Fitness for Duty Drug Testing Requirements, 71422-71463 [2022-24903]

Agencies

• NUCLEAR REGULATORY COMMISSION

[Federal Register Volume 87, Number 224 (Tuesday, November 22, 2022)]
[Rules and Regulations]
[Pages 71422-71463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24903]



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Vol. 87

Tuesday,

No. 224

November 22, 2022

Part II





Nuclear Regulatory Commission





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10 CFR Part 26





Fitness for Duty Drug Testing Requirements; Final Rule

Federal Register / Vol. 87 , No. 224 / Tuesday, November 22, 2022 / 
Rules and Regulations

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NUCLEAR REGULATORY COMMISSION

10 CFR Part 26

[NRC-2009-0225]
RIN 3150-AI67


Fitness for Duty Drug Testing Requirements

AGENCY: Nuclear Regulatory Commission.

ACTION: Final rule and guidance; issuance.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is amending its 
regulations regarding fitness for duty (FFD) programs for certain NRC 
licensees and other entities to align the NRC's drug testing 
requirements more closely with the updates made to the U.S. Department 
of Health and Human Services' ``Mandatory Guidelines for Federal 
Workplace Drug Testing Programs'' in 2008 and as revised in 2017. This 
final rule also incorporates lessons learned from implementing the 
NRC's current FFD regulations. These changes enhance the ability of NRC 
licensees and other entities to identify individuals using illegal 
drugs, misusing legal drugs, or attempting to subvert the drug testing 
process. This final rule provides additional protections to individuals 
subject to drug testing and improves the clarity, organization, and 
flexibility of the NRC's FFD regulations. This final rule provides a 
new flexibility for the collection and drug testing of an oral fluid 
specimen as an alternative to the collection and testing of a urine 
specimen under direct observation conditions. The NRC also is issuing 
final implementation guidance for this final rule.

DATES: 
    Effective date: This final rule is effective December 22, 2022.
    Compliance date: Compliance with this final rule is required by 
November 22, 2023.

ADDRESSES: Please refer to Docket ID NRC-2009-0225 when contacting the 
NRC about the availability of information for this action. You may 
obtain publicly-available information related to this action by any of 
the following methods:
     Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2009-0225. Address 
questions about NRC dockets to Dawn Forder; telephone: 301-415-3407; 
email: [email protected]. For technical questions, contact the 
individuals listed in the FOR FURTHER INFORMATION CONTACT section of 
this document.
     NRC's Agencywide Documents Access and Management System 
(ADAMS): You may obtain publicly available documents online in the 
ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, select ``Begin Web-based ADAMS 
Search.'' For problems with ADAMS, please contact the NRC's Public 
Document Room (PDR) reference staff at 1-800-397-4209, at 301-415-4737, 
or by email to [email protected]. For the convenience of the reader, 
instructions about obtaining materials referenced in this document are 
provided in the ``Availability of Documents'' section.
     Attention: You may examine and purchase copies of public 
documents, by appointment, at the NRC's Public Document Room (PDR), 
Room P1 B35, One White Flint North, 11555 Rockville Pike, Rockville, 
Maryland 20852. To make an appointment to visit the PDR, please send an 
email to [email protected] or call 1-800-397-4209 or 301-415-4737, 
between 8:00 a.m. and 4:00 p.m. eastern time, Monday through Friday, 
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Stewart Schneider, Office of Nuclear 
Material Safety and Safeguards, telephone: 301-415-4123; email: 
[email protected]; or Brian Zaleski, Office of Nuclear Security 
and Incident Response, telephone: 301-287-0638; email: 
[email protected]. Both are staff of the U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001.

SUPPLEMENTARY INFORMATION: 

Executive Summary

A. Need for the Regulatory Action

    The U.S. Nuclear Regulatory Commission (NRC) is amending its 
regulations regarding fitness for duty (FFD) programs for certain NRC 
licensees and other entities to align the NRC's drug testing 
requirements more closely with U.S. Department of Health and Human 
Services' (HHS) ``Mandatory Guidelines for Federal Workplace Drug 
Testing Programs'' (HHS Guidelines). The HHS Guidelines govern Federal 
employee workplace drug testing programs at more than 100 Federal 
agencies and Federal agency drug testing programs (e.g., U.S. 
Department of Transportation) that test civilians in safety- and 
security-sensitive positions similar to personnel tested under the 
NRC's program in part 26 of title 10 of the Code of Federal Regulations 
(10 CFR), ``Fitness for Duty Programs.'' The NRC published a proposed 
rule (84 FR 48750; September 16, 2019) to align its drug testing 
provisions under 10 CFR part 26 more closely with HHS Guidelines 
published in the Federal Register on November 25, 2008 (73 FR 71858), 
effective October 1, 2010 (75 FR 22809; April 30, 2010), and to seek 
public input on further aligning the NRC's provisions with the HHS 
Guidelines published in the Federal Register on January 23, 2017 (82 FR 
7920), effective on October 1, 2017. This final rule enhances the 
ability of licensees and other entities to identify individuals using 
illegal drugs and misusing legal drugs. This final rule also 
incorporates lessons learned from implementation of the 10 CFR part 26 
final rule published in the Federal Register on March 31, 2008 (73 FR 
16966; hereafter referred to as ``2008 FFD final rule''). These lessons 
include improved methods to identify attempts to subvert the drug 
testing process and improvements in the clarity, consistency, and 
flexibility of donor protections under 10 CFR part 26. Historically, 
the NRC has relied upon the HHS Guidelines to establish the technical 
requirements for urine specimen collection, drug testing, and results 
evaluation and has required licensees and other entities to use HHS-
certified laboratories to perform drug testing. The last NRC alignment 
with the HHS Guidelines was completed with the 2008 FFD final rule, 
which incorporated provisions from the 2004 HHS Guidelines (69 FR 
19643; April 13, 2004).

B. Major Provisions

    The major provisions of this final rule:
     Add initial and confirmatory drug testing for two illegal 
amphetamine-based controlled substances--methylenedioxymethamphetamine 
(MDMA) and methylenedioxyamphetamine (MDA)--referred to as ``Ecstasy-
type'' drugs in this final rule.
     Add initial and confirmatory drug testing for four opioid 
drugs (hydrocodone, hydromorphone, oxycodone, and oxymorphone).
     Add initial drug testing for 6-acetylmorphine (6-AM), a 
metabolite of the illegal drug heroin, and update the confirmatory drug 
testing method for 6-AM.
     Lower the initial and confirmatory drug testing cutoff 
levels for amphetamine, cocaine metabolite, and methamphetamine.
     Enhance the detection of subversion attempts by 
strengthening the testing methods used to identify drugs and drug 
metabolites in urine specimens with

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dilute validity test results and in specimens collected under direct 
observation.
     Permit the collection and drug testing of an oral fluid 
specimen as an alternative to the collection and testing of a directly 
observed urine specimen.
     Require Medical Review Officers (MROs) to evaluate the 
elapsed time from specimen collection to testing and exposure to high 
temperature, as possible causes of some invalid test results due to 
high solvated hydrogen ion concentration (i.e., pH).
     Improve the clarity, consistency, and organization of 10 
CFR part 26 by adding and updating definitions; increase flexibility by 
permitting additional personnel to monitor a donor that is hydrating 
during a shy-bladder situation; and enhance donor protections by 
providing additional instruction to same-gender observers used in 
observed collections and affording due process by requiring MROs to 
document the date and time that an oral request is received from a 
donor to initiate the retesting of a specimen.

C. Changes From the Proposed Rule to the Final Rule

    In response to public comments provided on the proposed rule and in 
developing this final rule, the NRC has made the following changes to:
     Expand the drug testing panel to include four additional 
opioids (hydrocodone, hydromorphone, oxycodone, oxymorphone) listed in 
the 2017 HHS Guidelines.
     Provide the option to collect an oral fluid specimen as an 
alternative to the collection and testing of a directly observed urine 
specimen.
     Set a compliance deadline for this final rule of 1 year, 
instead of the proposed 60 days.
     Remove the proposed requirement that hydration monitors 
must be FFD program personnel.

D. Costs and Benefits

    The NRC prepared a regulatory analysis to quantify the costs and 
benefits of this final rule, as well as to examine the qualitative 
factors to be considered in the NRC's rulemaking decision. This final 
rule, relative to the regulatory baseline, results in a net benefit to 
industry of between $418,356, based on a 7-percent net present value, 
and $692,799, based on a 3-percent net present value. This final rule 
results in an estimated total one-time industry cost of $136,936, 
followed by a total annual industry savings of $47,650. On a per 
licensee or other entity site basis, this final rule results in an 
average one-time cost of $2,321 and annual savings of $808. Thirteen 
qualitative factors were evaluated in the regulatory analysis: public 
health (accident), occupational health (accident), offsite property, 
onsite property, regulatory efficiency, safeguards and security 
considerations, and other considerations (public perception, public 
trust, worker productivity, improved protection of individual rights, 
work environment free of drugs and the effects of such substances, 
safety vulnerability, and security vulnerability). The regulatory 
analysis includes a discussion of each qualitative factor.
    The regulatory analysis results show that this rulemaking is 
justified because the total estimated quantified benefits exceed the 
estimated costs of the rule. The NRC concludes that adopting this final 
rule will result in an estimated increase of between 16 and 29 percent 
per year in the number of individuals identified as not fit for duty or 
trustworthy and reliable because of the use of illegal drugs, misuse of 
legal drugs, or an attempt to subvert the drug testing process. Based 
on the average number of individuals from calendar years 2009 through 
2019 with a positive test result or identified as attempting to subvert 
a test, the estimated increase in detection each year is equivalent to 
identifying approximately 180 additional individuals using illegal 
drugs, misusing legal drugs, or attempting to subvert the drug testing 
process. This improved detection prevents drug-using individuals from 
gaining or maintaining unescorted access authorization to NRC-licensed 
facilities (i.e., operating nuclear power reactors, nuclear power 
reactors under construction, and Category I fuel cycle facilities) and 
other locations (e.g., Emergency Operations Facilities, Technical 
Support Centers). In addition, the enhanced detection prevents drug-
using individuals from gaining or maintaining unescorted access 
authorization to strategic special nuclear material or sensitive 
information. An enhanced drug testing program may also deter drug-using 
individuals from seeking employment in 10 CFR part 26-regulated 
workplaces and incentivize those already in regulated positions to 
cease drug use or to seek assistance to address an addiction or misuse 
issue.
    The regulatory analysis is available as indicated in Section XVI, 
``Availability of Documents,'' of this document.

Table of Contents

I. Background
    A. Health and Human Services Guidelines
    B. History of the NRC's Fitness for Duty Program
    C. Proposed Rule and Stakeholder Outreach
II. Discussion
    A. The Need for Rulemaking
    1. Alignment With the Health and Human Services Guidelines
    2. Societal Drug Use
    B. Public Comment Analysis
    C. Description of Changes to 10 CFR Part 26
III. Section-by-Section Analysis
IV. Regulatory Flexibility Certification
V. Regulatory Analysis
VI. Backfitting and Issue Finality
VII. Cumulative Effects of Regulation
VIII. Plain Writing
IX. Environmental Impact: Categorical Exclusion
X. Paperwork Reduction Act Statement
XI. Congressional Review Act
XII. Criminal Penalties
XIII. Compatibility of Agreement State Regulations
XIV. Voluntary Consensus Standards
XV. Availability of Guidance
XVI. Availability of Documents

I. Background

A. Health and Human Services Guidelines

    Through Executive Order 12564--Drug-Free Federal Workplace (51 FR 
32889; September 17, 1986), the President of the United States 
designated the Department of Health and Human Services (HHS) as the 
Federal agency responsible for establishing and maintaining the 
requirements and guidance for conducting Federal employee workplace 
drug testing. In execution of this designation, and under the authority 
of Section 503 of Public Law 100-71, 5 U.S.C. Section 7301 notes, HHS 
developed the ``Mandatory Guidelines for Federal Workplace Drug Testing 
Programs'' (HHS Guidelines) that established a robust legal framework 
to conduct drug testing to provide the following: reasonable assurance 
of donor privacy; drug testing accuracy and precision; specimen 
collection, custody, and control; and results review by a Medical 
Review Officer (MRO).
    The HHS Guidelines also established the certification requirements 
that each laboratory must meet to test specimens for Federal employee 
workplace drug testing programs. To obtain certification, a laboratory 
must successfully complete several rounds of performance testing and a 
National Laboratory Certification Program (NLCP) inspection. The 
certification requirements include, but are not limited to, laboratory 
staffing and qualifications, testing procedures, quality assurance and 
quality control, and results reporting. Once certified, each laboratory 
is subject to quarterly performance testing and NLCP inspection every 6 
months to verify

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adherence to the HHS Guidelines. The HHS laboratory certification 
process provides assurance to the U.S. Nuclear Regulatory Commission 
(NRC), licensees, and other entities that the testing of specimens, 
under part 26 of title 10 of the Code of Federal Regulations (10 CFR), 
``Fitness for Duty Programs,'' is conducted with the highest standards 
of accuracy, precision, and quality.
    Periodically, HHS updates the HHS Guidelines to enhance testing 
program effectiveness based on advances in drug testing technologies, 
processes, methodologies, and instrumentation; revises the authorized 
substances in the testing panel as societal drug-use trends change; and 
incorporates lessons learned from the NLCP. Each revision of the HHS 
Guidelines is published following a rigorous process that includes 
scientific, policy, legal, and technical review by the independent Drug 
Testing Advisory Board, which advises the Administrator of the HHS 
Substance Abuse and Mental Health Services Administration (SAMHSA); 
academic peer reviews; public review and comment; and input from 
Federal agencies that implement the HHS Guidelines. The HHS also 
conducts extensive outreach with affected stakeholders and researches 
societal drug-use trends to promulgate effective drug testing methods.
    The HHS Guidelines govern the drug testing programs of over 100 
Federal agencies that test Federal employees; are used by many Federal 
agencies that test civilians in safety- and security-sensitive 
positions similar to personnel tested under 10 CFR part 26, such as the 
U.S. Department of Transportation (DOT); and by many private entities. 
The NRC historically has relied on the HHS Guidelines to establish the 
technical requirements for urine specimen collection, specimen testing, 
and test result evaluation; in general, the NRC deviates from the HHS 
Guidelines only for considerations specific to the nuclear industry. 
The NRC relies on the HHS Guidelines as part of its technical basis for 
the drug testing requirements contained under 10 CFR part 26. Updating 
10 CFR part 26 to align with changes in the HHS Guidelines ensures that 
the NRC's regulations continue to be scientifically and technically 
sound.

B. History of the NRC's Fitness for Duty Program

    In the 1970s, the NRC and the commercial nuclear power industry 
began addressing concerns about the potential public health and safety 
impacts of fitness-for-duty (FFD) problems at nuclear power plants. 
Most nuclear utilities voluntarily implemented FFD programs during the 
1980s, and the NRC monitored the comprehensiveness and effectiveness of 
these programs. On August 4, 1986, the NRC published the ``Commission 
Policy Statement on Fitness for Duty of Nuclear Power Plant Personnel'' 
(51 FR 27921), which outlined the need for nuclear power plant 
licensees to implement programs to address FFD problems--such as 
illegal drug use, alcohol abuse, and misuse of legal drugs that could 
impair job performance. An NRC evaluation of licensee programs 
following the implementation of the policy statement identified a wide 
range in the quality and comprehensiveness of licensee FFD testing 
programs that ultimately resulted in the NRC's decision to pursue 
rulemaking.
    The NRC published a final rule, entitled ``Fitness-for-Duty 
Programs,'' in the Federal Register on June 7, 1989 (54 FR 24468), 
adding 10 CFR part 26. The 1989 FFD final rule was based on the 1988 
version of the HHS Guidelines (53 FR 11970; April 11, 1988). A 
subsequent final rule, published in the Federal Register on June 3, 
1993 (58 FR 31467), expanded the scope of 10 CFR part 26 to include 
licensees authorized to possess, use, or transport formula quantities 
of strategic special nuclear materials.
    The NRC issued the first substantial revision to 10 CFR part 26 in 
a final rule on March 31, 2008 (73 FR 16966; hereafter referred to as 
the ``2008 FFD final rule''). The 2008 FFD final rule updated the NRC's 
drug testing requirements to align with the then-latest HHS Guidelines, 
which were issued in 2004 (69 FR 19644; April 13, 2004). The 2008 FFD 
final rule implemented (1) required validity testing of each specimen 
to address the potential for subversion of the testing process, (2) 
advancements in drug and alcohol testing technologies, (3) changes to 
drug and alcohol testing cutoff levels, and (4) lessons learned from 
the implementation of 10 CFR part 26 since its addition in 1989.
    On November 25, 2008, HHS issued the 2008 HHS Guidelines (73 FR 
71858), which included (1) an expanded drug testing panel, (2) lower 
drug testing cutoff levels for some substances, (3) advances in testing 
technologies, and (4) more detailed requirements for specimen 
collectors and MROs. The 2008 HHS Guidelines became effective on 
October 1, 2010.
    On January 23, 2017, HHS issued the 2017 HHS Guidelines (82 FR 
7920), which included (1) an expanded drug testing panel to include 
four opioid drugs (hydrocodone, hydromorphone, oxycodone, and 
oxymorphone) and testing for methylenedioxyamphetamine (MDA) as an 
initial test analyte, (2) removal of methylenedioxyethylamphetamine 
(MDEA) from the drug testing panel, (3) a change to the lower pH cutoff 
for identifying specimens as adulterated (raised from 3 to 4), and (4) 
MRO requalification training and reexamination.
    The 2008 and 2017 HHS Guidelines changes currently are not 
reflected in 10 CFR part 26.

C. Proposed Rule and Stakeholder Outreach

    In June 2019, the Commission issued staff requirements memorandum 
(SRM)-SECY-2017-0027, ``Proposed Rulemaking: Fitness-for-Duty Drug 
Testing Requirements (RIN 3150-AI67),'' approving publication of the 
proposed rule. On September 16, 2019, the NRC published the proposed 
rule, ``Fitness for Duty Drug Testing Requirements,'' in the Federal 
Register (84 FR 48750). The NRC proposed to align the drug testing 
requirements in 10 CFR part 26 more closely with the 2008 HHS 
Guidelines. The proposed rule contained changes to enhance the ability 
of NRC licensees and other entities to identify individuals using 
illegal drugs or misusing legal drugs. The proposed rule also 
incorporated lessons learned from implementing the NRC's current FFD 
regulations with regard to identifying individuals attempting to 
subvert the drug testing process, and provided additional protections 
to individuals subject to drug testing. Finally, the NRC proposed 
changes to improve the clarity, organization, and flexibility of the 
FFD regulations.
    The NRC conducted significant outreach and analysis before issuing 
the proposed rule, including four public meetings attended by 
representatives of nuclear power plant licensees, the Nuclear Energy 
Institute, the Institute of Nuclear Power Operations, the International 
Brotherhood of Electrical Workers, and HHS. The proposed rule contained 
a thorough description of the feedback the NRC received during public 
meetings and how the feedback shaped the proposed rule.
    The proposed rule provided a public comment period of 75 days. The 
NRC received 26 comment submissions on the proposed rule and draft 
implementation guidance, as discussed in Section II.B of this document.
    During the public comment period, the NRC held a Category 3 public 
meeting on November 7, 2019, to

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discuss with external stakeholders the proposed rule and associated 
draft guidance document.\1\ On April 13, 2021, the NRC held an 
information public meeting with a question-and-answer session on the 
final rule implementation schedule as it pertains to the Cumulative 
Effects of Regulation (CER). This public meeting occurred during the 
development of this final rule. Summaries of both public meetings are 
available in the NRC's Agencywide Documents Access and Management 
System (ADAMS), as provided in the ``Availability of Documents'' 
section of this document. The feedback from these public meetings 
informed the development of this final rule.
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    \1\ On March 19, 2021, the NRC modified the public meeting 
categorization system and redefined the three categories of public 
meetings (86 FR 14964).
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II. Discussion

A. The Need for Rulemaking

1. Alignment With the Health and Human Services Guidelines
    In the 2008 HHS Guidelines, HHS enhanced the detection of illegal 
drug use and the misuse of prescription drugs through the following 
changes: (1) lowering the initial and confirmatory testing cutoff 
levels for amphetamine, cocaine metabolite, and methamphetamine; (2) 
establishing an initial testing requirement and revising the 
confirmatory testing cutoff level for the heroin metabolite 6-
acetylmorphine (6-AM); and (3) establishing testing for ``Ecstasy-
type'' drugs (which are part of the amphetamine class of drugs).
    The effectiveness of the 2008 HHS Guidelines is demonstrated by the 
enhanced detection evident in the test results reported by HHS, DOT, 
and Quest Diagnostics[supreg] (Quest), which is an HHS-certified 
laboratory that conducts testing for both Federal workplace drug 
testing programs (i.e., Federally-mandated) and private company testing 
programs (i.e., U.S. general workforce). Quest annually publishes a 
Drug Testing Index\TM\ report, which presents Quest laboratory testing 
results for Federally-mandated drug tests. On March 13, 2012, Quest 
reported a 33-percent increase from 2010 to 2011 in cocaine positive 
test results for 1.6 million Federal workplace tests conducted. Quest 
attributed the increase, in large part, to the lower cocaine testing 
cutoff levels implemented as a result of the 2008 HHS Guidelines 
(Quest, 2012). In the same report, Quest also noted that amphetamines 
positives rose by nearly 26 percent, continuing an existing upward 
trend, but also were ``likely boosted by better detection related to 
the new, lower Federally-mandated cutoffs.'' In comparison to the 2010 
positive testing rates for Federal workplace drug testing performed by 
Quest, the results for 2012 indicate a 12.5-percent increase in cocaine 
positives and a 37-percent increase in amphetamines positives with 2013 
continuing the multi-year upward trend (Quest, 2014).
    An NRC analysis of annual FFD program performance reports submitted 
by licensees and other entities under Sec.  26.717, ``Fitness-for-duty 
program performance data,'' identified an adverse trend associated with 
amphetamines positive test results. The NRC report, ``Summary of 
Fitness for Duty Performance Reports for Calendar Year 2013,'' 
identified year-over-year increases in amphetamines positive test 
results from 2009 through 2013. In 2009, 0.023 percent of individuals 
tested positive for amphetamines and by 2013, the rate increased to 
0.053 percent. An NRC analysis of FFD program performance data through 
calendar year 2019 confirmed that the amphetamines positive test rate 
has continued to trend higher, with the highest rate reported at 0.095 
percent of tested individuals in 2017.
    Comparatively, in 2009, 0.095 percent of individuals tested 
positive for cocaine, with the highest rate from 2009 through 2019 
reported at 0.104 percent of tested individuals in 2017. While variable 
by year, these positive test rates demonstrate that amphetamines and 
cocaine collectively account for between 23.6 percent and 28.5 percent 
of drug testing positives \2\ each year, from 2015 through 2019.
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    \2\ Initial drug testing for amphetamines and confirmatory drug 
testing for amphetamine and methamphetamine are required by 10 CFR 
part 26.

                                                         Trends in Amphetamines and Cocaine Use
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                        Substance                              1990            2015            2016            2017            2018            2019
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Amphetamines............................................            2.8%            9.9%           13.4%           13.6%           12.9%           12.4%
Cocaine.................................................            29.0            13.8            14.3            14.9            12.6            11.2
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................            31.8            23.7            27.7            28.5            25.5            23.6
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Notes: 1. The positive testing percentages are calculated by taking the total number of positives for the particular substance and dividing that figure
  by the total number of positive drug test results in the year.
2. Data from 1990, the first year of 10 CFR part 26 testing, is included as the baseline for comparison.

    While most of the changes in the proposed rule were made to better 
align 10 CFR part 26 with the 2008 HHS Guidelines, some were based on 
lessons learned during the implementation of the 2008 FFD final rule by 
licensees and other entities. In particular, the NRC proposed a number 
of changes to enhance the ability of licensees and other entities to 
identify individuals attempting to subvert the drug testing process.
    Beginning in 2009, licensees and other entities had the option to 
use electronic reporting forms (e-forms \3\) created by the NRC, in 
collaboration with licensees and other entities, in order to meet the 
annual FFD program performance reporting requirements in Sec. Sec.  
26.717 and 26.417(b)(2). The use of e-forms provides a uniform way of 
reporting detailed information on each drug and alcohol testing 
violation to the NRC. By 2011, over 80 percent of licensees and other 
entities used e-forms, with full industry adoption achieved by 2014.
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    \3\ NRC Form 890, ``Single Positive Test Form;'' and NRC Form 
891, ``Annual Reporting Form for Drug and Alcohol Tests'' can be 
obtained at the following NRC website: https://www.nrc.gov/reactors/operating/ops-experience/fitness-for-duty-programs/submit-ffd-reports.html.
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    The NRC report ``Summary of Fitness for Duty Performance Reports 
for Calendar Year 2015'' described a second significant trend: the 
prevalence of subversion attempts of the drug testing process from 2011 
through 2015. In 2011, donor subversion attempts accounted for 13.7 
percent of the total testing violations, or 148 of 1,080 testing 
violations. By 2015, subversion attempts accounted for 19.3 percent of 
total testing violations, or 232 of 1,200 testing violations. The 
prevalence of subversion attempts has continued to rise in

[[Page 71426]]

subsequent years. Since 2016, subversion attempts have exceeded 20 
percent of all testing violations (26.1 percent in 2016, 25.9 percent 
in 2017, 25.1 percent in 2018, and 28.3 percent in 2019), with the 
highest number of individuals identified attempting to subvert a test 
in 2019 at 307 individuals.
    An attempt to subvert the testing process demonstrates a lack of 
integrity and honesty and a willful act to refuse to comply with an 
NRC-required drug test (see Sec. Sec.  26.89(c), 26.825, ``Criminal 
penalties,'' and 50.5, ``Deliberate misconduct''). Consequently, drug-
using individuals present a safety vulnerability because of the 
potential for human performance issues due to drug use. Drug-using 
individuals could also present a security vulnerability because of 
their impairment or willful misconduct. As a result, the NRC included a 
number of changes in the proposed rule to enhance the ability of FFD 
testing programs to detect individuals attempting to subvert the drug 
testing process. The NRC received public input on these changes, which 
is discussed in Section II.B of this document.
2. Societal Drug Use
    The prevalence of drug use in society is documented in the ``Key 
Substance Use and Mental Health Indicators in the United States: 
Results from the 2019 National Survey on Drug Use and Health'' (NSDUH), 
an annual survey sponsored by SAMHSA. This survey is the primary source 
of information on the use of illegal drugs, alcohol, and tobacco in the 
civilian, non-institutionalized population in the United States, ages 
12 and older. The NSDUH survey estimated that in 2019, 20.8 percent of 
the U.S. population aged 12 or older (approximately 57.2 million 
Americans) used an illegal drug in the past year. The most commonly 
used illegal drug in 2019 was marijuana (48.2 million people), followed 
by the misuse of prescription pain relievers (9.7 million people). 
Among young adults aged 18 to 25, 39.1 percent used an illegal drug in 
2019. In adults aged 26 or older, 18.3 percent used an illegal drug in 
2019. Societal drug use presents a continual challenge to the fitness 
of the workforce relied on by licensees and other entities to perform 
safety and security significant duties, with the result that potential 
impairment and the adverse impact on human performance may affect 
public health and safety.

B. Public Comment Analysis

    As stated in the background section, the NRC published the proposed 
rule and draft regulatory guide for public comment in the Federal 
Register. The NRC received 26 comment submissions. A comment submission 
is a communication or document submitted to the NRC by an individual or 
entity, with one or more individual comments addressing a subject or 
issue. Private citizens provided 18 comment submissions, 4 licensees 
provided comment submissions, 2 nuclear industry organizations provided 
comment submissions, and 1 drug and alcohol testing association 
provided a comment submission.
    The comment submissions were generally supportive of the regulatory 
action, with no comment submissions that objected to this rulemaking 
activity and one that did not address 10 CFR part 26. Out of the 25 
remaining comment submissions, 4 comment submissions specifically noted 
support of the rulemaking and provided reasons related to the positive 
changes being proposed, enhanced efficiencies while maintaining the 
reliability of the FFD program, and enhanced ability to identify 
individuals using illegal drugs, misusing legal drugs, or attempting to 
subvert the drug testing process. Twenty-one comment submissions agreed 
to or suggested additional changes to include expanding the drug 
testing panel to include four additional opioids (hydrocodone, 
hydromorphone, oxycodone, oxymorphone) in the 2017 HHS Guidelines, 
providing the option to collect an oral fluid specimen for direct 
observation conditions, or extending the compliance deadline for this 
final rule. The NRC received a number of comments that were outside the 
scope of this rulemaking, such as comments pertaining to marijuana use 
and legalization. The NRC considers the public comments requesting that 
the NRC expand the drug testing panel to include four opioids, and to 
permit the collection of an oral fluid specimen for observed collection 
conditions to be substantive because of the resultant changes to this 
final rule.
    The public comment submissions are available from the Federal e-
Rulemaking website at https://www.regulations.gov under Docket ID NRC-
2009-0225. The NRC prepared a summary and analysis of public comments 
received on the 2019 proposed rule and draft regulatory guide, as 
provided in the ``Availability of Documents'' section of this document. 
Responses to the public comments, including a summary of how the final 
rule text or guidance changed as a result of the public comments, can 
be found in the public comment analysis.
    For more information about the associated guidance document, see 
the ``Availability of Guidance'' section of this document.
    In Section V of the Supplementary Information section for the 
proposed rule, the NRC sought advice and recommendations from 
stakeholders on the proposed rule. The NRC was particularly interested 
in comments and supporting rationale from the public on seven topics. 
The following paragraphs restate each topic and its specific request 
for comment, summarize comments received from stakeholders, and present 
the NRC's resolution of these public comments.
1. Alignment With the HHS Guidelines
    Specific Request for Comment: Two proposed changes in this rule 
would eliminate redundant provisions in 10 CFR part 26 that also appear 
in the HHS Guidelines (i.e., HHS-certified laboratory personnel 
qualifications requirements in Sec.  26.155, ``Laboratory personnel,'' 
and HHS-certified laboratory procedures requirements specific to the 
HHS Guidelines in Sec.  26.157, ``Procedures''). Because the NLCP 
inspection process verifies laboratory compliance with the HHS 
Guidelines, additional review and oversight by NRC licensees and other 
entities (e.g., of laboratory security requirements) 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.
    Commenter's Response: One commenter agreed with the proposed 
changes to remove redundant provisions in 10 CFR part 26 that also 
appear in the HHS Guidelines, leading to duplicative oversight. In 
addition, the commenter recommended two new changes for consideration 
by the NRC. First, the commenter suggested that as long as the HHS 
Guidelines are followed, the NRC should remove the same-gender observed 
collection requirement in Sec.  26.115, which is included in Section 
4.4(b) of the HHS Guidelines. Second, the commenter stated that the NRC 
should eliminate the redundant requirements for MRO specimen handling 
in 10 CFR part 26.
    NRC Response: The NRC disagrees. The NRC acknowledges that the HHS 
Guidelines contain similar provisions regarding the same-gender 
collector requirement in Sec.  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 part 26 but are not 
required to comply with the HHS Guidelines. Because removing these 
requirements from 10 CFR part 26

