Fitness for Duty Drug Testing Requirements, 48750-48781 [2019-18491]

Agencies

• NUCLEAR REGULATORY COMMISSION

[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

[[Page 48750]]


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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

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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