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



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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  

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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 
[email protected].

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

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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

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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 
[email protected].
    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

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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 limited to, an insufficient

[[Page 17101]]

quantity of urine in the single specimen to permit retesting, either 
Bottle B or the aliquot of a single specimen is lost in transit to the 
second HHS-certified laboratory, or Bottle B has been misplaced. This 
provision requires the MRO to cancel the original test result, 
prohibits the licensee or other entity from imposing any sanctions on 
the donor, and requires the licensee or other entity to ensure that any 
records are expunged that could link the donor to the original 
positive, adulterated, or substituted test result and the 
administrative action required under Sec.  26.165(f)(1). The final 
rule, with respect to the proposed rule, adds the requirement that the 
MRO must direct the licensee or other entity to collect a second 
specimen under direct observation as soon as reasonably practical. The 
paragraph requires a second collection as soon as reasonably practical 
because other provisions of the regulation (see Subpart C) require 
negative test results in order for the licensee or other entity to 
grant or maintain the donor's authorization. The NRC made this change 
in response to public comments received on the proposed rule and to 
increase the consistency of Part 26 with the related requirements in 
the HHS Guidelines.
    The last sentence of Sec.  26.165(f)(2) requires the licensee or 
other entity to impose the appropriate sanctions, as specified in 
Subpart D, if the results of testing the specimen from a second 
collection are positive, adulterated, or substituted and confirmed by 
the MRO to be an FFD policy violation. However, the rule prohibits the 
licensee or other entity from considering the results of testing the 
original specimen when imposing sanctions because the donor was 
(inadvertently) denied his or her right to due process in this case.
    The new requirements in Sec.  26.165(f) are generally consistent 
with the related requirements in the HHS Guidelines. The differences 
from the HHS Guidelines' requirements in the rule are variations in the 
terminology used to adapt the language for the NRC's purposes and the 
addition of cross-references to other portions of the rule.
Section 26.167 Quality Assurance and Quality Control
    Section 26.167 updates former Section 2.8 in Appendix A to Part 26 
[Quality assurance and quality control], which established quality 
assurance and quality control requirements for drug testing at HHS-
certified laboratories. This section provides more detailed 
requirements for the quality assurance and quality control programs of 
HHS-certified laboratories to improve consistency with related 
provisions in the HHS Guidelines, and adds new requirements for 
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 26.167(a) [Quality assurance program] amends and combines 
former Section 2.8(a) and the last two sentences of Section 2.8(d) in 
Appendix A to Part 26, which required HHS-certified laboratories and 
licensee testing facilities to have quality assurance programs. For 
increased clarity in the language of the rule, the rule replaces the 
term ``specimen acquisition'' with the term ``specimen accessioning'' 
in the first sentence of former Section 2.8(a), which is the more 
accurate term. The rule also adds a requirement for the quality 
assurance program to encompass the certification of calibrators and 
controls to ensure that calibrators and controls are accurate. This 
requirement is consistent with the related provision in the HHS 
Guidelines.
    In addition, the rule moves to Sec.  26.167(a) and amends the 
requirements in the last two sentences of former Section 2.8(d) in 
Appendix A to Part 26, which required that the linearity and precision 
of testing methods used must be periodically documented as well as the 
procedures to ensure that carryover does not contaminate a donor's 
specimen. The rule updates these requirements for consistency with the 
HHS Guidelines and requires that (1) the performance characteristics 
(e.g., accuracy, precision, LOD, limit of quantitation (LOQ), 
specificity) for each test must be validated and documented; (2) 
validation of procedures must document that carryover does not affect 
the donor's specimen results, and (3) the laboratory must periodically 
re-verify the analytical procedures. The NRC relocated the updated 
requirements to Sec.  26.167(a) for organizational clarity because they 
are aspects of the laboratory's quality assurance program.
    The NRC has moved the requirements in former Section 2.8(a) in 
Appendix A to Part 26 that applied to licensee testing facilities to 
Sec.  26.137(a) [Quality assurance program] in Subpart F. Section 
26.167(a) retains the second sentence of former Section 2.8(a). The NRC 
also relocated the quality control requirements for initial tests at 
licensee testing facilities in former Section 2.8(b) in Appendix A to 
Part 26 to Sec.  26.137 in Subpart F. The NRC made these changes for 
organizational clarity in the rule.
    Section 26.167(b) [Calibrators and controls required] retains the 
portions of former Section 2.8(c) and (d) in Appendix A to Part 26 that 
required HHS-certified laboratories to use appropriate calibrators and 
controls for initial and confirmatory drug testing. The rule adds a 
requirement to include appropriate calibrators and controls for initial 
and confirmatory 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 added more 
detailed requirements for calibrators and controls to this section than 
were contained in the former section for consistency with the HHS 
Guidelines. The final rule presents these requirements in separate 
paragraphs that address each type of test to be performed by the HHS-
certified laboratory for organizational clarity.
    The NRC added Sec.  26.167(c) [Quality control requirements for 
performing initial and confirmatory validity tests] to establish 
quality control requirements for performing initial and confirmatory 
validity tests at an HHS-certified laboratory. The quality control 
requirements for validity tests in this paragraph incorporate the 
related provisions of the HHS Guidelines.
    The final rule adds Sec.  26.167(c)(1) [Requirements for performing 
creatinine tests] to require HHS-certified laboratories to measure 
creatinine concentration to 1 decimal place on initial and confirmatory 
creatinine tests and to establish requirements for the quality control 
samples to be used in initial and confirmatory tests for creatinine 
concentration.
    Section 26.167(c)(2) [Requirements for performing specific gravity 
tests] establishes the required characteristics of the refractometers 
that HHS-certified laboratories must use to measure specific gravity 
and the characteristics of the quality control samples to be used for 
initial and confirmatory tests for a specimen's specific gravity.
    Section 26.167(c)(3) [Requirements for performing pH tests] 
establishes quality control requirements for performing initial and 
confirmatory pH tests. Section 26.167(c)(3)(ii) through (c)(3)(vi) 
specifies the required calibrators and controls for pH testing, based 
on the type of testing instrument used and whether the laboratory has 
performed a pH validity screening test. In response to a public comment 
on the proposed rule, the NRC relocated the requirements for 
calibrators and controls for an initial colorimetric pH test from Sec.  
26.167(c)(3)(ii) in the proposed rule to Sec.  26.167(c)(3)(vi) in the 
final rule. The agency made this change to increase consistency between 
the organization of Part 26 and the

[[Page 17102]]

organization of the related requirements in the HHS Guidelines.
    The NRC has added three additional paragraphs related to quality 
control of initial and confirmatory validity testing: Sec.  
26.167(c)(4) [Requirements for performing oxidizing adulterant tests], 
Sec.  26.167(c)(5) [Requirements for performing nitrite tests], and 
Sec.  26.167(c)(6) [Requirements for performing ``other'' adulterant 
tests]. These paragraphs establish quality control requirements for 
performing initial and confirmatory tests for oxidizing adulterants, 
among which nitrites are one example, and for ``other'' adulterants. 
The added paragraphs are consistent with the related requirements in 
the HHS Guidelines. With respect to the proposed rule, the agency made 
minor editorial changes to these provisions in response to public 
comments to improve the clarity of the requirements. For example, the 
NRC implemented one commenter's suggestion to add cross-references in 
Sec.  26.167(c)(4)(i) and (c)(4)(ii) to the specific provisions in 
Sec.  26.161 that establish the cutoff criteria for oxidizing 
adulterants to clarify the adulterant concentrations that calibrators 
must contain.
    Section 26.167(d) [Quality control requirements for initial drug 
tests] amends and combines portions of former Sections 2.7(d) and 
(e)(1), and 2.8(c) in Appendix A to Part 26. The former sections 
established quality control requirements for performing initial tests 
for drugs and drug metabolites at HHS-certified laboratories. For 
organizational clarity, the final rule groups together these related 
requirements that were dispersed throughout the former rule. In 
addition, the NRC has amended a number of the former requirements, as 
follows:
    Section 26.167(d)(1) updates 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 HHS-certified laboratories. This section 
requires laboratories to use only immunoassay tests that meet the 
requirements of the Food and Drug Administration for commercial 
distribution. The requirements in the former paragraph related to 
initial drug testing at licensee testing facilities have been moved to 
Sec.  26.137(e)(1) of Subpart F to improve organizational clarity in 
the rule.
    Section 26.167(d)(2) permits HHS-certified laboratories to conduct 
multiple tests of a single specimen for the same drug or drug class. 
The final rule, with respect to the proposed rule, includes an example 
to clarify this section in response to a public comment. The 
requirements and example in this paragraph are consistent with a 
similar provision in the HHS Guidelines.
    Section 26.167(d)(3)(i)-(d)(3)(v) updates former Section 2.8(c) in 
Appendix A to Part 26. The former section required HHS-certified 
laboratories to include quality control samples in each analytical run 
of specimens for initial drug testing. Section 26.167(d)(3)(i)-
(d)(3)(v) specifies the number and characteristics of the quality 
control samples to be included in each analytical run of specimens. 
With respect to the proposed rule, the final rule contains minor 
language clarifications. These requirements are identical to those 
contained in Sec.  26.137(e)(6) and (e)(7) for initial drug tests at 
licensee testing facilities and have been added for consistency with 
the related provisions in the HHS Guidelines.
    In addition, in response to a public comment on the organization of 
this section, the final rule, with respect to the proposed rule, moves 
proposed Sec.  26.167(d)(3)(v) to Sec.  26.167(d)(4) to improve 
organizational clarity. Section 26.167(d)(4) requires that 10 percent 
of the specimens in each analytical run must be quality control 
samples.
    Proposed Sec.  26.167(e) [Quality control requirements for 
performing confirmatory drug tests] updates and combines portions of 
former Sections 2.7(f)(2) and 2.8(d) in Appendix A to Part 26. The 
former sections addressed quality control requirements for performing 
confirmatory drug tests. In general, the changes the NRC has made to 
the former requirements are made for organizational clarity in the 
final rule and to incorporate the related provisions in the HHS 
Guidelines.
    Section 26.167(e)(1) amends former Section 2.7(f)(2) in Appendix A 
to Part 26. The former provision required that confirmatory drug tests 
must be performed using GC/MS testing. The final rule permits HHS-
certified laboratories to use other techniques for confirmatory drug 
testing that the HHS Guidelines approve for use in Federal workplace 
drug testing programs.
    The NRC added Sec.  26.167(e)(2) to update Section 2.8(d) in 
Appendix A to Part 26 by establishing a requirement for the percentage 
of quality control samples that HHS-certified laboratories must include 
in each analytical run for confirmatory testing. The former rule did 
not specify a percentage. The NRC added this requirement for 
consistency with the HHS Guidelines. With respect to the proposed rule, 
the final rule separates the first and second sentences of the proposed 
provision into separate paragraphs and renumbers the second sentence of 
proposed Sec.  26.167(e)(2) as Sec.  26.167(e)(3) for organizational 
clarity, in response to a public comment.
    Section 26.167(e)(3)(i) through (e)(3)(iv) amends the requirements 
for quality control samples in former Section 2.8(d) in Appendix A to 
Part 26. The final rule, with respect to the proposed rule, makes minor 
language clarifications in this paragraph. Section 26.167(e)(3)(i) and 
(e)(3)(ii) retains the former requirements for laboratories to include 
blank samples and samples that contain known standards in each 
analytical run. The requirements adopt the simpler language from the 
related provisions in the HHS Guidelines to improve clarity in the 
language of the rule. For consistency with the related requirements in 
the HHS Guidelines, the paragraph provides more detailed requirements 
for ``positive controls with the drug or metabolite at or near the 
threshold'' than in former Section 2.8(d)(1) in Appendix A to Part 26. 
The rule requires, in Sec.  26.167(e)(3)(iii), at least one control 
fortified with a drug or drug metabolite targeted at 25 percent above 
the cutoff and, in Sec.  26.167(e)(3)(iv), at least one calibrator or 
control that is targeted at or below 40 percent of the cutoff.
    The NRC moved the requirements in proposed Sec.  26.167(f) [Blind 
performance testing] to a new section in the final rule, Sec.  26.168 
[Blind performance testing]. The agency made this change because 
licensees and other entities, rather than HHS-certified laboratories, 
are primarily responsible for implementing these requirements. 
Therefore, presenting requirements for licensees' and other entities' 
blind performance testing of HHS-certified laboratories in a separate 
section makes them easier to locate in the final rule and meets Goal 6 
to improve clarity in the organization of the rule.
    With respect to the proposed rule, the final rule renumbers 
proposed Sec.  26.167(g) [Errors in testing] as Sec.  26.167(f). This 
section amends former Section 2.8(e)(4) through (e)(6) in Appendix A to 
Part 26, and imposes requirements on licensees, other entities, and 
HHS-certified laboratories related to unsatisfactory performance, 
including false positive and false negative test results from the HHS-
certified laboratory. This paragraph requires the licensee or other 
entity to ensure that the HHS-certified laboratory investigates any 
conditions that may adversely reflect on the testing process. Notably, 
the rule no longer requires the licensee to perform the investigation, 
but rather to ``ensure'' that the

[[Page 17103]]

laboratory completes an investigation. The NRC made this change because 
licensees and other entities do not typically retain personnel with the 
expertise required to investigate the complex technologies and 
processes involved in testing at HHS-certified laboratories. The agency 
has moved the requirements for reporting and documentation of the 
investigation, which formerly appeared in Section 2.8(e)(4) in Appendix 
A to Part 26, to Sec. Sec.  26.715(b)(8) and 26.719(c) in Subpart N of 
the final rule for organizational clarity.
    Section 26.167(f)(1) explicitly states the requirements that were 
implied in former Section 2.8(e)(4) in Appendix A to Part 26 that the 
investigation must identify the root cause(s) of any unsatisfactory 
performance and the HHS-certified laboratory must take corrective 
actions. The rule expands these requirements to include the licensee or 
other entity, as well as the HHS-certified laboratory, depending on the 
causes identified and the extent to which the causes are within each 
entity's control. The NRC revised the former requirement to recognize 
that some testing errors are not attributable to the HHS-certified 
laboratory.
    Section 26.167(f)(2) amends former Section 2.8(e)(5) in Appendix A 
to Part 26. This provision required the licensee to notify the NRC if a 
false positive error occurred on a blind performance test sample and 
the error was determined to be administrative. The final rule requires 
the licensee or other entity, and the HHS-certified laboratory, to take 
corrective actions for any false positive errors in blind performance 
testing, in response to the findings of the investigation that would be 
required in this section. The rule continues to authorize licensees and 
other entities to require the laboratory to review and re-analyze 
previously tested specimens, if the investigation indicates that the 
error could have been systematic. The rule also deletes reference to 
administrative errors, which appeared in former Section 2.8(e)(5), so 
that any type of errors falls under the requirements of the paragraph. 
The NRC moved the reporting requirement in former Section 2.8(e)(5) to 
Sec.  26.719(c)(2) in Subpart N for organizational clarity.
    Section 26.167(f)(3) amends former Section 2.8(e)(6) in Appendix A 
to Part 26. This section addressed false positive errors resulting from 
technical or methodological errors by the laboratory. The rule 
incorporates reference to validity testing, consistent with the 
addition of requirements to conduct validity testing throughout the 
rule, as previously discussed with respect to Sec.  26.31(d)(3)(i). The 
rule deletes the last sentence of the former paragraph because it 
addressed the responsibilities of the HHS and is not relevant to the 
NRC or the licensees and other entities who are subject to Part 26. The 
paragraph retains the other provisions of former Section 2.8(e)(6), but 
adopts the simpler language of the related provision in the HHS 
Guidelines for increased clarity in the language of the rule. With 
respect to the proposed rule, the final rule replaces the term 
``certifying scientist'' in the third sentence of the proposed 
provision with the accurate term ``responsible person'' in response to 
a public comment which noted the use of the incorrect term in the 
proposed rule.
    Section 26.167(g) [Accuracy] retains former Section 2.7(o)(3)(i) in 
Appendix A to Part 26 with minor editorial revisions. The agency 
relocated the former paragraph to Sec.  26.167(g) because it relates to 
quality control of the HHS-certified laboratory's drug testing 
processes. The NRC made this change to meet Goal 6 of this rulemaking 
to improve clarity in the organization and language of the rule.
    Section 26.167(h) [Calibrators and controls] updates former Section 
2.7(o)(2) in Appendix A to Part 26. 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 has increased. The final rule 
updates 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. The labeling requirements in the second sentence of 
former Section 2.7(o)(2) have been retained without change.
Section 26.168 Blind Performance Testing
    Section 26.168 updates and expands former Section 2.8(e) in 
Appendix A to Part 26 [Licensee blind performance test procedures]. The 
former paragraph established requirements for licensees and other 
entities to conduct blind performance testing of HHS-certified 
laboratories. With respect to the proposed rule, the final rule has 
moved the requirements in proposed Sec.  26.167(f) to this new section 
because presenting them in a separate section makes them easier to 
locate in the final rule. The final rule also provides more detailed 
requirements for the formulation of blind performance test samples that 
licensees and other entities use to obtain HHS-certified laboratory 
performance data and revises the number, composition, and percentages 
of blind samples that licensees and other entities must submit to the 
HHS-certified laboratories. The NRC made these changes in response to 
detailed public comments that addressed these issues.
    The NRC added Sec.  26.168(a) to require licensees and other 
entities to submit blind performance test samples to the HHS-certified 
laboratories with whom they contract for drug testing services. To 
improve clarity in the language of the rule, the NRC added this 
provision to make explicit the same requirement that was implied in 
former Section 2.8(e) of Appendix A to Part 26.
    Section 26.168(a)(1) amends the portion of former Section 2.8(e)(2) 
in Appendix A to Part 26 that established the percentages and numbers 
of blind performance test samples that licensees and other entities 
must submit to the HHS-certified laboratory during the first 90 days of 
any initial contract with the HHS-certified laboratory. The final rule 
decreases the percentage of blind performance test samples that 
licensees and other entities must submit to the HHS-certified 
laboratory during the initial 90-day period of any contract (not 
including rewritten or renewed contracts). Specifically, the rule 
reduces the percentage from 50 percent to 20 percent of the total 
number of specimens submitted in the 90-day period, up to a maximum of 
100 blind samples, rather than a maximum of 500 samples as specified in 
the former rule. This decrease in the blind performance testing rate 
increases the consistency of Part 26 with related provisions in the HHS 
Guidelines. In addition, since the NRC published the former rule, the 
number and size of Federal agencies who conduct drug testing has 
substantially increased. These agencies are also required to submit 
blind performance test samples under the HHS Guidelines. As a result, 
especially with respect to the issue of correctly identifying negative 
specimens, the burden on Part 26 programs to conduct performance tests 
of the HHS-certified laboratories can be reduced without affecting the 
likelihood that errors in testing will be detected.
    The regulation also adds a requirement for licensees and other 
entities to submit a minimum of 30 blind performance test samples in 
the