[[Page 71427]]

would completely eliminate these requirements for NRC licensees and 
other entities, the NRC will not remove these requirements. No changes 
were made to this final rule as a result of this comment.
    Commenter's Response: One commenter recommended that the NRC 
establish a streamlined process other than rulemaking for nuclear 
facilities to adopt future HHS Guidelines upon issuance.
    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. No changes were made to this final rule as a result 
of this comment.
2. Special Analyses Testing
    Specific Request for Comment: The proposed rule includes new 
requirements in Sec.  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 requirement 
would expand special analyses testing to specimens collected under 
direct observation as required by Sec.  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 testing of individuals that 
already have tested positive on a 10 CFR part 26 test (i.e., denied 
unescorted access authorization by Sec.  26.75(d) for a first or second 
drug testing positive result). Requiring special analyses testing in 
this case would add a level of assurance to follow-up testing required 
by Sec.  26.69(b)(6), which is conducted to confirm continued 
abstinence from illegal drug use and/or the misuse of legal drugs.
    Commenter's Response: 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/mass spectrometry (GC/MS) confirmation tests. The 
commenter suggested that special analyses testing would identify new 
drugs used and provide trends in drug use by different business 
departments and employee levels.
    NRC Response: The NRC disagrees. The reasons the commenter provided 
for recommending that special analyses testing be applied to the 
testing of specimens collected from individuals with a prior drug 
testing positive result do not apply as follows:
    (1) Special analyses testing would not identify new drugs; it would 
only identify the drugs in the drug testing panel used by the licensee 
or other entity.
    (2) Special analyses testing would not provide additional 
transparency regarding the departments or employee levels where drug 
use is identified. The NRC already collects information in the annual 
FFD program performance reports that licensees and other entities 
submit to the NRC under Sec. Sec.  26.717 and 26.417(b)(2). Performance 
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 testing panel used by the licensee or other 
entity. Lower testing cutoff levels increase the timeframe of detection 
after use of a drug, thereby increasing the likelihood of detecting 
drug use. Accordingly, no changes were made to this final rule as a 
result of this comment.
    Commenter's Response: 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 retesting a 
specimen.
    NRC Response: The NRC disagrees. As described in the proposed rule, 
the NRC would expand special analyses testing to specimens collected 
under direct observation as required by Sec.  26.115(a)(1) through (3) 
and a new paragraph (a)(5). Specimens collected under the conditions 
described in Sec.  26.115(a)(1) through (3) and (a)(5) would not have 
already tested positive, as stated by the commenter. Instead, the 
specimens subject to special analyses testing would be collected under 
direct observation for the following reasons:
     The donor presents a specimen reported by an HHS-certified 
laboratory as adulterated, substituted, or invalid, and the MRO 
determines that no adequate medical explanation exists for the result 
and that another specimen should be collected from the donor;
     The donor provides a specimen that falls outside of the 
acceptable temperature range specified in Sec.  26.111(a);
     Donor conduct during the collection process indicates an 
attempt to dilute, substitute, or adulterate the specimen; or
     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, no changes were made to this final rule in response to 
this comment.
    Commenter's Response: 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.
    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 exclusive grounds for performing a directly observed 
collection in Sec.  26.115. As described below, appropriate mechanisms 
currently exist within 10 CFR part 26 to address a situation where an 
individual self-reports an illegal drug use problem to the licensee or 
other entity.
    The commenter's scenario most likely would apply to an individual 
that already had been granted unescorted access (UA) or unescorted 
access authorization (UAA) by a licensee. In this instance, if the 
individual was an employee of the licensee, they could utilize the 
Employee Assistance Program (EAP) that each FFD program must offer 
under Sec.  26.35. The EAP is designed to achieve early intervention 
and provide for confidential 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 individual's condition or actions pose or 
have posed an immediate hazard to himself or herself 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 Sec.  26.69(d), ``Maintaining authorization with other 
potentially disqualifying FFD information.'' The definition of 
``potentially disqualifying FFD information'' in Sec.  26.5 includes 
that an individual has used illegal drugs. The licensee or other entity 
also may consider conducting for-cause testing under Sec.  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 licensee, but had already provided a specimen 
for pre-access testing required under

[[Page 71428]]

Sec.  26.65, ``Pre-access drug and alcohol testing,'' or Sec.  26.69, 
``Authorization with potentially disqualifying fitness-for-duty 
information,'' and therefore would be subject to random testing, then 
the licensee would be required to evaluate the individual's disclosure 
under Sec.  26.69(c), ``Granting authorization with other potentially 
disqualifying FFD information.''
    The NRC did not propose changes to special analyses testing 
criteria for random tests, however, a licensee or other entity may use 
lower testing cutoff levels for any condition for testing if they meet 
the requirements in Sec.  26.31(d)(3)(iii). Accordingly, no changes 
were made to this final rule in response to this comment.
    Commenter's Response: One commenter indicated that special analyses 
testing will not 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 tests. However, it is 
reasonable to conduct special analyses testing for the first observed 
test.
    NRC Response: The NRC disagrees, in part. The NRC sought comment on 
whether 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 testing 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 lower testing cutoff levels 
increases the timeframe of detection after use of a drug, thereby 
increasing 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., count a random test as 
meeting a follow-up testing requirement), as currently permitted in 
Sec.  26.69(b)(6).
    The NRC did not propose nor request comment on whether an 
individual 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 Sec.  26.69(b). As a result, this 
comment is beyond the scope of this rulemaking. Accordingly, no changes 
were made to this final rule in response to this comment.
3. Provide Flexibility To Conduct Additional Specimen Validity Tests
    Specific Request for Comment: 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, Sec.  26.161(h) prohibits licensees and other entities 
from using more stringent cutoff levels for validity tests. The NRC is 
seeking comment on whether Sec.  26.161(h) should be revised to provide 
a licensee or other entity with the option to conduct additional 
specimen validity tests and/or to utilize lower cutoff levels if the 
HHS Guidelines are revised in the future to include such testing.
    Commenters' Response: Two commenters addressed the issue to provide 
flexibility to conduct additional specimen validity testing. The first 
commenter supported providing licensees and other entities with the 
option to use lower cutoff levels to conduct specimen validity testing. 
The commenter suggested that licensees and other entities have the 
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 parameters. 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 conduct 
additional specimen validity tests may result in an inconsistent 
approach across the industry and preferred a streamlined approach to 
adopt future updates to the HHS Guidelines.
    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 10 CFR 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 is consistent 
with the testing principle that the NRC established in Sec.  
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 10 CFR part 26 and does not require the review of the 
cutoff levels by a forensic toxicologist if the cutoff levels are 
consistent with 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 
goal of this rulemaking: enhance the methods for detecting subversion 
attempts. The NRC acknowledges that providing the option to use lower 
cutoff levels for existing validity tests may 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 Sec.  26.163(a)(2) until this final rule mandated such 
testing.
    Accordingly, Sec.  26.161(h) in this final rule has been revised to 
read, ``Validity test cutoff levels. Licensees and other entities may 
use more stringent cutoff levels for validity tests than those 
specified in this section only if the testing is performed 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 tests performed under 10 
CFR part 26. This comment is beyond the scope of this rulemaking.
4. Effective Date of the Final Rule
    Specific Request for Comment: If the proposed rule is finalized, 
the NRC anticipates providing 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 entities 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.
    Commenters' Response: Two commenters disagreed with the proposed 
effective date of 60 days after the publication date of the final rule. 
The first commenter argued 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 
commenter recommended at least 120 days and noted that this timeframe 
is still very aggressive.
    The second commenter stated that licensees will need approximately 
12 months to fully and effectively implement the new program utilizing 
established procedures. 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

[[Page 71429]]

during the transition period, any program may accept and rely on 
another program's FFD-related information as long as the information 
being shared is compliant with the sharing program's current 10 CFR 
part 26 processes.
    NRC Response: The information provided by the two commenters was 
insufficient to support a change to the proposed 60-day implementation 
timeframe to comply with the final rule changes. However, the public 
provided substantive information during the April 13, 2021, public 
meeting on the CER for this rule to justify additional implementation 
time. 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 licensee's FFD program 
staff before, during, and after Spring (February to May) and Fall 
(August 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 before, during, 
and 2 months after reactor outages. This industry stakeholder also 
described additional challenges in meeting the 60-day implementation 
timeframe due to updates to the FFD training system used by the 
industry, licensee information technology system changes, and the 
ongoing impacts of the Coronavirus Disease 2019 pandemic such as the 
remote work status of some staff. A summary of this meeting is 
available, as provided in the ``Availability of Documents'' section of 
this document. Three comment submissions received after the public 
comment period closed affirmed the stakeholder feedback presented at 
the CER public meeting on the implementation timeframe.
    Accordingly, the compliance deadline was revised to be 1 year from 
the date that this 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 CFR 
26.717 annual FFD program performance reports.
    The NRC disagrees with the second commenter's request to clarify 
that during the implementation period of the final rule, any program 
may accept and rely on another program's FFD-related information as 
long as the information being shared is compliant with the sharing 
program's current 10 CFR part 26 processes. No change is necessary 
because the existing requirements in 10 CFR part 26 permit the sharing 
of information. For example, to grant authorization, licensees and 
other entities shall ensure that a suitable inquiry has been conducted 
under Sec.  26.63, ``Suitable inquiry,'' to verify an individual's 
self-disclosed information and to determine whether any potentially 
disqualifying FFD information is available. A suitable inquiry can 
involve licensees sharing information about an individual collected 
under 10 CFR part 26. Accordingly, no changes were made to this final 
rule as a result of this request.
5. Direct Observation of Specimen Collection
    Specific Request for Comment: The proposed rule retains the 
requirement for direct observation during the collection of a second 
sample when there are indications of a subversion attempt during the 
initial collection. The NRC is seeking comment on whether there are any 
effective alternatives to direct observation that will assist in 
preventing subversion of the drug testing process.
    Commenters' Response: 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 conflicts of interest, no harassment, and no bribery).
    Another commenter offered that an oral fluid specimen collection is 
an effective alternative to collecting a urine specimen under direct 
observation. The commenter also suggested that an oral fluid specimen 
should be considered if a donor is unable to provide the minimum 
quantity of urine on the initial attempt and that 10 CFR part 26 should 
state that industry can adopt and implement the HHS Guidelines for oral 
fluid testing within their programs without submitting exemptions or 
awaiting rulemaking.
    NRC Response: The NRC agrees that collecting an oral fluid specimen 
under direct observation of the specimen collector is equivalent to and 
equally effective as collecting a urine specimen from a donor under the 
observed collection conditions in Sec.  26.115(a)(1) through (3) and a 
new paragraph (a)(5). The NRC's 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 Guidelines relied on the technical 
basis of the acceptability of oral fluid as an alternative specimen in 
the Federal employee workplace drug testing program that was presented 
in the proposed revisions to the HHS Guidelines published on May 15, 
2015 (80 FR 28101).
    Under the conditions permitted in this final rule, the testing of 
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 oversight process used for 
urine specimen testing laboratories.
    Although the NRC is permitting a licensee or other entity to 
collect a urine or oral fluid specimen under specified direct 
observation conditions, each specimen chosen has advantages and 
disadvantages. The intent of the flexibility offered by the changes in 
this final rule is to provide the licensee or other entity with the 
ability to collect and test the appropriate specimen for the collection 
condition encountered. The following discussion describes how both 
collection methods can detect attempts to subvert the testing process.
     Urine specimen collections are valuable in identifying 
subversion 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 waist and the 
knees. This clothing removal process has revealed cheating 
paraphernalia, definitive proof of a donor's attempt to subvert the 
testing process. An NRC analysis of FFD program performance data 
submitted to the NRC under Sec. Sec.  26.717 and 26.417(b)(2) 
determined that the two most likely subversion determination scenarios 
are either a donor refuses to provide a second urine specimen under 
direct observation, or the donor's second observed urine specimen tests 
positive for a drug and the donor's initial unobserved urine specimen 
tests negative for that drug. The collection and testing of a donor's 
two urine specimens, the first unobserved and second observed, also 
provide 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 MRO's comparison of the physical characteristics of the two 
specimens has identified medically impossible differences in specimen 
temperature, pH, creatinine, and specific gravity test results that 
have resulted in subversion determinations. The existing observed urine 
collection

[[Page 71430]]

process has proven effective in identifying subversion attempts and 
urine drug 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 
identify 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., the donor does not remove 
his or her clothing from the waist to the knees). It is possible 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 other 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 
paraphernalia before collecting an oral fluid specimen. In the absence 
of any identifiable subversion paraphernalia, the licensee or other 
entity could then conduct an oral fluid specimen 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 conditions that oral fluid testing is permitted in 
this final rule. Oral fluid drug testing is permitted for collection 
conditions warranted by information suggesting a possible subversion 
attempt. Individuals 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. It is 
unlikely that a donor would risk a permanent denial of unescorted 
access under Sec.  26.75, ``Sanctions,'' for an identified subversion 
attempt unless they likely would test positive on drug testing. As a 
result, the NRC believes that oral fluid and urine specimen testing 
likely would be equally effective in identifying recent drug use. It is 
notable that identifying any given substance through drug testing is 
dependent on the chemical properties of the substance, the retention 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 urine 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), 
whereas urine drug testing requires a volume of 30 to 45 mL. This 
volume difference must be taken into account by licensees 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 
Sec.  26.165.
    The oral fluid collection process requires fewer steps to complete, 
and therefore may take less time to complete than for a urine specimen. 
The stability of oral fluid specimens also may be better than urine 
specimens because oral fluid specimen collection 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 Sec.  
26.115(a)(1) through (3) and a new paragraph (a)(5), a licensee or 
other entity must always collect either urine or oral fluid specimens. 
For example, a licensee could continue to collect a urine specimen 
under every Sec.  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 Sec.  26.115(a)(1) directly observed collection condition 
after an invalid urine specimen test result without a legitimate 
medical explanation. The required special analyses testing provisions 
included in this final rule under Sec.  26.163(a)(2) apply to the 
specimens collected under direct observation 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 testing 
under specified direct observation conditions in this final rule, the 
NRC is making the changes discussed in Section II.C of this document, 
under ``Acceptable Specimens for Observed Collection.''
    The commenter's 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 oral fluid specimens when a donor is unable to provide the 
minimum quantity of urine on the initial collection attempt.
6. 2017 HHS Guidelines--New Test Analytes
    Specific Request for Comment: On January 23, 2017, HHS issued its 
latest revision of the Mandatory Guidelines for Federal Workplace Drug 
Testing Programs Using Urine Specimens (82 FR 7920). Subpart C, ``Urine 
Drug and Specimen Validity Tests,'' of the 2017 HHS Guidelines was 
revised to include additional initial and confirmatory test analytes 
for certain opioids; specifically, hydrocodone, hydromorphone, 
oxycodone, and oxymorphone. The NRC is seeking comment on whether 
Sec. Sec.  26.31(d)(1) and 26.405(d) should be revised to identify 
hydrocodone, hydromorphone, oxycodone, and oxymorphone test substances, 
and whether Sec. Sec.  26.133 and 26.163(a)(1) and (b)(1) should be 
revised to require initial and confirmatory testing of these drugs at 
the cutoff levels recommended in the 2017 HHS Guidelines.
    Commenters' Response: Three commenters expressed support for 
expanding the 10 CFR part 26 drug testing panel to include the four 
opioids added to the 2017 HHS Guidelines (i.e., hydrocodone, 
hydromorphone, oxycodone, and oxymorphone). One commenter stated that 
adopting this expanded drug testing panel will provide greater 
reassurances that persons with authorization to access licensed 
facilities are fit for duty. Another commenter expressly endorsed the 
cutoff levels recommended in the 2017 HHS Guidelines for these drugs.
    NRC Response: The NRC agrees. The NRC evaluated detection changes 
following 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 Guidelines on January 1, 2018 (82 
FR 52229; November 13, 2017). The NRC assessment of DOT test results 
data for 2018 identified a significant increase in the number of 
testing violations for opioid positive test results. The NRC analyzed 
drug testing data from the three modal administrations most comparable 
to the population tested under 10 CFR part 26 (Federal Aviation 
Administration (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

[[Page 71431]]

0.1623 percent in 2018 (365-percent increase). These increases in 
testing violations demonstrated both the effectiveness of the 2017 HHS 
Guidelines expanded opioid testing panel and also the prevalence of 
illicit use of these substances in analogous worker 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 product 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 safely perform 
assigned job activities. Required testing for the four additional 
opioids in the 2017 HHS 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 policy. 
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 
Sec.  26.75 for positive test results.
    Accordingly, the NRC revised Sec. Sec.  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 this 
final rule to align with the 2017 HHS Guidelines by adding testing for 
hydrocodone, hydromorphone, oxycodone, and oxymorphone.
    Commenter's Response: One commenter expressed concern with the 
increasing number of individuals being placed into follow-up testing 
programs as a result of the opioid epidemic. The commenter asserted 
that a select few of the nuclear facilities have expanded 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 addiction: ``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 
commenter declared that ``industry is currently ill equipped to monitor 
the problem because of the significant gap in the follow-up program's 
ability to detect on going opiate abuse.''
    The commenter recommended that the rule include language that 
addresses the opiate epidemic and includes provisions for collection 
and testing under every FFD test condition.
    NRC Response: The NRC agrees. See the previous NRC response.
7. Methylenedioxyethylamphetamine
    Specific Request for Comment: The 2008 HHS Guidelines adds 
methylenedioxyethylamphetamine (MDEA) as a confirmatory analyte to the 
drug testing panel in Section 3.4. However, when the HHS revised the 
mandatory guidelines in 2017, HHS removed MDEA from Section 3.4 stating 
that ``[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 provided to the 
Department through the NLCP) does not support testing all specimens for 
MDEA in Federal 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 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.
    Commenters' Response: Two commenters responded to the specific 
request for comment on whether MDEA and MDA testing is needed. The 
first commenter disagreed that the NRC should not include MDEA in the 
drug testing panel, and stated that 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 Guidelines, 
which does not include MDEA, even though ``Ecstasy drugs'' have not 
been a prevalent issue in the industry. However, the commenter 
recommended that if blind specimen testing remains a requirement, then 
NRC should consider eliminating the testing of drugs that are not 
prevalent issues in the industry.
    NRC Response: The NRC disagrees, in part. The 2017 HHS Guidelines 
established the appropriate minimum testing standard for the drugs and 
drug metabolites to be tested in the specimens collected from 
individuals subject to testing under 10 CFR part 26. The 2017 HHS 
Guidelines (82 FR 7923) stated that HHS ``understands that MDA and some 
other analytes also have a low incidence, but believes that continued 
testing for these analytes is warranted in a deterrent program. In 
particular, inclusion of MDA as an initial 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.
    Further, Sec.  26.31(d)(2) provides flexibility to licensees and 
other entities to consult with local law enforcement authorities, 
hospitals, and drug counseling services to determine whether other 
drugs with abuse potential are being used in the geographical locale of 
the facility and by the local workforce that may not be detected in the 
standard testing panel under Sec.  26.31(d)(1). When appropriate, a 
licensee or other entity may add other drugs to the testing panel, but 
only if the additional drugs are listed in Schedules I through V of 
section 202 of the Controlled Substances Act [21 U.S.C. 812]. MDEA is a 
Schedule 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 from any licensee or other 
entity that testing for Ecstasy-type drugs has been performed under a 
10 CFR part 26 testing program. Therefore, no basis exists to evaluate 
the commenter's position regarding the prevalence of Ecstasy-type drugs 
in the industry, but changes in substance abuse trends do occur over 
time and testing for substances in the amphetamines drug class supports 
a deterrent testing program.
    The commenter's requested change to the blind performance test 
sample requirements in Sec.  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.
    Accordingly, the NRC did not change this final rule in response to 
these comments.

C. Description of Changes to 10 CFR Part 26

Definitions
    This final rule adds seven new definitions and revises seven 
existing definitions under Sec.  26.5, ``Definitions.'' The revisions 
and additions improve consistency with Section 1.5 of the 2008 HHS 
Guidelines and improve the clarity, consistency, and accuracy of the 
requirements under 10 CFR part 26. Specifically, this final rule adds 
definitions for: Cancelled test, Carryover, Certifying Scientist, 
Federal custody and control form, Lot, Rejected for testing, and 
Responsible Person. This final rule also revises the definitions for: 
Calibrator, Control, Dilute specimen, HHS-certified laboratory, Invalid 
result,

[[Page 71432]]

Limit of quantitation, and Substituted specimen.
    Cancelled test. The MRO will cancel the testing of a donor's urine 
specimen and report that action to the licensee or other entity after 
the testing laboratory (i.e., licensee testing facility (LTF) or HHS-
certified laboratory) reports that the specimen was rejected for 
testing or the donor requested additional testing of a specimen at a 
second HHS-certified laboratory under Sec.  26.165(b) and the specimen 
was not available for testing due to circumstances outside of the 
donor's control (e.g., specimen is lost in transit). Sections 
26.129(b)(2) and 26.159(b)(2) describe the only circumstances requiring 
an MRO to ``cancel the testing of a donor's urine specimen.'' However, 
Sec. Sec.  26.129(b)(2) and 26.159(b)(2) do not use the term cancelled 
test, nor is the term defined under Sec.  26.5. Adding the definition 
for cancelled test and updating Sec. Sec.  26.129(b)(2) and 
26.159(b)(2) to specifically use that term clarifies the actions taken 
by an MRO and improves consistency between 10 CFR part 26 and the 2008 
and 2017 HHS Guidelines. The NRC is also adding the term cancelled test 
to Sec.  26.165(f)(1) and (f)(2) to clarify the actions taken by an MRO 
when a specimen is rejected for testing by the laboratory and the MRO 
cancels the testing of the specimen. For completeness, a cancelled test 
for alcohol breath testing is also defined. The definition presented by 
the NRC staff at the October 11, 2011, public meeting only described 
cancelled test results associated with urine testing. For alcohol 
testing only, cancelled test means a test result that was not 
acceptable because testing did not meet the quality assurance and 
quality control requirements in Sec.  26.91, ``Acceptable devices for 
conducting initial and confirmatory test for alcohol and methods of 
use.''
    Carryover. This final rule adds a definition for carryover to Sec.  
26.5. Carryover is the effect that occurs when a test result for a 
donor's specimen or quality control sample has been affected by a 
preceding specimen tested on the same analytical instrument. For 
example, if the concentration of a drug in one donor specimen was not 
completely eliminated from the analytical instrument before the next 
donor specimen is tested, the residual drug concentration in the 
instrument may contribute to a false positive test result for the next 
donor specimen tested. Carryover also applies to donor specimens 
containing an adulterant or interfering substance. The term carryover 
is not currently defined under Sec.  26.5. However, the term carryover 
is used in Sec. Sec.  26.137(e)(7) and 26.167(a), which require LTFs 
and HHS-certified laboratories to ensure that carryover does not 
contaminate the testing of a donor's specimen or otherwise affect a 
donor's specimen results. In addition, Sec.  26.91(c)(5) describes the 
requirement to ensure that carryover does not affect alcohol testing 
results when using evidential breath testing devices. The NRC's 
definition is similar to the definition in Section 1.5 of the 2008 and 
2017 HHS Guidelines but does not include the phrase ``(e.g., drug 
concentration)'' because carryover applies also to validity testing 
(e.g., adulterants, interfering substances) and alcohol testing.
    Certifying Scientist. This final rule adds a definition for 
Certifying Scientist to Sec.  26.5. The position title is used in Sec.  
26.169(a) and (g) but is not currently defined. A Certifying Scientist 
is defined as the individual at the HHS-certified laboratory 
responsible for verifying the chain of custody and scientific 
reliability of any test result reported by the HHS-certified 
laboratory. Adding this definition from the HHS Guidelines improves 
consistency between 10 CFR part 26 and the 2008 and 2017 HHS Guidelines 
and the clarity of 10 CFR part 26. A conforming change is made to Sec.  
26.169(a) to capitalize the position title in the phrase ``the 
laboratory's certifying scientist.''
    Federal custody and control form (Federal CCF). This final rule 
adds a definition for the term Federal custody and control form 
(Federal CCF) to Sec.  26.5. The Federal CCF is defined as any HHS-
approved form, which has not expired, that is published in the Federal 
Register and is used to document the collection, custody, transport, 
and testing of a specimen. Including this definition more closely 
aligns 10 CFR part 26 with Section 1.5 of the 2008 and 2017 HHS 
Guidelines and improves the clarity of the rule by defining the term, 
which is already used in Sec.  26.153(g). The NRC is using the generic 
title, Federal CCF, to avoid the need for future regulatory changes, 
should the title of the form change. The definition also provides 
flexibility in accounting for additional forms that SAMHSA may create 
for use when conducting drug testing of alternative specimens (e.g., 
hair). To align with the new definition, ``Federal custody-and-control 
form'' is replaced with the term ``Federal CCF'' in Sec.  26.153(g). In 
addition, to improve the consistency of terminology used throughout 10 
CFR part 26, this final rule replaces the term ``custody and control 
form'' with the term ``Federal CCF.'' The plural versions, ``custody 
and control forms'' and ``custody and control form(s),'' are also 
replaced with the terms ``Federal CCFs'' and ``Federal CCF(s),'' 
respectively. Finally, this final rule corrects inconsistencies where 
``custody-and-control'' form or forms were used incorrectly and instead 
should have referred to ``chain-of-custody'' form or forms.
    The NRC's regulations under 10 CFR part 26 do not preclude the use 
of electronic versions of the Federal CCF or the use of licensee or 
other entity-developed forms, consistent with existing requirements in 
Sec.  26.153(g). The NRC supports the use of technological advancements 
to improve the quality of information included on the Federal CCF 
(e.g., legibility, accuracy, and completeness of information); reduce 
undue delays and/or the canceling of specimen tests due to paperwork 
irregularities; facilitate timely transmission of information to and 
from collectors, laboratories, and responsible licensee representatives 
(e.g., the MRO); and reduce recordkeeping and reporting costs.
    Lot. This final rule adds a definition for lot to Sec.  26.5, 
representing units that have the same starting materials, performance 
characteristics, and expiration date. The term is used in 10 CFR part 
26 but is not currently defined. Adding this definition improves 
consistency between 10 CFR part 26 and the definition of lot in Section 
1.5 of the 2008 and 2017 HHS Guidelines and enhances the clarity of 10 
CFR part 26. This final rule uses the same definition in the 2008 HHS 
Guidelines by defining lot as a number of units of an item manufactured 
from the same starting materials within a specified period of time for 
which the manufacturer states that the items have essentially the same 
performance characteristics and the same expiration date. This final 
rule also includes in the definition the parenthetical statement from 
the 2008 HHS Guidelines definition that provides examples of the term 
``item.'' The NRC is changing one of the examples in the parenthetical 
statement by replacing ``quality control material'' with ``quality 
control samples.'' The term ``quality control material'' is not used in 
10 CFR part 26.
    Rejected for testing. This final rule adds to Sec.  26.5 a 
definition for rejected for testing that is similar to the definition 
in Section 1.5 of the 2008 and 2017 HHS Guidelines, referring to a 
report by an LTF or HHS-certified laboratory that no tests can be 
performed on a specimen. The term rejected for testing appears in Sec.  
26.169(h)(8) but currently is not defined. Including a definition 
clarifies what information is being reported by

[[Page 71433]]

the HHS-certified laboratory to the licensee or other entity in the 
annual quantitative summary of test results. In addition, defining the 
term aligns with two additional changes to Sec. Sec.  26.129(b)(1)(ii) 
and 26.159(b)(1)(ii), clarifying the existing step that an LTF or HHS-
certified laboratory would take, if a licensee or other entity had 
reason to question the integrity and identity of a specimen (i.e., 
reject the specimen for testing). In Sec.  26.129(b)(1)(ii), the phrase 
``the specimen may not be tested'' is replaced with the phrase ``the 
licensee testing facility shall reject the specimen for testing.'' In 
Sec.  26.159(b)(1)(ii), the phrase ``the specimens may not be tested'' 
is replaced with the phrase ``the laboratory shall reject the specimens 
for testing.'' Improving the consistency of terminology used when a 
specimen cannot be tested improves the regulatory efficiency of 10 CFR 
part 26.
    Responsible Person. This final rule adds a definition for 
Responsible Person to Sec.  26.5. The position title is used in Sec.  
26.31(d)(1)(D) but currently is not defined. A Responsible Person is 
defined as the person at the HHS-certified laboratory who assumes 
professional, organizational, educational, and administrative 
responsibility for the day-to-day management of the HHS-certified 
laboratory. Adding this definition from the HHS Guidelines improves 
consistency between 10 CFR part 26 and the 2008 and 2017 HHS Guidelines 
and the clarity of 10 CFR part 26. A conforming change is made to Sec.  
26.167(f)(3) to capitalize the position title in the phrase ``a 
statement by the laboratory's responsible person.''
    Calibrator. This final rule revises the definition for calibrator 
in Sec.  26.5 to align more closely with the definition in Section 1.5 
of the 2008 HHS Guidelines and to improve internal consistency of 
terminology used in 10 CFR part 26. The definition of calibrator is 
revised to include a clarifying statement that a calibrator is a 
solution of known concentration ``in the appropriate matrix.'' This 
change aligns NRC's definition with the definition in the 2008 HHS 
Guidelines. The phrase ``test specimen/sample'' in the definition of 
calibrator is replaced with the phrase ``donor specimen or quality 
control sample'' and improves consistency with the terminology used in 
10 CFR part 26. The revised definition deletes the last sentence of the 
current definition, ``calibrators may be used to establish a cutoff 
concentration and/or a calibration curve over a range of interest.'' 
Although a part of this sentence aligns with the 2008 HHS Guidelines, 
the sentence is not a definition, but rather a voluntary provision that 
a laboratory may use a calibrator to establish a calibration curve. The 
determination of calibration curves is an internal laboratory process 
that already must be described in standard operating procedures for 
LTFs in Sec.  26.127, ``Procedures,'' and is evaluated during NLCP 
inspection of HHS-certified laboratories.
    Control. This final rule revises the definition of control in Sec.  
26.5 to conform to the definition of the term in Section 1.5 of the 
2008 and 2017 HHS Guidelines and enhance the clarity of 10 CFR part 26. 
The term control in Sec.  26.5 is revised by replacing the phrase ``a 
sample used to monitor the status of an analysis to maintain its 
performance within predefined limits'' with the phrase ``a sample used 
to evaluate whether an analytical procedure or test is operating within 
predefined tolerance limits.''
    Dilute specimen. This final rule revises the definition of dilute 
specimen in Sec.  26.5 to conform to the definition of the term in 
Section 1.5 of the 2008 and 2017 HHS Guidelines. The phrase 
``concentrations that are lower than expected for human urine'' is 
revised to read as ``values that are lower than expected but are still 
within the physiologically producible ranges of human urine.'' The 
current definition incorrectly references ``concentrations,'' which 
does not apply to a specific gravity reading. The current definition 
also does not clearly state that lower than expected creatinine and 
specific gravity measurements in a dilute specimen are still within the 
range that could be produced by a human being.
    HHS-certified laboratory. The current definition of an HHS-
certified laboratory in Sec.  26.5 lists the Federal Register citation 
for each final version of the HHS Guidelines (originally published in 
1988, and amended in 1994, 1998, and 2004). Under this definition, an 
HHS-certified laboratory must meet the 2004 HHS Guidelines, which were 
published on April 13, 2004 (69 FR 19643). No laboratory performing 
testing for 10 CFR part 26 licensees or other entities currently meets 
this definition because the definition refers to the superseded 2004 
HHS Guidelines; rather, HHS certifies a laboratory to the HHS 
Guidelines that are in effect at the time that HHS certifies the 
laboratory. In the proposed rule, the NRC corrected this restriction by 
defining an HHS-certified laboratory as a laboratory that is certified 
to meet the standards of the HHS Guidelines at the time that drug and 
validity testing of a specimen is performed for a licensee or other 
entity. This change to the definition of HHS-certified laboratory 
eliminates the need to revise 10 CFR part 26 should future versions of 
the HHS Guidelines be published. This final rule removes the term 
``drug and validity'' that was included in the proposed definition 
because the NRC specifies in other sections of 10 CFR part 26 the types 
of tests that must be performed on specimens.
    Additionally, this final rule adds the statement ``and performs 
that testing for a licensee or other entity in accordance with the HHS 
Guidelines, unless otherwise specified in this part.'' The NRC is 
adding this new statement to the definition to clarify that not only 
must an HHS-certified laboratory be certified to meet the HHS 
Guidelines, but the 10 CFR part 26 testing for the licensee or other 
entity must be performed as required by the HHS Guidelines unless a 
provision in 10 CFR part 26 states otherwise. This change is based, in 
part, on a response to a specific request for comment in the proposed 
rule. As described in Section II.B.3 of this document, the NRC is 
revising Sec.  26.161(h) to allow licensees and other entities to use 
more stringent cutoff levels for validity testing than those specified 
in Sec.  26.161 only if the testing is performed at an HHS-certified 
laboratory. The addition of the new statement in the definition of HHS-
certified laboratory ensures that the more stringent cutoff levels will 
be consistent with the HHS Guidelines current as of the date of the 
validity testing.
    This final rule includes two conforming changes made as a result of 
the revised definition for HHS-certified laboratory. First, the phrase 
``HHS-certified laboratories as defined in Sec.  26.5'' is added to 
Sec. Sec.  26.4(j)(3) and 26.153(a). Second, the reference in Sec.  
26.153(a) to the physical address of SAMHSA's Division of Workplace 
Programs as the location to obtain information concerning the 
certification status of laboratories has been removed.
    Invalid result. This final rule revises the definition of invalid 
result in Sec.  26.5 to be consistent with the definition of the term 
in Section 1.5 of the 2008 and 2017 HHS Guidelines and improve the 
clarity and accuracy of the NRC's requirements in 10 CFR part 26. The 
current definition does not include the specific criteria under which a 
laboratory will report an invalid test result for a specimen. The 
phrase ``for a specimen that contains an unidentified adulterant, 
contains an unidentified interfering substance, has an abnormal 
physical characteristic, contains inconsistent physiological 
constituents, or has an endogenous

[[Page 71434]]

substance at an abnormal concentration that prevents the laboratory 
from completing testing or obtaining a valid drug test result'' is 
replaced with ``in accordance with the criteria established in Sec.  
26.161(f) when a positive, negative, adulterated, or substituted result 
cannot be established for a specific drug or specimen validity test.'' 
The revised definition also corrects an inaccuracy in the current 
definition of invalid result, which does not include ``specimen 
validity test.''
    Limit of Quantitation. This final rule revises the definition for 
limit of quantitation (LOQ) in Sec.  26.5 to align more closely with 
Section 1.5 of the 2008 and 2017 HHS Guidelines and enhance the clarity 
of 10 CFR part 26. In the proposed rule, the NRC noted that its 
proposed definition would continue to use ``analyte'' instead of the 
HHS term, ``measurand.'' \4\ However, the 2017 HHS Guidelines replaced 
``measurand'' with ``analyte.''
---------------------------------------------------------------------------

