[Federal Register Volume 73, Number 62 (Monday, March 31, 2008)]
[Rules and Regulations]
[Pages 16966-17235]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-4998]



[[Page 16965]]

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Part II





Nuclear Regulatory Commission





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10 CFR Part 26



Fitness for Duty Programs; Final Rule

Federal Register / Vol. 73, No. 62 / Monday, March 31, 2008 / Rules 
and Regulations

[[Page 16966]]


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NUCLEAR REGULATORY COMMISSION

10 CFR Part 26

RIN 3150-AF12


Fitness for Duty Programs

AGENCY: Nuclear Regulatory Commission.

ACTION: Final rule.

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SUMMARY: The Nuclear Regulatory Commission (NRC) is amending its 
regulations for Fitness for Duty (FFD) programs to update these 
requirements and enhance consistency with advances in other relevant 
Federal rules and guidelines, including the U.S. Department of Health 
and Human Services (HHS) Mandatory Guidelines for Federal Workplace 
Drug Testing Programs, and other Federal drug and alcohol testing 
programs that impose similar requirements on the private sector. The 
amendments require nuclear power plant licensees and other entities, 
including facilities possessing Category 1A material, to strengthen the 
effectiveness of their FFD programs. In addition, the amendments 
require nuclear power plant licensees and other entities to enhance 
consistency between with the FFD programs with NRC's access 
authorization requirements for nuclear power plants. The amendments 
also require nuclear power plant licensees to ensure against worker 
fatigue adversely affecting public health and safety and the common 
defense and security by establishing clear and enforceable requirements 
for the management of worker fatigue. The final rule ensures that 
individuals who are subject to these regulations are trustworthy and 
reliable, as demonstrated by avoiding substance abuse; are not under 
the influence of drugs or alcohol while performing their duties; and 
are not mentally or physically impaired from any other cause that would 
in any way adversely affect their ability to perform their duties 
safely and competently.
    This final rule also grants, in part, a petition for rulemaking 
(PRM-26-1) submitted by Virginia Electric and Power Company (now 
Dominion Virginia Power) on December 30, 1993, by relaxing several 
required FFD program audit frequencies, and partially grants a petition 
for rulemaking (PRM-26-2) submitted by Barry Quigley on December 28, 
1999.

DATES: This final rule is effective April 30, 2008. However, licensees 
and other applicable entities may defer implementation of this rule, 
except for Subparts I and K, until March 31, 2009. Subpart I must be 
implemented by licensees and other applicable entities no later than 
October 1, 2009. Licensees and other applicable entities shall comply 
with the requirements of Subpart K as of April 30, 2008.

FOR FURTHER INFORMATION CONTACT: David Diec, Office of Nuclear Reactor 
Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-
0001, telephone (301) 415-2834, Timothy McCune, Office of Nuclear 
Security and Incident Response, telephone (301) 415-6474, Dr. David R. 
Desaulniers, Office of New Reactors, telephone (301) 415-1043, or Dr. 
Valerie Barnes, Office of Nuclear Regulatory Research, telephone (301) 
415-5944. All of the above contacts may also be reached by e-mail to 
FITNESSFORDUTY@NRC.GOV.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
    A. Drug and Alcohol Testing Provisions, and General Fitness-for-
Duty Program Provisions
    B. Worker Fatigue Provisions
    C. Combined Part 26 Rulemaking
    D. Public Input Accepted Since 2000 ``Affirmed Rule''
II. Petitions and Request for Exemption
    A. Petition for Rulemaking PRM-26-1
    B. Petition for Rulemaking PRM-26-2
    C. Request for Exemption under 10 CFR 26.6
III. Abbreviations
IV. Discussion of Final Action
    A. Overview
    B. Goals of the Rulemaking Activity
    C. Overview of Final Rule
    D. Inclusion of Worker Fatigue Provisions in 10 CFR Part 26
V. Summary of Public Comments Submitted on Proposed Rule
VI. Section-by-Section Analysis of Substantive Changes
VII. Availability of Documents
VIII. Criminal Penalties
IX. Agreement State Compatibility
X. Plain Language
XI. Voluntary Consensus Standards
XII. Finding of No Significant Environmental Impact: Environmental 
Assessment
XIII. Paperwork Reduction Act Statement
XIV. Regulatory Analysis
    A. Aggregate Analysis
    B. Screening Review for Disaggregation
    C. Disaggregation of Worker Fatigue Provisions
XV. Regulatory Flexibility Act Certification
XVI. Backfit Analysis
    A. Consideration of Fuel Fabrication Facilities and Gaseous 
Diffusion Plants
    B. Aggregate Backfit Analysis
    C. Screening Review for Disaggregation
XVII. References
List of Subjects in 10 CFR Part 26

I. Background

A. Drug and Alcohol Testing Provisions, and General Fitness-for-Duty 
Program Provisions

    On June 7, 1989, the Commission announced the adoption of a new 
rule, 10 CFR Part 26, Fitness for Duty Programs (54 FR 24468), that 
required each licensee authorized to operate or construct a nuclear 
power reactor to implement an FFD program for all personnel having 
unescorted access to the protected area of its plant. A subsequent 
final rule published in the Federal Register on June 3, 1993 (58 FR 
31467), expanded the scope of Part 26 to include licensees authorized 
to possess, use, or transport formula quantities of Strategic Special 
Nuclear Materials (SSNM).
    At the time the FFD rule was published in 1989, the Commission 
directed the NRC staff to continue to analyze licensee programs, assess 
the effectiveness of the rule, and recommend appropriate improvements 
or changes. The NRC staff reviewed information from several sources 
including inspections, periodic reports by licensees on FFD program 
performance, reports of significant FFD events, industry-sponsored 
meetings, and current research literature, as well as initiatives by 
industry, the Substance Abuse and Mental Health Services Administration 
of the Department of HHS (SAMHSA, formerly the National Institute on 
Drug Abuse), and SAMHSA's Drug Testing Advisory Board, and recommended 
improvements and changes.
    As a result, the NRC published proposed amendments to the FFD rule 
in the Federal Register on May 9, 1996 (61 FR 21105). The 90-day public 
comment period for the proposed rule closed on August 7, 1996. The NRC 
staff reviewed and considered public comments on the proposed rule, and 
submitted a final rule to the Commission in a Commission paper (SECY-
00-0159), dated July 26, 2000. The Commission affirmed the rule in a 
Staff Requirements Memorandum (SRM-M001204A) dated December 4, 2000. 
The affirmed rule was sent to the Office of Management and Budget (OMB) 
to obtain a clearance under the Paperwork Reduction Act. The request 
for comments on the clearance was published in the Federal Register on 
February 2, 2001 (66 FR 8812). OMB and NRC received public comments 
that objected to some aspects of the rule. In SECY-01-0134, dated July 
23, 2001, the NRC staff recommended withdrawing the request for 
clearance and preparing a new proposed rule. In a Staff

[[Page 16967]]

Requirements Memorandum (SRM-SECY-01-0134) dated October 3, 2001, the 
Commission approved the staff's recommendation to withdraw the request 
for clearance and prepare a new proposed rule.

B. Worker Fatigue Provisions

    The NRC's ``Policy on Factors Causing Fatigue of Operating 
Personnel at Nuclear Reactors'' (referred to in this document as NRC's 
Policy on Worker Fatigue) was first published in the Federal Register 
on February 18, 1982 (47 FR 7352), and later issued through Generic 
Letter (GL) 82-12, ``Nuclear Power Plant Staff Working Hours,'' on June 
15, 1982 (referred to in this document as GL 82-12). In GL 82-12, the 
NRC requested licensees to revise the administrative section of their 
technical specifications to ensure that plant administrative procedures 
were consistent with the work-hour guidelines. Those guidelines were:
    (1) An individual should not be permitted to work more than 16 
consecutive hours (excluding shift turnover time);
    (2) An individual should not be permitted to work more than 16 
hours in any 24-hour period, nor more than 24 hours in any 48-hour 
period, nor more than 72 hours in any 7-day period (all excluding shift 
turnover time);
    (3) A break of at least 8 hours should be allowed between work 
periods (including shift turnover time); and
    (4) Except during extended shutdown periods, the use of overtime 
should be considered on an individual basis and not for the entire 
staff on a shift.
    Further, the guidelines permitted deviations from these limits in 
very unusual circumstances if authorized by the plant manager, his 
deputy, or higher levels of management in some cases. The NRC's Policy 
on Worker Fatigue was incorporated, directly or by reference, and with 
variations in wording and detail, into the technical specifications of 
all but three nuclear power plant sites who implemented the concept 
using other administrative controls.
    When 10 CFR Part 26 was issued on June 7, 1989 (54 FR 24468), it 
focused on establishing requirements for preventing and detecting 
personnel impairment from drugs and alcohol. However, consistent with 
SRM-SECY-88-129, dated July 18, 1988, several requirements addressed 
other causes of impairment, including fatigue. Those requirements 
included general performance objectives [Sec.  26.10(a) and (b)] that 
provided for ``reasonable assurance that nuclear power plant personnel 
* * * are not under the influence of any substance, legal or illegal, 
or mentally or physically impaired from any cause'' and ``early 
detection of persons who are not fit to perform activities within the 
scope of this part.'' A requirement was also included in Sec.  26.20(a) 
for licensee policies to ``address other factors that could affect 
fitness for duty such as mental stress, fatigue and illness.''
    In a letter dated February 25, 1999, Congressmen Dingell, Klink, 
and Markey expressed concerns to former NRC Chairman Shirley Ann 
Jackson that low staffing levels and excessive overtime may present a 
serious safety hazard at some commercial nuclear power plants. The 
Union of Concerned Scientists (UCS) expressed similar concerns on March 
18, 1999, in a letter from David Lochbaum to Chairman Jackson, and in 
the UCS report ``Overtime and Staffing Problems in the Commercial 
Nuclear Power Industry,'' dated March 1999. In a letter dated May 18, 
1999, to the Congressmen, the Chairman stated that the NRC staff would 
assess the need to revise the policy.
    On September 28, 1999, the Commission received a petition for 
rulemaking (PRM-26-2) from Barry Quigley. (The petition is discussed in 
greater detail in Section II.B of this document.) The petition 
requested that the NRC amend 10 CFR Parts 26 and 55 to establish clear 
and enforceable work-hour limits to mitigate the effects of fatigue for 
nuclear power plant personnel performing safety-related work.
    The UCS petitioned the NRC on April 24, 2001, under 10 CFR 2.206, 
to issue a Demand for Information (DFI) to specified licensees. The 
petition asserted that Wackenhut Corporation has the contractual right 
to fire security guards who refuse to report for mandatory overtime, 
and that this contractual right conflicts with 10 CFR Part 26. The NRC 
denied the DFI request (ADAMS Accession No. ML013230169), but addressed 
the concerns of the petition through the NRC's generic communication 
process. On May 10, 2002, the NRC issued NRC Regulatory Issue Summary 
(RIS) 2002-07, ``Clarification of NRC Requirements Applicable to Worker 
Fatigue and Self-Declarations of Fitness-for-Duty.'' The RIS addressed 
the applicability of 10 CFR Part 26 to worker fatigue, the potential 
for sanctions related to worker FFD concerns to have adverse 
implications for maintaining a work environment conducive to reporting 
FFD concerns, and the protections afforded workers by 10 CFR 50.7, 
``Employee Protection.''
    On January 10, 2002, in SRM-SECY-01-0113, the Commission approved a 
rulemaking plan, ``Fatigue of Workers at Nuclear Power Plants,'' dated 
June 22, 2001 (referred to in this document as SECY-01-0113). Under the 
approved plan, the NRC initiated a rulemaking to incorporate fatigue 
management into 10 CFR Part 26 in order to strengthen the effectiveness 
of FFD programs at nuclear power plants in ensuring against worker 
fatigue adversely affecting public health and safety and the common 
defense and security by establishing clear and enforceable requirements 
for the management of worker fatigue.
    During the development of the fatigue management requirements, the 
NRC observed an increase in concerns (e.g., allegations, media and 
public stakeholder reports) related to the workload and fatigue of 
security personnel following the terrorist attacks of September 11, 
2001. Subsequent to an NRC review of the control of work hours for 
security force personnel, and public interactions with stakeholders, 
the Commission issued Order EA-03-038 on April 29, 2003, requiring 
compensatory measures related to fitness-for-duty enhancements for 
security personnel at nuclear power plants, including work hour limits.
    The compensatory measures imposed by Order EA-03-038 were similar 
to the guidelines of the NRC's Policy on Worker Fatigue. The 
compensatory measures differed from the Policy guidelines in a few 
areas in which the NRC believed it was necessary to address previously 
identified deficiencies in the guidelines, including the need to 
address cumulative fatigue from prolonged periods of extended work 
hours, matters unique to security personnel and stakeholder input 
obtained through public meetings concerning the worker fatigue 
rulemaking and the order. The NRC imposed the requirements in the order 
to provide the Commission with reasonable assurance that the public 
health and safety and common defense and security continue to be 
adequately protected. The provisions specified in 10 CFR Part 26, 
Subpart I, Managing Fatigue, for security force personnel replace the 
requirements imposed by the order. Differences between the requirements 
in Subpart I and the requirements imposed by the order, and the 
rationale for those differences, are discussed in Section IV.D of this 
document.

C. Combined Part 26 Rulemaking

    On March 29, 2004, in COMSECY-04-0014, the NRC staff informed the 
Commission of the status of both

[[Page 16968]]

rulemaking activities. The NRC staff also noted that because both 
rulemaking activities were being completed in parallel, the draft 
proposed fatigue rule language was based on the draft language in the 
proposed overall revision to Part 26, rather than on the former 
language in Part 26. Therefore, meaningful public comment could be 
confounded by the simultaneous promulgation of two draft rules which 
are somewhat interdependent, and staff action to address a comment on 
one proposed rule could easily impact the other proposed rule, creating 
a high potential for the need to issue one or both proposed rules. In 
SRM-COMSECY-04-0014, dated May 25, 2004, the Commission directed the 
staff to combine the rulemaking related to nuclear power plant worker 
fatigue with the ongoing Part 26 rulemaking activity. This combined 
final rule withdraws the proposed rule published on May 9, 1996.

D. Public Input Accepted Since 2000 ``Affirmed Rule''

    In preparing this rule, the NRC considered comments received by OMB 
on the prior Part 26 final rule affirmed by the Commission in an SRM 
dated December 4, 2000. The NRC also considered feedback received from 
industry, as well as other interested parties and members of the 
public. The NRC held 11 stakeholder meetings on the drug and alcohol 
testing portions of the rule during 2001-2004, and 13 stakeholder 
meetings on the fatigue portions of the rule during 2002-2003. 
Following the Commission's decision to combine the two rulemaking 
efforts, the NRC held one stakeholder meeting on the combined rule in 
July, 2004, and two subsequent meetings on the fatigue provisions of 
the combined rule in August and September 2004.
    Throughout the time the meetings were being held, drafts of 
proposed rule language, regulatory and backfit analysis data, and other 
pertinent information were made available to the public on the 
Internet, as announced in the Federal Register on February 15, 2002 (67 
FR 7093). The NRC received feedback from stakeholders both through the 
public meetings and the NRC's Web site. Address questions about our 
rulemaking Web site to Carol Gallagher (301) 415-5905; e-mail 
cag@nrc.gov.
    These interactions with stakeholders were a significant benefit to 
the NRC in developing the language for the final rule in a manner to 
ensure it is clearly understandable, will be consistently interpreted, 
and does not result in unintended consequences. Many of the 
stakeholders' comments directly resulted in changes. When a comment was 
included in a provision, the comment is discussed in Section VI of this 
document.
    Many comments were received during the years the meetings were 
held. The draft proposed rule language was changed and re-posted to the 
Web numerous times.
    Following the publication of the August 25, 2005 (70 FR 50442) 
proposed rule, the NRC proposed a 4-month period to accept public 
comment submissions. However, the NRC accepted comments for several 
months after the proposed deadline for the submission of public 
comments. These comments are discussed in Section V of this document.
    The NRC also held several public meetings after the proposed rule 
was published to increase stakeholder involvement in the rulemaking. 
These meetings were held on September 21, 2005 (ADAMS Accession No. 
ML052420363), November 7 and 9, 2005 (ADAMS Accession No. ML052990048), 
December 15, 2005 (ADAMS Accession No. ML053400002), and March 29-30, 
2006 (ADAMS Accession No. ML060650535).

II. Petitions and Request for Exemption

A. Petition for Rulemaking PRM-26-1

    On December 30, 1993, Virginia Electric and Power Company (now 
Dominion Virginia Power) submitted a Petition for Rulemaking (PRM-26-1) 
requesting relaxation of the required 1-year audit frequency of 
licensee FFD programs and the program elements of contractors and 
vendors (C/Vs) that are relied upon by licensees. The petition 
requested that the first sentence of former 10 CFR 26.80(a) be amended 
to read:

    Each licensee subject to this Part shall audit the fitness-for-
duty program nominally every 24 months * * *. In addition, audits 
must be conducted, nominally every 24 months, of those portions of 
fitness-for-duty programs implemented by contractors and vendors.

    In a letter dated March 14, 1994, the NRC informed the petitioner 
that the petition would be addressed in a proposed rulemaking that was 
under development. The NRC has periodically communicated with the 
petitioner regarding the status of this rulemaking since that time.
    Section 26.41(b) of the final rule partially grants two aspects of 
the petition. The required audit frequency for licensees and other 
entities who are subject to 10 CFR Part 26 has been reduced from the 
nominal 1-year frequency in the former rule to a nominal 2-year 
frequency. Further, audits of C/V services that are performed on site 
and under the direct daily supervision or observation of licensee 
personnel will be conducted as part of the 2-year audits of the 
licensee or other entity's FFD program, under Sec.  26.41(b).
    Section 26.41(c)(1) of the final rule partially denies two aspects 
of the petition. The nominal annual audit requirement for HHS-certified 
laboratories has been retained. In addition, the annual audit 
requirement has been retained for FFD program elements provided by C/Vs 
whose personnel ``are off site or are not under the direct daily 
supervision or observation of licensee personnel.''
    The bases for these changes to the audit requirements in the rule 
are addressed in the subsequent sections of this supplementary 
information.

B. Petition for Rulemaking PRM-26-2

    On September 28, 1999, Barry Quigley submitted a Petition for 
Rulemaking (PRM-26-2) requesting that the NRC amend 10 CFR Parts 26 and 
55 to establish clear and enforceable work hour limits to mitigate the 
effects of fatigue for nuclear power plant personnel performing safety-
related work. The PRM was published for public comment on December 1, 
1999, (64 FR 67202). As described in detail in Attachment 3 to SECY-01-
0113, the petition requested the NRC to:
    (1) Add enforceable working hour limits to 10 CFR Part 26;
    (2) Add a criterion to 10 CFR 55.33(a)(1) to require evaluation of 
known sleeping disorders;
    (3) Revise the NRC Enforcement Policy to include examples of 
working hour violations that warrant various NRC sanctions; and
    (4) Revise NRC Form 396 to include self-disclosure of sleeping 
disorders by licensed operators.
    The NRC received 176 comment letters in response to the petition. 
The majority of the comments (157) were in favor of a rule. These 
comments were principally from individuals and public interest groups. 
Comments received from licensees, the Nuclear Energy Institute (NEI) 
and Winston and Strawn, a law firm representing several utilities, were 
opposed to PRM-26-2. A summary of the comments and responses is 
available in SECY-01-0113 as Attachment 2. This document may be 
obtained from the NRC's Web site, http://www.nrc.gov, by selecting the 
electronic reading room and then collections of documents by type. It 
is also available in the NRC's Agencywide Documentation and Management

[[Page 16969]]

System (ADAMS) under Package Accession Number ML010180224.
    Although the NRC received many comments concerning the specific 
requirements proposed in PRM-26-2, in general, letters in support of 
the rulemaking--
    (1) Cited the importance of ensuring that personnel who perform 
safety-related functions are not impaired by fatigue;
    (2) Expressed concern that the NRC does not have a regulation 
limiting working hours and the perception that the NRC lacks the 
authority to enforce the guidelines in the NRC's Policy on Worker 
Fatigue;
    (3) Asserted that the guidelines are ambiguous and that licensees 
interpret the guidelines as not applicable when the plant is in an 
outage;
    (4) Asserted that ``the NRC appears to look the other way'' when 
licensee work scheduling practices appear inconsistent with the 
guidelines; and
    (5) Expressed the concern that utility restructuring and cost 
competition will cause reductions in staffing levels and increased 
working hours and fatigue.
    Further, several commenters noted that the Federal Government has 
established work-hour limits for personnel in other industries and 
suggested that similar limits should apply to nuclear power plant 
workers.
    In general, comments that opposed the petition expressed the 
opinion that existing regulatory requirements (i.e., technical 
specifications and 10 CFR Part 26) are adequate to ensure that 
personnel are not impaired by fatigue, that the requirements would 
impose an unnecessary and excessive burden that could not be justified 
through a backfit analysis, and that industry performance data refute 
the petitioner's argument that a rule is necessary to prevent fatigued 
personnel from performing safety-related work.
    The NRC evaluated the merits of PRM-26-2, the comments received in 
response to the PRM, and assessed the Policy on Worker Fatigue. The NRC 
concluded that the petitioner proposed a comprehensive set of 
requirements that could reasonably be expected to effectively address 
fatigue from individual and programmatic causes. However, the NRC 
concluded that it is possible to achieve these objectives through 
alternative requirements that are more flexible, more directly focused 
on risk, and more aligned and integrated with current regulatory 
requirements. Therefore, the final rule grants, PRM-26-2, in part. A 
detailed discussion of the principal findings that led to the decision 
to grant, in part, PRM-26-2 through rulemaking are included in Section 
IV.D of this document. In addition, for item 3 of PRM-26-2, the NRC 
revised Inspection Procedure (IP) 71130.08, ``Fitness For Duty 
Programs'' on February 19, 2004, to reflect the requirements of Order 
EA-03-038, dated April 29, 2003, which required compensatory measures 
related to fitness-for-duty enhancements for security personnel at 
nuclear power plants, including work hour limits. The NRC will 
similarly revise this inspection procedure following issuance of the 
final rule. The self-disclosure of sleeping disorders by licensed 
operators (item 4) is being addressed by the NRC as a separate effort 
from this rule through changes to Regulatory Guide 1.134, ``Medical 
Evaluation of Licensed Personnel at Nuclear Power Plants.''

C. Request for Exemption Under 10 CFR 26.6

    The former rule required random drug and alcohol testing for 
personnel with unescorted access to the protected area of a nuclear 
power plant. By letter dated March 13, 1990, the International 
Brotherhood of Electrical Workers (IBEW) Local 1245 requested an 
exemption from random testing for clerical, warehouse, and maintenance 
workers at the Diablo Canyon Nuclear Power Plant (Diablo Canyon) under 
the provisions of 10 CFR 26.6. The NRC denied the request and IBEW 
Local 1245 sought judicial review. In 1992, the Ninth Circuit Court of 
Appeals affirmed the NRC's denial of the request (IBEW, Local 1245 v. 
NRC, No. 90-70647, 9th Cir., June 11, 1992). In its opinion, the court 
said that random testing may well be impermissible for clerical workers 
at Diablo Canyon who perform no safety-sensitive work and have no 
access to vital areas. However, in the record before the court at that 
time, IBEW Local 1245 had not established that such a group existed. On 
January 26 and December 6, 1993, IBEW Local 1245 renewed its request 
for exemption, specifically asking that the NRC exempt from 10 CFR Part 
26 requirements for random drug testing, clerical employees at Diablo 
Canyon who are members of Local 1245 of the IBEW and who have 
unescorted access to the protected area (PA) only, but not to the 
radiologically controlled areas (RCAs) or vital areas (VAs) and who are 
not required to staff the plant's emergency response center (ERC). The 
PA is the area inside the security fence of a nuclear power plant, 
which surrounds the entire plant, and the immediately surrounding area, 
whereas the VAs enclose key safety systems and are located within the 
PA. The RCAs contain elevated levels of radiation or contamination and 
are generally located within the PA. The ERC is located off site and is 
where the licensee evaluates and coordinates licensee activities 
related to an emergency, and communicates to Federal, State and local 
authorities responding to radiological emergencies. The NRC requested 
public comment on the issue in the Federal Register of May 11, 1994 (59 
FR 24373). Comments were received from the nuclear industry, which 
largely opposed a reduction in the scope of random testing, and from 
elements of the IBEW, including Local 1245, which favored it. In SRM-
SECY-04-0229, dated January 10, 2005 (available on the NRC Web site at 
http://www.nrc.gov/reading-rm/doc-collections/commission/srm/), the 
Commission denied the IBEW exemption request because it--
    (1) Would endanger the common defense and security (as a result of 
increasing the likelihood of an insider threat); and
    (2) Was not in the public interest (because reducing the scope of 
random drug testing could increase the risk to public health and safety 
due to a greater risk of both sabotage (insider threat due to 
vulnerability to coercion) and of an accident (impaired worker)).
    Consequently, this final rule maintains the former requirement for 
random drug and alcohol testing for all personnel with unescorted 
access to the PA at a nuclear power plant.

III. Abbreviations

    The following abbreviations and acronyms are used in this Statement 
of Considerations.

AEA Atomic Energy Act
ASDs Alcohol screening devices
BAC Blood alcohol concentration
CPL Conforming products list
C/V Contractor/vendor
DOT Department of Transportation
EAP Employee assistance program
EBT Evidential breath testing device
EPRI Electric Power Research Institute
FFD Fitness for duty
GC/MS Gas chromatography/mass spectrometry
HHS Department of Health and Human Services
IBEW International Brotherhood of Electrical Workers
ITAAC Inspections, Tests, Analyses, and Acceptance Criteria
KAs Knowledge and abilities
LOD Limit of detection
LOQ Limit of quantitation
mg/dL Milligrams per deciliter
MRO Medical Review Officer
NEI Nuclear Energy Institute
ng/dL Nanograms per deciliter
NHTSA National Highway Transportation Safety Administration

[[Page 16970]]

NRC Nuclear Regulatory Commission
NSF National Sleep Foundation
OMB Office of Management and Budget
PDFFDI Potentially disqualifying fitness-for-duty information
pH potential of hydrogen
POGO Project on Government Oversight
PROS Professional Reactor Operator Society
QA/QC Quality assurance/quality control
SAE Substance Abuse Expert
SAMHSA Substance Abuse and Mental Health Services Administration
SSNM Strategic special nuclear material
THC Tetrahydrocannabinol, delta-9-tetrahydrocannabinol-9-carboxylic 
acid
UCS Union of Concerned Scientists
6-AM 6-acetylmorphine

IV. Discussion of Final Action

A. Overview

    A review of FFD program experience confirms that the former 
regulatory approach of 10 CFR Part 26 was fundamentally sound and 
provided a means of deterrence and detection of substance abuse at 
licensee facilities. FFD Program Performance Reports through 2005 are 
published on the NRC's Web site, http://www.nrc.gov/reactors/operating/
ops-experience/fitness-for-duty-programs/performance-reports.html.
    Nonetheless, the NRC believes that revisions were needed to improve 
the effectiveness and efficiency of FFD programs; enhance consistency 
with advances in similar rules and guidelines, including HHS' Mandatory 
Guidelines for Federal Workplace Drug Testing Programs (herein called 
the HHS Guidelines) and other Federal drug and alcohol testing programs 
that place similar requirements on the private sector; strengthen the 
effectiveness of FFD programs at nuclear power plants in ensuring 
against worker fatigue adversely affecting public health and safety and 
the common defense and security by establishing clear and enforceable 
requirements for the management of worker fatigue; enhance consistency 
with the NRC's access authorization requirements; improve clarity in 
the organization and language of the rule; and improve Part 26 by 
eliminating or modifying unnecessary requirements.

B. Goals of the Rulemaking Activity

    The NRC is amending 10 CFR Part 26, Fitness For Duty Programs. The 
goals are to:
    (1) Update and enhance the consistency of 10 CFR Part 26 with 
advances in other relevant Federal rules and guidelines, including the 
HHS Guidelines and other Federal drug and alcohol testing programs 
(e.g., those required by the U.S. Department of Transportation [DOT]) 
that impose similar requirements on the private sector;
    (2) Strengthen the effectiveness of FFD programs at nuclear power 
plants in ensuring against worker fatigue adversely affecting public 
health and safety and the common defense and security by establishing 
clear and enforceable requirements for the management of worker 
fatigue;
    (3) Improve the effectiveness and efficiency of FFD programs;
    (4) Improve consistency between FFD requirements and access 
authorization requirements established in 10 CFR 73.56, as supplemented 
by orders to nuclear power plant licensees dated January 7, 2003;
    (5) Improve Part 26 by eliminating or modifying unnecessary 
requirements;
    (6) Improve clarity in the organization and language of the rule; 
and
    (7) Protect the privacy and other rights (including due process) of 
individuals who are subject to Part 26.
    Each of these goals is expected to result in substantial 
improvements in FFD programs. Many changes in the final rule relate to 
each goal. The major changes for each subpart and the reasons for those 
changes are described in Section IV.C of this document. For each of the 
many specific changes, detailed discussions are included in Section VI. 
However, the following discussion provides a description of each goal, 
a basis for the need to accomplish that goal, and several examples of 
changes to the former rule that will contribute to meeting the goal.
    Goal 1--Update and enhance the consistency of 10 CFR Part 26 with 
advances in other relevant Federal rules and guidelines, including HHS 
Guidelines and other Federal drug and alcohol testing programs (e.g., 
those required by the DOT that impose similar requirements on the 
private sector.) Goal 1 is central to this rulemaking activity. Many 
changes are included in the final rule to maintain consistency with 
advances in the conduct of FFD programs, including changes in the HHS 
Guidelines. The 1994, 1998, and 2004 revisions to the HHS Guidelines 
differ substantially from the 1988 version of the HHS Guidelines, upon 
which the former rule was based.
    The President of the United States designated HHS as the agency 
responsible for the Federal workplace drug testing program. HHS' SAMHSA 
is responsible for maintaining the HHS drug testing guidelines based on 
the most recent research and the accumulation of lessons learned from 
the Federal drug testing program, as well as others who are regulated. 
The NRC has historically relied on HHS to establish the technical 
requirements for urine specimen collection, testing, and evaluation, 
and has only deviated from HHS' guidelines for considerations that are 
specific to the nuclear industry. Updating Part 26 to be consistent 
with the most recent HHS Guidelines ensures that NRC regulations 
continue to be scientifically and technically sound.
    Further, the HHS-certified laboratories that Part 26 requires 
licensees to use for drug testing are required by HHS to follow the HHS 
Guidelines in order to retain their certification. Basing Part 26 on 
older versions of the HHS Guidelines, or deviating from those 
Guidelines, increases the cost of drug testing for the nuclear 
industry. Therefore, updating Part 26 to increase consistency with the 
HHS Guidelines not only ensures that Part 26 is based on the best 
scientific and technical information available, but also avoids 
imposing an unnecessary and costly regulatory burden on the nuclear 
industry.
    One example of an improvement from enhancing consistency with the 
HHS Guidelines is that several cutoff levels for detection of various 
drugs have been updated, including a revised lower cutoff level for the 
marijuana metabolite THC. The lower cutoff level will provide greater 
assurance that individuals who use marijuana are identified.
    Additionally, a revision to the HHS Guidelines, published in the 
Federal Register on April 13, 2004 (69 FR 19643) as a final rule, 
includes requirements for specimen validity tests to determine whether 
a urine specimen has been adulterated, diluted, or substituted. This 
final rule adopts significant portions of the final HHS specimen 
validity testing provisions. The new validity testing requirements will 
substantially improve the effectiveness of the measures to guard 
against subversion of the testing process that are contained in former 
Part 26.
    Several other provisions for drug testing are under consideration 
by HHS and were published as a proposed rule for public comment in the 
Federal Register on April 13, 2004 (69 FR 19672). One change to 10 CFR 
Part 26 that is included from the proposed HHS Guidelines is permission 
for licensees to use validity screening tests to determine whether a 
urine specimen must be

[[Page 16971]]

subject to further testing at an HHS-certified laboratory because it 
may have been adulterated, diluted, or substituted, in lieu of the 
instrumented validity testing required in the April 13, 2004, final 
version of the HHS Guidelines. Although the HHS Guidelines that would 
permit Federal drug testing programs to use validity screening tests 
for initial testing of urine specimens are not yet final, some NRC 
licensees desired the flexibility to use these testing methods. A 
technical basis for use of those methods is included in section VI. 
However, the NRC is not including other provisions in the proposed HHS 
Guidelines at this time. Those provisions include permitting the drug 
testing of specimens other than urine (e.g., hair, saliva, sweat), 
requirements for split specimen procedures for all specimens, and HHS 
certification of instrumented initial test facilities, which would be 
analogous to licensee testing facilities. Should such provisions be 
included in final HHS Guidelines in the future, the NRC will consider 
incorporating them into 10 CFR Part 26 at that time.
    In addition to the changes to 10 CFR Part 26 that incorporate the 
recent revisions to the HHS Guidelines, the DOT revised its Procedures 
for Transportation Workplace Drug and Alcohol Testing Programs (49 CFR 
Part 40, 65 FR 41944; August 9, 2001) to include the use of oral fluids 
(i.e., saliva) as acceptable specimens for initial alcohol screening 
tests. This final rule also reflects the new oral fluids testing 
technology to provide FFD programs with increased flexibility in 
administering initial alcohol tests.
    Because the HHS Guidelines do not establish requirements for 
alcohol testing, NRC relies on the DOT regulations, in part, to ensure 
that the alcohol testing provisions of Part 26 remain scientifically 
sound and legally defensible. Because the DOT programs test a much 
larger number of individuals in comparison to the number of alcohol 
tests that are conducted under Part 26, basing the NRC's alcohol 
testing regulations on portions of the DOT regulations reflects the 
lessons learned from that larger population.
    Goal 2--Strengthen the effectiveness of FFD programs at nuclear 
power plants in ensuring against worker fatigue adversely affecting 
public health and safety and the common defense and security by 
establishing clear and enforceable requirements for the management of 
worker fatigue. This goal is central to this rulemaking activity. 
Subpart I, Managing Fatigue, adds clear and enforceable requirements 
for licensee management of worker fatigue to 10 CFR Part 26. The 
requirements reduce the potential for worker fatigue and therefore, 
strengthen the effectiveness of FFD programs at nuclear power plants 
and substantially increase the protection of public health and safety 
and the common defense and security. Section VI of this document 
discusses the specific reasons for each worker fatigue provision. 
Section IV.D provides a detailed discussion of the overall basis for 
establishing fatigue management requirements for FFD programs, and the 
benefits expected to result.
    Goal 3--Improve the effectiveness and efficiency of FFD programs. 
The NRC has gained experience in the actual implementation of FFD 
programs since Part 26 was originally promulgated. The NRC is making 
many changes throughout Part 26 based on that experience in order to 
improve the industry's programs, specifically to increase both the 
effectiveness of the programs in achieving the goals of Part 26 and the 
efficiency of program operations. Increasing the effectiveness and 
efficiency of FFD programs will enhance the protection of public health 
and safety and the common defense and security.
    One example of a change related to Goal 3 is the reduction in the 
period within which pre-access testing must be performed from 60 days, 
in former Sec.  26.24(a)(1), to 30 days or less, in Subpart C [Granting 
and Maintaining Authorization]. This change improves the effectiveness 
of the pre-access test in detecting drug and alcohol use by individuals 
who are applying for authorization to have the types of access or 
perform the duties that require them to be subject to Part 26. Reducing 
the number of breath specimens required for alcohol testing from two 
each for initial and confirmatory testing, in former Section 2.4(g)(18) 
in Appendix A to Part 26, to one specimen for the initial test and one 
for the confirmatory test also increases the efficiency of FFD programs 
without compromising the accuracy and validity of alcohol test results.
    Another example of rule changes related to Goal 3 is establishing a 
regulatory framework for the management of worker fatigue that 
appropriately balances the need for flexibility to manage plant 
exigencies with the need for more readily enforceable requirements and 
efficient NRC oversight of licensee compliance with the requirements 
and performance objectives of the rule.
    Goal 4--Improve consistency between FFD requirements and the access 
authorization requirements established in 10 CFR 73.56, as supplemented 
by orders to nuclear power plant licensees dated January 7, 2003. Part 
26 and the access authorization requirements each contain provisions 
that require establishing the trustworthiness and reliability of 
personnel before granting unescorted access to the protected areas of 
nuclear power plants. The NRC determined that, because both sets of 
requirements share this same goal, revising Part 26 was necessary to 
clarify the relationship between these requirements, particularly for 
licensee access authorization decisions regarding personnel who move 
between sites with some interruption in their status of having 
unescorted access to a nuclear power plant. In addition, some 
requirements in former Part 26 addressed the granting of temporary 
unescorted access. In response to the terrorist attacks of September 
11, 2001, on the World Trade Center and the Pentagon, and the current 
threat environment, the Commission took action to curtail the use of 
temporary unescorted access at commercial nuclear power plants. 
Temporary unescorted access was eliminated by orders issued January 7, 
2003, which imposed enhancements to existing access authorization 
programs. Therefore, it was necessary to revise the related provisions 
in Part 26.
    Goal 5--Improve 10 CFR Part 26 by eliminating or modifying 
unnecessary requirements. The final rule incorporates a number of 
changes to eliminate or modify unnecessary requirements. The experience 
NRC has gained over the years since Part 26 was promulgated has 
enhanced the agency's understanding of implementation issues 
experienced by the industry, and the NRC is now eliminating or 
modifying some provisions, while at the same time maintaining 
protection of public health and safety and the common defense and 
security.
    For example, because of inconsistencies in how licensees 
interpreted the FFD and access authorization requirements for 
conducting employment inquiries, many licensees contacted an 
individual's previous employers twice--once to obtain the information 
required under Part 26 and once to obtain the information required for 
access authorization. The revisions to Part 26 clarify that licensees 
may obtain information to satisfy FFD suitable inquiry requirements and 
related access authorization requirements at the same time when 
conducting an employment inquiry.

[[Page 16972]]

    Goal 6--Improve clarity in the organization and language of the 
rule. The final rule is organized to facilitate implementation, as 
compared to the former rule, which has generated many questions from 
licensees. Therefore, in the final rule, the NRC has substantially 
reorganized the requirements to eliminate redundancies, to group 
related requirements, and to present requirements in the order in which 
they apply to licensees' FFD processes. In addition, the NRC has made 
many language changes to improve clarity. This substantial 
reorganization, which substantially reduces the likelihood of 
variations in FFD programs across the industry through differing 
interpretations of the rule, improves the protection of public health 
and safety and the common defense and security. The final rule is 
clearer in both organization and language, and is expected to result in 
more uniform implementation, and, consequently, more consistency in 
achieving the Part 26 goals.
    In contrast to certain NRC regulations, Part 26 includes a 
considerable number of detailed requirements. In the public meetings 
held during the development of the final rule, industry representatives 
indicated that they consider this level of detail necessary to help 
protect individual privacy and ensure consistency in implementing the 
requirements. Additionally, industry representatives indicated that 
this high level of detail can help to avoid unnecessary litigation 
between licensees and individual personnel regarding worker non-
compliance with specific drug and alcohol testing performance steps. 
Such litigation would be more likely if those specific performance 
steps were not required by NRC rule. The level of detail and the 
enhanced clarity in the new language and organization included in Part 
26 have eliminated the need for a guidance document for provisions 
pertaining to drug and alcohol testing. Industry representatives 
commented that a guidance document would not have the same weight as a 
rule, and that both licensees and individuals should be protected fully 
with rigor and specificity in a rule. Therefore, industry desired the 
rule to be more specific and detailed, in lieu of a guidance document.
    Goal 7--Protect the privacy rights and other rights (including due 
process) of individuals who are subject to 10 CFR Part 26. This goal 
was an implicit objective of the former rule, and the final rule 
continues to protect the privacy and other rights of individuals 
(including due process) who are subject to 10 CFR Part 26. The NRC, 
DOT, and HHS have all gained experience in implementing workplace drug 
and alcohol testing programs. This experience has led the DOT and HHS 
to modify many of their requirements for such testing to more clearly 
protect privacy and other rights of individuals. Many of the changes to 
Part 26 related to this goal are based on either DOT or HHS 
requirements. The NRC believes the protection of individual rights to 
be of the highest importance and is making changes to Part 26 to ensure 
that those rights are protected through rule language developed using 
the best available information. One example of such a change is that 
the final rule prohibits any testing of ``Bottle B, the second portion 
of a split urine specimen, or retesting an aliquot of a specimen'' 
without the donor's permission.

C. Overview of Final Rule

    The final rule is divided into subparts that contain related 
requirements. Each subpart is assigned a descriptive title to aid users 
in locating rule provisions and to simplify cross-referencing within 
the final rule. By grouping related requirements and presenting them 
generally in the order in which they apply to licensees' and other 
entities' FFD processes, the final rule improves the ease of 
implementing the rule. For example, the final rule adds Subpart K [FFD 
Programs for Construction] to consolidate FFD requirements for new 
reactor construction. Also, the provisions that were contained in 
Subparts J [Recordkeeping and Reporting Requirements] and K 
[Inspections, Violations, and Penalties] of the proposed rule are now 
contained in Subparts N and O, respectively, of the final rule.
    The major topics addressed in each subpart and the reasons that the 
NRC made major changes to the former rule are described below. A 
detailed cross-reference table between the former and final Part 26 
provisions is included at the end of this notice.
Subpart A Administrative Provisions
    The first subpart, Subpart A, replaces the General Provisions 
portion of the former rule, but continues to address the same subject 
matter. Thus, Subpart A addresses the purpose and scope of the rule, 
provides definitions of important terms used in the final rule, and 
updates former provisions related to requests for specific exemptions, 
interpretations of the rule, and communications with the NRC. The final 
rule also adds a section to Subpart A that consolidates FFD program 
applicability requirements for categories of individuals.
Subpart B Program Elements
    Subpart B of the final rule reorganizes and amends former 
Sec. Sec.  26.10 through 26.29. These sections of the former rule 
specified the performance objectives that FFD programs were required to 
meet and the FFD program elements that licensees and other entities 
were required to implement to meet the performance objectives. However, 
the final rule does not include former Sec.  26.27 [Management actions 
and sanctions to be imposed] in Subpart B for two reasons. First, the 
final rule is reorganized to be consistent with the order in which 
licensees and other entities implement their programs. Because Subpart 
B is focused on establishing the framework of FFD programs, it would be 
premature to present requirements related to implementing the FFD 
program (i.e., imposing sanctions on an individual for violating the 
FFD policy) at this point in the rule. Second, the subject matter of 
former Sec.  26.27 is sufficiently important and complex that a 
separate subpart is warranted. Therefore, the final rule presents 
requirements related to management actions and sanctions in Subpart D 
[Management Actions and Sanctions to be Imposed].
Subpart C Granting and Maintaining Authorization
    Subpart C of the final rule substantially amends former FFD 
requirements related to the process that licensees and other entities 
must follow in determining whether an individual is trustworthy and 
reliable, as demonstrated by avoiding substance abuse, and can be 
expected to perform his or her job duties safely and competently. The 
final rule introduces the concept of (authorization( to Part 26 to 
refer to the status of an individual who the licensee or other entity 
has determined can be trusted to avoid substance abuse, and, therefore, 
may be permitted to have the types of access or perform the duties 
described in Sec.  26.4 [FFD program applicability to categories of 
individuals], as a result of the process described in this subpart. For 
example, in the case of nuclear power plant personnel, a licensee may 
permit an individual who is ``authorized'' under Part 26 to have 
unescorted access to protected areas in nuclear power plants if the 
individual's job requires such access.
    The NRC has published other requirements, such as 10 CFR 73.56, 
that establish additional steps that licensees and other entities must 
take as part of the process of determining whether to grant unescorted 
access to an

[[Page 16973]]

individual or permit an individual to maintain unescorted access to 
protected areas. These additional requirements focus on aspects of an 
individual's character and reputation other than substance abuse, and, 
among other steps, require the licensee or other entities who are 
subject to the rule to conduct a psychological assessment of the 
individual, perform a credit and criminal history check, and interview 
individuals who have knowledge of the applicant for authorization. 
However, historically there have been some inconsistencies and 
redundancies between the Part 26 requirements related to granting and 
maintaining unescorted access and the other related regulations, 
particularly the NRC's access authorization requirements for nuclear 
power plant personnel. The inconsistencies have led to many 
implementation questions from licensees, as well as inconsistencies in 
how licensees have implemented the requirements. The redundancies have 
imposed an unnecessary burden on licensees in other cases. Therefore, a 
central goal of adding Subpart C to the final rule is to eliminate 
those inconsistencies and redundancies to ensure that licensees and the 
other entities who are subject to the rule have clear and easily 
interpretable requirements to follow when determining whether to grant 
or maintain an individual's unescorted access under Part 26 and also 
under other, related requirements, including, but not limited to, the 
January 7, 2003 access authorization orders issued by the NRC to 
nuclear power plant licensees.
    The requirements in Subpart C are based on several fundamental 
changes to the NRC's approach to the authorization requirements in 
former Part 26. The primary concern, which Subpart C is designed to 
address, is the necessity of increasing the rigor of the authorization 
process to provide reasonable assurance that any individual who is 
granted and maintains authorization is trustworthy and reliable, as 
demonstrated by avoiding substance abuse. The necessity for increased 
rigor in the authorization process is discussed in Section VI of this 
document with respect to Sec.  26.23(a) in terms of the increased 
insider threat since the terrorist attacks of September 11, 2001. One 
change to former Part 26 authorization requirements that reflects this 
concern is the elimination of temporary access authorization 
requirements in the second sentence of former Sec.  26.27(a)(4). Other 
changes are discussed in Section VI with respect to the specific 
provisions that incorporate them.
    A second, related change to the NRC's approach to authorization 
requirements, which has informed Subpart C, is an increased concern 
with the sharing of information about individuals between licensees and 
other entities. At the time the former Part 26 was developed, the 
industry structure was different and personnel transfers between 
licensees (i.e., leaving the employment of one licensee to work for 
another licensee) with interruptions in authorization were less common. 
Most licensees operated plants at a single site and maintained an FFD 
program that applied only to that site. When an individual left 
employment at one site and began working for another licensee, the 
individual was subject to a different FFD program that often had 
different requirements. Because some licensees were reluctant to share 
information about previous employees with the new employer, licensees 
often did not have access to the information the previous licensee had 
gathered about the individual and were required to gather the necessary 
information again. The additional effort to collect information that 
another licensee held created an unnecessary burden on both licensees. 
But, because few individuals transferred, the burden was not excessive.
    However, since 1989, the industry has undergone significant 
consolidation and developed new business practices to use its workforce 
more efficiently. Industry efforts to better use expertise and staffing 
resources have resulted in the development of a large transient 
workforce within the nuclear industry that travels from site to site as 
needed, such as roving outage crews. Although the industry has always 
relied on C/Vs for special expertise and staff for outages, the number 
of transient personnel who work solely in the nuclear industry has 
increased and the length of time they are on site has decreased. 
Because the former FFD regulations were written on the basis that 
individual licensees would maintain independent, site-specific FFD 
programs and shared limited information, and that the majority of 
nuclear personnel would remain at one site for years, the former 
regulations did not adequately address the transfer of personnel 
between sites.
    These changes in the industry have increased the need for 
information sharing among licensees and C/Vs. The increased insider 
threat since September 11, 2001, has also heightened the need for 
information sharing among licensees and C/Vs to ensure that licensees 
and other entities have information that is as complete as possible 
about an individual when making an authorization decision. To address 
this need, the access authorization orders issued by the NRC to nuclear 
power plant licensees on January 7, 2003, mandated increased sharing of 
information. In addition, Subpart C requires licensees and other 
entities to collect and share greater amounts of information than under 
the former rule, subject to the protections of individuals' privacy 
that are specified in Sec.  26.37 [Protection of information]. As a 
result, individuals who are subject to the rule will establish a 
detailed ``track record'' within the industry that will follow them if 
they change jobs and move to a new position that requires them to be 
granted authorization by another licensee or entity who is subject to 
the rule. This increased information sharing contributes to providing 
reasonable assurance that individuals who are granted and maintain 
authorization under Part 26 are trustworthy and reliable when 
individuals move between FFD programs.
    However, a consequence of increased information sharing is that one 
violation of any licensee's FFD policy has greater potential to end an 
individual's career. Although an individual who has an active substance 
abuse problem cannot be permitted to have unescorted access to 
protected areas, the NRC continues to affirm that individuals who 
pursue treatment, stop abusing drugs or alcohol, and maintain sobriety 
for an extended period of time should regain the public's trust. The 
length of time that an individual must maintain sobriety in order to 
demonstrate that he or she can again be trusted with the public's 
health and safety and the common defense and security has been a matter 
of debate since Part 26 was originally under development. However, the 
research literature continues to indicate that individuals who maintain 
sobriety past the first 3 years following treatment have substantially 
reduced recidivism rates (i.e., relapsing into substance abuse) than 
during the first 3 years after treatment. There is also a further drop 
in recidivism rates after 5 years of sobriety.
    Despite these research findings, some individuals who have had one 
confirmed positive test result have been prevented from working in 
operating nuclear power plants. The increased information sharing 
required under Subpart C has the potential to result in a greater 
number of these individuals being banned from working in the industry. 
Therefore, the NRC has added several requirements to Subpart C to

[[Page 16974]]

minimize these consequences for individuals who are able to demonstrate 
that they are effectively coping with a substance abuse problem. 
Additional requirements for protecting information to be gathered about 
individuals under Part 26 are specified in Sec.  26.37. The detailed 
changes to former requirements are discussed in Section VI with respect 
to the specific provisions that incorporate these requirements.
    In general, the authorization requirements in Subpart C are 
structured according to whether an individual who has applied for 
authorization has previously held authorization under Part 26. If an 
individual has not established a ``track record'' in the industry, the 
final rule requires licensees and other entities to meet an extensive 
set of requirements before granting authorization to the individual. If 
an individual has established a favorable track record in the industry, 
the amount of original information gathering that the final rule 
requires licensees and other entities to complete before granting 
authorization to the individual is reduced. The need for original 
information gathering in these instances is reduced because licensees 
and other entities will have access to all of the information that 
previous FFD programs have collected about the individual under the 
final rule.
    For individuals who have established a favorable track record in 
the industry, the steps that licensees and other entities are required 
to complete in order to grant authorization to an individual also 
depends upon the length of time that has elapsed since the individual's 
last period of authorization was terminated and the amount of 
supervision to which the individual was subject during the 
interruption. (The term ``interruption'' refers to the interval of time 
between periods during which an individual holds authorization under 
Part 26.) In general, the more time that has elapsed since an 
individual's last period of authorization ended, the more steps that 
the final rule requires licensees and other entities to complete before 
granting authorization to the individual. However, if the individual 
was subject to behavioral observation under a Part 26 program or 
continued to be subject to random drug and alcohol testing during the 
interruption, the final rule requires licensees and other entities to 
complete fewer steps in order to grant authorization to the individual. 
There are several reasons that the final rule requires fewer steps in 
the authorization process for these individuals.
    First, individuals who have established a favorable work history in 
the industry have demonstrated their trustworthiness and reliability 
from previous periods of authorization, so they pose less potential 
risk to public health and safety and the common defense and security 
than individuals who are new to the industry. Much is known about these 
individuals. Not only were they subject to the initial background 
screening requirements before they were initially granted 
authorization; but, while they were working under a Part 26 program, 
they were watched carefully through on-going behavioral observation, 
repeatedly attained negative results from random drug and alcohol 
tests, and demonstrated the ability to consistently comply with the 
many procedural requirements that are necessary to perform work safely 
at operating power reactor facilities.
    Second, individuals who have established a favorable work history 
in the industry and whose authorization has been interrupted for only a 
short period are unlikely to develop an active substance abuse problem 
during the interruption. The shorter the period of time since the 
individual's last period of authorization ended, the less likely it is 
that the individual has developed an active substance abuse problem or 
undergone other significant changes in lifestyle or character that 
would diminish his or her trustworthiness, reliability, and ability to 
perform work safely and competently.
    Further, if the individual was also subject to supervision under 
some elements of a Part 26 program (e.g., behavioral observation, a 
requirement to report any arrests, random drug and alcohol testing) 
during the period that his or her authorization was interrupted, the 
higher the assurance that the individual does not have an active 
substance problem. And, it is less likely that the individual could 
have undergone significant changes in lifestyle or character that would 
be undetected.
    Therefore, the final rule establishes categories of requirements 
for granting authorization to an individual that vary, based upon 
whether the individual has previously held authorization under Part 26; 
whether the individual's last period of authorization was terminated 
favorably or unfavorably; how long it has been since the individual 
last held authorization under Part 26; and whether the individual was 
subject to any elements of a Part 26 program during the interruption 
period. Section 26.55 [Initial authorization] establishes authorization 
requirements for individuals who have not previously held authorization 
under Part 26 and individuals who have not held authorization within 
the past 3 years. Section 26.57 [Authorization update] establishes 
authorization requirements for individuals who previously held 
authorization under Part 26, whose last period of authorization was 
terminated favorably more than 1 year ago but less than 3 years ago. 
Section 26.59 [Authorization reinstatement] establishes authorization 
requirements for individuals who previously held authorization under 
Part 26 and whose last period of authorization was terminated favorably 
within the past year. Section 26.69 [Authorization with potentially 
disqualifying fitness-for-duty information] defines the steps that 
licensees and other entities must take in granting authorization to an 
individual about whom potentially disqualifying FFD information has 
been disclosed or discovered.
    The time periods used to establish these categories of 
authorization requirements are consistent with the categories 
established in the access authorization orders issued by the NRC to 
nuclear power plant licensees on January 7, 2003. Basing the 
requirements on elapsed time is consistent with the programs of other 
Federal agencies who have similar needs to control access to sensitive 
information and protected areas. In addition, these time periods have 
been used successfully within nuclear power plant access authorization 
programs since 1989 and have met the NRC's goal of ensuring that 
individuals who are granted unescorted access are trustworthy and 
reliable. Therefore, the final rule incorporates these time periods 
within Part 26.
    In general, the steps that are required under this part to grant 
authorization to an individual who has recently held authorization and 
whose most recent period of authorization was terminated favorably are 
less extensive than the steps required for applicants for authorization 
who are new to the industry or those who have not recently held 
authorization. In addition, the NRC has strengthened the requirements 
for a rigorous evaluation process contained in the former Sec.  
26.27(e) that licensees and other entities are required to meet before 
granting authorization to an individual about whom potentially 
disqualifying FFD information has been disclosed or discovered (see 
Sec.  26.69). The final rule requires licensees and other entities to 
obtain and review a written self-disclosure from the applicant and an 
employment history, and ensure that a suitable inquiry and pre-access 
drug and alcohol testing are completed before granting authorization to 
an individual,

[[Page 16975]]

with certain exceptions. The exceptions to the self-disclosure and 
employment history, suitable inquiry, and pre-access testing 
requirements are specified in Sec. Sec.  26.61 [Self-disclosure and 
employment history], 26.63 [Suitable inquiry], and 26.65 [Pre-access 
drug and alcohol testing], respectively. The final rule also requires 
licensees and other entities to ensure that applicants are subject to 
random testing, as specified in Sec.  26.67 [Random drug and alcohol 
testing of individuals who have applied for authorization].
Subpart D Management Actions and Sanctions
    Subpart D of the final rule replaces former Sec.  26.27(b) and (c) 
and divides the former provisions into two separate sections that 
specify requirements for responding to FFD policy violations in Sec.  
26.75 [Sanctions], and indications of impairment in Sec.  26.77 
[Management actions regarding possible impairment]. The final rule adds 
a new Sec.  26.73 [Applicability] to specify the entities and 
individuals to whom the requirements of the subpart apply. The former 
rule has been reorganized to generally reflect the order in which the 
requirements apply to licensees' and other entities' FFD processes, and 
to group related requirements into separate sections. Therefore, the 
NRC has made these changes to meet Goal 6 of this rulemaking to improve 
clarity in the organization and language of the rule.
    In general, subpart D includes three significant changes from the 
related provisions in the former rule that are each intended to provide 
a stronger deterrent to engaging in the unwanted actions specified in 
the subpart. First, the final rule increases the severity of the 
minimum sanctions that are required if an individual violates a 
licensee's or other entity's FFD policy. The more stringent sanctions 
are necessary in order to strengthen the effectiveness of the rule in 
providing reasonable assurance that individuals who are subject to this 
part are trustworthy and reliable, as demonstrated by avoiding 
substance abuse, and by increasing the assurance that only individuals 
who are fit for duty are permitted to have the types of access or 
perform the duties listed in Sec.  26.4.
    Second, the final rule requires licensees and other entities who 
are subject to the rule to impose the same sanctions for an FFD 
violation involving the abuse of alcohol as required for the abuse of 
illegal drugs. Impairment caused by alcohol abuse creates a risk to 
public health and safety that is fundamentally similar to the risk 
posed by the use of illegal drugs. However, some licensees have imposed 
lesser sanctions for alcohol violations, an approach that is 
inconsistent with the NRC's intent. Therefore, the final rule rectifies 
this situation by explicitly requiring the same minimum sanctions for 
abuse of alcohol as formerly required for the use of illegal drugs.
    Third, the final rule adds the sanction of permanent denial of 
authorization for any individuals who subvert or attempt to subvert the 
testing process. The former rule permitted licensees and other entities 
to have flexibility in establishing sanctions for actions such as 
refusing to submit to testing and attempting to subvert the testing 
process by submitting an adulterated or substitute specimen. As a 
result, different FFD programs imposed different sanctions and some 
individuals were granted authorization or permitted to maintain 
authorization when they committed such acts. However, acts to defeat 
the testing process indicate that an individual is not trustworthy and 
reliable, and suggest that the individual may be engaging in substance 
abuse that could pose a risk to public health and safety and the common 
defense and security. Therefore, the final rule establishes a minimum 
sanction that all FFD programs must impose to deter attempts to subvert 
the testing process, as well as provide reasonable assurance that 
individuals who are granted and maintain authorization can be trusted 
to comply with the rules and regulations to which they are subject.
    These three changes have been made to meet Goal 3 of this 
rulemaking to improve the effectiveness of FFD programs. The NRC has 
made other changes to former Sec.  26.27(b) and (c) in subpart D 
primarily to eliminate or modify unnecessary requirements and clarify 
the intent of former provisions.
Subpart E Collecting for Testing
    Subpart E of the final rule reorganizes and amends the requirements 
related to collecting specimens for drug and alcohol testing that were 
contained in former Sec.  26.24 [Chemical and alcohol testing] and 
interspersed throughout former Appendix A to Part 26. The subpart 
groups the related requirements and presents them in the order in which 
they would be implemented by FFD programs. The final rule also 
eliminates some redundancies in the provisions of the former rule that 
were related to specimen collections. The NRC has made these changes to 
meet Goal 6 of the rulemaking to improve clarity in the organization 
and language of the rule.
    In general, the procedures in this subpart are more detailed than 
those in Appendix A to the former rule and NRC regulations that are 
based on a risk-informed, performance-based approach, for several 
reasons. First, the more detailed procedures in subpart E will increase 
the consistency of Part 26 drug and alcohol specimen collection 
procedures with those of other Federal agencies and therefore, take 
advantage of the scientific and technical advances that have been made 
in workplace drug and alcohol testing programs since the former Part 26 
was promulgated, as discussed in Section IV.B of this document. Second, 
the final rule permits FFD programs to accept and rely upon other FFD 
programs that are implemented under this part, as well as the programs 
of other Federal and State agencies, to a much greater extent than is 
permitted under the former rule. The permission to rely on other 
programs improves the effectiveness and efficiency of FFD programs 
(Goal 3 of the rulemaking) and improves the rule by eliminating or 
modifying unnecessary requirements (Goal 5 of the rulemaking). For 
example, under Sec.  26.69(b)(6), the final rule permits licensees and 
other entities to rely on another Part 26 program's drug and alcohol 
followup testing of an individual who has violated an FFD policy and is 
consequently required to have at least 15 followup tests within the 3-
year period following the violation, and is transferring from one 
licensee's site to another.
    The final rule requires the receiving licensee or entity to 
continue the followup testing program. However, the final rule permits 
the licensee or other entity to accept the followup testing that was 
completed by the previous FFD program when determining the remaining 
number of followup tests to which the individual must be subject and 
the period of time during which the individual must continue to be 
subject to followup testing. Therefore, because the final rule permits 
this reliance on other programs, more detailed requirements for 
conducting the activities on which other FFD programs may rely, 
including drug and alcohol testing, are necessary to provide greater 
assurance that all Part 26 programs meet minimum standards. Third, the 
final rule incorporates a greater level of detail in the specimen 
collection procedures of the final rule for the reasons discussed in 
Section IV.B.
    The NRC has made other major changes to the former rule's 
requirements for collecting specimens for drug and alcohol testing to 
incorporate specimen validity testing

[[Page 16976]]

requirements from the HHS Guidelines into Part 26 (Goal 1 of this 
rulemaking) and modify former alcohol testing requirements to improve 
the efficiency of FFD programs (Goal 3 of the rulemaking), while 
continuing to protect or enhance individuals' rights to privacy and due 
process under the rule (Goal 7 of the rulemaking).
Subpart F Licensee Testing Facilities
    Subpart F of the final rule presents detailed requirements for 
conducting initial urine specimen validity and drug tests at licensee 
testing facilities, as permitted in Sec.  26.24(d)(1) of the former 
rule and Sec.  26.31(d)(3)(ii) of the final rule. The subpart is 
entitled, ``Licensee Testing Facilities,'' for brevity, but permits 
other entities who are subject to the rule to establish and operate 
drug testing facilities under the final rule.
    The NRC has added this subpart to the final rule to group together 
in a single subpart the rule's requirements that are related to 
licensee testing facilities, which were intermixed with requirements 
related to drug testing at HHS-certified laboratories in Appendix A to 
Part 26 in the former rule. The final rule presents the requirements 
that are applicable to licensee testing facilities and HHS-certified 
laboratories in two separate subparts because the provisions of the 
former rule were not always clear with respect to which requirements 
applied to which type of testing facility. Also, the final rule 
includes the requirements that apply to both types of facilities in 
both subparts so that it is unnecessary for licensees and other 
entities who do not operate licensee testing facilities to be concerned 
with any provisions in subpart F. Although many of the requirements in 
this subpart are redundant with similar requirements in subpart G 
[Laboratories Certified by HHS], these changes meet Goal 6 of this 
rulemaking to improve clarity in the organization and language of the 
rule.
    The most important change in subpart F to the former requirements 
for licensee testing facilities is the addition of new requirements for 
licensee testing facilities to conduct initial urine specimen validity 
testing, based on similar provisions contained in the most recent 
revision to the HHS Guidelines (69 FR 19643; April 13, 2004). The 
reasons for requiring initial urine specimen validity testing are 
discussed with respect to Sec.  26.31(d)(3)(ii). The NRC believes that 
it is necessary for licensee testing facilities to conduct specimen 
validity testing because Part 26 permits licensees and other entities 
to make authorization decisions based on initial drug test results from 
such facilities. Thus, the rule permits licensees and other entities to 
grant authorization to an individual who has negative initial test 
results from pre-access testing without further analysis of the urine 
specimen by an HHS-certified laboratory. If the initial test results 
from the licensee testing facility are inaccurate because the urine 
specimen was adulterated or substituted, the licensee or other entity 
could grant authorization to an individual who poses a risk to public 
health and safety and the common defense and security. Similarly, if an 
individual who has been selected for random testing submits an 
adulterated or substituted specimen that is not detected by initial 
tests at the licensee testing facility, the individual would be 
permitted to maintain authorization if the results of drug testing are 
negative. Therefore, in order to increase the likelihood that 
individuals who may be using drugs and attempting to defeat the testing 
process are detected, and to ensure that they are not permitted to be 
granted or maintain authorization, the NRC has concluded that it is 
necessary to require licensee testing facilities to conduct urine 
specimen validity tests.
    However, in consideration of the increased costs and burden that 
are associated with instrumented initial validity testing, subpart F 
permits licensee testing facilities to use commercially available 
validity screening tests of urine specimens, which may be a less 
expensive alternative than the instrumented initial validity tests 
required in the current HHS Guidelines. As discussed in Section VI with 
respect to Sec.  26.5 [Definitions], the final rule uses the term 
``validity screening test'' to refer to these commercially available 
tests. The term ``initial validity test'' refers to instrumented 
validity testing.
    At the same time that the HHS published its regulations to require 
specimen validity testing, which have been incorporated in the final 
rule, HHS also published a proposed revision to the Guidelines (69 FR 
19673; April 13, 2004) that would permit the use of validity screening 
devices for the detection of substitution and the presence of 
adulterants in urine specimens. These devices include non-instrumented 
devices with visually-read endpoints as well as semi-automated or 
automated instrumented testing devices with machine-read end points. 
Specimen validity tests conducted with these devices use colorimetric 
assays, which is the same scientific principle as the initial tests 
conducted at HHS-certified laboratories. Non-instrumented specimen 
validity devices for urine testing have been shown to detect 
adulterants in urine specimens and creatinine concentrations on tests 
that were conducted on specimens that were spiked with drug analytes. 
However, the results from the preliminary studies are variable. 
Therefore, the proposed HHS Guidelines include extensive performance 
testing requirements for these devices, which subpart F also 
incorporates. Such performance testing is necessary to ensure that 
validity test results based on using these devices are accurate.
Subpart G Laboratories Certified by the Department of Health and Human 
Services
    Subpart G presents together in a single subpart requirements 
related to the HHS-certified laboratories that are used by licensees 
and other entities who are subject to Part 26 for validity and drug 
testing. The requirements in this subpart group together the former 
requirements in Appendix A to Part 26 as they relate to HHS-certified 
laboratories. However, the final rule updates the former requirements 
to be consistent with the HHS Guidelines that were published in the 
Federal Register on April 13, 2004 (69 FR 19643). The most important 
changes to the former rule's requirements for HHS-certified 
laboratories are the incorporation of extensive requirements for urine 
specimen validity testing.
Subpart H Determining Fitness-for-Duty Policy Violations and 
Determining Fitness
    Subpart H in the final rule reorganizes, clarifies, and enhances 
former requirements related to the decisions that medical review 
officers (MROs) and other healthcare professionals must make under Part 
26 to provide input to licensees' and other entities' management 
decisions with respect to granting and permitting an individual to 
maintain authorization under Subpart C and also with respect to 
imposing sanctions and taking actions to prevent an individual from 
performing duties that require an individual to be subject to this part 
under Subpart D. The former requirements, which were interspersed 
throughout the rule, are grouped together in Subpart H to make them 
easier to locate within the final rule, consistent with Goal 6 of this 
rulemaking to improve clarity in the organization and language of the 
rule. The subpart also makes several significant changes to the former 
requirements.
    In general, Subpart H includes more detailed requirements for 
determining

[[Page 16977]]

FFD policy violations and conducting determinations of fitness than 
were included in the former rule. The NRC has added these more detailed 
requirements in response to implementation questions that the NRC has 
received from licensees since Part 26 was first promulgated, lessons 
learned from NRC inspections of FFD programs, and the experience of 
other Federal agencies that similarly require workplace drug and 
alcohol testing. However, the NRC's primary concern in establishing 
more detailed requirements is to enhance the consistency in how FFD 
policy violations and fitness are determined among Part 26 programs. 
The final rule permits licensees and other entities to rely on the 
determinations made by other Part 26 programs to a greater extent than 
the former rule. For example, Sec.  26.63(b) of the final rule permits 
licensees and other entities to rely upon a previous licensee's or 
other entity's determinations of fitness, as well as their reviews and 
resolutions of potentially disqualifying FFD information, from previous 
periods of authorization. The reasons for adding these permissions were 
discussed previously in this section, with respect to Subpart C. 
However, to ensure that all licensees' and other entities' 
determinations of FFD policy violations and fitness can be relied upon 
by other FFD programs, it is necessary to enhance the former 
requirements and establish clear minimum standards for those processes. 
Therefore, the subpart includes greater detail to meet Goal 3 of this 
rulemaking to improve the effectiveness and efficiency of FFD programs.
    Under the final rule, licensees and other entities continue to be 
prohibited from imposing sanctions on an individual who has a positive 
confirmatory drug test result from testing at the HHS-certified 
laboratory until the MRO has had an opportunity to discuss the result 
with the individual and determines that there is no legitimate medical 
explanation for the positive result(s). The final rule extends this 
requirement to the review of positive confirmatory validity test 
results, consistent with the addition of requirements to conduct 
validity testing throughout the final rule, as discussed in Section VI 
with respect to Sec.  26.31(d)(3)(I). An MRO review of adulterated or 
substituted validity test results from an HHS-certified laboratory 
before a licensee or other entity imposes sanctions on an individual is 
necessary for the same reasons that an MRO review is required of 
positive drug test results. That is, there may be legitimate medical 
reasons for the adulterated or substituted test result and the test 
result may not indicate that the donor has violated the FFD policy, 
which in this case would mean that he or she has not attempted to 
subvert the testing process. The NRC added a requirement for the MRO to 
review adulterated or substituted validity test results to meet Goal 7 
of this rulemaking to protect the privacy and other rights (including 
due process) of individuals who are subject to Part 26 and ensure that 
the individuals are afforded accurate and consistent testing. The HHS 
Guidelines also require the MRO to review adulterated and substituted 
validity test results. Therefore, adding this requirement to the final 
rule also meets Goal 1 of this rulemaking to update and enhance the 
consistency of Part 26 with advances in other relevant Federal rules 
and guidelines.
    Another significant change that the final rule makes to former 
requirements is the establishment of a new position within FFD 
programs--the ``substance abuse expert'' (SAE). The SAE is responsible 
for performing a determination of fitness, which is determining whether 
there are indications that an individual may be in violation of the 
licensee's or other entity's FFD policy or is otherwise unable to 
safely and competently perform his or her duties, in those instances in 
which an individual may not be fit for duty for reasons related to drug 
or alcohol abuse. The NRC has added the SAE position for several 
reasons.
    First, some MROs who provide services under Part 26 have indicated 
that they do not feel qualified to assess the presence and severity of 
substance abuse disorders, make treatment recommendations, and 
determine when an individual who has had a substance abuse disorder may 
again be able to safely and competently perform duties under this part. 
The focus of MRO responsibilities under Part 26 and other Federal 
workplace drug testing programs is on the medical evaluation of 
positive, adulterated, substituted, or invalid test results, which 
requires a knowledge of substance abuse. However, some MROs do not have 
the extensive knowledge of substance abuse disorders that is necessary 
to make determinations of fitness and treatment recommendations as 
required under this part. Therefore, the final rule permits MROs to 
serve as SAEs if they meet the qualifications for this role that are 
established in this subpart. But, the rule requires licensees and other 
entities to rely on other healthcare professionals who have the 
necessary qualifications to conduct determinations of fitness if the 
MRO does not meet the SAE qualification requirements.
    Second, the NRC believes that healthcare professionals other than 
licensed physicians may have the requisite knowledge and skills to 
serve as SAEs under the rule. Therefore, the final rule defines the 
position of SAE in terms of the knowledge and skills required, and 
permits healthcare professionals other than licensed physicians to 
serve in this role.
    Third, under the final rule, FFD programs are permitted to accept 
determinations of fitness and treatment plans from other Part 26 
programs, if an individual who has had a substance abuse problem will 
be granted authorization by another licensee or entity. Consequently, 
detailed requirements for the qualifications and responsibilities of 
the SAE are necessary to ensure consistency among FFD programs. 
Detailed requirements for the qualifications and responsibilities of 
the SAE are necessary because of the key role the SAE plays in assuring 
the common defense and security and public health and safety when 
making a determination of fitness on which licensees and other entities 
will rely when making authorization decisions. It is critical that SAEs 
understand the potential impact on the common defense and security and 
public health and safety when determining that an individual who has 
had an active substance abuse problem has resolved the problem and is 
again worthy of the public's trust. A sophisticated understanding of 
substance abuse problems and the types of adverse behaviors they may 
involve, including knowledge of the research literature and clinical 
experience, is necessary to inform the SAE's clinical judgments in 
these circumstances.
    The NRC has adapted many of the provisions in the subpart from 
related DOT requirements regarding the ``substance abuse professional'' 
[49 CFR Part 40, subpart O; 65 FR 41944; August 9, 2001]. The SAE role 
is not defined in former Part 26.
Subpart I Managing Fatigue
    Subpart I of the final rule strengthens the effectiveness of FFD 
programs at nuclear power plants in ensuring against worker fatigue 
adversely affecting public health and safety and the common defense and 
security by establishing clear and enforceable requirements for the 
management of worker fatigue. Because the overall rationale for 
including Subpart I, Managing Fatigue, in Part 26, is detailed

[[Page 16978]]

and extensive, this discussion is presented separately in Section IV.D.
Subpart J [Reserved]
    As a result of adding Subpart K [FFD Programs for Construction] to 
the final rule, several subparts of the proposed rule have been 
renumbered. The provisions contained in Subpart J of the proposed rule 
have been moved to Subpart N of the final rule.
Subpart K FFD Programs for Construction
    As a result of reorganizating the final rule, the NRC has moved the 
provisions contained in Subpart K of the proposed rule [Inspections, 
Violations, and Penalties] to Subpart O of the final rule.
    The final rule adds a new Subpart K to revise and increase the 
level of detail of FFD requirements contained in Sec.  26.3(e) of the 
proposed rule pertaining to FFD programs for new reactor construction. 
The NRC has added this subpart to the final rule to clarify the 
requirements applicable to entities conducting construction activities 
in response to public comments that raised concerns with the proposed 
requirements. A detailed description of these public comments, as well 
as a summary of the features and objectives of Subpart K can be found 
in Section V of this document. A detailed section-by-section analysis 
of the provisions of Subpart K can be found in Section VI of this 
document.
Subpart L [Reserved]
Subpart M [Reserved]
Subpart N Recordkeeping and Reporting Requirements
    As a result of reorganizing the proposed rule, the NRC has moved 
the provisions contained in Subpart J of the proposed rule 
[Recordkeeping and Reporting Requirements] to this subpart of the final 
rule. The NRC has added Subpart N to the final rule to reorganize the 
former rule's requirements for maintaining records and submitting 
reports to the NRC. The subpart combines and amends two sections of the 
former rule: Section 26.71 [Recordkeeping requirements] and Sec.  26.73 
[Reporting requirements], and incorporates the record retention 
requirements of former Sec. Sec.  26.21(b), 26.22(c), and 26.80(c). The 
final rule adds a new Sec.  26.709 [Applicability]. The NRC has made 
these changes to meet Goal 6 of this rulemaking to improve clarity in 
the organization and language of the rule, by grouping related 
requirements together in the subpart.
    Major changes to the former rule's requirements for recordkeeping 
and reporting reflect the addition of requirements for specimen 
validity testing to the final rule, the addition of requirements for 
managing worker fatigue at nuclear power plants, and a relaxation of 
the required frequency with which Part 26 programs must submit FFD 
program performance reports to the NRC from bi-annually to annually.
Subpart O Inspections, Violations, and Penalties
    As a result of reorganizing the proposed rule, the NRC has moved 
the provisions contained in Subpart K of the proposed rule 
[Inspections, Violations, and Penalties] to this subpart of the final 
rule. The NRC added Subpart O to the final rule to combine into one 
subpart former Sec. Sec.  26.70 [Inspections], 26.90 [Violations], and 
26.91 [Criminal penalties]. The NRC has grouped these sections together 
in one subpart because they each establish requirements related to the 
NRC's oversight of the implementation of FFD programs. Section 26.821 
[Inspections] retains the requirements in former Sec.  26.70. Section 
26.823 [Violations] retains the requirements in former Sec.  26.90 
[Violations]. Section 26.825 [Criminal penalties] retains the 
requirements in former Sec.  26.91 [Criminal penalties].

D. Inclusion of Worker Fatigue Provisions in 10 CFR Part 26

    The NRC has determined that the effectiveness of FFD programs in 
ensuring against worker fatigue adversely affecting public health and 
safety and the common defense and security should be strengthened by 
establishing clear and enforceable requirements for the management of 
worker fatigue at nuclear power plants. Subpart I, Managing Fatigue, of 
the final rule includes these requirements and establishes an 
integrated approach to fatigue management for nuclear power plant 
workers, with fatigue prevention, detection, and mitigation as the 
fundamental components. The requirements in Subpart I provide a 
substantial increase in the protection of public health and safety and 
common defense and security. In establishing the provisions of this 
final rule, the NRC has taken into consideration the effects of 
fatigue; the specific work practices of the nuclear power industry that 
contribute to and mitigate fatigue; the inadequacy of the former 
regulatory framework; the excessive hours formerly worked by many 
nuclear power workers; and the practices of other industries and 
countries for regulating work hours. In addition, the NRC held many 
public meetings with the nuclear industry and the public to discuss 
provisions for the final rule.
    The NRC has determined that an integrated approach is necessary to 
effectively manage worker fatigue because individuals experience 
fatigue for many reasons, including long work hours, inadequate rest, 
and stressful or strenuous working conditions. Shiftwork, home-life 
demands, and sleep disorders can all contribute to inadequate sleep and 
excessive fatigue. Individual differences in workers' tolerance of 
these conditions also influence worker fitness for duty. As a 
consequence, fatigue is a complex phenomenon that requires an 
integrated approach to manage effectively. The requirements in Subpart 
I were developed on the premise that fatigue management requires the 
collaboration of individual workers and licensees.
    Each of the requirements in Subpart I is discussed in detail in 
Section VI. However, because Subpart I presents an integrated fatigue 
management approach, this section discusses the principal findings that 
led to the NRC's decision to include fatigue management provisions in 
Part 26, as well as supporting information on the causes and problems 
with worker fatigue in the nuclear power industry.
    The Commission approved a rulemaking plan to include worker fatigue 
provisions for nuclear power plants in 10 CFR Part 26 on January 10, 
2002, (SRM-SECY-01-0113), as described in Section I. Since that time, 
the NRC has continued to analyze the need for work-hour provisions in 
the final rule. The considerations listed in the numbered paragraphs 
that follow summarize the NRC's considerations concerning the 
appropriate regulatory action to address the potential for worker 
fatigue to affect public health and safety and the common defense and 
security. These considerations include:
    (1) The research literature demonstrating the substantive effects 
of fatigue and decreased alertness on an individual's ability to safely 
and competently perform his or her duties;
    (2) The conditions that contribute to worker fatigue in the U.S. 
nuclear power industry;
    (3) With the exception of orders limiting the work hours of 
security personnel, the NRC's former regulatory framework did not 
include consistent or readily enforceable requirements to address 
worker fatigue;
    (4) Reviews of industry control of work hours have repeatedly 
identified practices that were inconsistent with the NRC's Policy on 
Worker Fatigue, including excessive use of extended

[[Page 16979]]

work weeks and the overuse of work-hour limit deviations;
    (5) The former regulatory framework included requirements that were 
inadequate and incomplete for effective fatigue management;
    (6) Ensuring effective management of worker fatigue through 
rulemaking substantially enhances the effectiveness of FFD programs, 
but additional orders are not presently warranted to ensure adequate 
protection of public health and safety or the common defense and 
security; and
    (7) Addressing the fatigue of workers in safety-critical positions 
through regulation is consistent with practices in foreign countries 
and other industries in the U.S.
    Each of these considerations is discussed in greater detail below.
    (1) Fatigue and decreased alertness can substantively degrade an 
individual's ability to safely and competently perform his or her 
duties.
    The NRC previously noted in its ``Policy Statement on the Conduct 
of Nuclear Power Plant Operations,'' dated January 24, 1989 (54 FR 
3424), that ``nuclear power plant operators on each shift must have 
knowledge of those aspects of plant status relevant to their 
responsibilities to maintain their working environment free of 
distractions, and using all their senses, be alert to prevent or 
mitigate any operational problems.'' The degradation in an individual's 
cognitive functioning resulting from inadequate rest includes, but is 
not limited to, a reduced ability to sustain attention; maintain 
situational awareness; make timely and conservative decisions; 
communicate; and work effectively as a team member. These degradations 
in performance, if exhibited by individuals performing risk-significant 
functions, can adversely affect the safety and security of a nuclear 
power plant.
    The NRC evaluated the research available on the degradation of 
worker abilities that are important to safe plant operation. The 
research supports the fatigue management provisions in subpart I. Many 
of the specific research citations are listed in detail in section VI. 
The following is a discussion of the fundamental concerns associated 
with worker fatigue, and some of the overall research that forms the 
basis for the integrated fatigue management approach in Subpart I.
    Many studies have shown that fatigue impairs human alertness and 
performance (e.g., Alluisi and Morgan, 1982; Rosa, 1991; Scott, 1990; 
Dinges, 1992; Dinges, 1995; Dawson and Reid, 1997; Bobko, et al., 1998; 
Harrison and Horne, 2000; Williamson and Feyer, 2000). The lack of 
adequate days off and extended workdays (overtime) can result in a 
cumulative sleep debt (i.e., the difference between the amount of sleep 
an individual needs and the amount of sleep that individual actually 
obtains) and performance impairment (Webb and Agnew, 1974; Baker, et 
al., 1994; Colquhoun, et al., 1996; Tucker, et al., 1999; Williamson 
and Feyer, 2000; Department of Transportation (DOT), May 2, 2000, 65 FR 
25546). Across a broad range of industries, studies concerning extended 
work hours suggest that fatigue-induced personnel impairment can 
increase human error probabilities by a factor of more than 2 to 3 
times (Hanecke, et al., 1998; Colquhoun, et al., 1996; Akerstedt, 1995; 
U.S. DOT, 49 CFR parts 350, et al., Final Rule, May 2, 2000; 65 FR 
25544).
    Studies of the nuclear power industry indicate that normal daily 
variations in alertness associated with human circadian rhythms (i.e., 
physiological processes that vary on an approximate 24-hour cycle) may 
be responsible for daily variations in the incidence of personnel 
errors at nuclear power plants (Bobko, et al., 1998; Dorel, 1996; 
Maloney, 1992). The findings of these studies are consistent with the 
results of a survey of more than 100 nuclear power plant shift 
supervisors--over 90 percent stated that they notice times of day, and 
days in the schedule, during which control room operators are less 
alert, less vigilant, or make more mistakes (Baker, et al., 1990 [EPRI 
NP-6748]). These studies suggest that despite controls, such as 
standardized work practices and independent verification, to ensure 
correct and reliable human performance, factors that influence 
alertness may increase the incidence of human errors in nuclear power 
plants.
    Fatigue has generalized effects on human performance capabilities, 
and is associated with performance decrements at a base level, across a 
variety of tasks (Dinges, 1995). Fatigue can impair both physical and 
cognitive (i.e., mental) functioning.
    Generally, cognitive task performance is affected more readily by 
fatigue than physical or psychomotor tracking performance (Krueger, 
1989; 1991). General cognitive fatigue decreases an individual's 
ability to remain alert, process complex information, and correctly 
grasp a complex set of circumstances. Fatigue has been shown to cause 
memory problems, slowed responses, lapses and false responses 
(Williams, et al., 1959; Morgan, et al., 1974; Dinges, 1992; Dinges, 
1995). Many of the cognitive tasks performed by nuclear power plant 
personnel that are important to the protection of public health and 
safety and the common defense and security rely on their ability to 
sustain attention, analyze problems, make rapid, accurate decisions, 
and communicate and work as a team. The following effects of fatigue on 
cognitive abilities are the primary focus of the fatigue management 
requirements:
    (a) Sustaining attention--Vigilance and attention to detail are 
fundamental for plant safety, whether an individual is operating or 
maintaining equipment important to plant safety, performing 
surveillance procedures in the plant, monitoring system status in the 
control room, or monitoring plant security systems or barriers. Tasks 
requiring sustained attention (e.g., vigilance tasks) are among the 
most susceptible to fatigue-induced degradation (Monk and Carrier, 
2003). The sensitivity to fatigue of vigilance tasks is one of the 
primary reasons that tests, such as the psychomotor vigilance task 
(Dinges, et al., 1997; Doran, et al., 2001), are standard measurement 
tools used in studies of the effects of sleep deprivation and fatigue. 
Of particular note are research findings showing that, in operational 
settings, individuals may experience periods of sleep up to a few 
seconds (called microsleeps), during which they fail to respond to 
external stimuli, and are completely unaware that these episodes have 
occurred (Cabon, et al., 2003; Priest, et al., 2001; Summala, et al., 
1999).
    (b) Decision-making--Conservative decision-making is central to 
safe nuclear power plant operations. Fatigue is associated with more 
risky strategies and decreases in the effort individuals exert in 
decision-making (Schellekens, et al., 2000). Furthermore, Harrison and 
Horne (2000) reviewed the impact of sleep deprivation on decision-
making and reported that, contrary to popular belief, sleep deprivation 
impairs decision-making even if individuals try to compensate for lack 
of sleep when responding to heightened stimulation. As noted by Cabon, 
et al. (2003), studies have shown reductions in aircrew alertness, even 
during the critical descent phase. These findings suggest that the 
alerting stimuli of off-normal conditions (e.g., landing an airplane, 
acknowledging control room annunciators) may not fully negate the 
effects of fatigue on performance. The National Transportation Safety 
Board (NTSB) reviewed the performance of flight crews involved in 37 
major accidents and found that those crew members who had been awake 
longer than 12 hours before their accidents made more errors overall, 
and specifically more tactical decision

[[Page 16980]]

errors, than did crew members who had been awake for less time (NTSB, 
1994).
    (c) Problem solving--Perseveration is a term used to describe poor 
problem solving performance, characterized by an individual or group of 
individuals maintaining a faulty diagnosis or mitigation plan despite 
contrary information. An example of perseveration from the nuclear 
power industry was the initial response by plant operators to events at 
Three Mile Island Unit 2 in 1979. The operators' initial response was 
based on a faulty diagnosis of the plant condition (the operators 
failed to recognize they were dealing with a loss of coolant accident), 
which the operators maintained throughout the first 2 hours of the 
event in the face of numerous conflicting indications. Many factors 
contributed to human performance problems during the Three Mile Island 
accident and the NRC is not suggesting that operator fatigue was a 
contributing factor. However, fatigue is one factor that has been found 
to contribute to this type of performance degradation (Harrison and 
Horne, 2000), which may have serious consequences for public health and 
safety. Sleep-deprived workers fail to appropriately allocate 
attention, set task priorities, or sample for sources of potentially 
faulty information (Hockey, 1970; Krueger, 1989). Mental fatigue also 
contributes to decreased originality and flexibility in problem solving 
and sub-optimal planning (Van der Linden, et al., 2003; Lorist, et al., 
2000; Horne, 1988).
    (d) Communication and teamwork--Fatigue affects skills important to 
written and oral communication and teamwork. Fatigue degrades speech 
articulation, verbal fluency, grammatical reasoning (the ability to 
process oral and written instructions), and memory (Harrison and Horne, 
1997; 1998). Studies of individuals in simulated combat and command and 
control conditions have shown that fatigue slows the encoding, 
decoding, and transcription of information (Banderet, 1981; Angus and 
Heslegrave, 1985). Fatigued individuals also tend to be less 
communicative and have greater difficulty performing multiple tasks 
concurrently, as demonstrated in simulated aircraft cockpit tasks 
requiring monitoring and communications (Pascoe, et al., 1995; Harrison 
and Horne, 2000). These effects have been found in the analysis of 
incidents and accidents. In a study of major aircraft accidents, crews 
that had been awake longer (an average of 13.8 hours for captains and 
13.4 hours for first officers) made significantly more procedural and 
tactical decision errors than crews that had been awake for a shorter 
period (an average of 5.3 hours for captains and 5.2 hours for first 
officers) (NTSB, 1994). Similar to control room personnel in nuclear 
power plants, aircraft cockpit crews make extensive use of secondary 
checks to verify that decisions and performance are correct, and to 
mitigate the consequences of errors. Although the difference was not 
statistically significant, analysis of the crew errors indicated that 
crews that had been awake longer made nearly 50 percent more errors in 
failing to challenge a faulty action or inaction by another crew 
member. These studies highlight how fatigue cannot only degrade the 
fitness of an individual, but also the overall performance of a crew.
    Although fatigue has long been widely recognized as causing 
degraded performance, recent research has helped characterize the 
magnitude of these effects relative to a historical FFD concern: 
impairment from alcohol intoxication. Part 26 prohibited the use of 
alcohol on site and within several hours before a tour of duty, and 
established alcohol testing requirements for personnel on duty. The NRC 
established these requirements based on the recognition that alcohol 
can have significant adverse effects on a worker's ability to safely 
and competently perform his or her duties. Recent studies have shown 
that fatigue can cause performance degradations that are comparable to 
the levels observed from blood alcohol concentrations (BACs) in excess 
of those that would result in a positive breath alcohol test under the 
provisions of Part 26. In those studies, individuals who were awake for 
17-19 hours had cognitive and psychomotor performance comparable to 
individuals with a BAC of 0.05 percent (Dawson and Reid, 1997; 
Williamson and Feyer, 2000). Part 26 establishes breath alcohol cutoff 
level below 0.05 percent. The NRC considers the insight that fatigue 
can impair a worker at levels comparable to those prohibited for 
alcohol to be particularly significant.
    (2) Conditions that contribute to worker fatigue are prevalent in 
the U.S. nuclear power industry.
    Fatigue may result from an individual remaining awake continuously 
for an excessive period of time, or from the individual obtaining an 
inadequate amount or quality of sleep, or both. Conditions that 
contribute to worker fatigue include:
    (a) Extended work shifts with five or more consecutive work days--
Although the effects of shift length on worker performance are 
influenced by the nature of the task, various studies have shown that 
task performance declines after 12 hours on a task (Rosa, 1991; 
Folkard, 1997; Dawson and Reid, 1997). Other studies have shown that 
the relative risk of having an accident increases dramatically after 9 
consecutive hours on the job (Colquhoun, et al., 1996; Hanecke, et al., 
1998; U.S. DOT, 49 CFR parts 350, et al., Final Rule; 65 FR 25544; May 
2, 2000). The effects of extended working hours on worker performance 
can be exacerbated when many extended shifts are scheduled in 
succession. The National Institute for Occupational safety and Health 
published a report in 2004 (Caruso et al., 2004) that reviewed 52 
recent reports examining the association between long work hours and 
illness, injuries, health behaviors, and performance. NIOSH reported 
that ``a pattern of deteriorating performance on psychophysiolgical 
tests as well as injuries while working long hours was observed across 
study findings, particularly when 12-hour shifts combined with more 
than 40 hours of work a week.''
    The use of 12-hour shifts has become increasingly common at U.S. 
nuclear power plants. Schedules that include 5 or more 12-hour shifts 
in succession during routine operations are sometimes popular with 
workers because they allow a long sequence of days off. However, 
scheduling more than 4 consecutive 12-hour shifts is not a recommended 
means of managing fatigue (Baker, et al., 1990 [EPRI NP-6748]; NUREG/
CR-4248, ``Recommendations for NRC Policy on Shift Scheduling and 
Overtime at Nuclear Power Plants''). As noted in the 2000 Sleep in 
America Poll, ``waking up unrefreshed'' was more likely to be reported 
by individuals working more than 60 hours per week (58 percent vs. 42 
percent of those working 41-60 hours per week and 39 percent of those 
working 31-40 hours) (National Sleep Foundation, 2000).
    During the public meetings described in the preamble to the 
proposed rule, industry stakeholders noted that the use of 6 or more 
consecutive 12-hour shifts is now standard practice during plant 
outages. In SECY-01-0113, the NRC staff reported that more than 80 
percent of the authorizations written by licensees to exceed the 
technical specification work-hour limits during outages were for 
exceeding 72 hours (e.g., six 12-hour shifts) in a 7-day period. The 
NRC's more recent review of deviations authorized at six plants for 
refueling outages during 2003 and 2004 also indicated that deviations 
from the limit of 72 hours in 7 days continue to account for more than 
80 percent of the

[[Page 16981]]

deviations authorized. During the public meetings, industry 
stakeholders also reported that, during outages, some licensees have 
scheduled personnel for three or more weeks of consecutive 12-hour 
shifts without intervening days off.
    (b) Extensive Overtime--Many research studies report that excessive 
working hours cause worker fatigue (Akerstedt, 1995b; Rosa, 1995; 
Buxton, et al., 2002). The U.S. nuclear power industry makes extensive 
use of overtime, creating a combined effect of long work hours with 
reduced break periods. As noted in SECY-01-0113, at approximately one-
fourth of the sites, more than 20 percent of the personnel covered by 
working hour limits work more than 600 hours of overtime annually. This 
amount of overtime is more than two to three times the level permitted 
for personnel at some foreign nuclear power plants and more than twice 
the level recommended by an expert panel Commissioned by the NRC in 
1985 (NUREG/CR-4248). In SECY-01-0113, the NRC also noted that some 
licensees authorized hundreds to several thousand deviations from the 
limits of 16 hours of work in any 24-hour period, 24 hours of work in 
any 48-hour period, 72 hours of work in a 7-day period, and from the 
minimum break requirement of 8 hours between work periods. The NRC also 
noted the continued excessive use of such deviations in its survey of 
six plants in 2004.
    (c) Shiftwork--The nuclear power industry is a round-the-clock 
operation requiring individuals to be awake and working at times when 
they would normally be asleep. Although individuals can function in 
these circumstances, human alertness and task performance are 
cyclically affected by a daily biological clock, which runs on about a 
24-hour (circadian) cycle, as it assists in timing numerous 
physiological and psychological phenomena (such as core body 
temperature, the daily release of various hormones, mood swings, and 
wake-sleep cycle) (Liskowsky, et al., 1991). The circadian trough, or 
lowest levels of function reflected in, for example, alertness, 
performance, subjective mood, and body temperature, occurs around 3 
a.m. to 5 a.m., with many human functions showing reduced levels 
between 12 a.m. and 6 a.m. Sleepiness is most severe between 3 and 5 
a.m., with a less marked but significant expression again between 3 and 
5 p.m.
    There is substantial scientific literature on circadian variations 
in alertness that clearly demonstrates the significant roles that 
worker fatigue, sleep loss, and circadian rhythms play in contributing 
to errors and accidents (Kryger, et al., 1994; Akerstedt, 1995a; 
Dinges, 1995; Folkard, 1997; Comperatore and Krueger, 1990; Miller and 
Mitler, 1997). These findings range from reduced response speed on a 
variety of tasks, to missing warning signals, to minor hospital 
incidents and accidents (Krueger, 1994). In addition, as previously 
described in this section, circadian variations have also been noted in 
studies of the incidence of personnel errors at nuclear power plants 
(Bobko, et al., 1998; Dorel, 1996; Maloney, 1992) and noted in 
observations by a large number of nuclear power plant shift supervisors 
(Baker, et al., 1990 [EPRI NP-6748]).
    In addition to causing individuals to perform work at periods of 
depressed alertness, shiftwork also conflicts with circadian variations 
in alertness by requiring individuals to sleep during naturally 
occurring periods of increased cognitive arousal. Circadian rhythms, 
and naturally occurring tendencies for sleep and wakefulness, do not 
fully adapt to shiftwork schedules. In addition, daylight, noise and 
the ``regular day'' schedules of other family members challenge the 
ability of shiftworkers to obtain adequate rest. As a result, 
shiftworkers generally obtain less sleep, and report a higher incidence 
of sleepiness and sleep-related complaints. For example, in a survey of 
1,154 U.S. adults, the National Sleep Foundation (NSF) found that 
shiftworkers, on average, get less sleep (6 hours, 30 minutes) than 
regular day workers (6 hours, 54 minutes). Almost half of the 
shiftworkers they surveyed obtained less than 6.5 hours of sleep per 
``night'' during the work-week, 30-90 minutes less than recommended by 
most sleep experts. In comparison to regular day workers, shiftworkers 
were more likely to be sleepy at work 2 or more days per week (34 
percent vs. 23 percent) (National Sleep Foundation, 2000). Many studies 
have demonstrated that decreased performance and increased errors and 
accidents are associated with night work and are affected by varying 
sleep schedules and durations of sleep periods (e.g., Balkin, et al., 
2000).
    The challenge for shiftworkers to remain alert during the early 
morning hours of a shift can be exacerbated by extended shift lengths, 
overtime, and the inability of many shiftworkers to obtain adequate 
sleep during the day (Hanecke, 1998). The powerful drive for sleep that 
is associated with circadian factors, and the fact that shiftwork is a 
daily influence on the alertness of all shiftworkers at nuclear power 
plants, has been demonstrated by a number of recent events. For 
example, there have been instances of operators falling asleep in the 
control rooms at the Pilgrim nuclear power station (2004) and the test 
and research reactor at the Massachusetts Institute of Technology 
(2003), as well as a security officer falling asleep at the Braidwood 
nuclear power plant while driving a patrol vehicle (2004), despite 
these individuals recognizing the potential safety and disciplinary 
consequences.
    (d) Early start times and extended commutes --Although many plant 
personnel do not work rotating shifts, start times before 7 a.m. can 
interfere with a worker's ability to obtain adequate rest if the 
schedule is not aligned with his or her circadian cycle and naturally 
occurring tendency for sleep and wakefulness. Such start times 
typically cause workers to wake before 6 a.m., thereby reducing the 
amount of sleep that can be obtained between midnight and 6 a.m., the 
most effective time period for most people to sleep. In addition, long 
commutes to remote work sites such as nuclear power plants, which are 
frequently located in rural areas and distanced from major population 
centers, contribute to the potential for fatigue associated with early 
start times.
    (e) Sleep disorders--Sleep disorders, such as sleep apnea, 
insomnia, and restless leg syndrome (i.e., a condition that is 
characterized by uncomfortable or unpleasant sensations in the legs, 
causing an overwhelming urge to move them, often contributing to 
difficulty in staying or falling asleep), are conditions that can 
significantly reduce the quantity and quality of sleep that individuals 
are able to obtain, affect an individual's ability to remain alert, and 
ultimately degrade an individual's ability to safely and competently 
perform his or her duties (Kryger, et al., 1994; Lewis and Wessely, 
1992). These factors are not effectively addressed by limits on working 
hours in the absence of other fatigue management practices. Although 
the NRC does not have data for the incidence of sleep disorders that 
are specific to U.S. nuclear power plant workers, in the general U.S. 
population, these conditions are not uncommon. For example, the 
prevalence of sleep apnea is estimated to be 4 percent for adult males 
and 2 percent for adult females (Strollo and Rogers, 1996). The 
incidence of sleep apnea may in fact be higher for shiftworkers at 
power plants, as this condition is more common in middle-age adult 
males than in the general population. A survey by the NSF of 1,154 
adults living in households in the continental U.S.

[[Page 16982]]

found self-reports of sleep apnea were more common from shiftworkers 
than regular day workers (15 percent vs. 9 percent) (National Sleep 
Foundation, 2000). Similarly, the NSF found that shiftworkers reported 
a higher incidence of insomnia (66 percent vs. 55 percent) than regular 
day workers.
    Although worker motivation can mitigate to a limited degree the 
effects of fatigue, fatigue has a physiological basis, including 
changes in glucose metabolism in the brain (Wu, et al., 1991; Thomas, 
et al., 2000). These changes are beyond the individual's control. In 
addition, several studies have suggested caution with regard to the 
abilities of individuals to self-monitor their capacity to safely and 
competently perform their duties when fatigued (Dinges, et al., 1997; 
Belenky, et al., 2003; Akerstedt, 2003). These studies note that 
individuals experience microsleeps without being aware of their lapses 
in attention and underestimate their propensity for uncontrolled sleep 
episodes. As a consequence, a worker's motivation to remain alert does 
not provide reasonable assurance that an individual will be able to 
safely and competently perform his or her duties.
    Considering the above factors, fatigue can have a significant 
adverse effect on worker abilities. Further, the likelihood of a 
nuclear power plant worker being impaired from fatigue is not trivial, 
and potentially greater than the likelihood of impairment from drugs 
and alcohol, which the NRC requires licensees to address through their 
FFD programs. Therefore, the NRC believes that regulatory action is 
warranted to ensure that fatigue is adequately addressed through 
licensee FFD programs. Further, the NRC asserts that rulemaking is the 
appropriate regulatory action for the following reasons:
    (3) With the exception of orders limiting the work hours of 
security personnel, the NRC's former regulatory framework did not 
include consistent or readily enforceable requirements to address 
worker fatigue.
    The principal components of the former regulatory framework for 
matters pertaining to working hours and fatigue for non-security 
personnel were (a) NRC's Policy on Worker Fatigue, as issued on June 
15, 1982, in GL 82-12, and (b) plant technical specifications related 
to this policy statement, and (c) certain limited requirements of 10 
CFR Part 26.
    As part of the assessment of PRM-26-2, in which Barry Quigley 
petitioned for rulemaking to establish enforceable requirements 
addressing fatigue of workers at nuclear power plants, the NRC reviewed 
and assessed the implementation and enforceability of the NRC's former 
regulatory framework applicable to worker fatigue, including licensee 
technical specifications for the administrative control of work hours. 
This review was documented in detail in Attachment 1 to SECY-01-0113. 
The NRC continued this evaluation during development of this final 
rule, and the principal findings include:
    (a) NRC's Policy on Worker Fatigue--NRC guidance documents do not 
prescribe requirements. Guidance documents establish policy or provide 
advice on meeting a regulatory requirement. As a result, a policy is 
enforceable only to the extent that the guidelines have been 
incorporated into a license condition or technical specifications. For 
the three nuclear power plant sites that have not incorporated the 
guidelines from the NRC's Policy on Worker Fatigue into a license 
condition or technical specification, the guidelines are unenforceable. 
These plant sites have implemented the concept using other 
administrative controls that the NRC has determined to be adequate. 
However, had the NRC determined that the controls were inadequate, it 
would have had no basis for taking enforcement action.
    (b) Technical Specifications--For those licensees who have 
incorporated the NRC's Policy on Worker Fatigue into a license 
condition or technical specifications, consistent enforcement has been 
complicated by the following factors:

--The language in plant technical specifications is largely advisory 
(e.g., an individual should not be permitted to work more than 16 hours 
straight) and key terms have not been defined. This deficiency has 
resulted in inconsistent interpretation and implementation of technical 
specifications by licensees, as well as difficulty for the NRC in 
enforcing the requirements. For example, many technical specifications 
use the terms, ``routine heavy use of overtime,'' ``unforeseen 
problems,'' and ``temporary basis.'' The NRC has not defined any of 
these terms and has not consistently pursued enforcement on the basis 
of the amount or frequency of overtime authorized.
--The technical specifications have inconsistent levels of detail from 
one nuclear power plant licensee to another. Only three-quarters of the 
licensees' technical specifications include the quantitative work-hour 
limit guidelines of the NRC's Policy on Worker Fatigue.
--The technical specifications contain varying scopes of requirements. 
Some plant technical specifications require periodic reviews of 
overtime approvals to ensure that excessive hours have not been 
assigned, while other technical specifications contain no equivalent 
requirements. Although the observed variability in the controls does 
not by itself present a safety concern, such variability is 
inconsistent with establishing a uniform level of assurance that 
personnel are not in a fatigued condition that could significantly 
reduce their mental alertness and decision-making capabilities.
--Licensees have inconsistently interpreted the scope of personnel who 
must be subject to the technical specification work-hour limits. The 
NRC's Policy on Worker Fatigue applies to personnel who are performing 
safety-related functions. The NRC's review of work-hour data gathered 
by NEI regarding the work hours of personnel subject to the technical 
specifications (Nuclear Energy Institute, 2000) identified variation in 
the numbers and types of personnel covered by these controls. A limited 
number of sites may not have been applying work-hour controls to all 
personnel performing safety-related functions. At least two nuclear 
plant sites do not apply the work hour controls to any maintenance 
personnel even though GL 83-14, ``Definition of `Key Maintenance 
Personnel' (Clarification of GL 82-12),'' issued March 7, 1983, defined 
key maintenance personnel to include individuals who work on safety-
related equipment.
--The basic measure used to determine whether an individual's work 
hours are within or above the technical specification limits has not 
been implemented consistently from one nuclear power plant to another. 
Work hours included within the limits at some nuclear power plants have 
not been included at others, effectively creating substantively 
different work-hour limits among plants.