[[Page 17104]]

initial 90-day period. The agency has established this minimum to 
address Part 26 programs who submit only a small number of specimens to 
HHS-certified laboratories for testing each quarter. For example, for a 
very small program, 20 percent of the number of specimens submitted in 
the initial 90-day period could be less than one blind performance test 
sample. Establishing a minimum number of samples will provide assurance 
that the HHS-certified laboratories used by these Part 26 programs are 
providing accurate test results.
    Section 26.168(a)(2) amends the portion of former Section 2.8(e)(2) 
in Appendix A to Part 26 that addressed ongoing blind performance 
testing after the first 90 days of an initial contract with an HHS-
certified laboratory. The rule decreases the rate at which licensees 
and other entities must submit blind performance test samples to an 
HHS-certified laboratory in each quarter after the initial 90-day 
period from 10 percent in the former rule to one percent, or a total of 
10 samples, whichever is greater. The rule also decreases the maximum 
number of samples to be submitted per quarter from 250 to 100 samples. 
The rationale for these changes is the same as discussed with respect 
to Sec.  26.168(a)(1).
    The NRC added Sec.  26.168(a)(3) to require licensees and other 
entities to submit blind performance test samples to the HHS-certified 
laboratory at a frequency that is similar to the frequency for other 
specimens. This change enhances the consistency of Part 26 with the HHS 
Guidelines.
    Section 26.168(b) amends and expands former Section 2.8(e)(3) in 
Appendix A to Part 26, which required that 80 percent of the blind 
samples submitted by the licensee or other entity each quarter to the 
HHS-certified laboratory must be ``blank'' (i.e., certified to contain 
no drugs or drug metabolites). With respect to the proposed rule, the 
NRC has substantially changed the requirements in proposed Sec.  
26.167(f)(3) in response to extensive comments on the proposed blind 
performance test sample provisions. In the final rule, Sec.  26.168(b) 
now requires that approximately 60 percent of all blind performance 
test samples that licensees and other entities send to the HHS-
certified laboratory must be positive for one or more of the drugs for 
which the licensee or other entity tests, and that all drugs for which 
the licensee or other entity tests must be submitted to the HHS 
certified laboratory at least once a quarter except as indicated in 
Sec.  26.168(b)(1) and (2). The requirement that approximately 60 
percent of all blind samples submitted to HHS-certified laboratories 
must be positive for one or more drugs per sample will ensure that all 
licensees, including those who will only send the minimum number of 
blind samples required under this rule, will submit several samples for 
each drug being tested. This change will permit licensees and other 
entities to better monitor and make more informed decisions regarding 
their HHS-laboratories' performance. Under the previous ``80 percent 
negative'' rule, licensees who submitted only the 40 minimum blind 
samples required would nominally receive two results per year on three 
drugs (which were chosen by the licensee or other entity). This 
requirement provided licensees with scant information to determine 
independently, as required by rule, whether the HHS-certified 
laboratory was meeting the licensee or other entity contract provisions 
with the HHS-certified laboratory. Under the revised section, assuming 
a reasonable distribution, even those licensees and other entities who 
submit only the minimum 40 required blind samples a year will receive 
results from marijuana blind performance test samples at least 8 times 
a year, from cocaine text samples at least 7 times a year, from 
amphetamines and opiate test samples at least 3 times a year, and from 
PCP test samples at least 2 times a year. The NRC's increased emphasis 
on testing for marijuana and cocaine and the reduction in testing for 
PCP in Sec.  26.168(b)(1) and (2) reflect the fact that among all FFD 
programs, marijuana and cocaine have resulted in the largest number of 
confirmed positive drug tests and PCP the least number of confirmed 
positive drug tests, as reported in the NRC's ``Summary of FFD 
Performance Reports'', from 1990 through 2005. Therefore, the NRC has 
made these changes to meet Goal 3 of this rulemaking to enhance the 
effectiveness and efficiency of the rule.
    Section 26.168(c) limits the submission of positive blind 
performance test samples to the HHS-certified laboratory to samples 
containing only those drugs for which the licensee or other entity 
tests and requires that the blind samples sent to HHS-certified 
laboratories must be formulated according to the requirements 
established in Sec.  26.168(g)(2). This provision updates former 
Section 2.8(e)(3) in Appendix A to Part 26, which also limited 
performance testing to only those drugs included in the licensee's 
panel. With respect to the proposed rule, the final rule replaces the 
proposed requirement for positive samples to be spiked to between 60 
and 80 percent of the initial cutoff levels used by the licensee or 
other entity with a cross-reference to the more detailed requirements 
for positive blind performance test samples in Sec.  26.168(g)(2), as 
discussed with respect to that section.
    The NRC has added Sec.  26.168(d) to require licensees and other 
entities to submit approximately 10 percent of all blind performance 
test samples as false negative challenge samples to the HHS-certified 
laboratory according to the requirements established in Sec.  
26.168(g)(3). The NRC has added this provision in response to public 
comments on proposed Sec.  26.167(f) that blind samples containing 
drugs or drug metabolites at a concentration 20 percent above the 
cutoff levels would frequently yield false negative test results and, 
therefore, unfairly challenge HHS-certified laboratories. False 
negatives occur when drug levels that are positive but close to the 
initial drug test cutoff level may actually be reported as negative. 
Assuming that an initial negative drug test has an error rate of one 
percent (one percent false negatives) and all HHS-certified 
laboratories perform equally, then over time, for every 100 people who 
have recently used drugs and been tested by licensees and other 
entities, one person will not be identified as having a positive test 
result for one or more drugs on the basis of the initial test alone. 
Recent research [Cone et al., 2003] strongly suggests that the issue of 
false negatives may be significantly greater than previously 
understood. The NRC recognizes that false negatives will occur within 
its drug testing guidelines, but intends to minimize them as much as is 
reasonably possible within scientific constraints and practical 
limitations of resources. Therefore, the NRC has established the 
requirements for the characteristics of false negative challenge 
samples under the final rule to present a fair test to HHS-certified 
laboratories because they are targeted at specimens clearly above the 
range of laboratory controls yet below the standard cutoff levels.
    Section 26.168(e) requires licensees and other entities to submit 
approximately 20 percent of all blind samples as adulterated, diluted, 
or substituted and formulated according to the requirements established 
in Sec.  26.168(g)(4)-(g)(6). The NRC added this provision for 
consistency 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). This

[[Page 17105]]

performance testing is necessary to challenge the accuracy of the HHS-
certified laboratories' specimen validity testing. With respect to the 
proposed rule at proposed Sec.  26.167(f)(3), the final rule increases 
the proportion of blind samples that licensees and other entities must 
submit to challenge the laboratories' specimen validity testing. The 
NRC made this change in response to public comments on the proposed 
rule and the NRC's concern that validity test results are accurate. The 
requirements elaborated in this section protect public health and 
safety and the common defense and security by increasing the 
effectiveness of FFD programs (Goal 3 of this rulemaking) in ensuring 
that an individual whose fitness for duty is questionable does not 
perform duties or have the types of access that require the individual 
to be subject to this part.
    The final rule substantially decreases the percentage of negative 
blind performance test samples that licensees were required to submit 
to HHS-certified laboratories in former Section 2.8(e)(3) of Appendix 
A, as retained in proposed Sec.  26.168(f). The former and proposed 
provision required 80 percent of blind samples to be negative. The 
final rule revises this percentage to 10 percent. The NRC made this 
change in response to public comments on the proposed rule and because 
the NRC believes that carryover effects (i.e., a positive sample 
contaminates a negative sample because of improper laboratory equipment 
cleaning), while a concern during the early years of drug testing, are 
not an issue in current HHS-certified laboratories based on current 
specimen testing practices. The agency also believes that it is more 
appropriate to challenge the drug and validity testing capabilities of 
HHS-certified laboratories and therefore, is increasing the percentage 
of positive, adulterated, substituted, dilute, and invalid specimens 
submitted as blind performance test samples in each quarter of testing. 
With regard to the issue of correctly identifying negative specimens 
(i.e., ensuring that laboratories do not report false positive test 
results), the NRC is confidant that the 10 percent negative sample 
requirement in the final rule will provide adequate oversight regarding 
false positive test results due to carryover and other related issues. 
Another reason that the NRC is decreasing the required percentage of 
negative samples in the final rule is that the number and size of 
Federal agencies who conduct drug testing has substantially increased 
since Part 26 was first promulgated. Also, these agencies are required 
to submit negative blind performance test samples at a rate of 80 
percent under the HHS Guidelines. Therefore, the previous need for Part 
26 programs to so extensively challenge the HHS-certified laboratories' 
false positive rates is reduced.
    The NRC has added formulation standards for the blind performance 
test samples that licensees and other entities must use in Sec.  
26.168(g). The final rule revises proposed Sec.  26.167(f)(5)(i) in 
response to detailed public comments on the scientific and technical 
suitability of the proposed standards in achieving the NRC's objective 
of ensuring that the performance testing required under this rule 
ensures that test results from HHS-certified laboratories are accurate.
    The agency added Sec.  26.168(g)(1) to require that negative blind 
performance test samples may not contain a measurable amount of a 
target drug or analyte, and must be confirmed by immunoassay and 
confirmatory testing. Section 26.168(g)(2) requires that positive blind 
performance test samples must contain drug or analyte concentrations 
between 150 and 200 percent of the initial cutoff levels and be 
certified by immunoassay and confirmatory testing to contain one or 
more drug(s) or drug metabolites. Section 26.168(g)(3) requires that 
false negative challenge samples must contain target drug or analyte 
concentrations between 130 and 155 percent of the initial cutoff 
values. Section 26.168(g)(4) requires that an adulterated blind 
performance test sample must have a pH of less than or equal to 2, or 
greater than or equal to 12, or nitrite or other oxidant concentration 
equal to or greater than 500 mcg/mL) using either a nitrite 
colorimetric test or a general oxidant colorimetric test. Section 
26.168(g)(5) requires that a dilute blind performance test sample must 
contain a creatinine concentration that is equal to or greater than 5 
mg/dL but less than 20 mg/dL, and the specific gravity must be greater 
than 1.0010 but less than 1.0030. Section 26.168(g)(6) requires that a 
substituted blind performance test sample must contain less than 2 mg/
dL of creatinine and the specific gravity must be less than or equal to 
1.0010, or equal to or greater than 1.0200.
    The NRC has made these changes in Sec.  26.168(b)-(g) to increase 
the ability of licensees and other entities to independently monitor 
the ability of their HHS-certified laboratories to consistently 
identify positive, adulterated, dilute, and substituted specimens and 
hold false negatives to a minimum. The NRC recognizes that these issues 
are routinely scrutinized and evaluated by the HHS Laboratory 
Certification Program (LCP), but is mindful that the LCP challenges are 
not blind to the HHS-certified laboratories. Because of its over-
arching interest in making the Part 26 drug testing program as rigorous 
as possible, as evidenced by the detail of Subparts F and G, the NRC 
believes that a more aggressive licensee and other entity blind 
challenge to the HHS-certified laboratories in these area adds an 
important independent dimension to ensuring licensee and other entity 
confidence in the overall drug testing program.
    Section 26.168(h) has been added to establish additional detailed 
requirements for the blind performance test samples that licensees and 
other entities must submit to the HHS-certified laboratories and to 
ensure the consistency and effectiveness of the blind performance 
testing process. Section 26.168(h)(1) requires the supplier of the 
blind samples to certify that all blind specimen batches are confirmed 
by an HHS-certified laboratory prior to being put into service and to 
remove blind specimen batches from service after they have been open 
for 6 months. Section 26.168(h)(2) requires the supplier to provide an 
expiration date for each sample. Section 26.168(h)(3) requires the 
supplier to monitor each open batch on a bi-monthly (i.e., every two 
months) basis to ensure that the remaining batch does not fall below 
the criteria in this section. These requirements are based on related 
provisions in the HHS Guidelines and DOT's procedures for drug and 
alcohol testing. The NRC added these requirements in response to a 
public comment on the proposed rule requesting the NRC to clarify the 
requirements in proposed Sec.  26.167(f)(5).
    The NRC added Sec.  26.168(i) to provide specific requirements for 
ensuring that blind performance test samples are indistinguishable to 
laboratory personnel from a donor's specimen in response to a public 
comment on proposed Sec.  26.167(f)(5). These requirements are based on 
the related DOT procedures.
    Section 26.168(i)(1) requires the licensee or other entity to ship 
blind performance test samples to the HHS-certified laboratory in the 
same way donors' specimens are sent to the laboratory. This provision 
provides greater assurance than the former rule that personnel at the 
HHS-certified laboratories will not be aware that the specimen they are 
handling is a blind performance test sample. The NRC