    \4\ ``Analyte'' means the drug or drug metabolite measured by an 
initial or confirmatory drug test.
---------------------------------------------------------------------------

    Substituted specimen. This final rule revises the definition of 
substituted specimen in Sec.  26.5 to align with the definition of the 
term in Section 1.5 of the 2008 and 2017 HHS Guidelines. The phrase 
``specimen with creatinine and specific gravity values that are so 
diminished or so divergent that they are not consistent with normal 
human physiology'' is replaced with ``a specimen that has been 
submitted in place of the donor's urine, as evidenced by creatinine and 
specific gravity values that are outside the physiologically producible 
ranges of human urine.'' \5\ The revision improves the clarity of the 
rule by explaining that a substituted specimen is the result of donor 
action to subvert the testing process: ``a specimen that has been 
submitted in place of the donor's urine.''
---------------------------------------------------------------------------

    \5\ ``Creatinine'' means a substance that is created in a human 
being as a result of muscle metabolism and is excreted in urine. The 
creatinine concentration of each urine specimen is measured by 
validity testing.
---------------------------------------------------------------------------

Drug Testing Panel Additions
    This final rule adds two amphetamine-based chemical compounds--
methylenedioxymethamphetamine (MDMA) and methylenedioxyamphetamine 
(MDA)--to the NRC-required drug testing panel, consistent with the drug 
testing panel in Section 3.4 of the 2008 and 2017 HHS Guidelines. MDMA 
(also known as Ecstasy or Molly) and MDA are listed on Schedule I of 
the Schedules of Controlled Substances (21 CFR 1308.11). A Schedule I 
drug or substance has a high potential for abuse, has no currently 
accepted medical use in treatment in the United States, and there is a 
lack of accepted safety for use of the drug or substance under medical 
supervision (21 U.S.C. 812). This final rule adds testing for MDMA and 
MDA because of their potential adverse effects on human performance, 
which were detailed by HHS in the notice of proposed revisions to the 
HHS Guidelines, published in the Federal Register on April 13, 2004 (69 
FR 19673). The proposed rule also included testing for an additional 
amphetamine-based chemical compound, methylenedioxyethylamphetamine 
(MDEA), consistent with the 2008 HHS Guidelines. However, the final 
rule does not include testing for MDEA as it was subsequently removed 
in the 2017 HHS Guidelines because HHS determined that the number of 
positive MDEA specimens reported from its certified laboratories did 
not support continued testing for the substance.
    This final rule also adds four opioids (i.e., hydrocodone, 
hydromorphone, oxycodone, and oxymorphone) to the NRC-required drug 
testing panel. The NRC made the change in response to comments received 
on the proposed rule, as discussed in Section II.B.6 of this document, 
and to fully align with Section 3.4 of the 2017 HHS Guidelines. Each of 
the opioids is listed on Schedule II of the Schedules of Controlled 
Substances (21 CFR 1308.12). A Schedule II drug or substance has a high 
potential for abuse, has a currently accepted medical use in treatment 
in the United States or a currently accepted medical use with severe 
restrictions, and abuse of the drug or substance may lead to severe 
psychological or physical dependence. HHS recommended the addition of 
these opioids in its notice of proposed revisions to the HHS Guidelines 
published on May 15, 2015 and based its decision on drug abuse trends 
and the scientific ability to test for these substances.
    By requiring licensees and other entities to test for additional 
substances, a greater range of addictive drugs that impair human 
performance can be detected. Testing for additional substances may also 
identify individuals using illegal drugs, a characteristic of not being 
trustworthy and reliable.
    This final rule revises Sec. Sec.  26.31(d)(1) and 26.405(d) to 
include hydrocodone, hydromorphone, MDMA, MDA, oxycodone, and 
oxymorphone in the list of substances that licensees and other entities 
are required to test. This final rule adds these six substances to the 
initial drug testing tables that appear in Sec.  26.133, ``Cutoff 
levels for drugs and drug metabolites,'' and Sec.  26.163(a)(1) for 
LTFs and HHS-certified laboratories, respectively. The six substances 
also are added to the confirmatory drug testing table that appears in 
Sec.  26.163(b)(1) for HHS-certified laboratories. This final rule also 
adds two new tables to Sec.  26.163(a)(1) and (b)(1) that specify the 
substances and cutoff levels for initial and confirmatory testing of 
oral fluid specimens, as further discussed in Section II.C of this 
document, under ``Acceptable Specimens for Observed Collection.'' The 
tables throughout 10 CFR part 26 are accordingly retitled and 
renumbered.
    This final rule replaces the terms ``opiate'' and ``opiates'' with 
``opioid'' and ``opioids,'' respectively. An opiate is a naturally 
occurring substance found in the opium poppy plant (Papaver 
somniferum). Codeine and morphine are opiates. The addition of 
hydrocodone, hydromorphone, oxycodone, and oxymorphone to the required 
drug testing panel in this final rule necessitates a terminology change 
because each of these substances is a semi-synthetic opioid, which 
means it is synthesized in a laboratory using a naturally occurring 
opium product. It is more accurate to refer to these substances under 
the more inclusive drug class term ``opioid,'' which includes the 
plant-based substances and those synthesized in laboratories. This 
terminology change is consistent with Section 3.1(b) of the 2017 HHS 
Guidelines. This final rule replaces the term ``opiates'' with 
``opioids'' in Sec. Sec.  26.31(d)(1), 26.163(b)(1), 26.169(h)(3)(iii), 
and 26.405(d). This final rule replaces the term ``opiate metabolites'' 
with ``opioids'' in the initial test cutoff level tables in Sec. Sec.  
26.133 and 26.163(a)(1).
    The reporting requirement for HHS-certified laboratories in Sec.  
26.169(c)(2) is revised to remove the word ``opiate'' from the phrase 
``confirmatory opiate test results for morphine or codeine.'' The word 
opiate is unnecessary in this sentence because each applicable 
substance is listed.
    This final rule revises Sec.  26.185(j) introductory text to 
replace ``opiates'' with ``opioids'' in the first sentence. Section 
26.185(j)(1) is revised to replace ``opiates'' with ``opioids (i.e., 
codeine and/or morphine)'' and to replace the statement ``opium, an 
opiate, or an opium derivative (e.g., morphine/codeine)'' with 
``morphine and/or codeine.'' The addition of hydrocodone, 
hydromorphone, oxycodone, oxymorphone to the drug testing panel in this 
final rule is the basis for these

[[Page 71435]]

changes. Clarifying that the evaluation for the clinical signs of abuse 
is limited to positive test results for the opiates morphine and 
codeine is necessary because these two substances can be consumed in 
food. The HHS document, ``Medical Review Officer Manual for Federal 
Workplace Drug Testing Programs,'' provides information on the review 
of opioid tests results, both for the existing substances tested for 
under 10 CFR part 26 (codeine, morphine, and 6-AM) and also for the 
additional opioids added in the 2017 HHS Guidelines. The manual 
states--

    The opioid drug class poses some unique challenges with regard 
to interpretation because a positive result may be for a legitimate 
source, including the following: Codeine and morphine may be present 
due to the consumption of poppy seeds[; and] a positive result for 
any of the opioid analytes (with the exception of 6-AM) may be from 
legitimate use of a drug product.

    The MRO manual also states that hydrocodone, hydromorphone, 
oxycodone, and oxymorphone are not found in food products and are 
therefore subject to review as the only appropriate use is by 
prescription. The 2017 HHS Guidelines in Section 13.4(d)(1) provided 
for the MRO review of laboratory test results and stated that if the 
donor is unable to provide a legitimate medical explanation, then the 
MRO reports a positive result to the agency for all drugs except 
codeine and morphine.
    This final rule also replaces the term ``opiates'' with ``opioids'' 
in Sec.  26.185(j)(2), which applies to the MRO review of a ``positive 
confirmatory test result for drugs other than opiates,'' and in Sec.  
26.185(j)(4), which states that the MRO may consider the use of 
medication from a foreign country for ``a positive confirmatory test 
result for opiates.''
    This final rule also expands the NRC-required drug testing panel to 
include initial testing for 6-AM, consistent with Section 3.4 of the 
2008 and 2017 HHS Guidelines. This change improves the assurance that 
the testing method used under 10 CFR part 26 identifies individuals 
using heroin, a Schedule I drug. Currently, 10 CFR part 26 only permits 
the testing of a specimen for 6-AM when the specimen also tests 
positive for morphine (i.e., the morphine concentration is greater than 
the confirmatory testing cutoff level). The HHS implemented initial 
testing for 6-AM in the 2008 HHS Guidelines based on the analysis of 
laboratory testing data that demonstrated that 6-AM was detectable in 
the specimens of some individuals even when the specimens tested 
negative for morphine. Performing initial testing for 6-AM also 
improves the speed at which testing is completed for this heroin 
metabolite. Initial drug testing is typically completed on a specimen 
within 24 hours of receipt at an HHS-certified laboratory. Confirmatory 
testing can take several days, depending on when the laboratory 
performs testing on specimens for a particular drug or drug metabolite. 
Because the current testing for 6-AM is only performed after initial 
and confirmatory testing of morphine returns a positive test result, it 
is typical for a laboratory to take the full 5 business days permitted 
under Sec.  26.169(a) to complete 6-AM testing and then report that 
result to the MRO for review. This final rule change to conduct initial 
testing for 6-AM independent of morphine will improve how quickly an 
HHS-certified laboratory will complete testing, which is of critical 
importance for any individual actively performing duties that subject 
them to the requirements of 10 CFR part 26.
    This final rule updates the test result information that each HHS-
certified laboratory must include in the annual statistical summary 
report provided to a licensee or other entity under Sec.  26.169(h)(3) 
by adding hydrocodone, hydromorphone, MDMA, MDA, oxycodone, and 
oxymorphone to the reporting requirements. This final rule also revises 
Sec.  26.169(h), as further discussed in Section II.C of this document 
under the topic ``Acceptable Specimens for Observed Collection.''
Revised Initial Drug Testing Cutoff Levels
    The 2008 HHS Guidelines established the scientific and technical 
bases for lowering the initial drug testing cutoff levels for testing 
urine specimens for amphetamines and cocaine metabolites. This final 
rule updates the cutoff levels for initial drug testing of urine, as 
listed in the table in Sec.  26.133 for testing performed at LTFs, and 
in the table in Sec.  26.163(a)(1) for testing performed at HHS-
certified laboratories. The changes to Sec. Sec.  26.133 and 
26.163(a)(1) conform with Section 3.4 of the 2008 and 2017 HHS 
Guidelines. Specifically, this final rule makes the following changes 
in each table: (1) lowers the initial test cutoff level for cocaine 
metabolites, (2) replaces the term ``opiate metabolites'' with 
``codeine/morphine'' to clarify the existing testing requirement and 
includes a new footnote 1 to clarify that the target analyte for 
``codeine/morphine'' testing is morphine, (3) lowers the initial test 
cutoff level for amphetamines (abbreviated in the tables as AMP), (4) 
clarifies in a new footnote 2 that either a single or multiple initial 
test kit(s) may be used for amphetamines testing, and (5) includes a 
new footnote 3 to clarify that methamphetamine (abbreviated in the 
tables as MAMP) is the target analyte for amphetamines and 
methamphetamine testing. The column header ``Drug or metabolites'' in 
each table is revised to ``Drugs or drug metabolites'' to align with 
the table title.
    Lowering the cutoff levels for these existing drugs and drug 
metabolites in the NRC-required testing panel increases the timeframe 
(i.e., the window of detection) in which these drugs can be detected in 
an individual's urine after use and may also lead to improved 
deterrence. Increasing the window of detection for these substances 
provides a higher degree of assurance that persons who are using 
illegal drugs or misusing legal drugs would be identified. The NRC 
anticipates that the lower testing cutoff levels will increase the 
number of urine specimens identified as containing amphetamine, cocaine 
metabolite, and methamphetamine. These anticipated outcomes are based 
on increases in detection reported by Federal employee workplace drug 
testing programs and the DOT testing program subsequent to implementing 
the lower testing cutoff levels in the 2008 HHS Guidelines, as 
discussed in the regulatory basis and the regulatory analysis for this 
final rule.
    In addition, this final rule revises Sec. Sec.  26.133 and 
26.163(a)(1) to clarify that the specified testing cutoff levels are 
used by an LTF or an HHS-certified laboratory to determine whether a 
specimen is either ``negative'' or ``positive'' for each drug or drug 
metabolite being tested. This change better aligns 10 CFR part 26 with 
Section 11.19(b) and (c) of the 2008 and 2017 HHS Guidelines, which 
require the HHS-certified laboratory to make a determination that each 
specimen is either ``negative'' or ``positive'' for each drug and drug 
metabolite tested.
Revised Confirmatory Drug Testing Cutoff Levels
    The 2008 HHS Guidelines established the scientific and technical 
bases to justify lowering the confirmatory drug testing cutoff levels 
for testing urine specimens for amphetamine, the cocaine metabolite 
benzoylecgonine, and methamphetamine.
    The NRC is lowering the cutoff levels for confirmatory drug tests 
for urine, as listed in the table in Sec.  26.163(b)(1), to align with 
Section 3.4 of the 2008 and 2017 HHS Guidelines. Specifically, this 
final rule makes the following changes: (1) lowers the confirmatory 
test cutoff

[[Page 71436]]

levels for amphetamine, cocaine metabolite, and methamphetamine, (2) 
eliminates table footnote 3, which specified the requirement that 
confirmatory testing of 6-AM only proceed when confirmatory testing 
shows a morphine concentration exceeding 2000 ng/mL; \6\ and (3) 
redesignates table footnote 4 as footnote 3 and updates the text to 
lower the amphetamine concentration that also must be present in a 
specimen for it to be determined positive for methamphetamine. Similar 
to the changes made to the initial testing cutoff levels, lowering the 
confirmatory testing cutoff levels for amphetamine, cocaine metabolite, 
and methamphetamine increases the timeframe in which these drugs can be 
detected in an individual's urine after use and may also add to the 
deterrent effect of the rule. In addition, this final rule makes two 
clarifying changes to the initial drug testing cutoff level table for 
urine specimens in Sec.  26.163(b)(1) by replacing ``Opiates'' with 
``Opioids'' and adding the abbreviation ``(6-AM)'' after 6-
acetylmorphine. The change to ``Opioids'' is necessary because of the 
addition of hydrocodone, hydromorphone, oxycodone, and oxymorphone in 
this final rule.
---------------------------------------------------------------------------

    \6\ The unit ng/mL is nanograms per milliliter or a millionth of 
a gram per liter.
---------------------------------------------------------------------------

    Finally, the column header ``Drug or metabolites'' in the table in 
Sec.  26.163(b)(1) is revised to ``Drugs or drug metabolites'' to align 
with the table title. These changes improve consistency with Section 
3.4 of the 2008 and 2017 HHS Guidelines and with the revisions to 
Sec. Sec.  26.133 and 26.163(a)(1).
    This final rule makes conforming changes to the Sec.  26.169(h)(3) 
annual statistical summary reporting requirements that apply to HHS-
certified laboratories, by improving the clarity and uniformity of the 
names of the drugs and drug metabolites. Specifically, this final rule 
adds ``(as THCA)'' \7\ after ``Marijuana metabolite,'' adds ``(as 
benzoylecgonine)'' after ``Cocaine metabolite,'' revises ``6-AM'' to 
``6-acetylmorphine (6-AM),'' and revises ``Phencyclidine'' to 
``Phencyclidine (PCP).''
---------------------------------------------------------------------------

    \7\ THCA is an abbreviation for delta-9-tetrahydrocannabinol-9-
carboxylic acid.
---------------------------------------------------------------------------

Validity Testing of Adulterants at HHS-Certified Laboratories
    This final rule revises the decision point used in the validity 
tests performed by HHS-certified laboratories, as described in Sec.  
26.161(c)(3) through (c)(6) and Sec.  26.161(f)(5) and (f)(7), by 
replacing the limit of detection (LOD) with the limit of quantitation 
(LOQ) as the decision point for determining if a specimen contains an 
adulterant (i.e., adulterated test result) or the possible presence of 
an adulterant (i.e., invalid test result). The difference between the 
LOD and the LOQ for a testing assay is the ability to reliably quantify 
the analyte. At the LOD, the validity test must meet all HHS-certified 
laboratory criteria for result acceptance, except quantitation. At the 
LOQ, the validity test must reliably confirm the presence of the 
analyte, reliably quantify the concentration of the analyte, and meet 
all HHS-certified laboratory criteria for result acceptance. Use of the 
LOQ provides an additional donor protection on the accuracy of validity 
testing (i.e., in making the conclusion that results are adulterated or 
invalid).
    The changes in this final rule to Sec.  26.161(c)(3) through (c)(6) 
are consistent with Section 3.5 of the 2008 HHS Guidelines and Section 
3.6 of the 2017 HHS Guidelines, which describe the validity testing 
criteria for the adulterants chromium (VI), halogen (e.g., bleach, 
iodine, fluoride), glutaraldehyde, and pyridine (pyridinium 
chlorochromate). The changes in this final rule to Sec.  26.161(f)(5) 
and (f)(7) are consistent with the validity testing criteria in Section 
3.8 of the 2008 HHS Guidelines and Section 3.9 of the 2017 HHS 
Guidelines for invalid test results due to the possible presence of 
halogen or an oxidizing adulterant.
    The NRC did not change the initial validity testing requirement in 
Sec.  26.131(b)(5) that applies to LTF testing for the possible 
presence of halogen. Section 26.131(b)(5) currently permits an LTF to 
use a ``halogen colorimetric test (halogen concentration equal to or 
greater than the limit of detection (LOD)).'' The NRC did not change 
the use of LOD in this instance, because LTFs already must send any 
specimen identified with the possible presence of an adulterant to an 
HHS-certified laboratory for initial and confirmatory validity testing, 
where the LOQ of the test would be utilized.
    This final rule revises Sec.  26.161(c)(5) and (c)(6) to permit 
HHS-certified laboratories to conduct confirmatory validity testing for 
the adulterants glutaraldehyde and pyridinium chlorochromate using ``a 
different confirmatory method (e.g., gas chromatography/mass 
spectrometry (GC/MS))'' instead of what is currently required, which is 
only ``GC/MS for the confirmatory test.'' This final rule provides 
additional flexibility in the confirmatory testing methods that may be 
used by the laboratory and aligns with similar testing requirements in 
Sec.  26.167(e)(1), the current version of Sec.  26.153(c) (as 
described in the Statement of Considerations for the 2008 FFD final 
rule, see 73 FR 17091 and 17102), and Section 11.19(d) of the 2008 and 
2017 HHS Guidelines.
Special Analyses Testing of Urine Specimens
    Special analyses testing is an NRC testing methodology introduced 
in the 2008 FFD final rule to address the circumstance where a donor 
consumes a large quantity of fluid just before providing a urine 
specimen for testing in the hope of diluting the concentration of any 
drugs and drug metabolites in the specimen below the testing cutoff 
levels to avoid detection (i.e., to produce a negative drug test 
result). This testing methodology is not included in the HHS 
Guidelines, but provides licensees and other entities with an added 
level of assurance that an individual with a dilute specimen is not 
attempting to hide drug use. Section 26.163(a)(2) currently provides 
each licensee and other entity with the option to require the HHS-
certified laboratory to conduct special analyses of dilute specimens 
(i.e., conduct confirmatory testing to the LOD for drugs and drug 
metabolites when the immunoassay response of the initial drug test is 
equal to or greater than 50 percent of the cutoff calibrator). For 
example, if a specimen is dilute and the initial test for marijuana 
metabolites measured a concentration of 25 ng/mL (the initial cutoff 
level for marijuana metabolites is 50 ng/mL), special analyses testing 
would then be performed on the specimen. Using a lower cutoff level for 
the testing of a dilute specimen enhances the ability of licensees and 
other entities to identify drug-using individuals attempting to avoid 
detection through the consumption of large quantities of fluid just 
before providing a specimen for testing.
    This final rule makes four changes to the special analyses testing 
requirements in Sec.  26.163(a)(2). First, this final rule requires all 
licensees and other entities to conduct special analyses testing of 
dilute specimens. An analysis of the NRC's FFD program performance 
reports for calendar years 2011 through 2019 demonstrates the 
effectiveness of special analyses testing because these data show that 
additional positive results were identified for pre-access, random, and 
post-event special analyses tests. As of 2019, 93 percent of licensees 
and other entities have adopted the special analyses testing policy. 
This final rule eliminates

[[Page 71437]]

references to the option for licensees and other entities to conduct 
special analyses testing of specimens with dilute validity test results 
that appear in Sec. Sec.  26.31(d)(1)(ii); 26.163(a)(1) and (b)(1); 
26.183(c), (c)(1), and (d)(2)(ii); and 26.185(g)(2) and (3). These 
tests are now required.
    Second, this final rule lowers the immunoassay percentage response 
for initial testing in Sec.  26.163(a)(2)(ii) that HHS-certified 
laboratories must use to determine if special analyses testing is to be 
conducted. This final rule lowers the immunoassay response from ``equal 
to or greater than 50 percent of the cutoff calibrator'' to ``equal to 
or greater than 40 percent of the cutoff calibrator.'' Use of a lower 
cutoff level to evaluate the immunoassay response could increase the 
number of specimens subject to special analyses testing and improves 
the ability of licensees and other entities to identify drug-using 
individuals attempting to subvert the drug testing process. This change 
does not affect the drug testing assays used by HHS-certified 
laboratories because under the HHS Guidelines, each laboratory must 
already validate the accuracy of each assay to 40 percent of the cutoff 
calibrator. Each laboratory will need to change its administrative 
procedures that define the initial test result concentrations that 
trigger special analyses testing.
    Third, this final rule replaces the LOD with the LOQ as the 
confirmatory drug testing cutoff level to be used by HHS-certified 
laboratories when conducting special analyses testing. Currently, Sec.  
26.163(a)(2)(ii) requires the use of the LOD as the cutoff level for 
special analyses testing of dilute specimens. The difference between 
the LOD and the LOQ for a drug testing assay is the ability to reliably 
quantify the analyte. At the LOD, the confirmatory drug test must meet 
all HHS-certified laboratory criteria for result acceptance except 
quantitation. At the LOQ, the confirmatory drug test must reliably 
confirm the presence of the analyte, reliably quantify the 
concentration of the analyte, and meet all HHS-certified laboratory 
criteria for result acceptance. The LOQ provides an additional donor 
protection on the accuracy of special analyses test results. To receive 
and maintain laboratory certification by the NLCP, HHS-certified 
laboratories must already determine both the LOD and LOQ for each drug 
testing assay. Therefore, changing the decision point from the LOD to 
the LOQ for reporting confirmatory drug test results does not result in 
changes to the testing assays used at the laboratories.
    The NLCP also requires all HHS-certified laboratories to validate 
the accuracy and precision of each confirmatory drug test at or below 
40 percent of the cutoff. To meet this testing specification, the 
laboratory must establish both the LOD and the LOQ below the 40 percent 
cutoff, which results in variability among laboratories on how far 
below the 40 percent cutoff the LOD and LOQ are established. This is 
dependent, in part, on the instrumentation and testing processes used 
at the laboratory. The NRC acknowledges this variability. Some 
attendees at public meetings requested a standardized level be used 
across all laboratories performing special analyses testing. However, 
this position is contrary to the 10 CFR part 26 regulatory framework 
that enables licensees and other entities to use lower cutoff levels in 
the testing for drugs and drug metabolites, as permitted under Sec.  
26.31(d)(3)(iii).
    Fourth, this final rule expands the special analyses testing 
requirement in Sec.  26.163(a)(2)(i) to include the testing of some 
specimens collected under direct observation. Section 26.115(a) 
describes the exclusive grounds for performing a directly observed 
collection. Under the current requirements, a directly observed 
collection may be performed when sufficient information has been 
obtained during the collection process or in the testing of a previous 
specimen to indicate a possible subversion attempt by the donor or when 
an individual has a confirmed positive drug test result on a prior 
occasion. As such, a directly observed collection after either of these 
circumstances provides additional assurance that the subsequent 
specimen obtained for testing came directly from the donor's body and 
was not altered to avoid detection of drug use. Likewise, special 
analyses testing provides additional assurance that drugs and drug 
metabolites present in the specimen collected under direct observation 
from a donor will be identified, which improves the MRO's ability to 
determine whether a subversion attempt was made on the initial specimen 
collected from the donor. For example, an initial unobserved specimen 
provided by a donor is determined by the collector to be out of the 
acceptable temperature range specified in Sec.  26.111(a) and tests 
negative for drugs, and the second specimen collected under direct 
observation from the donor tests positive for a drug. In this example, 
the differences in test results from the initial and second specimen 
collected provide conclusive evidence to the MRO to make a subversion 
determination on the initial specimen provided. Therefore, this final 
rule revises Sec.  26.163(a)(2)(i) to require that special analyses 
testing be performed on specimens collected through directly observed 
collections under Sec.  26.115(a)(1) through (3), and (a)(5).
    Section 26.115(a)(1) describes the situation where a donor has 
presented a specimen that has been reported by an HHS-certified 
laboratory as adulterated, substituted, or invalid, and the MRO 
determines that no adequate medical explanation exists for the result 
and that another specimen should be collected from the donor. An 
analysis of the NRC's FFD program performance reports for calendar 
years 2011 through 2019 identified subversion attempts where the HHS-
certified laboratory reported an invalid test result for the initial 
specimen provided by the donor and either the donor refused to provide 
a second specimen under direct observation or the second specimen 
collected under direct observation tested positive for a drug. Use of 
special analyses testing on the second specimen collected provides 
additional assurance that drug use is detected because a period of days 
would lapse from the point of collection of the initial specimen, 
testing of that specimen at a laboratory, MRO review of the test 
results and discussion with the donor, MRO determination that a second 
specimen should be collected, and the donor appearance at a collection 
site to provide a second specimen under direct observation.
    Section 26.115(a)(2) describes the situation where a donor provides 
a specimen that falls out of the acceptable temperature range specified 
in Sec.  26.111(a). Section 26.115(a)(3) describes the situation where 
donor conduct during the collection process indicates an attempt to 
dilute, substitute, or adulterate the specimen. An analysis of the 
NRC's FFD program performance reports for calendar years 2011 through 
2019 demonstrates that the majority of subversion attempts are 
identified based on information obtained during the specimen collection 
process by the collector (e.g., specimen temperature) and the 
collection of a second specimen from the donor under direct 
observation. Use of special analyses testing in these two instances 
provides additional assurance that the drug use is detected in the 
second specimen collected under direct observation because the 
information from the initial collection process indicated a possible 
subversion attempt.
    Section 26.115(a)(5) addresses the situation where the MRO verifies 
that a

[[Page 71438]]

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. As a result, 
the confirmed test result from the initial testing laboratory must be 
cancelled by the MRO because the donor was not afforded the opportunity 
to verify the test results through additional testing at a second HHS-
certified laboratory. Use of special analyses testing in this instance 
provides additional assurance for the same reason described for 
specimens collected under Sec.  26.115(a)(1).
    The change in this final rule to require special analyses testing 
of specimens collected under direct observation will require licensees 
and other entities to establish an approach for the licensee or other 
entity to use when notifying a laboratory that special analyses testing 
is required for a specimen.
Alternative Specimen Collection Sites
    Sections 26.4(e)(6)(iv) and 26.31(b)(2) include the statement that 
licensees and other entities may rely on a local hospital or other 
organization that meets the requirements of 49 CFR part 40, 
``Procedures for Department of Transportation Workplace Drug and 
Alcohol Testing Programs (65 FR 41944; August 9, 2001).'' Section 
26.415(c) also includes a statement that licensees and other entities 
need not audit the specimen collection and alcohol testing services 
that meet the requirements of 49 CFR part 40, ``Procedures for 
Department of Transportation Workplace Drug and Alcohol Testing 
Programs (65 FR 41944; August 9, 2001).'' This final rule eliminates 
the Federal Register citation from each of these 10 CFR part 26 
sections because the DOT final rule found on page 41944 in the August 
9, 2001, edition of the Federal Register no longer represents the 
current version of 49 CFR part 40. The intent of these provisions is to 
provide licensees and other entities with flexibility to utilize 
collection sites that meet the DOT specimen collection requirements in 
49 CFR part 40. Listing the specific Federal Register notice of the 
applicable DOT final rule is not necessary because the existing 
requirements in Sec. Sec.  26.4(e)(6)(iv), 26.31(b)(2), 26.405(e), and 
26.415(c) already specify that the local hospital or other organization 
must meet the requirements in 49 CFR part 40.
Specimen Collection Procedures
    This final rule revises a number of specimen collection procedures 
in 10 CFR part 26 to (1) clarify and enhance the instructions for 
conducting an observed collection, (2) permit the use of mirrors to 
assist in performing directly observed collections, (3) allow 
additional personnel to observe a donor who is in the hydration process 
following the donor's inability to provide a specimen of adequate 
volume, and (4) clarify urine specimen quantity and acceptability 
provisions. The revisions improve the clarity, consistency, and 
flexibility of the collection procedures and align the NRC's 
requirements more closely with the HHS Guidelines.
    This final rule revises Sec.  26.115(e), (f), and (f)(1) through 
(3) to clarify the instruction for conducting a directly observed 
specimen collection and provide consistency with Sections 4.4(a) and 
8.9 of the 2008 and 2017 HHS Guidelines.
    This final rule removes the first sentence in Sec.  26.115(f), 
which states, ``If someone other than the collector is to observe the 
collection, the collector shall instruct the observer to follow the 
procedures in this paragraph.'' This final rule adds the following 
sentence to the end of the existing requirements in Sec.  26.115(e): 
``If the observer is not a trained collector, the collector shall, in 
the presence of the donor, instruct the observer on the collection 
procedures in paragraph (f).'' This change improves the clarity of the 
existing requirements and ensures that the donor is informed that an 
individual other than the collector is to observe the specimen 
provision and that the observer understands the procedures that must be 
followed to complete the specimen collection.
    In Sec.  26.115(f)(2), this final rule adds the following statement 
to the end of the existing requirement: ``A mirror may be used to 
assist in observing the provision of the specimen only if the physical 
configuration of the room, stall, or private area used for urination is 
not sufficient to meet this direct observation requirement; the use of 
a video camera to assist in the observation process is not permitted.'' 
This change also incorporates stakeholder feedback at the public 
meeting on October 11, 2011, during which the NRC proposed to prohibit 
the use of mirrors and video cameras to aid an observer in conducting a 
directly observed specimen collection, to align with Section 8.9(b) of 
the 2008 HHS Guidelines. Several industry participants commented that 
mirrors currently are used at some collection facilities where the 
configuration of the stall does not provide adequate space for the 
collector to directly observe the provision of a specimen from the 
donor's body into the specimen container. These participants suggested 
that if the NRC prohibited the use of a mirror to aid in the direct 
observation process, physical configuration changes at some collection 
sites would be needed.
    Based on subsequent licensee and NRC inspector feedback, the NRC 
has concluded that the observed collection process in Sec.  
26.115(f)(1) continues to ensure that subversion paraphernalia would be 
identified before the provision of a specimen during the observed 
collection process and that the use of reflective mirrors, but not two-
way mirrors, would be acceptable. As required by Sec.  26.115(f)(1), 
before conducting the directly observed collection, the donor already 
must adjust his or her clothing to expose the area between his or her 
waist and knees. This step ensures that no materials to subvert the 
testing process (e.g., a prosthetic device, a container of synthetic 
urine, an ampule of an oxidizing chemical, or other subversion 
paraphernalia) are concealed on the donor's body and could be used 
during the specimen collection. Subsequent to this step, the observer 
would then watch urine flow from the donor's body into the collection 
cup. To accomplish this, the collector (or same-gender observer) must 
be in close proximity (in the stall or room where the specimen is 
provided) to meet this observation requirement. The use of a reflective 
mirror only aids in this assurance by preventing the donor's body or 
the configuration of the stall or room from obstructing the collector's 
view of urine flowing from the donor's body directly into the specimen 
collection container. By observing the area where the urine leaves the 
body, the direct observation process ensures the integrity of the 
specimen collection process by verifying that the specimen provided is 
from the donor. As a result, this final rule revises Sec.  26.115(f)(2) 
to permit the use of reflective mirrors.
    This final rule also revises Sec.  26.115(f)(2) to prohibit the use 
of video cameras to assist in visualizing the provision of a specimen 
under direct observation. The NRC does not consider a video camera to 
be an acceptable means of providing direct observation. The use of a 
video camera for direct observation would be inconsistent with the 
intent of the rule because the collector or observer would not be in 
the room or stall with the donor. Further, a video feed is an 
incomplete source of information because it may not detail the 
physiological characteristics associated with a subversion attempt and 
also cannot guarantee the privacy of

