[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
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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
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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