    (c) 10 CFR Part 26, ``Fitness for Duty Programs''--The general 
performance objectives of former Sec.  26.10 required that licensees 
provide ``reasonable assurance that nuclear power plant personnel * * * 
are not * * * mentally or physically impaired from any cause, which in 
any way adversely affects their ability to perform their duties.'' 
Although former 10 CFR Part 26 contained specific requirements 
pertaining to alcohol and drug usage, it did not include prescriptive

[[Page 16983]]

requirements regarding fatigue. Rather, former Sec.  26.20 used 
general, non-mandatory language to state that the FFD policy ``should'' 
address other factors that can affect a worker's ability to safely and 
competently perform his or her duties, ``such as mental stress, 
fatigue, and illness.'' As a result, it has been difficult for the NRC 
to justify a violation of the regulation based on a licensee's failure 
to limit overtime hours. In addition, without a numerical limit on 
overtime hours, or a provision limiting overtime, a range of overtime 
practices could be viewed as ``reasonable,'' and therefore in 
compliance with the regulation.
    In summary, the broad and non-prescriptive provisions of Part 26, 
and the technical specifications and license conditions pertaining to 
fatigue, in the absence of clearly defined terms or measures of 
fatigue, have made it difficult for the NRC to enforce worker fatigue 
requirements and work-hours limits in an effective, efficient, and 
uniform manner that ensures that all licensees provide reasonable 
assurance that workers are able to safely and competently perform their 
duties. The NRC believes that a consistent fatigue management program 
and its uniform implementation across the industry is essential, and 
the most effective regulatory mechanism is to incorporate worker 
fatigue requirements into 10 CFR Part 26.
    (4) Reviews of industry control of work hours have repeatedly 
identified practices that were inconsistent with the NRC's Policy on 
Worker Fatigue, including excessive use of work hours and work hour 
limit deviations.
    The policy states, in part, ``Enough plant operating personnel 
should be employed to maintain adequate shift coverage without routine 
heavy use of overtime.'' Surveys and expert panels have suggested that 
tolerance for overtime is generally limited to 300-400 hours of 
overtime per year (ADAMS Accession No. ML05270310; NUREG/CR-4248). 
Baker, et al. (1994) reviewed the hours worked by nuclear power plant 
operations, technical, and maintenance personnel during 1986, four 
years after the NRC issued its policy. Based on a sample of 63 percent 
of U.S. nuclear power plants operating at that time, Baker and 
colleagues found that operations personnel averaged more than 500 hours 
of overtime annually at 20 percent of the plants, and more than 700 
hours of overtime at 9 percent of the plants. Technical personnel 
averaged more than 500 hours of overtime annually at 30 percent of the 
plants, and more than 700 hours of overtime at 18 percent of the 
plants. Maintenance personnel averaged more than 500 hours of overtime 
annually at 80 percent of the plants and more than 700 hours of 
overtime at 14 percent of the plants.
    The NRC's Policy on Worker Fatigue included provisions for 
licensees to authorize deviations from the NRC's work and rest 
guidelines for individual workers in ``very unusual circumstances.'' On 
June 10, 1991, following several NRC inspections noting concerns 
related to licensee work hour control, the NRC issued Information 
Notice (IN) 91-36, Nuclear Power Plant Staff Working Hours, to alert 
licensees of potential problems resulting from inadequate controls to 
prevent excessive working hours. The conditions cited in the notice 
included an event attributed to fatigue, excessive use of deviations 
and overtime, and overtime deviations authorized after the fact. 
Subsequent NRC reviews completed in 1999 and 2001 identified continued 
problems with industry control of work hours. In 1999, the NRC reviewed 
licensee event reports and NRC inspection reports from January 1994 
through April 1999. The NRC found that only a few events of limited 
risk significance had been attributed to fatigue. However, the staff 
found several instances each year in which licensee use of overtime 
appeared to be inconsistent with the general objectives or specific 
guidelines of the NRC's Policy on Worker Fatigue.
    NEI conducted a survey in the summer of 2000 concerning industry 
control of work hours for personnel subject to the technical 
specifications (letter dated August 29, 2000, from J. W. Davis, NEI, to 
G. M. Tracy, NRC, ADAMS Accession No. ML003746495). Forty-seven sites 
responded to the survey, providing data from 1997-1999. The NRC staff's 
review of the data is documented in Attachment 1 to SECY-01-0113. The 
NRC evaluated the results of the survey concerning overtime and found 
that 8 of 36 sites providing data had more than 20 percent of the 
personnel covered by the policy working in excess of 600 hours of 
overtime per year. Considering all plants that provided data, the 
percentage of personnel working in excess of 600 hours of overtime per 
year increased from 7 percent in 1997 to 11 percent in 1999. The 
percentage of licensed operators working in excess of 600 hours of 
overtime per year increased from 13 percent in 1997 to more than 16 
percent in 1999. The NRC considers these percentages to represent 
excessive use of overtime in the nuclear industry.
    The NRC also reviewed the data collected by NEI concerning 
deviations, which showed that approximately one-third of the 
respondents were authorizing more than a thousand, to as many as 7,500, 
deviations in a year to exceed the policy guidelines. The frequency of 
deviations did not appear to be consistent with either the specific 
guidelines or the general objective of the policy. As previously 
described in this section, the policy permits deviations from the 
guidelines in ``very unusual circumstances.''
    Subsequent to the Commission's decision to initiate rulemaking for 
worker fatigue, the NRC staff also obtained data from six sites in 
2004. Those data indicated that between 95 and 603 deviations, with an 
average of 311 deviations, were issued for individuals. The data were 
provided by the six sites for each plant's most recent refueling outage 
and one month of power operation, and therefore do not reflect the 
total number of deviations issued for individuals during all of 2004, 
except for one of the six sites that provided its deviation data (101 
deviations) for all of 2004. Data on the deviations from 2004 in this 
sample are reported in detail in Appendix 3 of the Regulatory Analysis. 
The NRC believes that licensee use of deviations and overtime at some 
sites has been excessive, and has been inconsistent with the intent of 
the NRC's Policy on Worker Fatigue.
    In addition to excessive work hours and work-hour guidelines 
deviations, the NRC has recently identified other concerns related to 
licensee policies and practices applicable to worker fatigue. On May 
10, 2002, the NRC issued Regulatory Issue Summary (RIS) 2002-007, 
``Clarification of NRC Requirements Applicable to Worker Fatigue and 
Self-Declaration of Fitness-for-Duty.'' The NRC issued the RIS 
following several allegations made to the NRC regarding the 
appropriateness of licensee actions or policies related to individuals 
declaring they are not fit due to fatigue. These concerns indicate a 
need to ensure that individuals and licensees clearly understand their 
responsibilities with respect to self-declarations of worker fatigue. 
The final rule establishes requirements to address this need.
    (5) The former regulatory framework included requirements that were 
inadequate and incomplete for effective fatigue management.
    (a) The NRC's Policy on Worker Fatigue did not establish clear 
expectations for the control of work hours. As previously noted in this 
section, the NRC did not define key terms of the policy, and, as a

[[Page 16984]]

consequence, implementation has been varied across the industry.
    (b) Certain policy guidelines and technical specifications were 
inadequate to provide reasonable assurance that individuals remain 
capable of safely and competently performing their duties. For example, 
the requirement for an 8-hour break between work periods has been 
revised to a 10-hour break. The basis for this revision to increase the 
length of this break period is described in detail in Section VI with 
respect to Sec.  26.205(d)(2)(i).
    In addition, although the policy established an objective of a 
nominal 40-hour work week, the specific work hour guidelines of the 
policy and most technical specifications for the administrative control 
of work hours have principally focused on acute fatigue. These 
guidelines did not adequately address the longer term control of work 
hours and the cumulative fatigue that can result from prolonged periods 
of extended work hours. Acute fatigue results from restricted sleep, 
sustained wakefulness, or continuous task demands over the past 24 
hours or more. Cumulative fatigue results from inadequate rest over 
consecutive sleep-wake periods when the worker obtains less sleep than 
he or she requires. An individual incurs a sleep debt for each day 
during which the worker obtains insufficient sleep. If the individual 
continues to obtain insufficient sleep, this debt accumulates over 
successive days, resulting in increasing fatigue and impairment 
(Belenky, et al., 2003).
    The inadequacy of the former regulatory framework for addressing 
cumulative fatigue became particularly apparent in the months following 
the terrorist attacks of September 11, 2001. The NRC received numerous 
allegations from nuclear security officers that certain licensees 
required them to work excessive amounts of overtime over long periods 
due to the post-September 11, 2001, threat environment. These 
individuals questioned their readiness and ability to perform their 
required job duties due to the adverse effects of cumulative fatigue. 
The NRC reviewed the actual hours worked by security personnel and 
determined that, in the majority of cases, individual work hours did 
not exceed the guidelines specified in the NRC's Policy on Worker 
Fatigue, but the review confirmed that individuals had been working up 
to 60 hours per week for extended periods. The concerns expressed by 
individuals regarding their FFD, in light of work schedules that did 
not exceed the specific guidelines of the policy, as well as relevant 
technical research supporting the basis for cumulative fatigue, led the 
NRC to conclude that the work hour guidelines of the policy were 
inadequate for addressing cumulative fatigue. The NRC obtained 
additional worker feedback supporting this conclusion through a review 
of worker fatigue concerns and work hours during a long-term outage at 
the Davis Besse nuclear plant (NRC Inspection Report 05000346/2004003, 
dated March 31, 2004, ADAMS Accession No. ML040910335).
    The comprehensive fatigue management approach in Subpart I, 
Managing Fatigue, establishes controls to address cumulative fatigue. 
Limits to mitigate cumulative fatigue for nuclear power plant security 
personnel were implemented by Order EA-03-038. The final rule codifies, 
with changes, these requirements. Changes to those limits that have 
been imposed by this rule are discussed in detail in Section VI, which 
also includes a detailed discussion of the limits and other controls to 
mitigate cumulative fatigue for other personnel who perform safety-
related duties at nuclear power plants.
    (c) The former regulatory framework did not effectively ensure that 
fatigue from causes other than work hours was addressed. Work hour 
controls are necessary, but not sufficient, to effectively manage 
worker fatigue. As a consequence, training and fatigue assessments are 
essential. Worker fatigue, and its effects on worker alertness and 
performance, can result from many causes in addition to work hours 
(e.g., stress, sleep disorders, daily living obligations) (Rosa, 1995; 
Presser, 2000). In addition, there are substantial individual 
differences in the abilities of individuals to work for extended 
periods without performance degradation from fatigue (Gander, 1998; Van 
Dongen, et al., 2004a; Van Dongen, et al., 2004b; Jansen, et al., 
2003). Subpart I, Managing Fatigue, requires a comprehensive fatigue 
management program. One example is the strengthening of FFD training 
requirements concerning worker fatigue. The training requirements will 
improve the effectiveness of behavioral observation and the assessment 
of worker fatigue, self-declaration as a means for early detection of 
fatigue, worker self-management of fatigue, the ability of workers to 
obtain adequate rest on a shiftwork schedule, and licensee use of 
effective fatigue counter-measures.
    (6) Ensuring effective management of worker fatigue through 
rulemaking will substantially enhance the effectiveness of FFD 
programs, but additional orders are not presently warranted to ensure 
adequate protection of public health and safety or the common defense 
and security.
    Adequate protection of public health and safety and the common 
defense and security were ensured under the former regulatory 
framework, including Order EA-03-038 (for security personnel), the 
NRC's Policy on Worker Fatigue, and licensee technical specifications. 
Licensee FFD programs included behavioral observation programs to 
identify individuals whose behavior indicates they may not be fit to 
safely and competently perform their duties, and ensure that those 
individuals are removed from duty until any question regarding their 
fitness has been resolved. The former work-hour controls, in 
conjunction with licensee behavioral observation programs, automatic 
reactor protection systems and other administrative controls on worker 
activities (e.g., post-maintenance testing, peer checks, independent 
verifications) ensured adequate protection of public health and safety 
and the common defense and security. However, there were substantial 
limitations to the former regulatory framework, as detailed in this 
section. Therefore, although the previous regulatory framework provided 
adequate protection, including work-hour controls in 10 CFR Part 26 
provides a substantial increase in public health and safety and the 
common defense and security. The NRC has incorporated worker fatigue 
provisions in Part 26 in light of the substantial increase in safety 
and security that is expected to result.
    (7) Addressing fatigue of workers in safety-critical positions 
through regulation is consistent with practices in foreign countries 
and other industries in the U.S.
    The NRC reviewed the limits on work hours for nuclear plant workers 
in eight other countries, as well as six other industries in the United 
States and Canada. These are summarized in Attachment 1 of SECY-01-
0113. Although many factors influence specific regulatory limits, and 
requirements for other industries should be considered in context, the 
NRC found that the NRC's former guidelines are the least restrictive 
among those reviewed.
    The work hours of nuclear power plant personnel in other countries 
are largely based on labor laws or union agreements that apply to 
multiple industries. With the exception of Spain, which has limits 
consistent with the NRC's Policy on Worker Fatigue, each of the other 
eight countries has more stringent requirements. The more stringent 
requirements have largely

[[Page 16985]]

preempted the need in those countries for regulation of work hours 
based on nuclear safety concerns.
    The Department of Transportation (DOT) has established regulatory 
limits on the work hours of pilots, air traffic controllers, and 
maintenance personnel in the commercial aviation industry (14 CFR parts 
121 and 135); in the maritime industry (46 U.S.C. 8104; 46 CFR parts 
15.705, 15.710 and 15.111); in the rail industry (49 U.S.C. 211; 49 CFR 
Part 228); and for drivers of heavy trucks in the commercial trucking 
industry (49 CFR Part 395). The DOT recognized that fatigue can 
substantively degrade the ability of individuals to perform these 
duties and, therefore, promulgated regulatory requirements for each of 
these modes of transportation in keeping with the department's mission 
to protect public safety. In the late 1980s and early 1990s, the 
National Transportation Safety Board (NTSB) identified equipment 
operator fatigue as a significant issue affecting all transportation 
modes (Beal and Rosekind, 1995). As a result, DOT classified operator 
fatigue management as a DOT ``Flagship Initiative'' and several 
proactive fatigue management activities ensued across the 
transportation industries (e.g. U.S. DOT, 1995; Rogers, 1996, 1997; 
Hartley, 1998; Carroll, 1999).
    In 1999, the NTSB evaluated DOT's decade of efforts on operator 
fatigue (NTSB, 1999). Not satisfied that enough was being done, NTSB 
subsequently offered DOT three recommendations: (1) expedite a 
coordinated research program on the effects of fatigue, sleepiness, 
sleep disorders, and circadian factors on transportation safety; (2) 
develop and disseminate educational materials for transportation 
industry personnel and management regarding shift work, work rest 
schedules, and proper regimens of health, diet, and rest; and (3) 
review and upgrade regulations governing hours of service for all 
transportation modes to assure they are consistent and incorporate the 
results of the latest research on fatigue and sleep issues (NTSB, 
1999).
    On April 28, 2003, the DOT issued revised hours-of-service 
regulations to require motor carriers to provide drivers with better 
opportunities to obtain sleep. Among other provisions, the regulations 
(1) increase the required off-duty time from 8 to 10 consecutive hours; 
(2) limit driving time to 11 cumulative hours following 10 consecutive 
hours off duty; (3) prohibit work after the end of the fourteenth hour 
after the driver began work; and (4) require long break recovery 
periods to prevent cumulative fatigue (68 FR 22456-22517; April 28, 
2003, as amended by 70 FR 50071; August 25, 2005).
    Nuclear power plant licensees in the U.S. have sometimes asserted 
that the characteristics of the work tasks in nuclear power plants 
differ from other occupations that have work hour controls (e.g. 
transportation equipment operators); therefore information from other 
occupations may not be applicable. In addition, licensees have 
suggested that the level of automation in nuclear power plants provides 
an important barrier to human errors resulting from fatigue, and that 
the amount of control room crew interaction and oversight of operators' 
actions assures that fatigue-induced errors will be detected and 
corrected before they have an opportunity to impact plant operations. 
The NRC concurs that requirements for other industries should be 
considered in context. Nevertheless, the fact that other Federal 
agencies with a safety mission have established regulations to address 
fatigue is relevant for several reasons.
    First, the human need for sleep and the deleterious effects of 
sleep deprivation have a physiological basis (e.g., changes in brain 
glucose metabolism) that is independent of the nature of the work being 
performed (Wu, et al., 1991). Second, circadian variations in alertness 
and performance, and the underlying changes in physiological processes, 
have been observed in individuals performing a wide range of tasks 
across many industries (Kecklund, et al., 1997). For all individuals, 
time since awakening, the time of day, and the amount of prior sleep 
that an individual obtains relative to his or her sleep needs are 
primary determinants of fatigue and the need for sleep.
    The NRC acknowledges that task characteristics and time on task may 
exacerbate the effects of fatigue on the ability of individuals to 
remain alert. For example, a concern for task-specific effects is 
reflected in the DOT hours-of-service regulations for commercial truck 
drivers, which establish a daily limit on driving time of 11 hours per 
day. This limit is in addition to the requirements prohibiting driving 
after 14 hours on duty and mandating minimum 10-hour break periods, 
which reflect the human physiological need for rest that is necessary 
to maintain performance (68 FR 22456-22517; April 28, 2003).
    By comparison to driving a truck, the characteristics of some jobs 
in nuclear power plants (e.g., reactor operator) permit greater freedom 
of movement and social interaction, which may serve to temporarily 
mitigate the effects of fatigue on alertness. However, there is no 
evidence to indicate that worker motivation or the stimulating effects 
of the job or environment alter the underlying physiological processes. 
Although crew interactions and other job characteristics may serve to 
bolster worker alertness temporarily, environmental stimulation only 
masks individuals' physiological need for sleep. Removing the 
stimulation (e.g., transitioning from the activity of shift turnover to 
monitoring steady state plant operations during a night shift) will 
increase the potential for lapses in attention and uncontrolled sleep 
episodes among individuals who may be partially sleep deprived or 
otherwise fatigued.
    Another consideration regarding the relevance of other regulations 
limiting work hours is that adverse fatigue effects are observed across 
a broad range of cognitive functions in addition to alertness. Whereas 
crew interactions may help sustain alertness, sleep deprivation and 
sustained periods of wakefulness continue to degrade other cognitive 
functions (e.g., memory and decision making) and elements of 
performance that are important to safe nuclear plant operations, such 
as communications and following written and oral instructions. For 
example, as discussed earlier in this section, studies of crew 
performance in critical phases of commercial aircraft flight (e.g., 
take-off and landings) and in simulated battle command station 
operations have shown fatigue-related degradations in performance 
despite the stimulation of the interactions, the intense level of 
activity, and the implications of degraded performance for the loss of 
human life. Regulations limiting work hours in other industries that 
use operating crews (e.g., aviation) and allow greater freedom of 
movement than trucking (e.g. maritime) are consistent with this 
understanding of the broad effects of fatigue on cognitive performance. 
There is no reason to believe that nuclear power plant workers' 
physiological processes and the adverse effects of fatigue on their 
abilities to perform their tasks would differ. In addition, the notion 
that human performance practices in the nuclear industry prevent 
fatigue-related performance decrements from resulting in human errors 
is not supported by studies that have shown circadian variations in 
performance at nuclear power plants (Bobko, et al., 1998; Dorel, 1996; 
Maloney, 1992).
    The NRC acknowledges that the nuclear power industry is perhaps 
unique, relative to many other

[[Page 16986]]

industries, in its use of automated safety systems to protect against 
the consequences of equipment failure and human error. Nevertheless, 
reliable human performance remains an essential element in the 
protection of public health and safety and the common defense and 
security. NRC requirements, such as the minimum onsite staffing 
requirements of 10 CFR 50.54(m) and minimum security staffing 
requirements in site security plans, are predicated on the expectation 
that all personnel in these positions are fit for duty and are able to 
safely and competently perform their duties. As a consequence, the NRC 
does not consider the use of automated safety systems to be an 
appropriate basis for permitting conditions that could allow fatigue to 
degrade the important line of defense of reliable human performance. 
Further, despite automated systems, the contribution of human error to 
risk in operating events continues to be notable (NUREG/CR-6753, 
``Review of Findings for Human Error Contribution to Risk in Operating 
Events'').
    Because the NRC concurs that task characteristics are an 
appropriate consideration, the final rule differs from other Federal 
agencies' requirements with respect to specific work hour requirements 
and requires licensees to consider task characteristics when 
authorizing any waiver from the work hour controls. Nevertheless, the 
NRC believes that it remains relevant that other Federal agencies with 
public safety missions have chosen to address worker fatigue through 
regulation.
    In summary, the NRC believes that the requirements in Subpart I 
will provide a substantial increase in the protection of public health 
and safety and common defense and security. In determining the 
provisions of this final rule, the NRC has taken into consideration the 
effects of fatigue on human performance, the specific work practices of 
the nuclear power industry that both mitigate and contribute to 
fatigue, the inadequacy of the former regulatory framework, the 
excessive hours formerly worked by many nuclear power plant personnel, 
and the relevant research and practices of other industries and 
countries for regulating work hour limits. In addition, many public 
meetings were held with the nuclear industry and the public to discuss 
draft provisions for the final rule. The specific basis for each 
provision of the fatigue management portions of the final rule are 
discussed in Section VI.
    The requirements for managing fatigue will provide a substantial 
increase in the protection of public health and safety and common 
defense and security by:
    (1) Establishing specific, integrated, comprehensive, and 
enforceable requirements for the effective prevention, detection, and 
mitigation of worker fatigue;
    (2) Ensuring that personnel who perform functions that are 
significant to the protection of public health and safety or the common 
defense and security are subject to appropriate work hour controls, 
including: individuals performing risk significant operations or 
maintenance duties; health physics, chemistry, and fire brigade duties 
important to emergency response; and individuals performing security 
duties important to maintaining the security of the plant;
    (3) Establishing work hour controls that provide increased 
assurance that workers will have adequate opportunity for rest and that 
deviations from the work hour limits will only be authorized as 
necessary for plant safety or security and following appropriate 
assessment of the worker's ability to safely and competently perform 
his or her duties;
    (4) Ensuring that work hour deviations are only permitted when 
necessary for plant safety or security, and following assessment of the 
worker's ability to safely and competently perform his or her duties;
    (5) Establishing controls to prevent cumulative fatigue that can 
result from consecutive weeks of extended work hours;
    (6) Ensuring workers are provided with sufficient break periods to 
provide for adequate opportunity for sleep to mitigate acute and 
cumulative fatigue;
    (7) Ensuring that, in addition to work hours, other factors that 
can affect worker fatigue and the ability of workers to remain alert 
are adequately addressed through licensee FFD programs;
    (8) Encouraging effective fatigue management by permitting 
licensees to use alternate measures for prevention and mitigation of 
fatigue; and
    (9) Strengthening FFD training requirements concerning worker 
fatigue. This will improve behavioral observation and assessment of 
worker fatigue; self-declaration as a means for early detection of 
fatigue; worker self-management of fatigue; the ability of workers to 
obtain adequate rest on a shiftwork schedule; and licensee use of 
effective fatigue counter-measures.

E. Subsequent Rulemakings

    On August 28, 2007 (72 FR 49352), the Commission issued a final 
rule amending its regulations by revising the provisions, particularly 
10 CFR Part 52, applicable to the licensing and approval processes for 
future nuclear power plants. The Part 52 final rule also clarified 
portions of the former Part 26 to explicitly extend the applicability 
of sections of the former Part 26 to a combined license holder after 
the date that the NRC makes the finding under Sec.  52.103(g), a 
combined license holder before the date that the NRC makes the finding 
under Sec.  52.103(g), a manufacturing license holder under Subpart F 
of 10 CFR Part 52, and a person authorized to conduct the construction 
activities under Sec.  50.10(e)(3). The Part 52 final rule accomplished 
this by:
    (1) Revising the former Sec.  26.2(a) to refer to combined license 
holders after the date that the NRC makes the finding under Sec.  
52.103(g);
    (2) Revising the former Sec.  26.2(c) to refer to a holder of a 
combined license before the date that the NRC makes the finding under 
Sec.  52.103(g), a holder of a manufacturing license under Subpart F of 
Part 52, and a person authorized to conduct the activities under Sec.  
50.10(e)(3);
    (3) Revising the former Sec.  26.10(a) to refer to the personnel of 
a holder of a manufacturing license and those authorized to conduct the 
activities under Sec.  50.10(e)(3); and
    (4) Revising the former Appendix A to Part 26, paragraph 1.1(1) to 
include a reference to a holder of a combined license after the date 
that the NRC makes the finding under Sec.  52.103(g).
    The Part 52 final rule changes to Part 26 went into effect on 
September 27, 2007. Each of the Part 26 provisions revised by the Part 
52 final rule has been modified by this final rule, as discussed in 
section VI of this document.
    On October 9, 2007 (72 FR 57416), the Commission issued a final 
rule amending its regulations applicable to limited work authorizations 
(LWAs), which allow certain construction activities on production and 
utilization facilities to commence before a construction permit or 
combined license is issued. The LWA final rule modified the scope of 
activities that are considered construction for which a construction 
permit, combined license or LWA is necessary, specified the scope of 
construction activities that may be performed under a LWA, and changed 
the review and approval process for LWA requests. By making these 
changes in the LWA final rule, the Commission also revised the scope of 
Part 26 by clarifying which entities could be subject to Part 26. The 
extent to which the LWA final rule impacted

[[Page 16987]]

Part 26 is discussed in section VI in this document.

V. Summary of Public Comments Submitted on Proposed Rule

Description of Public Comments and Public Meetings

    The NRC received 81 written public comments on the proposed Part 26 
published on August 26, 2005. The NRC also considered six comments 
submitted on a previous working draft of the proposed rule that NRC 
posted on its Web site on May 19, 2005, but which were received too 
late to consider at that time. These 87 written comments contained more 
than 350 pages of material. The stakeholders who submitted these 87 
comments are as follows: 25 (29 percent) from nuclear energy industry 
representatives, including several substantive comments from NEI; five 
(6 percent) from other organizations; seven (8 percent) from unions; 21 
(24 percent) from individuals who work in the nuclear energy industry 
(i.e. operators, maintenance workers); 15 (17 percent) from other 
individuals; and 14 (16 percent) from anonymous commenters.
    The NRC considered comments contained in the transcript of a public 
meeting held on September 21, 2005, in which 28 individuals, including 
NRC staff, spoke. Four written comments were submitted anonymously at 
this meeting. The NRC also considered comments from several other 
public meetings: November 7 and 9, 2005 (ADAMS Accession No. 
ML052990048) to provide clarification on the proposed rule; and 
December 15, 2005 (ADAMS Accession No. ML053400002) regarding NEI's 
proposed alternative approach to the work-hour portions of the proposed 
rule.
    The written comments received on the proposed rule addressed many 
issues that were of stakeholder concern. The NRC analyzed all of these 
comments as part of the process for developing this final rule. In 
particular, commenters raised several important concerns relating to 
fatigue management, the application of FFD requirements to entities 
involved in new plant construction and manufacturing activities, and 
validity testing of urine specimens. These concerns are discussed in 
some detail below. As discussed in Section VI, commenters also raised 
numerous other smaller issues that led the NRC to modify many final 
rule provisions. Finally, many comments resulted in minor changes to 
the proposed rule to improve clarity in the rule's organization and 
language, consistent with Goal 6 of this rulemaking. Virtually all of 
the comments supported the objectives of the proposed rule.

Public Comment on Subpart I

    The NRC has reorganized the overall structure of the proposed rule 
and renumbered several subparts. This necessitated renumbering the 
affected sections of Subpart I [Managing Fatigue].
    Subpart I contains requirements for the management of worker 
fatigue at nuclear power plants. Most comments recommended 
modifications to Subpart I to address specific concerns with the 
proposed rule language or certain provisions of the rule. However, the 
vast majority of the stakeholders commenting on Subpart I expressed 
their general support for the NRC's objective of establishing a set of 
clear and enforceable requirements to address the management of worker 
fatigue at nuclear power plants. Commenters supported the fatigue 
provisions for various reasons. In particular, commenters expected that 
the rule would increase the clarity of work hour requirements, reduce 
forced overtime, provide reasonable assurance that the risk of fatigue-
related events is managed, increase staffing levels, and prevent worker 
injuries. Those who opposed the rule asserted that it would place an 
unnecessary burden on licensees, reduce worker income, and make it more 
difficult for licensees to attract supplemental workers during outages.
    The NRC received several substantive comments that addressed 
specific provisions in proposed Sec.  26.199 [Work hour controls]. This 
section would have established requirements for the control of work 
hours for a limited scope of personnel at a nuclear power plant. In 
general, the individuals who would have been subject to these 
requirements perform functions that most directly affect the protection 
of public health and safety and common defense and security. The 
provisions that were the subject of these comments were proposed Sec.  
26.199(d)(2)(ii), which would have required a minimum 24-hour break in 
any 7-day period; proposed Sec.  26.199(d)(2)(iii), which would have 
required a minimum 48-hour break in any 14-day period; and proposed 
Sec.  26.199(f) [Collective work hour limits], which would have 
required licensees to control the average work hours of specified duty 
groups (e.g., operations, security). The NRC also received substantive 
comments on the reporting requirements in Subpart I of the proposed 
rule. Specifically, the comments concerned the proposed Sec.  26.197(e) 
[Reporting] which would have required licensees to provide information 
concerning the implementation of certain work hour requirements as part 
of an annual FFD program report.

Proposed Requirements for a Minimum 24-Hour Break in Any 7-Day Period

    Section 26.199(d)(2)(ii) of the proposed rule would have required a 
minimum 24-hour break in any 7-day period. Commenters noted that 
licensees who currently use 8-hour schedules often include periods of 7 
consecutive work days in their schedules. These schedules limit the 
frequency of shift rotations and enable licensees to conduct training 
on a Monday-through-Friday schedule. The commenters also asserted that 
the requirement for a minimum 24-hour break in any 7-day period would 
substantially reduce licensee flexibility in scheduling 8-hour shifts 
and would cause them to switch to 12-hour shifts. The NRC agrees that 
the proposed requirement for a minimum 24-hour break in any 7-day 
period would have adversely affected licensee scheduling of 8-hour 
shifts as described in the comments and has revised the maximum number 
of work days that the rule permits between breaks.
    Section 26.205(d)(2)(ii) of the final rule replaces proposed Sec.  
26.199(d)(2)(ii) and requires a minimum 34-hour break in any 9-day 
period. In revising the requirement, the NRC considered that, although 
the final rule permits more consecutive work shifts for 8-hour and 10-
hour shift schedules, the additional flexibility allows licensees to 
more readily optimize their 8-hour shift schedules to minimize the 
transitions between day, evening, and night shifts that can lead to 
worker fatigue. Although this relaxation also allows more consecutive 
shifts for individuals on 10-hour shifts, these individuals typically 
do not work a rotating schedule and therefore do not experience the 
disruption of their circadian cycle that exacerbates the cumulative 
fatigue effects of consecutive work shifts. The rule also establishes 
minimum day of requirements in Sec.  26.205(d)(3) that effectively 
limit within each shift cycle the number of times individuals can work 
the 8 consecutive work days allowed by Sec.  26.205(d)(2)(ii). The 
scheduling of 12-hour shifts is unaffected by this requirement because 
Sec.  26.205(d)(1)(iii) effectively limits the scheduling of 12-hour 
shifts to not more than 6 consecutive days. The final rule also 
provides the licensee with sufficient flexibility to accommodate other

[[Page 16988]]

practical considerations, such as scheduling training on a Monday-
through-Friday basis, and allows a contingency day for 8-hour shift 
schedules that include a series of seven consecutive 8-hour shifts.
    The final rule also revises the minimum duration of the break 
period from 24 hours, as specified in Sec.  26.199(d)(2)(ii) of the 
proposed rule, to a minimum of 34 hours. The revision more clearly 
reflects the NRC's intent to require a periodic ``day off'' in which 
individuals have the opportunity for two consecutive sleep periods 
without an intervening work period. The 34-hour break duration provides 
this opportunity, supports use of forward rotating and fixed shifts, 
and allows for the possibility that individuals may work 26 hours in a 
48-hour period contiguous to the break.

Proposed Requirement for a Minimum 48-Hour Break in Any 14-Day Period 
and Collective Work Hour Limits

    Section 26.199(d)(2)(iii) of the proposed rule would have required 
a minimum 48-hour break in any 14-day period. This requirement would 
have provided periodic breaks to prevent and mitigate cumulative 
fatigue. Although this requirement would have also been applicable when 
a reactor was operating, the NRC considered it particularly important 
for the control of work hours during outages. During these periods, 
successive weeks of extended work hours (i.e., up to 72 hours per week) 
are common. However, the NRC received substantive comments regarding 
this provision.
    Several commenters expressed concern that a mandatory 48-hour break 
would limit the ability of licensees to provide adequate coverage for 
unplanned maintenance (e.g., to quickly restore inoperable equipment). 
Several commenters also stated that the break requirements would 
encourage supplemental workers to seek jobs in other industries that 
offer more overtime. Therefore, commenters were concerned that this 
unintended consequence of the break requirements would harm the 
licensees' ability to attract and retain qualified workers. Other 
commenters stated that, although the recovery concept is scientifically 
supported, the approach used to prevent cumulative fatigue should 
consider existing work schedules and scheduling practices. Commenters 
also asserted that a 48-hour break during a series of night shifts 
would adversely affect the circadian cycle of those workers who had 
adjusted to the night shift. These commenters stated that for workers 
on the night shift, having 1 day off provides an additional rest period 
and allows the worker to maintain a consistent pattern of work and 
sleep habits, thus reducing the risk of accidents on the job. However, 
two days off may interfere with a worker's sleep cycle, requiring the 
individual to readjust to the night shift after a 2-day break. 
Commenters also asserted that a 1-day break in any 7-day period is more 
than adequate when combined with other rule provisions to address 
cumulative fatigue.
    The NRC considered public comments on the proposed 48-hour break 
requirement in conjunction with public comments on the collective work 
hour limits of the proposed rule. The collective work hour limits in 
proposed Sec.  26.199(f) would have required licensees to control the 
average work hours of specified groups of personnel that perform the 
same job function. In general, this provision would have required 
licensees to ensure that the collective work hours of individuals 
within each group did not average more than 48 hours per week, when 
averaged over a period of up to 13 weeks. The objective of the 
collective work hour limits, like the 48-hour break requirement, was to 
prevent cumulative fatigue. In contrast to the 48-hour break 
requirement, the collective work hour limits would typically have been 
applicable only when a reactor was operating. Thus, the 48-hour break 
requirement in conjunction with the 24-hour break requirement of 
proposed Sec.  26.199(d)(2)(i) would have been the principal mechanism 
to address cumulative fatigue during outages, and collective work hour 
limits would have been the principal means of preventing cumulative 
fatigue while a plant was operating.
    Some commenters stated that the collective work hour limits would 
be an ineffective means for addressing fatigue because it is 
experienced on an individual basis. That is, the collective work hour 
limits could not ensure that each individual would be protected from 
cumulative fatigue. One commenter stated that the collective work hour 
controls would allow licensees to force individuals to work overtime. 
Other commenters stated that licensees may be able to manipulate the 
collective work hour calculations. Still other commenters asserted that 
the collective work hour controls were unnecessary to mitigate the 
effects of cumulative fatigue and that they would limit licensee 
flexibility to increase work hours for a job-duty group based on 
operational needs. These commenters stated that other rule provisions, 
such as the work scheduling requirement, individual work hour limits, 
individual break requirements, and the provisions concerning fatigue 
assessments and the self-declaration process, adequately address the 
possibility of cumulative fatigue.
    The NRC agrees, in part, with certain comments on the proposed 48-
hour break requirement and the collective work hour limits of the 
proposed rule, and has revised the final rule accordingly. To address 
cumulative fatigue during periods when a plant is operating, the NRC 
replaced the proposed rule requirement for a minimum 48-hour break in 
Sec.  26.199(d)(2)(iii) and the collective work hour limits in Sec.  
26.199(f) with the requirements in Sec.  26.205(d)(3) of the final 
rule. This section requires that each individual subject to the work 
hour requirements has a minimum average number of days off per week 
while the plant is operating. This provision addresses comments on the 
proposed 48-hour break requirement and collective work hour limits as 
follows:
     The minimum day-off requirements of Sec.  26.205(d)(3) 
address cumulative fatigue on an individual basis. In contrast to the 
proposed collective work hour limits, the final rule provides more 
uniform assurance of worker FFD and addresses the concern that, 
although duty groups could have met the collective work hour 
requirements, individuals in those groups may have worked excessive 
hours.
     The minimum day-off requirements of Sec.  26.205(d)(3) 
establish limits that in most circumstances are tailored to the 
duration of the shifts that individuals work (e.g., individuals on 8-
hour shifts must average at least 1 day off per week; individuals on 
10-hour shifts must average 2 days off per week). As a consequence, in 
contrast to the single set of break requirements in the proposed rule, 
the final rule provides a better correlation between the number of 
hours an individual works and the amount of restorative rest required 
by the rule.
     The minimum day-off requirements of Sec.  26.205(d)(3) 
establish a flexible approach to addressing cumulative fatigue. This 
provision requires a minimum average number of days off per week, 
averaged over a shift cycle of up to 6 weeks. Accordingly, the rule 
does not require that individuals meet the average each week, but does 
ensure that individuals receive a minimum number of days off over the 
course of the shift cycle. As a consequence, the NRC has established a 
requirement that accommodates a wide range of scheduling practices and 
short-term fluctuations in workload. The

[[Page 16989]]

requirement also allows licensees considerable flexibility in 
accommodating individual worker preferences concerning the timing and 
distribution of days off.
     The minimum day-off requirements of Sec.  26.205(d)(3) 
establish limits that are practical and likely to impose less 
administrative burden on licensees than would have been required by the 
collective work hour limits in the proposed rule.\1\ By establishing 
limits that require the control of work hours on an individual basis, 
licensees need not define and track membership in duty groups. In 
addition, the requirements in the final rule largely adopt an approach 
proposed by NEI as an industry-recommended alternative to the group 
work hour controls. Thus, the NRC expects that licensees will consider 
the administrative requirements of this work hour control method to be 
less burdensome.
---------------------------------------------------------------------------

    \1\ Although the NRC believes that the minimum day off 
requirements of Sec.  26.205(d)(3) will impose less administrative 
burden on licensees than the collective work hour limits of the 
proposed rule, the NRC has conservatively retained the 
administrative burden estimate of the collective work hour limits 
for Sec.  26.205(d)(3) of the final rule.
---------------------------------------------------------------------------

    To address cumulative fatigue during periods when a plant is in a 
unit or planned security system outage, the NRC has replaced the 
proposed rule requirements for a minimum 48-hour break (Sec.  
26.199(d)(2)(iii)) and the collective work hour limits applicable to 
security personnel during outages (Sec.  26.199(f)(2)(i)) with the 
requirements in Sec.  26.205(d)(4) and (d)(5) of the final rule. 
Section 26.205(d)(4) requires that licensees provide individuals who 
perform the operations, health physics or chemistry, and fire brigade 
duties described in Sec.  26.4(a)(1) through (a)(3) of the final rule a 
minimum of 3 days off in each successive 15-day period of a unit 
outage. Section 26.205(d)(4) also requires that licensees provide 
individuals who perform the maintenance duties described in Sec.  
26.4(a)(4) at least 1 day off in any 7-day period. Section 26.205(d)(5) 
applies to individuals who perform the security duties described in 
Sec.  26.4(a)(5) of the final rule and requires a minimum of 4 days off 
in each successive 15-day period of a unit outage or planned security 
system outage. These final rule provisions address those comments on 
the 48-hour break and collective work hour requirements applicable to 
outage periods as follows:
     The minimum day-off requirements of Sec.  26.205(d)(4) do 
not mandate that licensees schedule 2 consecutive days off as would 
have been required by the 48-hour break requirement. As a result, 
licensees are better able to establish schedules that minimize the 
potential for disrupting the circadian cycle of individuals who are on 
fixed night shifts.
     The minimum day-off requirements of Sec.  26.205(d)(4) 
allow licensees substantial flexibility in scheduling the required days 
off within the 15-day outage periods. As a result, licensees are able 
to implement a range of scheduling options to meet known outage 
schedule demands and have the flexibility to revise schedules as 
necessary to address emergent needs.
     The minimum day-off requirements of Sec.  26.205(d)(4) 
allow licensees to use a predictable, repeating schedule. The 
requirements permit a schedule of four consecutive 12-hour shifts 
followed by 1 day off. This 5-day sequence can repeat three times in 
each 15-day period creating a schedule that is predictable and 
repeatable, characteristics typically desired by workers and 
schedulers. This schedule limits the number of consecutive work shifts 
to prevent cumulative fatigue and includes sufficient periodic days off 
to mitigate fatigue. For individuals performing the maintenance duties 
described in Sec.  26.4(a)(4) the requirement permits a predictable, 
repeating schedule of 6 consecutive work days followed by 1 day off.
     The minimum day-off requirements of Sec.  26.205(d)(4), in 
conjunction with the other requirements in Sec.  26.205 [Work hours], 
allow a maximum workweek of 72 hours and an average workweek of 67.2 to 
72 hours for a period of up to 60 days. As a result, the requirements 
allow licensees to offer substantial amounts of overtime within these 
limits to attract supplemental workers for outage activities. The NRC 
acknowledges that some individuals may want to work more than 72 hours, 
or even more than 84 hours, per week. However, the NRC notes that the 
work hour limits of Sec.  26.205 apply only to those duties that the 
agency believes have the most direct impact on the protection of public 
health and safety and common defense and security. As a result, the 
requirements do not prevent individuals from working more than 72 hours 
per week, unless those individuals are performing (1) duties on 
structures, systems, and components (SSCs) that a risk-informed 
evaluation process has shown to be significant to public health and 
safety, (2) critical emergency or fire response duties, or (3) duties 
as members of the site security force that are necessary for the 
execution of the site security plan.
     Several commenters recommended that the 8-week exclusion 
period be extended to 10 weeks to accommodate extended outages for 
activities such as reactor vessel head and steam generator 
replacements. In conjunction with these comments, industry stakeholders 
asserted at public meetings held for this rulemaking that cumulative 
fatigue was not a concern during these extended outages because 
individuals often had periods when they were not required to work the 
extended work hours typically associated with outages. In response to 
this comment, the NRC includes a provision in Sec.  26.205(d)(6) of the 
final rule which allows licensees to extend the 60-day exception for 
individuals by 1 week for each 7-day period the individual worked not 
more than 48 hours during the outage. Thus, the rule allows the outage 
exception to be extended when directly justified by an individual's 
actual work history. In light of the significant work hours allowed by 
the requirements, as discussed in the preceding paragraph, the NRC 
considers this approach to be better justified for the management of 
worker fatigue than the proposal for a blanket extension of the outage 
exclusion to 10 weeks.
    Section 26.205(d)(5) of the final rule applies to individuals who 
perform the security duties described in Sec.  26.4(a)(5) and requires 
a minimum of 4 days off in each successive 15-day period of a unit 
outage or planned security system outage. This minimum days-off 
requirement is comparable to the work hour limits imposed for security 
personnel by order EA-03-038 and the 60-hour collective work hour 
average that the proposed rule would have required. The NRC replaced 
the collective work hour limits for security personnel with the 
requirements in Sec.  26.205(d)(5) of the final rule for the following 
three reasons:
    (1) In addition to other commenters, security personnel expressed 
concerns about the effectiveness of the collective work hour controls 
to fully protect against impairment from fatigue for all personnel in a 
group.
    (2) Elimination of the 48-hour break requirement sets aside a key 
requirement for preventing an excessive number of consecutive work days 
that would have otherwise been allowed under the collective work hour 
limits. As a result, the NRC concluded that the collective work hour 
limits, absent the 48-hour break requirement, would not provide 
reasonable assurance that nuclear power plant security personnel would 
be protected from cumulative fatigue from excessive work hours.
    (3) Revision of the outage requirements to a minimum of 4 days off 
in a 15-day period avoids the potential confusion and additional

[[Page 16990]]

burden of two different approaches and accounting systems (i.e., 
minimum day off requirements and collective work hour limits) for the 
control of personnel work hours at a site.
    The NRC believes that the minimum day-off requirements of Sec.  
26.205(d)(3) through (d)(6) of the final rule address the range of 
comments on the rule, several of which expressed opposing views 
regarding the need to relax the requirements or to make them more 
restrictive.
    The NRC does not agree with the comments that asserted that the 
proposed requirements to address cumulative fatigue were unnecessary 
and that a 1-day break in any 7-day period is more than adequate when 
combined with the other rule provisions (e.g., self-declaration and 
training) to address cumulative fatigue. The NRC has concluded that, 
given a broad range of considerations, a 1-day break in any 7-day 
period is an appropriate requirement for individuals performing the 
maintenance duties described in Sec.  26.4(a)(4) for a limited time 
period during unit outages. The NRC has also concluded that additional 
days off are necessary for individuals performing other duties 
described in Sec.  26.4(a) to ensure that those individuals are not 
impaired by the cumulative fatigue that would result if they routinely 
worked the maximum work hours that would otherwise be allowed by the 
requirements in Sec.  26.205(d)(1) and (d)(2). Accordingly, the final 
rule requires more than a 1-day break in any 7-day period for 
individuals performing the duties described in Sec.  26.4(a)(1) through 
(a)(3) and (a)(5) during unit outages. For periods when the plant is 
operating, the final rule requires that all individuals working 10 or 
12-hour shifts receive on average more than one day off per week. The 
rule requires only one day off per week on average for individuals 
working 8-hour shifts because individuals on 8-hour shifts could not be 
practically scheduled at the maximum work hours allowed by the 
requirements in Sec.  26.205(d)(1) and (d)(2).
    The NRC acknowledges the important role of self-declaration and 
training in fatigue management, as noted by some commenters, but also 
recognizes the inherent limitations of these provisions to effectively 
address fatigue, particularly during periods of outage schedule 
conditions. As noted by Michael T. Coyle, NEI, comment letter 
49, and supported by several other commenters, ``for many 
supplemental workers the availability of overtime is a key factor in 
where they decide to work.'' The NRC also recognizes that outages are 
periods when individuals may perceive increased schedule pressure and 
is aware that at least one site offered bonuses for perfect attendance 
during outages. Self-declaration would likely cause individuals to 
forfeit a portion of that overtime and possibly a bonus. As a result, 
despite the best efforts of licensees to emphasize safety and worker 
FFD, the NRC anticipates that self-declaration and training in methods 
to obtain adequate rest may not be implemented as effectively or 
consistently during outage periods as during periods of routine plant 
operation, and therefore, they are not a substitute for work hour 
controls that effectively prevent cumulative fatigue.
    In asserting that a 1-day break is more than adequate to address 
cumulative fatigue, industry stakeholders have cited the basis for the 
Federal Motor Carrier Safety Administration's (FMCSA) minimum 34-hour 
break provision for commercial motor vehicle (CMV) operators. The NRC 
reviewed the FMCSA regulations (49 CFR Part 395), associated statements 
of considerations (65 FR 25540 (May 2, 2000); 70 FR 49978 (Aug 25, 
2005), the findings of an expert panel commissioned by the FMCSA 
(Belenky et al., 1998), a petition for review of the final rule (Brief 
of Public Citizen, et al., Owner-Operator Independent Drivers Ass'n, 
Inc. v. Federal Motor Carrier Safety Admin., 494 F.3d 188 (D.C. Cir. 
July 24, 2007) (No. 06-1035) (``FMCSA'')), and the decision of the 
court with regard to the petition. FMCSA. The NRC concluded that, for a 
limited range of conditions, the studies cited by FMCSA support a 34-
hour break as an appropriate minimum rest period. However, the NRC 
staff does not agree that the basis cited by the FMCSA supports a 
requirement that would routinely allow 72 hours of work for all nuclear 
power plant workers performing functions important to the protection of 
public health and safety before such a break is required. The NRC notes 
that:
    (1) The FMCSA regulations for CMV operators include requirements 
that prohibit driving after 60 hours of duty in 7 days. By contrast the 
NEI proposal would allow 72 hours of work in a 7-day period, excluding 
turnover.
    (2) The statement of considerations for the FMCSA regulation 
establishes that long work weeks with minimum break periods are the 
exception for CMV operators. The FMCSA sets forth this information as a 
premise for the adequacy of the 34-hour break. By contrast, application 
of the industry proposed requirement to the control of work hours 
during unit outages would allow licensed operators \2\ and other plant 
personnel to work regularly occurring periods of multiple consecutive 
72-hour work weeks with minimum break periods. The NRC notes that a 
federal appeals court vacated the 2005 provision of the FMCSA 
requirements that would have permitted a 34-hour break to restart the 
weekly limits. Among the reasons cited by the court was that FMCSA's 
operator-fatigue model did not ``account for cumulative fatigue due to 
the increased weekly driving and working hours permitted by the 34-hour 
restart provision.'' FMCSA at 206.
---------------------------------------------------------------------------

    \2\ At multi-unit sites with common control rooms, all licensed 
operators would be subject to the limits applicable to unit outages, 
including operators responsible for operating units.
---------------------------------------------------------------------------

    (3) Contrary to the NEI assertion that a 34-hour break is ``more 
than adequate'' the expert panel commissioned by the FMCSA described 
the 34-hour break as ``absolutely minimal.'' Further, the expert panel 
noted that a fundamental assumption for the adequacy of the 34-hour 
break is that it will provide two consecutive nights of uninterrupted 
sleep between midnight and 6 a.m. Given common outage scheduling 
practices, the NRC believes that no workers on night shifts and few 
workers on day shifts would meet this assumption.
    In addition, the NRC does not agree with industry stakeholder 
comments that an opportunity for 8 hours of sleep between shifts 
prevents cumulative fatigue. This argument is contrary to common 
experience in that it implies workers should be able to work 12 hours 
per day, without degradation in their performance, for an unlimited 
number of days. To the contrary, the National Institute for 
Occupational Safety and Health (NIOSH) found that ``up to five 
consecutive 12/14-hour shifts * * * creates the potential for excessive 
fatigue, even when 8 hours of sleep per day are obtained'' (2000 NIOSH 
3). Similarly, the NRC notes that it has received increased reports of 
excessive fatigue following extended periods of 12-hour shifts, such as 
in the months following the terrorist attacks of September 11, 2001, 
and during the extended head replacement outage at Davis Besse (NRC 
Inspection Report 05000346/2004003, dated March 31, 2004, ADAMS 
Accession No. ML040910335). The NRC found that workers typically did 
not average more than 60 work hours per week during these periods. As a 
result, even if a 34-hour break was adequate to mitigate cumulative 
fatigue from 72 or more hours of work, the 1 day off in a 7-day

[[Page 16991]]

period that the industry's proposed would not ensure that breaks would 
be provided on a sufficient frequency to prevent weekly occurrences of 
cumulative fatigue. A NIOSH review (Caruso, et al., 2004) of 52 recent 
reports examining the association between long work hours and illness, 
injuries, health behaviors, and performance, reported ``a pattern of 
deteriorating performance on psychophysiological tests as well as 
injuries while working long hours was observed across study findings, 
particularly when 12-hour shifts combined with more than 40 hours of 
work a week.''
    Considering the limitations of the technical basis cited by the 
industry and its applicability to outage scheduling practices and 
operating experience and technical literature indicating that 1 day off 
in 7 days is not adequate for recovery when individuals are working in 
excess of 60 hours per week, the NRC concluded that the industry 
proposal would not effectively prevent cumulative fatigue for 
individuals performing the operations, health physics, chemistry, fire 
brigade and security duties described in Sec.  26.4(a)(1) through 
(a)(3) and (a)(5) for multiple consecutive weeks of extended work 
hours. The NRC considers the minimum day off requirements of the final 
rule provide adequate flexibility to accommodate emergent work and a 
range of scheduling practices while supporting reasonable assurance of 
worker FFD. By limiting the use of the maximum work hours and minimum 
break guidelines to a ``temporary basis,'' the requirements of Sec.  
26.205(d)(3) through (d)(6) are consistent with the NRC's long-standing 
``Policy on Factors Causing Fatigue of Operating Personnel at Nuclear 
Reactors.''

Proposed Reporting Requirements

    Many comments addressed the reporting requirements for the fatigue 
provisions. Section 26.197(e) of the proposed rule would have required 
licensees to submit, as part of the annual FFD program report required 
under Sec.  26.717 [Fitness-for-duty program performance data] of the 
final rule, information concerning the licensee's implementation of the 
work hour controls and management of worker fatigue. The proposed rule 
would have required the annual report to include a summary of the 
waivers the licensee approved during the calendar year, information 
pertaining to instances of job duty groups exceeding a collective work 
hour average of 48 hours in any averaging period during the calendar 
year, and information pertaining to instances of fatigue assessments 
conducted during the calendar year.
    Several commenters from industry asserted that the reporting 
requirements in the proposed Sec.  26.197(e) should be deleted from the 
rule because they would not provide new or unique information to the 
NRC, would be unnecessary to protect public health and safety, would be 
unnecessary to facilitate NRC oversight of the revised rule, and would 
be unduly burdensome. One commenter further stated that the NRC's 
proposed FFD rule and supporting materials did not demonstrate that the 
industry would fail to comply with the requirements of the revised rule 
without the imposition of these reporting requirements. The commenter 
asserted that the existing regulatory process is adequate to ensure 
compliance with the rule. Some commenters believed that the reporting 
requirement would create a significant duplication in licensee efforts, 
noting that proposed Sec.  26.199(j) required periodic reviews by 
licensees to assess the effectiveness of the work hour controls, and 
that these reviews are documented and trended under the licensee's 
corrective action program which is periodically inspected by the NRC.
    Some commenters stated that the reports the rule would require 
would not be a meaningful indicator of licensee performance in managing 
work hours because a number of valid conditions may warrant waivers of 
work hour controls. Two commenters suggested that the rule require 
licensees to report the number of workers covered under Sec.  26.199(a) 
[Individuals subject to work hour controls] of the proposed rule to 
provide appropriate context for the annual reporting of waivers.
    Several commenters from industry also stated that the NRC did not 
meet its obligation under the Paperwork Reduction Act with respect to 
the information collection requirements proposed in Sec.  26.197(e). 
They argued that the NRC failed to adequately justify the need for 
these provisions to achieve the objectives of the proposed FFD rule and 
failed to objectively support its estimate of the burden placed on 
affected licensees. The commenters asserted that the annual report 
would require at least 30 clerical hours to develop and 20 management 
hours to review.
    In response to public comments on the reporting requirements, the 
NRC revised certain requirements for the inclusion of fatigue 
management information in the annual FFD program report. The NRC also 
made conforming changes to the reporting requirements as part of 
changes to other provisions of the rule.
    Section 26.203(e) [Reporting] of the final rule presents the 
reporting requirements associated with licensee implementation of 
Subpart I. This section does not retain the requirements in proposed 
Sec.  26.197(e)(2) for the reporting of information pertaining to the 
control of collective work hours because the final rule does not 
include collective work hour controls. In addition, the agency revised 
the requirements in proposed Sec.  26.197(e)(1) and (e)(2) in response 
to comments that the required information would not provide a 
meaningful indication of licensee performance in managing work hours 
because a number of valid conditions may warrant waivers of work hour 
controls. Through its review of authorized waivers from the work hour 
limits in plant technical specifications, the NRC has found that 
waivers are most frequently associated with outage activities. 
Accordingly, the NRC has revised the final rule to require licensees to 
report whether a waiver of the work hour requirements in Sec.  26.205 
was associated with an outage activity.
    As a result of these revisions, the NRC will be better able to 
interpret a licensee's changes in waiver use over time and understand 
why certain annual reports for a given licensee may indicate a 
heightened level of waiver use relative to the licensee's previous 
reports. The NRC recognizes that outages are not the only cause of 
waivers; however, the agency expects that most other causes of waiver 
use will be for substantially shorter periods of time or involve 
smaller groups of workers and that these other conditions would not 
have a substantive effect on overall waiver use. For unique causes that 
may have more substantive effects (e.g., licensee response to 
hurricanes), the NRC is likely to be aware of or able to identify these 
conditions if they were to significantly affect waiver use. The NRC 
notes that the frequency of waiver use (i.e., how often individuals 
exceed the work hour limits while performing functions important to 
safety and security) indicates the potential for worker fatigue to 
affect the performance of these functions, regardless of whether a 
waiver is the result of an activity associated with an outage or a 
cause that is beyond the licensee's control.
    In addition to requiring an indication of whether a waiver was 
associated with an outage activity, the NRC revised the annual report 
requirement to require a frequency distribution of waivers for each of 
the five duty groups described in Sec.  26.4(a) of the final rule. As a 
result, the annual report would include, for

[[Page 16992]]

example, a table that shows the number of operators who received just 
one waiver during the year, the number of operators who received two 
waivers during the year, and so on. The NRC incorporated this 
requirement in the final rule in response to comments that the rule 
should also require licensees to report the number of workers covered 
under Sec.  26.199(a) of the proposed rule to provide an appropriate 
context for the annual reporting of waivers. The NRC understood that 
the intent of this comment was to provide a basis for evaluating the 
number of waivers from the work hour controls relative to the number of 
individuals subject to those controls. The NRC chose not to require 
licensees to report the number of individuals covered under Sec.  
26.4(a) of the final rule because that number will vary throughout the 
course of the reporting period, particularly when the reporting period 
includes a unit outage. In addition, the NRC believes that the required 
distribution of waivers more effectively provides context to the waiver 
use information by indicating whether the waivers were concentrated 
among individuals performing a certain duty and whether the waiver use 
in a duty group was associated with relatively few individuals or 
distributed among many individuals.
    The NRC does not agree with comments that the requirements for 
including fatigue management information should be deleted from the 
rule because they would not provide new or unique information to the 
NRC, would be unnecessary to protect public health and safety, would be 
unnecessary to facilitate NRC oversight of the revised rule, and would 
be unduly burdensome. In choosing to retain reporting requirements for 
waiver use, the NRC considered several aspects of the work hour 
requirements in the final rule. First, the NRC established the work 
hour limits in the final rule at levels such that the potential for 
fatigue is substantive for individuals working in excess of those 
limits. Second, the rule permits licensees to authorize waivers of the 
limits only for circumstances in which the additional work hours are 
necessary to prevent or mitigate a condition adverse to safety or 
security. Finally, the rule only requires a waiver if the individual is 
operating or maintaining an SSC that a risk-informed evaluation process 
has shown to be important to the protection of public health and safety 
or if the individual is performing specified functions that are 
essential to an effective response to a fire, plant emergency, or 
implementation of the site security plan. As a result, information 
concerning licensee use of waivers indicates (1) the number of hours 
worked on risk-significant activities by individuals who are at 
increased potential for impairment, and (2) how often a licensee must 
mitigate or prevent a condition adverse to safety while relying on 
individuals who are at increased potential for impairment. The NRC 
considers this unique information, not otherwise reported, to be 
relevant to the agency's mission.
    The NRC similarly considered the need to retain reporting 
requirements regarding fatigue assessments and any management actions 
in response to the fatigue assessments. The NRC concluded that the 
fatigue assessment information that would have been reported under the 
requirements of the proposed rule is more the purview of a licensee's 
corrective action program, and would have been more detailed than the 
program performance data for drug and alcohol testing required under 
Sec.  26.717(c) of the final rule. Accordingly, the final rule requires 
licensees to report a summary of corrective actions, if any, resulting 
from the licensee's analysis of waiver and fatigue assessment data. As 
a consequence, the required reports will provide information that will 
focus more on licensee performance in managing worker fatigue and will 
enable NRC to review licensee reporting of waivers in the context of 
associated corrective actions.
    The NRC expects that the information provided by licensees in 
response to the annual reporting requirements in Subpart I will 
facilitate NRC oversight of the implementation of the requirements 
through the following means:
     Consistency, efficiency, and continuity of NRC oversight--
Information provided through the annual FFD program performance reports 
concerning fatigue management will enable the NRC to achieve a higher 
level of consistency and efficiency in the oversight of the 
implementation of the requirements in Subpart I and in the enforcement 
of those requirements. Without the reporting requirements, the NRC's 
inspection of licensee FFD programs would likely be limited to 
individual inspectors evaluating licensee fatigue management for a 
sample of workers at a site for a limited time period. These 
assessments would necessarily be conducted without the benefit of 
broader contextual information from the site or the industry normative 
information that would be available through the annual reports. In 
contrast, the annual reports will help ensure a common perspective and 
maintain consistency among inspectors conducting the oversight process. 
In addition, the annual reports can enhance the efficiency of the NRC 
inspection process by providing information necessary to allow the 
agency to focus inspection resources on duty groups (e.g., security or 
maintenance) that may warrant review. The reports will enable the NRC 
to be better focused in preparing for the inspection, reduce the burden 
of onsite inspection hours, and potentially reduce the total number of 
hours required for a baseline inspection. Further, the annual reporting 
will also help to achieve a more complete and continuous assessment of 
licensee performance because the NRC intends to conduct the baseline 
inspection of FFD programs only once every 2 years.
     Evaluation of rule implementation for lessons learned--
Although the NRC and stakeholders have made extensive efforts to ensure 
clear and enforceable requirements that are effective and practical for 
the management of worker fatigue, the rule introduces the potential for 
unintended consequences and lessons learned. In addition, changes in 
the size and composition of the nuclear industry may have unforeseen 
implications for site staffing and fatigue management. The NRC expects 
that the site-specific and normative information obtained through the 
annual reports can provide important insights regarding opportunities 
to amend the rule to improve its effectiveness or reduce unnecessary 
burden. The NRC notes that information provided by the FFD program 
performance reports was the basis for reducing the random testing rate 
for drugs and alcohol required in a previous amendment to Part 26.
     Consistent interpretation of waiver criterion--The final 
rule provides licensees the discretion to use waivers to exceed the 
work hour limits, thereby allowing levels of work hours that could 
adversely affect worker FFD. The principal basis for allowing waivers 
is to reduce the additional staffing burden that licensees would 
otherwise incur if waivers were not available to address exigent 
circumstances. The annual reporting of waiver use in conjunction with 
the corrective action summaries will enable the NRC to ensure that 
licensees use this discretion in a manner consistent with the 
objectives of the rule and not as a means to compensate for a lack of 
adequate staffing. Further, although the use of waivers is limited to 
conditions when the work hours are ``necessary to prevent or mitigate a 
condition adverse to safety or security,'' the NRC recognizes the 
potential for licensees to develop different

[[Page 16993]]

interpretations regarding this criterion. Some industry commenters on 
the proposed rule took exception to the NRC's characterization of high 
levels of waiver use at some sites as abuse. These commenters suggested 
that differences in licensee waiver practices could be attributed to 
the policy being subject to a number of interpretations during the many 
years that it has been in effect. Regardless of the cause of the 
differences in licensee use of work hour control waivers, the NRC 
considers it prudent to address, through rulemaking, the lessons 
learned from past implementation of the policy and provide a level of 
oversight through the annual reporting requirement that will ensure 
consistent implementation of the waiver criteria in the future.
    In addition to the reasons cited in the preceding paragraphs 
explaining the need for reporting requirements to ensure the effective 
and efficient oversight of the implementation of the rule, the NRC 
considers the reporting requirements to be justified and beneficial for 
the following additional reasons:
     Consistency with other Part 26 requirements and 
performance objective--The final rule retains the requirement of the 
former rule that licensees must report the results of drug and alcohol 
testing and the performance objective for reasonable assurance that 
individuals are not impaired from any cause (Sec. Sec.  26.719 
[Reporting requirements] and 26.23(b) of the final rule). In addition, 
several studies discussed in detail in Section IV.D of this document 
have demonstrated that worker fatigue can produce levels of impairment 
that are comparable to blood alcohol concentrations above the levels 
permitted by this rule. Further, given the frequency of worker concerns 
regarding fatigue and the work scheduling practices that are common 
during outages, the incidence of impairment from fatigue is likely to 
be greater than the very low incidence of drug and alcohol use that is 
detected through testing. Therefore, the NRC considers the reporting of 
information pertaining to licensee management of worker fatigue to be 
consistent with the requirements for reporting information pertaining 
to drug and alcohol testing, the performance objective of this 
rulemaking for licensees to implement a comprehensive FFD program, and 
the NRC's belief that the management of worker fatigue is no less 
important to worker FFD than the effective detection and deterrence of 
drug and alcohol use.
     Public confidence--Public interest groups such as the UCS 
and the Project on Government Oversight have commented at public 
meetings that relevant information regarding worker fatigue is withheld 
to either protect alleger identity or, in the case of security 
personnel, plant security. In addition, several public media articles 
have been published during the past 2 years reporting instances of 
guards sleeping and guards fearing repercussions for refusing forced 
and excessive overtime. Information submitted by licensees in the 
annual reports will be publicly available and will reassure public 
stakeholders that the NRC is appropriately cognizant of licensee 
actions regarding fatigue management and that the NRC's oversight of 
these activities is transparent to all stakeholders.
     The burden is limited and justified--Section 26.203(e) of 
the final rule requires licensees to report information concerning 
fatigue management as part of the annual FFD program report. As a 
result, the burden associated with this reporting requirement is an 
incremental change to the reporting requirement for drug and alcohol 
testing. In addition, the fatigue management information required by 
Sec.  26.203(e) of the final rule is largely information that licensees 
will have already generated to demonstrate compliance with other 
provisions of Subpart I. As a result, the burden associated with the 
report will be largely associated with compiling the information in an 
appropriate form and reviewing that compilation. The NRC has reviewed 
the public comments suggesting that the agency underestimated the 
number of clerical and management hours associated with this 
requirement and has taken these comments into consideration in 
estimating the burden of the reporting requirements in Sec.  26.203(e) 
of the final rule. Nevertheless, the NRC considers the burden 
associated with the annual reporting requirements to be justified for 
the reasons described in this and the preceding paragraphs.
    The NRC also considered comments that the reporting requirement 
ignores significant duplication in licensee efforts. The NRC agrees 
that Sec.  26.205(e) of the final rule requires licensees to 
periodically review and assess the effectiveness of the work hour 
controls and that the licensee's corrective action program, which is 
routinely inspected by the NRC, will document and trend these reviews. 
However, as noted previously, the NRC considers the annual reports to 
be a limited burden that will enable the NRC to provide more effective 
and consistent oversight and achieve other objectives for the effective 
implementation of the requirements in Subpart I.

Public Comments on FFD Programs for Construction and Manufacturing

    In response to substantive public comments and industry efforts to 
develop guidance on the subject, the NRC has added Subpart K to the 
final rule to clarify Sec.  26.3(e) of the proposed rule, which 
contained requirements for combined license holders, combined license 
applicants, construction permit holders, construction permit 
applicants, as well as manufacturing license holders under Part 52.
    Subpart K's FFD program is intended to provide reasonable assurance 
that individuals involved in the construction of a nuclear power plant 
who perform specified duties at the site are fit for duty, trustworthy, 
and reliable, commensurate with the potential risks to public health 
and safety and the common defense and security that their activities 
and access to certain information would pose.
    Proposed Sec.  26.3(e) would have retained and updated the 
requirements of Sec.  26.2(c) of the former rule. However, proposed 
Sec.  26.3(e) would not have revised the basic approach taken in former 
Sec.  26.2(c). The former rule specified the regulations in Part 26 
that applied to licensees holding permits to construct a nuclear power 
plant. Section 26.2(c) of the former rule required each construction 
permit holder with a plant under active construction to comply with 
Sec. Sec.  26.10 [General performance objectives], 26.20 [Written 
policy and procedures], 26.23 [Contractors and vendors], 26.70 
[Inspections], and 26.73 [Reporting requirements] of the former rule. 
This provision also explained that permit holders with plants under 
active construction were required to implement a chemical testing 
program, including random tests, and make provisions for employee 
assistance programs (EAPs), imposition of sanctions, appeals 
procedures, the protection of information, and recordkeeping.
    Proposed Sec.  26.3(e) would have explicitly reflected the NRC's 
combined licensing procedure for nuclear power plants under 10 CFR Part 
52, ``Early Site Permits; Standard Design Certifications; and Combined 
Licenses for Nuclear Power Plants.'' It would have specified the 
entities that are regulated by the NRC (specifically, combined license 
holders before the Commission has made the finding under Sec.  52.103 
[Operation under a combined license], combined license applicants who 
have received authorization to construct under Sec.  50.10(e)(3), 
construction permit

[[Page 16994]]

holders under Part 50, ``Domestic Licensing of Production and 
Utilization Facilities,'' construction permit applicants who have 
received authorization to construct under Sec.  50.10(e)(3), and 
holders of manufacturing licenses under Part 52) who would be 
responsible for meeting certain Part 26 requirements. (The Part 52 
final rule amended Sec.  26.2(c) of the former rule to include in Sec.  
26.2(c) combined license holders before the date that the Commission 
makes the finding under Sec.  52.103(g), holders of manufacturing 
licenses, and persons authorized to conduct the activities under Sec.  
50.10(e)(3).)
    The proposed rule would have replaced the cross-references to other 
sections of the former rule with updated cross-references to the 
related sections in the proposed rule (i.e., Sec. Sec.  26.23 
[Performance objectives], 26.41 [Audits and corrective action], and 
26.189 [Determination of fitness]). The proposed rule would also have 
stipulated that the specified entities should implement a drug and 
alcohol testing program, including random testing, and make provisions 
for EAPs, imposition of sanctions, procedures for the objective and 
impartial review of authorization decisions, protection of information, 
and recordkeeping. However, the proposed rule did not specify in detail 
how the FFD programs of the entities listed in proposed Sec.  26.3(e) 
were to address these topics or the categories of workers who would be 
subject to the programs.
    Some comments received during the public comment period stated that 
the proposed rule did not clearly describe the type of FFD programs the 
NRC expected under proposed Sec.  26.3(e). Commenters stated that 
because the proposed rule required FFD programs for construction to 
comply with a few specific sections of the rule, it would have imposed 
virtually all of the rule's requirements on FFD programs for 
construction, because it would be difficult to ensure compliance with 
the referenced sections of the rule without applying the entire rule. 
Other comments received from industry representatives during the public 
comment period indicated that the NRC should not require FFD programs 
for construction that are more rigorous than industrial safety programs 
implemented during construction of other large, commercial facilities 
because construction activities do not pose risks to public health and 
safety or the common defense and security until nuclear fuel arrives on 
site. In response to these comments, the NRC staff gathered additional 
information about FFD programs for construction in other industries, 
developed a new Subpart K, ``FFD Programs for Construction,'' and 
revised other sections of the rule to clarify the scope of requirements 
for construction activities.
    The results of the NRC staff's benchmarking activities indicated 
that, as a result of the higher incidence of substance problems among 
construction workers than other occupational groups, pre-employment, 
for-cause, and post-accident drug and alcohol testing are increasingly 
common at large, commercial construction projects and some labor union 
coalitions have implemented drug and alcohol testing and substance 
abuse treatment-referral programs for their members. In addition, the 
staff also identified several private-sector entities in the 
petrochemical and steel manufacturing industries that require drug and 
alcohol testing, including random testing, for construction workers on 
large projects, as well as employment history evaluations and other 
background checks. Where safety and/or security during construction are 
critical, large construction projects initiated by some Federal 
agencies (e.g., the Department of Energy) require drug and alcohol 
testing, including random testing, extensive background checks, and 
continuous behavioral observation for the most sensitive construction 
tasks. The NRC concluded that (1) implementing FFD requirements for new 
nuclear power plant construction activities is consistent with the 
practices of other industries, and (2) taking a graded approach to FFD 
requirements, by imposing requirements that are commensurate with the 
potential risks to public health and safety and the common defense and 
security that the results of construction activities may pose when a 
plant begins operations, is consistent with the approach implemented by 
other government agencies when constructing facilities that have the 
potential to affect public health and safety or the common defense and 
security.
    The NRC also determined that some of the requirements in proposed 
Sec.  26.3(e) would be difficult to implement. For example, much of the 
nuclear power plant construction workforce will likely be transient and 
rapidly changing. As a result, it may be challenging to conduct random 
drug and alcohol testing in a manner that would meet all of the random 
testing requirements Part 26 includes for operating plants. In 
addition, some new reactors will be constructed near an operating plant 
that has readily accessible FFD program resources, such as a specimen 
collection and alcohol testing site, a licensee testing facility, an 
FFD training program, and expert staff (e.g., a substance abuse expert, 
MRO, or EAP representative). However, other new reactors may be 
constructed at locations that are distant from the FFD program 
resources of an operating plant. Therefore, the NRC concluded that 
applying some of the requirements in the proposed rule would be overly 
burdensome, such as requiring random testing of all construction 
workers, the requirement for all nuclear power plant construction 
workers to have access to an EAP, and the proposed requirement for a 
determination of fitness process performed by a substance abuse expert 
under Sec.  26.189 of the final rule.
    To streamline administration of the FFD program for construction, 
add flexibility, and implement an approach that is commensurate with 
the potential risks resulting from new plant construction, the final 
rule requires two different levels of FFD requirements for workers in 
different job roles. Because of their important oversight 
responsibilities, the first category of workers, specified in Sec.  
26.4(e), includes any individual whose duties, once construction 
activities begin, require him or her to perform the following 
activities at the location where the nuclear power plant will be 
constructed and operated: serve as security personnel required by the 
NRC; perform quality assurance, quality control, or quality 
verification activities related to safety- and security-related 
construction activities; based on a designation under Sec.  26.406 by a 
licensee or other entity, monitor the fitness of the individuals 
specified in Sec.  26.4(f); witness or determine inspections, tests, 
and analyses certification required under Part 52; supervise or manage 
the construction of safety- or security-related SSCs; or direct or 
implement the licensee's or other entity's access authorization 
program. These individuals must be subject to a full FFD program that 
meets the same requirements as FFD programs for operating plants 
(including random drug and alcohol testing at the 50 percent annual 
rate, behavioral observation training, and a suitable inquiry/
employment history check but excluding the requirements of Subpart I) 
when they are performing duties at the location where the nuclear power 
plant is being constructed and will operate. However, individuals who 
serve as security personnel required by the NRC must meet the 
requirements applicable to security personnel in Sec.  26.4(a)(5) at 
the time the licensee or other entity

[[Page 16995]]

receives special nuclear material in the form of fuel assemblies.
    A new definition of ``supervises or manages'' in Sec.  26.5 
explains that these terms mean the exercise of control over work 
activity by an individual who is not directly involved in the execution 
of the work activity, but who either makes technical decisions for that 
activity without subsequent technical review, or is ultimately 
responsible for the correct performance of that work activity. The 
reference to security personnel is modified by the addition of the 
words ``required by the NRC'' to clarify that the FFD requirements are 
meant to apply to security personnel who perform duties specified by 
NRC regulations and orders, while other security personnel, if any, are 
not covered by the requirements.
    By contrast to the requirements for those individuals listed under 
Sec.  26.4(e), Sec.  26.4(f) provides that the FFD program in Subpart K 
applies only to individuals who are constructing or directing the 
construction of safety- or security-related SSCs. Section 26.5 explains 
that ``construction or construction activities'' means the tasks 
involved in building a nuclear power plant that are performed at the 
location where the nuclear power plant will be constructed and 
operated, and that these tasks include fabricating, erecting, 
integrating, and testing safety- and security-related SSCs and the 
installation of their foundations, including the placement of concrete. 
At a minimum, these individuals must be subject to an FFD program that 
meets the requirements of Subpart K, which emphasizes performance 
objectives and does not incorporate all of the requirements of Part 26, 
unless the licensee or other entity chooses to subject them to an FFD 
program that meets the Part 26 requirements for operating plants, 
except the fatigue management requirements in Subpart I of the final 
rule. The rule adds new definitions of ``safety-related SSCs'' and 
``security-related SSCs'' (described further in Section VI.A of this 
SOC) that clarify the intended coverage of Sec.  26.4(f).
    If a licensee or other entity specified in Sec.  26.3(c) of the 
final rule chooses to implement an FFD program for construction under 
Subpart K, the entity must submit to the NRC a description of the FFD 
program and its implementation as part of the license, permit, or 
limited work authorization application. The description must include a 
written FFD policy that will be given to all individuals covered by the 
program and FFD procedures. The program must include pre-assignment, 
for-cause, and post-accident drug and alcohol testing. Subpart K 
requires an FFD program for construction to include sanctions for FFD 
policy violations, a system of files and procedures to protect personal 
information, and procedures for reviewing determinations that an 
individual has violated the FFD policy. The entity who elects to 
implement a program under Subpart K must conduct periodic audits, 
maintain records, provide reports to the NRC, and develop and apply 
procedures for suitability and fitness evaluations to determine whether 
to assign individuals to constructing safety- and security-related 
SSCs. The program description will be evaluated as a part of the 
application for the license, permit, or limited work authorization and 
the NRC's finding on the application will include a finding on the FFD 
program description. Before work begins on the foundations, including 
placement of concrete, for the safety- or security-related SSCs under 
the license, permit, or limited work authorization, the entity will be 
required to implement the FFD program that it has described in its 
application.
    To detect and deter substance abuse by individuals who are 
constructing safety- and security-related SSCs, Subpart K of the final 
rule permits a licensee or other entity listed in Sec.  26.3(c) of the 
final rule to subject these individuals either to random testing for 
drugs and alcohol or a fitness monitoring program. Subpart K also 
permits FFD programs for construction to--
    (1) Collect specimens other than urine for drug testing and/or rely 
on collection sites at local hospitals or clinics that conduct testing 
under U.S. DOT procedures, rather than those specified in Subpart E, 
``Collecting Specimens for Testing,'' of Part 26;
    (2) Rely on healthcare professionals other than a substance abuse 
expert to evaluate an individual's fitness;
    (3) Designate the persons who will perform fitness monitoring, if 
the entity elects this option, and adjust the number of fitness 
monitors performing monitoring and the frequency of monitoring to 
accommodate the stage of construction and local conditions; and
    (4) Establish the random testing rate and limit the selection of 
individuals for testing to only those who are present and constructing 
safety- or security-related SSCs on a given day, if the entity elects 
this option.
    In the course of its analysis and development of Subpart K of the 
final rule, the NRC published a Federal Register notice (71 FR 13782; 
March 17, 2006) that described the NRC's alternative concepts for FFD 
programs during construction and announced a meeting to obtain 
stakeholder feedback. The concepts described included a requirement for 
FFD policies and procedures on a limited set of topics; pre-access drug 
and alcohol testing, for-cause drug and alcohol testing, and post-event 
testing for accidents; requirements for protection of information; 
requirements for collecting specimens and conducting alcohol tests; the 
option to test specimens at a licensee testing facility; initial and 
confirmatory testing of urine specimens for drugs and validity at an 
HHS-certified laboratory; a review of drug test results by an MRO; and 
annual reports of FFD program performance. The notice listed fatigue 
management requirements, random drug and alcohol testing, the 
requirement for an EAP, and the determination of fitness process 
described in the proposed Part 26 rule as concepts the NRC was not 
currently pursuing for FFD programs for construction. These concepts, 
along with draft guidance for construction programs being prepared by 
nuclear industry representatives, were discussed at the public meeting 
held on March 29, 2006.
    On October 24, 2006, the NRC published the entire draft final rule 
text of 10 CFR Part 26 on the NRC's rulemaking Web site and, on 
November 7, 2006, held a second public meeting with stakeholders to 
present the technical basis for Subpart K and to describe the fitness 
monitoring option included in Subpart K as an alternative to random 
drug and alcohol testing of construction workers. The NRC staff 
described four primary reasons for imposing regulatory requirements for 
FFD programs during construction: (1) The quality of work could be 
adversely affected by construction workers who are impaired by 
substance abuse where studies indicate that members of this group have 
the highest rates of substance abuse problems among occupational groups 
in the U.S. (e.g., SAMHSA's NHSDA covering the years 2000-2001 and 
SAMHSA's National Survey on Drug Use and Health covering the years 
2002-2004), (2) individuals who have become addicted to illegal drugs 
are susceptible to coercion and will interact with others involved in 
the drug trade, (3) past experience has demonstrated that errors during 
construction can adversely affect subsequent plant operations (NUREG/
CR-6819, Vols. 1-4, ``Common-Cause Failure Event Insights,'' (May 2003) 
and NUREG-1837, ``Regulatory Effectiveness Assessment of Generic Issue 
43 and Generic Letter 88-14,'' (October, 2005)), and (4) quality 
assurance by design uses

[[Page 16996]]

a sampling process. The staff stated that, despite having a high degree 
of confidence in the effectiveness of quality assurance/quality control 
programs (required under 10 CFR Part 50) and the inspections, tests, 
analyses, and acceptance criteria (ITAAC) programs (required under 10 
CFR Part 52) to detect construction errors, it is prudent to require an 
FFD program during construction to provide reasonable assurance that 
impaired construction workers do not introduce faults in safety- or 
security-related SSCs that may cause the SSCs to fail when the plant is 
operational. In addition, the staff expressed concern that some 
construction personnel who have substance abuse problems will have 
access to sensitive information that could be useful to an adversary, 
as well as physical access to safety- and security-related SSCs that 
may provide opportunities for malicious acts.
    The staff acknowledged, in part, that the full defense-in-depth 
approach of the FFD program for operating plants is not appropriate for 
all construction workers because many construction activities do not 
have the potential to impact subsequent plant operations, and, before 
fuel arrives on site, do not impose immediate radiological risks. The 
staff stated that, therefore, the rule's requirements for construction 
require a full FFD program for only a limited number of personnel who 
have critical oversight responsibilities for verifying that safety- and 
security-related SSCs are constructed properly. For workers who will 
construct the safety- and security-related SSCs, the FFD program 
requirements in Subpart K are less stringent. For example, Subpart K 
does not require a suitable inquiry/employment history check for these 
workers. In addition, the staff acknowledged the many complex 
logistical challenges associated with implementing FFD requirements 
during construction. Therefore, the Subpart K requirements provide a 
licensee or other entity listed in Sec.  26.3(c) of the final rule 
greater flexibility in implementing FFD programs for construction than 
the rule permits for FFD programs at operating plants.
    The staff also stated that the NRC has decided to defer adopting 
requirements for reactor manufacturing facilities in the final rule. 
Although proposed Sec.  26.3(e) would have covered these facilities, 
and the Part 52 final rule amended Sec.  26.2(c) of the former rule to 
include holders of manufacturing licenses, the NRC has concluded that 
it needs additional information before proceeding with FFD requirements 
for these facilities.
    Stakeholder responses to the staff's presentation varied. Industry 
stakeholders asserted that Part 26 requirements during nuclear power 
plant construction are not warranted until shortly before fuel arrives 
on site. Some industry commenters indicated that, because there are no 
immediate radiological risks to public health and safety or the common 
defense and security during the construction of new plants, the NRC 
should not require FFD programs for construction that are more rigorous 
than the industrial safety programs implemented during construction of 
other large, commercial facilities. Industry stakeholders also asserted 
that NRC requirements for FFD programs during construction are 
unnecessary because the NRC-mandated quality assurance processes will 
detect any errors in construction and are adequate to protect public 
health and safety and the common defense and security, and the industry 
will voluntarily implement FFD programs during construction for 
industrial safety and business reasons. Industry stakeholders also 
commented that the fitness monitoring program, which is permitted under 
Subpart K in lieu of random drug and alcohol testing of workers who are 
constructing safety- and security-related SSCs, is an unfamiliar 
concept and asked several implementation questions. The staff indicated 
that it will work with stakeholders to develop a guidance document that 
would provide examples of acceptable means to implement an FFD program 
under Subpart K, including fitness monitoring.
    A representative from a public interest group stated that the 
Subpart K requirements are necessary for FFD during construction. 
However, this representative questioned the staff's concerns about 
construction workers having unfettered access to sensitive information 
as partial justification for the FFD requirements before fuel receipt. 
This individual stated that safety considerations alone, independent of 
any potential security concerns, warrant regulations for FFD programs 
for construction before fuel receipt.
    Based on the staff's assessment of the potential risks to public 
health and safety and the common defense and security that the results 
of construction activities may pose when a plant begins operations, the 
staff concluded that--
    (1) Relying on voluntary FFD programs would not ensure that all 
workers who construct safety- and security-related SSCs or provide 
oversight of those construction activities are subject to a program;
    (2) Relying on voluntary FFD programs that include only pre-
employment, for-cause, and post-accident testing would not provide the 
on-going detection and deterrence of substance abuse that is achieved 
by either random testing or a fitness monitoring program;
    (3) The extensive programs required for operating plants are not 
warranted for all nuclear power plant construction activities, but 
consistent implementation of FFD programs that provide on-going 
detection and deterrence of substance abuse is warranted; and
    (4) Public confidence in new plant construction will be enhanced by 
a program to provide reasonable assurance that individuals who 
construct safety- and security-related SSCs are fit for duty.
    The NRC believes that the requirements for FFD programs for 
construction in Subpart K of the final rule (1) provide reasonable 
assurance that individuals who are responsible for constructing and 
assuring the quality of safety- and security-related SSCs are fit for 
duty, trustworthy, and reliable, commensurate with the potential risk 
to public health and safety and the common defense and security, (2) 
permit licensees and other entities the flexibility to implement 
programs that are appropriate for local circumstances and the 
challenges created by a large and transient workforce, and (3) ensure 
that the privacy and other rights (including due process) of 
individuals who are subject to the requirements will be protected.
Public Comment on Drug and Alcohol Testing Provisions
    The NRC received several detailed comments on the drug and alcohol 
testing provisions contained in Subparts E, F, and G. Most 
significantly, no comments disagreed with NRC's proposed inclusion of 
specimen validity testing of all urine specimens collected under Part 
26 provisions. Most comments related to improving the clarity and 
intent of the proposed rule. Many comments received were of a technical 
nature and addressed inconsistencies between the NRC's proposed rule 
and requirements in other federal testing programs, mainly the HHS's 
Mandatory Guidelines for Federal Workplace Drug Testing and DOT drug 
and alcohol testing regulations (49 CFR Part 40). The NRC, in large 
part, agrees with many of the comments and has made clarifying 
revisions to the final rule.
    Stakeholder commenters raised several concerns relating to the drug 
and

[[Page 16997]]

alcohol provisions of the proposed rule. First, numerous comments were 
received on the validity testing provisions for screening and initial 
validity tests conducted at licensee testing facilities. Some 
stakeholders disagreed with the NRC's proposal to permit licensee 
testing facilities to use point-of-collection type tests to conduct 
validity screening tests. The NRC considered the comments, but has 
retained in the final rule the proposed provision to allow licensee 
testing facilities to use point-of-collection type tests to conduct 
validity screening tests. However, in response to the comments 
received, the NRC has revised the performance testing provisions in 
Sec.  26.137 to ensure that the functional capabilities of the 
performance testing of screening tests meet the criteria of the final 
rule. In addition, another set of comments pointed out that the 
proposed rule did not afford licensee testing facilities the 
opportunity to conducting specific gravity testing on specimens, which 
is a required component of reporting specimens as dilute, substituted, 
or invalid. The NRC continues to believe that any specimen that has a 
creatinine concentration below 20 mg/dL must be forwarded for 
additional testing at an HHS certified laboratory (including specific 
gravity testing). Finally, the NRC received numerous comments on the 
use of the term ``non-negative.'' Some commenters believed that the 
term created significant confusion with respect to understanding 
specimen test results. The NRC agrees with the commenters and has 
replaced the term ``non-negative test result'' in the final rule with 
the term ``positive'' (for drug test results) and the term 
``adulterated, substituted, and invalid'' (for validity test results). 
In addition, the NRC has replaced the term ``non-negative test result'' 
with the new term ``questionable validity'' for licensee testing 
facility test results that indicate that a specimen may be adulterated, 
substituted, dilute, or invalid.

VI. Section-by-Section Analysis of Substantive Changes

    The final rule is organized into twelve subparts that are comprised 
of related requirements, as follows:

Subpart A--Administrative Provisions
Subpart B--Program Elements
Subpart C--Granting and Maintaining Authorization
Subpart D--Management Actions and Sanctions to be Imposed
Subpart E--Collecting Specimens for Testing
Subpart F--Licensee Testing Facilities
Subpart G--Laboratories Certified by the Department of Health and 
Human Services
Subpart H--Determining Fitness-for-Duty Policy Violations and 
Determining Fitness
Subpart I--Managing Fatigue
Subpart J--[Reserved]
Subpart K--FFD Programs for Construction
Subpart L--[Reserved]
Subpart M--[Reserved]
Subpart N--Recordkeeping and Reporting Requirements
Subpart O--Inspections, Violations, and Penalties
    A detailed cross-reference table between the former and final Part 
26 provisions is included at the end of this document.
    The NRC has deleted Appendix A of the former rule and moved the 
detailed requirements for conducting drug and alcohol testing that were 
contained in Appendix A to 10 CFR Part 26 to Subpart E [Collecting 
Specimens for Testing], Subpart F [Licensee Testing Facilities], and 
Subpart G [Laboratories Certified by the Department of Health and Human 
Services] of the final rule.

Subpart A--Administrative Provisions

Section 26.1 Purpose
    Section 26.1 of the final rule amends the language of the 
corresponding section of the former rule. The final rule deletes the 
term ``certain aspects'' and adds the term ``implementation'' to the 
phrase in the former rule which stated, ``for the establishment and 
maintenance of * * * fitness-for-duty programs,'' in order to convey 
more accurately that the final rule includes requirements for 
implementing FFD programs, in addition to requirements for establishing 
and maintaining such programs. The NRC has moved the portion of former 
Sec.  26.1 that referred to the entities who are subject to the rule to 
Sec.  26.3 [Scope] in order to meet Goal 6 of the rulemaking to improve 
clarity in the organization and language of the final rule, by 
consolidating related requirements into one section.
Section 26.3 Scope
    The NRC has reorganized, renumbered, and amended Sec.  26.3 
relative to both former Sec.  26.2 [Scope], as modified by the Part 52 
final rule, and proposed Sec.  26.3 [Scope] based upon the NRC's 
consideration of issues raised by public comments on the proposed rule. 
In general, the final rule retains and clarifies most of the provisions 
pertaining to the scope of the former and proposed rules. However, one 
public comment stated that the proposed rule was confusing with regard 
to the entities and individuals who are subject to the different 
requirements of this part. Therefore, the final rule amends this 
section of the proposed and former rules and adds a new Sec.  26.4 [FFD 
program applicability to categories of individuals], as discussed with 
respect to that section, to clarify the rule text. Also, the final rule 
makes a substantive change to the proposed rule by adding Sec.  
26.3(c), which modifies the requirements of proposed Sec.  26.3(e) 
pertaining to combined license holders and applicants and construction 
permit holders and applicants. As in Sec.  26.3(e) of the proposed 
rule, Sec.  26.3(c) of the final rule specifies the requirements to 
which these entities are subject. However, the final rule modifies 
these requirements and moves them to a new Subpart K [FFD Programs for 
Construction]. These changes are discussed in more detail with respect 
to Sec.  26.3(c).
    Section 26.3(a) of the final rule specifies that licensed nuclear 
power reactor operators and combined license holders after the 
Commission has made the finding in Sec.  52.103(g) shall comply with 
the requirements of this part, with the exception of Subpart K. The 
Part 52 final rule modified former Sec.  26.2(a) to expressly require 
combined license holders after the Commission has made the finding in 
Sec.  52.103(g) to comply with the requirements of Part 26.
    The final rule clarifies that the regulations contained in Subpart 
K do not apply to the licensees and other entities specified in Sec.  
26.3(a) because only entities specified in Sec.  26.3(c) are permitted 
to implement an FFD program under the more flexible program 
requirements in Subpart K. The final rule also adds a requirement that 
licensees who receive their operating license under Sec.  50.57 after 
the date of publication of the final rule in the Federal Register and 
holders of a combined license under Part 52 after the Commission has 
made the finding in Sec.  52.103(g) must implement an FFD program 
meeting all of the requirements of Part 26 except Subpart K before 
receipt of special nuclear material in the form of fuel assemblies. The 
NRC believes that once fuel assemblies have arrived on site, the full 
range of potential risks to public health and safety and the common 
defense and security that Part 26 is designed to avert are possible. 
Therefore, the NRC believes that a more rigorous FFD program must be in 
place at this time.
    Section 26.3(b) of the final rule combines Sec.  26.3(b) and (c) of 
the proposed rule. This section retains the requirement in the first 
sentence of former Sec.  26.2(a) that licensees who are authorized to 
possess, use, or transport formula quantities of are subject to the 
regulations in this part. Section 26.3(b) also retains the requirements 
of former

[[Page 16998]]

Sec.  26.2(d) and specifies that corporations and entities other than a 
corporation are subject to the regulations of this part because there 
may be entities who are organized as firms, partnerships, limited 
liability companies, or associations who may also obtain a certificate 
or approved compliance plan under Part 76 and elect to engage in 
activities involving formula quantities of SSNM.
    However, the entities specified in this paragraph are not subject 
to the requirements contained in Subpart I [Managing Fatigue] for the 
reasons that are discussed with respect to Sec.  26.201 
[Applicability]. With respect to the proposed rule, the final rule adds 
a specification that the entities listed in Sec.  26.3(b) are not 
subject to the requirements contained in Subpart K, because the 
requirements of Subpart K apply only to the entities specified in Sec.  
26.3(c). The provision also eliminates the cross reference to Sec.  
26.25(a)(3) of the proposed rule because the final rule has moved the 
proposed provisions in Sec.  26.25 to Sec.  26.4 of the final rule for 
increased clarity in the rule's organization.
    Section 26.3(c) of the final rule retains but modifies the 
provisions of former Sec.  26.2(c) and proposed Sec.  26.3(e). Proposed 
Sec.  26.3(e) would have retained and updated the requirements of Sec.  
26.2(c) of the former rule before Part 26 was amended by the Part 52 
final rule. However, proposed Sec.  26.3(e) did not revise the basic 
approach taken in former Sec.  26.2(c), and specified the regulations 
in Part 26 that applied to the entities listed in proposed Sec.  
26.3(e). Section 26.3(c) of the final rule specifies that the entities 
listed are subject to the requirements of Part 26, except Subpart I.
    The NRC received a public comment, discussed in detail in Section V 
of this document, that argued that proposed Sec.  26.3(e) was unclear 
regarding the type of FFD program the NRC expected from the licensees 
specified in this paragraph. The NRC acknowledged these concerns, and 
for the reasons discussed in Section V of this document, the final rule 
amends the requirements of proposed Sec.  26.3(e) and moves them to a 
separate Subpart K. The specific requirements applicable to the 
entities specified in Sec.  26.3(c) are discussed in this document with 
respect to Subpart K.
    Like the proposed rule, the final rule specifies the requirements 
that are applicable to combined license holders before the Commission 
has made the finding under Sec.  52.103(g) and to construction permit 
holders. Section 26.3(c)(2) and 26.3(c)(4) specifies that combined 
license holders before the Commission has made the finding under Sec.  
52.103(g) and construction permit holders, respectively, are subject to 
the requirements of Part 26, except for Subpart I.
    The final rule, however, to be consistent with the LWA final rule, 
amends the proposed rule with respect to combined license applicants 
and construction permit applicants. Section 26.3(c)(1) and (c)(3) 
addresses combined license applicants and construction permit 
applicants, respectively. Although the proposed rule specified combined 
license applicants and construction permit applicants who have 
``received the authorization to construct under Sec.  50.10(e)(3),'' 
revisions to Part 50 in the LWA final rule have changed the content and 
applicability of Sec.  50.10(e)(3). As a result, the Part 26 final rule 
specifies combined license applicants and construction permit 
applicants who ``have been issued a limited work authorization under 
Sec.  50.10(e), if the limited work authorization authorizes the 
applicant to install the foundations, including the placement of 
concrete, for safety- and security-related [SSCs] under the limited 
work authorization.'' Similarly, in Sec.  26.3(c)(5), the final rule, 
with respect to the proposed rule, adds a new specification for early 
site permit holders ``who have been issued a limited work authorization 
under Sec.  50.10(e), if the limited work authorization authorizes the 
early site permit holder to install the foundations, including the 
placement of concrete, for safety- and security-related SSCs under the 
limited work authorization.'' (The final rule contains definitions of 
safety- and security-related SSCs in Sec.  26.5, and those definitions 
are discussed with respect to that section.)
    The LWA final rule modified the scope of activities that are 
considered construction for which a construction permit, combined 
license, or LWA is necessary, and specified the scope of construction 
activities that may be performed under an LWA. Under an LWA, entities 
are allowed to perform some or all of the following activities: driving 
of piles, subsurface preparation, placement of backfill, concrete, or 
permanent retaining walls within an excavation, and installation of the 
foundation, including placement of concrete, any of which are for an 
SSC of a production or utilization facility for which either a 
construction permit or combined license is otherwise required under 10 
CFR 50.10(c).
    The NRC has concluded that if the entity is authorized under the 
LWA to perform only the driving of piles, subsurface preparation, or 
placement of backfill, concrete or permanent retaining walls within an 
excavation for safety- and security-related SSCs, it will not be 
required to comply with Part 26. Entities who are authorized under the 
LWA to perform installation of the foundation, including placement of 
concrete, for safety- or security-related SSCs, however, will be 
required to comply with Part 26 and establish either an FFD program 
under Subpart K of Part 26 or an FFD program that complies with all of 
Part 26 except Subparts I and K.
    The NRC based its decision to distinguish the installation of the 
foundation, including placement of concrete, from the other activities 
listed under Sec.  50.10(d)(1) on the following considerations. First, 
until the NRC broadened the concept of construction because of its 
early interpretation of the National Environmental Policy Act, 
construction requiring NRC approval in the form of a construction 
permit was defined in Sec.  50.10 as ``pouring the foundation for, or 
the installation of, any portion of the permanent facility on the 
site.'' Thus, installation of the foundation has in the past been 
identified by the agency as a key step in construction.
    Second, the NRC concluded that installation of the foundation is 
different in kind from the other activities listed under Sec.  
50.10(d)(1). A common meaning of ``foundation'' is the underlying base 
or support for a building or the substructure of a building. Therefore, 
the foundation is an integral component of the fabric of a safety- or 
security-related SSC, while piles, backfill, and retaining walls are 
not. The foundation must be installed properly on the first attempt, as 
any flaws in the foundation or voids or concrete will be difficult to 
detect and impossible to correct without complete re-installation of 
the foundation. The individuals who install foundations for safety- and 
security-related SSCs must therefore be fit-for-duty and trustworthy 
and reliable. Thus, the installation of foundations has a closer and 
more significant nexus with public health and safety and common defense 
and security, and the individuals who construct or direct the 
construction of such SSCs should be subject to an FFD program.
    Third, the public can be expected to view installation of 
foundations as different from, and more important than, other 
activities under an LWA because of the integral nature of foundations 
with the SSCs and the nexus with public health and safety and common 
defense and security. An FFD program that provides reasonable

[[Page 16999]]

assurance that the individuals who perform installation of foundations 
of safety- or security-related SSCs are trustworthy and reliable and 
fit to perform their duties will enhance public confidence in the NRC's 
regulatory processes and the safety and security of newly constructed 
nuclear power plants.
    Further, Sec.  26.3(c) of the final rule explains that if the 
licensees and other entities specified in Sec.  26.3(c)(1) through (5) 
receive special nuclear material in the form of fuel assemblies, then 
those entities must comply with all of the requirements of Part 26. 
This requirement is consistent with the requirement in Sec.  26.3(a) 
that licensees who receive their operating license under Sec.  50.57 
after the date of publication of the final rule in the Federal Register 
and holders of a combined license under Part 52 after the Commission 
has made the finding in Sec.  52.103(g) must comply with the 
requirements of Part 26, except Subpart K, before the receipt of 
special nuclear material in the form of fuel assemblies. Under both 
Sec.  26.3(a) and (c), no later than when fuel arrives on site, the 
applicable licensees and other entities must implement an FFD program 
that complies with the requirements of Part 26 for the reasons 
discussed with respect to Sec.  26.3(a).
    The NRC has decided to defer adopting requirements for reactor 
manufacturing facilities. Although these facilities would have been 
covered under proposed Sec.  26.3(e) and were temporarily included in 
the former Sec.  26.2(c) as amended by the Part 52 final rule, the 
agency has concluded that it needs additional information before going 
forward with FFD requirements for such facilities, particularly when 
FFD requirements are closely linked to issues of access authorization 
and physical security. The NRC is considering, but has not yet 
completed, regulatory requirements on those subjects for reactor 
manufacturing facilities. Any industry stakeholders with a potential 
interest in pursuing a license for a reactor manufacturing facility 
should ensure that they engage in early discussions with the NRC so 
that suitable requirements can be developed in a timely manner.
    Section 26.3(d) of the final rule retains the meaning of a portion 
of former Sec.  26.23(a)(1), but amends some of the terminology used in 
the former rule. Like the proposed rule, the final rule requires that a 
C/V FFD program must meet the standards of Part 26 if licensees and 
other entities specified in paragraphs (a) through (c) of Sec.  26.3 
rely upon the C/V's FFD program or program elements to meet the 
requirements of Part 26. The provision adds C/Vs to the list of 
entities who are subject to Part 26 in Sec.  26.3 to more clearly 
convey that C/Vs may be directly subject to NRC inspection and 
enforcement actions than the former rule language implied. The former 
rule text presented the applicability of the rule's requirements to a 
C/V's FFD program in terms of the contractual relationship between a 
licensee and the C/V. For example, former Sec.  26.23(a)(1) stated, 
``The contractor or vendor is responsible to the licensee [emphasis 
added] for adhering to the licensee's fitness-for-duty policy, or 
maintaining and adhering to an effective fitness-for-duty program; 
which meets the standards of this part.'' This paragraph, and others in 
the former rule, could be interpreted as implying that a C/V is 
accountable to the licensee but not to the NRC, should significant 
weaknesses be identified in the C/V's FFD program upon which a licensee 
relies. However, this interpretation would be incorrect. Therefore, 
Sec.  26.3(d) of the final rule includes C/V FFD programs and program 
elements upon which the licensees and other entities specified in 
paragraphs (a) through (c) of this section rely within this section to 
convey more accurately that C/Vs are directly accountable for meeting 
the applicable requirements of Part 26, not only through their 
contractual relationships with the licensees and other entities who are 
subject to the rule. This clarification also is necessary to maintain 
the internal consistency of the final rule because some provisions of 
the rule apply only to C/Vs, including, but not limited to Sec.  
26.717(g). The final rule makes this change to meet Goal 6 of the 
rulemaking to improve the clarity in the organization and language of 
the rule.
    The phrases ``program elements'' and ``licensees and other entities 
specified in paragraphs (a) through (c) of this section'' are used in 
Sec.  26.3(d) of the final rule because C/Vs need only meet the 
requirements of Part 26 for those FFD program elements upon which 
licensees and other entities rely to meet the requirements of the rule. 
For example, a C/V may choose to implement all of the program elements 
that are required for a full FFD program under the final rule except 
drug and alcohol testing. In this case, the final rule does not require 
the C/V to address drug and alcohol testing in the C/V's FFD policy, 
procedures, and training program; establish contracts with drug-testing 
laboratories; collect specimens for drug and alcohol testing; or meet 
any other requirements in the final rule that relate to conducting drug 
and alcohol testing. However, if a C/V chooses to conduct drug and 
alcohol testing under some or all of the conditions specified in Sec.  
26.31(c) [Conditions for testing], such as for cause testing, and a 
licensee or other entity specified in Sec.  26.3(a) through (c) relies 
upon the results of the C/V's tests in determining whether to grant 
authorization to an individual (see Subpart C [Granting and Maintaining 
Authorization]), then the use of these phrases in the provision would 
be correctly interpreted to mean that the C/V's drug and alcohol 
testing program element must meet the final rule's requirements related 
to drug and alcohol testing when conducting the tests on which the 
licensee or other entity relies. In contrast, if a C/V implements an 
FFD program element that is addressed in this part, but that program 
element is not relied upon by a licensee or other entity specified in 
paragraphs (a) through (c) of this section, then the provision does not 
require the C/V to meet the applicable Part 26 requirements for that 
FFD program element. Section 26.3(d) requires C/Vs to meet the 
requirements of Subpart I of the final rule, if any nuclear power 
reactor licensees specified in Sec.  26.3(a) through (c) rely upon a C/
V's fatigue management program element to meet the requirements of 
Subpart I. The applicability of Subpart I to C/Vs is discussed with 
respect to Sec.  26.201.
    The NRC has either eliminated or moved to other places of the final 
rule other provisions of former Sec.  26.23 [Contractors and vendors]. 
The NRC has moved the former requirement for licensees to retain 
written agreements with C/Vs in the second sentence of Sec.  26.23 to 
Subpart N [Recordkeeping and Reporting Requirements] of the final rule. 
The NRC has moved the requirement in former Sec.  26.23(a)(1) to 
Subpart C of the final rule. That provision requires that individuals 
who have violated an FFD program must not be assigned to work within 
the scope of this part without the knowledge and consent of the 
licensee. The NRC has addressed the audit requirement contained in 
former Sec.  26.23(b) in Sec.  26.41(d) [Contracts] of the final rule. 
By moving the former requirements to different sections of the final 
rule and grouping related requirements together in one section or 
subpart that addresses similar topics, the NRC has met Goal 6 of this 
rulemaking to improve clarity in the organization and language of the 
rule.
    The NRC has amended and moved the requirements of proposed Sec.  
26.3(e) to

[[Page 17000]]