[[Page 71439]]

the donor beyond the individual conducting the observation.
    In Sec.  26.115(f)(3), this final rule replaces the phrase ``If the 
observer is not the collector, the observer may not take the collection 
container from the donor, but shall observe the specimen as the donor 
takes it to the collector,'' with the phrase ``If the observer is not 
the collector, the observer may not touch or handle the collection 
container but shall maintain visual contact with the specimen until the 
donor hands the collection container to the collector.'' The changes 
improve the clarity of the existing requirement by more closely 
aligning with Sections 8.9(c) and (d)(2) of the 2008 HHS Guidelines and 
Sections 8.10(d)(3) and (d)(4)(ii) of the 2017 HHS Guidelines and by 
using terminology consistent with Sec.  26.113(b)(3).
    The NRC received two public comments on the proposed rule changes 
to add Sec.  26.4(g)(6) and revise Sec.  26.109(b)(1) to improve the 
efficiency of FFD programs by providing licensees and other entities 
with flexibility in the type of personnel who may monitor a donor 
during the hydration process. The hydration process is the 3-hour 
period of time that is initiated after a donor is unable to provide an 
acceptable quantity of urine during the initial specimen collection 
attempt (i.e., a shy bladder). During the hydration process, fluid is 
provided to assist the donor in providing a specimen of adequate 
volume. Provisions in the proposed rule permitted a staff member 
designated as FFD program personnel in Sec.  26.4(g) to monitor the 
donor during the hydration process in place of the original collector. 
The proposed rule also contained provisions that permitted another 
specimen collector who met the requirements in Sec.  26.85(a) to 
monitor the donor in the hydration process. The two commenters 
recommended that the NRC delete the proposed requirement for hydration 
monitors to be FFD program personnel under Sec.  26.4(g). The 
commenters explained that Sec.  26.31, ``Drug and alcohol testing,'' 
permits an individual who is not designated as FFD program personnel to 
monitor more significant collection processes, while receiving training 
only on the activities to be performed. One of the two commenters also 
referenced the observation process in Sec.  26.115, ``Collecting a 
urine specimen under direct observation,'' for the same reason. To 
ensure proper completion of required activities, the commenters 
suggested that the rule be modified to include instructions to the 
hydration monitor on observation responsibilities.
    The NRC agrees that persons monitoring a donor during the hydration 
process need not be designated as FFD program personnel, because 10 CFR 
part 26 already permits three comparable or more significant 
observation activities to be performed without such a restriction:
    (1) Monitoring the collection of a specimen when a donor and 
collector have a personal relationship (Sec.  26.31(b)(1)(iii));
    (2) Observing a donor provide a urine specimen under direct 
observation when a same-gender collector is not available (Sec.  
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-event test), and a same-gender collector is not 
available to stand outside the area to be used for the specimen 
collection (Sec.  26.87(f)(3)).
    In these three instances, the individual observing the collection 
process must receive training or instruction on the applicable 
collection procedures to be permitted to perform the observation 
activity.
    Accordingly, the NRC modified this final rule to:
    (1) Remove proposed Sec.  26.4(g)(6), which read: ``All persons 
monitoring a donor during the hydration process described in Sec.  
26.109(b)''; and
    (2) Revise proposed Sec.  26.109(b)(1) to replace the phrase ``or 
to a hydration monitor who meets the requirements in Sec.  26.4(g)(6)'' 
with ``or to a hydration monitor.''
    This final rule retains the proposed rule requirement in Sec.  
26.109(b)(1)(i) that the original collector provide instruction to the 
hydration monitor on the hydration process and acceptable donor 
behavior.
    If a hydration monitor or another collector is used, this final 
rule requires in Sec.  26.109(b)(1)(ii) that the original collector 
document the name of the individual on the Federal CCF. The proposed 
rule then required under Sec.  26.109(b)(1)(ii) that the original 
specimen collector provide the hydration monitor or second collector 
with the Federal CCF during the observation process (e.g., to document 
the time and volume of fluid provided to the donor, to note any unusual 
donor behavior, and to verify that the donor is provided with 3 hours 
to provide a specimen). The NRC received one public comment on the 
proposed Sec.  26.109(b)(1)(ii) requirement that the original specimen 
collector provide the Federal CCF to that hydration monitor or other 
collector observing the donor during the hydration process. The 
commenter stated that the Federal CCF should remain with the original 
collector during the hydration process.
    The NRC agrees that is it unnecessary for another specimen 
collector 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 hydration process (i.e., 
space on the one line on the Federal CCF for comments would be limited 
because it already would include the name of the hydration monitor or 
other collector). A licensee or other entity could, consistent with its 
collection procedures, establish a documentation method for the 
hydration monitor or other specimen collector to record information 
about the hydration process. Accordingly, the NRC updated this final 
rule by removing the phrases ``and then provide the Federal CCF to the 
individual for the duration of the hydration process'' in Sec.  
26.109(b)(1)(ii), and ``except as provided in Sec.  26.109(b)(1)(ii) 
for the Federal CCF'' in Sec.  26.117(g).
    This final rule also makes clarifying changes to Sec.  26.109 by 
moving the last sentence in Sec.  26.109(b)(1), ``The collector shall 
provide the donor with a separate collection container for each 
successive specimen,'' to be the new first sentence of Sec.  
26.109(b)(2). Section 26.109(b)(1) describes the procedures for 
providing fluid to a donor who is in the hydration process and includes 
the instruction to the collector to provide a separate collection 
container for each successive specimen provided by the donor. The 
instruction to provide a separate collection container for each 
specimen is more appropriate in Sec.  26.109(b)(2), which describes the 
provision of subsequent specimens once a donor is in the hydration 
process.
    This final rule revises Sec.  26.89(d) in three ways. First, Sec.  
26.89(d) is revised to clarify that a collector shall conduct only one 
collection procedure at any given time, except in the instance when 
another collector who meets the requirements in Sec.  26.85(a) or a 
hydration monitor is observing the donor during the hydration process, 
as permitted by the change to Sec.  26.109(b)(1) in this final rule. 
The NRC received a public comment on a second change in the proposed 
rule that more precisely described the actions taken by the collector 
when sealing the collection container with tamper-evident tape and 
completing the Federal CCF to end the collection process. The proposed 
rule replaced the phrase ``the urine specimen container has been sealed 
and initialed, the chain of custody form has been executed, and the 
donor has departed

[[Page 71440]]

the collection site'' with the phrase ``the urine specimen container 
has been sealed with tamper-evident tape, the seal has been dated and 
initialed, and the Federal CCF has been completed.'' The commenter 
requested that the term ``tamper-evident tape'' be replaced with the 
term ``tamper-evident seal'' to ensure consistent use of the term, 
which also appears in Sec.  26.117(c). The NRC agrees and corrects this 
inconsistency. Finally, the phrase ``or when a refusal to test has been 
determined'' is added to Sec.  26.89(d) to more accurately describe 
when the collection process has been completed if a refusal to test has 
been determined. These three changes improve the clarity of the 
existing collection requirements, correct an editorial error in the 
name of the form that is used to document the specimen collection, and 
include a reference to a refusal to test as another circumstance when 
the collection process is complete.
    The proposed rule included a change to Sec.  26.89(d) to add the 
phrase ``or when a refusal to test has been determined under Sec.  
26.107(d).'' The addition of an oral fluid specimen collection and 
testing option in this final rule resulted in a change to the proposed 
addition to Sec.  26.89(d) because Sec.  26.107(d) applies only to 
refusal to test actions associated with a urine specimen collection. By 
removing the words ``under Sec.  26.107(d)'' from the proposed phrase, 
Sec.  26.89(d) now refers to ``refusal to test,'' a term that applies 
to all drug testing specimen collections.
    This final rule revises Sec.  26.107, ``Collecting a urine 
specimen,'' in four ways to clarify how the donor is observed. First, 
this final rule redesignates paragraph (b) as paragraph (b)(1). Second, 
the phrase ``, except as provided in Sec.  26.109(b)(1),'' is added in 
the first sentence after ``The collector shall pay careful attention to 
the donor during the entire collection process.'' This revision is 
necessary because this final rule permits an individual other than the 
original specimen collector to monitor a donor in the hydration 
process; as a result, the original collector may not be present with 
the donor during the entire collection process. Third, Sec.  
26.107(b)(1) is revised to replace the phrase ``to note any conduct 
that clearly indicates an attempt to tamper with a specimen (e.g., 
substitute urine is in plain view or an attempt to bring an adulterant 
or urine substitute into the private area used for urination)'' with 
the phrase ``to observe any conduct that indicates an attempt to 
subvert the testing process (e.g., tampering with a specimen; having a 
substitute urine specimen in plain view; attempting to bring an 
adulterant, urine substitute, temperature measurement device, and/or 
heating element into the room, stall, or private area used for 
urination).'' The changes in this final rule provide additional 
examples of subversion attempt actions that have been reported by 
licensees and other entities in the annual information reports required 
by Sec.  26.717, ``Fitness-for-duty performance data.'' More accurate 
examples of subversion attempts in the regulatory text provide 
additional clarity on donor actions that may be considered a subversion 
attempt.
    Lastly, this final rule replaces the phrase in Sec.  26.107(b)(1), 
``the collector shall document the conduct'' with ``the collector shall 
document a description of the conduct.'' This change clarifies the 
requirement. Related to this Sec.  26.107(b)(1) requirement, the NRC 
received a public comment that draft regulatory guide (DG)-5040, 
``Urine Specimen Collection and Test Result Review under 10 CFR part 
26, `Fitness for Duty Programs,' '' specified an excessive amount of 
information to be documented on the Federal CCF. The commenter 
expressed concern that the Federal CCF did not contain sufficient space 
to document information regarding a subversion attempt and indicated 
that most licensees have internal documentation processes to capture 
this information. The commenter requested that the NRC revise Section 
C.1.B.(3) of DG-5040 to require that ``a description of the donor's 
conduct should be immediately documented.''
    The NRC agrees, in part, that the available space on the Federal 
CCF is limited (i.e., a single blank line to write text on the 
``Remarks'' line of the form). Therefore, depending on the number of 
observations regarding a possible subversion attempt, the Federal CCF 
may not contain adequate space to record all information. However, the 
NRC disagrees with the commenter's suggested change to eliminate the 
reference to documenting information on the Federal CCF in Section 
C.1.B.(3) of DG-5040 because it is an existing requirement in Sec.  
26.107(b)(1). Instead, the NRC revises Sec.  26.107(b)(1) in this final 
rule and Section C.1.B.(3) in Regulatory Guide (RG) 5.89, ``Fitness-
for-Duty Programs for Commercial Power Reactor and Category I Special 
Nuclear Material Licensees,'' to provide the collector with the option 
to document information about a subversion attempt on the Federal CCF 
or through another documentation method that is consistent with the 
collection procedures of the licensee or other entity. The method used 
by the licensee or other 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 
management to assist in the determination of appropriate next steps 
(e.g., terminate the collection process, collect a specimen under 
direct observation). This final rule revises Sec. Sec.  26.107(d)(3) 
and 26.111(b), which also require the collector to document 
observations on the Federal CCF.
    Section 26.107(b)(2) is added to ensure that if a hydration monitor 
is used to observe a donor during the Sec.  26.109(b) hydration 
process, this individual would immediately inform the collector of any 
donor conduct that may indicate an attempt to subvert the testing 
process, such as the donor leaving the collection site or refusing to 
follow directions. This final rule change is necessary because the 
collector must be informed of any unacceptable donor behavior so that 
appropriate action may be taken.
    This final rule revises Sec.  26.89(c) to correct an editorial 
error in the instructions that a collector must provide to the donor 
regarding refusing to cooperate with the testing process. Currently, 
the word ``adulterated'' is used twice in the phrase ``adulterated, 
diluted, or adulterated the specimen,'' which describes the situation 
where a donor admits to subverting the testing process. The phrase is 
revised to ``adulterated, diluted, or substituted the specimen.''
    This final rule revises Sec.  26.117, ``Preparing urine specimens 
for storage and shipping,'' in several ways. First, this final rule 
revises the title of Sec.  26.117, ``Preparing urine specimens for 
storage and shipping,'' to ``Preparing drug testing specimens for 
storage and shipping,'' replacing the word ``urine'' with the phrase 
``drug testing.'' Second, this final rule revises Sec.  26.117(a) to 
add the phrase ``Once the collector is presented with the specimen from 
the donor'' at the beginning of the first sentence to clarify when the 
collector would begin to keep the donor's ``specimen(s) in view at all 
times,'' and remove the word ``urine.'' This revision improves the 
clarity of an existing activity in the collection process. For example, 
the collector would not be able to keep the donor's urine specimen in 
view at all times when the donor is in the room, stall, or private area 
used for urination in an unobserved collection, as described in Sec.  
26.107(a). Third, this final rule corrects two editorial errors in 
Sec.  26.117(f): the term ``chain-of-custody forms'' is replaced with 
the term ``Federal CCFs'' and the phrase ``or the

[[Page 71441]]

licensee's testing facility'' is replaced with the phrase ``or to the 
licensee testing facility.'' Fourth, this final rule revises Sec. Sec.  
26.117(i) and (j) as further discussed in Section II.C of this 
document, under ``Acceptable Specimens for Observed Collection.''
    With regard to urine specimen acceptability, this final rule 
revises the term ``altered,'' as used in Sec.  26.111(a) and (c), to 
clarify that the term means that the collector has determined that a 
specimen may have been adulterated and/or diluted. This determination 
by a collector is not equivalent to the determination that a specimen 
is an adulterated specimen as defined in Sec.  26.5, which is a 
specimen testing determination made by an HHS-certified laboratory.
    This final rule corrects an editorial error in Sec.  26.111(a) 
associated with the minimum volume requirement for a urine specimen. 
Specifically, the phrase ``but greater than 15 mL'' is replaced with 
``but equal to or greater than 15 mL.'' This change conforms with the 
existing minimum specimen volume requirements in Sec. Sec.  
26.109(b)(4) and 26.111(b) and (d).
Collector Actions Following a Refusal to Test
    This final rule adds Sec.  26.107(d) and revises Sec. Sec.  
26.111(c) and (e) and 26.115(g) to more explicitly describe the actions 
that a collector must take when a refusal to test is determined during 
the specimen collection process, including the retention or disposal of 
any specimen(s) provided by the donor.
    Section 26.107(d) is added by this final rule to state that if the 
collector determines a refusal to test during the specimen collection 
process, the collector shall do the following: (1) inform the donor 
that a refusal to test has been determined; (2) terminate the 
collection process; (3) document a description of the refusal to test 
on the Federal CCF or through another documentation method consistent 
with the collection procedures of the licensee or other entity; (4) 
discard any urine specimen(s) provided by the donor, unless the 
specimen was collected for a post-event test under Sec.  26.31(c)(3); 
and (5) immediately inform the FFD program manager of the refusal to 
test. The majority of these changes are consistent with existing 
collector practice. However, the change to discard any urine specimens, 
except if collected for a post-event test, is a new requirement that 
improves the uniformity of licensee and other entity actions taken once 
a refusal to test had been determined. The NRC is aware of instances in 
which a licensee or other entity would conduct specimen testing, even 
though a refusal to test had already been determined at the collection 
site. This change addresses this inconsistency. The revisions to Sec.  
26.107(d) ensure that if a donor refuses to cooperate with the 
collection process, uniform action is taken, which makes 10 CFR part 26 
more consistent with Section 8.12 of the 2008 HHS Guidelines and 
Section 8.13 of the 2017 HHS Guidelines.
    The final rule change to retain and test any specimen collected for 
a post-event test under Sec.  26.31(c)(3) helps to inform licensee root 
cause determinations, as required by other parts of the NRC's 
regulations, such as Sec. Sec.  20.2203(b), 50.73(b), and 70.50(c). 
Although a refusal to test determination at the collection site 
subsequent to a specimen being provided for a post-event test is a very 
rare occurrence, a regulatory framework is needed to enable the testing 
of an individual's urine (or other specimen matrix such as oral fluid) 
to assist in determining whether the individual who committed or 
contributed to the event may have been impaired from the use of 
alcohol, an illegal drug, or prescription or over-the-counter 
medication. This assessment (which is informed by the requirements in 
Sec. Sec.  26.185, ``Determining a fitness-for-duty policy violation,'' 
and 26.189, ``Determination of fitness'') is very important because 
post-event testing is conducted, in part, in response to the occurrence 
of a very significant event such as, but not limited to: (1) a death, 
(2) a significant illness or personal injury, (3) a radiation exposure 
or release of radioactivity in excess of regulatory limits, or (4) an 
actual or potential substantial degradation of the level of safety of 
the plant.
    Section 26.111(c) is revised to remove the word ``designated'' from 
the phrase ``designated FFD program manager.'' This change conforms 
with the existing terminology used in Sec. Sec.  26.105(b), 
26.109(b)(3), 26.111(c), 26.115(a), (b), and (h), and 26.139(b). The 
parenthetical phrase ``(e.g., adulterated or diluted)'' is added after 
the word ``altered'' in the second sentence of Sec.  26.111(c) to 
provide additional clarity.
    Section 26.111(e) specifies that ``as much of the suspect specimen 
as possible must be preserved.'' This final rule adds the clarifying 
phrase ``except under the conditions described in Sec.  26.107(d)(4)'' 
to reference the conditions when a collector is to discard any urine 
specimen(s) collected. This change aligns with the changes to Sec.  
26.107(d) in this final rule.
    Some participants at the public meeting on October 11, 2011, 
requested that the NRC consider eliminating Sec.  26.111(f) because 
they believe this particular requirement is unnecessary. Section 
26.111(f) defines the criteria for an acceptable urine specimen as free 
from apparent contaminants, of at least 30 mL in quantity, and within 
the acceptable temperature range. However, this requirement does not 
aid in the implementation of 10 CFR part 26 and is not used in the 
NRC's drug testing requirements. The participants stated that this 
provision is unnecessary because other sections in 10 CFR part 26 
require specimens that do not meet the criteria in Sec.  26.111(f) to 
be sent to an HHS-certified laboratory for testing. The NRC agrees that 
this requirement is unnecessary because other sections in the rule 
already provide explicit detail as to the determination of whether a 
specimen is valid or invalid, as well as the specific steps required if 
either determination is made. Section 26.109, ``Urine specimen 
quantity,'' contains provisions regarding urine specimen quantity; 
Sec.  26.111(a) contains provisions regarding specimen temperature; and 
Sec.  26.111(d) requires that any specimen a collector suspects has 
been adulterated, diluted, or substituted, or that is collected under 
direct observation must be sent to an HHS-certified laboratory for 
initial and, if necessary, confirmatory testing. Therefore, this final 
rule removes Sec.  26.111(f) to improve the clarity of 10 CFR part 26.
    Section 26.115(g) states that a donor's refusal to allow a directly 
observed collection is an act to subvert the testing process. This 
final rule includes a new requirement that in this instance ``the 
collector shall follow the procedures in Sec.  26.107(d).'' This new 
requirement describes the actions that the collector must take when a 
refusal to test has been determined during the specimen collection 
process.
Blind Performance Test Sample Lot In-Service Requirement
    This final rule revises Sec.  26.168(h)(1), which currently 
requires blind performance test sample (BPTS) suppliers to place a 
sample lot in service for no more than 6 months. Feedback received from 
industry and BPTS suppliers indicated that sample lots can remain 
viable for much longer than 6 months (e.g., 2 years). Further, Section 
10.2 of the 2008 and 2017 HHS Guidelines do not impose a time limit on 
the use of a BPTS lot. This final rule eliminates the 6-month use 
limit, which enables the BPTS supplier, based on laboratory testing 
data on lot stability, to establish a specified shelf life for each

[[Page 71442]]

BPTS lot. Allowing the BPTS supplier to determine the expiration date, 
instead of the NRC requiring a uniform shelf life, improves the 
effectiveness of 10 CFR part 26, reduces costs for BPTS suppliers and 
entities implementing 10 CFR part 26 requirements, and aligns with the 
HHS Guidelines. Furthermore, if a BPTS is no longer stable and 
unexpected test results are reported by an HHS-certified laboratory, 
Sec.  26.719(c) already requires the licensee or other entity to report 
to the NRC the testing error and the results of the investigation. The 
Sec.  26.719(c) reporting requirement ensures that the NRC receives 
timely information on any BPTS formulation irregularities.
HHS-Certified Laboratory Personnel Qualifications and Responsibilities
    This final rule removes Sec.  26.155, ``Laboratory personnel,'' 
which re-states the qualifications and responsibilities of HHS-
certified laboratory personnel (e.g., Responsible Person, Certifying 
Scientist) included in the HHS Guidelines. The NRC finds that it is 
unnecessary to restate these HHS Guidelines requirements in 10 CFR part 
26 because licensees and other entities are required to use HHS-
certified laboratories as described in Sec. Sec.  26.31(d)(3) and 
26.153(a). Each laboratory is certified and then inspected every 6 
months by the NLCP, which provides assurance that laboratory personnel 
are appropriately trained, qualified, and meet acceptable academic and 
technical requirements. This final rule change reduces the potential 
for dual regulation of HHS-certified laboratories because each 
laboratory is annually inspected by the licensee or other entity as 
required in Sec.  26.41(c).
    A conforming change based on the removal of Sec.  26.155 eliminates 
the reference to Sec.  26.155 in Sec.  26.8, ``Information collection 
requirements; OMB approval,'' which lists the information collection 
requirements in 10 CFR part 26 that were approved by the Office of 
Management and Budget (OMB). A second conforming change eliminates the 
records retention requirement for personnel files at HHS-certified 
laboratories under Sec.  26.715(b)(1).
HHS-Certified Laboratory Procedures
    This final rule removes Sec.  26.157(b) through (e), which re-state 
the laboratory procedures requirements included in the HHS Guidelines. 
Section 26.157, ``Procedures,'' describes the written procedures that 
HHS-certified laboratories must develop, implement, and maintain. The 
NRC finds that it is unnecessary to restate these HHS Guidelines 
requirements in 10 CFR part 26 because licensees and other entities are 
required to use HHS-certified laboratories to conduct drug and validity 
testing in Sec.  26.153(a). As previously discussed with regard to the 
Sec.  26.155 changes in this final rule, each HHS-certified laboratory 
is certified and inspected on a periodic basis by the NLCP. This 
provides assurance that each laboratory meets the requirements in the 
HHS Guidelines to develop, implement, and maintain procedures. This 
final rule change reduces the potential for dual regulation of HHS-
certified laboratories with respect to maintaining a duplicative set of 
laboratory procedures already required to be maintained by the HHS 
Guidelines and reviewed and evaluated by the NLCP.
    This final rule revises Sec.  26.157(a) by replacing the phrase 
``develop, implement, and maintain clear and well-documented procedures 
for accession, receipt, shipment, and testing of urine specimens'' with 
``develop, implement, and maintain procedures specific to this part 
that document the accession, receipt, shipment, and testing of 
specimens.'' The changes do the following: (1) ensure that each 
laboratory continues to maintain procedures specific to 10 CFR part 26, 
such as for special analyses testing in Sec.  26.163(a) and the use of 
more stringent testing cutoff levels and/or the testing of additional 
substances permitted in Sec.  26.31(d)(3); (2) remove the word 
``urine'' from the phrase ``testing of urine specimens'' to provide 
additional flexibility, should the testing of additional specimen 
matrices (e.g., hair) be allowed by future changes to the HHS 
Guidelines and subsequent amendments to 10 CFR part 26 requirements; 
and (3) replace ``clear and well-documented'' with ``documented'' 
laboratory procedures to better align with the terminology in Sec.  
26.27(c) and the 2008 and 2017 HHS Guidelines. The changes to Sec.  
26.157(a) in this final rule enhance regulatory efficiency by 
clarifying that each laboratory must maintain procedures specific only 
to 10 CFR part 26 testing.
Quality Control Samples for Validity and Drug Testing
    Section 26.137(e)(6) lists the specifications for the quality 
control samples to be included in each analytical run of initial drug 
testing performed at an LTF, and Sec.  26.167(d)(3) and (e) list the 
quality control sample specifications to be included in each analytical 
run of initial and confirmatory drug tests performed at an HHS-
certified laboratory, respectively. This final rule makes a number of 
conforming changes to these quality control sample requirements to 
improve the clarity of 10 CFR part 26 and its consistency with Sections 
11.12 and 11.15(a)(1) of the 2008 and 2017 HHS Guidelines.
    This final rule replaces the word ``drugs'' in the first sentence 
of Sec.  26.137(e)(6) and the phrase ``drug and metabolite'' in the 
second sentence of Sec.  26.137(e)(6) with ``drugs and drug 
metabolites'' and ``drug and drug metabolite,'' respectively. The 
phrases ``drug(s) or drug metabolite(s)'' in Sec.  26.137(e)(6)(ii) and 
(e)(6)(iii) and ``a drug(s) or drug metabolite(s)'' in Sec.  
26.167(d)(3)(ii), (d)(3)(iii), and (e)(3)(iii) are replaced with the 
phrase ``the drug or drug metabolite.'' Similarly, the phrase ``no 
drug'' is expanded to ``no drug or drug metabolite'' in Sec.  
26.167(e)(3)(i), and the phrase ``no drugs or drug metabolites'' is 
revised to ``no drug or drug metabolite'' in Sec. Sec.  26.137(e)(6)(i) 
and 26.167(d)(3)(i).
    This final rule removes the parenthetical phrase ``(i.e., negative 
urine samples)'' from Sec. Sec.  26.137(e)(6)(i) and 26.167(d)(3)(i) 
and (e)(3)(i). Each of those requirements already specifies that the 
quality control sample is to contain no drug or drug metabolite, so the 
parenthetical is redundant.
    The phrase ``targeted at 25 percent below the cutoff'' is replaced 
in this final rule with the phrase ``targeted at 75 percent of the 
cutoff'' in Sec. Sec.  26.137(e)(6)(iii) and 26.167(d)(3)(iii).
    The term ``sample(s)'' is replaced in this final rule with the 
phrase ``at least one control'' in Sec. Sec.  26.137(e)(6)(i) and 
26.167(d)(3)(i) and (e)(3)(i). Similarly, the phrase ``at least one 
calibrator or control that is'' is replaced in this final rule with the 
phrase ``at least one control'' in Sec.  26.167(e)(3)(iv).
    The parenthetical statement ``(i.e., calibrators and controls)'' is 
added after the phrase ``quality control samples'' in Sec. Sec.  
26.137(e)(6) and 26.167(d)(4), and a conforming change is made in Sec.  
26.167(e)(2) to the phrase ``calibrators and controls'' by replacing it 
with the phrase ``quality control samples (i.e., calibrators and 
controls).''
    The phrase ``Positive calibrator(s) and control(s) with a drug(s) 
or drug metabolite(s)'' in Sec.  26.167(e)(3)(ii) is replaced in this 
final rule with the phrase ``A calibrator with its drug concentration 
at the cutoff.''
    This final rule replaces the phrase ``A minimum of 10 percent of 
all specimens in each analytical run'' in Sec.  26.137(e)(6) with the 
phrase ``A minimum of 10 percent of the total specimens in each 
analytical run,'' to more clearly describe

[[Page 71443]]

how to determine the number of quality control samples to include in 
each analytical run of initial drug testing performed at an LTF. 
Conforming changes in Sec.  26.167(e)(2) to the quality control samples 
that are to be included in each analytical run of confirmatory drug 
tests performed at an HHS-certified laboratory replace the phrase ``At 
least 10 percent of the samples in each analytical run of specimens'' 
with the phrase ``A minimum of 10 percent of the total specimens in 
each analytical run.'' This final rule change to Sec.  26.167(e)(2) is 
consistent with the existing terminology used in the quality control 
sample requirement for initial drug testing in Sec.  26.167(d)(4).
    Section 26.167(f)(3) is revised to make an editorial correction to 
the phrase ``a statement by the laboratory's responsible person'' by 
capitalizing the ``r'' and the ``p'' in the position title, so that it 
reads as follows: ``Responsible Person.''
    This final rule also addresses two issues that pertain to the LTF 
quality control sample requirements for initial validity testing in 
Sec.  26.137(d)(5) and for initial drug testing in Sec.  
26.137(e)(6)(v), which were described in an NRC enforcement guidance 
memorandum (EGM 09-003), dated March 31, 2009. A third issue identified 
in EGM 09-03 on the LTF quality control sample requirements, 
incorrectly using the term ``laboratory analysts'' instead of 
``licensee testing facility technicians,'' was addressed in a 10 CFR 
part 26 final rule correcting amendment (74 FR 38326; August 3, 2009).
    The first issue pertains to Sec.  26.137(d)(5) and (e)(6)(v), which 
require that at least one quality control sample in each analytical run 
must appear as a ``donor specimen'' to the LTF technician. To meet this 
requirement, a different individual would be required to prepare the 
quality control sample to ensure that the LTF technician that is 
conducting the specimen testing would be unaware of the origin of the 
sample. The current 10 CFR part 26 regulations do not require that the 
preparation of quality control samples and the conduct of specimen 
testing are to be performed by different individuals. Without EGM-09-
003, Sec.  26.137(d)(5) and (e)(6)(v) would have placed an unnecessary 
burden on licensees and other entities because additional LTF 
procedural changes would be necessary, including the use of an 
additional qualified person, either to prepare quality control samples 
or to conduct specimen testing. The majority of LTFs use a single LTF 
technician to prepare quality control samples and to perform specimen 
testing, which is consistent with the intent of the current 
requirements. Because the LTF technician may prepare quality control 
samples and perform specimen testing, the technician will know when he 
or she is testing a quality control sample. Therefore, the appearance 
of the quality control sample is irrelevant. For this reason, this 
final rule removes the phrase ``that appears to be a donor specimen to 
the licensee testing facility technicians'' in Sec.  26.137(d)(5) and 
(e)(6)(v).
    The second issue pertains to the requirement in Sec.  
26.137(e)(6)(v) that ``at least one positive control'' is to be 
included in each analytical run of initial drug testing of specimens at 
an LTF. This requirement is already met through the requirements in 
Sec.  26.137(e)(6)(ii) and (e)(6)(iii), which specify the positive 
quality control samples to be included in each analytical run. 
Furthermore, as explained in EGM 09-003, the sample required by Sec.  
26.137(e)(6)(v) does not need to be positive. This requirement is 
already met by Sec.  26.137(e)(6)(i), which requires each analytical 
run to include sample(s) certified by an HHS-certified laboratory to 
contain no drugs or drug metabolites. Because the ``at least one 
positive control'' requirement in Sec.  26.137(e)(6)(v) is unnecessary 
and the NRC is removing the phrase ``that appears to be a donor 
specimen to the licensee testing facility technicians'' from Sec.  
26.137(e)(6)(v), the NRC is deleting Sec.  26.137(e)(6)(v).
    The NRC is withdrawing EGM 09-003 upon the effective date of this 
final rule, which corrects these issues.
Additional MRO Review for Invalid Specimens With pH of 9.0 to 9.5
    Section 26.185(f) describes the process that an MRO is to use to 
review invalid urine specimen test results. This final rule 
redesignates paragraph (f)(3) as paragraph (f)(4) and adds a new 
paragraph (f)(3) to Sec.  26.185, to align the MRO review process for 
invalid specimen test results with Section 13.4(f) of the 2008 and 
Section 13.5(e) of the 2017 HHS Guidelines. Specifically, if a donor 
does not provide an acceptable medical explanation to the MRO for a pH 
value in the range of 9.0 to 9.5, then the MRO must consider if elapsed 
time and/or high temperature might have caused the test result. This 
change addresses research that demonstrated that exposing a urine 
specimen to high temperature and/or an extended delay in specimen 
testing from the time of collection may result in a pH in the range of 
9.0 to 9.5 (Cook, et al., 2007). In this final rule, if the MRO obtains 
sufficient information from the licensee or other entity, collection 
site, LTF, or HHS-certified laboratory regarding elapsed time and/or 
temperature conditions at specimen collection, receipt, transportation, 
or storage to conclude that an acceptable technical explanation exists 
for the invalid test result due to pH, then the MRO directs the 
licensee or other entity to collect a second urine specimen from the 
donor, as soon as reasonably practicable. The second specimen is not 
collected under direct observation because sufficient evidence was 
obtained to conclude that donor action likely was not the cause of the 
invalid test result. This new step to consider technical explanations 
for a discrepant pH result provides an additional protection to the 
donor and limits the instances in which a second collection under 
direct observation is necessary (i.e., only for invalid specimen test 
results where no legitimate medical or technical explanation has been 
determined by the MRO). Although Section 13.4(f) of the 2008 HHS 
Guidelines and Section 13.5(e) of the 2017 HHS Guidelines differ in 
that a second test in these circumstances is not required, not 
requiring a second test in these circumstances is inapplicable to 10 
CFR part 26 because a valid test is necessary for determining whether 
to grant or deny FFD authorization.
    The NRC included guidance on the methods an MRO could use to review 
invalid test results reported under Sec.  26.185(f)(3) in new RG 5.89, 
issued concurrently with this final rule.
Donor Request for Specimen Retesting or Bottle B Testing
    Section 26.165(b)(2) instructs the MRO to ``inform the donor that 
he or she may, within 3 business days of notification by the MRO of the 
confirmed positive, adulterated, or substituted test result, request 
the retesting of an aliquot of the single specimen or the testing of 
the Bottle B split specimen.'' \8\ This final rule includes a new 
requirement in Sec.  26.165(b)(2) for the MRO to document in his or her 
records the date and time a request was received from the donor to 
retest an aliquot of the single specimen or to test the Bottle B split 
specimen. Documenting when a donor initiated the request for testing 
ensures that a record is maintained to demonstrate that the donor had 
made