[[Page 17106]]

added this provision to increase the effectiveness of blind performance 
testing under the rule.
    Section 26.168(i)(2) specifies the information that must be entered 
on the custody-and-control form accompanying the blind performance test 
sample. This information is necessary to ensure that the MRO is aware 
that the specimen is a blind performance test sample.
    Section 26.168(i)(3) requires licensees and other entities to 
submit split samples where applicable. This provision is necessary to 
ensure that the FFD program submits blind performance test samples that 
appear to be normal specimens that the laboratory may receive from a 
donor.
Section 26.169 Reporting Results
    This section contains requirements for HHS-certified laboratories' 
reporting of test results to the licensee's or other entity's MRO. The 
final rule in Sec.  26.169 updates former Section 2.7(g) in Appendix A 
to Part 26. The rule updates the former requirements for consistency 
with the HHS Guidelines. In addition, the rule adds requirements for 
reporting the results of 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). With respect to the 
proposed rule, the NRC has made several organizational changes to 
improve clarity by presenting the provisions in the order that is more 
consistent with the order in which HHS-certified laboratories, 
licensees, and other entities will implement them, consistent with Goal 
6 of this rulemaking.
    Section 26.169(a) amends former Section 2.7(g)(1) in Appendix A to 
Part 26, which established a time-limit on the HHS-certified 
laboratory's reporting of test results to the MRO and requirements for 
the processing and content of the report. The NRC has retained the 
requirement for the laboratory to report results to the MRO within 5 
business days of receiving the specimen at the laboratory. Under the 
final rule, the HHS-certified laboratory's ``certifying scientist,'' 
rather than the laboratory's ``responsible individual,'' certifies the 
test results. This change has been made for consistency with the 
updated term used to refer to this individual, as discussed with 
respect to Sec.  26.155(b). The rule adds a reference to validity test 
results, consistent with the addition of requirements to conduct 
validity testing throughout the proposed rule, as discussed with 
respect to Sec.  26.31(d)(3)(i). The final rule deletes the former 
prohibition on reporting test results for any specimen in a group of 
specimens sent to the laboratory by the licensee or other entity until 
the laboratory completes testing of all of the specimens in the group. 
The prohibition in the former rule was based on a concern for 
maintaining control of specimen identity. However, new technologies for 
identifying specimens and aliquots (such as bar codes on specimen 
labels matched to bar codes on aliquots and the associated custody-and-
control forms) have reduced the likelihood that specimen identity may 
be lost, and, therefore, have substantially reduced the need for the 
requirement in the former rule.
    Section 26.169(b) amends portions of former Section 2.7(f)(2) in 
Appendix A to Part 26 by eliminating the requirement for the HHS-
certified laboratory to conduct tests for drugs and drug metabolites 
using both the cutoff levels specified in this part and any more 
stringent cutoff levels specified by the FFD program. If the FFD 
program specifies cutoff levels that are more stringent than those 
specified in this part, the final rule requires the laboratory only to 
conduct testing using those more stringent cutoff levels, and only to 
report results from those tests to the MRO. The NRC made this change 
for the reasons discussed with respect to Sec.  26.31(d)(1)(i)(D). This 
provision was Sec.  26.169(c) in the proposed rule.
    Section 26.169(c) (Sec.  26.169(b) in the proposed rule) 
establishes requirements for the laboratory's reporting of validity 
test results. This provision amends former Section 2.7(g)(2) in 
Appendix A to Part 26, which established requirements for the manner in 
which HHS-certified laboratories and licensee testing facilities must 
report test results to licensee management. The NRC has moved the 
requirements in the former paragraph that are related to reporting test 
results from the licensee testing facility to Sec.  26.139(a) of 
Subpart F for organizational clarity. The final rule 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). In addition, the final rule makes 
minor changes in terminology, such as referring to a ``drug or drug 
metabolite,'' rather than a ``substance,'' for clarity in the rule 
language.
    The NRC has renumbered proposed Sec.  26.169(e) as Sec.  
26.169(c)(1) in the final rule. The NRC added this provision to require 
the HHS-certified laboratory to report all test results for a single 
specimen, if the laboratory obtains more than one positive, 
adulterated, substituted, or invalid test result from testing of the 
specimen. The regulation requires the laboratory to report any positive 
test results, as well as any adulterated, substituted, or invalid 
validity test results from the same specimen. This change is necessary 
because sanctions for the different test results differ under Sec.  
26.75. Reporting multiple test results for a single specimen is 
consistent with related requirements in the HHS Guidelines.
    Section 26.169(c)(2) updates former Section 2.7(g)(3) in Appendix A 
to Part 26, which permitted the MRO routinely to obtain quantitative 
test results from the HHS-certified laboratory. This paragraph 
incorporates the first two sentences of proposed Sec.  26.169(d). 
Specifically, the final rule revises the first sentence of former 
Section 2.7(g)(3) by stating that the HHS-certified laboratory shall 
provide quantitative test results for a positive confirmatory drug test 
result to the MRO on request. The paragraph clarifies the former 
requirement by stating that the MRO's request may be either a general 
request covering all such results or a specific case-by-case request. 
The changes to this paragraph are consistent with the related 
provisions in the HHS Guidelines. The final rule also moves the 
requirement that was contained in proposed Sec.  26.169(g) to this 
paragraph for organizational clarity. Therefore, this provision of the 
final rule requires the HHS-certified laboratory to routinely report to 
the MRO, whether requested or not, quantitative values for confirmatory 
opiate test results for morphine or codeine that are equal to or 
greater than 15,000 ng/mL. The rule adds this requirement for 
consistency with the related provision in the HHS Guidelines and 
because the MRO is not required to perform an assessment for clinical 
signs of opiate abuse in this instance, as discussed with respect to 
Sec.  26.185(j)(1). The reference to test results from blood specimens 
in former Section 2.7(g)(3) in Appendix A to Part 26 has been deleted 
for the reasons discussed with respect to Sec.  26.83(a).
    In response to public comments on the proposed rule, the NRC has 
added Sec.  26.169(c)(3) to require the HHS-certified laboratory to 
report to the MRO numerical values supporting an adulterated or 
substituted test result. The final rule also adds instructions for the 
laboratory's report to the MRO if a specimen's numerical values for 
creatinine are below the LOD. The NRC added this provision for 
consistency with the HHS Guidelines.
    Section 26.169(c)(4) requires the HHS-certified laboratory to 
contact the MRO after the HHS-certified laboratory has

[[Page 17107]]

determined that a specimen has an invalid result, but before reporting 
out the test result, to determine whether testing by a second HHS-
certified laboratory would be useful. The rule permits the laboratory's 
contact with the MRO to occur using electronic means, such as 
telephone, fax, and e-mail. If no further testing is necessary, the 
final rule requires the laboratory to report the invalid result to the 
MRO. These reporting requirements have been added for consistency with 
the related provisions in the HHS Guidelines. This provision retains 
the portions of proposed Sec.  26.169(d) that pertained to reporting 
invalid test results but the final rule presents them in a separate 
paragraph to improve organizational clarity.
    Section 26.169(c)(5) establishes requirements for the HHS-certified 
laboratory in reporting drug, metabolite, or adulterant concentrations 
that exceed normal testing ranges. This provision updates the last 
sentence of former Section 2.7(f)(2) in Appendix A to Part 26 for 
consistency with the HHS Guidelines. This provision appeared in the 
proposed rule as the third sentence of proposed Sec.  26.169(d).
    Section 26.169(d) retains the portion of former Section 2.7(g)(3) 
in Appendix to Part 26 that prohibited the MRO from disclosing 
quantitative results to a licensee or other entity and extends it to 
MRO staff for clarity in the language of the rule. This provision 
requires the MRO to only report whether the specimen was positive (and 
for which analyte), adulterated, substituted, dilute, invalid, or 
negative, except as permitted under Sec.  26.37(b). This provision 
appeared as the fourth and fifth sentences of proposed Sec.  26.169(f).
    Section 26.169(e), which was Sec.  26.169(h) in the proposed rule, 
amends former Section 2.7(g)(4) in Appendix A to Part 26, which 
established requirements for the electronic transmission of test 
results from the HHS-certified laboratory to the MRO. Specifically, the 
rule clarifies that the licensee or other entity is responsible for 
assuring the security of data transmissions from the laboratory to the 
MRO, rather than only the HHS-certified laboratory, as specified in the 
former requirement. This change responds to stakeholder comments at the 
public meetings discussed in Section V. The stakeholders accurately 
noted that licensees and other entities are responsible to the NRC for 
ensuring the security of their HHS-certified laboratories' data storage 
and transmission systems through their contracts with and audits of the 
laboratories. This revision accurately characterizes these 
relationships without changing the intent of the former provision.
    Section 26.169(f) updates former Section 2.7(g)(5) in Appendix A to 
Part 26, which established requirements for transmitting chain-of-
custody documentation with test results to the MRO. The rule permits 
HHS-certified laboratories to use various means to transmit test 
results to the MRO, including transmittal of a computer-generated 
electronic report for negative test results. However, for positive, 
adulterated, substituted, or invalid test results, the rule requires 
the laboratory to transmit a legible image or copy of the completed 
custody-and-control form to the MRO. The change has been made for 
consistency with the related provision in the HHS Guidelines. This 
provision contains the requirements in Sec.  26.169(i) of the proposed 
rule.
    Section 26.169(g) further amends former Section 2.7(g)(5) in 
Appendix A to Part 26. The paragraph continues to require that the HHS-
certified laboratory must retain the original custody-and-control form 
for any positive, adulterated, substituted, or invalid specimens. 
However, the paragraph assigns responsibility for certifying the test 
results to the laboratory's certifying scientist, rather than to ``the 
individual responsible for day-to-day management of the laboratory or 
the individual responsible for attesting to the validity of the test 
reports.'' The change has been made for consistency with the updated 
terminology used to refer to this individual in the HHS Guidelines, as 
discussed with respect to Sec.  26.155(b). This provision was Sec.  
26.169(j) in the proposed rule.
    Section 26.169(h) combines and amends former Section 2.7(g)(6) and 
(g)(7) in Appendix A to Part 26, which required the laboratory to 
submit a monthly statistical summary of drug test results to the 
licensee or other entity. The rule reduces the required frequency of 
the statistical summary report from monthly to annually in order to 
reduce the burden on licensees, other entities, and their laboratories. 
The requirement for annual reporting makes the reporting time 
consistent with the NRC's need for the information as it relates to the 
NRC's inspection schedule and the annual FFD program performance report 
that is required under Sec.  26.717, for the reasons discussed with 
respect to that section. The rule also deletes the existing reference 
to blood specimens because the option for donors to request blood 
testing for alcohol has been eliminated from the rule, as discussed 
with respect to Sec.  26.83(a). The rule also deletes the requirement 
to report drug test results at the cutoff levels specified in this 
part, if the FFD program uses more stringent cutoff levels, for the 
reasons discussed with respect to Sec.  26.169(b). The rule adds a 
requirement to report initial and confirmatory test results for 
additional drugs (if the FFD program tests for additional drugs), as 
well as a requirement to report the number of specimens with confirmed 
positive 6-AM test results. (The rule includes testing for 6-AM, 
because the presence of 6-AM in a specimen uniquely identifies heroin 
use.) In addition, the rule adds requirements to report the results of 
validity testing. The NRC has made these changes to conform to other 
changes in the rule, as discussed with respect to Sec. Sec.  
26.717(b)(2), 26.185(j)(1), and 26.31(d)(3)(i). With respect to the 
proposed rule, the NRC has added requirements for the laboratory to 
report whether a specimen that has been reported as positive and dilute 
was subject to the special analyses permitted under Sec.  26.163(a)(2) 
and the number of specimens reported as rejected for testing. The NRC 
added these reporting requirements in response to public comment noting 
that the NRC will require this information to maintain adequate 
oversight of FFD programs and for consistency with related provisions 
in the HHS Guidelines. This requirement appeared as proposed Sec.  
26.169(k) in the proposed rule.

Subpart H--Determining Fitness-for-Duty Policy Violations and 
Determining Fitness

    Throughout this subpart, 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. For example, the 
final rule eliminates the term ``non-negative,'' which was used in 
proposed Subpart H in many places and replaces it with the terms 
``positive, adulterated, substituted, dilute, or invalid,'' as 
appropriate, for the reasons discussed with respect to Sec.  26.5 
[Definitions]. Also, in Sec.  26.185, the final rule adds the term 
``confirmatory'' when referring to test results that have been reported 
to the MRO by the HHS-certified laboratory and deletes the ambiguous 
term ``referral'' when referring to a physician. The final rule also 
uses ``business days'' instead of only ``days'' to be consistent with 
other provisions in 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.

[[Page 17108]]

The substantive changes in this subpart can be found in Sec. Sec.  
26.183(b), (d), (d)(1), and (d)(2)(iv); 26.185(g), (g)(2), (g)(5), 
(h)(1), and (i)(1); 26.187(a) and (f); and 26.189(a) and (c). 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 26.181 Purpose
    Section 26.181 of the final rule describes the purpose of Subpart 
H, which is to establish requirements for MRO reviews of positive, 
adulterated, substituted, dilute or invalid confirmatory drug test 
results and for making determinations of fitness. This section provides 
an overview of the contents of the subpart, consistent with Goal 6 of 
this rulemaking to improve clarity in the organization and language of 
the rule.
Section 26.183 Medical Review Officer
    The NRC has added Sec.  26.183 to the final rule to present 
requirements related to the qualifications, relationships, staff, and 
responsibilities of the MRO. Grouping these requirements together in a 
single section meets Goal 6 of this rulemaking to improve clarity in 
the organization and language of the rule.
    Section 26.183(a) [Qualifications] of the final rule combines and 
amends the requirements in former Sec.  26.3 [Definitions] and Section 
1.2 of Appendix A to Part 26, as well as portions of former Section 
2.9(b) in Appendix A to Part 26. The provision reorganizes the former 
requirements to eliminate redundancies and group in one paragraph the 
related provisions in the former rule. These changes meet Goal 6 of 
this rulemaking to improve clarity in the organization and language of 
the rule.
    The provision amends portions of the former requirements related to 
MRO qualifications. It continues to provide that the MRO must be a 
licensed physician, but clarifies that the MRO may hold either a Doctor 
of Medicine or Doctor of Osteopathy degree for consistency with the 
related regulations of other Federal agencies. The provision adds a 
requirement that the MRO must be knowledgeable of Part 26 and the FFD 
policies and procedures of the licensees and other entities for whom 
the MRO provides services. The requirements of this part and the 
policies and procedures of various Part 26 FFD programs may differ from 
those of other workplace drug and alcohol testing programs for which an 
MRO provides services. This provision ensures that an MRO is able to 
perform his or her function appropriately under this part. In addition, 
the provision adds a requirement that within 2 years following the date 
on which this rule is published in the Federal Register, the MRO must 
pass an MRO certification examination. The requirement increases 
consistency in the performance of the MRO function among FFD programs 
because licensees and other entities are permitted to accept test 
results and the results of determinations of fitness conducted by other 
licensees and entities who are subject to the FFD rule. The 2-year 
implementation date provides MROs who are not currently certified with 
an opportunity to pass the required examination. With the exception of 
the first sentence of this provision that specifically relates to the 
MRO function under Part 26, these MRO qualification requirements are 
consistent with those of other Federal agencies.
    Section 26.183(b) [Relationships] of the final rule establishes 
requirements related to the relationships that are permitted or 
prohibited between the MRO, the licensee or other entity, and HHS-
certified laboratories. The first sentence of this provision retains 
the portion of the first sentence of former Section 2.9(b) in Appendix 
A to Part 26 that permitted the MRO to be an employee of a licensee or 
other entity, or a contractor. The NRC has added requirements to 
prohibit the MRO from being an employee or agent of, or have any 
financial interest in, a laboratory or a contracted operator of a 
licensee testing facility for whom the MRO reviews drug testing results 
for the licensee or other entity. The NRC has added this prohibition 
based upon the experiences of other Federal agencies and to be 
consistent with the related provision in the HHS Guidelines, 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.
    With respect to the proposed rule, the final rule adds the last 
sentence of Sec.  26.183(b) and paragraphs (b)(1) through (b)(6) to 
provide some examples of relationships between laboratories and MROs 
that create conflicts of interest. The NRC has included these examples 
in response to a public comment requesting more clarification regarding 
such conflict-of-interest relationships. The basis for these examples 
is 49 CFR Part 40, ``Procedures for Department of Transportation 
Workplace Drug and Alcohol Testing Programs'' (65 FR 41944; August 9, 
2001). Adding these examples meets Goal 1 of this rulemaking to update 
and enhance the consistency of Part 26 with advances in other Federal 
rules and guidelines and Goal 6 of the rulemaking to improve clarity in 
the rule language.
    Section 26.183(c) [Responsibilities] of the final rule reorganizes 
and updates the requirements in former Sec.  26.3, as well as former 
Sections 1.2, 2.4(j), 2.7(d), and 2.9(a) and (b) in Appendix A to Part 
26 to specify the responsibilities of the MRO in Part 26 programs. This 
provision reorganizes the former provisions and combines them. In 
addition, the NRC has revised the terminology to be consistent with 
that used throughout the FFD rule. These changes meet Goal 6 of this 
rulemaking to improve clarity in the organization and language of the 
rule.
    Section 26.183(c) retains the requirement in former Section 2.9(a) 
in Appendix A to Part 26 for the MRO to review positive confirmatory 
drug test results from the HHS-certified laboratory. The provision also 
adds a requirement for the MRO to review adulterated, substituted, or 
invalid results from confirmatory 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). If a 
licensee's or other entity's FFD program elects to conduct the special 
analyses of dilute specimens permitted in Sec.  26.163(a)(2), the MRO 
also is required to review those results. This provision also requires 
the MRO to identify evidence of subversion of the testing process, 
identify issues or problems associated with the collection and testing 
of specimens, and work with FFD program management to ensure the 
overall effectiveness of the FFD program. The final rule adds these 
responsibilities to clarify that the MRO carries programmatic 
responsibilities within a licensee's or other entity's FFD program, in 
addition to responsibility for reviewing drug and specimen validity 
test results. These additional responsibilities strengthen the 
effectiveness of FFD programs by ensuring that the MRO's expertise is 
brought to bear in the management of FFD programs. This provision also 
increases the consistency of the MROs' responsibilities under Part 26 
with the responsibilities of MROs in the drug and alcohol testing 
programs of other Federal agencies. Therefore, the changes meet 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 3 
to improve the effectiveness and efficiency of FFD programs.