Sec.  26.3(c) and Subpart K of the final rule. The requirements 
contained in proposed Sec.  26.3(e) are discussed in this document with 
regard to those sections.
    Section 26.3(e) of the final rule, like the proposed rule, retains 
the second sentence of former Sec.  26.2(b) and addresses entities who 
are not subject to the rule. The NRC has moved the first sentence of 
former Sec.  26.2(b), which addressed individuals who are not subject 
to the rule, to Sec.  26.4(i) of the final rule for organizational 
clarity.
Section 26.4 FFD Program Applicability to Categories of Individuals
    In the proposed rule, the NRC moved the provisions in former Sec.  
26.2 that specified the individuals whose duties require them to be 
subject to the rule and exempt certain other individuals to Sec.  26.25 
[Individuals subject to the fitness-for-duty program]. However, the NRC 
has deleted Sec.  26.25 from the final rule, and has amended, 
reorganized, and moved all of the provisions in proposed Sec.  26.25 to 
a new Sec.  26.4 to group related applicability requirements together 
in one section.
    The provisions moved into new Sec.  26.4 include the second 
sentence of former Sec.  26.2(a), the first sentence of former Sec.  
26.2(b), and the portion of the second sentence of former Sec.  26.2(d) 
that pertained to personnel. The NRC determined that separating into 
two different sections the requirements that address the entities who 
are subject to the rule and the requirements that address the 
individuals who must be subject to the rule makes the two sets of 
provisions easier to locate within the final rule without compromising 
the intended meaning of these provisions. Also, moving the 
applicability requirements for individuals into Subpart A [Scope] from 
Subpart B [Program Elements], where they were located in the proposed 
rule, is appropriate because some categories of individuals who are 
subject to the rule are not subject to Subpart B of the final rule. The 
applicability requirements in Sec.  26.4 clearly specify the categories 
of individuals who are subject to Part 26. The NRC determined that 
grouping all of the applicability requirements into one subpart of the 
final rule increases the ease of locating these provisions, consistent 
with Goal 6 of this rulemaking to improve clarity in the organization 
of the rule.
    Section 26.4(a) of the final rule retains portions of proposed 
Sec.  26.25(a)(1). Proposed Sec.  26.25(a)(1) amended portions of 
former Sec.  26.2(a) and (d) and described the individuals whose duties 
require them to be subject to Part 26. The final rule specifies that 
the persons who are granted unescorted access to nuclear power reactor 
protected areas by the licensees and other entities in Sec.  26.3(a) 
and (c), as applicable, and who perform the duties in Sec.  26.4(a)(1) 
through (a)(5) shall be subject to an FFD program that meets the 
requirements of this part, except Subpart K but including Subpart I. 
The NRC has moved the categories of individuals specified in Sec.  
26.199(a)(1) through (a)(5) of the proposed rule to Sec.  26.4(a)(1) 
through (a)(5) of the final rule in order to group together all related 
applicability requirements for individuals in one section. This change 
is consistent with Goal 6 of this rulemaking to improve clarity in the 
organization and language of the rule. Additional concerns regarding 
the reasons why individuals performing these duties shall be subject to 
the fatigue management provisions of Subpart I are discussed with 
respect to Sec.  26.205(a) [Individuals subject to work hour controls]. 
The final rule clarifies that these individuals may not be subject to 
the more flexible FFD program described in Subpart K because they may 
be granted unescorted access by the licensees in Sec.  26.3(a), to whom 
all of the requirements of this part, except Subpart K, apply, and 
entities in Sec.  26.3(c), as applicable, to whom all of the 
requirements of this part apply.
    Section 26.4(b) of the final rule retains portions of and amends 
proposed Sec.  26.25(a)(1). The final rule adds Sec.  26.4(b) to 
clarify that individuals who are granted unescorted access to nuclear 
power reactor protected areas by the licensees and other entities in 
Sec.  26.3(a) and (c), as applicable and who do not perform the duties 
described in Sec.  26.4(a), shall be subject to an FFD program that 
meets all of the requirements of Part 26, except Sec.  26.205 [Work 
hours] through Sec.  26.209 [Self-declarations] and Subpart K. Section 
26.4(b) does not permit these individuals to be subject to an FFD 
program that meets the more flexible requirements of Subpart K because 
they may be granted unescorted access to protected areas by the 
licensees in Sec.  26.3(a), to whom all of the requirements of this 
part, except Subpart K, apply, and the entities in Sec.  26.3(c), as 
applicable, to whom all of the requirements of this part apply. This 
paragraph does not require the individuals in this paragraph to be 
subject to an FFD program that meets the requirements of Sec.  26.205 
through Sec.  26.209 for the reasons discussed with regard to Sec.  
26.205(a).
    Section 26.4(c) of the final rule retains and amends proposed Sec.  
26.25(a)(2). Proposed Sec.  26.25(a)(2) amended portions of former 
Sec.  26.2(a) and (d) and described the individuals whose duties 
require them to be subject to Part 26. Section 26.4(c) of the final 
rule states that all persons who are required by a licensee or other 
entity in Sec.  26.3(a), and, as applicable, (c) to physically report 
to the licensee's Technical Support Center or Emergency Operations 
Facility shall be subject to an FFD program that meets all of the 
requirements of this part, except Sec.  26.205 through Sec.  26.209 and 
Subpart K. Section 26.4(c) of the final rule does not permit these 
individuals to be subject to an FFD program that meets the more 
flexible requirements of Subpart K because they may be granted 
unescorted access by the licensees in Sec.  26.3(a), to whom all of the 
requirements of this part, except Subpart K, apply, and the entities in 
Sec.  26.3(c), as applicable, to whom all of the requirements of this 
part apply. This paragraph also does not require the specified 
individuals to be subject to an FFD program that meets the requirements 
of Sec.  26.205 through Sec.  26.209 for the reasons discussed with 
regard to Sec.  26.205(a).
    Section 26.4(d) of the final rule retains and amends portions of 
proposed Sec.  26.25(a)(3). Proposed Sec.  26.25(a)(3) amended the 
portions of former Sec.  26.2(a) and (d) and described the individuals 
whose duties require them to be subject to Part 26. Section 26.4(d) of 
the final rule specifies that any individual whose duties for the 
licensees and other entities in Sec.  26.3(b) require him or her to 
have the types of access or perform the activities in paragraphs (d)(1) 
through (d)(5) shall be subject to an FFD program that meets all of the 
requirements of this part, except Subparts I and K. Section 26.4(d) of 
the final rule does not require these individuals to be subject to an 
FFD program that meets the requirements of Subparts I or K, which is 
consistent with the provisions of the proposed rule.
    The NRC has added Sec.  26.4(e) to the final rule to specify that 
individuals whose duties when construction activities begin require 
them to have the types of access or perform the activities specified in 
Sec.  26.4(e)(1) through (e)(6) at the location where the nuclear power 
plant will be constructed and operated must be subject to a rigorous 
FFD program that complies with the requirements of Part 26, except for 
the requirements of Subparts I and K. These individuals have direct 
responsibility for assuring the quality and security of construction 
activities and, thereby, the safety and security of the completed 
nuclear power plant. The NRC considers

[[Page 17001]]

it prudent that these personnel are verified to be trustworthy and 
reliable, as demonstrated by the avoidance of substance abuse, and fit 
for duty with an FFD program that is equivalent to the program required 
for an operating plant, which includes a 50 percent random testing rate 
and a suitable inquiry and employment history check. These individuals 
include all individuals whose duties at the location where the nuclear 
power plant will be constructed and operated require them to: (1) Serve 
as security personnel required by the NRC, until the licensee or other 
entity receives special nuclear material in the form of fuel 
assemblies, at which time individuals who serve as security personnel 
required by the NRC must meet the requirements applicable to security 
personnel in Sec.  26.4(a)(5); (2) perform quality assurance, quality 
control, or quality verification activities related to safety- and 
security-related construction activities; (3) based on a designation 
under Sec.  26.406 by a licensee or other entity, monitor the fitness 
of the individuals specified in Sec.  26.4(f) (and thus has also 
received fitness monitoring training); (4) witness or determine 
inspections, tests, and analyses certification required by Part 52; (5) 
supervise or manage the construction of safety- or security-related 
SSCs; or (6) direct, as defined in Sec.  26.5, or implement the access 
authorization program. Section 26.4(e)(5) specifies that an individual 
who ``supervises or manages the construction of safety- or security-
related SSCs'' must be subject to an FFD program that complies with the 
requirements of Part 26, except the requirements of Subparts I and K. 
The NRC has added this provision based upon information from 
stakeholders at public meetings at which the conceptual framework for 
Subpart K was discussed. The NRC has included a definition of 
``supervises or manages'' in the final rule, which means ``exercises 
control over a work activity by an individual who is not directly 
involved in the execution of the work activity.'' The final rule 
specifies that this requirement applies only to those individuals who 
supervise or manage the construction of safety- or security-related 
SSCs ``at the location where the nuclear power plant will be 
constructed and operated'' (i.e., only those individuals whose 
activities at the site where the nuclear power plant will be 
constructed and operated may negatively impact public health and safety 
and the common defense and security).
    Section 26.4(e)(6)(i) through (e)(6)(vii) specifies that 
individuals who direct or implement the licensee's or other entity's 
access authorization program during construction must be subject to an 
FFD program that complies with the requirements of Part 26, except the 
requirements of Subparts I and K. The NRC expects that, in the absence 
of an order or regulation requiring a specific access authorization 
program during construction, an access authorization program during 
construction would require individuals to perform the same duties and 
activities as would a licensee's access authorization program under 
Sec.  73.55 and Sec.  73.56 when the plant is operating. These duties 
and activities include having access to the information used by the 
licensee or other entity to make access authorization determinations, 
including information stored in electronic format, as specified in 
(e)(6)(i); making access authorization determinations, as specified in 
(e)(6)(ii); issuing entry-control picture badges in accordance with 
access authorization determinations, as specified in (e)(6)(iii); 
conducting background investigations or psychological assessments used 
by the licensee or other entity to make access authorization 
determinations, as specified in (e)(6)(iv); adjudicating reviews or 
appeals of access authorization determinations, as specified in 
(e)(6)(v); auditing the access authorization program, as specified in 
(e)(6)(vi); or performing any of the activities or having any of the 
duties listed in Sec.  26.4(e)(6) for any C/V upon whom the licensee's 
or other entity's access authorization program will rely, as specified 
in (e)(6)(vii). Section 26.4(e)(6)(iv) includes the following exception 
for individuals who conduct background investigations or psychological 
assessments used by the licensee or other entity to make access 
authorization determinations: ``He or she shall be subject to 
behavioral observation only when he or she is present at the location 
where the nuclear power plant will be constructed and operated, and 
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) to collect his or her specimens 
for drug and alcohol testing.'' The requirements for persons conducting 
background checks and psychological assessments are relaxed for reasons 
similar to requirements for MROs and certain FFD program personnel, as 
described in detail with respect to Sec.  26.31(b)(1)(v) and (b)(2). 
The NRC has added the requirements of Sec.  26.4(e)(6) in accordance 
with Goal 1 of this rulemaking, which is to update and enhance the 
consistency of 10 CFR Part 26 with advances in other relevant Federal 
rules and guidelines.
    Section 26.4(e)(1) includes the phrase ``until the licensees or 
other entities receive special nuclear material in the form of fuel 
assemblies, at which time individuals who serve as security personnel 
required by the NRC must meet the requirements applicable to security 
personnel in paragraph (a)(5) of this section'' to clarify that, once 
fuel is received on site, security personnel must be subject to all the 
requirements of this part, except the requirements of Subpart K, and 
including the requirements of Subpart I. The individuals listed in 
Sec.  26.4(e)(2) through (6), once construction activities begin and 
until a licensee or other entity specified in Sec.  26.3(a) or (c) 
grants them unescorted access to the nuclear power plant protected 
areas, must be subject to the requirements of this part, except the 
requirements of Subparts I and K. However, once the individuals listed 
in Sec.  26.4(e)(2) through (6) are granted unescorted access to the 
nuclear power plant protected areas, they must be subject to the 
requirements of Sec.  26.4(b), which require them to be subject to the 
requirements of this part, except those in (Sec. Sec.  26.205 through 
26.209 and Subpart K.
    The NRC has added Sec.  26.4(f) to the final rule to specify the 
individuals involved in the construction of a new reactor plant who, at 
the licensee's or other entity's discretion, must be subject to either 
a more flexible FFD program under Subpart K, or a more rigorous FFD 
program that meets the requirements in the other portions of Part 26, 
except Subparts I and K. These individuals include any individual who 
is constructing or directing the construction of safety- or security-
related SSCs at the location where the nuclear power plant will be 
constructed and operated. However, if and when a licensee or entity 
specified in Sec.  26.3(a) or (c) grants these individuals unescorted 
access to the nuclear power plant protected area, these individuals 
must be subject to the requirements of Sec.  26.4(a) or (b), as 
applicable. As specified by the definition of (constructing or 
construction activities' in Sec.  26.5, these tasks include 
fabricating, erecting, integrating, and testing safety- or security-
related SSCs and the installation of their foundations, including the 
placement of concrete. The final rule also contains a definition of 
``directing'' in Sec.  26.5, which means

[[Page 17002]]

the exercise of control over a work activity by an individual ``who is 
directly involved in the execution of the work activity.'' This 
definition is distinguished from the term ``supervises or manages,'' 
used in Sec.  26.4(e)(5), which means the exercise of control over a 
work activity by an individual ``who is not directly involved in the 
execution of the work activity.'' The NRC determined that it is 
necessary to impose FFD requirements on individuals who are 
constructing or directing the construction of safety- or security-
related SSCs because (1) the quality of work could be adversely 
affected by construction workers who are impaired by substance abuse 
where studies indicate that members of this group have the highest 
rates of substance abuse problems among occupational groups in the U.S. 
(e.g., SAMHSA's NHSDA covering the years 2000-2001 and SAMHSA's 
National Survey on Drug Use and Health covering the years 2002-2004), 
(2) individuals who have become addicted to illegal drugs are 
susceptible to coercion and will interact with others involved in the 
drug trade, (3) past experience has demonstrated that errors during 
construction can adversely affect subsequent plant operations (NUREG/
CR-6819, Vols. 1-4, ``Common-Cause Failure Event Insights,'' (May 2003) 
and NUREG-1837, ``Regulatory Effectiveness Assessment of Generic Issue 
43 and Generic Letter 88-14,'' (October 2005)), and (4) quality 
assurance by design uses a sampling process. Despite having a high 
degree of confidence in the effectiveness of quality assurance and 
ITAAC programs to detect construction errors, the NRC believes it is 
prudent to require an FFD program during construction to provide 
reasonable assurance that impaired construction workers or individuals 
directing construction workers do not introduce faults in safety- or 
security-related SSCs that may cause the SSCs to fail to perform their 
intended functions when the plant is operating. In addition, the NRC is 
concerned that some construction personnel who have substance abuse 
problems will have access to sensitive information that could be useful 
to an adversary, as well as physical access to safety- and security-
related SSCs that may provide opportunities for malicious acts. 
Therefore, the NRC is requiring individuals who are directly involved 
in constructing safety- and security-related SSCs to be subject to an 
FFD program.
    Section 26.4(g) of the final rule contains the provisions in 
proposed Sec.  26.25(a)(4). Proposed Sec.  26.25(a)(4) clarified the 
NRC's original intent that FFD program personnel must be subject to the 
FFD program. Although former Section 2.3 in Appendix A to Part 26 
required licensees to carefully select and monitor individuals who are 
responsible for administering the drug and alcohol testing program 
based upon the highest standards of honesty and integrity, some 
licensees' testing programs did not include all of the FFD program 
personnel who the NRC originally intended to be subject to testing. The 
final rule clarifies the NRC's original intent because the actions of 
these individuals have an ongoing effect on public health and safety 
and the common defense and security as a result of their responsibility 
to ensure that FFD programs are effective. In addition, these 
individuals' actions affect the confidence that the public, management, 
and individuals who are subject to testing have in the integrity of the 
program and the accuracy and reliability of test results. Individuals 
who are involved in the day-to-day operations of an FFD program are in 
a position to permit substance abusers to remain undetected. For 
example, specimen collectors could inadvertently commit errors when 
testing others as a result of being impaired from drug or alcohol abuse 
or intentionally omit testing an individual because of motives 
associated with maintaining a collector's substance abuse or empathy 
with an abuser. Further, several reported incidents have confirmed the 
need to assure that FFD program personnel meet the highest standards of 
honesty, integrity, reliability, and trustworthiness. For example, one 
licensee added specimen collectors to the testing pool after 
investigating an allegation and determining that two collectors were 
substance abusers. In another instance, a contracted MRO who was not in 
the testing pool was reported to be an alcoholic and an abuser of 
prescription drugs. Some MROs who provide their services to other 
Federally regulated industries also have been identified as substance 
abusers. Therefore, the revision to former Sec.  26.2(a) fulfills the 
NRC's original objective and requires licensees and other entities to 
extend their programs to include FFD personnel who (1) can link test 
results with the individual who was tested before an FFD policy 
violation determination is made, including, but not limited to, the 
MRO, as specified in Sec.  26.4(g)(1); (2) make determinations of 
fitness, as specified in Sec.  26.4(g)(2); (3) make authorization 
decisions, as specified in Sec.  26.4(g)(3); (4) are involved in 
selecting or notifying individuals for testing, as specified in Sec.  
26.4(g)(4); or (5) are involved in the collection or on-site testing of 
specimens, as specified in Sec.  26.4(g)(5).
    Although job titles and responsibilities may differ among different 
Part 26 FFD programs, examples of FFD program personnel who are subject 
to Part 26 under the final rule include, but are not limited to, the 
following: The FFD program manager under Sec.  26.4(g)(1) through 
(g)(5); the MRO and MRO staff under Sec.  26.4(g)(1); the licensee's or 
other entity's reviewing officials under Sec.  26.4(g)(3); specimen 
collectors under Sec.  26.4(g)(5); SAEs who are under contract to or 
employed by the FFD program under Sec.  26.4(g)(2); and licensee 
testing facility personnel under Sec.  26.4(g)(5). In some cases, 
information technology personnel who design and implement software 
programs for selecting individuals for random testing also may be 
subject to the rule under Sec.  26.4(g)(4) if such personnel have 
knowledge of who was selected for random testing before the individual 
is notified or the ability to affect the selection of specific 
individuals for random testing.
    Section 26.4(g) of the final rule amends the proposed rule to 
clarify the requirements that the FFD programs specified in this 
paragraph must meet. The section specifies that FFD program personnel 
who are involved in the day-to-day operations of the program, as 
defined by the procedures of the licensees or other entities, and whose 
duties require them to have the types of access and perform the 
activities in Sec.  26.4(g)(1) through (g)(5) shall be subject to an 
FFD program that meets all of the requirements of Part 26, except 
Subparts I and K, and at the licensees's discretion, Subpart C. The 
final rule clarifies that the procedures referenced are those of the 
licensees and other entities specified in Sec.  26.3(a) through (c) 
and, as applicable, (d). Licensees may use different FFD program 
personnel for a Subpart K program, in which case, those FFD program 
personnel would be subject to a full program under the rule. However, 
individuals specified in Sec.  26.4(i)(1) are not subject to an FFD 
program under Part 26. The term ``as applicable'' in this provision 
specifies that entities listed in Sec.  26.3(d) must subject FFD 
program personnel to all of the requirements of this part if they 
perform the activities specified in Sec.  26.4(g). The final rule also 
clarifies that the FFD programs for FFD program personnel performing 
the listed activities in Sec.  26.4(g) must meet all the requirements 
of Part 26, except Subparts

[[Page 17003]]

I and K, which is consistent with the provisions of proposed rule. The 
final rule clarifies that the licensees and other entities may subject 
FFD program personnel to an FFD program that meets the requirements of 
Subpart C, for the reasons discussed with respect to Sec.  26.31(b). 
These clarifications are consistent with Goal 6 of this rulemaking to 
improve clarity in the organization and language of the final rule.
    Section 26.4(h) retains and amends the requirements contained in 
proposed Sec.  26.25(d). Proposed Sec.  26.25(d) clarified that 
individuals who have applied for authorization or perform duties that 
require them to be subject to Part 26 also would be subject to some 
provisions of Part 26. The former Part 26 required an applicant for 
authorization to provide a written statement related to his or her past 
activities under this part in former Sec.  26.27(a)(1); provide 
permission to the licensee to conduct a suitable inquiry in former 
Sec.  26.27(a)(2); and submit to pre-access testing in former Sec.  
26.24(a)(1). Although the proposed rule used general terms, such as 
``applicable requirements of this part'' and ``applicable protections 
of this part,'' the final rule clarifies the requirements to which the 
individuals specified in this paragraph are subject. The final rule 
requires that individuals who have applied for authorization to have 
the types of access or perform the activities described in Sec.  
26.4(a) through (d) shall be subject to the requirements in Sec. Sec.  
26.31(c)(1), 26.35(b), 26.37, 26.39 and the applicable requirements of 
Subparts C, and E [Collecting Specimens for Testing] through H 
[Determining Fitness-for-Duty Violations and Determining Fitness]. 
These clarifications ensure the internal consistency of the final rule 
and meet Goal 6 of this rulemaking to improve clarity in the 
organization and language of the rule.
    Section 26.4(i)(1) through (i)(3) contains the provisions of 
proposed Sec.  26.25(b)(1) through (b)(3). The final rule groups 
together in one paragraph the former rule's provisions that identify 
individuals who would not be subject to the rule. This change has been 
made to meet Goal 6 of this rulemaking to improve clarity in the 
organization and language of the rule.
    The NRC has added Sec.  26.4(i)(1) to the final rule as a result of 
extensive discussions with industry stakeholders at the public meetings 
mentioned in the Section I.D of this document. Industry stakeholders 
expressed strong concern that the related language in the affirmed rule 
(which was discussed in the preamble to the proposed rule) that 
delineated the FFD program personnel who must be subject to Part 26 was 
too broad. Stakeholders agreed that FFD program personnel who work on 
site and are involved in the day-to-day operations of the FFD program 
should be subject to the rule. However, the stakeholders noted that the 
language used in the affirmed rule was so vague that it could be 
interpreted as requiring, for example, that offsite human resources 
staff at a licensee's or other entity's corporate offices, who may have 
access to some FFD information about individuals, must be covered, as 
well as any medical or treatment personnel and their managers, at a 
hospital or substance abuse treatment facility who provide an 
occasional FFD program service. These interpretations of the intent of 
the affirmed rule provisions would be incorrect.
    The stakeholders also strongly disagreed with the requirement in 
the affirmed rule that some FFD program personnel who maintain offices 
at locations other than a licensee's or other entity's facilities and 
are not involved in day-to-day program operations, such as EAP 
counselors and some contract MROs, should be subject to the rule. The 
stakeholders indicated that they believe the honesty and integrity of 
such off-site personnel is maintained through their professions' 
oversight and standards, with the result that requiring these 
individuals to be subject to the rule would create a significant and 
unnecessary regulatory burden. Stakeholders stated that the regulatory 
burden would result from the significant logistical difficulties 
involved in ensuring that these individuals are subject to behavioral 
observation and drug and alcohol testing, and excessive costs to hire 
additional MRO(s) to review any positive, adulterated, substituted, or 
dilute drug test results from MRO(s) who serve the FFD program.
    Based on the stakeholders' input, lessons learned from FFD program 
experience since the rule was first implemented, the experience gained 
by other Federal agencies and their regulated industries, and the 
continuing need to ensure that FFD program personnel meet the highest 
standards of honesty and integrity, the NRC added Sec.  26.4(i)(1) to 
the final rule. The provision excludes from the rule individuals who 
may be called upon to provide an FFD program service to a licensee or 
other entity in special circumstances and who meet all of the following 
criteria:
    (1) They are not employed by the licensee or other entity;
    (2) They do not routinely provide services to the licensee's or 
other entity's FFD program; and
    (3) They do not normally work at a licensee's or other entity's 
facility.
    Examples of individuals who are not subject to the rule under this 
provision may include, but are not limited to, a nurse at a local 
hospital who collects a single specimen for a post-event test from an 
individual who has been injured, and a counselor at a residential 
substance abuse treatment facility who performs behavioral observation 
of a patient while the individual is in residence. Personnel who meet 
the three criteria specified in the paragraph are excluded from the FFD 
program because the limited nature of their involvement with the FFD 
program makes it unlikely that they would be subject to coercion or 
influence attempts to subvert the testing process and the NRC is not 
aware of any reports indicating that these types of individuals have 
been involved in any adverse incidents.
    However, Sec.  26.4(g) of the final rule requires MROs and SAEs to 
be subject to Part 26 (see the discussion of Sec.  26.187 [Substance 
abuse expert] in Section VI of this document for a detailed description 
of the SAE's roles and responsibilities under the FFD program), as well 
as any EAP counselor who serves as the SAE for a licensee's or other 
entity's FFD program. Individuals who serve in these positions play the 
key roles of determining whether a positive, adulterated, or 
substituted drug test result is an FFD policy violation (i.e., the MRO 
under Sec.  26.185) and whether an individual is fit to safely and 
competently perform the duties that require the individual to be 
subject to this part (i.e., the SAE). Although the NRC recognizes the 
significant logistical difficulties and costs that may be associated 
with covering these individuals, the NRC concluded that MROs and SAEs 
play such critical roles in the effective functioning of an FFD program 
that ensuring their continuing honesty and integrity by requiring them 
to be subject to the rule is warranted.
    Section 26.4(i)(2) and (i)(3) retains the first sentence of former 
Sec.  26.2(b) but divides it into two paragraphs. This organizational 
change makes it easier to locate these requirements within the rule 
text and to support cross-referencing to these paragraphs from other 
portions of the rule. The NRC has moved the second sentence of former 
Sec.  26.2(b) to Sec.  26.3(e) of the final rule, rather than retain it 
in this provision, because it addressed entities who would not be 
subject to the rule, rather than individuals. The NRC has made these

[[Page 17004]]

changes to meet Goal 6 of this rulemaking to improve clarity in the 
organization and language of the rule.
    The final rule adds a new Sec.  26.4(i)(4), which specifies that 
FFD program personnel of a program that is regulated by another Federal 
agency or State upon which a licensee or other entity relies to meet 
the requirements of this part, as permitted in Sec.  26.4(j), Sec.  
26.31(b)(2), and Sec.  26.405(e)(3) are not subject to a licensee's or 
other entity's program if the FFD program personnel are not employed by 
the licensee or other entity and their normal workplace is not at the 
licensee's or other entity' facility.
    Section 26.4(j) contains the provisions of proposed Sec.  26.25(c). 
This provision provides that persons who are covered by a program 
regulated by another Federal agency or State need not also be covered 
by duplicate elements of a licensee's or other entity's FFD program. 
Duplicate testing and training requirements applicable to an 
appreciable number of individuals working at nuclear facilities have 
become an increasing problem as the facilities have implemented the 
DOT's drug and alcohol testing requirements [49 CFR Part 40, 65 FR 
41944, August 9, 2001]. This revision reduces the burden on some 
individuals who are currently subject to Federal and State programs 
with requirements that duplicate those of Part 26. Minor differences in 
specific program requirements for conducting drug and alcohol testing 
would be unlikely to adversely affect the ability of a licensee's or 
other entity's FFD program to meet the performance objectives of this 
part. The licensee or other entity continues to be responsible for 
implementing any Part 26 program elements that may not be addressed by 
the alternate Federal or State program. These program elements may 
include, but are not limited to, providing behavioral observation and 
initiating for cause testing, if necessary, when an individual who is 
covered by an alternate program is on site at a licensee's or other 
entity's facility and is performing the duties that require the 
individual to be subject to the rule, as well as immediate removal from 
duty of persons whose fitness may be questionable.
    Section 26.4(j)(1) through (j)(5) of the final rule contains the 
provisions in proposed Sec.  26.25(c)(1) through (c)(4) and (c)(6). The 
final rule lists the necessary characteristics of an alternative 
Federal or State program that, under the final rule, licensees and 
other entities may rely upon to satisfy the requirements of this part 
for an individual who is subject both to Part 26 and an alternative 
program. Paragraphs 26.4(j)(1) and (j)(3) permit licensees and other 
entities to rely on the alternative program to meet the final rule's 
drug testing requirements if the alternative program tests for the 
drugs and drug metabolites that are specified in the final rule at or 
below the cutoff levels established in the final rule and an HHS-
certified laboratory conducts the program's specimen validity and drug 
testing. Similarly, Sec.  26.4(j)(2) permits licensees and other 
entities to rely on the alternative program to meet the final rule's 
alcohol testing requirements if the alternative program's alcohol 
testing procedures and devices meet the final rule's requirements and 
the alternative program uses cutoff levels that are at least as 
stringent as those specified in Sec.  26.103(a). Section 26.4(j)(4) 
permits the licensee or other entity to rely on an alternative 
program's FFD training if that training addresses the knowledge and 
abilities listed in Sec.  26.29(a)(1) through (a)(10). If the licensee 
or other entity relies on the alternative program, Sec.  26.4(j)(5) 
requires the licensee or other entity to ensure that the alternative 
program informs the licensee or other entity of any FFD violations.
    The final rule deletes the provision that was contained in proposed 
Sec.  26.25(c)(5). The proposed provision allowed individuals subject 
to Part 26 and to a Federal agency- or State-regulated program to be 
covered only by those elements of an FFD program that are not included 
in the Federal agency or State program if an impartial and objective 
procedure is provided for the review and reversal of any findings of an 
FFD policy violation. The NRC has deleted this provision because it 
recognizes that it would be impractical to require a licensee to ensure 
that a Federal agency or State program would include an impartial and 
objective procedure for the review and reversal of any findings of an 
FFD policy violation. Such assurance would be beyond the licensee's 
ability to obtain or provide because the licensee would not control the 
Federal agency or State program. Therefore, this change is consistent 
with Goal 5 of this rulemaking to improve Part 26 by eliminating or 
modifying unnecessary requirements.
    These provisions are consistent with the former and final rules' 
approaches to permitting licensees and other entities to rely on C/V 
FFD programs and program elements to meet the requirements of this part 
if the C/V's program or program element meets the requirements of this 
part, as discussed with respect to Sec.  26.21 [Fitness-for-duty 
programs]. In general, permitting licensees and other entities to rely 
on FFD programs and program elements that are implemented by others, 
when those programs or program elements meet the requirements of this 
part, fulfills the rule's performance objectives and improves Part 26 
by eliminating or modifying unnecessary requirements, which is Goal 5 
of this rulemaking. However, an important difference between the final 
rule's permission for licensees and other entities to rely on the 
programs of other Federal and State agencies, compared to the final 
rule's permission for licensees and other entities to rely on C/V 
programs, is that the final rule does not require licensees and other 
entities to audit the alternate Federal and State programs under Sec.  
26.41 [Audits and corrective action]. Auditing Federal and State 
programs is unnecessary because these programs are subject to other, 
equally effective audit and inspection requirements. Relieving 
licensees and other entities who are subject to this part from an audit 
requirement also is in keeping with Goal 5 of this rulemaking.
Section 26.5 Definitions
    Section 26.5 amends former Sec.  26.3 [Definitions] to (1) clarify 
some definitions; (2) make the listed terms and their definitions more 
consistent with those used by other Federal agencies (including SAMHSA 
and DOT); (3) define new terms used in other sections of the rule; and 
(4) move definitions into this section from former Section 1.2 in 
Appendix A to 10 CFR Part 26, which contained definitions of important 
terms used in Appendix A to Part 26. The rule also eliminates six terms 
in former Sec.  26.3 and Section 1.2 in Appendix A to Part 26 because 
they are fully defined in the provisions of the final rule or are not 
used in the final rule. In addition, the rule eliminates redundant 
definitions of some terms, which appear in both former Sec.  26.3 and 
Section 1.2 in Appendix A to Part 26. Finally, the NRC has revised some 
definitions to make them simpler and easier to understand, consistent 
with the NRC's commitment to using plain language. For example, some 
definitions in the former rule included requirements that were also 
contained in other sections of the rule. In these instances, the final 
rule eliminates the embedded requirements from within the definitions, 
but retains the definitions in this section. The NRC has moved these 
requirements to the related sections of the final rule for 
organizational clarity.
    The final rule modifies several definitions of the proposed rule 
due to public comment or to increase clarity in the language of the 
rule, consistent with Goal 6 of the rulemaking. These changes

[[Page 17005]]

are discussed below. Otherwise, the final rule adopts the definitions 
of this section as proposed, without change.
    The NRC has made the majority of the changes to this section as a 
result of adding new requirements for urine drug testing, including 
specimen validity testing, to the rule. The rule incorporates advances 
in the science and technology of urine drug testing that are based on 
the most recent revision to the HHS Guidelines, as published in the 
Federal Register on April 13, 2004 (69 FR 19643). These changes require 
adding terms to Sec.  26.5, modifying a number of the terms that were 
used in the former rule, and revising the definitions of some terms in 
the former rule that are also used in the final rule, as described in 
the following paragraphs.
    The final rule modifies several terms that are used in the former 
and proposed rules to describe the results of drug and alcohol testing, 
in order to reduce the number of terms, increase consistency with terms 
used by other Federal agencies, and address the addition of urine 
specimen validity testing requirements. The final rule has deleted the 
term ``non-negative'' from the proposed rule. The NRC has added the 
term ``non-negative'' to the proposed rule to refer to any adverse test 
result from the different types of urine testing that are required 
under the final rule. However, the NRC received a public comment that 
requested clarification of ``non-negative'' with respect to 
``positive'''' in the proposed rule. Therefore, the NRC has deleted 
``non-negative'' from the final rule and replaced it with more specific 
terminology. The final rule uses the term ``positive'' to refer to 
results from drug and alcohol testing indicating the presences of drugs 
or drug metabolites in a urine specimen or the presence of alcohol 
above the cutoff levels established in this part in breath or oral 
fluids specimens. The final rule uses the terms ``adulterated, dilute, 
substituted, or invalid,'' as appropriate, to refer to results of 
validity tests of urine specimens indicating that the specimen may not 
be normal human urine. Consequently, the NRC has replaced the term 
``non-negative'' in the following definitions in this section: 
``confirmed test result,'' ``cutoff level,'' and ``Medical Review 
Officer (MRO).''
    The final rule, with respect to both the former and proposed rules, 
adds the term ``positive result'' to specify what positive results mean 
for drug and alcohol testing. The definition clarifies that, when the 
laboratory has conducted the special analysis permitted in Sec.  
26.163(a)(2), a result reported by an HHS-certified laboratory that a 
specimen contains a drug or drug metabolite below the cutoff 
concentration is also a positive result.
    The final rule also changes the former term ``confirmed positive 
test'' to ``confirmed test result'' to clarify that this term refers to 
the results of the MRO's review of both drug and validity tests of 
urine specimens, rather than to a type of testing. The final rule also 
removes the reference to testing of blood specimens for alcohol that is 
contained in the former definition of ``confirmed positive test'' from 
the definition of ``confirmed test result'' because blood specimens are 
no longer collected at the donor's request for confirmatory alcohol 
testing, as discussed with respect to Sec.  26.83(a). With respect to 
the proposed rule, the final rule specifies that a confirmed test 
result demonstrates that an individual has used drugs ``and/or'' 
alcohol. The NRC has made these changes to meet Goal 6 of this 
rulemaking, as it relates to improving clarity in the language of the 
final rule.
    The final rule adds several terms to refer to urine specimens that 
have characteristics that are inconsistent with those expected of 
normal human urine, as identified through validity testing. The terms 
include ``adulterated specimen,'' ``dilute specimen,'' ``substituted 
specimen,'' and ``invalid result.'' The final rule also adds the term 
``oxidizing adulterant'' to refer to one class of substances that may 
be used to adulterate urine specimens. These new terms and definitions 
have been adapted from the HHS Guidelines.
    With respect to the proposed rule, the final rule adds the term 
``questionable validity'' to mean the results of validity screening or 
initial validity tests at a licensee testing facility indicating that a 
urine specimen may be adulterated, substituted, dilute, or invalid. The 
NRC has added this term based on the consideration identified by a 
commenter that licensee testing facilities may not be able to determine 
whether a specimen is substituted, dilute, or meets some of the invalid 
criteria because they are not required to test for specific gravity of 
a specimen. This term replaces the term ``suspect specimens'' in the 
former rule. Therefore, the NRC has made this change to improve clarity 
in the language of the rule, consistent with Goal 6 of this rulemaking.
    The final rule also adds several terms that are associated with new 
requirements for maintaining quality control of urine specimen validity 
and drug testing, such as the term ``quality control sample.'' The 
final rule also adds definitions of the terms ``calibrator,'' 
``control,'' and ``standard'' to distinguish among the types of quality 
control samples that are associated with urine specimen testing in 
Subparts F [Licensee Testing Facilities] and G [Laboratories Certified 
by the Department of Health and Human Services] of the final rule.
    The final rule changes certain terms that describe drug and alcohol 
tests to reflect the addition of urine specimen validity testing 
requirements. The changes include replacing the term ``initial or 
screening test'' with more specific terms to distinguish between drug 
testing and testing for urine specimen validity. The NRC has added the 
terms ``validity screening test,'' ``initial drug test,'' and ``initial 
validity test'' to refer to the first tests of a urine specimen that 
are performed to determine whether a urine specimen is free of drugs 
and drug metabolites and has the expected characteristics of normal 
urine, or whether further testing of the specimen is required. The 
final rule modifies the proposed definition of ``validity screening 
test'' to clarify that both non-instrumented tests, in which the 
endpoint result is obtained by visual evaluation, and instrumented 
(machine read) tests are acceptable methods to determine the need for 
initial validity testing of urine specimen. The NRC has made these 
changes to improve clarity in the language of the rule, consistent with 
Goal 6 of this rulemaking.
    The final rule also modifies the definition of ``initial or 
screening test'' in the former rule to eliminate the requirement that 
the test must be performed using immunoassay techniques because the NRC 
addresses that requirement in other sections of the rule. The final 
rule replaces the general term ``confirmatory test'' in the former rule 
with the more specific terms, ``confirmatory drug or alcohol test'' and 
``confirmatory validity test.'' In addition, the definitions of these 
terms in the final rule do not include requirements for the methods to 
be used in performing confirmatory tests because these requirements are 
addressed in other sections of the rule. Therefore, the NRC has removed 
the requirement that confirmatory drug testing be performed using gas 
chromatography/mass spectrometry (GC/MS) testing from the definition. 
The final rule also eliminates the reference to GC/MS testing of blood 
samples for confirmatory alcohol testing in the definition of 
``confirmatory drug or alcohol test'' because the final rule does not 
allow donors the option to provide a blood sample for alcohol 
confirmatory testing, as discussed with respect to Sec.  26.83(a).

[[Page 17006]]

    The final rule also adds two terms that refer to testing for very 
low levels of drugs, drug metabolites, or adulterants in a urine 
specimen, ``limit of detection (LOD)'' and ``limit of quantitation 
(LOQ).'' The NRC has adapted the definitions of these terms from the 
HHS Guidelines.
    In addition, the final rule modifies the definitions of two terms 
in the former and proposed rules to be consistent with the new drug and 
alcohol testing terminology that is used throughout the rule. The final 
rule amends the definition of ``cutoff level'' in the former rule to 
clarify that the term is also applicable to the interpretation of 
results from specimen validity testing. The final rule further modifies 
this definition to refer to test results as ``positive,'' ``of 
questionable validity,'' and ``adulterated, substituted, dilute, or 
invalid'' to account for validity tests results from a licensee testing 
facility. The final rule amends the definition of ``Medical Review 
Officer (MRO)'' to refer to a ``drug and validity'' test result, rather 
than a ``positive'' test result, to clarify that the MRO reviews 
validity test results in addition to drug test results.
    The rule also adds six terms that are related to the requirements 
contained in Subpart C. The term ``potentially disqualifying FFD 
information'' refers to the types of information that licensees and 
other entities who are subject to the rule consider when deciding 
whether to grant or maintain an individual's authorization to have the 
types of access or perform the duties that are listed in Sec.  26.4. 
The final rule also adds definitions for four terms that are used 
within the definition of ``potentially disqualifying FFD information,'' 
including ``substance abuse,'' ``legal action,'' ``employment action,'' 
and ``reviewing official.'' The NRC has also added the term ``best 
effort'' to refer to the actions that a licensee or other entity who is 
subject to the rule must take to obtain the information that is 
necessary to complete a suitable inquiry and employment history check, 
as discussed with respect to Sec.  26.63(a).
    The final rule, with respect to the proposed rule, also adds a 
definition of the term ``authorization'' in response to public comment. 
The final rule uses the term, ``authorization,'' to refer to an 
individual's status as having been determined by a licensee or other 
entity to be eligible to perform the duties or have the types of access 
listed in Sec.  26.4(a) through (e), and at the licensee's or other 
entity's discretion, Sec.  26.4(f) and (g) of the final rule. The 
agency selected this term to differentiate ``authorization'' under Part 
26 from the terms, ``unescorted access authorization'' and ``unescorted 
access,'' that are used by nuclear power plant licensees to refer to 
individuals who are subject to both Part 26 and related access 
authorization requirements under 10 CFR 73.56 [Personnel access 
authorization requirements for nuclear power plants]. The NRC created a 
new term because some categories of individuals who are subject to Part 
26 are not required to meet the additional requirements of 10 CFR 
73.56. For example, the NRC has not promulgated access authorization 
requirements in Sec.  73.56 for FFD program personnel. Therefore, the 
final rule uses the term ``authorization'' to refer to the 
determination that these categories of individuals may perform the 
duties or have the types of access specified in Sec.  26.4 to 
distinguish the requirements in this part from the additional 
requirements that a licensee or other entity must meet in order to 
grant individual ``unescorted access authorization'' or ``unescorted 
access'' to nuclear power plant protected areas.
    The final rule adds a definition of ``maintenance'' to clarify the 
scope of duties described as maintenance in Sec.  26.4(a)(4) of the 
final rule. The definition also distinguishes duties performed by 
individuals covered by Sec.  26.4(a)(4) from duties performed by 
individuals that are subject to different work hour limits, such as the 
duties described in Sec.  26.4(a)(1) through (3). Specifically, the 
definition clarifies that Sec.  26.205(a) requires that individuals 
identified in Sec.  26.4(a)(4) (i.e., individuals who are maintaining 
or providing onsite direction for the maintenance of systems and 
components that ``a risk informed evaluation process has shown to be 
significant to public health and safety'') must be subject to the work 
hour requirements. These requirements apply to those individuals who 
perform the following maintenance activities within the licensee's 
owner-controlled area: modification, surveillance, post-maintenance 
testing, and corrective and preventive maintenance. This definition is 
similar to the language used in GL 83-14, ``Definition of `Key 
Maintenance Personnel,' (Clarification of Generic Letter 82-12)'' and 
10 CFR 50.65, ``Requirements for Monitoring the Effectiveness of 
Maintenance at Nuclear Power Plants.'' The definition of 
``maintenance'' in Sec.  26.5 of the final rule excludes the term 
``calibration,'' found in GL 83-14, because the NRC considers 
``calibration'' to be part of ``preventive maintenance'' and, 
therefore, within the definition of ``maintenance.''
    The final rule also adds several terms that are necessary to 
implement the requirements of Subpart I. These terms include 
``fatigue,'' ``acute fatigue,'' and ``cumulative fatigue,'' which refer 
to the degradation in an individual's cognitive (mental) and motor 
(physical) functioning resulting from inadequate rest within the past 
24 hours or over successive days and weeks, respectively. The rule also 
uses the term ``alertness'' to refer to an individual's ability to 
remain awake and sustain attention, which is adversely affected by 
fatigue. The new term ``circadian variation in alertness and 
performance'' defines a factor that licensees would consider when 
conducting a fatigue assessment under Sec.  26.211 [Fatigue 
assessments]. The final rule also adds the term ``increased threat 
condition'' to refer to circumstances in which the rule provides 
licensees with some flexibility in implementing the work hour controls 
of Sec.  26.205. With respect to the proposed rule, the final rule 
modifies the term ``increased threat condition'' to clarify that any 
increase in the protective measure level is relative to the lowest 
protective measure applicable to the site during the previous 60 days.
    The final rule, with respect to the proposed rule, adds a 
definition of ``shift cycle'' to mean a series of consecutive work 
shifts and days off that is planned by the licensee or other entity to 
repeat regularly, thereby constituting a continuous shift schedule. 
Similarly, the final rule adds ``8-hour shift schedule,'' ``10-hour 
shift schedule,'' and ``12-hour shift schedule'' to define these 
schedules in terms of allowable hours of a workday averaged over a 
shift cycle.
    Also, the NRC has added the term ``unit outage'' to the final rule 
to clarify that the specific reactor unit has to be disconnected from 
the electrical grid to be declared in an outage. This term was added in 
response to stakeholder comment raised at a public meeting on whether, 
for purposes of implementing the work hour controls, a unit was 
considered to be in an outage if reactor power was reduced for repair 
or maintenance of a system or component, but the reactor was not 
shutdown. Consequently, the NRC defined unit outage as the reactor 
being disconnected from the electrical grid. This definition provides a 
clearly identifiable plant state for applying the work hour controls in 
Sec.  26.205(d)(4) and (d)(5).
    The term ``directing'' clarifies new requirements for MRO staff 
under Sec.  26.183(d) and the scope of individuals who would be subject 
to work hour controls in Sec.  26.205. The NRC has

[[Page 17007]]

revised this definition in response to public comment regarding the 
lack of clarity of the term ``directing'' as used in Subpart I in the 
proposed rule and the scope of personnel that should be subject to work 
hour controls. Specific comments included remarks regarding the scope 
of engineering functions that should or should not be subject to work 
hour controls. The revised definition in the final rule clarifies the 
NRC's expectations that a limited scope of personnel providing 
technical input would be subject to the requirements of Sec.  26.205. 
The definition explicitly states the criteria that the term 
``directing'' refers to an individual who is ``directly involved in the 
execution of the work activity'' or ``is ultimately responsible for the 
correct performance of that work activity'' as opposed to, for example, 
the planning, development or scheduling of the activity, and that the 
technical input does not receive ``subsequent technical review.'' The 
NRC believes that, in the context of Subpart I, the revised definition 
more clearly focuses on activities that have the potential to 
substantively and immediately affect safety. These changes are 
consistent with the changes that the NRC has made to the final rule in 
Subpart I and meet Goal 6 of this rulemaking as it relates to improving 
clarity in the language of the rule.
    Similarly, with respect to the proposed rule, the NRC has added the 
term ``supervises or manages'' to the final rule. The definition of 
``supervises or manages'' explicitly states the criteria that the term 
refers to an individual who is ``not directly involved in the execution 
of the work activity,'' but who either makes technical decisions 
without technical review, or is ``ultimately responsible for the 
correct performance of that work activity,'' as opposed to, for 
example, the planning, development or scheduling of the activity, and 
that the technical input does not receive ``subsequent technical 
review.'' This definition is intended to clearly focus on activities 
that have the potential to substantively and immediately affect safety. 
These changes are consistent with the changes that the NRC has made to 
the final rule in Subpart I and meet Goal 6 of this rulemaking as it 
relates to improving clarity in the language of the rule.
    The final rule, with respect to the proposed rule, also adds 
several terms that are necessary to interpret and implement the 
requirements in Subpart K. The final rule includes definitions of 
``constructing or construction activities,'' ``safety-related SSCs,'' 
and ``security-related SSCs.'' The NRC has added these definitions in 
response to public comments that recommended that the NRC reconsider 
the proposed requirements for licensees or other entities who will 
build new nuclear power plants. The NRC defined these terms to clarify 
the point in the construction process at which an FFD program for 
construction is required, the physical location where the FFD program 
for construction must be implemented, and to specify the individuals 
who are subject to an FFD program for construction in terms of the 
duties they will perform.
    The former rule in Sec.  26.2(c) imposed FFD requirements on 
construction permit holders ``with a plant under active construction'' 
but did not define that term. The proposed rule in Sec.  26.3(e) would 
have required an FFD program for construction following NRC 
authorization to construct. However, the NRC recognizes that there may 
be a period of time that elapses between the authorization to construct 
and the commencement of specific construction activities that have the 
potential to affect public health and safety and the common defense and 
security when the nuclear power plant begins operations. Therefore, the 
NRC has added a definition of ``constructing and construction 
activities'' to clarify that an FFD program for construction is not 
required until a licensee or other entity begins ``fabricating, 
erecting, integrating, and testing safety- and security-related SSCs, 
and the installation of their foundations, including the placement of 
concrete.''
    In addition, this definition specifies that the FFD program for 
construction applies only to construction activities that are performed 
at the location where the new plant will be constructed and operated. 
The NRC added this phrase to the definition of construction activities 
to clarify that any fabrication, integration, or testing of safety- or 
security-related SSCs that is not performed within or near the 
licensee's or other entity's owner-controlled area in which the new 
plant will be operated would not be subject to Subpart K. For example, 
fabricating, integrating, and testing safety- or security-related SSCs 
at a vendor's or manufacturer's facility that is located in another 
city or state or outside of the U.S. would not be subject to Subpart K, 
whereas producing the concrete to be used for the foundation of the 
reactor building in a facility located on the site where the nuclear 
power plant will be constructed and operated would be subject to 
Subpart K (although the construction of the cement mixing facility 
would not). The NRC anticipates that the focus of the Subpart K program 
on construction activities involving safety- and security-related SSCs 
at the location where the new plant will be constructed and operated 
will lead licensees and other entities to ensure that the program 
covers all those individuals who perform construction activities within 
the footprint of the new power reactor (e.g., the exterior boundary of 
the reactor building once it is completed) as well as the nearby areas 
where safety- and security-related SSCs will be installed and operated 
when the plant begins operations.
    The former rule and the proposed rule also did not specify the 
individuals who would be subject to an FFD program for construction. 
The NRC recognizes that there will be other construction work performed 
at the location where a new plant will be constructed and operated that 
will not have the potential to affect public health and safety and the 
common defense and security when the nuclear power plant begins 
operations, such as constructing a building that will be used only for 
training or administration purposes. The NRC does not intend that 
individuals who are performing these other construction activities must 
be subject to the FFD program. Therefore, the final rule also includes 
definitions of safety- and security-related SSCs to clarify that only 
those individuals who are constructing (i.e., fabricating, erecting, 
integrating, testing, and installing foundations of) these specific 
SSCs must be subject to a Subpart K program. Thus, as one example of a 
safety-related SSC, the rule requires individuals who are constructing 
the containment structure that surrounds the reactor to be subject to 
an FFD program because the containment is relied on to mitigate the 
consequences of accidents that could result in potential offsite 
exposure. Similarly, individuals who are constructing security-related 
SSCs, such as the central and secondary alarm stations, physical 
barriers, communications systems, guard towers, surveillance and 
detection systems, or installing locks and illumination systems, that 
will be necessary to implement the physical security and safeguards 
contingency plans that are required under 10 CFR Part 73 also are 
subject to an FFD program for construction.
    The development of the revised requirements contained in Subpart K 
(described in Sections V and VI of this document) compelled the NRC to 
define these terms in the final rule. Adding definitions of these terms 
satisfies Goal 6 of this rulemaking as it relates to improving clarity 
in the language of the rule.

[[Page 17008]]

    The final rule also adds many terms related to other revisions to 
the former rule. Specifically, the final rule adds ``analytical run'' 
for use in establishing amended performance testing requirements for 
licensee testing facilities in Sec.  26.137 [Quality assurance and 
quality control]. For consistency with the use of the term in the 
related regulations of other Federal agencies, the term ``donor'' 
replaces the former terms that are used to refer to an individual from 
whom a specimen is collected for drug or alcohol testing. The new term 
``nominal'' refers to the leeway in the time periods within which 
certain requirements must be met, such as the requirement for annual 
FFD refresher training in Sec.  26.29(c)(2). The term ``other entity'' 
refers to organizations who are subject to Part 26, but who are not 
licensed by the NRC, including, but not limited to, the organizations 
who hold the NRC certificates or permits listed in Sec.  26.3. The 
terms ``formula quantity'' and ``strategic special nuclear material'' 
(SSNM) have been defined consistently with the definitions of the same 
terms in 10 CFR 70.4. The term ``subversion and subvert the testing 
process'' clarifies the language of provisions related to urine 
specimen validity testing, as discussed with respect to Sec.  
26.31(d)(3)(i), and sanctions in Sec.  26.75(b) that are imposed on 
individuals who are subject to Part 26.
    Section 26.5 of the final rule also retains and amends a number of 
other definitions formerly contained in Sec.  26.3 and Section 1.2 in 
Appendix A to Part 26, as described in the following paragraphs.
    The rule revises the former definition of ``aliquot'' to clarify 
that an aliquot is a representative sample of a urine specimen that may 
be used for testing. The amended definition is consistent with the same 
definition in the HHS Guidelines.
    The final rule simplifies the former definition of ``blood alcohol 
concentration (BAC)'' by deleting references to the instruments that 
licensees and other entities are permitted to use for alcohol testing. 
The text of Sec.  26.91 [Acceptable devices for conducting initial and 
confirmatory tests for alcohol and methods of use] specifies acceptable 
devices for alcohol testing under the final rule.
    The final rule revises the definition of ``category IA material'' 
to conform with the former definition contained in 10 CFR 74.4.
    The final rule expands the definition of ``chain of custody'' to 
indicate that the terms ``chain of custody'' and ``custody and 
control'' are synonymous.
    The NRC has modified the definition of ``collection site'' in the 
final rule to include a reference to oral fluids as specimens that are 
acceptable for initial alcohol testing. The basis for permitting the 
use of oral fluids for initial alcohol testing is discussed in Section 
VI of this document with respect to Sec.  26.83(a).
    The final rule replaces the term ``collection site person'' with 
the term ``collector'' to simplify the terminology used to refer to 
individuals who collect specimens for testing and for consistency with 
the terminology used by other Federal agencies. In addition, the 
definition no longer includes the qualifications required for 
collectors because they are specified in Sec.  26.85 [Collector 
qualifications and responsibilities].
    The final rule adds the term ``contractor/vendor (C/V),'' combining 
the definitions of ``contractor'' and ``vendor'' in the former rule, 
because the final rule does not distinguish between the two types of 
entities.
    The final rule updates the definition of ``HHS-certified 
laboratory'' to reference the most recent version of the HHS Mandatory 
Guidelines for Federal Workplace Drug Testing Programs.
    In addition, the final rule simplifies the definition of ``licensee 
testing facility'' by eliminating the reference to collecting specimens 
for alcohol testing in the former definition, because alcohol testing 
typically occurs at a collection site rather than at the licensee 
testing facility. Also, with respect to the proposed rule, the NRC has 
clarified this definition in the final rule to be consistent with the 
inclusion of specimen validity testing at licensee testing facilities.
    Finally, the final rule eliminates six terms that were defined in 
former Sec.  26.3 and Section 1.2 in Appendix A to Part 26. 
Specifically, the rule eliminates ``followup testing,'' ``random 
test,'' ``suitable inquiry,'' ``reason to believe,'' and ``split 
specimen'' because the text of the rule defines them in the section 
where each term is used. The rule also eliminates the term ``permanent 
record book'' in former Section 1.2 in Appendix A to Part 26 because 
laboratories now use other mechanisms to maintain testing records. 
Therefore, this term is no longer used in the rule.
Section 26.7 Interpretations
    Section 26.7 in the final rule retains former Sec.  26.4 
[Interpretations] but moves the qualifying phrase, ``other than a 
written interpretation by the General Counsel,'' to the end of the 
sentence to improve its clarity. The NRC has made this change in 
keeping with the Commission's commitment to using plain language in its 
regulations and to meet Goal 6 of this rulemaking to improve clarity in 
the organization and language of the final rule.
Section 26.8 Information Collection Requirements: OMB Approval
    Section 26.8 in the final rule amends former Sec.  26.8 
[Information collection requirements: OMB approval] to reflect the 
modified sections of the final rule in which recordkeeping requirements 
are incorporated.
Section 26.9 Specific Exemptions
    Section 26.9 in the final rule revises former Sec.  26.6 
[Exemptions] to include the citation of 10 CFR 50.12 and 70.17. The NRC 
has made this change in the final rule to ensure consistency between 
Part 26 and these related requirements.
Section 26.11 Communications
    New Sec.  26.11 in the final rule improves consistency with similar 
sections in other parts of 10 CFR and ensures that communications with 
the NRC are addressed and, therefore, processed properly.

Subpart B--Program Elements

    Throughout Subpart B, the final rule makes minor clarifications to 
the proposed rule because of public comment, to make conforming 
changes, and to meet Goal 6 of this rulemaking to improve clarity in 
the organization and language of the rule.
    The final rule also makes more substantive changes to the proposed 
rule in this subpart because of public comment or to improve clarity in 
the organization and language of the rule. The substantive changes in 
this subpart can be found in Sec. Sec.  26.21; 26.27(b)(3), (c)(1), 
(c)(2)(ii), (c)(3), and (c)(3)(ii); 26.29(c)(2); 26.31(d)(1)(ii), 
(d)(1)(iii), (d)(2)(i)(A), (d)(2)(v), (d)(3)(i), and (d)(3)(iii); 
26.35(b); 26.37(a), (b)(5) and (d); 26.39(c) and (e); and 26.41(a). 
These changes are discussed in detail below. However, other than the 
changes mentioned above, the final rule adopts the provisions of this 
subpart as proposed, without change.
Section 26.21 Fitness-for-Duty Program
    The final rule modifies the proposed rule's text in this section to 
specify which entities and individuals are subject to the requirements 
of this subpart. This section requires that the licensees and other 
entities specified in Sec.  26.3(a) through (c) must establish, 
implement, and maintain FFD programs that, at a minimum, comprise the 
program elements contained in this subpart. This new statement serves 
as

[[Page 17009]]

an introduction to the remaining text of the final rule and eliminates 
the need for the phrase ``[licensees and other entities] who are 
subject to this subpart'' (or a derivation of this phrase) from several 
provisions in this subpart. These changes are consistent with Goal 6 of 
this rulemaking to improve clarity in the organization and language of 
the rule.
    The NRC has also added a sentence to this section to specify which 
individuals are subject to FFD programs. The sentence in the final rule 
includes cross-references to provisions in Sec.  26.4 [FFD program 
applicability to categories of individuals], which eliminates the need 
for the phrase ``[individuals] who are subject to this part'' (or a 
derivation of this phrase) from several provisions in this subpart. 
This change is consistent with Goal 6 of this rulemaking to improve 
clarity in the organization and language of the rule.
    The third sentence of the section of the final rule is based on 
former Sec.  26.23(b). This provision retains permission for licensees 
and other entities to rely upon the FFD program or program elements of 
a C/V to meet the requirements of this part, if the FFD program or 
program element of a C/V meets the applicable requirements of this 
part. The other requirements contained in former Sec.  26.23 
[Contractors and vendors] are discussed with respect to Sec.  26.23 
[Performance objectives].
Section 26.23 Performance Objectives
    Section 26.23 amends former Sec.  26.10 [General performance 
objectives] as described in the following paragraphs.
    The final rule divides the performance objectives contained in 
Sec.  26.10(a) into two provisions (Sec.  26.23(a) and (b), 
respectively) to clarify that the performance objective of assuring 
that personnel are trustworthy and reliable is separate and distinct 
from the performance objective of assuring that personnel are fit for 
duty.
    Section 26.23(a) of the final rule requires that FFD programs 
provide reasonable assurance that persons who are subject to this part 
are trustworthy and reliable as demonstrated by the avoidance of 
substance abuse and the adverse behaviors that accompany it. The NRC 
has placed an increased emphasis on the trustworthiness and reliability 
of individuals who have access to certain types of sensitive 
information, certain types of radiological materials, and protected 
areas in nuclear power plants since September 11, 2001. These are the 
same individuals who are subject to the final rule. Because these 
individuals have unimpeded access to sensitive information and safety 
equipment and systems, their trustworthiness and reliability are 
essential. This level of emphasis is necessary to reduce the risk of an 
insider threat, maintain public health and safety, and provide for the 
common defense and security in the post-September 11, 2001, threat 
environment. Substance abuse by these individuals presents an 
unacceptable risk to public health and safety and the common defense 
and security in several ways.
    First, by increasing an individual's vulnerability to coercion, 
substance abuse increases the likelihood that such individuals may pose 
an insider threat. Under 10 CFR 73.1 [Purpose and scope], a passive 
insider is defined as an individual who obtains or attempts to obtain 
safeguards or other relevant information, such as a nuclear power 
plant's physical configuration and design, and who does not have a 
functional or operational need to know this information. Section 73.1 
defines an active insider as a knowledgeable individual who, while 
within the protected area of a nuclear power plant in an unescorted 
status, takes direct action to facilitate entrance and exit, disable 
alarms and communications, and/or participates in a violent attack. An 
individual who uses illegal drugs may be coerced into cooperating, 
actively or passively, with a terrorist in an attempt to commit 
radiological sabotage if, for example, the terrorist were to threaten 
the individual with revealing his or her illegal drug use or was 
somehow able to withhold drugs from an individual who is addicted.
    Second, an individual's judgment and self-control are impaired 
while an individual is abusing drugs or alcohol. When an individual is 
intoxicated from abusing any of the substances for which testing is 
conducted under Part 26, including alcohol, the individual is more 
likely to inadvertently reveal sensitive information that terrorists 
could use in a radiological sabotage attempt than when he or she is not 
intoxicated.
    Third, the use of illegal drugs establishes that an individual is 
willing to disobey the law, thus indicating that the individual will 
disregard other rules and regulations. The use of illegal drugs raises 
questions about the individual's trustworthiness and reliability in 
terms of scrupulously following the regulations, procedures, and other 
requirements, such as safeguards requirements, that ensure the 
protection of public health and safety.
    Many provisions of the former rule provided means to identify and 
reduce the risks posed by any individuals whose substance abuse casts 
doubt on their trustworthiness and reliability. In combination with 
other measures the NRC has taken since September 11, 2001, a number of 
the changes to the former rule provide further assurance that 
individuals who are subject to the rule are trustworthy and reliable. 
Changes to strengthen the effectiveness of the final rule in assuring 
individuals' trustworthiness and reliability include, but are not 
limited to, the following:
    (1) Adding requirements for specimen validity testing to identify 
individuals who are willing to attempt to subvert the testing process, 
and may be willing to subvert other rules and regulations that are 
important for public health and safety and the common defense and 
security;
    (2) Increasing the rigor of the evaluations that licensees and 
other entities must perform before granting authorization to an 
individual who has previously violated Part 26 requirements to ensure 
that the individual has ceased abusing drugs or alcohol; and
    (3) Imposing more stringent sanctions on individuals who violate 
Part 26 requirements, including, but not limited to, permanently 
denying authorization to any individual who attempts to subvert the 
drug and alcohol testing process.
    The NRC believes that implementation of these provisions of the 
final rule, in addition to related measures the agency has taken in the 
post-September 11, 2001, threat environment, provides an increased 
level of requirements appropriate for the new threat environment, as 
well as reasonable assurance that individuals who are subject to the 
rule are trustworthy and reliable.
    Section 26.23(b) of the final rule retains the performance 
objective of providing reasonable assurance that personnel are fit for 
duty, which appeared in former Sec.  26.10(a). The use of the term 
``reasonable'' to describe the level of assurance required by the rule 
reflects the NRC's awareness that many different factors may affect an 
individual's fitness at any particular moment in time. Some of these 
factors may be difficult for the licensee or other entity to detect and 
many (such as a transitory illness) may not warrant management action 
or the imposition of sanctions because they do not pose a significant 
risk to public health and safety.
    As mentioned above, the level of requirements associated with 
achieving reasonable assurance of trustworthiness and reliability is 
greater than that associated with achieving reasonable assurance that 
individuals are not

[[Page 17010]]

impaired. Another example of this relates to the sanctions that the 
final rule requires licensees and other entities to impose on 
individuals who demonstrate questionable trustworthiness and 
reliability compared to the management actions licensees are expected 
to take with individuals who may be impaired. For example, if an 
individual demonstrates dishonesty by attempting to bring a substitute 
urine specimen to the collection site with a clear intent to subvert 
the testing process or demonstrates a willingness to break the law by 
possessing illegal drugs on site, the final rule (under Sec.  26.75(b) 
and 26.75(c), respectively) requires the licensee or other entity to 
terminate the individual's authorization. Terminating the individual's 
authorization is necessary to provide reasonable assurance that the 
individual could pose no further risk to public health and safety or 
the common defense and security. In contrast, the final rule does not 
require a licensee or other entity to terminate an individual's 
authorization if he or she is mentally or physically impaired while on 
duty from such transitory causes as illness or emotional stress 
resulting from a family problem.
    For example, an individual who arrives at work with a severe 
migraine headache may suffer impairment on the job that would adversely 
affect the individual's ability to perform his or her duties safely and 
competently while the headache persists. The final (and former) rule 
(under Sec.  26.77(b)(3) and former Sec.  26.27(b)(1), respectively) 
require the licensee or other entity to take action to prevent the 
individual from performing the duties that require the individual to be 
subject to this part if the individual's fitness is questionable. These 
actions could include, for example, assigning the individual to other 
duties until medication brings the headache under control or sending 
the individual home until the headache resolves. Such actions `meet the 
performance objective of providing reasonable assurance that the 
individual is fit when he or she resumes his or her normal duties. 
However, it would be unreasonable for a licensee's FFD policy to impose 
sanctions on the individual, such as terminating his or her 
authorization. Sanctions could have no deterrent effect on the 
recurrence of the individual's headache, which is one purpose of 
including requirements for minimum sanctions in Part 26. In addition, 
there would not be any continuing risk to public health and safety from 
permitting the individual to resume his or her duties after the 
headache is resolved.
    Another difference between the performance objectives of providing 
``reasonable'' assurance of trustworthiness and reliability and 
``reasonable'' assurance that the individuals who are subject to the 
final rule are fit for duty lies in the severity of the enforcement 
actions that the NRC would be likely to take against an FFD program 
that failed to meet these performance objectives. The NRC's enforcement 
actions would be severe in the case of an FFD program that, for 
example, granted authorization to an individual who had previously had 
his or her authorization permanently denied under Sec.  26.75(b) but 
would take less severe enforcement action in the case of an FFD program 
that failed to remove an individual who was experiencing impairment 
related to family stress from his or her duties under Sec.  
26.77(b)(3).
    Section 26.23(c) of the final rule retains the performance 
objective in former Sec.  26.10(b) to ``provide reasonable measures for 
the early detection of persons who are not fit to perform activities 
within the scope of this part.'' However, the final rule replaces the 
phrase ``perform activities within the scope of this part'' with the 
phrase ``perform the duties that require them to be subject to the FFD 
program.'' The final rule requires that certain individuals must be 
subject to an FFD program based on their duties. These duties include 
performing activities, such as measuring, guarding, or transporting 
Category IA material. They also include having access to certain 
locations, material, and sensitive information, such as nuclear power 
plant protected areas, Category IA material, procedures and records for 
safeguarding SSNM, and the drug test results of an individual before 
the MRO reviews those results. Therefore, the phrase ``perform the 
duties that require them to be subject to the FFD program'' is more 
accurate. Replacing the former phrase with the more accurate phrase is 
consistent with Goal 6 of the rulemaking to improve clarity in the 
organization and language of the rule.
    Section 26.23(d) of the final rule amends former Sec.  26.10(c) to 
require that FFD programs must provide reasonable assurance that the 
workplaces subject to this part are free from the presence and effects 
of illegal drugs and alcohol. The final rule revises the former 
performance objective to ``have a goal of achieving a drug-free 
workplace and a workplace free of the effects of such substances'' for 
several reasons. First, the terms ``drug-free'' and ``free from the 
effects of such substances'' do not accurately capture the NRC's intent 
with respect to this performance objective. These terms could be 
misunderstood as requiring FFD programs to have the goal of preventing 
any drugs and their effects from being present in the workplace, which 
could include medications that individuals who are subject to the rule 
may take to treat health problems. Therefore, the final rule replaces 
``drug-free'' and ``free of the effects of such substances'' with the 
more specific phrase ``free from the presence and effects of illegal 
drugs and alcohol'' to refer to the specific substances that are 
proscribed. This revision clarifies that the NRC does not intend for 
FFD programs to prohibit individuals from taking the medications they 
need to maintain their health or bringing those medications to the 
workplace. The NRC has made this change to meet Goal 6 of this 
rulemaking to improve clarity in the organization and language of the 
rule.
    The final rule also replaces the phrase ``have a goal of'' in the 
former rule with the phrase ``provide reasonable assurance'' which more 
accurately captures the intent of this performance objective. The NRC 
has eliminated the phrase ``have a goal of'' because Sec.  26.23(d) is 
a performance objective and, therefore, the phrase is unnecessary. The 
NRC has made this change to meet Goal 6 of this rulemaking to improve 
clarity in the organization and language of the rule without changing 
the intended meaning of the performance objective.
    Section 26.23(e) of the final rule adds a provision to require 
licensees and other entities to provide reasonable assurance that the 
effects of fatigue and degraded alertness on individuals' abilities to 
safely and competently perform their duties are managed commensurate 
with maintaining public health and safety. This new performance 
objective, consistent with Goal 2 of this rulemaking to strengthen the 
effectiveness of FFD programs at nuclear power plants in ensuring 
against worker fatigue adversely affecting public health and safety and 
the common defense and security by establishing clear and enforceable 
requirements for the management of worker fatigue, specifies the 
objective of the requirements concerning worker fatigue that the NRC 
has added to the final rule. Worker fatigue cannot be measured or 
controlled with precision. Also, licensees and other entities do not 
have direct control over all matters that may influence worker fatigue. 
Therefore, Sec.  26.23(e) establishes a ``reasonable assurance'' 
criterion for the performance objective. Worker fatigue

[[Page 17011]]

can result from many causes (e.g., work hours, sleep disorders, demands 
outside the workplace). In addition, individuals differ in their 
responses to conditions that cause fatigue. As a consequence, work-hour 
limits alone do not address all causes of fatigue, nor do they prevent 
fatigue related to work hours for all workers. Contemporary methods for 
addressing worker fatigue (e.g., Rogers, 1996, 1997; Hartley, 1998; 
Carroll, 1999) are commonly referred to as ``fatigue management'' 
programs and use diverse methods (e.g., training, behavioral 
observation, fatigue countermeasures) in addition to work-hour controls 
to prevent, detect, and mitigate fatigue. Accordingly, Sec.  26.23(e) 
establishes a performance objective of reasonable assurance that the 
effects of fatigue and degraded alertness on individuals' abilities to 
safely and competently perform their duties are ``managed'' 
commensurate with maintaining public health and safety. The performance 
objective permits licensees and other entities to apply risk-informed 
fatigue management controls for individuals consistent with the 
significance of their work activities to the protection of public 
health and safety.
Section 26.25 [Reserved]
    The final rule has amended and moved the requirements from proposed 
Sec.  26.25 [Individuals subject to the fitness-for-duty program] to 
Sec.  26.4 of the final rule. This change is discussed in detail in 
this document with regard to Sec.  26.4.
Section 26.27 Written Policy And Procedures
    Section 26.27 of the final rule reorganizes and amends former Sec.  
26.20 [Written policy and procedures. The final rule divides into 
separate paragraphs the requirements related to the FFD policy and FFD 
program procedures that are intermixed within the former section. This 
organizational change makes the requirements related to the FFD policy 
and procedures easier to locate within this section, consistent with 
Goal 6 of this rulemaking to improve clarity in the organization and 
language of the rule.
    Section 26.27(a) of the final rule amends the first paragraph of 
former Sec.  26.20. The former provision required licensees to 
establish and implement written policies and procedures designed to 
meet the performance objectives and specific requirements of this part 
and to retain superseded copies of the policies and procedures. The 
final rule replaces the term ``licensee'' in the former rule with the 
phrase ``licensees and other entities'' because entities other than 
licensees are subject to this requirement, as discussed with respect to 
Sec.  26.3 [Scope]. The final rule adds the term ``maintain'' to the 
former requirement to ``establish and implement'' written policies and 
procedures to reflect the fact that licensees and other entities who 
are subject to Part 26 must occasionally revise FFD program policies 
and procedures to keep them current when FFD program personnel or other 
aspects of the FFD program change. The final rule replaces ``specific'' 
with the term ``applicable'' in the final sentence because all the 
requirements in Part 26 do not apply to all the licensees and other 
entities who are subject to the rule, as discussed with respect to 
Sec.  26.3. The final rule also eliminates ``designed to'' from this 
sentence because it is unnecessary. The NRC has moved the records 
retention requirements contained in the second sentence of the former 
provision to Sec.  26.713(d) in Subpart N [Recordkeeping and Reporting 
Requirements] of the final rule. Subpart N groups together the 
recordkeeping and reporting requirements that are interspersed 
throughout the former rule. The NRC has made these changes to the 
organization and language of former Sec.  26.20 to meet Goal 6 of this 
rulemaking to improve clarity in the organization and language of the 
rule.
    Section 26.27(b) of the final rule amends former Sec.  26.20(a). 
The former provision established requirements for the written FFD 
policy, and the final rule expands the list of topics that the FFD 
policy must address as a result of discussions with stakeholders during 
the public meetings mentioned in Section I.D. Stakeholders noted that 
the list of topics in the former rule is incomplete because it does not 
include many topics about which individuals who are subject to the 
policy should be aware in order to be able to comply with the policy. 
Therefore, the final rule adds topics to the policy content 
requirements in former Sec.  26.20(a) to ensure that FFD policies will 
be complete. The NRC has made this change to meet Goal 7 of this 
rulemaking to protect the rights (including due process) of individuals 
who are subject to Part 26.
    Section 26.27(b) of the final rule also adds requirements for the 
written FFD policy to be clear, concise, and readily available to all 
individuals who are subject to the policy because neither the former 
nor final rules require licensees and other entities to provide site-
specific FFD training to individuals. However, FFD policies may vary 
between licensees and other entities with respect to, for example, the 
sanctions that are applied for confirmed positive, adulterated, or 
substituted test results, the cutoff levels used in drug or alcohol 
testing, or the time periods within which an individual who has been 
selected for random testing must report to the collection site.
    Under this final rule, the written FFD policy continues to be the 
primary means by which a licensee or other entity communicates local 
variations in FFD policy. In the past, however, a few individuals 
challenged determinations that they had violated a licensee's FFD 
policy on the basis that they were not aware of the specific provisions 
of the policy to which they were subject. Therefore, the final rule 
adds requirements that the FFD policy must be clear, concise, and 
readily available in order to promote individuals' awareness of the 
site-specific FFD policy to which they are subject. The NRC has made 
this change to meet Goal 7 of this rulemaking to protect the rights 
(including due process) of individuals who are subject to Part 26.
    The final rule also adds examples of acceptable methods to make the 
written policy ``readily available'' to individuals who are subject to 
the FFD policy, including, but not limited to, posting the policy in 
various work areas throughout the licensee's or other entity's 
facilities, providing individuals with brochures, or allowing 
individuals to print the policy from a computer. The NRC has added 
these examples to meet Goal 6 of this rulemaking to improve clarity in 
the organization and language of the rule.
    Section 26.27(b)(1) amends the second sentence of former Sec.  
26.20(a). Former Sec.  26.20(a) required that ``the policy must address 
the use of illegal drugs and abuse of legal drugs (e.g., alcohol, 
prescription and over-the-counter drugs).'' Section 26.27(b)(1) of the 
final rule expands this sentence to require the FFD policy to describe 
the consequences of onsite or offsite use, sale, or possession of 
illegal drugs in Sec.  26.27(b)(i); the abuse of legal drugs and 
alcohol in Sec.  26.27(b)(ii); and the misuse of prescription and over-
the-counter drugs in Sec.  26.27(b)(iii). The final rule replaces the 
phrase ``must address'' in the former sentence with the phrase ``must 
describe the consequences of.'' The updated phrase clarifies the 
information that the policy must convey to ensure that individuals who 
are subject to the policy are aware of the consequences of these 
actions, as specified in the licensee's or other entity's FFD policy. 
The NRC has made these changes to meet Goal 6 of this

[[Page 17012]]

rulemaking to improve clarity in the organization and language of the 
rule.
    The final rule adds Sec.  26.27(b)(2) that requires the FFD policy 
to state the time period specified by the licensee or other entity 
within which individuals must report to the collection site after being 
notified that they have been selected for random testing. The provision 
does not establish a time limit because there are a variety of 
circumstances among the different licensees and other entities who are 
subject to this rule that make it impractical to establish a universal 
time limit. However, adding the requirement for the licensee's or other 
entity's FFD policy to establish and convey a time limit is necessary 
because some programs have not done so. As a result, circumstances have 
arisen in which individuals who were selected for random testing 
intentionally delayed reporting to the collection site in order to take 
steps to subvert the testing process, such as obtaining an adulterant 
to bring to the collection site or drinking large amounts of liquid to 
be able to provide a dilute specimen. Furthermore, the longer that an 
individual who has abused illegal drugs or alcohol is able to delay 
providing specimens for testing, the more likely it is that the 
concentrations of an illegal drug or alcohol in the individual's urine, 
breath, or oral fluids will decrease because of metabolism. As a 
result, the concentrations may fall below the cutoff levels for those 
substances by the time the specimens are collected and the individual's 
substance abuse would not be detected. Therefore, the requirement to 
establish a time limit within which individuals must report for random 
testing after notification meets Goal 3 of this rulemaking to improve 
the effectiveness and efficiency of FFD programs. The final rule also 
requires the FFD policy to convey this time limit to ensure that 
individuals are aware of it, given that a failure to appear for testing 
within the prescribed time limit may lead to the imposition of 
sanctions under the FFD policy. The NRC has made this change to meet 
Goal 7 of this rulemaking to protect the rights (including due process) 
of individuals who are subject to Part 26.
    Section 26.27(b)(3) adds a requirement that the FFD policy inform 
individuals of the consequences of refusing to be tested and attempting 
to subvert the testing process. With respect to the proposed rule, the 
final rule clarifies that the written policy statement must also 
describe the actions that constitute a refusal to provide a specimen 
for testing. This change, in response to a public comment, clarifies 
the intent of the provision, consistent with Goal 6 of the rulemaking 
to improve clarity in the language and organization of the rule. This 
provision ensures that persons who are subject to the rule are aware of 
Sec.  26.75(b), which requires licensees and other entities to impose 
the sanction of permanent denial of authorization for these actions. 
Section 26.27(b)(3) protects the due process rights of individuals who 
are subject to drug and alcohol testing under this part by ensuring 
that they are informed, in advance, of the licensee's or other entity's 
policies to which they are subject. Therefore, adding this requirement 
to the final rule meets Goal 7 of this rulemaking to protect the rights 
(including due process) of individuals who are subject to Part 26.
    Section 26.27(b)(4)(i) amends former Sec.  26.20(a)(1). Former 
Sec.  26.20(a)(1) required the FFD policy to prohibit the consumption 
of alcohol within an abstinence period of at least 5 hours preceding 
``any scheduled working tour.'' The final rule replaces the phrase 
``any scheduled working tour'' with the phrase ``the individual's 
arrival at the licensee's or other entity's facility'' as a result of 
stakeholder comments on the language in the former rule at the public 
meetings mentioned in Section I.D. The stakeholders commented that the 
former phrase lacked clarity and could be misinterpreted as meaning, 
``any working tour scheduled by the licensee or other entity.'' If the 
phrase was so interpreted, individuals who are subject to the rule may 
believe that, if they work on a weekend or work overtime that is not 
part of their normally scheduled working tour, the rule would permit 
them to consume alcohol within the 5-hour period before they arrive at 
work, which would be incorrect. Therefore, the revised language of the 
final rule clarifies that the pre-work abstinence period applies to the 
5 hours before an individual arrives at the licensee's or other 
entity's facility for any purpose, except if an individual is called in 
to perform an unscheduled working tour, as discussed with respect to 
Sec.  26.27(c)(3). The NRC has made this final change to meet Goal 6 of 
this rulemaking to improve clarity in the organization and language of 
the rule.
    Section 26.27(b)(4)(ii) retains former Sec.  26.20(a)(2) without 
change.
    The NRC has added Sec.  26.27(b)(5) to the final rule to require 
that the FFD policy inform individuals that abstinence from alcohol 
during the 5 hours preceding any scheduled tour of duty may not be 
sufficient to ensure that an individual is fit for duty upon reporting 
to work. Some individuals who have complied with the 5-hour abstinence 
requirement could have BACs above the cutoff levels specified in Sec.  
26.103 [Determining a confirmed positive test result for alcohol] 
preceding a scheduled tour of duty, depending on the amount of alcohol 
and food that the individual consumed before the abstinence period 
began, body weight, and other factors. By ensuring that individuals who 
are subject to this part are aware that the required 5-hour abstinence 
period may be insufficient to ensure they have a BAC below the cutoff 
levels in this part when arriving at the licensee's or other entity's 
facility, this provision to meet Goal 7 of this rulemaking to protect 
the rights (including due process) of individuals who are subject to 
alcohol testing under Part 26.
    Section 26.27(b)(6) amends the last sentence of former Sec.  
26.20(a). That sentence required the FFD policy to address other 
factors that could affect individuals' abilities to perform their 
duties safely and competently, such as mental stress, fatigue, and 
illness. The final rule adds a requirement for the FFD policy also to 
address the use of prescription and over-the-counter medications that 
could cause impairment at work. For example, some licensees or other 
entities may require individuals to self-report to the FFD program 
their use of any prescription medications that are labeled with a 
warning indicating that use of the medication may cause impairment. The 
licensee's or other entity's FFD policy may require that an individual 
who is taking a medication that can cause impairment must be 
temporarily reassigned to duties that the individual can perform 
without posing a risk to the individual or public health and safety 
while he or she is taking the medication. Therefore, the final rule 
requires licensees and other entities to include such information in 
the FFD policy to ensure that individuals are aware of the actions they 
may be required to take when using these substances, consistent with 
Goal 7 of this rulemaking with respect to protecting the rights 
(including due process) of individuals who are subject to the policy. 
The addition of this requirement also increases the internal 
consistency of the rule because other portions of the final rule 
establish requirements related to using prescription and over-the-
counter medications. For example, Sec.  26.29(a)(6) requires FFD 
training to address use of prescription and over-the-counter 
medication. Also, Sec.  26.185(j)(2) requires the MRO to determine 
whether a positive confirmatory drug test result that results from 
using a prescription or over-the-counter medication represents

[[Page 17013]]

substance abuse. Therefore, the requirement for the FFD policy to 
address the use of prescription and over-the-counter medications that 
could cause impairment at work also meets Goal 6 of this rulemaking to 
improve clarity in the organization and language of the rule.
    Section 26.27(b)(7) amends former Sec.  26.20(b). Former Sec.  
26.20(b) required the FFD policy to describe programs that are 
available to individuals desiring assistance in dealing with drug, 
alcohol, or other problems that may adversely affect their performance 
of their duties. Section 26.27(b)(7) of the final rule adds fatigue as 
one of the problems for which individuals may be seeking assistance 
because sleep disorders (e.g., sleep apnea, insomnia, restless leg 
syndrome) can substantially affect individuals' abilities to obtain 
sufficient quality sleep. Poor quality sleep causes fatigue that may 
degrade an individual's ability to safely and competently perform his 
or her duties. Sleep disorders affect a sizeable portion of the U.S. 
work force. According to polls conducted by NSF, about two-thirds of 
U.S. adults report experiencing one or more symptoms associated with 
insomnia, sleep apnea, or restless leg syndrome at least a few nights a 
week (National Sleep Foundation, 2003) and nearly one out of five (19 
percent) report making occasional or frequent errors because of 
sleepiness (National Sleep Foundation, 2000). Section 26.27(b)(7) 
ensures that individuals are aware of the services that are available 
for diagnosing and treating sleep disorders that can adversely affect 
their job performance. The NRC has made this change to meet Goal 2 of 
this rulemaking to strengthen the effectiveness of FFD programs at 
nuclear power plants by reducing the potential for worker fatigue to 
adversely affect public health and safety and the common defense and 
security, through establishing clear and more readily enforceable 
requirements concerning the management of worker fatigue. In addition, 
the final rule replaces the phrase ``adversely affect the performance 
of activities within the scope of this part'' in the former provision 
with the phrase ``could adversely affect an individual's ability to 
safely and competently perform the duties that require an individual to 
be subject to this part'' for the reasons discussed with respect to 
Sec.  26.23(c).
    Section 26.27(b)(8) retains the requirement in former Sec.  
26.20(d) that the FFD policy must specify the consequences of violating 
the policy. The NRC has moved the former requirements that were related 
to the procedures that the licensee or other entity would implement if 
an individual violates the FFD policy to Sec.  26.27(c) of the final 
rule, which addresses FFD program procedures, for organizational 
clarity.
    Section 26.27(b)(9) adds a requirement that licensees' and other 
entities' FFD policies must describe the individual's responsibility to 
report legal actions, as defined in Sec.  26.5 [Definitions]. The new 
requirement to report legal actions is discussed with respect to Sec.  
26.61 [Self-disclosure and employment history]. The final rule requires 
the FFD policy to address the reporting of legal actions to ensure that 
individuals are aware of this and are not at risk of sanctions for 
failing to report any legal actions. Thus, the NRC has made this change 
to meet Goal 7 of this rulemaking to protect the rights (including due 
process) of individuals who are subject to the policy.
    Section 26.27(b)(10) adds a requirement for the FFD policy to 
describe the responsibilities of managers, supervisors, and escorts to 
report FFD concerns. The former rule implied that managers and 
supervisors have the responsibility to report FFD concerns in Sec.  
26.22(a)(5), which required managers and supervisors to be trained in 
procedures ``for initiating appropriate corrective action.'' Similarly, 
the last phrase of former Sec.  26.22(b) required that escorts be 
trained in procedures ``for reporting problems to supervisory or 
security personnel'' and, therefore, also implied that escorts have a 
reporting responsibility. However, the former rule did not explicitly 
state that the FFD policy must convey this requirement. Therefore, the 
final rule adds Sec.  26.27(b)(10) to enhance the internal consistency 
of the rule. The NRC has made this change to meet Goal 6 of this 
rulemaking to improve clarity in the organization and language of the 
rule.
    Section 26.27(b)(11) adds a requirement for the FFD policy to state 
that individuals who are subject to the rule must report FFD concerns, 
consistent with Sec.  26.33 [Behavioral observation]. Section 26.33 
requires individuals who are subject to the rule to perform behavioral 
observation and to report an FFD concern if they detect behaviors that 
may indicate possible use, sale, or possession of illegal drugs; use or 
possession of alcohol on site or while on duty; or impairment from 
fatigue or any cause that, if left unattended, may constitute a risk to 
the health and safety of the public. Section 26.29 [Training] requires 
individuals to be trained in behavioral observation. The agency has 
added these requirements to enhance the effectiveness of Part 26 by 
ensuring the early detection of individuals who are not fit to perform 
the duties that require them to be subject to this part. This is one of 
the performance objectives that FFD programs must meet, as discussed 
with respect to Sec.  26.23(c). This provision also improves 
consistency between FFD requirements and access authorization 
requirements established in 10 CFR 73.56 [Personnel access 
authorization requirements for nuclear power plants] as supplemented by 
orders to nuclear power plant licensees dated January 7, 2003, as 
discussed in Section IV.B of this document. The specific requirement in 
Sec.  26.27(b)(11) for licensees' and other entities' FFD policies to 
state that individuals must report FFD concerns is necessary to ensure 
that individuals are aware of their responsibility to report concerns 
(and that sanctions may be imposed if they do not) to meet Goal 7 of 
this rulemaking to protect the rights (including due process) of 
individuals who are subject to the policy.
    Section 26.27(c) of the final rule combines the requirements 
related to procedures contained in former Sec.  26.20(c) through (e), 
and adds other requirements, as described in the following paragraphs.
    Section 26.27(c)(1) retains the requirements in former Sec.  
26.20(c). The NRC has replaced the phrase in the proposed rule 
``privacy and due process rights of an individual who provides a 
specimen'' with the phrase ``privacy and other rights (including due 
process) of an individual who provides a specimen'' in the final rule. 
The NRC has made this change in response to a public comment that 
stated the proposed phrase may be interpreted to limit individuals' 
protected rights to due process. This phrase clarifies the requirement 
for ``protecting the employee'' contained in former Sec.  26.20(c). For 
example, individuals' privacy rights under the final rule include, but 
are not limited to, requirements for the protection of personal 
information that is collected about the individual and individual 
privacy during specimen collections. Other examples of individuals' 
rights under the final rule include, but are not limited to, the right 
to an objective and impartial review of a determination that the 
individual has violated the FFD policy, the right to advance knowledge 
of rule provisions and FFD policy requirements that affect the 
individual, and the right to request testing of a split specimen or 
retesting an aliquot of a single specimen, if the individual questions 
a confirmed positive, adulterated, or substituted test result.

[[Page 17014]]

The NRC has made this change to meet Goal 6 of this rulemaking to 
improve clarity in the organization and language of the rule.
    Section 26.27(c)(2)(i) and (c)(2)(ii) divides former Sec.  26.20(d) 
into separate paragraphs that address different topics. Section 
26.27(c)(2)(i) retains the former requirement that licensees and other 
entities must have procedures that specify the immediate and followup 
actions that must be taken if an individual is determined to have been 
involved in the use, sale, or possession of illegal drugs. Like the 
former provision, Sec.  26.27(c)(2)(ii) requires licensees' and other 
entities' procedures to specify the immediate and followup actions to 
be taken if an individual is determined to have consumed alcohol to 
excess before the mandatory prework abstinence period, or while on 
duty, as determined by a test that measures BAC. With respect to the 
proposed rule, the final rule also adds the phrase ``or consumed any 
alcohol during the mandatory prework abstinence period'' to clarify the 
prohibition against any alcohol consumption, not only excess 
consumption, during the pre-work abstinence period. The NRC has made 
these changes to meet Goal 6 of this rulemaking to improve clarity in 
the organization and language of the rule.
    Section 26.27(c)(2)(iii) and (c)(2)(iv) adds requirements that 
licensees and other entities must prepare written procedures for 
implementing the FFD program that describe immediate and followup 
actions for attempted subversion of the testing process. Section 
26.27(c)(2)(iii) requires procedures to specify immediate and followup 
actions if an individual has attempted to subvert the testing process 
by adulterating, substituting, or diluting specimens (in vivo or in 
vitro), or by any other means. Section 26.27(c)(2)(iv) requires 
procedures to address the actions to be taken if an individual has 
refused to provide a specimen for testing. The final rule adds these 
provisions for consistency with Sec.  26.75(b). Section 26.75(b) 
requires licensees and other entities to terminate an individual's 
authorization and, thereafter, permanently deny authorization to any 
individual who has committed or attempted any act to subvert the 
testing process, including refusing to provide a specimen and providing 
or attempting to provide a substituted or adulterated specimen for any 
test required under Sec.  26.31(c). Adding the requirements for 
procedures to address these circumstances meets Goal 6 of this 
rulemaking to improve clarity in the organization and language of the 
rule.
    Section 26.27(c)(2)(v) adds a requirement that the written 
procedures must describe immediate and followup actions for individuals 
who have had drug- or alcohol-related legal actions taken against them, 
as defined in Sec.  26.5. This provision supports related provisions in 
Sec.  26.69(d). Section 26.69(d), in general, requires licensees and 
other entities to take certain steps if an individual has had drug- or 
alcohol-related legal actions taken against them while they are 
maintaining authorization to perform the duties that require them to be 
subject to this part. Adding the requirement for procedures to address 
these circumstances ensures the internal consistency of the final rule 
and meets Goal 6 of this rulemaking to improve clarity in the 
organization and language of the rule.
    The NRC has reorganized Sec.  26.27(c)(3) of the final rule, with 
respect to the proposed rule, to clarify which provisions apply to 
``emergencies'' and which apply to ``unscheduled working tours.'' The 
NRC received a public comment that suggested the term ``emergency'' may 
be too limiting. However, the NRC believes the term ``emergency'' 
accurately reflects NRC's intent and has retained this term in the 
final rule. Section 26.27(c)(3) amends former Sec.  26.20(e). The 
provision requires licensees and other entities to have procedures to 
describe the process that the licensee or other entity will use to 
ensure that individuals who are called in to perform an unscheduled 
working tour are fit for duty.
    The final rule retains and modifies the other requirements of 
former Sec.  26.20(e), as described in the following paragraphs.
    Section 26.27(c)(3)(i) retains former Sec.  26.20(e)(1). The 
provision requires the individual who is called in to state whether the 
individual considers himself or herself fit for duty and whether he or 
she has consumed alcohol within the pre-duty abstinence period stated 
in the FFD policy. The final rule adds the requirement to state whether 
he or she considers himself or herself to be fit for duty, in addition 
to stating whether he or she has consumed alcohol because the NRC 
recognizes that conditions other than the consumption of alcohol may 
cause an individual to be unable to safely and competently perform 
duties, including, but not limited to, fatigue (as discussed with 
respect to Subpart I [Managing Fatigue]). The NRC received a comment 
suggesting that individuals who are called in should only be required 
to report if they are not fit for duty or have consumed alcohol during 
the pre-duty abstinence period. The NRC believes that this alternative 
would be less protective of public health and safety, as an affirmative 
obligation to provide a statement may dissuade individuals who would be 
tempted to remain silent. Requiring individuals to report other 
conditions that may cause them to be impaired when called in under 
Sec.  26.27(c)(3)(i), strengthens the effectiveness of FFD programs by 
providing the licensee or other entity with more complete information 
about the individual's condition to determine whether there is a need 
to establish controls and conditions under which the individual may 
safely perform work, as required under Sec.  26.27(c)(3)(iii). 
Therefore, the NRC has adopted the proposed provision as final. The NRC 
has made these changes to meet Goal 3 of this rulemaking to improve the 
effectiveness and efficiency of FFD programs.
    Section 26.27(c)(3)(ii) specifies the procedures to follow if the 
individual has consumed alcohol in the pre-duty abstinence period and 
is called in for an unscheduled working tour, including an unscheduled 
working tour to respond to an emergency. Section 26.27(c)(3)(ii)(A) 
retains former Sec.  26.20(e)(2). The provision requires that an 
individual who reports that he or she has used alcohol and is called in 
must be subject to a determination of fitness by breath analysis. The 
NRC has added a new Sec.  26.27(c)(3)(ii)(B) to the final rule to 
permit the licensee or other entity to assign the individual to duties 
that require him or her to be subject to this part, if the results of 
the determination of fitness indicate that the individual is fit to 
safely and competently perform his or her duties. The NRC has also 
added a new Sec.  26.27(c)(3)(ii)(C) to the final rule to prohibit the 
licensee or other entity from assigning the individual to duties that 
require him or her to be subject to this part, if the individual is not 
required to respond to an emergency and the results of the 
determination of fitness indicate that the individual may be impaired. 
The NRC has also added Sec.  26.27(c)(3)(ii)(D) that retains a portion 
of former Sec.  26.20(e)(3). The provision requires the procedures to 
state that consumption of alcohol during the 5-hour abstinence period 
required in paragraph (b)(4)(i) of this section may not by itself 
preclude a licensee or other entity from using individuals who are 
needed to respond to an emergency. This provision also retains and 
modifies a portion of former Sec.  26.20(c)(3). It states that if the 
determination of fitness indicates that an individual who has been 
called in for an unscheduled working tour to

[[Page 17015]]

respond to an emergency may be impaired, the procedure must require the 
establishment of controls and conditions under which the individual who 
has been called in can perform work if necessary.
    The NRC has added Sec.  26.27(c)(3)(ii)(E) to the final rule to 
clarify that licensees and other entities may not impose sanctions if 
an individual is called in for an unscheduled working tour for having 
consumed alcohol during the preduty abstinence period specified in the 
FFD policy. This change ensures that, if an individual who is called in 
unexpectedly has a confirmed positive test result for alcohol, he or 
she would not be subject to the sanctions that are otherwise required 
under this part for a confirmed positive alcohol test result. The NRC 
believes that sanctions for the consumption of alcohol in these 
circumstances would be inappropriate because the individual would have 
been unaware that he or she would be called in to work. The revision is 
also consistent with the original intent of the rule. Therefore, the 
NRC has made these changes to meet Goal 6 of this rulemaking to improve 
clarity in the organization and language of the rule.
    Section 26.27(c)(4) adds a requirement that FFD procedures must 
describe the process to be followed when another individual's behavior 
raises an FFD concern and the process for reporting the concern. As 
discussed with respect to Sec.  26.27(b)(11), this provision is 
consistent with Sec.  26.33, which establishes a requirement that all 
individuals must perform behavioral observation and report any FFD 
concerns. This provision is also consistent with Sec.  26.29, which 
requires individuals to be trained to perform behavioral observation. 
The NRC has added this requirement to meet Goal 3 of this rulemaking to 
improve the effectiveness and efficiency of FFD programs and Goal 4 to 
improve consistency between FFD requirements and access authorization 
requirements established in 10 CFR 73.56, as supplemented by orders to 
nuclear power plant licensees dated January 7, 2003.
    Section 26.27(d) of the final rule retains the requirements of 
former Sec.  26.20(f) without changes.
Section 26.29 Training
    Section 26.29 of the final rule combines and amends former Sec.  
26.21 [Policy communications and awareness training] and Sec.  26.22 
[Training of supervisors and escorts]. This section clarifies that all 
individuals subject to this subpart must receive the same scope of 
training, to include, for example, behavioral observation, whereas 
former Sec.  26.22 required that only supervisors and escorts must 
receive behavioral observation training. Increasing the number of 
individuals who are trained in behavioral observation enhances the 
effectiveness of FFD programs by increasing the likelihood of detecting 
potential impairment, consistent with Goal 3 of this rulemaking.
    Section 26.29(a) of the final rule combines the training topics 
listed in former Sec. Sec.  26.21(a)(1) through (a)(5), 26.22(a)(1) 
through (a)(5), and 26.22(b). The agency has rewritten the required 
training topics in terms of knowledge and abilities (KAs) to be 
consistent with terminology used by licensees and other entities in 
other required training programs. This change meets Goal 6 of this 
rulemaking to improve clarity in the organization and language of the 
rule.
    Section 26.29(a)(1) combines former Sec.  26.21(a)(1) with the 
latter portion of former Sec.  26.21(a)(5). Consistent with the former 
training requirements, the provision requires licensees and other 
entities to ensure that individuals who are subject to this subpart 
have knowledge of the FFD policy and procedures that apply to them, the 
methods used to implement the policy and procedures, and the 
consequences of violating the policy and procedures.
    Section 26.29(a)(2) retains the requirement in former Sec.  
26.22(a)(1) that licensees and other entities must ensure that 
individuals understand their roles and responsibilities under the FFD 
program, such as avoiding substance abuse and reporting for testing 
within the time limit specified in FFD program procedures.
    Section 26.29(a)(3) amends the terminology used in former Sec.  
26.22(a)(2). Former Sec.  26.22(a)(2) required FFD training to address 
the roles and responsibilities of others, such as the personnel, 
medical, and EAP staffs. The final rule replaces the references to the 
``personnel'' function and ``medical'' staff in former Sec.  
26.22(a)(2) with ``human resources'' and ``FFD'' staff, respectively. 
The final rule also moves the reference to the MRO into this section 
from former Sec.  26.21(a)(3). These updates to the terminology in this 
section are consistent with other terms used throughout the final rule 
to meet Goal 6 of this rulemaking to improve clarity in the 
organization and language of the rule.
    Section 26.29(a)(4) and (a)(5) amends former Sec.  26.21(a)(4) and 
(a)(2), respectively, by changing some of the language used in the 
former provisions. Former Sec.  26.21(a)(4) required FFD training to 
inform individuals who are subject to the rule of any EAPs that are 
available to them. The final rule eliminates the reference to EAPs 
``provided by the licensee'' in the former provision and amends it as 
``EAP services available to the individual'' because other entities are 
also subject to this requirement under the final rule. Section 
26.29(a)(5) amends former Sec.  26.21(a)(2) by replacing the phrase 
``abuse of drugs and misuse of alcohol'' with ``abuse of illegal and 
legal drugs and alcohol'' for greater accuracy in describing the 
required knowledge. The NRC has made these changes to meet Goal 6 of 
this rulemaking to improve clarity in the language of the rule.
    Section 26.29(a)(6) retains the portion of former Sec.  26.21(a)(3) 
that required licensees to ensure that individuals understand the 
effects of prescription and over-the-counter drugs and dietary factors 
on job performance. The final rule adds a requirement for FFD training 
to address the effects of alcohol, illness, mental stress, and fatigue 
on job performance, in order to ensure that individuals understand the 
bases for the licensee's or other entity's FFD policy regarding these 
conditions. The NRC has moved the requirement in the last sentence of 
former Sec.  26.20(a) to Sec.  26.27(b)(6) of the final rule because 
that section addresses FFD policy requirements. The NRC has made these 
changes to meet Goal 6 of this rulemaking to improve clarity in the 
organization and language of the rule.
    Section 26.29(a)(7) retains the portion of former Sec.  26.21(a)(3) 
that required licensees and other entities to ensure that individuals 
who are subject to the rule understand the effects of prescription and 
over-the-counter drugs and dietary factors on drug and alcohol test 
results. Examples of medications, supplements, and dietary factors that 
can affect drug and alcohol test results may include, but are not 
limited to, ingesting foods containing poppy seeds, drinking coca tea, 
using some liquid or inhalant cold and cough preparations containing 
alcohol or codeine, and taking supplements containing hemp oil.
    Section 26.29(a)(8) and (a)(9) of the final rule retains the 
requirements in former Sec.  26.22(a)(3) and (a)(4), respectively, 
without changes.
    Section 26.29(a)(10) amends former Sec.  26.22(a)(5). The provision 
retains the former requirement for FFD training to address the 
licensee's or other entity's process for initiating appropriate 
corrective action if an individual has an FFD concern about another 
person, including referral to the EAP. The final rule adds a 
requirement for FFD training

[[Page 17016]]

to ensure that individuals understand their responsibility to report 
FFD concerns to the person(s) who are designated to receive such 
reports in FFD program procedures. This change is consistent with Sec.  
26.33, which requires individuals to perform behavioral observation and 
report any FFD concerns, as discussed with respect to Sec.  
26.27(b)(11). The change is also consistent with Sec.  26.27(c)(4), 
which requires procedures for implementing the requirement. The NRC has 
added this group of interrelated requirements to meet Goal 3 of this 
rulemaking to improve the effectiveness and efficiency of FFD programs 
and Goal 4 to improve consistency between FFD requirements and access 
authorization requirements established in 10 CFR 73.56, as supplemented 
by orders to nuclear power plant licensees dated January 7, 2003.
    Section 26.29(b) of the final rule adds a requirement that 
individuals must demonstrate attainment of the KAs specified in Sec.  
26.29(a) by passing a comprehensive examination. The NRC has added this 
requirement because in several instances since Part 26 was first 
promulgated, individuals were able to overturn determinations that they 
had violated a licensee's FFD policy on the basis that they had not 
understood the information they received during FFD training and could 
not be expected to comply with the requirements of the policy. 
Therefore, the final rule requires individuals to demonstrate their 
attainment of the KAs listed in Sec.  26.29(a) to ensure that the FFD 
training has been effective. The final rule requires remedial training 
for those who fail to achieve a passing score of 80 percent on the 
examination. Section 26.29(b) also requires the examination to include 
at least one question for each KA. These requirements are modeled on 
other required training programs that have been successful in ensuring 
that examinations are valid and individuals have achieved an adequate 
understanding of the subject matter. Establishing a method to ensure 
that individuals understand the requirements with which they must 
comply meets Goal 3 of this rulemaking to improve the effectiveness of 
FFD programs.
    The provision also permits the use of various media for 
administering the comprehensive examination, in order to achieve the 
efficiencies associated with computer-based training and testing, for 
example, and other new training delivery technologies that may become 
available. Permitting the use of various media to administer the 
examination meets the portion of Goal 3 of this rulemaking to improve 
the efficiency of FFD programs. The permission also meets Goal 5 to 
improve Part 26 by eliminating or modifying unnecessary requirements 
through providing flexibility in the methods that licensees and other 
entities may use to administer the required examination.
    Section 26.29(c) of the final rule combines and amends the portions 
of former Sec. Sec.  26.21(b) and 26.22(c) that required FFD training 
for individuals who are subject to this section before they are 
permitted to perform duties that require them to be subject to this 
part.
    Section 26.29(c)(1) requires that all personnel who are subject to 
this section must complete FFD training before the licensee or other 
entity grants initial authorization to the individual, as defined in 
Sec.  26.55 [Initial authorization]. The final rule also requires that 
an individual's training must be current before the licensee or other 
entity grants an authorization update or reinstatement to the 
individual, as defined in Sec.  26.57 [Authorization update] and Sec.  
26.59 [Authorization reinstatement], respectively. The provision also 
eliminates the requirement in former Sec.  26.22(c) to upgrade training 
for newly assigned supervisors within 3 months of a supervisory 
assignment because all personnel will receive the same scope of 
training and be required to complete the training before a licensee or 
other entity grants authorization to any individual. These changes are 
consistent with the requirements related to granting and maintaining 
authorization that are established in Subpart C [Granting and 
Maintaining Authorization] of the final rule, as discussed in this 
document with respect to that subpart. The changes also meet Goal 3 of 
this rulemaking to improve the effectiveness and efficiency of FFD 
programs.
    Section 26.29(c)(2) retains and combines the requirements for 
annual refresher training in former Sec. Sec.  26.21(b) and 26.22(c). 
Former Sec.  26.21(b) addressed individuals who are subject to this 
part and former Sec.  26.22(c) addressed supervisors and escorts. The 
final rule combines the former requirements because all personnel 
receive the same scope of training under the final rule. The final rule 
specifies that individuals must complete the refresher training every 
12 months, or more frequently when the need is indicated. With respect 
to the proposed rule, the final rule gives some examples of situations 
that indicate a need to conduct the refresher training more frequently 
than every 12 months, but this list is not inclusive of all situations 
that may indicate this need. Adding these examples clarifies the NRC's 
intent and meets Goal 6 of the rulemaking to clarify the language of 
the rule. The final provision permits individuals who pass a 
comprehensive annual examination that demonstrates their continued 
understanding of the FFD program requirements to be excused from the 
refresher training that the provision otherwise requires. The 
examination is necessary to meet the examination requirements specified 
in Sec.  26.29(b) [Comprehensive examination]. Individuals who do not 
pass must undergo remedial training. Permitting individuals to pass a 
comprehensive examination rather than take refresher training each year 
ensures that they are retaining their FFD KAs while reducing some costs 
associated with meeting the annual refresher training requirement. 
Therefore, this change meets Goal 5 of this rulemaking to improve Part 
26 by eliminating or modifying unnecessary requirements.
    Section 26.29(c)(3) permits licensees and other entities to use 
various media, in addition to traditional classroom instruction, for 
presenting initial and refresher training for the same reasons 
discussed with respect to the portion of Sec.  26.29(b) that permits 
licensees and other entities to use various media to administer the 
comprehensive examination. The requirements for a licensee or other 
entity to monitor the completion of training and provide access to an 
instructor or subject matter expert ensures that individuals who are 
trained using different media achieve the same understanding as persons 
who are trained in a classroom setting with an instructor present. This 
flexibility may reduce the costs associated with presenting initial and 
refresher training only in a classroom setting. Therefore, this change 
meets Goal 5 of this rulemaking to improve Part 26 by eliminating or 
modifying unnecessary requirements.
    To meet the annual refresher training requirement for individuals, 
Sec.  26.29(d) of the final rule permits licensees and other entities 
to accept the training of individuals who have been subject to another 
training program that meets the requirements of this section. Licensees 
and other entities are also permitted to accept a passing result from a 
comprehensive examination that was administered by another training 
program that meets the requirements of this section in lieu of 
refresher training, if the examination meets the requirements of Sec.  
26.29(b). This requirement meets Goal 3 of this rulemaking to improve 
the effectiveness and efficiency of FFD programs.