[[Page 71444]]

the request within the required 3 business days. This final rule change 
is consistent with the existing practice of MROs documenting this 
information when receiving such a request.
---------------------------------------------------------------------------

    \8\ ``Aliquot'' means a portion of a specimen that is used for 
testing. It is taken as a sample representing the whole specimen. 
``Bottle B testing'' means the drug or validity testing performed by 
a second HHS-certified laboratory on the split (Bottle B) specimen 
to verify the test results reported by the first HHS-certified 
laboratory that tested the Bottle A specimen.
---------------------------------------------------------------------------

    Section 26.165(b)(3) requires the donor to provide his or her 
permission for the retesting of an aliquot of the single specimen or 
the testing of Bottle B and states that ``Neither the licensee, MRO, 
NRC, nor any other entity may order retesting of the single specimen or 
testing of the single specimen or testing of the specimen in Bottle B 
without the donor's written permission, except as permitted in Sec.  
26.185(l).'' This final rule revises Sec.  26.165(b)(3) to state that 
``No entity, other than the MRO as permitted in Sec.  26.185(l), may 
order the retesting of an aliquot of the single specimen or the testing 
of the Bottle B split specimen.'' This final rule addresses an 
inconsistency in the current requirements because Sec.  26.165(b)(2) 
already states that the ``donor's request may be oral or in writing.'' 
At present, even though the MRO may have received an oral request from 
the donor to proceed with the retesting of an aliquot of the single 
specimen or to test the Bottle B split specimen, some licensees are 
interpreting the current provision to require that the MRO must receive 
written permission from the donor before initiating the retesting of a 
specimen.
    These final rule changes to Sec.  26.165(b)(2) and (b)(3) improve 
the consistency of 10 CFR part 26 with Section 14.1(b) of the 2008 and 
2017 HHS Guidelines and enhance due process by ensuring that the 
retesting of an aliquot of the single specimen or the testing of the 
Bottle B split specimen can proceed as quickly as possible.
Collection of a Second Specimen Under Direct Observation When Bottle B 
or an Aliquot of the Single Specimen Is Not Available for Testing
    Section 26.115(a) lists the exclusive grounds for collecting a 
urine specimen under direct observation. However, the list does not 
include an existing requirement in Sec.  26.165(f)(2) in which an 
observed collection is required when a donor requests a retest and 
either Bottle B or the single specimen is not available, due to 
circumstances outside of the donor's control. This final rule corrects 
this omission by including a new paragraph (a)(5) to reference the 
direct observation requirement in Sec.  26.165(f)(2).
    Section 26.165(f)(2) requires MRO action for a positive drug test 
result or an adulterated or substituted validity test result when the 
Bottle B of a split specimen or an aliquot of the single specimen is 
not available for testing at the donor's request. In this instance, the 
MRO is required to cancel the initial test result and inform the 
licensee or other entity that a second specimen must be collected under 
direct observation ``as soon as reasonably practical.'' Section 14.1(c) 
of the 2008 and 2017 HHS Guidelines, for this same circumstance, states 
that no notice is to be given to the donor regarding the second 
specimen collection until immediately before the collection is to 
commence. This final rule revises Sec.  26.165(f)(2) to specify that no 
prior notice shall be given to a donor until immediately before the 
collection. Clarifying the procedure to follow in this circumstance 
improves the effectiveness of licensees' or other entities' testing 
programs to detect illegal drug use and/or the misuse of legal drugs 
and would align 10 CFR part 26 with the 2008 and 2017 HHS Guidelines.
    This final rule also revises Sec.  26.165(f)(2) to state that the 
MRO is to report a cancelled test result to the licensee or other 
entity. The process in Sec.  26.165(f)(2) already states that the 
licensee or other entity may not impose any sanctions on the donor for 
a cancelled test result. This revision clarifies the existing action 
that the MRO must take to report the results of the testing of a 
donor's specimen to the licensee or other entity. Subsequent action by 
the licensee or other entity cannot be taken until the MRO provides the 
test result information for a donor's specimen. The revision also 
states that the licensee or other entity must continue the 
administrative withdrawal of an individual's FFD authorization until 
the test results from the second specimen collection are determined. 
Continuing to administratively withdraw an individual's FFD 
authorization is consistent with Sec.  26.165(f)(1), which requires the 
licensee or other entity to administratively withdraw an individual's 
FFD authorization on the basis of the first confirmed positive, 
adulterated, or substituted test result until the results of a donor-
requested Bottle B split specimen test or single specimen retest are 
available and have been reviewed by the MRO.
    A participant at the October 11, 2011, public meeting also 
requested that the NRC include in Sec.  26.165(f)(2) a reference to 
Sec. Sec.  26.129(b)(2) and 26.159(b)(2) to clarify that the action of 
the licensee or other entity was taken based on the test results of the 
second specimen collected under direct observation. The NRC agrees with 
this request, and has revised this section accordingly.
FFD Program Performance Data Reporting
    The NRC has periodically received questions from licensees and 
other entities on the annual drug and alcohol testing reporting 
requirements on ``populations tested'' in Sec.  26.717(b)(3) and (4). 
Specifically, the reporting requirements to provide FFD program 
performance data by populations tested (i.e., individuals in applicant 
status, permanent licensee employees, contractor/vendors (C/Vs)) has 
resulted in two types of questions.
    First, licensees already report the pre-access testing results 
separately for the licensee employee and C/V tested populations, so 
they requested clarification on the term ``individuals in applicant 
status.'' Applicant status is not a distinct tested population 
category; rather, it is the status of individuals that are subject to 
pre-access testing. Currently, licensees and other entities must report 
the test results by tested population for each condition of testing 
(i.e., pre-access, random, for-cause, post-event, and follow-up) as 
required by Sec.  26.717(b)(5). By reporting the pre-access test 
results for each of the two tested populations (i.e., licensee 
employees, C/Vs), licensees and other entities are already reporting 
the results for individuals in ``applicant status.'' This final rule 
removes the phrase ``individuals in applicant status'' from Sec.  
26.717(b)(3) and (4) to clarify the existing reporting requirement.
    Second, the NRC has received questions from entities other than the 
licensees that report Sec.  26.717 drug and alcohol test results. 
Because Sec.  26.717(b)(3) and (4) do not specify ``other entity'' in 
the parenthetical statements defining the tested populations, these 
entities were unclear on how to classify their tested populations on 
the Sec.  26.717 annual summary reports to the NRC. To correct this 
oversight, this final rule revises the tested population ``licensee 
employees'' to ``licensee or other entity employees'' in Sec.  
26.717(b)(3) and (b)(4).
Acceptable Specimens for Observed Collection
    As described in Section II.B.5 of this document, this final rule is 
allowing a licensee or other entity to collect an oral fluid specimen 
instead of a urine specimen for any of the observed collection 
conditions in Sec.  26.115(a)(1) through (3), and (a)(5). To provide 
the flexibility to conduct oral fluid specimen, the NRC has made 
conforming and clarifying changes in this final rule, as well as 
included additional new requirements specific to

[[Page 71445]]

the testing of oral fluid specimens. These changes, grouped by topic 
area, include the following:
     Specimens to be collected. This final rule revises the 
Sec.  26.83(b) restriction to ``Collect only urine specimens for both 
initial and confirmatory tests for drugs'' by allowing the collection 
and testing of an oral fluid specimen for any of the observed specimen 
collection conditions under Sec.  26.115(a)(1) through (3) and (a)(5), 
as long as the ``licensee establishes through its policy and procedures 
that an oral fluid specimen'' can be collected and tested. This final 
rule also requires, for each of the directly observed collection 
conditions in Sec.  26.115(a)(1) through (3) and (a)(5), that a 
licensee or other entity always collect either urine or an oral fluid 
specimen.
     Collector qualifications and responsibilities. This final 
rule consolidates the urine collector requirements in Sec.  26.85(a) 
and the alcohol collector requirements in Sec.  26.85(b) into Sec.  
26.85(a), to provide uniform qualifications and responsibilities for 
collectors based on the specimen the collector is qualified to collect 
under this part. The existing urine and alcohol collector requirements 
are the same, with two exceptions. First, different terminology is used 
for ``methods to address problem collections'' with respect to a 
donor's inability to provide a specimen: ``shy bladder'' for urine and 
``shy lung'' for alcohol. This final rule addresses the terminology 
differences for a donor's inability to provide a specimen by providing 
both terms in a parenthetical statement after ``inability to provide a 
specimen'' under Sec.  26.85(a)(2)(i). Second, the alcohol collector 
qualification requirements in current Sec.  26.85(b)(2) include the 
``operation of the particular testing device(s),'' which is not 
applicable to urine collectors. This final rule revises the ``operation 
of the particular alcohol testing devices [i.e., the alcohol screening 
devices (ASDs) or EBTs]'' in Sec.  26.85(b)(2) to ``operation of the 
particular specimen collection or alcohol testing device(s) (e.g., 
alcohol screening device (ASD), EBT, oral fluid)'' in Sec.  
26.85(a)(3). Lastly, this final rule renumbers Sec.  26.85(a)(5), 
replaces the phrase ``specimen collection and transfer process'' with 
``specimen collection process,'' and adds the phrase ``, and the 
specimen transfer process, if applicable'' to the end of the existing 
requirement. This is a conforming change necessary because ``transfer 
process'' does not apply to all specimens collected (e.g., the 
collection of a breath specimen for alcohol).
     Collection sites. This final rule revises three collection 
site requirements in Sec.  26.87, ``Collection sites,'' to provide 
flexibility to collect oral fluid specimens in addition to urine 
specimens for drug testing. The revisions also clarify, if appropriate, 
that a requirement is specific to the collection of one specimen type 
(e.g., urine). First, Sec.  26.87(a) is revised to replace the phrase 
``shipping or transportation of urine specimens to a drug testing 
laboratory; the collection of oral fluids or breath specimens; and the 
security of alcohol testing devices'' with ``shipping or transportation 
of specimens to a drug testing laboratory; the testing of specimens for 
alcohol; the security of specimen collection and testing devices.'' 
Second, Sec.  26.87(b) is revised to state that the collection site 
must provide visual privacy for the donor and collector during an oral 
fluid specimen collection. This privacy provision is consistent with 
the provision of individual privacy while the donor submits a urine 
specimen as described in Sec.  26.87(b). Third, Sec.  26.87(f) is 
revised in Sec. Sec.  26.87(f) and (f)(5), to replace the term ``urine 
specimen'' with ``specimen for drug testing'' for an ``exceptional 
event'' that a designated collection site is inaccessible. Section 
26.87(f)(2) is revised to replace the phrase ``If practical, a water 
coloring agent'' with ``If practical when a urine specimen is to be 
collected, a water coloring agent.'' Section 26.87(f)(3) is revised to 
replace the phrase ``area that will be used for a specimen collection'' 
with ``area that will be used for a urine specimen collection.'' 
Section 26.87(f)(4) is revised in two ways. First, the phrase ``the 
collector shall inspect the toilet bowl and area to ensure that there 
is no evidence of a subversion attempt'' is replaced with ``if the 
specimen is urine, the collector shall inspect the toilet bowl and area 
to ensure that there is no evidence of a subversion attempt.'' This 
change clarifies the inspection of the toilet bowl and area only 
applies to urine specimen collections. Second, Sec.  26.87(f)(4) is 
revised to replace the phrase ``the collector shall instruct the donor 
to participate with the collector'' with ``for any specimen collected 
for drug testing, the collector shall instruct the donor to participate 
with the collector.'' This change clarifies that donor participation 
with the collector in completing the chain of custody procedures 
applies to any specimen collected for drug testing.
     Preparing to collect specimens for drug testing. This 
final rule revises Sec.  26.89(d) by removing the word ``urine'' from 
the phrases ``urine collection procedure'' and ``urine specimen 
container.'' These changes provide flexibility to permit the collection 
of any specimen for drug testing (e.g., urine, oral fluid). This final 
rule also revises Sec.  26.105, ``Prepare for urine collection,'' to 
accommodate for the collection of urine and oral fluid specimens. The 
title of Sec.  26.105, ``Preparing for urine collection,'' is revised 
to ``Preparing for the collection of a specimen for drug testing.'' In 
Sec. Sec.  26.105(a) and (d), the word ``urine'' is removed from the 
phrase ``urine specimen'' where it appears. In Sec.  26.105(c), the 
phrase ``wash and dry his or her hands before urinating'' is revised to 
``wash and dry his or her hands before providing a specimen.'' In the 
first sentence of Sec.  26.105(e), the phrase ``sealed collection 
container from the collection kit materials'' is replaced with ``sealed 
urine specimen collection container from the collection kit materials 
or an oral fluid specimen collection device.'' In the second sentence 
of Sec.  26.105(e), the phrase ``the collection container'' is replaced 
with ``urine specimen collection container.'' The changes in Sec.  
26.105(e) ensure that the collection process is consistent for oral 
fluid and urine specimens.
     Collecting oral fluid specimens. This final rule revises 
Sec.  26.97, ``Conducting an initial test for alcohol using a specimen 
of oral fluids,'' which was specific to the collection of oral fluid 
specimens for alcohol testing, by making minor conforming changes to 
accommodate for the collection of oral fluid specimens for both alcohol 
and drug testing. The title of Sec.  26.97 is revised to ``Collecting 
oral fluid specimens for alcohol and drug testing.'' The word ``test'' 
is replaced with the phrase ``specimen collection'' in Sec.  26.97(a), 
(a)(4), and (b)(1) through (3). Section 26.97(c)(2) is revised to 
replace the phrase ``initial test using an EBT'' with ``specimen 
collection (i.e., initial test using an EBT for alcohol, or urine 
specimen collection for drug testing).'' Section 26.97(d) is revised to 
replace the phrase ``The collector shall read the result'' with ``For 
alcohol testing of oral fluids, the collector shall read the result.''
     Preparing specimens for storage and shipping. This final 
rule revises Sec.  26.117 to accommodate for the collection of oral 
fluid specimens. The title of Sec.  26.117, ``Preparing urine specimens 
for storage and shipping,'' is revised to ``Preparing drug testing 
specimens for storage and shipping.'' The first sentence in Sec.  
26.117(a) is revised to replace the phrase ``Both the donor and the 
collector shall keep the donor's urine specimen(s) in view'' with

[[Page 71446]]

``Once the collector is presented with the specimen from the donor, 
both the donor and collector shall keep the donor's specimen(s) in 
view.'' In Sec.  26.117(i), the phrase ``packaged with its associated 
urine specimen bottle'' is replaced with ``packaged with its associated 
specimen bottle.'' In the third sentence of Sec.  26.117(j), the phrase 
``Specimens that have not been shipped'' is replaced with ``Urine 
specimens that have not been shipped'' and the phrase ``any specimen'' 
is replaced with ``any urine specimen.'' A new fourth sentence is added 
to state that ``Oral fluid specimens shall be stored under the 
conditions specified by the oral fluid specimen collection device 
manufacturer.'' This new provision is necessary because the 
refrigeration provision for urine specimens in Sec.  26.117(j) may not 
be appropriate or necessary given the buffering solution that oral 
fluid specimen collection devices may contain.
     FFD program testing requirements. Section 26.31(d)(3)(i) 
is revised by adding ``urine'' to the start of the existing 
requirement, ``Specimens sent to the HHS-certified laboratories must be 
subject to initial validity and initial drug testing by the 
laboratory.'' A new sentence is added in Sec.  26.31(d)(3)(i) that 
states that ``Oral fluid specimens sent to the HHS-certified 
laboratories must be subject to initial drug testing by the 
laboratory.'' Unlike the collection of urine specimens that are 
typically provided by the donor in the privacy of a room, stall or 
enclosure, oral fluid specimens are directly observed by the collector. 
Standard validity testing is necessary for urine specimens because of 
the lack of direct observation of all specimens and to provide 
assurance that a donor has not attempted to subvert the testing 
process. The 2019 HHS Guidelines for oral fluid testing also do not 
mandate validity testing of all specimens.
     HHS-certified laboratory specimen testing.
    [cir] Use of HHS-certified laboratories. This final rule revises 
Sec.  26.151, ``Purpose,'' to replace the phrase ``HHS-certified 
laboratories that licensees and other entities who are subject to this 
part use for testing urine specimens for validity and the presence of 
drugs and drug metabolites'' with ``HHS-certified laboratories that 
licensees and other entities use to perform testing under this part.'' 
This final rule also revises the title of Sec.  26.153, ``Using 
certified laboratories for testing urine specimens,'' by removing the 
word ``urine.'' These changes accommodate the testing of oral fluid 
specimens at HHS-certified laboratories.
    [cir] Drug testing cutoff levels. This final rule includes the 
testing cutoff levels for initial and confirmatory drug testing 
consistent with Section 3.4 of the 2019 HHS Guidelines for oral fluid 
testing. This final rule adds a new table to Sec.  26.163(a)(1), for 
initial testing of oral fluid specimens, and adds a new table to Sec.  
26.163(b)(1), for confirmatory drug testing of oral fluid specimens. 
Each table lists the drugs and drug metabolites and test cutoff levels, 
and includes footnotes to define substance names such as ``Amphetamine 
(AMP)'' and initial testing specifications.
    [cir] Validity testing. This final rule revises Sec. Sec.  
26.161(b), (d), and (e) to clarify that these validity testing 
provisions only apply to urine specimens. In Sec.  26.161(b), the 
phrase ``Initial validity testing'' is replaced with ``Initial validity 
testing of urine.'' In Sec.  26.161(d), the phrase ``Results indicating 
a substituted specimen'' is replaced with the phrase ``Results 
indicating a substituted urine specimen.'' In Sec.  26.161(e), the 
phrase ``Results indicating a dilute specimen'' is replaced with the 
phrase ``Results indicating a dilute urine specimen.'' Section 
26.31(d)(1) is also revised to remove the word ``adulterants'' from the 
``substances tested'' list. Including adulterants in the substance list 
is unnecessary because Sec. Sec.  26.131 and 26.161 describe each 
validity test that is to be performed on urine specimens at licensee 
testing facilities and HHS-certified laboratories, respectively. 
Adulterant testing is only one of the required validity tests performed 
on urine specimens. A conforming change is made in this final rule to 
Sec.  26.405(d), which specifies the required substances that FFD 
programs for construction must test in specimens. ``Adulterants'' is 
removed from the first sentence in Sec.  26.405(d), which describes the 
substances that licensees and other entities must test for in 
specimens. Instead, the second sentence in Sec.  26.405(d), ``Urine 
specimens collected for drug testing must be subject to validity 
testing,'' is revised to ``Urine specimens collected for drug testing 
must be subject to validity testing that includes testing for 
adulterants.'' This change clarifies that adulterant testing applies to 
validity testing of urine specimens.
    [cir] Quality assurance and quality control. Section 26.167(c) is 
revised in this final rule to replace the phrase ``validity tests'' 
with ``validity tests on urine.'' Validity testing in 10 CFR part 26 
only applies to urine specimens. Section 26.167(d)(1) is revised to 
replace the phrase ``Any initial drug test performed by an HHS-
certified laboratory'' with ``Any initial drug test of urine performed 
by an HHS-certified laboratory.''
    [cir] Annual statistical summary reports. Section 26.169(h) is 
revised to remove the word ``urinalysis'' from the phrase ``annual 
statistical summary of urinalysis testing.'' This change ensures that 
the summary of test results provided by the HHS-certified laboratory 
includes the results for all urine and oral fluid specimens tested for 
a licensee or other entity.

III. Section-by-Section Analysis

    The following paragraphs describe the specific changes within this 
final rule:

Nomenclature Changes

    Throughout 10 CFR part 26, this final rule removes the term 
``custody and control form'' and replaces it with the term ``Federal 
CCF.'' This final rule also removes two additional iterations of the 
term, ``custody-and-control forms'' and ``custody-and-control 
form(s),'' and replaces them with the terms ``Federal CCFs'' and 
``Federal CCF(s),'' respectively.
    Throughout 10 CFR part 26, this final rule replaces the term 
``chain-of-custody'' with the term ``chain of custody.''

Section 26.4 FFD Program Applicability to Categories of Individuals

    This final rule amends paragraph (e)(6)(iv) to eliminate the phrase 
``(65 FR 41944; August 9, 2001).''
    This final rule revises paragraph (j)(3) to replace the phrase 
``laboratory certified by the Department of Health and Human Services 
(HHS)'' with ``Department of Health and Human Services (HHS)-certified 
laboratory as defined in Sec.  26.5.''

Section 26.5 Definitions

    This final rule adds definitions for Cancelled test, Carryover, 
Certifying Scientist, Federal custody and control form, Lot, Rejected 
for testing, and Responsible Person. This final rule also revises the 
definitions for Calibrator, Control, Dilute specimen, HHS-certified 
laboratory, Invalid result, Limit of quantitation, and Substituted 
specimen.

Section 26.8 Information Collection Requirements: OMB Approval

    This final rule amends paragraph (b) to remove the reference to 
Sec.  26.155.

[[Page 71447]]

Section 26.31 Drug and Alcohol Testing

    This final rule amends paragraph (b)(2) to eliminate the phrase 
``(65 FR 41944; August 9, 2001).''
    This final rule revises paragraph (d)(1) introductory text to 
include hydrocodone, hydromorphone, MDMA, MDA, oxycodone, and 
oxymorphone as substances for which licensees and other entities are 
required to test in each specimen. The rule also replaces the term 
``opiates'' with the term ``opioids,'' and removes the term 
``adulterants.''
    This final rule amends paragraph (d)(1)(i)(D) to eliminate the 
phrase ``as specified in Sec.  26.155(a).''
    This final rule revises the third sentence of paragraph (d)(1)(ii) 
to replace the phrase ``except if the specimen is dilute and the 
licensee or other entity has required the HHS-certified laboratory to 
evaluate the specimen under Sec. Sec.  26.163(a)(2) or 26.168(g)(3)'' 
with the phrase ``except if special analyses of the specimen is 
performed under Sec.  26.163(a)(2) by the HHS-certified laboratory.''
    This final rule revises paragraph (d)(3)(i) to add ``urine'' to the 
beginning of the second sentence to read ``Urine specimens sent to HHS-
certified laboratories must be subject to initial validity and initial 
drug testing by the laboratory,'' and to add a new third sentence to 
read ``Oral fluid specimens sent to HHS-certified laboratories must be 
subject to initial drug testing by the laboratory.''

Section 26.83 Specimens To Be Collected

    This final rule revises paragraph (b) to add to the end of the 
existing requirement the phrase ``unless the licensee or other entity 
establishes through its policy and procedures that an oral fluid 
specimen can be collected and tested for any of the observed specimen 
collection conditions under Sec.  26.115(a)(1) through (3) and 
(a)(5).'' This final rule also revises paragraph (b) to add a new 
sentence: read ``For each observed collection condition under Sec.  
26.115(a)(1) through (3) and (a)(5), the licensee or other entity shall 
always collect and test the same specimen type.''

Section 26.85 Collector Qualifications and Responsibilities

    This final rule revises paragraph (a) introductory text to remove 
``urine'' from the first sentence ``Urine collector qualifications.'' 
In the second sentence, the final rule replaces the phrase ``Urine 
collectors'' with ``Each collector'' and replaces the words ``urine 
collection procedures'' with the phrase ``the collection procedures for 
each specimen the individual is qualified to collect under this part.'' 
In the third sentence, the final rule replaces the term ``Collectors'' 
with ``Each collector.''
    This final rule revises paragraph (a)(2) to remove the phrase 
``collections involving `shy-bladder' and attempts to tamper with a 
specimen.'' The final rule adds a new paragraph (a)(2)(i) to specify 
the ``Inability to provide a specimen (e.g., `shy bladder' for a urine 
specimen, `shy lung' for a breath specimen, dry mouth for an oral fluid 
specimen),'' and a new paragraph (a)(2)(ii) to specify ``Attempts to 
tamper with a specimen.''
    This final rule redesignates paragraphs (a)(3) and (4) as 
paragraphs (a)(4) and (5), respectively, and adds a new paragraph 
(a)(3). In the renumbered paragraph (a)(5), this final rule replaces 
the phrase ``specimen collection and transfer process'' with ``specimen 
collection process,'' and adds the phrase ``, and the specimen transfer 
process, if applicable'' to the end of the existing requirement.
    This final rule removes paragraph (b) and redesignates paragraphs 
(c), (d), and (e) as paragraphs (b), (c), and (d), respectively. In the 
redesignated paragraph (b)(1), the final rule replaces the phrase ``the 
requirements of paragraphs (a) and (b) of this section'' with the 
phrase ``the requirements of paragraph (a) of this section'' as a 
conforming change.

Section 26.87 Collection Sites

    This final rule revises the second sentence of paragraph (a) to 
replace the phrase ``shipping or transportation of urine specimens to a 
drug testing laboratory; the collection of oral fluids or breath 
specimens; and the security of alcohol testing devices'' with 
``shipping or transportation of specimens to a drug testing laboratory; 
the testing of specimens for alcohol; the security of specimen 
collection and testing devices.''
    This final rule revises paragraph (b) to replace the phrase ``The 
collection site must provide for the donor's visual privacy while the 
donor and collector are viewing the results of an alcohol test, and for 
individual privacy while the donor is submitting a urine specimen,'' 
with the sentences ``Visual privacy must be provided to the donor and 
collector when viewing alcohol test results and during the collection 
of an oral fluid specimen for drug testing. The donor must be provided 
with individual privacy while the donor is submitting a urine 
specimen.''
    This final rule amends paragraph (f) to replace the term ``urine 
specimen'' with ``specimen for drug testing.''
    This final rule amends paragraph (f)(2) to replace the phrase ``If 
practical, a water coloring agent'' with ``If practical when a urine 
specimen is to be collected, a water coloring agent.''
    This final rule amends paragraph (f)(3) to replace the phrase 
``area that will be used for a specimen collection'' with ``area that 
will be used for a urine specimen collection.''
    This final rule amends paragraph (f)(4) to read ``Once the 
collector has possession of the specimen, if the specimen is urine, the 
collector shall inspect the toilet bowl and area to ensure that there 
is no evidence of a subversion attempt and shall then flush the toilet, 
and for any specimen collected for drug testing, the collector shall 
instruct the donor to participate with the collector in completing the 
chain of custody procedures.''
    This final rule amends paragraph (f)(5) to replace the phrase 
``urine specimen'' with ``specimen for drug testing.''

Section 26.89 Preparing To Collect Specimens for Testing

    This final rule amends paragraph (c) to replace the phrase 
``adulterated, diluted, or adulterated the specimen'' with the phrase 
``adulterated, diluted, or substituted the specimen.''
    This final rule revises paragraph (d) to include this phrase at the 
end of the first sentence: ``, except as described in Sec.  
26.109(b)(1).'' The rule also revises the second sentence in paragraph 
(d) to replace the phrase ``For this purpose, a urine collection 
procedure is complete when the urine specimen'' with the phrase ``For 
the collection of specimen(s) for drug testing, the collection 
procedure is complete when the specimen'', to replace the phrase 
``sealed and initialed'' with the phrase ``sealed with tamper-evident 
seal, the seal has been dated and initialed'', and to replace the 
phrase ``the chain of custody form has been executed, and the donor has 
departed the collection site'' with the phrase ``and the Federal CCF 
has been completed or when a refusal to test has been determined.''

Section 26.97 Conducting an Initial Test for Alcohol Using a Specimen 
of Oral Fluids

    This final rule revises the section heading to read ``Collecting 
oral fluid specimens for alcohol and drug testing.''
    This final rule amends paragraphs (a) introductory text, (a)(4), 
and (b)(1) through (3), to replace the word ``test''

[[Page 71448]]

with the phrase ``specimen collection'' wherever it appears.
    This final rule revises paragraph (c)(2) to replace the phrase 
``initial test using an EBT'' with ``specimen collection (i.e., initial 
test using an EBT for alcohol, or urine specimen collection for drug 
testing).''
    This final rule revises paragraph (d) to replace the phrase ``The 
collector shall read the result'' with ``For alcohol testing of oral 
fluids, the collector shall read the result.''

Section 26.105 Preparing for Urine Collection

    This final rule revises the section heading to ``Preparing for the 
collection of a specimen for drug testing.''
    This final rule amends paragraphs (a) and (d) to remove the word 
``urine'' from the phrase ``urine specimen'' wherever it appears.
    This final rules amends paragraph (c) to replace the phrase ``wash 
and dry his or her hands before urinating'' with ``wash and dry his or 
her hands before providing a specimen.''
    This final rule revises the first sentence of paragraph (e) to 
change the phrase ``sealed collection container from the collection kit 
materials'' to ``sealed urine specimen collection container from the 
collection kit materials or an oral fluid specimen collection device'', 
and in the second sentence, replaces the phrase ``the collection 
container'' with ``the urine specimen collection container.''

Section 26.107 Collecting a Urine Specimen

    This final rule revises paragraph (b) by redesignating paragraph 
(b) as paragraph (b)(1) to include the exception provided in Sec.  
26.109(b)(1) for a hydration monitor, expand the examples of subversion 
attempt actions, and add flexibility for other documentation methods. 
This final rule also adds new paragraph (b)(2) to ensure that if a 
hydration monitor is used to observe a donor during the Sec.  26.109(b) 
hydration process, this individual shall immediately inform the 
collector of any donor conduct that may indicate an attempt to subvert 
the testing process (e.g., donor leaves the collection site, donor 
refuses to follow directions).
    This final rule adds paragraph (d) to describe the requirements for 
the actions a collector must take if a refusal to test is determined at 
any point during the specimen collection process.

Section 26.109 Urine Specimen Quantity

    This final rule renames paragraph (b)(1) as introductory text and 
adds new paragraphs (b)(1)(i) through (iii) to provide a licensee or 
other entity with new flexibility in the personnel that may be used to 
monitor a donor during the hydration process that is initiated when a 
donor is unable to provide an acceptable quantity of urine during the 
initial collection attempt (i.e., a shy bladder). For clarity, the last 
sentence of former paragraph (b)(1) becomes the new first sentence of 
paragraph (b)(2).

Section 26.111 Checking the Acceptability of the Urine Specimen

    This final rule revises paragraph (a) to replace the phrase 
``greater than 15 mL'' with the phrase ``equal to or greater than 15 
mL'' and to add the phrase ``(e.g., adulterated or diluted)'' after the 
word ``altered.''
    This final rule revises the second sentence of paragraph (b) to 
replace ``custody-and-control form'' with the phrase ``Federal CCF or 
through another documentation method consistent with the collection 
procedures of the licensee or other entity'' at the end of the existing 
requirement.
    This final rule amends the first sentence of paragraph (c) to 
remove the word ``designated'' from the phrase ``designated FFD program 
manager'', and revises the parenthetical phrase in the third sentence 
to add ``(e.g., adulterated or diluted)'' after the word ``altered''.
    This final rule revises paragraph (e) to include the phrase ``, 
except under the conditions described in Sec.  26.107(d)(4)'' at the 
end of the existing requirement, and removes paragraph (f).