[[Page 17109]]

    Section 26.183(c)(1) retains and updates the former definitions of 
the term ``Medical Review Officer'' contained in former Sec.  26.3 and 
Sections 1.2 and 2.9(b) in Appendix A to Part 26. This provision 
continues to require the MRO to examine alternate medical explanations 
for any positive drug test results. It also adds a requirement to 
examine alternate medical explanations for adulterated, substituted, 
invalid, or, at the licensee's or other entity's discretion, dilute 
test results report by the HHS-certified laboratory. The provision also 
retains the former provision that the MRO may interview the donor and 
review the donor's medical history and any other relevant biomedical 
factors, and review all medical records that the donor may make 
available to the MRO. In addition to the responsible use of legally 
prescribed medication, this provision requires the MRO to consider a 
documented condition or disease state and the demonstrated physiology 
of the donor in determining whether a positive, adulterated, 
substituted, or invalid test result is an FFD policy violation. The 
provision requires the MRO to consider the latter factors because they 
may cause some adulterated, substituted, invalid, or dilute validity 
test results. These changes are necessary for consistency with the 
addition of requirements to conduct validity testing throughout the 
rule, as discussed with respect to Sec.  26.31(d)(3)(i). The changes 
also increase the consistency of Part 26 with advances in other 
relevant Federal rules and guidelines, which is Goal 1 of this 
rulemaking.
    Section 26.183(c)(2) retains the meaning of the last sentence of 
former Section 2.9(b) in Appendix A to Part 26, but adds minor 
editorial revisions for consistency with the terminology used 
throughout the rule. For example, the rule replaces the term ``split 
samples'' in the former rule with the term ``split specimens.'' 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.  26.183(d) [MRO staff] to the final rule to 
establish requirements related to individuals who provide routine 
administrative support functions to MROs, whether the individuals are 
employees of the licensee or other entity, employees of the MRO, or 
employees of an organization with whom the licensee or other entity 
contracts for MRO services. This provision adds requirements related to 
MRO staff because these individuals have access to drug test results 
that are forwarded to an MRO from the HHS-certified laboratory, perform 
some administrative functions for MROs that permit them to view donors' 
private medical information, and often have contact with donors. The 
NRC is not aware of any instances when individuals who serve as MRO 
staff have compromised the confidentiality of donors' test results, 
medical information, or otherwise acted improperly in Part 26 programs. 
However, this provision adopts requirements related to the MRO staff 
function from the regulations of other Federal agencies who similarly 
permit MRO staff to provide administrative support to MROs to ensure 
that donors' medical information is handled with the highest concern 
for individual privacy. The requirement also ensures that information 
related to positive, adulterated, substituted, invalid, or dilute test 
results is not released to licensee or other entity management 
personnel unless the MRO has determined that a donor has violated the 
FFD policy. These changes meet 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 and due 
process rights of individuals who are subject to Part 26.
    With respect to the proposed rule, the final rule adds another 
sentence to Sec.  26.183(d) to clarify that employees of a licensee or 
other entity who serve MRO staff functions may also perform other 
duties for the licensee or other entity and need not be under the 
direction of the MRO while performing those other duties. The final 
rule also clarifies Sec.  26.183(d)(1) to reflect this intent and 
specify that individuals who serve MRO staff functions need only to be 
under the direction of the MRO while performing those functions. The 
NRC has added these changes to specify NRC's intent in response to a 
public comment that requested clarification on this issue.
    The NRC has added Sec.  26.183(d)(1) [Direction of MRO staff 
activities] to require an MRO to be directly responsible for the 
administrative, technical, and professional activities of individuals 
who perform MRO staff duties. As discussed with respect to Sec.  26.5, 
directing means the exercise of control over a work activity by an 
individual who is directly involved in the execution of the activity 
and either makes technical decisions for that activity without 
subsequent technical review, or is ultimately responsible for the 
correct performance of that work activity. The NRC does not intend to 
mandate that MROs must share the same physical space with all their 
staff members at all times. Direction of staff activities need not 
occur face-to-face on an all-day, every-day basis. Also, the definition 
of directing, specifically the phrase ``directly involved in the 
execution of the work activity,'' does not require the MRO to be on 
site when giving direction to individuals who are performing MRO staff 
functions. For example, the MRO must be directly involved in the work 
of onsite licensee MRO staff, even if that direct involvement occurs by 
telephone. Direction may also take place through using a variety of 
electronic communications.
    However, this provision requires that the MRO's direction of staff 
must be meaningful. Meaningful direction involves personal oversight of 
staff members' work; providing input to their performance evaluation; 
line authority over the staff for decisions, direction, and control; 
and regular contact and oversight concerning drug testing program 
matters. This provision also requires that the MRO's direction and 
control of the staff members cannot be superseded by or delegated to 
anyone else with respect to the review of negative tests and other 
functions that staff members perform for the MRO. In addition, the 
provision requires that MROs must personally review a confirmed 
positive drug test result that is received from the HHS-certified 
laboratory, as well an adulterated, substituted, invalid, or dilute 
result. This requirement is 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 26.183(d)(1)(i) requires that MRO staff duties must be 
independent from any other activity or interest of the licensee or 
other entity. The rule has added this requirement because, in contrast 
to other Federal agencies' regulations, Part 26 permits employees of 
licensees and other entities to perform MRO staff activities for MROs 
who work off site and are not physically present to supervise the 
staff. These circumstances may provide greater opportunities for 
inadvertent compromise of the independence of the MRO function than 
situations when the MRO and his or her staff are physically co-located, 
such as the inadvertent release of positive, adulterated, substituted, 
or invalid test results before the MRO has discussed the results with 
the donor. Therefore, the NRC believes that the requirement is 
necessary to protect the integrity of the MRO function and donors' 
privacy, consistent with Goal 7 of this rulemaking to protect the 
privacy and other rights (including

[[Page 17110]]

due process) of individuals who are subject to Part 26.
    The NRC has added Sec.  26.183(d)(ii) to the final rule to further 
specify the MRO's responsibilities for directing MRO staff. These 
responsibilities include, but are not limited to, ensuring that the 
procedures that must be followed by MRO staff meet the regulations of 
this part and HHS and professional standards of practice. The MRO must 
also ensure that personal information about the donor is maintained 
confidentially with the highest regard for individual privacy. These 
requirements 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 also added Sec.  26.183(d)(1)(iii) to prohibit the MRO 
from delegating his or her responsibilities for directing MRO staff 
activities to any individual or entity, other than another MRO. 
Although the NRC is unaware of any instances when the MRO function has 
been compromised by MRO staff in Part 26 programs, the experience of 
other Federal agencies has indicated that clear limits on who may 
direct MRO staff activities are advisable to maintain the independence 
and integrity of the MRO function. Therefore, Sec.  26.183(d)(1)(iii) 
establishes these clear limits and is consistent with Goal 3 of this 
rulemaking to improve the effectiveness of the FFD program.
    The NRC has added Sec.  26.183(d)(2) [MRO staff responsibilities] 
to specify the duties that MRO staff may and may not perform. The 
provisions are also based on the experience of other Federal agencies, 
which has indicated that clear limits on MRO staff duties are necessary 
to protect donor confidentiality and the integrity of the MRO process. 
Therefore, this addition 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. Section 26.183(d)(2)(i) permits 
MRO staff to receive results from the HHS-certified laboratory and to 
review and report negative test results to the licensee's or other 
entity's designated reviewing official under the MRO's direction. 
Section 26.183(d)(2)(ii) permits MRO staff to review the custody-and-
control forms for specimens that the laboratory reports as positive, 
adulterated, substituted, invalid, or dilute, and to correct errors. 
However, the MRO is required to review and approve the corrections. 
Section 26.183(d)(2)(iii) prohibits staff from conducting interviews 
with donors to discuss positive, adulterated, substituted, invalid, or 
dilute test results. The provision also prohibits MRO staff from 
requesting or reviewing medical information from donors related to any 
positive, adulterated, substituted, dilute, or invalid test results.
    Section 26.183(d)(2)(iv) prohibits MRO staff from reporting or 
discussing positive, adulterated, substituted, invalid, or dilute test 
results received from the HHS-certified laboratory with any individuals 
other than the MRO and other MRO staff. The provisions are necessary to 
protect donor confidentiality and the integrity of the MRO review 
process, consistent with Goal 7 of this rulemaking to protect privacy 
and other rights (including due process) of individuals who are subject 
to Part 26. At the same time, the provision permits licensees and other 
entities to realize the cost efficiencies associated with the MRO 
delegating some tasks to staff, consistent with Goal 3 of this 
rulemaking to increase the effectiveness and efficiency of Part 26 
programs. With respect to the proposed rule, the NRC has clarified this 
provision to specify that the MRO staff may not report or discuss 
positive, adulterated, substituted, dilute, or invalid test results 
received from the HHS-certified laboratory with any individuals other 
than the MRO and other MRO staff before those results have been 
reviewed and confirmed by the MRO. The final rule also adds limitations 
on with whom the MRO staff can discuss confirmed positive, adulterated, 
substituted or invalid test results, as well as limitations on 
discussion of quantitative test results and any personal medical 
information. The NRC believes that only the MRO is qualified to answer 
questions from FFD program personnel about the basis for his or her 
decisions and the proper interpretation of test results from the HHS 
lab. These changes are consistent with Goal 6 of this rulemaking to 
improve clarity in the language of the rule.
Section 26.185 Determining a Fitness-for-Duty Policy Violation
    Section 26.185 of the final rule contains requirements related to 
the MRO's determination that a positive, adulterated, substituted, 
invalid, or dilute test result constitutes an FFD policy violation.
    Section 26.185(a) [MRO review required] of the final rule amends 
portions of former Section 2.9(a) in Appendix A to Part 26. The former 
section established requirements for the MRO's review of test results 
from the HHS-certified laboratory. The final rule expands the MRO's 
responsibilities to include assisting the licensee or other entity in 
determining whether a donor has attempted to subvert the testing 
process. These responsibilities may include, but are not limited to, 
reviewing positive, adulterated, substituted, dilute, or invalid test 
results and authorizing the testing at an HHS-certified laboratory of 
any suspicious substance discovered in a donor's pockets that could be 
used to adulterate or substitute a urine specimen. The change meets 
Goal 3 of the rulemaking as it relates to improving the effectiveness 
of FFD programs and is consistent with the NRC's increased concern with 
potential subversion of the testing process, as discussed with respect 
to Sec.  26.31(d)(3)(i). This provision also deletes the former 
reference to ``nuclear power plant worker'' and replaces it with 
``individual'' because persons other than nuclear power plant workers 
are subject to the requirement. In addition, this provision eliminates 
the former requirement for the MRO to review blood test results from 
the HHS-certified laboratory because the rule no longer permits donors 
to request testing of a blood specimen for alcohol, as discussed with 
respect to Sec.  26.83(a). However, the provision retains the former 
requirement that the MRO must complete the review of any positive, 
adulterated, substituted, invalid, and, at the licensee's or other 
entity's discretion, dilute test results before transmitting results to 
a licensee's or other entity's designated representative.
    With regard to the proposed rule, the NRC received a public comment 
stating that the MRO should not be required to determine whether a 
donor has violated the FFD policy because MRO expertise is exclusively 
medical. The NRC believes that an MRO has the medical expertise and 
detailed knowledge of possible alternate medical explanations that is 
essential to the review process. Therefore, the NRC maintains that the 
MRO is required to determine whether a donor has violated the FFD 
policy.
    Section 26.185(b) [Reporting of initial test results prohibited] of 
the final rule retains the intent of the requirement in the last 
sentence of former Section 2.9(a) in Appendix A to Part 26. 
Specifically, this provision continues to prohibit the MRO from 
communicating to licensees and other entities any positive, 
adulterated, substituted, dilute, or invalid initial test results 
reported by the HHS-certified laboratory before confirmatory testing 
has been completed and the MRO has conducted his or her review. 
However, this provision extends the prohibition to MRO staff, 
consistent with Goal 7 of this rulemaking and the

[[Page 17111]]

