[Federal Register Volume 84, Number 179 (Monday, September 16, 2019)]
[Proposed Rules]
[Pages 48750-48781]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18491]
[[Page 48749]]
Vol. 84
Monday,
No. 179
September 16, 2019
Part III
Nuclear Regulatory Commission
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10 CFR Part 26
Fitness for Duty Drug Testing Requirements; Proposed Rule
Federal Register / Vol. 84 , No. 179 / Monday, September 16, 2019 /
Proposed Rules
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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: Proposed rule and draft regulatory guide; request for comment.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is proposing to
amend its regulations regarding fitness for duty (FFD) programs for
certain NRC licensees and other entities to more closely align the
NRC's drug testing requirements with the updates made to the U.S.
Department of Health and Human Services ``Mandatory Guidelines for
Federal Workplace Drug Testing Programs'' in 2008, which became
effective on October 1, 2010. The proposed rule would also incorporate
lessons learned from implementation of the NRC's current FFD
regulations. These changes would 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. The proposed rule would also provide additional protections to
individuals subject to drug testing and would improve the clarity,
organization, and flexibility of the NRC's FFD regulations. The NRC is
also requesting comment on draft regulatory guide 5040.
DATES: Submit comments by December 2, 2019. Comments received after
this date will be considered if it is practical to do so, but the NRC
is able to assure consideration only for comments received on or before
this date.
ADDRESSES: You may submit comments by any of the following methods
(unless this document describes a different method for submitting
comments on a specific subject):
Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2009-0225. Address
questions about NRC dockets to Carol Gallagher; telephone: 301-415-
3463; email: [email protected]. For technical questions, contact
the individual listed in the FOR FURTHER INFORMATION CONTACT section of
this proposed rule.
Email comments to: [email protected]. If you do
not receive an automatic email reply confirming receipt, then contact
us at 301-415-1677.
Fax comments to: Secretary, U.S. Nuclear Regulatory
Commission at 301-415-1101.
Mail comments to: Secretary, U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001, ATTN: Rulemakings and
Adjudications Staff.
Hand deliver comments to: 11555 Rockville Pike, Rockville,
Maryland 20852, between 7:30 a.m. and 4:15 p.m. (Eastern Time) Federal
workdays; telephone: 301-415-1677.
For additional direction on obtaining information and submitting
comments, see ``Obtaining Information and Submitting Comments'' in the
SUPPLEMENTARY INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT: Stewart Schneider, Office of Nuclear
Material Safety and Safeguards, telephone: 301-415-4123; email:
[email protected]; Brian Zaleski, Office of Nuclear Security
and Incident Response, telephone: 301-287-0638; email:
[email protected]; or Paul Harris, Office of Nuclear Security and
Incident Response, telephone: 301-287-9294; email: [email protected];
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 proposing to amend
its regulations regarding fitness for duty (FFD) programs for certain
NRC licensees and other entities to more closely align the NRC's drug
testing requirements with the updates made in 2008 to the U.S.
Department of Health and Human Services (HHS) ``Mandatory Guidelines
for Federal Workplace Drug Testing Programs'' (HHS Guidelines), which
were published in the Federal Register on November 25, 2008 (73 FR
71858), corrected on December 10, 2008 (73 FR 75122), and became
effective on October 1, 2010 (75 FR 22809; April 30, 2010). 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 (DOT)) that test civilians in
safety- and security-sensitive positions similar to personnel tested
under part 26, ``Fitness for Duty Programs,'' in title 10 of the Code
of Federal Regulations (10 CFR). More closely aligning the drug testing
provisions under 10 CFR part 26 with the 2008 HHS Guidelines would
enhance the ability of licensees and other entities to identify
individuals using illegal drugs and misusing legal drugs. The proposed
rule would also incorporate 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
Major provisions of the proposed rule include the following:
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 proposed rule.
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 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 dilute validity test results and in
specimens collected under direct observation.
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
addressing personnel who may monitor a donor in a shy-bladder situation
who is hydrating; and enhance both donor protections by providing
additional
[[Page 48751]]
instructions for same-gender observers used in observed collections and
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. Costs and Benefits
The NRC prepared a draft regulatory analysis to quantify the costs
and benefits of the proposed rule, as well as to examine the
qualitative factors to be considered in the NRC's rulemaking decision.
The analysis concluded that the proposed rule would result in net costs
to the industry. The proposed rule, relative to the regulatory
baseline, would result in a net cost to industry of between $2.4
million based on a 7 percent net present value and $3.4 million based
on a 3 percent net present value. The estimated average net cost per
licensee or other entity site would be a one-time cost of $5,031 and an
annual cost of $2,516. Thirteen qualitative factors were evaluated in
the draft 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 draft regulatory analysis includes a
narrative discussion of each qualitative factor.
If the results of the regulatory analysis were based solely on the
costs and the benefits that could be quantified, then the regulatory
analysis would show that rulemaking is not justified because the total
estimated quantified benefits of the proposed regulatory action do not
equal or exceed the estimated costs of the proposed regulatory action.
However, when the qualitative benefits are considered, together with
the quantified benefits, then the benefits outweigh the identified
quantitative and qualitative impacts.
In the draft regulatory analysis, the NRC concluded that the
proposed rule should be adopted because it would result in a 10- to 12-
percent increase per year in the detection of individuals using drugs
or attempting to subvert the drug testing process. In comparison to the
test results from calendar years 2013 and 2014, the estimated increase
in detection each year is equivalent to identifying approximately 95
additional individuals using illegal drugs, misusing legal drugs, or
attempting to subvert the drug testing process. This improved detection
would prevent 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 would prevent drug-using individuals
from gaining or maintaining unescorted access authorization to special
strategic nuclear material (SSNM) or sensitive information. An enhanced
drug testing program might also deter drug-using individuals from
seeking employment in 10 CFR part 26 regulated positions and/or
incentivize those already in regulated positions to cease drug use or
to seek medical assistance to address an addiction or misuse issue.
For more information, please see the regulatory analysis (Accession
No. ML19169A115 in the NRC's Agencywide Documents Access and Management
System (ADAMS)).
Table of Contents
I. Obtaining Information and Submitting Comments
A. Obtaining Information
B. Submitting Comments
II. Background
A. The Health and Human Services Guidelines
B. History of the NRC's Fitness for Duty Program
III. Discussion
A. The Need for Rulemaking
1. Alignment With the 2008 Health and Human Services Guidelines
2. Societal Drug Use
B. Public Input Regarding Proposed Revisions to 10 CFR Part 26
To Include Aspects of the 2008 Health and Human Services Guidelines
C. Description of Proposed Changes
IV. Section-by-Section Analysis
V. Specific Requests for Comments
VI. Regulatory Flexibility Certification
VII. Regulatory Analysis
VIII. Backfitting and Issue Finality
IX. Cumulative Effects of Regulation
X. Plain Writing
XI. Environmental Impact: Categorical Exclusion
XII. Paperwork Reduction Act Statement
XIII. Compatibility of Agreement State Regulations
XIV. Voluntary Consensus Standards
XV. Availability of Guidance
XVI. Availability of Documents
I. Obtaining Information and Submitting Comments
A. Obtaining Information
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.
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, 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.
NRC's PDR: You may examine and purchase copies of public
documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555
Rockville Pike, Rockville, Maryland 20852.
B. Submitting Comments
Please include Docket ID NRC-2009-0225 in your comment submission.
The NRC cautions you not to include identifying or contact
information that you do not want to be publicly disclosed in your
comment submission. The NRC will post all comment submissions at
https://www.regulations.gov as well as enter the comment submissions
into ADAMS. The NRC does not routinely edit comment submissions to
remove identifying or contact information.
If you are requesting or aggregating comments from other persons
for submission to the NRC, then you should inform those persons not to
include identifying or contact information that they do not want to be
publicly disclosed in their comment submission. Your request should
state that the NRC does not routinely edit comment submissions to
remove such information before making the comment submissions available
to the public or entering the comment into ADAMS.
II. Background
A. The Health and Human Services Guidelines
Through Executive Order 12564 (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
[[Page 48752]]
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 adherence to the HHS Guidelines. The HHS laboratory
certification process provides assurance to the NRC, licensees, and
other entities that the testing of specimens, under 10 CFR part 26, 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; revise the authorized
substances in the testing panel as societal drug-use trends change; and
incorporate 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 has historically relied on HHS to establish the technical
requirements for urine specimen collection, specimen testing and test
result evaluation, and in general only deviates from the HHS Guidelines
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 2008 HHS Guidelines would help to ensure 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 (51 FR 27921), the NRC published the
Commission Policy Statement on Fitness for Duty of Nuclear Power Plant
Personnel, which outlined the need for nuclear power plant licensees to
implement programs to address FFD problems--including illegal drug use,
alcohol abuse, misuse of legal drugs, and any other mental or physical
problems that could impair job performance. An 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 (SSNM).
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 10 CFR
part 26 updates included the following: (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 the following: (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. The 2008 Guidelines' updates to the 2004
Guidelines are currently not reflected in 10 CFR part 26.
III. Discussion
A. The Need for Rulemaking
1. Alignment With the 2008 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, and methamphetamine; (2) establishing
an initial testing requirement and revising the confirmatory testing
cutoff level for the heroin metabolite 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, the
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
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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).
As detailed in the NRC report, ``Summary of Fitness for Duty
Performance Reports for Calendar Year 2013,'' an adverse trend in the
commercial nuclear industry had been observed over the prior 5 years
associated with the year-over-year increases in amphetamines \1\
positive test results (see table in this section). While accounting for
a relatively small percentage of the total positive drug test results
in 2013 at 8.9 percent, amphetamines positives have continued to grow
in comparison to previous years. For example, the share of amphetamines
positives, as a percentage of all positive drug test results in 2013
(8.9 percent), is 2.3 times higher than the percentage in 2009 (3.9
percent). Viewed another way, the percentage of individuals testing
positive for amphetamines has trended upward since 2009. In 2009, 0.023
percent of individuals tested positive for amphetamines; by 2013, the
positive rate increased to 0.052 percent. Conversely, cocaine use as a
percentage of all positives has declined by 15.9 percent from 1990 (the
first year of 10 CFR part 26 drug testing) to 2013. While cocaine use
has trended downward, it continues to be the third most detected
substance, accounting for 13.2 percent of positive drug test results in
2013.
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\1\ Initial drug testing for amphetamines and confirmatory drug
testing for amphetamine and methamphetamine is required by 10 CFR
part 26.
Trends in Amphetamines and Cocaine Use
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Change (1990-
Substance 1990 2009 2010 2011 2012 2013 2013)
(percent) (percent) (percent) (percent) (percent) (percent) (percent)
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Amphetamines.............................................. 2.8 3.9 5.7 8.3 6.2 8.9 6.1
Cocaine................................................... 29.0 16.2 13.1 12.4 12.9 13.2 -15.9
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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 testing under 10 CFR part 26, are included as the baseline for comparison.
While most of the proposed changes in this rulemaking would be made
to better align 10 CFR part 26 with the 2008 HHS Guidelines, some are
based on lessons learned during the implementation of the 2008 FFD
final rule by licensees and other entities. In particular, the NRC is
proposing a number of changes that would 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) created by the NRC, in
collaboration with licensees and other entities, in order to meet the
annual FFD drug and alcohol testing program reporting requirements in
Sec. 26.717, ``Fitness-for-duty program performance data'' and Sec.
26.417(b)(2). These e-forms \2\ provide a uniform way of reporting
detailed information on each drug and alcohol testing violation, and
their use by licensees and other entities has continued to grow (from
over 80 percent in 2011 to 93 percent in 2013).
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\2\ The NRC FFD electronic forms are available for review 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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Analysis of FFD program performance data from 2011 through 2014
identified a significant new trend: The prevalence of subversion
attempts of the drug testing process. In 2011, over 13.2 percent of the
total testing violations were donor subversion attempts (143 of 1,080
testing violations), with even more subversion attempts in subsequent
years: 15.9 percent in 2012 (177 of 1,114 testing violations), 14.7
percent in 2013 (148 of 1,007 violations), and 16.5 percent in 2014
(187 of 1,133 testing violations). If the number of alcohol positive
testing violations is removed from the total testing violations each
year, the percentage of drug testing violations determined to be
subversion attempts increases to 17.5 percent in 2011, 20.6 percent in
2012, 19.2 percent in 2013, and 21.3 percent in 2014. 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 10 CFR 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 is proposing a number of changes in
this proposed rule to enhance the ability of FFD testing programs to
detect individuals attempting to subvert the drug testing process.