[[Page 17017]]

Section 26.31 Drug and Alcohol Testing
    Section 26.31 of the final rule renames former Sec.  26.24 
[Chemical and alcohol testing]. The final rule, in general, replaces 
the former term ``chemical testing'' with ``drug testing'' because the 
testing for chemicals that is required in the rule is performed only in 
the context of urine drug testing. Therefore, the term ``drug testing'' 
more accurately conveys the nature of the testing that is performed. 
The NRC has made these changes to meet Goal 6 of this rulemaking to 
improve clarity in the organization and language of the rule.
    Section 26.31(a) [General] of the final rule retains but updates 
the language in former Sec.  26.24(a) to be consistent with the new 
terminology used throughout the rule as discussed in Sec.  26.5. The 
NRC has made this change to meet Goal 6 of this rulemaking to improve 
clarity in the language of the rule.
    Section 26.31(b) [Assuring the honesty and integrity of FFD program 
personnel] of the final rule amends former Section 2.3 in Appendix A to 
Part 26. Other than making minor clarifications to the rule text as 
explained below, the NRC has adopted the requirements of paragraph (b) 
of this section as proposed, without change.
    Section 26.31(b)(1) amends the first paragraph of former Section 
2.3 in Appendix A to Part 26. This paragraph required licensees to 
carefully select and monitor persons responsible for administering the 
testing program to ensure that they meet the highest standards of 
honesty and integrity. The final rule replaces the former list of 
individuals who are subject to this requirement with a cross-reference 
to Sec.  26.4(g) of the final rule, which specifies in detail the FFD 
program personnel who must be subject to the FFD program. This cross-
reference avoids repeating the list of personnel in this provision.
    The provision also adds a reference to factors, other than a 
personal relationship with an individual who is subject to testing, 
that have the potential to cause an individual to be subject to 
influence attempts or may adversely affect the honesty and integrity of 
FFD program personnel. In addition to a personal relationship with an 
individual who is subject to testing, factors that could cause an 
individual to be compromised may include, but are not limited to, a 
substance abuse problem or financial problems. Therefore, the final 
rule adds a reference to these additional factors to more accurately 
characterize the scope of potential concerns that licensees and other 
entities must consider when selecting and monitoring the honesty and 
integrity of FFD program personnel. The NRC has made these changes to 
meet Goal 6 of this rulemaking to improve clarity in the language of 
the rule.
    Section 26.31(b)(1)(i) amends former Section 2.3(2) in Appendix A 
to Part 26 in response to implementation questions regarding the former 
requirements. The provision clarifies that the background 
investigations, credit and criminal history checks, and psychological 
evaluations that are required for persons who are granted unescorted 
access to protected areas in nuclear power plants are acceptable when 
determining the honesty and integrity of FFD program personnel. The 
final rule retains the term ``appropriate'' in the former rule for two 
reasons. First, it indicates that FFD program personnel who are 
employed by entities who are subject to the rule but are not nuclear 
power plants, may meet the requirements through investigations, checks, 
and evaluations that provide the information needed to determine the 
honesty and integrity of FFD program personnel, but the investigations, 
checks, and evaluations may differ from those required under nuclear 
power plant access authorization programs. In addition, the final rule 
retains the term ``appropriate'' because it has particular relevance to 
the requirement for licensees and other entities to conduct criminal 
history checks for FFD program personnel. In some cases, licensees and 
other entities cannot legally obtain the same type of criminal history 
information about FFD program personnel as they are able to obtain for 
other individuals who are subject to Part 26. Therefore, the term 
``appropriate'' is used to indicate that local criminal history checks 
for FFD program personnel who do not have unescorted access to nuclear 
power plant protected areas are acceptable. The NRC has made these 
changes to meet the portion of Goal 6 of this rulemaking that pertains 
to improving clarity in the language of the rule.
    The NRC has relaxed the requirement in former Section 2.3(2) in 
Appendix A to Part 26 for appropriate background checks and 
psychological evaluations to be conducted at least once every 3 years 
to require that credit and criminal history checks and updated 
psychological assessments be conducted nominally every 5 years. The 
final rule relaxes the former requirement for several reasons. First, 
the NRC is not aware of any instances in which licensees and other 
entities have identified new information about FFD program personnel 
from updating the background checks and psychological assessments that 
had not already been identified through other avenues, including self-
reports by FFD program personnel, drug and alcohol testing, and 
behavioral observation. However, the NRC continues to believe that the 
required updates provide an independent method to verify the ongoing 
honesty and integrity of FFD program personnel that is necessary 
because of the critical importance of FFD program personnel in assuring 
program effectiveness. Therefore, the final rule retains the former 
requirement for updated background checks and psychological 
assessments, but reduces the required frequency of these updates from 
every 3 years to every 5 years under the final rule. The NRC has made 
this change to meet Goal 5 of this rulemaking to improve Part 26 by 
eliminating or modifying unnecessary requirements. In addition, the 
frequency for these updates increases the consistency of Part 26 with 
access authorization requirements established in 10 CFR 73.56, as 
supplemented by orders to nuclear power plant licensees dated January 
7, 2003, which is Goal 4 of this rulemaking.
    Section 26.31(b)(1)(ii) amends and clarifies former Section 2.3(1) 
in Appendix A to Part 26 in response to the many implementation 
questions that have arisen after the regulation was published. The 
former rule prohibited individuals who have a personal relationship 
with the individual being tested (i.e., a donor), such as the donor's 
``supervisors, coworkers, and relatives,'' from performing any 
``collection, assessment, or evaluation procedures'' involving the 
individual being tested. The NRC included the restriction on 
``supervisors, coworkers, and relatives'' in the former rule to provide 
examples of the ``personal relationships'' referenced in the 
introductory paragraph of former Section 2.3 in Appendix A to Part 26. 
Some licensees have misinterpreted the restriction on coworkers in the 
former rule as meaning that no one who is an employee of the same 
corporation may be involved in collection, assessment, or evaluation 
procedures. However, in a large corporation, many individuals employed 
by the same corporation will not have personal relationships with FFD 
program personnel, specifically, or with other individuals who are 
subject to testing, in general. Therefore, in Sec.  26.31(b)(1)(ii), 
the phrase ``in the same work group'' clarifies that the example 
regarding coworkers pertains to individuals who report to the same 
manager. For example, FFD program

[[Page 17018]]

personnel report to the FFD program manager and would be considered 
``coworkers in the same work group'' to whom the restriction applies. 
In addition, the section adds a reference to determinations of fitness 
(discussed with respect to Sec.  26.189 [Determination of fitness]) to 
provide a clarifying example of the assessment and evaluation 
procedures that FFD program personnel are prohibited from performing if 
the FFD program staff member has a personal relationship with the 
subject individual. The NRC has made these changes to meet Goal 6 of 
this rulemaking to improve clarity in the organization and language of 
the rule.
    Section 26.31(b)(1)(iii) relaxes the prohibition on individuals who 
have ``personal relationships'' with the donor from performing specimen 
collection procedures in former Section 2.3(1) in Appendix A to Part 
26. The NRC acknowledges that the former restriction imposed an 
unnecessary burden when the objective of ensuring the integrity of 
specimen collections in these circumstances could be achieved by other 
means. Therefore, in Sec.  26.31(b)(1)(iii), individuals who have a 
personal relationship with a donor are permitted to collect specimens, 
if another individual who does not have a personal relationship with 
the donor and is not a supervisor, a coworker in the same work group, 
or a relative of the donor monitors the collection and preparation of 
the specimens for shipping. The section also provides examples of the 
types of individuals who may monitor the integrity of specimen 
collection procedures in these circumstances, including but not limited 
to, security force or quality assurance personnel. By permitting 
monitored collections in these circumstances while continuing to assure 
the integrity of specimen collections from FFD program personnel, this 
provision meets Goal 5 of this rulemaking to improve Part 26 by 
eliminating or modifying unnecessary requirements. The final rule 
retains the prohibition for individuals who have personal relationships 
with the donor from performing assessment and evaluation procedures 
because monitoring of these activities by qualified personnel is not 
feasible.
    If a directly observed collection is required, Sec.  
26.31(b)(1)(iv) of the final rule adds a prohibition for an individual 
who has a personal relationship with the donor from acting as a urine 
collector or observer. This prohibition is necessary to minimize 
embarrassment to the donor (and the collector) during a directly 
observed collection. The NRC has added this provision to meet Goal 7 of 
this rulemaking, relating to protecting the privacy rights of 
individuals who are subject to Part 26.
    Section 26.31(b)(1)(v) amends former Section 2.3(3) in Appendix A 
to Part 26 to require that MROs who are on site at a licensee's or 
other entity's facility must be subject to behavioral observation. For 
the purposes of Sec.  26.31(b)(1)(v), a ``facility'' includes, but is 
not limited to, a licensee's or other entity's corporate offices and 
any medical facilities that the licensee or other entity operates. The 
NRC has added this requirement because MROs are ``persons responsible 
for administering the testing program,'' but some FFD programs have not 
included MROs in the behavioral observation element of their programs. 
However, the final rule limits the behavioral observation of MROs to 
those times when they are on site at a licensee's or other entity's 
facility in order to permit licensees and other entities to continue 
relying on the services of MROs who normally work independently, often 
alone, in offices at a geographical distance from the licensee's or 
other entity's facilities so that behavioral observation is 
impractical. Limiting the requirement for behavioral observation of 
MROs to those instances in which the MRO is working on site at a 
licensee's or other entity's facility is adequate to ensure the 
continuing honesty and integrity of these MROs because MROs who work 
off site would not interact on a daily basis with other individuals who 
are subject to the FFD program. Therefore, off site MROs would be less 
likely to be subject to potential influence attempts than MROs who 
normally work on site because they are generally inaccessible. The 
final rule continues to require all MROs to be subject to the other FFD 
program elements that are required in this subpart. These elements 
include drug and alcohol testing and regular psychological assessments 
and background investigations, which permit licensees and other 
entities to monitor the honesty and integrity of off site MROs. The NRC 
has added this relaxation to meet Goal 5 of this rulemaking to improve 
Part 26 by eliminating or modifying unnecessary requirements.
    A new Sec.  26.31(b)(2) provides another relaxation from the former 
rule related to collecting specimens from FFD program personnel. The 
provision permits FFD program personnel to submit specimens for testing 
at collection sites 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). As discussed 
with respect to Sec.  26.31(b)(1), some FFD program personnel, such as 
contract MROs and EAP staff members, normally work at locations that 
are so distant from a licensee's collection site(s) as to make it 
impractical for them to be randomly tested at a licensee's or other 
entity's collection site. Permitting these FFD program personnel to be 
tested at local collection sites that follow similar procedures is 
adequate to meet the goal of ensuring their continuing honesty and 
integrity. Therefore, the NRC has added this provision to meet Goal 5 
of this rulemaking to improve Part 26 by eliminating or modifying 
unnecessary requirements.
    Section 26.31(c) [Conditions for testing] replaces former Sec.  
26.24(a)(1) through (a)(4). The provision lists the situations in which 
testing is required in separate paragraphs, such as ``pre-access,'' 
``for cause,'' and ``post-event'' testing to clarify that each 
situation for which testing is required stands on its own. The former 
provision in Sec.  26.24(a)(3), in particular, has led to confusion and 
misinterpretation of the requirements, to be corrected as noted below. 
Subparts E [Collecting Specimens for Testing], F [Licensee Testing 
Facilities], and G [Laboratories Certified by the Department of Health 
and Human Services] address the specific requirements for conducting 
the testing. The final rule reorganizes and amends former Sec.  
26.24(a)(1) through (a)(4) to meet Goal 6 of this rulemaking to improve 
clarity in the organization and language of the rule.
    Section 26.31(c)(1) [Pre-access] amends former Sec.  26.24(a)(1). 
Former Sec.  26.24(a)(1) required pre-access testing within 60 days 
before the initial granting of unescorted access to protected areas or 
assignment to duties within the scope of this part. Section 26.31(c) of 
the final rule introduces the concepts of ``initial authorization,'' 
``authorization update,'' and ``authorization reinstatement,'' which 
refer to categories of requirements that licensees and other entities 
must meet in order to assign an individual to duties that require the 
individual to be subject to Part 26. Section 26.65 [Pre-access drug and 
alcohol testing] in Subpart C of the final rule specifies detailed 
requirements for conducting pre-access testing.
    Section 26.31(c)(2) [For cause] and (c)(3) [Post event] clarifies 
and amends former Sec.  26.24(a)(3), as follows:
    Section 26.31(c)(2) continues to require for-cause testing in 
response to any observed behavior or physical

[[Page 17019]]

condition indicating possible substance abuse. The final rule also 
retains the former requirement for testing if the licensee or other 
entity receives credible information that an individual is engaging in 
substance abuse. Section 26.3 defines the term ``substance abuse.''
    Section 26.31(c)(3) [Post event] amends the portion of former Sec.  
26.24(a)(3) that required drug and alcohol testing when an event 
involving a failure in individual performance leads to significant 
consequences. The final rule amends the former provision because it has 
been subject to misinterpretation and numerous questions from 
licensees.
    The phrase ``if there is reasonable suspicion that the worker's 
behavior contributed to the event'' in former Sec.  26.24(a)(3) has 
been subject to misinterpretation. The location of this phrase at the 
end of the list of conditions under which post-event testing must be 
performed has led some licensees to conclude that this phrase applies 
only to events involving actual or potential substantial degradations 
of the level of safety of the plant. Other licensees have 
misinterpreted the term ``reasonable suspicion'' as meaning 
``reasonable suspicion of substance abuse'' or some other ``illegal'' 
or ``disreputable'' activity. Neither of these interpretations is 
consistent with the intent of this provision. Therefore, to clarify the 
intent of the provision, the final rule eliminates the phrase ``if 
there is reasonable suspicion that the worker's behavior contributed to 
the event'' from the end of the list of significant events that require 
post-event testing and, instead, requires post-event testing as soon as 
practical after significant events (as listed in Sec.  26.31(c)(3)(i) 
through (c)(3)(iii)) involving a human error that may have caused or 
contributed to the event. The final rule uses the term ``human error'' 
rather than the former term ``worker's behavior'' to emphasize that 
post-event testing is required for acts that unintentionally deviated 
from what was planned or expected in a given task environment (see 
NUREG/CR-6751, ``The Human Performance Evaluation Process: A Resource 
for Reviewing the Identification and Resolution of Human Performance 
Problems'') as well as failures to act (i.e., errors of omission). 
Therefore, testing is required regardless of whether there was 
``reasonable suspicion'' that the individual was abusing drugs or 
alcohol for the consequences listed in the section.
    In addition, the NRC has added the second sentence of Sec.  
26.31(c)(3) to clearly delineate the scope of individuals who must be 
subject to post-event testing. Some licensees have misinterpreted the 
former provision as requiring the testing of all individuals who are 
involved in a significant event, including individuals whose behavior 
played no causal or contributing role in the event. For example, these 
licensees' FFD programs would require testing an individual who was 
exposed to radiation in excess of regulatory limits, even if other 
individuals' actions (or failures to act) were responsible for the 
event and the individual who suffered the exposure was a bystander. 
Therefore, the second sentence of the provision clarifies the original 
intent of this section by stating that only the individual(s) who 
committed the error(s) is subject to post-event testing.
    Section 26.31(c)(3)(i) provides a threshold for the types of 
workplace personal injuries and illnesses for which post-event testing 
is required in response to implementation questions related to former 
Sec.  26.24(a)(3). Some licensees have misinterpreted the former 
provision as requiring post-event testing for any personal injury, no 
matter how minor. This section clarifies the type of personal injuries 
and illnesses for which post-event testing would be required by 
establishing a threshold that is based on the general criteria 
contained in 29 CFR 1904.7, ``General Recording Criteria,'' of the 
regulations of the Occupational Safety and Health Administration (OSHA) 
for recording occupational injuries and illnesses. As defined in the 
OSHA standard and the final rule, these include any injuries and 
illnesses which result in death, days away from work, restricted work, 
transfer to another job, medical treatment beyond first aid, loss of 
consciousness, or other significant injury or illness as diagnosed by a 
physician or other licensed health care professional. In the case of a 
significant injury or illness diagnosed by a physician or health care 
professional, a serious injury or illness does not need to result in 
death, days away from work, restricted work, transfer to another job, 
medical treatment beyond first aid, or loss of consciousness. The final 
rule adds this clarification to reduce the number of unnecessary post-
event tests performed for minor injuries and illnesses and meet Goal 3 
of this rulemaking to improve the effectiveness and efficiency of FFD 
programs.
    Section 26.31(c)(3)(i) also includes the qualifying phrase, 
``within 4 hours after the event,'' with reference to the recordable 
personal injuries and illnesses that would trigger post-event testing. 
The NRC acknowledges that in some cases it is difficult to detect 
illnesses and injuries that meet the threshold for post-event testing 
at the time they occur. For example, if an individual has been injured 
on site but does not report the injury to the licensee or other entity 
and waits for several days to seek treatment from his or her private 
physician, the licensee or other entity may not learn of the injury. 
The extent of an injury may be unclear at the time it occurs and may 
appear to fall below the threshold for post-event testing until several 
days have passed. In these examples, if the licensee or other entity 
learns after several days that the injury would have met the threshold 
for post-event testing, it would be too late for post-event testing to 
be of any value in determining whether the individual's use of drugs or 
alcohol may have contributed to the event. If alcohol or drug use had 
contributed to the event, testing several days later would be unlikely 
to detect it because of the effects of metabolism. Further, it would be 
difficult to prove that any positive test results reflected the 
individual's condition at the time the event occurred rather than 
subsequent drug or alcohol use. Therefore, the final rule limits post-
event testing to situations in which the licensee or other entity can 
determine that an injury or illness meets the threshold within four 
hours after the event has occurred, and can conduct the testing within 
a time frame that will provide useful information about the 
individual's condition at the time of the event. However, the section 
should not be misinterpreted as requiring post-event testing to be 
completed within four hours after the event. Section 26.31(c)(3) 
defines the time period after the event within which testing must be 
completed as ``as soon as practical.'' The NRC has made this change to 
meet Goal 3 of this rulemaking to improve the effectiveness and 
efficiency of FFD programs.
    Section 26.31(c)(3)(ii) retains the relevant language in the 
corresponding portion of former Sec.  26.24(a)(3) without change.
    Section 26.31(c)(3)(iii) retains the relevant language in the 
corresponding portion of former Sec.  26.24(a)(3). However, as 
discussed with respect to Sec.  26.31(c), the final rule eliminates the 
former qualifying phrase ``if there is reasonable suspicion that the 
worker's behavior contributed to the event.'' The NRC has eliminated 
this phrase because it is preferable to determine the need for post-
event testing using an objective standard based on the severity of the 
underlying event. The experience of the DOT with post-accident testing, 
for example, is that it is more effective to separate completely ``for 
cause''

[[Page 17020]]

concepts (such as ``reasonable suspicion'' of substance abuse) from 
post-event testing. Under the final rule's approach, if one of the 
events occurs that is defined in the regulations as requiring post-
event testing, then that testing should be carried out irrespective of 
the presence or absence of any ``reasonable suspicion'' of substance 
abuse.
    Section 26.31(c)(4) [Followup] retains the intent of former Sec.  
26.24(a)(4) but amends its language. The final rule eliminates the 
former phrase ``to verify an individual's continued abstention from the 
use of substances covered under this part'' because it could be 
misinterpreted as limiting the substances for which followup testing is 
permitted to only those listed in Sec.  26.31(d)(1) [Substances 
tested]. The final rule revises this phrase as ``to verify continued 
abstinence from substance abuse'' to clarify that FFD programs are 
permitted to conduct followup testing for any substances an individual 
may have abused, subject to certain additional requirements discussed 
with respect to Sec.  26.31(d)(1)(i). Section 26.69 [Authorization with 
potentially disqualifying fitness-for-duty information] establishes 
detailed requirements for conducting followup testing, where they apply 
to licensees' and other entities' processes for granting and 
maintaining authorization. The final rule makes these changes to meet 
Goal 6 of this rulemaking to improve clarity in the organization and 
language of the rule.
    Section 26.31(c)(5) [Random] simplifies former Sec.  26.24(a)(2) to 
define random testing as one of the conditions under which testing is 
required. The NRC has moved the detailed requirements for implementing 
random testing that were contained in former Sec.  26.24(a)(2) to Sec.  
26.31(d) [General requirements for drug and alcohol testing] of the 
final rule. The NRC has made these changes to meet Goal 6 of this 
rulemaking to improve clarity in the organization and language of the 
rule.
    The NRC has added Sec.  26.31(d) to the final rule to better 
organize requirements related to the general administration of drug and 
alcohol testing. The final rule presents more detailed requirements for 
conducting drug and alcohol testing in Subparts E, F, and G. The NRC 
has made these changes to meet Goal 6 of this rulemaking to improve 
clarity in the organization and language of the rule.
    Section 26.31(d)(1) [Substances tested] retains the list of drugs 
for which testing must be conducted in former Section 2.1(a) in 
Appendix A to Part 26, but clarifies that for some drugs the testing is 
conducted to detect drug metabolites. The NRC has moved the provisions 
detailing the circumstances in which testing for these substances must 
be performed (i.e., pre-access, post-event, random) to Sec.  26.31(c) 
for organizational clarity. In addition, the section adds adulterants 
to the list of substances for which testing must be conducted, 
consistent with the addition of specimen validity testing requirements 
to the final rule, as discussed with respect to Sec.  26.31(d)(3)(i). 
Section 26.31(d)(1)(i) retains the permission in the second sentence of 
former Sec.  26.24(c) for licensees and other entities to consult with 
local law enforcement agencies or other sources of information to 
identify drugs that may be abused by individuals in the geographical 
locale of the FFD program.
    Section 26.31(d)(1)(i)(A) retains the permission in former Sec.  
26.24(c) for licensees and other entities to add to the panel of drugs 
for which testing is required in Sec.  26.31(d)(1). Additional drugs 
may include, but are not limited to, ``designer drugs,'' such as 
ecstasy or ketamine, and illegal drugs that are popular in some 
geographical areas, such as lysergic acid diethylamide-25 (LSD). The 
provision also requires that any additional drugs must be listed on 
Schedules I-V of section 202 of the Controlled Substances Act [21 
U.S.C. 812], which is consistent with the definition of ``illegal 
drugs'' in former Sec.  26.3.
    Section 26.31(d)(1)(i)(B) retains the last sentence in former Sec.  
26.24(c). The provision requires licensees and other entities to 
establish appropriate cutoff levels for any additional substances for 
which testing will be conducted.
    Section 26.31(d)(1)(i)(C) retains the requirement in former Section 
2.1(c) in Appendix A to Part 26. The provision specifies that licensees 
and other entities must establish rigorous testing procedures for any 
additional drugs.
    Section 26.31(d)(1)(i)(D) further clarifies the requirement in 
Sec.  26.31(d)(1)(i)(C) for ``rigorous testing procedures.'' The 
provision replaces the portion of former Section 1.1(2) in Appendix A 
to Part 26 that required licensees to obtain written approval from the 
NRC to test for additional drugs. The purpose of the former requirement 
was to provide an opportunity for the NRC to verify that the assays and 
cutoff levels licensees use in testing for additional drugs are 
scientifically sound and legally defensible. However, the former 
requirement also imposed a reporting burden. The final provision 
eliminates this reporting requirement and replaces it with requirements 
for an independent forensic toxicologist who has no relationships that 
could be construed as potential conflicts of interest to conduct the 
review that the NRC currently performs. The final rule requires the 
independent forensic toxicologist to certify, in advance and in 
writing, that the assay to be used in testing for any additional drugs 
or drug metabolites, and the cutoff levels to be applied, are 
scientifically sound and legally defensible. This section also 
specifies the required qualifications for the forensic toxicologist.
    Certification of the assay and cutoff levels are not required in 
two circumstances: (1) If the HHS Guidelines are revised to permit use 
of the assay and the cutoff levels in Federal workplace drug testing 
programs and the licensee or other entity uses the cutoff levels 
established in the HHS Guidelines for drug or drug metabolites; and (2) 
if the licensee and other entity received written approval of the NRC 
to test for the additional drug or drug metabolites before the 
implementation date of the final rule, which is 365 days after the date 
the final rule is published in the Federal Register. Certification by a 
toxicologist is unnecessary in these two circumstances because it would 
be redundant. By eliminating or modifying unnecessary requirements, 
while continuing to ensure that any drug testing conducted under Part 
26 is scientifically sound and legally defensible, this provision meets 
Goal 5 of this rulemaking.
    Section 26.31(d)(1)(ii) amends former Section 2.1(b) in Appendix A 
to Part 26. The provision permits licensees and other entities, when 
conducting for-cause, post-event, and followup testing, to test for any 
drugs listed on Schedules I-V of the Controlled Substances Act that the 
licensee or other entity suspects the individual may have abused, as 
follows:
    The section adds a reference to post-event testing for consistency 
with the intent of former Section 2.1(b) in Appendix A to Part 26, 
which permitted testing for any illegal drugs during a for-cause test. 
The former rule included post-event testing within the definition of 
for-cause testing. The final rule uses a distinct term ``post-event'' 
testing to refer to the testing that is required following certain 
events as discussed with respect to Sec.  26.31(d)(3). Therefore, it is 
necessary to add a reference to post-event testing to this section to 
retain the full intent of the former provision.
    The section also adds a reference to followup testing, which 
permits the

[[Page 17021]]

licensee or other entity to test for an additional drug if an 
individual who is subject to followup testing is suspected of having 
abused it. For example, if an SAE, in the course of performing a 
determination of fitness under Sec.  26.189 found that an individual 
was abusing barbiturates, this provision would permit followup testing 
to verify that the individual is abstaining from such abuse. The NRC 
has made this change to strengthen the followup testing element of FFD 
programs by ensuring that followup testing would detect continued drug 
abuse. Therefore, this provision is consistent with Goal 3 of this 
rulemaking to improve the effectiveness and efficiency of FFD programs.
    The section retains the limitation in former Section 2.1(b) in 
Appendix A to Part 26 that permitted testing only for illegal drugs 
that the individual is suspected of having abused and extends that 
limitation to followup testing. The final rule extends this limitation 
to followup testing to protect donors' rights to privacy, which is the 
same reason that the limitation was established in the former rule with 
respect to for-cause testing. Licensees and other entities are 
prohibited from conducting a wide spectrum of tests for any drugs 
without suspicion that the individual had abused them because such 
tests could reveal personal medical information about the individual 
that is irrelevant to the performance objectives of this part, as 
discussed with respect to Sec.  26.23. Thus, extending the former 
limitation on for-cause testing to followup testing meets Goal 7 of 
this rulemaking to protect the privacy rights and other rights 
(including due process) of individuals who are subject to Part 26.
    The final rule replaces the term ``illegal drugs'' in former 
Section 2.1(b) in Appendix A to Part 26 with a specific reference to 
the drugs that are listed on Schedules I-V of the Controlled Substances 
Act. These schedules list drugs with abuse potential and include many 
drugs with legitimate medical uses that are not ``illegal'' when used 
with a valid prescription for medical purposes. Therefore, replacing 
the term ``illegal drugs'' with the reference to Schedules I-V of the 
Controlled Substances Act (CSA) more accurately characterizes the 
specific drugs for which testing is permitted. The NRC has made this 
change to meet Goal 6 of this rulemaking to improve clarity in the 
language of the rule.
    Section 26.31(d)(1)(ii) also applies the new requirements in Sec.  
26.31(d)(1)(i)(D) related to testing for drugs that are not included in 
the FFD program's panel of drugs to for-cause, post-event, and followup 
testing. The section requires that a forensic toxicologist certify the 
assays and cutoff levels to be used in testing for the additional 
drugs. The provision provides consistency with Sec.  26.31(d)(1)(i)(D) 
and ensures that the testing is scientifically sound and legally 
defensible. The NRC has made this change to protect donors' rights as 
it relates to minimizing the possibility of false positive test 
results. The provision also strengthens the effectiveness of FFD 
programs by ensuring that tests for additional drugs that are conducted 
for cause, post-event, or as part of a followup program will accurately 
detect drugs that an individual may have abused. Therefore, the NRC has 
made this change to meet Goal 7 of this rulemaking to protect the 
rights (including due process) of individuals who are subject to Part 
26 and Goal 3 to improve the effectiveness and efficiency of FFD 
programs.
    The NRC has added the last sentence of Sec.  26.31(d)(1)(ii) to 
prohibit inappropriate practices that some FFD programs have 
implemented. The NRC is aware that some FFD programs have directed 
their HHS-certified laboratories to test specimens that are collected 
for for-cause, post-event, or followup testing at the assay's LOD 
without first subjecting the specimens to initial testing. In addition, 
if a drug or drug metabolite is detected at the LOD, the MROs in these 
programs have confirmed the test result as an FFD policy violation even 
if the quantitative test result falls below the FFD program's 
established confirmatory cutoff level. Although these practices may 
increase the likelihood of detecting drug abuse, they are inconsistent 
with one of the bases for establishing cutoff levels for drug testing. 
This basis is to minimize the likelihood of false positives that could 
result in the imposition of sanctions on an individual who has not 
abused drugs. It also subjects individuals who are undergoing for-
cause, post-event, or followup testing to unequal treatment when 
compared to individuals who are subject to random and pre-access 
testing, in which the established cutoff levels must be applied. 
Therefore, the final rule specifically prohibits these practices, but 
adds, with respect to the proposed rule, an exception for a situation 
in which the specimen is dilute and the licensee or other entity has 
requested the HHS-certified laboratory to evaluate the specimen under 
Sec. Sec.  26.163(a)(2) and 26.185(g)(3). The NRC has made these 
changes to meet Goal 7 of this rulemaking as it relates to protecting 
the rights of individuals (including due process) who are subject to 
Part 26, by requiring that individuals who are subject to for-cause, 
post-event, and followup testing must be subject to the same testing 
procedures and cutoff levels as others who are tested under this part.
    With respect to the proposed rule, the NRC has added Sec.  
26.31(d)(1)(iii) to the final rule to require the licensee or other 
entity to document the additional drug(s) for which testing will be 
performed in written policies and procedures. A public comment 
suggested that licensees and other entities should not screen for drugs 
in addition to those listed in paragraph (d)(1) of this section without 
identifying them in advance. The NRC agrees that informing individuals 
of the substances for which testing will routinely occur and the cutoff 
levels to be applied may deter abuse of those substances. Information 
about the drugs for which testing will occur, and their potential 
effects on job performance, is also an important part of the FFD 
training that individuals must receive under Sec.  26.29, to assist 
individuals in meeting their responsibilities under the rule. This 
added provision is also consistent with Sec.  26.31(d)(3)(iii)(A) that 
requires licensees and other entities to document more stringent cutoff 
levels for drug testing than those specified in Sec.  26.163 in written 
policies and procedures. However, the NRC does not agree that a 
licensee should be prohibited from testing for drugs in addition to 
those listed in the rule without identifying them in advance. Although 
deterring substance abuse is an important goal of the rule, detecting 
substance abuse is equally important. Therefore, both the former and 
final rules permit licensees to add drugs to the panel of substances 
for which they routinely test, as well as to conduct tests to detect 
any drugs listed on Schedules I-IV of the CSA in followup, post-event, 
and for-cause testing that the individual is suspected of abusing. The 
NRC has added this requirement to meet Goal 3 of this rulemaking to 
improve the effectiveness and efficiency of FFD programs and Goal 6 to 
improve clarity in the organization and language of the rule.
    Section 26.31(d)(2) [Random testing] reorganizes and amends the 
requirements for conducting random testing. These requirements appeared 
in former Sec.  26.24(a)(2), as described in the following paragraphs.
    Section 26.31(d)(2)(i) adds a requirement for licensees and other 
entities to administer random testing in a manner that provides 
reasonable assurance that individuals are unable to

[[Page 17022]]

predict the time periods during which specimens will be collected. The 
NRC has added this provision because the NRC is aware of instances when 
individuals who believed they would have a positive test result if 
tested have been able to determine the days on which collections were 
being conducted. This determination then gave them the opportunity to 
leave work under the guise of illness in order to avoid the possibility 
of being tested. The ability to detect that specimens are being or will 
be collected for random testing also provides an opportunity for 
individuals to be prepared to subvert the testing by procuring an 
adulterant or urine substitute and keeping it available on their 
persons during the periods that specimens are collected. However, the 
NRC also recognizes that it is impossible to ensure that individuals 
are unable to detect the periods when specimens are being collected. At 
a minimum, coworkers will be suspicious that collections are occurring 
if they observe an individual leaving the work site and returning 
within a short time, even if the supervisor and individual do not 
discuss the reason for the individual's short absence. Therefore, the 
section requires licensees and other entities to conduct random testing 
in a manner that would provide ``reasonable assurance'' that 
individuals are unable to predict when specimens will be collected, 
rather than requiring them to ``ensure'' that the period of time during 
which specimens will be collected cannot be detected. However, 
licensees and other entities are required to minimize the likelihood 
that individuals who are subject to testing know that they are more 
likely to be called for testing at certain times than others.
    Within this context, Sec.  26.31(d)(2)(i)(A) adds a requirement 
that licensees and other entities take reasonable steps to either 
conceal from the workforce that collections will be performed during a 
scheduled collection period, or create the appearance that specimens 
are being collected during a portion of each day on at least 4 days in 
each calendar week at each site. With respect to the proposed rule, the 
final rule clarifies that in the latter instance, the portions of each 
day and the days of the week must vary in a manner that cannot be 
predicted by donors. The NRC, after publishing the proposed rule, 
recognized the need for additional clarity in this provision to 
illustrate the NRC's intent. Therefore, the NRC has made this change to 
meet Goal 6 of this rulemaking to improve clarity in the language of 
the rule.
    Section 23.31(d)(2)(i)(A) requires licensees and other entities to 
take reasonable steps to minimize the cues that persons may use to 
detect that specimens will be collected at a certain time. These cues 
may include, but are not limited to, the presence of a mobile 
collection facility on site and the presence of collectors at the site 
only on days that collections occur, or having the lights on in a 
designated collection site and occupying it only when the collection 
site is in use. A reasonable step to minimize cues associated with 
activities inside a collection site could be covering any outside 
windows so that a passerby cannot detect whether the collection site is 
occupied. Other steps to meet the requirement could include, but would 
not be limited to, stationing a mobile collection facility on site for 
some part of the day on 4 days each week or assigning individuals to 
staff the designated collection site during periods that specimens are 
not being collected during some portion of each day on at least 4 days 
in each calendar week. Maintaining the appearance that the collection 
site is active on more than half of the days in each week makes it more 
difficult for individuals to plan to subvert the testing process by 
leaving work when they believe specimens are being collected. By 
reducing the opportunities for individuals to subvert the testing 
process by having advanced warning that specimens are being collected, 
the requirements in Sec.  26.31(d)(2)(i) and paragraph (A) of this 
section meet Goal 3 of this rulemaking to improve the effectiveness of 
FFD programs.
    Section 26.31(d)(2)(i)(B) amends the third sentence of former Sec.  
26.24(a)(2). This sentence required that specimens must be collected 
``at various times during the day.'' The final rule expands the former 
requirement to require licensees and other entities to collect 
specimens on an unpredictable schedule, including weekends, backshifts, 
and holidays, and at various times during a shift. The purpose of the 
former and final provisions is to ensure that individuals cannot 
predict the times they will be tested, as well as prevent them from 
perceiving that there are ``safe'' periods during which they will not 
be tested, which may lead them to believe they could engage in 
substance abuse without fear of detection. Varying the time periods 
during which specimens are collected on an unpredictable schedule also 
increases the rule's effectiveness in deterring substance abuse, which 
meets Goal 3 of this rulemaking to improve the effectiveness of FFD 
programs.
    Section 26.31(d)(2)(ii) retains the third sentence of former Sec.  
26.24(a)(2). Section 26.31(d)(2)(ii) states that random testing must be 
administered on a nominal weekly frequency. The former requirement to 
collect specimens for random testing at ``various times during the 
day'' is retained in Sec.  26.31(d)(2)(i)(B).
    Section 26.31(d)(2)(iii) requires individuals who are selected for 
random testing to report to the collection site as soon as reasonably 
practicable after they have been notified that they have been selected 
for testing within the time period established in the FFD policy. The 
necessity for the FFD policy to establish a time limit within which 
individuals must report for testing is discussed with respect to Sec.  
26.27(b)(2). Section 26.31(d)(2)(iii) further clarifies this 
requirement by emphasizing the individual's responsibility to report as 
soon as reasonably practicable after notification. For example, in 
order to cover all of the possible situations when it may not be 
possible for an individual to immediately report for testing after 
notification (which could include the time required to travel to a 
collection site or to change clothes and be monitored for contamination 
after working under a radiation work permit), the FFD policy may permit 
individuals up to two hours to report for testing after notification. 
However, if no legitimate work, travel, or other demands would prevent 
an individual from immediately reporting for testing, the provision 
requires the individual to report as soon as he or she is notified. 
This provision strengthens FFD programs by further reducing 
opportunities for individuals to subvert the testing process and, 
therefore, meets Goal 3 of this rulemaking to improve the effectiveness 
of FFD programs.
    Section (d)(2)(iv) retains the portion of the first sentence of 
former Sec.  26.24(a)(2) that required licensees to ensure that 
individuals subject to testing have an equal probability of being 
selected and tested. The final rule splits proposed Sec.  
26.31(d)(2)(iv) into two paragraphs after the first sentence of the 
proposed paragraph, and renumbers the subsequent paragraphs to 
accommodate this change. This reorganization is an effort to clarify 
the requirements of this section, consistent with Goal 6 of this 
rulemaking to improve clarity in organization and language of the rule.
    As a result of this renumbering, Sec.  26.31(d)(2)(v) of the final 
rule amends the first sentence of former Sec.  26.24(a)(2) to clarify 
that individuals who are off site when selected for testing and not 
reasonably available for testing when selected, must be tested at the 
earliest

[[Page 17023]]

reasonable and practical opportunity. However, the final rule, with 
respect to the proposed rule, adds a clarification that individuals who 
are on site and not reasonably available for testing also must be 
tested at the earliest reasonable and practical opportunity. The NRC 
has made this change in response to a public comment, which suggested 
that the second sentence of proposed Sec.  26.31(d)(2)(iv) could be 
interpreted as requiring individuals who are on site but not reasonably 
available for testing to be tested immediately. The commenter gave the 
example of an individual who is suited up for work in a radiologically 
controlled area from which he or she could not exit to be tested in a 
reasonable period of time. The NRC notes that in these cases, 
individuals who are on site but not reasonably be available for testing 
are required to report to the collection site as soon as reasonably 
practical after notification (emphasis on ``notification''), under 
Sec.  26.31(d)(2)(iii). In the given example, the supervisor would only 
notify the individual about testing after he or she is out of 
containment and has changed back to street clothes. If this were to 
occur at the end of the shift when collectors have left the site, this 
individual would not be notified that he or she must report for testing 
until the next time both the donor and the collectors are available to 
collect specimens for testing. Because there would be no known reason 
that this individual will test positive at the time of collection, any 
possible delays in testing should not compromise the performance 
objectives of the FFD program. However, the FFD program is responsible 
for preventing potential abuses brought on by such delays, which could 
include a supervisor protecting known substance abusers through 
improper notifications or delaying testing until completion of a 
critical job. Therefore, based on this analysis, the NRC has clarified 
this provision to reflect the public comment and clarify the NRC's 
intent, consistent with Goal 6 of this rulemaking to improve clarity in 
the language of the rule.
    The requirements of Sec.  26.31(d)(2)(v) prohibit licensees and 
other entities from returning the names of the individuals who are 
offsite when selected for testing or who are on site and not reasonably 
available for testing when selected to the random testing pool without 
conducting a test, as has been the practice of some licensees. 
Returning these individuals' names to the random testing pool without 
conducting a test ensures that they are immediately eligible for 
another unannounced test, as required in Sec.  26.31(d)(2)(vi), but 
does not ensure that all individuals who are subject to this part have 
an equal probability of being tested. Therefore, the requirement that 
individuals who are off site when selected for testing or who are on 
site and not reasonably available for testing when selected must be 
tested at the earliest reasonable and practical opportunity meets Goal 
3 of this rulemaking to improve the effectiveness of FFD programs.
    The section includes the phrase ``at the earliest reasonable and 
practical opportunity when both the donor and collectors are available 
to collect specimens for testing'' to clarify that licensees and other 
entities are not required to call an individual back to the site if he 
or she is off site when selected for testing. In addition, the 
provision does not require licensees and other entities to make special 
arrangements to ensure that a collector is available to collect the 
specimens as soon as the individual returns to the site. The NRC is 
aware that some licensees have called in individuals and collectors in 
the past under these circumstances. However, these practices may permit 
individuals to predict that they will be subject to testing when they 
return to the site. This prediction would provide them with an 
opportunity to take actions to subvert the testing process, as 
discussed with respect to Sec.  26.31(d)(2)(i). Therefore, the 
provision requires licensees and other entities to collect specimens 
from an individual who is off site when selected for testing or on site 
and not reasonably available for testing, in a manner that also ensures 
that the individual does not have advance notification that he or she 
has been selected for testing. The NRC has made this change to meet 
Goal 3 of this rulemaking to improve the effectiveness and efficiency 
of FFD programs.
    Section 26.31(d)(2)(vi) of the final rule, renumbered from 
(d)(2)(v) in the proposed rule, retains the second sentence of former 
Sec.  26.24(a)(2). This provision requires that an individual who has 
completed a test is immediately eligible for another random test.
    Section 26.31(d)(2)(vii) of the final rule, renumbered from 
(d)(2)(vi) in the proposed rule, amends the last sentence of former 
Sec.  26.24(a)(2). The NRC has made this change in response to licensee 
implementation questions with respect to the meaning of the term 
``workforce'' in the former rule. These questions related to whether 
``workforce'' means all individuals who are employed by the licensee, 
including individuals who are not subject to Part 26, all individuals 
at a site, or all individuals who are subject to the licensee's FFD 
program. This provision clarifies that the number of random tests that 
must be performed in a year must equal 50 percent of the population of 
individuals who are subject to random testing under the FFD program. If 
a common FFD program covers several sites, the ``population'' would 
include all individuals who are subject to the common FFD program. The 
population also includes individuals who have applied for authorization 
and who are subject to random testing under Sec.  26.67 [Random drug 
and alcohol testing of individuals who have applied for authorization]. 
The NRC has made this change to meet Goal 6 of this rulemaking to 
improve clarity in the organization and language of the rule.
    The NRC has added Sec.  26.31(d)(3) [Drug testing] to the final 
rule to group requirements in one section that are related to the 
general administration of drug testing. The NRC has made this change 
because requirements that address this topic were dispersed throughout 
the former rule. Grouping them together in a section makes them easier 
to locate within the final rule. This reorganization meets Goal 6 of 
this rulemaking to improve clarity in the organization and language of 
the rule.
    Section 26.31(d)(3)(i) combines and modifies some of the 
requirements in former Section 1.1(3) in Appendix A to Part 26, former 
Sec.  26.24(f), the first sentence of former Section 2.8(e)(1) in 
Appendix A, and former Section 2.8(a) and (b) in Appendix A to Part 26. 
These former provisions required licensees and other entities to use 
only HHS-certified laboratories to perform drug testing, except if 
initial tests were performed at a licensee testing facility. However, 
the final rule has clarified the first sentence of this section, with 
respect to the proposed rule, to include validity tests, validity 
screening tests, and initial validity tests. The NRC has retained other 
detailed requirements in these sections, but they are presented in the 
appropriate sections in Subparts E, F, and G of the final rule. The 
agency has made these changes to meet Goal 6 of this rulemaking to 
improve the organizational clarity of the rule.
    In addition, Sec.  26.31(d)(3)(i) requires that specimens sent to 
the HHS-certified laboratory by the licensee or other entity must be 
subject to initial validity and drug testing by the laboratory. 
However, the final rule clarifies the language of the proposed rule to 
require that any specimens that yield ``positive initial drug test 
results or are determined by initial validity testing to be of

[[Page 17024]]

questionable validity'' must be subject to confirmatory testing by the 
laboratory. The final rule deletes the term ``non-negative'' from the 
proposed rule and adds the term ``questionable validity'' for the 
reasons discussed with respect to Sec.  26.5. The NRC has made these 
changes to meet Goal 6 of this rulemaking to improve the organizational 
clarity of the rule.
    Specimen validity testing refers to testing conducted by a 
laboratory to identify attempts to tamper with a specimen. Attempts to 
tamper with a specimen may include:
    (1) Adulteration, which means putting a substance into a specimen 
that is designed to mask or destroy the drug or drug metabolite that 
the specimen may contain or to adversely affect the assay reagent;
    (2) Dilution, which means adding a liquid that, in contrast to an 
adulterant, would not be detected by validity testing, to the urine 
specimen to decrease the concentration of a drug or metabolite below 
the cutoff concentration; and
    (3) Substitution, which means replacing a valid urine specimen with 
a drug-free specimen.
    When HHS published its Notice of Final Revisions to the HHS 
Guidelines (66 FR 43876; August 21, 2001) to establish requirements for 
specimen validity testing performed by HHS-certified laboratories, HHS 
reported that the number of adulterated and substituted urine specimens 
has been increasing among the specimens tested under the Federal agency 
workplace drug testing program and the DOT regulations (49 CFR Part 
40). Program experience gained after Part 26 was first promulgated has 
also indicated an increasing number of adulterated and substituted 
urine specimens submitted to HHS-certified laboratories from Part 26 
testing programs.
    Although former Part 26 contained a number of requirements related 
to specimen validity (e.g., the fifth sentence of former Sections 
2.1(e), 2.4(f)(2), 2.4(g)(14) through (g)(16), and 2.7(d) in Appendix A 
to Part 26), the methods available to tamper with specimens have become 
more sophisticated after the rule was first published and more 
sophisticated methods of detecting tampering are necessary. Therefore, 
the final rule incorporates new requirements for HHS-certified 
laboratories to conduct specimen validity tests that are consistent 
with similar provisions contained in the most recent revision to the 
HHS Guidelines (69FR 19643; April 13, 2004). The NRC has added these 
new requirements for specimen validity testing to strengthen FFD 
programs by improving current laboratory procedures to detect specimens 
that are diluted, adulterated, or substituted. This change is 
consistent with Goal 1 of this rulemaking to update and enhance the 
consistency of Part 26 with advances in other relevant Federal rules 
and guidelines. Detecting specimen tampering is necessary to identify 
individuals who may attempt to hide drug abuse. Attempts to tamper with 
a specimen provide clear evidence that the individual is not 
trustworthy and reliable. Also, these individuals' drug use may pose a 
risk to public health and safety and the common defense and security, 
as discussed with respect to Sec.  26.23.
    Section 26.31(d)(3)(ii) amends the first sentence of former Sec.  
26.24(d)(1). This sentence permits licensees and other entities to 
conduct initial testing of urine specimens at a licensee testing 
facility, provided that the licensee testing facility staff possesses 
the necessary training and skills for the tasks assigned, the staff's 
qualifications are documented, and adequate quality controls for the 
testing are implemented. The final rule adds permission for licensees 
and other entities to perform initial validity testing at a licensee 
testing facility for the reasons discussed with respect to Sec.  
26.31(d)(3)(i). Subpart F establishes detailed requirements related to 
specimen validity testing at licensee testing facilities.
    Section 26.31(d)(3)(iii) is based upon the portions of former 
Section 2.7(e)(1) and (f)(2) in Appendix A to Part 26. These former 
sections established the cutoff levels for initial and confirmatory 
drug testing, respectively, which licensees must apply under the former 
rule. However, the final rule requires FFD programs to apply the 
updated cutoff levels specified in Sec.  26.163(a)(1) for initial drug 
testing and Sec.  26.163(b)(1) for confirmatory drug testing. The final 
rule clarifies the language of the proposed rule by adding that either 
the licensee testing facility or HHS-certified lab conducts the initial 
drug testing and the HHS-certified laboratory conducts the confirmatory 
testing. Consistent with the first sentence of former Sec.  26.24(b), 
the second sentence of this provision permits FFD programs to implement 
more stringent cutoff levels than specified in the rule, but 
establishes additional requirements related to lower cutoff levels, as 
is discussed with respect to paragraphs (d)(3)(iii)(A) through (C). The 
NRC has relocated the permission in the first sentence of former Sec.  
26.24(b) to implement a broader panel of drugs to Sec.  26.31(d)(1), as 
discussed with respect to that section. The NRC has made these changes 
to meet Goal 6 of this rulemaking to improve clarity in the 
organization and language of the rule.
    Section 26.31(d)(3)(iii)(A) retains the third and fourth sentences 
of former Sec.  26.24(b) regarding management actions and sanctions for 
confirmed positive drug test results based on any lower cutoff levels 
established by the FFD program. The final rule adds a requirement that 
the FFD program's written policy and procedures must document the FFD 
program's lower cutoff levels in the written policy and procedures to 
ensure that individuals who are subject to testing are aware of the 
cutoff levels that would be applied to their drug test results in order 
to protect their rights. The NRC has made this change to meet Goal 7 of 
this rulemaking to protect the privacy and other rights (including due 
process) of individuals who are subject to Part 26.
    Section 26.31(d)(3)(iii)(B) requires the uniform application of the 
FFD program's cutoff levels for drugs and drug metabolites, including 
any more stringent cutoff levels in all tests conducted under this part 
and equally to all individuals who are subject to testing, except as 
permitted under Sec.  Sec.  26.31(d)(1)(ii), 26.163(a)(2) for dilute 
specimens, and Sec.  26.165(c)(2) for retesting specimens. As discussed 
with respect to Sec.  26.31(d)(1)(ii), some FFD programs have adopted 
the practice of testing specimens at the assay's LOD for for-cause, 
post-event, and followup tests, which results in some individuals 
receiving unequal treatment under the rule. Therefore, the NRC has 
added the section to meet Goal 7 of this rulemaking to protect the 
privacy and other rights (including due process) of individuals who are 
subject to Part 26.
    The NRC has added Sec.  26.31(d)(3)(iii)(C) to the final rule to 
specify requirements for establishing more stringent cutoff levels. 
Before implementing the more stringent cutoff levels, licensees and 
other entities are required to obtain certification from a forensic 
toxicologist that the more stringent cutoff levels are technically 
sound and legally defensible, with two exceptions. Certification by a 
forensic toxicologist is not required if: (1) If the HHS Guidelines are 
revised to lower the cutoff levels for the drug or drug metabolites in 
Federal workplace drug testing programs and the licensee or other 
entity implements the cutoff levels published in the HHS guidelines; or 
(2) if the licensee or other entity received written approval of the 
NRC to test for lower cutoff levels before the implementation date of 
this rule, which is 365 days after the date the final rule

[[Page 17025]]

is published in the Federal Register. Certification by a toxicologist 
is unnecessary in these two circumstances because it would be 
redundant. The NRC has made this change to meet Goal 5 of this 
rulemaking to improve Part 26 by eliminating or modifying unnecessary 
requirements, while continuing to protect donors' right to accurate and 
reliable drug testing.
    Section 26.31(d)(4) [Alcohol testing] updates former Sec.  26.24(g) 
that contained general requirements for conducting alcohol testing. The 
update reflects other changes that have been made in the final rule. 
The NRC has amended the former cross-reference to Section 2.7(o)(3) in 
Appendix A to Part 26 to refer to Sec.  26.91(a) in Subpart E, which 
contains detailed requirements for conducting alcohol testing. The NRC 
has added the reference to oral fluids as acceptable specimens for 
initial alcohol testing to this section. The basis for adding oral 
fluids as acceptable specimens for initial alcohol testing is discussed 
with respect to Sec.  26.83 [Specimens to be collected]. The NRC has 
changed the BAC at which a confirmatory test is required to 0.02 
percent (from 0.04 percent) in the provision for consistency with the 
revised alcohol cutoff levels in Sec.  26.99 [Determining the need for 
a confirmatory test for alcohol] and Sec.  26.103 [Determining a 
confirmed positive test result for alcohol]. The basis for the revised 
alcohol cutoff levels is discussed with respect to those sections of 
the final rule. The agency has deleted reference to blood testing for 
alcohol because the final rule no longer permits donors to request 
blood testing for alcohol, as discussed with respect to Sec.  26.83(a) 
of the final rule.
    The NRC has added Sec.  26.31(d)(5) [Medical conditions] to the 
final rule to address circumstances when it may be impossible or 
inadvisable to test an individual using the procedures specified in 
this part. Circumstances have arisen under Part 26, as well as the 
programs of other Federal agencies, when an individual's medical 
condition has made it inadvisable to implement testing procedures under 
the relevant requirements. Therefore, Sec.  26.31(d)(5)(i) permits 
alternative specimen collection and evaluation procedures for rare 
instances when it would be difficult or hazardous to the donor to 
collect breath, oral fluids, or urine specimens, including, but not 
limited to, required post-event testing when an individual has been 
seriously injured. Only the MRO is permitted to authorize an 
alternative evaluation procedure that may include, but is not limited 
to blood testing for alcohol. Section 26.31(d)(5)(ii) clarifies that 
necessary medical treatment may not be delayed in order to conduct drug 
and alcohol testing. These sections are consistent with the 
requirements of other Federal agencies and meet Goal 1 of this 
rulemaking to update and enhance the consistency of Part 26 with 
advances in other relevant Federal rules and guidelines.
    Section 26.31(d)(6) [Limitations of testing] retains and amends 
former Section 2.1(d) in Appendix A to Part 26. This former section 
stated that specimens collected under Part 26 may only be designated or 
approved for testing as described in this part and may not be used for 
any other analysis or test without the permission of the tested 
individual. The final rule adds examples of the types of analyses and 
tests that are prohibited without the donor's written permission. 
Although the NRC is not aware of any instances when such unauthorized 
testing has occurred in FFD programs under this part, the technology 
for performing these analyses and tests has become increasingly 
available since the regulation was first promulgated. The NRC has added 
these examples to meet Goal 7 of this rulemaking to protect the privacy 
and other rights (including due process) of individuals who are subject 
to Part 26.
Section 26.33 Behavioral Observation
    The NRC has added Sec.  26.33 to the final rule to emphasize that 
behavioral observation is a required element of FFD programs. The first 
sentence of Sec.  26.33 requires behavioral observation of individuals 
subject to this subpart. The second sentence retains former Sec.  
26.22(a)(3), (a)(4), and (b), which stated that the individuals who 
perform behavioral observation must be trained. The third sentence of 
the section requires that individuals must report FFD concerns arising 
from behavioral observation to the appropriate personnel designated in 
the FFD program procedures. The NRC has added these requirements to the 
final rule to strengthen the behavioral observation element of FFD 
programs by increasing the likelihood that the licensees and other 
entities detect and appropriately address impairment and other adverse 
behaviors. These changes are consistent with Goal 3 of the rulemaking 
to improve the effectiveness and efficiency of FFD programs.
Section 26.35 Employee Assistance Programs
    Section 26.35 amends former Sec.  26.25 [Employee assistance 
programs].
    Section 26.35(a) retains the former provision without change and 
specifies that licensees and other entities shall maintain EAPs that 
offer confidential assessment, short-term counseling, referral 
services, and treatment monitoring to individuals who have problems 
that could adversely affect the individuals' abilities to safely and 
competently perform their duties. The provision also requires that the 
EAP be designed to achieve early intervention and provide for 
confidential assistance.
    The NRC has added Sec.  26.35(b) to the final rule to clarify that 
licensees and other entities are not required to provide EAP services 
to C/V employees, including those who are working at a licensee's or 
other entity's facility. With respect to the proposed rule, the final 
rule clarifies that licensees and other entities are not required to 
provide EAP services to C/V employees whose work location is a 
licensee's or other entity's facility. This provision is consistent 
with the interpretation of the former rule in item 13.1.4 of NUREG-
1354. The final rule continues to require that C/V employees who are 
subject to Part 26 must have access to an EAP, and that licensees and 
other entities who rely upon the FFD program of a C/V continue to be 
required to ensure that the EAP of a C/V meets the requirements of this 
part.
    The provision also states that licensees and other entities need 
not provide EAP services to individuals who have applied for but have 
not yet been granted authorization under Subpart C. Licensees and other 
entities are not required to provide an EAP to applicants for 
authorization because these individuals would not yet be performing 
duties that could affect public health and safety or the common defense 
and security. The NRC has added this clarification because applicants 
are subject to other requirements under the final rule as discussed 
with respect to Sec.  26.4(h).
    Section 26.35(c) amends the last sentence of former Sec.  26.25. 
The provision emphasizes that the identity and privacy of an individual 
who seeks EAP services must be protected and clarifies the conditions 
under which EAP personnel may or must violate an individual's 
confidentiality. The final rule permits EAP personnel to communicate 
information about an individual by name to the licensee or other entity 
under only two conditions: (1) If the individual waives the right to 
privacy, or (2) EAP personnel determine that the individual's condition 
or actions pose or have posed an immediate threat to himself or herself 
or others. By clarifying the NRC's intent

[[Page 17026]]

with respect to EAP confidentiality, the provision meets Goal 6 of this 
rulemaking to improve clarity in the language of the rule because the 
former provision has been misinterpreted.
    The last sentence of former Sec.  26.25 required confidentiality 
for individuals who seek EAP services, except if EAP professionals 
determine that the individual's condition ``constitutes a hazard to 
himself or herself or others.'' Some licensees have over-interpreted 
this phrase and routinely require EAP staff to report individuals who 
self-refer for any reason, which is not the intent of this provision. 
The NRC is also aware that some individuals who are subject to the rule 
have misinterpreted this phrase as meaning that no self-referral to the 
EAP would remain confidential and that EAP staff always report self-
referrals to licensee management. This perception appears to be widely 
shared, including by individuals who are subject to FFD programs that 
have not misinterpreted the former rule and who correctly permit EAP 
staff to make the determination of whether to report an individual's 
condition to licensee management.
    A key purpose of requiring EAPs under Part 26 is to encourage 
individuals and their family members to self-refer for any type of 
problem that could potentially impair job performance, so that early 
intervention may be offered to prevent the problem from adversely 
affecting the individuals' job performance. Upon assessment, it is not 
uncommon for EAP staff to find that a developing substance abuse 
problem is contributing to a financial or family problem for which an 
individual has sought assistance. As a result, the EAP provides an 
important means to detect and achieve early resolution of developing 
substance abuse and other problems, which if left untreated could have 
the potential to adversely affect an individual's ability to safely and 
competently perform his or her duties. The knowledge or perception 
among individuals who are subject to the rule that self-referrals to 
the EAP will be reported to management and will routinely result in the 
loss of authorization represents a significant barrier to the 
effectiveness of the EAP element of FFD programs. Therefore, the 
section amends the last sentence of former Sec.  26.25 to clarify that 
an individual's use of the licensee's or other entity's EAP must remain 
confidential, except in very limited circumstances.
    The NRC has added Sec.  26.35(c)(1) to the final rule to prohibit 
licensees and other entities from requiring the EAP to routinely report 
the names of individuals who self-refer to the EAP and the nature of 
assistance the individuals sought. The provision is necessary to 
eliminate some licensees' practices of requiring these reports, protect 
individuals' privacy, and strengthen the EAP element of FFD programs by 
eliminating a former barrier to self-referrals in some FFD programs. 
The term ``routinely'' is used to indicate that the final rule permits 
EAP personnel to report individuals' names and the nature of their 
problems if the individuals have waived the right to privacy in writing 
or EAP personnel determine that an individual's condition or actions 
pose or have posed an immediate risk to public health and safety or the 
common defense and security. The provision does not prohibit EAPs from 
reporting program utilization statistics or aggregated data that 
characterize the types of problems for which the program has provided 
services because this type of information does not compromise 
individuals' privacy.
    The NRC has added Sec.  26.35(c)(2) to the final rule to provide 
further clarity in the language of the rule with respect to the 
conditions under which EAP personnel are excepted from the 
confidentiality requirement in Sec.  26.35(c) and required to report a 
concern about an individual to the licensee or other entity. The NRC is 
confident that EAP personnel have the qualifications and training 
necessary to continue to make the professional judgments required under 
the regulations in these circumstances. However, the final rule 
includes more detail with respect to the conditions and actions that an 
EAP professional is required to report to ensure that licensees, other 
entities, and individuals who are subject to the rule better understand 
the intent of the former and final provisions. The final rule requires 
EAP personnel to report a concern about a specific individual to 
licensee or other entity management only when they have substantive 
reasons to believe that an individual's condition or actions pose or 
have posed an immediate hazard to themselves or others. The phrase 
``substantive reasons to believe'' is used to clarify that casual and/
or contextually appropriate comments made by an individual during a 
counseling session are not a sufficient basis for reporting to the 
licensee or other entity. For example, an individual's statement that 
he or she is concerned about becoming an alcoholic would not constitute 
a substantive reason to believe that the individual's condition poses 
an immediate hazard. In contrast, this stated concern, in addition to 
evidence that the individual's personal relationships, financial 
condition, and/or health are suffering from his or her alcohol 
consumption, and any indications that the individual has been impaired 
while in a work status, would constitute substantive reasons to believe 
that the individual's condition poses an immediate hazard and must be 
reported.
    The NRC has added Sec.  26.35(c)(2)(i) through (iii) to the final 
rule to provide several examples of conditions and actions that require 
EAP personnel to provide a report about an individual who has self-
referred to licensee or other entity management. Section 26.35(c)(2)(i) 
requires reporting if the EAP staff has substantive reasons to believe 
that an individual may harm himself or herself or others, including, 
but not limited to, plans threatening suicide, radiological sabotage, 
or physical violence against others. Section 26.35(c)(2)(ii) requires 
reporting if the EAP staff has substantive reasons to believe that an 
individual has been impaired from drugs or alcohol while in a work 
status and is likely to be impaired in the future, as discussed with 
respect to Sec.  26.35(c)(2). Section 26.35(c)(2)(iii) requires 
reporting if the EAP staff has substantive reasons to believe that an 
individual has committed any of the acts that would require a report to 
the NRC under Sec.  26.719(b)(1) through (b)(3), including but not 
limited to, the use, sale, distribution, possession, or presence of 
illegal drugs, or the consumption or presence of alcohol within a 
protected area or while performing duties that require the individual 
to be subject to this part. The examples included in these sections are 
illustrative, and do not represent an exhaustive list of the conditions 
and actions that EAP staff may encounter that would be reported to 
licensee or other entity management under the final rule.
    For additional clarity, the NRC has added Sec.  26.35(c)(3) to the 
final rule to cross-reference the provisions in the final rule that 
specify the actions that licensees and other entities would take after 
receiving a report from EAP personnel that an individual's condition or 
actions pose or have posed an immediate hazard to himself or herself or 
others. As discussed with respect to (Sec. Sec.  26.69(d) and 26.77(b) 
of the final rule, those provisions require the licensee or other 
entity to take immediate action to prevent the individual from 
performing any duties that require the individual to be subject to this 
part, ensure that a determination of fitness is performed by a 
professional who has specific qualifications and

[[Page 17027]]

training to address the nature of the individual's problem, and either 
terminate the individual's authorization or ensure that the condition 
is resolved before permitting him or her to return to performing duties 
under this part.
    These changes to former Sec.  26.25 are consistent with Goal 7 of 
this rulemaking to protect the privacy and other rights (including due 
process) of individuals who are subject to Part 26, as well as Goal 3 
to improve the effectiveness and efficiency of FFD programs.
Section 26.37 Protection of Information
    Section 26.37 amends former Sec.  26.29 that contained requirements 
for protecting the personal information that must be collected under 
Part 26. In general, this section of the final rule groups requirements 
related to the protection of personal information that were dispersed 
throughout the former rule to aid in locating these requirements in the 
final rule. The NRC has moved the records retention requirement in 
former Sec.  26.29(a) to Subpart N of the final rule. The NRC has made 
these changes to meet Goal 6 of this rulemaking to improve clarity in 
the organization of the rule.
    Section 26.37(a) combines and retains the first sentence of former 
Sec.  26.29(a) and the second sentence of former Section 3.1 in 
Appendix A to Part 26. The final rule modifies the language of the 
proposed rule to require licensees and other entities to establish, 
use, and maintain a system of files and procedures that protects the 
individuals' privacy. The NRC, after publishing the proposed rule, 
recognized the need for more clarity in the language of this provision 
to illustrate the NRC's intent. Therefore, this change meets Goal 6 of 
the rulemaking to improve clarity in the language of the rule.
    Section 26.37(b) amends former Sec.  26.29(b) and divides it into 
several sections for clarity. The first sentence of the section amends 
the first sentence of former Sec.  26.29(b) that prohibited licensees 
and other entities from disclosing personal information collected under 
this part to any individuals other than those listed in the sentence. 
The final rule continues to permit disclosure of the personal 
information to the listed individuals and adds permission for the 
licensee or entity to disclose the personal information to others if 
the licensee or other entity has obtained a signed release for such a 
disclosure from the individual. The NRC has added the permission to 
release the personal information to individuals who are not listed in 
the section with the written consent of the subject individual because 
some licensees have misinterpreted the former requirement as 
prohibiting them from releasing the personal information under any 
circumstances, except to the parties listed in this section. In some 
instances, such failures to release information have inappropriately 
inhibited an individual's ability to obtain information that was 
necessary for a review or appeal of the licensee's determination that 
the individual had violated the FFD policy. Therefore, the NRC has 
added the explicit permission for licensees and other entities to 
release personal information when an individual consents to the 
release, in writing, to meet Goal 7 of this rulemaking to protect the 
privacy rights and other rights (including due process) of individuals 
who are subject to Part 26.
    Section 26.37(b)(1) through (b)(8) lists the individuals to whom 
licensees and other entities are permitted to release personal 
information about an individual. Section 26.37(b)(3), (b)(4), and 
(b)(8) retains unchanged the permission for the release of information 
to NRC representatives, appropriate law enforcement officials under 
court order, and other persons as required by court order. Section 
26.37(b)(1), (b)(2), (b)(5), (b)(6), and (b)(7) amends the related 
requirements contained in former Sec.  26.29(b) to meet Goal 6 of this 
rulemaking to improve clarity in the organization and language of the 
rule. The specific changes to former Sec.  26.29(b) include the 
following:
    Section 26.37(b)(1) retains the permission for the release of 
information to the subject individual and his or her designated 
representative. The provision adds requirements for the individual to 
designate his or her representative in writing and specify the FFD 
matters to be disclosed. The NRC has made these changes in response to 
implementation questions from licensees. Licensees have sought guidance 
from the NRC related to the way an individual must ``designate'' a 
representative.
    Section 26.37(b)(2) retains the permission for the release of 
information to the licensee's or other entity's MROs. The final rule 
also permits the release of information to MRO staff members for 
consistency with Sec.  26.183(d), which permits MRO staff to serve some 
MRO functions under the direction of the MRO. MRO staff require access 
to the personal information in order to perform their duties. The role 
of MRO staff in FFD programs is discussed with respect to Sec.  
26.183(d) of the final rule.
    Section 26.37(b)(5) amends the former reference to licensee 
representatives who have a need to have access to the information in 
performing assigned duties. The former rule referred only to 
individuals who are performing audits of FFD programs. As a result, 
some licensees have misinterpreted the former rule as limiting the 
release of personal information only to such individuals. This was not 
the intent of the provision. Rather, the NRC intended that licensees 
and other entities were permitted to release information to their 
representatives who must have access to the personal information in 
order to perform assigned duties.
    With respect to the proposed rule, the final rule modifies proposed 
Sec.  26.37(b)(5) to clarify the NRC's intent that the only licensee or 
other entity representatives who may have access to the personal 
information collected under this part are persons who have a need for 
that information to implement the requirements of the rule. The NRC 
made this change to provide greater assurance that personal 
information, such as medical records that an individual has submitted 
to the MRO to document prescription medication for a ``shy bladder'' 
situation, is not released to persons who do not have assigned duties 
under the FFD program that specifically require access to that 
information. Reviewing officials, MROs, SAEs, and other FFD program 
personnel, as well as auditors, require access to some personal 
information about individuals in order to perform their assigned duties 
to implement the FFD program. Human resources personnel may need to 
know that an individual has violated the FFD policy, if the licensee or 
other entity terminates an individual's employment in response to an 
FFD policy violation, but do not need access to the personal 
information collected about the individual under the FFD program to 
carry out the process of terminating the individual's employment. The 
NRC has determined that this additional clarification is necessary to 
provide further protection of the privacy of persons who are subject to 
the rule.
    Section 26.37(b)(6) and (b)(7) amends the portion of former Sec.  
26.29(b) that referred to ``persons deciding matters on review or 
appeal.'' The NRC has amended the provision in response to 
implementation questions from licensees, including whether the rule 
covers persons deciding matters in judicial proceedings or only the 
internal appeals process specified in former Sec.  26.28 [Appeals], as 
well as whether

[[Page 17028]]

information could be released in a judicial proceeding that the subject 
individual did not initiate. The final rule clarifies that the 
permission includes individuals who are presiding in a judicial or 
administrative proceeding, but only if the subject individual in Sec.  
26.37(b)(6) initiates the proceeding. Section 26.37(b)(7) covers 
``persons deciding matters under review in Sec.  26.39'' [Review 
process for fitness-for-duty policy violations], as discussed with 
respect to that section. The NRC has made these changes to meet Goal 6 
of this rulemaking relating to improving clarity in the organization 
and language of the rule.
    The NRC has added Sec.  26.37(c) to the final rule to require the 
disclosure of relevant information to licensees and other entities, 
including C/Vs, and their authorized representatives who have a 
legitimate need for the information and a signed release from an 
individual who is seeking authorization under this part. This provision 
clarifies former Sec.  26.29(b) because some licensees have 
misinterpreted the former provision as prohibiting the release of 
information to C/Vs who have licensee-approved FFD programs and conduct 
suitable inquiries on behalf of licensees and other entities. The NRC 
has made this change to meet Goal 6 of this rulemaking to improve 
clarity in the organization and language of the rule.
    Section 26.37(d) through (f) retains several requirements related 
to the protection of information in the former rule but moves them into 
this section for organizational clarity. Section 26.37(d) combines 
requirements in former Sec.  26.29(b) and Section 3.2 in Appendix A to 
Part 26 as they relate to an individual's access to records that are 
necessary for a review of an FFD policy violation. However, the final 
rule modifies the language of the proposed rule by specifying that it 
is the FFD program that is required to promptly provide all requested 
records. The NRC has made this change to meet Goal 6 of the rulemaking 
to improve clarity in the language of the rule. The final rule also 
adds ``collection site'' and ``SAE'' to the list of entities who must 
provide records to an individual or his or her designated 
representative. The final rule also expands the proposed language to 
specify the types of records that must be provided. The examples given 
for the types of records that must be provided to the individual are 
illustrative, but are not comprehensive of all the types of records 
that must be provided upon request. The agency has made these changes 
in response to public comment, to clarify the rule language, to ensure 
that individuals and representatives can verify the accuracy of FFD 
records, and to meet Goal 7 of this rulemaking to protect the privacy 
and other rights (including due process) of individuals subject to Part 
26. Section 26.37(e) and (f) retains former Section 3.1 in Appendix A 
to Part 26 and the last sentence of former Sec.  26.29(b), 
respectively.
Section 26.39 Review Process for Fitness-for-Duty Policy Violations
    Section 26.39 amends former Sec.  26.28 and separates it into 
several sections. The change from the former section heading eliminates 
the implication that the internal management review is a legal 
proceeding. The agency has added several requirements to clarify and 
strengthen individuals' rights during the review, consistent with Goal 
7 of this rulemaking, as described in the following paragraphs.
    Former Sec.  26.28 required that individuals who are subject to the 
rule have an opportunity for a management review of a determination 
that the individual has violated the licensee's or other entity's FFD 
policy. Section 26.39(a) retains the requirement that the review must 
be impartial and adds a requirement that the review must be objective. 
The NRC has added the requirement for an objective review because some 
licensees have permitted the same individuals who were involved in the 
initial determination that an individual violated the FFD policy to 
provide the review that was required under former Sec.  26.28. The 
impartiality of individuals who are reviewing their own decisions is 
questionable and calls into question the effectiveness of the review 
process. Therefore, the requirement for the review to be both impartial 
and objective emphasizes the NRC's intent that the review process be 
effective.
    In keeping with revisions to several other sections that are 
intended to counter subversion of the testing process, Sec.  26.39(a) 
extends this opportunity to request a review to all FFD violations, 
including, but not limited to, violations based upon confirmed 
positive, adulterated, or substituted, or invalid test results. The 
section also clarifies that applicants for authorization must be given 
the opportunity for a review. Experience with implementing this section 
of Part 26 has indicated that some licensees did not provide a review 
process to individuals who tested positive on pre-access tests. 
However, the factors that could produce false positive test results 
among licensee and C/V employees (e.g., administrative or testing 
errors) are equally likely to occur during pre-access testing of 
applicants for authorization. If applicants are not provided with a 
review process, it is possible that some of them would be effectively 
barred from the industry based on test results erroneously determined 
to be a violation of the licensee's or other entity's FFD policy. 
Providing applicants with the opportunity to request a review also 
enhances program credibility.
    Section 26.39(b) specifies that FFD procedures must describe the 
contents and purpose of the notice that licensees and other entities 
would be required to provide to an individual who has violated an FFD 
policy. The provision also requires that the procedures must state that 
the individual may submit additional relevant information as part of 
the review process. This clarification is necessary because experience 
with implementing former Sec.  26.28 has indicated that individuals do 
not understand the purpose of the review process and their associated 
rights in some cases.
    Section 26.39(c) specifies that the procedure must ensure that the 
individual who conducts the review is not associated with the 
administration of the FFD program. The final rule modifies the proposed 
rule by requiring that only one representative of the licensee's or 
other entity's management shall conduct the review. The final rule 
allows only one individual to conduct the review in response to a 
public comment that stated that the review process required by this 
section should be consistent with that required by 10 CFR 73.56(e) 
(personnel access authorization) because this would simplify licensee 
procedures and would improve the consistency between FFD requirements 
and access authorization requirements. In specifying that the reviewer 
may not be anyone associated with the administration of the FFD 
program, including anyone who made the initial determination that the 
individual violated the FFD policy, the final rule strengthens the 
impartiality and objectivity of the review process in order to further 
enhance individuals' rights. The NRC has made these changes to meet 
Goal 3 of the rulemaking to increase the effectiveness and efficiency 
of FFD programs, and Goal 7 to protect the privacy and other rights 
(including due process) of individuals who are subject to Part 26.
    Section 26.39(d) adds a requirement that any records associated 
with the FFD policy violation must be deleted or corrected, as 
appropriate, if the policy violation decision is overturned. This 
requirement is necessary because the final rule permits licensees and 
other entities to share and rely on information

[[Page 17029]]

gathered by other Part 26 programs to a greater extent than is 
currently possible. Therefore, incorrect records related to an FFD 
policy violation could significantly inhibit an individual from further 
employment under a Part 26 program if this information is transmitted 
to other licensees and entities who are considering whether to grant 
authorization to an individual. The requirement to delete or correct 
any records associated with an FFD policy violation that has been 
overturned will protect individuals from such potential adverse 
consequences.
    Section 26.39(e) of the final rule amends the last sentence of 
former Sec.  26.28. This sentence stated that licensees and other 
entities are not required to provide a review procedure to C/V 
employees and applicants when the C/V is administering its own drug and 
alcohol testing. The final rule amends the former paragraph in response 
to implementation questions from licensees who have asked whether the 
former provision excuses them from providing a review process for C/V 
employees at any time, including situations when the FFD policy 
violation was determined as a result of testing conducted by the 
licensee. The final rule revises this sentence to clarify that the 
licensee or other entity need not provide a review process if the C/V's 
drug and alcohol testing program identified the FFD violation to be 
reviewed. If the licensee's drug and alcohol testing determined the FFD 
violation, the licensee is required to provide the impartial and 
objective review. The final rule modifies the proposed rule to state 
that the licensee need not provide a review procedure to a C/V 
subcontractor when the FFD policy violation was determined under a C/
V's program. These changes are consistent with Goal 6 of this 
rulemaking to improve clarity in the organization and language of the 
rule.
Section 26.41 Audits and Corrective Action
    Section 26.41 of the final rule renames and amends former Sec.  
26.80 [Audits]. The NRC has added the phrase ``and corrective action'' 
to the section heading to emphasize the NRC's intent that licensees and 
other entities must ensure that corrective actions are taken in 
response to any adverse findings resulting from an audit. In addition, 
the final rule reorganizes the audit requirements in former Sec.  
26.80, and moves several audit and inspection requirements into this 
section that were addressed in Appendix A to Part 26. The NRC has made 
these changes to meet Goal 6 of this rulemaking to improve clarity in 
the organization and language of the rule.
    Section 26.41(a) [General] of the final rule amends the last 
sentence in former Sec.  26.80(a). This sentence stated that licensees 
retain responsibility for the effectiveness of C/V programs and the 
implementation of appropriate corrective action. The final rule revises 
this requirement to include HHS-certified laboratories, as well as any 
C/V FFD program elements and FFD programs that the licensee or other 
entity relies upon, consistent with the intent of the former 
requirement. The final rule has added a phrase to the proposed rule 
that requires licensees to be responsible for the continuing 
effectiveness of any FFD program services a subcontractor provides to 
the C/V. The NRC has made these changes to meet Goal 6 of this 
rulemaking to improve clarity in the language of the rule.
    Section 26.41(b) [FFD program] of the final rule amends the 
required audit frequency in former Sec.  26.80(a). (Other provisions of 
Sec.  26.41 address the other requirements contained in former Sec.  
26.80(a), as discussed with respect to the sections of the final rule 
that address those topics.) The final rule decreases the former 12-
month FFD program audit frequency to a nominal 24-month frequency, 
which grants a petition for rulemaking (PRM-26-1) submitted by Virginia 
Power on December 30, 1993. Experience with implementing Part 26 has 
shown that annual audits of the entire FFD program are unnecessary to 
ensure continued program effectiveness and, therefore, place an 
unnecessary burden on those entities who are subject to the rule. The 
NRC decreased the audit frequency to 24 months to relieve this burden 
and to be consistent with the NRC's schedule for inspecting FFD 
programs. The change is consistent with Goal 5 of this rulemaking to 
improve Part 26 by eliminating or modifying unnecessary requirements.
    Although the final rule decreases the required audit frequency, 
licensees and other entities are required to monitor program 
performance indicators and operating experience, consistent with a 
performance-based approach, and audit FFD program elements more 
frequently than every 24 months as needed. In determining the need for 
more frequent audits, the final rule requires licensees and other 
entities to consider FFD performance, including but not limited to, the 
frequency, nature, and severity of discovered problems, testing errors, 
personnel or procedural changes, and previous audit findings. The 
provision is intended to promote performance-based rather than 
compliance-based audit activities and clarify that programs must be 
audited following a significant change in personnel, procedures, or 
equipment as soon as reasonably practicable. The NRC recognizes that 
FFD programs evolve and new issues and problems continue to arise. 
Turnover of FFD program personnel and contracted services personnel, 
such as specimen collectors, exacerbates this concern. Licensee audits 
have identified problems that were associated in some way with 
personnel changes, such as new personnel not understanding their duties 
or procedures, the implications of actions that they took or did not 
take, or changes in processes. The purpose of these focused audits is 
to ensure that changes in personnel, procedures, or equipment do not 
adversely affect the operation of the particular program element or 
function in question. Accordingly, the audit requirement ensures that 
any programmatic problems that may result from significant changes in 
personnel, procedures, or equipment are detected and corrected on a 
timely basis. By requiring more frequent audits of FFD program 
performance that may require closer monitoring than a nominal 24-month 
frequency would provide, these changes meet Goal 3 of this rulemaking 
to improve the effectiveness and efficiency of FFD programs.
    Section 26.41(c) [C/Vs and HHS-certified laboratories] of the final 
rule amends the audit and inspection requirements that are contained in 
the second sentence of former Sec.  26.80(a) and the third sentence of 
Section 2.7(m) in Appendix A to Part 26, as follows:
    Section 26.41(c)(1) further amends the requirement in former Sec.  
26.80(a) for annual audits of C/V FFD programs and program elements and 
HHS-certified laboratories. The former annual audit frequency is 
retained only for those portions of C/V FFD programs whose personnel 
work off site and are not under the daily supervision of FFD program 
personnel. The activities of C/V personnel who work on site and are 
under the daily supervision of FFD program personnel are audited under 
Sec.  26.41(b). Retention of the annual audit requirement for C/Vs 
whose personnel work off site meets Goal 3 of this rulemaking to 
improve the effectiveness and efficiency of FD programs. The provision 
is necessary to ensure that the services provided continue to be 
effective because other means of monitoring their effectiveness, such 
as daily oversight, are unavailable. The section also retains the 
annual audit requirement for HHS-certified laboratories. The NRC has 
retained this audit frequency because of the key role

[[Page 17030]]

the laboratories play in the overall effectiveness of Part 26 programs. 
Retention of these annual audit requirements in the section denies the 
petition for rulemaking (PRM-26-1) submitted by Virginia Power on 
December 30, 1993.
    Section 26.41(c)(2) relaxes some requirements related to annual 
audits and inspections of the HHS-certified laboratories that licensees 
and other entities rely upon for drug testing services. The final rule 
permits licensees and other entities who are subject to the rule to 
rely upon the inspections of HHS laboratories that are performed for 
HHS-certification reviews and no longer requires licensees and other 
entities to audit the effectiveness of services that HHS inspectors 
review. The former rule contained a number of requirements that are 
inconsistent with the requirements for drug testing under other 
Federally mandated programs. For example, the former rule permitted 
donors to request confirmatory alcohol testing of a blood specimen at 
an HHS-certified laboratory, which other Federal agencies do not 
permit. Also, some of the cutoff levels established in the former rule 
are higher, in the case of testing for marijuana metabolite, or lower, 
in the case of testing for opiates, than those of other Federal 
agencies. These programmatic discrepancies have made licensee audits of 
HHS-certified laboratories necessary to ensure the effectiveness of the 
unique drug and alcohol testing services required for Part 26 programs 
because HHS inspections do not address these services. The final rule 
eliminates the majority of these discrepancies. Therefore, the annual 
audits of HHS-certified laboratories by licensees that have been 
necessary under the former rule would be redundant under the final 
rule, except in certain conditions described below. The NRC has made 
these changes to meet Goal 5 of this rulemaking to improve Part 26 by 
eliminating or modifying unnecessary requirements.
    Section 26.41(c)(2) continues to require licensees and other 
entities to conduct annual audits of any services provided to the 
licensee or other entity that the annual HHS-certification review did 
not address. The NRC has retained this annual audit requirement because 
Sec.  26.31(d) retains the permission in the former rule for licensees 
and other entities to establish lower cutoff levels and test for drugs 
in addition to those for which testing is required under this part. If 
a licensee or other entity chooses to implement more stringent cutoff 
levels or a broader panel of drugs than required under the final rule, 
the licensee or other entity is required to ensure that annual audits 
of the HHS-certified services related to those cutoff levels and drug 
tests are performed.
    The NRC has added the last sentence of Sec.  26.41(c)(2) to clarify 
the scope of the former audit requirements. The final rule does not 
require licensees and other entities to audit organizations that do not 
routinely provide FFD services to the licensee or other entity, such as 
local hospitals or a substance abuse treatment facility. It is 
unnecessary to audit these organizations because the FFD program would 
use their services infrequently, there would be a reasonable 
expectation of quality, and weaknesses in these services could be 
identified through other means. For example, Sec.  26.187 [Substance 
abuse expert] requires the SAE to monitor the substance abuse treatment 
of individuals who require it and the SAE would have the qualifications 
and information necessary to assess the quality of the treatment 
services an individual receives. The SAE has the authority to seek 
other services on behalf of the FFD program if he or she identifies 
weaknesses in a treatment program. Therefore, the NRC has made these 
changes to meet Goal 5 of this rulemaking to improve Part 26 by 
eliminating or modifying unnecessary requirements.
    Section 26.41(d) [Contracts] of the final rule incorporates and 
amends the requirements of former Section 2.7(m) in Appendix A to Part 
26 and others that addressed contractual relationships to permit 
licensees and other entities access to the HHS-certified laboratories 
for the purposes of conducting the audits and inspections required 
under the rule. The portions of former Section 2.7(m) in Appendix A to 
Part 26 that related to NRC inspections of HHS-certified laboratories 
have been moved to Sec.  26.821 [Inspections] in Subpart O 
[Inspections, violations, and penalties] of the final rule, consistent 
with Goal 6 of this rulemaking to improve clarity in the organization 
and language of the rule.
    Section 26.41(d)(1) amends the second sentence of former Section 
2.7(m) in Appendix A to Part 26. The former section required licensee 
contracts with HHS-certified laboratories for drug testing and alcohol 
confirmatory testing, as well as contracts for collection site 
services, to permit the licensee to conduct unannounced inspections. 
The final rule retains the former requirement with respect to HHS-
certified laboratories and expands it to require that contracts with 
any C/V (which would include collection services providers) must permit 
the licensee or other entity to conduct audits at any time, including 
unannounced times, and to review all information and documentation that 
is reasonably relevant to the audits. The provision extends the former 
requirement to any C/V with whom the licensee or other entity contracts 
for FFD program services to enhance the effectiveness of the licensees' 
and other entities' audits should unannounced audits appear to be 
necessary. For example, a licensee or other entity may receive 
allegations that an offsite C/V is falsifying records or that a 
contract MRO or SAE is using drugs. The licensee or other entity may 
determine that an unannounced audit would provide the most effective 
means to investigate these allegations. This provision ensures that the 
licensee's or other entity's contract with the C/V permits the 
unannounced audit as well as access to any information necessary to 
conduct the audit. Therefore, the NRC has made this change to meet Goal 
3 of this rulemaking to improve the effectiveness and efficiency of FFD 
programs.
    The NRC had added Sec.  26.41(d)(2) to ensure that licensees' and 
other entities' contracts with C/Vs and HHS-certified laboratories 
permit the licensee or other entity to obtain copies of and take away 
any documents that auditors may need to assure that the C/V, its 
subcontractors, or the HHS-certified laboratory are performing their 
functions properly and that staff and procedures meet applicable 
requirements. This provision responds to several incidents when parties 
under contract to licensees did not permit Part 26 auditors to remove 
documents from a premises of a C/V that were necessary to document 
audit findings, develop corrective actions, and ensure the 
effectiveness of the corrective actions. Therefore, the new requirement 
meets Goal 3 of this rulemaking to improve the effectiveness and 
efficiency of FFD programs. The provision permits HHS-certified 
laboratories to reasonably limit the use and dissemination of the 
documentation that auditors copy and take off site. This change meets 
Goal 7 of this rulemaking to protect the privacy of individuals who are 
subject to Part 26 and protects the trade secrets of HHS-certified 
laboratories who are subject to auditing under the final rule.
    Section 26.41(d)(3) amends the third sentence of former Section 
2.7(m) in Appendix A to Part 26. This sentence required licensees and 
other entities to carry out inspections and evaluations of the 
procedural aspects of an HHS-certified laboratory drug testing 
operations before awarding a contract to the laboratory. The final rule 
adds a cross-reference to Sec.  26.41(g). Section

[[Page 17031]]

26.41(g) permits licensees and other entities to forego the otherwise 
required pre-award evaluation under certain specific circumstances, as 
discussed with respect to that section.
    Section 26.41(e) [Conduct of audits] of the final rule retains the 
requirements in former Sec.  26.80(b).
    Section 26.41(f) [Audit results] of the final rule retains the 
portion of former Sec.  26.80(c) that required licensees and other 
entities to document audit findings and recommendations, report them to 
senior management, and document corrective actions taken in response to 
any identified adverse conditions. The final rule adds two 
requirements. The second sentence of Sec.  26.41(f) specifies the 
required content of audit reports, including identification of any 
conditions that are adverse to the proper performance of the FFD 
program, the cause of the condition(s), and recommended corrective 
actions. The third sentence of the section requires licensees and other 
entities to review the audit findings and take corrective actions, 
including reauditing of indicated deficient areas, to preclude, within 
reason, repetition of the condition. The final rule adds these two 
sentences for consistency with Criterion XVI in Appendix B to 10 CFR 
Part 50 [Domestic licensing of production and utilization facilities] 
to indicate that the corrective action programs of licensees and other 
entities must include FFD audit reports. Some licensees have handled 
FFD audit reports outside of their normal corrective action programs 
that address other conditions adverse to quality. As a result, some 
corrective actions for FFD program weaknesses have not been timely or 
effective. Therefore, the final rule adds these requirements to meet 
Goal 3 of this rulemaking to improve the effectiveness and efficiency 
of FFD programs.
    The NRC has deleted the last sentence of former Sec.  26.80(c) that 
referred to the requirements for auditing HHS-certified laboratories in 
Appendix A to Part 26 because it is redundant with Sec.  26.41(c). The 
NRC has made this change to meet Goal 6 of this rulemaking to improve 
clarity in the organization of the rule.
    Section 26.41(g) [Sharing of audits] of the final rule responds to 
licensees' implementation questions related to the third and fourth 
sentences in former Sec.  26.80(a) that permitted licensees and other 
entities to accept audits of C/Vs that other FFD programs conduct. The 
section clarifies the former permission to accept and rely on others' 
audits in response to implementation questions that the NRC has 
received from licensees with respect to the sharing of audits, as 
documented in Section 17 of NUREG-1354, and items 11.4 and 11.5 of 
NUREG-1385, ``Fitness for Duty in the Nuclear Power Industry: Responses 
to Implementation Questions.''
    Section 26.41(g) amends the former provision to incorporate 
specific permission for licensees and other entities to jointly conduct 
audits as well as rely on one another's audits. The NRC has also added 
a reference to HHS-certified laboratories to indicate the applicability 
of these permissions to licensees' and other entities' audits of HHS-
certified laboratories. These changes are consistent with the guidance 
issued by the NRC in the documents referenced above and current 
licensee practices. Therefore, the NRC has made these changes to meet 
Goal 6 of this rulemaking to improve clarity in the organization and 
language of the rule.
    The NRC has added Sec.  26.41(g)(1) and (g)(2) to the final rule to 
require licensees and other entities to identify any areas that were 
not covered by a shared or accepted audit and ensure that any unique 
services used by the licensee or other entity that were not covered by 
the shared audit are audited. For example, an FFD program may use lower 
cutoff levels for drug testing than the FFD program(s) that conducted a 
shared audit with the result that the shared audit did not address the 
HHS-certified laboratories' procedures for testing at the first FFD 
program's lower cutoff levels. In this case, the first FFD program is 
not permitted to rely on the shared audit with respect to the lower 
cutoff levels and is required to ensure that the HHS-certified 
laboratories' procedures for testing at the lower cutoff levels are 
audited separately (or in conjunction with other FFD programs that use 
the same cutoff levels). These provisions are consistent with the 
guidance issued by the NRC in the documents referenced above and 
current licensee practices. Therefore, the NRC has made these changes 
to meet Goal 6 of this rulemaking to improve clarity in the 
organization and language of the rule.
    Section 26.41(g)(3) retains the portion of the third sentence of 
former Sec.  26.80(a) that stated that licensees and other entities 
need not re-audit the same C/V for the same period of time. This 
provision extends this permission to audits of HHS-certified 
laboratories, which is consistent with the guidance issued by the NRC 
in the documents referenced above and current licensee practices. 
Therefore, the NRC has made this change to meet Goal 6 of this 
rulemaking to improve clarity in the organization and language of the 
rule.
    Section 26.41(g)(4) retains the fourth sentence of former Sec.  
26.80(a). This provision requires licensees and other entities to 
retain copies of the shared audit reports.
    The NRC has added Sec.  26.41(g)(5) to the final rule. The 
provision permits licensees and other entities to immediately obtain 
drug testing services from another HHS-certified laboratory, subject to 
certain conditions, if the laboratory used by the licensee or other 
entity loses its certification. Within 3 months of obtaining services 
from the replacement laboratory, the section requires the licensee or 
other entity to ensure that an audit is conducted of any aspects of the 
laboratory's services that the licensee or other entity use that have 
not been audited within the past 12 months by another licensee or 
entity who is subject to this subpart. This provision enhances the 
effectiveness of FFD programs by ensuring that drug testing will not be 
interrupted or delayed if an HHS-certified laboratory loses its 
certification as some licensees have experienced. The reliability of 
drug testing services provided by the replacement laboratory is ensured 
by the auditing and inspection activities of other licensees and 
entities who have been using the services of the replacement 
laboratory, as well as the audit conducted by the licensee or other 
entity of any services that have not been audited by other licensees or 
entities who are subject to this part. The NRC has made this change to 
meet Goal 3 of this rulemaking to improve the effectiveness and 
efficiency of FFD programs.