addition of requirements related to MRO staff in Sec.  26.183(d), as 
discussed with respect to that provision.
    Section 26.185(c) [Discussion with the donor] of the final rule 
amends former Section 2.9(c) in Appendix A to Part 26. This provision 
continues to require the MRO to discuss a positive confirmatory drug 
test result with the donor before determining that the FFD policy had 
been violated. This provision adds a requirement for the MRO to discuss 
adulterated, substituted, dilute or invalid confirmatory validity test 
results with the donor as part of the review process, consistent with 
the addition of requirements to conduct validity testing throughout the 
rule, as discussed with respect to Sec.  26.31(d)(3)(i). This provision 
also adds a reference to ``other occurrence'' to address circumstances 
when the donor may have engaged in a subversion attempt that would be 
detected through other means, including, but not limited to, the 
specimen collection process in Subpart E [Collecting Specimens for 
Testing]. This provision eliminates the former requirement for the MRO 
to contact the EAP. Under this provision, referral to the EAP is at the 
licensee's or other entity's discretion, as documented in FFD 
procedures. The NRC has eliminated the former requirement because most 
licensees terminate the employment of individuals who have a confirmed 
positive, adulterated, or substituted drug test result. It is 
inappropriate to require licensees and other entities to provide EAP 
services to persons they will no longer employ. If a licensee or other 
entity plans to consider granting authorization to the individual after 
his or her authorization has been terminated unfavorably for the FFD 
policy violation, this provision requires the licensee or other entity 
to meet the applicable requirements of Sec.  26.69 [Authorization with 
potentially disqualifying fitness-for-duty information]. The NRC has 
made these changes in the paragraph for consistency with other changes 
to the regulation and to meet Goal 3 of the rulemaking as it relates to 
increasing efficiency in FFD programs.
    The NRC has added Sec.  26.185(d) [Donor unavailability] to the 
final rule to clarify the circumstances when the MRO may confirm a 
positive, adulterated, substituted, dilute, or invalid test result, or 
other occurrence, as an FFD policy violation without having first 
discussed the test result or occurrence with the donor. These 
circumstances include when--
    (1) The donor expressly declines the opportunity to discuss the 
possible FFD policy violation with the MRO, as specified in Sec.  
26.185(d)(1);
    (2) The donor fails to contact the MRO within one business day 
after being contacted by the licensee or other entity, or an MRO staff 
member, as specified in Sec.  26.185(d)(2); and
    (3) The MRO is unable to contact the donor after making a 
reasonable effort to do so as specified in Sec.  26.185(d)(2).
    These provisions provide more detailed guidance than the first 
sentence of former Section 2.9(c) in Appendix A to Part 26 in response 
to many questions that have arisen regarding implementation of the 
requirement for MROs to discuss test results with the donor. The 
revisions also respond to stakeholders' requests during the public 
meetings discussed in Section I.D. In questions to the NRC staff and 
during the public meetings, licensees have pointed out that the former 
rule made no provision for these circumstances that do occasionally 
arise. Therefore, these provisions address these circumstances. The NRC 
believes that these provisions give the donor adequate opportunity to 
be contacted, consistent with Goal 7 of this rulemaking to protect the 
rights of individuals subject to Part 26, while allowing licensees to 
make ``reasonable efforts'' to contact the donor; thus meeting Goal 3 
of this rulemaking as it relates to improving efficiency in the FFD 
program.
    For the same reasons, Sec.  26.185(e) [Additional opportunity for 
discussion] of the final rule specifies procedures for addressing a 
circumstance when the donor was unable to be contacted by the MRO to 
discuss a positive, adulterated, substituted, dilute, or invalid test 
result, or other occurrence. This provision permits the donor to 
present information to the MRO documenting the circumstances that 
unavoidably prevented the donor from being contacted by or from 
contacting the MRO, and permits the MRO to reopen the procedure for 
determining whether the donor had violated the FFD policy. This 
provision also permits the MRO to modify the initial determination 
based on the information that the donor provides.
    The requirements in Sec.  26.185(d) and (e) incorporate the related 
requirements in 49 CFR Part 40, ``Procedures for Department of 
Transportation Workplace Drug and Alcohol Testing Programs'' (65 FR 
41944; August 9, 2001). Therefore, in addition to responding to 
implementation questions from licensees and stakeholder requests, the 
provisions meet 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.  26.185(f) through (i) to the final rule to 
establish requirements for the MRO's review of validity test results. 
The NRC has added these paragraphs for consistency with the addition of 
requirements to conduct validity testing throughout the rule, as 
discussed with respect to Sec.  26.31(d)(3)(i) to meet Goal 3 of this 
rulemaking to increase the effectiveness and efficiency of Part 26 
programs.
    Section 26.185(f) [Review of invalid specimens] clarifies the MRO's 
responsibilities if the HHS-certified laboratory reports that a 
specimen is invalid. This provision is consistent with related 
provisions in the HHS Guidelines and is necessary because MRO actions 
in response to an invalid specimen are not specified in the former 
rule. Section 26.185(f) provides the MRO with the following several 
alternative courses of action if a specimen is declared to be invalid 
by the laboratory:
    Section 26.185(f)(1) requires the MRO to consult with the HHS-
certified laboratory to determine whether additional testing by another 
HHS-certified laboratory may be useful for completing testing of the 
specimen. Another laboratory may use different testing methods that 
could provide more definitive test results regarding the invalid 
specimen, such as the ability to identify a new adulterant or obtain 
valid drug test results despite the presence of an interfering 
substance in the specimen. If the MRO and laboratory agree that 
additional testing would be useful, the MRO shall direct the laboratory 
to forward an aliquot of the specimen to a second HHS-certified 
laboratory for further testing.
    Section 26.185(f)(2) requires the MRO to contact the donor to 
determine whether there is an acceptable medical explanation for the 
invalid result if the MRO and HHS-certified laboratory agree that 
testing at a second laboratory would not be useful. If the MRO 
determines that there is an acceptable medical explanation for the 
invalid result, the MRO would report to the licensee or other entity 
that no FFD policy violation had occurred, but that a negative test 
result had not been obtained. Because the specimen did not yield 
negative test results, the licensee or other entity could not use the 
invalid test result in the decision to grant or deny authorization. 
However, this provision also requires the MRO to assess whether the 
medical condition would similarly affect a second specimen collection. 
If the MRO determines that the medical condition is temporary and would 
not

[[Page 17112]]

affect a second specimen, he or she would direct the licensee or other 
entity to collect another specimen from the donor. The licensee or 
other entity would then rely upon the results of the second test to 
make an authorization decision. This provision does not require the 
second specimen to be collected under direct observation in this 
situation because there is no reason to believe that the individual may 
have attempted to subvert the testing process. If the MRO determines 
that the medical condition would likely affect the validity of further 
urine specimens, the MRO may authorize an alternative method for drug 
testing. At this time, the NRC declines to specify the alternative 
methods that the MRO may authorize, which may include, but are not 
limited to, testing of alternate specimens, such as hair, oral fluids, 
or sweat. The NRC leaves the selection of an alternative method to the 
professional judgement of the MRO. This provision also prohibits 
licensees and other entities from taking management actions or imposing 
sanctions on the basis of an invalid test result from a medical 
condition because no FFD violation would have occurred.
    Section 26.185(f)(3) requires the MRO to direct the licensee or 
other entity to collect another specimen under direct observation, if 
testing by another laboratory would not be useful in obtaining a valid 
result and the donor did not provide an acceptable medical explanation 
for the invalid specimen. The invasion of privacy associated with a 
directly observed collection is warranted in this situation because the 
invalid specimen may be the result of a subversion attempt. This 
provision requires the licensee or other entity to rely on the test 
results from the directly observed collection in authorization 
decision-making because the result from the invalid specimen would be 
neither negative nor positive, adulterated, substituted, or invalid, 
and could not meet the requirements for granting authorization to an 
individual in Subpart C [Granting and Maintaining Authorization] or 
serve as the basis for imposing the sanctions specified in Subpart D 
[Management Actions and Sanctions].
    The NRC has added Sec.  26.185(g) [Review of dilute specimens] to 
the final rule to establish requirements for the MRO's review of 
positive confirmatory drug test results from dilute specimens. The NRC 
has added this paragraph because reviewing test results from a dilute 
specimen is complex and MRO actions in response to a dilute specimen 
are not addressed in the former rule.
    Section 26.185(g)(1) requires the MRO to confirm a drug-positive 
FFD violation for a dilute specimen in which drugs or drug metabolites 
are detected, if the MRO determines that there is no legitimate medical 
explanation for the presence of the drugs or metabolites in the 
specimen. The final rule amends the proposed rule by clarifying that a 
clinical examination is one of the criteria that must be met before the 
MRO can confirm a drug-positive FFD violation, consistent with Goal 6 
of this rulemaking to improve clarity in the organization and language 
of the rulemaking. There are many legitimate reasons for submitting a 
dilute specimen, which is the basis for omitting the submission of a 
dilute specimen as one type of subversion attempt for which a permanent 
denial of authorization is required in Sec.  26.75(b). Although neither 
the submission of a dilute specimen nor the presence of drugs or drug 
metabolites in a dilute specimen establishes that the donor has 
attempted to subvert the testing process without additional evidence of 
subversion, the presence of drugs or metabolites in a dilute specimen 
without a legitimate medical explanation is a sufficient basis for the 
MRO to confirm that the donor has violated the FFD policy.
    The final rule modifies and clarifies Sec.  26.185(g)(2) of the 
former and proposed rules. This provision specifies the conditions that 
must be met in order for the MRO to determine whether the positive and 
dilute specimen is a refusal to test. These conditions include when--
    (1) The HHS-certified laboratory conducts the special analysis of 
dilute specimens permitted in 26.163(a)(2) and the results show the 
presence of drugs or drug metabolites in the specimen;
    (2) The MRO determines there is no legitimate medical explanation 
for the presence of drugs or drug metabolites in the specimen; and
    (3) a clinical examination has been conducted in accordance with 
this section.
    The provision also specifies when the MRO shall determine that drug 
test results are positive and the donor has violated FFD policy. These 
changes are consistent with the changes the NRC has made to procedures 
for processing dilute specimens, as discussed in Sec.  26.163(a)(2).
    Section 26.185(g)(2)(i) through (g)(2)(iii) defines the 
circumstances that may constitute a reason to believe that a donor may 
have attempted to subvert the testing process and provide a sufficient 
basis for the MRO to require the additional testing permitted in Sec.  
26.185(g)(2). These circumstances are the same as those specified in 
Sec.  26.115(a)(1) through (a)(3). The final rule clarifies this 
provision of the proposed rule by specifying that these circumstances 
must be considered by the MRO, if applicable, and are not the exclusive 
grounds to believe the donor may have diluted the specimen in a 
subversion attempt. This NRC has made this change in response to public 
comment and to meet Goal 6 of this rulemaking to improve clarity in the 
organization and language of the rule.
    Section 26.185(g)(3) clarifies that the MRO may also require the 
additional testing of a dilute specimen that is permitted in Sec.  
26.185(g)(2) if the specimen was collected under direct observation. 
This provision adds this permission for consistency with the related 
provisions in the FFD rule.
    Section 26.185(g)(4) requires the MRO to determine whether there is 
clinical evidence of the illegal use of opiates or if opiates other 
than 6-AM at any concentration are detected in a dilute specimen before 
the MRO verifies that the donor has violated the FFD policy. This 
provision does not require an evaluation for clinical evidence of 
illegal use of opiates for 6-AM because its presence in a specimen is 
proof of heroin use. However, the provision does not establish cutoff 
levels below and above which an evaluation for clinical evidence of 
illegal opiate use is not required (in contrast to those contained in 
paragraph (j) of this section) because the concentration of opiates in 
a dilute specimen does not bear any known relationship to the 
concentration of opiates in vivo (i.e., in the donor's body). For 
similar reasons, this provision also requires an evaluation for 
clinical evidence of abuse before the MRO determines that the donor has 
violated the FFD policy when drugs or drug metabolites are detected in 
a dilute specimen, indicating that the donor has used prescription or 
over-the-counter medications.
    The NRC has added Sec.  26.185(g)(5) to the final rule, with 
respect to the proposed rule, to specify the circumstances under which 
MRO review is not required. This change is consistent with related 
provisions in the HHS guidelines.
    The NRC has added Sec.  26.185(h) [Review of substituted specimens] 
to the final rule to establish requirements for the MRO review of 
substituted test results. These provisions have been added because MRO 
actions in determining an FFD policy violation for a substituted 
specimen are consistent with the related provisions in the HHS

[[Page 17113]]

Guidelines and are not addressed in the former rule.
    Section 26.185(h)(1) requires the MRO to contact the donor to 
determine whether there is a legitimate medical reason for the 
substituted result. This provision requires the MRO to give the donor 
the opportunity to provide legitimate medical evidence, within 5 
business days of being contacted by the MRO, that he or she produced 
the specimen for which the HHS-certified laboratory reported a 
substituted result. The final rule, with respect to the proposed rule, 
specifies that a qualified and experienced physician, as verified by 
the MRO, shall submit the medical evidence. The NRC has made this 
change because after publishing the proposed rule, it recognized the 
need for additional clarity in this provision to specify the NRC's 
intent. This provision also provides examples of donor claims that the 
MRO may not consider to be legitimate medical explanations, including, 
but not limited to, race, gender, body weight, and dietary factors.
    Section 26.185(h)(2) directs the MRO to report to the licensee or 
other entity that the specimen was substituted if the MRO determines 
that there is no acceptable medical explanation for the substituted 
test result.
    Section 26.185(h)(3) directs the MRO to report to the licensee or 
other entity that no FFD policy violation has occurred if the MRO 
determines that the donor has provided an acceptable medical 
explanation for the substituted test result.
    Section 26.185(i) [Review of adulterated specimens] of the final 
rule establishes requirements for the MRO's review of adulterated test 
results. This provision has been added because MRO actions in 
determining an FFD policy violation for an adulterated specimen are not 
addressed in the former rule. Section 26.185(i)(1) requires the MRO to 
contact the donor and offer him or her the opportunity to provide an 
acceptable medical explanation for the adulterated result within 5 
business days after the donor produced the adulterated result. The 
final rule, with respect to the proposed rule, specifies that a 
qualified and experienced physician, as verified by the MRO, shall 
submit the medical evidence. The NRC has made this change because after 
publishing the proposed rule, it recognized the need for additional 
clarity in this provision to specify the NRC's intent. If the MRO 
determines that there is no legitimate acceptable medical explanation 
for the adulterated result, Sec.  26.185(i)(2) requires the MRO to 
report to the licensee or other entity that the specimen is 
adulterated. If the donor provides an acceptable medical explanation, 
Sec.  26.185(j)(3) requires the MRO to report that no FFD policy 
violation had occurred. These requirements are consistent with the 
related provisions in the HHS Guidelines.
    Section 26.185(j) [Review for opiates, prescription and over-the-
counter medications] of the final rule amends former Section 2.9(d) in 
Appendix A to Part 26. It addresses circumstances that have arisen 
since Part 26 was first published and about which licensees have sought 
guidance from the NRC. These changes are consistent with Goal 3 of the 
rulemaking to improve the effectiveness of FFD programs. The paragraph 
amends the former requirements in Section 2.9(d) in Appendix A to Part 
26 and adds others, as follows:
    Section 26.185(j)(1) incorporates updated requirements from the HHS 
Guidelines related to the MRO's review of a positive drug test result 
for opiates. The rule revises but retains the meaning of the 
requirement for the MRO to determine that there is clinical evidence of 
illegal use of opiates, which appeared in former Section 2.9(d) in 
Appendix A to Part 26. Because some licensees and other entities rely 
on MROs who work off site and are not available to conduct the required 
assessment, the rule permits the MRO to designate another licensed 
physician who has knowledge of the clinical signs of drug abuse to 
conduct the evaluation. This change ensures that the clinical 
assessment is performed by a qualified physician while reducing 
unnecessary burden by permitting FFD programs to continue to rely on 
off site MROs. Therefore, the change meets Goal 5 of this rulemaking to 
improve Part 26 by eliminating or modifying unnecessary requirements.
    This provision eliminates the examples of clinical signs of opiate 
abuse in former Section 2.9(d) in Appendix A to Part 26 because these 
signs are addressed as part of the training that MROs must obtain in 
order to pass the comprehensive certification examination required in 
Sec.  26.183(a) [Qualifications]. The rule retains the provision in 
former Section 2.9(d) that permits the MRO to omit the evaluation for 
clinical evidence of abuse if the laboratory identifies 6-AM in the 
specimen. However, the rule adds permission for the MRO to omit the 
evaluation if the morphine or codeine concentration in the specimen is 
equal to or greater than 15,000 ng/mL without a legitimate medical 
explanation for the presence of opiates at or above this concentration. 
The NRC has made this change because, in the experience of other 
Federal programs, such concentrations without a legitimate medical 
explanation can only indicate substance abuse. In addition, the rule 
prohibits the MRO from considering consumption of food products as a 
legitimate medical explanation for the specimen having morphine or 
codeine concentrations at or above 15,000 ng/mL because food 
consumption could not result in a concentration at this level.
    Section 26.185(j)(2) retains the last sentence of former Section 
2.9(d) in Appendix A to Part 26. This provision requires the MRO to 
determine whether there is clinical evidence of abuse of these 
substances or their derivatives, in addition to the positive 
confirmatory test result.
    The NRC has added Sec.  26.185(j)(3) to the final rule to provide 
greater consistency in MRO determinations related to a donor's use of 
another person's prescription medication. The NRC is aware that MROs in 
different FFD programs have varied in their determinations as to 
whether the use of another person's prescription medication is an FFD 
policy violation. The paragraph clarifies the NRC's intent with respect 
to these circumstances. In the final rule, if a donor claims, and the 
MRO confirms, that a positive, adulterated, substituted, or invalid 
drug test result is due to the unauthorized use of another person's 
prescription medication, the rule requires the MRO to evaluate or 
ensure that the donor is evaluated for clinical evidence of abuse. If 
no clinical evidence of abuse is identified, the MRO shall report to 
the licensee or other entity that a violation of the FFD policy 
regarding misuse of a prescription medication had occurred. If clinical 
evidence of abuse is identified, the MRO will confirm that the test 
results are positive for the drug or metabolites detected.
    The NRC has added Sec.  26.185(j)(4) to the final rule to assure 
greater consistency in MRO determinations related to a donor's use of a 
prescription or over-the-counter medication that the donor obtained 
legally in a foreign country. Again, the NRC is aware that MROs in 
different FFD programs have varied in their determinations as to 
whether the use of medications legally obtained in a foreign county is 
an FFD policy violation. The paragraph clarifies the NRC's intent with 
respect to these circumstances. At the licensee's or other entity's 
discretion and in accordance with the FFD policy and procedures, the 
rule permits the MRO to confirm a test result as negative if there is a 
legitimate medical use for the medication that the donor obtained 
legally in a foreign