Section 26.115 Collecting a Urine Specimen Under Direct Observation

    This final rule revises paragraph (a)(3) to replace the phase ``The 
collector observes conduct clearly and unequivocally indicating an 
attempt to dilute, substitute, or adulterate the specimen'' with the 
phrase ``The collector, or the hydration monitor if one is used as 
permitted in Sec.  26.109(b)(1), observes conduct by the donor 
indicating an attempt to subvert the testing process.'' Also, this 
final rule removes the word ``and'' at the end of paragraph (a)(3). The 
rule adds paragraph (a)(5) to include an additional instance when an 
observed collection is required: ``The donor requests a retest and 
either Bottle B or the single specimen is not available due to 
circumstances outside of the donor's control, as specified in Sec.  
26.165(f)(2).'' The rule also replaces the period at the end of the 
sentence in paragraph (a)(4) with ``; or'' to accommodate adding a new 
paragraph (a)(5) in the list of exclusive grounds for performing a 
directly observed collection.
    This final rule revises the first sentence of paragraph (f) 
introductory text, ``If someone other than the collector is to observe 
the collection, the collector shall instruct the observer to follow the 
procedures in this paragraph,'' so that it reads ``If the observer is 
not a trained collector, the collector shall, in the presence of the 
donor, instruct the observer on the collection procedures in paragraph 
(f)'', and adds it to the end of the existing requirements in paragraph 
(e).
    This final rule revises paragraph (f)(2) to add the following 
statement to the end of the existing requirement: ``A reflective mirror 
may be used to assist in observing the provision of the specimen only 
if the physical configuration of the room, stall, or private area used 
for urination is not sufficient to meet this direct observation 
requirement; the use of a video camera to assist in the observation 
process is not permitted.''
    This final rule revises paragraph (f)(3) to replace the phrase ``If 
the observer is not the collector, the observer may not take the 
collection container from the donor, but shall observe the specimen as 
the donor takes it to the collector'' with the phrase ``If the observer 
is not the collector, the observer may not touch or handle the 
collection container but shall maintain visual contact with the 
specimen until the donor hands the collection container to the 
collector.''
    This final rule revises paragraph (g) to include the phrase ``, and 
the collector shall follow the procedures in Sec.  26.107(d)'' at the 
end of the existing requirement.

Section 26.117 Preparing Urine Specimens for Storage and Shipping

    This final rule revises the section heading to ``Preparing drug 
testing specimens for storage and shipping.''
    This final rule revises paragraph (a) to replace the phrase ``Both 
the donor and the collector shall keep the donor's urine specimen(s) in 
view'' with the phrase ``Once the collector is presented with the 
specimen from the donor, both the donor and the collector shall keep 
the donor's specimen(s) in view.''
    This final rule revises the first sentence in paragraph (f) to 
replace the term ``chain-of-custody forms'' with the term ``Federal 
CCFs'' and to replace the phrase ``or the licensee's testing 
facility,'' with the phrase ``or to the licensee testing facility.''
    This final rule amends paragraph (g) to add the phrase ``, except 
as provided in Sec.  26.109(b)(1)(ii) for the Federal CCF,'' to the end 
of the first sentence.

[[Page 71449]]

    This final rule amends paragraph (i) to replace the phrase ``urine 
specimen bottle'' with ``specimen bottle.''
    This final rule amends paragraph (j) to replace the word 
``specimens'' with the phrase ``urine specimens'' and the word 
``specimen'' with the phrase ``urine specimen'' in the third sentence 
and to add a new fourth sentence to state that ``Oral fluid specimens 
shall be stored under the conditions specified by the oral fluid 
specimen collection device manufacturer.''

Section 26.129 Assuring Specimen Security, Chain of Custody, and 
Preservation

    This final rule revises paragraph (b)(1)(ii) to replace the phrase 
``the specimen may not be tested,'' with the phrase ``the licensee 
testing facility shall reject the specimen for testing.''
    This final rule revises paragraph (b)(2) introductory text to add 
the phrase ``and report a cancelled test result to the licensee or 
other entity,'' after the phrase ``requiring the MRO to cancel the 
testing of a donor's urine specimen.''

Section 26.133 Cutoff Levels for Drugs and Drug Metabolites

    This final rule revises the introductory text to clarify that the 
specified cutoff level must be used to determine whether the specimen 
is negative or positive for the indicated drugs or drug metabolites 
being tested. The rule also revises the table heading to ``Table 1 to 
Sec.  26.133-Urine, Initial Test Cutoff Levels for Drugs and Drug 
Metabolites'' and the column header ``Drug or metabolites'' to ``Drugs 
or drug metabolites'' to align with the table heading. The rule further 
revises the table to (1) lower the initial test cutoff level for 
cocaine metabolites from 300 ng/mL to 150 ng/mL, (2) replace ``opiate 
metabolites'' with ``codeine/morphine'' and include a new footnote 1 to 
clarify the existing requirement that morphine is the target analyte 
for codeine/morphine testing, (3) add initial testing for hydrocodone 
and hydromorphone at a cutoff level of 300 ng/mL, (4) add initial 
testing for oxycodone and oxymorphone at a cutoff level of 100 ng/mL, 
(5) add the drug class ``Opioids:'' to appear above the listing for 
``codeine/morphine,'' (6) add initial testing for 6-AM at a cutoff 
level of 10 ng/mL, (7) lower the initial test cutoff level for 
amphetamines (abbreviated in the table as AMP) from 1000 ng/mL to 500 
ng/mL, (8) include a new table footnote 2 regarding initial test kits, 
(9) include a new table footnote 3 to clarify that for amphetamines 
testing, methamphetamine (abbreviated in the table as MAMP) is the 
target analyte, (10) add initial testing for MDMA and MDA at a cutoff 
level of 500 ng/mL, and 11) provide the full chemical name for MDMA and 
MDA in new footnotes 4 and 5 to the table, respectively.

Section 26.137 Quality Assurance and Quality Control

    This final revises paragraph (d)(5) to remove the phrase ``that 
appears to be a donor specimen to the licensee testing facility 
technicians.''
    This final rule revises paragraph (e)(6) introductory text to 
replace the phrase ``A minimum of 10 percent of all specimens in each 
analytical run'' at the start of the first sentence with the phrase ``A 
minimum of 10 percent of the total specimens in each analytical run'' 
and adds the parenthetical phrase ``(i.e., calibrators and controls)'' 
after the phrase ``quality control samples.'' The rule also replaces 
the word ``drugs'' in the first sentence and the phrase ``drug and 
metabolite'' in the second sentence with the phrases ``drugs and drug 
metabolites'' and ``drug and drug metabolite,'' respectively.
    This final rule revises paragraph (e)(6)(i) to replace the phrase 
``Sample(s) certified by an HHS-certified laboratory to contain no 
drugs or drug metabolites (i.e., negative urine samples)'' with the 
phrase ``At least one control certified by an HHS-certified laboratory 
to contain no drug or drug metabolite.''
    This final rule revises paragraph (e)(6)(ii) to replace the phrase 
``drug(s) or drug metabolite(s)'' with the phrase ``the drug or drug 
metabolite.''
    This final rule revises paragraph (e)(6)(iii) to replace the phrase 
``the drug(s) or drug metabolite(s) targeted at 25 percent below the 
cutoff'' with the phrase ``the drug or drug metabolite targeted at 75 
percent of the cutoff.''
    This final rule removes paragraph (e)(6)(v).

Section 26.151 Purpose

    This final rule revises the purpose of Subpart G, ``Laboratories 
Certified by the Department of Health and Human Services,'' to read 
``This subpart contains requirements for the HHS-certified laboratories 
that licensees and other entities use to perform testing under this 
part.''

Section 26.153 Using Certified Laboratories for Testing Urine Specimens

    This final rule revises the section heading to read ``Using 
certified laboratories for testing specimens.''
    This final rule revises paragraph (a) to replace the phrase 
``laboratories certified under the Department of Health and Human 
Services (HHS) Mandatory Guidelines for Federal Workplace Drug Testing 
Programs [published in the Federal Register on April 11, 1988 (53 FR 
11970), and as amended, June 9, 1994 (59 FR 29908), November 13, 1998 
(63 FR 63483), and April 13, 2004 (69 FR 19643)]'' with the phrase 
``HHS-certified laboratories as defined in Sec.  26.5.'' The rule also 
removes the sentence ``Information concerning the current certification 
status of laboratories is available from the Division of Workplace 
Programs, Center for Substance Abuse Prevention, Substance Abuse and 
Mental Health Services Administration, Room 815, 5600 Fishers Lane, 
Rockwall 2 Bldg., Rockville, Maryland 20857.''
    This final rule revises paragraph (g) to replace the term ``Federal 
custody-and-control form'' with ``Federal CCF'' and the term ``non-
Federal form'' with ``non-Federal CCF.''

Section 26.155 Laboratory Personnel

    This final rule removes and reserves Sec.  26.155.

Section 26.157 Procedures

    This final rule revises paragraph (a) to replace the phrase ``clear 
and well-documented procedures for'' with the phrase ``procedures 
specific to this part that document the'' and to remove ``urine'' in 
the phrase ``testing of urine specimens.''
    This final rule removes and reserves paragraph (b) and removes 
paragraphs (c) through (e).

Section 26.159 Assuring Specimen Security, Chain of Custody, and 
Preservation

    This final rule revises paragraph (b)(1)(ii) to replace the phrase 
``the specimens may not be tested and the licensee or entity shall'' 
with the phrase ``the laboratory shall reject the specimens for 
testing. The licensee or other entity shall.''
    This final rule revises paragraph (b)(2) introductory text to add 
after ``The following are exclusive grounds requiring the MRO to cancel 
the testing of a donor's urine specimen,'' the phrase ``and report a 
cancelled test to the licensee or other entity.''
    This final rule revises the second sentence of paragraph (c) to 
replace the term ``custody-and-control'' with the term ``chain of 
custody.''
    This final rule revises paragraph (d) to replace the term 
``custody-and-control'' with the term ``chain of custody.''
    This final rule revises paragraph (e) to replace the term 
``custody-and-control'' with the term ``chain of custody'' in the two 
instances that it occurs in the paragraph.

[[Page 71450]]

Section 26.161 Cutoff Levels for Validity Testing

    This final rule amends paragraph (b) introductory text to replace 
the phrase ``Initial validity testing'' with the phrase ``Initial 
validity testing of urine.''
    This final rule amends paragraphs (c)(3) through (6) to replace all 
instances of ``LOD'' with ``LOQ.''
    This final rule revises paragraph (c)(5) to replace the phrase 
``GC/MS for the confirmatory test'' with the phrase ``a different 
confirmatory method (e.g., gas chromatography/mass spectrometry (GC/
MS)).''
    This final rule revises paragraph (c)(6) to replace the phrase 
``GC/MS for the confirmatory test'' with the phrase ``a different 
confirmatory method (e.g., GC/MS).''
    This final rule amends paragraph (d) to replace the phrase 
``Results indicating a substituted specimen,'' with the phrase 
``Results indicating a substituted urine specimen.''
    This final rule amends paragraph (e) to replace the phrase 
``Results indicating a dilute specimen,'' with the phrase ``Results 
indicating a dilute urine specimen.''
    This final rule amends paragraphs (f)(5) and (7) to replace all 
instances of the term ``LOD'' with the term ``LOQ.''
    This final rule revises the first sentence of paragraph (h) to 
replace ``More stringent validity test cutoff levels are prohibited'' 
with ``Validity test cutoff levels.'' The final rule also revises the 
second sentence to replace the phrase ``may not specify more stringent 
cutoff levels'' with ``may use more stringent cutoff levels'', and the 
phrase ``only if testing is performed at an HHS-certified laboratory'' 
is added to the end of the sentence.

Section 26.163 Cutoff Levels for Drug and Drug Metabolites

    This final rule revises paragraph (a)(1) introductory text to 
replace the phrase ``negative for the indicated drugs and drug 
metabolites'' with the phrase ``negative or positive for the indicated 
drugs and drug metabolites'' and revise the phrase ``except if validity 
testing indicates that the specimen is dilute'' to read ``except as 
specified in paragraph (a)(2) of this section.''
    This final rule revises the table heading in paragraph (a)(1) to 
``Table 1 to paragraph (a)(1)-Urine, Initial Test Cutoff Levels for 
Drugs and Drug Metabolites'' and the column header ``Drug or 
metabolites'' in Table 1 to ``Drugs or drug metabolites'' to align with 
the table heading. This final rule further revises the initial test 
cutoff level table for urine testing to (1) lower the initial test 
cutoff level for cocaine metabolites from 300 ng/mL to 150 ng/mL, (2) 
replace ``opiate metabolites'' with ``codeine/morphine'' and include a 
new footnote 1 to clarify the existing requirement that morphine is the 
target analyte for codeine/morphine testing, (3) add initial testing 
for hydrocodone and hydromorphone at a cutoff level of 300 ng/mL, (4) 
add initial testing for oxycodone and oxymorphone at a cutoff level of 
100 ng/mL, (5) add the drug class ``Opioids:'' to appear above the 
listing for ``codeine/morphine,'' (6) add initial testing for 6-AM at a 
cutoff level of 10 ng/mL, (7) lower the initial test cutoff level for 
amphetamines (abbreviated in the table as AMP) from 1000 ng/mL to 500 
ng/mL, (8) include a new footnote 2 regarding initial test kits, (9) 
include a new footnote 3 to clarify that for amphetamines testing, 
methamphetamine (abbreviated in the table as MAMP) is the target 
analyte, (10) add initial testing for MDMA and MDA at a cutoff level of 
500 ng/mL, and (11) provide the full chemical names for MDMA and MDA in 
new footnotes 4 and 5 to the table, respectively.
    This final rule adds a second table to paragraph (a)(1) titled 
``Table 2 to paragraph (a)(1)-Oral Fluid, Initial Test Cutoff Levels 
for Drugs and Drug Metabolites.'' Table 2 lists each drug and drug 
metabolite and the cutoff level for initial testing of oral fluid 
specimens. The table includes the following substances and associated 
cutoff levels in nanograms (ng) per milliliter (mL): (1) ``marijuana 
(THC)'' at 4 ng/mL; (2) ``cocaine/benzoylecgonine'' at 15 ng/mL; (3) 
the drug class ``opioids'' is listed; (4) ``codeine/morphine'' at 30 
ng/mL; (5) ``hydrocodone/hydromorphone'' at 30 ng/mL; (6) ``oxycodone/
oxymorphone'' at 30 ng/mL; (7) ``6-acetylmorphone (6-AM)'' at 4 ng/mL, 
(8) ``phencyclidine (PCP)'' at 10 ng/mL; (9) the drug class 
``amphetamines'' is listed; (10) ``AMP/MAMP'' at 50 ng/mL; and (11) 
``MDMA/MDA'' at 50 ng/mL. The table includes five footnotes. Footnote 1 
is for column header ``Cutoff level [nanograms (ng/mL)]'' and describes 
the requirements for grouped analytes testing. Footnote 2 is for the 
substance ``marijuana (THC)'' and describes the target analyte for this 
testing. Footnote 3 is assigned to the cutoff level for 6-
acetylmorphine and describes the alternate technology testing 
requirements. Footnote 4 presents the full chemical names for AMP 
(amphetamine) and (MAMP) methamphetamine because the table includes the 
acronyms for clarity of presentation. Footnote 5 presents the full 
chemical names for MDMA (methylenedioxymethamphetamine) and MDA 
(methylenedioxyamphetamine) because the table includes the acronyms for 
clarity of presentation.
    This final rule revises paragraph (a)(2) introductory text to 
remove the phrase ``At the licensee's or other entity's discretion, as 
documented in the FFD program policies and procedures, the licensee or 
other entity may require the HHS-certified laboratory to conduct 
special analyses of dilute specimens'' and replace it with the phrase 
``HHS-certified laboratories shall conduct special analyses of 
specimens.''
    This final rule revises paragraph (a)(2)(i) to add the phrase ``, 
or if a specimen is collected under direct observation for any of the 
conditions specified in Sec.  26.115(a)(1) through (3) or (a)(5),'' 
after the phrase ``If initial validity testing indicates that a 
specimen is dilute.'' The rule also revises paragraph (a)(2)(i) to 
replace the phrase ``the HHS-certified laboratory shall compare the 
responses of the dilute specimen to the cutoff calibrator in each of 
the drug classes'' with the phrase ``the laboratory shall compare the 
immunoassay responses of the specimen to the cutoff calibrator in each 
drug class tested.''
    This final rule revises paragraph (a)(2)(ii) to state ``If any 
immunoassay response is equal to or greater than 40 percent of the 
cutoff calibrator, the laboratory shall conduct confirmatory drug 
testing of the specimen to the LOQ for those drugs and/or drug 
metabolites; and.''
    This final rule revises paragraph (b)(1) introductory text to 
replace the phrase ``except if the licensee or other entity requires 
the special analysis of dilute specimens as permitted in paragraph 
(a)(2)'' with the phrase ``except as permitted in paragraph (a)(2).''
    This final rule revises the table heading in paragraph (b)(1) to 
read ``Table 3 to paragraph (b)(1)-Urine, Confirmatory Test Cutoff 
Levels for Drugs and Drug Metabolites'' and the column header ``Drug or 
metabolites'' in the initial test cutoff level table for urine testing 
to read ``Drugs or drug metabolites.'' The final rule further revises 
the initial test cutoff level table for urine testing to (1) lower the 
confirmatory test cutoff level for cocaine metabolite from 150 ng/mL to 
100 ng/mL, (2) revise ``Opiates'' to read ``Opioids,'' (3) add 
confirmatory testing for hydrocodone, hydromorphone, oxycodone, and 
oxymorphone at a cutoff level of 100 ng/mL, (4) remove footnote 3 
regarding the requirement that confirmatory testing of 6-AM only 
proceed when confirmatory testing

[[Page 71451]]

shows a morphine concentration exceeding 2000 ng/mL, (5) lower the 
confirmatory test cutoff levels for amphetamine and methamphetamine 
from 500 ng/mL to 250 ng/mL, (6) redesignate footnote 4 as footnote 3 
and revise the text to lower the concentration of amphetamine that must 
be present in the specimen from 200 ng/mL to 100 ng/mL, and (7) add 
confirmatory testing for MDMA and MDA at a cutoff level of 250 ng/mL.
    This final rule adds another new table to paragraph (b)(1) titled 
``Table 4 to paragraph (b)(1)-Oral Fluid, Confirmatory Test Cutoff 
Levels for Drugs and Drug Metabolites.'' Table 4 lists each drug and 
drug metabolite and the cutoff level for confirmatory testing of the 
substance in oral fluid. The table includes the following substances 
and associated cutoff levels in ng/mL: (1) ``marijuana (THC)'' at 2 ng/
mL; (2) ``cocaine'' and ``benzoylecgonine'' each at 8 ng/mL; (3) the 
drug class ``opioids'' is listed; (4) ``codeine'' and ``morphine'' each 
at 15 ng/mL; (5) ``hydrocodone,'' ``hydromorphone,'' ``oxycodone,'' and 
``oxymorphone'' each at 15 ng/mL; (6) 6-acetylmorphone (6-AM) at 2 ng/
mL, (7) ``phencyclidine (PCP)'' at 10 ng/mL; (8) the drug class 
``amphetamines'' is listed; and (9) ``amphetamine,'' 
``methamphetamine,'' ``MDMA,'' and ``MDA'' each at 25 ng/mL.

Section 26.165 Testing Split Specimens and Retesting Single Specimens

    This final rule adds a new fifth sentence to paragraph (b)(2) that 
states, ``The MRO shall document in his or her records when (i.e., date 
and time) the request was received from the donor to retest an aliquot 
of the single specimen or to test the Bottle B split specimen.''
    This final rule deletes the first sentence in paragraph (b)(3) and 
revises the second sentence to state ``No entity, other than the MRO as 
permitted in Sec.  26.185(l), may order the retesting of an aliquot of 
the single specimen or the testing of the Bottle B split specimen.''
    This final rule revises the last sentence in paragraph (f)(1) 
introductory text by adding the phrase ``the MRO shall report a 
cancelled test result to the licensee or other entity, and'' to 
indicate that the MRO must report the cancelled test.
    This final rule revises paragraph (f)(2) to add: (1) instruction 
for the MRO to ``report a cancelled test result to the licensee or 
other entity for the donor's specimen''; (2) instruction for the 
licensee or other entity that ``the donor shall receive no notice of 
the collection requirement before he or she is instructed to proceed to 
the collection site''; (3) that the ``licensee or other entity shall 
continue to administratively withdraw the individual's authorization, 
as required by Sec.  26.165(f)(1) until the results of the second 
collection have been received by the MRO''; and (4) a reference to 
Sec. Sec.  26.129(b)(2) and 26.159(b)(2), which describes the 
circumstances that require the MRO to cancel a test result.

Section 26.167 Quality Assurance and Quality Control

    This final rule amends paragraph (c) to replace the phrase 
``validity tests'' with ``validity tests on urine.''
    This final rule amends paragraph (d)(1) to replace the phrase ``Any 
initial drug test performed by an HHS-certified laboratory'' with ``Any 
initial drug test of urine performed by an HHS-certified laboratory.''
    This final rule revises paragraph (d)(3)(i) to replace the phrase 
``Sample(s) certified to contain no drugs or drug metabolites (i.e., 
negative urine samples)'' with the phrase ``At least one control 
certified to contain no drug or drug metabolite.''
    This final rule revises paragraph (d)(3)(ii) to replace the phrase 
``a drug(s) or drug metabolite(s)'' with the phrase ``the drug or drug 
metabolite.''
    This final rule revises paragraph (d)(3)(iii) to replace the phrase 
``a drug(s) or drug metabolite(s) targeted at 25 percent below the 
cutoff'' with the phrase ``the drug or drug metabolite targeted at 75 
percent of the cutoff.''
    This final rule revises paragraph (d)(4) to add the parenthetical 
statement ``(i.e., calibrators and controls)'' after the phrase 
``quality control samples.''
    This final rule revises paragraph (e)(2) to replace the phrase ``At 
least 10 percent of the samples in each analytical run of specimens 
must be calibrators and controls'' with the phrase ``A minimum of 10 
percent of the total specimens in each analytical run must be quality 
control samples (i.e., calibrators and controls).''
    This final rule revises paragraph (e)(3)(i) to replace the phrase 
``Sample(s) certified to contain no drug (i.e., negative urine 
samples)'' with the phrase ``At least one control certified to contain 
no drug or drug metabolite.''
    This final rule revises paragraph (e)(3)(ii) to replace the phrase 
``Positive calibrator(s) and control(s) with a drug(s) or drug 
metabolite(s)'' with the phrase ``A calibrator with its drug 
concentration at the cutoff.''
    This final rule revises paragraph (e)(3)(iii) to replace the phrase 
``a drug(s) or drug metabolite(s)'' with the phrase ``the drug or drug 
metabolite.''
    This final rule revises paragraph (e)(3)(iv) to replace the phrase 
``At least one calibrator or control that is targeted'' with the phrase 
``At least one control targeted.''
    This final rule amends paragraph (f)(3) to correct the 
capitalization of the ``r'' and the ``p'' in the position title in the 
phrase ``the laboratory's responsible person'' to ``Responsible 
Person.''

Section 26.168 Blind Performance Testing

    This final rule revises paragraph (h)(1) to remove the phrase ``, 
and for no more than 6 months'' from this requirement.

Section 26.169 Reporting Results

    This final rule amends paragraph (a) to correct the capitalization 
of the ``c'' and the ``s'' in the position title in the phrase ``the 
laboratory's certifying scientist'' to ``Certifying Scientist.''
    This final rule amends paragraph (c)(2) to remove the word 
``opiate'' from the phrase ``confirmatory opiate test results for 
morphine or codeine.''
    This final rule amends paragraph (h) introductory text to remove 
the word ``urinalysis'' from the phrase ``annual statistical summary of 
urinalysis testing.''
    This final rule also makes conforming changes to the names of the 
drugs and drug metabolites listed in paragraph (h)(3) to include adding 
``(as THCA)'' after ``Marijuana metabolite'' in paragraph (h)(3)(i); 
adding ``(as benzoylecgonine)'' after ``Cocaine metabolite'' in 
paragraph (h)(3)(ii); revising ``Opiates (total)'' to ``Opioids 
(total)'' in paragraph (h)(3)(iii) introductory text; removing ``and'' 
in paragraph (h)(3)(iii)(B); revising 6-AM to ``6-acetylmorphine (6-
AM)'' in paragraph (h)(3)(iii)(C); adding new paragraphs (h)(3)(iii)(D) 
through (G) to add hydrocodone, hydromorphone, oxycodone, and 
oxymorphone to the list of opioid test results; and revising 
``Phencyclidine'' to ``Phencyclidine (PCP)'' in paragraph (h)(3)(iv).
    This final rule revises paragraph (h)(3)(v) to add new paragraphs 
(h)(3)(v)(C) and (D) to add ``Methylenedioxymethamphetamine (MDMA) and 
``Methylenedioxyamphetamine (MDA)'' to the list of amphetamines test 
results.

Section 26.183 Medical Review Officer

    This final rule revises paragraphs (c) introductory text, (c)(1), 
and (d)(2)(ii) to remove the phrase ``at the licensee's or other 
entity's discretion.''

[[Page 71452]]

Section 26.185 Determining a Fitness-for-Duty Policy Violation

    This final rule redesignates paragraph (f)(3) as paragraph (f)(4) 
and adds a new paragraph (f)(3) to state that if the MRO and the 
laboratory agree that further testing would not be useful and there is 
no legitimate technical or medical explanation for an invalid urine 
specimen test result based on a pH result in the range of 9.0 to 9.5, 
the MRO shall consider whether there is evidence of elapsed time, 
exposure of the specimen to high temperature, or both that could 
account for the pH value. If the MRO obtains objective and sufficient 
information regarding elapsed time, temperature conditions, or both to 
conclude that an acceptable explanation exists for the invalid test 
result due to pH, the MRO would direct the licensee or other entity to 
collect a second urine specimen from the donor as soon as reasonably 
practicable. This second specimen may not be collected from the donor 
under direct observation conditions.
    This final rule amends paragraph (g)(1) to replace the phrase 
``paragraph (g)(4)'' with the phrase ``paragraph (g)(3).''
    This final rule revises paragraph (g)(2) introductory text to 
replace the phrase ``If the licensee or other entity requires the HHS-
certified laboratory to conduct the special analysis of dilute 
specimens permitted by Sec.  26.163(a)(2), the results of the special 
analysis are positive,'' with the phrase ``If the results of the 
special analysis testing required by Sec.  26.163(a)(2) are positive.'' 
The rule also revises paragraph (g)(2) to replace the phrase ``under 
paragraph (g)(4)'' with the phrase ``under paragraph (g)(3).''
    This final rule revises paragraph (g)(2)(iii) to remove the phrase 
``clearly and unequivocally.''
    This final rule removes paragraph (g)(3).
    This final rule redesignates paragraphs (g)(4) and (5) as 
paragraphs (g)(3) and (4), respectively. The rule amends newly 
redesignated paragraph (g)(3) to replace the phrase ``any opium, 
opiate, or opium derivative (e.g., morphine and/or codeine)'' with 
``opioids (i.e., morphine and/or codeine).''
    This final rule revises paragraph (j) introductory text to replace 
``opiates'' with ``opioids'' and to correct an editorial error in the 
first sentence.
    This final rule revises the first sentence of paragraph (j)(1) to 
replace ``opiates'' with ``opioids (i.e., morphine and/or codeine)'', 
and to replace the phrase ``opium, an opiate, or an opium derivative 
(e.g., morphine/codeine)'' with ``morphine and/or codeine.''
    This final rule amends paragraph (j)(2) to replace ``opiates'' with 
``opioids''.
    This final rule amends paragraph (j)(3) to replace ``opiates'' with 
``opioids (i.e., morphine and/or codeine).''
    This final rule amends paragraph (j)(4) to replace ``opiates'' with 
``opioids.''

Section 26.405 Drug and Alcohol Testing

    This final rule revises paragraph (d) to add hydrocodone, 
hydromorphone, MDMA, MDA, oxycodone, and oxymorphone as substances for 
which licensees and other entities are required to test in each 
specimen. The term ``opiates'' is also replaced with the term 
``opioids.''
    The rule also removes the term ``adulterants'' from the first 
sentence in paragraph (d), which describes the substances that 
licensees and other entities must test for in specimens. Instead, the 
final rule revises the second sentence ``Urine specimens collected for 
drug testing must be subject to validity testing'' to ``Urine specimens 
collected for drug testing must be subject to validity testing that 
includes testing for adulterants.''

Section 26.415 Audits

    This final rule amends paragraph (c) to eliminate the phrase ``(65 
FR 41944; August 9, 2001).''

Section 26.715 Recordkeeping Requirements for Collection Sites, 
Licensee Testing Facilities, and Laboratories Certified by the 
Department of Health and Human Services

    This final rule amends paragraph (b)(1) to replace the phrase 
``collection site, licensee testing facility, or HHS-certified 
laboratory'' with the phrase ``collection site or licensee testing 
facility.''

Section 26.717 Fitness-for-Duty Program Performance Data

    This final rule revises paragraph (b)(3) to replace the phrase 
``(i.e., individuals in applicant status, permanent licensee employees, 
C/Vs),'' with the phrase ``(i.e., licensee and other entity employees, 
C/Vs).''
    This final rule revises paragraph (b)(4) to replace the phrase 
``(i.e., individuals in applicant status, permanent licensee employees, 
C/Vs),'' with the phrase ``(i.e., licensee and other entity employees, 
C/Vs).''

IV. Regulatory Flexibility Certification

    Under the Regulatory Flexibility Act (5 U.S.C. 605(b)), the NRC 
certifies that this rule will not have a significant economic impact on 
a substantial number of small entities. This final rule affects the 
licensing and operation of nuclear power plants and Category I fuel 
cycle facilities. The companies that own these facilities do not fall 
within the scope of the definition of ``small entities'' set forth in 
the Regulatory Flexibility Act or the size standards established by the 
NRC (Sec.  2.810).
    The NRC estimates that none of the 59 entities affected by the rule 
fall within the scope of the definition of ``small entities'' set forth 
in the Regulatory Flexibility Act or the size standards established by 
the NRC (Sec.  2.810). Therefore, the rule does not impact a 
substantial number of small entities.
    The NRC requested comment on the proposed rule and accompanying 
regulatory analysis on the impact of the proposed rule on small 
entities. The NRC received no comment submissions from an identified 
small entity.

V. Regulatory Analysis

    The NRC has prepared a regulatory analysis on this regulation. The 
analysis examines the costs and benefits of the alternatives considered 
by the NRC. The regulatory analysis is available as indicated in the 
``Availability of Documents'' section of this document.

VI. Backfitting and Issue Finality

    The Commission has completed a backfitting and issue finality 
assessment for this final rule under Sec. Sec.  50.109, 
``Backfitting,'' 52.98, ``Finality of combined licenses; information 
requests,'' and 70.76, ``Backfitting.'' This final rule constitutes 
backfitting for current holders of operating licenses and construction 
permits for power reactors under 10 CFR part 50, ``Domestic licensing 
of production and utilization facilities,'' and renewed licenses under 
10 CFR part 54, ``Requirements for renewal of operating licenses for 
nuclear power plants,'' and under Sec.  70.76(a)(1) for applicable 
current 10 CFR part 70 licensees. This final rule affects the issue 
finality accorded to current holders of combined licenses under Sec.  
52.98. This final rule is being imposed as a cost-justified substantial 
increase in the overall protection of the public health and safety or 
common defense and security. The bases for this determination are 
presented in the backfit and issue finality assessment, which is 
available as indicated in the ``Availability of Documents'' section of 
this document.

[[Page 71453]]

Regulatory Guidance

    As explained in Regulatory Guide (RG) 5.89, ``Fitness-for-Duty 
Programs for Commercial Power Reactor and Category I Special Nuclear 
Material Licensees,'' applicants and licensees are not required to 
comply with the positions set forth in RG 5.89. Therefore, issuance of 
RG 5.89 does not constitute backfitting, as that term is defined in 
Sec.  50.109 and as described in NRC Management Directive 8.4, 
``Management of Backfitting, Forward Fitting, Issue Finality, and 
Information Requests,'' or affect the issue finality of any approval 
issued under 10 CFR part 52.

VII. Cumulative Effects of Regulation

    Cumulative Effects of Regulation (CER) consists of the challenges 
licensees may face in addressing the implementation of new regulatory 
positions, programs, and requirements (e.g., rulemaking, guidance, 
generic letters, backfits, inspections). The CER may manifest in 
several ways, including the total burden imposed on licensees by the 
NRC from simultaneous or consecutive regulatory actions that can 
adversely affect the licensee's capability to implement those 
requirements, while continuing to operate or construct its facility in 
a safe and secure manner.
    The goals of the NRC's CER effort were met throughout the 
development of this final rule. The NRC engaged external stakeholders 
at public meetings and by soliciting public comments on the proposed 
rule and associated draft guidance document. The proposed rule and 
draft guidance (84 FR 48750) were issued on September 16, 2019, for 
public comment. A public meeting was held on November 7, 2019, to 
discuss the proposed rule and draft guidance. A public meeting on 
implementation was held on April 13, 2021. Summaries of both meetings 
are available in ADAMS, as provided in the ``Availability of 
Documents'' section of this document. The feedback from the April 13, 
2021, public meeting informed the NRC's final rule implementation 
schedule.
    Based upon input from the public and affected licensees, the NRC 
has established a compliance deadline for the requirements in this 
final rule of 1 year from the date of publication of this final rule in 
the Federal Register. See the DATES section of this document.

VIII. Plain Writing

    The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal 
agencies to write documents in a clear, concise, and well-organized 
manner. The NRC has written this document to be consistent with the 
Plain Writing Act as well as the Presidential Memorandum, ``Plain 
Language in Government Writing,'' published June 10, 1998 (63 FR 
31885).

