal CCF for the hydration process because the Federal CCF would not contain enough space to document observations made during the h ydration process (i.e., space on the one line on the Federal CCF for comments would be limite d because it already would include the name of the hydration monitor or other collector). A licensee or other entity could,

29 consistent with its collection procedures, establish a document ation method for the hydration monitor or other specimen collector to record information about the hydration process.

Accordingly, the NRC updated the final rule by removing the phr ases and then provide the Federal CCF to the individual for the duration of the hydration process in 10 CFR 26.109(b)(1)(ii), and except as provided in 10 CFR 26.1 09(b)(1)(ii) for the Federal CCF in 10 CFR 26.117(g).

L. Collecting a Urine Specimen Under Direct Observation

The following comments pertain to 10 CFR 26.115, Collecting a urine specimen under direct observation.

Comment L-1: Donor gender identity. One commenter requested that the same-gender collection requirement be modified for the circumstance when a donor identifies as one gender but has the physical anatomy of the opposite gender, or those w ho identify as gender X. In this instance, the commenter suggested permitting a medical professi onal, such as a doctor or nurse that is of the opposite gender of the donor, to complete the direct observation. The commenter stated that this approach would not be allowed under the proposed wording.

The commenter recommended 10 CFR 26.115(e) be revised as follow s: The collector shall reasonably ensure that the observer is the same gender as the i ndividual donor. The observer may be a different person from the collector and need not be a qualified collector. If the observer is not a qualified collector, the collector shall, in the presence of the donor, instruct the observer on the collection procedures in paragraph (f) of this section before proceeding with the directly observed collection. (NEI1-A1-19)

NRC Response: The NRC disagrees. The NRC did not propose changes to, nor r equest comment on, the requirement in 10 CFR 26.115(e) for the observe r of an observed collection be the same gender as the donor. As a result, this comment is bey ond the scope of this rulemaking.

However, because 10 CFR Part 26 does not define the term gende r, a licensee or other entity could establish through its written policy and procedures in 10 CFR 26.27, how to conduct an observed collection when a donor identifies as one gender but h as the physical anatomy of the opposite gender, or the donor identifies as gender X.

Licensees and other entities could consider the same-gender col lection procedures in the 2017 HHS Guidelines, which were updated to address a donors ge nder identity. Specifically, Section 1.5 was updated to define a new term, gender identity, as an individuals internal sense of being male or female, which may be different from an i ndividuals sex assigned at birth. The direct observation collection procedure in Section 8.10 of the 2017 HHS Guidelines also was revised to allow the donor to be observed by an observ er whose gender matches the donors gender. Specifically, at the beginning of the observed collection, the collector is to request that the donor document the donors gender on the Feder al CCF and initial the annotation. An observer of the same gender would then be provi ded, and the collector would record the name and gender of the observer on the Federal CCF.

30 Accordingly, the NRC did not change the final rule in response to this comment.

M. Preparing Urine Specimens for Storage and Shipping

The following comments pertain to 10 CFR 26.117, Preparing uri ne specimens for storage and shipping.

Comment M-1: Specimen handling. One commenter expressed concern that shipping delays due to multi-day holidays could impact specimen integrity by ca using invalid test results. The commenter indicated that the 10 CFR 26.117(j) requirement that a specimen be delivered to the laboratory within 2 business days of shipment may not be protec tive of the donor. The commenter stated that rather than limiting the rule change to h ow invalid test results will be handled, the rule should be changed to require a specimen to be received by the laboratory within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of shipment. On the other hand, the commenter also offered that the licensee or other entity could contractually require the courier service to provide notification whenever the 2-business day receipt requirement could not be met. (INPO-2)

NRC Response: The NRC disagrees. The NRC did not propose changes to, nor r equest comment on, the requirements in 10 CFR 26.117(j) regarding the timing of the transfer of a urine specimen from a collection site to a testing laboratory. As a result, this comment is beyond the scope of this rulemaking.

A licensee or other entity is responsible for ensuring that a s pecimen is delivered to an HHS-certified laboratory within 2 business days of shipment fro m the collection site, except under unusual circumstances. For example, if a licensee sends a specimen to the HHS-certified laboratory on Friday for delivery on Saturday morning, but the laboratory normally does not accept specimens for testing on Saturday and Sunday, the li censee would not be meeting the 10 CFR 26.117(j) requirement. In this example, the collect ion site would maintain the specimen in storage until the laboratory would be available to take receipt of the specimen.