Subpart C--Granting and Maintaining Authorization

    Throughout Subpart C, the final rule makes minor clarifications to 
the proposed rule based on public comment, to accommodate conforming 
changes, and to meet Goal 6 of this rulemaking to improve clarity in 
the organization and language of the rule.
    One clarification that the final rule makes in numerous sections in 
this subpart is to state that licensees or other entities subject to 
this subpart shall ``ensure'' that a requirement under this subpart has 
been met. This language differs from that of the proposed rule, which 
stated that the licensee or other entity shall explicitly perform the 
activity (i.e., obtain, review, conduct, complete) to meet the 
requirement. For example, in Sec.  26.55(a)(1), the proposed rule 
stated that the licensee or other entity shall ``obtain and review a 
self-disclosure.'' The final rule states that the licensee or other 
entity shall ``ensure that a self-disclosure has been obtained

[[Page 17032]]

and reviewed.'' This modified language clarifies the NRC's intent that 
licensees or other entities may rely on other entities to assist in 
performing the activities necessary to meet the requirements of this 
subpart. For example, many licensees rely on contractors to conduct the 
suitable inquiry required under Sec.  26.63. However, the final rule 
retains the language of the proposed rule in Sec.  26.69(b) for the 
reasons discussed with respect to that paragraph. In another change 
from the proposed rule text, the NRC has eliminated the term ``non-
negative'' and replaced it with the phrase ``positive, adulterated, or 
substituted'' for the reasons discussed with respect to Sec.  26.5 
[Definitions].
    The final rule also makes more substantive changes to the proposed 
rule in this subpart because of public comment or to improve clarity in 
the organization and language of the rule. The substantive changes in 
this subpart can be found in Sec.  Sec.  26.51; 26.53(d) through (i); 
26.57(b); 26.61(c) and (d); 26.63(c), (c)(3), (d) and (f); 26.65(c), 
(c)(2), (d)(1)(i), (d)(2)(ii), (e) and (f); and 26.69(c), (c)(1) and 
(e)(1). These changes are discussed in detail below. However, other 
than the changes mentioned above, the final rule adopts the provisions 
of this subpart as proposed, without change.
Section 26.51 Applicability
    The final rule amends Sec.  26.51 of the proposed rule to describe 
the applicability of the subpart. The NRC has changed the heading of 
this section from ``Purpose'' to ``Applicability'' because the NRC has 
revised the content of the section to specify the licensees, entities, 
and categories of individuals to whom the requirements Subpart C apply 
by using cross-references to the relevant paragraphs in Sec.  Sec.  
26.3 [Scope] and 26.4 [FFD program applicability to categories of 
individuals]. The NRC made this change in response to public comments 
requesting this clarification in the rule text and to meet Goal 6 of 
this rulemaking.
Section 26.53 General Provisions
    The NRC has added Sec.  26.53 to the final rule to provide an 
overview of the requirements and process for determining when 
individuals may be granted and maintain authorization. With respect to 
the proposed rule, paragraph (e) has been added to this section to 
specify the requirements for relying on the FFD program of a C/V when 
granting or maintaining authorization. Paragraph (f) specifies that 
licensees and other entities may not rely on FFD programs under Subpart 
K [FFD programs for Construction] of this rule to meet the requirements 
of this subpart. The reasons for adding these paragraphs are discussed 
with respect to the specific paragraphs.
    Section 26.53(a) of the final rule introduces four new terms to 
Part 26: ``Initial authorization,'' ``authorization update,'' 
``authorization reinstatement,'' and ``authorization with potentially 
disqualifying FFD information.'' The final rule uses these terms to 
describe categories of requirements for granting authorization. These 
categories are based on whether an applicant has previously held 
authorization under Part 26 and the length of time that has elapsed 
after the individual's last period of authorization ended, and are 
described in Sec.  26.55 [Initial authorization], Sec.  26.57 
[Authorization update], Sec.  26.59 [Authorization reinstatement], and 
Sec.  26.69 [Authorization with potentially disqualifying fitness-for-
duty information]. Section 26.53(a) directs licensees or other entities 
to use the criteria for granting authorization to individuals found in 
Sec.  Sec.  26.55, 26.57, 26.59, or 26.69, depending on which of these 
sections applies to the individual seeking authorization. The former 
rule in Sec.  26.27 [Management actions and sanctions to be imposed] 
discussed actions that the licensee must take before initially granting 
access or assigning specified duties to an individual, but did not use 
the concepts of ``initial authorization,'' ``authorization update,'' 
``authorization reinstatement,'' or ``authorization with potentially 
disqualifying FFD information.'' The final rule uses these concepts to 
focus the requirements for authorization more precisely on whether the 
individual has an established record (i.e. authorization history) in 
the industry. The NRC also uses these concepts to specify the amount of 
original information-gathering activities licensees or other entities 
are required to perform, according to whether previous FFD programs 
have collected information about the individual. In addition, the NRC 
uses similar concepts in access authorization requirements found in 10 
CFR 73.56 [Personnel access authorization requirements for nuclear 
power plants] and access authorization orders issued by the agency to 
nuclear power plant licensees. The NRC has incorporated these concepts 
into Part 26 to increase the consistency between the related 
regulations in accordance with Goal 4 of this rulemaking.
    Section 26.53(b) of the final rule defines the meaning of the term 
``interruption'' which is used in Sec.  26.57 and Sec.  26.59 to refer 
to the interval of time between periods during which an individual 
holds authorization under Part 26. Licensees and other entities shall 
calculate an interruption in authorization as the total number of days 
falling between the day the individual's last period of authorization 
ended and the day the licensee or other entity grants authorization to 
the individual. Section 26.53(b) also specifies that if potentially 
disqualifying FFD information is disclosed or discovered about an 
individual, licensees and other entities must implement the applicable 
requirements in Sec.  26.69 in order to grant or maintain an 
individual's authorization, rather than relying on the requirements in 
Sec.  Sec.  26.55, 26.57, or 26.59.
    Section 26.53(c) of the final rule references the FFD training 
requirements in Sec.  26.29 [Training] and the fatigue training 
requirements in Sec.  26.203(c) [Training and examinations] to clarify 
that all individuals who are subject to Subpart C must meet the 
applicable requirements for initial or refresher FFD training, as 
appropriate, before the licensee or other entity may grant 
authorization to the individuals. This provision references the 
training requirements for organizational clarity because they apply to 
the authorization process. As discussed in the preamble to the proposed 
rule, stakeholders requested that the regulation present requirements 
in the order in which they would apply to licensees' and other 
entities' FFD processes. The NRC has added this paragraph to meet Goal 
6 of this rulemaking to improve clarity in the organization and 
language of the rule.
    Section 26.53(d) of the final rule permits licensees and other 
entities to rely on other licensees' or entities' FFD programs and 
program elements to meet the requirements of this subpart for granting 
and maintaining authorization. Section 26.53(d) expands upon a section 
of the former rule that similarly permitted licensees and other 
entities to accept and rely on other FFD programs and program elements. 
Specifically, former Sec.  26.24(a)(1) permitted licensees to accept 
results from drug and alcohol tests that were administered under 
another Part 26 program within the past 60 days. Consistent with the 
principle of permitting licensees to accept and rely on other Part 26 
programs in their authorization decisions, guidance contained in NUREG-
1385, ``Fitness for Duty in the Nuclear Power Industry: Responses to 
Implementation Questions,'' also indicates that licensees may 
``accept'' an authorization granted by a previous licensee for 
individuals

[[Page 17033]]

who transfer between licensees with only a short break in 
authorization.
    The final rule substantially increases the specificity of the 
requirements that licensees or other entities must meet for granting 
authorization and establishes detailed minimum standards that all 
programs must meet. The agency designed these detailed minimum 
standards to address recent changes in industry practices that have 
resulted in a more transient workforce. Because the FFD programs of 
licensees and other entities will be substantially more consistent than 
in the past under these detailed standards, permitting licensees and 
other entities to rely on other FFD programs to meet the rule's 
requirements is reasonable and appropriate. Section 26.53(d) eliminates 
unnecessary redundancies in the steps required to grant authorization 
to an individual who is transferring from one FFD program to another, 
consistent with Goal 5 of this rulemaking to improve Part 26 by 
eliminating or modifying unnecessary requirements. With respect to the 
proposed rule, the final rule specifies that the receiving FFD program 
shall ensure that the program elements to which the individual is 
subject under the transferring FFD program remain current. The NRC has 
made this change to the proposed rule in recognition of the need for 
additional consistency between the final rule and the access 
authorization requirements. Therefore, this change helps meet Goal 4 of 
this rulemaking to improve consistency between FFD requirements and 
access authorization requirements established in 10 CFR 73.56, as 
supplemented by orders to nuclear power plant licensees dated January 
7, 2003.
    In response to public comment, the final rule adds paragraph (e) to 
Sec.  26.53 to clarify the relationship between licensees' and other 
entities' FFD programs and those of C/Vs. Section 26.53(e) retains the 
permission in former Sec.  26.23 [Contractors and vendors] for 
licensees to rely upon C/Vs' FFD programs that have been formally 
reviewed and approved by the licensee. The paragraph also permits the 
licensees and other entities in Sec.  26.3(a) through (c) to rely on a 
C/V's FFD program elements that meet the requirements of Part 26. For 
example, some C/Vs ensure that their employees receive initial and 
refresher FFD training so that, when the employee is assigned to work 
on a contract that requires him or her to have unescorted access to a 
nuclear power plant protected area, it is unnecessary for the licensee 
to provide FFD training to the C/V's employee in order to grant 
unescorted access to this individual. The final rule adds this 
permission to rely on a C/V's FFD program elements to codify a long-
standing industry practice that has been endorsed by the NRC and to 
provide clarity in the language of the rule.
    Section 26.53(e)(1) permits a C/V to grant, maintain, deny, or 
unfavorably terminate an individual's authorization under the C/V's FFD 
program. As defined in Sec.  26.5, granting authorization in this case 
means that a C/V has determined that the individual has met the 
requirements in this subpart and is eligible to have the types of 
access and perform the duties specified in Sec.  26.4. Maintaining 
authorization under a C/V's FFD program means that the individual 
continues to meet the requirements of this subpart and be eligible to 
perform the duties specified in Sec.  26.4. However, the second 
sentence of Sec.  26.53(e)(1) retains the intent of the provisions in 
former Sec.  26.23 that placed responsibility on licensees for ensuring 
that individuals who are ``performing activities within the scope of 
this part'' meet the requirements in Part 26. However, the final rule 
updates the terminology used to convey this intent and adds cross-
references to other sections of the rule for clarity and consistency 
with other rule changes.
    Section 26.53(e)(2) further clarifies the relationship between 
authorization under a C/V's FFD program and authorization under the FFD 
programs of licensees and other entities in Sec.  26.3(a) through (c). 
This provision addresses circumstances when a C/V's FFD program 
determines that an individual does not meet the requirements of this 
subpart to be granted or maintain authorization and denies or 
unfavorably terminates the individual's authorization under the C/V's 
program. The rule requires that if the C/V's FFD program denies or 
unfavorably terminates the authorization of an individual who is 
performing the duties for a licensee that are listed in the specified 
sections of Sec.  26.4, the C/V must inform the affected licensee or 
other entity of the denial or unfavorable termination. In this case, 
the licensee or other entity shall, on the day the licensee receives 
the information from the C/V, deny or unfavorably terminate the 
individual's authorization or implement the applicable process in Sec.  
26.69 to maintain the individual's authorization. For example, if a C/
V's employee is convicted of selling illegal drugs and reports the 
conviction to the C/V, the C/V would unfavorably terminate this 
individual's authorization under the C/V's FFD program. If the 
individual was also assigned to a contract that required him or her to 
have unescorted access to the protected area of a nuclear power plant 
at the time he or she was convicted, this provision requires the C/V to 
inform the FFD program of the licensee or other entity of the 
conviction. The licensee would then either terminate the individual's 
unescorted access on the day that the licensee or other entity receives 
the information from the C/V or, in unlikely circumstances, may 
implement the process established in Sec.  26.69(d) for determining 
whether an individual may maintain authorization after potentially 
disqualifying FFD information is disclosed or discovered. This 
provision codifies a long-standing industry practice that has been 
endorsed by the NRC and adds clarity in the rule language. The NRC has 
also added this requirement in recognition of the need for additional 
consistency between the final rule and the access authorization 
requirements. Therefore, this change helps meet Goal 4 of this 
rulemaking to improve consistency between FFD requirements and access 
authorization requirements established in 10 CFR 73.56, as supplemented 
by orders to nuclear power plant licensees dated January 7, 2003.
    The final rule has added Sec.  26.53(e)(3) to the final rule to 
explicitly permit the licensees and other entities in Sec.  26.3(a) 
through (c) to rely on a C/V's FFD program and program elements, or a 
combination of program elements from the licensee's or other entity's 
FFD program and the C/V's FFD program, to satisfy the requirements of 
Subpart C for maintaining an individual's authorization. This paragraph 
repeats the language in Sec.  26.53(d), which permits licensees and 
other entities to rely on one another's FFD programs and program 
elements, but applies it to C/V FFD programs and program elements for 
additional clarity in the language of the rule. The final rule also 
clarifies that the receiving licensee's or other entity's FFD program 
shall ensure that the program elements to which the individual is 
subject under the C/V's FFD program remain current. The NRC has made 
this change to the proposed rule in recognition of the need for 
additional consistency between the final rule and the access 
authorization requirements. Therefore, this change helps meet Goal 4 of 
this rulemaking to improve consistency between FFD requirements and 
access authorization requirements established in 10 CFR 73.56, as 
supplemented by orders to nuclear power plant licensees dated January 
7, 2003.
    The NRC has also added Sec.  26.53(f) to the final rule to prohibit 
licensees and

[[Page 17034]]

other entities from relying on an FFD program that has been implemented 
under Subpart K of this part when granting authorization to an 
individual. This prohibition is necessary because Subpart K permits the 
licensees and other entities specified in Sec.  26.3(c) greater 
flexibility in establishing and implementing an FFD program than is 
permitted in Subpart C. For example, Subpart K does not require the 
licensees and other entities in Sec.  26.3(c) to conduct a suitable 
inquiry of individuals who are permitted to perform the duties 
described in Sec.  26.4(f). Therefore, in order to grant authorization 
to such an individual to have the types of access or perform the duties 
in Sec.  26.4(a) or (b), for example, a licensee in Sec.  26.3(a) would 
be required to ensure that a suitable inquiry has been completed under 
Sec.  26.63. However, this new provision would permit a licensee or 
other entity to rely on the program elements of a Subpart K FFD program 
if the program elements meet the applicable requirements of Subpart C. 
For example, if a Subpart K program included suitable inquiry 
requirements and implemented them under Sec.  26.63, a licensee or 
other entity could rely on those suitable inquiry results when granting 
authorization under Subpart C. This section satisfies Goal 3 of this 
rulemaking by improving the effectiveness and efficiency of FFD 
programs.
    The NRC has added 26.53(g) to the final rule to require licensees 
and other entities to identify any FFD violation to any licensee who 
has relied or intends to rely on the FFD program element that is 
determined to be in violation of this part. The NRC has made this 
change to the proposed rule in recognition of the need for additional 
consistency between the final rule and the access authorization 
requirements. Therefore, this change helps meet Goal 4 of this 
rulemaking to improve consistency between FFD requirements and access 
authorization requirements established in 10 CFR 73.56, as supplemented 
by orders to nuclear power plant licensees dated January 7, 2003.
    In the final rule, the NRC has added a new provision in Sec.  
26.53(h) to prohibit licensees and other entities from initiating any 
actions under Subpart C, such as beginning to gather information about 
the individual's authorization history from other licensees or 
entities, without the knowledge and consent of the individual who is 
applying for authorization. The new provision in the final rule also 
informs individuals that they may withdraw consent at any time, and 
specifies the actions that licensees and other entities must take if an 
individual withdraws his or her consent. The NRC has added this 
provision to provide additional protection of individuals' privacy by 
ensuring that licensees and other entities do not gather personal 
information about an individual without his or her permission. The 
requirements to inform the individual that he or she may withdraw 
consent and for licensees and other entities to inform the individual 
of what information will be documented and shared with other licensees 
or entities following a withdrawal of consent are necessary to protect 
individuals' other rights under the rule, including due process. 
Therefore, this provision meets Goal 7 of this rulemaking to protect 
the privacy and other rights (including due process) of individuals 
subject to Part 26. This provision meets Goal 4 of this rulemaking to 
improve consistency between FFD requirements and access authorization 
requirements established in 10 CFR 73.56, as supplemented by orders to 
nuclear power plant licensees dated January 7, 2003.
    The NRC has added Sec.  26.53(i) to the final rule to require 
licensees and other entities specified in Sec.  26.3(a) and, as 
applicable, (c) and (d), to inform individuals applying for 
authorizations of the actions related to providing and sharing personal 
information that are sufficient cause for denial or unfavorable 
termination of authorization. The actions that are sufficient cause for 
denial or unfavorable termination of authorization include refusal to 
provide written consent, as specified in Sec.  26.53(i)(1), and refusal 
to provide or the falsification of any personal information required 
under this subpart, including the failure to report any previous denial 
or unfavorable termination of authorization, as specified in Sec.  
26.53(i)(2). These provisions were moved from Sec.  26.63(d) and Sec.  
26.61(d) of the proposed rule, respectively. The NRC has added Sec.  
26.53(i)(3) and (i)(4) to specify that a refusal to provide written 
consent for the sharing of personal information with other licensees or 
other entities, as required in Sec.  26.53(h), and a failure to report 
any legal actions, respectively, are also sufficient cause for denial 
or unfavorable termination of authorization. Also, the NRC has made 
these changes to the proposed rule in recognition of the need for 
additional consistency between the final rule and the access 
authorization requirements. Therefore, this change helps meet Goal 4 of 
this rulemaking to improve consistency between FFD requirements and 
access authorization requirements established in 10 CFR 73.56, as 
supplemented by orders to nuclear power plant licensees dated January 
7, 2003.
Section 26.55 Initial Authorization
    The NRC has added Sec.  26.55 to the final rule, which defines the 
category of ``initial authorization'' requirements as applying both to 
individuals who have not previously held authorization under Part 26 
and those whose authorization has been interrupted for a period of 3 
years or more and ended favorably.
    Two considerations support the mandate for individuals whose last 
period of authorization ended 3 or more years previously to satisfy the 
same requirements as individuals who have never previously held 
authorization. In general, the longer the period of time since the 
individual's last period of authorization ended, the greater the 
possibility that the individual has developed an active substance abuse 
problem or undergone significant changes in lifestyle or character that 
would diminish his or her trustworthiness, reliability, and ability to 
perform work safely and competently. Therefore, it is reasonable to 
require a full and extensive screening identical to that given an 
individual who has not held authorization, and has not been subject to 
drug and alcohol testing and behavioral observation, for 3 years or 
more. For similar reasons, access authorization requirements also 
require that individuals who have not held authorization for 3 years or 
more must be subject to the same screening as individuals who have not 
previously held authorization. Therefore, mandating that individuals 
whose last period of authorization ended 3 or more years previously 
must satisfy the same requirements as individuals who have never held 
authorization increases the consistency of Part 26 with the related 
access authorization requirements, consistent with Goal 4 of this 
rulemaking.
    Section 26.55(a)(1) requires the licensee or other entity, before 
granting initial authorization to an individual, to ensure that a self-
disclosure has been obtained and reviewed in accordance with the 
applicable requirements of Sec.  26.61 [Self-disclosure and employment 
history]. As discussed with respect to Sec.  26.61, the self-disclosure 
and employment history requirements mandate that the individual report 
violations, if any, involving drugs or alcohol and the individual's 
current and past employment history. The requirement is similar to that 
in Sec.  26.27(a)(1) of the former rule that a

[[Page 17035]]

written statement must be obtained from the individual addressing the 
topics that are specified in former Sec.  26.27(a)(1). The discussion 
of Sec.  26.61 in this document compares the topics required to be 
addressed in the written statement under the former rule with the 
topics that are addressed in the self-disclosure under this final rule. 
As discussed with respect to Sec.  26.61(b)(3), an applicant for 
initial authorization must address in the self-disclosure the shorter 
period of either the past 5 years or the interval of time that has 
elapsed since the individual's eighteenth birthday.
    Section 26.55(a)(2) requires the licensee or other entity to ensure 
that a suitable inquiry has been completed under the applicable 
requirements of Sec.  26.63 [Suitable inquiry] before granting initial 
authorization to an individual. The requirement is similar to that in 
Sec.  26.27(a)(2) of the former rule that a suitable inquiry must be 
completed addressing the topics that are specified in Sec.  
26.27(a)(2). The discussion of Sec.  26.63 in this document compares 
the topics that the suitable inquiry must address under the former rule 
with the topics that it addresses under the final rule. Section 
26.63(f)(1) specifies that the suitable inquiry for an initial 
authorization must address the shorter period of either the past 3 
years or the interval of time that has elapsed since the individual's 
eighteenth birthday.
    Section 26.55(a)(3) requires the licensee or other entity to ensure 
that the individual has been subject to pre-access drug and alcohol 
testing under the applicable requirements of Sec.  26.65 [Pre-access 
drug and alcohol testing] before granting initial authorization to an 
individual. Former Sec.  26.24(a)(1) required testing within the 60 
days before initially granting unescorted access to protected areas or 
assignment to activities within the scope of Part 26. The discussion of 
Sec.  26.65 in this document compares the pre-access drug and alcohol 
testing requirements for initial authorization in this rule to the 
requirements in the former rule. Section 26.65 requires the licensee or 
other entity to ensure that the individual had negative drug and 
alcohol test results from testing that had been completed within the 
past 30 days before granting authorization to the individual.
    Section 26.55(a)(4) requires the licensee or other entity also to 
ensure that the individual has been subject to random drug and alcohol 
testing under the applicable requirements of Sec.  26.67 [Random drug 
and alcohol testing of individuals who have applied for authorization]. 
Former Sec.  26.64(a)(2) required unannounced drug and alcohol tests 
imposed in a statistically random and unpredictable manner. The 
discussion of Sec.  26.67 in this document compares the random drug and 
alcohol testing requirements for initial authorization in this rule to 
the requirements in the former rule.
    Section 26.55(b) of the final rule mandates that the licensee or 
other entity must meet the requirements in Sec.  26.69 to grant 
authorization to the individual, if potentially disqualifying FFD 
information is disclosed or discovered about the individual who is 
applying for authorization that another licensee or other entity has 
not previously evaluated.
Section 26.57 Authorization Update
    The NRC has added Sec.  26.57 to the final rule, which defines the 
category of ``authorization update'' requirements for granting 
authorization to individuals whose authorization has been interrupted 
for more than 365 days but less than 3 years and whose last period of 
authorization was terminated favorably.
    As noted in the discussion of Subpart C in Section IV.C, the 
requirements for granting an authorization update are less stringent 
than the requirements for granting initial authorization. The 
requirements are less stringent because (1) the individual who is 
applying for an authorization update will have a more recent history of 
successful performance within the industry, and (2) the licensee or 
other entity will have access to information about the individual from 
the licensee or other entity who last granted authorization to him or 
her because of the increased information-sharing requirements of the 
final rule. However, the requirements in the final rule for an 
authorization update focus on gathering and evaluating information from 
the interruption period because the licensee or other entity will not 
have information about the individual's activities during the period of 
the interruption. For example, in the case of an individual whose last 
period of authorization ended 2 years ago, the licensee or other entity 
will focus on gathering information about the individual's activities 
within the 2-year interruption period. If an individual's last period 
of authorization ended 13 months ago, the licensee or other entity will 
focus on gathering information about the individual's activities within 
those 13 months.
    Section 26.57(a) of the final rule, like Sec.  26.55(a), requires 
the licensee or other entity before granting authorization to ensure 
that:
    (1) A self-disclosure has been obtained and reviewed under the 
applicable requirements of Sec.  26.61;
    (2) A suitable inquiry has been completed under the applicable 
requirements of Sec.  26.63;
    (3) The individual has been subject to pre-access drug and alcohol 
testing under the applicable requirements of Sec.  26.65; and
    (4) The individual has been subject to random drug and alcohol 
testing under the applicable requirements of Sec.  26.67.
    However, Sec.  26.61(b)(3)(iii) and (c)(3) limits the period of 
time to be addressed in the self-disclosure and employment history to 
the interruption period. If an individual's last period of 
authorization ended 2 years ago, the self-disclosure and employment 
history would cover only the past 2 years. Similarly, Sec.  26.63(f)(2) 
provides that the suitable inquiry for an authorization update must 
cover the interruption period. The final rule requires the self-
disclosure, employment history, and suitable inquiry to address only 
the interruption period because the licensee or other entity may obtain 
information from earlier periods in the individual's history from the 
licensee or other entity who had last granted authorization to the 
individual.
    The NRC has added Sec.  26.57(b) to specify that if potentially 
disqualifying FFD information is disclosed or discovered about the 
individual who is applying for authorization, the licensee or other 
entity may not grant authorization to the individual, except under 
Sec.  26.69.
Section 26.59 Authorization Reinstatement
    The NRC has added Sec.  26.59 to the final rule, which establishes 
two categories of authorization reinstatement requirements for 
individuals whose authorization has been interrupted for a short period 
and whose last period of authorization was terminated favorably.
    One category of authorization reinstatement requirements applies to 
individuals whose authorization has been interrupted for more than 30 
days but no more than 365 days in Sec.  26.59(a), and the other to 
individuals whose authorization has been interrupted for 30 or fewer 
days in Sec.  26.59(c). The steps for reinstating an individual's 
authorization after an interruption of 365 or fewer days are less 
stringent than those required for initial authorization or an 
authorization update because these individuals will have a recent, 
positive record within the industry and pose little risk to public 
health and

[[Page 17036]]

safety or the common defense and security.
    The requirements that are related to an individual whose 
authorization has been interrupted for more than 30 days but no more 
than 365 days are more extensive than the requirements for granting 
authorization to an individual whose authorization has been interrupted 
for 30 or fewer days. The requirements for the 31-365-day category are 
consistent with those contained in the access authorization orders 
issued by the NRC to nuclear power plant licensees dated January 7, 
2003. However, the requirements for individuals whose authorization has 
been interrupted for 30 or fewer days are more stringent than those 
contained in those orders. Under the access authorization orders, 
licensees are required to obtain and review a self-disclosure and 
employment history from the applicant before reinstating the 
individual's authorization. Under this amendment, licensees and other 
entities are also required to subject the individual to the possibility 
of selection for pre-access testing under Sec.  26.65(e) [Authorization 
reinstatement after an interruption of 30 or fewer days]. The NRC has 
determined that this additional requirement is necessary to meet the 
final rule's performance objective of providing reasonable assurance 
that individuals are trustworthy and reliable by extending the 
deterrent effect of pre-access testing to individuals who have had an 
interruption in authorization of 30 or fewer days in length.
    For individuals whose authorization has been interrupted for 31-365 
days, Sec.  26.59(a)(1) requires the licensee or other entity to ensure 
that a self-disclosure and employment history has been obtained and 
reviewed in order to reinstate authorization. Consistent with the 
requirements for authorization updates in Sec.  26.57, the final rule 
in Sec.  26.61(b)(3)(iii) and (c)(3) limits the period of time to be 
addressed in the self-disclosure and employment history to the period 
of the interruption in authorization. A self-disclosure and employment 
history for earlier periods of time is unnecessary because the granting 
licensee or other entity will have access to information about the 
individual from the licensee or other entity who recently terminated 
the individual's authorization.
    Section 26.59(a)(2) permits the licensee or other entity to 
reinstate an individual's authorization without first ensuring that a 
suitable inquiry has been completed, in contrast to the requirements 
for an initial authorization and an authorization update. The final 
rule permits this because these individuals will have a recent, 
positive record within the industry and pose little risk to public 
health and safety or the common defense and security. As is required 
for an authorization update, this provision limits the period of time 
to be addressed by the suitable inquiry to the interruption period in 
Sec.  26.63(f)(3). However, this provision requires licensees and other 
entities to ensure that the suitable inquiry is completed within 5 
business days after reinstating the individual's authorization. If the 
suitable inquiry is not completed within the 5-day period, the licensee 
or other entity can maintain the individual's authorization for up to 
10 business days following the day authorization was reinstated, but 
only if the licensee or other entity is unaware of any potentially 
disqualifying information about the individual. If the suitable inquiry 
is not completed within 10 business days, the rule requires the 
licensee or other entity to administratively withdraw the individual's 
authorization until the suitable inquiry is completed.
    Section 26.59(a)(3) requires the licensee or other entity to ensure 
that the individual whose authorization has been interrupted for 31-365 
days has been subject to pre-access drug and alcohol testing, and Sec.  
26.59(a)(4) requires the licensee or other entity to ensure that the 
individual whose authorization has been interrupted for 31-365 days is 
subject to random testing. Section 26.65(d) [Authorization 
reinstatement after an interruption of more than 30 days] establishes 
pre-access drug and alcohol testing requirements for authorization 
reinstatements. Section 26.67 specifies the requirements for the random 
testing of individuals who are applying for an authorization 
reinstatement.
    The NRC has added Sec.  26.59(b) to the final rule to ensure that 
any administrative withdrawal of authorization required under Sec.  
26.59(a)(2) is not reported or recorded as an unfavorable termination 
of authorization until the suitable inquiry is completed and it 
indicates that authorization should not be granted. This provision 
ensures that a temporary administrative withdrawal of authorization 
caused by a licensee's or other entity's delay in completing the 
suitable inquiry is not treated as an unfavorable termination caused by 
an FFD violation. The final rule specifies that the individual may not 
be required to disclose the administrative action in response to 
requests for self-disclosure of potentially disqualifying FFD 
information. With respect to the proposed rule, the final rule 
clarifies that the individual is required to disclose the 
administrative action if the individual's authorization was 
subsequently denied or terminated unfavorably. The NRC has made this 
change to the proposed rule in recognition of the need for additional 
consistency between the final rule and the access authorization 
requirements. Therefore, this change helps meet Goal 4 of this 
rulemaking to improve consistency between FFD requirements and access 
authorization requirements established in 10 CFR 73.56, as supplemented 
by orders to nuclear power plant licensees dated January 7, 2003. 
Section 26.59(b) is necessary to meet Goal 7 of this rulemaking to 
protect the privacy and other rights (including due process) of 
individuals who are subject to Part 26 by ensuring that they are not 
subject to any adverse consequences for the licensee's or other 
entity's delay in completing the suitable inquiry.
    Section 26.59(c) of the final rule establishes authorization 
requirements for individuals whose authorization has been interrupted 
for 30 or fewer days. Section 26.59(c)(1) requires the licensee or 
other entity to ensure that a self-disclosure has been obtained and 
reviewed with certain exceptions that are specified in Sec.  26.61. The 
licensee or other entity is permitted to forego conducting a suitable 
inquiry for individuals whose authorization has been interrupted for 
such a short period. Section 26.59(c)(2) permits licensees and other 
entities also to forego pre-access drug and alcohol testing of 
individuals whose authorization has been interrupted for 5 or fewer 
days. However, pre-access testing may be required under Sec.  26.65(e) 
for individuals whose authorization has been interrupted for 6 to 30 
days. Sections 26.61 and 26.65 specify the exceptions to the self-
disclosure and pre-access testing requirements in this provision, 
respectively.
Section 26.61 Self-Disclosure and Employment History
    The NRC has added Sec.  26.61 to the final rule to replace former 
Sec.  26.27(a)(1) for the reasons discussed in Section IV.C. The final 
rule replaces the term ``written statement'' in the former rule with 
the phrase ``self-disclosure and employment history'' to more 
accurately characterize the requirement. The NRC has made this change 
to meet Goal 6 of this rulemaking to improve clarity in the language of 
the rule.
    The NRC has added Sec.  26.61(a) to the final rule to require 
licensees and other entities to ensure that a written self-disclosure 
and employment history has

[[Page 17037]]

been obtained from every applicant before granting authorization to the 
individual, except in two circumstances, as follows.
    Section 26.61(a)(1) permits the licensee or other entity to forego 
obtaining a self-disclosure and employment history if all three of the 
following conditions are met:
    (1) The individual previously held authorization under Part 26;
    (2) The individual's last period of authorization was terminated 
favorably; and
    (3) The individual has been subject to a behavioral observation and 
arrest-reporting program that meets the requirements of this part 
throughout the time the individual's authorization was interrupted.
    The information to be obtained from the self-disclosure and 
employment history is unnecessary in these circumstances because it 
will already be available to the granting licensee or other entity from 
the FFD program that had been implementing the behavioral observation 
and arrest-reporting program during the interruption in the 
individual's authorization. A requirement for licensees and other 
entities to conduct another suitable inquiry is redundant and imposes 
an unnecessary burden.
    Section 26.61(a)(2) permits licensees and other entities to forego 
obtaining an employment history from applicants for an authorization 
reinstatement whose authorization has been interrupted for 30 or fewer 
days. The employment history information is unnecessary in this case 
because the final rule does not require licensees or other entities to 
conduct a suitable inquiry for individuals who have had such a short 
break in authorization.
    The NRC has added Sec.  26.61(b) to the final rule to specify the 
required content of the written self-disclosure. Affirmative responses 
to any of the questions in Sec.  26.61(b)(1) are considered potentially 
disqualifying FFD information, as defined in Sec.  26.5. The final rule 
expands the scope of the questions to be asked from those required in 
former Sec.  26.27(a)(1) in order to provide greater assurance that 
individuals will disclose information indicating an active substance 
abuse problem or an increased risk of recidivism into an active 
substance abuse problem after treatment. Former Sec.  26.27(a)(2) 
required information about whether the applicant ``tested positive for 
drugs or use of alcohol that resulted in on-duty impairment.'' Section 
26.61(b)(1) requires information about whether the applicant used, 
sold, or possessed illegal drugs, subverted or attempted to subvert a 
drug or alcohol testing program, or refused to take a drug or alcohol 
test. Both former Sec.  26.27(a)(2) and Sec.  26.61(b)(1) require 
information on whether the applicant has been subject to a plan for 
substance abuse treatment (except for a self-referral). Both require 
information about previous denials or terminations of authorization.
    The NRC has added Sec.  26.61(b)(2) to the final rule to require 
the applicant to disclose the circumstances surrounding any potentially 
disqualifying FFD information and the resolution of the matter. For 
example, Sec.  26.61(b)(1) requires an applicant to report an arrest on 
drug-related charges, while Sec.  26.61(b)(2) requires the applicant to 
report the outcome of the arrest (e.g., charges, a conviction, a 
finding of not guilty, the dropping of the charges).
    Section 26.61(b)(3) defines the time period that the self-
disclosure must address. The final rule establishes a time limit on the 
number of years in the past for which an individual is required to 
report and account for potentially disqualifying FFD information. One 
purpose of the self-disclosure is to identify indicators of an active 
substance abuse problem or an increased risk of recidivism into an 
active substance abuse problem after treatment. The relevant research 
literature indicates that post-treatment recidivism (i.e., relapse) 
rates decrease after 3 years of no further substance abuse, and a 
larger decrease occurs in the recidivism rate after 5 years. If the 
applicant discloses no indicators of a substance abuse problem within 
the past 5 years (or since the applicant's eighteenth birthday, in the 
case of an applicant who is less than 23 years of age), an applicant 
for initial authorization (see Sec.  26.55) is not required to disclose 
earlier events related to substance abuse. For applicants who held 
authorization within the past 3 years, the self-disclosure addresses 
only the time interval after the individual's last period of 
authorization ended. However, the licensee or other entity shall obtain 
further information about the applicant over the past 5 years by 
reviewing the information made available by licensees or other entities 
who granted authorization to the applicant in the past. This includes 
information developed as part of previous suitable inquiries (see Sec.  
26.63) as well as information from the period(s) during which the 
individual was subject to other FFD programs.
    Section 26.61(c) in the final rule modifies this provision as 
proposed. The proposed rule specified that applicants must provide 
information about current and past employers, which the licensee or 
other entity then uses for the suitable inquiry if a suitable inquiry 
is required under Sec.  26.63. However, the final rule requires the 
individual to provide a list of employers to include the employer by 
whom he or she claims to have been employed on the day before he or she 
completes the employment history. The agency has also made this change 
in Sec.  26.63(c). The NRC has made this change in response to a public 
comment, which stated that a licensee or other entity has the ability 
to ensure that a suitable inquiry has been conducted only of those 
employers that are listed in the self-disclosure or employment history. 
The NRC believes that this revision provides more specificity in cases 
when an individual's current employer changes after he or she submits 
the self-disclosure. This change is consistent with Goal 6 of the 
rulemaking to improve clarity in the organization and language of the 
rule.
    The NRC has moved the provision in proposed Sec.  26.61(d) to Sec.  
26.53(i)(2) of the final rule to meet Goal 6 of this rulemaking to 
improve clarity in the organization of the rule.
Section 26.63 Suitable Inquiry
    The NRC has added Sec.  26.63 to the final rule. This section 
amends former Sec.  26.27(a)(2) and the requirements related to 
conducting a suitable inquiry that are contained within the definition 
of the term ``suitable inquiry'' in former Sec.  26.3. The former rule 
defined a suitable inquiry as a ``best-effort verification of 
employment history for the past 5 years, but in no case less than 3 
years, obtained through contacts with previous employers to determine 
if a person was, in the past, tested positive for illegal drugs, 
subject to a plan for treating substance abuse, removed from, or made 
ineligible for activities within the scope of 10 CFR Part 26, or denied 
unescorted access at any other nuclear power plant or other employment 
in accordance with a fitness-for-duty policy.'' In general, the NRC 
intends that the changes to the former requirements better focus the 
suitable inquiry on indicators of an active substance problem and/or an 
increased risk of recidivism into an active substance abuse problem 
following treatment, as discussed in Section IV.C; increase the 
consistency in implementing suitable inquiries among FFD programs by 
providing more detailed requirements, also as discussed in Section 
IV.C; and improve Part 26 by eliminating or modifying unnecessary

[[Page 17038]]

requirements, which is Goal 5 of this rulemaking.
    For all authorization categories, the suitable inquiry required by 
the final rule is more thorough than previous industry practices to 
increase the likelihood that any potentially disqualifying FFD 
information is identified and provide reasonable assurance that 
individuals are trustworthy and reliable, as demonstrated by avoiding 
substance abuse. For individuals who have established a recent, 
favorable work history under Part 26, as demonstrated by having held 
authorization that was terminated favorably within the past 3 years, 
the NRC has reduced the period of time addressed in the suitable 
inquiry from the past 5 years in every case, to the past 3 years or 
fewer, depending on how recently the applicant held authorization. If 
potentially disqualifying FFD information within the past 5 years is 
identified regarding an applicant and a previous licensee or other 
entity has not addressed and favorably resolved it, the suitable 
inquiry requirements are more extensive, as described in Sec.  26.69.
    The NRC has added Sec.  26.63(a) to the final rule to require 
licensees and other entities to ensure that a suitable inquiry has been 
conducted to verify the information provided by the applicant in the 
self-disclosure and employment history obtained under Sec.  26.61 and 
to determine if additional potentially disqualifying FFD information is 
available regarding the applicant. The provision also establishes the 
circumstances in which a licensee or other entity is permitted to 
forego the suitable inquiry in order to grant authorization to 
individuals. A licensee or other entity is permitted to forego the 
suitable inquiry if the individual previously held authorization under 
Part 26, his or her last period of authorization was terminated 
favorably, and the individual was subject to a behavioral observation 
and arrest-reporting program that meets the requirements of this part 
throughout the period during which the individual's authorization was 
interrupted. The information to be obtained from a suitable inquiry is 
unnecessary in these circumstances because it will already be available 
to the granting licensee or other entity from the Part 26 program that 
implemented the behavioral observation and arrest-reporting program 
during the interruption in authorization.
    The final rule adds Sec.  26.63(b) to the final rule to permit 
licensees and other entities to rely on suitable inquiry information 
that was gathered by previous licensees and other entities who are 
subject to this subpart. This provision reduces the number of redundant 
suitable inquiries that licensees and other entities must conduct when 
the suitable inquiries would address the same employers and same time 
periods. The provision also permits licensees and other entities to 
accept the results of determinations of fitness that were performed 
under a previous Part 26 program, rather than requiring each new 
licensee and other entity to reevaluate the same information that was 
reviewed and resolved under the same requirements in another Part 26 
program. The NRC has made this change to meet Goal 5 of this rulemaking 
to improve Part 26 by eliminating or modifying unnecessary 
requirements.
    With respect to the proposed rule, the final rule adds a cross-
reference to Sec.  26.189 [Determination of fitness] in Sec.  26.63(b) 
to specify that licensees and other entities may only rely on 
determinations of fitness that were conducted under Sec.  26.189. This 
change is necessary because the licensees and other entities specified 
in Sec.  26.3(c) have greater latitude in conducting fitness 
evaluations under Subpart K than is permitted under Sec.  26.189. 
However, as discussed with respect to Sec.  26.53(f), a licensee or 
other entity who is subject to this subpart is permitted to rely on a 
determination of fitness conducted under a Subpart K program if the 
determination of fitness met the requirements in Sec.  26.189.
    The NRC has added Sec.  26.63(c) to the final rule, which specifies 
requirements for conducting suitable inquiries. Licensees and other 
entities shall ensure that a ``best effort'' is demonstrated to 
complete the suitable inquiry. The ``best effort'' criterion recognizes 
licensees' and other entities' status as commercial entities with no 
legal authority to require the release of the information from other 
private employers and educational institutions. Because of privacy and 
potential litigation concerns, some private employers and educational 
institutions may be unable or unwilling to release qualitative 
information about a former employee or student. For example, a former 
employer may verify the dates that the company employed an individual, 
but may be unwilling to reveal that the individual had been in 
treatment for drug or alcohol abuse while employed with the company. 
Therefore, the ``best effort'' criterion requires licensees and other 
entities to ensure that suitable inquiry information is sought from the 
primary source (e.g., a company, private employer, or educational 
institution that the applicant has listed on his or her employment 
history), but recognizes that it may not be forthcoming. The ``best 
effort'' criterion in the paragraph is consistent with the ``best-
efforts basis'' in former Sec.  26.27(a)(2). However, the final rule 
provides more detailed requirements in response to questions that the 
NRC has received from licensees about implementing a suitable inquiry 
on a ``best effort'' basis after Part 26 was first promulgated. Also, 
the final rule modifies the proposed rule to more clearly specify which 
employers must be questioned as discussed with respect to Sec.  
26.61(c).
    The NRC has added Sec.  26.63(c)(1) to the final rule, which 
specifies the type of information that the licensee or other entity 
must seek from employers regarding the applicant for authorization. 
This provision requires the licensee or other entity to ascertain the 
reason that the individual's employment was terminated, his or her 
eligibility for rehire, and other information that could reflect on the 
individual's fitness to be granted authorization. The requirement to 
obtain this information is consistent with long-standing industry 
practices related to granting access authorization and related 
requirements in the access authorization requirements established in 10 
CFR 73.56, as supplemented by orders to nuclear power plant licensees 
dated January 7, 2003.
    Section 26.63(c)(2) specifies the type of information that 
licensees and other entities must seek when an applicant's claimed 
periods of employment include military service. The NRC has added this 
requirement for consistency with related requirements in the access 
authorization requirements established in 10 CFR 73.56, as supplemented 
by orders to nuclear power plant licensees dated January 7, 2003.
    The NRC has added Sec.  26.63(c)(3) to the final rule to address 
circumstances in which a primary source of information refuses to 
provide the necessary suitable inquiry information or indicates an 
inability or unwillingness to provide it within 3 days of the request. 
Licensees and other entities are required to document that the request 
for information was directed to the primary source and the nature of 
the response (i.e., a refusal, inability, or unwillingness). If a 
licensee or other entity encounters the circumstances addressed in 
Sec.  26.63(c)(3), the provision requires the licensee or other entity 
to seek suitable inquiry information from an alternate source to the 
extent of the alternate source's ability to provide the information. An 
alternate source may include, but is not limited to, a co-

[[Page 17039]]

worker or supervisor at the same company who had personal knowledge of 
the applicant, if such an individual could be located. However, the 
final rule prohibits the licensee or other entity from using the 
alternate source of suitable inquiry information to meet any other 
access authorization requirements for a character reference. The 
provision permits licensees and other entities to grant authorization, 
if warranted, when a response has been obtained from an alternate 
source without waiting more than 3 days after the request for 
information was directed to a primary source. With respect to the 
proposed rule, the final rule clarifies that the licensee shall 
evaluate and document the response if it is received. The NRC has made 
this change to the proposed rule in recognition of the need for 
additional consistency between the final rule and the access 
authorization requirements. Therefore, this change helps meet Goal 4 of 
this rulemaking to improve consistency between FFD requirements and 
access authorization requirements established in 10 CFR 73.56, as 
supplemented by orders to nuclear power plant licensees dated January 
7, 2003. These alternative methods of meeting the suitable inquiry 
requirement are necessary because some employers are unwilling or 
unable to provide suitable inquiry information.
    The NRC has added Sec.  26.63(d) to the final rule, which requires 
licensees and other entities to share suitable inquiry information that 
they have collected when contacted by another licensee or entity who 
has a release signed by the applicant for authorization that permits 
the sharing of that information. This provision restates the permission 
to release suitable inquiry information in former Sec.  26.29(b) as a 
requirement that licensees and other entities must share the 
information necessary to conduct the suitable inquiry. With respect to 
the proposed rule, the final rule clarifies this provision as a result 
of a public comment that disagreed with the use of the word 
``presentation'' in the proposed provision. The NRC concurred with the 
comment and believes that current practices in the industry allow for 
verification of a signed release without the licensee presenting the 
actual document. Therefore, the NRC has made this change to meet Goal 6 
of the rulemaking to improve clarity in the organization and language 
of the rule. Also, the final rule expands the list of the types of 
information that licensees and other entities must make available and 
on which the denial or unfavorable determination of authorization was 
based. The NRC has made this change because after publishing the 
proposed rule, it recognized the need for additional clarity to reflect 
the NRC's intent beyond what the proposed rule contained.
    Section 26.63(d) clarifies that the information must also be 
released to C/Vs who have licensee-approved FFD programs when the C/V 
has obtained the required signed release from the applicant. This 
clarification is necessary because some licensees have misinterpreted 
former Sec.  26.29(b) as prohibiting the release of suitable inquiry 
information to C/Vs who have licensee-approved FFD programs. The 
provision also imposes the requirement on licensees and other entities 
who may be implementing an FFD program under Subpart K of this part. 
The NRC has made this change for consistency with the new requirements 
in Subpart K of this rule and to meet Goal 3 of the rulemaking to 
improve the effectiveness and efficiency of FFD programs.
    The NRC has moved the portion of proposed Sec.  26.63(d) that 
specified that a failure of an individual to authorize the release of 
information for the suitable inquiry is sufficient cause for a denial 
of authorization to Sec.  26.53(i)(1) of the final rule. The NRC has 
made this change to meet Goal 6 of the rulemaking to improve clarity in 
the organization and language of the rule.
    The NRC has added Sec.  26.63(e) to the final rule to permit 
licensees and other entities to use electronic means to obtain the 
suitable inquiry information. This permission is consistent with access 
authorization requirements established in 10 CFR 73.56, as supplemented 
by orders to nuclear power plant licensees dated January 7, 2003. The 
paragraph also adds cross-references to the applicable records 
retention requirements in Sec.  26.711 [General provisions] and Sec.  
26.713 [Recordkeeping requirements for licensees and other entities] in 
Subpart N [Recordkeeping and Reporting Requirements] to the final rule 
to ensure that licensees and other entities are aware of the 
applicability of these requirements to the suitable inquiry information 
obtained electronically. These changes are consistent with Goal 6 of 
this rulemaking to improve clarity in the organization and language of 
the rule.
    The NRC has added Sec.  26.63(f) to the final rule, which specifies 
the period(s) of time that the suitable inquiry must address for 
applicants for initial authorization, authorization update, and 
authorization reinstatement. The final rule specifies that the suitable 
inquiry requirements in this provision apply only to those individuals 
about whom no potentially disqualifying FFD information is known at the 
time the suitable inquiry is initiated. The NRC added this provision to 
meet Goal 6 of the rulemaking to improve clarity in the organization 
and language of the rule.
    Section 26.63(f) specifies the following additional requirements 
for conducting the suitable inquiry for these authorization categories. 
Section 26.63(f)(1) [Initial authorization] requires licensees and 
other entities to conduct a suitable inquiry to address the 3-year 
period preceding the date the individual applies for authorization. The 
NRC has reduced the period of time that the suitable inquiry must 
address for applicants for initial authorization who do not disclose 
any potentially disqualifying FFD information. The NRC has reduced the 
period of time to be addressed in the suitable inquiry from 5 years in 
the former regulation to 3 years to better focus the suitable inquiry 
on identifying indicators of an active substance abuse problem or an 
increased risk of recidivism following treatment. If an applicant for 
initial authorization discloses no potentially disqualifying FFD 
information from the past 5 years and none is identified through the 
suitable inquiry or other means, it is unlikely that the applicant has 
an active substance abuse problem. Therefore, seeking a full 5 years of 
information about the individual would be unlikely to provide useful 
data and imposes an unnecessary burden. Industry experience has shown 
that employers are often reluctant to disclose adverse information to 
other private employers about former employees. Also, the longer it has 
been since an individual was employed, the less likely it is that a 
former employer will disclose useful information. Therefore, rather 
than retaining the requirement for a 5-year suitable inquiry in all 
cases, the final rule increases the thoroughness of the suitable 
inquiry over the past 3 years.
    Section 26.63(f)(1) requires the licensee or other entity to ensure 
that the suitable inquiry has been conducted with every employer by 
whom the applicant claims to have been employed within the past year. 
This requirement leads to a more rigorous suitable inquiry than was 
common industry practice before the issuance of the January 7, 2003, 
access authorization orders, which imposed additional compensatory 
measures related to access authorization. The purpose of contacting 
every employer is to ensure that the licensee or other entity sought 
information related to any active substance abuse problem. For the 
earlier years of the suitable inquiry period, the

[[Page 17040]]

provision requires the licensee or other entity to ensure that the 
suitable inquiry has been conducted with every employer by whom the 
applicant claims to have been employed the longest within each calendar 
month. Contacting these employers increases the likelihood that the 
employers would have knowledge of the applicant and may provide more 
useful information than contacting employers who employed the applicant 
only briefly.
    The NRC has added Sec.  26.63(f)(2) [Authorization update] to the 
final rule, which specifies the period of time that the suitable 
inquiry must address for applicants for an authorization update (i.e., 
those who held authorization within the past 3 years and whose last 
period of authorization was terminated favorably, but who have not held 
authorization within the past year). The paragraph requires the 
licensee or other entity to ensure that the suitable inquiry has been 
conducted in the same manner as described in Sec.  26.63(f)(1). 
However, for an authorization update, the suitable inquiry addresses 
only the period during which the individual's authorization was 
interrupted, rather than the full 3 years that is required for initial 
authorization. A 3-year period for the suitable inquiry is unnecessary 
for these individuals because the licensee or other entity will have 
access to the information about the individual that was gathered by the 
licensee or other entity under whose program the individual had been 
granted and successfully maintained authorization within the past 3 
years.
    Section 26.63(f)(3) [Authorization reinstatement after an 
interruption of more than 30 days] specifies the period of time that 
the suitable inquiry must address for applicants who held authorization 
within the past year and whose last period of authorization was 
terminated favorably, but who have not held authorization within the 
past 30 days. The final rule requires licensees and other entities to 
ensure that the suitable inquiry has been conducted with the employer 
by whom the applicant claims to have been employed the longest in each 
calendar month of the interruption. This provision does not require 
licensees and other entities to ensure that every employer by whom the 
individual claimed to have been employed during the interruption is 
contacted for the reasons discussed with respect to Sec.  26.59(a)(2). 
Because these individuals have had only a short break in authorization, 
a sampling of employers from the interruption period is sufficient to 
determine if any indications exist that the individual has developed a 
previously undetected substance abuse or other problem that would 
adversely affect his or her fitness to have authorization reinstated.
    The time periods and approach to conducting the suitable inquiry 
established in Sec.  26.63(f)(1) through (f)(3) are consistent with 
those established in the access authorization orders issued to nuclear 
power plant licensees dated January 7, 2003.
Section 26.65 Pre-Access Drug and Alcohol Testing
    Section 26.65 of the final rule amends former Sec.  26.24(a)(1). 
The former provision required drug and alcohol ``testing within 60 days 
prior to the initial granting of unescorted access to protected areas 
or assignment to activities within the scope of this part.'' The final 
rule amends the former pre-access drug and alcohol testing requirement 
for individuals who are seeking authorization under Part 26 to 
strengthen the effectiveness of FFD programs.
    The NRC has added Sec.  26.65(a) [Purpose] to the final rule to 
describe the purpose of the section and identify the individuals to 
whom the requirements in the section apply. The pre-access testing 
requirements in this section cover applicants for authorization who 
have never held authorization under Part 26 or have held authorization 
under Part 26 and whose most recent period of authorization was 
terminated favorably, and about whom no potentially disqualifying FFD 
information has been discovered or disclosed that was not reviewed and 
favorably resolved by another licensee or entity who is subject to 
Subpart C. Requirements for granting authorization to individuals whose 
previous periods of authorization were terminated unfavorably or 
denied, or about whom new potentially disqualifying FFD information has 
been discovered or disclosed, are contained in Sec.  26.69.
    The NRC has added Sec.  26.65(b) [Accepting tests conducted within 
the past 30 days] to the final rule to permit licensees and other 
entities to forego pre-access testing of an individual who has negative 
results from drug and alcohol tests that were performed under the 
requirements of Part 26 within the 30-day period before the licensee or 
other entity grants authorization to the individual, including tests 
that were conducted before the individual applied for authorization 
from the licensee or other entity. For example, if an individual was 
subject to random testing under another Part 26 program and was 
selected for testing under the other program before applying for 
authorization from the granting licensee or other entity, the final 
rule permits the granting licensee or other entity to accept negative 
test results from the random test in lieu of performing a pre-access 
test, if the random test was conducted within 30 days before the day 
authorization is granted to the individual. A requirement for the 
licensee or other entity to conduct pre-access testing in these 
circumstances is redundant and unnecessary.
    The NRC has added Sec.  26.65(c) [Initial authorization and 
authorization update] to the final rule, which establishes pre-access 
testing requirements for individuals who are applying for initial 
authorization and an authorization update. The final rule, with respect 
to the proposed rule, has added a specification that before granting 
initial authorization, any pre-access drug and alcohol tests must be 
conducted within the 30-day period preceding the day the licensee or 
other entity grants authorization to the individual. Under former Sec.  
26.24(a)(1), licensees and other entities were permitted to complete 
pre-access testing within the 60-day period before authorization is 
granted. The inclusion in the final rule of a shorter time period 
within which pre-access testing must be conducted, if required, 
increases the likelihood of detecting an active substance abuse problem 
among applicants for unescorted access to nuclear power plants and 
others who are subject to Part 26 by increasing the number of pre-
access tests that are performed. In addition, the decreased time period 
for pre-access testing increases the likelihood that recent drug use, 
particularly marijuana, is detected before the concentration of 
metabolites in an individual's body could decrease below the cutoff 
levels prescribed in the final rule. Also, the final rule's provision 
for a decreased time period within which pre-access testing must be 
performed provides greater assurance that individuals subject to this 
part are trustworthy and reliable, as demonstrated by the avoidance of 
substance abuse, as discussed with respect to Sec.  26.23(a).
    The final rule requires negative results from pre-access testing 
before the licensee or other entity grants authorization to the 
individual, except in the two circumstances described in Sec.  
26.65(c)(1) and (c)(2). Pre-access testing in these two circumstances 
is unnecessary because there is sufficient opportunity to detect 
substance abuse without the testing. In Sec.  26.65(c)(1), licensees 
and other entities are permitted to forego pre-access testing if the 
applicant had been subject to drug and alcohol testing (including 
random testing), behavioral observation, and

[[Page 17041]]

arrest-reporting requirements under a Part 26 FFD program throughout 
the period the individual's authorization was interrupted.
    In proposed Sec.  26.65(c)(2), licensees and other entities were 
permitted to forego pre-access testing of an applicant who had negative 
results from Part 26 drug and alcohol tests that were performed within 
the past 30 days and who was subject to behavioral observation and 
arrest-reporting requirements during the time interval between the day 
the specimens were collected and the day the licensee or other entity 
grants authorization to the individual. However, the NRC received a 
public comment regarding this provision, which stated that licensees 
should be able to rely on drug and alcohol tests that were conducted 
before the individual applied for authorization if the individual has 
been subject to a behavioral observation and arrest-reporting program, 
and random drug and alcohol testing, during the time period following 
the drug and alcohol tests. The NRC agrees that pre-access testing 
within 30 days before authorization is granted is unnecessary in these 
circumstances and has removed reference to Sec.  26.65(b) in this 
provision. This amendment clarifies that licensees may rely on drug and 
alcohol tests that were conducted at any time before the individual 
applied for authorization, provided that the individual has been 
subject to a random drug and alcohol testing program, a behavioral 
observation program, and an arrest-reporting program that meet the 
applicable requirements of this part. The NRC has made this change 
under Goal 5 of the rulemaking to improve the rule by eliminating or 
modifying unnecessary requirements.
    The NRC has added Sec.  26.65(d) [Authorization reinstatement after 
an interruption of more than 30 days] and (e) [Authorization 
reinstatement after an interruption of 30 or fewer days] to the final 
rule, which establish requirements for the pre-access testing of 
individuals who are applying for an authorization reinstatement. The 
requirements for pre-access testing of these individuals are less 
stringent than the requirements for initial authorization and an 
authorization update. The provision relaxes the pre-access testing 
requirements in former Sec.  26.24(a)(1), which mandated that all 
applicants for authorization must be subject to pre-access testing 
within 60 days before granting authorization. Less stringent pre-access 
testing requirements are appropriate because these individuals have met 
the rigorous criteria for initial authorization, established a recent 
record of successfully maintaining authorization under Part 26, and had 
only a short break in authorization.
    Section 26.65(d) of the final rule specifies pre-access testing 
requirements for individuals whose authorization has been interrupted 
for more than 30 days but no more than 1 year. Section 26.65(d)(1)(i) 
requires the licensee or other entity to administer an alcohol test and 
collect a urine specimen for drug testing. The final rule, with respect 
to the proposed rule, clarifies that before granting initial 
authorization, any required pre-access drug and alcohol tests must be 
conducted within the 30-day period preceding the day the licensee or 
other entity grants authorization to the individual. The licensee or 
other entity is permitted to reinstate the individual's authorization 
if the alcohol test results are negative before the drug test results 
are available. Section 26.65(d)(1)(ii) permits the licensee or other 
entity to maintain the individual's authorization for 5 business days 
after reinstatement without receiving the drug test results. However, 
if the licensee or other entity does not receive negative drug test 
results within 5 business days of reinstating the individual's 
authorization, the final rule requires the licensee or other entity to 
administratively withdraw the individual's authorization until negative 
drug test results are received. These requirements ensure that 
individuals whose authorization has been interrupted for more than 30 
days are subject to pre-access drug and alcohol testing to deter 
substance abuse and to detect any current substance abuse problem. 
However, the provisions do not unduly delay authorization reinstatement 
because these individuals' recent successful histories of maintaining 
authorization under Part 26 indicate that they are at low risk of 
engaging in substance abuse.
    Section 26.65(d)(2) permits licensees and other entities to forego 
pre-access testing of these applicants for reinstatement in the 
circumstances discussed with respect to Sec.  26.65(c)(1) and (c)(2). 
The discussion with regard to Sec.  26.65(c)(2) also specifies the 
reasons for the changes from the proposed rule in Sec.  
26.65(d)(2)(ii).
    The NRC has added Sec.  26.65(e)(1) to the final rule to permit 
licensees and other entities to forego pre-access testing of applicants 
whose authorization has been interrupted for 5 or fewer days. This 
provision is consistent with current licensee practices and 
recommendations regarding short breaks in authorization in NUREG-1385 
and other access authorization requirements. The final rule also has 
moved the provisions from paragraph (e)(3) of the proposed rule into 
this paragraph of the final rule to improve clarity in the organization 
of the final rule, consistent with Goal 3 of the rulemaking. This 
provision permits licensees and other entities also to forego 
subjecting an individual to the possibility of selection for pre-access 
testing if the applicant has been subject to the drug and alcohol 
testing (including random testing), behavioral observation, and arrest-
reporting elements of a Part 26 FFD program throughout the interruption 
in the individual's authorization. The NRC believes that being subject 
to these program elements during the interruption period is sufficient 
to deter substance abuse and provide assurance that substance abuse 
would be detected. Section 26.65 enhances the deterrent effect of pre-
access testing for individuals who have had a very short break in 
authorization without imposing the burden of requiring that every 
individual must be tested.
    Section 26.65(e)(2) of the final rule requires licensees and other 
entities to subject applicants whose authorization has been interrupted 
for 6 to 30 days to the possibility of selection for pre-access testing 
in order to deter any potential for substance abuse. However, this 
provision specifies that the licensee or other entity may forego 
subjecting an individual to the possibility of being selected for pre-
access testing if the applicant has been subject to the drug and 
alcohol testing (including random testing), behavioral observation, and 
arrest-reporting elements of a Part 26 FFD program throughout the 
interruption in the individual's authorization.
    Section 26.65(e)(2)(i) requires the licensee or other entity to 
subject the applicant to a one-time chance of being selected for 
testing at a probability of approximately 4 percent. This probability 
approximates the likelihood that individuals who are subject to random 
testing at the 50-percent annual testing rate in Sec.  26.31(d)(2)(vii) 
are selected for testing at some point within a 30-day period. Section 
26.65(e)(2)(ii) clarifies that if an applicant is not selected for pre-
access testing under the preceding section, the licensee or other 
entity is not required to perform a pre-access test. Section 
26.65(e)(2)(iii)(A) and (B) specifies requirements for conducting the 
pre-access testing if an individual is selected for testing under Sec.  
26.65(e)(2)(i). The licensee or other entity shall complete an alcohol 
test and collect a specimen for drug testing before reinstating the 
individual's authorization. In order to maintain the individual's 
reinstated authorization,

[[Page 17042]]

the final rule requires that the licensee or other entity must receive 
negative drug test results within 5 business days after reinstatement 
or administratively withdraw the individual's authorization until 
negative drug test results are received.
    The NRC has deleted from the final rule Sec.  26.65(f) [Time period 
for testing] of the proposed rule. The proposed provision mandated that 
specimens that are collected for any pre-access testing required in 
this section must be collected within the 30-day period preceding the 
day the licensee grants authorization to an individual. The NRC 
received a public comment that stated that licensees currently conduct 
pre-access drug and alcohol testing within the 30-day period preceding 
the date the licensee grants authorization and that proposed Sec.  
26.65(f) only requires licensees to collect a sample in this timeframe. 
The NRC agrees with the comments and, therefore, has deleted this 
provision from the final rule to increase efficiency, consistent with 
Goal 5 of the rulemaking to eliminate unnecessary requirements. 
However, the NRC has added requirements to Sec.  26.65(c) and (d)(1)(i) 
to specify that any pre-access testing required in this section must be 
conducted within the 30-day period preceding the day upon which the 
licensee grants authorization to an individual, consistent with the 
proposed rule's intent. Under former Sec.  26.24(a)(1), licensees and 
other entities were permitted to complete pre-access testing within the 
60-day period before authorization is granted. The reason why the final 
rule shortens this time period to 30 days is discussed with respect to 
Sec.  26.65(c).
    The NRC has added Sec.  26.65(f) [Administrative withdrawal of 
authorization] (changed from Sec.  26.65(g) in the proposed rule 
because of renumbering) to the final rule to ensure that the licensee 
or other entity does not record or report as an unfavorable termination 
any administrative withdrawal of authorization that may be required 
under paragraphs (d)(1)(ii) or (e)(2)(iii)(B) of this section. The time 
a licensee or other entity receives drug test results is not under the 
applicant's control and does not reflect on the applicant's fitness, 
trustworthiness, or reliability, if the licensee or other entity is 
unable to obtain drug test results within the 5 days permitted and must 
administratively withdraw the individual's authorization. Therefore, 
subjecting the individual to the severe consequences associated with a 
record of an unfavorable termination is inappropriate, except if the 
individual's authorization was subsequently denied or terminated 
unfavorably by a licensee or entity. However, if the drug test results 
are positive, adulterated, or substituted and the licensee or other 
entity terminates the individual's authorization for cause, the 
termination is then recorded as unfavorable. However, with respect to 
the proposed rule, the final rule adds a clarification that the 
individual is required to disclose administrative action if the 
individual's authorization was subsequently denied or terminated 
unfavorably. The NRC has made this change to the proposed rule in 
recognition of the need for additional consistency between the final 
rule and the access authorization requirements. Therefore, this change 
helps meet Goal 4 of this rulemaking to improve consistency between FFD 
requirements and access authorization requirements established in 10 
CFR 73.56, as supplemented by orders to nuclear power plant licensees 
dated January 7, 2003.
    The NRC has added Sec.  26.65(g) [Sanctions] (changed from Sec.  
26.65(h) in the proposed rule because of renumbering) to the final 
rule, which specifies the minimum sanctions to be imposed on an 
individual whose pre-access test results the MRO confirms as an FFD 
policy violation. Section 26.65(g)(1) and (g)(2) contains cross-
references to the relevant sanctions specified in Subpart D [Management 
Actions and Sanctions To Be Imposed] to clarify that those sanctions 
apply to applicants for authorization. For example, if the MRO 
determines that an individual has submitted an adulterated urine 
specimen for a pre-access drug test, the licensee or other entity is 
required to impose the sanction for an attempt to subvert the testing 
process (i.e., permanent denial of authorization) in Sec.  26.75(b).
    The NRC has added Sec.  26.65(g)(3) to the final rule to permit 
licensees and other entities to grant authorization to an individual 
whose confirmed positive, adulterated, or substituted test result is a 
first drug- or alcohol-related violation under a Part 26 program, 
consistent with former Sec.  26.27(b)(2). However, the final rule 
permits authorization to be granted only under the stringent 
requirements contained in Sec.  26.69.
Section 26.67 Random Drug and Alcohol Testing of Individuals Who Have 
Applied for Authorization
    The NRC has added Sec.  26.67 to the final rule, which extends 
former random testing requirements to individuals who have applied for 
authorization under Part 26 but who have not yet been granted 
authorization. The NRC has added the requirements in this section to 
the access authorization requirements that were established by orders 
to nuclear power plant licensees dated January 7, 2003, to enhance the 
effectiveness of FFD programs by increasing the likelihood that 
substance abuse will be detected before authorization is granted and to 
deter the potential for substance abuse among applicants. Therefore, 
the NRC has made these changes to meet Goal 3 of this rulemaking to 
improve the effectiveness and efficiency of FFD programs.
    The NRC has added Sec.  26.67(a) to the final rule, which requires 
licensees and other entities to conduct random testing of applicants 
under the requirements of Sec.  26.31(d)(2). The licensee or other 
entity must add applicants for authorization to the FFD program's 
normal population of individuals who are subject to random testing, 
select individuals for testing at the 50-percent annual rate, and 
otherwise subject applicants to the same random testing requirements as 
individuals who currently hold authorization under Part 26. An 
applicant is subject to random testing beginning when the licensee or 
other entity collects the specimens for any required pre-access test 
and continues thereafter, if the licensee or other entity grants 
authorization to the individual.
    Licensees and other entities are permitted to forego random testing 
of applicants in the two circumstances described in Sec.  26.67(a)(1) 
and (a)(2). Section 26.67(a)(1) permits a licensee or other entity to 
discontinue random testing of any applicant to whom the licensee or 
other entity does not grant authorization for any reason, including a 
termination or denial of authorization or a withdrawal of the 
application for authorization by the individual or the individual's 
employer, in the case of a C/V. Section 26.67(a)(2) addresses the 
circumstance described in Sec.  26.65(b), in which the licensee or 
other entity is permitted to meet pre-access testing requirements by 
relying on negative test results from specimens collected under another 
Part 26 program within 30 days before granting authorization to the 
individual. Under Sec.  26.67(a)(2), the licensee or other entity shall 
begin subjecting the applicant to random testing when the licensee or 
other entity takes the first formal action to process the individual's 
application for authorization.
    The formal actions may include, but are not limited to, the time 
when the licensee or other entity receives the individual's signed 
consent form and begins creating a record of the

[[Page 17043]]

individual's application that would be accessible to other licensees 
and entities; conducts a psychological evaluation; begins a suitable 
inquiry; or takes other actions that are required under NRC regulations 
to grant authorization. The first formal action that the licensee or 
other entity takes to process an individual's application for 
authorization will vary, depending on the licensee's FFD and access 
authorization program procedures, whether the applicant's FFD training 
is up-to-date, and other factors. These considerations make it 
impractical to establish a single point in the authorization process 
established in the rule when random testing must begin. Therefore, the 
provision requires the licensee or other entity to begin subjecting the 
individual to random testing when the licensee or other entity takes 
the first formal action, but does not define a specific formal action 
that would initiate random testing of applicants in all cases.
    The NRC has added Sec.  26.67(b) to the final rule, which permits 
licensees and other entities to grant authorization to an individual 
before random testing is completed if the individual has met all of the 
requirements for authorization but has been selected for one or more 
random tests while in applicant status. The final rule does not require 
the testing to be completed before the licensee or other entity grants 
authorization to the individual because the primary purpose of randomly 
testing applicants is to deter substance abuse rather than to provide 
information for the authorization decision. Pre-access testing provides 
the necessary information for authorization decision making.
    Section 26.67(c) of the final rule cross-references the minimum 
sanctions to be imposed on an individual whose drug or alcohol results 
from random testing are confirmed as positive, adulterated, or 
substituted. The final rule also makes a minor language clarification 
to the proposed rule by modifying the term ``non-negative'' of this 
section. Section 26.67(c)(1) and (c)(2) refers to the relevant 
sanctions specified in Subpart D. Section 26.67(c)(3) continues to 
permit licensees and other entities to grant authorization to an 
individual whose confirmed positive, adulterated, or substituted test 
result is a first drug- or alcohol-related violation under a Part 26 
program, consistent with former Sec.  26.27(b)(2). However, the final 
rule permits authorization to be granted only under the stringent 
requirements contained in Sec.  26.69.
Section 26.69 Authorization With Potentially Disqualifying Fitness-for-
Duty Information
    The NRC adds Sec.  26.69 to the final rule to replace and clarify 
the requirements contained in former Sec.  26.27(b)(4). Former Sec.  
26.27(b)(4) established requirements for granting authorization to an 
individual who has violated an FFD policy and had his or her 
authorization terminated unfavorably or denied for a period of 3 or 
more years under the former rule. Consistent with Goal 6 of this 
rulemaking to improve clarity in the organization and language of the 
rule, this section of the final rule addresses problems that have 
arisen in implementing the former rule and clarifies the NRC's intent 
with respect to several situations that the former rule did not 
address.
    The NRC has added Sec.  26.69(a) [Purpose] to the final rule to 
describe the purpose of the section and the applicants who are subject 
to these requirements. The provision requires licensees and other 
entities to meet the applicable requirements in this section before 
granting authorization to an individual or permitting an individual to 
maintain his or her authorization when potentially disqualifying FFD 
information is obtained about the individual through any means and a 
previous licensee or other entity has not assessed and favorably 
resolved the information. Section 26.63(b) permits licensees and other 
entities to rely on the results of determinations of fitness that 
previous licensees or other entities conducted, rather than requiring 
each new licensee or other entity to reevaluate the same information 
that was reviewed and resolved under another Part 26 program. However, 
if the potentially disqualifying FFD information was not previously 
reviewed and favorably resolved by another FFD program under this 
subpart, licensees and other entities must implement the requirements 
contained in this section.
    Section 26.69(a) also revises the language contained in former 
Sec.  26.27(b)(2) to recognize that licensees and other entities may 
decide not to grant authorization to the subject individual and so, in 
that case, are not required to implement these requirements. At the 
public meetings discussed in Section I.D, stakeholders noted that some 
individuals have misinterpreted the former rule as requiring licensees 
to provide individuals who have violated an FFD policy with the 
opportunity to seek treatment for a substance abuse problem and to have 
authorization reinstated. However, although the NRC continues to affirm 
that individuals who pursue treatment and maintain sobriety may be 
considered for authorization, both the former and final rules assign 
the responsibility for making authorization decisions to the licensee 
or other entity. Therefore, the paragraph clarifies that granting or 
maintaining the authorization of an individual about whom potentially 
disqualifying FFD information has been disclosed or discovered is ``at 
the licensee's or other entity's discretion.''
    The NRC has added Sec.  26.69(b) [Authorization after a first 
confirmed positive drug or alcohol test result or a 5-year denial of 
authorization] to the final rule to define requirements for granting 
authorization at the licensee's or other entity's discretion to an 
individual who had confirmed positive drug or alcohol test results and 
whose authorization was previously terminated unfavorably or denied for 
5 years. The requirements in this section apply to:
    (1) An applicant who had a first confirmed positive test result on 
a pre-access test and was consequently denied authorization by a 
licensee;
    (2) An individual who is returning to duty following the 14-day 
assessment period required in Sec.  26.75(e)(1) (The NRC has moved the 
provisions in former Sec.  26.26(b)(2) to Sec.  26.75(e)(1));
    (3) An individual whose authorization was terminated unfavorably 
under another Part 26 program and who had an interruption in 
authorization that was longer than 14 days; and
    (4) An individual whose authorization was denied for 5 years under 
the requirements of Sec.  26.75(c), (d), (e)(2), or (f).
    This provision replaces and strengthens the requirements contained 
in former Sec.  26.27(b)(2) and expands them to address confirmed 
positive alcohol test results, which were excluded from this process in 
former Sec.  26.27(b)(5). The paragraph includes confirmed positive 
alcohol test results for the reasons discussed with respect to Sec.  
26.75(e).
    The NRC has retained the language of the proposed rule to state 
that the licensee or other entity shall perform the activities listed 
in paragraphs (b)(1) through (b)(6) of this section. In the situations 
presented in this section, the NRC believes that the licensees or other 
entities will likely conduct these tasks themselves because another 
licensee has not reviewed and resolved the individual's situation. 
Therefore, the licensees will have to collect more original data about 
the individual, rather than relying on that collected by another 
licensee. However, by retaining

[[Page 17044]]

the language of the proposed rule in this section, the NRC does not 
intend to require that the licensees or other entities must conduct 
these tasks themselves in these situations. The NRC maintains that the 
licensee may rely on information collected by others to meet the 
requirements of Sec.  26.69 if that is the most reasonable way to 
proceed. For example, if the licensee or other entity uses a background 
screening company, they would most likely continue to have the company 
perform the employment history required in this section.
    Section 26.69(b)(1) requires the licensee or other entity to obtain 
and review a self-disclosure and employment history from the applicant 
to verify that it does not contain any previously undisclosed 
potentially disqualifying FFD information. The final rule has added 
``employment history,'' with respect to the proposed rule, to state the 
intent that both a self-disclosure and employment history shall be 
reviewed. When an individual's last period of authorization was 
terminated unfavorably or denied, licensees and other entities are not 
permitted to forego obtaining a self-disclosure and employment history 
under any circumstances because it is important to review the 
individual's activities during the interruption period. The period of 
time the self-disclosure must address is the shorter of either the past 
5 years or the intervening period after the individual last held 
authorization.
    Section 26.69(b)(2) increases the scope of the suitable inquiry by 
requiring the licensee or other entity to conduct the suitable inquiry 
with every employer by whom the applicant claims to have been employed 
during the period of time addressed in the individual's employment 
history. The final rule replaces ``self-disclosure'' in the proposed 
rule with ``employment history'' to clarify that the time period 
covered is that which the employment history addresses. This extensive 
suitable inquiry is necessary to determine if any indications exist 
that the individual has continued to engage in substance abuse. The 
final rule also requires licensees and other entities to obtain and 
review any records that other licensees or entities may have developed 
related to any potentially disqualifying FFD information about the 
individual from the past 5 years. These records may include, but are 
not limited to, the results of past suitable inquiries or other 
investigations, records of arrests or convictions, drug and alcohol 
test results, treatment records, and the results of determinations of 
fitness. The SAE uses this information to assess the individual's 
fitness and the licensee's or other entity's reviewing official uses it 
to determine whether authorization is warranted.
    Section 26.69(b)(3) applies only to individuals whose authorization 
was denied for 5 years under the former rule or under Sec.  26.75(c), 
(d), (e)(2), or (f) of the final rule. The paragraph requires the 
licensee or other entity to verify, before granting authorization, that 
the individual had not abused alcohol or drugs during the 5-year 
interruption, at a minimum. The requirement is consistent with the 
portion of former Sec.  26.27(b)(4) that required licensees to obtain 
``satisfactory medical assurance that the person has abstained from 
drugs for at least 3 years.'' However, the final rule extends the 
requirement to 5 years to ensure that such an individual is at the 
lowest risk of recidivism into an active substance abuse problem before 
the licensee or other entity grants authorization to the individual.
    Section 26.69(b)(4) amends the requirement in former Sec.  
26.27(b)(2). The former provision mandated that an individual who has a 
first confirmed positive test result must be referred to the EAP for 
assessment and counseling before the licensee or other entity may grant 
authorization to the individual. The final rule makes several changes 
to the former provision. First, the final rule replaces the term 
``management and medical assurance of fitness'' which was used in 
former Sec.  26.27(b)(2) and (b)(4), with the term ``determination of 
fitness'' to improve the accuracy of the language in the final rule. 
The final rule does not use ``management'' because the licensee's or 
other entity's reviewing official [see the discussion of Sec.  
26.69(c)(3) and the definition of ``reviewing official'' in Sec.  26.5] 
is the individual who licensees and other entities currently designate 
to make authorization decisions and the reviewing official may not be a 
manager. In addition, the final rule permits professionals other than a 
licensed physician to conduct a determination of fitness, for the 
reasons discussed with respect to Sec.  26.189. The NRC has made these 
change to meet Goal 6 of this rulemaking to improve clarity in the 
organization and language of the rule.
    Consistent with the intent of the former requirement, the provision 
requires the licensee or other entity to ensure that an SAE has 
conducted a determination of fitness, as defined in Sec.  26.189, as 
part of the authorization decision. Section 26.187 [Substance abuse 
expert] requires that an SAE must perform determinations of fitness 
that are conducted for authorization decisions. Section 26.187 also 
defines the role, responsibilities, and required qualifications of an 
SAE. Therefore, Sec.  26.69(b)(4) requires that the individual must be 
referred to an SAE for a determination of fitness. However, the final 
rule does not require the SAE to be an EAP employee. Permitting 
licensees and other entities to rely on a professional who meets the 
required qualifications for an SAE rather than only on EAP personnel, 
more appropriately focuses this requirement on ensuring that the 
professional who performs the assessment and treatment planning is 
qualified, rather than on the professional's organizational 
affiliation. The NRC received a comment requesting that the rule rely 
on a Substance Abuse Professional (SAP) to meet the requirement of this 
section. The NRC acknowledges that the SAP training and credentialing 
process emphasizes knowledge about the SAP role in programs under 10 
CFR Part 40, ``Domestic Licensing of Source Material.'' However, 
although an SAP under Part 40 meets many of the criteria established in 
the rule, thorough knowledge of Part 26 requirements is also necessary. 
Therefore, the NRC has not modified the proposed provision in the final 
rule.
    Section 26.69(b)(4)(i) through (b)(4)(iii) replaces and strengthens 
the requirement in former Sec.  26.27(b)(2). The former provision 
stated that ``any rehabilitation program deemed appropriate must be 
initiated during such suspension period.'' The final rule requires that 
the individual must be in compliance with or have successfully 
completed treatment and follow-up testing plans, rather than simply 
started treatment, in order for the licensee or other entity to grant 
authorization to the individual and maintain the individual's 
authorization after it has been granted.
    The NRC has added Sec.  26.69(b)(5) to the final rule to impose 
more stringent pre-access testing requirements on an individual who is 
being considered for authorization following an unfavorable termination 
or denial of authorization than those required for individuals whose 
last period of authorization was terminated favorably. The provision 
requires negative results from an alcohol test performed within 10 
business days before authorization is granted. Similarly, the provision 
requires negative results from a urine specimen that was collected 
under direct observation for drug testing within 10 business days 
before authorization is granted. The provision prohibits the licensee 
or other entity from granting authorization to the individual before 
the drug test results are reported to the

[[Page 17045]]

licensee's or other entity's MRO. The MRO may then determine whether 
the drug test results indicate that the individual has not engaged in 
any further drug abuse [see the discussion of Sec.  26.69(f)]. 
Completing drug and alcohol testing within 10 business days before 
granting authorization rather than the 30 days that is permitted in 
Sec.  26.65 for the other authorization categories provides evidence 
that the individual has abstained from abusing proscribed substances 
during the interruption period and that the individual is able to 
safely and competently perform duties under this part when 
authorization is reinstated, if the individual's authorization has been 
interrupted for the 14-day assessment period required under former 
Sec.  26.27(b)(2) and retained in Sec.  26.75(e)(1). Requiring direct 
observation of the urine specimen collection is necessary to provide 
added assurance that the specimen is valid and yields accurate drug 
test results.
    Section 26.69(b)(6) applies only to individuals whose authorization 
has been unfavorably terminated or denied for at least 14 days for a 
first confirmed positive drug or alcohol test result. The provision 
replaces the third sentence of former Sec.  26.27(b)(4). This sentence 
established requirements and a schedule for followup drug and alcohol 
testing for an individual whose authorization was denied for 3 years 
under the former rule. The final rule applies the requirement for 
followup testing to individuals who have had a first confirmed positive 
test result for drugs or alcohol. This requirement provides greater 
deterrence of further drug and alcohol use than former Sec.  
26.27(b)(4), which required this followup testing only for the more 
serious FFD violations that result in a denial of authorization for 3 
years or longer. The more stringent requirement provides higher 
assurance that individuals who are subject to this part are 
trustworthy, reliable, and fit for duty.
    Section 26.69(b)(6) amends the former fixed schedule for followup 
testing by requiring licensees and other entities to subject the 
individual to the possibility of being selected for followup testing, 
during any period in which he or she holds authorization under Part 26, 
for a period of 3 calendar years after the individual's authorization 
is restored following termination or denial for the first confirmed 
positive drug or alcohol test result. The rule requires licensees and 
other entities to ensure that the individual is subject to unannounced 
testing at least 15 times within the 3-year period and to verify that 
the individual's test results are negative. Either random or followup 
tests, which are both unannounced, may be used to meet this final 
requirement. The final rule requires licensees and other entities to 
distribute the unannounced tests over the 3-year period, with at least 
one unannounced test conducted each quarter.
    The NRC has added Sec.  26.69(b)(6)(i) through (b)(6)(iii) to the 
final rule to address circumstances when an individual is not 
continuously subject to a Part 26 program during the 3 years following 
the restoration of authorization. Section 26.69(b)(6)(i) requires that 
an individual who intermittently holds authorization over the 3-year 
period must be subject to unannounced testing at least once in each 
quarter during which the individual is authorized. Section 
26.69(b)(6)(ii) permits the licensee or other entity to extend the 
followup testing period to 5 years, if the requirement for 15 tests 
over the 3-year period has not been met because the individual has not 
been authorized a sufficient number of times or for sufficient periods 
of time during the first 3 years to meet the final 15-test requirement. 
Section 26.69(b)(6)(iii) permits the licensee or other entity to have 
an SAE conduct a determination of fitness to determine whether further 
followup testing is required, if an individual is unable to meet the 
15-test requirement after 5 years because of brief and infrequent 
periods of authorization. The revision of these requirements increase 
the flexibility with which licensees and other entities may implement 
followup testing, but retains the former effectiveness of followup 
testing in detecting and deterring substance abuse.
    The NRC has added Sec.  26.69(b)(7) to the final rule, which 
requires the licensee or other entity to verify that the results of all 
drug and alcohol tests that are administered to the individual under a 
Part 26 program following the restoration of the individual's 
authorization indicate no further drug or alcohol abuse. The provision 
does not specify that the drug test results must be negative because 
the metabolites of some drugs, such as marijuana, may be present in an 
individual's urine for several weeks after the individual has stopped 
using the drug. If an individual is tested again soon after the 
original test that resulted in an FFD violation was conducted, the 
specimen may yield positive results which would not, in fact, reflect 
new drug use. Therefore, if subsequent drug test results show the 
presence of the same drug or drug metabolites in the individual's urine 
as detected in the original confirmed positive test result, the MRO, 
under Sec.  26.185(o), is required to determine whether the results 
indicate new drug use or are consistent with results that are expected 
from the drug use that resulted in the previous confirmed positive test 
result. The rule adds this requirement in response to inconsistencies 
in the way some MROs have implemented former requirements related to 
return-to-duty drug testing. Some MROs have been inappropriately 
reluctant to declare a second drug test result as negative if any 
concentration of the drug or drug metabolites that resulted in a first 
confirmed positive drug test result are detected in the specimen. The 
change permits an individual who has not engaged in further drug use 
after a first confirmed positive drug test result to regain 
authorization at the licensee's discretion rather than be incorrectly 
denied authorization for 5 years on the basis of a subsequent FFD 
policy violation, under Sec.  26.75(e)(2).
    The NRC has added Sec.  26.69(c) [Granting authorization with other 
potentially disqualifying FFD information] to the final rule to 
establish requirements for granting authorization to an individual 
about whom potentially disqualifying FFD information is discovered or 
disclosed that was not a confirmed positive, adulterated, substituted, 
or invalid drug or alcohol test result or 5-year denial of 
authorization. For example, this type of potentially disqualifying FFD 
information may include, but is not limited to:
    (1) A report of an arrest for an alcohol-related traffic violation;
    (2) Information from the suitable inquiry that a previous private-
sector employer terminated an individual's employment because of drug- 
or alcohol-related job performance problems; or
    (3) Information obtained from the suitable inquiry or other sources 
of information indicating that the individual is known to abuse illegal 
drugs or alcohol or is experiencing significant mental or emotional 
stress.
    This provision is necessary because the former rule did not address 
the authorization process in these circumstances and the NRC is aware 
that licensees and other entities have handled these circumstances 
inconsistently. Therefore, the final rule adds these requirements to 
establish the NRC's intent with respect to these circumstances and 
increase consistency between Part 26 programs.
    The NRC has added a second sentence to Sec.  26.69(c) in the final 
rule to clarify that if potentially disqualifying FFD information is 
obtained about an

[[Page 17046]]

individual by any means, the licensee shall perform the activities in 
paragraphs (c)(1) through (c)(5) of this section before granting 
authorization to the individual. The NRC has made this change to meet 
Goal 6 of the rulemaking to improve clarity in the organization and 
language of the rule.
    The NRC has added Sec.  26.69(c)(1) to the final rule, which 
requires the licensee or other entity to obtain and review the 
individual's self-disclosure and employment history. The final rule has 
added the term ``employment history'' to clarify that the licensee must 
obtain and review that in addition to the self-disclosure. The final 
rule also modifies the language of the proposed rule by eliminating 
reference to Sec.  26.31(b)(3) and instead adding paragraphs (c)(1)(i) 
through (c)(1)(iii) to Sec.  26.69 to specify exactly the time period 
that the self-disclosure and employment history must address. The NRC 
has made this change in response to a public comment suggesting that 
this provision needed clarification and to meet Goal 6 of the 
rulemaking to improve clarity in the organization and language of the 
rule.
    Section 26.69(c)(2) requires the licensee or other entity to 
conduct a suitable inquiry with every employer for the period that the 
employment history addresses. In this section, the final rule deletes 
``self-disclosure'' and replaces it with the phrase ``employment 
history required under paragraph 26.63(a) through (e)'' to clarify the 
time period addressed. If the potentially disqualifying FFD information 
was identified during the course of conducting a suitable inquiry under 
Sec.  26.63(f) so that the suitable inquiry was partially completed, 
Sec.  26.69(c)(2) requires the licensee or other entity to conduct a 
more complete suitable inquiry by contacting every employer that the 
individual listed during the interruption period. The provision also 
requires that if the individual held authorization within the past 5 
years, the licensee or entity shall obtain and review any records that 
other licensees or entities who are subject to this part may have 
developed with regard to potentially disqualifying FFD information 
about the individual from the past 5 years. The final rule, with 
respect to the proposed rule, has added the phrase ``if the individual 
held authorization within the past 5 years'' to meet Goal 6 of the 
rulemaking to improve clarity in the language of the rule. This more 
complete suitable inquiry is necessary to ensure that the licensee or 
other entity has more information about the individual than is required 
for individuals whose last period of authorization was terminated 
favorably in order to make an appropriate authorization decision.
    The NRC has added Sec.  26.69(c)(3) to the final rule, which uses 
the term ``reviewing official'' to refer to the employee whom the 
licensee or other entity designates to make authorization decisions as 
discussed with respect to Sec.  26.5. This provision permits the 
reviewing official to grant or deny authorization based upon his or her 
review of the circumstances associated with the potentially 
disqualifying FFD information. Because of the variety of circumstances 
that may arise, the provision also grants discretion to the reviewing 
official in deciding whether a determination of fitness is required 
rather than requiring a determination of fitness in every case. 
However, if the reviewing official requests a determination of fitness 
and the professional who performs it recommends any form of treatment 
or drug and alcohol testing, including the collection of urine 
specimens under direct observation, Sec.  26.69(c)(4) requires the 
licensee or other entity to implement the treatment and testing 
recommendations.
    The NRC has added Sec.  26.69(c)(5) to the final rule to require 
pre-access and random testing of the applicant for authorization. This 
provision requires the licensee or other entity to verify that the 
results of pre-access drug and alcohol tests are negative before 
granting authorization to the individual, to provide evidence that the 
individual is avoiding substance abuse.
    The NRC has added Sec.  26.69(d) [Maintaining authorization with 
other potentially disqualifying FFD information] to the final rule, 
which establishes requirements for maintaining an individual's 
authorization when new potentially disqualifying FFD information is 
disclosed or discovered that was not a confirmed positive drug or 
alcohol test result, or 5-year denial of authorization, if the 
reviewing official determines that maintaining authorization is 
warranted. A self-disclosure, suitable inquiry, and pre-access testing 
are not required because the individual would not be applying for 
authorization. However, the provision requires the reviewing official 
to consider the circumstances related to the information and, at his or 
her discretion, ensure that a professional with the appropriate 
qualifications makes a determination of fitness. The provision mandates 
that the licensee or other entity must implement any treatment or 
testing requirements resulting from the determination of fitness. The 
NRC has added the provision because the former rule did not address 
maintaining an individual's authorization in these circumstances. Also, 
the NRC is aware that licensees and other entities have handled these 
circumstances inconsistently. Therefore, the final rule adds these 
requirements to establish the NRC's intent with respect to these 
circumstances and to increase consistency between Part 26 programs.
    The NRC has added Sec.  26.69(e) [Accepting followup testing and 
treatment from another Part 26 program] to the final rule to establish 
continuity of care requirements for individuals who were subject to a 
followup testing and/or a substance abuse treatment plan under one Part 
26 program and transfer to another FFD program, or leave and then 
return to the same FFD program.
    Section 26.69(e)(1) requires the receiving licensee or other entity 
to continue the testing and treatment plan to which the individual was 
subject under the previous FFD program. However, with respect to the 
proposed rule, the final rule clarifies that the licensee or other 
entity who imposed the treatment and/or followup testing plan shall 
ensure that information documenting the treatment and/or followup 
testing plan is identified to any subsequent licensee or other entity 
who seeks to grant authorization to the individual. The NRC has made 
this change to clarify the intent of the provision and in recognition 
of the need for additional consistency between the final rule and the 
access authorization requirements. Therefore, this change helps meet 
Goal 4 of this rulemaking to improve consistency between FFD 
requirements and access authorization requirements established in 10 
CFR 73.56, as supplemented by orders to nuclear power plant licensees 
dated January 7, 2003.
    Section 26.69(e)(1) of the final rule also adds a specification 
that if it is impractical for the individual to comply with the 
treatment plan that was developed under another FFD program, the 
granting FFD program shall ensure that an SAE develops a comparable 
treatment plan. The NRC has made this change because it received a 
public comment stating that the proposed provision that required the 
licensee to assume responsibility for overseeing the continuation of 
treatment and follow-up testing for an employee who had a positive test 
result under another FFD program could be burdensome, especially if the 
individual is applying for authorization at a new site that makes it 
impossible to use the same treatment providers.
    Section 26.69(e)(2) permits the receiving licensee or other entity 
to

[[Page 17047]]

accept and rely on any followup testing that was completed while the 
individual was subject to the previous Part 26 program to determine how 
long followup testing must continue. For example, if an individual met 
all of the requirements for authorization by a new licensee but had 
completed only 2 of the 3 years of followup testing required under a 
previous Part 26 program, the granting licensee would then administer 
the final year of the followup testing. However, the licensee is not 
required to conduct another 3 full years of followup testing after the 
individual was authorized. If the transferring individual successfully 
completed any followup testing and treatment program required under the 
first FFD program, a previous determination of fitness indicated that 
the individual is fit for duty, and the individual's authorization by 
the first licensee or other entity was terminated favorably, this 
provision permits the receiving licensee or other entity to accept the 
previous determination of fitness and does not require the granting 
licensee to develop and implement an additional testing and treatment 
plan.
    The NRC has added Sec.  26.69(f) [Sanctions] to the final rule to 
clarify the minimum sanctions to be imposed on an individual who has 
confirmed positive, adulterated, or substituted drug and alcohol test 
results on any tests that may be required under this section. Section 
26.69(f)(1) and (f)(2) cross-references the relevant sanctions 
specified in Subpart D to establish that those sanctions apply to 
individuals about whom potentially disqualifying FFD information has 
been discovered or disclosed.
Section 26.71 Maintaining Authorization
    The NRC has added Sec.  26.71 to the final rule to state the 
requirements for maintaining authorization under this part and has 
adopted the provisions in this section as proposed without change. 
Section 26.71(a) of the final rule provides that individuals may 
maintain authorization under the conditions listed in Sec.  26.71(a)(1) 
through (a)(4), as follows:
    Section 26.71(a)(1) establishes that an individual must comply with 
the licensee's or other entity's FFD policies to which the individual 
is subject. This requirement relates, although it does not refer to 
Sec.  26.27 [Written policy and procedures] that requires the licensee 
or other entity to prepare a clear and concise statement of its FFD 
policy and make that policy readily available to all individuals who 
are subject to the policy. The final rule requires that all individuals 
who are subject to the FFD policy must have information on the 
expectations of them and the consequences that may result from a lack 
of adherence to the policy. Section 26.71 also requires that in order 
to maintain authorization, an individual must report any legal actions 
as defined in Sec.  26.5. Finally, although not explicitly specified in 
Sec.  26.71(a)(1), Sec.  26.33 [Behavioral observation] requires 
individuals to report any FFD concern to the personnel designated in 
the FFD policy.
    Section 26.71(a)(2) establishes that an individual may maintain 
authorization if the individual remains subject to a drug and alcohol 
testing program that complies with the requirements of Part 26, 
including random testing. Licensees and other entities who are subject 
to Part 26 are responsible for implementing drug and alcohol testing 
programs that comply with the requirements in Sec.  26.31 [Drug and 
alcohol testing]. The failure of a licensee or other entity to maintain 
a program would terminate the authorizations of individuals who have 
been granted authorization by the licensee or other entity (see the 
discussion of Sec.  26.71(b)). Section 26.31 also places certain 
responsibilities on individuals who are subject to the testing program. 
In particular, under Sec.  26.31(d)(2)(iii), individuals who are 
selected for random testing are required to report to the collection 
site as soon as reasonably practicable after notification within the 
time period specified in FFD program procedures, as well as to 
cooperate in the testing process. In appropriate circumstances, an 
individual's failure to report or cooperate could be the basis for 
terminating the individual's authorization.
    Section 26.71(a)(3) establishes that an individual may maintain 
authorization if the individual remains subject to a behavioral 
observation program that complies with the requirements of Part 26. 
Behavioral observation, as required by Sec.  26.33, is performed by 
individuals, including coworkers, who have been trained to detect 
behaviors that may indicate possible use, sale, or possession of 
illegal drugs; use or possession of alcohol on site or while on duty; 
or impairment from fatigue or any cause that, if left unattended, might 
constitute a threat to the health and safety of the public or the 
common defense and security.
    Section 26.71(a)(4) establishes that a condition for maintaining 
authorization is the individual's successful completion required of FFD 
training, according to the schedule in Sec.  26.29(c). As specified in 
Sec.  26.29(c)(1), the final rule requires the individual to complete 
training before the licensee or other entity grants initial 
authorization. Thereafter, as specified in Sec.  26.29(c)(2), the rule 
requires individuals to complete refresher training or pass a 
comprehensive examination on a nominal 12-month frequency. Section 
26.29(d) provides that licensees and other entities may accept the 
training of individuals who have been subject to another Part 26 
program and have either had initial or refresher training or 
successfully passed a comprehensive examination within the past 12 
months that meets the requirements of Sec.  26.29.
    Section 26.71(b) of the final rule requires a licensee or other 
entity to terminate an individual's authorization if the individual is 
not subject to an FFD program that meets the requirements of Part 26 
for more than 30 (consecutive) days. The requirements of the paragraph 
permits an individual to be away from all elements of a Part 26 program 
for this period of time in order to accommodate vacations and 
significant illnesses when the individual is not reasonably available 
for behavioral observation or to collect specimens for random drug and 
alcohol testing. The NRC has added this paragraph to the final rule in 
response to stakeholder requests, and it is consistent with related 
requirements in the access authorization orders issued to nuclear power 
plant licensees on January 7, 2003.

Subpart D--Management Actions and Sanctions To Be Imposed

    Throughout this subpart, the final rule makes minor clarifications 
to the proposed rule due to public comment, to accommodate conforming 
changes, and to meet Goal 6 of this rulemaking to improve clarity in 
the organization and language of the rule. The final rule makes other 
substantive changes in Sec. Sec.  26.73; 26.75(e)(1) and (h); and 
26.77(b)(2) that are discussed with regard to those sections. 
Otherwise, the final rule has adopted the provisions in this section as 
proposed without change.
Section 26.73 Applicability
    The NRC has added Sec.  26.73 to the final rule to describe the 
applicability of the subpart. The new Sec.  26.73 specifies, by using 
applicable cross-references to Sec. Sec.  26.3 [Scope] and 26.4 [FFD 
program applicability to categories of individuals], the licensees and 
other entities, as well as individuals, to whom the requirements of 
this subpart apply.
Section 26.75 Sanctions
    The first sentence of Sec.  26.75(a) of the final rule introduces 
the purpose of the section, which is to define the minimum

[[Page 17048]]

sanctions that licensees and other entities must impose when an 
individual has violated the drug and alcohol provisions of an FFD 
policy. The second sentence of the paragraph restates the second 
sentence of former Sec.  26.27(b). This sentence permits licensees and 
other entities to impose more stringent sanctions than those specified 
in the final rule. The final rule adds a cross-reference to paragraph 
(h) of this section, which establishes limits on the sanctions that 
licensees and other entities may impose for positive, adulterated, 
substituted, or invalid drug test results. Adding a cross-reference to 
paragraph (h) of this section clarifies that the blanket permission to 
impose more stringent sanctions granted in this paragraph has one 
exception, as discussed with respect to paragraph (h) of this section. 
The NRC has made these changes to meet Goal 6 of this rulemaking to 
improve clarity in the organization and language of the rule.
    The NRC has added Sec.  26.75(b) to the final rule to require 
licensees and other entities to permanently deny authorization to 
individuals who refuse to be tested or who in any way subvert or 
attempt to subvert the testing process. This sanction is necessary 
because acts to subvert the testing process reflect a sufficiently 
egregious lack of trustworthiness and reliability to warrant permanent 
denial of authorization. An individual's willingness to subvert or 
attempt to subvert the testing process provides strong evidence that 
the individual will also be willing to disregard other rules and 
regulations, such as safeguards requirements, which ensure the 
protection of public health and safety and the common defense and 
security. In addition, if an individual succeeds in subverting the 
testing process in order to hide substance abuse, the individual may 
pose an undetected and unacceptable risk to public health and safety or 
the common defense and security by performing the duties that require 
him or her to be subject to this part while impaired. Therefore, by 
deterring acts to defeat the testing process as well as preventing any 
individuals who engage in them from posing any further risk to public 
health and safety and the common defense and security, this change 
meets Goal 3 of this rulemaking to improve the effectiveness of FFD 
programs.
    The final rule specifies three examples of actions that are 
considered subversion or an attempt to subvert the testing process. 
These include refusing to provide a specimen and providing or 
attempting to provide a substituted or adulterated specimen. However, 
these examples are not intended to be exhaustive. For example, if a 
licensee or other entity determines that several individuals colluded 
to notify potential donors that they would be selected for random 
testing on a particular day, so that the potential donors could plan to 
avoid work on that day or take other actions to ensure that their 
illegal drug use would not be detected, the NRC expects the licensee or 
other entity to permanently deny authorization to all of the 
individuals who were involved in the collusion.
    The final rule does not include submitting a dilute specimen as an 
example of a subversion attempt without additional evidence that the 
donor had diluted the specimen in order to mask the presence of drugs 
or drug metabolites in the specimen, for the reasons discussed with 
respect to Sec.  26.185(g). Submitting a dilute specimen, in itself, 
does not necessarily indicate an attempt to subvert the testing process 
because there are many legitimate causes for a dilute specimen, 
including drinking liquids in order to provide a specimen of sufficient 
quantity, as permitted in Section 2.4(g)(11) in Appendix A of the 
former rule and in Sec.  26.109(b)(1) of the final rule. Therefore, the 
final rule does not require licensees and other entities to apply the 
sanction of permanent denial of authorization for submitting a dilute 
specimen, unless there is other evidence that the donor had diluted the 
specimen in an attempt to subvert the testing process.
    The NRC used the phrase ``for any test required under this part'' 
in Sec.  26.75(b) in the proposed rule to indicate that applicants for 
authorization who subvert or attempt to subvert a pre-access or random 
test are also subject to permanent denial of authorization. However, 
the NRC has changed this phrase in the final rule to ``for any test 
required under 26.31(c).'' This change clarifies the intent of the 
provision and is consistent with Goal 6 of this rulemaking to improve 
clarity in the organization and language of the rule. Although these 
individuals would not yet be performing any duties that could affect 
public health and safety or the common defense and security, an attempt 
to subvert the testing process while in an applicant status provides 
strong evidence that the individual cannot be trusted to perform those 
duties. Therefore, it is necessary to ensure that any applicant who 
subverts or attempts to subvert the testing process is denied 
authorization.
    Section 26.75(c) of the final rule amends former Sec.  26.27(b)(3). 
Former Sec.  26.27(b)(3) established sanctions for the sale, use, or 
possession of illegal drugs within a protected area of any nuclear 
power plant, within a facility that is licensed to possess or use 
formula quantities of SSNM, or within a transporter's facility or 
vehicle. The final rule retains the former sanction of a 5-year denial 
of authorization in these instances and adds two other instances in 
which a 5-year denial of authorization is required.
    First, the final rule requires licensees and other entities to 
impose a 5-year denial of authorization on any individual who is 
determined to have consumed alcohol within a protected area of any 
nuclear power plant, within a facility that is licensed to possess or 
use formula quantities of SSNM, or within a transporter's facility or 
vehicle. This change from the former rule is necessary because 
consuming alcohol causes impairment, which poses the same risks to 
public health and safety as impairment from illegal drugs. Extending 
the scope of the former sanction to alcohol consumption is also 
consistent with the revised FFD program performance objective in Sec.  
26.23(d), which is to provide reasonable assurance that the workplaces 
subject to this part are free from the presence and effects of alcohol 
as well as illegal drugs. Therefore, by reducing the risk to public 
health and safety and the common defense and security that the onsite 
use of alcohol poses, this change meets Goal 3 of this rulemaking to 
improve the effectiveness of FFD programs.
    Second, the final rule adds the phrase ``or while performing the 
duties that require the individual to be subject to this part'' to 
address circumstances in which an individual may be performing the 
duties that require him or her to be subject to this part but is not 
doing so within the protected area of a nuclear power plant, within a 
facility that is licensed to possess or use formula quantities of SSNM, 
or within a transporter's facility or vehicle. As one example, many 
nuclear power plant licensees' designated collection sites are located 
outside of the plant's protected area. The intent of the former rule 
was to prohibit the presence, sale, and use of alcohol or illegal drugs 
by FFD program personnel at a collection site that is located outside 
of the protected area, but the former rule did not specifically address 
such circumstances. The majority of licensees have appropriately 
interpreted the intent of the former rule, but the final rule adds this 
phrase to meet Goal 6 of this rulemaking to improve clarity in the 
organization and language of the rule.

[[Page 17049]]

    In addition, the final rule deletes the list of activities in the 
paragraph of the former rule that an individual is prohibited from 
performing. The final rule replaces this list with the summary term 
``authorization'' for consistency with the use of this term throughout 
the final rule. As discussed with respect to Sec.  26.4, the NRC 
presents the list of duties that require individuals to maintain 
authorization and to be subject to this part once in that section, 
rather than repeatedly throughout the rule, for consistency with Goal 6 
of this rulemaking to improve clarity in the organization and language 
of the rule.
    Section 26.75(d) of the final rule amends a portion of former Sec.  
26.27(c) that required licensees or other entities to record as a 
removal ``for cause'' an individual's resignation that occurs before 
the licensee removes the individual for violating the FFD policy. This 
portion of the former provision has raised implementation questions 
from licensees regarding the appropriate action to take in these 
circumstances. Licensees have questioned whether the former requirement 
was intended to deny authorization to an individual for some period of 
time, as required under former Sec.  26.27(b)(2) through (b)(4), 
permanently deny authorization to the individual, or merely to record 
the resignation. Therefore, the final rule clarifies the intent of the 
former provision as follows:
    The final rule establishes the sanction of a 5-year denial of 
authorization for an individual who resigns before a licensee or other 
entity terminates the individual's authorization or denies 
authorization to an applicant for a first violation of the FFD policy 
involving a confirmed positive drug or alcohol test result. The 
paragraph establishes a 5-year denial of authorization because the 
confirmed positive drug or alcohol test result in combination with such 
a resignation, is a strong indication that the individual has an active 
substance abuse problem. However, because the individual resigned or 
withdrew his or her application for authorization, the individual would 
not be available for the SAE to evaluate the seriousness of his or her 
substance abuse problem and devise an appropriate treatment plan, as 
required under Sec.  26.189 [Determination of fitness]. Therefore, 
prohibiting the individual from being granted authorization for a 5-
year period gives the individual an opportunity to seek treatment and 
establish a 5-year history of sobriety, which is required to regain 
authorization under Sec.  26.69 [Authorization with potentially 
disqualifying fitness-for-duty information]. This prohibition also 
ensures that such an individual is not granted authorization without 
having demonstrated that he or she has overcome the substance abuse 
problem. Therefore, the NRC has made this change to meet Goal 3 of this 
rulemaking to improve the effectiveness and efficiency of FFD programs.
    In addition, for any type of FFD policy violation, this provision 
requires the licensee or other entity to record the fact that the 
individual had resigned or withdrawn his or her application for 
authorization, the nature of the FFD policy violation, and the sanction 
that would have been imposed if the individual had not resigned or 
withdrawn. Recording this information is necessary to ensure that any 
licensees or other entities who may consider granting authorization to 
the individual in the future are aware of the individual's behavior and 
the nature of the FFD policy violation. Subsequent licensees and other 
entities will then be able to ensure that the minimum requirements of 
this section are met. For example, if the FFD policy violation was a 
third confirmed positive drug or alcohol test result, Sec.  26.75(g) 
prohibits a subsequent licensee or other entity from granting 
authorization to the individual under any circumstances. The NRC has 
made this change to meet Goal 3 of this rulemaking to improve the 
effectiveness and efficiency of FFD programs.
    The NRC has moved the portion of former Sec.  26.27(c) that 
referred to a refusal to provide a specimen for testing to Sec.  
26.75(b) of the final rule to meet Goal 6 of this rulemaking, regarding 
organizational clarity.
    Section 26.75(e) of the final rule amends former Sec.  26.27(b)(2) 
and expands its scope to include alcohol. The NRC no longer excludes 
the abuse of alcohol from the sanctions specified in this section for 
several reasons. First, although the possession and use of alcohol are 
legal for adults and do not adversely reflect on an individual's 
trustworthiness and reliability, a perceived need to conceal an 
untreated active alcohol abuse problem could cause an individual to be 
vulnerable to influence to act in ways that are adverse to the common 
defense and security. Second, alcohol-related impairment in the nuclear 
workplace poses an undue potential risk to public health and safety 
that is comparable to the risk imposed by impairment from the use of 
drugs. Third, some licensees have not imposed appropriately stringent 
sanctions on individuals who have abused alcohol in a manner that could 
cause the individual to be impaired while performing the duties that 
require individuals to be subject to this part. Therefore, in order to 
deter individuals from abusing alcohol and ensure that individuals who 
may be impaired from alcohol are not permitted to perform the duties 
that require individuals to be subject to this part, this final rule 
imposes the same sanctions for abusing alcohol as those required for 
abusing drugs. The NRC has made this change to meet Goal 3 of this 
rulemaking to improve the effectiveness of FFD programs.
    Section 26.75(e)(1) retains but amends the intent of the second 
sentence of former Sec.  26.27(b)(2). The former Sec.  26.27(b)(2) 
stated that licensees and other entities must remove an individual from 
performing activities under this part for at least 14 days following a 
first confirmed positive test result. However, the final rule requires 
licensees and other entities to immediately unfavorably terminate the 
individual's authorization for at least 14 days from the date of the 
unfavorable termination, rather than ``remove'' the individual. With 
respect to the proposed rule, the final rule adds a clarification that 
the 14-day termination begins on the date of the unfavorable 
termination. The NRC has made this change because after publishing the 
proposed rule, it recognized the need for additional clarity in this 
provision to illustrate the NRC's intent. At the public meetings 
discussed in Section I.D, the stakeholders indicated that the term 
``remove'' is confusing because it could be interpreted as requiring 
licensees and other entities to terminate the individual's employment, 
which is not the intent of this paragraph. The stakeholders suggested 
using the phrase ``terminate the individual's authorization'' to more 
accurately characterize the required action. This change is consistent 
with Goal 6 of this rulemaking to improve clarity in the organization 
and language of the rule.
    The stakeholders also requested that the agency eliminate from 
Sec.  26.75(e)(1) the requirements in the former paragraph related to 
referring the individual to the EAP for assessment and counseling. The 
stakeholders noted that many licensees terminate an individual's 
employment at the same time that they terminate the individual's 
authorization after a first confirmed positive test result. They 
suggested that if the licensee or other entity terminates the 
individual's employment and does not intend to provide the individual 
with an opportunity to regain authorization, it is inappropriate to 
require the licensee or other entity to provide assessment and 
counseling services to the individual. However, some licensees have 
interpreted the

[[Page 17050]]

former provision as requiring them to provide EAP services to 
individuals whom they no longer employ. The NRC concurs that the intent 
of the former rule is for licensees and other entities to provide 
assessment and counseling services only in those instances when the 
licensee or other entity desires to reinstate the individual's 
authorization. Therefore, the NRC has made this change, consistent with 
Goal 6 of this rulemaking to improve clarity in the organization and 
language of the rule.
    The final rule also moves the requirements in former Sec.  
26.27(b)(2) that were related to permitting the individual to regain 
authorization to Subpart C [Granting and Maintaining Authorization] of 
the final rule instead of retaining them in Sec.  26.75(e)(1) because 
Sec.  26.75(e)(1) addresses sanctions for FFD policy violations, rather 
than FFD requirements for granting authorization. Subpart C addresses 
the requirements for granting authorization to an individual after his 
or her authorization has been terminated unfavorably for a first 
confirmed positive drug or alcohol test result in Sec.  26.69(b). The 
NRC has made this change to meet Goal 6 of this rulemaking to improve 
organizational clarity in the rule.
    Section 26.75(e)(2) increases the length of the period for which 
licensees and other entities must deny an individual's authorization 
for a second confirmed positive drug or alcohol test result from 3 
years in former Sec.  26.27(b)(vii) to 5 years in the final rule. This 
change provides greater assurance that individuals who have had a 
second confirmed positive drug or alcohol test result are able to 
abstain from substance abuse for at least 5 years before a licensee or 
other entity may again consider granting authorization to them. The 5-
year period is based on the research literature indicating that 
individuals who abstain from substance abuse for 5 years after 
treatment are less likely to relapse than individuals who have been 
able to abstain for 3 years. In addition, the more stringent sanction 
for a second confirmed positive drug or alcohol test result provides 
greater deterrence to recidivism than the former 3-year period. The NRC 
has made this change to meet Goal 3 of this rulemaking to improve the 
effectiveness and efficiency of FFD programs.
    Section 26.75(f) of the final rule amends former Sec.  26.27(b)(5). 
Former Sec.  26.27(b)(5) stated that the sanctions for confirmed 
positive drug test results in former Sec.  26.27 [Written policy and 
procedures] did not apply to the misuse of alcohol, valid 
prescriptions, and over-the-counter drugs, but required licensee FFD 
policies to establish sanctions that are sufficient to deter the misuse 
of those substances. The final rule requires the same minimum sanctions 
for alcohol abuse as those required for drug abuse. Impairment caused 
by alcohol abuse creates a risk to public health and safety that is 
fundamentally similar to the risk posed by the use of illegal drugs. 
However, some licensees have imposed lesser sanctions for alcohol 
violations, an approach that is inconsistent with the NRC's intent. 
Therefore, the final rule rectifies this situation by explicitly 
requiring the same minimum sanctions for the abuse of alcohol as 
currently required for the use of illegal drugs. The NRC has made this 
change to meet Goal 3 of this rulemaking to improve the effectiveness 
and efficiency of FFD programs and Goal 6 to improve clarity in the 
organization and language of the rule.
    In addition, Sec.  26.75(f) of the final rule requires licensees 
and other entities to impose the same sanctions as mandated for the 
abuse of illegal drugs if the MRO determines that the misuse of 
prescription drugs or over-the-counter medications resulting in a 
positive drug or alcohol test result represents substance abuse. The 
MRO makes this determination under Sec.  26.185(j). Misuse of 
prescription and over-the-counter medications may include, for example, 
the use of a spouse's or other family member's prescription medications 
that may cause impairment, such as some pain relievers, or the 
excessive use of some over-the-counter cold and cough preparations 
containing alcohol or other active ingredients that may cause 
impairment. However, an individual who has a substance abuse problem 
may use the same substances. For example, an individual who has become 
addicted to opiates may use a spouse's or other family member's codeine 
tablets or other opiates that were prescribed for pain relief to assist 
the addicted individual in avoiding withdrawal symptoms. Under this 
provision, if the MRO determines that an individual's use of a 
prescription or over-the-counter medication represents substance abuse, 
the licensee or other entity is required to impose the minimum 
sanctions specified in this section for a confirmed positive drug or 
alcohol test result, as appropriate. If the MRO determines that the 
misuse of a prescription or over-the-counter medication does not 
represent substance abuse, the final rule requires the licensee or 
other entity to impose the sanctions for substance misuse that the 
licensee or other entity specifies in the FFD policy.
    The final rule also retains but revises the requirement in the last 
sentence of former Sec.  26.27(b)(5). Section 26.75(f) retains the 
former requirement that sanctions for the misuse of prescription and 
over-the-counter drugs must be sufficient to ``deter abuse of legally 
obtainable substances'' because such misuse may lead to impairment on 
the job. However, the final rule eliminates the phrase ``as a 
substitute for abuse of prescribed drugs'' in the last sentence of 
former Sec.  26.27(b)(5) because it unnecessarily limited the 
circumstances in which sanctions for the misuse of prescription and 
over-the-counter drugs must be imposed. The NRC has made these changes 
to meet Goal 3 of the rulemaking to improve the effectiveness and 
efficiency of FFD programs, and Goal 6 to improve clarity in the 
organization and language of the rule.
    Section 26.75(g) of the final rule amends former Sec.  26.27(b)(4). 
The NRC has moved the portions of the former paragraph that established 
requirements for granting authorization to an individual who has 
violated the licensee's or other entity's FFD policy to Sec.  26.69 in 
Subpart C of the final rule for organizational clarity because Sec.  
26.75(g) only addresses sanctions for FFD policy violations. This 
provision retains the portion of the former paragraph that required 
licensees and other entities to permanently deny authorization to an 
individual who has repeatedly violated a licensee's or other entity's 
FFD policy. The final rule requires the permanent denial of an 
individual's authorization if he or she has another confirmed positive 
drug or alcohol test result after he or she has had authorization 
denied for 5 years under other paragraphs in this section. Requiring 
this more stringent sanction meets Goal 3 of this rulemaking to improve 
the effectiveness and efficiency of FFD programs because this provides 
reasonable assurance that individuals are trustworthy and reliable, as 
demonstrated by avoiding substance abuse, and increases the assurance 
that only individuals who are fit for duty are permitted to perform the 
duties listed in Sec.  26.4.
    Section 26.75(h) and (i) of the final rule amends former Sec.  
26.24(d)(2). The former provision permitted licensees to temporarily 
suspend an individual's authorization or take other administrative 
action if an individual has a positive drug test result for marijuana 
or cocaine metabolites that is identified through initial testing at 
the licensee testing facility. For organizational clarity, consistent 
with Goal 6 of this rulemaking, the final rule divides the former 
paragraph into two paragraphs to separate the requirements related to 
the conditions under which licensees and other entities may and

[[Page 17051]]

may not take action on the basis of initial test results.
    Section 26.75(h) prohibits licensees and other entities from taking 
administrative actions or imposing sanctions on an individual based on 
a positive test result from any initial drug test result reported by an 
HHS-certified laboratory. This section also permits licensees and other 
entities to take administrative actions on the basis of positive 
initial drug test results for marijuana and cocaine from a licensee 
testing facility. However, in order for the licensee or other entity to 
take action, the final rule requires that the urine specimen that 
yields a positive, adulterated, or substituted drug test result(s) must 
also appear to be a valid specimen, based on the results of validity 
screening or initial validity test results at the licensee testing 
facility. In addition, this section prohibits licensees and other 
entities from imposing sanctions or taking other actions in response to 
adulterated, substituted, or invalid screening or initial validity test 
results from a specimen in which no drug metabolites were detected. The 
NRC has added this prohibition because the procedures, instruments, and 
devices used in conducting validity screening and initial validity 
tests have not yet been proven to be sufficiently accurate and reliable 
to support management actions or sanctions without confirmatory 
testing. Permitting licensees and other entities to take actions on the 
basis of validity screening or initial validity test results risks 
imposing substantial burdens on individuals from false positive, 
adulterated, substituted, or invalid test results. Therefore, the NRC 
has added this prohibition to meet Goal 7 of this rulemaking to protect 
the privacy and other rights (including due process) of individuals who 
are subject to Part 26.
    With respect to the proposed rule, the final rule adds a provision 
that the licensee or other entity may not subject an individual to 
administrative action based upon validity testing results indicating 
that a specimen is of questionable validity. This change is based on 
analysis of public comment, which is discussed with respect to the term 
``questionable validity'' in Sec.  26.5 [Definitions].
    Section 26.75(i)(1) through (i)(4) retains the requirements in 
former Sec.  26.24(d)(2)(i) through (iv) that established the 
conditions under which licensees and other entities may take 
administrative actions on the basis of a positive initial drug test 
result for marijuana or cocaine metabolites from a licensee testing 
facility. The final rule adds a requirement for specimen validity 
testing (see the discussion of Sec.  26.31(d)(3)(i) with respect to the 
addition of validity testing requirements in this rule and the 
requirement that the specimen for which action will be taken must 
appear to be valid, based on validity screening or initial validity 
test results from the licensee testing facility). The final rule also 
revises the terminology used in the former provision to be consistent 
with the terminology used throughout the final rule (see the discussion 
of Sec.  26.5 with respect to the new terminology adopted in the final 
rule) and updates the cross-references to other sections of the rule to 
be consistent with the organization of the final rule. The NRC has made 
these changes to meet Goal 6 of this rulemaking to improve clarity in 
the organization and language of the rule.
Section 26.77 Management Actions Regarding Possible Impairment
    The NRC has added Sec.  26.77 [Management actions regarding 
possible impairment], which amends the requirements of former Sec.  
26.27(b)(1). The former section required licensees and other entities 
to remove impaired workers, or those whose fitness may be questionable, 
from performing activities within the scope of this part. The former 
provision also permitted licensees and other entities to return the 
individuals to duty only after the individuals were determined to be 
fit to safely and competently perform their duties. The final rule 
retains the intent of the former provision, but the terminology used in 
the section is consistent with the terminology used throughout the 
final rule. The NRC has updated cross-references to other sections of 
the rule, consistent with Goal 6 of this rulemaking to improve clarity 
in the organization and language of the rule. In addition, the agency 
has added several new requirements.
    The NRC has added Sec.  26.77(a) to the final rule to introduce and 
describe the purpose of the section, which is to prescribe the 
management actions that licensees and other entities must take when an 
individual shows indications that he or she is not fit to safely and 
competently perform their duties. The NRC has added this paragraph to 
meet Goal 6 of this rulemaking to improve clarity in the organization 
and language of the rule.
    Section 26.77(b) of the final rule retains the portion of former 
Sec.  26.27(b)(1) that required the licensee or other entity to take 
immediate action to prevent an individual from performing the duties 
that require him or her to be subject to this part if an individual 
appears to be impaired, or his or her fitness is questionable. This 
section of the final rule adds cross-references to Sec.  Sec.  
26.27(c)(3), 26.207, and 26.209 (updated from the proposed rule) 
because those provisions provide exceptions to the requirement for 
immediate action. Section 26.27(c)(3) permits licensees and other 
entities to use individuals who have consumed alcohol if they are 
needed to respond to an emergency and the licensee or other entity 
establishes controls and conditions under which the individual may 
perform work safely. Sections 26.207 and 26.209 contain the provisions 
for waivers and exceptions and self-declarations, which exempt 
individuals from the work hour controls of Subpart I [Managing Fatigue] 
under certain circumstances. The NRC has added the cross-references to 
meet Goal 6 of this rulemaking to improve clarity in the organization 
and language of the rule.
    The final rule also revises some terminology used in the former 
provision in response to stakeholder requests during the public 
meetings discussed in Section I.D. The stakeholders indicated that, 
because the former rule requires them to ``remove'' individuals whose 
fitness may be questionable, some FFD programs have interpreted the 
former paragraph as requiring them to terminate the individual's 
authorization. This was not the intent of the former provision. In this 
instance, the intent of the rule was for licensees and other entities 
to prevent the individual from performing the duties that would require 
the individual to be subject to this part in order to ensure that any 
potential impairment could not result in errors or lapses in judgment 
that may pose a risk to public health and safety or the common defense 
and security until the cause of the problem could be identified and 
resolved. Therefore, the final rule replaces the phrase, ``removed from 
activities within the scope of this part,'' with the phrase, ``prevent 
the individual from performing the duties,'' and makes other minor 
changes to the wording of the former requirement to clarify the intent 
of the provision. The NRC has made these changes to meet Goal 6 of this 
rulemaking to improve clarity in the language of the rule.
    Section 26.77(b)(1) retains the intent of former Sec.  26.24(a)(3). 
This provision requires licensees and other entities to conduct drug 
and alcohol testing for cause. The final rule requires for-cause 
testing based upon a ``reasonable suspicion'' that the individual may 
be impaired from possible substance abuse. Reasonable suspicion of 
substance abuse could be based upon an observed

[[Page 17052]]

behavior, such as unusual lack of coordination or slurred speech, or a 
physical condition, such as the smell of alcohol. If the only basis for 
a reasonable suspicion is the smell of alcohol, then alcohol testing is 
required. However, the final rule does not require the licensee or 
other entity to perform a drug test unless other physical or behavioral 
indicators of possible impairment are present.
    The stakeholder comments received during the public meetings 
discussed in Section I.D reported that many of the for cause tests they 
perform are initiated as a result of a security officer or other person 
reporting that an individual smells of alcohol without behavioral 
indications of impairment. They also noted that the very large majority 
of the for-cause drug tests that they conduct in these circumstances 
yields negative results, including those instances in which the alcohol 
test results are positive. The stakeholders suggested that the former 
requirement to conduct drug tests in these circumstances imposes a 
significant burden because the drugs tests impose costs, not only for 
collecting and testing the urine specimens, but also because they 
cannot permit the individual to resume performing his or her duties 
until the drug test results are available, which may take several days. 
The stakeholders argued that the burden is unnecessary because the drug 
tests yield positive results so infrequently and, therefore, do not 
serve their intended purpose of detecting drug abuse. Based on these 
stakeholders' arguments and the FFD program performance data that 
support them, the NRC concurs that drug testing is unnecessary when the 
smell of alcohol is the only indication that for cause testing is 
required, and has eliminated it from the final rule. The final rule 
continues to require drug testing if there are behavioral or physical 
indications of impairment in addition to the smell of alcohol.
    The NRC has added Sec.  26.77(b)(2) to apply only to nuclear power 
plant licensees and C/Vs who are subject to Subpart I. With respect to 
the proposed rule, the final rule modifies the language of this 
provision to improve its clarity and to more clearly specify the NRC's 
intent. This section permits these entities to forego drug and alcohol 
testing and the determination of fitness process required by Sec.  
26.189 if a fatigue assessment conducted under Sec.  26.211 confirms 
that the individual's observed behavior or physical condition is solely 
a result of fatigue. This section applies only to licensees and C/Vs 
who are subject to Subpart I because licensees not subject to Subpart I 
would not have the requisite training to evaluate whether the observed 
behavior is caused by fatigue. The NRC has made this change to meet 
Goal 2 of this rulemaking to ensure against worker fatigue at nuclear 
power plants and Goal 3 to improve the effectiveness and efficiency of 
FFD programs.
    The NRC has added Sec.  26.77(b)(3) to specify the actions that 
licensees and other entities must take when there are indications that 
an individual may be impaired, other than behavior or a physical 
condition that creates a reasonable suspicion of substance abuse (or 
fatigue, in the case of licensees who are subject to Subpart I). 
Consistent with former Sec.  26.27(b)(1), the final rule permits the 
licensee or other entity to return the individual to duty only after 
identifying and resolving the cause of the impairing condition and 
making a determination of fitness indicating that the individual is fit 
to safely and competently perform his or her duties (see the discussion 
of Sec.  26.189 for more details regarding the determination of fitness 
process). This section does not require licensees and other entities to 
unfavorably terminate an individual's authorization for illness, 
fatigue, temporary mental and emotional stress, or other conditions 
that may affect an individual's fitness, but prohibits the licensee or 
other entity from assigning the impaired individual to perform the 
duties that require him or her to be subject to this subpart until a 
determination is made that the individual is fit to return to duty. The 
NRC has made this change to meet Goal 2 of this rulemaking to ensure 
against worker fatigue at nuclear power plants and Goal 3 to improve 
the effectiveness and efficiency of FFD programs.
    Section 26.77(c) of the final rule updates former Sec.  26.27(d) to 
be consistent with current NRC notification procedures.