Stakeholder outreach on the proposed rule is described in Section
III.B of this document. The basis for each proposed change is discussed
in Section III.C of this document. The regulatory basis for this
proposed rule, issued on May 10, 2013, provides further discussion on
the technical merits of this rulemaking.
2. Societal Drug Use
As described in the President's 2014 ``National Drug Control
Strategy,'' societal use of legal and illegal drugs and substances
continues to evolve and affects every sector of society. The prevalence
of drug use in society is also documented in the ``Behavioral Health
Trends in the United States: Results from the 2014 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 2014, 10.2 percent of the U.S. population aged 12 or
older (approximately 27.0 million Americans) used an illegal drug in
the past month. This estimate was based on the number of individuals
surveyed that reported using an illegal drug during the month prior to
participating in the NSDUH survey interview. Among adults aged 26 or
older, those potentially in the U.S. workforce, the rate of illegal
drug
[[Page 48754]]
use was 8.3 percent, representing an upward trend since 2002. Although
SAMHSA attributes this increase to marijuana use, it demonstrates the
prevalence of illegal drug use in the workforce. 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 Input Regarding Proposed Revisions to 10 CFR Part 26 To
Include Aspects of the 2008 Health and Human Services Guidelines
After HHS issued the 2008 HHS Guidelines, the NRC performed a
comprehensive review of 10 CFR part 26 and the 2008 HHS Guidelines to
identify provisions in the NRC's regulations that may need to be
revised. Two public meetings were held in 2009, on February 24 and June
24, with regulated entities, interest groups, and members of the
general public to discuss the changes in the 2008 HHS Guidelines. In
2010, the NRC analyzed the DOT's final rule changes to 49 CFR part 40,
``Procedures for Transportation Workplace Drug and Alcohol Testing
Programs'' (75 FR 49850; August 16, 2010) to understand how another
Federal agency that tests civilians implemented the 2008 HHS
Guidelines. The NRC also analyzed lessons learned from implementation
of the 2008 FFD final rule. Collectively, these efforts resulted in a
list of potential changes to 10 CFR part 26 that the NRC presented, for
feedback, at a third public meeting held on October 11, 2011. The NRC
summarized public comments received at the October 11 meeting, as well
as emailed comments received subsequent to the meeting, in a document
titled ``Comments for the October 11, 2011, Public Meeting'' (included
as Enclosure 3 in package available via ADAMS Accession No.
ML112930153). A fourth meeting was held on September 11, 2013, to
inform the public of the status of the rulemaking. Public meetings were
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.
Based upon feedback received during the four public meetings, some
of the NRC-proposed revisions were removed from consideration because
the NRC decided that it was not appropriate to pursue those particular
issues in this rulemaking, while others were revised. The NRC-proposed
revisions, along with associated issues raised by the public, are
discussed in Section III.C of this document.
C. Description of Proposed Changes
This section includes a description of each proposed change, the
rationale for each change, and a discussion of public comments that
informed the NRC's development of the changes.
Definitions
During the October 11, 2011, public meeting, an industry
participant requested that the NRC review the use of certain terms
under 10 CFR part 26 for consistency with the 2008 HHS Guidelines. The
NRC performed a review and proposes to add seven new definitions and
revise seven existing definitions under Sec. 26.5, ``Definitions.''
The revisions and additions would improve consistency with Section 1.5
of the 2008 HHS Guidelines and would improve the clarity, consistency,
and accuracy of the requirements under 10 CFR part 26. Specifically,
the following definitions would be added: Cancelled test, carryover,
Certifying Scientist, Federal custody and control form, lot, rejected
for testing, and Responsible Person. The following definitions would be
revised: calibrator, control, dilute specimen, HHS-certified
laboratory, invalid result, 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 would clarify the actions
taken by an MRO and improve consistency between 10 CFR part 26 and the
2008 HHS Guidelines. The NRC is also proposing to add 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.
Carryover. The proposed rule would add 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 would also apply 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
proposed definition is similar to the definition in Section 1.5 of the
2008 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. The proposed rule would add 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
would be 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 would improve consistency between 10
CFR part 26 and the 2008 HHS Guidelines. A conforming change would be
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). The proposed rule
would add a definition for the term Federal
[[Page 48755]]
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 would align 10 CFR part 26 with Section 1.5 of the 2008
HHS Guidelines and improve the clarity of the rule by defining the
term, which is already used in Sec. 26.153(g). The proposed rule would
revise the NRC's initial proposed definition of Federal CCF, based on
feedback received during the October 11, 2011, public meeting. The
definition that the NRC proposed at that meeting listed the specific
name of the HHS-approved form used for urine drug testing (i.e.,
Federal Drug Testing Custody and Control Form) and closely paralleled
the definition in Section 1.5 of the 2008 HHS Guidelines. However,
based on comments received during the meeting, the NRC agrees that
referencing the specific name on the form was too prescriptive and
could require additional revision to 10 CFR part 26, should HHS revise
the form name in the future. Therefore, the NRC is proposing to use the
generic title, Federal CCF, to avoid the need for future regulatory
changes, should the title of the form change. The definition may also
provide flexibility in accounting for additional forms that SAMHSA may
create for use when conducting drug and validity testing of alternative
specimens (e.g., oral fluids, hair). To align with the new definition,
``Federal custody-and-control form,'' which appears in Sec. 26.153(g),
would be replaced with the term ``Federal CCF.'' In addition, to
improve the consistency of terminology used throughout 10 CFR part 26,
the NRC is also proposing to replace the term ``custody and control
form'' with the term ``Federal CCF.'' The plural versions, ``custody
and control forms'' and ``custody and control form(s),'' would also be
replaced with the terms ``Federal CCFs'' and ``Federal CCF(s),''
respectively. Finally, the proposed rule would correct 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. The proposed rule would add 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
would improve consistency between 10 CFR part 26 and the definition of
lot in Section 1.5 of the 2008 HHS Guidelines. The proposed rule would
use 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. The proposed rule also
would include in the definition the parenthetical statement from the
2008 HHS Guidelines definition that provides examples of the term
``item.'' The NRC would change one of the examples in the parenthetical
statement by replacing ``quality control material'' with ``quality
control samples.'' The term ``quality control material'' has not been
used in 10 CFR part 26.
Rejected for testing. The proposed rule would add to Sec. 26.5 a
definition for rejected for testing that is similar to the definition
in Section 1.5 of the 2008 HHS Guidelines, referring to a report by a
licensee testing facility 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 is not currently defined. Including a definition
would clarify what information is being reported by the HHS-certified
laboratory to the licensee or other entity in the annual quantitative
summary of test results. In addition, defining the term would align
with two additional proposed 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'' would be 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'' would be 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. The proposed rule would add a definition for
Responsible Person to Sec. 26.5. The position title is used in Sec.
26.31(d)(1)(D) but is not currently defined. A Responsible Person would
be 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 would improve consistency between 10
CFR part 26 and the 2008 HHS Guidelines. A conforming change would be
made to Sec. 26.167(f)(3) to capitalize the position title in the
phrase ``a statement by the laboratory's responsible person.''
Calibrator. The proposed rule would revise the definition for
calibrator in Sec. 26.5 to more closely align with the definition in
Section 1.5 of the 2008 HHS Guidelines and to also improve internal
consistency of terminology used in 10 CFR part 26. The definition of
calibrator would be revised to include a clarifying statement that a
calibrator is a solution of known concentration ``in the appropriate
matrix'' that aligns with the definition in the 2008 HHS Guidelines.
The phrase ``test specimen/sample'' would be replaced with the phrase
``donor specimen or quality control sample'' to improve consistency
with the terminology used in 10 CFR part 26. The last sentence of the
definition, which states that ``calibrators may be used to establish a
cutoff concentration and/or a calibration curve over a range of
interest,'' would be deleted. 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. The proposed rule would revise the definition of control
in Sec. 26.5 to conform to the definition of the term in Section 1.5
of the 2008 HHS Guidelines. The term control in Sec. 26.5 would be
revised by replacing the phrase ``a sample used to monitor the status
of an analysis to maintain its
[[Page 48756]]
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. The proposed rule would revise the definition of
dilute specimen in Sec. 26.5 to conform to the definition of the term
in Section 1.5 of the 2008 HHS Guidelines. The phrase ``concentrations
that are lower than expected for human urine'' would be 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 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 citations
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 laboratories to the HHS
Guidelines that are in effect. The proposed rule would correct 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. Other requirements in 10 CFR part 26 already
specify the drug testing panel and testing cutoff levels, validity
testing requirements, and quality control requirements. The proposed
change to the definition of HHS-certified laboratory would eliminate
the need to revise 10 CFR part 26, should future versions of the HHS
Guidelines be published. Two conforming changes would also be made,
based on the revision to the definition of HHS-certified laboratory.
The first change would revise Sec. Sec. 26.4(j)(3) and 26.153(a) to
reference ``HHS-certified laboratories as defined in Sec. 26.5.''
Section 26.153(a) would also be revised to remove the reference to the
physical address of the Division of Workplace Programs as the location
to obtain information concerning the certification status of
laboratories.
Invalid result. The proposed rule would revise 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 HHS Guidelines and would also
improve the clarity and accuracy of the 10 CFR part 26 rule. 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 substance at an abnormal concentration that prevents
the laboratory from completing testing or obtaining a valid drug test
result'' would be 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 would also correct an
inaccuracy in the current definition of invalid result, which does not
include ``specimen validity test.''
Limit of Quantitation. The proposed rule would revise the
definition for Limit of Quantitation (LOQ) in Sec. 26.5 to more
closely align with Section 1.5 of the 2008 HHS Guidelines. To align
with the terminology used in 10 CFR part 26, the proposed definition
would use ``analyte'' instead of the word ``measurand.'' \3\
---------------------------------------------------------------------------
\3\ ``Analyte'' means the drug or drug metabolite measured by an
initial or confirmatory drug test.
---------------------------------------------------------------------------
Substituted specimen. The proposed rule would revise the definition
of substituted specimen in Sec. 26.5 to align with the definition of
the term in Section 1.5 of the 2008 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'' would be 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.'' \4\ The revision would also improve the
clarity of the rule by explaining that a substituted specimen is the
result of donor action to subvert the testing process by stating that
the specimen ``has been submitted in place of the donor's urine.''
---------------------------------------------------------------------------
\4\ ``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
The proposed rule would add 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 HHS
Guidelines. The 2008 HHS Guidelines also added an additional
amphetamine-based chemical compound, methylenedioxyethylamphetamine
(MDEA); however, in its 2017 mandatory guidelines (82 FR 7920; January
23, 2017) HHS subsequently removed MDEA from its drug testing panel
because HHS determined that the number of positive MDEA specimens
reported from its certified laboratories does not support testing
specimens for MDEA. MDMA (also known as Ecstasy or Molly) and MDA are
listed in 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 lacks an accepted safety for use of the drug or substance
under medical supervision (21 U.S.C. 812 (2012)). The proposed rule
would revise Sec. Sec. 26.31(d)(1) and 26.405(d) to identify MDMA and
MDA as substances for which licensees and other entities are required
to test; Sec. 26.133, ``Cutoff levels for drugs and drug
metabolites,'' and Sec. 26.163(a)(1) to require initial testing for
MDMA and MDA; and Sec. 26.163(b)(1) to require confirmatory testing
for MDMA and MDA. By requiring licensees and other entities to test for
additional substances, a greater range of drugs that impair human
performance can be detected. Also, it would assist in the
identification of those persons who, because they use illegal drugs,
exhibit characteristics of not being trustworthy and reliable. The
drugs MDMA and MDA would be added to the NRC-required drug testing
panel because of their potential adverse effects on human performance,
which were detailed by the 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 would also expand the NRC-required drug testing
panel to include initial testing for 6-AM, consistent with Section 3.4
of the 2008 HHS Guidelines. This change would improve the assurance
that the testing method used under 10 CFR part 26 would identify an
individual using heroin, a Schedule I drug. Currently, 10
[[Page 48757]]
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.
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
amphetamines and cocaine metabolites. The proposed rule would update
the substances and cutoff levels for initial drug testing, as listed in
the tables in Sec. Sec. 26.133 and 26.163(a)(1), to conform with
Section 3.4 of the 2008 HHS Guidelines. Specifically, the proposed rule
would make the following changes in each table: (1) Lower the initial
test cutoff level for amphetamines (abbreviated in the tables as AMP),
(2) lower the initial test cutoff level for cocaine metabolites, (3)
clarify the existing testing requirement for ``opiate metabolites'' by
replacing the term with ``codeine/morphine,'' (4) include a new
footnote 1 to each table to clarify that the target analyte for
``codeine/morphine'' testing is morphine, (5) clarify in a new footnote
2 to each table that either a single or multiple initial test kit(s)
may be used for amphetamines testing, and (6) include a new footnote 3
in each table 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
the tables in Sec. Sec. 26.133 and 26.163(b)(1) would also be revised
to ``Drugs or drug metabolites'' to align with the table titles.