Accordingly, the NRC did not change the final rule in response to this comment.

N. Determining Shy Bladder

The following comments pertain to 10 CFR 26.119, Determining shy bladder.

Comment N-1.1: Medical evaluation. One commenter expressed concern that meeting the 5-business day requirement for a donor to obtain an evaluation from a licensed physician for a shy bladder presents unique challenges. The commenter indicate d that additional time was necessary because of transient workers who do not have health i nsurance or a personal physician. Workers who are trav eling and away from their resid ence must now (when unable to produce a specimen) attempt to tr avel home and find a physician who will immediately schedule an appointment and see them. Finding an appointment with a phy sician in the immediate area of the plant is difficult due to the short time frame. In this frequent scenario, the worker is unable to meet the 5-day standard, which invariably results in a permanent denial.

31 The commenter recommended that the NRC provide a more realistic time frame to complete the evaluation, such as a minimum of 10 days, not to exceed 30 days, with the approval of the MRO or program manager. (JR9-1)

NRC Response: The NRC did not propose changes to, nor request comment on, a ny provisions in 10 CFR 26.119. As a result, this comment is beyo nd the scope of this rulemaking.

However, the commenters request could inform future considerat ions by the NRC.

Accordingly, the NRC did not change the final rule in response to this comment.

Comment N-1.2: Alternative specimen. One commenter suggested that an acceptable alternative for individuals unable to provide a urine specimen is the collection and testing of oral fluid. The 2019 HHS Guidelines for oral fluid specimen collect ion and testing should provide MROs and program managers with the needed tools and guidance to address this issue. The commenter requested that the NRC establish requirements for the conditions when oral fluid specimen collection is appropriate for drug testing. Furthermo re, the commenter requested that the NRC provide flexibility to collect and test oral fluid unde r any testing condition. (JR9-2)

NRC Response: The NRC disagrees with the commenters request that the NRC p rovide flexibility to collect and test an oral fluid specimen instead of a urine specimen under any testing condition specified under 10 CFR 26.31(c). The NRC did not propose nor request comment on whether to allow this flexibility, so the request is beyond the scope of this rulemaking. However, Part 26 already provides flexibility to collect and test an alt ernative specimen under three circumstances (see 10 CFR 26.31(d)(5)(i), 26.119(g)(3), and 26. 185(f)(2)). In each instance, either a medical condition prevents the donor from providing a urine specimen for testing, or a donors medical condition affects the ability to test the speci men (i.e., invalid test result). The NRC has chosen not to specify any b iological specimen type that is acceptable for collection and testing to provide the most flexibility to the MRO given a donors unique medical circumstances. However, the commenters request could inform f uture considerations by the NRC.

The NRC addresses the commenters request that the NRC establis h requirements for the conditions when an oral fluid specimen is appropriate for colle ction and drug testing under the NRC Response to Comment B-5.1.

Accordingly, the NRC did not change the final rule in response to this comment.

O. Cutoff Levels for Validity Testing

The following comments pertain to 10 CFR 26.161, Cutoff levels for validity testing.

Comment O-1: Validity testing. One commenter asked if 10 CFR Part 26 required a quantitative determination to report a dilute validity test res ult. (JC-1)

NRC Response: The commenters concern is addressed in 10 CFR 26.161(e), whi ch provides the criteria by which an HHS-certified laboratory determines wh ether a validity test specimen is dilute and must be reported to the MRO. A dilute specimen is r eported when the creatinine

32 concentration of a specimen is equal to or greater than 2 mg/dL but less than 20 mg/dL and its specific gravity is greater than 1.0010 but less than 1.0030 on a single aliquot.

Accordingly, the NRC did not change the final rule in response to this comment.

P. Blind Performance Testing

The following comments pertain to 10 CFR 26.168, Blind perform ance testing.