[[Page 17114]]

country and the donor has used it properly for its intended medical 
purpose. The rule prohibits the MRO from confirming a test result as 
negative if the drug used has no legitimate medical purpose, including, 
but not limited to phencyclidine and heroin.
    The NRC has added Sec.  26.185(j)(5) to prohibit the MRO from 
considering the consumption of food products, supplements, and other 
preparations that are available over-the-counter as a legitimate 
medical explanation for the specimen having drugs or drug metabolites 
above the cutoff levels specified in Sec.  26.163, including, but not 
limited to hemp products and coca leaf tea. In so doing, the rule 
provides guidance concerning a potential subversion technique that has 
become an issue for several licensees (i.e., claims of ingestion of 
hemp food products as the basis for a positive marijuana test). 
Ingestion of food products containing hemp seeds or extracts has 
produced marijuana positive test results even though the seller claimed 
that the seeds or extracts were sterilized to remove the THC 
metabolite. The NRC endorses the Federal policy in this matter that was 
published by the DOT, with the concurrence of the Departments of 
Justice and Health and Human Services and the Office of National Drug 
Control Policy. MROs must never accept an assertion of consumption of a 
hemp food product as a basis for confirming that a marijuana test is 
negative. Consuming a hemp food product is not a legitimate medical 
explanation for a prohibited substance or metabolite in an individual's 
specimen. When a specimen is positive for THC, the only legitimate 
medical explanation for its presence is a prescription for marinol. 
Under Sec.  26.29(a)(6) and (a)(7), individuals who are subject to Part 
26 receive training in order to be able to avoid ingesting substances 
that could result in positive drug test results, such as over-the-
counter medications, food products, supplements, and other 
preparations.
    The NRC has added Sec.  26.185(j)(6) to the final rule to prohibit 
the MRO from accepting the use of any drugs that are listed in Schedule 
I of section 202 of the Controlled Substances Act [21 U.S.C. 812] as a 
legitimate medical explanation for a positive confirmatory drug test 
result, even if the drug may be legally prescribed and used under State 
law. Drugs that are listed in Schedule I of section 202 of the 
Controlled Substances Act have the following characteristics:
    (1) The drug or other substance has a high potential for abuse;
    (2) The drug or other substance has no currently accepted medical 
use in treatment in the United States; and
    (3) There is a lack of accepted safety for use of the drug or other 
substance under medical supervision.
    The prohibition is primarily intended to address the medical use of 
marijuana, which some States permit, as well as the use of certain 
hallucinogenic drugs. Although some have argued that the use of such 
drugs under State laws may not adversely reflect on an individual's 
trustworthiness and reliability, the requirement is necessary to ensure 
that individuals who are subject to this part can be trusted and relied 
upon to comply with Part 26 requirements and are not impaired from 
using these drugs when performing duties that require them to be 
subject to this part.
    Section 26.185(k) [Results consistent with legitimate drug use] of 
the final rule amends former Section 2.9(f) in Appendix A to Part 26. 
The former provision instructed the MRO to report to the licensee that 
a drug test result is negative if, after review, the MRO determines 
that there is a legitimate medical explanation for the positive test 
result and that use of the substance identified through testing in the 
manner and at the dosage prescribed does not reflect a lack of 
reliability and is unlikely to create on-the-job impairment. However, 
the former provision did not provide instructions for MRO action in the 
case of an individual whose drug use is legitimate but may cause 
impairment on duty. Therefore, if the MRO determines that a risk 
exists, the final rule requires that a determination of fitness must be 
performed. Because the MRO determined that the drug test result was 
negative, the licensee or other entity shall not impose sanctions on 
the individual. However, the results of the determination of fitness 
may indicate a need to establish controls and conditions on the 
individual's performance of certain duties in order to ensure that any 
impairment from the drug use does not result in adverse impacts on 
public health and safety or the common defense and security. By 
providing greater assurance that individuals who are subject to the 
rule are fit to safely and competently perform their duties, the 
provision meets Goal 3 of this rulemaking to improve the effectiveness 
of FFD programs.
    Section 26.185(l) [Retesting authorized] of the final rule amends 
former Section 2.9(e) in Appendix A to Part 26. This provision permits 
the MRO to authorize retesting of an aliquot of a specimen or the 
analysis of any split specimen (Bottle B) if there is any question 
about the accuracy or scientific validity of a drug test result in 
order to determine whether the FFD policy has been violated. The final 
rule retains the provisions in former Section 2.9(e) that permitted a 
donor to request a retest of an aliquot of a single specimen or a split 
specimen if the FFD program follows split specimen procedures. However, 
the final rule updates the former requirement for consistency with the 
terminology used throughout the final rule (e.g., ``Bottle B'' to refer 
to a split specimen), as discussed with respect to Sec.  26.5. The 
final rule also includes a requirement that the retesting must be 
conducted at a second HHS-certified laboratory that did not conduct the 
original tests. The requirement that retesting must be performed at a 
second HHS-certified laboratory ensures the independence of the second 
testing and provide additional protection of donors' due process rights 
under the rule. In addition, the requirement increases the consistency 
of Part 26 with related provisions in the HHS Guidelines, consistent 
with Goal 1 of the rulemaking to update and enhance the consistency of 
Part 26 with advances in other Federal rules and guidelines.
    The proposed rule required the donor to request the retest in 
writing in order to ensure donors' control over the specimen and rights 
to privacy under Sec.  26.135(b). However, the final rule eliminates 
the provision that the donor's authorization for re-testing must be in 
writing. This change is in response to public comment stating that 
obtaining a written request poses an unnecessary logistical burden on 
the donor and the MRO and that verbal requests are and have been 
sufficient in the past. Therefore, the NRC has made this change, 
consistent with other Federal regulations and Goal 1 of this rulemaking 
to update and enhance the consistency of Part 26 with advances in other 
relevant Federal rules and guidelines.
    Section 26.185(m) [Results scientifically insufficient] of the 
final rule amends the first sentence of the former Section 2.9(g) in 
Appendix A to Part 26. This provision permits the MRO to determine that 
a positive, adulterated, substituted or invalid test result is 
scientifically insufficient for further action. The final rule 
instructs the MRO to report that the drug or validity test result is 
not an FFD policy violation in these circumstances, but that a negative 
test result was not obtained. The NRC has made this change for 
consistency with other changes in the rule related to invalid test 
results (see Sec.  26.185(f)). A test result that the MRO determines to

[[Page 17115]]

be scientifically insufficient for further action (as well as an 
invalid test result) could not be a basis for a licensee or other 
entity to grant or deny authorization or impose sanctions because it 
would be neither a negative nor positive, adulterated, or substituted 
test result. Therefore, the change meets Goal 6 of this rulemaking to 
improve clarity in the language of the rule. The NRC has changed some 
of the terminology used in the former paragraph in the final rule for 
consistency with the terminology used throughout the final rule (e.g., 
``samples'' is changed to ``specimens''). The final rule also makes the 
following changes to this provision:
    The final rule also adds a statement to the former paragraph to 
indicate that the MRO is neither expected nor required to request 
retesting of the specimen unless, in the sole opinion of the MRO, such 
retesting is warranted. The final rule includes this statement because, 
in the experience of other Federal agencies, some MROs have been 
pressured by the organization to whom they provide services to request 
retesting of specimens that the MRO has confirmed to be positive, 
adulterated, substituted, or invalid. Although the NRC is not aware of 
any such instances in Part 26 programs, the rule clarifies that the MRO 
alone is authorized to request retesting to further protect the 
independence of the MRO function.
    In addition, the NRC has moved the last sentence of former Section 
2.9(g), which contained records retention requirements, to Sec.  
26.215(b)(11) of Subpart N [Recordkeeping and Reporting Requirements] 
of the final rule. The NRC has moved this provision to group it with 
other records retention requirements in the rule for organizational 
clarity.
    Section 26.185(n) [Evaluating results from a second laboratory] 
establishes new requirements for the MRO's determination of an FFD 
policy violation based on a retest of a single specimen or a test of 
the specimen in Bottle B of a split specimen. This provision specifies 
that the test result(s) from the second HHS-certified laboratory 
supersede the confirmatory test results provided by the HHS-certified 
laboratory that performed the original testing of the specimen. The 
final rule incorporates these requirements from the HHS Guidelines 
because the former rule did not address MRO actions in response to test 
results from a second laboratory. Therefore, the provision is 
consistent with the related provisions in the HHS Guidelines 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.  26.185(o) [Re-authorization after a first 
violation] to the final rule. This provision addresses the MRO's review 
of drug test results following a first violation of the FFD policy 
based on a confirmed positive drug test result. The former rule did not 
require the MRO to evaluate whether drug test results in these 
instances indicated subsequent drug use after a first confirmed 
positive drug test result, and MROs from different FFD programs have 
implemented different policies. Specifically, the final rule requires 
the MRO to determine whether subsequent drug test results indicate 
further drug use since the first positive drug test result was 
obtained. For example, because marijuana metabolites are fat-soluble 
and may be released slowly over an extended period of time, a second 
positive test result for marijuana from a test that is performed within 
several weeks after a first confirmed positive test result for 
marijuana may not, in fact, indicate further marijuana use. Therefore, 
in this case, the provision prohibits the MRO from determining that a 
second FFD policy violation for marijuana had occurred if the 
quantitative results from confirmatory testing of the second specimen 
are positive for marijuana metabolites, but at a concentration that is 
inconsistent with additional marijuana use since the first positive, 
adulterated, substituted, or invalid test result was obtained. If the 
MRO concludes that the concentration of marijuana metabolites 
identified by confirmatory testing is inconsistent with further 
marijuana use since the first positive test result, the MRO would 
declare the test result as negative, even if the quantitative test 
result exceeds the 15 ng/mL confirmatory cutoff level specified in this 
part or a licensee's or other entity's more stringent cutoff level. The 
provision prevents individuals from being subject to a 5-year denial of 
authorization for a second confirmed positive drug test result under 
Sec.  26.75(e), when the donor has not engaged in further drug use, 
consistent with Goal 7 of this rulemaking to protect the privacy and 
other rights (including due process rights) of individuals who are 
subject to Part 26.
    Section 26.185(p) [Time to complete MRO review] of the final rule 
amends former Sec.  26.24(e). This provision requires the MRO to 
complete his or her review of test results and notify management of the 
results of his or her review within 10 business days after an initial 
positive, adulterated or substituted test result. The rule replaces the 
former phrase, ``initial presumptive positive screening test result,'' 
with the phrase, ``initial positive, adulterated or substituted test 
result,'' for consistency with the terminology used throughout the rule 
(see Sec.  26.5). This provision also requires the MRO to report his or 
her determination that a test result is an FFD policy violation in 
writing to the licensee or other entity and in a manner that ensures 
the confidentiality of the information. The NRC has made these changes 
for consistency with the related provisions in the HHS Guidelines, 
consistent with Goal 1 of this rulemaking.
Section 26.187 Substance Abuse Expert
    The NRC has added Sec.  26.187 to the final rule. This section 
establishes minimum requirements for a new position within FFD 
programs, the ``substance abuse expert'' (SAE). These added provisions 
meet Goal 3 of the rulemaking to improve the effectiveness and 
efficiency of FFD programs.
    The NRC has added Sec.  26.187(a) [Implementation] to the final 
rule. This provision requires SAEs to meet the requirements of this 
section within 2 years of the date on which the final rule is published 
in the Federal Register. The NRC has imposed the 2-year period in order 
to ensure that professionals who may currently be performing 
determinations of fitness, but who do not meet these proposed 
requirements, have the time necessary to obtain the required 
credentials, knowledge, and qualification training. With respect to the 
proposed rule, the final rule adds a sentence that allows an MRO who 
meets the requirements of this section to serve as both an MRO and as 
an SAE. The NRC has made this change in response to a public comment 
suggesting that allowing the MRO, if qualified, the option to function 
as the SAE would avoid any unnecessary financial burden for licensees 
that have an MRO that can make SAE determinations.
    The NRC has added Sec.  26.187(b) [Credentials] to the final rule 
to establish the credentials required for an individual to serve as an 
SAE under this part. The rule requires that the SAE must possess the 
extensive education, training, and supervised clinical experience that 
are prerequisites for obtaining the professional credentials listed in 
Sec.  26.187(b)(1) through (b)(5). Further, Sec.  26.187(c) through (e) 
requires an SAE to possess additional knowledge and experience directly 
related to substance abuse disorders and the requirements of this part.
    The NRC has added Sec.  26.187(c) [Basic knowledge] and (d) 
[Qualification

[[Page 17116]]

training] to the final rule to establish the specific areas of 
expertise and training that are required for an individual to serve as 
an SAE under this part. The knowledge and training requirements in 
these two paragraphs are necessary to ensure that SAEs possess the 
knowledge and clinical experience required to perform the SAE function 
effectively in a Part 26 program.
    Section 26.187(c) requires SAEs to possess the following types of 
knowledge: (1) Knowledge of and clinical experience in the diagnosis 
and treatment of alcohol and controlled-substance abuse disorders, in 
Sec.  26.187(c)(1); (2) knowledge of the SAE function as it relates to 
individuals who perform the duties that require an individual to be 
subject to this part, in Sec.  26.187(c)(2); and (3) knowledge of this 
part and any changes to its requirements, in Sec.  26.187(c)(3).
    Section 26.187(d) establishes the topical areas in which an SAE 
must be trained. The qualification training requirements include 
training in the following areas: (1) The background, rationale, and 
scope of this part, in Sec.  26.187(d)(1); (2) key drug and alcohol 
testing requirements of this part, in Sec.  26.187(d)(2) and (d)(3), 
respectively; (3) SAE qualifications and prohibitions, in Sec.  
26.187(d)(4); (4) the role of the SAE in making determinations of 
fitness, and developing treatment recommendations and followup testing 
plans, in Sec.  26.187(d)(5); (5) procedures for consulting and 
communicating with licensee or other entity officials and the MRO, in 
Sec.  26.187(d)(6); (6) reporting and recordkeeping requirements of 
this part as they related to the SAE function, in Sec.  26.187(d)(7); 
and (7) appropriate methods for addressing issues that SAEs confront in 
carrying out their duties under this part, in Sec.  26.187(d)(8).
    The NRC has added Sec.  26.187(e) [Continuing education] to the 
final rule to ensure that SAEs maintain the knowledge and skills 
required to perform the SAE function. The paragraph requires SAEs to 
complete at least 12 continuing professional education hours relevant 
to performing the SAE function during each 3-year period following 
completion of initial qualification training. Section 26.187(e)(1) 
describes the topics that must be covered in the continuing education 
training, to include, but not limited to, new drug and alcohol testing 
technologies, and any rule interpretations or new guidance, rule 
changes, or other developments in SAE practice under this part since 
the SAE completed the qualification training requirements in Sec.  
26.187(d). Section 26.187(e)(2) requires documented assessment of the 
SAE's understanding of the material presented in the continuing 
education activities in order to ensure that the SAE learned the 
material. These continuing education requirements are necessary to 
ensure that SAEs maintain updated knowledge and skills to continue 
performing the SAE function effectively under this part.
    The NRC has added Sec.  26.187(f) [Documentation] to the final rule 
to specify the records that the SAE must maintain in order to 
demonstrate that he or she meets the requirements of this section. The 
SAE is required to provide the documentation, as requested, to NRC 
representatives, and to licensees or other entities who rely on the 
SAE's services. Licensees and other entities who intend to rely upon a 
determination of fitness that is made by an SAE under another FFD 
program are also required to have access to this documentation. These 
requirements are necessary to ensure that licensees and other entities, 
and the NRC, have access to the documentation required to verify that 
the SAE's knowledge, training, and practice meet the requirements of 
this part. The final rule, with respect to the proposed rule, adds a 
cross-reference to ensure that this provision is consistent with the 
protection of information requirements in Sec.  26.37 of this part.
    The NRC has added Sec.  26.187(g) [Responsibilities and 
prohibitions] to the final rule to specify the responsibilities of SAEs 
within a licensee's or other entity's FFD program and their 
limitations.
    Section 26.187(g)(1) specifies at least three circumstances in 
which the SAE is responsible for making a determination of fitness 
under the rule. In Sec.  26.187(g)(1)(i), an SAE may be called upon to 
make a determination of fitness regarding an applicant for 
authorization when the self-disclosure, the suitable inquiry, or other 
sources of information identify potentially disqualifying FFD 
information about the applicant. In Sec.  26.187(g)(1)(ii), an SAE may 
be called upon to make a determination of fitness when an individual 
has violated the substance abuse provisions of a licensee's or other 
entity's FFD policy, including, but not limited to a first confirmed 
positive drug test result. Related provisions in Sec.  26.69 require 
the licensee or other entity to rely upon the results of the SAE's 
determination of fitness when making a decision to grant or maintain an 
individual's authorization and implement any recommendations from the 
SAE for treatment and followup testing. In Sec.  26.187(g)(1)(iii), an 
SAE may be called upon to make a determination of fitness when there is 
a concern that an individual may be impaired as a result of the use of 
prescription or over-the-counter medications or alcohol. Related 
provisions in Sec.  26.77 [Management actions regarding possible 
impairment] require the licensee or other entity to rely upon the 
results of the SAE's determination of fitness when determining whether 
an individual may perform duties that require the individual to be 
subject to this part. Therefore, the NRC has added the paragraph for 
consistency with other related provisions in the rule.
    The NRC has added Sec.  26.187(g)(2) to the final rule to require 
the SAE to act as a referral source to assist an individual's entry 
into an appropriate treatment or education program. The provision also 
prohibits the SAE from engaging in any activities that could create the 
appearance of a conflict of interest. Section 26.187(g)(2)(i) prohibits 
the SAE from referring an individual to any organization with whom the 
SAE has a financial relationship, including the SAE's private practice, 
to avoid creating the appearance of a conflict of interest. However, 
Sec.  26.187(g)(2)(ii)(A) through (g)(2)(ii)(D) specifies circumstances 
in which the prohibition in Sec.  26.187(g)(2)(i) does not apply. In 
general, the rule permits the SAE to refer an individual to an entity 
with whom the SAE has a financial relationship in situations where 
treatment and educational resources may be limited by cost 
considerations or geographical availability. These provisions are 
necessary to ensure that the SAE's determinations are not influenced by 
financial gain and that individuals who are subject to the rule and the 
public can have confidence in the integrity and independence of the SAE 
function in Part 26 programs.
Section 26.189 Determination of Fitness
    The NRC has added Sec.  26.189 to the final rule to present in one 
section and amend former requirements related to the determination that 
an individual is fit to safely and competently perform the duties that 
require individuals to be subject to this part.
    The final rule replaces the terms ``medical assurance'' and 
``medical determination of fitness'' used in various sections of the 
former rule (e.g., Sec.  26.27(a)(3), (b)(2) and (b)(4)) with the term 
``determination of fitness'' as defined in this section. The NRC has 
made this change in terminology because the rule permits healthcare 
professionals other than licensed physicians to conduct determinations 
of fitness, as discussed with respect to Sec.  26.187 [Substance abuse 
expert].