Lowering the cutoff levels for these existing drugs and drug
metabolites in the NRC-required testing panel would increase 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 would provide a higher degree of assurance that persons who
are using illegal drugs or misusing legal drugs would be identified.
The NRC anticipates that the proposed lower testing cutoff levels would
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 proposed rule.
In addition, the proposed rule would revise 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 HHS Guidelines, which require the
HHS-certified laboratory to make a determination that each specimen is
either ``negative'' or ``positive,'' respectively, 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 amphetamine, cocaine metabolite, and methamphetamine and expanding
the testing panel to include confirmatory drug testing for the Ecstasy
drugs MDMA and MDA. The NRC proposes to expand the number of substances
in the NRC-required testing panel and to lower the cutoff levels for
confirmatory drug tests, as listed in the table in Sec. 26.163(b)(1),
to align with Section 3.4 of the 2008 HHS Guidelines. Specifically, the
proposed rule would make the following changes: (1) Lower the
confirmatory test cutoff level for amphetamine from 500 ng/mL \5\ to
250 ng/mL; (2) lower the confirmatory test cutoff level for cocaine
metabolite from 150 ng/mL to 100 ng/mL; (3) lower the confirmatory test
cutoff level for methamphetamine from 500 ng/mL to 250 ng/mL; (4)
eliminate 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; (5) redesignate
table footnote 4 as footnote 3 and update the text to lower the
amphetamine concentration from 200 ng/mL to 100 ng/mL that must also be
present in a specimen to be positive for methamphetamine; and (6)
include confirmatory testing for MDMA and MDA at a cutoff level of 250
ng/mL. Similar to the changes made to the initial testing cutoff
levels, lowering the confirmatory testing cutoff levels for
amphetamine, cocaine metabolite, and methamphetamine would increase 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, the proposed rule would make two clarifying changes to the
table in Sec. 26.163(b)(1) by revising the term ``Opiates'' to
``Opiate metabolites'' and adding the abbreviation ``(6-AM)'' after 6-
acetylmorphine. Finally, the column header ``Drug or metabolites'' in
the table in Sec. 26.163(b)(1) would be revised to ``Drugs or drug
metabolites'' to align with the table title. These changes would
improve consistency with Section 3.4 of the 2008 HHS Guidelines and
with the proposed revisions to Sec. Sec. 26.133 and 26.163(a)(1).
---------------------------------------------------------------------------
\5\ The unit ng/mL is nanograms per milliliter or a millionth of
a gram per liter.
---------------------------------------------------------------------------
The proposed rule would update the information that each HHS-
certified laboratory must include in the annual statistical summary
report of test results provided to each licensee or other entity under
Sec. 26.169(h)(3) to reflect the expanded drug testing panel in
revised Sec. Sec. 26.31(d)(1) and 26.405. Specifically, the proposed
rule would require each HHS-certified laboratory to include, in the
annual statistical summary of urinalysis testing provided to each
licensee and other entity, the number of specimens reported as positive
for MDMA and MDA. Additional conforming changes would improve the
clarity and uniformity of the names of the drugs and drug metabolites
listed in Sec. 26.169(h)(3), to include adding ``(as THCA)'' \6\ after
``Marijuana metabolites,'' adding ``(as benzoylecgonine)'' after
``Cocaine metabolite,'' revising ``6-AM'' to ``6-acetylemorphine (6-
AM),'' and revising ``Phencyclidine'' to ``Phencyclidine (PCP).''
---------------------------------------------------------------------------
\6\ THCA is an abbreviation for delta-9-tetrahydrocannabinol-9-
carboxylic acid.
---------------------------------------------------------------------------
Validity Testing of Adulterants at HHS-Certified Laboratories
The proposed rule would revise 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
[[Page 48758]]
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 proposed changes to Sec. 26.161(c)(3) through (c)(6) are
consistent with Section 3.5 of the 2008 HHS Guidelines, which describes
the validity testing criteria for the adulterants chromium (VI),
halogens (e.g., bleach, iodine, fluoride), glutaraldehyde, and pyridine
(pyridinium chlorochromate). The proposed changes 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 for the same adulterants described in
the previous sentence but as applied to invalid results.
The NRC is not proposing to 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 is not
proposing to 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.
The proposed rule would also revise 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.''
The proposed changes would provide additional flexibility in the
confirmatory testing methods that may be used by the laboratory and
would align 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 (73 FR 17091 and 17102;
March 31, 2008), and Section 11.19(d) of the 2008 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 prior to providing a urine
specimen for testing in the hope of diluting the concentration of any
drugs and drug metabolites in the specimen below the standard 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 dilute specimens 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
prior to providing a specimen for testing. The proposed rule would make
four changes to the special analyses testing requirements in Sec.
26.163(a)(2).
First, the proposed rule would require 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 2014 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 2014, 92 percent of licensees and other entities
have adopted the special analyses testing policy. The proposed rule
would eliminate 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 (g)(3). These tests would instead be required.
Second, the proposed rule would lower 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. The proposed rule would lower 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 would improve the ability of licensees and
other entities to identify drug-using individuals attempting to subvert
the drug testing process. This change would not affect the drug testing
assays used by HHS-certified laboratories because under the 2008 HHS
Guidelines, each laboratory must already validate the accuracy of each
assay to 40 percent of the cutoff calibrator. Laboratories would need
to change their administrative procedures to define the initial test
result concentration that would trigger special analyses testing.
Third, the proposed rule would replace 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 would not require
laboratories to change the testing assays used.
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
[[Page 48759]]
testing specification, the laboratory must establish both the LOD and
the LOQ below the 40 percent cutoff, which results in variability
amongst 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 the public meetings requested a
standardized level be used across all laboratories performing special
analyses testing. However, this position would be 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, the proposed rule would expand 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 rule, 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 would
provide additional assurance that drugs and drug metabolites present in
the specimen collected under direct observation from a donor would be
identified, which would improve 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 provides
conclusive evidence to the MRO to make a subversion determination on
the initial specimen provided. Therefore, the proposed rule would
revise Sec. 26.163(a)(2)(i) to require that special analyses testing
be performed on specimens collected under Sec. 26.115(a)(1) through
(a)(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 2014 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 would provide
additional assurance that drug use would be 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
2014 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
would provide additional assurance that drug use would be 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 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 would provide additional assurance for the same reason
described for specimens collected under Sec. 26.115(a)(1).
The proposed change to require special analyses testing of
specimens collected under direct observation would 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).'' The proposed rule would eliminate the Federal
Register citation from each part 26 section 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 was 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
The proposed rule would make a number of revisions to the specimen
collection procedures in 10 CFR part 26: (1) Clarify and enhance the
instructions on conducting an observed collection, (2) permit the use
of mirrors to assist in
[[Page 48760]]
performing directly observed collections, (3) allow FFD program
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 would improve the clarity, consistency, and flexibility of
the collection procedures and to align more closely with the 2008 HHS
Guidelines.
Section 26.115(e), (f), and (f)(1) through (f)(3) would be revised
to improve the clarity of instruction on conducting a directly observed
specimen collection, which would improve consistency with Sections
4.4(a) and 8.9 of the 2008 HHS Guidelines.
The proposed rule would remove 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.'' The NRC proposes to add 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) of this section.'' The proposed
change would improve the clarity of the existing requirements and
ensure that the donor is informed that an individual other than the
collector is to observe the specimen provision and understands the
procedures that must be followed to complete the specimen collection.
The proposed change also incorporates feedback received at the October
11, 2011, public meeting, at which a participant suggested using the
phrase ``who has received instruction'' instead of the phrase ``who has
received training,'' when referring to the information that is provided
to a same-gender observer by the collector. ``Training'' implies a
formal process rather than providing oral or written instructions. The
NRC agrees that the commenter's proposed wording conveys a more
accurate description of how the collector would convey the information
regarding specimen collection to a same-gender observer. The collector
would only be required to give the same-gender observer instructions,
rather than formal training.
In Sec. 26.115(f)(2), the proposed rule would add the
parenthetical statement ``(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 is not sufficient to meet this direct
observation requirement; the use of a video camera to assist in the
observation process is not permitted)'' to the end of the existing
requirement. This proposed change also incorporates stakeholder
feedback at the public meeting on October 11, 2011, at 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 are currently 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 prior to the provision of a specimen during the observed
collection process and that the use of reflective mirrors, not two-way
mirrors, would be acceptable. As required by Sec. 26.115(f)(1), prior
to 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 that the specimen provided is from
the donor and ensures the integrity of the specimen collection process.
As a result, the NRC is proposing to revise Sec. 26.115(f)(2) to
permit the use of reflective mirrors.
The NRC also proposes to revise 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, in
part, because the conversion of visible light to an electronic format,
through a video camera, is not a 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 the donor beyond the individual conducting the observation.
During the public meeting on October 11, 2011, one participant
requested that the NRC consider eliminating the requirement in Sec.
26.115(f)(1) that the donor adjust his or her clothing during the
observed collection process to expose the area of the donor's body from
the waist to the knees. The NRC considered this request but is not
proposing to eliminate this provision for three reasons. First, the
purpose of directly observing the provision of a specimen is to ensure
that the drug testing process is not being subverted. The NRC's
collection procedure requires the donor to remove his or her clothing
between the waist and knees so that the collector can identify any
paraphernalia on the individual's body that may be used to subvert the
testing process, such as a prosthetic device, a container of synthetic
urine, or ampule of an oxidizing chemical. Second, materials used to
subvert a drug test are easily available for purchase, and licensees
and other entities have reported in annual performance reports required
by Sec. 26.717 that subversion attempts have been identified during
the directly observed collection process. Finally, the prevalence of
subversion attempts demonstrates that individuals are actively
attempting to thwart the drug testing process by specimen adulteration,
substitution, and dilution.
In Sec. 26.115(f)(3), the proposed rule would 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
[[Page 48761]]
collection container but shall maintain visual contact with the
specimen until the donor hands the collection container to the
collector.'' The proposed rule changes would 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 by using terminology consistent
with Sec. 26.113(b)(3).
The proposed rule would add Sec. 26.4(g)(6) and would revise Sec.
26.109(b)(1) to improve the efficiency of FFD programs by providing
licensees and other entities with additional flexibility in the
personnel who may monitor a donor during the hydration process, which
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, during which fluid is provided to assist the donor
in providing a specimen of adequate volume. In addition to the specimen
collector that initiated the specimen collection process with the
donor, a staff member designated as FFD program personnel in Sec.
26.4(g) would be allowed to monitor the donor during the hydration
process in place of the original collector. All FFD program personnel
must meet honesty and integrity requirements in Sec. 26.31(b) and have
familiarity with the collection facility, specimen collectors, and 10
CFR part 26 requirements sufficient to monitor the donor during the
hydration process. The additional flexibility of collection monitoring
provided by the rule change would enable the collector, who initiated
the collection process with a donor, to complete additional specimen
collections with other donors while the initial donor hydrates. Another
specimen collector, who meets the requirements in Sec. 26.85(a), could
also monitor the donor in the hydration process. The proposed change
could reduce the regulatory burden on FFD programs by affording
licensees and other entities additional staffing options to better
manage the collection process, while maintaining appropriate oversight
of the collection process. If a hydration monitor or another collector
is used, the original collector would be required to note the name of
the individual on the Federal CCF and the hydration monitor or second
collector then would maintain control of 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).
In addition, to improve the clarity of Sec. 26.109, the NRC is also
proposing that the last sentence of Sec. 26.109(b)(1), ``The collector
shall provide the donor with a separate collection container for each
successive specimen,'' would become 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.
The proposed rule would revise Sec. 26.89(d) in three ways. First,
Sec. 26.89(d) would be 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 proposed change to Sec.
26.109(b)(1). Second, Sec. 26.89(d) would be revised to more precisely
describe 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 phrase ``the urine specimen container
has been sealed and initialed, the chain of custody form has been
executed, and the donor has departed the collection site'' would be
replaced 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.'' Third, the phrase ``or when a
refusal to test has been determined under Sec. 26.107(d)'' would be
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.