Comment P-1: Eliminate blind performance testing. Two commenters requested that the NRC eliminate the blind performance test sample (BPTS) requirements in 10 CFR 26.168 or permit industry plants to share results and thus reduce the costs of t he program. The commenters stated that the DOT had discontinued the blind specimen submiss ions (Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Ad dition of Certain Schedule II Drugs to the Department of Transportations Drug-Testing Panel and Certain Minor Amendments, 82 FR 52229; November 13, 2017) for its regulated entities under 49 CFR Part 40 and because of the rigorous HHS oversight of the laboratories. (JR12-1, NEI1-CL2, NEI1-A1-21)

NRC Response: The NRC disagrees. The NRC did not propose to eliminate the BPTS requirements in 10 CFR 26.168 or to permit FFD programs of mult iple licensees or other entities to share results. Therefore, this comment is outside the scope of this rulemaking. Further, the NRC disagrees with eliminating the BPTS requirements for the fo llowing reasons:

1) The reporting of events under 10 CFR 26.719, Reporting requ irements, demonstrates almost every year that HHS-certified laboratories do not always perform satisfactorily. In most cases, these performance deficiencies were only identified beca use of the BPTS program.

2) The Part 26 drug testing program is different than what the National Laboratory Certification Program (NLCP) evaluates under the HHS-certified laboratory bia nnual inspection process and performance testing program. For example, the special analyses testing process in 10 CFR 26.163(a)(2) is not a part of the HHS Guidelines or the DOT testing requirements.

Part 26 also permits, and some licensee FFD programs utilize, l ower testing cutoff levels than required by 10 CFR Part 26, expansion of the testing panel to i nclude additional substances beyond the minimum panel in 10 CFR Part 26, or both. In each i nstance, no analogous BPTS measures provided by the NLCP performance testing process would validate the accuracy of testing conducted by HHS-certified laboratories under 10 CFR Pa rt 26.

3) The BPTS requirements in 10 CFR 26.168 ensure that each HHS-certified laboratory used by a licensee or other entity performs testing in compliance with 10 CFR Part 26 drug and validity testing requirements, which maintains assurance of the accuracy of tests performed. Accurate testing of specimens is a fundamental aspect of each FFD progra m and is a critical donor protection. The assurance to the accuracy of test results is al so of paramount importance to the NRC given the required minimum sanctions in 10 CFR 26.75 that a pply to individuals based on a first, second, or third positive drug test result, as well as a subversion attempt.

4) Part 26 licensees and other entities rely upon a small numbe r of HHS-certified laboratories.

As such, an unsatisfactory test result at one laboratory can ha ve a direct impact on a significant number of testing programs. In addition, beyond the small numb er of laboratories used, many

33 multi-site utilities use the same HHS-certified laboratory(ies) for their fleet and as a result, unsatisfactory performance at one laboratory could have a direc t impact on the testing program for the entire utilitys fleet.

5) While the DOT eliminated the blind performance testing requi rements for its regulated entities, the HHS Guidelines continue to maintain the requireme nt (i.e., 2008 and 2017 HHS Guidelines, Subpart J, Blind Samples Submitted by an Agency).

Accordingly, the NRC did not change the final rule in response to this comment.

Q. Determining a Fitness-for-Duty Policy Violation

The following comments pertain to 10 CFR 26.185, Determining a fitness-for-duty policy violation.

Comment Q-1: MRO evaluation of invalid results. One commenter requested that the proposed rule change in 10 CFR 26.185(f)(3) to require MRO revi ew of invalid specimen test results due to pH in the range of 9.0 to 9.5 be deleted unless the process is required by other Federal programs. (NEI1-A1-20)

NRC Response: The NRC disagrees. As discussed in the proposed rule, the re view of invalid specimens due to pH in the range of 9.0 to 9.5 is based on scie ntific evidence that elapsed time, exposure to high temperature, or both, can cause a urine specim en pH in this range. This additional MRO review is necessary to ensure that an individual is not unjustifiably subjected to the collection of a second specimen under direct observation. This MRO review is required by the HHS Guidelines that apply to Federal employee workplace dru g testing programs, as well as the DOTs testing requirements in 49 CFR 40.159(a)(6).

However, the required MRO review in 10 CFR 26.185(f)(3) would n ot be applicable if the licensee or other entitys chosen specimen for observed collect ions for invalid specimens is oral fluid, as is being permitted in the final rule (see the NRC Res ponse to Comment B-5.1). An MRO evaluation of the handing conditions for the initial urine specimen collected would be unnecessary in this instance because the oral fluid specimen wo uld be observed by the collector.

Accordingly, the NRC did not change 10 CFR Part 26 in response to this comment.

R. Substance Abuse Expert

The following comments pertain to 10 CFR 26.187, Substance abu se expert.