Subpart E--Collecting Specimens for Testing

    Throughout Subpart E, the final rule makes minor clarifications to 
the proposed rule because of public comment, to accommodate conforming 
changes, and to meet Goal 6 of this rulemaking to improve clarity in 
the organization and language of the rule. The final rule also makes 
more substantive changes to the proposed rule in this subpart because 
of public comment or to improve clarity in the organization and 
language of the rule. The substantive changes in this subpart can be 
found in Sec. Sec.  26.81; 26.85(c)(1), (c)(2), and (e); 26.87(e); 
26.89(a)(2) and (c); 26.91(e)(4); 26.109(b)(1); and 26.111(a), (c) and 
(d). These changes are discussed in detail below. However, other than 
the changes mentioned above, the final rule adopts the provisions of 
this subpart as proposed without change.
Section 26.81 Purpose and Applicability
    This added section describes the purpose of Subpart E, which is to 
establish requirements for collecting specimens for drug and alcohol 
testing. The new section assists in locating provisions within the rule 
and is consistent with Goal 6 of the rulemaking to improve clarity in 
the organization and language of the rule.
    The NRC revised the title of this section from ``Purpose'' in the 
proposed rule to ``Purpose and applicability'' in the final rule to 
reflect other modifications to this paragraph that the agency has made 
in response to public comments that the applicability of the proposed 
rule's requirements was unclear. This paragraph specifies that the 
requirements of Subpart E apply to the licensees and other entities in 
Sec.  26.3(a) through (d) to the extent that a C/V conducts drug and 
alcohol testing on which a licensee or other entity in Sec.  26.3(a) 
through (d) relies. The provision further specifies the applicability 
of Subpart E's requirements by also listing the categories of 
individuals who are subject to the subpart. These include the 
categories of individuals listed in Sec.  26.4(a) through (e). In 
addition, licensees and other entities may choose to conduct specimen 
collections and alcohol testing under the requirements of this subpart 
for the categories of individuals specified in Sec.  26.4(f) and (g). 
However, Sec. Sec.  26.4(j), 26.31(b)(2), and Subpart K [FFD Programs 
for Construction] permit licensees and other entities to rely on 
specimen collections and alcohol testing that are conducted under the 
requirements of 49 CFR Part 40, ``Procedures for Transportation 
Workplace Drug Testing Programs'' (65 FR 41944; August 9, 2001), for 
the reasons discussed with respect to those sections. In these 
instances, Sec.  26.81 permits the specimen collections and alcohol 
testing to be performed under DOT's procedures, rather than those 
contained in Subpart E, for individuals who are subject to another 
Federal or State FFD program in Sec.  26.4(j), FFD program personnel in 
Sec.  26.31(b)(2), and the categories of individuals identified in 
Sec.  26.4(f). These changes meet Goal 6 of the rulemaking to improve 
clarity in the organization and language of the rule.

[[Page 17053]]

Section 26.83 Specimens To Be Collected
    The NRC has added Sec.  26.83, which specifies the types of 
specimens that licensees and other entities must collect for initial 
and confirmatory drug and alcohol testing.
    Section 26.83(a) requires licensees and other entities to collect 
either breath or oral fluids (i.e., saliva) for initial alcohol tests. 
The final rule continues to require collecting only breath specimens 
for confirmatory alcohol testing. The final rule permits the use of 
oral fluids (i.e., saliva) for initial alcohol tests because devices 
for testing oral fluids for alcohol have matured sufficiently to 
provide valid and reliable initial test results. Circumstances may 
arise, such as collecting a specimen of oral fluids from a donor who 
has impaired lung functioning, in which the use of these devices is 
more efficient than collecting breath specimens for both donors and the 
FFD program. Therefore, the permission to collect oral fluids for 
initial alcohol testing meets Goal 3 of this rulemaking to improve the 
efficiency of FFD programs. Additionally, other Federally mandated 
alcohol testing programs permit the use of these devices for initial 
alcohol testing. Therefore, adding permission to collect oral fluids 
for initial alcohol testing to the final rule is consistent with Goal 1 
of the rulemaking to update and enhance the consistency of Part 26 with 
advances in other relevant Federal rules and guidelines.
    The final rule eliminates the use of blood as a specimen for 
alcohol testing at the donor's discretion, which was permitted in 
former Sec.  26.24(g) and Section 2.2(d)(4) in Appendix A to Part 26. 
The final rule eliminates the former provisions related to blood 
alcohol testing for several reasons. Since the former rule was first 
promulgated, licensees have repeatedly raised questions related to the 
proper interpretation of a confirmatory alcohol test result using an 
evidential breath testing device (EBT) and an alcohol test result 
derived from a blood specimen when the results from the two types of 
testing differ. Specifically, if a confirmatory alcohol test result 
using an EBT is positive, but the result from testing a blood specimen 
is negative, licensees have asked which test result they should rely on 
in determining whether the donor has violated the FFD policy. Although 
the NRC's original intent was that the result from the blood test was 
to be definitive, delays in obtaining a blood specimen sometimes 
resulted in blood test results that fell below the alcohol cutoff level 
of 0.04 percent BAC due to alcohol metabolism during the period of the 
delay. Some licensees have been reluctant to apply sanctions for a 
positive alcohol test result in these instances even though alcohol 
metabolism over time explains the lower test result from the blood 
sample. Further, experience has shown that few donors request testing 
of a blood sample. Data gathered from a sampling of representative FFD 
programs show that individuals requested an average of fewer than one 
blood test per program within the period reviewed (January-May 2002). 
Additionally, the use of EBTs for confirmatory alcohol tests has 
consistently withstood legal challenge. The added protection of donors' 
rights that the NRC envisioned when promulgating the provisions for 
voluntary testing of blood specimens has not been realized in practice. 
The former requirement has also been costly for licensees. Licensees 
must ensure that an individual who is trained to draw blood is 
available to do so should a donor request blood testing. Based on 
information provided by stakeholders at the public meetings discussed 
in the preamble to the proposed rule, the NRC determined that the costs 
associated with retaining this provision are not justified because of 
the very few instances in which donors have requested blood alcohol 
testing. Therefore, the agency has deleted from the final rule 
references to collecting and testing blood specimens for alcohol.
    Section 26.83(b) retains, but makes explicit, the implied 
requirement in the first sentence of former Sec.  26.24(b) (and other 
provisions that are interspersed throughout the former rule) for 
licensees and other entities to collect only urine specimens for drug 
testing. When the former rule was promulgated, it was unnecessary to 
establish an explicit requirement to collect and test only urine 
specimens for drugs in Part 26 programs because methods for testing 
other specimens were not available and the HHS Guidelines only 
addressed testing urine specimens. Since that time, methods for testing 
alternate specimens, such as oral fluids, sweat, and hair, have become 
commercially available and HHS has published proposed revisions to its 
guidelines (69 FR 19673; April 13, 2004) that would permit the use of 
alternate specimens for drug testing in Federal workplace drug testing 
programs. The NRC is considering permitting the use of alternate 
specimens for drug testing when HHS has published final revisions to 
its guidelines related to these types of specimens. The revised HHS 
Guidelines will establish acceptable collection procedures and testing 
methods. However, HHS has not yet published final guidelines for 
collecting and testing these alternate specimens. Therefore, it is 
necessary to add Sec.  26.83(b) to the final rule to clarify that the 
NRC intends to continue prohibiting the collection and drug testing of 
specimens other than urine in this rulemaking except as permitted under 
Sec.  26.31(d)(5) [Medical conditions]. The reasons are as discussed 
with respect to that section.
Section 26.85 Collector Qualifications and Responsibilities
    This added section replaces the collector qualifications and 
training requirements specified in the definition of ``collection site 
person'' in the former rule and in former Sections 1.2, 2.2(d), and 
2.4(b) in Appendix A to Part 26. This section retains the intent of the 
former provisions, but the final rule groups the requirements together 
to improve organizational clarity. In addition, the final rule amends 
the former collector qualifications and training requirements to 
increase the consistency of Part 26 with the requirements of other 
Federal agencies and incorporates the lessons learned from those 
programs as discussed with respect to Goal 1 of this rulemaking.
    Section 26.85(a) [Urine collector qualifications] provides more 
detailed requirements for urine collector qualifications and training 
than are contained in the former definition of ``collection site 
person'' and former Section 2.2(d) in Appendix A to Part 26. The final 
rule requires urine collectors to be knowledgeable of the requirements 
of this part, the FFD policy and procedures of the licensees or other 
entities for whom they perform collections, and to keep current on any 
changes to urine collection procedures. These changes increase the 
consistency of urine collector qualification requirements with those of 
other Federal workplace drug testing programs as well as consistency in 
urine collection procedures among FFD programs that are subject to this 
subpart.
    Section 26.85(a) retains the requirements in former Section 2.2(d) 
that urine collectors must receive training to perform their duties and 
demonstrate proficiency in applying the requirements of this section 
before serving as a collector. Section 26.85(a)(1) through (a)(4) lists 
the topics that the final rule requires collector training to address. 
Section 26.85(a)(1) requires collectors to be trained in the steps that 
are necessary to complete a collection correctly and the proper

[[Page 17054]]

completion and transmission of the custody-and-control form to the 
licensee testing facility or HHS-certified laboratory, as appropriate. 
Section 26.85(a)(2) requires training in methods to address ``problem'' 
collections. These may include, but are not limited to, collections 
involving ``shy bladder'' (see the discussion of proposed Sec.  26.119 
[Determining ``shy'' bladder] for an explanation of this term and the 
procedures involved) and attempts by a donor to tamper with a specimen. 
Section 26.85(a)(3) requires the training to instruct collectors on 
correcting collection problems. These may include, but are not limited 
to, a donor refusing to cooperate with the collection process or an 
incident in which a urine specimen is spilled. Section 26.85(a)(4) 
requires training so that a collector is knowledgeable in maintaining 
the integrity of the specimen collection and transfer process, and 
ensuring that donors' privacy and modesty are maintained. The NRC added 
these requirements to meet Goal 1 of this rulemaking to update and 
enhance the consistency of Part 26 with advances in other relevant 
Federal rules and guidelines.
    Section 26.85(a)(4) retains the portion of former Section 2.2(d)(1) 
in Appendix A to Part 26 that required collector training to emphasize 
the collector's responsibility for maintaining the integrity of the 
specimen collection and transfer process, carefully ensuring the 
modesty and privacy of the donor, and avoiding any conduct or remarks 
that might be construed as accusatorial or otherwise offensive or 
inappropriate.
    The NRC added Sec.  26.85(b) [Alcohol collector qualifications] to 
specify requirements related to alcohol collector qualifications and 
training. Portions of this section are the same as the requirements for 
urine collectors in Sec.  26.85(a), including the first three sentences 
of Sec.  26.85(b), and (b)(4) and (b)(5). The agency added these 
requirements here for the same reasons discussed with respect to the 
first three sentences of Sec.  26.85(a), and (a)(3) and (a)(4), 
respectively. The final rule repeats the requirements that are 
applicable to both urine and alcohol collectors in each of these 
paragraphs because some FFD programs may not train collectors to 
perform both types of collections. Repeating the requirements makes it 
easier to locate the requirements that apply to urine or alcohol 
collectors and meets Goal 6 of the rulemaking to improve clarity in the 
organization of the rule.
    Section 26.85(b)(1) and (b)(3) requires alcohol collectors to 
receive training that addresses the alcohol testing requirements of 
this part and methods to address ``problem'' collections. These 
include, but are not limited to, collections involving ``shy lung'' 
problems or attempts by a donor to tamper with a specimen. In contrast 
to Sec.  26.85(a)(2), which addresses ``shy bladder'' problems in urine 
collections, the final rule does not incorporate the related DOT 
procedures for evaluating ``shy lung'' problems in alcohol collections. 
During the public meetings discussed in the preamble to the proposed 
rule, stakeholders requested that the proposed rule incorporate DOT's 
``shy bladder'' procedures, but did not believe that adding DOT's ``shy 
lung'' procedures to the final rule is necessary. The stakeholders 
reported that donors have not experienced problems related to ``shy 
lung,'' based on their experience implementing the breath testing 
requirements of Part 26 since the rule was first promulgated. 
Therefore, Sec.  26.85(b)(3) requires alcohol collectors to be able to 
implement the ``shy lung'' procedures established by any FFD program 
for whom the collectors are providing collection services, but does not 
establish requirements for responding to ``shy lung'' problems in the 
rule.
    The final rule adds Sec.  26.85(b)(2) to require alcohol collectors 
to be trained in the operation of the particular alcohol testing 
device(s) (i.e., the ASDs and EBTs) to be used in conducting alcohol 
tests, consistent with the most recent version of the manufacturers' 
instructions. The final rule adds this requirement because the NRC is 
aware that some FFD programs did not implement device manufacturers' 
recommended changes to instructions for using the testing devices. 
Although the NRC staff is not aware of any testing errors or instances 
in which donors have challenged the results of alcohol tests that were 
not performed in accordance with the most recent version of the device 
manufacturer's instructions, the final rule adds this requirement to 
ensure that alcohol test results continue to be accurate and cannot be 
challenged on this basis. The changes are also consistent with the 
alcohol collector training requirements of other Federal agencies.
    Section 26.85(c) [Alternative collectors] amends the last sentence 
of former Section 2.2(d)(2) in Appendix A to Part 26. The former 
provision permitted medical personnel to perform specimen collections 
without receiving the required training for non-medical collectors. The 
final rule permits medical personnel to conduct specimen collections 
for the purposes of this subpart only under the conditions specified in 
Sec.  26.85(c)(1) through (c)(5). These conditions may include, but are 
not limited to, the collection of specimens for post-event testing by a 
nurse or medical technician at a hospital. The final rule limits the 
circumstances in which an untrained medical professional, technologist, 
or technician may perform collections for a licensee or other entity 
because the experience of other Federal agencies has shown that medical 
personnel who are untrained in specific collection procedures have 
committed errors in collections that resulted in unnecessary legal 
challenges to test results. At the same time, the NRC is also aware 
that licensees and other entities may occasionally have to rely on 
these individuals to collect specimens for drug and alcohol testing, as 
discussed with respect to Sec.  26.4(i)(1). Therefore, the final rule 
permits untrained medical personnel to collect specimens to facilitate 
the collection of specimens for testing in rare circumstances in which 
a qualified collector could not reasonably be expected to be available, 
but otherwise requires medical personnel who do not meet the criteria 
specified in Sec.  26.85(c)(1) through (c)(5) to receive the same 
training as non-medical collectors. The NRC made this change to meet 
Goal 3 of the rulemaking to improve the effectiveness and efficiency of 
FFD programs, by reducing the likelihood of errors and legal challenges 
to test results. In addition, the final rule also makes minor changes 
to the organization of this paragraph in response to a public comment 
indicating a lack of clarity in the same provision in the proposed 
rule.
    The NRC has eliminated former Section 2.2(d)(4) in Appendix A to 
Part 26, which required that donors must be informed of the option to 
request blood testing. The agency eliminated the former requirement 
because the final rule no longer permits donors to request blood 
testing for alcohol, as discussed with respect to Sec.  26.83(a).
    Section 26.85(d) amends former Section 2.7(o)(5) [Personnel 
available to testify at proceedings] in Appendix A to Part 26. This 
section required the licensee testing facility and HHS-certified 
laboratory to make available qualified individuals to testify in 
administrative or disciplinary proceedings related to drug and alcohol 
test results. The final rule adds an explicit requirement for 
collection site personnel to be available to testify at proceedings 
because the former provision implied, but did not explicitly state this 
requirement. When the rule was first published, licensee testing 
facilities and collection sites were

[[Page 17055]]

typically co-located at a site. However, this is no longer the case. In 
some current FFD programs, alcohol testing and urine specimen 
collections occur at the collection site, but initial testing of urine 
specimens is performed at a licensee testing facility that may not be 
co-located with the collection site. Therefore, the NRC has added this 
paragraph to retain the former rule's original intent that licensees 
and other entities must make available collection site personnel to 
testify, as needed, in administrative and/or legal proceedings related 
to an alcohol or drug test result. For organizational clarity, the 
final rule moves the requirements in the former paragraph that 
addressed the availability of personnel to testify in proceedings 
related to drug test results from the licensee testing facility to 
Sec.  26.139(c) of Subpart F [Licensee Testing Facilities] and those 
related to HHS-certified laboratories to Sec.  26.153(f)(2) of Subpart 
G [Laboratories Certified by the Department of Health and Human 
Services].
    The NRC added Sec.  26.85(e) to the final rule in response to a 
public comment noting that the proposed rule did not include a 
requirement for licensees and other entities to ensure that personnel 
files are maintained for collectors. The new paragraph establishes 
requirements for personnel files for collectors to document their 
training and other qualifications for the positions they hold. This 
documentation may be necessary in administrative and/or legal 
proceedings related to an alcohol or drug test result.
Section 26.87 Collection Sites
    The NRC has reorganized requirements related to specimen collection 
sites in the former rule and grouped them together in this section. 
Requirements related to collection sites were distributed among several 
different sections in Appendix A to Part 26 of the former rule. The 
agency made this change to improve organizational clarity in the rule.
    Section 26.87(a) amends former Section 2.4(a) in Appendix A to Part 
26. This former section required FFD programs to designate collection 
sites and ensure that they are fully equipped to collect specimens for 
testing. The final rule deletes references to blood specimens because 
the final rule no longer provides donors with the option to request 
blood testing for alcohol for the reasons discussed with respect to 
Sec.  26.83(a). The final rule adds a requirement for collection sites 
to be capable of alcohol testing that the former section implied but 
did not explicitly state. The agency made this change to meet Goal 6 of 
this rulemaking to improve clarity in the language of the rule. This 
section retains the permission in the former rule for licensees and 
other entities to use properly equipped mobile collection facilities.
    Section 26.87(b) revises the first sentence of former Section 
2.4(f) in Appendix A to Part 26 to require visual privacy for donors 
while the donor and collector are viewing the results of an alcohol 
test and retains the former requirement for individual privacy during 
urine specimen collections, except if the urine specimen collection 
must be conducted under direct observation. The new requirement for 
visual privacy while viewing alcohol test results increases the 
consistency of Part 26 with the alcohol testing procedures of other 
Federal agencies and assures greater privacy for donors who are subject 
to FFD programs that did not provide visual privacy under the former 
rule. The NRC made this change to meet Goal 7 of this rulemaking to 
protect the privacy of individuals who are subject to Part 26. For 
organizational clarity, the final rule moves the former requirements in 
Section 2.4(f) in Appendix A to Part 26 that are related to collecting 
a specimen under direct observation to Sec.  26.115 [Collecting a urine 
specimen under direct observation].
    Section 26.87(c) retains only the portion of former Section 2.7(m) 
in Appendix A to Part 26 that required licensees' and other entities' 
contracts for collection site services to permit unfettered NRC, 
licensee, and other entity access to collection sites for unannounced 
inspections. The final rule moves the portions of the former section 
that apply to HHS-certified laboratories to Sec.  26.153(f) of Subpart 
G for organizational clarity. In addition, Sec.  26.87(c) adds a 
requirement that licensees' and other entities' contracts for 
collection site services must permit unfettered NRC, licensee, and 
other entity access to all information and documentation that is 
reasonably relevant to inspections and audits. The final rule adds this 
requirement for access to documentation for consistency with the HHS 
Guidelines, which also require collection sites to provide information 
and documentation as part of inspections and audits. Therefore, this 
change meets Goal 1 of this rulemaking to update and enhance the 
consistency of Part 26 with advances in other relevant Federal rules 
and guidelines. The agency also added the term ``audit'' to this 
section because, although the NRC conducts inspections, licensees and 
other entities are required to conduct audits under Sec.  26.41 [Audits 
and corrective action]. Adding this term to this paragraph increases 
the clarity of its language, consistent with Goal 6 of the rulemaking.
    Section 26.87(d) revises former Section 2.4(c) in Appendix A to 
Part 26 to clarify requirements for assuring collection site security 
and the integrity of specimen collection procedures. For organizational 
clarity, the final rule groups requirements related to assuring the 
security of a licensee's or other entity's designated collection site 
in this paragraph. For the same reason, the final rule moves to Sec.  
26.87(f) the requirements contained in former Section 2.4(c) in 
Appendix A to Part 26 that address assuring collection security when a 
designated collection site is inaccessible and there is an immediate 
requirement to collect a urine specimen. Section 26.87(d) includes 
other clarifying changes to former Section 2.4(c) in Appendix A to Part 
26, in response to stakeholder requests at the public meetings 
discussed in Section IV.D.
    Section 26.87(d)(1) retains the first sentence of former Section 
2.4(e) in Appendix A to Part 26 and permits only authorized personnel 
to have access to any part of a collection site in which specimens are 
collected and stored. For organizational clarity, the final rule moves 
this requirement to this section because it addresses the topic of 
collection site security.
    Section 26.87(d)(2) amends the second sentence of former Section 
2.4(c) in Appendix A to Part 26. The former provision required 
collection sites to be secure, and the final rule adds examples of 
acceptable methods to assure collection site security. The NRC added 
these examples in response to stakeholder requests during the public 
meetings discussed in the preamble to the proposed rule. The 
stakeholders noted that the requirement that collection sites ``must be 
secure'' has raised many implementation questions. Therefore, the final 
rule adds examples of acceptable means to ensure collection site 
security, including, but not limited to, physical measures to control 
access, such as locked doors, alarms, or visual monitoring of the 
collection site when it is not occupied. The agency made this change to 
meet Goal 6 of this rulemaking to improve clarity in the language of 
the rule.
    Section 26.87(d)(3) amends the third sentence in former Section 
2.4(c) in Appendix A to Part 26. The former provision required that the 
portion of any facility that is not dedicated solely to drug and 
alcohol testing must be secured during testing. The final rule

[[Page 17056]]

retains that requirement and combines it with the third sentence of 
former Section 2.4(c)(1) in Appendix A to Part 26. The provision 
requires the protection of the facility against unauthorized access 
during the collection. The final rule replaces the phrase, ``in the 
case of a public restroom,'' in the last sentence of former Section 
2.4(c)(1) in Appendix A to Part 26, with the phrase, ``if a collection 
site cannot be dedicated solely to collecting specimens,'' to clarify 
that a specimen may be collected at locations other than public 
restrooms. The NRC makes these changes to meet Goal 6 of this 
rulemaking to improve clarity in the organization and language of the 
rule.
    The agency has added Sec.  26.87(e) to specify the steps that 
licensees and other entities must take to deter dilution and 
adulteration of specimens during urine collections. This section 
retains and amends portions of former Section 2.4(g) in Appendix A to 
Part 26.
    Section 26.87(e)(1) relaxes the former requirement in Section 
2.4(g)(1) of Appendix A to Part 26 to use a bluing agent in any source 
of standing water, such as a toilet bowl or tank. The final rule 
permits licensees and other entities to use colors other than blue. 
However, the final rule prohibits use of a yellow coloring agent 
because it precludes the collector's ability to determine whether a 
donor had diluted the specimen with water from a source of standing 
water in the stall or room in which the donor provides a specimen. The 
relaxation does not affect the accuracy of drug tests but gives FFD 
programs increased flexibility in the choice of coloring agents. The 
agency made this change in response to stakeholder requests during the 
public meetings discussed in the preamble to the proposed rule and to 
meet Goal 5 of this rulemaking to improve Part 26 by eliminating or 
modifying unnecessary requirements.
    Section 26.87(e)(2) retains the second sentence of former Section 
2.4(g)(1) in Appendix A to Part 26, which requires sources of standing 
water to be secured, but shortens it without changing the intended 
meaning of the requirement. The agency made this change to improve 
clarity in the language of the rule.
    The final rule adds Sec.  26.87(e)(3) to require that chemicals or 
products that could be used to adulterate a urine specimen must be 
secured or removed from the collection site. The paragraph also 
requires the collector to inspect the enclosure to ensure that no 
potential adulterants are available before the donor enters the stall 
or enclosure. The agency intends these requirements to prevent possible 
donor attempts to subvert the testing process by adulterating a urine 
specimen with materials that are available at the collection site. This 
provision meets Goal 3 of this rulemaking to improve the effectiveness 
of FFD programs. The provision is also consistent with the related 
requirements of other Federal agencies.
    Section 26.87(f) reorganizes former Section 2.4(c)(1), portions of 
Section 2.4(c)(2), and Section 2.4(g)(10) in Appendix A to Part 26 to 
prescribe acceptable procedures for collecting specimens at locations 
other than a designated collection site in unusual circumstances, such 
as a specimen collection for post-event testing at a hospital. The 
final rule groups these requirements together in a single paragraph and 
separates them from those related to collecting specimens at a 
designated collection site in Sec.  26.87(d) and (e) to make it easier 
to locate these requirements within the rule. The NRC made this change 
to improve organizational clarity in the rule.
    Section 26.87(f)(1) amends former Section 2.4(c)(1) in Appendix A 
to Part 26, which established requirements for securing a location that 
is not a designated collection site but will be used for a specimen 
collection(s). The final rule requires either an individual to guard 
access to a public rest room while the collection is occurring or the 
posting of a sign to ensure that no unauthorized personnel enter the 
area during the collection. The former rule required only the posting 
of a sign. However, stationing an individual to guard access is at 
least as effective. The final rule permits an individual to guard 
access to the collection area in response to stakeholder requests for 
this flexibility during the public meetings discussed in the preamble 
to the proposed rule. This change meets Goal 5 of this rulemaking to 
improve Part 26 by eliminating or modifying unnecessary requirements.
    Section 26.87(f)(2) retains the third sentence of former Section 
2.4(g)(10) in Appendix A to Part 26 that requires using a water-
coloring agent, if possible, to deter a possible dilution or 
adulteration attempt when a collection must occur at a location other 
than the licensee's or other entity's designated collection site.
    Section 26.87(f)(3) retains the requirement in the second sentence 
of former Section 2.4(g)(10) that the collector must be the same gender 
as the donor in the exceptional event of a specimen collection 
occurring at a location other than the FFD program's designated 
collection site. However, if a collector of the same gender is 
unavailable, the rule permits another person of the same gender who is 
instructed in the requirements of Subpart E [Collecting Specimens for 
Testing] to assist in the collection. The provision requires either the 
collector or the observer to remain outside the area in which the donor 
will provide the urine specimen to protect the donor's privacy and the 
integrity of the collection process. The rule requires documentation of 
the observer's identity on the custody-and-control form so that the 
observer may be located should any subsequent questions arise with 
respect to the collection in a review under Sec.  26.39 [Review process 
for fitness-for-duty policy violations] or legal proceedings. The 
flexibility to rely on a person of the same gender as an observer, if a 
collector of the same gender is unavailable, is consistent with the 
procedures of other Federal agencies and reduces potential 
embarrassment to the donor. Therefore, this change meets Goal 1 of this 
rulemaking to update and enhance the consistency of Part 26 with 
advances in other relevant Federal rules and guidelines, and Goal 7 to 
protect the privacy of individuals who are subject to Part 26.
    Section 26.87(f)(4) requires the collector, once he or she is in 
possession of the donor's specimen, to inspect the area in which the 
specimen donation occurred for any evidence of a subversion attempt by 
the donor. This paragraph amends the fifth and sixth sentences of 
former Section 2.4(g)(10) in Appendix A to Part 26 that described the 
required sequence of actions during a specimen collection and specified 
that a donor is permitted to flush the toilet after a specimen 
donation. The final rule eliminates the option for the donor to flush 
the toilet and directs the collector to instruct the donor not to flush 
the toilet. The change reduces the possibility that a donor could 
dispose of evidence of a subversion attempt by flushing it down the 
toilet. Section 26.87(f)(4) directs the collector to inspect the toilet 
bowl and area once he or she receives the specimen from the donor. The 
final rule adds these provisions to reduce the opportunities for a 
donor to subvert the testing process at a location that is not a 
designated collection site to meet Goal 3 of this rulemaking to improve 
the effectiveness of FFD programs. The requirements also meet Goal 1 to 
update and enhance the consistency of Part 26 with advances in other 
relevant Federal rules and guidelines.
    Section 26.87(f)(5) amends the portions of former Section 2.4(c)(2) 
in Appendix A to Part 26 that defined requirements for maintaining 
control of

[[Page 17057]]

specimens that are not collected at a designated collection site. The 
final rule permits an ``authorized individual,'' including, for 
example, a security officer or hospital medical technician, to maintain 
physical custody and control of specimens, rather than only the 
collector, as the former rule required. The licensee or other entity 
must designate the ``authorized individual'' and ensure that he or she 
is instructed in his or her responsibilities for maintaining custody 
and control of the specimen. The authorized individual's custody of the 
specimen must be documented on the custody-and-control form to ensure 
that the individual may be located should any subsequent questions 
arise with respect to the collection in a review under Sec.  26.39 or 
legal proceedings. This change continues to ensure specimen integrity 
and security, but responds to industry experience, as described by 
stakeholders at the public meetings discussed in the preamble to the 
proposed rule. The stakeholders reported that it is sometimes difficult 
in unusual circumstances, such as the hospital setting, for the 
collector to maintain physical custody of the specimen until it is 
prepared for transfer, storage, or shipping. Therefore, the NRC made 
this change to meet Goal 5 of this rulemaking, to improve Part 26 by 
eliminating or modifying unnecessary requirements, while also 
continuing to meet Goal 7 to protect the privacy and other rights 
(including due process) of individuals who are subject to Part 26.
Section 26.89 Preparing To Collect Specimens for Testing
    This added section describes the preliminary steps that the 
collector and donor must take before specimens will be collected for 
drug and alcohol testing. This section reorganizes and amends portions 
of the former Appendix A to Part 26, and adds several new requirements. 
The final rule presents these requirements in a new section to 
facilitate locating them within the final rule to meet Goal 6 of this 
rulemaking to improve clarity in the organization of the rule.
    Section 26.89(a) provides more detailed requirements than those 
contained in former Section 2.4(g)(3) in Appendix A to Part 26 for 
actions to be taken if an individual does not appear for testing. The 
former rule required the collector to contact an ``appropriate 
authority'' to determine the actions to take if a donor does not appear 
for testing. At the public meetings discussed in the preamble to the 
proposed rule, some stakeholders indicated that the lack of specificity 
in the former rule with respect to the actions that the ``appropriate 
authority'' must take in these circumstances has led some FFD programs 
to interpret this provision as requiring the imposition of the 
sanctions for a ``refusal to test'' on an individual who fails to 
appear, including situations in which there is clear evidence that the 
individual had not been informed that he or she was required to appear 
for testing or was otherwise not at fault for the failure. This was not 
the NRC's intent. Therefore, under this new provision, when informed 
that an individual who was selected for testing has not appeared at the 
required time, FFD program management must ensure that the 
circumstances are investigated and determine whether the individual's 
absence or tardiness represents an attempt to avoid testing and, 
therefore, subvert the testing process. The final rule requires the 
licensee or other entity to impose the sanctions specified in Sec.  
26.75(b) for a refusal to test only if the investigation identifies 
evidence that the individual's failure to appear for testing was a 
subversion attempt. If the investigation does not identify evidence of 
a subversion attempt, the final rule prohibits the licensee or other 
entity from imposing sanctions and requires testing the individual at 
the earliest reasonable and practical opportunity after the individual 
is located. The NRC has added these more detailed requirements to 
strengthen the rule's effectiveness in preventing subversion by 
ensuring that a failure to appear for testing is investigated to 
increase the likelihood of detecting a willful attempt to avoid 
testing. In addition, the requirements prevent an individual from being 
subject to a permanent denial of authorization, as required under Sec.  
26.75(b), if the individual's failure to appear is determined to be 
outside of the individual's control or otherwise not a result of a 
willful attempt to avoid testing. The agency has made these changes to 
meet Goal 3 of this rulemaking to improve the effectiveness of FFD 
programs, and Goal 7 to protect the privacy and other rights (including 
due process) of individuals who are subject to Part 26.
    Section 26.89(b) reorganizes and expands former Section 2.4(g)(2) 
in Appendix A to Part 26, which required the collector to ensure that 
an individual who arrives at the collection site for testing is 
positively identified. The final rule adds more detailed requirements 
for the reasons discussed with respect to each requirement.
    Section 26.89(b)(1) retains the requirement in former Section 
2.4(g)(2) in Appendix A to Part 26 for the collector to positively 
identify the donor before beginning a collection. This section 
specifies the types of photo identification that the licensee or other 
entity may accept to establish a donor's identity.
    Section 26.89(b)(2) amends the portion of former Section 2.4(g)(2) 
in Appendix A to Part 26 that directed the collector to stop the 
collection if the individual cannot be positively identified. The 
amended provision directs the collector to proceed with the collection 
and inform FFD program management that the donor did not present 
acceptable photo identification. This paragraph requires FFD management 
to take the necessary steps to determine whether the lack of 
identification is an attempt to subvert the testing process. However, 
the provision retains the former requirement for the collector to delay 
the collection until the individual can be identified if it is a pre-
access test. The NRC has made these changes for several reasons.
    First, lessons learned from implementing the former rule have 
indicated that the large majority of failures to present acceptable 
identification result from miscommunication or other errors that are 
easily resolved. However, stopping or delaying the specimen collection 
may alter test results (e.g., if an individual has consumed alcohol, 
the individual's alcohol test result would show a lower BAC after a 
delay or may not be detected if testing is not conducted). Therefore, 
collecting the specimens first and then resolving the individual's 
identity ensures that test results are available and accurate from 
donors who are currently authorized and whose identity the licensee or 
other entity has previously confirmed. Therefore, this change meets 
Goal 3 of this rulemaking to improve the effectiveness and efficiency 
of FFD programs.
    Second, the former requirement to stop the collection without 
investigating the reasons that the individual is unable to present 
acceptable identification does not ensure that an attempt by an 
individual to subvert the testing process is detected. For example, an 
individual who has engaged in substance abuse could delay specimen 
collection by claiming to have ``forgotten'' his or her photo 
identification in his or her car or locker. Permitting the individual 
to leave the collection site to obtain his or her identification 
provides an opportunity for the individual to obtain an adulterant or 
substitute urine that he or she could then use to subvert the testing 
process. Steps that FFD program management could take to investigate

[[Page 17058]]

the reasons that the individual did not present acceptable 
identification in this instance could include assigning a security 
officer to accompany the individual to his or her car or locker to 
verify the individual's claim, as well as to ensure that the individual 
does not have the opportunity to bring an adulterant or substitute 
urine back to the collection site. Therefore, the new requirement 
strengthens the effectiveness of FFD programs in detecting attempts to 
subvert the testing process.
    The final rule modifies the proposed rule to permit an individual's 
supervisor, except for pre-access tests, to positively identify an 
individual who appears for testing without acceptable photo 
identification. The NRC made this change in response to a public 
comment, which noted that under many FFD programs, supervisors are 
trusted to notify donors that they have been selected for random 
testing, and, therefore, it is reasonable to trust supervisors also to 
verify a donor's identity. The change increases the consistency of Part 
26 with access authorization requirements established in 10 CFR 73.56, 
as supplemented by orders to nuclear power plant licensees dated 
January 7, 2003 (Goal 4 of this rulemaking).
    Section 26.89(b)(3) retains the former requirement to delay the 
specimen collection until the individual presents acceptable 
identification if it is a pre-access test, at the request of 
stakeholders during the public meetings discussed in the preamble to 
the proposed rule. The stakeholders noted that the former requirement 
to delay pre-access testing until the individual presents acceptable 
photo identification does not present a risk to public health and 
safety or the common defense and security from a possible subversion 
attempt because the individual does not yet have access to sensitive 
information, radiological materials, or safety systems and equipment. 
Furthermore, stakeholders noted that retaining the former provision 
saves licensees and other entities from the expense associated with 
collecting and testing a specimen from the wrong individual. Therefore, 
the NRC believes it is reasonable to retain the former requirement as 
it relates to pre-access tests.
    Section 26.89(b)(4) updates former Section 2.4(g)(4) and 
2.4(g)(23)(ii) in Appendix A to Part 26, in which, before any specimens 
are collected, donors were required to list the prescription and over-
the-counter medications they had used within the 30 days before 
testing. To be consistent with the privacy requirements of the 
Americans with Disabilities Act [Pub. L. 101-336, July 26, 1990], the 
final rule eliminates the requirement to list medications prior to 
specimen collection and testing. The final rule requires donors to 
provide medication information to the MRO only in the event of 
positive, adulterated, substituted, or invalid confirmatory validity 
and/or drug test result to enhance their rights to privacy under the 
rule. This revised requirement is also consistent with the procedures 
of other Federal agencies and meets Goal 1 of this rulemaking to update 
and enhance the consistency of Part 26 with advances in other relevant 
Federal rules and guidelines.
    Section 26.89(b)(4) also adds a requirement for the collector to 
explain the testing procedure to the donor. Former Section 2.2(d)(3) in 
Appendix A to Part 26 required providing individuals who are subject to 
testing with standard written instructions setting forth their 
responsibilities. However, the NRC is aware that individuals typically 
receive these instructions as part of the training that is required 
under former Sec.  26.21 [Policy communications and awareness training] 
rather than at the collection site before starting the specimen 
collection process. This was not the intent of Section 2.2(d)(3) in 
Appendix A to Part 26. Rather than retaining and clarifying the former 
provision for standard written instructions that some individuals may 
have difficulty comprehending, the final rule adopts the related 
practices of other Federal agencies, which require the collector to 
explain the testing procedure to the donor. This change ensures that 
individuals are informed of the testing process in which they must 
participate and their responsibilities. It also meets Goal 7 of this 
rulemaking to protect the privacy and other rights (including due 
process) of individuals who are subject to Part 26, and Goal 1, by 
enhancing the consistency of Part 26 with the requirements of other 
Federal agencies.
    The NRC added Sec.  26.89(c) to ensure that the donor is aware of 
his or her responsibilities to cooperate with the specimen collection 
process. This paragraph responds to reports from stakeholders at the 
public meetings discussed in the preamble to the proposed rule that 
some donors have attempted to obstruct or delay the collection process 
on the basis that the former rule implied, but did not explicitly 
state, the donor's responsibility to cooperate with the collection 
process. Therefore, the new provision eliminates that basis for 
obstructing or delaying collections, which improves the effectiveness 
and efficiency of FFD programs, consistent with Goal 3 of this 
rulemaking.
    This section also requires the collector to inform the donor that a 
failure to cooperate in the specimen collection process is considered a 
refusal to test and may result in a permanent denial of authorization 
under Sec.  26.75(b). In response to public comment, the final rule 
adds examples to those in the proposed rule describing behavior that 
may be determined to be a refusal to test. In addition to leaving the 
collection site before the collection is complete, the final rule adds 
behaving in a confrontational manner that disrupts the testing process; 
admitting to the collector that the donor has substituted, diluted, or 
adulterated the specimen; or the collector finds that the donor has a 
device, such as a prosthetic appliance, the purpose of which is to 
interfere with providing an actual urine specimen. Other examples could 
include a donor refusing to permit the collector to examine the 
contents of the donor's pockets or the donor refusing to wash his or 
her hands when directed by the collector. The final rule does not 
provide an exhaustive list of behaviors that comprise a refusal to test 
because they are too numerous to list. However, the NRC has added these 
examples for increased clarity in the rule. Informing donors of the 
potential consequences of failing to cooperate in the collection 
process, in advance, is consistent with Goal 7 of this rulemaking to 
protect the privacy and other rights (including due process) of 
individuals who are subject to Part 26. The requirements of this 
section also meet Goal 1 to improve the consistency of NRC requirements 
with those of other Federal agencies.
    Section 26.89(d) retains the last two sentences of former Section 
2.4(e) in Appendix A to Part 26. These provisions require the collector 
to conduct only one urine specimen collection at a time and define the 
point at which the collection process ends, which is when the donor has 
left the collection site. The NRC has retained these provisions in this 
paragraph because they relate to the topic of this section, which is 
preparing for specimen collections, to ensure that collectors are aware 
of this requirement before they begin collecting any specimens. The 
change improves the organizational clarity of the rule.
Section 26.91 Acceptable Devices for Conducting Initial and 
Confirmatory Tests for Alcohol and Methods of Use
    This added section amends requirements in the former rule that 
addressed alcohol testing devices and

[[Page 17059]]

methods of use. The requirements in the former rule that are related to 
this topic appeared in former Sec.  26.24(g) and Sections 2.4(g)(18) 
and 2.7(o)(3)(ii) in Appendix A to Part 26. This section combines these 
requirements, amends the former requirements, and adds others. The 
final rule groups these requirements in one section to meet Goal 6 of 
this rulemaking to improve clarity in the organization of the rule.
    The agency added Sec.  26.91(a) [Acceptable alcohol screening 
devices] to permit the use of alcohol screening devices (ASDs) for 
initial testing and establish requirements for the ASDs that may be 
used. Acceptable ASDs include alcohol saliva analysis devices and 
breath testing devices that are listed on the most recent version of 
NHTSA's Conforming Products List (CPL) for ASDs (66 FR 22639; May 4, 
2001, and subsequent amendments). Former Section 2.7(o)(3)(ii) in 
Appendix A to Part 26 limited FFD programs to using only evidential-
grade breath testing devices. However, permitting FFD programs to use 
ASDs listed on NHTSA's CPL for initial alcohol testing is consistent 
with other Federal agencies' procedures for workplace alcohol testing. 
Therefore, the change meets Goal 1 of this rulemaking to update and 
enhance the consistency of Part 26 with advances in other relevant 
Federal rules and guidelines.
    Further, permitting the use of some ASDs for initial alcohol 
testing provides increased flexibility in conducting initial alcohol 
tests. Licensees and other entities may find that, over time, it is 
less expensive to use a particular ASD than to continue using EBTs for 
all initial alcohol tests. The option to use alcohol saliva analysis 
devices also may reduce the burden of alcohol testing for some donors, 
such as individuals who have impaired lung functioning. The final 
rule's permission to use ASDs that are listed on NHTSA's CPL for ASDs 
for initial alcohol testing meets Goal 5 of this rulemaking to improve 
Part 26 by eliminating or modifying unnecessary requirements by 
increasing FFD programs' flexibility in administering initial alcohol 
tests.
    Section 26.91(b) [Acceptable evidential breath testing devices] 
amends former Section 2.7(o)(3)(ii) in Appendix A to Part 26 and 
establishes new requirements for the EBTs that licensees and other 
entities must use for confirmatory alcohol breath testing. The new 
section requires licensees and other entities to use EBTs that are 
listed on the most recent version of NHTSA's CPL for evidential breath 
testing devices without an asterisk (67 FR 62091; October 3, 2002, and 
subsequent amendments) when conducting confirmatory alcohol tests, and 
permits licensees and other entities to use these EBTs for conducting 
initial alcohol tests. The EBTs that are listed without an asterisk 
incorporate many improvements in EBT technology and have been shown to 
accurately detect BACs at the 0.02 percent level. Therefore, they are 
the appropriate instruments to use for confirmatory testing at the 
revised alcohol cutoff levels specified in Sec.  26.103 [Determining a 
confirmed positive test result for alcohol].
    Further, because these EBTs have been shown to provide valid, 
reliable, and legally defensible results in other Federal programs that 
also require workplace alcohol testing, the new requirement to use 
these EBTs permits two additional changes to the alcohol testing 
procedures contained in former Section 2.4(g)(18) in Appendix A to Part 
26: (1) Collecting only one breath specimen for the initial alcohol 
test and one for the confirmatory test in Sec. Sec.  26.95(c) and 
26.101(c), rather than the two specimens that were required for each 
test under the former rule; and (2) conducting both the initial and 
confirmatory tests (if a confirmatory test is required) using the same 
EBT in Sec.  26.101(d). As discussed further with respect to Sec. Sec.  
26.95(c) and 26.101(c) and (d), these changes to the former alcohol 
testing requirements improve the efficiency of alcohol testing while 
continuing to provide valid, reliable, and legally defensible results 
that are necessary to protect donor's rights under workplace alcohol 
testing programs. The use of these improved EBTs is similarly required 
for confirmatory alcohol testing and permitted for initial testing 
under 49 CFR Part 40. Therefore, this change meets Goal 1 of this 
rulemaking to update and enhance the consistency of Part 26 with 
advances in other relevant Federal rules and guidelines; Goal 3 to 
improve the efficiency of FFD programs; and Goal 5 to improve Part 26 
by eliminating or modifying unnecessary requirements.
    The NRC added Sec.  26.91(c) [EBT capabilities] to specify the 
required capabilities of the EBTs that licensees and other entities may 
use for initial alcohol testing and must use for confirmatory alcohol 
tests. The EBT capabilities listed in Sec.  26.91(c)(1) through (c)(3) 
are necessary to ensure that a confirmatory alcohol test result can be 
uniquely associated with the instrument used, the time of testing, and 
the donor. These capabilities are necessary to establish an 
unimpeachable chain of custody for confirmatory alcohol test results as 
well as permit the accurate identification of any test results that may 
have been affected by instrument malfunctions that are discovered later 
through additional quality assurance checks. The EBT capabilities 
listed in Sec.  26.91(c)(4) and (c)(5) ensure that test results will be 
accurate by requiring collectors to verify before each test that the 
instrument is functioning properly and there will be no carryover 
effects from previous testing. With respect to the proposed rule, the 
final rule revises the language of proposed Sec.  26.91(c)(6) to 
clarify that EBTs must have the capability to support a calibration 
check using an external standard in response to public comments that 
the intended meaning of the proposed provision was unclear. Commenters 
were unfamiliar with the meaning of the term, ``external calibration 
check,'' and stated that the proposed provision implied that the EBT 
itself must be capable of performing an external calibration check to 
be acceptable for testing under this part. This was not the NRC's 
intent. As discussed with respect to Sec.  26.91(e)(1), EBT 
manufacturers must submit a quality assurance plan to NHTSA that, among 
other attributes, specifies the minimum frequency with which the EBT 
must be subject to an external calibration check. An external 
calibration check simulates delivering a breath sample with a known 
alcohol concentration to the EBT to verify that the EBT is reading 
within acceptable limits. The external standards used for the 
calibration checks are typically either wet bath (i.e., a solution of 
ethanol in water) or dry gas (i.e., a mixture of pressurized gas, 
usually ethanol in nitrogen) and are delivered to the EBT through a 
regulator or other device that simulates a human breath exhalation. 
Calibrating devices may be included in an EBT ``kit'' or sold 
separately. Section 26.91(c)(6) of the final rule clarifies that EBTs 
used for confirmatory alcohol testing must be capable of being 
calibrated using external standards, rather than implying that the EBTs 
must be self-calibrating with external standards. The capabilities 
specified in Sec.  26.91(c)(4) through (c)(6) improve the effectiveness 
and efficiency of confirmatory alcohol testing by limiting the need to 
cancel test results due to instrument errors, as required under Sec.  
26.91(e)(3). Using EBTs that have the required capabilities for 
confirmatory alcohol tests protects donors' rights to accurate test 
results, provides greater assurance that test results will withstand 
any legal challenges, and improves FFD

[[Page 17060]]

programs' abilities to identify tests that instrument errors may have 
affected. Therefore, these requirements meet Goal 3 of this rulemaking 
to improve the effectiveness and efficiency of FFD programs.
    The NRC added Sec.  26.91(d) [Quality assurance and quality control 
of ASDs] to establish quality assurance and quality control 
requirements for ASDs. These requirements are necessary to ensure that 
initial tests that are conducted using an ASD do not yield false 
negative test results. If an ASD provides a false negative test result, 
the test would not detect a donor who has an alcohol concentration that 
exceeds the cutoff levels established in this part, and the donor may 
be permitted to perform duties while impaired, potentially creating an 
unacceptable risk to public health and safety or the common defense and 
security. The final rule continues to require confirmatory testing if 
initial alcohol test results are positive, so false positive test 
results from an ASD lead to confirmatory testing, which provides 
accurate test results. False positive test results from initial testing 
reduce the efficiency of FFD programs and inconvenience donors by 
causing them to be subject to unnecessary confirmatory testing, but do 
not pose any risks to public health and safety or the common defense 
and security. However, confirmatory testing is not required if the 
result of an initial alcohol test result is negative. Therefore, the 
quality assurance and quality control requirements contained in this 
paragraph are necessary to maintain the effectiveness of FFD programs, 
which is Goal 3 of this rulemaking.
    The agency added Sec.  26.91(d)(1) to require FFD programs to 
implement the most recent version of the quality assurance plan that a 
manufacturer has submitted to NHTSA for any ASD that the licensee or 
other entity uses for initial alcohol testing. To obtain NHTSA approval 
for an ASD, the manufacturer of the device must submit a quality 
assurance plan that (1) specifies the methods that must be used for 
quality control checks, (2) the temperatures at which the ASD must be 
stored and used, (3) the shelf life of the device, (4) environmental 
conditions (e.g., temperature, altitude, humidity) that may affect the 
ASD's performance, (5) instructions for its use and care, (6) the time 
period after specimen collection within which the device must be read, 
where applicable, and (7) the manner in which the reading is made. This 
paragraph requires licensees and other entities who intend to use an 
ASD to obtain and implement the most recent version of the 
manufacturer's quality assurance plan to ensure that the ASD will not 
provide false negative test results from improper storage or use. As 
discussed with respect to Sec.  26.91(d), the new provision is 
necessary to maintain the effectiveness of FFD programs that rely on 
ASDs for initial alcohol testing.
    The NRC added Sec.  26.91(d)(2) to prohibit licensees and other 
entities from using an ASD that fails the quality control checks that 
are specified in the most recent version of the manufacturer's quality 
assurance plan or that has passed its expiration date. This prohibition 
is necessary to ensure that test results from using the ASD are 
accurate both to protect public health and safety and donors' rights to 
accurate test results under the rule.
    The NRC added Sec.  26.91(d)(3) to require licensees and other 
entities to follow the device use and care requirements that are 
specified in Sec.  26.91(e) for any ASD that tests breath specimens. 
The agency added this requirement because some ASDs test specimens of 
oral fluids while others test breath specimens, and some ASDs that test 
breath specimens also appear on NHTSA's CPL for evidential breath 
testing devices (67 FR 62091: October 3, 2002, and subsequent 
amendments). Those ASDs that do test breath specimens and are used for 
confirmatory testing have more detailed quality assurance and quality 
control provisions because their results must be legally defensible.
    Section 26.91(e) [Quality assurance and quality control of EBTs] 
establishes new quality assurance and quality control requirements for 
EBTs. The new requirements are consistent with those of other Federal 
agencies that require workplace alcohol testing and, therefore, update 
and enhance the consistency of Part 26 with advances in other relevant 
Federal rules and guidelines.
    Section 26.91(e)(1) adds a requirement that licensees and other 
entities must implement the most recent version of the manufacturer's 
instructions for the use and care of the EBT consistent with the 
quality assurance plan submitted to NHTSA for the EBT, including the 
required frequency for conducting calibration checks using external 
standards (``external calibration checks''). An EBT manufacturer is 
required to submit to NHTSA a quality assurance plan that addresses 
methods used to perform external calibration checks on the EBT, the 
tolerances within which the EBT is regarded as being in proper 
calibration, and the intervals at which these checks must be performed. 
The final rule requires licensees and other entities to perform 
calibration checks using external standards at the manufacturer's 
recommended intervals, at a minimum. These calibration intervals take 
into account factors such as frequency of use, environmental conditions 
(e.g., temperature, humidity, altitude), and type of operation (e.g., 
stationary or mobile). Therefore, this provision is intended to ensure 
that the EBT will not provide false test results from improper storage 
or use.
    Section 26.91(e)(2) adds a requirement for licensees and other 
entities to use only calibration devices appearing on NHTSA's CPL for 
``Calibrating Units for Breath Alcohol Tests'' when conducting external 
calibration checks. This requirement is necessary to ensure that the 
calibrating units used by licensees and other entities meet minimum 
standards and provide accurate results.
    The final rule adds Sec.  26.91(e)(3) to address circumstances in 
which an EBT fails an external calibration check. This section requires 
the licensee or other entity to take the EBT out of service and 
prohibits its use until it has been repaired and passes an external 
calibration check. An EBT that has failed an external calibration check 
must be taken out of service to avoid inaccurate reporting of breath 
alcohol test results that could result either in the imposition of 
sanctions on a donor who has not abused alcohol or the failure to 
identify a donor who has.
    The NRC moved and amended the requirement in proposed Sec.  
26.91(e)(3) to cancel any positive confirmatory alcohol test results 
that were obtained from an EBT that fails an external calibration check 
and also to cancel the results of any tests that were conducted with 
that EBT subsequent to its last successful external calibration check. 
The final rule retains this requirement in Sec.  26.91(e)(4)(i), but 
presents it as one of two options licensees and other entities must 
implement if an EBT fails an external calibration check. The final rule 
adds a second option for handling circumstances in which an EBT fails 
an external calibration check in Sec.  26.91(e)(4)(ii). This new 
section permits licensees and other entities to conduct an external 
calibration check of the EBT after each positive confirmatory alcohol 
test result. If the EBT fails the check, the provision requires the 
collector to cancel the donor's test result and perform another initial 
and confirmatory alcohol test, if necessary, using a different EBT. The 
requirements to cancel tests from an EBT that has failed an external 
calibration check are necessary to protect donors' right to accurate 
testing under the rule because

[[Page 17061]]

positive test results from an EBT that has failed an external 
calibration check are questionable and donors should not be subject to 
sanctions on the basis of these test results.
    The NRC added Sec.  26.91(e)(4)(ii) in response to a public comment 
on proposed Sec.  26.91(e)(3). The commenter stated that canceling 
donors' positive confirmatory test results from an EBT that fails an 
external calibration check may not adequately protect donors' rights 
under the rule, if a licensee or other entity performs external 
calibration checks at the manufacturers' recommended intervals. The 
commenter noted that most EBT manufacturers' recommended intervals for 
conducting external calibration checks are 1 month, which could result 
in several canceled tests, if an EBT has yielded false positive test 
results that are only discovered when the EBT fails the monthly check. 
However, if the licensee or other entity has already imposed sanctions 
on a donor for a positive confirmatory alcohol test result from the 
EBT, the donor will experience the adverse consequences of those 
sanctions, which may include job loss, before the licensee or other 
entity identifies the instrument malfunction and cancels the donor's 
confirmed positive test result.
    The NRC considered several options to address this concern, 
including requiring more frequent external calibration checks, but 
could not identify a technical basis for establishing schedules that 
would be more appropriate for every EBT on the NHTSA list than those 
recommended by the EBT manufacturers. Further, the agency recognizes 
that canceling tests imposes a burden on licensees and other entities 
as well as on donors and expects that licensees and other entities will 
likely choose to conduct external calibration checks more often than 
recommended by the EBT manufacturers to avoid canceling multiple tests. 
Therefore, the final rule retains the proposed requirement as an option 
in Sec.  26.91(e)(4)(i), but adds a second option for handling 
circumstances in which an EBT fails an external calibration check in 
Sec.  26.91(e)(4)(ii). Under the latter provision, it is unnecessary 
for a licensee or other entity to cancel any previous donors' confirmed 
positive alcohol test results from using the EBT because the licensee 
or other entity will perform the external calibration check after every 
positive confirmatory test result and no other donors will have been 
affected by false positive test results from an EBT that fails the 
check. Under this option, a donor will not be subject to adverse 
consequences for a false positive test result because the malfunction 
will be detected before the licensee or other entity imposes any 
sanctions. The NRC has added this provision to meet Goal 7 of the 
rulemaking to protect donors' privacy and other rights (including due 
process) under the rule.
    The final rule renumbers as Sec.  26.91(e)(5) the provision 
contained in Sec.  26.91(e)(4) of the proposed rule. This section 
requires an EBT manufacturer or a maintenance representative or other 
individual who is certified by the manufacturer, a State health agency, 
or other appropriate State agency to inspect, maintain, and calibrate 
the EBT. This new provision ensures that qualified personnel perform 
inspection, maintenance, and calibration of EBTs (1) to ensure that the 
EBTs used in Part 26 programs continue to provide accurate test 
results, and (2) because the experience of other Federal agencies that 
require workplace alcohol testing has demonstrated that such stringent 
EBT inspection, maintenance, and calibration requirements are necessary 
to withstand legal challenges to alcohol test results. The final rule 
adds ``or other individual who is certified'' to the proposed provision 
because some licensees and other entities may choose to obtain the 
required certification for their FFD program personnel or other 
employees, and the NRC does not intend to prohibit this practice.
Section 26.93 Preparing for Alcohol Testing
    This added section expands on former Section 2.4(g)(18) in Appendix 
A to Part 26, which specified procedures for alcohol testing. The final 
rule provides more detailed procedures than the former paragraph to 
increase the consistency of these procedures with those of other 
Federal workplace alcohol testing programs as well as consistency among 
the alcohol testing procedures of Part 26 programs. The agency added 
more detailed requirements for the reasons discussed in Section IV.B.
    Section 26.93(a) contains more detailed procedures for implementing 
the requirement in the first sentence of former Section 2.4(g)(18) in 
Appendix A. That provision instructed collectors to delay alcohol 
breath testing for 15 minutes if the donor has engaged in any of the 
activities listed (e.g., smoking, regurgitation of stomach contents 
from vomiting). Section 26.93(a)(1) through (a)(6) requires the 
collector to provide the donor with more detailed information about 
mouth alcohol and the testing process than was required under the 
former rule and document that the information is provided. Providing 
more detailed requirements for the 15-minute waiting period improves 
the effectiveness and efficiency of the alcohol testing process by 
reducing false positive test results that are due to residual mouth 
alcohol or other substances that could potentially trigger a false 
positive result. Section 26.93(a)(1) retains the former requirement for 
the collector to ask the donor about behaviors such as eating and 
drinking that may have occurred within the 15 minutes before an alcohol 
test and adds a requirement for the collector to advise the donor to 
avoid these activities during the collection process. Section 
26.93(a)(2) permits alcohol testing to proceed if the donor states that 
none of the activities listed in Sec.  26.93(a)(1) has occurred, while 
Sec.  26.93(a)(3) retains the former requirement for a 15-minute 
waiting period before a donor may be tested if he or she had engaged in 
the activities listed in Sec.  26.93(a)(1). Section 26.93(a)(4) adds a 
requirement for the collector to explain that it is to the donor's 
benefit to avoid the activities listed in Sec.  26.93(a)(1) during the 
collection process. Section 26.93(a)(5) adds a requirement for the 
collector to explain to the donor that initial and confirmatory alcohol 
tests will be conducted at the end of the waiting period regardless of 
whether the donor has engaged in any of the activities listed in Sec.  
26.93(a)(1). Section 26.93(a)(6) adds a requirement for the collector 
to document that he or she has communicated the instructions to the 
donor. The additional requirements for the collector to communicate 
with the donor about the potential effects on test results of the 
activities listed in Sec.  26.93(a)(1) ensure that donors clearly 
understand the reasons for avoiding those activities and the potential 
consequences of engaging in them to protect their rights to accurate 
test results under the rule. The requirement for the collector to 
document that the instructions were communicated to the donor ensures 
that the collector does not inadvertently omit the instructions and, 
therefore, improves the legal defensibility of the collection 
procedure, should a donor challenge it.
    The final rule adds Sec.  26.93(b) to require collectors to 
minimize delays in administering for-cause drug and alcohol tests and 
complete alcohol testing before collecting a specimen for drug testing. 
These requirements decrease the likelihood that a donor's test results 
will fall below the program's cutoff levels as a result of metabolic

[[Page 17062]]

processes over time, which could prevent the detection of proscribed 
alcohol consumption and drug use. Delays between the time at which a 
donor reports for testing and the time at which testing occurs continue 
to be permitted for tests conducted under conditions other than for 
cause, because, in contrast to for-cause testing, there is no reason to 
believe that an individual may have used drugs or alcohol in violation 
of the FFD policy. Therefore, there is no basis for a concern that 
metabolic processes may cause inaccurate test results. The new 
provision is consistent with the related regulations of other Federal 
agencies.
Section 26.95 Conducting an Initial Test for Alcohol Using a Breath 
Specimen
    Section 26.95 replaces portions of former Section 2.4(g)(18) in 
Appendix A to Part 26 that specified procedures for conducting an 
initial test for alcohol. Collectors follow the procedures in this 
section when using ASDs that test breath specimens and EBTs. The new 
section increases the consistency of Part 26 with the procedures of 
other Federal agencies for workplace alcohol testing. Consistent with 
other agencies' procedures, the final rule eliminates the requirement 
in former Section 2.4(g)(18) in Appendix A to Part 26 for collecting a 
second breath specimen for the initial alcohol test. The experience of 
other Federal agencies indicates that the former Part 26 requirement 
for two breath specimens is unnecessary to obtain a valid, reliable, 
and legally defensible test result if the procedures specified in the 
new section are followed. Therefore, the final rule amends the former 
procedures to reduce the burden on FFD programs and donors that is 
associated with collecting two breath specimens for the initial alcohol 
test, while continuing to ensure that breath alcohol testing provides 
accurate results.
    The agency added Sec.  26.95(a) to require the collector to start 
breath testing as soon as reasonably practical after the donor 
indicates that he or she has not engaged in any activities that may 
result in the presence of mouth alcohol or after the 15-minute waiting 
period, if required. The final rule adds the phrase, ``as soon as 
reasonably practical,'' to this paragraph in response to stakeholder 
comments at the public meetings discussed in the preamble to the 
proposed rule. The intent of the provision is for the collector to 
conduct the initial alcohol test as soon as the individual has received 
the instructions specified in Sec.  26.93 [Preparing for alcohol 
testing] to ensure the accuracy of the test result. Delays in 
conducting the test increase the possibility that the donor may 
inadvertently engage in a behavior that could result in the presence of 
mouth alcohol as well as permit the donor's metabolism to lower the 
alcohol concentration in the specimen if the donor has consumed 
alcohol. However, the stakeholders noted that when preparing for 
outages, in which it is sometimes necessary to test large numbers of 
individuals, collectors often provide the instructions in Sec.  26.93 
to groups of donors at the same time and it is not feasible to test 
each one immediately after providing the instructions. Therefore, the 
final rule adds the phrase, ``as soon as reasonably practical,'' to 
permit reasonable delays in testing associated with outage planning.
    Section 26.95(b)(1) permits the donor to select a mouthpiece to be 
used for his or her test, at the collector's discretion. The rule does 
not require the collector to permit the donor to select the mouthpiece. 
However, this practice may increase the donor's confidence in the 
integrity of the testing process by assuring the donor that the 
selection of the mouthpiece is random if he or she is concerned that a 
collector may attempt to subvert the testing process by selecting a 
mouthpiece that had been contaminated with alcohol or other means of 
tampering with the testing device. The NRC is not aware of any 
instances in Part 26 programs in which a donor has accused a collector 
of altering an alcohol testing device. However, the experience of other 
Federal agencies who similarly require workplace alcohol testing 
indicates that taking steps to reduce potential donor concerns about 
the integrity of the testing process increases donors' willingness to 
participate in the testing procedures and reduces the potential for 
legal challenges.
    In Sec.  26.95(b)(2), the NRC has added a requirement for the 
collector to open the mouthpiece packaging and insert it into the 
device in view of the donor for the same reason described with respect 
to Sec.  26.95(b)(1).
    Section 26.95(b)(3) requires the donor to blow into the mouthpiece 
for at least 6 seconds in order to obtain an adequate breath sample. 
The NRC deleted the requirement to obtain the specimen from the end of 
the breath exhalation in former Section 2.4(g)(18) in Appendix A to 
Part 26 because it is unnecessary, based on improvements to breath-
testing technology.
    Section 26.95(b)(4) requires the collector to show the test result 
to the donor. This requirement is consistent with current industry 
practices and is intended to increase donor confidence in the integrity 
of the testing process by ensuring that both the donor and the 
collector have access to the same information about the donor's test 
result. The requirement is consistent with Goal 7 of this rulemaking to 
protect the privacy and other rights (including due process) of 
individuals who are subject to Part 26, by ensuring that donors are 
aware of the information used by the collector to determine whether an 
alcohol test result is positive or negative.
    Section 26.95(b)(5) requires the collector to ensure that the test 
result record can be associated with the donor and is maintained 
securely, consistent with the many provisions throughout the former and 
final rules that the chain of custody must be maintained for specimens 
and the associated documentation of test results. Sections 26.129 
[Assuring specimen security, chain of custody, and preservation] and 
26.159 [Assuring specimen security, chain of custody, and preservation] 
establish similar requirements for urine specimens at licensee testing 
facilities and HHS-certified laboratories, respectively.
    The NRC has added Sec.  26.95(c) to require the collection of only 
one breath specimen for the initial test unless problems in the 
collection require repetition of the collection. Problems in the 
collection may include, but are not limited to, device malfunctions or 
a donor's inability to provide an adequate breath specimen on the first 
try. If a repeat collection is required, the collector must rely on the 
result from the first successful collection in determining the need for 
confirmatory alcohol testing. If the procedures specified in this 
paragraph are followed, relying on one breath specimen for the initial 
test, rather than the two required in the former rule, increases the 
consistency of Part 26 collection procedures with those of other 
Federal agencies, in accordance with Goal 1 of this rulemaking. The new 
requirement also reduces the time required for breath specimen 
collections without compromising the accuracy, validity, or reliability 
of the test results. Therefore, the provision also meets Goal 3 to 
improve the efficiency of FFD programs.
Section 26.97 Conducting an Initial Test for Alcohol Using a Specimen 
of Oral Fluids
    The NRC added this section to establish requirements for conducting 
initial alcohol tests using an ASD for testing oral fluids specimens. 
The final rule permits licensees and other entities to rely on ASDs 
that test oral fluids for

[[Page 17063]]

the reasons discussed with respect to Sec.  26.83(a). The procedures 
for conducting alcohol testing of oral fluids with an ASD incorporate 
the related requirements from 49 CFR Part 40 and have been added to the 
final rule to ensure that initial alcohol tests of oral fluids provide 
accurate and legally defensible test results.
    The agency has added Sec.  26.97(a) to specify the procedures that 
the collector must follow in using an ASD for testing oral fluids.
    Section 26.97(a)(1) requires the collector to check the expiration 
date on the device and show it to the donor. Because some devices 
degrade during storage, this step is necessary to assure both the donor 
and the collector that the device can be expected to function properly.
    Section 26.97(a)(2) requires the collector to open an individually 
wrapped or sealed package containing the device in the presence of the 
donor for the reasons discussed with respect to Sec.  26.95(b)(1).
    Section 26.97(a)(3) requires the collector to offer the donor a 
choice of using the device or having the collector use it. If the donor 
chooses to use the device, the collector must provide instructions for 
its proper use. The final rule requires the collector to offer the 
donor the choice of using the device to increase the donor's confidence 
in the integrity of the testing process, as discussed with respect to 
Sec.  26.95(b)(1).
    Section 26.97(a)(4) requires the collector to gather oral fluids in 
the proper manner if the donor chooses not to use the device, or in 
cases in which a second test is necessary because the device failed to 
activate. In addition, the collector is required to wear single-use 
examination or similar gloves while doing so and change them following 
each test. Section 26.97(a)(5) requires the collector to follow the 
manufacturer's instructions to ensure that the device has activated. 
The NRC has added the requirements in these sections to ensure that the 
collection is properly conducted. The requirement to use single-use 
examination gloves ensures that the collector and donor are protected 
from possible infection from exposure to body fluids.
    The NRC added Sec.  26.97(b) to specify the procedures that the 
collector must follow if the first attempt to conduct the test using 
the ASD fails for any reason, including, but not limited to, the ASD 
failing to activate or because the device is dropped on the floor.
    Section 26.97(b)(1) requires the collector to discard the device 
and conduct another test using a new device that has been under the 
collector's control if the first attempt fails. The final rule requires 
the second device to have been under the collector's control to ensure 
that the donor or another individual has no opportunity to substitute 
the new device with another that has been altered to provide a false 
negative test result. This provision is necessary to protect the 
integrity of the collection process.
    Section 26.97(b)(2) requires the collector to record the reason for 
the new test. This requirement ensures that the information is 
available, should any questions arise with respect to the collection 
procedure in a review conducted under Sec.  26.39 or legal proceedings.
    Section 26.97(b)(3) requires the collector to offer the donor the 
choice of using the device or having the collector use it, unless the 
collector concludes that the donor was responsible for the new test 
needing to be conducted. The final rule requires the collector to offer 
the donor the choice of using the device for the reasons discussed with 
respect to Sec.  26.95(b)(1). The requirement for the collector to use 
the device if he or she concludes that the donor was responsible for 
the second test needing to be conducted enhances the efficiency of the 
collection procedure by ensuring that the second collection is 
conducted properly.
    Section 26.97(b)(4) requires the collector to repeat the collection 
procedures outlined in Sec.  26.97(a) for the second collection.
    If the second collection attempt fails, Sec.  26.97(c) directs the 
collector to use an EBT to perform the initial alcohol test instead. 
The final rule requires the collector to use an EBT to perform the 
initial test after two failed attempts at testing oral fluids specimens 
to ensure that a valid test result is obtained to enhance the 
efficiency of the collection procedure by changing the method used to 
conduct the test.
    If the specimen collection using the ASD for testing oral fluids is 
successful, Sec.  26.97(d) instructs the collector to follow the device 
manufacturer's instructions for reading the result and show the result 
to the donor. The final rule prohibits the collector from reading the 
result sooner than instructed by the device manufacturer because some 
devices require several minutes after specimen collection to provide an 
accurate result, but no more than 15 minutes in all cases. The 
requirement for the collector to show the test result to the donor is 
intended to increase donor confidence in the integrity of the testing 
process by ensuring that both the donor and the collector have access 
to the same information about the donor's test result. This paragraph 
also requires the collector to record the test result and document that 
an ASD was used to ensure that the information is available, should any 
questions arise with respect to the collection procedure in a review 
conducted under Sec.  26.39 or legal proceedings.
    To protect collectors and donors from any possible biohazards, the 
final rule adds Sec.  26.97(e) to prohibit the reuse of any devices, 
swabs, gloves, and other materials used in collecting oral fluids.
Section 26.99 Determining the Need for a Confirmatory Test for Alcohol
    Section 26.99 amends the requirements in former Sec.  26.24(g) and 
the portion of Section 2.7(e)(1) in Appendix A to Part 26 that 
addressed cutoff levels for alcohol testing. The final rule amends the 
former requirements for consistency with a new approach to determining 
positive alcohol test results in Sec.  26.103. The NRC adopted the new 
approach because some licensees have not taken appropriate action when 
a donor has obtained alcohol test results just below the 0.04 percent 
BAC cutoff level after the donor has been at work for several hours. A 
BAC below 0.04 percent after the donor has been at work for several 
hours allows very little doubt that the donor has had an unacceptably 
high BAC, and has probably been impaired, at some time during the work 
period. Therefore, the final rule establishes new cutoff levels for 
alcohol testing in Sec. Sec.  26.99 and 26.103 that take into account 
the average rate at which individuals metabolize alcohol over time. In 
Sec.  26.99(a), the agency decreased the cutoff level for the initial 
alcohol test result from 0.04 to 0.02 percent BAC and requires a 
confirmatory alcohol test if a donor's initial test result is 0.02 
percent BAC or higher. In addition, Sec.  26.99(b) requires the 
collector to record the time at which the initial alcohol test result 
is obtained, so that the length of time during which the donor has been 
in a work status can be calculated to determine whether a confirmatory 
test result is positive, in accordance with Sec.  26.103. These changes 
to the initial alcohol test cutoff level and testing procedure are 
necessary to support the provisions of Sec.  26.103, which require the 
collector to declare an alcohol test as positive if the donor's 
confirmatory test result is 0.03 percent or higher after the donor has 
been on duty for 1 hour, or 0.02 percent or higher after the donor has 
been on duty for 2 hours. The revised lower cutoff level for the 
initial test of 0.02 percent BAC permits licensees and other entities 
to identify donors who

[[Page 17064]]

have had a BAC of 0.04 percent or higher while in a work status, and to 
initiate confirmatory testing for those individuals.
Section 26.101 Conducting a Confirmatory Test for Alcohol
    The NRC added this section to provide detailed procedures for 
conducting confirmatory breath alcohol tests. These procedures 
incorporate the related requirements from 49 CFR Part 40, which the NRC 
has added to the final rule to ensure that confirmatory breath alcohol 
tests provide accurate and legally defensible test results when using 
the EBTs that are required in Sec.  26.91(b) [Acceptable evidential 
breath testing devices] and relying on one breath specimen for 
confirmatory testing, as is required in Sec.  26.91(c).
    Section 26.101(a) requires licensees and other entities to conduct 
the confirmatory test as soon as possible following the initial alcohol 
test, and in all cases, no later than 30 minutes after the initial 
test. The final rule adds this requirement to reduce the possibility 
that alcohol metabolism will cause a confirmatory test to provide a 
result falling below the applicable cutoff level. Former Section 
2.4(g)(18) in Appendix A to Part 26 did not require conducting a 
confirmatory test as soon as possible after obtaining a positive 
initial alcohol test result, although licensees follow this practice. 
However, the agency had added a 30-minute limit because some FFD 
program personnel may be tested under DOT procedures, as permitted in 
Sec.  26.31(b)(2), and an EBT that is suitable for confirmatory testing 
may not be immediately available at the collection site, such that 
transport to another collection site is required. The 30-minute interim 
period is unnecessary at licensees' and other entities' collection 
sites because licensees' and other entities' collection sites must have 
the capability to conduct confirmatory tests with an EBT, as required 
under Sec.  26.87(a). Therefore, except in these unusual circumstances, 
licensees and other entities are expected to continue their current 
practice of conducting the confirmatory test immediately after a 
donor's initial test result is determined to be positive.
    The NRC added Sec.  26.101(b) to specify procedures for conducting 
a confirmatory alcohol test.
    Sections 26.101(b)(1) and (b)(2) require the collector to conduct 
an air blank before beginning the confirmatory test and verify that the 
air blank reading is 0.00. These steps are necessary to ensure that the 
EBT is functioning properly before the test begins.
    Section 26.101(b)(3) requires the collector to take the EBT out of 
service if a second air blank test reading is above 0.00. This step is 
necessary because a reading above 0.00 on an air blank test indicates 
that the EBT is not functioning properly and may provide inaccurate 
test results.
    The NRC has added Sec.  26.101(b)(4) through (b)(7) to specify 
requirements for handling the EBT's mouthpiece; reading the test number 
displayed on the EBT; blowing into the EBT; and showing, recording, and 
documenting the result displayed on the EBT, respectively. The need for 
these steps is the same as for those discussed with respect to the 
related steps in Sec.  26.95 [Conducting an initial test for alcohol 
using a breath specimen]. However, the final rule does not permit the 
donor to insert the mouthpiece into the EBT for the confirmatory test 
because it is necessary to ensure that the confirmatory test is 
conducted strictly in accordance with the proper procedures to produce 
a result that meets evidential standards. Meeting evidential standards 
is necessary if any questions arise with respect to the collection 
procedure in a review conducted under Sec.  26.39 or legal proceedings.
    Section 26.101(c) requires that only one breath specimen must be 
collected for the confirmatory alcohol test, unless problems in the 
collection require that the collection be repeated. If a repeat 
collection is required, the collector must rely on the result from the 
first successful collection in determining the confirmatory test 
result. As discussed under Sec.  26.95(c), if the specified procedures 
are followed, relying on one breath specimen for the initial test 
rather than the two required in the former rule increases the 
consistency of Part 26 collection procedures with those of other 
Federal agencies. This also reduces the time required for breath 
specimen collections without compromising the accuracy, validity, or 
reliability of the test results. This section also prohibits licensees 
and other entities from combining or averaging results from more than 
one test in order to arrive at the confirmatory test result. These 
calculations, required by former Section 2.4(g)(18) in Appendix A to 
Part 26, are no longer necessary because of the mandatory use of the 
EBTs specified in Sec.  26.91(b). The change meets Goal 3 of this 
rulemaking to improve the efficiency of FFD programs.
    Section 26.101(d) amends the portion of former Section 2.4(g)(18) 
in Appendix A of Part 26 that required using a different EBT to conduct 
the confirmatory alcohol test than used for initial alcohol testing. 
The final rule permits the use of the same EBT for both initial and 
confirmatory alcohol testing, instead of requiring the use of two 
different EBTs. The licensee or other entity must obtain one breath 
specimen for initial alcohol testing and one for confirmatory testing, 
if necessary, but is permitted to conduct both tests using the same 
EBT. The NRC has made this change because improvements in EBT 
technology assure that valid and reliable test results may be obtained 
from a single EBT if the specimen collection and quality assurance 
procedures in this part are followed. Reducing the number of breath 
specimens required for alcohol testing not only reduces the costs 
associated with alcohol testing, but also reduces the burden on donors 
that the collection process imposes. Use of the same EBT for initial 
and confirmatory testing is consistent with the procedures of other 
Federal agencies for workplace alcohol testing.
Section 26.103 Determining a Confirmed Positive Test Result for Alcohol
    Section 26.103 amends the cutoff level for determining whether a 
confirmatory alcohol test result is positive, as specified in former 
Sec.  26.24(g) and Section 2.7(f)(2) in Appendix A to Part 26. This 
section establishes new cutoff levels that take into account the length 
of time the donor has been in a work status for the reasons discussed 
with respect to Sec.  26.99 [Determining the need for a confirmatory 
test for alcohol]. Section 26.103(a)(1) retains the 0.04 percent BAC in 
former Sec.  26.24(g) and Section 2.7(f)(2) in Appendix A to Part 26 as 
the cutoff level for a confirmed positive alcohol test result at any 
time regardless of the length of time the donor has been in a work 
status. Sections 26.103(a)(2) and (a)(3) establish new cutoff levels 
for positive alcohol test results that are above the 0.02 percent BAC 
cutoff level on the initial test and do not meet or exceed the 0.04 
percent BAC cutoff level on confirmatory testing but indicate that the 
donor had a BAC of 0.04 percent or greater while in a work status or 
consumed alcohol while on duty. The cutoff levels and time periods in 
Sec.  26.103(a)(2) and (a)(3) are based on the average rate at which 
normal metabolic processes reduce an individual's BAC over time, which 
is about 0.01 percent BAC per hour. Therefore, a donor whose BAC is 
measured as 0.03 percent after the donor has been in a work status for 
1 hour would have had a BAC of approximately 0.04 percent when he or 
she reported for work an hour ago.

[[Page 17065]]

Through the same metabolic processes, a donor whose BAC is measured as 
0.02 percent after he or she has been in a work status for 2 hours 
would also have had a BAC of approximately 0.04 percent when he or she 
reported for work 2 hours ago. These changes improve the effectiveness 
of FFD programs by ensuring that confirmatory alcohol testing 
identifies donors who have been impaired from alcohol use while on duty 
and, therefore, may have posed a risk to public health and safety.
    The NRC added Sec.  26.103(b) to strengthen FFD programs by 
requiring licensees and other entities to address circumstances in 
which a donor's confirmatory alcohol test result is greater than 0.01 
percent BAC when the individual has been in a work status for 3 hours 
or more, but his or her BAC falls below the cutoff levels in Sec.  
26.103(a). The final rule requires the collector to declare the test as 
negative because NHTSA has not thoroughly evaluated some of the EBTs 
that licensees and other entities are permitted to use for confirmatory 
alcohol testing under the final rule for accurately estimating BAC 
levels below 0.02 percent. However, if an individual has an alcohol 
test result above 0.01 percent BAC and has been in a work status for 3 
hours or more, the test result provides a reason to believe that the 
individual has been impaired while on duty. Therefore, the provision 
requires the licensee or other entity, after testing, to ensure that 
the donor's alcohol use is evaluated, a determination of fitness is 
performed, and the determination of fitness indicates that the donor is 
fit to safely and competently perform his or her duties before the 
individual is permitted to perform the duties that require him or her 
to be subject to this part. This change strengthens the effectiveness 
of FFD programs by ensuring that the alcohol use of individuals who may 
have been impaired when reporting for duty is assessed to determine 
whether such individuals' alcohol use is problematic and may pose a 
future risk to public health and safety and the common defense and 
security.
    The NRC has deleted former Section 2.4(g)(19) in Appendix A to Part 
26, which established requirements for collecting a blood specimen for 
alcohol testing, in its entirety because the final rule no longer 
permits blood testing for alcohol, at the donor's discretion, for the 
reasons discussed with respect to Sec.  26.83(a).
Section 26.105 Preparing for Urine Collection
    This section is added to describe the preliminary steps for 
collecting a urine specimen for drug testing. For organizational 
clarity, this section reorganizes the requirements in former Section 
2.4(g)(5) through (g)(7) in Appendix A to Part 26 by separating alcohol 
and urine specimen collection procedures into separate sections of the 
final rule. The section also establishes several new requirements that 
the agency has added to meet Goal 1 of this rulemaking to update and 
enhance the consistency of Part 26 with advances in other relevant 
Federal rules and guidelines.
    Section 26.105(a) revises former Section 2.4(g)(5) in Appendix A to 
Part 26. The final rule retains the former requirement for the donor to 
remove any unnecessary outer garments and belongings that might conceal 
items or substances that could be used to tamper with a urine, breath, 
or blood specimen. However, the final rule eliminates the references to 
blood and breath specimens in the former paragraph because the final 
rule no longer permits donors to request blood testing for alcohol. 
This paragraph also eliminates reference to breath specimens because 
the final rule presents requirements related to preparing for alcohol 
testing in a separate section (Sec.  26.93) for organizational clarity.
    The NRC added Sec.  26.105(b) to require the donor to empty his or 
her pockets and display the items contained in them. The new 
requirement for the collector to examine the articles in the donor's 
pockets increases the likelihood of detecting items (e.g., a vial of 
powdered urine, bleach, a portable heating unit, a false penis or any 
other tube or device that may be used to replicate the function of 
urinary excretion) that could be used to adulterate or substitute the 
specimen in a subversion attempt. The rule requires the collector to 
use his or her judgment in determining whether an item found in the 
donor's pockets indicates a clear intent to attempt to subvert the 
testing process. For example, whereas a container of urine found in a 
donor's pocket would be clear evidence of an intent to subvert the 
testing process, a container of eye drops, which could be used to 
adulterate the specimen, would, in most cases, be unlikely to indicate 
an intent to subvert the testing process. Should the collector identify 
an item that indicates a possible intent to subvert the testing 
process, this section requires him or her to contact the FFD program 
manager or MRO in order to obtain direction regarding the need for a 
directly observed collection. If the collector identifies an item that 
could be used to tamper with the specimen, but does not indicate an 
intent to subvert testing, then the collector must secure the item and 
continue with the collection. The agency added these requirements to 
meet Goal 1 of this rulemaking to update and enhance the consistency of 
Part 26 with advances in other relevant Federal rules and guidelines, 
as well as Goal 3 to improve the effectiveness of FFD programs, by 
improving the ability of the collector to identify attempts to subvert 
the drug testing process. Adding the requirement for the donor to 
permit the collector to make this examination ensures that donors 
understand that they must cooperate with the examination.
    Section 26.105(c) retains former Section 2.4(g)(6) in Appendix A to 
Part 26, which required the individual to be instructed to wash his or 
her hands prior to urination. The final rule makes two minor editorial 
changes to the former provision for clarity in the language of the 
final rule. The final rule clarifies that the collector is to instruct 
the donor to wash and dry his or her hands and replaces the term 
``individual'' with the term ``donor.''
    Section 26.105(d) retains former Section 2.4(g)(7) in Appendix A to 
Part 26 and requires the donor to remain in the presence of the 
collection site person and not to have access to any source of water or 
other materials that could be used to tamper with the specimen. The 
final rule makes two minor editorial changes to the former provision 
for clarity in the language of the rule. The final rule replaces the 
term ``collection site person'' with the simpler term ``collector'' and 
the term ``individual'' with the term ``donor.''
    The NRC added Sec.  26.105(e) to permit the donor, at the 
collector's discretion, to select the specimen collection container 
that he or she will use. Permitting the donor to select the collection 
kit is not required. However, this practice may increase the donor's 
confidence in the integrity of the testing process by assuring the 
donor that the selection of the collection kit is random if he or she 
is concerned that a collector may attempt to subvert the testing 
process by selecting a kit that had been contaminated with a substance 
that would produce a positive, adulterated, substituted, or invalid 
test result in order to entrap the donor. The importance of providing 
assurance to the donor regarding the integrity of the collection 
process is discussed with respect to Sec.  26.95(b)(1). This paragraph 
also prohibits the donor from taking collection kit materials (such as 
the specimen label) other than the collection container, into the 
private area used for urination. This prohibition ensures that a donor 
could not tamper

[[Page 17066]]

with the other collection kit materials and thereby disrupt the chain 
of custody for the urine specimen.
    This section is consistent with the related requirements of other 
Federal agencies and so meets Goal 1 of this rulemaking to update and 
enhance the consistency of Part 26 with advances in other relevant 
Federal rules and guidelines, as well as Goal 3 to improve the 
effectiveness of FFD programs, by improving the ability of the 
collector to identify attempts to subvert the drug testing process. The 
final rule adds the new provision requiring the donor to permit the 
collector to make this examination in response to stakeholder requests 
at the public meetings discussed in the preamble to the proposed rule 
to ensure that donors understand that they must cooperate with the 
examination.
Section 26.107 Collecting a Urine Specimen
    Section 26.107 amends former Section 2.4(g)(8), (g)(9), and (g)(12) 
in Appendix A to Part 26 to update the rule's urine specimen collection 
procedures and incorporate advances in other relevant Federal rules and 
guidelines, consistent with Goal 1 of this rulemaking.
    The NRC added Sec.  26.107(a)(1) to specify the instructions that 
the collector is required to provide to the donor. This paragraph 
requires the collector to instruct the donor to go into the room or 
stall used for urination, provide a specimen of the quantity that the 
licensee or other entity has predetermined, refrain from flushing the 
toilet, and return with the specimen as soon as the donor has completed 
the void. The final rule requires the collector to provide these 
instructions to the donor so that the donor understands his or her 
responsibilities with respect to the urine collection procedure. In 
addition, the instructions are necessary to implement other provisions 
of the final rule. For example, the quantity of urine that the 
collector instructs the donor to provide is based on the requirements 
of the licensee's or other entity's drug testing program, as discussed 
with respect to Sec.  26.109 [Urine specimen quantity]. The collector 
instructs the donor not to flush the toilet so that the collector may 
inspect the private area in which the donor voided after receiving the 
specimen, as discussed with respect to Sec.  26.109(c). The collector 
must instruct the donor to return with the specimen as soon as the 
donor has completed the void in order to minimize the possibility that 
the urine specimen cools and its temperature falls below the acceptable 
specimen temperature range specified in Sec.  26.111(b).
    Section 26.107(a)(1) further amends former Section 2.4(g)(8) in 
Appendix A to Part 26. The former provision stated that the individual 
may provide his or her urine specimen in the privacy of a stall or 
otherwise partitioned area that protects individual privacy. For 
clarity, this paragraph replaces ``may'' in the former rule with 
``shall'' to indicate that the area in which the donor will urinate 
must provide for individual privacy. The final rule also adds an 
exception to the former requirement for privacy in the case of a 
directly observed collection. The agency made this change for greater 
accuracy in the rule language because the requirement for individual 
privacy does not apply in the case of a directly observed collection, 
as discussed with respect to Sec.  26.115.
    The NRC added Sec.  26.107(a)(2) to further emphasize the 
requirement in former Section 2.4(g)(8) in Appendix A to Part 26 that 
donors must be afforded individual privacy when providing a urine 
specimen. The new paragraph requires that, unless the specimen is to be 
collected under direct observation, no one other than the donor may go 
into the private area in which the donor will urinate. Although the NRC 
is not aware of any instances in Part 26 programs in which the former 
requirement for individual privacy has been compromised, the experience 
of other Federal agencies has indicated that such emphasis is 
necessary.
    Section 26.107(a)(3) permits the collector to set a reasonable time 
limit for the donor to void. Rather than establishing a specific time 
limit, the final rule permits the collector to rely on his or her 
professional judgment in order to ensure that individuals who may 
experience difficulty in voiding have sufficient time to provide a 
specimen while also permitting collectors to prevent donors from 
disrupting the testing process by taking an unduly long time to provide 
a specimen. In Sec.  26.85(a), the rule specifies new training and 
qualification requirements to ensure that collectors are able to 
exercise professional judgment appropriately. At the public meetings 
discussed in the preamble to the proposed rule, stakeholders reported 
incidents in which donors appeared to be attempting to disrupt the 
testing process by spending an unduly long time providing a specimen 
and challenged the collector's authority to set a time limit. The new 
paragraph clarifies that collectors have the authority to set a 
reasonable time limit for voiding. In addition, this paragraph 
increases the consistency of Part 26 with the procedures implemented by 
other Federal agencies in accordance with Goal 1 of this rulemaking.
    Section 26.107(b) amends former Section 2.4(g)(9) in Appendix A to 
Part 26. The former provision required the collector to note any 
unusual behavior or appearance in the permanent record book and on the 
custody-and-control form. This section clarifies the intent of the 
former requirement, which raised implementation questions from 
licensees, by specifying that the collector must pay careful attention 
to the donor during the collection process so that the collector can 
note any conduct that may indicate an attempt to substitute or tamper 
with the specimen. This section also provides examples of the types of 
behavior that may indicate a subversion attempt and requires the 
collector to contact FFD program management if he or she observes such 
behavior. This section requires FFD program management to determine 
whether a directly observed collection is necessary under Sec.  26.115.
    The NRC added Sec.  26.107(c) to specify the actions to be taken by 
the collector and donor to complete the specimen collection procedure. 
The first sentence of Sec.  26.107(c) retains the instruction in former 
Section 2.4(g)(12) in Appendix A to Part 26 that prohibits the donor 
from washing his or her hands until the specimen has been delivered to 
the collector. This paragraph also adds a requirement for the collector 
to inspect the private area for any evidence of a subversion attempt 
prior to flushing the toilet. This additional requirement is consistent 
with existing industry practices and the procedures of other Federal 
agencies. It is intended to increase the likelihood of detecting 
subversion attempts if the donor leaves any physical evidence in the 
toilet bowl or private area where the donor voided, which could 
include, but is not limited to, an empty vial that contains an 
adulterant, powdered urine spilled on the floor, or the remains of an 
adulterant in the toilet bowel.
Section 26.109 Urine Specimen Quantity
    Section 26.109 amends former Section 2.4(g)(11) in Appendix A to 
Part 26. The former provision established 60 milliliters (mL) as the 
minimum quantity of urine that an FFD program must collect from donors 
and the procedures to be followed if a donor is unable to provide the 
specified quantity. The final rule reduces to 30 mL the basic quantity 
of urine to be collected.
    Section 26.109(a) introduces a new term ``the predetermined 
quantity.'' The licensee or other entity establishes a

[[Page 17067]]

predetermined quantity of urine that each donor is requested to 
provide, depending on the characteristics of the licensee's or other 
entity's testing program. The final rule requires the predetermined 
quantity to include at least 30 mL of urine, but licensees and other 
entities may request a larger quantity of urine if--
    The specimen will be initially tested at a licensee testing 
facility;
    Testing will be conducted for additional drugs beyond those 
required in Sec.  26.31(d)(1);
    Split specimen procedures will be followed; or
    The licensee's or other entity's program includes some combination 
of these characteristics.
    The NRC has reduced the 60-mL quantity that was required in former 
Section 2.4(g)(11) in Appendix A to Part 26 to 30 mL to decrease the 
burden on donors, while ensuring that a sufficient quantity of urine is 
available to complete initial validity and drug tests, confirmatory 
validity and drug tests (if required), and any retests that may be 
requested by the donor and authorized by the MRO under Sec.  26.165(b). 
NRC staff discussions with representatives of HHS-certified 
laboratories indicated that advances in testing technologies allow for 
these minimum testing and retesting procedures to be completed on a 30-
mL specimen. Therefore, a 60-mL specimen is no longer necessary to 
achieve the NRC's minimum objectives of conducting validity and drug 
tests on each specimen for the five classes of drugs specified in Sec.  
26.31(d)(1), as well as retesting of the specimen, if required.
    Section 26.109(a) also specifies the additional quantity of urine, 
above the basic 30 mL, to be collected when the testing program follows 
split specimen procedures. The rule requires licensees and other 
entities to collect an additional 15 mL for transfer into Bottle B of a 
split specimen for storage and possible testing. (As discussed with 
respect to Sec.  26.113(b), the final rule replaces the terms, 
``primary specimen'' and ``split specimen,'' in the former rule with 
the terms, ``Bottle A'' and ``Bottle B,'' for clarity in the language 
of the rule and consistency with the terminology used by other Federal 
agencies.) This additional 15 mL is sufficient to permit the HHS-
certified laboratory to conduct validity and drug tests of the specimen 
in Bottle B, at the donor's request, and is consistent with the 
quantity required in the related provisions of other Federal agencies. 
Therefore, if a licensee's or other entity's testing program follows 
split specimen procedures, but does not include initial tests at the 
licensee testing facility or testing for additional drugs beyond those 
specified in Sec.  26.31(d)(1), then the predetermined quantity for 
this testing program is 45 mL (30 mL for basic testing + 15 mL for the 
split specimen). The predetermined quantity must be larger than 45 mL 
if the testing program also includes initial tests at a licensee 
testing facility and testing for additional drugs.
    Section 26.109(a) also permits licensees and other entities to 
include in the predetermined quantity the additional amount of urine 
that is necessary to support testing for additional drugs beyond those 
specified in Sec.  26.31(d)(1). Licensees and other entities must 
consult with the HHS-certified laboratories they use to identify the 
quantity of urine required to test for the additional drugs. For 
example, if the licensee's or other entity's testing program does not 
include initial tests at a licensee testing facility and does not 
follow split specimen procedures, then the predetermined quantity for 
that testing program consists of the 30-mL basic quantity plus the 
additional amount of urine needed to test for additional drugs. As 
another example, if a licensee's or other entity's testing program 
includes initial tests at a licensee testing facility, follows split 
specimen procedures, and tests for additional drugs, then the 
predetermined quantity consists of the 30-mL basic quantity plus 15 mL 
for the split specimen plus the additional amount required by the 
licensee testing facility and HHS-certified laboratory to test for the 
additional drugs.
    Section 26.109(a) also permits licensees and other entities to 
include in the predetermined quantity the additional amount of urine 
that is necessary to perform initial validity and drug tests at the 
licensee testing facility, if initial tests are performed there. For 
example, one licensee testing program currently requires an additional 
10 mL of urine for initial testing at the licensee testing facility, 
but does not test for other drugs or follow split specimen procedures. 
In this program, the predetermined quantity that collectors must 
request the donor to provide is 40 mL. As another example, if a 
licensee's or other entity's testing program includes initial tests at 
the licensee testing facility, does not test for additional drugs, and 
follows: split specimen procedures, the predetermined quantity may be 
55 mL (30 mL for basic testing + 15 mL for the split specimen + 10 mL 
for initial testing at the licensee testing facility). If this program 
also tests for additional drugs, the predetermined quantity may be 
larger than 55 mL.
    The final rule adds Sec.  26.109(b) to establish the actions that 
the collector must take if a donor provides a specimen that is less 
than the 30-mL basic quantity. NRC staff discussions with 
representatives of HHS-certified laboratories indicated that 30 mL is 
sufficient to meet the NRC's primary objectives of detecting drug use 
and subversion attempts through initial validity and drug testing, and 
for confirmatory validity and drug tests, if required, at an HHS-
certified laboratory for the panel of drugs for which testing is 
required in Sec.  26.31(d)(1). The 30-mL quantity also ensures that 
sufficient urine is available for retesting the specimen for validity 
and for drugs and drug metabolites, should the donor request such 
retesting, as permitted in Sec.  26.165(b). Therefore, the 30-mL basic 
quantity is necessary to achieve the NRC's drug-testing objectives, 
although it is insufficient to permit testing for additional drugs, 
initial testing at licensee testing facilities, or splitting the 
specimen, which this part does not require.
    Section 26.109(b)(1) amends the portions of former Section 
2.4(g)(11) in Appendix A to Part 26 that prescribed collector actions 
if a donor provides an insufficient specimen. The final rule requires 
the collector to ``encourage'' the donor to drink a reasonable amount 
of liquid in order to provide a specimen of at least 30 mL, rather than 
``allow'' the donor to drink additional liquid as required under the 
former rule. The NRC made this change to enhance the efficiency of FFD 
programs, consistent with Goal 3 of this rulemaking, by potentially 
reducing the time required to obtain a specimen of the required 
quantity from the donor and, thereby, to complete the collection, 
should the donor choose to comply. However, this paragraph establishes 
a limit on the amount of liquid that the individual is permitted to 
consume to avoid the potential for ``water intoxication,'' which is a 
physical response to consuming too many liquids that may cause harm to 
the donor. Although the limit of 24 ounces of water over a 3-hour 
period in the proposed rule is the same limit imposed in the HHS 
Guidelines, the NRC raised the limit in the final rule to 40 ounces 
over a 3-hour period for consistency with the DOT limit, in response to 
public comment. This limit continues to be conservative to ensure that 
individuals who may have a medical condition that makes them more 
subject to water intoxication, such as some forms of renal disease, or 
who are taking some medications, would not be placed at risk. The final 
rule retains

[[Page 17068]]

the former requirement in Section 2.4(g)(11) in Appendix A to Part 26 
to collect successive specimens in separate containers.
    The NRC added Sec.  26.109(b)(2) to require the collector to end 
the specimen collection process as soon as the donor provides a 
specimen of at least 30 mL in a subsequent attempt. This requirement 
reduces the burden on donors who may have some difficulty providing a 
urine specimen while meeting the NRC's objectives of obtaining a 
specimen of sufficient size to support initial and confirmatory 
validity and drug testing, as well as retesting of the specimen.
    Section 26.109(b)(2) also specifies that the licensee or other 
entity may not impose any sanctions if a donor provides a subsequent 
specimen that is less than the licensee's or other entity's 
predetermined quantity, as long as the specimen quantity is at least 30 
mL. Imposing sanctions for failing to provide sufficient urine to 
support initial testing at the licensee's testing facility, split 
specimen procedures, or testing for additional drugs is inappropriate, 
because a specimen of at least 30 mL is sufficient to meet the NRC's 
objectives and, therefore, could not be considered a refusal to test.
    Section 26.109(b)(2) also requires the collector to forward a 
subsequent specimen that is greater than 30 mL, but less than the 
licensee's or other entity's predetermined quantity, to the HHS-
certified laboratory for testing, rather than permit the specimen to be 
tested at the licensee testing facility. This provision is necessary to 
ensure that a sufficient quantity of urine is available for validity 
and drug testing and retesting at the HHS-certified laboratory, if 
required, consistent with the NRC's objectives. However, if the 
subsequent specimen is equal to or greater than the licensee's or other 
entity's predetermined quantity, the licensee or other entity is 
permitted to follow the FFD program's normal testing procedures. 
Following normal testing procedures in this instance is permissible 
because there is sufficient urine to implement the FFD program's 
testing procedures (e.g., split specimen procedures, testing for 
additional drugs, initial testing at a licensee testing facility), 
while continuing to ensure that sufficient urine is available for 
testing and retesting at the HHS-certified laboratory, if required.
    The agency added Sec.  26.109(b)(3) to require the implementation 
of ``shy bladder'' procedures if a donor is unable to provide a 30-mL 
specimen within 3 hours of the initial attempt to provide a specimen, 
for the reasons discussed with respect to Sec.  26.119. Requirements 
for implementing ``shy bladder'' procedures are contained in that 
section.
    The NRC added Sec.  26.109(b)(4) to establish additional 
requirements for specimen collections when a donor provides a specimen 
of less than 30 mL.
    This section eliminates the requirement in former Section 
2.4(g)(11) in Appendix A to Part 26 to combine successive specimens 
from a donor in order to obtain a specimen of 60 mL. The final rule 
prohibits the practice of combining specimens to ensure that successive 
specimens neither contaminate nor dilute a specimen that will be 
tested. In addition, the prohibition increases the consistency of Part 
26 with the related requirements of other Federal agencies (Goal 1 of 
this rulemaking).
    Section 26.109(b)(4) also requires the collector to discard any 
specimens of less than 30 mL unless there is reason to believe that a 
specimen may have been altered. Examples of reasons to believe that a 
donor may have attempted to alter the specimen may include, but are not 
limited to: (1) Observation of powder (that could be an adulterant or 
powdered urine) spilled in the private area in which the donor urinated 
or on the donor's clothing; (2) unexpected sounds from the private area 
while the donor should be voiding, such as the sound of something being 
unwrapped or dropping to the floor; (3) observation that the donor's 
pocket appears to contain an item that was not visible before the donor 
entered the private area (that the donor may have previously had taped 
to his body); and (4) an unusual color or lack of clarity in the urine 
specimen. The final rule requires the collector to discard specimens of 
less than 30 mL when there is no reason to believe that the specimens 
have been subject to tampering because they are not used for testing 
and there is no reason to retain them.
    If the collector suspects that a specimen has been altered and the 
suspect specimen is equal to or greater than 15 mL, the rule requires 
the collector to forward the suspect specimen to the HHS-certified 
laboratory for testing, consistent with former Section 2.4(g)(16) in 
Appendix A to Part 26. NRC staff discussions with representatives of 
HHS-certified laboratories indicate that 15 mL is the minimum quantity 
necessary for HHS-certified laboratories to perform the initial and 
confirmatory (if necessary) validity and drug testing required in this 
part, although it is insufficient to support retesting of the specimen 
at the donor's request. When the collector has observed donor conduct 
or specimen characteristics that indicate there is a reason to believe 
that the donor may have altered the specimen, the NRC's interest in 
assuring that the testing process is not subverted takes precedence 
over the donor's ability to request retesting of the specimen. Any 
results of validity testing that confirm that the specimen was 
adulterated or substituted, in combination with the collector's 
observations, provide clear evidence that a donor has tampered with the 
specimen and thereby attempted to subvert the testing process.
    This section also amends former Section 2.4(g)(17) in Appendix A to 
Part 26. The former provision required a directly observed collection 
whenever there is a reason to believe that a donor has or may attempt 
to alter a specimen. The amended provision requires the collector to 
contact FFD program management to determine whether a directly observed 
collection is required, but does not require a directly observed 
collection in every circumstance. At the public meetings discussed in 
the preamble to the proposed rule, the stakeholders requested 
flexibility in the decision to collect another specimen under direct 
observation. They noted that numerous instances have occurred in which 
a collector identified incontrovertible evidence that the donor 
intended to or had tampered with a specimen and that, in such cases, 
drug testing would not provide additional information that justifies 
the costs associated with conducting a directly observed collection and 
testing the additional specimen. The NRC believes that the presence of 
drugs and drug metabolites in a specimen that is collected under direct 
observation establishes a clear motive for an alleged attempt to tamper 
with a specimen and adds further evidence supporting the imposition of 
sanctions on the donor for attempting to subvert the testing process. 
However, the NRC believes that such additional evidence is unnecessary 
when there is incontrovertible evidence that the donor intends to or 
has attempted to tamper with a specimen. Therefore, the final rule 
permits FFD program management to determine whether an additional 
specimen collection under direct observation must be conducted. The 
agency has made this change to meet Goal 3 of this rulemaking to 
improve the efficiency of FFD programs, by reducing the number of 
directly observed collections required under the rule.