IX. Environmental Impact: Categorical Exclusion

    The NRC has determined that this final rule is the type of action 
described under Sec.  51.22(c)(1). Therefore, neither an environmental 
impact statement nor an environmental assessment has been prepared for 
this final rule.

X. Paperwork Reduction Act Statement

    This final rule contains new or amended collections of information 
subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq). 
The collections of information were approved by the Office of 
Management and Budget (OMB), control number 3150-0146.
    The burden to the public for the information collections is 
estimated to average 0.8 hours per response for information collection 
requirements contained in 10 CFR part 26, including the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining data needed, and completing and reviewing the information 
collections.
    The information collection contained in 10 CFR part 26 is impacted 
by the revision of existing and addition of new requirements to align 
the NRC's drug testing requirements more closely with updates made to 
the HHS Guidelines. The NRC updated the drug testing panel and lowered 
the testing cutoff levels for some drugs tested, which impacts the 
existing information collections contained in 10 CFR part 26, because 
additional individuals will likely test positive for drugs. Additional 
positive test results will increase the costs associated with the 
recordkeeping and reporting requirements applicable to licensees and 
other entities. In addition, the NRC is including new information 
collection requirements in Sec. Sec.  26.107(d), 26.157(a), 
26.165(b)(2), 26.165(f)(1) and 26.185(f)(3). This information will be 
used by the NRC to uniformly address subversion attempts identified at 
the collection site (Sec.  26.107(d)), clarify that HHS-certified 
laboratories are to maintain testing procedures specific to 10 CFR part 
26 (Sec.  26.157(a)), permit the MRO to initiate retesting of a donor 
specimen upon receiving an oral request from the donor and maintaining 
a record of receiving that request (Sec.  26.165(b)(2)), document the 
existing process that the MRO is to report a cancelled test result to 
the licensee or other entity if the results of specimen retesting fail 
to confirm the test results from the initial laboratory (Sec.  
26.165(f)(1)), and establish procedures to review invalid specimen test 
results due to high pH values (Sec.  26.165(f)(3)). In addition, the 
NRC updated NRC Form 890, ``Single Positive Test Form,'' and NRC Form 
891, ``Annual Reporting Form for Drug and Alcohol Tests,'' to reflect 
the requirements of this final rule. Confidential and proprietary 
information submitted to the NRC is protected in accordance with NRC 
regulations at Sec. Sec.  9.17(a) and 2.390(b).
    You may submit comments on any aspect of the information 
collections, including suggestions for reducing the burden, by the 
following methods:
     Federal rulemaking website: Go to https://www.regulations.gov and search for Docket ID NRC-2009-0225.
     Mail comments to: FOIA, Library, and Information 
Collections Branch, Office of the Chief Information Officer, Mail Stop: 
T6-A10M, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, 
or by email to [email protected], and to the OMB reviewer 
at: OMB Office of Information and Regulatory Affairs (3150-0146), Attn: 
Desk Officer for the Nuclear Regulatory Commission, 725 17th Street, NW 
Washington, DC 20503; email: [email protected].

Public Protection Notification

    The NRC may not conduct or sponsor, and a person is not required to 
respond to, a request for information unless the document requesting or 
requiring the collection displays a currently valid OMB control number.

XI. Congressional Review Act

    This final rule is a rule as defined in the Congressional Review 
Act (5 U.S.C 801-808). However, the Office of Management and Budget has 
not found it to be a major rule as defined in the Congressional Review 
Act.

XII. Criminal Penalties

    For the purposes of Section 223 of the Atomic Energy Act of 1954, 
as amended (AEA), the NRC is issuing this final rule that will amend 
Sec. Sec.  26.4, 26.31, 26.83, 26.85, 26.87, 26.89, 26.97, 26.105, 
26.107, 26.109, 26.111, 26.115, 26.117, 26.129, 26.133, 26.137, 26.153, 
26.155, 26.157, 26.159, 26.161, 26.163, 26.165, 26.167, 26.168, 26.169, 
26.183, 26.185, 26.405, 26.415, 26.717 under one or more of Sections 
161b, 161i, or 161o of the AEA. Willful violations of the rule would be 
subject to criminal enforcement. Criminal penalties as they apply to 
regulations in 10 CFR part 26 are discussed in Sec.  26.825, ``Criminal 
penalties.''

[[Page 71454]]

XIII. Compatibility of Agreement State Regulations

    Under the ``Agreement State Program Policy Statement'' approved by 
the Commission on October 2, 2017, and published in the Federal 
Register (82 FR 48535; October 18, 2017), this rule is classified as 
compatibility ``NRC.'' Compatibility is not required for Category 
``NRC'' regulations. The NRC program elements in this category are 
those that relate directly to areas of regulation reserved to the NRC 
by the AEA or the provisions of 10 CFR, and although an Agreement State 
may not adopt program elements reserved to the NRC, it may wish to 
inform its licensees of certain requirements via a mechanism that is 
consistent with the particular State's administrative procedure laws 
but does not confer regulatory authority on the State.

XIV. Voluntary Consensus Standards

    The National Technology Transfer and Advancement Act of 1995, 
Public Law 104-113, requires that Federal agencies use technical 
standards that are developed or adopted by voluntary consensus 
standards bodies unless the use of such a standard is inconsistent with 
applicable law or otherwise impractical. In this final rule, the NRC 
updated and enhanced the consistency of 10 CFR part 26 with the HHS 
Guidelines; improving the effectiveness and efficiency of FFD programs 
with regard to drug testing; and improving clarity in the organization 
and language of the rule. This action does not constitute the 
establishment of a voluntary consensus standard that contains generally 
applicable requirements.

XV. Availability of Guidance

    The NRC is issuing new guidance, Regulatory Guide 5.89, ``Fitness-
for-Duty Programs for Commercial Power Reactor and Category I Special 
Nuclear Material Licensees,'' to support the implementation of the 
requirements in this final rule. New RG 5.89 is publicly available in 
ADAMS under Accession No. ML20143A034. Information and public comment 
submissions related to the guidance can be accessed by searching on the 
Federal e-Rulemaking website, https://www.regulations.gov, under Docket 
ID NRC-2009-0225. The associated draft regulatory guide (DG-5040) was 
published for public comment in conjunction with the proposed rule. The 
final guidance reflects public comments received on the draft 
regulatory guide. The NRC's response to the public comments on this 
guidance is available in ADAMS, as provided in the ``Availability of 
Documents'' section of this document.
    Regulatory Guide 5.89 describes methods that the NRC considers 
acceptable for complying with some of the changes in this final rule. 
For example, guidance is provided concerning monitoring of a donor 
during the 3-hour hydration period, use of reflective mirrors for 
directly observed collections, use of a same-gender observer other than 
the collector during a directly observed collection, and MRO review of 
invalid test results due to high pH.

XVI. Availability of Documents

    The documents identified in the following table are available to 
interested persons through one or more of the following methods, as 
indicated.

------------------------------------------------------------------------
                                           ADAMS accession No./Federal
               Document                         Register citation
------------------------------------------------------------------------
1988 HHS Guidelines--Final Guidelines   53 FR 11970
 (April 11, 1988).
1994 HHS Guidelines--Revised Mandatory  59 FR 29908
 Guidelines (June 9, 1994).
1998 HHS Guidelines--Revised Mandatory  63 FR 63483
 Guidelines (November 13, 1998).
2004 HHS Guidelines--Notice of          69 FR 19673
 Proposed Revisions to Mandatory
 Guidelines (April 13, 2004).
2004 HHS Guidelines--Revised Mandatory  69 FR 19643
 Guidelines (April 13, 2004).
2008 HHS Guidelines--Revised Mandatory  73 FR 71858
 Guidelines (November 25, 2008).
2008 HHS Guidelines--Revised Mandatory  73 FR 75122
 Guidelines, Correction of Effective
 Date (December 10, 2008).
2008 HHS Guidelines--Revised Mandatory  75 FR 22809
 Guidelines, Change in Effective Date
 (April 30, 2010).
2015 HHS Guidelines--Notice of          80 FR 28101
 Proposed Revisions to Mandatory
 Guidelines (May 15, 2015).
2017 HHS Guidelines--Revised Mandatory  82 FR 7920
 Guidelines (January 23, 2017).
HHS ``Medical Review Officer Manual     ML21119A058
 for Federal Workplace Drug Testing
 Programs,'' effective October 1,
 2017, revised March 2018.
2019 HHS Guidelines--Issuance of        84 FR 57554
 Mandatory Guidelines for Federal
 Workplace Drug Testing Programs--Oral/
 Fluid (October 25, 2019).
2019 NRC 10 CFR Part 26 Proposed Rule   84 FR 48750
 (September 16, 2019).
1989 NRC 10 CFR Part 26 Final Rule      54 FR 24468
 (June 7, 1989).
1993 NRC 10 CFR Part 26 Final Rule      58 FR 31467
 (June 3, 1993).
2008 NRC 10 CFR Part 26 Final Rule      73 FR 16966
 (March 31, 2008).
2009 NRC 10 CFR Part 26 Final Rule,     74 FR 38326
 Correcting Amendment (August 3, 2009).
Policy Statement on Adequacy and        62 FR 46517
 Compatibility of Agreement State
 Programs (September 3, 1997).
Presidential Memorandum, ``Plain        63 FR 31885
 Language in Government Writing''
 (June 10, 1998).
2001 DOT 49 CFR Part 40 Final Rule,     66 FR 41944
 Procedures for Transportation
 Workplace Drug and Alcohol Testing
 Programs, Technical Amendments
 (August 9, 2001).
2010 DOT 49 CFR Part 40 Final Rule,     75 FR 49850
 Procedures for Transportation
 Workplace Drug and Alcohol Testing
 Programs (August 16, 2010).
2017 DOT 49 CFR Part 40 Final Rule,     82 FR 52229
 Procedures for Transportation
 Workplace Drug and Alcohol Testing
 Program: Addition of Certain Schedule
 II Drugs to the Department of
 Transportation's Drug-Testing Panel
 and Certain Minor Amendments
 (November 13, 2017).
Commission Policy Statement on Fitness  51 FR 27921
 for Duty of Nuclear Power Plant
 Personnel (August 4, 1986).
Cook J.D., Strauss K.A., Caplan Y.H.,   https://academic.oup.com/jat/
 LoDico C.P., and Bush D.M. (2007),      article/31/8/486/757830
 ``Urine pH: The Effects of Time and
 Temperature After Collection,''
 Journal of Analytical Toxicology,
 Vol. 31, 486-496.
Executive Order 12564, Drug-free        51 FR 32889
 Federal Workplace (September 17,
 1986).
Key Substance Use and Mental Health     ML21166A009
 Indicators in the United States:
 Results from the 2019 National Survey
 on Drug Use and Health (NSDUH)
 (September 2020), HHS Publication
 Number PEP20-07-01-001.
NRC Draft Regulatory Guide DG-5040,     ML19116A077
 ``Urine Specimen Collection and Test
 Result Review under 10 CFR Part 26,
 `Fitness for Duty Programs' ''
 (August 2019).

[[Page 71455]]

 
NRC Enforcement Guidance Memorandum--   ML090760728
 Dispositioning Violations of NRC
 Requirements for Initial Validity and
 Drug Tests at Licensee Testing
 Facilities (EGM-09-003) (March 31,
 2009).
NRC Management Directive 8.4,           ML18093B087
 ``Management of Backfitting, Forward
 Fitting, Issue Finality, and
 Information Requests'' (September 20,
 2019).
NRC Backfitting and Issue Finality      ML22133A046
 Assessment for the 10 CFR Part 26
 Fitness for Duty Drug Testing
 Requirements Final Rule (November
 2022).
NRC Public Meeting Summary and Meeting  ML112930153
 Materials (October 11, 2011).
NRC Public Meeting Summary (November    ML19336A003
 7, 2019).
NRC Public Meeting Summary (April 13,   ML21096A015
 2021).
NRC Regulatory Analysis for the 10 CFR  ML22133A044
 Part 26 Fitness for Duty Drug Testing
 Requirements Final Rule (November
 2022).
NRC Regulatory Analysis Guidelines,     ML19261A277
 NUREG/BR-0058, Draft Revision 5
 (February 2020).
NRC Regulatory Basis: Proposed          ML13066A703
 Rulemaking to Amend 10 CFR Part 26,
 ``Fitness for Duty Programs,'' based
 on Select Provisions of the 2008 HHS
 Guidelines (May 10, 2013).
NRC Regulatory Guide 5.89, ``Fitness-   ML20143A034
 for-Duty Programs for Commercial
 Power Reactor and Category I Special
 Nuclear Material Licensees''
 (November 1, 2022).
NRC Responses to Public Comments        ML22133A052
 (November 2022).
NRC Report ``Summary of Fitness for     ML14246A440
 Duty Program Performance Reports for
 Calendar Year 2013'' (September 3,
 2014).
NRC Report ``Summary of Fitness for     ML17313A337
 Duty Program Performance Reports for
 Calendar Year 2015'' (November 13,
 2017).
Paperwork Reduction Act Statement: 10   ML21111A046
 CFR Part 26, Fitness for Duty
 Programs, Information Collections
 Contained in Fitness for Duty Drug
 Testing Requirements Final Rule
 (October 19, 2022).
Quest Diagnostics (2011). Impacts of    ML19169A153
 Panel Changes--The First Three Months
 (January 25, 2011).
Quest Diagnostics (2012). Cocaine       ML19169A156
 Positives Spike 33% After New
 Government Rule for Safety-Sensitive
 Workers (March 13, 2012).
Quest Diagnostics (2014). Workforce     ML19169A147
 Drug Test Positivity Rate Increases
 for the First Time in 10 Years,
 Driven by Marijuana and Amphetamines,
 Finds Quest Diagnostics Drug Testing
 Index\TM\ Analysis of Employment Drug
 Tests (Press Release and Drug Testing
 Index, 2014 Report) (September 11,
 2014).
------------------------------------------------------------------------

    The NRC may post materials related to this document, including 
public comments, on the Federal rulemaking website at https://www.regulations.gov under Docket ID NRC-2009-0225. In addition, the 
Federal rulemaking website allows members of the public to receive 
alerts when changes or additions occur in a docket folder. To 
subscribe: (1) navigate to the docket folder (NRC-2009-0225); (2) click 
the ``Subscribe'' link; and (3) enter an email address and click on the 
``Subscribe'' link.

List of Subjects in 10 CFR Part 26

    Administrative practice and procedure, Alcohol abuse, Alcohol 
testing, Appeals, Chemical testing, Drug abuse, Drug testing, Employee 
assistance programs, Fitness for duty, Management actions, Nuclear 
power plants and reactors, Privacy, Protection of information, 
Radiation protection, Reporting and recordkeeping requirements.
    For the reasons set out in the preamble and under the authority of 
the Atomic Energy Act of 1954, as amended; the Energy Reorganization 
Act of 1974, as amended; and 5 U.S.C. 552 and 553, the NRC is adopting 
the following amendments to 10 CFR part 26:

PART 26--FITNESS FOR DUTY PROGRAMS

0
1. The authority citation for part 26 continues to read as follows:

    Authority:  Atomic Energy Act of 1954, secs. 53, 103, 104, 107, 
161, 223, 234, 1701 (42 U.S.C. 2073, 2133, 2134, 2137, 2201, 2273, 
2282, 2297f); Energy Reorganization Act of 1974, secs. 201, 202 (42 
U.S.C. 5841, 5842); 44 U.S.C. 3504 note.

0
2. In part 26, wherever they may occur:
0
a. Remove the term ``custody-and-control form'' and add in its place 
the term ``Federal CCF'';
0
b. Remove the term ``custody-and-control forms'' and add in its place 
the term ``Federal CCFs'';
0
c. Remove the term ``custody-and-control form(s)'' and add in its place 
the term ``Federal CCF(s)''; and
0
d. Remove the phrase ``chain-of-custody'' and add in its place the 
phrase ``chain of custody''.

0
3. In Sec.  26.4:
0
a. In paragraph (e)(6)(iv), remove ``(65 FR 41944; August 9, 2001)''; 
and
0
b. Revise paragraph (j)(3).
    The revision reads as follows:


Sec.  26.4  FFD program applicability to categories of individuals.

* * * * *
    (j) * * *
    (3) Urine specimens are tested for validity and the presence of 
drugs and drug metabolites at a Department of Health and Human Services 
(HHS)-certified laboratory, as defined in Sec.  26.5;
* * * * *

0
4. In Sec.  26.5:
0
a. Revise the definition of ``Calibrator'';
0
b. Add in alphabetical order definitions for ``Cancelled test'', 
``Carryover'', and ``Certifying Scientist'';
0
c. Revise the definitions of ``Control'' and ``Dilute specimen'';
0
d. Add in alphabetical order a definition for ``Federal custody and 
control form (Federal CCF)'';
0
e. Revise the definitions of ``HHS-certified laboratory'', ``Invalid 
result'', and ``Limit of quantitation'';
0
f. Adding in alphabetical order definitions for ``Lot'', ``Rejected for 
testing'', and ``Responsible Person''; and
0
g. Revising the definition of ``Substituted specimen''.
    The revisions and additions read as follows:


Sec.  26.5  Definitions.

* * * * *
    Calibrator means a solution of known concentration in the 
appropriate matrix that is used to define expected outcomes of a 
measurement procedure or to compare the response obtained with the 
response of a donor specimen or quality control sample. The 
concentration of the analyte of interest in the calibrator is known 
within limits ascertained during its preparation.
    Cancelled test means the test result reported by the MRO to the 
licensee or other entity when a specimen has been reported to the MRO 
by the HHS-certified laboratory as an invalid result (for which the 
donor has no legitimate explanation), a specimen has been rejected for 
testing by the licensee

[[Page 71456]]

testing facility or HHS-certified laboratory, or the retesting of a 
single specimen or the testing of Bottle B of a split specimen fails to 
reconfirm the original test result. For alcohol testing only, cancelled 
test means a test result that was not acceptable because testing did 
not meet the quality assurance and quality control requirements in 
Sec.  26.91.
    Carryover means the effect that occurs when a test result has been 
affected by a preceding sample or specimen during analysis.
    Certifying Scientist means the individual at an HHS-certified 
laboratory responsible for verifying the chain of custody and 
scientific reliability of any test result reported by an HHS-certified 
laboratory.
* * * * *
    Control means a sample used to evaluate whether an analytical 
procedure or test is operating within predefined tolerance limits.
* * * * *
    Dilute specimen means a urine specimen with creatinine and specific 
gravity values that are lower than expected but are still within the 
physiologically producible ranges of human urine.
* * * * *
    Federal custody and control form (Federal CCF) means any HHS-
approved form, which has not expired, that is published in the Federal 
Register and is used to document the collection, custody, transport, 
and testing of a specimen.
* * * * *
    HHS-certified laboratory means a laboratory that is certified to 
meet the standards of the Mandatory Guidelines for Federal Workplace 
Drug Testing Programs (the HHS Guidelines) at the time that testing of 
a specimen is performed for a licensee or other entity and performs 
that testing for a licensee or other entity in accordance with the HHS 
Guidelines, unless otherwise specified in this part.
* * * * *
    Invalid result means the result reported by an HHS-certified 
laboratory in accordance with the criteria established in Sec.  
26.161(f) when a positive, negative, adulterated, or substituted result 
cannot be established for a specific drug or specimen validity test.
* * * * *
    Limit of quantitation (LOQ) means for quantitation assays, the 
lowest concentration at which the identity and concentration of the 
analyte can be accurately established.
    Lot means a number 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 
states that the items have essentially the same performance 
characteristics and the same expiration date.
* * * * *
    Rejected for testing means the result reported to the MRO by a 
licensee testing facility or HHS-certified laboratory when no tests can 
be performed on a specimen.
* * * * *
    Responsible Person means the person at the HHS-certified laboratory 
who assumes professional, organizational, educational, and 
administrative responsibility for the day-to-day management of the HHS-
certified laboratory.
* * * * *
    Substituted specimen means a specimen that has been submitted in 
place of the donor's urine, as evidenced by creatinine and specific 
gravity values that are outside the physiologically producible ranges 
of human urine.
* * * * *


Sec.  26.8  [Amended]

0
5. In Sec.  26.8, in paragraph (b), remove the reference ``26.155''.


0
6. In Sec.  26.31:
0
a. In paragraph (b)(2), remove the phrase ``(65 FR 41944; August 9, 
2001)'';
0
b. Revise paragraph (d)(1) introductory text;
0
c. In paragraph (d)(1)(i)(D), remove the phrase ``, as specified in 
Sec.  26.155(a)'';
0
d. In paragraph (d)(1)(ii), revise the third sentence; and
0
e. In paragraph (d)(3)(i), revise the second sentence and add a new 
third sentence.
    The addition and revisions read as follows:


Sec.  26.31  Drug and alcohol testing.

* * * * *
    (d) * * *
    (1) Substances tested. At a minimum, licensees and other entities 
shall test for marijuana metabolite, cocaine metabolite, opioids 
(codeine, morphine, 6-acetylmorphine, hydrocodone, hydromorphone, 
oxycodone, and oxymorphone), amphetamines (amphetamine, 
methamphetamine, methylenedioxymethamphetamine, and 
methylenedioxyamphetamine), phencyclidine, and alcohol.
* * * * *
    (ii) * * * Test results that fall below the established cutoff 
levels may not be considered when determining appropriate action under 
subpart D of this part, except if special analyses of the specimen is 
performed under Sec.  26.163(a)(2) by the HHS-certified laboratory. * * 
*
* * * * *
    (3) * * *
    (i) * * * Urine specimens sent to HHS-certified laboratories must 
be subject to initial validity and initial drug testing by the 
laboratory. Oral fluid specimens sent to HHS-certified laboratories 
must be subject to initial drug testing by the laboratory. * * *
* * * * *

0
7. In Sec.  26.83, revise paragraph (b) to read as follows:


Sec.  26.83  Specimens to be collected.

* * * * *
    (b) Collect only urine specimens for both initial and confirmatory 
tests for drugs, unless the licensee or other entity establishes 
through its policy and procedures that an oral fluid specimen can be 
collected and tested for any of the observed specimen collection 
conditions under Sec.  26.115(a)(1) through (3) and (5). For each 
observed collection condition under Sec.  26.115(a)(1) through (3) and 
(5), the licensee or other entity shall always collect and test the 
same specimen type.

0
8. In Sec.  26.85:
0
a. Revise paragraphs (a) introductory text and (a)(2);
0
b. Redesignate paragraphs (a)(3) and (4) as paragraphs (a)(4) and (5), 
respectively, and add new paragraph (a)(3);
0
c. In newly redesignated paragraph (a)(5), remove the phrase 
``collection and transfer process'' and add in its place the phrase 
``collection process'', and add at the end of the paragraph the phrase 
``, and the specimen transfer process, if applicable'';
0
d. Remove paragraph (b) and redesignate paragraphs (c) through (e) as 
paragraphs (b) through (d), respectively; and
0
e. In newly redesignated paragraph (b)(1), remove ``paragraphs (a) or 
(b)'' and add in its place ``paragraph (a)''.
    The revisions and addition read as follows:


Sec.  26.85  Collector qualifications and responsibilities.

* * * * *
    (a) Collector qualifications. Each collector shall be knowledgeable 
of the requirements of this part and the FFD policy and procedures of 
the licensee or other entity for whom collections are performed, and 
shall keep current on any changes to the collection procedures for each 
specimen the individual is qualified to collect under

[[Page 71457]]

this part. Each collector shall receive qualification training that 
meets the requirements of this paragraph and demonstrate proficiency in 
applying the requirements of this paragraph before serving as a 
collector. At a minimum, qualification training must provide 
instruction on the following subjects:
* * * * *
    (2) Methods to address ``problem'' collections, including, but not 
limited to:
    (i) Inability to provide a specimen (e.g., ``shy bladder'' for a 
urine specimen, ``shy lung'' for a breath specimen, dry mouth for an 
oral fluid specimen); and
    (ii) Attempts to tamper with a specimen;
    (3) Operation of the particular specimen collection or alcohol 
testing device(s) (e.g., alcohol screening device (ASD), EBT, oral 
fluid) to be used, consistent with the most recent version of the 
manufacturers' instructions;
* * * * *

0
9. In Sec.  26.87:
0
a. Revise the second sentence in paragraph (a) and revise paragraph 
(b);
0
b. In paragraph (f) introductory text, remove the phrase ``collect a 
urine specimen'' and add in its place the phrase ``collect a specimen 
for drug testing'';
0
c. In paragraph (f)(2), remove the phrase ``If practical, a water 
coloring agent'' and add in its place the phrase ``If practical when a 
urine specimen is to be collected, a water coloring agent'';
0
d. In paragraph (f)(3), remove the phrase ``area that will be used for 
specimen collection'' and add in its place the phrase ``the area that 
will be used for a urine specimen collection'';
0
e. Revise paragraph (f)(4); and
0
f. In paragraph (f)(5), in the first sentence, remove the phrase 
``urine specimen'' and add in its place the phrase ``specimen for drug 
testing''.
    The revisions read as follows:


Sec.  26.87  Collection sites.

    (a) * * * Each collection site must provide for the collection, 
security, temporary storage, and shipping or transportation of 
specimens to a drug testing laboratory; the testing of specimens for 
alcohol; the security of specimen collection and testing devices; and 
test results. * * *
    (b) Visual privacy must be provided to the donor and collector when 
viewing alcohol test results and during the collection of an oral fluid 
specimen for drug testing. The donor must be provided with individual 
privacy while submitting a urine specimen, except if a directly 
observed urine specimen collection is required. Unauthorized personnel 
may not be present for the specimen collection.
* * * * *
    (f) * * *
    (4) Once the collector has possession of the specimen, if the 
specimen is urine, the collector shall inspect the toilet bowl and area 
to ensure that there is no evidence of a subversion attempt and shall 
then flush the toilet, and for any specimen collected for drug testing, 
the collector shall instruct the donor to participate with the 
collector in completing the chain of custody procedures.
* * * * *

0
10. In Sec.  26.89:
0
a. In paragraph (c), remove the words ``adulterated, diluted, or 
adulterated the specimen'' and add in their place the words 
``adulterated, diluted, or substituted the specimen''; and
0
b. Revise paragraph (d).
    The revision reads as follows:


Sec.  26.89  Preparing to collect specimens for testing.

* * * * *
    (d) In order to promote the security of specimens, avoid 
distraction of the collector, and ensure against any confusion in the 
identification of specimens, a collector shall conduct only one 
collection procedure at any given time, except as described in Sec.  
26.109(b)(1). For the collection of specimen(s) for drug testing, the 
collection procedure is complete when the specimen container has been 
sealed with a tamper-evident seal, the seal has been dated and 
initialed, and the Federal CCF has been completed or when a refusal to 
test has been determined.

0
11. In Sec.  26.97:
0
a. Revise the section heading;
0
b. In paragraphs (a) introductory text, (a)(4), and (b)(1) through (3), 
wherever it appears, remove the word ``test'' and add in its place the 
phrase ``specimen collection''; and
0
c. Revise paragraph (c)(2), and the first sentence in paragraph (d).
    The revisions read as follows:


Sec.  26.97  Collecting oral fluid specimens for alcohol and drug 
testing.

* * * * *
    (c) * * *
    (2) Immediately conduct another specimen collection (i.e., initial 
test using an EBT for alcohol, or urine specimen collection for drug 
testing).
    (d) For alcohol testing of oral fluids, the collector shall read 
the result displayed on the device no sooner than the device's 
manufacturer instructs. * * *
* * * * *

0
12. In Sec.  26.105:
0
a. Revise the section heading;
0
b. In paragraph (a), wherever it appears, remove the word ``urine'';
0
c. In paragraph (c), remove the phrase ``wash and dry his or her hands 
before urinating'' and add in its place the phrase ``wash and dry his 
or her hands before providing a specimen'';
0
d. In paragraph (d), remove the word ``urine''; and
0
e. Revise paragraph (e).
    The revisions read as follows:


Sec.  26.105  Preparing for the collection of a specimen for drug 
testing.

* * * * *
    (e) The collector may select, or allow the donor to select, an 
individually wrapped or sealed urine specimen collection container from 
the collection kit materials or an oral fluid specimen collection 
device. Either the collector or the donor, with both present, shall 
unwrap or break the seal of the urine specimen collection container. 
With the exception of the collection container, the donor may not take 
anything from the collection kit into the room or stall used for 
urination.

0
13. In Sec.  26.107, revise paragraph (b) and add paragraph (d) to read 
as follows:


Sec.  26.107  Collecting a urine specimen.

* * * * *
    (b)(1) The collector shall pay careful attention to the donor 
during the entire collection process, except as provided in Sec.  
26.109(b)(1), to observe any conduct that indicates an attempt to 
subvert the testing process (e.g., tampering with a specimen; having a 
substitute urine specimen in plain view; attempting to bring an 
adulterant, urine substitute, heating element, and/or temperature 
measurement device into the room, stall, or private area used for 
urination). If any such conduct is detected, the collector shall 
document a description of the conduct on the Federal CCF or through 
another documentation method consistent with the collection procedures 
of the licensee or other entity, and contact FFD program management to 
determine whether a directly observed collection is required, as 
described in Sec.  26.115.
    (2) If a hydration monitor is used to observe a donor during the 
Sec.  26.109(b)(1) hydration process, this individual shall immediately 
inform the collector of any donor conduct that may indicate an attempt 
to subvert the testing process (e.g., donor leaves the

[[Page 71458]]

collection site, donor refuses to follow instructions).
* * * * *
    (d) If a refusal to test is determined at any point during the 
specimen collection process, the collector shall do the following:
    (1) Inform the donor that a refusal to test has been determined;
    (2) Terminate the collection process;
    (3) Document a description of the refusal to test on the Federal 
CCF or through another documentation method consistent with the 
collection procedures of the licensee or other entity;
    (4) Discard any urine specimen(s) provided by the donor, unless the 
specimen was collected for a post-event test under Sec.  26.31(c)(3); 
and
    (5) Immediately inform the FFD program manager.

0
14. In Sec.  26.109, revise paragraph (b)(1) and add a new first 
sentence to paragraph (b)(2) to read as follows:


Sec.  26.109  Urine specimen quantity.

* * * * *
    (b) * * *
    (1) The collector shall encourage the donor to drink a reasonable 
amount of liquid (normally, 8 ounces of water every 30 minutes, but not 
to exceed a maximum of 40 ounces over 3 hours) until the donor provides 
a specimen of at least 30 mL. Alternatively, as specified in the 
licensee's or other entity's FFD program procedures, the collector may 
assign responsibility for monitoring a donor during the hydration 
process to another collector who meets the requirements in Sec.  
26.85(a) or to a hydration monitor. If another collector or hydration 
monitor is used, the collector:
    (i) Shall explain the hydration process and acceptable donor 
behavior to the hydration monitor;
    (ii) Shall record the name of the other collector or hydration 
monitor on the Federal CCF; and
    (iii) May perform other collections while the donor is in the 
hydration process;
    (2) The collector shall provide the donor with a separate 
collection container for each successive specimen. * * *
* * * * *

0
15. In Sec.  26.111:
0
a. Revise paragraph (a) and the second sentence in paragraph (b);
0
b. In paragraph (c), the first sentence, remove the word ``designated'' 
and revise the third sentence;
0
c. Revise paragraph (e); and
0
d. Remove paragraph (f).
    The revisions read as follows:


Sec.  26.111  Checking the acceptability of the urine specimen.

    (a) Immediately after the donor provides the urine specimen to the 
collector, including specimens of less than 30 mL but equal to or 
greater than 15 mL, the collector shall measure the temperature of the 
specimen. The temperature-measuring device used must accurately reflect 
the temperature of the specimen and not contaminate the specimen. The 
time from urination to temperature measurement may not exceed 4 
minutes. If the temperature of a urine specimen is outside the range of 
90 [deg]F to 100 [deg]F (32 [deg]C to 38 [deg]C), that is a reason to 
believe the donor may have altered (e.g., adulterated or diluted) or 
substituted the specimen.
    (b) * * * The collector shall note any unusual findings on the 
Federal CCF or through another documentation method consistent with the 
collection procedures of the licensee or other entity.
    (c) * * * In addition, the collector shall inform the donor that he 
or she may volunteer to submit a second specimen under direct 
observation to counter the reason to believe the donor may have altered 
(e.g., adulterated or diluted) or substituted the specimen.
* * * * *
    (e) As much of the suspect specimen as possible must be preserved, 
except under the conditions described in Sec.  26.107(d)(4).

0
16. In Sec.  26.115:
0
a. Republish paragraph (a) introductory text, revise paragraphs (a)(3) 
and (4), and add paragraph (a)(5);
0
b. Revise paragraph (e);
0
c. Revise paragraph (f) introductory text, republish paragraph (f)(1), 
and revise paragraphs (f)(2) and (3); and
0
d. Revise paragraph (g).
    The republications, revisions, and addition read as follows:


Sec.  26.115  Collecting a urine specimen under direct observation.