Comment R-1: Substance abuse expert qualifications. One commenter requested an update to the requirements in 10 CFR 26.187 pertaining to substance ab use expert (SAE) qualifications. The commenter recommended that a masters degr ee in addictions be added as a credential to be qualified to serve as an SAE under 10 CFR Pa rt 26. (JR10-1)

NRC Response: The NRC disagrees. The request to amend the SAE qualificatio n requirements in 10 CFR 26.187 to add a masters degree in addictions as an acceptable

34 credential to be qualified to serve as an SAE, is beyond the sc ope of this rulemaking. The NRC did not propose any changes to the SAE qualifications in 10 CFR Part 26. However, the change recommended by the commenter could inform future considerations by the NRC.

Accordingly, the NRC did not change 10 CFR Part 26 in response to this comment.

S. Determination of Fitness

The following comments pertain to 10 CFR 26.189, Determination of fitness.

Comment S-1: Conditions for initiating a determination of fitness. One commenter expressed concern that a determination of fitness (DOF) is often initiate d based on observed behavior, but the regulations do not currently define what manner of observed behavior constitutes an evaluation. The commenter suggested that DOFs are being perfor med in response to reports of observed behaviors such as looking at another worker in an odd manner. The commenter recommended revising the regulations to clarify the role of the FFD program management in obtaining relevant information that will contribute to a formal referral for a DOF. Specifically, describe FFD management responsibility on a preliminary assessm ent for conducting interviews, ruling out the possibility that drug use may have p layed a role in the behavior by conducting FFD testing, reviewing past behavior observations, a nd reviewing past self reports.

(JR11-1)

NRC Response: The commenters request to revise the determination of fitnes s requirements in 10 CFR 26.189 is outside the scope of this rulemaking. The NRC did not propose changes to, nor request comment on, the determination of fitness requir ements. However, the change recommended by the commenter could inform future considerations by the NRC.

Accordingly, the NRC did not change the final rule in response to this comment.

T. Other Comments

Comment T-1: Marijuana legalization. One commenter advocated for the rescheduling of marijuana for legal use. (BC-1)

NRC Response: The action requested by the commenter is outside the regulato ry authority of the NRC. The U.S. Drug Enforcement Administration is responsib le for the scheduling and rescheduling of drugs under 21 U.S.C. 812, Schedules of contro lled substances.

Accordingly, the NRC did not change the final rule in response to this comment.

Comment T-2: U.S. Department of Transportation regulations. One commenter provided information on a legal action that was taken with regards to th e results of a drug test performed under the DOTs 49 CFR Part 40 requirements. This legal action did not involve an NRC regulated entity. (MB-1)

NRC Response: This comment is about testing performed under the authority o f another Federal agency. As such, this comment is not responsive to thi s 10 CFR Part 26 rulemaking.

35 Accordingly, the NRC did not change the final rule in response to this comment.

U. Draft Regulatory Guide

In Section XV of the Supplementary Information for the proposed rule, the NRC solicited stakeholder comment on new draft regulatory guidance, DG-5040 d ated August 2019 (ADAMS Accession No. ML19116A077), to support the implementation of th e proposed requirements. In the final rule, DG-5040 is now RG 5.89, Fitness-for-Duty Progr ams for Commercial Power Reactors and Category I Special Nuclear Material Licensees (AD AMS Accession No. ML20143A034). The title of DG-5040 was revised to more uniform ly align with the other applicable regulatory guide issued under 10 CFR Part 26, RG 5.8 4, Fitness-For-Duty Programs at Nuclear Reactor Construction Sites.

U-1 Monitoring a donor during the hydration process

Comment U-1.1: One commenter stated that there is no benefit or useful purpo se in entering the name of the hydration monitor on the CCF as described in Se ction C.1.A.(7) of DG-5040.

(NEI1-A2-1)

NRC Response: The NRC disagrees. Listing the name of the observer of the h ydration process on the Federal CCF is a donor protection and ensures to the transparency of the process. Capturing the name of the observer on the Federal CCF alerts the MRO and FFD program manager that a donor was observed by an individual othe r than the collector that initiated the collection process. The hydration monitors name is also important information that an NRC inspector might evaluate during an FFD program inspectio n. In addition, because proposed 10 CFR 26.107(b)(2) would require the hydration monito r to immediately inform the collector of any donor conduct that may indicate an attempt to subvert the testing process (e.g., donor leaves the collection site, donor refuses to follo w directions), the observations and statements made by a hydration monitor could form the basis for a subversion attempt determination, the sanction of which is a permanent denial of a uthorization under 10 CFR 26.75(b). Therefore, it is appropriate to require the n ame of the hydration monitor to be written on the Federal CCF, as required in proposed rule 10 CFR 26.109(b)(1)(ii) and described in Section C.1.A.(7) of DG-5040.