[[Page 17117]]

Therefore, the change meets Goal 6 of this rulemaking to improve 
clarity in the organization and language of the rule.
    The NRC has added Sec.  26.189(a) to the final rule. The first 
sentence of the paragraph defines the term ``determination of 
fitness.'' This term refers to the process entered when 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. The final rule amends this 
definition as it was proposed, due to public comment, to clarify the 
intent of the provision.
    In general, the final rule requires that professionals who perform 
determinations of fitness must be qualified and possess the requisite 
clinical experience, as verified by the licensee or other entity, to 
assess the specific fitness issues presented by an individual whose 
fitness may be questionable. The approach to designating the healthcare 
professionals who may conduct a determination of fitness focuses on the 
appropriateness of the professional's expertise for addressing the 
subject individual's fitness issue, rather than on the professional's 
organizational affiliation [see the discussion of Sec.  26.69(b)(4)] or 
whether the individual is a licensed physician. Therefore, Sec.  
26.189(a)(1) through (a)(5) provides examples of the healthcare 
professionals who are qualified to address various fitness issues that 
may arise in a FFD program. When a decision must be made to determine 
whether an individual may be granted or maintain authorization and a 
substance abuse disorder is involved, only professionals who meet the 
requirements to serve as an SAE are permitted to make determinations of 
fitness under Sec.  26.189(a)(1). The final rule permits other 
healthcare professionals to perform determinations of fitness that 
involve assessing and diagnosing impairment from causes other than 
substance abuse, such as clinical psychologists in Sec.  26.189(a)(2), 
psychiatrists in Sec.  26.189(a)(3), physicians in Sec.  26.189(a)(4), 
or an MRO in Sec.  26.189(a)(5), consistent with their professional 
qualifications. The final rule also permits other licensed and 
certified professionals who are not listed in the paragraph, such as 
registered nurses or physicians' assistants who have the appropriate 
training and qualifications, to perform a determination of fitness 
regarding specific fitness issues that are within their areas of 
expertise. However, the critical tasks of assessing the presence of a 
substance abuse disorder, providing input to authorization decisions, 
and developing treatment plans are reserved for healthcare 
professionals who have met the specific training, clinical experience, 
and knowledge requirements for an SAE under Sec.  26.187 for the 
reasons discussed with respect to that section.
    The final rule also prohibits healthcare professionals who may 
conduct a determination of fitness for a Part 26 program from 
addressing fitness issues that are outside of their specific areas of 
expertise, consistent with the ethical standards of healthcare 
professionals' disciplines as well as State laws. The rule adds this 
prohibition to clarify that the ethical standards and State laws also 
apply to making determinations of fitness under Part 26 because a 
determination of fitness conducted by a professional who is not 
qualified to address the specific fitness issue would be of 
questionable validity. Therefore, the prohibition is necessary to meet 
Goal 3 of this rulemaking to improve the effectiveness and efficiency 
of FFD programs, as well as Goal 7 to protect the privacy and other 
rights (including due process rights) of individuals who are subject to 
Part 26.
    Section 26.189(b)(1) through (b)(4) of the final rule lists and 
presents together the circumstances in which a determination of fitness 
must be performed, as required in other sections of the rule. Although 
this paragraph is redundant with other sections of the rule, these 
circumstances are listed in one paragraph 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 order in which 
they would apply to licensees' and other entities' FFD processes.
    Section 26.189(b)(1) reiterates the requirement in former Section 
2.9(f) in Appendix A to Part 26 and Sec.  26.185(k) of the final rule 
that a determination of fitness must be performed when there is a 
medical explanation for a positive, adulterated, substituted, or 
invalid test result, but a potential for impairment exists. For 
example, legitimate use of some psychotropic medications or medications 
for pain relief may cause impairment in some individuals and it may be 
necessary to limit the types of tasks the individual performs until the 
medication is no longer necessary or the person adjusts to its effects.
    Section 26.189(b)(2) reiterates requirements in former Sec.  
26.27(b)(1) and (b)(4) and Sec.  26.69(b) [Authorization after a first 
confirmed positive drug or alcohol test result or a 5-year denial of 
authorization] of the final rule that a determination of fitness must 
be performed before an individual is granted authorization following an 
unfavorable termination or denial of authorization for a violation of a 
licensee's or other entity's FFD policy.
    Section 26.189(b)(3) reiterates the requirement in Sec.  26.69(c) 
[Granting authorization with other potentially disqualifying FFD 
information] that a determination of fitness must be performed before 
an individual is granted authorization when potentially disqualifying 
FFD information is identified that has not been previously addressed 
and resolved under the requirements of this subpart.
    Section 26.189(b)(4) addresses other circumstances in which a 
determination of fitness may be required. For example, a determination 
of fitness may be necessary if an FFD concern has been raised regarding 
another individual, as required in Sec.  26.27(c)(4), and if a 
licensee's or other entity's reviewing official requires one, under 
Sec.  26.69(c)(3) and (d)(2).
    The NRC has added Sec.  26.189(c) to the final rule to establish 
requirements for a determination of fitness that is conducted ``for 
cause.'' Specifically, Sec.  26.189(c) requires that a determination of 
fitness that is conducted for cause must be conducted through face-to-
face interaction. With respect to the proposed rule, the final rule 
clarifies that a face-to-face interaction is required only when there 
is observed behavior or a physical condition. This provision ensures 
that the professional who is performing the determination has available 
all of the sensory information that may be required for the assessment, 
such as the smell of alcohol or the individual's physical appearance. 
The NRC does not require a for-cause determination of fitness to be 
conducted under this section if there is an absence of physical or 
sensory information (i.e., based solely on receiving information that 
an individual is engaging in substance abuse). The immediacy of the 
decision limits the amount of information that can be gathered and made 
available to the professional by others. The provision does not require 
that determinations of fitness for other purposes be conducted face-to-
face. These other purposes may include, but are not limited to, the 
determination of fitness that is required when an applicant for 
authorization has self-disclosed potentially disqualifying FFD 
information. Determinations of fitness in these other circumstances 
would focus primarily on historical, rather than immediate, 
information. In these cases, the professional would have access to 
information that could be gathered by others about the individual,

[[Page 17118]]

and no time urgency would be involved in the evaluation. Therefore, NRC 
has added the paragraph to meet Goal 3 of this rulemaking to improve 
the effectiveness and efficiency of FFD programs. This provision also 
requires a face-to-face assessment in some circumstances where 
electronic means of communication could not provide the requisite 
information for the evaluation. It also permits other means of 
conducting the assessment when those means provide increased 
flexibility to licensees and other entities while continuing to achieve 
the goal of the evaluation.
    Section 26.189(c)(1) through (c)(2) specifies the required outcomes 
of a for cause determination of fitness. The final rule provides an 
increased level of detail in these requirements to increase consistency 
in implementing the for cause determination of fitness process among 
FFD programs for the reasons discussed with respect to Sec.  26.187.
    Section 26.189(c)(1) requires that, if there is neither conclusive 
evidence of an FFD policy violation nor a significant basis for concern 
that the individual may be impaired while on duty, then the individual 
must be determined to be fit for duty. The licensee or other entity 
shall permit the individual to perform the duties that require the 
individual to be subject to this part.
    Section 26.189(c)(2) requires that, if there is no conclusive 
evidence of an FFD policy violation, but there is a significant basis 
for concern that the individual may be impaired while on duty, then the 
individual must be determined to be unfit for duty. Such a 
determination does not constitute a violation of Part 26 or the 
licensee's or other entity's FFD policy. Therefore, no sanctions shall 
be applied. Examples of circumstances in which an individual may be 
determined to be unfit under this paragraph could include a temporary 
illness, such as a severe migraine headache, or transitory but severe 
stress in a personal relationship. These circumstances may impact an 
individual's ability to work safely for a short period, but would have 
no implications for the individual's overall fitness to perform the 
duties that require the individual to be subject to this part. In 
addition, the final rule requires the professional who conducts the 
determination of fitness to consult with the licensee's or other 
entity's management personnel to identify and implement any necessary 
limitations on the impaired individual's activities to ensure that the 
individual's condition would not affect workplace or public health and 
safety. If appropriate, the individual may be referred to the EAP for 
assistance.
    The NRC has added Sec.  26.189(d) to the final rule to prohibit 
licensees and other entities from seeking a second determination of 
fitness if a determination of fitness under Part 26 has already been 
performed by a qualified professional who is employed by or under 
contract to the licensee or other entity. The paragraph also requires 
that the professional who made the initial determination must be 
responsible for modifications to the initial determination based on new 
or additional information. However, if the initial professional is no 
longer available, then the licensee or other entity is required to 
assist in arranging for consultation between a new professional and the 
professional who is no longer employed by or under contract to the 
licensee or other entity. The paragraph is necessary to ensure 
consistency and continuity in the treatment of an individual who may be 
undergoing treatment, aftercare, and followup testing. Therefore, this 
addition meets Goal 3 of the rulemaking to improve the effectiveness 
and efficiency of FFD programs.

Subpart I--Managing Fatigue

Section 26.201 Applicability
    Section 26.201 specifies the licensees and other entities to whom 
the requirements in Subpart I apply. This section replaces, with 
limited editorial changes, Sec.  26.195 of the proposed rule. Subpart I 
applies to licensees who are authorized to operate a nuclear power 
reactor (under Sec.  50.57 [Issuance of operating license] of this 
chapter) and holders of a combined license after the Commission has 
made the finding under Sec.  52.103(g) [Operation under a combined 
license] of this chapter, as specified in Sec.  26.3(a), and licensees 
and other entities specified in Sec.  26.3(c) at the time the licensee 
or other entity receives special nuclear material in the form of fuel 
assemblies. Also, Subpart I applies to Contractors/Vendors (C/Vs) who 
implement FFD programs or program elements upon which these licensees 
rely, as specified in Sec.  26.3(d). As discussed in Section IV.D, the 
final rule requires nuclear power plant licensees to implement the 
requirements in Subpart I for the following reasons:
    (1) Fatigue and decreased alertness can substantively degrade an 
individual's ability to safely and competently perform his or her 
duties.
    (2) Conditions that contribute to worker fatigue are prevalent in 
the U.S. nuclear power industry.
    (3) With the exception of NRC orders limiting the work hours of 
security personnel, the former NRC regulatory framework did not include 
consistent requirements to prevent worker fatigue from adversely 
impacting safe operations and the former requirements are difficult to 
readily and efficiently enforce.
    (4) Reviews of nuclear power plant licensees' controls on work 
hours have repeatedly identified practices that are inconsistent with 
the NRC Policy on Worker Fatigue, including excessive work hours and 
the overuse of work hour limit deviations.
    (5) The former regulatory framework was comprised of 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 
(i.e., the new requirements are cost-justified safety enhancements) 
and,
    (7) Preventing the fatigue of workers in safety-critical positions 
through regulation is consistent with practices in foreign countries 
and other industries in the United States.
    The requirements in the final rule also apply to C/Vs who implement 
FFD programs or program elements, to the extent that nuclear power 
plant licensees rely upon those C/V FFD programs or program elements to 
meet the requirements of this part. This final rule provision permits a 
licensee to rely on the fatigue management program of a C/V, which is 
consistent with former Sec.  26.23(a), so long as the C/V relies on 
licensee-approved FFD programs and program elements, as retained in 
Sec.  26.3 [Scope].
    Subpart I does not apply to the materials licensees who are 
otherwise subject to Part 26 (see Sec.  26.3) for two reasons. First, 
NRC analyses indicate that significant offsite radiological exposure is 
not a realistic accident consequence at a materials facility that is 
subject to Part 26 regulations because of the nature of the radioactive 
materials that are involved and the multiple layers of controls that 
NRC regulations require. Second, no analysis has been done to date to 
determine if there is evidence of excessive overtime use by the 
materials licensees. Therefore, at this time, the final rule does not 
impose the requirements of Subpart I on materials licensees. However, 
requirements to prevent fatigue from adversely affecting the job 
performance of security personnel at materials facilities provide a 
substantial enhancement to the security of these facilities. In SRM-
COMSECY-04-0037,

[[Page 17119]]