    (a) Procedures for collecting urine specimens must provide for the 
donor's privacy unless directed by this subpart or the MRO or FFD 
program manager determines that a directly observed collection is 
warranted. The following circumstances constitute the exclusive grounds 
for performing a directly observed collection:
* * * * *
    (3) The collector, or the hydration monitor if one is used as 
permitted in Sec.  26.109(b)(1), observes conduct by the donor 
indicating an attempt to subvert the testing process;
    (4) A directly observed collection is required under Sec.  26.69; 
or
    (5) The donor requests a retest and either Bottle B or the single 
specimen is not available due to circumstances outside of the donor's 
control, as described in Sec.  26.165(f)(2).
* * * * *
    (e) The collector shall ensure that the observer is the same gender 
as the donor. A person of the opposite gender may not act as the 
observer under any conditions. The 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.
    (f) The individual who observes the collection shall follow these 
procedures:
    (1) The observer shall instruct the donor to adjust his or her 
clothing to ensure that the area of the donor's body between the waist 
and knees is exposed;
    (2) The observer shall watch the donor urinate into the collection 
container. Specifically, the observer shall watch the urine go from the 
donor's body into the collection container. A reflective mirror may be 
used to assist in observing the provision of the specimen only if the 
physical configuration of the room, stall, or private area used for 
urination is not sufficient to meet this direct observation 
requirement; the use of a video camera to assist in the observation 
process is not permitted;
    (3) If the observer is not the collector, the observer may not 
touch or handle the collection container but shall maintain visual 
contact with the specimen until the donor hands the collection 
container to the collector; and
* * * * *
    (g) If a donor declines to allow a directly observed collection 
that is required or permitted under this section, the donor's refusal 
constitutes an act to subvert the testing process, and the collector 
shall follow the procedures in Sec.  26.107(d).
* * * * *

0
17. In Sec.  26.117:
0
a. Revise the section heading;
0
b. In paragraph (a), revise the first sentence and republish the second 
sentence;
0
c. Revise the first sentence in paragraph (f);
0
d. In paragraph (g), at the end of the first sentence, add the phrase 
``, except as provided in Sec.  26.109(b)(1)(ii) for the Federal CCF'';
0
e. In paragraph (i), remove the words ``urine specimen bottle'' and add 
in

[[Page 71459]]

their place the words ``specimen bottle''; and
0
f. In paragraph (j) remove the phrase ``Specimens that have not been 
shipped'' and add in their place the phrase ``Urine specimens that have 
not shipped''; remove phrase ``any specimen'' and add in its place the 
phrase ``any urine specimen''; and add a new fourth sentence.
    The revisions, republication, and addition read as follows:


Sec.  26.117  Preparing drug testing specimens for storage and 
shipping.

    (a) Once the collector is presented with the specimen from the 
donor, both the donor and the collector shall keep the donor's 
specimen(s) in view at all times before the specimen(s) are sealed and 
labeled. If any specimen or aliquot is transferred to another 
container, the collector shall ask the donor to observe the transfer 
and sealing of the container with a tamper-evident seal.
* * * * *
    (f) The specimens and Federal CCFs must be packaged for transfer to 
the HHS-certified laboratory or to the licensee testing facility. * * *
* * * * *
    (j) * * * Oral fluid specimens shall be stored under the conditions 
specified by the oral fluid specimen collection device manufacturer. * 
* *
* * * * *


0
18. In Sec.  26.129, revise paragraphs (b)(1)(ii) and (b)(2) 
introductory text to read as follows:


Sec.  26.129  Assuring specimen security, chain of custody, and 
preservation.

* * * * *
    (b) * * *
    (1) * * *
    (ii) If there is reason to believe that the integrity or identity 
of a specimen is in question (as a result of tampering or discrepancies 
between the information on the specimen bottle and on the accompanying 
Federal CCFs that cannot be resolved), the licensee testing facility 
shall reject the specimen for testing. The licensee or other entity 
shall ensure that another collection occurs as soon as reasonably 
practical, except if a split specimen collection was performed, either 
the Bottle A or Bottle B seal remains intact, and the intact specimen 
contains at least 15 mL of urine. In this instance, the licensee 
testing facility shall forward the intact specimen for testing to the 
HHS-certified laboratory and may not conduct any testing at the 
licensee testing facility.
    (2) The following are exclusive grounds requiring the MRO to cancel 
the testing of a donor's urine specimen and report a cancelled test 
result to the licensee or other entity:
* * * * *

0
19. Revise Sec.  26.133 to read as follows:


Sec.  26.133  Cutoff levels for drugs and drug metabolites.

    Subject to the provisions of Sec.  26.31(d)(3)(iii), licensees and 
other entities may specify more stringent cutoff levels for drugs and 
drug metabolites than those in Table 1 to Sec.  26.133 and, in such 
cases, may report initial test results for only the more stringent 
cutoff levels. Otherwise, the following cutoff levels must be used for 
initial testing of urine specimens to determine whether they are 
negative or positive for the indicated drugs and drug metabolites:

  Table 1 to Sec.   26.133--Urine, Initial Test Cutoff Levels for Drugs
                          and Drug Metabolites
------------------------------------------------------------------------
                                                           Cutoff level
                Drugs or drug metabolites                   [nanograms
                                                             (ng)/mL]
------------------------------------------------------------------------
Marijuana metabolites...................................              50
Cocaine metabolites.....................................             150
Opioids:
  Codeine/Morphine \1\..................................           2,000
  Hydrocodone/Hydromorphone.............................             300
  Oxycodone/Oxymorphone.................................             100
  6-acetylmorphine (6-AM)...............................              10
Phencyclidine (PCP).....................................              25
Amphetamines: \2\
  AMP/MAMP \3\..........................................             500
  MDMA \4\/MDA \5\......................................             500
------------------------------------------------------------------------
\1\ Morphine is the target analyte for codeine/morphine testing.
\2\ Either a single initial test kit or multiple initial test kits may
  be used provided the single test kit detects each target analyte
  independently at the specified cutoff.
\3\ Methamphetamine (MAMP) is the target analyte for amphetamine (AMP)/
  MAMP testing.
\4\ Methylenedioxymethamphetamine.
\5\ Methylenedioxyamphetamine.



0
20. In Sec.  26.137,
0
a. Revise paragraphs (d)(5), (e)(6) introductory text, and (e)(6)(i) 
through (iii); and
0
b. Remove paragraph (e)(6)(v).
    The revisions read as follows:


Sec.  26.137  Quality assurance and quality control.

* * * * *
    (d) * * *
    (5) Each analytical run performed to conduct initial validity 
testing shall include at least one quality control sample.
* * * * *
    (e) * * *
    (6) A minimum of 10 percent of the total specimens in each 
analytical run of specimens to be initially tested for drugs and drug 
metabolites by the licensee testing facility must be quality control 
samples (i.e., calibrators and controls), which the licensee testing 
facility shall use for internal quality control purposes. (These 
samples are not forwarded to the HHS-certified laboratory for further 
testing, other than for performance testing of the samples.) Licensee 
testing facilities shall ensure that quality control samples that are 
positive for each drug and drug metabolite for which the FFD program 
conducts testing are included in at least one analytical run each 
calendar quarter. The quality control samples for each analytical run 
must include--
    (i) At least one control certified by an HHS-certified laboratory 
to contain no drug or drug metabolite;
    (ii) At least one positive control with the drug or drug metabolite 
targeted at 25 percent above the cutoff;
    (iii) At least one positive control with the drug or drug 
metabolite targeted at 75 percent of the cutoff;
* * * * *


0
21. Revise Sec.  26.151 to read as follows:


Sec.  26.151  Purpose.

    This subpart contains requirements for the HHS-certified 
laboratories that licensees and other entities use to perform testing 
under this part.

0
22. In Sec.  26.153, revise the section heading and paragraphs (a) and 
(g) to read as follows:


Sec.  26.153  Using certified laboratories for testing specimens.

    (a) Licensees and other entities who are subject to this part shall 
use only HHS-certified laboratories as defined in Sec.  26.5.
* * * * *
    (g) If licensees or other entities use a form other than the 
current Federal CCF, licensees and other entities shall provide a 
memorandum to the laboratory explaining why a non-Federal CCF was used, 
but must ensure, at a minimum, that the form used contains all the 
required information on the Federal CCF.


Sec.  26.155  [Removed and Reserved]

0
23. Remove and reserve Sec.  26.155.

0
24. In Sec.  26.157, revise paragraph (a), remove and reserve paragraph 
(b), and remove paragraphs (c) through (e) and the undesignated 
paragraph at the end.
    The revision reads as follows:


Sec.  26.157  Procedures.

    (a) HHS-certified laboratories shall develop, implement, and 
maintain procedures specific to this part that document the accession, 
receipt, shipment, and testing of specimens.
* * * * *

[[Page 71460]]


0
25. In Sec.  26.159, revise paragraphs (b)(1)(ii) and (b)(2) 
introductory text, the second sentence in paragraph (c), and paragraphs 
(d) and (e) to read as follows:


Sec.  26.159  Assuring specimen security, chain of custody, and 
preservation.

* * * * *
    (b) * * *
    (1) * * *
    (ii) If the licensee or other entity has reason to question the 
integrity and identity of the specimens, the laboratory shall reject 
the specimens for testing. The licensee or other entity shall ensure 
that another collection occurs as soon as reasonably practical, except 
if a split specimen collection was performed, either the Bottle A or 
Bottle B seal remains intact, and the intact specimen contains at least 
15 mL of urine. In this instance, if the licensee testing facility has 
retained the specimen in Bottle B, the licensee testing facility shall 
forward the intact specimen for testing to the HHS-certified laboratory 
and may not conduct any testing at the licensee testing facility.
    (2) The following are exclusive grounds requiring the MRO to cancel 
the testing of a donor's urine specimen and report a cancelled test to 
the licensee or other entity:
* * * * *
    (c) * * * Laboratory personnel shall use aliquots and laboratory 
internal chain of custody forms when conducting initial and 
confirmatory tests. * * *
    (d) The laboratory's internal chain of custody form must allow for 
identification of the donor and documentation of the testing process 
and transfers of custody of the specimen.
    (e) Each time a specimen is handled or transferred within the 
laboratory, laboratory personnel shall document the date and purpose on 
the chain of custody form and every individual in the chain shall be 
identified. Authorized technicians are responsible for each urine 
specimen or aliquot in their possession and shall sign and complete 
chain of custody forms for those specimens or aliquots as they are 
received.
* * * * *

0
26. In Sec.  26.161:
0
a. In paragraph (b) introductory text, remove the phrase ``Initial 
validity testing'' and add in its place the phrase ``Initial validity 
testing of urine'';
0
b. In paragraphs (c)(3) and (4), wherever it appears, remove the term 
``LOD'' and add in its place the term ``LOQ'';
0
c. Revise paragraphs (c)(5) and (6);
0
d. Revise the headings for paragraphs (d) and (e);
0
e. In paragraphs (f)(5) and (7), wherever it appears, remove the term 
``LOD'' and add in its place the term ``LOQ''; and
0
f. Revise paragraph (h).
    The revisions read as follows:


Sec.  26.161  Cutoff levels for validity testing.

* * * * *
    (c) * * *
    (5) The presence of glutaraldehyde is verified using either an 
aldehyde test (aldehyde present) or the specimen yields the 
characteristic immunoassay response on one or more drug immunoassay 
tests for the initial test on the first aliquot and a different 
confirmatory test (e.g., gas chromatography/mass spectrometry (GC/MS)) 
for the confirmatory test with the glutaraldehyde concentration equal 
to or greater than the LOQ of the analysis on the second aliquot;
    (6) The presence of pyridine (pyridinium chlorochromate) is 
verified using either a general oxidant colorimetric test (with a 
cutoff equal to or greater than 200 mcg/mL nitrite-equivalents or a 
cutoff equal to or greater than 50 mcg/mL chromium (VI)-equivalents) or 
a chromium (VI) colorimetric test (chromium (VI) concentration equal to 
or greater than 50 mcg/mL) for the initial test on the first aliquot 
and a different confirmatory test (e.g., GC/MS) for the confirmatory 
test with the pyridine concentration equal to or greater than the LOQ 
of the analysis on the second aliquot;
* * * * *
    (d) Results indicating a substituted urine specimen. * * *
    (e) Results indicating a dilute urine specimen. * * *
* * * * *
    (h) Validity test cutoff levels. Licensees and other entities may 
use more stringent cutoff levels for validity tests than those 
specified in this section only if the testing is performed at an HHS-
certified laboratory.

0
27. In Sec.  26.163:
0
a. Republish the paragraph (a) heading;
0
b. Revise paragraph (a)(1);
0
c. Revise paragraph (a)(2) introductory text and (a)(2)(i) and (ii);
0
d. Republish the paragraph (b) heading; and
0
e. Revise paragraph (b)(1).
    The republications and revisions read as follows:


Sec.  26.163  Cutoff levels for drugs and drug metabolites.

    (a) Initial drug testing. (1) HHS-certified laboratories shall 
apply the following cutoff levels for initial testing of specimens to 
determine whether they are negative or positive for the indicated drugs 
and drug metabolites, except as specified in paragraph (a)(2) of this 
section or the licensee or other entity has established more stringent 
cutoff levels:

Table 1 to Paragraph (a)(1)--Urine, Initial Test Cutoff Levels for Drugs
                          and Drug Metabolites
------------------------------------------------------------------------
                                                           Cutoff level
                Drugs or drug metabolites                   [nanograms
                                                             (ng)/mL]
------------------------------------------------------------------------
Marijuana metabolites...................................              50
Cocaine metabolites.....................................             150
Opioids:
  Codeine/Morphine\1\...................................           2,000
  Hydrocodone/Hydromorphone.............................             300
  Oxycodone/Oxymorphone.................................             100
  6-acetylmorphine (6-AM)...............................              10
Phencyclidine (PCP).....................................              25
Amphetamines: \2\
  AMP/MAMP \3\..........................................             500
  MDMA \4\/MDA \5\......................................             500
------------------------------------------------------------------------
\1\ Morphine is the target analyte for codeine/morphine testing.
\2\ Either a single initial test kit or multiple initial test kits may
  be used provided the single test kit detects each target analyte
  independently at the specified cutoff.
\3\ Methamphetamine (MAMP) is the target analyte for amphetamine (AMP)/
  MAMP testing.
\4\ Methylenedioxymethamphetamine.
\5\ Methylenedioxyamphetamine.


[[Page 71461]]


 Table 2 to Paragraph (a)(1)--Oral Fluid, Initial Test Cutoff Levels for
                       Drugs and Drug Metabolites
------------------------------------------------------------------------
                                                           Cutoff level
                Drugs or drug metabolites                 \1\ [nanograms
                                                             (ng)/mL]
------------------------------------------------------------------------
Marijuana (THC) \2\ \3\.................................               4
Cocaine/Benzoylecgonine.................................              15
Opioids:
  Codeine/Morphine......................................              30
  Hydrocodone/Hydromorphone.............................              30
  Oxycodone/Oxymorphone.................................              30
  6-acetylmorphine (6-AM)...............................           4 \3\
Phencyclidine (PCP).....................................              10
Amphetamines:
  AMP/MAMP \4\..........................................              50
  MDMA/MDA \5\..........................................              50
------------------------------------------------------------------------
\1\ For grouped analytes (i.e., two or more analytes in the same drug
  class with the same initial test cutoff):
 Immunoassay: The test must be calibrated with one analyte from
  the group identified as the target analyte. The cross reactivity of
  the immunoassay to the other analyte(s) within the group must be 80
  percent or greater; if not, separate immunoassays must be used for the
  analytes within the group.
 Alternative technology: Either one analyte or all analytes from
  the group must be used for calibration, depending on the technology.
  At least one analyte within the group must have a concentration equal
  to or greater than the initial test cutoff or, alternatively, the sum
  of the analytes present.
\2\ An immunoassay must be calibrated with the target analyte, delta-9-
  tetrahydrocannabinol (THC).
\3\ Alternate technology (THC and 6-AM): The confirmatory tests cutoff
  must be used for an alternate technology initial test that is specific
  for the target analyte (i.e., 2 ng/mL for THC, 2 ng/mL for 6-AM).
\4\ Amphetamine (AMP) and methamphetamine (MAMP).
\5\ Methylenedioxymethamphetamine (MDMA) and methylenedioxyamphetamine
  (MDA).

    (2) HHS-certified laboratories shall conduct special analyses of 
specimens as follows:
    (i) If initial validity testing indicates that a specimen is 
dilute, or if a specimen is collected under direct observation for any 
of the conditions specified in Sec.  26.115(a)(1) through (3) or 
(a)(5), the laboratory shall compare the immunoassay responses of the 
specimen to the cutoff calibrator in each drug class tested;
    (ii) If any immunoassay response is equal to or greater than 40 
percent of the cutoff calibrator, the laboratory shall conduct 
confirmatory drug testing of the specimen to the LOQ for those drugs 
and/or drug metabolites; and
* * * * *
    (b) Confirmatory drug testing. (1) A specimen that is identified as 
positive on an initial drug test must be subject to confirmatory 
testing for the class(es) of drugs for which the specimen initially 
tested positive. The HHS-certified laboratory shall apply the 
confirmatory cutoff levels specified in this paragraph, except as 
permitted in paragraph (a)(2) of this section or the licensee or other 
entity has established more stringent cutoff levels.

 Table 3 to Paragraph (b)(1)--Urine, Confirmatory Test Cutoff Levels for
                       Drugs and Drug Metabolites
------------------------------------------------------------------------
                                                           Cutoff level
                Drugs or drug metabolites                     (ng/mL)
------------------------------------------------------------------------
Marijuana metabolite \1\................................              15
Cocaine metabolite \2\..................................             100
Opioids:
  Morphine..............................................           2,000
  Codeine...............................................           2,000
  Hydrocodone...........................................             100
  Hydromorphone.........................................             100
  Oxycodone.............................................             100
  Oxymorphone...........................................             100
  6-acetylmorphine (6-AM)...............................              10
Phencyclidine (PCP).....................................              25
Amphetamines:
  Amphetamine...........................................             250
  Methamphetamine \3\...................................             250
  Methylenedioxymethamphetamine (MDMA)..................             250
  Methylenedioxyamphetamine (MDA).......................             250
------------------------------------------------------------------------
\1\ As delta-9-tetrahydrocannabinol-9-carboxylic acid (THCA).
\2\ As benzoylecgonine.
\3\ To be reported positive for methamphetamine, a specimen must also
  contain amphetamine at a concentration equal to or greater than 100 ng/
  mL.


Table 4 to Paragraph (b)(1)--Oral Fluid, Confirmatory Test Cutoff Levels
                     for Drugs and Drug Metabolites
------------------------------------------------------------------------
                                                           Cutoff level
                Drugs or drug metabolites                   [nanograms
                                                             (ng)/mL]
------------------------------------------------------------------------
Marijuana (THC).........................................               2
Cocaine.................................................               8
Benzoylecgonine.........................................               8
Opioids:
  Codeine...............................................              15
  Morphine..............................................              15
  Hydrocodone...........................................              15
  Hydromorphone.........................................              15
  Oxycodone.............................................              15
  Oxymorphone...........................................              15
  6-acetylmorphine (6-AM)...............................               2
Phencyclidine (PCP).....................................              10
Amphetamines:
  Amphetamine...........................................              25
  Methamphetamine.......................................              25
  Methylenedioxymethamphetamine (MDMA)..................              25
  Methylenedioxyamphetamine (MDA).......................              25
------------------------------------------------------------------------

* * * * *

0
28. In Sec.  26.165:
0
a. Add a fifth sentence to paragraph (b)(2); and
0
b. Revise paragraph (b)(3);
0
c. In paragraph (f)(1) introductory text, remove the phrase ``If the 
results of testing Bottle B or retesting the aliquot of a single 
specimen are negative, the licensee or other entity--'' and add in its 
place the phrase ``If the results of testing Bottle B or retesting the 
aliquot of a single specimen are negative, the MRO shall report a 
cancelled test result to the licensee or other entity, and the licensee 
and other entity--''; and
0
d. Revise paragraph (f)(2).
    The addition and revisions read as follows:


Sec.  26.165  Testing split specimens and retesting single specimens.

* * * * *
    (b) * * *
    (2) * * * The MRO shall document in his or her records when (i.e., 
date and time) the request was received from the donor to retest an 
aliquot of the single specimen or to test the Bottle B split specimen.
    (3) No entity, other than the MRO as permitted in Sec.  26.185(l), 
may order the retesting of an aliquot of the single specimen or the 
testing of the Bottle B split specimen.
* * * * *
    (f) * * *
    (2) If a donor requests that Bottle B be tested or that an aliquot 
of the single specimen be retested, and either Bottle B or the single 
specimen are not available due to circumstances outside of the donor's 
control (including, but not limited to, circumstances in which there is 
an insufficient quantity of the single specimen or the specimen in 
Bottle B to permit retesting, either Bottle B or the original single 
specimen is lost in transit to the second HHS-certified laboratory, or 
Bottle B has been lost at the HHS-certified laboratory or licensee 
testing facility), the MRO shall cancel the test, report a cancelled 
test result to the licensee or other entity for the donor's specimen, 
and inform the licensee or other entity that another collection is 
required under direct observation as soon as reasonably practical. The 
donor shall receive no notice of the collection requirement before he 
or she is instructed to proceed to the collection site. The licensee or 
other entity shall continue to administratively withdraw the 
individual's authorization, as required by Sec.  26.165(f)(1) until the 
results of the second specimen collection have been received by the 
MRO. The licensee or other entity shall eliminate from the donor's 
personnel and other records any matter that could link the donor to the 
original positive, adulterated, or substituted test result(s) and any 
temporary administrative action, and may not impose any sanctions on 
the donor for a cancelled test. If test results from the second 
specimen collected are positive, adulterated, or substituted and the 
MRO determines that the donor has violated the FFD policy, the licensee 
or other entity shall impose the appropriate sanctions specified in 
subpart D of this part, but may not consider the original confirmed 
positive, adulterated, or substituted test result that was reported as 
a cancelled

[[Page 71462]]

test by the MRO under Sec.  26.129(b)(2) or Sec.  26.159(b)(2) in 
determining the appropriate sanctions.

0
29. In Sec.  26.167:
0
a. In the paragraph (c) heading, remove the phrase ``validity tests'' 
and add in its place the phrase ``validity tests on urine'';
0
b. In paragraph (d)(1), remove the phrase ``Any initial drug test 
performed by an HHS-certified laboratory'' and add in its place the 
phrase ``Any initial drug test of urine performed by an HHS-certified 
laboratory'';
0
c. Republish paragraph (d)(3) introductory text, and revise paragraphs 
(d)(3)(i) through (iii);
0
d. Revise paragraph (d)(4);
0
e. Revise paragraph (e)(2), republish paragraph (e)(3) introductory 
text, and revise paragraphs (e)(3)(i) through (iv); and
0
f. In paragraph (f)(3), in the third sentence, remove the words 
``responsible person'' and add in their place the words ``Responsible 
Person''.
    The republications and revisions read as follows:


Sec.  26.167  Quality assurance and quality control.

* * * * *
    (d) * * *
    (3) Quality control samples for each analytical run of specimens 
for initial testing must include--
    (i) At least one control certified to contain no drug or drug 
metabolite;
    (ii) At least one positive control with the drug or drug metabolite 
targeted at 25 percent above the cutoff;
    (iii) At least one positive control with the drug or drug 
metabolite targeted at 75 percent of the cutoff;
* * * * *
    (4) A minimum of 10 percent of the total specimens in each 
analytical run must be quality control samples (i.e., calibrators and 
controls), as defined by paragraphs (d)(3)(i) through (iv) of this 
section.
    (e) * * *
    (2) A minimum of 10 percent of the total specimens in each 
analytical run must be quality control samples (i.e., calibrators and 
controls).
    (3) Each analytical run of specimens that are subjected to 
confirmatory testing must include--
    (i) At least one control certified to contain no drug or drug 
metabolite;
    (ii) A calibrator with its drug concentration at the cutoff;
    (iii) At least one positive control with the drug or drug 
metabolite targeted at 25 percent above the cutoff; and
    (iv) At least one control targeted at or below 40 percent of the 
cutoff.
* * * * *

0
30. In Sec.  26.168, revise paragraph (h)(1) to read as follows:


Sec.  26.168  Blind performance testing.

* * * * *
    (h) * * *
    (1) Ensure that all blind performance test sample lots are placed 
in service by the supplier only after confirmation by an HHS-certified 
laboratory;
* * * * *

0
31. In Sec.  26.169:
0
a. In paragraph (a), remove the words ``certifying scientist'' and add 
in their place the words ``Certifying Scientist'';
0
b. In paragraph (c)(2), remove the word ``opiate'';
0
c. In paragraph (h) introductory text, in the first sentence, remove 
the word ``urinalysis'';
0
d. Republish paragraph (h)(3) introductory text and revise paragraphs 
(h)(3)(i) and (ii), (h)(3)(iii) introductory text, and (h)(3)(iii)(B) 
and (C);
0
e. Add paragraphs (h)(3)(iii)(D) through (G);
0
f. Revise paragraph (h)(3)(iv);
0
g. Republish paragraph (h)(3)(v) introductory text and revise paragraph 
(h)(3)(v)(A); and
0
h. Add paragraphs (h)(3)(v)(C) and (D).
    The republications, revisions, and additions read as follows:


Sec.  26.169  Reporting results.

* * * * *
    (h) * * *
    (3) Number of specimens reported as positive on confirmatory tests 
by drug or drug metabolite for which testing is conducted, including, 
but not limited to--
    (i) Marijuana metabolite (as THCA);
    (ii) Cocaine metabolite (as benzoylecgonine);
    (iii) Opioids (total);
* * * * *
    (B) Morphine;
    (C) 6-acetylmorphine (6-AM);
    (D) Hydrocodone;
    (E) Hydromorphone;
    (F) Oxycodone; and
    (G) Oxymorphone;
    (iv) Phencyclidine (PCP);
    (v) Amphetamines (total);
    (A) Amphetamine;
* * * * *
    (C) Methylenedioxymethamphetamine (MDMA); and
    (D) Methylenedioxyamphetamine (MDA);
* * * * *

0
32. In Sec.  26.183, revise paragraphs (c) introductory text, (c)(1), 
and (d)(2)(ii) to read as follows:


Sec.  26.183  Medical review officer.

* * * * *
    (c) Responsibilities. The primary role of the MRO is to review and 
interpret positive, adulterated, substituted, invalid, and dilute test 
results obtained through the licensee's or other entity's testing 
program and to identify any evidence of subversion of the testing 
process. The MRO is also responsible for identifying any issues 
associated with collecting and testing specimens, and for advising and 
assisting FFD program management in planning and overseeing the overall 
FFD program.
    (1) In carrying out these responsibilities, the MRO shall examine 
alternate medical explanations for any positive, adulterated, 
substituted, invalid, or dilute test result. This action may include, 
but is not limited to, conducting a medical interview with the donor, 
reviewing the donor's medical history, or reviewing any other relevant 
biomedical factors. The MRO shall review all medical records that the 
donor may make available when a positive, adulterated, substituted, 
invalid, or dilute test result could have resulted from responsible use 
of legally prescribed medication, a documented condition or disease 
state, or the demonstrated physiology of the donor.
* * * * *
    (d) * * *
    (2) * * *
    (ii) The staff reviews of positive, adulterated, substituted, 
invalid, and dilute test results must be limited to reviewing the 
Federal CCF to determine whether it contains any errors that may 
require corrective action and to ensure that it is consistent with the 
information on the MRO's copy. The staff may resolve errors in Federal 
CCFs that require corrective action(s), but shall forward the Federal 
CCFs to the MRO for review and approval of the resolution.
* * * * *

0
33. In Sec.  26.185:
0
a. Redesignate paragraph (f)(3) as paragraph (f)(4) and add new 
paragraph (f)(3);
0
b. In paragraph (g)(1), remove the reference ``paragraph (g)(4)'' and 
add in its place the reference ``paragraph (g)(3)'';
0
c. Revise paragraphs (g)(2) introductory text and (g)(2)(iii);
0
d. Remove paragraph (g)(3), and redesignate paragraphs (g)(4) and (5) 
as paragraphs (g)(3) and (4), respectively;
0
e. In newly redesignated paragraph (g)(3), remove the phrase ``any 
opium, opiate, or opium derivative (e.g., morphine/codeine)'' and add 
in its place ``opioids (i.e., morphine and/or codeine)'';
0
f. Revise the paragraph (j) heading and the first sentence in paragraph 
(j)(1); and

[[Page 71463]]

0
g. In paragraph (j)(2), remove the word ``opiates'' and add in its 
place the word ``opioids''; in paragraph (j)(3), remove the word 
``opiates'' and add in its place the phrase ``opioids (i.e., morphine 
and/or codeine)''; and in paragraph (j)(4) introductory text, remove 
the word ``opiates'' and add in its place the word ``opioids''.
    The addition and revisions read as follows:


Sec.  26.185  Determining a fitness-for-duty policy violation.

* * * * *
    (f) * * *
    (3) If the MRO and the laboratory agree that further testing would 
not be useful and there is no legitimate technical or medical 
explanation, and the invalid result is based on pH in the range of 9.0 
to 9.5, the MRO shall consider whether there is evidence of elapsed 
time, exposure of the specimen to high temperature, or both that could 
account for the pH value. If an acceptable explanation exists for the 
invalid test result due to pH, based on objective and sufficient 
information, that elapsed time, high temperature, or both caused the 
high pH and donor action did not result in the invalid pH result, the 
MRO shall report a cancelled test result to the licensee or other 
entity, cancel the test result, and direct the licensee or other entity 
to collect a second urine specimen from the donor as soon as reasonably 
practicable. The second specimen collected may not be collected under 
direct observation.
* * * * *
    (g) * * *
    (2) If the results of the special analysis testing required by 
Sec.  26.163(a)(2) are positive, the MRO determines that there is no 
legitimate medical explanation for the presence of the drug(s) or drug 
metabolite(s) in the specimen, and a clinical examination, if required 
under paragraph (g)(3) of this section, has been conducted under 
paragraph (j) of this section, the MRO shall determine whether the 
positive and dilute specimen is a refusal to test. If the MRO does not 
have sufficient reason to believe that the positive and dilute specimen 
is a subversion attempt, he or she shall determine that the drug test 
results are positive and that the donor has violated the FFD policy. 
When determining whether the donor has diluted the specimen in a 
subversion attempt, the MRO shall also consider the following 
circumstances, if applicable:
* * * * *
    (iii) The collector observed conduct indicating an attempt to 
dilute the specimen.
* * * * *
    (j) Review for opioids and prescription and over-the-counter 
medications. (1) If the MRO determines that there is no legitimate 
medical explanation for a positive confirmatory test result for opioids 
(i.e., morphine and/or codeine) and before the MRO determines that the 
test result is a violation of the FFD policy, the MRO or his/her 
designee, who shall also be a licensed physician with knowledge of the 
clinical signs of drug abuse, shall determine that there is clinical 
evidence, in addition to the positive confirmatory test result, that 
the donor has illegally used morphine and/or codeine. * * *
* * * * *

0
34. In Sec.  26.405, revise paragraph (d) to read as follows:


Sec.  26.405  Drug and alcohol testing.

* * * * *
    (d) At a minimum, licensees and other entities shall test specimens 
for marijuana metabolite, cocaine metabolite, opioids (codeine, 
morphine, 6-acetylmorphine, hydrocodone, hydromorphone, oxycodone, and 
oxymorphone), amphetamines (amphetamine, methamphetamine, 
methylenedioxymethamphetamine, and methylenedioxyamphetamine), 
phencyclidine, and alcohol at the cutoff levels specified in this part, 
or comparable cutoff levels if specimens other than urine are collected 
for drug testing. Urine specimens collected for drug testing must be 
subject to validity testing that includes testing for adulterants.
* * * * *


Sec.  26.415  [Amended]

0
35. In Sec.  26.415, in paragraph (c), remove the citation ``(65 FR 
41944; August 9, 2001)''.


Sec.  26.715  [Amended]

0
36. In Sec.  26.715, in paragraph (b)(1), remove the phrase 
``collection site, licensee testing facility, or HHS-certified 
laboratory'' and add in its place the phrase ``collection site or 
licensee testing facility.''

0
37.

0
38. In Sec.  26.717, revise paragraphs (b)(3) and (4) to read as 
follows:


Sec.  26.717  Fitness-for-duty program performance data.

* * * * *
    (b) * * *
    (3) Populations tested (i.e., licensee or other entity employees, 
C/Vs);
    (4) Number of tests administered and results of those tests sorted 
by population tested (i.e., licensee or other entity employees, C/Vs);
* * * * *

    Dated November 9, 2022.

    For the Nuclear Regulatory Commission.
Brooke P. Clark,
Secretary of the Commission.
[FR Doc. 2022-24903 Filed 11-21-22; 8:45 am]
BILLING CODE 7590-01-P