Accordingly, the NRC did not change the final rule or RG 5.89 i n response to this comment.

See also NRC Response to Comment K-2 for additional discussion on 10 CFR 26.109(b)(1)(ii).

Comment U-1.2: One commenter stated that synchronizing clocks during the h ydration process is difficult to manage and is an un-necessary administ rative burden. This comment pertained to Section C.1.A.(7) of DG-5040. The commenter recom mended revising the guidance to read: (7) The area used for hydration should have a working clock visible to the donor(s) and the collector or hydration monitor. The collector is ultimately responsible for monitoring the clock. (NEI1 A2-2)

NRC Response: The NRC agrees that it is unnecessarily prescriptive to state that the clock that is used should be synchronized with the clock that the col lector uses to document the start of the 3-hour hydration process. The intent of Section C.1.A. (7) of DG-5040 is to ensure that

36 an accurate method is used to track the amount of time that a d onor is afforded to provide a specimen during the hydration pr ocess, which is a donor protect ion. For example, the collector could use a countdown timer that is initiated upon the first un successful attempt to provide a specimen and that same timer be used during the hydration proce ss. Because the inability to provide a specimen of adequate volume within 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br /> of the ini tial unsuccessful attempt may result in a permanent denial of authorization sanction under 10 CFR 26.75(b), the time tracking method must be accurate.

Accordingly, the NRC revised the guidance document to specify t hat the licensee or other entity should use a method that ensures that the 3-hour hydration peri od is accurately tracked and that the donor and hydration monitor or collector observing the hydration process understand the amount of time remaining in the hydration period.

The NRC did not change the final rule in response to this comme nt.

Comment U-1.3: One commenter stated that [t]hroughout the guidance an exces sive amount of information is required to be documented on the CCF. There is not adequate room on the CCF to document such information. Most licensees have internal documentation processes for documenting this information. To address this concern, the co mmenter suggested that the text in Section C.1.B.(3) of DG-5040 be revised to: (3) If during the hydration process, the collector or hydration monitor observes any action or behavior by the don or that may indicate an attempt to subvert the testing process, a description of the donors co nduct should be immediately documented. If a hydration monitor observes the donor conduct, the hydration monitor shall then inform the collector of the observation. The hydration mo nitor should communicate this information to the collector while maintaining continuous monit oring of the donor. (NEI1-A2-3)

NRC Response: The NRC agrees that the available space on the Federal CCF to document information about a possible subversion attempt is limited (i.e., a single blank line to write text on the Remarks line of the form). Therefore, depending on th e number of observations regarding an event, the Federal CCF may not contain adequate sp ace to record all information.

The NRC disagrees with the commenters suggested change to elim inate the reference to documenting information on the Federal CCF in Section C.1.B.(3) of DG-5040, which is also an existing rule requirement in 10 CFR 26.107(b)(1). Instead, the NRC has revised 10 CFR 26.107(b)(1) in the final rule and Section C.1.B.(3) in RG 5.89 to provide the collector with the option to document information about a subversion atte mpt on the Federal CCF or through another documentation method that is consistent with th e collection procedures of the licensee or other entity. The method used by the licensee or o ther entity should ensure that all information documented by the collector or hydration monitor on donor actions regarding a possible subversion attempt be provided to FFD program manageme nt to assist in the determination of appropriate next steps (e.g., terminate the co llection process, collect a specimen under direct observation). Conforming changes have be en made in the final rule to 10 CFR 26.107(d)(3) and 26.111(b), which also require the colle ctor to document observations on the Federal CCF, and to RG 5.89.

Comment U-1.4: One commenter requested that the guidance in Section C.1.D.(3 ) of DG-5040 be revised to: (3) If the hydration monitor is not qualified as a collector, the donor shall be transferred to an available collector when the donor is ready t o attempt to provide a specimen.