[[Page 17069]]

Section 26.111 Checking the Acceptability of the Urine Specimen
    Section 26.111 amends former requirements for assessing specimen 
validity at the collection site, which appeared in Section 2.4(g)(13) 
through (g)(17) in Appendix A to Part 26. In general, the NRC has made 
changes in this section to meet Goal 1 of this rulemaking to update and 
enhance the consistency of Part 26 with advances in other relevant 
Federal rules and guidelines. In addition, the NRC changed the heading 
of this section from ``Checking the validity of the urine specimen'' in 
the proposed rule to ``Checking the acceptability of the urine 
specimen,'' in response to a public comment which noted that 
``acceptability'' more accurately characterizes the purpose of the 
requirements in this section.
    Section 26.111(a) amends former Section 2.4(g)(13) in Appendix A to 
Part 26. The former provision required the collector to measure the 
temperature of the specimen immediately after the urine specimen is 
collected. The new provision requires the collector to measure the 
temperature of any specimen that is 15 mL or more. The final rule does 
not mandate measuring the temperature of smaller specimens because the 
collector is required to discard them, as discussed with respect to 
Sec.  26.109(b)(4). This paragraph also replaces former Section 
2.4(g)(14) in Appendix A to Part 26, which established the acceptable 
specimen temperature range and required conducting a second specimen 
collection under direct observation if a specimen's temperature falls 
outside the acceptable range. The final rule increases the range of 
acceptable specimen temperatures from 90.5[deg]F-99.8[deg]F in the 
former provision to 90[deg]F-100[deg]F for consistency with the 
temperature range specified in the HHS Guidelines. The wider acceptable 
temperature range provides increased protection against false low or 
false high temperature readings and, therefore, protects donors from 
the imposition of sanctions based on inaccurate specimen temperature 
readings. The portion of former Section 2.4(g)(14) that specified 
collector actions if there is a reason to believe that the individual 
may have tampered with the specimen has been moved to Sec.  26.111(d) 
for organizational clarity.
    In response to a public comment, the final rule eliminates the 
requirement in Sec.  26.111(a), which appeared in both the former and 
proposed rules, for the collector to offer the donor an opportunity to 
provide a measurement of body temperature. In addition, the final rule 
deletes Sec.  26.111(b) in the proposed rule entirely and has 
renumbered the paragraphs in this section accordingly. The NRC has made 
these changes in response to public comments, which reported that DOT's 
experience indicates that there are often discrepancies when comparing 
the temperature provided by a specimen container temperature strip and 
that provided by a device that measures body temperature. Further, with 
the increase in the range of acceptable specimen temperatures, as 
discussed with respect to Sec.  26.111(a), a measurement of body 
temperature is less useful to counter a reason to believe that the 
donor has altered the specimen (e.g., humans who have a body 
temperature at or below 90[deg]F would be suffering from severe 
hypothermia). Therefore, eliminating the opportunity for a donor to 
provide a measure of body temperature in this paragraph meets Goal 5 of 
this rulemaking to improve Part 26 by eliminating or modifying 
unnecessary requirements.
    Section 26.111(b) amends former Section 2.4(g)(15) in Appendix A to 
Part 26. The former provision required the collector to inspect the 
specimen's color, determine whether there were any signs of 
contaminants, and record any unusual findings in the permanent record 
book. The final rule amends this provision by deleting reference to the 
permanent record book and requiring the collector to use the custody-
and-control form to record this information. The NRC has made this 
change because the final rule no longer requires collection sites to 
maintain a permanent record book, consistent with the elimination of 
the requirement to maintain a permanent record book in the HHS 
Guidelines. The final rule also makes minor editorial revisions to the 
former provision by incorporating the related language from the HHS 
Guidelines. The agency made these changes to meet Goal 1 of this 
rulemaking to update and enhance the consistency of Part 26 with the 
regulations of other Federal agencies.
    Section 26.111(c) replaces and amends the first sentence of former 
Section 2.4(g)(14) in Appendix A to Part 26. The former provision 
required a second specimen to be collected under direct observation if 
the temperature of the first specimen submitted by a donor fell outside 
of the acceptable specimen temperature range. The final rule eliminates 
the requirement for a second specimen collection under direct 
observation if the specimen temperature falls outside of the required 
range, although licensees and other entities could, at their 
discretion, continue this practice. Instead, the new provision requires 
the collector to contact the FFD program manager, if the collector has 
a reason to believe the donor has attempted to subvert the testing 
process based on observed donor behavior, the specimen temperature, 
unusual specimen characteristics, or other observations. The FFD 
program manager, at his or her discretion, may consult with the MRO to 
determine whether the collector's observations provide sufficient 
evidence that a subversion attempt has occurred to warrant the 
imposition of sanctions. If the MRO and/or FFD program manager 
determine that a subversion attempt has occurred on the basis of the 
collector's observations, the final rule permits the licensee or other 
entity to impose the sanctions for a subversion attempt in Sec.  
26.75(b) without conducting a directly observed collection. However, at 
the FFD program manager's or the MRO's discretion, a second specimen 
may be collected under direct observation. The rule permits a second 
specimen to be collected under direct observation to provide further 
information to assist the MRO in determining whether or not a 
subversion attempt has occurred. For example, positive drug test 
results from a second specimen that is collected under direct 
observation provide additional evidence that the donor attempted to 
tamper with his or her first specimen to hide drug use. The NRC has 
made this change in response to stakeholder requests, for the reasons 
discussed with respect to proposed Sec.  26.109(b)(4).
    The NRC also added permission in Sec.  26.111(c) for a donor to 
volunteer to submit another specimen under direct observation to 
counter any reason to believe that he or she may have altered the first 
specimen. The agency added this permission in response to a public 
comment suggesting this change and because it is consistent with Goal 7 
of the rulemaking to protect donor's rights (including due process) 
under the rule.
    Section 26.111(d) replaces and revises former Section 2.4(g)(16) in 
Appendix A to Part 26. The former provision required forwarding all 
urine specimens that are suspected of being adulterated or diluted to 
the HHS-certified laboratory for testing. The final rule adds a third 
reason, suspicion that a specimen has been substituted, for forwarding 
a specimen to the HHS-certified laboratory. As discussed with respect 
to Sec.  26.31(d)(3)(i), substitution entails replacing a valid urine 
specimen with a drug-free specimen. The NRC has made this change for 
consistency with the addition of substitution to the final

[[Page 17070]]

rule as another method of attempting to subvert the testing process for 
which licensees and other entities are required to impose sanctions, as 
discussed with respect to Sec.  26.75(b). This paragraph also adds a 
provision that specifically prohibits testing any suspect specimen at a 
licensee testing facility to (1) limit the potential for specimen 
degradation during the time period required to conduct testing at the 
licensee testing facility; (2) decrease the time required to obtain 
confirmatory validity test results if the specimen, in fact, has been 
altered; and (3) ensure that a sufficient quantity of urine is 
available for conducting validity tests at more than one HHS-certified 
laboratory if, for example, the specimen contains a new adulterant or 
an adulterant that the licensee's or other entity's primary laboratory 
is not capable of identifying (see Sec.  26.161(g)). Only suspect 
specimens of 15 mL or more must be sent for testing, rather than all 
specimens. The final rule establishes this lower limit on specimen 
quantity to ensure that there is sufficient urine available for the 
HHS-certified laboratory to conduct all of the validity and drug tests 
on the specimen that are required under this part. In response to a 
comment, this paragraph of the final rule also adds a requirement to 
send specimens of 15 mL or more, collected under direct observation in 
accordance with Sec.  26.111(c), to an HHS-certified laboratory for 
initial and confirmatory testing.
    Section 26.111(e) requires collectors and the HHS-certified 
laboratory to preserve as much of a suspect specimen as possible. The 
NRC has added this requirement to provide increased assurance that a 
sufficient quantity of urine is available to support further testing, 
in the event that further testing of the specimen is necessary, and to 
enhance the consistency of Part 26 with the related provisions of other 
Federal agencies.
    The agency also added Sec.  26.111(f) to inform donors and 
collectors of the characteristics of a specimen that is acceptable for 
testing at an HHS-certified laboratory. This paragraph incorporates the 
related provision from the HHS Guidelines.
Section 26.113 Splitting the Urine Specimen
    Section 26.113 updates former Sections 2.4(g)(20) and 2.7(j) in 
Appendix A to Part 26. This section amends collection site procedures 
for split specimens in the former rule and groups them together in one 
section within the final rule for organizational clarity.
    Section 26.113(a) of the final rule revises the same provision in 
the proposed rule, in that the NRC has deleted the phrase ``who are 
subject to this part'' to provide additional clarity to the language of 
the rule, in response to public comment. The NRC deleted this phrase 
because not all of the licensees and entities who are subject to Part 
26 are required to meet the requirements of this section.
    For organizational clarity, the NRC has added Sec.  26.113(b) to 
group together in one paragraph the steps that the collector and donor 
must follow for the split specimen collection procedure. These steps 
were embedded in former Section 2.4(g)(20) and portions of Section 
2.7(j) in Appendix A to Part 26. The final rule also replaces the 
terminology used in the former rule that referred to the split specimen 
as an ``aliquot,'' and uses the terms, ``Bottle A'' and ``Bottle B,'' 
to refer to the primary and split specimen, respectively. The agency 
made these changes for increased clarity in the language of the rule 
and consistency with the terminology used in other relevant Federal 
rules and guidelines.
    In response to a public comment, the NRC revised proposed Sec.  
26.113(b)(1) to delete the option of using a specimen bottle to collect 
a urine specimen to eliminate the possibility of problems arising from 
collecting urine in two different types of containers. The final rule 
retains the requirement for the collector to instruct the donor to void 
into a specimen container to clarify that the donor is not required to 
divide a specimen into Bottle A and Bottle B while urinating. This 
paragraph incorporates the related provision in the HHS Guidelines.
    Section 26.113(b)(2) amends the portions of former Section 2.7(j) 
in Appendix A to Part 26 that specified the amount of urine to be 
poured into the split specimen bottles. The rule replaces the implied 
requirements in the second and third sentences of Section 2.4(j), which 
referred to the split specimens as ``halves'' of the specimen that was 
collected, with updated requirements that are consistent with those 
established in Sec.  26.109 and the related provisions in the HHS 
Guidelines. This paragraph requires the collector to ensure that Bottle 
A contains 30 mL and that Bottle B contains a minimum of 15 mL of 
urine. As discussed with respect to Sec.  26.109, advances in urine 
testing technologies since the agency first promulgated Part 26 permit 
a reduction in the quantity of urine that must be collected from donors 
in order to conduct the testing this part requires. Therefore, 30 mL of 
urine is now a sufficient quantity for conducting all of the testing 
that may be required under this part and 15 mL is sufficient for 
conducting testing of the specimen in Bottle B.
    In response to public comment, the NRC has revised this paragraph 
in the final rule to more clearly specify that the specimen in Bottle A 
must be used for drug and validity testing even if there is less than 
15 mL of urine available for Bottle B. The agency added this 
clarification to the final rule because, in the experience of other 
Federal agencies, some collection sites have discarded any specimen of 
less than 45 mL and conducted another collection to obtain a sufficient 
amount of urine to fill both Bottles A and B. Following this practice 
would reduce the efficiency of FFD programs and unnecessarily increase 
the burden on donors who are subject to testing. The final rule 
incorporates this clarification from the HHS Guidelines to ensure that 
Part 26 programs do not adopt this inefficient and burdensome practice.
    Section 26.113(b)(3) retains the portion of former Section 
2.4(g)(20) in Appendix A to Part 26 that requires the donor to observe 
the process of splitting the specimens and maintain visual contact with 
the specimen bottles until they are sealed and prepared for storage or 
shipping.
    The NRC added Sec.  26.113(c) to establish priorities for using the 
specimen that has been collected. The paragraph permits the licensee 
testing facility to test aliquots of the specimen at a licensee testing 
facility or to test for additional drugs beyond those required under 
Sec.  26.31(d)(1), but only if the donor has provided a specimen of at 
least the predetermined quantity, as discussed with respect to Sec.  
26.109. As discussed with respect to Sec.  26.113(b)(2), the final rule 
requires the collector first to ensure that 30 mL of urine is available 
for Bottle A and 15 mL for Bottle B. If the donor has provided more 
than 45 mL of urine and the additional amount is sufficient to support 
testing at the licensee testing facility, testing for additional drugs, 
or both, the final rule permits the remaining amount of urine to be 
subject to such testing. However, if the donor has provided only 45 mL 
of urine, the final rule requires that the 15 mL of urine that remains 
after 30 mL has been retained for Bottle A must be used for Bottle B 
rather than to conduct testing at the licensee testing facility or 
testing for additional drugs. The final rule establishes this priority 
because the FFD program has established the expectation among donors in 
this instance that the FFD program will follow split specimen 
procedures and

[[Page 17071]]

that Bottle B will be available for retesting at the donor's request. 
Reserving the 15 mL of urine for Bottle B is also consistent with the 
principle that is established in the last sentences of Sec. Sec.  
26.135(b) and 26.165(a)(4) that control over testing of the specimen 
contained in Bottle B resides with the donor.
Section 26.115 Collecting a Urine Specimen Under Direct Observation
    Section 26.115 groups together in one section the former rule's 
requirements that apply to collecting a urine specimen under direct 
observation. The NRC has made this organizational change because 
requirements that address this topic were dispersed throughout the 
former rule. This section also incorporates more detailed procedures 
for collecting specimens under direct observation that are based on 
related requirements from other relevant Federal rules and guidelines. 
More detailed procedures are necessary because devices and techniques 
to subvert the testing process have been developed since Part 26 was 
first published that are difficult to detect in many collection 
circumstances, including under direct observation, such as a false 
penis or other realistic urine delivery device containing a substitute 
urine specimen and heating element that may be used to replicate 
urination. Therefore, the agency has made these changes to increase the 
likelihood of detecting attempts to subvert the testing process and 
increase the effectiveness of directly observed collections in assuring 
that a valid specimen is obtained from the donor.
    Section 26.115(a) amends and combines former Section 2.4(f), 
2.4(g)(17), and (g)(25) in Appendix A to Part 26. The former provisions 
established requirements for collecting a urine specimen under direct 
observation. This paragraph of the final rule assigns responsibility 
for approving a directly observed collection to the MRO or FFD program 
manager, rather than a ``higher level supervisor'' of the collector, as 
stated in former Section 2.4(b)(25) in Appendix A to Part 26. This 
change ensures that an individual who is thoroughly knowledgeable of 
the requirements of this part, and the emphasis that the NRC places on 
maintaining the individual privacy of donors, makes the decision to 
conduct a directly observed collection. The change is also consistent 
with revised requirements in the HHS Guidelines related to who may 
authorize a directly observed collection.
    The final rule also lists the circumstances that constitute a 
reason to believe that a donor may dilute, substitute, adulterate, or 
otherwise alter a specimen, and that warrant the invasion of individual 
privacy associated with a directly observed collection.
    Section 26.115(a)(1) amends former Section 2.4(f)(2) in Appendix A 
to Part 26, which stated that a directly observed collection may be 
performed if the last urine specimen provided by the donor yielded 
specific gravity and creatinine concentration results that were 
inconsistent with normal human urine. The new paragraph amends the 
former provision in several ways.
    First, the final rule eliminates the limitation in the former 
paragraph that a specimen may be collected under direct observation if 
``the last urine specimen'' provided by the individual yielded specific 
gravity and creatinine concentration results that are inconsistent with 
normal human urine. The final rule permits a directly observed 
collection if the donor had presented a specimen with characteristics 
that are inconsistent with normal human urine ``at this or a previous 
collection.'' The change is consistent with Sec.  26.75(b), which 
requires that an individual who has subverted or attempted to subvert 
any test conducted under Part 26 must be subject to a permanent denial 
of authorization. Because Sec.  26.75(b) requires permanent denial of 
authorization to a donor who has engaged in a subversion attempt, 
individuals whose last specimen had characteristics that are 
inconsistent with normal human urine are not subject to further testing 
under the rule. However, instances may arise in which a licensee or 
other entity is aware that an individual engaged in a subversion 
attempt under a drug testing program that the NRC does not regulate. If 
the licensee or other entity is considering granting authorization 
under Part 26 to the individual, then a directly observed collection is 
warranted to ensure that the donor does not have an opportunity to 
tamper with the specimen and, therefore, that drug test results will be 
accurate. The amended language of the new provision permits collecting 
a specimen under direct observation in these circumstances.
    Second, the final rule updates the former provision by replacing 
the specific gravity and creatinine concentration values in the former 
paragraph with references to a urine specimen that ``the HHS-certified 
laboratory reported as being substituted, adulterated, or invalid to 
the MRO and the MRO reported to the licensee or other entity that there 
is no adequate medical explanation for the result.'' The NRC made this 
change for consistency with the addition of more detailed requirements 
for validity testing throughout the final rule, as discussed with 
respect to Sec.  26.31(d)(3)(i). Section 26.161 [Cutoff levels for 
validity testing] specifies the cutoff concentrations and specimen 
characteristics that require the HHS-laboratory to report a specimen as 
substituted, adulterated, or invalid. Section 26.185 [Determining a 
fitness-for-duty policy violation] specifies the requirements for the 
MRO's review of these test results.
    Section 26.115(a)(2) combines and updates former Sections 2.4(f)(1) 
and 2.4(g)(14) in Appendix A to Part 26. The former provisions stated 
that the presentation of a specimen that falls outside of the required 
temperature range is sufficient grounds to conduct a directly observed 
collection. The new paragraph retains the requirement in former Section 
2.4(f)(1) in Appendix A to Part 26, which specified that a directly 
observed collection may be conducted at any time the specimen's 
temperature falls outside of the required temperature range. However, 
the final rule deletes the provisions of the proposed rule that 
addressed measuring the donor's body temperature for the reasons 
discussed with respect to Sec.  26.111(a).
    Section 26.115(a)(3) updates former Section 2.4(f)(3) in Appendix A 
to Part 26. The former provision permitted a directly observed 
collection if a collector observed donor conduct that clearly and 
unequivocally demonstrates an attempt by the donor to substitute the 
specimen. The final rule adds references to attempts to dilute and 
adulterate a specimen, in addition to substitution, as behaviors that 
demonstrate a subversion attempt, consistent with the NRC's heightened 
concern in the final rule for ensuring specimen validity, as discussed 
with respect to Sec.  26.31(d)(3)(i). As discussed with respect to 
Sec.  26.107(b), donor conduct that clearly and unequivocally 
demonstrates an attempt to alter a specimen may include, but is not 
limited to, possession of a urine specimen before the collection has 
occurred; possession of a vial, or vials, filled with chemicals that 
are subsequently determined to be urine or an adulterant; possession of 
a heating element; or evidence that the coloring agent used by the 
licensee or other entity in a source of standing water at the 
collection site (see Sec.  26.87(e)(1)) discolors the specimen.
    Section 26.115(a)(4) updates former Section 2.4(f)(4) in Appendix A 
to Part 26. The former provision permitted

[[Page 17072]]

directly observed collections if a donor had previously been determined 
to have engaged in substance abuse and the specimen was being collected 
as part of a rehabilitation program and/or pre-access testing following 
a confirmed positive test result. This paragraph updates the former 
requirement by adding a cross-reference to Sec.  26.69 [Authorization 
with potentially disqualifying fitness-for-duty information], which 
establishes requirements for granting or maintaining the authorization 
of an individual about whom potentially disqualifying FFD information 
has been discovered or disclosed. Several provisions in Sec.  26.69 
permit or require directly observed collections, including Sec.  
26.69(b)(5), which requires specimens to be collected under direct 
observation for pre-access drug testing of individuals who have been 
subject to sanctions under the rule. For organizational clarity, this 
paragraph replaces the former requirement with a cross-reference to 
Sec.  26.69, rather than repeat the applicable requirements in this 
section.
    Section 26.115(b) amends the requirement in former Section 
2.4(g)(25) in Appendix A to Part 26 that the collector must obtain 
permission from a ``higher level supervisor'' before conducting a 
directly observed collection, as discussed with respect to Sec.  
26.115(a). The NRC has added the second sentence of this paragraph to 
require that, once the decision has been made to conduct a directly 
observed collection based on a reason to believe that the donor may 
alter a specimen, the collection must occur as soon as reasonably 
practical. Although the NRC is not aware of any occasions in Part 26 
programs in which a directly observed collection has been unreasonably 
delayed, the new requirement ensures that test results from the 
directly observed collection provide information about the presence or 
absence of drugs and drug metabolites in the donor's urine. If a 
collection is delayed for a day or more, metabolism may cause the 
concentration of drugs and drug metabolites in the donor's urine, if 
any are present, to fall below the cutoff levels established in this 
part or by the FFD program and, therefore, not be detected by testing. 
Positive, adulterated, substituted, or invalid test results from a 
specimen collected under direct observation provide evidence to support 
a conclusion that the individual had attempted to subvert the testing 
process in order to mask drug abuse, whereas negative test results may 
counter the reason to believe that the individual had attempted to 
subvert the testing process. Therefore, conducting the directly 
observed collection as soon as reasonably practical ensures that test 
results from the specimen provide relevant and useful information. The 
requirement is also consistent with those of other relevant Federal 
rules and guidelines.
    The agency added Sec.  26.115(c) to require the collector to inform 
the donor of the reason(s) for the directly observed collection so that 
the donor is aware of the nature of the concern that has initiated a 
directly observed collection. The final rule includes this requirement 
for two reasons: (1) knowing the reason for a directly observed 
collection may increase a donor's willingness to cooperate in the 
procedure in order to counter the reason to believe that the donor has 
or may attempt to alter the specimen, and (2) informing the donor of 
the reason for a directly observed collection meets Goal 7 of this 
rulemaking to protect the privacy and other rights (including due 
process) of individuals who are subject to Part 26 by ensuring that the 
donor is aware of the concern that has initiated the collection. This 
paragraph also meets Goal 1 of this rulemaking by improving consistency 
with the requirements of other relevant Federal rules and guidelines.
    The NRC added Sec.  26.115(d) to establish recordkeeping 
requirements related to the directly observed collection. This 
provision requires the collector to record on the specimen's custody-
and-control form that the specimen was collected under direct 
observation and the reason(s) for the directly observed collection. 
This requirement ensures that the HHS-certified laboratory and the MRO 
have this information available when the specimen is tested and the MRO 
conducts his or her review of the test results, as is required under 
Sec.  26.185. This information is important in an MRO's decision to 
request the laboratory to test a specimen that appeared to have been 
diluted, as permitted under Sec.  26.185(g)(2), in order to compare the 
results from testing the dilute specimen with those obtained from 
testing the specimen that was collected under direct observation. 
Positive, adulterated, substituted, or invalid test results from the 
dilute specimen and the presence of the same drugs or drug metabolites 
in the specimen collected under direct observation provide evidence 
that the donor diluted the first specimen in an attempt to mask drug 
use. This section is also consistent with the requirements of other 
relevant Federal rules and guidelines.
    Section 26.115(e) retains and combines the former requirements in 
Sections 1.2, 2.4(b), 2.4(g)(14), (g)(17), and (g)(25) in Appendix A to 
Part 26. These provisions required that the individual who observes the 
specimen collection must be of the same gender as the donor. Consistent 
with the former requirements, the final rule permits another individual 
of the same gender to serve as the observer if a qualified urine 
collector of the same gender is not available as long as the observer 
receives the instructions specified in Sec.  26.115(f). The final rule 
combines the former requirements in this paragraph for organizational 
clarity.
    The NRC added Sec.  26.115(f) to specify the procedures that must 
be followed in conducting a directly observed collection by either a 
qualified collector or an individual of the same gender who may serve 
as the observer. These more detailed procedures are necessary because 
devices and techniques to subvert the testing process have been 
developed since Part 26 was first published that can be used under 
direct observation without detection. Therefore, the agency made these 
changes to increase the likelihood of detecting attempts to subvert the 
testing process and, thereby, increase the effectiveness of directly 
observed collections in assuring that a valid specimen is obtained from 
the donor.
    The NRC added Sec.  26.115(f)(1) to specify that the observer must 
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. This 
requirement ensures that the observer is able to detect the use of an 
anatomically correct urine delivery device.
    The agency added Sec.  26.115(f)(2) to specify the action to be 
observed during the collection. This paragraph is consistent with the 
requirements of other Federal agencies and is intended to ensure that 
the urine specimen is obtained from the donor's body.
    The rule adds Sec.  26.115(f)(3) to prohibit an observer who is not 
the collector from touching the specimen container. The new provision 
is consistent with the related requirements of other Federal agencies 
and is intended to protect the observer from any potential claims by a 
donor that the observer had altered the specimen.
    The new Sec.  26.115(f)(4) requires the collector to record the 
observer's name on the custody-and-control form if the observer is not 
the collector. This mandate is consistent with the related requirements 
of other Federal agencies

[[Page 17073]]

and is intended to ensure that the observer's identity is documented 
should future questions arise regarding the collection.
    The NRC added Sec.  26.115(g) to clarify that a donor's refusal to 
participate in the directly observed collection constitutes a refusal 
to test and, therefore, is considered to be an act to subvert the 
testing process under Sec.  26.75(b). Former Section 2.4(j) in Appendix 
A to Part 26 required the collector to inform the MRO, and the MRO to 
inform licensee management, if a donor failed to cooperate with the 
specimen collection process, including, but not limited, to a refusal 
to provide a complete specimen, complete paperwork, or initial the 
specimen bottles. The former requirement did not specifically mention 
that a refusal to participate in a directly observed collection is also 
an instance of a failure to cooperate. In addition, the former rule did 
not require the licensee or other entity to impose sanctions on a donor 
for refusing to be tested. Therefore, the final rule adds a provision 
that both clarifies the NRC's original intent by stating that a refusal 
to participate in a directly observed collection constitutes a refusal 
to test and updates the former requirement by adding a cross-reference 
to the sanction of permanent denial of authorization that is required 
under Sec.  26.75(b).
    The agency added Sec.  26.115(h) to specify the actions that a 
collector must take if a directly observed collection was required but 
not performed. The collector must report the omission to the FFD 
program manager or designee, who ensures that a directly observed 
collection is immediately performed. Although the concentrations of any 
drugs, drug metabolites, or blood alcohol in the donor's specimens may 
fall below the cutoff levels that are specified in this part or in the 
licensee's or other entity's FFD policy if several days have elapsed 
since the directly observed collection should have occurred, testing a 
specimen collected several days later increases the likelihood of 
detecting any subsequent drug or alcohol use. In addition, the 
metabolites from using some drugs, such as marijuana, linger in an 
individual's body. Therefore, conducting a directly observed collection 
may result in detecting these metabolites. However, because elapsed 
time reduces the concentrations of drugs, drug metabolites, or alcohol 
in the donor's specimens, the final rule requires a directly observed 
collection to be performed immediately. This section uses the term 
``immediately'' to indicate that the licensee or other entity may be 
required to call in the donor and a collector to perform the directly 
observed collection, if the donor and collectors are not on site when 
the oversight is identified. This requirement increases consistency 
with the related requirements of other Federal agencies and is intended 
to provide instructions for correcting an oversight that the former 
rule did not address.
Section 26.117 Preparing Urine Specimens for Storage and Shipping
    A new Sec.  26.117 reorganizes and presents together in one section 
former requirements for safeguarding specimens and preparing them for 
transfer from the collection site to the licensee's testing facility or 
the HHS-certified laboratory for testing. The NRC made this 
organizational change because requirements that address these topics 
were dispersed throughout the former rule and grouping them together in 
a single section in the final rule makes them easier to locate.
    Section 26.117(a) amends former Section 2.4(g)(20) in Appendix A to 
Part 26, which required the donor and collector to maintain visual 
contact with specimens until they were sealed and labeled. The final 
rule eliminates reference to blood specimens because donors are no 
longer permitted to request blood testing for alcohol under the final 
rule, as discussed with respect to Sec.  26.83(a). The new paragraph 
also amends the requirements in the second sentence of the former 
provision. For organizational clarity, the final rule moves to Sec.  
26.113 [Splitting the urine specimen] procedural requirements for 
observing the splitting of a specimen and sealing the split specimen 
bottles. However, this provision broadens the former requirement, which 
addressed only split specimens, to require the donor to observe the 
transfer of any specimen or aliquot that the collector transfers to a 
second container and the sealing of the container(s). This requirement 
is necessary because some FFD programs who operate licensee testing 
facilities may transfer an aliquot of the urine specimen to a second 
container for initial testing at the licensee testing facility, while 
preserving the primary specimen in the first or another container. The 
final rule requires the donor to observe these actions to ensure that 
the specimen or aliquot(s) that are transferred belong to the donor and 
that the identity and integrity of the specimen are maintained.
    Section 26.117(b) retains former Section 2.4(g)(21) in Appendix A 
to Part 26. This provision requires the donor and collector to remain 
present while the procedures for sealing and preparing the specimen 
(and aliquots, if applicable) for transfer are performed.
    Section 26.117(c) retains the meaning of former Section 2.4(g)(22) 
in Appendix A to Part 26. This provision establishes requirements for 
labeling and sealing the specimen(s), but the final rule splits the 
former requirement into several sentences for increased clarity in the 
language of the provision.
    For organizational clarity, Sec.  26.117(d) retains and combines 
former Section 2.4(g)(23) and 2.4(g)(23)(i) in Appendix A to Part 26. 
These provisions required the donor to certify that the specimen was 
collected from him or her. However, the final rule deletes former 
Section 2.4(g)(23)(ii), which required the donor to have an opportunity 
to list on the custody-and-control form any medications he or she had 
taken within the past 30 days for the reasons discussed with respect to 
Sec.  26.89(b)(3).
    The final rule deletes former Section 2.4(g)(24) in Appendix A to 
Part 26, which required the collector to enter into the permanent 
record book all information identifying the specimen. The agency 
eliminated this requirement because the final rule no longer requires 
collection sites to maintain a permanent record book, consistent with 
the elimination of the requirement to maintain a permanent record book 
in the HHS Guidelines. Collection sites are permitted to use other 
means of tracking specimen identity, including, but not limited to, bar 
coding.
    Section 26.117(e) amends former Section 2.4(g)(26) in Appendix A to 
Part 26. The former provision required the collector to complete the 
chain-of-custody forms for both the aliquot and the split sample and 
certify proper completion of the collection. The final rule eliminates 
reference to the aliquot and split sample in the former section to 
clarify the intent of this requirement, which is that the collector 
must complete the appropriate chain-of-custody forms for all of the 
sealed specimen and aliquot containers, not simply those resulting from 
a split specimen procedure. For example, if an FFD program follows 
split specimen procedures and conducts initial testing at a licensee 
testing facility, the donor's urine specimen may be divided into Bottle 
A, Bottle B, and another container that would be used for tests at the 
licensee testing facility. This section retains the former requirement 
for the collector to certify proper completion of the collection.
    Section 26.117(f) amends former Section 2.4(g)(27) in Appendix A to 
Part 26. The former provision stated that the specimens and chain-of-
custody forms

[[Page 17074]]

``are now ready for transfer'' and must be appropriately safeguarded if 
they are not immediately prepared for shipment. The final rule replaces 
the first sentence of the former provision, which stated that the 
specimens and forms are ready for transfer, with a requirement for the 
collector to package the specimens and forms for transfer to the HHS-
certified laboratory or licensee testing facility. This change improves 
the clarity in the rule's language because it is necessary for the 
collector to package the specimens and chain-of-custody forms for 
transfer before they are ready to be transferred. This section retains 
the second sentence of the former provision.
    Section 26.117(g) retains former Section 2.4(g)(28) in Appendix A 
to Part 26. This provision requires the collector to maintain control 
of the specimens and custody documents and ensure they are secure, if 
he or she must leave the workstation or collection site for any reason. 
The final rule makes minor editorial changes to some of the terminology 
used in the former section for consistency with the terminology used 
throughout the final rule, as discussed with respect to Sec.  26.5 
[Definitions], but retains the intended meaning of the former 
requirements.
    Section 26.117(h) retains the requirements in former Section 
2.4(c)(2) in Appendix A to Part 26 related to maintaining specimen 
security until the specimens are sent from the collection site to the 
licensee testing facility or the HHS-certified laboratory for testing. 
For organizational clarity, the NRC moved the former paragraph to this 
section of the final rule because requirements for maintaining specimen 
security apply at this point in the specimen collection process. 
Likewise, the agency has moved the portion of the former section that 
applies to situations in which it is impractical to maintain continuous 
physical security of a collection site to Sec.  26.87(f)(5) because 
Sec.  26.87(f) addresses those circumstances.
    Section 26.117(i) updates the specimen packaging requirements in 
former Section 2.7(i) in Appendix A to Part 26 by replacing the former 
section with the related provision from the HHS Guidelines. For 
organizational clarity, the rule moves Sec.  26.117(j) to the first 
sentence of the former section, which directs collection site personnel 
to arrange to transfer the specimens to the licensee testing facility 
or HHS-certified laboratory. Section 26.117(j) addresses transfer and 
storage requirements, while Sec.  26.117(i) addresses packaging 
requirements. This section also eliminates the initial phrases in the 
second sentence of the former provision, which listed the conditions 
under which specimens were transferred offsite (e.g., shipping 
specimens that test as ``presumptive positive'' on initial testing at 
the licensee testing facility, special processing of suspect 
specimens), because they are redundant with other portions of the final 
rule. For organizational clarity, the rule moves new requirements 
related to transferring specimens from a licensee testing facility to 
an HHS-certified laboratory for further testing to Sec.  26.129(g) in 
Subpart F. The final rule also eliminates the third sentence of the 
former section, which required the collector to sign and date the tape 
used to seal the container. The NRC eliminated this requirement because 
licensees and other entities now transfer specimens using courier 
services who offer other means of tracking the sender and the date that 
a container of specimens is shipped. Program experience has shown these 
other means to be equally effective. This new section retains the 
intended meaning of the former requirements for the collector to place 
the specimens in a second container that minimizes the possibility of 
damage during shipment and seal them so that tampering will be 
detected. At the request of stakeholders during the public meetings 
discussed in the preamble to the proposed rule, the final rule adds 
shipping bags to the former set of examples of acceptable shipping 
containers that protect the specimens from damage. Also at the request 
of stakeholders, the final rule deletes the last sentence of the former 
section, which required the collector to ensure that chain-of-custody 
documents were attached to the container used to ship the specimens to 
the licensee testing facility or laboratory. The stakeholders requested 
this change because their practice is to seal a specimen's custody-and-
control documentation inside the shipping container to ensure that it 
cannot be altered. The NRC endorses this practice as providing greater 
protection for donors and, therefore, adopts this change.
    Section 26.117(j) amends and combines the first sentence of former 
Section 2.4(i) in Appendix A to Part 26 with the requirements 
applicable to the short-term storage of specimens at collection sites 
in former Section 2.7(c) in Appendix A to Part 26. The NRC moved to 
this section the first sentence of former Section 2.4(i) in Appendix A 
to Part 26 for the reasons discussed with respect to Sec.  26.117(i). 
Under this section, as a result of advances in testing technologies, 
the rule no longer requires short-term refrigerated storage of 
specimens within 6 hours of collection. However, the final rule 
continues to require licensees and other entities to protect specimens 
from any conditions that could cause specimen degradation. Collection 
site personnel are required to refrigerate specimens that are not 
transferred or shipped to the licensee testing facility or the HHS-
certified laboratory within 24 hours of collection. The final rule also 
requires that any specimens that may have been substituted or 
adulterated must be refrigerated as soon as they are collected because 
some adulterants may interfere with drug testing results unless the 
specimen is refrigerated. The final rule establishes a time limit of 2 
business days for receipt of specimens at the licensee testing facility 
or HHS-certified laboratory after shipment from the collection site to 
further protect against potential specimen degradation.
    Section 26.117(k) amends the portions of former Section 2.4(h) in 
Appendix A to Part 26 that required a specimen's custody-and-control 
form to identify every individual in the chain of custody. The final 
rule does not require couriers to meet the requirements in former 
Section 2.4(h), which stated that each time a specimen is handled or 
transferred, the date and purpose of the transfer must be documented on 
the chain-of-custody form and every individual in the chain of custody 
must be identified. Couriers are not required to meet these 
requirements because custody-and-control forms for individual specimens 
are packaged inside the shipping container, where they are inaccessible 
to couriers, so that it is impractical to expect them to sign the forms 
when handling the specimen shipping containers. This new paragraph 
codifies licensees' and other entities' practice of relying on courier 
services' normal package tracking systems to maintain accountability 
for specimen shipping containers, which is consistent with the HHS 
Guidelines and standard forensic practices. The final rule also 
eliminates the former requirement, contained in the last sentence of 
Section 2.4(h) in Appendix A to Part 26, to minimize the number of 
persons handling specimens because this requirement cannot be enforced.
Section 26.119 Determining ``Shy'' Bladder
    The agency has adapted a new Sec.  26.119 from the DOT Procedures 
at 49 CFR 40.193 [What happens when an employee does not provide a 
sufficient amount of urine for a drug test?] to specify procedures for 
determining whether a donor who does not provide a urine specimen of 30 
mL within the 3 hours that is permitted for a specimen

[[Page 17075]]

collection is refusing to test or has a medical reason for being unable 
to provide the required 30 mL specimen. This new section responds to 
stakeholder requests during public meetings discussed in the preamble 
to the proposed rule. The stakeholders reported that some donors have 
had difficulty providing the minimum 60 mL of urine required in former 
Section 2.4(g)(11) for medical reasons, but the former rule did not 
establish procedures for handling such circumstances. As a result, some 
FFD programs have adopted the DOT ``shy bladder'' procedures, but 
stakeholders preferred that the final rule incorporate the requirements 
to (1) clarify that the NRC accepts the procedures, (2) inform donors 
of the procedures that they are required to follow if they have medical 
reasons for being unable to provide a sufficient quantity of urine for 
testing, (3) enhance consistency among Part 26 programs, and (4) 
enhance the consistency of Part 26 procedures with the procedures that 
collectors must follow when conducting tests under DOT requirements. 
The NRC expects that fewer donors will be subject to ``shy bladder'' 
problems under the final rule because Sec.  26.109 reduces the minimum 
quantity of urine required from 60 mL in the former rule to 30 mL. 
However, because some donors' medical problems may also interfere with 
their ability to provide 30 mL of urine, the final rule incorporates 
the DOT procedures. These procedures are intended to protect the due 
process rights of individuals who are subject to Part 26. That is, this 
section establishes procedures for ensuring that there is a legitimate 
medical reason that a donor was or is unable to provide a urine 
specimen of the required quantity so that the licensee or other entity 
has a medical basis for not imposing sanctions on the individual. In 
addition, the MRO is authorized to devise alternative methods of drug 
testing, if it appears that the donor's medical problem prevents him or 
her from being able to provide sufficient urine for drug testing in 
future tests.
    The agency has added Sec.  26.119(a) to require that a licensed 
physician, who has appropriate expertise in the medical issues raised 
by the donor's failure to provide a sufficient specimen, must evaluate 
a donor who was unable to provide a urine specimen of at least 30 mL. 
The rule permits the MRO to perform the evaluation if the MRO possesses 
the appropriate expertise. If not, the rule requires the MRO to review 
the qualifications of the physician and agree to the selection of that 
physician. These requirements for the physician who performs the 
evaluation to be qualified in the relevant medical issues ensure that 
the results of the evaluation are valid.
    This section also requires that the evaluation must be completed 
within 5 calendar days of the unsuccessful collection. The agency has 
established the time limit of 5 calendar days as a trade off between 
the need to provide the donor with sufficient time to locate a 
qualified physician, obtain an appointment, and for the physician to 
complete the evaluation (i.e, the donor's right to due process), and 
the public's interest in a rapid determination of whether the donor had 
attempted to subvert the testing process by refusing to provide a 
sufficient specimen. DOT's experience indicates that 5 days is 
sufficient to complete the evaluation.
    The final rule adds Sec.  26.119(b) to specify the information that 
the MRO must provide to the physician who is selected to perform the 
evaluation if the MRO does not perform it. Sections 26.119(b)(1) and 
(b)(2) require the MRO to inform the physician that the donor was 
required to take a drug test under Part 26 but was unable to provide a 
sufficient quantity of urine for testing and explain the potential 
consequences to the donor for a refusal to test. These requirements 
ensure that the evaluating physician understands the context in which 
he or she is being asked to perform the evaluation. Section 
26.119(b)(3) also requires the MRO to inform the physician that he or 
she must agree to follow the procedures specified in Sec.  26.119(c) 
through (f) if he or she performs the evaluation. This requirement 
ensures that the physician understands and consents to follow the 
procedures specified in this section.
    The NRC added Sec.  26.119(c) to describe the conclusions that the 
physician must provide to the MRO following the evaluation. Under Sec.  
26.119(c)(1), the physician may determine that a medical condition has, 
or with a high degree of probability could have, precluded the donor 
from providing the required quantity of urine. Or, under Sec.  
26.119(c)(2), the physician may determine that there is an inadequate 
basis for determining that a medical condition has, or with a high 
degree of probability could have, precluded the donor from providing a 
sufficient quantity of urine. The final rule limits the physician's 
conclusions to one of these two alternatives to ensure that the results 
of the evaluation are relevant to and useful for determining whether 
sanctions must be imposed on the donor for a refusal to test.
    The agency added Sec.  26.119(d) to define the physical and 
psychological conditions that constitute a medical condition that could 
have precluded the donor from providing a 30-mL specimen as well as to 
provide examples of conditions that do not constitute a legitimate 
medical condition. Legitimate medical conditions include an 
ascertainable physiological condition (e.g., a urinary system 
dysfunction) or a medically documented pre-existing psychological 
disorder that precluded the donor from providing a 30-mL specimen. 
Unsupported assertions of ``situational anxiety'' or dehydration are 
examples of conditions that could not be considered legitimate medical 
conditions. The final rule adds this section to provide necessary 
guidance to the evaluating physician.
    The final rule adds Sec.  26.119(e) to require the evaluating 
physician to provide a written statement of his or her findings and 
conclusion from the evaluation. By implication, if the MRO performs the 
evaluation, the MRO provides this written statement. The written 
statement is necessary to communicate the results of the evaluation and 
create a record of it, should any question arise later with respect to 
the determination.
    This section also requires that the physician must provide only the 
information that is necessary to support the physician's conclusion. 
The NRC has added this requirement to protect the donor's privacy by 
ensuring that the physician documents only the medical information that 
is necessary to support the determination.
    The NRC added Sec.  26.119(f) to require the physician to inform 
the MRO, in the written statement, whether any medical condition that 
may be identified also precludes the donor from providing specimens of 
30 mL or more in future collections. This information is necessary for 
the MRO to determine whether to implement alternative methods of drug 
testing for the donor, as required under Sec.  26.119(g)(3).
    The agency added Sec.  26.119(g) to prescribe the actions that the 
MRO must take based on the results of the evaluation, as follows:
    Section 26.119(g)(1) requires the MRO to determine that the donor 
did not violate the FFD policy, if the physician concluded that a 
medical condition could account for the insufficient specimen and the 
MRO concurred with that conclusion. In this instance, the licensee or 
other entity does not impose sanctions on the donor because the donor 
had not violated the FFD policy by refusing to test.

[[Page 17076]]

    Section 26.119(g)(2) requires the MRO to determine that the donor 
had refused to be tested by failing to provide a sufficient specimen, 
if the physician concluded that a medical condition could not account 
for the insufficient specimen. In this instance, the licensee or other 
entity imposes the sanction of a permanent denial of authorization for 
an attempt to subvert the testing process, as required under Sec.  
26.75(b).
    Section 26.119(g)(3) requires the MRO to devise an alternative 
method of collecting specimens for drug testing, if the donor's medical 
condition, over the long-term, consistently prevents the donor from 
providing urine specimens of 30 mL or more. For example, the provision 
permits the MRO to direct the collection and testing of alternate 
specimens, including, but not limited to, hair, or other bodily fluids, 
if, in the MRO's professional judgment, the collection and analysis of 
these alternate specimens is scientifically defensible and forensically 
sound. The section grants flexibility to the MRO in exercising his or 
her professional judgment in determining an alternative method of 
conducting drug testing, rather than establishing detailed requirements 
that may not appropriately address the range of possible medical 
conditions that could arise.

Subpart F--Licensee Testing Facilities

    In this subpart, the final rule replaces two terms used in the 
proposed rule in response to public comments. These language changes 
affect numerous sections within Subpart F. First, one public comment 
addressed a proposed provision in Sec.  26.137(b) [Performance testing 
and quality control requirements for validity screening tests] that 
permitted licensee testing facilities to use validity screening tests 
approved by the U.S. Food and Drug Administration (FDA). The NRC has 
eliminated both the requirement and the use of the term ``device'' with 
respect to validity screening testing because the FDA is not 
responsible for approving validity screening devices. The final rule 
has replaced the term ``device'' in ``validity screening device'' with 
the term ``test'' throughout Subpart F. Second, several public comments 
addressed the use of the term ``non-negative'' to refer to drug and 
validity test results and requested that the NRC eliminate the term 
from the final rule and instead use a more familiar term such as 
``positive'' test result. Throughout Subpart F, the NRC has replaced 
the term ``non-negative'' with a new term to address validity screening 
and initial validity testing results from a licensee testing facility 
that indicate that a specimen may be adulterated, substituted, dilute, 
or invalid. The new term used for these validity testing results is 
``questionable validity.'' The NRC has added a definition for 
``questionable validity'' to Sec.  26.5 [Definitions]. Adding the term 
``questionable validity'' addresses the commenters' concern and 
improves the clarity of the final rule to meet Goal 6 of this 
rulemaking. The NRC retained the use of ``positive'' to refer to 
results from initial testing for drugs that indicate the presence of a 
prohibited drug in the specimen.
Section 26.121 Purpose
    The NRC added Sec.  26.121 to provide an overview of the contents 
of the proposed subpart, consistent with Goal 6 of this rulemaking to 
improve clarity in the organization and language of the final rule.
Section 26.123 Testing Facility Capabilities
    Section 26.123 amends the second sentence of former Section 
2.7(l)(2) in Appendix A to Part 26 as it related to the capabilities of 
licensee testing facilities. The final rule retains the former 
requirement for licensee testing facilities to be capable of performing 
initial tests for each drug and drug metabolite for which testing is 
conducted by the FFD program and adds a requirement for licensee 
testing facilities to have the capability to perform either validity 
screening tests, initial validity tests, or both. The agency moved the 
first sentence of former Section 2.7(l)(2), which established 
requirements for the capabilities of HHS-certified laboratories, to 
Subpart G [Laboratories Certified by the Department of Health and Human 
Services]. The NRC deleted the last sentence of the former paragraph, 
which permitted the testing of breath specimens for alcohol at the 
collection site, because the final rule addresses alcohol testing in 
Subpart E [Collecting Specimens for Testing]. The NRC made these 
changes to the former provision to meet Goal 6 of this rulemaking to 
improve organizational clarity in the final rule.
Section 26.125 Licensee Testing Facility Personnel
    Section 26.125 amends former Section 2.6 in Appendix A to Part 26 
[Licensee testing facility personnel], as follows:
    Section 26.125(a) retains former Section 2.6(a) in Appendix A to 
Part 26. This provision requires each licensee testing facility to have 
one or more individuals who are responsible for the day-to-day 
operations of the facility and establishes requirements for those 
individuals' qualifications. The final rule makes minor changes in the 
former provision to improve consistency with amended language in the 
related portion of the HHS Guidelines.
    Section 26.125(b) amends former Section 2.6(b) in Appendix A to 
Part 26. This provision required laboratory technicians and 
nontechnical staff to have the necessary training and skills for the 
tasks assigned to them. The final rule retains the former provision and 
adds another. The final rule requires laboratory technicians who 
perform urine specimen testing to demonstrate proficiency in operating 
the instruments and tests used at the licensee testing facility. The 
NRC added this proficiency requirement to ensure that technicians are 
capable of correctly using the instruments and tests that the licensee 
testing facility has selected for validity and drug testing. This 
change is necessary for several reasons. First, the final rule adds new 
requirements for licensee testing facilities to conduct validity 
testing, and the instruments and tests that the technicians will use 
are likely to differ from those previously used at licensee testing 
facilities. Therefore, additional training and proficiency testing is 
required to ensure that validity testing is conducted properly. Second, 
the final rule permits licensees and other entities to rely on drug 
test results from testing that was performed by another Part 26 program 
to a greater extent than the former rule. Therefore, it is necessary to 
ensure that all drug testing performed under Part 26, including tests 
performed at licensee testing facilities, meets minimum standards. The 
requirement for technicians to demonstrate proficiency, then, 
contributes to meeting this goal. Third, the experience of other 
Federal agencies has shown that requirements for technicians to 
demonstrate proficiency assist in any litigation that may occur with 
respect to urine test results.
    With respect to the proposed rule and in response to a public 
comment that proficiency documentation requirements were missing from 
the proposed rule in several locations, the final rule adds a 
requirement for licensee testing facilities to document the proficiency 
of its technicians. Although proposed Sec.  26.125(c) required licensee 
testing facility personnel files to include documentation of training 
and experience and the results of tests that establish employee 
competency for the position he or she holds, the final rule adds a 
requirement for documentation of proficiency in Sec.  26.125(b) to 
further clarify that this documentation is required and

[[Page 17077]]

specifically applies to laboratory technicians who perform urine drug 
testing. The NRC made this change to meet Goal 6 of this rulemaking to 
improve clarity in the organization and language of the rule.
    Section 26.125(c) amends former Section 2.6(c) in Appendix A to 
Part 26. The provision establishes recordkeeping requirements for the 
personnel files of licensee testing facility staff. The final rule, 
with respect to the proposed rule, further clarifies the intent of the 
licensee testing facility personnel competency requirements by 
specifying that personnel must be proficient in conducting testing 
using the most recent instructions from instrument and test 
manufacturers. In addition, in response to comments received on the 
elimination of the former provision in Section 2.5(f) in Appendix A to 
Part 26 that required licensees and other entities to maintain color 
blindness testing records in files for licensee testing facility 
personnel, the final rule reinstates the requirement. The final rule 
retains the color blindness testing recordkeeping requirement because 
some validity screening and initial validity tests require laboratory 
testing facility personnel to visually evaluate the color of the assay 
to determine the test result. Retaining records of color blindness 
testing is necessary to demonstrate licensee testing facility personnel 
competency.
Section 26.127 Procedures
    Section 26.127 combines, reorganizes, and amends requirements for 
procedures that were interspersed throughout Appendix A to Part 26, 
including requirements in former Sections 2.2 [General administration 
of testing] and 2.7 [Laboratory and testing facility analysis 
procedures]. These changes improve clarity in the organization of the 
final rule by grouping procedural requirements for licensee testing 
facilities in one section, consistent with Goal 6 of this rulemaking.
    Section 26.127(a) makes minor editorial changes to the first 
sentence of former Section 2.2 in Appendix A to Part 26. The former 
provision required licensee testing facilities and HHS-certified 
laboratories to have detailed procedures for conducting testing. The 
final rule deletes the reference to blood samples in the former 
provision because donors no longer have the option to request blood 
testing for alcohol, as discussed with respect to Sec.  26.83(a). For 
organizational clarity, the final rule moves the reference to HHS-
certified laboratories to Sec.  26.157(a) in Subpart G. The final rule 
also deletes the former reference to procedures for specimen 
collections in this paragraph because procedural requirements for 
specimen collections are addressed in Subpart E.
    Section 26.127(b) amends and combines portions of the requirements 
in the first sentence of former Section 2.4(d) and 2.7(a)(2) in 
Appendix A to Part 26 related to the content and implementation of 
specimen chain-of-custody procedures. The final rule retains the 
portions of the former provisions that required licensee testing 
facilities to develop, implement, and maintain written chain-of-custody 
procedures to maintain control and accountability of specimens from 
receipt through completion of testing and reporting of results, during 
storage and shipping to the HHS-certified laboratory, and continuing 
until final disposition of the specimens. For organizational clarity, 
the NRC moved the former requirements related to HHS-certified 
laboratories to Sec.  26.157(b) in Subpart G. The final rule also 
removes references to custody-and-control procedures for blood 
specimens because donors no longer have the option to request blood 
testing for alcohol, as discussed with respect to Sec.  26.83(a).
    Section 26.127(c) retains the portions of former Section 2.7(o)(1) 
in Appendix A to Part 26 that addressed the required content of 
procedures for licensee testing facilities and amends the former 
requirements. The final rule retains the portions of the former 
provision that required licensee testing facilities to develop and 
maintain procedures to specify all of the elements of the testing 
process, including, but not limited to, the principles of each test and 
the preparation of reagents, standards, and controls. The final rule 
presents the required topics of the procedures in a list format in 
Sec.  26.127(c)(1)-(c)(12) to clarify that each topic stands on its own 
and to meet Goal 6 of this rulemaking to improve clarity in the 
organization of the rule.
    Section 26.127(c) also amends former Section 2.7(o)(1) in Appendix 
A to Part 26 in several ways. First, the final rule eliminates the 
former requirement for the procedures to be maintained in a laboratory 
manual as unnecessarily restrictive. The final rule permits licensee 
testing facilities to use other means to maintain their procedures. 
Second, the agency has added a requirement for the development, 
implementation, and maintenance of written standard operating 
procedures for all laboratory instruments and validity screening tests, 
consistent with the addition of requirements to conduct validity 
testing throughout the final rule. Third, the final rule moves two 
portions of the former provision to other subparts of the rule that 
address related topics to improve clarity in the organization and 
language of the final rule, as follows: The agency relocated the last 
two sentences of former Section 2.7(o)(1) in Appendix A to Part 26, 
which addressed requirements for retaining copies of superceded 
procedures, to Sec.  26.715(a) of Subpart N [Recordkeeping and 
Reporting Requirements], and the final rule moves procedural 
requirements for HHS-certified laboratories to Sec.  26.157(b) in 
Subpart G.
    Section 26.127(d) amends former Section 2.7(o)(3)(iii) in Appendix 
A to Part 26. This provision required procedures for the setup and 
normal operation of testing instruments, a schedule for checking 
critical operating characteristics for all instruments, tolerance 
limits for acceptable function checks, and instructions for major 
troubleshooting and repair. The final rule extends the former 
requirements to non-instrumented tests (such as some validity screening 
tests, if the licensee testing facility uses these tests), consistent 
with the addition of requirements to conduct validity testing 
throughout the final rule. The final rule also makes three 
organizational changes to the former provision. The final rule presents 
the required topics of the procedures in a list format in Sec.  
26.127(d)(1)-(d)(3) to clarify that each topic stands on its own. The 
NRC relocated the former requirement to maintain records of 
preventative maintenance to Sec.  26.715(b)(10) in Subpart N. And, the 
NRC has moved the former requirements that applied to HHS-certified 
laboratories to Sec.  26.157(d) in Subpart G. These changes improve 
clarity in the organization of the rule, consistent with Goal 6 of this 
rulemaking.
    Section 26.127(e) reorganizes and amends former Section 2.7(o)(4) 
in Appendix A to Part 26. The former provision required corrective 
actions to be documented if systems are out of acceptable limits or 
errors are detected. The final rule extends the former requirement to 
validity screening tests if the licensee testing facility uses these 
tests, consistent with the addition of requirements to conduct validity 
testing throughout the final rule. The final rule, with respect to the 
proposed rule, also adds the term ``instrumented'' to clarify that a 
licensee testing facility must develop and implement procedures for 
remedial actions on testing facility equipment, instruments, and tests. 
The NRC has moved the requirements in the former paragraph that applied 
to HHS-

[[Page 17078]]

certified laboratories to Sec.  26.157(e) in Subpart G for 
organizational clarity.
Section 26.129 Assuring Specimen Security, Chain of Custody, and 
Preservation
    Section 26.129 has been added to group together in one section the 
requirements of the final rule that apply to licensee testing 
facilities with respect to the safeguarding of specimen identity, 
integrity, and security. The NRC made this organizational change 
because requirements that addressed these topics were dispersed 
throughout the former rule. Grouping them together in a single section 
makes them easier to locate within the final rule and meets Goal 6 of 
this rulemaking to improve clarity in the language and organization of 
the rule.
    Section 26.129(a) retains the first four sentences of former 
Section 2.7(a)(1) in Appendix A to Part 26. The provision requires 
licensee testing facilities to be secure and accessible only to 
authorized personnel. The final rule moves the requirements in the 
former provision that applied to HHS-certified laboratories to Sec.  
26.159(a). The final rule moves the last sentence of the former 
paragraph, which established recordkeeping requirements, to Sec.  
26.715(b)(13) in Subpart N. The NRC made these changes for 
organizational clarity.
    Section 26.129(b) amends former Section 2.7(b)(1) in Appendix A to 
Part 26. This provision established requirements for receiving 
specimens at the licensee testing facility and assuring their integrity 
and identity. For organizational clarity, the final rule moves the 
former requirements related to HHS-certified laboratories to Sec.  
26.159(b) in Subpart G. The final rule, with respect to the proposed 
rule, adds Sec.  26.129(b)(1) and (b)(2) to improve the clarity of the 
organization of the rule. The NRC has also added several requirements 
to the former provision, as follows:
    In Sec.  26.129(b), the final rule retains the requirement for 
licensee testing facility personnel to inspect specimens received for 
testing to determine whether there is any evidence of tampering with 
the specimens and to ensure that the custody-and-control documents are 
correct. With respect to the proposed rule, the final rule adds a 
requirement for licensee testing facility personnel to attempt to 
resolve any discrepancies in the information on specimen bottles or on 
the accompanying custody-and-control forms to ensure the identity and 
integrity of specimens and prevent specimens from being unnecessarily 
rejected for testing by the HHS-certified laboratory (if the specimen 
must be subject to additional testing) when flaws can be corrected. For 
example, if the collector's signature is missing on the custody-and-
control form, licensee testing facility personnel will work with 
collection site personnel to attempt to identify the collector and 
obtain a memorandum for the record from the collector if possible. This 
requirement reduces the potential burden on donors who may otherwise be 
required to submit additional specimens to replace those for which the 
chain of custody could not be confirmed. The final rule, with respect 
to the proposed rule, adds a provision that specifies the procedures to 
be followed by licensee testing facility personnel to correct custody-
and-control form errors that are identified after the specimen 
collection process has been completed and the donor has departed from 
the collection site. This addition is based on a comment received on 
the proposed rule requesting the addition of these procedures. The 
requirements also improve the efficiency of FFD programs by avoiding 
the need to conduct additional specimen collections when discrepancies 
can be corrected. The additional provision meets Goal 7 of this 
rulemaking to protect the privacy and other rights (including due 
process) of individuals who are subject to Part 26, as well as Goal 1 
of this rulemaking, to update and enhance the consistency of Part 26 
with advances in other relevant Federal rules and guidelines.
    Section 26.129(b)(1) adds requirements for licensee testing 
facility personnel to report to management any indications of specimen 
tampering within 8 hours of the discovery. This provision also requires 
licensee or other entity management personnel to initiate an 
investigation to determine whether tampering has occurred. Section 
26.129(b)(i) requires management to take corrective actions if 
tampering is confirmed. The final rule adds these requirements because 
some licensees did not investigate or take corrective actions in 
response to indications of tampering with specimens under the former 
rule. The appropriate corrective actions that management personnel 
would take depend on the nature of the tampering identified as a result 
of the investigation. For example, if the investigation indicated that 
the tampering was an attempt to subvert the testing process and the 
persons involved were identified, management personnel would impose the 
sanctions in Sec.  26.75(b) for a subversion attempt. This provision 
also requires management personnel to correct any systematic weaknesses 
in specimen custody-and-control procedures that may be identified in 
the investigation, such as inadequate safeguarding of specimen shipping 
containers.
    Section 26.129(b)(1)(ii) adds a prohibition on testing of any 
specimen if the licensee or other entity has reason to believe that the 
specimen was subject to tampering or altered in a manner as to affect 
specimen identity and integrity. In this circumstance, the MRO will 
cancel testing of the specimen or any test results for the specimen, 
and require the licensee or other entity to retest the donor who 
submitted the original specimen. The final rule, with respect to the 
proposed rule, adds an exception for split specimen collections in 
response to a public comment that requested additional clarification of 
the proposed rule's requirements for cancelling tests. For a split 
specimen collection, if the tamper-evident seal remains intact on 
either Bottle A or Bottle B of the specimen and the bottle contains at 
least 15 mL of urine, the final rule requires the licensee testing 
facility to forward the intact specimen to the HHS-certified laboratory 
and prohibits any testing at the licensee testing facility. This new 
provision serves to eliminate unnecessary additional specimen 
collections, thereby meeting Goal 3 of this rulemaking to improve the 
effectiveness and efficiency of FFD programs.
    The NRC added Sec.  26.129(b)(2) in the final rule, with respect to 
the proposed rule, to include specific instances that would require the 
cancellation of the testing of a donor's urine specimen. This change 
has been made in response to a public comment that requested the NRC to 
add information in the final rule to describe the actions that must be 
taken if the integrity of a specimen is in question. Adding this 
information to the final rule meets Goal 7 of this rulemaking to 
protect the privacy and other rights (including due process) of 
individuals who are subject to Part 26, as well as Goal 1 to improve 
the consistency of NRC requirements with those of other Federal 
agencies. The provisions are modeled on similar requirements in the 
DOT's drug testing program.
    Although the NRC is not aware of any instances when these 
circumstances have arisen in Part 26 programs, the experience of other 
Federal agencies indicates that specimen tampering is possible. 
Therefore, the requirements in Sec.  26.129(b) are necessary to ensure 
that donors are not subject to sanctions for positive, adulterated, 
substituted, or invalid test results from a specimen that

[[Page 17079]]

may not have been theirs. These changes meet Goal 7 of this rulemaking 
to protect the privacy and other rights (including due process) of 
individuals who are subject to Part 26 and ensure that the individuals 
are afforded accurate and consistent testing. These requirements are 
also consistent with the requirements of other Federal agencies.
    Section 26.129(c) amends former Section 2.7(b)(2) in Appendix A to 
Part 26. This provision established requirements for chain-of-custody 
procedures for specimens and aliquots at licensee testing facilities. 
The final rule moves the requirements in the former paragraph that were 
related to HHS-certified laboratories to Subpart G to improve 
organizational clarity.
    The section incorporates two additional changes to the former 
provision at the request of stakeholders at the public meetings 
discussed in Section I.D. The stakeholders requested that the NRC 
permit licensee testing facilities to use methods other than a custody-
and-control form to maintain the chain of custody for aliquots of a 
specimen that are tested at the licensee testing facility. The NRC 
incorporated this change because methods other than a custody-and-
control form, such as the use of bar coding, have been shown to be 
equally effective at tracking the chain of custody for an aliquot at 
licensee testing facilities. Adding this flexibility is consistent with 
Goal 5 of this rulemaking to improve Part 26 by eliminating or 
modifying unnecessary requirements.
    The stakeholders also requested that the section specify the 
conditions under which specimens and aliquots may be discarded because 
the former rule did not address discarding of negative specimens. 
Therefore, the final rule permits licensee testing facilities to 
discard specimens and aliquots as soon as practical after validity 
screening or initial validity tests have demonstrated that the specimen 
is valid and initial test results for drugs and drug metabolites are 
negative. The clarification codifies licensee practices. This 
permission has no impact on donors' rights under the final rule because 
donors are not at risk of management actions or sanctions as a result 
of negative test results and, therefore, do not need the licensee 
testing facility to retain the specimen for additional testing for 
review or litigation purposes. The change has been made to meet Goal 6 
of this rulemaking to improve clarity in the language of the final 
rule.
    Section 26.129(d) updates former Section 2.7(a)(2) in Appendix A to 
Part 26. This provision required licensee testing facility personnel to 
maintain and document the chain of custody for specimens and aliquots. 
The final rule incorporates the simpler language of the related 
provision from the HHS Guidelines while retaining the intent of the 
former provision. The final rule relocates the requirements in the 
former section that were related to HHS-certified laboratories to Sec.  
26.159(d) and (e) in Subpart G to improve organizational clarity.
    Section 26.129(e) amends the first sentence of former Section 
2.7(d) in Appendix A to Part 26 [Specimen processing]. That sentence 
required specimens that test as ``presumptive positive'' at the 
licensee testing facility to be shipped to the HHS-certified laboratory 
for further testing. The final rule replaces the term ``presumptive 
positive'' with terms to describe the specific test results, as 
appropriate (i.e., ``positive,'' ``questionable validity'') in order to 
address validity testing results, consistent with the addition of 
requirements to conduct validity testing throughout the final rule, as 
discussed with respect to Sec.  26.31(d)(3)(i). For organizational 
clarity, the agency has moved the requirements in former Section 2.7(d) 
in Appendix A to Part 26 that related to quality control procedures for 
testing at licensee testing facilities and HHS-certified laboratories 
to Sec.  26.137 [Quality assurance and quality control] and Sec.  
26.167 [Quality assurance and quality control] of the final rule, 
respectively.
    Section 26.129(f) clarifies and revises former Section 2.7(c) in 
Appendix A to Part 26 [Short term refrigerated storage], as it related 
to refrigerating urine specimens to protect them from degradation. For 
organizational clarity, the final rule moves the former requirements 
that applied to HHS-certified laboratories to Sec.  26.159(h) in 
Subpart G. The final rule restates portions of the former provision and 
adds a performance standard regarding ``appropriate and prudent 
actions'' to minimize specimen degradation. For the reasons discussed 
with respect to Sec.  26.117(j), the final rule no longer requires all 
specimens to be refrigerated within 6 hours after collection, but adds 
a requirement that any specimen that has not been tested within 24 
hours of receipt at the licensee testing facility must be refrigerated. 
The final rule continues to require the licensee or other entity to 
refrigerate any specimen (and the associated Bottle B for that specimen 
if the FFD program follows split specimen procedures) that yields a 
positive test result from initial drug testing at the licensee testing 
facility. The final rule also adds a requirement for refrigerating any 
specimen (and the associated Bottle B specimen if a split specimen 
collection is performed) that yields a questionable validity test 
result from validity screening or initial validity testing. 
Refrigerating these specimens is necessary because some adulterants 
have been shown to interfere with drug test results more rapidly if the 
specimen remains at room temperature.
    The final rule also updates the terminology used in the former 
paragraph to be consistent with the new terminology adopted throughout 
the final rule for referring to split specimens. Therefore, in the 
final rule, the licensee testing facility continues to be responsible 
for protecting from degradation the primary specimen (Bottle A) and the 
specimen in Bottle B of a split specimen if the FFD program follows 
split specimen procedures. The rule also requires the licensee testing 
facility to refrigerate any specimen that yields a positive test result 
or a questionable validity test result. This includes the specimen in 
Bottle B associated with any aliquot that yields a positive or 
questionable validity test result at the licensee testing facility. The 
NRC made these changes in the terminology of the paragraph to improve 
clarity in the language of the final rule.
    The final rule separates former Section 2.4(i) in Appendix A to 
Part 26 [Transportation to laboratory or testing facility] into two 
paragraphs, Sec.  26.129(g) and (h), for organizational clarity and 
amends the former provision for the reasons previously discussed with 
respect to Sec.  26.117(i) and (k). Section 26.129(g) and (h), which 
repeats the requirements for packaging and shipping specimens contained 
in Sec.  26.117(i) and (k) of Subpart E, applies these requirements to 
packaging and shipping specimens from licensee testing facilities to 
HHS-certified laboratories. The basis for these requirements is 
discussed with respect to Sec.  26.117(i) and (k).
Section 26.131 Cutoff Levels for Validity Screening and Initial 
Validity Tests
    The NRC has added Sec.  26.131 to establish cutoff levels for 
validity screening and initial validity tests that are conducted at 
licensee testing facilities. The procedures, substances, and cutoff 
levels for initial validity testing in this section incorporate related 
requirements from the HHS Guidelines (69 FR 19643; April 13, 2004). The 
validity screening test requirements have been adapted, in large part, 
from the HHS proposed

[[Page 17080]]

revision to the Guidelines that was also published in the Federal 
Register on April 13, 2004 (69 FR 19673).
    In contrast to the requirements for initial validity testing in the 
HHS Guidelines, the final rule does not permit licensee testing 
facilities to evaluate the specific gravity of any specimens. To 
determine if a specimen is dilute or substituted, specific gravity 
testing is required. If the creatinine concentration of a specimen is 
less than 20 mg/dL, the final rule requires the licensee testing 
facility to forward the specimen to the HHS-certified laboratory to 
complete the testing, where the specimen's specific gravity will be 
measured. The final rule differs from the HHS Guidelines in this 
provision because the costs of the instruments (i.e., refractometers) 
that are required in the Guidelines for measuring specific gravity are 
high. Some licensee testing facilities are currently measuring the 
specific gravity of specimens. However, the cutoff levels established 
in the Guidelines require more sensitive measurement and licensee 
testing facilities would be required to purchase new equipment in order 
to test at the new HHS specific gravity cutoff levels. Therefore, the 
final rule requires licensee testing facilities to transfer all 
specimens with creatinine concentrations less than 20 mg/dL to an HHS-
certified laboratory to complete the initial testing process and does 
not include cutoff levels for specific gravity or quality control 
requirements for measuring specific gravity.
    Section 26.131(a) has been added to require licensee testing 
facilities to perform either validity screening tests, initial validity 
tests, or both. Consistent with related requirements for further 
testing of a specimen at an HHS-certified laboratory when initial drug 
testing at the licensee testing facility yields a positive test result, 
the final rule also requires licensee testing facilities to forward 
specimens that yield a questionable validity screening or initial 
validity test result to an HHS-certified laboratory for further 
testing. Further testing at an HHS-certified laboratory is necessary 
because licensee testing facilities do not have the sophisticated 
testing instruments required for conducting confirmatory testing that 
are required under the HHS Guidelines. In addition, further testing at 
an HHS-certified laboratory provides an independent check on test 
results from licensee testing facilities that is necessary to ensure 
that donors are afforded accurate and consistent testing under this 
part, consistent with Goal 7 of this rulemaking.
    As discussed in Section IV.C, the primary distinction between 
validity screening tests and initial validity tests is that validity 
screening tests may be performed using non-instrumented devices, such 
as dipsticks, whereas initial validity tests generally rely on more 
complex instrumented testing technologies. The final rule permits 
licensee testing facilities to perform validity screening tests before 
performing initial validity tests but does not require them to do so 
because validity screening tests are unnecessary if the licensee 
testing facility performs initial validity testing. Licensees and other 
entities may choose to conduct validity screening tests, followed by 
initial validity testing of any specimens that are identified to be of 
questionable validity as a result of validity screening, potentially to 
reduce the number of donor specimens that must be forwarded to the HHS-
certified laboratory. In addition, the rule permits licensee testing 
facilities to choose whether to conduct validity screening tests or 
initial validity testing for each type of validity testing that is 
required under the rule. For example, a licensee or other entity may 
choose to use dipsticks (a validity screening test) to evaluate a 
specimen's creatinine concentration and only a pH meter (a method for 
conducting initial validity testing) without first performing a 
validity screening test for pH to evaluate the specimen's pH. The NRC 
is permitting flexibility in the means licensee testing facilities use 
to conduct specimen validity testing to meet Goal 3 of this rulemaking 
to enhance the efficiency and effectiveness of FFD programs.
    Section 26.131(b) requires licensee testing facilities to test each 
urine specimen for creatinine concentration, pH, and the presence of 
one or more oxidizing adulterants, such as nitrite or bleach. Abnormal 
creatinine concentrations, abnormal pH values, or the possible presence 
of an oxidizing adulterant indicate that a donor may have altered the 
specimen (e.g., adulterated the specimen or substituted another 
substance in place of the donor's urine) in an attempt to subvert the 
testing process. The final rule permits licensees and other entities to 
choose the oxidizing adulterant(s) for which testing will be conducted. 
The requirements in this paragraph are consistent with the related 
requirements in the HHS Guidelines.
    Because validity testing is complex and the methods for testing are 
relatively new, the second sentence of Sec.  26.131(b) prohibits an FFD 
program from establishing more stringent cutoff levels for validity 
screening and initial validity testing than the cutoff levels 
established in this provision. This prohibition is necessary to 
decrease the risk of obtaining false adulterated, substituted, or 
invalid test results and ensures that donors are not subject to 
sanctions on the basis of inaccurate test results.
    Section 26.131(b)(1)-(b)(8) specifies the criteria for determining 
whether the licensee testing facility must forward a specimen to an 
HHS-certified laboratory for further validity testing. These criteria 
are incorporated from the HHS Guidelines. With respect to the proposed 
rule, the agency modified the requirements in the final rule in 
response to public comments received on the proposed specimen pH and 
nitrite levels. Specifically, the commenters identified that the 
proposed rule did not include pH and nitrite levels that would permit 
the licensee testing facility to detect a specimen that meets the 
criteria for an invalid test result in the HHS Guidelines. Therefore, 
Sec.  26.131(b)(2) in the final rule establishes a pH level of less 
than 4.5, rather than a pH level of less than 3.0 in the proposed rule, 
as one criterion for determining that a specimen requires additional 
validity testing. The NRC also revised the nitrite concentration from 
equal to or greater than 500 micrograms (mcg) per mL in proposed Sec.  
26.131(b)(3) to equal to or greater than 200 mcg/mL in the final rule. 
These changes to the pH and nitrite criteria in the final rule are 
consistent with the current HHS Guidelines and meet Goal 1 of this 
rulemaking to update and enhance the consistency of Part 26 with 
advances in other relevant Federal rules and guidelines. By ensuring 
detection of specimens that may be invalid, these changes also meet 
Goal 3 of this rulemaking to improve the effectiveness and efficiency 
of FFD programs.
Section 26.133 Cutoff Levels for Drugs and Drug Metabolites
    Section 26.133 replaces former Section 2.7(e)(1) in Appendix A to 
Part 26. That section established cutoff levels for initial testing for 
drugs and drug metabolites. Section 26.133 replaces and amends some 
cutoff levels for initial tests for drugs and drug metabolites in 
former Section 2.7(e)(1) in Appendix A to Part 26 to be consistent with 
the HHS cutoff levels for the same substances.
    The NRC has decreased the initial test cutoff level for marijuana 
metabolites from 100 nanograms (ng) per milliliter (mL) to 50 ng/mL. 
Current immunoassay techniques can now reliably detect the presence of 
marijuana metabolites at

[[Page 17081]]

this cutoff level. As discussed in Section IV.B, this change 
strengthens the effectiveness of FFD programs by increasing the 
likelihood of detecting marijuana use.
    The final rule increases the initial test cutoff level for opiate 
metabolites from 300 ng/mL in the former rule to 2,000 ng/mL. The 
change in the cutoff level for opiate metabolites substantially reduces 
the number of positive opiate test results that are reported to MROs by 
HHS-certified laboratories that MROs ultimately verify as negative.
    The final rule retains the permission in the former rule for 
licensees and other entities to establish more stringent cutoff levels 
for initial drug tests, subject to the requirements specified in Sec.  
26.31(d)(3)(iii), for the reasons discussed with respect to that 
paragraph.
    The final rule eliminates the former requirement for licensees and 
other entities to report drug test results for both the cutoff levels 
in the former rule and any more stringent cutoff levels they applied. 
The NRC in the former rule required FFD programs to report test results 
for the cutoff levels specified in this part, when the licensee was 
applying more stringent cutoff levels, because it provided means for 
the NRC to monitor licensees' implementation of the permission to use 
more stringent cutoff levels. The final rule eliminates this 
requirement because Sec.  26.31(d)(3)(iii)(C) requires a qualified 
forensic toxicologist to certify the scientific and technical validity 
of the licensee's or other entity's testing process at any lower cutoff 
levels. Therefore, the reporting requirement is no longer needed to 
ensure licensee testing facility performance in this area. Eliminating 
this requirement meets Goal 5 of this rulemaking to improve Part 26 by 
eliminating or modifying unnecessary requirements.
Section 26.135 Split Specimens
    The NRC has added Sec.  26.135 to reorganize and amend the 
requirements contained in former Section 2.7(j) in Appendix A to Part 
26 that related to licensee testing facility handling of split 
specimens. The requirements in this section apply only to FFD programs 
that follow split specimen collection procedures. The NRC has divided 
the former provision into separate paragraphs in this section to 
indicate that each requirement stands on its own. This change has been 
made to meet Goal 6 of this rulemaking to improve clarity in the 
organization and language of the final rule.
    Section 26.135(a) amends the second, third, and fourth sentences of 
former Section 2.7(j) in Appendix A to Part 26. The final rule revises 
the terminology used in these sentences (e.g., ``Bottle A'' rather than 
``primary specimen,'' ``Bottle B'' rather than ``split specimen,'' 
``positive or of questionable validity'' rather than ``presumptive 
positive'') to be consistent with terminology used in other parts of 
the regulation without amending the meaning of the sentences. The final 
rule deletes the requirement in the third sentence of former Section 
2.7(j) to seal the split specimen prior to placing it in secure storage 
because Bottles A and B have already been sealed at the collection 
site, as required under Sec.  26.113(b)(3). The final rule adds a 
requirement to forward the Bottle A specimen to an HHS-certified 
laboratory if the licensee testing facility obtains a questionable 
validity test result. This requirement is consistent with the addition 
of requirements to conduct validity testing throughout the final rule, 
as discussed with respect to Sec.  26.31(d)(3)(i). With respect to the 
proposed rule, the final rule adds a requirement that Bottle B 
specimens must remain in secure storage under the requirements in Sec.  
26.159(i) if the licensee testing facility retains Bottle B specimens 
rather than sending the specimens to the HHS-certified laboratory with 
Bottle A specimens.
    Section 26.135(b) amends the requirements in former Section 2.7(j) 
in Appendix A to Part 26 related to donor requests for testing of the 
specimen in Bottle B. The final rule adds adulterated or substituted 
validity test results as a basis for a donor request for testing the 
specimen in Bottle B consistent with the addition of requirements to 
conduct validity testing throughout the final rule, as discussed with 
respect to Sec.  26.31(d)(3)(i). The final rule, with respect to the 
proposed rule, imposes a requirement on the MRO to ensure that Bottle B 
is forwarded to a second HHS-certified laboratory that did not test the 
specimen in Bottle A, at the request of the donor, and to follow the 
procedures specified in Sec.  26.165(b). In addition, the NRC 
eliminated the procedures for donor requests for testing the specimen 
in Bottle B that were included in this provision in the proposed rule 
because they were incomplete and partially redundant with the related 
provision in Sec.  26.165(b). The NRC made these changes to meet Goal 6 
of this rulemaking to improve clarity in the organization and language 
of the rule.
    The final rule eliminates the requirement in the fourth sentence of 
former Section 2.7(j) in Appendix A to Part 26 that required the 
licensee testing facility or HHS-certified laboratory to forward the 
split specimen to another HHS-certified laboratory for testing on the 
same day of the donor request. The final rule, with respect to the 
proposed rule, references the provisions in Sec.  26.165(b) pertaining 
to the time period (1 business day) within which licensee testing 
facilities must forward a specimen to a second HHS-certified laboratory 
following the donor request. This change responds to stakeholder 
feedback provided during the public meetings discussed in Section IV.D. 
The stakeholders reported that implementing the former same-day 
requirement was often difficult for a number of reasons, including, for 
example, communication delays among donors, MROs, and FFD program 
personnel, particularly on weekends and holidays, and the time required 
to identify a second laboratory with the appropriate capability to test 
the split specimen, depending on the nature of the non-negative test 
result. The final rule alleviates some of these logistical difficulties 
(e.g., logistical problems associated with weekends and holidays) while 
continuing to provide the donor with timely test results. Therefore, 
the NRC made this change to meet Goal 5 of this rulemaking to improve 
Part 26 by eliminating or modifying unnecessary requirements.
    Section 26.135(c) amends former Section 2.7(c) in Appendix A to 
Part 26 that applied to storing specimens at licensee testing 
facilities. The NRC has amended some of the terminology used in the 
former provision for consistency with the terminology changes made 
throughout the rule. For example, the provision replaces the term 
``split specimen'' with the term ``Bottle B.'' In addition, the final 
rule imposes the requirements for long-term frozen storage of split 
specimens in former Section 2.7(h) in Appendix A to Part 26 on 
licensees and other entities who choose to retain Bottle B of a split 
specimen at the licensee testing facility rather than forwarding it 
with Bottle A to the HHS-certified laboratory when additional testing 
at the HHS-certified laboratory is required. The final rule requires 
licensees and other entities to ensure that Bottle B of any specimen 
that the MRO has confirmed to be positive, adulterated, substituted, or 
invalid is retained in long-term frozen storage for at least 1 year. 
The final rule, with respect to the proposed rule, includes a 
requirement that licensee testing facilities who retain Bottle B 
specimens must ensure that proper specimen storage conditions (i.e., 
frozen storage) are maintained during extended power outages. This 
change is based on comments received on the proposed

[[Page 17082]]

rule noting the oversight. The final rule is consistent with former 
Section 2.7(c) in Appendix A to Part 26, which required licensee 
testing facilities to have emergency power equipment available in case 
of a prolonged power failure. The final rule extends the former 
requirement to apply to Bottle B of any specimen that has yielded 
adulterated, substituted, or invalid validity test results, consistent 
with the addition of requirements to conduct validity testing 
throughout the final rule, as discussed with respect to Sec.  
26.31(d)(3)(i). The final rule moves the portions of former Section 
2.7(h) in Appendix A to Part 26 that applied to HHS-certified 
laboratories to Sec.  26.159(i) in subpart G to improve the 
organizational clarity of the final rule.
Section 26.137 Quality Assurance and Quality Control
    The NRC has added Sec.  26.137 to amend former Section 2.8 in 
Appendix A to Part 26 [Quality assurance and quality control] . This 
section adds quality control requirements for performing validity 
screening tests, initial validity tests, and initial tests for drugs 
and drug metabolites at the licensee testing facility, for the reasons 
discussed with respect to each paragraph. The final rule incorporates 
the related requirements from the HHS Guidelines to meet, in part, Goal 
1 of this rulemaking to update and enhance the consistency of Part 26 
with advances in other relevant Federal rules and guidelines. The NRC 
has relocated the portions of former Section 2.8 in Appendix A to Part 
26 that established requirements for HHS-certified laboratories to 
Sec.  26.167 in Subpart G of the final rule for organizational clarity. 
The agency has made many changes in this section with respect to the 
proposed rule in response to detailed technical comments the NRC 
received on the proposed rule. The performance testing and quality 
control requirements in the final rule are consistent, in large part, 
with those required for initial testing at the HHS-certified 
laboratories.
    Section Sec.  26.137(a) [Quality assurance program] amends former 
Section 2.8(a) in Appendix A to Part 26, which required licensee 
testing facilities and HHS-certified laboratories to have a quality 
assurance program for all aspects of the testing process. The NRC moved 
the former requirements related to HHS-certified laboratories to Sec.  
26.167(a) in Subpart G to improve organizational clarity. The final 
rule extends the former requirements for licensee testing facilities to 
have a quality assurance program and procedures for drug testing to 
validity testing at the licensee testing facility, consistent with the 
addition of requirements to conduct validity testing throughout the 
proposed rule, as discussed with respect to proposed Sec.  
26.31(d)(3)(i).
    Section 26.137(b) [Performance testing and quality control 
requirements for validity screening tests] establishes new requirements 
for performance testing and quality control of validity screening 
testing at the licensee testing facility. This section permits licensee 
testing facilities to use validity screening tests to determine whether 
a specimen is valid or must be subject to further validity testing. 
However, any specific validity screening test that a licensee testing 
facility chooses to use (e.g., a validity screening test for creatinine 
concentration, a validity screening test for pH, a validity screening 
test for oxidizing adulterants) must meet the stringent performance 
testing requirements in this section. The requirements in this section 
are based on requirements that were proposed by HHS in a Notice of 
Proposed Revisions to the Mandatory Guidelines dated April 13, 2004 (69 
FR 19673). However, in response to detailed public comments on the 
proposed rule and further technical analyses, the NRC has revised 
several of the proposed HHS requirements that were incorporated in this 
section in the proposed rule, as discussed with respect to each 
provision the NRC has changed.
    Section 26.137(b)(1) permits licensee testing facilities to use 
validity screening tests to determine whether a specimen is valid or 
must be subject to further validity testing. However, under Sec.  
26.137(b)(1)(i) and (ii), the NRC requires licensee testing facilities 
to use only validity screening tests that either have been placed on 
the SAMHSA list of point-of-collection testing devices that are 
certified for use in the Federal Workplace Drug Testing Program as 
published in the Federal Register, or that meet the performance testing 
criteria set forth in Sec.  26.137(b)(1)(ii) for the reasons discussed 
with respect to that provision. With respect to the proposed rule, 
Sec.  26.137(b)(1) in the final rule includes a new provision to 
address an unintentional omission in the proposed rule. Specifically, 
the NRC has added a requirement that licensee testing facilities must 
use an HHS-certified laboratory that has the capabilities to confirm 
the presence of any adulterant for which the licensee testing facility 
conducts validity screening tests. The inclusion of this provision is 
necessary because, as proposed, a licensee testing facility could have 
used a validity screening test that identified an adulterant that the 
HHS-certified laboratory could not identify because the laboratory did 
not also test for the adulterant in their validity testing panel. If 
this was the case, a specimen with a questionable validity result from 
a licensee testing facility would be tested by the HHS-certified 
laboratory and the specimen would receive a negative or invalid 
validity test result, creating conflicting results. The final rule 
resolves this inconsistency.
    In addition, the final rule eliminates the term, ``non-instrumented 
devices,'' that was used in proposed Sec.  26.137(b)(1). By eliminating 
the specific reference to non-instrumented tests and by revising the 
definition of ``validity screening test'' in Sec.  26.5, the NRC is 
permitting licensee testing facilities to use instrumented tests, in 
addition to non-instrumented tests, to perform validity screening 
testing. The NRC made this change in response to a public comment. The 
commenter suggested that the proposed requirement that limited licensee 
testing facilities to using only non-instrumented devices to perform 
validity screening tests was unduly restrictive. Specifically, the 
commenter stated that instrumented tests could successfully meet the 
performance testing requirements (e.g., pH testing) for some validity 
screening tests described in proposed Sec.  26.137(b)(1). The inclusion 
of instrumented tests for validity screening testing meets Goal 3 of 
this rulemaking to improve the effectiveness and efficiency of FFD 
programs.
    In Sec.  26.137(b)(1)(i) of the final rule, the NRC permits 
licensee testing facilities to use validity screening tests that are 
identified, by lot number, on the SAMHSA list of point-of-collection 
tests approved for use in the Federal Workplace Drug Testing Program, 
as published in the Federal Register. The NRC is aware that SAMHSA has 
yet to publish a list of approved point-of-collection tests but added 
this permission so that licensee testing facilities may rely on that 
list when it is available. With respect to the proposed rule, the final 
rule has removed the requirement that validity screening tests must be 
cleared by the FDA in response to a public comment. The NRC eliminated 
the proposed requirement because, as the commenter pointed out, the FDA 
is not responsible for clearing specimen validity point-of-collection 
tests. The final rule also clarifies the proposed provision by adding 
the requirement that licensee testing facilities may only use validity 
screening tests from ``lots'' (i.e., batches or groups of tests that 
are manufactured

[[Page 17083]]

from the same original materials) that are identified on the SAMHSA 
list when it is available. The NRC added this clarification because 
SAMHSA approval will apply to all validity screening tests from the 
same lot but may not apply to other lots of the test that do not meet 
SAMHSA's criteria for approval.
    Because SAMHSA has yet to publish a list of approved validity 
screening tests, the NRC has added Sec.  26.137(b)(1)(ii) to permit 
licensee testing facilities to use validity screening tests that meet 
the stringent performance testing requirements established in this 
section. Adding these requirements to the final rule permits licensee 
testing facilities to conduct the required performance testing and 
begin using any validity screening tests that meet the criteria before 
SAMHSA's list is published. The NRC is aware that the performance 
testing requirements in Sec.  26.137(b)(1)(ii) are stringent and that 
few, if any, validity screening devices are yet available that meet 
them. However, because individuals may be subject to a temporary 
administrative withdrawal of authorization on the basis of a positive 
initial drug test result for marijuana or cocaine from a specimen that 
yields negative test results from validity screening (see proposed 
Sec.  26.75(i)), it is critical that any validity screening tests used 
in Part 26 programs provide accurate results. The proposed performance 
testing requirements are necessary to protect donors from inaccurate 
results and ensure that specimens of questionable validity are 
detected.
    The final rule eliminates the proposed provision in Sec.  
26.137(b)(1)(ii)(A) that required a licensee testing facility or HHS-
certified laboratory to conduct performance testing of 100 validity 
screening devices from all currently available manufactured lots of the 
device to ensure that the devices met the performance testing criteria 
in proposed Sec.  26.137(b)(1)(ii)(C) before the licensee testing 
facility began using the validity screening test. The NRC eliminated 
proposed Sec.  26.137(b)(1)(ii)(A) to address public comments received 
suggesting that licensee testing facilities and HHS-certified 
laboratories may not have the experience or expertise to conduct 
performance testing of validity screening devices. The commenters 
suggested that the NRC should instead consider requiring the 
manufacturer of the validity screening tests to perform and document 
validation studies of the validity screening tests as well as conduct 
tests of performance testing samples that licensee testing facilities 
submit to the manufacturer. The NRC agrees with the commenters and has 
revised the proposed rule to require manufacturers to perform and 
document validation studies in Sec.  26.137(b)(1)(ii)(D) of the final 
rule. The final rule also requires licensees and others entities that 
intend to use validity screening tests to submit performance testing 
samples to the validity screening test manufacturer in Sec.  
26.137(b)(1)(ii)(E) of the final rule. This change ensures that the 
evaluation of a validity screening test is conducted by an 
individual(s) endorsed by the manufacturer. If an individual with 
limited training were used to conduct the tests, the manufacturer may 
have a reason to question the test results obtained by the licensee 
testing facility or the HHS-certified laboratory. The NRC believes that 
the validity screening test manufacturer is best qualified to 
demonstrate the effectiveness of each test because the manufacturer is 
the entity with the greatest knowledge of correct testing procedures.
    Another public comment received on proposed Sec.  
26.137(b)(1)(ii)(A) stated that the requirement to test 100 validity 
screening devices was overly burdensome. The NRC agrees with the 
commenter, has revised the requirement, and relocated the amended 
provision to Sec.  26.137(b)(1)(ii)(E). The new Sec.  
26.137(b)(1)(ii)(E) requires a licensee or other entity to submit three 
consecutive sets (at least 6 samples in each set) of performance 
testing samples to the validity screening test manufacturer for 
performance testing before the licensee testing facility begins using a 
validity screening to test donor specimens. Therefore, the final rule 
requires the licensee or other entity to submit a minium of 18 samples 
for each validity screening test to be used by a licensee or other 
entity. If a licensee or other entity chooses to use validity screening 
tests to conduct all of the validity testing required by this subpart 
(e.g., creatinine, pH, and oxidizing adulterants), the total minimum 
number of performance test samples that a licensee testing facility 
must submit to meet the minimum performance testing requirements in the 
final rule is 72 samples (18 samples for a creatinine test divided into 
three sets, 18 samples for pH testing at levels equal to or less than 
4.5 divided into three sets, 18 samples for pH testing at levels equal 
to or greater than 9 divided into three sets, and 18 samples for an 
oxidant test divided into three sets). If a licensee or other entity 
chooses to use a validity screening test for only one of the types of 
validity testing required in this subpart, the total number of 
performance test samples that the licensee testing facility must submit 
is less. For example, if a licensee or other entity chooses to use a 
validity screening test only for determining creatinine concentration, 
the total number of performance samples that the licensee testing 
facility must submit for testing is 18 samples divided into three sets. 
The NRC believes that the revised performance testing sample 
requirements reduce the burden on licensees and other entities imposed 
by these performance testing requirements while ensuring that the 
validity screening tests provide accurate and consistent test results.
    The agency has also relocated and revised the requirements in 
proposed Sec.  26.137(b)(1)(ii)(B) and (b)(1)(ii)(C). These proposed 
provisions established requirements for the formulation of performance 
testing samples and criteria for licensees and other entities to apply 
when evaluating performance testing results, respectively. The final 
rule combines these requirements in Sec.  26.137(b)(1)(ii)(E) and 
presents them in the rule in the sequence in which licensees and other 
entities would implement them for organizational clarity. The NRC has 
also made other changes to the provisions in proposed Sec.  
26.137(b)(1)(ii) to address a public comment that stated that the 
performance testing standards in the proposed rule were unduly 
prescriptive and should instead be performance based. The NRC agrees 
with the commenter and has further revised the performance testing 
provisions in proposed Sec.  26.137(b) as is subsequently discussed 
with respect to each provision in the final rule.
    Section 26.137(b)(1)(ii)(A) of the final rule specifies that a 
validity screening test that a licensee testing facility intends to use 
to conduct creatinine testing must be able to detect whether a 
specimen's creatinine concentration is less than 20 mg/dL. This 
provision replaces the portions of proposed Sec.  26.137(b)(1)(ii)(B) 
and (b)(4) that established the required creatinine measurement 
capabilities of validity screening devices. The NRC revised the 
provision in response to a public comment received on proposed Sec.  
26.137(b)(4) that stated that tests currently available that could be 
used for validity screening testing for creatinine cannot distinguish 
creatinine concentrations in the proposed ranges of 5-20 and 1-5 mg/dL. 
The commenter noted that current validity screening tests, at best, can 
detect creatinine concentration at a cutoff of 20 mg/dL. Because the 
rule does not require licensee testing facilities to determine

[[Page 17084]]

whether a specimen meets the criteria for substitution or dilution, 
which depend on the results of specific gravity testing in addition to 
lower creatinine concentrations, the NRC agrees with the commenter that 
the proposed creatinine testing to lower concentrations is unnecessary. 
A validity screening test that can detect creatinine concentration at a 
cutoff of 20 mg/dL is adequate for a licensee testing facility to 
determine that a specimen is of questionable validity and requires 
further testing at an HHS-certified laboratory. This revision avoids 
imposing an unnecessary burden on licensee testing facilities while 
ensuring that the validity screening test will support the creatinine 
concentration cutoff at 20 mg/dL established in Sec.  26.131(b)(1).
    Section 26.137(b)(1)(ii)(B) of the final rule specifies that a 
validity screening test that a licensee testing facility intends to use 
to conduct pH testing must be able to identify specimens with pH of 
less than 4.5 and pH equal to or greater than 9. This provision 
replaces the portions of proposed Sec.  26.137(b)(1)(ii)(B) and (b)(4) 
that established the required pH measurement capabilities of validity 
screening devices. Proposed Sec.  26.137(b)(1)(ii)(B) and (b)(4) would 
have required pH validity screening tests to be capable of detecting pH 
in the ranges of 1-3 and 10-12. However, the NRC received two comments 
noting that the proposed pH ranges would not permit the licensee 
testing facility to detect a specimen that meets the criteria for an 
invalid test result in the HHS Guidelines (i.e., pH less than 4.5 or 
equal or greater than 9). Therefore, this change addresses the issue 
raised by the commenter and ensures that the validity screening test 
will support the pH cutoffs established in Sec.  26.131(b)(2) as 
revised in the final rule.
    Section 26.137(b)(1)(ii)(C) of the final rule specifies the 
required performance capabilities for a validity screening test that a 
licensee testing facility intends to use to conduct testing for 
oxidizing adulterants. This provision replaces the portions of proposed 
Sec.  26.137(b)(1)(ii)(B) and (b)(4) that established the required 
oxidizing adulterant measurement capabilities of validity screening 
devices. Proposed Sec.  26.137(b)(1)(ii)(B) and (b)(4) would have 
required oxidizing adulterant validity screening tests to be capable of 
detecting nitrite in the ranges of 250 mcg/mL to 400 mcg/mL and from 
650 mcg/mL to 800 mcg/mL. However, one commenter on the proposed rule 
noted that the proposed nitrite concentrations for performance testing 
samples ranging from 250 mcg/mL to 400 mcg/mL and from 650 mcg/mL to 
800 mcg/mL would not identify specimens that meet the invalid specimen 
testing criteria in the HHS Guidelines (i.e., nitrite concentration 
equal to or greater than 200 mcg/mL). The NRC agrees with the commenter 
and has revised the oxidant measurement requirements for validity 
screening tests to detect nitrite concentration at a cutoff of 200 mcg/
mL in Sec.  26.137(b)(1)(ii)(C) of the final rule. For completeness, 
the final rule also includes performance testing criteria for 
additional oxidant tests (i.e., chromium, halogen) that a licensee 
testing facility could perform to meet the requirements for testing for 
oxidizing adulterants in Sec.  26.131(b). Therefore, these changes 
improve the clarity of the performance testing requirements in this 
section and the consistency of the final rule with the HHS Guidelines.
    At the suggestion of a commenter, the NRC has added Sec.  
26.137(b)(1)(ii)(D) to the final rule. This provision requires the 
manufacturer of a validity screening test to conduct and document 
validation studies demonstrating the performance characteristics of the 
validity screening test around the cutoff levels established in this 
subpart. The commenter suggested that the majority of the burden of 
demonstrating the performance capabilities of validity screening tests 
should rest with the manufacturer rather than with licensees and other 
entities or HHS-certified laboratories, as required by several 
provisions of the proposed rule. The NRC agrees with the commenter and 
believes that the manufacturer of each validity screening test is the 
most appropriate entity to demonstrate the performance characteristics 
of the validity screening tests before a licensee or other entity 
begins using a test in an FFD program. The NRC believes it is necessary 
to establish requirements similar to those that exist for other types 
of testing performed by licensee testing facilities and HHS-certified 
laboratories. Both the former and final rules require licensee testing 
facilities and HHS-certified laboratories to validate their analytical 
methods before conducting drug testing of donor specimens. The 
requirement for manufacturers to validate their validity screening 
tests before providing them to licensee testing facilities is 
essentially parallel to these requirements for licensee testing 
facilities and HHS-certified laboratories. The NRC believes the 
validation requirement is necessary to ensure that the manufacturer has 
verified the performance characteristics of the validity screening test 
before shipment to suppliers and use by licensee testing facilities.
    As discussed with respect to proposed Sec.  26.137(b)(1)(ii)(A), 
the NRC has revised the performance testing requirements in proposed 
Sec.  26.137(b)(1)(ii)(A)-(b)(1)(ii)(C). In addition to the changes to 
performance testing requirements previously discussed, the final rule 
revises the portion of proposed Sec.  26.137(b)(1)(ii)(C) that 
established the percentage of total performance test samples that 
validity screening tests must correctly identify when licensees and 
other entities submit performance testing samples to the manufacturer. 
In Sec.  26.137(b)(1)(ii)(E), the NRC has increased this required 
percentage from 80 percent in the proposed rule to 90 percent in the 
final rule. The more rigorous criterion for validity screening tests 
increases consistency among the rule's criteria for licensee testing 
facility drug testing performance and criteria in the HHS Guidelines 
for HHS-certified laboratory drug and validity testing performance. The 
NRC has made this revision in the final rule to ensure that validity 
screening tests perform accurately and reliably and that each FFD 
program effectively evaluates the validity of urine specimens.
    Section 26.137(b)(1)(iii) revises proposed Sec.  26.137(b)(1)(iii) 
to further reduce the performance testing burden on licensees and other 
entities who use validity screening tests. The proposed rule would have 
required licensees and other entities to ensure the continued 
effectiveness of any validity screening tests it is using, after they 
have been placed in service, by conducting or requesting the HHS-
certified laboratory to conduct performance testing of 50 devices on a 
nominal annual frequency. Consistent with other changes to the 
performance testing requirements in Sec.  26.137(b), the final rule 
requires the validity screening tests' manufacturers to conduct this 
followup performance testing rather than licensee testing facilities or 
HHS-certified laboratories as proposed. In addition, the final rule 
eliminates the specific requirement for testing of 50 devices annually 
and replaces it with a performance-based standard in response to a 
public comment suggesting that the specificity in the proposed 
provision was unnecessarily burdensome. The final rule does not specify 
the number of performance testing samples to be tested by the 
manufacturer using validity screening tests from the lot in use by the 
licensee testing facility. The final rule instead requires the 
manufacturer to test performance testing samples that are formulated 
around the cutoff levels for