The three changes would 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 would revise Sec. 26.107, ``Collecting a urine
specimen,'' in four ways related to how the donor is observed. First,
the proposed rule would redesignate paragraph (b) as paragraph (b)(1)
of this section. Second, the phrase ``, except as provided in Sec.
26.109(b)(1),'' would be 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 of the
proposed rule change to permit 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) would be
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 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 proposed
changes would provide additional examples of subversion attempt actions
that have been reported by licensees and other entities in the annual
information reports required by Sec. 26.719, ``Reporting
requirements.'' More accurate examples of subversion attempts in the
regulatory text provide additional clarity on donor actions that may be
considered a subversion attempt. Lastly, the phrase ``the collector
shall document the conduct'' in proposed Sec. 26.107(b)(1) would be
revised to ``the collector shall document a description of the
conduct,'' which would improve the clarity of the existing regulatory
requirement.
Section 26.107(b)(2) would be 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 rule change would be necessary because the
collector must be informed of any unacceptable donor behavior so that
appropriate action may be taken.
The proposed rule would revise 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 would be revised to ``adulterated, diluted, or substituted
the specimen.''
The proposed rule would revise Sec. 26.117, ``Preparing urine
specimens
[[Page 48762]]
for storage and shipping,'' in three ways. First, the proposed rule
would revise 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 ``urine specimen(s) in view at all times.'' This revision would
improve 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, as described in Sec. 26.107(a).
Second, two editorial errors would also be corrected in Sec.
26.117(f): The term ``chain-of-custody forms'' would be replaced with
the term ``Federal CCFs'' and the phrase ``or the licensee's testing
facility'' would be replaced with the phrase ``or to the licensee
testing facility.'' Third, the proposed rule would revise Sec.
26.117(g) to add the phrase ``except as provided in Sec.
26.109(b)(1)(ii), for the Federal CCF,'' to describe an instance when
the custody documents would not be under the control of the collector.
This change is needed because the proposed rule change to Sec.
26.109(b)(1)(ii) would permit another collector or hydration monitor to
observe the donor during the hydration process and to maintain the
Federal CCF during that time period.
With regard to urine specimen acceptability, the proposed rule
would revise 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.
The proposed rule would correct 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'' would be
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
The proposed rule would add Sec. 26.107(d) and revise 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) would be added 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; (4) discard any urine specimen(s) provided by the donor,
unless provided for a post-event test in Sec. 26.31(c)(3); and (5)
immediately inform the FFD program manager of the refusal to test. The
majority of these proposed changes are consistent with existing
collector practice. However, the proposed change to discard any urine
specimens, except if collected for a post-event test, would be a new
requirement to improve 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 would address this
inconsistency. The proposed revisions to Sec. 26.107(d) would help
ensure that if a donor refuses to cooperate with the collection
process, uniform action is taken, which would make 10 CFR part 26
consistent with Section 8.12 of the 2008 HHS Guidelines and improve its
effectiveness.
The proposed change to retain and test any specimen collected for a
post-event test in Sec. 26.31(c)(3) would help 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) would be revised to remove the word
``designated'' from the phrase ``designated FFD program manager.'' This
proposed 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).
Section 26.111(e) specifies that ``as much of the suspect specimen
as possible must be preserved.'' The proposed rule would add 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
proposed changes to Sec. 26.107(d).
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, substituted, or that is collected under
direct observation must be sent to an HHS-certified laboratory for
initial and, if necessary, confirmatory testing. Therefore, the NRC is
proposing to remove Sec. 26.111(f) to improve the clarity of 10 CFR
part 26.
Section 26.115(g) states that a donor declining to allow a directly
observed collection is an act to subvert the testing process. The
proposed rule would include a new requirement that in this instance
``the collector shall follow the procedures in Sec. 26.107(d).'' This
proposed requirement describes the
[[Page 48763]]
actions that the collector must take when a refusal to test has been
determined during the specimen collection process.
The NRC also received a public comment regarding the retention or
disposal of a urine specimen. The commenter recommended that the
initially collected specimen be retained, unless the MRO or FFD program
manager determined that a directly observed collection was necessary
and the donor refused to comply, which the NRC interpreted as a
reference to Sec. 26.111(c) of the regulations. Section 26.111(c)
requires the collector to contact the FFD program manager if there is
reason to believe that a donor may have attempted to adulterate,
dilute, or substitute a specimen based on the physical characteristics
of a specimen (e.g., temperature, color, odor, presence of a
precipitant) or other observations made during the collection. The FFD
program manager may consult with the MRO to determine if the donor has
attempted to subvert the testing process, and the FFD program manager
or the MRO may require the donor to provide a second specimen, as soon
as possible, and under direct observation. This section also requires
the collector to inform the donor that he or she may volunteer to
submit a second specimen under direct observation. The NRC has
determined that there is no regulatory necessity to maintain any
specimen provided by a donor, who has subsequently refused to cooperate
or otherwise subverted the testing process, unless this specimen was
for a post-event test, as required by Sec. 26.31(c)(3). This approach
is justified because upon such a determination, the donor who refuses
to test is permanently denied authorization to have the types of access
or perform the activities described in paragraphs (a) through (d) of
Sec. 26.4, ``FFD program applicability to categories of individuals,''
regardless of the outcome of the drug test. Therefore, the NRC is not
proposing a rule change based on the public comment.
Blind Performance Test Sample Lot In-Service Requirement
The proposed rule would revise 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 indicates that sample lots can remain
viable for much longer than 6 months (e.g., 2 years). Further, Section
10.2 of the 2008 HHS Guidelines does not impose an in-service limit on
BPTS lots. The NRC is proposing to eliminate the 6 month use limit and
to enable the BPTS supplier, based on laboratory testing data on lot
stability, to establish a specified shelf-life for each BPTS sample
lot. Allowing the BPTS supplier to determine the expiration date,
instead of the NRC requiring a uniform shelf life, would improve the
effectiveness of 10 CFR part 26, reduce burden on BPTS suppliers and
entities implementing 10 CFR part 26 requirements, and align with the
2008 HHS Guidelines. Furthermore, if a BPTS is no longer stable and
unexpected test results were reported by the laboratory inconsistent
with the formulation, 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
The proposed rule would remove 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 to conduct drug and validity testing in
Sec. 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. The proposed change would reduce
the potential for dual regulation of HHS-certified laboratories because
each laboratory is also annually inspected by the licensee or other
entity as required in Sec. 26.41(c). Eliminating these redundant
requirements would improve the regulatory efficiency of 10 CFR part 26
by reducing unnecessary regulatory oversight.
A conforming change based on the removal of Sec. 26.155 would be
to eliminate 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).
HHS-Certified Laboratory Procedures
The proposed rule would remove 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 discussed for the proposed
changes to Sec. 26.155, each HHS-certified laboratory is certified and
then inspected on a periodic basis by the NLCP, which provides
assurance that the procedures requirements in the HHS Guidelines are
developed, implemented, and maintained by the laboratory. The proposed
change would reduce 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.
The proposed rule would revise Sec. 26.157(a) to replace 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 proposed changes would do the following:
(1) Ensure that each laboratory would continue 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, oral fluids) 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 HHS Guidelines. The proposed
changes to Sec. 26.157(a) would enhance regulatory efficiency and
reduce burden 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
[[Page 48764]]
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. The
proposed rule would make 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, 11.14, and 11.15(a)(1)
of the 2008 HHS Guidelines.
The proposed rule would replace 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) would be replaced with
the phrase ``the drug or drug metabolite.'' Similarly, the phrase ``no
drug'' would be expanded to ``no drug or drug metabolite'' in Sec.
26.167(e)(3)(i), and the phrase ``no drugs or drug metabolites'' would
be revised to ``no drug or drug metabolite'' in Sec. Sec.
26.137(e)(6)(i) and 26.167(d)(3)(i).
The proposed rule would remove 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'' would be
replaced in the proposed 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)'' would be replaced in the proposed 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'' would be replaced in the proposed rule
with the phrase ``at least one control'' in Sec. 26.167(e)(3)(iv).
The parenthetical statement ``(i.e., calibrators and controls)''
would be added after the phrase ``quality control samples'' in
Sec. Sec. 26.137(e)(6) and 26.167(d)(4), and a conforming change would
be 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) would be replaced in
the proposed rule with the phrase ``A calibrator with its drug
concentration at the cutoff.''
The proposed rule would replace 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 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 would be
made 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, by replacing 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.'' The proposed 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) would be 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.''
The proposed rule would also correct two of three inaccuracies
described in an NRC enforcement guidance memorandum (EGM-09-003, dated
March 31, 2009) 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). The third inaccuracy,
incorrectly using the term ``laboratory analysts'' instead of
``licensee testing facility technicians,'' has already been addressed
in a 10 CFR part 26 final rule correcting amendment, which was
published in the Federal Register on August 3, 2009 (74 FR 38326).
The first inaccuracy pertains to the requirements in Sec.
26.137(d)(5) and (e)(6)(v), which require that at least one quality
control specimen in each analytical run must appear as a ``donor
specimen'' instead of as a ``normal 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 rule does not require that different
individuals prepare quality control samples and conduct specimen
testing. Without EGM-09-003, Sec. 26.137(d)(5) and (e)(6)(v) would
place 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
rule. To correct this inaccuracy and to address the currently
applicable enforcement discretion, the proposed rule would replace the
phrase ``donor specimen'' with the phrase ``normal specimen'' in Sec.
26.137(d)(5) and (e)(6)(v).
The second inaccuracy 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. The intent of this requirement is to verify the custody and
control procedures and confirm the accuracy of initial drug testing
performed at an LTF, neither of which require the use of only a
positive quality control sample. Since Sec. 26.137(e)(6)(ii) and
(e)(6)(iii) already specify the positive quality control samples to be
included in each analytical run, the proposed rule would replace the
phrase ``at least one positive control, certified to be positive by an
HHS-certified laboratory'' with the phrase ``at least one quality
control sample'' in Sec. 26.137(e)(6)(v).
The NRC would rescind EGM-09-003 if the proposed rule changes
correcting these inaccuracies are finalized.
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 specimen test results. The proposed rule would
redesignate paragraph (f)(3) as paragraph (f)(4) and would add 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 HHS
Guidelines. Specifically, if a donor did not provide an acceptable
medical explanation to the MRO for a pH value in the range of 9.0 to
9.5, the MRO would then have to consider if elapsed time and/or high
temperature might have caused the test result. This change is being
proposed because of 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). The 2008 HHS Guidelines addressed this
topic in Section 13.4(f). In the proposed rule, if the MRO obtains
sufficient information from the licensee
[[Page 48765]]
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 would direct the licensee or other entity to
collect a second urine specimen from the donor, as soon as reasonably
practicable. The second specimen would not be 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
proposed new step to consider technical explanations for a discrepant
pH result would provide an additional protection to the donor and limit
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). While Section 13.4(f) of the 2008 HHS Guidelines differs in that
it does not require a second test in these circumstances, this approach
is inapplicable because a valid test is necessary for determining
whether to grant or deny authorization.
Based on feedback received during the October 11, 2011, public
meeting, the NRC has chosen not to propose adding detailed instructions
in 10 CFR part 26 on how the MRO is to interpret time and temperature
information with respect to specimen pH. Meeting participants commented
that the draft instructions presented by the NRC at the public meeting
were too prescriptive and unnecessary and that the MRO should be
provided with flexibility in making this determination. The NRC agreed
and instead is proposing to include guidance on the methods an MRO
could use to review invalid test results reported in Sec. 26.185(f)(3)
in draft regulatory guide (DG) 5040, ``Urine Specimen Collection and
Test Result Review under 10 CFR part 26, Fitness for Duty Programs.''
This draft guidance is being issued concurrently for comment with this
proposed rule.
The NRC also discussed at the October 11, 2011, public meeting the
potential to change Sec. 26.131(b)(2) to assist in the documentation
of time and/or temperature information for invalid test results, based
on a pH of 9.0 or greater obtained at an LTF. However, participants
opposed these documentation requirements because they would be
burdensome to implement. The NRC agreed and instead is proposing to
include in DG-5040 the methods that LTF staff may use to document
information to support the MRO review of invalid test results in Sec.
26.185(f)(3).
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.'' \7\ The proposed rule would include 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
would ensure that a record was maintained to demonstrate that the donor
had made the request within the required 3 business days timeframe.
This rule change would document an existing practice of MROs when
receiving such a request.