37 This change would clarify that the collector also needs to be a vailable to start the collection process with the donor. (NEI1-A2-4)

NRC Response: The NRC agrees.

Accordingly, the NRC has replaced the phrase the donor shall b e transferred to a collector with then the donor shall be transferred to an available colle ctor in Section C.1.D.(3) of RG 5.89 in response to this comment.

The NRC did not change the final rule in response to this comme nt.

U-2 Using mirrors during specimen collections under direct obse rvation

Comment U-2: One commenter stated that permanently affixed mirrors create a perception that could compromise privacy for non-observed tests and sugges ted that portable mirrors be permitted to facilitate the use of temporary collection facilit ies. The commenter requested that the NRC permit the use of mirrors that are not secured to a wal l or structure. (NEI1-A2-5)

NRC Response: The NRC disagrees. The text in Section C.2.D of DG-5040 stat ed that all mirrors should be sufficiently affixed or secured to a wall or structure, but did not require any mirror to be permanently affixed. Therefore, a mirror could be installed only when needed to effectively implement a directly observed collection, which add resses the commenters concern regarding donor privacy for non-observed collections.

The use of non-secured mirror(s) during the observed collection process could result in injury, as stated in the draft guidance, but also could result in an ob server coming into an unacceptably close proximity to the donor during the collection process or r esult in an unintentional contact with the donor (e.g., use of a hand-held mirror). Permitting t he use of a non-secured mirror during the collection process also could increase the level of anxiety of the donor and interfere with the provision of a specimen, which is contrary to the inte nt of the provision.

Accordingly, the NRC did not change the final rule or RG 5.89 i n response to this comment.

U-3 MRO consideration of factors influencing invalid test resul ts

Comment U-3: One commenter requested that the NRC eliminate Section C.3 of DG-5040, which provided guidance on implementing the proposed new requir ement in 10 CFR 26.185(f)(3). This new requirement would have the MRO c onsider the impacts of time and temperature when evaluating an invalid test result due to p H in the range of 9.0 to 9.5. The commenter asserted that NRCs proposed guidance is unnecessary because of the technical instruction that MROs receive during certification and requalif ication training. On the other hand, the commenter had no issue with keeping the proposed guid ance if it is being used by other Federal programs. (NEI1-A2-6)

NRC Response: The NRC disagrees. The guidance on the MRO review of invalid test results due to pH in the range of 9.0 to 9.5 is provided in Section C.3 of DG-5040 as one acceptable method for the consistent review of these test results by MROs.

38 Contrary to the commenters statement, 10 CFR Part 26 does not include a periodic MRO requalification training requirement. Section 26.183(a) does r equire that an MRO shall be knowledgeable of this part and of the FFD policies of the licen sees and other entities for whom the MRO provides services [and that t]he MRO shall have passed an examination administered by a nationally-recognized MRO certification board or subspecia lty board for medical practitioners in the field of medical review of Federally manda ted drug tests. Therefore, if an MRO has already passed an examin ation by a nationally-recognize d MRO certification board or subspecialty board before or soon after this 10 CFR Part 26 fin al rule is published, it is possible that no training on the new invalid test result review requirem ent would be received.

Accordingly, the NRC did not change the final rule or RG 5.89 i n response to this comment.

V. Draft Regulatory Analysis

The NRC received no public comments on the draft regulatory ana lysis, Draft Regulatory Analysis and Backfitting and Issue Finality, 10 CFR Part 26 Fit ness for Duty Drug Testing Requirements (ADAMS Accession No. ML19169A115), which examines the costs and benefits of the alternatives considered by the NRC.

W. Information Collections

The NRC requested public comment on the potential impact of the information collections contained in the proposed rule (Supporting Statement for 10 CF R Part 26, Fitness for Duty Programs, Information Collections Contained in Fitness For Duty Drug Testing Requirements Proposed Rule (ADAMS Accession No. ML16123A003). The NRC rece ived no public comments in response to this request.

X. Backfitting and Issue Finality

The NRC received no public comments on backfitting or issue fin ality.

Y. Cumulative Effects of Regulation

The NRC requested public comment on the potential cumulative ef fects of regulation implications incurred by licenses and other entities due to the proposed rule. The NRC received no public comments in response to this request. (See the NRC Response to Comment B-4.1 regarding the related NRC request for public comment on the Ef fective Date of the Final Rule.)

39