[[Page 17085]]

validity testing in this subpart. The NRC believes this standard is 
adequate to determine whether validity screening tests in each lot are 
continuing to provide accurate and consistent test results and avoids 
imposing unnecessarily restrictive requirements.
    The NRC has eliminated proposed Sec.  26.137(b)(1)(iv) from the 
final rule. That provision required licensees and other entities to 
ensure that the manufacturer of a validity screening test that is used 
by the licensee testing facility informs the licensee or other entity 
of any changes to the device that may require additional performance 
and to conduct additional performance testing if recommended by the MRO 
or HHS-certified laboratory. This provision is no longer necessary 
because the revised performance testing requirements in the final rule 
are focused on each lot of validity screening tests the licensee 
testing facility intends to use. Because manufacturers cannot make 
changes to a validity screening test after a lot of the tests has been 
produced, information about changes to the tests in that lot and 
additional performance testing are not required.
    Section 26.137(b)(2) establishes quality control requirements that 
licensee testing facility personnel must implement at the beginning of 
any 8-hour period when validity screening tests will be performed and 
while conducting validity screening testing. With respect to the 
proposed rule, the NRC has revised the quality control requirements 
that were in Sec.  26.137(b)(2) in the proposed rule and relocated them 
to Sec.  26.137(b)(2)(i). The agency made this change because the final 
rule adds a new Sec.  26.137(b)(2)(ii) and it is necessary to group the 
related requirements together for organizational clarity in the final 
rule.
    In response to a public comment, the agency has revised Sec.  
26.137(b)(2) in the final rule to require that the licensee testing 
facility personnel who will be or are performing validity screening 
testing must implement the quality control requirements in this 
section. The commenter reasoned that because some validity screening 
tests have visually read endpoints, the test result must be interpreted 
by the tester. Therefore, it is necessary to verify that each tester is 
able to interpret the quality control samples correctly before 
conducting tests on donor specimens and during the testing process. The 
NRC agrees with this comment and made the appropriate change in the 
final rule.
    Section 26.137(b)(2)(i) revises portions of proposed Sec.  
26.137(b)(2) and requires that the quality control samples to be tested 
before beginning to test donor specimens in any 8-hour period must 
consist of one sample that is certified as negative and one that is 
formulated to appropriately challenge each type of validity screening 
test to be conducted (e.g., certified to contain an oxidizing 
adulterant, to have creatinine below 20 ng/mL). For example, the final 
rule requires that if a licensee testing facility is using a validity 
screening test to determine the nitrite concentration of a specimen, 
licensee testing facility personnel must use a certified quality 
control sample containing nitrite. This requirement is necessary to 
verify that the validity screening tests to be used are functioning 
properly and that licensee testing facility personnel are able to 
conduct the tests appropriately, as discussed with respect to Sec.  
26.137(b)(2). The final rule replaces the term ``non-negative'' in the 
proposed rule, which was used to describe the quality control samples 
that licensees and other entities must use, with a requirement that the 
quality control samples must be formulated to challenge each validity 
screening test around the cutoffs for initial validity testing 
specified in this subpart. The NRC made this change to improve the 
clarity in the language of the rule, as discussed with respect to Sec.  
26.5.
    The final rule, with respect to the proposed rule, adds a provision 
to require validity screening tests to be challenged by licensee 
testing facility personnel after screening every 10 donor specimens in 
Sec.  26.137(b)(2)(ii). Specifically, this provision requires the 
licensee testing facility to test at least 1 quality control sample 
after testing every 10 donor specimens during an 8-hour testing period 
and requires the quality control sample to be formulated to challenge 
the validity screening test(s) in use around the cutoffs specified in 
Subpart F. The NRC has added this provision to enhance the consistency 
of quality control procedures for conducting validity screening testing 
with quality control procedures for conducting initial validity and 
drug testing at licensee testing facilities. As discussed with respect 
to Sec.  26.137(d) and (e), the NRC requires licensee testing 
facilities to test calibrators, controls, and blind quality control 
samples during each analytical run of initial validity and drug testing 
conducted at the licensee testing facility (See Sec.  26.5 for a 
discussion of the term, ``analytical run'') to monitor the accuracy of 
testing. However, because it may not be possible to conduct validity 
screening tests in batches (i.e., the tester may have to insert a 
dipstick into an aliquot of each donor's specimen manually), it is 
impractical to impose similar requirements for calibrators, controls 
and blind quality control testing each time a single validity screening 
test is performed. Therefore, the NRC added this provision to ensure, 
without imposing unrealistic requirements, that validity screening 
tests continue to perform reliably during any 8-hour period in which 
the validity screening tests are used and to increase consistency among 
quality control requirements for validity screening and initial 
validity and drug testing in this section.
    The NRC has moved the requirements in proposed Sec.  26.137(b)(2) 
that addressed the steps that licensee testing facilities must take if 
a validity screening tests fails to perform correctly when testing 
quality control samples. For organizational clarity, the NRC relocated 
the proposed provisions to Sec.  26.137(f) in the final rule because 
Sec.  26.137(f) establishes requirements related to the topic of the 
proposed provisions, errors in testing.
    Section 26.137(b)(3) requires licensee testing facility personnel 
to submit 1 out of every 10 donor specimens that yield negative results 
using validity screening tests to an HHS-certified laboratory. This 
requirement is necessary to detect false negative test results from 
validity screening tests. A false negative test result in this instance 
is a result from a validity screening test indicating that the specimen 
is valid when, in fact, validity testing at the HHS-certified 
laboratory identifies the specimen as adulterated, substituted, or 
invalid. Assessing the validity screening test's rate of false negative 
test results is necessary because false negative results from a 
validity screening test could mean that some attempts to subvert the 
testing process may not be detected. For example, if an individual had 
adulterated his or her specimen and it was not detected because of a 
faulty device, the licensee or other entity would have no reason to 
terminate the individual's authorization. As a result, an individual 
who has demonstrated that he or she is not trustworthy and reliable 
would be permitted to perform duties under this part and may pose a 
risk to public health and safety and the common defense and security.
    With respect to the proposed rule, the NRC has moved the 
requirements in proposed Sec.  26.137(b)(3) that addressed the steps 
that licensee testing facilities must take if the HHS-certified 
laboratory's results indicate that the validity screening test provided 
a false negative result. For organizational clarity, the NRC relocated 
the proposed provisions to Sec.  26.137(f) in the final rule

[[Page 17086]]

because Sec.  26.137(f) establishes requirements related to the topic 
of the proposed provisions, errors in testing.
    The NRC notifications required in Sec.  26.137(b)(2)and (b)(3) are 
necessary because false negative results from a validity screening test 
indicate the laboratory testing process may not be successfully 
detecting donor attempts to subvert the testing process through 
specimen adulteration or substitution. For example, if an individual 
had adulterated his or her specimen and it was not detected because of 
a faulty test, the licensee or other entity would have no reason to 
terminate the individual's authorization. As a result, an individual 
who has demonstrated that he or she is not trustworthy and reliable 
would be permitted to perform duties under this part and may pose a 
risk to public health and safety and the common defense and security. 
The NRC will use the information to ensure that HHS is notified of the 
test failure as well as inform other licensees and entities who may 
also be using the test of the false negative results to prevent 
additional testing errors. Therefore, the notifications are necessary 
to protect donors from inaccurate test results, to ensure that 
specimens of questionable validity are detected, and to ensure that any 
problems with a test are detected and corrected as soon as possible.
    In response to public comments, the NRC has eliminated proposed 
Sec.  26.137(b)(4) that required validity screening tests to be capable 
of measuring a specimen's creatinine concentration to 1 decimal place. 
Specificity below 20 mg/dL is unnecessary because NRC is not requiring 
licensee testing facilities to conduct the tests for specific gravity 
that are necessary for reporting substituted, dilute, or invalid 
validity test results, as discussed with respect to Sec.  
26.137(b)(1)(ii)(A). This change reflects the current capabilities of 
validity screening tests and supports the intent of the NRC that 
licensee testing facilities need only be able to identify whether a 
specimen has a creatinine concentration of less than 20 mg/dL and 
therefore requires additional testing at an HHS-certified laboratory.
    The NRC has added a new Sec.  26.137(b)(4) in the final rule to 
establish requirements for storing validity screening tests and 
requires licensee testing facilities to maintain the tests consistent 
with the manufacturer's storage specifications. Storing the tests as 
required by the manufacturer's instructions is necessary to ensure that 
the tests continue to function optimally. This requirement is 
consistent with the quality control requirements for ASDs in Sec.  
26.91(d) and meets Goal 3 of this rulemaking to improve the 
effectiveness and efficiency of FFD programs.
    The NRC has deleted proposed Sec.  26.137(b)(5) and (b)(6) from the 
final rule and replaced these provisions with the performance testing 
requirements in Sec.  26.137(b)(1)(ii) for the reasons discussed with 
respect to that section.
    The NRC added Sec.  26.137(c) [Validity screening test results] to 
specify the actions that the licensee testing facility must take if a 
donor's specimen yields questionable results from validity screening 
testing. If a specimen has a questionable validity screening test 
result, the final rule requires instrumented initial validity testing 
either at the licensee testing facility or the HHS-certified 
laboratory. This provision is consistent with the rule's requirements 
for transferring to the HHS-certified laboratory specimens with initial 
positive drug test results from testing at a licensee testing facility. 
Further testing of a specimen of questionable validity is necessary to 
protect donors from inaccurate test results, as well as provide 
assurance that specimens of questionable validity are detected using 
the more sophisticated technologies required for instrumented initial 
validity testing in the HHS Guidelines and the final rule. The final 
rule, with respect to the proposed rule, eliminates the term ``non-
negative'' from the heading of the provision for the reasons discussed 
with respect to Sec.  26.5 related to the elimination of this term 
throughout the final rule.
    The agency added Sec.  26.137(d) [Quality control requirements for 
performing initial validity tests] to specify the required methods for 
performing initial validity tests at a licensee testing facility that 
are necessary to ensure that initial validity testing at the licensee 
testing facility provides accurate results. The requirements in this 
paragraph incorporate the related requirements in the HHS Guidelines as 
revised on April 13, 2004 (69 FR 19644). The paragraph has been added 
to meet Goal 1 of this rulemaking to update and enhance the consistency 
of Part 26 with advances in other relevant Federal rules and 
guidelines.
    Section 26.137(d)(1) requires licensee testing facilities to 
measure creatinine concentration to 1 decimal place and establishes 
requirements for the controls to be used in initial tests for 
creatinine concentration.
    Section 26.137(d)(2) establishes quality control requirements for 
performing initial pH tests. Sections 26.137(d)(2)(i)-(d)(2)(v) specify 
the required calibrators and controls for initial pH testing, based on 
the type of testing instrument used and whether a pH validity screening 
test has been performed.
    Section 26.137(d)(3) establishes quality control requirements for 
performing initial tests for oxidizing adulterants, including nitrite, 
and Sec.  26.137(d)(4) establishes quality control requirements for 
performing initial tests for ``other'' adulterants at the licensee 
testing facility.
    Section 26.137(d)(5) requires that one of the quality control 
samples included in each analytical run must appear to be a donor 
specimen to laboratory analysts. The final rule retains the related 
requirement in the last paragraph of Section 2.8(c)(3) in Appendix A to 
Part 26 and amends the provision to be consistent with the same 
requirement in the HHS Guidelines. With respect to the proposed rule, 
the NRC relocated this requirement from proposed Sec.  26.137(e)(7) to 
Sec.  26.137(d)(5) in the final rule to clarify that the requirement to 
test one blind quality control sample in each analytical run applies to 
initial validity test runs as well as to initial drug testing if the 
licensee testing facility does not conduct initial validity and drug 
testing concurrently. However, if a licensee testing facility conducts 
initial validity and drug testing of specimens concurrently, the NRC 
intends that the licensee testing facility would include only one blind 
performance test sample in the analytical run to meet this requirement 
as well as the same requirement in Sec.  26.137(e)(6)(v) for drug 
testing runs. The NRC made these changes to meet Goal 6 of this 
rulemaking to improve clarity in the organization of the rule.
    The NRC also added Sec.  26.137(d)(6) in the final rule to require 
licensee testing facilities to send 1 out of 10 specimens that test 
negative on initial validity tests to an HHS-certified laboratory for 
initial and, if necessary, confirmatory validity testing. The NRC added 
this requirement in response to public comments noting inconsistencies 
in the proposed rule's quality control requirements for validity 
screening, initial validity testing, and initial drug testing, and for 
the reasons discussed with respect to the addition of a similar 
requirement applicable to validity screening testing in Sec.  
26.137(b)(3). Adding this provision ensures that licensee testing 
facilities can assess their rates of false negative initial validity 
test results and therefore meets Goal 3 of this rulemaking to improve 
the effectiveness of FFD programs.
    Section 26.137(e) [Quality control requirements for initial drug 
tests]

[[Page 17087]]

amends and combines portions of former Section 2.7(d), 2.7(e)(1), and 
2.8(b) in Appendix A to Part 26. The former provisions established 
quality control requirements for performing initial tests for drugs and 
drug metabolites at licensee testing facilities. The final rule groups 
together in one paragraph the requirements that were dispersed 
throughout the former rule to meet Goal 6 of this rulemaking to improve 
clarity in the organization of the final rule.
    Section 26.137(e)(1) amends the first sentence of former Section 
2.7(e)(1) in Appendix A to Part 26 but retains the intent of the former 
provision as it applies to licensee testing facilities. This provision 
retains the former requirement that licensee testing facilities may use 
only immunoassay tests that meet the requirements of the Food and Drug 
Administration for commercial distribution. The NRC has moved the 
requirements in the former provision related to initial drug testing at 
HHS-certified laboratories to Sec.  26.167(d)(1) of Subpart G of the 
final rule to improve organizational clarity in the rule.
    In addition, Sec.  26.137(e)(1) prohibits licensee testing 
facilities from relying on drug test results from any tests they may 
use to perform validity screening tests. The NRC added this prohibition 
because several non-instrumented devices are available that combine 
tests for the presence of drugs and drug metabolites in a urine 
specimen with tests for other attributes of a urine specimen, such as 
creatinine concentration. The final rule permits licensee testing 
facilities to use such combination tests as validity screening tests if 
the tests meet the requirements of Sec.  26.137(b)(1). However, the 
drug testing capabilities of these tests are not yet sufficiently 
accurate and sensitive to be used in Part 26 programs, in which 
licensees and other entities are permitted to administratively withdraw 
an individual's authorization on the basis of positive initial drug 
test results for marijuana and cocaine metabolites. The NRC may 
consider accepting the use of initial drug test results from non-
instrumented tests in a future rulemaking, when HHS publishes a final 
revision to the Mandatory Guidelines that establishes requirements for 
their use in Federal workplace drug testing programs. At this time, 
however, the final rule retains the former prohibition on using such 
tests for drug testing at licensee testing facilities.
    The NRC added Sec.  26.137(e)(2) to require licensee testing 
facilities to either discard specimens that yield negative results from 
initial tests at the licensee testing facility or pool them and use 
these specimens as quality control specimens, if the specimens are 
certified as negative and valid by an HHS-certified laboratory. This 
provision incorporates the related provision from the HHS Guidelines to 
meet Goal 1 of this rulemaking to update and enhance the consistency of 
Part 26 with advances in other relevant Federal rules and guidelines. 
With respect to the proposed rule, the final rule adds a sentence 
prohibiting licensee testing facilities from retaining any information 
linking donors to specimens pooled for use in the internal quality 
control program. The agency added this prohibition in response to a 
public comment requesting this addition. This change meets Goal 7 of 
this rulemaking to protect the privacy and other rights (including due 
process) of individuals who are subject to Part 26.
    Section 26.137(e)(3) permits licensee testing facilities to conduct 
multiple tests of a single specimen for the same drug or drug class. 
The NRC has revised Sec.  26.137(e)(3) in the final rule, with respect 
to the proposed rule, to include a more precise description of when 
multiple initial drug tests on a specimen (also know as rescreening) 
are permitted. The NRC added this information in the final rule in 
response to a comment received on the proposed provision requesting the 
addition. The requirements in the provision are consistent with a 
similar provision in the HHS Guidelines and, therefore, meet Goal 1 of 
this rulemaking to update and enhance the consistency of Part 26 with 
advances in other relevant Federal rules and guidelines.
    Section 26.137(e)(4) amends the first sentence of former Section 
2.8(b) in Appendix A to Part 26. The former sentence stated that 
licensee testing facilities are not required to assess their false 
positive rates in drug testing. The final rule retains the intent of 
the former requirement, but the NRC has updated the terminology in the 
provision to use the new terms that are used throughout the final rule, 
e.g., ``initial'' rather than ``screening,'' as discussed with respect 
to Sec.  26.5.
    Section 26.137(e)(5) amends the second sentence of former Section 
2.8(b) in Appendix A to Part 26. This provision required licensee 
testing facilities to submit specimens that yield negative results from 
initial testing to the HHS-certified laboratory as a quality control 
check on the licensee testing facility's drug testing process. The 
paragraph retains the intent of the former provision but makes several 
changes to the specific requirements.
    The paragraph uses the term ``analytical run'' rather than the 
former term ``test run'' to reflect changes in testing technologies 
that some licensee testing facilities have adopted since the former 
rule was published. Requirements for blind performance and other 
quality control testing in the former rule were based on the assumption 
that specimens would be tested in batches. However, many licensee 
testing facilities now conduct continuous testing, and no longer test 
specimens in batches. Therefore, the final rule uses the term, 
``analytical run,'' to refer to both batch and continuous processing, 
as defined in Sec.  26.5. This change has been made to meet Goal 6 of 
this rulemaking to improve clarity in the language of the final rule.
    The former rule did not establish a number or percentage of 
negative specimens that licensee testing facilities were required to 
submit to the HHS-certified laboratory for performance testing, which 
raised implementation questions from licensees who have wanted to know 
how many specimens must be submitted. Therefore, to clarify the former 
requirement to ``submit a sampling of specimens,'' the final rule 
requires licensee testing facilities to forward at least one specimen 
that yields negative drug test results from each analytical run to the 
HHS-certified laboratory for performance testing. The final rule also 
establishes five percent of the specimens tested in each analytical run 
as the percentage of negative specimens that the licensee testing 
facility must submit to the HHS-certified laboratory for testing, 
except if five percent of an analytical run is a number less than one 
specimen. In the latter case, the licensee testing facility submits at 
least one negative specimen from the analytical run. This requirement 
ensures the ongoing evaluation of the accuracy of the licensee testing 
facility's initial drug testing without imposing a large performance 
testing burden.
    The NRC has moved the last sentence of the former paragraph, which 
addressed performance testing of breath analysis equipment for alcohol 
testing, to Sec.  26.91(e) in Subpart E because that subpart of the 
final rule addresses quality control requirements for alcohol testing. 
The NRC made this change to meet Goal 6 of this rulemaking to improve 
clarity in the organization of the final rule.
    Section 26.137(e)(6) amends the requirements of former Section 
2.8(c) in Appendix A to Part 26 and applies them to licensee testing 
facilities. The NRC is applying requirements for quality

[[Page 17088]]

controls to initial drug testing at licensee testing facilities to 
provide greater assurance that initial drug tests performed by these 
facilities provide accurate results. The increased performance testing 
requirements in the final rule are necessary because the final rule 
permits licensees and other entities to rely on test results from other 
Part 26 programs to a greater extent that the former rule. Therefore, 
it is necessary to ensure that any tests performed at licensee testing 
facilities meet minimum standards. This change meets Goal 3 of this 
rulemaking to improve the effectiveness of FFD programs.
    The final rule, with respect to the proposed rule, moves the 
provision in proposed Sec.  26.137(e)(7) to Sec.  26.137(e)(6) in the 
final rule to improve organizational clarity. The NRC made this change 
to address a public comment received on the proposed rule that noted 
that because the second sentence in proposed Sec.  26.137(e)(7) 
discussed a quality control sample requirement, the provision would be 
more appropriately located in Sec.  26.137(e)(6) which describes the 
quality control sample requirements for each analytical run.
    Section 26.137(e)(6) establishes requirements for the number of 
quality control samples to be included in each analytical run at the 
licensee testing facility. The final rule requires that a minimum of 10 
percent of the specimens in each analytical run must be quality control 
samples. For example, if an analytical run consists of 50 donor 
specimens, an additional 5 quality control samples would be included in 
the analytical run for a total of 55 specimens tested in the run. The 
licensee testing facility will not send the quality control samples to 
the HHS-certified laboratory for confirmatory testing, but use them for 
internal quality control purposes only. The requirements in this 
paragraph incorporate the related requirements in the HHS Guidelines 
and meet Goal 1 of this rulemaking, which is to update and enhance the 
consistency of Part 26 with advances in other relevant Federal rules 
and guidelines.
    The final rule also requires licensee testing facilities to ensure 
that quality control samples that are positive for each drug and 
metabolite for which the FFD program conducts testing are included in 
at least one analytical run in each quarter of the calendar year. The 
NRC added this provision at the request of comments received addressing 
inconsistences within the proposed rule. The proposed rule required 
quality control samples for each type of validity test, but failed to 
specify the required distribution of quality control samples among the 
drugs and metabolites for which the FFD program tests. This provision 
clarifies the former rule and increases the internal consistency of 
this subpart. Additionally, this provision provides for enhanced 
monitoring of the effectiveness of the licensee testing facilities' 
drug testing procedures to meet Goal 3 of this rulemaking to improve 
the effectiveness of FFD programs.
    The NRC has added Sec.  26.137(e)(6)(i)-(e)(6)(iii) to describe the 
required characteristics of the quality control samples that the 
licensee testing facility must include in each analytical run of 
specimen testing. These provisions require each analytical run to 
include at least one negative quality control sample as well as quality 
control samples targeted at 25 percent above the cutoff and at 25 
percent below the cutoff level for each drug and drug metabolite for 
which testing is conducted. The final rule, with respect to the 
proposed rule, revises the requirement that a quality control sample 
must be targeted at 75 percent of the cutoff level and instead, the 
final rule requires the calibrator to be targeted at 25 percent below 
the cutoff level. This change was made to improve the clarity of the 
language of the final rule without changing the intent of the 
provision. These requirements are consistent with the current HHS 
Guidelines for processing quality control samples during initial drug 
testing.
    With respect to the proposed rule, the final rule has added Sec.  
26.137(e)(6)(iv) and Sec.  26.137(e)(6)(v) to further enhance quality 
control requirements for initial drug testing at licensee testing 
facilities. In response to a public comment, the NRC added Sec.  
26.137(e)(6)(iv) to require that each analytical run has a sufficient 
number of calibrators to ensure linearity of the assay. This additional 
provision is consistent with the related requirement in the HHS 
Guidelines. Section 26.137(e)(6)(v) requires that one sample must 
appear to be a donor sample to the laboratory analysts. This 
requirement was previously embedded in Sec.  26.137(e)(7) of the 
proposed rule, and the NRC moved the requirement to Sec.  
26.137(e)(6)(v) of the final rule in response to a comment received 
that noted this move would enhance organizational clarity in the rule. 
The NRC agrees with the commenter.
    Section 26.137(e)(7) extends to licensee testing facilities the 
requirement in the third sentence of the last paragraph of former 
Section 2.8(c) in Appendix A to Part 26. That provision required HHS-
certified laboratories to implement procedures to ensure that carryover 
does not contaminate the testing of a donor's specimen and to document 
the procedures. The final rule extends this requirement to licensee 
testing facilities because it is a standard forensic practice that is 
necessary to ensure the integrity of the testing process.
    The NRC has added Sec.  26.137(f) [Errors in testing] to require 
licensees and other entities who maintain testing facilities to 
investigate any errors or unsatisfactory performance of the testing 
process, identify the cause(s) of the adverse conditions, and correct 
them. The final rule requires the licensee or other entity to document 
the investigation and any corrective actions taken. The provision 
requires licensees and other entities to investigate any testing errors 
or unsatisfactory performance identified throughout the testing process 
or during the review process that are required under Sec.  26.91 
[Review process for fitness-for-duty policy violations]. The NRC 
intended, in the original rule, that testing or process errors 
discovered in any part of the program, including through the review 
process, be investigated as an unsatisfactory performance of a test. 
This provision clarifies that intent. Thorough investigation and 
reporting of such test results will continue to assist the NRC, the 
licensees, HHS, and the HHS-certified laboratories in preventing future 
occurrences.
    The NRC has reorganized the requirements in proposed Sec.  
26.137(f) into a list format in Sec.  26.137(f)(1)-(f)(5) in the final 
rule to improve the organizational clarity of the rule and added new 
requirements to this section for the reasons discussed with respect to 
each provision.
    Section 26.137(f)(1) requires, whenever possible, that the 
investigation of testing or processing errors must determine relevant 
facts and identify the root cause(s) of the error. Section 26.137(f)(2) 
requires the licensee testing facility to take action to correct the 
cause of any error or unsatisfactory performance within the licensee 
testing facility's control.
    The NRC has added Sec.  26.137(f)(3) to the final rule, with 
respect to the proposed rule, to address instances when testing of a 
quality control sample at a licensee testing facility yields a false 
negative test result. This provision requires the licensee testing 
facility to forward all donor specimens from the analytical run in 
which the error is detected to the HHS-certified laboratory for 
additional testing. This requirement is necessary to ensure that 
licensees and other entities do not permit individuals who may have 
altered a specimen or

[[Page 17089]]

used prohibited drugs to be granted or maintain authorization to have 
the types of access or perform the duties that require them to be 
subject to the rule. Additional testing at the HHS-certified laboratory 
of the donor specimens included in the analytical run during which the 
error is identified ensures that public health and safety and the 
common defense and security are not placed at risk because initial 
validity or drug test results from the licensee testing facility failed 
to identify an individual who has attempted to subvert the testing 
process or engaged in substance abuse. In addition, testing of these 
specimens at the HHS-certified laboratory may also provide the licensee 
testing facility with additional information regarding the cause(s) and 
extent of condition that resulted in the error. The NRC added this 
requirement to the final rule to enhance consistency of the rule's 
requirements for addressing errors in testing at licensee testing 
facilities with those required for addressing errors in testing at HHS-
certified laboratories and in response to public comments received on 
the proposed rule noting the inconsistencies. This requirement is 
consistent with standard forensic practices and meets Goal 1 of this 
rulemaking to update and enhance the consistency of Part 26 with 
advances in other relevant Federal rules and guidelines.
    Section Sec.  26.137(f)(3) also requires the licensee testing 
facility to implement corrective actions before resuming testing of 
donor specimens. For example, if testing of a certified-positive 
quality control sample at the licensee testing facility yields false 
negative test results for opiates, this provision requires the licensee 
testing facility to stop testing donor specimens for opiates until the 
cause(s) of the false negative test are identified and corrected. 
Similarly, if a quality control sample that has been certified to 
contain an adulterant at a concentration above the cutoff levels 
established in Subpart F for validity screening or initial validity 
testing yields a false negative test result, this provision requires 
the licensee testing facility to stop testing for that adulterant until 
the cause(s) of the false negative test result are identified and 
corrected. This requirement is necessary to prevent additional errors 
in testing that could permit individuals who may have altered a 
specimen or used prohibited drugs to be granted or maintain 
authorization to have the types of access or perform the duties that 
require them to be subject to the rule. The NRC added this requirement 
to the final rule to enhance consistency of the rule's requirements for 
addressing errors in testing at licensee testing facilities with those 
required for addressing errors in testing at HHS-certified laboratories 
and in response to public comments received on the proposed rule 
mentioning the inconsistencies. This requirement is consistent with 
standard forensic practices and meets Goal 1 of this rulemaking to 
update and enhance the consistency of Part 26 with advances in other 
relevant Federal rules and guidelines.
    The NRC has added Sec.  26.137(f)(4) to address instances where 
testing conducted at an HHS-certified laboratory identifies a specimen 
that yielded a false negative test result from the licensee testing 
facility. To evaluate whether tests at a licensee testing facility may 
be providing false negative test results, Sec.  26.137(b)(3), (d)(6), 
and (e)(5) require the licensee testing facility to submit some donor 
specimens that yield negative test results to an HHS-certified 
laboratory for additional testing. If, after confirmatory testing by 
the HHS-certified laboratory, a donor specimen yields positive, 
substituted, adulterated, or invalid results, Sec.  26.137(f)(4) 
mandates that the licensee testing facility must take corrective 
action(s) before resuming testing for the drug(s), drug metabolite(s), 
adulterant(s), or other specimen characteristics (i.e., creatinine, pH) 
associated with the donor specimen(s) that yielded the false negative 
result(s). Additionally, Sec.  26.137(f)(4) permits the licensee or 
other entity to re-collect and test specimens from any donor whose test 
results from initial testing at the licensee testing facility may have 
been inaccurate. The NRC added this provision to the final rule for the 
same reasons discussed with respect to Sec.  26.137(f)(3).
    Section 26.137(f)(5) requires the licensee or other entity to 
document the investigation and any corrective actions taken for 
consistency with Criterion XVI in Appendix B to 10 CFR Part 50.
    Section 26.137(g) [Accuracy] retains former Section 2.7(o)(3)(i) in 
Appendix A to Part 26 as it applied to licensee testing facilities. 
This provision requires checking the instruments used in testing for 
accuracy. The final rule moves the former requirement as it relates to 
HHS-certified laboratories to Sec.  26.167(h) in Subpart G for 
organizational clarity.
    Section 26.137(h) [Calibrators and controls] updates former Section 
2.7(o)(2) in Appendix A to Part 26, which established requirements for 
the standards and quality control samples used for performance testing. 
At the time the original paragraph was written, most laboratories 
prepared their own standards and controls. In the ensuing years, the 
number and variety of sources for materials used in performance testing 
have increased. This provision updates the former requirements to refer 
to several of the alternatives, including, but not limited to, pure 
drug reference materials, stock standard solutions from other 
laboratories, and standard solutions obtained from commercial 
manufacturers. The requirements in this paragraph incorporate the 
related requirements in the HHS Guidelines and meet Goal 1 of this 
rulemaking to update and enhance the consistency of Part 26 with 
advances in other relevant Federal rules and guidelines.
Section 26.139 Reporting Initial Validity and Drug Test Results
    The NRC has added Sec.  26.139 to combine requirements related to 
the reporting and management of test results from the licensee testing 
facility that were interspersed throughout former Appendix A to Part 
26. The agency made this change to meet Goal 6 of this rulemaking to 
improve clarity in the organization of the final rule, by grouping 
related requirements together in a single section.
    Section 26.139(a) amends former Section 2.7(g)(2) in Appendix A to 
Part 26. That provision established requirements for the manner in 
which HHS-certified laboratories and licensee testing facilities must 
report test results to licensee management. The final rule amends the 
former provision by moving the former requirements that were related to 
reporting test results from HHS-certified laboratories to Sec.  
26.169(b) of Subpart G for organizational clarity. The final rule also 
deletes the former reference to ``special processing'' and replaces it 
with reference to validity test results, consistent with the addition 
of requirements to conduct validity testing throughout the final rule, 
as discussed with respect to Sec.  26.31(d)(3)(i). The NRC made these 
changes to improve clarity in the language and organization of the rule 
consistent with Goal 6 of this rulemaking.
    With respect to the proposed rule, the final rule eliminates use of 
the term ``non-negative'' in Sec.  26.139(a) for the reasons discussed 
with respect to Sec.  26.5 for eliminating this term throughout the 
proposed rule. Eliminating the term ``non-negative'' and replacing it 
with terms to describe specific results of drug and validity testing 
(e.g., ``positive,'' ``adulterated''), necessitates splitting the last 
sentence of proposed Sec.  26.139(a) into two sentences for clarity. 
Therefore, the final rule prohibits licensee testing facilities from 
reporting to licensee or

[[Page 17090]]

other entity management any positive drug test results from initial 
drug testing at the licensee testing facility, except as permitted 
under Sec.  26.75(h). The final rule also prohibits licensee testing 
facilities from reporting to licensee or other entity management any 
validity screening and initial validity test results that indicate a 
specimen is of questionable validity and any positive initial drug test 
results from specimens that are of questionable validity. The NRC made 
these changes to improve clarity in the language of the rule, 
consistent with Goal 6 of this rulemaking.
    Section 26.139(b) amends the last sentence of former Sec.  
26.24(d)(1), which specified the individuals to whom results of initial 
tests from the licensee testing facility may be released. The NRC added 
the MRO's staff to the list of individuals who are permitted to have 
access to the results of initial tests performed at the licensee 
testing facility consistent with the addition of this job role to the 
final rule. Individuals who are serving as MRO staff members require 
access to initial test results from a licensee's testing facility in 
the course of performing their administrative duties for the MRO. 
Additionally, with respect to the proposed rule, the final rule permits 
an SAE to access initial test results when appropriate consistent with 
the addition of this job role to the final rule. Omitting the SAE from 
this provision was an unintended oversight in the proposed rule which 
the NRC has corrected in the final rule.
    Section 26.139(c) amends former Section 2.7(o)(5) in Appendix A to 
Part 26. The NRC has moved the requirements in the former paragraph 
that addressed the availability of personnel to testify in proceedings 
related to drug test results from an HHS-certified laboratory to Sec.  
26.153(f)(2) of Subpart G for organizational clarity. The final rule 
moves the former requirement for licensee testing facility personnel to 
be available to testify at any proceedings with respect to breath 
analysis test results to Sec.  26.85(d) [Personnel available to testify 
at proceedings] because the collection site and not the licensee 
testing facility is typically responsible for quality control of 
alcohol testing equipment. The agency made these changes for 
organizational clarity in the rule, consistent with Goal 6 of this 
rulemaking.
    Section 26.139(d) amends the portions of former Section 2.7(g)(6) 
in Appendix A to Part 26 that applied to the summary report that 
licensee testing facilities must provide to FFD program management. The 
NRC has replaced the former requirement for the licensee testing 
facility to prepare a monthly report of test results with a requirement 
for the licensee testing facility to summarize the data annually in the 
FFD program performance report required under Sec.  26.717(b) of the 
final rule. Experience implementing the former requirement for a 
monthly statistical summary has indicated that the monthly summary has 
not been as useful to licensees for ongoing monitoring of testing 
program effectiveness as other mechanisms that licensees have 
developed. Therefore, the final rule replaces the monthly reporting 
requirement in former Section 2.7(g)(6) in Appendix A to Part 26 with a 
requirement in Sec.  26.139(f) of the final rule for FFD program 
management to monitor the ongoing effectiveness of the licensee testing 
facility testing program. This change meets Goal 5 of this rulemaking 
to improve Part 26 by eliminating or modifying unnecessary 
requirements. The NRC has moved the requirements in the former 
paragraph that addressed summary reports from HHS-certified 
laboratories to Sec.  26.169(k) of Subpart G for organizational 
clarity. With respect to the proposed rule, the agency changed the 
cross-reference to FFD program performance reporting requirements in 
Sec.  26.217(b) in the proposed rule to Sec.  26.717(b) in the final 
rule to reflect the changes the NRC has made in the organization of the 
final rule.
    Section 26.139(e) amends former Section 2.7(g)(7) in Appendix A to 
Part 26. That provision required licensee testing facilities and HHS-
certified laboratories to report test results for both the cutoff 
levels specified in Part 26 and any more stringent cutoff levels used 
by the FFD program. The NRC has relocated the former requirement 
related to HHS-certified laboratories to Sec.  26.169(c) of Subpart G 
for organizational clarity. The final rule requires licensees and other 
entities who operate testing facilities, and have adopted more 
stringent cutoff levels for initial tests for drugs and drug 
metabolites than those specified in Sec.  26.133 [Cutoff levels for 
drugs and drug metabolites], to conduct tests and report test results 
based only on their more stringent cutoff levels. The basis for the 
former requirement to conduct tests and report test results for the 
cutoff levels specified in this part, when the licensee is using more 
stringent cutoff levels, was a method by which the NRC monitored 
licensee implementation of the permission to use more stringent cutoff 
levels. The final rule eliminates this requirement, because Sec.  
26.31(d)(3)(iii)(C) requires a qualified forensic toxicologist to 
certify the scientific and technical suitability of the licensee's or 
other entity's testing process at any lower cutoff levels. Therefore, 
the testing and reporting requirements in the former rule are no longer 
needed to monitor licensee testing facility performance in this area. 
The final rule continues to require licensee testing facilities to 
report test results (and the cutoff levels used) from testing for 
additional drugs and drug metabolites, beyond those specified in Sec.  
26.31(b)(1).
    Section 26.139(f) has been added to require FFD program management 
to monitor the ongoing effectiveness of the licensee testing facility 
testing program. The final rule provides examples of the types of 
information and possible program performance indicators that licensees 
and other entities may use for program monitoring. The final rule also 
requires FFD program management to make adjustments to the testing 
program in response to information gained from the ongoing monitoring. 
These requirements replace the monthly summary report required under 
former Section 2.7(g)(7) in Appendix A to Part 26 to strengthen FFD 
programs by ensuring that licensees monitor licensee testing facility 
performance on an ongoing basis and correct any weaknesses as they are 
identified. The paragraph is also consistent with the NRC's 
performance-based approach to regulation. This change meets Goal 3 of 
this rulemaking to improve the effectiveness of FFD programs, as 
discussed in Section IV.B.

Subpart G--Laboratories Certified by the Department of Health and Human 
Services

Section 26.151 Purpose
    The NRC has added Sec.  26.151 to introduce the purpose of the 
subpart, which is to establish requirements for the HHS-certified 
laboratories that licensees and other entities must use for testing 
urine specimens for validity and the presence of drugs and drug 
metabolites. Adding this paragraph meets Goal 6 of this rulemaking to 
improve clarity in the organization and language of the rule. The 
majority of the requirements in this subpart are based on the former 
requirements in Appendix A to Part 26, as they relate to HHS-certified 
laboratories. However, the rule substantially updates the former 
requirements to be consistent with the HHS Guidelines.

[[Page 17091]]

Section 26.153 Using Certified Laboratories for Testing Urine Specimens
    The NRC added Sec.  26.153 to group into one section requirements 
related to the use of HHS-certified laboratories by licensees and other 
entities who are subject to the rule.
    Section 26.153(a) combines and updates former requirements for 
licensees and other entities to use HHS-certified laboratories for 
initial and confirmatory drug testing of urine specimens. The paragraph 
relocates and combines former Sec.  26.24(f) and former Sections 1.1(3) 
and 4.1(a) in Appendix A to Part 26. These provisions required 
licensees and other entities to use HHS-certified laboratories for drug 
testing. The NRC made this change to eliminate redundancies in the 
former rule and improve organizational clarity. The paragraph updates 
the former citations for the HHS Guidelines because the guidelines have 
been amended several times since the former rule was published. In 
addition, the provision provides current contact information for 
obtaining information about the certification status of HHS-certified 
laboratories because the contact information has changed since the 
former rule was published. The paragraph also adds a requirement for 
licensees and other entities to use HHS-certified laboratories for 
initial and confirmatory validity testing, consistent with the addition 
of urine specimen validity testing requirements to the rule, as 
discussed with respect to Sec.  26.31(d)(3)(i). The rule also updates 
the cross-reference to former Sec.  26.24(d), which permitted licensee 
testing facilities to conduct initial drug tests, to reference the 
related provision in the final rule, Sec.  26.31(d)(3)(ii).
    Section 26.153(b) amends the first sentence of former Section 
2.7(l)(2) in Appendix A to Part 26. The former provision required HHS-
certified laboratories to have the capability, at the same laboratory 
premises, of performing initial and confirmatory tests for any drug and 
drug metabolite for which service is offered and confirmatory testing 
of blood for alcohol concentrations. The former requirement for HHS-
certified laboratories to be capable of conducting confirmatory alcohol 
testing of blood has been deleted for the reasons discussed with 
respect to Sec.  26.83(a). The paragraph adds a requirement for HHS-
certified laboratories to have the capability to perform both initial 
validity and confirmatory validity tests at the same premises for 
consistency with the addition of requirements to perform validity 
testing to the rule, as discussed with respect to Sec.  26.31(d)(3)(i). 
The second sentence of former Section 2.7(l)(2) in Appendix A to Part 
26, which established requirements for the capabilities of licensee 
testing facilities, has been moved to Sec.  26.123 of Subpart F 
[Licensee Testing Facilities] for organizational clarity. The agency 
deleted the last sentence of the former paragraph, which permitted the 
testing of breath specimens for alcohol at the collection site, because 
the rule addresses alcohol testing in Subpart E [Collecting Specimens 
for Testing]. These organizational changes to the former paragraph have 
been made to meet Goal 6 of this rulemaking to improve clarity in the 
organization and language of the rule.
    Section 26.153(c) amends the first sentence of former Section 
2.7(k) in Appendix A to Part 26. The former provision prohibited HHS-
certified laboratories from subcontracting unless authorized by the 
licensee. The rule extends this restriction to subcontracting for 
specimen validity testing for consistency with the addition of 
requirements to perform validity testing to the rule, as discussed with 
respect to Sec.  26.31(d)(3)(i). The second sentence of former Section 
2.7(k) has been deleted from the paragraph for several reasons: First, 
the requirement to have the capability to test for marijuana, cocaine, 
opiates, phencyclidine, and amphetamines has been deleted because it is 
redundant with Sec.  26.31(d)(1). The requirement to be capable of 
testing whole blood has been deleted because the rule no longer permits 
donors to request confirmatory alcohol testing of blood for the reasons 
discussed with respect to Sec.  26.83(a). Finally, the requirement for 
laboratories to be capable of using gas chromatography/mass 
spectrometry (GC/MS) has been eliminated because HHS-certified 
laboratories would be permitted to use other methods of confirmatory 
testing, consistent with related revisions to the HHS Guidelines.
    Section 26.153(d) amends former Section 4.1(b) in Appendix A to 
Part 26, which required licensees and C/Vs to use only HHS-certified 
laboratories who agree to follow the same rigorous testing, quality 
control, and chain-of-custody procedures when testing for more 
stringent cutoff levels, additional drugs to those for which testing 
required under Part 26, and blood. The final rule eliminates reference 
to testing for blood in this provision because the rule no longer 
permits donors to request confirmatory alcohol testing of blood for the 
reasons discussed with respect to Sec.  26.83(a).
    Section 26.153(e) amends the third sentence of former Section 
2.7(m) in Appendix A to Part 26. That sentence required licensees to 
conduct an inspection and evaluation of a laboratory's drug testing 
operations before using the laboratory's services. Some licensees have 
incorrectly interpreted the former regulation as requiring licensee 
employees to perform the pre-award inspection and evaluation. In many 
cases, however, appropriately qualified licensee employees may not be 
available to perform the inspection and evaluation, and the use of 
contracted experts may be necessary to achieve the NRC's intent. The 
paragraph revises the former requirement to indicate that licensees and 
other entities are responsible ``to ensure'' that the inspection and 
evaluation is performed, in order to clearly indicate that the use of 
expert contractors is acceptable. In addition, the rule clarifies that 
the pre-award inspection and evaluation must be performed by qualified 
individuals.
    Section 26.153(e) also permits a licensee or other entity to begin 
using the services of another HHS-certified laboratory immediately, 
without a pre-award evaluation and inspection, in the event that the 
licensee's or other entity's primary laboratory loses its 
certification. To be considered acceptable, the rule requires that the 
replacement laboratory must be in use by another Part 26 program. The 
rule adds this provision to ensure that testing can continue, in the 
event that the HHS-certified laboratory on whom a licensee or other 
entity relies loses its certification, as some licensees have 
experienced. Related requirements for auditing the replacement 
laboratory are specified in Sec.  26.41(g)(5).
    The agency added Sec.  26.153(f) to require that licensees' and 
other entities' contracts with HHS-certified laboratories must require 
the laboratories to implement the applicable requirements of this part. 
Because the NRC does not regulate HHS-certified laboratories, this 
revision would ensure that the agency has a legal basis for requiring 
HHS-certified laboratories to comply with this part when conducting 
testing for licensees and other entities.
    Section 26.153(f)(1) retains the requirement in former Section 
2.7(l)(1) in Appendix A to Part 26. The former requirement stated that 
HHS-certified laboratories must comply with applicable State licensor 
requirements. The final rule replaces the term ``HHS-certified 
laboratories'' with the term ``laboratory facilities'' to clarify that 
State requirements apply to laboratory facilities rather than to the 
HHS-

[[Page 17092]]

certified laboratory as a corporate entity. The clarification is 
necessary because some HHS-certified laboratories are operated by large 
national corporations with facilities in several different States, and 
only the facilities in a specific State are required to meet the 
requirements of that State. The NRC made this change for clarity in the 
language of the rule as well as consistency with the HHS Guidelines.
    Section 26.153(f)(2) amends former Section 2.7(o)(5) in Appendix A 
to Part 26. The former regulation required HHS-certified laboratories 
to make available qualified personnel to testify in proceedings based 
on urinalysis results reported by the laboratory. The NRC moved the 
reference to licensee testing facilities to Sec.  26.139(c) in Subpart 
F for organizational clarity. The requirement for qualified personnel 
to be available to testify in proceedings related to breath analysis 
results has been moved to Sec.  26.85(d) in Subpart E for 
organizational clarity and because responsibility for testifying with 
respect to breath analysis results resides with the licensee's or other 
entity's collection site personnel.
    Section 26.153(f)(3) updates former Section 3.1 in Appendix A to 
Part 26, which required HHS-certified laboratories to protect donors' 
records. The former requirement for licensee testing facilities to 
protect donors' records has been subsumed within the second sentence of 
Sec.  26.37(a) for organizational clarity. The cross-reference to 
former Sec.  26.29 has been updated to reference Sec.  26.39 in the 
final rule.
    Section 26.153(f)(4) updates former Section 3.2 in Appendix A to 
Part 26. Specifically, the rule adds a reference to Sec. 503 of Pub. L. 
100-71 to document the basis for this requirement. The paragraph adds a 
requirement for a donor to have access to records relating to his or 
her validity test results for consistency with the addition of validity 
testing requirements to the rule, as discussed with respect to Sec.  
26.31(d)(3)(i). The paragraph deletes the former reference to records 
related to alcohol test results because the final rule will no longer 
require HHS-certified laboratories to be capable of testing blood 
specimens for alcohol, as discussed with respect to Sec.  26.83(a). 
With respect to the proposed rule, the NRC has added a phrase to the 
provision to clarify that a donor's designated representative is also 
permitted to have access to records relating to the donor's validity 
test results. The NRC made this change in response to a public comment 
requesting the clarification.
    The NRC added Sec.  26.153(f)(5) to clarify that HHS-certified 
laboratories must avoid relationships with a licensee's or other 
entity's MRO(s) that may be construed as a potential conflict of 
interest. The final rule, with respect to the proposed rule, adds a 
reference to provisions added in the final rule at Sec.  26.183(b) to 
specify specific conflict of interest relationships. The NRC added the 
provisions in Sec.  26.183(b) in response to a comment on the proposed 
rule requesting the NRC to consider using the examples of MRO conflict 
of interest relationships specified in DOT's drug and alcohol testing 
regulations. The paragraph responds to the experiences of other Federal 
agencies regarding apparent conflicts of interest involving 
laboratories and MROs. Although the NRC is not aware of any situations 
of this type in Part 26 programs, the integrity of the MRO function is 
sufficiently important that incorporating this requirement is warranted 
to prevent potential conflict of interest concerns. The paragraph is 
consistent with the related provision in the HHS Guidelines.
    Section 26.153(f)(6) amends the requirements in the first two 
sentences of former Section 2.7(m) in Appendix A to Part 26, which 
required HHS-certified laboratories to permit the NRC, licensees, and 
other entities to conduct inspections at any time, including 
unannounced inspections. The rule deletes, for organizational clarity, 
the existing references to collection site services and licensee 
testing facilities, which are covered under Subpart F. The paragraph 
also deletes reference to confirmatory testing of blood specimens for 
alcohol because HHS-certified laboratories are no longer testing blood 
specimens for alcohol, as discussed with respect to Sec.  26.83(a).
    A new Sec.  26.153(g) requires licensees and other entities to 
provide a memorandum for the record to the HHS-certified laboratories 
that they use to document why the licensee or other entity is using a 
non-Federal custody-and-control form. Under the HHS Guidelines, 
laboratories may reject any specimen that is submitted for testing with 
a non-Federal custody-and-control form unless the licensee or other 
entity provides a memorandum for the record. The paragraph is necessary 
to prevent licensee and other entity specimens from being rejected.
Section 26.155 Laboratory Personnel
    Section 26.155 updates former Section 2.5 in Appendix A to Part 26 
to be consistent with revisions to the HHS Guidelines.
    Section 26.155(a) [Day-to-day management of the HHS-certified 
laboratory] amends former Section 2.5(a)(1) in Appendix A to Part 26, 
which required the HHS-certified laboratory to have a qualified 
individual to assume responsibility for day-to-day management of the 
HHS-certified laboratory. Specifically, the paragraph replaces the term 
``qualified individual'' with the term ``responsible person'' for 
consistency with terminology that other Federal agencies use to refer 
to this job role. The final rule retains the majority of Section 
2.5(a)(2) in Appendix A to Part 26 and establishes qualification 
requirements for the responsible person. The provisions in Sec.  
26.155(a)(1)(i)-(a)(1)(iv) retain former Section 2.5(a)(2)(i)-
(a)(2)(iv) in Appendix A to Part 26, with minor grammatical changes 
that are consistent with similar changes to the related provisions in 
the HHS Guidelines.
    Section 26.155(a)(2) and (a)(3) establishes minimum day-to-day 
management responsibilities of the responsible person and retains 
former Section 2.5(a)(4) and (a)(5) in Appendix A to Part 26.
    Section 26.155(a)(4) retains former Section 2.5(a)(5) in Appendix A 
to Part 26, which relates to the responsible person's responsibility to 
maintain the HHS-certified laboratory procedures in a manual. With 
respect to the proposed rule, the final rule includes a provision that 
HHS-certified laboratories' procedures be maintained in a manual of 
standard operating procedures. The proposed rule eliminated the former 
requirement in Section 2.5(a)(5) to provide flexibility to HHS-
certified laboratories in how laboratory operating procedures were 
maintained. However, based on a comment received on the proposed rule, 
the NRC has reinstituted the former requirement that laboratory 
procedures be maintained in a manual to improve consistency with the 
HHS Guidelines, meeting Goal 1 of this rulemaking. The paragraph 
retains the former requirements in the second and third sentences of 
Section 2.5(a)(5) in Appendix A to Part 26, and requires the 
responsible person to review, sign, and date the procedures when they 
are first placed in use, changed, or a new individual assumes 
responsibility for management of the laboratory. The responsible person 
must also maintain copies of the procedures. The final rule updates the 
former cross-reference to Section 2.7(o) in Appendix A to Part 26 to 
reference Sec.  26.157, consistent with the organizational changes made 
to the rule.
    Section 26.155(a)(5) and (a)(6) retains former Section 2.5(a)(6) 
and (a)(7) in

[[Page 17093]]

Appendix A to Part 26. These provisions define the responsible person's 
responsibilities with respect to maintaining a quality assurance 
program and taking remedial actions to maintain satisfactory laboratory 
operations.
    Section 26.155(b) [Certifying scientist] amends former Section 
2.5(b) in Appendix A to Part 26 to be consistent with changes made to 
the related requirement in the HHS Guidelines. Consistent with the HHS 
Guidelines, the rule provides more detailed requirements with respect 
to the individual who certifies test results at the HHS-certified 
laboratory before they are transmitted to the licensee or other 
entity's MRO.
    In Sec.  26.155(b)(1), a new job title, ``certifying scientist,'' 
replaces the term ``qualified individual(s)'' in the first sentence of 
former Section 2.5(b) in Appendix A to Part 26 for consistency with a 
related change in the HHS Guidelines. The final rule, with respect to 
the proposed rule, replaces the phrase ``attest the validity of'' with 
``certify'' test results, as this is a more accurate description of the 
responsibilities of a certifying scientist. The NRC made this change in 
response to a comment received on the proposed rule. Section 
26.155(b)(2) specifies the required qualifications of individuals who 
serve as certifying scientists. Section 26.155(b)(3) permits 
laboratories to use more than one certifying scientist with differing 
responsibilities.
    Section 26.155(c) [Day-to-day operations and supervision of 
analysts] retains former Section 2.5(c) in Appendix A to Part 26. The 
rule makes minor language changes to the former paragraph to increase 
the consistency of the language in this provision with that of the 
related provision in the HHS Guidelines.
    Section 26.155(d) [Other personnel] and (e) [Training] retains 
former Section 2.5(d) and (e) in Appendix A to Part 26, respectively.
    Section 26.155(f) [Files] updates former Section 2.5(f) in Appendix 
A to Part 26. The revisions are consistent with related requirements in 
the HHS Guidelines.
Section 26.157 Procedures
    Section 26.157 reorganizes and amends requirements for HHS-
certified laboratories' procedures. The requirements for procedures 
were interspersed throughout former Appendix A to Part 26, including 
requirements contained in former Sections 2.2 and 2.7 in Appendix A to 
Part 26. The NRC has combined procedural requirements for the 
laboratories into a single section to improve organizational clarity in 
the rule.
    In Sec.  26.157(a), the agency has made minor editorial changes to 
the first sentence of former Section 2.2 in Appendix A to Part 26, but 
retains the former requirement for HHS-certified laboratories to have 
detailed procedures for conducting testing. The rule deletes the former 
reference to blood samples because donors no longer have the option to 
request blood testing for alcohol, as discussed with respect to Sec.  
26.83(a). Reference to licensee testing facilities has been moved to 
Sec.  26.127(a) in Subpart F for organizational clarity. The rule also 
deletes reference to procedures for specimen collections, because the 
NRC relocated procedural requirements for specimen collections to 
Subpart E in the final rule.
    Section 26.157(b) combines and amends portions of the requirements 
in the first sentence of former Sections 2.4(d) and 2.7(a)(2) in 
Appendix A to Part 26 related to the content and implementation of 
specimen chain-of-custody procedures. The regulation retains the 
portions of the former paragraphs that required HHS-certified 
laboratories to develop, implement, and maintain written chain-of-
custody procedures to maintain control and accountability of specimens 
from receipt through completion of testing and reporting of results, 
during storage and shipping to another HHS-certified laboratory, and 
continuing until final disposition of the specimens. The former 
requirements related to licensee testing facilities have been moved to 
Sec.  26.127(b) in Subpart F for organizational clarity. The rule also 
removes references to custody-and-control procedures for blood 
specimens because donors no longer have the option to request blood 
testing for alcohol, as discussed with respect to Sec.  26.83(a).
    The NRC has amended the portions of former Section 2.7(o)(1) in 
Appendix A to Part 26 that address the required content of procedures 
for HHS-certified laboratories. Section 26.157(c) retains the portions 
of the former provision that required laboratories to develop and 
maintain written procedures to specify all of the elements of the 
testing process, including, but not limited to, the principles of each 
test and the preparation of reagents, standards, and controls. The 
paragraph presents the required topics of the procedures in a list 
format in Sec.  26.157(c)(1) through (c)(12) to clarify that each topic 
stands on its own. For organizational clarity, two portions of the 
former provision have been moved to other subparts of the rule that 
address related topics. The NRC relocated requirements for licensee 
testing facility procedures to Sec.  26.127(c) in Subpart F. In 
addition, the rule moves the last two sentences of former Section 
2.7(o)(1), which specify records retention requirements, to Sec.  
26.715(b)(4) of Subpart N [Recordkeeping and Reporting Requirements].
    Section 26.157(d) amends former Section 2.7(o)(3)(iii) in Appendix 
A to Part 26. The final (and former) provision requires procedures for 
the setup and normal operation of testing instruments; a schedule for 
checking critical operating characteristics for all instruments; 
tolerance limits for acceptable function checks; and instructions for 
major troubleshooting and repair. The rule makes three changes to the 
former provision for organizational clarity. The paragraph presents the 
required topics of the procedures in a list format in Sec.  
26.157(d)(1)-(d)(3) to clarify that each topic stands on its own. The 
former requirement to maintain records of preventative maintenance has 
been relocated to Sec.  26.715(b)(10) in Subpart N. And, the rule moves 
the former requirements that apply to licensee testing facilities to 
Sec.  26.127(d) in Subpart F.
    Section 26.157(e) amends former Section 2.7(o)(4) in Appendix A to 
Part 26, but continues to require documented corrective actions if 
systems are out of acceptable limits or errors are detected. The 
requirements in the former paragraph that apply to licensee testing 
facilities have been moved to Sec.  26.127(e) in Subpart F for 
organizational clarity.
Section 26.159 Assuring Specimen Security, Chain of Custody, and 
Preservation
    The NRC added Sec.  26.159 to present in one section the 
requirements of the rule that apply to HHS-certified laboratories with 
respect to the safeguarding of specimen identity, integrity, and 
security. This organizational change consolidates requirements that 
were dispersed throughout the former rule.
    Section 26.159(a) amends former Section 2.7(a)(1) in Appendix A to 
Part 26. This provision retains the first three sentences of former 
Section 2.7(a)(1) in Appendix A to Part 26, which required HHS-
certified laboratories to be secure and accessible only to authorized 
personnel. For organizational clarity, the NRC moved the requirements 
that apply to licensee testing facilities to Sec.  26.129(a) in Subpart 
F. The last sentence of the former paragraph, which establishes 
recordkeeping requirements, has been moved to Sec.  26.715(b)(13) in 
Subpart N. In addition, the NRC has

[[Page 17094]]

revised the last sentence of the former paragraph to increase clarity 
in the requirement and expands the list of persons who are authorized 
to have access to the laboratory to include representatives of the 
Secretary of HHS and emergency responders. This change increases the 
consistency of Part 26 with the related provision in the HHS 
Guidelines.
    Section 26.159(b) amends former Section 2.7(b)(1) in Appendix A to 
Part 26. That provision established requirements for receiving 
specimens at the HHS-certified laboratory and assuring their integrity 
and identity. The final rule makes several organizational changes to 
the former rule by dividing the provision into paragraphs Sec.  
26.159(b)(1) and (b)(2) for increased organizational clarity.
    Section 26.159(b)(1) retains the former requirement for the HHS-
certified laboratory to report evidence of tampering to licensees' or 
other entities' management within 24 hours of discovery, as well as the 
requirement for the laboratory to document any evidence of tampering on 
the specimen's custody-and-control form. The rule moves the former 
requirements related to licensee testing facilities to Sec.  26.129(b) 
in Subpart F for organizational clarity. With respect to the proposed 
rule, the final rule adds several requirements to the provision.
    The NRC has renumbered as Sec.  26.159(b)(1)(i), but retained 
without change, the portion of proposed Sec.  26.159(b)(1) that 
required licensee or other entity management personnel to ensure that 
an investigation is initiated if any indications of specimen tampering 
are identified, and take corrective actions if tampering is confirmed. 
The appropriate corrective actions will depend on the nature of the 
tampering identified as a result of the investigation. For example, if 
the investigation indicates that the tampering was an attempt to 
subvert the testing process and the persons involved are identified, 
the rule requires licensee and other entity management personnel to 
impose the sanctions in Sec.  26.75(b) for a subversion attempt.
    Section 26.159(b)(1)(ii) requires the licensee and other entity to 
collect another specimen as soon as possible, if the licensee or other 
entity has reason to question the integrity and identity of a specimen. 
With respect to the proposed rule, the final rule eliminates the need 
to collect another specimen 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. If this circumstance 
arises and the licensee testing facility has retained the specimen in 
Bottle B and it is intact, the rule requires the licensee testing 
facility to forward the intact specimen for testing to the HHS-
certified laboratory. The NRC added this provision to the final rule in 
response to public comments on the related provision in the proposed 
rule. The commenters requested the NRC to include this provision from 
DOT's procedures. The NRC agreed with the commenters' suggestion 
because eliminating the recollection when an intact specimen is 
available reduces the burden on donors that a recollection would 
impose.
    The final rule, with respect to the proposed rule, establishes a 
new section, Sec.  26.159(b)(2) to specify the exclusive grounds 
requiring an MRO to cancel a test. The NRC added this section in 
response to public comments received on the proposed rule that 
requested this clarification. Section 26.159(b)(2)(i) requires the MRO 
to cancel a test if the custody and control form does not contain 
information to identify the specimen collector and the collection site 
cannot provide conclusive evidence of the collector's identity. Section 
26.159(b)(2)(ii) requires the MRO to cancel a test if the 
identification numbers on the specimen bottle seal(s) do not match the 
identification numbers on the custody-and-control form. Section 
26.159(b)(2)(iii) requires the MRO to cancel a test if a specimen 
bottle seal is broken or shows evidence of tampering and an intact 
specimen, as specified in paragraph (b)(1)(ii) of this section, does 
not exist. Section 26.159(b)(2)(iv) requires the MRO to cancel a test 
if the specimen appears to have leaked out of its sealed bottle and 
there is less than 15 mL remaining, and an intact specimen, as 
specified in paragraph (b)(1)(ii) of this section, does not exist. 
Section 26.159(b)(2)(v) requires the MRO to cancel a test if the 
provisions of Sec.  26.165(f)(2) apply. The NRC incorporated these 
requirements from the related DOT procedures.
    Section 26.159(c) updates and combines former Section 2.7(b)(2) in 
Appendix A to Part 26 with portions of former Sections 2.7(n) and 3.1 
in Appendix A to Part 26. These regulations in the former rule 
established requirements for chain-of-custody procedures for specimens 
and aliquots at licensee testing facilities and HHS-certified 
laboratories. For organizational clarity, the NRC has relocated the 
requirements in the former paragraphs that are related to licensee 
testing facilities to Sec.  26.129(c) in Subpart F. The final rule 
retains the requirements in former Sections 2.7(n) and 3.1 in Appendix 
A to Part 26, which require the laboratory to maintain the original 
specimen and custody-and-control form in secure storage at the HHS-
certified laboratory. The NRC made these changes to reduce redundancies 
and improve the organizational clarity of the rule.
    Section 26.159(d) and (e) updates the portions of former Section 
2.7(a)(2) in Appendix A to Part 26 that established requirements for 
HHS-certified laboratory personnel to maintain and document the chain 
of custody for specimens and aliquots, by replacing the former 
paragraph with two related provisions from the HHS Guidelines. 
Paragraph (d) in this section requires the laboratory's internal 
custody-and-control form to allow for identification of the donor, 
documentation of the testing process and transfers of custody of the 
specimen. The agency added the phrase, ``within the laboratory,'' to 
paragraph (e) of this section to clarify that the requirement to 
document each instance of handling and transfer of specimens applies to 
internal laboratory activities and does not apply to transfers 
involving couriers. For organizational clarity, the rule relocates the 
requirements in the former paragraph that are related to licensee 
testing facilities to Sec.  26.129(d) and (e) in Subpart F.
    Section 26.159(f) and (g) separates former Section 2.4(i) in 
Appendix A to Part 26 into two paragraphs, for the reasons discussed 
with respect to the similar provisions of Sec.  26.117(i) and (k) and 
Sec.  26.129(g) and (h). The paragraphs repeat the requirements for 
packaging and shipping positive, adulterated, substituted, or invalid 
specimens that have been presented in Sec.  26.117(i) and (k) of 
Subpart E and Sec.  26.129(g) and (h) in Subpart F, but apply them to 
packaging and shipping specimens from one HHS-certified laboratory to 
another. The bases for these requirements are discussed with respect to 
Sec.  26.117(i) and (k). With respect to the proposed rule, the final 
rule clarifies Sec.  26.159(f) to ensure that a copy of the custody-
and-control form, rather than the original custody-and-control form, is 
included with an aliquot of a single specimen or Bottle B of a split 
specimen that is transferred to a second HHS-certified laboratory for 
testing. The NRC made this change in response to a public comment on 
this provision that noted the proposed provision was inconsistent with 
the related requirement in the HHS Guidelines.
    Section 26.159(h) replaces former Section 2.7(c) in Appendix A to 
Part 26. The former provision established requirements for 
refrigerating urine

[[Page 17095]]

specimens at the HHS-certified laboratory and licensee testing facility 
to protect them from degradation. The rule replaces the former 
paragraph with the simplified language of the related provision in the 
HHS Guidelines. The NRC moved the requirements related to short-term 
refrigerated storage at licensee testing facilities to Sec.  26.129(f) 
in Subpart F for organizational clarity. The final rule, with respect 
to the proposed rule, adds the Fahrenheit temperature level that is 
equivalent to the Celsius temperature level included in the proposed 
rule to improve the clarity of the final rule.
    In Sec.  26.159(i), the NRC amends former Section 2.7(h) in 
Appendix A to Part 26. The former requirement established requirements 
for long-term frozen storage of positive urine specimens at HHS-
certified laboratories and licensee testing facilities. For 
organizational clarity, the NRC moved the requirements related to long-
term storage of specimens by licensee testing facilities to Sec.  
26.135(c) in Subpart F. The rule adds requirements for storing 
specimens that yield adulterated, substituted, or invalid test results 
from specimen validity testing, consistent with the addition of 
requirements to conduct validity testing throughout the rule, as 
discussed with respect to Sec.  26.31(d)(3)(i). The NRC has eliminated 
the reference to ``administrative or disciplinary proceedings'' in the 
first sentence of the former paragraph because there are other 
circumstances in which it may be necessary to have a specimen available 
for retesting, including, but not limited to, retesting an aliquot of 
an invalid specimen at a second HHS-certified laboratory under Sec.  
26.161(g). The rule also updates the terminology used in the former 
paragraph by adding a reference to ``Bottle B'' of a split specimen. As 
discussed with respect to Sec.  26.5 [Definitions], these changes in 
terminology are intended to improve clarity in the language of the 
rule.
    The NRC added Sec.  26.159(j) to incorporate related changes to the 
HHS Guidelines. The final rule permits the HHS-certified laboratory to 
discard negative specimens. This paragraph also permits laboratories to 
pool specimens that are certified to be negative for drugs and drug 
metabolites and valid, as well as use them as quality control samples, 
as permitted under the HHS Guidelines. With respect to the proposed 
rule, the final rule prohibits the laboratory from retaining any 
information linking donors to specimens that are pooled for use in the 
laboratory's internal quality control program. The NRC added this 
prohibition in response to a public comment received on the proposed 
rule. This addition meets Goal 7 of this rulemaking to protect the 
privacy and other rights (including due process) of individuals who are 
subject to Part 26.
Section 26.161 Cutoff Levels for Validity Testing
    A new Sec.  26.161 establishes maximum cutoff levels and methods 
for conducting specimen validity testing at HHS-certified laboratories, 
consistent with the addition of requirements to conduct validity 
testing throughout the rule, as discussed with respect to Sec.  
26.31(d)(3)(i). The rule incorporates these requirements from the HHS 
Guidelines as revised on April 13, 2004, (69 FR 19644) to meet, in 
part, Goal 1 of this rulemaking to update and enhance the consistency 
of Part 26 with advances in other relevant Federal rules and 
guidelines. This section prohibits licensee and other entities from 
using more stringent validity test cutoff levels to ensure consistency 
among licensees and other entities and reduce the likelihood of false 
adulterated, substituted, or invalid test results, and ensure that 
donors are not subject to sanctions on the basis of inaccurate test 
results. The prohibition supports Goal 7 of this rulemaking to protect 
the privacy and other rights (including due process) of individuals who 
are subject to Part 26.
    The NRC added Sec.  26.161(a) to specify that HHS-certified 
laboratories must conduct initial and, if necessary, confirmatory 
validity testing using two different aliquots of a urine specimen. This 
provision incorporates the related provision from the HHS Guidelines. 
With respect to the proposed rule, the final rule revises the provision 
to clarify that confirmatory testing of a second aliquot is required if 
initial validity test results indicate that the specimen may be 
adulterated, substitute, dilute, or invalid. The final rule also adds a 
requirement that licensees and other entities must ensure that the HHS-
certified laboratory is capable of conducting, and conducts, 
confirmatory testing for at least one oxidizing adulterant and any 
other adulterants for which the licensee's or other entity's FFD 
program conducts testing. The agency made these changes in response to 
public comments and to improve clarity in the language of the rule.
    The agency added Sec.  26.161(b) to establish requirements and 
cutoff levels for initial validity tests to be performed at HHS-
certified laboratories. With respect to the proposed rule, the final 
rule renumbers these paragraphs to improve the organization and clarity 
of the rule. Section 26.161(b)(1) through (b)(5) establishes 
requirements for initial validity tests that HHS-certified laboratories 
must conduct on a primary specimen. The primary specimen is either a 
single specimen submitted by an FFD program that does not follow split 
specimen procedures, or the specimen contained in Bottle A of a split 
specimen. For initial validity tests of each specimen, HHS-certified 
laboratories will determine the creatinine concentration of each 
specimen under Sec.  26.161(b)(1). If the creatinine concentration is 
less than 20 mg/dL, the laboratory will determine the specimen's 
specific gravity under Sec.  26.161(b)(2). Section 26.161(b)(3) 
requires the laboratory to determine each specimen's pH. Section 
26.161(b)(4) requires the laboratory to test the specimen for the 
presence of oxidizing adulterants, and Sec.  26.161(b)(5) requires 
additional validity testing, depending on the characteristics of the 
specimen.
    With respect to the proposed rule, the final rule deletes proposed 
Sec.  26.161(b)(2). The proposed paragraph specified the results from 
initial validity testing that would indicate the need for the HHS-
certified laboratory to conduct confirmatory validity testing. The NRC 
deleted this paragraph in the final rule because the criteria it 
contained repeated the criteria embedded in Sec.  26.161(c)-(f). In 
addition, the HHS Guidelines do not include these criteria separately. 
Therefore, this revision increases the consistency of Part 26 with the 
related provisions in the HHS Guidelines.
    The final rule adds Sec.  26.161(c) to establish criteria for HHS-
certified laboratories to apply in determining whether to report to a 
licensee's or other entity's MRO that a specimen is adulterated. 
Section 26.161(c)(1) through (c)(8) specifies results from initial and 
confirmatory validity testing that indicate that a specimen is 
adulterated. The paragraphs also specify the appropriate testing 
devices and instruments to be used for initial and confirmatory 
validity tests. In general, the paragraphs require the HHS-certified 
laboratory to report to the MRO that a urine specimen is adulterated if 
it meets any one of the following criteria: (1) It is confirmed to 
contain a substance that should not be present at all in normal human 
urine; (2) it is confirmed to contain a substance which, although it 
could be present in normal human urine, is found to be at a 
concentration that appears to be inconsistent with human physiology; or 
(3) it presents an acid/base balance (pH) that appears to be 
inconsistent with human life. The paragraphs address several substances

[[Page 17096]]

that some donors have used to try to defeat drug tests through ``in 
vitro'' contamination (i.e., adding the substance to a urine specimen). 
These adulterants include substances that create a urine pH 
inconsistent with human life, oxidizing adulterants, chromium (VI), 
halogens, glutaraldehyde, pyridine, and surfactants. These substances, 
when either placed into an already voided urine specimen or used in 
place of a urine specimen, generally either attempt to defeat the 
chemistry of the test or destroy a drug that is present. The NRC 
recognizes that this list will be updated and/or modified as new 
substances and formulas are introduced, and methods to detect them have 
been developed and implemented by HHS-certified laboratories. Section 
26.161(c)(8) recognizes that new adulterants will be found and, 
therefore, requires HHS-certified laboratories to use appropriate 
testing methods when conducting initial and confirmatory testing for 
new adulterants for which cutoff levels and criteria have not yet been 
established.
    Section 26.161(d) and (e) establishes cutoff levels and criteria 
for a determination by the laboratory that a specimen has been 
substituted or is dilute, respectively. In Sec.  26.161(d), the HHS-
certified laboratory will report to the MRO that a specimen is 
substituted if it contains less than 2 mg/dL of creatinine and the 
specific gravity is less than or equal to 1.0010 or equal to or greater 
than 1.0200. These low creatinine concentrations combined with the 
highly skewed specific gravity values indicate that the specimen is not 
human urine. In Sec.  26.161(e), the HHS-certified laboratory is 
required to report to the MRO that a specimen is dilute if the 
creatinine concentration is equal to or greater than 2 mg/dL but less 
than 20 mg/dL and the specimen specific gravity is greater than 1.0010 
but less than 1.0030.
    The NRC added Sec.  26.161(f)(1) through (f)(12) to establish the 
criteria that HHS-certified laboratories apply when determining that a 
specimen is invalid. In 1998, HHS established criteria for what were 
termed ``unsuitable'' specimens (Program Document 35, September 28, 
1998). An unsuitable specimen was defined as one that contained an 
interfering substance but the laboratory could not determine the nature 
of the substance with scientific certainty. In these circumstances, the 
laboratory could not achieve a ``valid'' test result. The HHS 
recognized that in some cases, an interfering substance could be a 
legitimately ingested medication (some non-steroidal anti-inflammatory 
drugs have been known to interfere with the chemistry of some of the 
initial tests). However, it was also recognized that many of these 
problem specimens actually contained an adulterant that the laboratory 
could not specifically identify with ``scientific certainty'' which is 
the requirement for reporting a specimen as adulterated. Therefore, the 
HHS adopted the term ``invalid specimen'' to mean that the laboratory 
has determined that valid test results cannot be obtained from a 
specimen or an unknown substance interfered with the confirmatory test. 
The rule adopts the term ``invalid specimen'' with the same meaning.
    The rule adds Sec.  26.161(g) to address circumstances in which an 
HHS-certified laboratory suspects that a specimen is adulterated but 
cannot identify the adulterant. The paragraph permits the laboratory to 
transfer the specimen to a second HHS-certified laboratory for 
additional testing, if the first HHS-certified laboratory cannot 
identify a possible adulterant in the specimen using their standard 
testing technologies and the licensee's or other entity's MRO concurs 
with the additional testing. Personnel at the first HHS-certified 
laboratory will consult with the licensee's or other entity's MRO to 
determine whether to transfer the specimen to a second laboratory for 
additional testing.
    The agency added Sec.  26.161(h) to prohibit licensees and other 
entities from requiring an HHS-certified laboratory to apply validity 
testing cutoff levels and criteria that are more stringent than those 
specified in this proposed section. Because validity testing is complex 
and the methods for testing are relatively new, the rule does not 
permit an FFD program to establish more stringent cutoff levels for 
validity testing. The prohibition is necessary to decrease the risk of 
obtaining false adulterated, substituted, or invalid test results and 
ensure that donors are not subject to sanctions on the basis of 
inaccurate test results.
Section 26.163 Cutoff Levels for Drugs and Drug Metabolites
    Section 26.163 groups together in one section, for organizational 
clarity, the requirements for conducting initial and confirmatory tests 
for drugs and drug metabolites at HHS-certified laboratories. The 
section also updates requirements related to cutoff levels for drugs 
and drug metabolites in the former rule to meet Goal 1 of this 
rulemaking to update and enhance the consistency of Part 26 with 
advances in other relevant Federal rules and guidelines.
    Section 26.163(a) [Initial drug testing] amends former Section 
2.7(e) in Appendix A to Part 26. When determining whether to report to 
the MRO that a specimen is positive for drug(s) or drug metabolite(s), 
Sec.  26.163(a)(1) requires HHS-certified laboratories to apply the 
same cutoff levels that licensee testing facilities are required to use 
in Sec.  26.133, except if the FFD program specifies more stringent 
cutoff levels or the specimen is dilute, as discussed further in Sec.  
26.163(a)(2). The paragraph reiterates the former permission for 
licensees and other entities to establish lower cutoff levels. In 
addition, Sec.  26.163(a)(1) decreases the initial test cutoff level 
for marijuana metabolites from 100 nanograms (ng) per milliliter (mL) 
to 50 ng/mL and increases the initial test cutoff level for opiate 
metabolites from 300 ng/mL to 2,000 ng/mL for the reasons discussed 
with respect to Sec.  26.133. The changes are consistent with the HHS 
cutoff levels for the same substances.
    A new Sec.  26.163(a)(2) establishes requirements and criteria for 
the initial drug testing of any specimen that confirmatory validity 
testing indicates is dilute. Although there are many legitimate reasons 
that a donor may provide a urine specimen that is dilute, dilution is 
also a method used to subvert the testing process. Dilution of a 
specimen decreases the concentration of any drugs or drug metabolites 
in the specimen. Dilution may decrease the concentration sufficiently 
that applying the cutoff levels specified in this part, or a licensee's 
or other entity's more stringent cutoff levels, would provide false 
negative drug test results. Therefore, the rule adds special testing 
procedures and criteria for determining which dilute specimens must be 
subject to confirmatory drug testing. With respect to the proposed 
rule, the NRC has eliminated the optional provision for FFD programs to 
test specimens with initial validity test results that indicate a 
specimen is dilute using FDA approved kits for the lowest concentration 
levels marketed for the technologies being used to conduct initial 
testing of specimens for drug or drug metabolites. This change is based 
on a comment received on the proposed provision. Instead, the NRC is 
adopting the procedure proposed by the commenter. That is, for dilute 
specimens, the final rule permits an FFD program to request the HHS-
certified laboratory to conduct confirmatory testing of dilute 
specimens at the confirmatory assay's LOD for a drug or drug class, if 
the response to the initial drug test for any drug class for

[[Page 17097]]

which testing is performed is within 50 percent of the cutoff 
calibrator level. The NRC agrees that the commenter's approach is 
consistent with the intent of the proposed provision, while reducing 
the burden on HHS-certified laboratories imposed by the proposed 
requirements. This special processing of dilute specimens increases the 
likelihood that any drugs and drug metabolites in the specimen will be 
detected. Therefore, this requirement meets Goal 3 of this rulemaking 
to improve the effectiveness of FFD programs, by increasing the 
likelihood that testing of dilute specimens will reveal drug use if the 
donor had engaged in substance abuse.
    As discussed with respect to Sec.  26.133, the final rule 
eliminates the requirement in the last sentence of former Section 
2.7(e)(1) of Appendix A to Part 26 for HHS-certified laboratories to 
report drug test results for both the cutoff levels in the rule and any 
more stringent cutoff levels that the licensee or other entity may 
establish. The basis for the former requirement to report test results 
for the cutoff levels specified in this part, when the licensee is 
using more stringent cutoff levels, was a means by which the NRC 
monitored implementation of the permission to use more stringent cutoff 
levels. The rule eliminates this requirement, because Sec.  
26.31(d)(3)(iii)(C) requires a qualified forensic toxicologist to 
certify the scientific and technical validity of any testing at lower 
cutoff levels. Therefore, the former reporting requirement is no longer 
needed to ensure laboratory performance in this area. Eliminating this 
requirement meets Goal 5 of this rulemaking to improve Part 26 by 
eliminating or modifying unnecessary requirements.
    The rule also eliminates former Section 2.7(e)(2) in Appendix A to 
Part 26. The former provision stated that the list of substances and 
cutoff levels contained in Appendix A to Part 26 were subject to change 
by the NRC. At the time the former rule was published, the NRC expected 
to be able to amend the list of substances and cutoff levels in the 
former rule without additional rulemaking. However, the NRC has 
determined that rulemaking is required to make such changes. Therefore, 
the rule deletes this paragraph because it is unnecessary.
    The final rule replaces former Section 2.7(f) in Appendix A to Part 
26 with Sec.  26.163(b) [Confirmatory drug testing]. The former 
provision established cutoff levels and requirements related to 
confirmatory testing for drugs and drug metabolites at the HHS-
certified laboratory. The rule also makes a number of changes to the 
former paragraph.
    The agency has moved former Section 2.7(f)(1) in Appendix A to Part 
26 to Sec.  26.169(b)(1) of the final rule. Former Section 2.7(f)(1) 
required the HHS-certified laboratory to report to the MRO that test 
results are negative for any specimens that yield negative test results 
when they are subjected to confirmatory testing. The NRC moved this 
requirement to Sec.  26.169(b)(1) for organizational clarity because 
Sec.  26.169 addresses the topic of reporting test results by the HHS-
certified laboratory to the MRO.
    The NRC has also eliminated the requirement in former Section 
2.7(f)(1) in Appendix A to Part 26 that the laboratory must conduct 
confirmatory testing using both the maximum cutoff values established 
in Part 26 as well as any more stringent cutoff levels adopted by the 
licensee's or other entity's FFD program. The former requirement to 
conduct testing for the cutoff levels specified in this part, when the 
licensee is using more stringent cutoff levels, was a means by which 
the NRC monitored implementation of the permission to use more 
stringent cutoff levels. The rule eliminates this requirement, because 
Sec.  26.31(d)(3)(iii)(C) requires a qualified forensic toxicologist to 
certify the scientific and technical validity of any testing at lower 
cutoff levels. Therefore, the requirement to test at both cutoff levels 
is no longer needed to assure laboratory performance in this area.
    For organizational clarity, the NRC has moved the first sentence of 
former Section 2.7(f)(2) in Appendix A to Part 26 that required the 
laboratory to use GC/MS techniques for confirmatory testing to Sec.  
26.167(e)(1) in the final rule. Section 26.167(e)(1) addresses quality 
control requirements for conducting confirmatory drug tests.
    The rule eliminates former Section 2.7(f)(3) in Appendix A to Part 
26. The former provision required HHS-certified laboratories to use GC 
analysis of blood specimens in testing for alcohol. The final rule also 
eliminates the confirmatory alcohol cutoff level in former Section 
2.7(f)(1) in Appendix A to Part 26. The NRC eliminated these provisions 
because the rule no longer permits donors to request confirmatory 
testing of a blood specimen for alcohol, as discussed with respect to 
Sec.  26.83(a).
    In addition, the rule eliminates former Section 2.7(f)(4) in 
Appendix A to Part 26 for the same reasons discussed with respect to 
former Section 2.7(e)(2) in Appendix A to Part 26.
    Section 26.163(b)(1) amends several of the cutoff levels in former 
Section 2.7(f)(1) in Appendix A to Part 26 that the HHS-certified 
laboratory uses to determine that a confirmatory drug test result is 
positive. The rule increases the confirmatory test cutoff levels for 
morphine and codeine to 2,000 ng/mL. This change in the cutoff level 
for opiate metabolites substantially reduces the number of positive 
opiate test results that are reported to MROs by HHS-certified 
laboratories that MROs ultimately verify as negative and is consistent 
with the opiate cutoff levels contained in the HHS Guidelines.
    Section 26.163(b)(1) also amends two of the testing procedures in 
former Section 2.7(f) in Appendix A to Part 26. The rule amends former 
Section 2.7(f)(5) in Appendix A to Part 26, which required the 
laboratory to test for 6-acetylmorphine (6-AM) if a specimen tests 
positive for opiates on the initial drug test. The rule requires the 
HHS-certified laboratory to test for 6-AM, if test results for morphine 
are at or above the 2,000 ng/mL opiate cutoff levels, and establishes a 
cutoff level of 10 ng/mL for determining that a specimen is positive 
for 6-AM. In addition, Sec.  26.163(b)(1) adds a requirement that a 
specimen must also contain amphetamine at a concentration equal to or 
greater than 200 ng/mL in order for the HHS-certified laboratory to 
report to the MRO that the specimen has yielded a positive test result 
for methamphetamine. These changes are consistent with the related 
provisions in the HHS Guidelines.
    Section 26.163(b)(1) updates the terminology used in former Section 
2.7(f)(1) in Appendix A to Part 26. As discussed with respect to Sec.  
26.5, the final rule replaces the term ``presumptive positive'' with 
the phrase ``positive on an initial drug test'' to increase clarity in 
the language of the rule.
    A new Sec.  26.163(b)(2) amends the second sentence of former 
Section 2.7(f)(2) in Appendix A to Part 26. The former sentence 
required the HHS-certified laboratory to document drug and drug 
metabolite concentrations that exceed the linear region of the standard 
curve in the laboratory record. The rule replaces the former sentence 
with a paragraph that incorporates the related provision from the HHS 
Guidelines. The HHS Guidelines permit the laboratory to dilute an 
aliquot of the specimen to obtain an accurate quantitative result when 
the concentration is above the upper limit of the linear range. This 
change has been made to meet Goal 1 of this rulemaking to update and 
enhance the consistency of Part 26 with advances in other relevant 
Federal rules and guidelines.

[[Page 17098]]

Section 26.165 Testing Split Specimens and Retesting Single Specimens
    Section 26.165 reorganizes and amends the requirements formerly 
found in Sec.  26.24(f), and Section 2.7(i) and (j) in Appendix A to 
Part 26 that related to testing split specimens and retesting specimens 
at HHS-certified laboratories. For organizational clarity, the final 
rule groups the requirements together in a single section to make them 
easier to locate in the rule. The section also adds several new 
requirements.
    Section 26.165(a) [Testing split specimens] combines and amends 
former Sec.  26.24(f) and Section 2.7(j) in Appendix A to Part 26. 
Those provisions established requirements for HHS-certified 
laboratories when testing split specimens. The final rule uses the 
terms ``Bottle A'' and ``Bottle B'' to refer to the primary and split 
specimens, respectively, for consistency with the updated terminology 
used throughout the rule. The rule also requires specimen validity 
testing, consistent with the addition of requirements to conduct 
validity testing throughout the rule, as discussed with respect to 
Sec.  26.31(d)(3)(i).
    Section 26.165(a)(1) retains the portions of former Section 2.7(j) 
in Appendix A to Part 26 that required the HHS-certified laboratory to 
analyze the primary specimen of a split specimen. The former 
requirements related to licensee testing facilities in this section 
have been moved to Sec.  26.135 in Subpart F for organizational 
clarity. This paragraph retains the former requirement that the primary 
specimen (Bottle A) must be subject to initial testing by the HHS-
certified laboratory, and confirmatory testing, if the results of 
initial testing indicate that the specimen is positive. The final rule 
adds a requirement for HHS-certified laboratories also to conduct 
initial and, if necessary, confirmatory validity testing of the 
specimen in Bottle A of a split specimen.
    Section 26.165(a)(2) retains the portion of the second sentence of 
former Sec.  26.24(f) that required the HHS-certified laboratory to 
perform initial and confirmatory tests, if required, on the primary 
specimen in Bottle A, even if a licensee testing facility conducted 
initial testing on an aliquot of the specimen. The NRC moved the former 
requirement to this section for organizational clarity. With respect to 
the proposed rule, the final rule replaces the term ``non-negative'' in 
the proposed rule with the more specific terms ``positive'' and ``of 
questionable validity'' to refer to the results of testing at the 
licensee testing facility. The agency made this change to improve the 
clarity of the rule's language.
    Section 26.165(a)(3) retains the authorization in the second 
sentence of former Section 2.7(j) in Appendix A to Part 26 for licensee 
testing facilities to retain custody of the split specimen in Bottle B 
or forward it with Bottle A to the HHS-certified laboratory for storage 
until testing of Bottle A is completed. The final rule also retains the 
former authorization for the specimens in Bottle A and Bottle B to be 
discarded if test results from the HHS-certified laboratory are 
negative. With respect to the proposed rule, the final rule makes minor 
editorial changes to this provision to increase the clarity of the 
language. In addition, the final rule adds cross-references to Sec.  
26.135(a) and (c). These provisions contain requirements for storing 
Bottle B of a split specimen at a licensee testing facility, if the 
licensee testing facility chooses to retain Bottle B rather than 
forwarding it with Bottle A to the HHS-certified laboratory. The NRC 
made these changes to improve clarity in the language of the rule and 
in response to a public comment requesting the clarifications.
    The NRC added Sec.  26.165(b) [Donor request to MRO for a retest of 
a single specimen or testing Bottle B of a split specimen] to permit 
donors to request retesting of an aliquot from a single specimen, if 
the FFD program does not follow split specimen procedures, and testing 
of Bottle B if the program follows split specimen procedures. This 
paragraph assures that donors who are subject to a program that does 
not follow split specimen procedures have the right to request 
additional testing. With respect to the proposed rule, the final rule 
combines and reorganizes the provisions in proposed Sec.  26.165(b) 
pertaining to a donor's request for retesting a single specimen with 
those in proposed Sec.  26.165(c) pertaining to a donor's request for 
testing of Bottle B of a split specimen. The agency made these changes 
in response to a public comment. The commenter noted that the separate 
paragraphs in the proposed rule contained redundant requirements and 
that separating the requirements into two paragraphs was inconsistent 
with the related provisions in the HHS Guidelines. Therefore, the NRC 
also changed the title of this section from ``Donor request to MRO for 
a retest of a single specimen'' in the proposed rule to ``Donor request 
to MRO for a retest of a single specimen or testing of Bottle B of a 
split specimen'' in the final rule.
    Section 26.165(b)(1) assures that donors may request through the 
MRO additional testing of an aliquot from a single specimen or testing 
of Bottle B by a second HHS-certified laboratory. This permission is 
consistent with related provisions in the HHS Guidelines and amends the 
requirements in former Section 2.7(j) in Appendix A to Part 26 that 
pertained to donor requests to test the specimen in Bottle B. The final 
rule permits donors to request retesting of an aliquot of a single 
specimen by a second HHS-certified laboratory to protect donors' rights 
to retesting under FFD programs that do not follow split specimen 
procedures. The rule adds confirmed adulterated and substituted 
validity test results as bases for a donor request for testing the 
specimen in Bottle B or retesting an aliquot of a single specimen, 
consistent with the addition of requirements to conduct validity 
testing throughout the rule, as discussed with respect to Sec.  
26.31(d)(3)(i). However, in order to have sufficient urine to support 
retesting, the paragraph applies only if the donor had originally 
submitted a specimen of 30 mL or more in a single specimen, or a 
specimen in Bottle A. Specimens that the HHS-certified laboratory 
determines to be invalid are not eligible for retesting because of the 
risk of damage to laboratory equipment that some invalid specimens may 
pose and because retesting the specimen would not provide useful 
information. The procedures for requesting and conducting the retest of 
a single specimen are consistent with those for requesting and 
conducting tests on the specimen in Bottle B of a split specimen in the 
final rule.
    Section 26.165(b)(2) adds a requirement for the MRO to inform the 
donor that he or she may, within 3 business days of notification by the 
MRO of a confirmed positive, adulterated, or substituted test result, 
request a retest of an aliquot of a single specimen or, as appropriate, 
Bottle B of a split specimen. The NRC also added a requirement that the 
donor must request retesting an aliquot of a single specimen or testing 
the Bottle B specimen within 3 business days after notification by the 
MRO that a single specimen or the specimen in Bottle A of a split 
specimen has yielded positive, adulterated, or substituted test 
results. Since 1994, the HHS Guidelines have allowed up to 72 hours for 
a donor to make this request, so this change increases the consistency 
of Part 26 with the HHS Guidelines. This provision combines proposed 
Sec.  26.165(a)(4) and (b)(1) into one paragraph for the reasons 
discussed with respect to Sec.  26.165(b).
    The final rule, with respect to the proposed rule, includes a new

[[Page 17099]]

requirement that the MRO must provide the donor with specific contact 
information and have the ability to verify the time the donor's call 
was received by the MRO's office if telephone notifications for 
retesting are the preferred method of the MRO's office. The NRC added 
this provision in response to a public comment received on the proposed 
rule that requested the addition to further protect donors' rights 
under the rule. The requirement is consistent with related requirements 
in the DOT's drug and alcohol testing procedures and, therefore, meets 
Goal 1 of the this rulemaking to enhance the consistency of Part 26 
with the related regulations of other Federal agencies.
    In Sec.  26.165(b)(2) of the final rule, the NRC has modified the 
requirement in proposed Sec.  26.165(a)(4) that a donor must inform the 
MRO in writing of his or her request to conduct testing of an aliquot 
of the single specimen or the specimen contained in Bottle B at a 
second HHS-certified laboratory. This change is based on public 
comments received on the proposed rule which stated that requiring a 
donor to make a written request for additional specimen testing would 
be unduly restrictive given that other Federal agencies permit the 
donor to make these requests verbally. The NRC agrees that a donor 
should be provided with as much flexibility as possible, while ensuring 
the request is made in a secure and accurate manner. Therefore, the 
final rule permits the donor to make his or her request for additional 
testing verbally to the MRO or in writing. This change meets Goal 1 of 
this rulemaking to update and enhance the consistency of Part 26 with 
advances in other relevant Federal drug and alcohol testing programs.
    Section 26.165(b)(3) combines into one paragraph the requirements 
that were contained in the last sentences of proposed Sec.  
26.165(a)(4) and (b)(1) for the reasons discussed with respect to Sec.  
26.165(b). The final rule requires permission from the donor for 
testing Bottle B of a split specimen or retesting an aliquot of a 
single specimen and prohibits the MRO, NRC, or any other entity from 
requiring additional tests of a donor's specimen without his or her 
permission. These limitations are consistent with the principle 
established in Sec.  26.31(d)(6) that affirms the donor's right to 
retain control over his or her specimen. Therefore, adding this 
provision meets Goal 7 of this rulemaking to protect the privacy and 
other rights (including due process) of individuals who are subject to 
Part 26.
    In Sec.  26.165(b)(4) of the final rule, with respect to the 
proposed rule, the NRC has added a new provision that permits a donor 
to present to the MRO evidence supporting the inability of the donor to 
make a timely request for retesting of a single specimen or the testing 
of the Bottle B specimen after the 3-business-day period permitted has 
elapsed. For example, a donor may have been severely ill when informed 
of a confirmed positive, adulterated, or substituted test result and 
was unable to contact the MRO to make the request because of 
hospitalization. On the basis of the information the donor presents, 
the MRO will make the sole determination whether the circumstances 
described unavoidably prevented the donor from making a timely request. 
If the MRO makes this determination, he or she will direct a retest of 
an aliquot of a single specimen or testing of Bottle B of a split 
specimen by a second HHS-certified laboratory, as if a timely request 
was made. The NRC added this provision in response to public comments 
on the proposed rule, and has incorporated the related requirement in 
the DOTs' procedures. The added provision protects donors' rights to 
fair and consistent testing procedures under the rule, consistent with 
Goal 7 of this rulemaking, and meets Goal 1 to update and enhance the 
consistency of Part 26 with advances in other relevant Federal rules 
and guidelines.
    Section 26.165(b)(5) requires the MRO, in response to a donor's 
timely request for a retest of an aliquot of a single specimen or 
testing of Bottle B of a split specimen, to ensure that either the HHS-
certified laboratory forwards an aliquot of a single specimen, or the 
HHS-certified laboratory or licensee testing facility forwards Bottle B 
of a split specimen, as appropriate, to a second HHS-certified 
laboratory that did not test the specimen in Bottle A. This paragraph 
amends the requirement in the fourth sentence of former Section 2.7(j) 
in Appendix A to Part 26, which required that the split specimen must 
be forwarded to another HHS-certified laboratory for testing on the 
same day of the donor request. The final rule requires the licensee 
testing facility or HHS-certified laboratory, as applicable, to forward 
Bottle B of a split specimen or the aliquot of a single specimen to a 
second laboratory as soon as reasonably practical and not more than 1 
business day following the day of the donor's request. The NRC amended 
the former provision to respond to stakeholder comments during the 
public meetings discussed in Section I.D. The stakeholders indicated 
that implementing the ``same-day'' requirement for forwarding Bottle B 
in former Section 2.7(j) of Appendix A to Part 26 has often been 
difficult for a number of reasons. These reasons included communication 
delays among donors, MROs, the HHS-certified laboratory, and FFD 
program personnel, particularly on weekends, holidays, and the time 
required to identify a second HHS-certified laboratory with the 
appropriate capability to test the specimen, depending on the nature of 
the positive test result. The change alleviates some types of 
logistical problems associated with weekends and holidays while 
continuing to provide the donor with timely test results. This change 
meets Goal 5 of this rulemaking to improve Part 26 by eliminating or 
modifying unnecessary requirements. The final rule renumbers proposed 
Sec.  26.165(a)(5) as Sec.  26.165(b)(5) for the reasons discussed with 
respect to Sec.  26.165(b).
    Section 26.165(b)(6) retains the last sentence of former Section 
2.7(j) in Appendix A to Part 26. This provision requires the second 
HHS-certified laboratory to provide quantitative test results from 
Bottle B to the MRO, who provides them to the donor. The rule adopts 
the simpler language from the related provision in the HHS Guidelines, 
consistent with Goal 6 of this rulemaking to improve clarity in the 
language of the rule. This provision also extends the former 
requirement to apply to communicating results from retesting an aliquot 
of a single specimen, consistent with the explicit permission the NRC 
has added for a donor to request retesting of a single specimen if the 
FFD program does not follow split specimen procedures. With respect to 
the proposed rule, Sec.  26.165(b)(6) combines the redundant 
requirements in proposed Sec.  26.165(a)(6) and (c)(4) for the reasons 
discussed with respect to Sec.  26.165(b).
    Section 26.165(c) [Retesting a specimen for drugs] amends former 
Section 2.7(i) in Appendix A to Part 26, which specified that retesting 
of a specimen is not subject to cutoff requirements. This paragraph 
updates and expands the former requirements for retesting a single 
specimen or Bottle B of a split specimen for drugs and drug metabolites 
to be consistent with the related provisions in the HHS Guidelines, as 
follows:
    The NRC added Sec.  26.165(c)(1) to require the second HHS-
certified laboratory to use the laboratory's confirmatory test for the 
drug or drug metabolite for which the specimen tested positive at the 
first laboratory. The second HHS-certified laboratory will not conduct 
initial tests, or tests for

[[Page 17100]]

other drugs or drug metabolites, consistent with the related 
requirements in the HHS Guidelines. With respect to the proposed rule, 
for completeness, the final rule adds a reference to conducting 
confirmatory tests on specimens that the first laboratory confirmed to 
be positive and dilute as a result of the special analysis permitted in 
Sec.  26.169(a)(2). In addition, in response to a public comment, the 
final rule eliminates the reference to the second laboratory's 
``standard'' confirmatory drug test in the proposed provision because 
HHS-certified laboratories do not have ``standard'' confirmatory drug 
tests. The NRC made this change to enhance clarity in the language of 
the rule.
    Section 26.165(c)(2) amends former Section 2.7(i) in Appendix A to 
Part 26, which specified that retesting of a specimen is not subject to 
cutoff requirements. The paragraph retains the requirement for the 
second HHS-certified laboratory to provide data sufficient to confirm 
the presence of the drug(s) or drug metabolite(s) and adds permission 
to test the specimen at the assay's LOD. This addition ensures that the 
second laboratory's testing is as sensitive to the presence of the 
drug(s) or drug metabolite(s) as is scientifically and legally 
defensible.
    The NRC has added Sec.  26.165(c)(3) to require the second 
laboratory, if retesting fails to confirm the presence of the drug(s) 
or drug metabolite(s) identified by the first HHS-certified laboratory, 
to attempt to determine the reason why it could not reconfirm the drug 
test results from the first laboratory. The provision requires the 
second laboratory to conduct specimen validity testing if the second 
laboratory fails to reconfirm the first laboratory's findings, 
consistent with the related requirements in the HHS Guidelines.
    Section 26.165(c)(4) retains the requirement in the last sentence 
of former Section 2.7(j) in Appendix A to Part 26 that requires the 
second laboratory to report the test results of testing a split 
specimen to the MRO. The rule extends this requirement to reporting 
results from retesting an aliquot of a single specimen, consistent with 
the explicit permission the rule adds in Sec.  26.165(b) for a donor to 
request retesting of a single specimen if the FFD program does not 
follow split specimen procedures. The requirement is consistent with 
the related requirements in the HHS Guidelines.
    The NRC added Sec.  26.165(d) [Retesting a specimen for 
adulterants] to incorporate related requirements in the HHS Guidelines 
for performing retests for adulterants at a second HHS-certified 
laboratory. The final rule limits retesting for adulterants to 
conducting confirmatory testing only for the adulterant(s) identified 
by the first laboratory. This limitation is consistent with limitations 
on retesting specimens for drugs and drug metabolites in the related 
requirements of the HHS Guidelines. With respect to the proposed rule, 
the final rule, when discussing confirmatory validity testing in Sec.  
26.165(d), replaces the phrase ``appropriate confirmatory test'' with 
``required confirmatory test'' in response to a comment received on the 
proposed rule. The commenter noted that the confirmatory testing 
requirements in Sec.  26.161(d) are ``required'' rather than 
``appropriate,'' and the NRC concurs. The agency made this change to 
enhance the consistency of the final rule with the HHS Guidelines and 
improve clarity in the language of the rule.
    The NRC added Sec.  26.165(e) [Retesting a specimen for 
substitution] to incorporate related requirements in the HHS Guidelines 
for performing retests on substituted specimens at a second HHS-
certified laboratory. The rule limits retesting for specimen 
substitution to conducting confirmatory testing only for creatinine and 
specific gravity. This limitation is consistent with limitations on 
retesting specimens for drugs and drug metabolites and the related 
requirements in the HHS Guidelines. With respect to the proposed rule, 
the final rule eliminates the second sentence of the proposed provision 
in response to a public comment that noted it was inconsistent with the 
related provision in the HHS Guidelines.
    Section 26.165(f) [Management actions and sanctions] has been added 
to specify the management actions that licensees and other entities 
must take when a donor requests a retest of a single specimen or 
testing of Bottle B of a split specimen. The NRC added this paragraph 
to establish the requirements for management actions and sanctions when 
an individual has had a confirmed positive, adulterated, or substituted 
test result and requests a retest of a single specimen or Bottle B of a 
split specimen. This section responds to stakeholder comments at the 
public meetings discussed in Section I.D. The stakeholders noted that 
the former rule did not address required management actions when an 
individual has had a confirmed positive test result and requests a 
retest of a single specimen or Bottle B of a split specimen. Therefore, 
the NRC added this section to establish such requirements.
    The agency added Sec.  26.165(f)(1) to address circumstances in 
which the MRO has confirmed a positive, adulterated, or substituted 
test result from the first HHS-certified laboratory that tested the 
specimen as a violation of the licensee's or other entity's FFD policy 
and the donor requests a retest of a single specimen or testing of the 
specimen in Bottle B. This provision requires the licensee or other 
entity to take the same actions in response to the confirmed positive, 
adulterated, or substituted test result(s) from the first HHS-certified 
laboratory, as explained in Sec.  26.75(i), in response to a positive 
drug test result for marijuana or cocaine from initial testing at a 
licensee testing facility. That is, Sec.  26.165(f)(1) requires the 
licensee or other entity to administratively withdraw the donor's 
authorization until the test results from the second HHS-certified 
laboratory have been reported to and reviewed by the MRO. If the test 
results from the second laboratory reconfirm any positive, adulterated, 
or substituted test results from the first HHS-certified laboratory, 
the rule requires the licensee or other entity to impose the 
appropriate sanctions that are specified in subpart D for any positive, 
adulterated, or substituted results that were confirmed by the second 
laboratory. If the test results from the second laboratory do not 
reconfirm the positive, adulterated, or substituted test results from 
the first laboratory, the rule (1) prohibits the licensee or other 
entity from imposing any sanctions on the individual; (2) requires the 
licensee or other entity to eliminate any records of the first 
confirmed positive, adulterated, or substituted results; and (3) 
requires the licensee or other entity to inform the donor, in writing, 
that the records have been expunged and that he or she need not 
disclose the temporary administrative action to any other licensee or 
entity. These requirements protect public health and safety and the 
common defense and security by ensuring that an individual whose 
fitness for duty is questionable does not perform any duties or have 
the types of access that require the individual to be subject to this 
part, while serving to protect the privacy rights of individuals who 
are subject to Part 26 and ensure that the individuals are afforded 
accurate and consistent testing.
    The NRC added Sec.  26.165(f)(2) to address the unlikely 
circumstances in which a donor requests retesting of a single specimen 
or testing Bottle B of a split specimen, but the testing cannot be 
performed because the single specimen or Bottle B is no longer 
available due to causes that are outside of the donor's control. These 
causes could include, but are not limi