---------------------------------------------------------------------------
\7\ ``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 specimen in Bottle B without the donor's written
permission, except as permitted in Sec. 26.185(l).'' The proposed rule
would revise 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 a single specimen or the testing of the Bottle B split
specimen.'' The proposed change would address an inconsistency in the
current rule 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 a single specimen or to test the
Bottle B split specimen, some licensees are interpreting the current
rule to require that the MRO must receive written permission from the
donor before initiating the retesting of a specimen.
These proposed changes to Sec. 26.165(b)(2) and (b)(3) would
improve the consistency of 10 CFR part 26 with Section 14.1(b) of the
2008 HHS Guidelines and would enhance due process by ensuring that the
retesting of an aliquot of a single specimen or the testing of the
Bottle B split specimen could proceed as quickly as possible.
Collection of a Second Specimen Under Direct Observation When Bottle B
or an Aliquot of a 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. The proposed rule would
correct 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 a 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 HHS Guidelines, for this same circumstance, states that no
advanced notice is to be provided to the donor regarding the second
specimen collection until immediately before the collection is to
commence. The proposed rule would revise the requirement in 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 would improve 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 HHS Guidelines.
The proposed rule would also revise 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
[[Page 48766]]
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 would also state 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 authorization would be 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 is proposing to revise 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) and (c).
Specifically, the reporting requirements to provide FFD program
performance data by populations tested ``(i.e., individuals in
applicant status, permanent licensee employees, [contractors/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.'' To improve the
clarity of the existing reporting requirement, the proposed rule would
remove the phrase ``individuals in applicant status'' from Sec.
26.717(b)(3) and (b)(4).
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 (b)(4) does 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, the proposed rule would revise the tested population
``licensee employees'' to ``licensee or other entity employees'' in
Sec. 26.717(b)(3) and (b)(4).
IV. Section-by-Section Analysis
Nomenclature Changes
Throughout 10 CFR part 26, the NRC is proposing to revise the term
``custody and control form'' to read ``Federal CCF.'' Two additional
iterations of the term, ``custody-and-control forms'' and ``custody-
and-control form(s),'' would also be revised to read ``Federal CCFs''
and ``Federal CCF(s),'' respectively.
Throughout 10 CFR part 26, the NRC is proposing to revise the term
``chain-of-custody'' to read ``chain of custody.''
The nomenclature changes to ``custody-and-control form'' and
``chain-of-custody'' would align with the spelling of these terms in
the 2008 HHS Guidelines and would also improve consistency in 10 CFR
part 26.
The proposed rule would also correct a number of instances where
``chain-of-custody form'' was used instead of ``custody and control
form,'' and vice versa. These corrections pertain to Sec. Sec.
26.89(d); 26.117(f); and 26.159(c), (d) and (e), as described later in
this section.
Sec. 26.4 FFD Program Applicability to Categories of Individuals
Section 26.4(e)(6)(iv) would be revised to eliminate the phrase
``(65 FR 41944; August 9, 2001).''
Section 26.4(g)(6) would be added to describe a new activity that
the FFD program personnel could perform: Monitoring a donor during the
hydration process described in Sec. 26.109(b). The punctuation at the
end of Sec. 26.4(g)(4) and (5) would be updated to accommodate the
addition of Sec. 26.4(g)(6).
Section 26.4(j)(3) would be revised 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.''
Sec. 26.5 Definitions
As described in Section III.C of this document, the NRC is
proposing to add definitions for Cancelled test, Carryover, Certifying
Scientist, Federal custody and control form, Lot, Rejected for testing,
and Responsible Person.
The definition for calibrator would be revised to include a
clarifying statement that a calibrator is a solution of known
concentration ``in the appropriate matrix.'' The phrase ``test
specimen/sample'' would be replaced with the phrase ``donor specimen or
quality control sample.'' The last sentence of the current definition
which states that ``calibrators may be used to establish a cutoff
concentration and/or a calibration curve over a range of interest''
would be deleted.
The definition for control would be 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.''
The definition for dilute specimen would be revised by replacing
the phrase ``concentrations that are lower than expected for human
urine'' with the phrase ``values that are lower than expected but are
still within the physiologically producible ranges of human urine.''
The definition for HHS-certified laboratory would be revised to
eliminate the Federal Register citations for each final version of the
HHS Guidelines. Instead, the definition would state that ``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 drug and
validity testing of a specimen is performed for a licensee or other
entity.''
The definition for invalid result would be revised to replace 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 substance at an abnormal
concentration that prevents the laboratory from completing testing or
obtaining a valid drug test result'' with the phrase ``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.''
[[Page 48767]]
The definition for limit of quantitation (LOQ) would be revised to
replace the phrase ``the lowest concentration of an analyte at which
the concentration of the analyte can be accurately determined under
defined conditions'' with the phrase ``for quantitation assays, the
lowest concentration at which the identity and concentration of the
analyte can be accurately established.''
The definition for substituted specimen would be revised to replace
the phrase ``with creatinine and specific gravity values that are so
diminished or so divergent that they are not consistent with normal
human physiology'' with the phrase ``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 Information Collection Requirements: OMB Approval
Section 26.8(b) would be revised to remove the reference to Sec.
26.155.
Sec. 26.31 Drug and Alcohol Testing
Section 26.31(b)(2) would be revised to eliminate the phrase ``(65
FR 41944; August 9, 2001).''
Section 26.31(d)(1) would be revised to include MDMA and MDA as
substances for which licensees and other entities are required to test
in each specimen.
Section 26.31(d)(1)(i)(D) would be revised to eliminate the phrase
``as specified in Sec. 26.155(a).''
Section 26.31(d)(1)(ii) would be revised 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 in
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.''
Sec. 26.89 Preparing To Collect Specimens for Testing
Section 26.89(c) would be revised to replace the phrase
``adulterated, diluted, or adulterated the specimen'' with the phrase
``adulterated, diluted, or substituted the specimen.''
Section 26.89(d) would be revised to include this phrase at the end
of the first sentence: ``, except as described in Sec. 26.109(b)(1).''
The second sentence in Sec. 26.89(d) would be revised in three ways.
First, the phrase ``For this purpose, a urine collection'' would be
replaced with the phrase ``The urine collection.'' Second, the phrase
``sealed and initialed'' would be replaced with the phrase ``sealed
with tamper-evident tape, the seal has been dated and initialed.''
Finally, the phrase ``the chain of custody form has been executed, and
the donor has departed the collection site'' would be replaced with the
phrase ``and the Federal CCF has been completed or when a refusal to
test has been determined under Sec. 26.107(d).''
Sec. 26.107 Collecting a Urine Specimen
Section 26.107(b) would be revised in four ways. First, the
proposed rule would redesignate paragraph (b) as paragraph (b)(1) of
this section. Secondly, the phrase ``except as provided in Sec.
26.109(b)(1)'' would be added in the first sentence after ``The
collector shall pay careful attention to the donor during the entire
collection process.'' Third, Sec. 26.107(b) would be 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
privacy area)'' 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 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).'' Lastly, the phrase ``the collector shall document the
conduct'' would be revised to read as follows: ``the collector shall
document a description of the conduct.''
Section 26.107(b)(2) would be added 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).
Section 26.107(d) and (d)(1) through (d)(5) would be added to
describe requirements regarding the actions a collector must take if a
refusal to test is determined at any point during the specimen
collection process. Specifically, the collector shall: (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, (4) discard any urine specimen(s) provided by the
donor unless the specimen was collected for a post-event test required
by Sec. 26.31(c)(3), and (5) immediately inform the FFD program
manager of the refusal to test.
Sec. 26.109 Urine Specimen Quantity
Section 26.109(b)(1) would be revised, and new paragraphs (b)(1)(i)
through (b)(1)(iii) would be added 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. For clarity, the last sentence of Sec.
26.109(b)(1) would become the new first sentence of Sec. 26.109(b)(2).
The proposed rule would permit another staff member designated as FFD
program personnel, as described in Sec. 26.4(g)(6), or another
specimen collector meeting the requirements in Sec. 26.85(a), instead
of the specimen collector who initiated the collection process, to
monitor a donor during the hydration process. The collector shall (1)
explain the hydration process and acceptable donor behavior to the
hydration monitor and (2) record the name of the individual observing
the donor on the Federal CCF and then provide the Federal CCF to the
observer for the duration of the hydration process. The original
collector may then perform other collections while the donor is in the
hydration process.
Sec. 26.111 Checking the Acceptability of the Urine Specimen
Section 26.111(a) would be revised 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.''
Section 26.111(c) would be revised to remove the word
``designated'' from the phrase ``designated FFD program manager'' in
the first sentence. The parenthetical phrase ``(e.g., adulterated or
diluted)'' would be added after the word ``altered'' in the second
sentence.
Section 26.111(e) would be revised to include the phrase ``, except
under the conditions described in Sec. 26.107(d)(4)'' at the end of
the existing requirement.
Section 26.111(f) would be removed.
Sec. 26.115 Collecting a Urine Specimen Under Direct Observation
Section 26.115(a)(3) would be revised 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, the
proposed rule would remove the word ``and'' at
[[Page 48768]]
the end of Sec. 26.115(a)(3). Paragraph (a)(5) would be added 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 period at the end of
the sentence in Sec. 26.115(a)(4) would be replaced with a ``; or'' to
accommodate for the new paragraph (a)(5) of this section in the list of
exclusive grounds for performing a directly observed collection.
In Sec. 26.115(f), the proposed rule would revise the first
sentence, ``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) of this section.'' The revised sentence would be added to the end
of existing requirements in Sec. 26.115(e).
In Sec. 26.115(f)(2), the proposed rule would 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 is
not sufficient to meet this direct observation requirement; the use of
a video camera to assist in the observation process is not permitted.''
In Sec. 26.115(f)(3), the proposed rule would 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.''
Section 26.115(g) would be revised to include the phrase ``, and
the collector shall follow the procedures in Sec. 26.107(d)'' at the
end of the existing requirement.
Sec. 26.117 Preparing Urine Specimens for Storage and Shipment
Section 26.117(a) would be revised 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 ``urine specimen(s) in view at all times.''
Section 26.117(f) would be revised to replace the term ``chain-of-
custody forms'' with the term ``Federal CCFs.'' Section 26.117(f) would
also be revised to replace the phrase ``or the licensee's testing
facility,'' with the phrase ``or to the licensee testing facility.''
Section 26.117(g) would be revised 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.
Sec. 26.129 Assuring Specimen Security, Chain of Custody, and
Preservation
Section 26.129(b)(1)(ii) would be revised by replacing the phrase
``the specimen may not be tested,'' with the phrase ``the licensee
testing facility shall reject the specimen for testing.''
Section 26.129(b)(2) would be revised by adding 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.''
Sec. 26.133 Cutoff Levels for Drugs and Drug Metabolites
The introductory paragraph under Sec. 26.133 would be revised to
clarify that the specified cutoff level must be used to determine
whether the specimen is negative ``or positive'' for the indicated drug
or drug metabolite being tested. The table in Sec. 26.133 would be
revised to: (1) Lower the initial test cutoff level for cocaine
metabolites from 300 ng/mL to 150 ng/mL, (2) include a new footnote 1
to clarify that the initial test cutoff level for opiate metabolites is
for codeine/morphine and that morphine is the target analyte, (3) lower
the initial test cutoff level for amphetamines (abbreviated in the
table as AMP) from 1000 ng/mL to 500 ng/mL, (4) add initial testing for
6-AM at a cutoff level of 10 ng/mL, (5) include a new table footnote 2
regarding initial test kits, (6) include a new table footnote 3 to
clarify that for amphetamines testing, methamphetamine (abbreviated in
the table as MAMP) is the target analyte, (7) add initial testing for
MDMA and MDA at a cutoff level of 500 ng/mL, and (8) provide the full
chemical name for MDMA and MDA in new footnotes 4 and 5 to the table,
respectively. The column header ``Drug or metabolites'' in the table in
Sec. 26.133 would also be revised to ``Drugs or drug metabolites'' to
align with the table title.
Sec. 26.137 Quality Assurance and Quality Control
Section 26.137(d)(5) would be revised to replace the term ``donor
specimen'' with the term ``normal specimen.''
Section 26.137(e)(6) would replace the phrase ``A minimum of 10
percent of all specimens'' at the start of the first sentence with the
phrase ``A minimum of 10 percent of the total specimens.'' The
parenthetical phrase ``(i.e., calibrators and controls)'' would be
added after the phrase ``quality control samples'' in the first
sentence of Sec. 26.137(e)(6). 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) would be replaced with the
phrases ``drugs and drug metabolites'' and ``drug and drug
metabolite,'' respectively.
Section 26.137(e)(6)(i) would 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.''
Section 26.137(e)(6)(ii) would be revised to replace the phrase
``drug(s) or drug metabolite(s)'' with the phrase ``the drug or drug
metabolite.''
Section 26.137(e)(6)(iii) would be revised 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.''
Section 26.137(e)(6)(v) would be revised to replace the phrase ``At
least one positive control, certified to be positive by an HHS-
certified laboratory, which appears to be a donor specimen'' with the
phrase ``At least one quality control sample that appears to be a
normal specimen.''
Sec. 26.153 Using Certified Laboratories for Testing Urine Specimens
Section 26.153(a) would be revised 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 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'' would be removed.
Section 26.153(g) would be revised to replace the term ``Federal
custody-and-control form'' with ``Federal CCF'' and the term ``non-
Federal form'' with ``non-Federal CCF.''
[[Page 48769]]
Sec. 26.155 Laboratory Personnel
Section 26.155 would be removed and reserved.
Sec. 26.157 Procedures
Section 26.157(a) would be revised to replace the phrase ``clear
and well-documented procedures for'' with the phrase ``procedures
specific to this part that document the.'' Section 26.157(a) would also
be revised to remove ``urine'' in the phrase ``testing of urine
specimens.''
Section 26.157(b) would be removed and reserved, and Sec.
26.157(c) through (e) would be removed.
Sec. 26.159 Assuring Specimen Security, Chain of Custody, and
Preservation
Section 26.159(b)(1)(ii) would be revised to replace the phrase
``the specimens may not be tested'' with the phrase ``the laboratory
shall reject the specimens for testing'' when the integrity or identity
of the specimens is in question.
Section 26.159(b)(2) would be revised 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.''
Section 26.159(c) would be revised in the second sentence of the
paragraph to replace the term ``custody-and-control'' with the term
``chain of custody.'' Also, the term ``custody-and-control form'' would
be replaced with the term ``Federal CCF'' in the third sentence of the
paragraph.
Section 26.159(d) would be revised to replace the term ``custody-
and-control'' with the term ``chain of custody.''
Section 26.159(e) would be revised to replace the term ``custody-
and-control'' with the term ``chain of custody'' in the two instances
that it occurs in the paragraph.
Sec. 26.161 Cutoff Levels for Validity Testing
Sections 26.161(c)(3) through (c)(6) would be revised to replace
all instances of ``LOD'' with ``LOQ.''
Sections 26.161(c)(5) would be revised 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)).''
Sections 26.161(c)(6) would be revised to replace the phrase ``GC/
MS for the confirmatory test'' with the phrase ``a different
confirmatory method (e.g., GC/MS).''
Sections 26.161(f)(5) and (f)(7) would be revised to replace all
instances of the term ``LOD'' with the term ``LOQ.''
Sec. 26.163 Cutoff Levels for Drug and Drug Metabolites
Section 26.163(a)(1) would be revised 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.'' The phrase ``except if validity testing indicates that
the specimen is dilute'' would also be revised to ``except as specified
in paragraph (a)(2) of this section.''
The table in Sec. 26.163(a)(1) would be revised to: (1) Lower the
initial test cutoff level for cocaine metabolites from 300 ng/mL to 150
ng/mL, (2) include a new footnote 1 to clarify that the initial test
cutoff level for opiate metabolites is for codeine/morphine and that
morphine is the target analyte, (3) lower the initial test cutoff level
for amphetamines (abbreviated in the table as AMP) from 1000 ng/mL to
500 ng/mL, (4) add initial testing for 6-AM at a cutoff level of 10 ng/
mL, (5) include a new footnote 2 regarding initial test kits, (6)
include a new footnote 3 to clarify that for amphetamines testing,
methamphetamine (abbreviated in the table as MAMP) is the target
analyte, (7) add initial testing for MDMA and MDA at a cutoff level of
500 ng/mL, and (8) provide the full chemical names for MDMA and MDA in
new footnotes 4 and 5 to the table, respectively. The column header
``Drug or metabolites'' in the table in Sec. 26.163(a)(1) would also
be revised to ``Drugs or drug metabolites'' to align with the table
title. Section 26.163(a)(2) would be revised 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'' and replace the provision with ``HHS-certified
laboratories shall conduct special analyses of specimens as follows:.''
Section 26.163(a)(2)(i) would be revised 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 ``or if a specimen is collected under direct
observation for any of the conditions specified in Sec. 26.115(a)(1)
through (a)(3) or (a)(5).''
Section 26.163(a)(2)(ii) would be revised 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.''
The table in Sec. 26.163(b)(1) would be revised to: (1) Lower the
confirmatory test cutoff level for cocaine metabolite from 150 ng/mL to
100 ng/mL, (2) revise ``Opiates'' to read ``Opiate metabolites,'' (3)
remove footnote 3 regarding the requirement that confirmatory testing
of 6-AM only proceed when confirmatory testing shows a morphine
concentration exceeding 2000 ng/mL, (4) lower the confirmatory test
cutoff levels for amphetamine and methamphetamine from 500 ng/mL to 250
ng/mL, (5) 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 (6) add confirmatory testing
for MDMA and MDA at a cutoff level of 250 ng/mL. The column header
``Drug or metabolites'' in the table in Sec. 26.163(b)(1) would also
be revised to ``Drugs or drug metabolites.''
Sec. 26.165 Testing Split Specimens and Retesting Single Specimens
A new fifth sentence would be added to Sec. 26.165(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.''
The first sentence in Sec. 26.165(b)(3) would be deleted. The
second sentence in Sec. 26.165(b)(3) would be revised to state ``No
entity, other than the MRO as permitted in Sec. 26.185(l), may order
the retesting of an aliquot of a single specimen or the testing of the
Bottle B split specimen.''
The last sentence in Sec. 26.165(f)(1) would be revised 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.
Section 26.165(f)(2) would be revised to clarify the actions that
an MRO is to take when a donor requests testing of Bottle B or a retest
of a single specimen and the specimen to be tested is unavailable due
to circumstances outside of the donor's control. Specifically, the
proposed rule would: (1) Add instruction for the MRO to report a
cancelled test to the licensee or other entity for the donor's
specimen; (2) add instruction for the licensee or other entity to
perform a second collection without prior notice to the donor and to
continue to administratively withdraw the individual's authorization
until the results of the second collection are received by the MRO; and
(3) add 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.
[[Page 48770]]
Sec. 26.167 Quality Assurance and Quality Control
Section 26.167(d)(3)(i) would be revised 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.''
Section 26.167(d)(3)(ii) would be revised to replace the phrase ``a
drug(s) or drug metabolites'' with the phrase ``the drug or drug
metabolite.''
Section 26.167(d)(3)(iii) would be revised 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.''
Section 26.167(d)(4) would be revised to add the parenthetical
statement ``(i.e., calibrators and controls)'' after the phrase
``quality control samples.''
Section 26.167(e)(2) would be revised 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).''
Section 26.167(e)(3)(i) would be revised 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.''
Section 26.167(e)(3)(ii) would be revised 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.''
Section 26.167(e)(3)(iii) would be revised to replace the phrase
``a drug(s) or drug metabolites'' with the phrase ``the drug or drug
metabolite.''
Section 26.167(e)(3)(iv) would be revised to replace the phrase
``At least one calibrator or control that is targeted'' with the phrase
``At least one control targeted.''
Section 26.167(f)(3) would be revised to make an editorial
correction to the phrase ``a statement by the laboratory's responsible
person'' by capitalizing the position title in that phrase to
``Responsible Person.''
Sec. 26.168 Blind Performance Testing
Section 26.168(h)(1) would be revised to remove the phrase ``and
for no more than 6 months'' from this requirement.
Sec. 26.169 Reporting Results
Section 26.169(a) would be revised 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.''
The HHS-certified laboratory annual statistical summary reporting
requirements in Sec. 26.169(h)(3) would be revised to add MDMA and MDA
to the list of amphetamines test results that a laboratory must report
as required by Sec. 26.169(h)(3)(v). Additional conforming changes
would be made to the names of the drugs and drug metabolites listed in
Sec. 26.169(h)(3) to include adding ``(as THCA)'' after ``Marijuana
metabolite'' in Sec. 26.169(h)(3)(i), adding ``(as benzoylecgonine)''
after ``Cocaine metabolite'' in Sec. 26.169(h)(3)(ii), revising 6-AM
to ``6-acetylmorphine (6-AM)'' in Sec. 26.169(h)(3)(iii)(C), and
revising ``Phencyclidine'' to ``Phencyclidine (PCP)'' in Sec.
26.169(h)(3)(iv).
Sec. 26.183 Medical Review Officer
Section 26.183 would be revised to remove the phrase ``at the
licensee's or other entity's discretion'' from Sec. 26.183(c), (c)(1),
and (d)(2)(ii).
Sec. 26.185 Determining a Fitness-for-Duty Policy Violation
Section 26.185(f)(3) would be redesignated as (f)(4), and a new
paragraph (f)(3) would be added to state that if there is no legitimate
technical or medical explanation for an invalid test result based on a
pH result greater than or equal to 9.0 but less than or equal 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.
Section 26.185(g)(2) would be revised 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.''
Section 26.185(g)(2)(iii) would be revised to remove the phrase
``clearly and unequivocally.''
Section 26.185(g)(3) would be removed.
Section 26.185(g)(4) and (g)(5) would be redesignated as Sec.
26.185(g)(3) and (g)(4), respectively, and the cross-reference under
Sec. 26.163(a)(1) would be updated to reflect these changes.
Sec. 26.405 Drug and Alcohol Testing
Section 26.405(d) would be revised to add MDMA and MDA as
substances for which licensees and other entities are required to test
in each specimen.
Sec. 26.415 Audits
Section 26.415(c) would be revised to eliminate the phrase ``(65 FR
41944; August 9, 2001).''
Sec. 26.717 Fitness-for-Duty Program Performance Data
Section 26.717(b)(3) would be revised 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).''
Section 26.717(b)(4) would be revised 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).''
V. Specific Requests for Comment
The NRC is seeking advice and recommendations from stakeholders on
this proposed rule. We are particularly interested in comments and
supporting rationale from the public on the following:
1. Alignment With the HHS Guidelines
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.
2. Special Analyses Testing
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
[[Page 48771]]
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 (a)(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.
3. Provide Flexibility To Conduct Additional Specimen Validity Tests
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.
4. Effective Date of the Final Rule
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.
5. Direct Observation of Specimen Collection
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.
6. 2017 HHS Guidelines--New Test Analytes
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.
7. Methylenedioxyethylamphetamine
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.
VI. Regulatory Flexibility Certification
Under the Regulatory Flexibility Act (5 U.S.C. 605(b)), the NRC
certifies that this rule will not, if promulgated, have a significant
economic impact on a substantial number of small entities. This
proposed 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 67 entities affected by the rule
would 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 would not
impact a substantial number of small entities.
VII. Regulatory Analysis
The NRC has prepared a draft regulatory analysis on this proposed
regulation. The analysis examines the costs and benefits of the
alternatives considered by the NRC. The NRC requests public comment on
the draft regulatory analysis. The regulatory analysis is available as
indicated in the ``Availability of Documents'' section of this
document. Comments on the draft analysis may be submitted to the NRC as
indicated under the ADDRESSES caption of this document.
VIII. Backfitting and Issue Finality
The proposed rule would apply to all current nuclear power plant
licensees (including holders of renewed licenses under 10 CFR part 54,
``Requirements for Renewal of Operating Licenses for Nuclear Power
Plants,'' and combined licenses under 10 CFR part 52, ``Licenses,
Certifications, and Approvals for Nuclear Power Plants'') and holders
of licenses authorizing the possession, use, or transport of formula
quantities of SSNM under 10 CFR part 70, ``Domestic Licensing of
Special Nuclear Material.'' The proposed rule would apply to holders of
a certificate of compliance or an approved compliance plan under the
provisions of 10 CFR part 76, ``Certification of Gaseous Diffusion
Plants,'' if the holder engages in activities involving formula
quantities of SSNM. Some or all of the proposed rule would apply to:
(i) Current and future applicants for combined licenses under 10 CFR
part 52 who have been issued a limited work authorization (LWA) under
Sec. 50.10(e), if the LWA authorizes the applicant to install the
foundations, including the placement of concrete, for safety- and
security-related structures, systems, and components (SSCs) under the
LWA; (ii) combined license holders before the Commission has made the
finding under Sec. 52.103(g); (iii) power reactor construction permit
applicants (under 10 CFR part 50, ``Domestic Licensing of Production
and Utilization Facilities'') who have been
[[Page 48772]]
issued an LWA, if the LWA authorizes the applicant to install the
foundations, including the placement of concrete, for safety- and
security-related SSCs under the LWA; (iv) power reactor construction
permit holders; and (v) early site permit holders who have been issued
an LWA, if the LWA authorizes the early site permit holder to install
the foundations, including the placement of concrete, for safety- and
security-related SSCs under the LWA.
The rule would constitute backfitting as defined under Sec.
50.109(a)(1) for current holders of 10 CFR part 50 operating licenses
and construction permits for power reactors and under Sec. 70.76(a)(1)
for applicable current 10 CFR part 70 licensees. The NRC has performed
a backfit analysis consistent with NUREG/BR-0058, Revision 4,
``Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory
Commission.'' The backfit analysis can be found at appendix E of the
regulatory analysis. The NRC has determined the backfitting is
justified because: (1) There would be a substantial increase in the
overall level of protection of the public health and safety or the
common defense and security to be derived from the backfitting and (2)
the costs of implementation and the annual costs would be justified in
view of this increase.
Imposing the requirements of the proposed rule on current holders
of combined licenses would represent an inconsistency with the issue
finality provision applicable to combined licenses under Sec. 52.98,
``Finality of combined licenses; information requests.'' Therefore, the
NRC has addressed the criteria in Sec. 52.98 that would allow
imposition of the proposed rule on current holders of combined
licenses, despite the issue finality accorded to the combined license
holders. The NRC believes that the proposed rule may be imposed as a
cost-justified substantial increase in the protection of the public
health and safety or common defense and security. The bases for this
determination are presented in the backfit analysis found in appendix F
of the regulatory analysis.
Imposing the requirements of the proposed rule on current and
future applicants for power reactor construction permits under 10 CFR
part 50, part 70 licenses, or early site permits or combined licenses
under 10 CFR part 52 would not constitute backfitting. Neither Sec.
50.109, ``Backfitting,'' nor the issue finality provisions for early
site permits or combined licenses under 10 CFR part 52 protect either a
current or prospective applicant for a construction permit, part 70
license, early site permit, or combined license from changes in the NRC
rules and regulations. The NRC has long adopted the position that Sec.
50.109 does not protect current or prospective applicants from changes
in NRC requirements or guidance because the policies underlying Sec.
50.109 are largely inapplicable in the context of a current or future
application. This position also applies to each of the issue finality
provisions under 10 CFR part 52.
The provisions under 10 CFR part 26 also apply to applicants for
construction permits, early site permits, or combined licenses who have
been issued an LWA, if the LWA authorizes the applicant to install the
foundations, including the placement of concrete, for safety- and
security-related SSCs under the LWA. As of September 16, 2019, no LWAs
have been issued to an applicant for a construction permit, early site
permit, or combined license, so no such entity is protected by the
backfitting and issue finality provisions from the changes proposed in
this rulemaking.
Similarly, no entity holds a certificate of compliance or an
approved compliance plan under the provisions of 10 CFR part 76, so no
entity is protected by the backfitting provisions of Sec. 76.76,
``Backfitting,'' from the changes proposed in this rulemaking.
Draft Regulatory Guidance
The guidance in DG-5040 presents methods acceptable to the NRC for
implementing portions of this proposed rule. The draft guide would
apply to current holders of nuclear power plant licenses (including
holders of renewed licenses under 10 CFR part 54 and combined licenses
under 10 CFR part 52) and current holders of licenses authorizing the
possession, use, or transport of formula quantities of SSNM under 10
CFR part 70. The DG would also apply to holders of a certificate of
compliance or an approved compliance plan under the provisions of 10
CFR part 76 if the holder engages in activities involving formula
quantities of SSNM.
The DG would also apply to the following current and future
entities: (1) Applicants for combined licenses under 10 CFR part 52 who
have been issued an LWA under Sec. 50.10(e), if the LWA authorizes the
applicant to install the foundations, including the placement of
concrete, for safety- and security-related SSCs under the LWA; (2)
combined license holders before the Commission has made the finding
under Sec. 52.103(g); (3) power reactor construction permit applicants
(under 10 CFR part 50) who have been issued an LWA, if the LWA
authorizes the applicant to install the foundations, including the
placement of concrete, for safety- and security-related SSCs under the
LWA; (4) power reactor construction permit holders; and (5) early site
permit holders who have been issued an LWA, if the LWA authorizes the
early site permit holder to install the foundations, including the
placement of concrete, for safety- and security-related SSCs under the
LWA, if these entities elect to implement an FFD program that meets the
requirements of subparts A through H, N, and O of 10 CFR part 26.
Issuance of the DG in final form would not constitute backfitting
under 10 CFR part 50, 70, or 76 and would not otherwise be inconsistent
with the issue finality provisions under 10 CFR part 52. As discussed
in the ``Implementation'' section of the DG, the NRC has no current
intention to impose the DG, if finalized, on current holders of 10 CFR
part 50 operating licenses or construction permits, 10 CFR part 52
combined licenses or early site permits, 10 CFR part 70 licenses, or 10
CFR part 76 certificates of compliance or approved compliance plans.
The DG, if finalized, could be applied to applicants for 10 CFR
part 50 operating licenses or construction permits for power reactors,
10 CFR part 52 combined licenses or early site permits, licenses issued
under 10 CFR part 70, or 10 CFR part 76 certificates of compliance or
approved compliance plans. Such action would not constitute backfitting
as defined under Sec. 50.109, Sec. 70.76, or Sec. 76.76, or be
otherwise inconsistent with the applicable issue finality provisions
under 10 CFR part 52, inasmuch as such applicants are not within the
scope of entities protected by Sec. 50.109, Sec. 70.76, Sec. 76.76,
or the relevant issue finality provisions under 10 CFR part 52, except
in one circumstance. The exception to this principle is a combined
license, early site permit, or construction permit applicant that has
been issued an LWA, if the LWA authorizes the applicant to install the
foundations, including the placement of concrete, for safety- and
security-related SSCs under the LWA. However, that exception would
provide backfitting and issue finality protection for the LWA holder
only to the extent that it conducts activities under the LWA.
IX. Cumulative Effects of Regulation
The NRC seeks to minimize any potential negative consequences
resulting from the cumulative effects of regulation (CER). The CER
describes the challenges that licensees, or other impacted entities
such as State partners, may face while implementing new regulatory
positions, programs, or requirements (e.g., rules, generic letters,
backfits, inspections). The CER is an organizational effectiveness
challenge
[[Page 48773]]
that may result from a licensee or impacted entity implementing a
number of complex regulatory positions, programs, or requirements
within limited available resources.
In an effort to better understand the potential CER implications
incurred due to this proposed rule, the NRC is requesting comment on
the following questions. Responding to these questions is voluntary,
and the NRC will respond to any comments received in the final rule.
1. In light of any current or projected CER challenges, does the
proposed rule's effective date provide sufficient time to implement the
new proposed requirements, including changes to programs, procedures,
and the facility?
2. If current or projected CER challenges exist, what should be
done to address this situation? For example, if more time is required
for implementation of the new requirements, what period of time is
sufficient?
3. Do other regulatory actions (from the NRC or other agencies)
influence the implementation of the proposed rule's requirements?
4. Are there unintended consequences? Does the proposed rule create
conditions that would be contrary to the proposed rule's purpose and
objectives? If so, what are the unintended consequences, and how should
they be addressed?
5. Please comment on the NRC's cost and benefit estimates in the
regulatory analysis that supports the proposed rule.
X. 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). The NRC requests comment on this document with respect to the
clarity and effectiveness of the language used.
XI. Environmental Impact: Categorical Exclusion
The NRC has determined that this proposed 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 proposed rule.
XII. Paperwork Reduction Act Statement
This proposed rule contains new or amended collections of
information subject to the Paperwork Reduction Act of 1995 (44 U.S.C.
3501 et seq.). This proposed rule has been submitted to the Office of
Management and Budget (OMB) for review and approval of the information
collection(s).
Type of submission, new or revision: Revision.
The title of the information collection: 10 CFR part 26, Fitness
for Duty Drug Testing Requirements.
The form number if applicable: Not applicable.
How often the collection is required: Once and annually. One-time
information collections include the licensee or other entity of each
FFD program completing revisions to the FFD program policy and FFD
procedures, to distribute information on the FFD program policy updates
to individuals subject to 10 CFR part 26, and for those subject
individuals to review the information on the FFD program policy
changes. Annual information collections include the licensee or other
entity of each FFD program submitting an FFD program performance report
to the NRC to provide information on the additional positive drug test
results that would result from the proposed rule changes. On occasion,
a third party disclosure would be made for each additional positive
drug test result from the proposed rule changes. Also, on occasion, the
license or other entity would report information to the NRC in the form
of a 24-hour event report when some individuals (e.g., licensed reactor
operators, supervisors) test positive as a result of the proposed rule
changes.
Who will be required or asked to report: Licensees of nuclear power
reactor sites (operating and under construction), licensees of Category
I fuel cycle facilities, contractors/vendors, HHS-certified
laboratories, and individuals with a positive drug test result.
An estimate of the number of annual responses: 7,813 (33
recordkeepers + 68 reporting responses + 7,712 third-party
disclosures).
The estimated number of annual respondents: 149 (27 FFD programs,
12 HHS-certified laboratories, 6 licensee testing facilities, and 104
individuals with a positive drug test result).
An estimate of the total number of hours needed annually to
complete the requirement or request: 1,382 (559 hours recordkeeping +
71 hours reporting + 752 hours third-party disclosure).
Abstract: 10 CFR part 26 contains the NRC's requirements for
licensee and other entity FFD programs, which focus on preventing and
detecting the impairment of personnel from the misuse of legal drugs
and alcohol, use of illegal drugs, fatigue, and any other causes such
as mental or psychological distress. The NRC is seeking to update the
drug testing panel and to lower the testing cutoff levels for some
drugs tested, which would impact the information collections contained
in 10 CFR part 26, because additional individuals would likely test
positive for drugs. The expected additional positive test results would
increase the recordkeeping and reporting burdens on licensees and other
entities. The NRC is proposing to include new information collection
requirements in Sec. Sec. 26.107(d), 26.157(a), 26.165(b)(2) and
(b)(3), 26.165(f)(1) and 26.185(f)(3). This information is needed 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) and (b)(3)), 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)).
The NRC is seeking public comment on the potential impact of the
information collection(s) contained in this proposed rule and on the
following issues:
1. Is the proposed information collection necessary for the proper
performance of the functions of the NRC, including whether the
information will have practical utility?
2. Is the estimate of burden of the proposed information collection
accurate?
3. Is there a way to enhance the quality, utility, and clarity of
the information to be collected?
4. How can the burden of the proposed information collection on
respondents be minimized, including the use of automated collection
techniques or other forms of information technology?
A copy of the OMB clearance package and proposed rule is available
in ADAMS under Accession No. ML16123A003 or may be viewed free of
[[Page 48774]]
charge at the NRC's PDR, One White Flint North, 11555 Rockville Pike,
Room O-1 F21, Rockville, MD 20852. You may obtain information and
comment submissions related to the OMB clearance package by searching
on https://www.regulations.gov under Docket ID NRC-2009-0225.
You may submit comments on any aspect of these proposed information
collection(s), including suggestions for reducing the burden and on the
above issues, by the following methods:
Federal rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2009-0225.
Mail comments to: Information Services Branch: 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].
Submit comments by October 16, 2019. Comments received after this
date will be considered if it is practical to do so, but the NRC staff
is able to ensure consideration only for comments received on or before
this date.
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.
XIII. Compatibility of Agreement State Regulations
Under the ``Policy Statement on Adequacy and Compatibility of
Agreement State Programs'' approved by the Commission on June 30, 1997,
and published in the Federal Register (62 FR 46517; September 3, 1997),
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 title 10 of the
Code of Federal Regulations, 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 proposed rule, the NRC
is proposing to update and enhance the consistency of 10 CFR part 26
with the 2008 HHS Guidelines; improve the effectiveness and efficiency
of FFD programs with regard to drug testing; and improve clarity in the
organization and language of the rule. This action would not constitute
the establishment of a voluntary consensus standard that contains
generally applicable requirements.
XV. Availability of Guidance
The NRC is issuing for comment new draft regulatory guidance, Draft
Regulatory Guide DG-5040, ``Urine Specimen Collection and Test Result
Review under 10 CFR Part 26, Fitness for Duty Programs,'' to support
the implementation of the proposed requirements in this rulemaking. You
may access information and comment submissions related to the DG by
searching on https://www.regulations.gov under Docket ID NRC-2009-0225.
Comments on the DG may be submitted to the NRC as indicated under the
ADDRESSES caption of this document.
The guidance describes methods that the NRC would consider
acceptable for complying with some of the proposed changes in this
notice. For example, guidance would be 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).
2017 HHS Guidelines--Revised Mandatory 82 FR 7920
Guidelines (January 23, 2017).
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).
2014 National Drug Control Strategy ML19169A230
(July 9, 2014).
Behavioral Health Trends in the United ML19169A160
States: Results from the 2014
National Survey on Drug Use and
Health (September 2015), HHS
Publication No. SMA 15-4927.
Commission Policy Statement on Fitness 51 FR 27921
for Duty of Nuclear Power Plant
Personnel (August 4, 1986).
[[Page 48775]]
Cook J.D., Strauss K.A., Caplan Y.H., ML19169A178
LoDico C.P., and Bush D.M. (2007),
``Urine pH: the effects of time and
temperature after collection,''
Journal of Analytical Toxicology,
Vol. 31, 486-496.
Executive Order 12564 (September 17, 51 FR 32889
1986).
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).
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 Public Meeting Summary (February ML090771060
24, 2009).
NRC Public Meeting Summary (June 24, ML091910511
2009).
NRC Public Meeting Summary and Meeting ML112930153
Materials (October 11, 2011).
NRC Public Meeting Summary (September ML13290A236
11, 2013).
NRC Regulatory Analysis and Backfit ML19169A115
Analysis, Fitness For Duty Drug
Testing Requirements (August 2019).
NRC Regulatory Analysis Guidelines, ML042820192
NUREG/BR-0058, Revision 4 (September
30, 2004).
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 report ``Summary of Fitness for ML14246A440
Duty Program Performance Reports for
Calendar Year 2013'' (September 3,
2014).
NRC report ``Summary of Fitness for ML13225A131
Duty Program Performance Reports for
Calendar Year 2012'' (August 13,
2013).
NRC report ``Summary of Fitness for ML12151A270
Duty Program Performance Reports for
Calendar Year 2011'' (August 1, 2012).
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).
------------------------------------------------------------------------
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 proposing
to adopt 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. Amend part 26, wherever they may occur by:
0
a. Removing the term ``custody-and-control form'' and adding in its
place the term ``Federal CCF'';
0
b. Removing the term ``custody-and-control forms'' and adding in its
place the term ``Federal CCFs.''
0
c. Removing the term ``custody-and-control form(s)'' and adding in its
place the term ``Federal CCF(s)''; and
0
d. Removing the phrase ``chain-of-custody'' and adding in its place the
phrase ``chain of custody''.
0
3. Amend Sec. 26.4 by:
0
a. Removing in paragraph (e)(6)(iv), the phrase ``(65 FR 41944; August
9, 2001)'';
0
b. Removing in paragraph (g)(4), word ``and'' at the end;
0
c. Removing in paragraph (g)(5), the period at the end and add in its
place ``; and'';
0
d. Adding new paragraph (g)(6); and
0
e. Revising paragraph (j)(3).
The additions and revisions read as follows:
Sec. 26.4 FFD program applicability to categories of individuals.
* * * * *
(g) * * *
(6) All persons monitoring a donor during the hydration process
described in Sec. 26.109(b).
* * * * *
(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. Amend Sec. 26.5 by:
0
a. Adding the definitions for cancelled test, carryover, Certifying
Scientist, Federal custody and control form (Federal CCF), lot,
rejected for testing, and Responsible Person in alphabetical order; and
0
b. Revising the definitions for calibrator, control, dilute specimen,
HHS-certified laboratory, invalid result, limit of quantitation, and
substituted specimen.
The additions and revisions 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 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
[[Page 48776]]
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 drug and
validity testing of a specimen is performed for a licensee or other
entity.
* * * * *
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, remove the reference ``26.155'' in paragraph (b).
0
6. Amend Sec. 26.31 by:
0
a. Removing in paragraph (b)(2) the phrase ``(65 FR 41944; August 9,
2001)'';
0
b. Revising paragraph (d)(1) introductory text;
0
c. Removing in paragraph (d)(1)(i)(D) the phrase ``, as specified in
Sec. 26.155(a)'' at the end of the second sentence; and
0
d. Revising in paragraph (d)(1)(ii) the third sentence.
The 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, opiates
(codeine, morphine, and 6-acetylmorphine), amphetamines (amphetamine,
methamphetamine, methylenedioxymethamphetamine, and
methylenedioxyamphethamine), phencyclidine, adulterants, 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.
* * * * *
0
7. Amend Sec. 26.89 by:
0
a. Removing in paragraph (c) in the first sentence, the words
``adulterated, diluted, or adulterated the specimen'' and adding in its
place the words ``adulterated, diluted, or substituted the specimen'';
and
0
b. Revising paragraph (d) to read 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). The urine collection procedure is complete when 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 or
when a refusal to test has been determined under Sec. 26.107(d).
0
8. 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 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 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 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 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;
(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
[[Page 48777]]
(5) Immediately inform the FFD program manager.
0
9. 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 who meets the requirements in Sec.
26.4(g)(6). 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 then provide the Federal CCF to that
individual for the duration of the hydration process; 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
10. Amend Sec. 26.111 by:
0
a. Revising paragraph (a);
0
b. Removing in paragraph (c) the first sentence the word ``designated''
and revising the third sentence;
0
c. Revising paragraph (e); and
0
d. Removing 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.
* * * * *
(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
11. Amend Sec. 26.115 by:
0
a. Republishing paragraph (a) introductory text, revising paragraphs
(a)(3) and (4), and adding paragraph (a)(5);
0
b. Revising paragraph (e);
0
c. Revising paragraph (f) introductory text, republishing paragraph
(f)(1), and revise paragraphs (f)(2) and (3); and
0
d. Revising paragraph (g).
The additions and revisions 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 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
12. Amend Sec. 26.117 by:
0
a. Revising paragraph (a);
0
b. Revising the first sentence in paragraph (f); and
0
c. Adding in paragraph (g) the phrase ``, except as provided in Sec.
26.109(b)(1)(ii) for the Federal CCF'' to the end of the first
sentence.
The revisions read as follows:
Sec. 26.117 Preparing urine specimen 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 urine
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. * * *
* * * * *
0
13. 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.
* * * * *
[[Page 48778]]
(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
14. 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 the table below 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:
Initial Test Cutoff Levels for Drugs and Drug Metabolites
------------------------------------------------------------------------
Cutoff level
Drugs or drug metabolites [nanograms
(ng)/mL]
------------------------------------------------------------------------
Marijuana metabolites................................... 50
Cocaine metabolites..................................... 150
Opiate metabolites:
Codeine/Morphine \1\.................................. 2000
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
15. In Sec. 26.137, revise paragraphs (d)(5), (e)(6)(i) through (iii),
and (e)(6)(v) to 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 that appears
to be a normal specimen to the licensee testing facility technicians.
* * * * *
(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;
* * * * *
(v) At least one quality control sample that appears to be a normal
specimen to the licensee testing facility technicians.
* * * * *
0
16. In Sec. 26.153, revise paragraphs (a) and (g) to read as follows:
Sec. 26.153 Using certified laboratories for testing urine 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
17. Remove and reserve Sec. 26.155.
0
18. Amend Sec. 26.157 by:
0
a. Revising paragraph (a),
0
b. Removing and reserving paragraph (b), and removing paragraphs (c)
through (e).
The revisions read 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.
(b) [Reserved]
0
19. In Sec. 26.159, revise paragraphs (b)(1)(ii), (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
[[Page 48779]]
possession and shall sign and complete chain of custody forms for those
specimens or aliquots as they are received.
* * * * *
0
20. Amend Sec. 26.161 by:
0
a. Removing in paragraphs (c)(3) and (c)(4), (f)(5), and (f)(7) the
term ``LOD'' and adding in its place the term ``LOQ''; and
0
b. Revising paragraphs (c)(5) and (c)(6).
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 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 an
equal to or greater than 200 mcg/mL nitrite-equivalent cutoff or an
equal to or greater than 50 mcg/mL chromium (VI)- equivalent cutoff) 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;
* * * * *
0
21. Amend Sec. 26.163 by:
0
a. Republishing paragraph (a) introductory text,
0
b. Revising paragraphs (a)(1), (a)(2) introductory text, (a)(2)(i), and
(ii),
0
c. Republishing paragraph (b) introductory text, and
0
d. Revising paragraph (b)(1).
The 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:
Initial Test Cutoff Levels for Drugs and Drug Metabolites
------------------------------------------------------------------------
Cutoff level
Drugs or drug metabolites [nanograms
(ng)/mL]
------------------------------------------------------------------------
Marijuana metabolites................................... 50
Cocaine metabolites..................................... 150
Opiate metabolites:
Codeine/Morphine \1\.................................. 2000
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.
(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 (a)(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.
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
Opiate metabolites:
Morphine.............................................. 2000
Codeine............................................... 2000
6-acetylmorphine (6-AM)............................... 10
Phencyclidine (PCP)..................................... 25
Amphetamines:
Amphetamine........................................... 250
Methamphetamine \3\................................... 250
MDMA.................................................. 250
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.
* * * * *
0
22. In Sec. 26.165, revise the fourth sentence in paragraph (b)(2),
paragraph (b)(3), the last sentence in paragraph (f)(1) introductory
text, and paragraph (f)(2) to 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 a single specimen or the
testing of the Bottle B split specimen.
* * * * *
(f) * * *
(1) * * * 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--
* * * * *
(2) If a donor requests that Bottle B be tested or that an aliquot
of a 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
[[Page 48780]]
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 test by the MRO under Sec. Sec. 26.129(b)(2) or
26.159(b)(2) in determining the appropriate sanctions.
0
23. Amend Sec. 26.167 by:
0
a. Republishing paragraph (d)(3) introductory text, and revising
paragraphs (d)(3)(i) through (iii);
0
b. Revising paragraph (d)(4);
0
c. Revising paragraph (e)(2), republishing paragraph (e)(3)
introductory text, and revising paragraphs (e)(3)(i) through (iv); and
0
d. Removing in paragraph (f)(3) the third sentence, the words
``responsible person'' and adding in their place the words
``Responsible Person''.
The 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
24. 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
25. Amend Sec. 26.169 by:
0
a. Removing in paragraph (a), wherever they may appear, the words
``certifying scientist'' and adding in their place the words
``Certifying Scientist''.
0
b. Republishing paragraph (h)(3) introductory text, and revising
paragraphs (h)(3)(i) and (ii), (h)(3)(iii)(C), and (h)(3)(iv);
0
c. Republishing paragraph (h)(3)(v) introductory text and revising
paragraph (h)(3)(v)(A); and
0
d. Adding new paragraphs (h)(3)(v)(C) through (D).
The additions and revisions 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);
* * * * *
(C) 6-acetylmorphine (6-AM);
(iv) Phencyclidine (PCP);
(v) Amphetamines (total);
(A) Amphetamine;
* * * * *
(C) Methylene dioxy meth am phet a mine (MDMA); and
(D) Methylenedioxyamphetamine (MDA);
* * * * *
0
26. 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
27. Amend Sec. 26.185 by:
0
a. Redesignating paragraph (f)(3) as (f)(4), and adding new paragraph
(f)(3);
0
b. Removing in paragraph (g)(1) the reference ``paragraph (g)(4)'' and
adding in its place the reference ``paragraph (g)(3)''; and
0
c. Revising paragraphs (g)(2) introductory text and (g)(2)(iii),
removing paragraph (g)(3), and redesignating paragraphs (g)(4) and
(g)(5) as paragraphs (g)(3) and (g)(4), respectively.
The addition and revisions read as follows:
Sec. 26.185 Determining a fitness-for-duty policy violation.
* * * * *
[[Page 48781]]
(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.
* * * * *
0
28. 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, opiates (codeine,
morphine, and 6-acetylmorphine), amphetamines (amphetamine,
methamphetamine, methylenedioxymethamphetamine, and
methylenedioxyamphetamine), phencyclidine, adulterants, 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.
* * * * *
Sec. 26.415 [Amended]
0
29. In Sec. 26.415 paragraph (c), remove the citation, ``(65 FR 41944;
August 9, 2001)''.
0
30. 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 at Rockville, Maryland, this 22nd day of August, 2019.
For the Nuclear Regulatory Commission.
Russell E. Chazell,
Acting Secretary of the Commission.
[FR Doc. 2019-18491 Filed 9-13-19; 8:45 am]
BILLING CODE 7590-01-P