``Staff Requirements: Fitness-For-Duty Orders to Address Fatigue of 
Nuclear Facility Security Force Personnel,'' dated September 1, 2004, 
the Commission determined that FFD program enhancements related to the 
fatigue of security force personnel at independent spent fuel storage 
installations, decommissioning reactors, Category I fuel cycle 
facilities, gaseous diffusion plants, and the natural uranium 
conversion facility should be pursued as a separate rulemaking activity 
with additional stakeholder interactions.
Section 26.203 General Provisions
    Section 26.203 establishes fatigue management requirements for 
licensees' FFD programs. This section replaces Sec.  26.197 of the 
proposed rule with limited editorial changes. These editorial changes 
include the addition of recordkeeping requirements under Sec.  
26.197(d) and the removal of collective work hour requirements from 
Sec.  26.197(e)(2) of the proposed rule. The general provisions in this 
section establish requirements for licensees' fatigue management 
policies, procedures, training, examinations, recordkeeping, and 
reporting. The NRC's objective in establishing these general provisions 
is to facilitate integrating fatigue management into licensees' FFD 
programs, as discussed in Section IV.D.
    Section 26.203(a) [Policy] requires each licensee to have a written 
policy statement that describes its management's expectations and 
methods for managing fatigue to ensure that fatigue does not adversely 
affect any individual's ability to safely and competently perform his 
or her duties. This section replaces Sec.  26.197(a) of the proposed 
rule with limited editorial changes. The policy required in this 
section will apply to all individuals subject to the licensee's FFD 
program and not just those individuals subject to the work hour 
requirements presented in Sec.  26.205 [Work hours], which contains the 
revised work hour requirements presented in proposed Sec.  26.199. The 
NRC considers the responsibility for ensuring that each individual is 
fit to safely and competently perform his or her duties to be shared 
between the licensee and the individuals who perform duties on the 
licensee's behalf. Therefore, the final rule requires each licensee's 
FFD policy to delineate the licensee's fatigue management policy. Thus, 
individuals who are subject to this policy will be aware of and can 
comply with the fatigue management requirements for which they will be 
held accountable. The final rule requires each licensee to incorporate 
the fatigue management policy statement into the written FFD policy 
that is required under Sec.  26.27(b) [Policy]. As discussed with 
respect to Sec.  26.27(b), the final rule requires the policy statement 
to be clear, concise, and readily available, in its most current form, 
to all individuals who are subject to the policy.
    The NRC's past experience with worker fatigue, such as that 
documented in NRC Regulatory Issue Summary (RIS) 2002-007, 
``Clarification of NRC Requirements Applicable to Worker Fatigue and 
Self-Declarations of Fitness-For-Duty,'' dated May 10, 2002 (referred 
to in this document as RIS 2002-007), indicates that a need exists for 
individuals to clearly understand their own fatigue management 
responsibilities, as well as those of the licensee. These 
responsibilities include the individual's duty to report FFD concerns, 
including concerns related to the impact of fatigue on the individual's 
ability to safely and competently perform his or her duties, as well as 
concerns related to others, and the licensee's obligation to assess 
such fatigue-related FFD concerns. Further, the final rule does not 
prohibit licensees from imposing sanctions on individuals who fail to 
comply with the portions of the licensees' fatigue management policies 
that assign certain responsibilities to individuals. For example, a 
licensee may impose sanctions on an individual who fails to seek 
recommended treatment for a sleep disorder that, as part of a 
determination of fitness performed in accordance with Sec.  26.189 
[Determination of fitness], a healthcare professional has determined is 
adversely affecting the individual's job performance and potentially 
could be medically resolved. The final rule does not establish minimum 
sanctions for specific failures to comply with such fatigue management 
requirements because the reasons that an individual may report to work 
in a fatigued state are varied and often highly personal. Rather, the 
NRC prefers to permit licensees and the appropriate healthcare 
professionals to respond to such circumstances on a case-by-case basis. 
However, to protect an individual's rights under the rule, it is 
necessary for a licensee's fatigue management policies to communicate 
any sanctions that the licensee may impose on an individual for failing 
to comply with the policy's requirements.
    Section 26.203(b) [Procedures] requires each licensee to develop, 
implement, and maintain procedures to carry out the fatigue management 
policy that Sec.  26.203(a) [Policy] requires. Procedures are necessary 
to ensure that licensees' fatigue management programs are properly and 
consistently implemented. This section replaces Sec.  26.197(b) of the 
proposed rule with limited editorial changes.
    Section 26.203(b)(1) requires licensees to develop, implement, and 
maintain procedures that describe the process that an individual 
subject to the licensee's FFD program should follow when reporting to a 
supervisor that he or she is unfit for duty because of fatigue (i.e., 
he or she makes a self-declaration). In RIS 2002-007, the NRC noted 
that self-declaration is an important adjunct to behavioral observation 
in meeting the requirements of the performance objective in former 
Sec.  26.10(b) (as retained in Sec.  26.23(c)), which is ``to provide 
reasonable measures for the early detection of persons who are not fit 
to perform the duties that require them to be subject to this part.'' 
Because individuals are the first line of defense against the potential 
for fatigue-related impairment to adversely affect their job 
performance, it is essential that all individuals who are subject to a 
licensee's FFD program understand when and how to make a self-
declaration that they are unfit for duty. Individuals must also 
understand how the licensee's response to a worker's self-declaration 
will differ from a licensee's response to an individual's general 
statement of fatigue (e.g., casually commenting to a co-worker, ``I'm 
really tired today''), if the individual does not express a concern 
that is specific to his or her FFD (e.g., formally stating to a 
supervisor, ``I am too tired right now to check these valve lineups 
accurately'').
    Section 26.203(b)(1)(i) requires the licensee's self-declaration 
procedure to describe the responsibilities and rights of individuals 
and licensees and the actions they must take with respect to an 
individual's self-declaration of fatigue. The licensee's self-
declaration procedure may explain the employees' right to know what is 
going to happen to them if they self-declare, including any sanctions 
that may be imposed on them. The procedure may also describe the 
employees' right to privacy regarding the causes for the self-
declaration. This section ensures that all parties involved in the 
self-declaration process understand the process and responsibilities 
and the extent and limitations of their rights related to self-
declaration. The NRC has considered industry experience with 
individuals refusing to report to work on the basis that they were too 
tired. The NRC concluded that detailed procedures are necessary to 
specify (1) the individual's

[[Page 17120]]

responsibility to be available at work for a fatigue assessment, which 
must be conducted face-to-face under Sec.  26.211(b) for the reasons 
discussed with respect to that section, (2) the individual's 
responsibility to cooperate with the fatigue assessment process by 
providing the necessary information (see the discussion of Sec.  
26.211(c)(2)), and (3) the licensee's responsibility for conducting a 
fatigue assessment in response to an individual's self-declaration, as 
required under Sec.  26.211(a)(2), to determine whether, and under what 
controls and conditions if any, the individual is permitted or required 
to work. Section 26.211 [Fatigue assessments] retains with, limited 
editorial changes, the requirements in proposed Sec.  26.201 
[Applicability].
    Section 26.203(b)(1)(ii) requires the licensee's self-declaration 
procedure to describe requirements for establishing controls and 
conditions under which an individual is permitted or required to 
perform work after that individual declares that he or she is not fit 
for duty as a result of fatigue. This portion of the procedure ensures 
correct and consistent implementation of the requirements in Sec.  
26.211(b), which states that a supervisor or staff member of the FFD 
program must conduct the fatigue assessment and determine whether, and 
under what conditions, an individual who has self-declared can be 
returned to duty. For example, the licensee's procedure will provide 
guidance on establishing appropriate controls and conditions under 
which an individual could be permitted or directed to return to work 
after declaring that he or she is unfit because of fatigue. Controls 
and conditions will include, but will not be limited to, (1) controls 
on the type of work to be performed (e.g., physical or mental, tedious 
or stimulating, individual or group, risk-significant or not), (2) the 
required level of supervision (continuous or intermittent) and other 
oversight (e.g., peer checks, independent verifications, quality 
assurance reviews, and operability checks), and (3) the need to 
implement fatigue countermeasures (e.g., naps, rest breaks). The 
purpose of the controls and conditions is to mitigate the risks to 
public health and safety or the common defense and security that a 
fatigue-induced human error could pose, as discussed in Section IV.D.
    Section 26.203(b)(1)(iii) requires licensee procedures to describe 
the processes to be followed if an individual disagrees with the 
results of a fatigue assessment conducted in response to the 
individual's self-declaration. These procedures will address situations 
in which the individual disagrees with the licensee's determination 
either that the individual is capable of performing work safely (with 
appropriate controls and conditions, if necessary) or that the 
individual cannot safely be permitted to perform the duties listed in 
Sec.  26.205(a) [Individuals subject to work hour controls] because of 
fatigue. For example, the licensee's procedure may refer an individual 
who disagrees with the outcome of the fatigue assessment to the 
bargaining unit to initiate a grievance process, the employee concerns 
program, or the corrective action program.
    The final rule adds this requirement for several reasons. First, in 
RIS 2002-007, the NRC documented concerns associated with past 
instances of self-declaration. These instances indicate the need for 
licensees to describe the processes to be followed if an individual 
disagrees with the results of a fatigue assessment following a self-
declaration. In addition, at the public meetings discussed in the 
preamble to the proposed rule, several stakeholders asked the NRC to 
add this provision to the final rule to ensure that individuals have 
recourse if they disagree with the results of a fatigue assessment 
conducted in response to a self-declaration. Some of the stakeholders 
expressed a concern for the potential impact on public health and 
safety if an individual is convinced that he or she is too fatigued to 
perform work safely, but the licensee requires the individual to work. 
Other stakeholders expressed concerns that an individual may experience 
adverse employment and financial consequences if he or she is prevented 
from working because of fatigue.
    The NRC agrees that licensee policies and procedures related to 
implementing the requirements of this subpart must address these 
potential issues to protect the rights of individuals subject to the 
rule. However, the final rule does not establish specific requirements 
for the process(es) to be followed in such instances for two reasons, 
(1) licensees have already implemented a number of processes for 
addressing similar safety and employment issues that provide 
appropriate mechanisms for resolving fatigue-related issues, and (2) 
the wide variety of possible issues that may arise limits the ability 
of a single mechanism established in the final rule to appropriately 
address them all. Therefore, the final rule requires licensees to have 
procedures for addressing situations in which an individual who has 
self-declared disagrees with the outcome of a fatigue assessment, but 
it does not require a new process or specify the required 
characteristics of the licensees' process(es).
    Section 26.203(b)(2) requires licensees to develop, implement, and 
maintain procedures that describe the process for implementing the work 
hour requirements in Sec.  26.205. For example, the procedures will 
detail individual and organizational responsibilities and requirements, 
including items such as scheduling, tracking and calculating work 
hours, granting waivers from the individual work hour requirements, 
reviewing the implementation of the work hour requirements, documenting 
the results of the reviews, and implementing any necessary corrective 
actions. These procedures are necessary to ensure that individuals 
understand the work hour requirements to which they are subject and 
that licensees consistently implement the work hour requirements in 
Sec.  26.205 as the NRC intends.
    Section 26.203(b)(3) requires licensees to develop, implement, and 
maintain procedures that describe the process(es) they will follow in 
conducting a fatigue assessment, as required under Sec.  26.211(a). 
These procedures will establish the methods by which the licensee will 
determine whether an individual is fatigued, whether the individual 
will be permitted or required to perform work, and whether controls and 
conditions are necessary for the individual to be able to perform work 
safely and competently. The licensee's procedure will address fatigue 
assessments that are conducted following an individual's self-
declaration or an event, for cause, or to reassess an individual after 
returning the individual to work despite a self-declaration of fatigue 
(the situations in which the final rule requires licensees to conduct 
fatigue assessments are discussed in Sec.  26.211(a)). Because of the 
potentially subjective and personal nature of the fatigue assessment 
task and the potential for conflict and sanctions (e.g., if an 
individual is found to have been asleep while on duty), comprehensive 
procedures are necessary to ensure consistent implementation of the 
fatigue assessment requirements in Sec.  26.211. Therefore, the NRC 
expects these procedures to describe measures to ensure that fatigue 
assessments (1) are performed by properly trained personnel, (2) are 
free of bias, (3) methodically address the factors that commonly 
contribute to fatigue, (4) are based on complete and accurate 
information, (5) protect the privacy of the individuals being assessed, 
(6) recognize the fact that an individual can

[[Page 17121]]

be fatigued and unfit for duty even though he or she has not exceeded 
the work hour limits, (7) are thoroughly documented, and (8) are 
reviewed, as required by Sec.  26.205(e)(1)(iii). These procedures are 
necessary to implement the requirements in this subpart and protect the 
privacy rights and other rights of individuals, consistent with Goal 7 
of this rulemaking.
    Section 26.203(b)(4) requires licensees to develop, implement, and 
maintain procedures that describe the disciplinary actions they may 
impose on individuals, if any, following a fatigue assessment (e.g., 
termination or leave without pay) and the conditions and considerations 
for imposing those disciplinary actions. In the final rule, the NRC 
revised Sec.  26.203(b)(4) to replace the word ``sanctions'' with the 
words ``disciplinary actions'' to avoid confusion that might develop 
from the multiple meanings of the word ``sanctions.'' During the public 
meetings discussed in the preamble to the proposed rule, several 
industry representatives indicated that licensees may rely upon the 
results of a fatigue assessment as the basis for determining that an 
individual has not met management expectations for maintaining his or 
her FFD. Although the NRC neither endorses nor prohibits the imposition 
of disciplinary actions in cases of fatigue, clear communication 
regarding possible disciplinary actions and the considerations for 
taking those disciplinary actions is necessary for individuals to meet 
their responsibility for self-declaration without unwarranted fear of 
potential outcomes. For this reason, procedures are necessary to ensure 
that licensees fully disclose the conditions under which disciplinary 
actions will be considered; the nature of the possible disciplinary 
actions; and the process for administering and imposing the 
disciplinary actions, including management's expectations and the 
individual's right to a review of the determination that he or she has 
violated the FFD policy, as required under Sec.  26.39 [Review process 
for fitness-for-duty policy violations].
    Section 26.203(c) [Training and examinations] establishes fatigue-
related training and examination requirements in addition to those 
required under Sec.  26.29(a) [Training content] and (b) [Comprehensive 
examination]. This section retains without change the requirement in 
Sec.  26.197(c) of the proposed rule. Several of the knowledge and 
abilities (KAs) requirements listed in Sec.  26.29(a) ensure that 
individuals are familiar with a licensee's or other entity's fatigue 
policies and procedures. However, individuals who are subject to 
Subpart I should also have a working-level knowledge of specific, 
fatigue-related topics that may facilitate personal decisions and 
actions that are consistent with the objective of preventing, 
detecting, and mitigating the adverse effects of fatigue on worker job 
performance. Individual workers typically do not possess these KAs 
without training (Folkard and Tucker, 2003; Knauth and Hornberger, 
2003; Monk, 2000). Therefore, the final rule requires licensee FFD 
training and testing programs to address the topics specified in Sec.  
26.203(c)(1) and (c)(2).
    Section 26.203(c)(1) requires FFD training and examinations to 
ensure that individuals who are subject to Subpart I understand the 
contributors to worker fatigue, circadian variations in alertness and 
performance, indications and risk factors for common sleep disorders, 
shiftwork strategies for obtaining adequate rest, and the effective use 
of fatigue countermeasures. Examples of topics that licensee training 
and examinations will address that are related to this KA will include, 
but are not limited to, (1) the principal factors that influence worker 
fatigue, (2) knowledge that a worker's ability to perform and remain 
alert is influenced by physiological changes that follow a daily 
pattern, (3) the time periods during which workers are most likely to 
exhibit degraded alertness and performance, (4) the principal symptoms 
of common sleep disorders (e.g., sleep apnea and insomnia) and the 
conditions that can contribute to their onset, (5) the methods for 
optimizing sleep periods on a shiftwork schedule, and (6) how to safely 
and effectively counteract fatigue with measures such as caffeine and 
strategic napping. Knowledge of these topics is necessary to ensure 
that individuals are able to (1) self-manage fatigue that is caused by 
shiftwork and factors other than work hours, (2) take actions to 
maintain their alertness at work, and (3) recognize and seek treatment 
for sleep disorders that might be creating or exacerbating their own 
fatigue. In addition, training in methods for coping with the 
challenges of shiftwork may contribute to a more stable workforce by 
reducing worker turnover. A Circadian Technologies, Inc. survey of 550 
facilities in the United States and Canada found that turnover at 
facilities with operations extending beyond 7 a.m. to 7 p.m. averaged 
10 percent in 2003, compared with 3.4 percent in all U.S. companies. 
Facilities offering no training on specific coping strategies had an 
average turnover rate of 11.4 percent, compared to 7.6 percent for 
facilities that offered such training to their employees, and 2.9 
percent for those offering the training to employees and their family 
members (Circadian Technologies, Inc., 2004).
    Section 26.203(c)(2) requires FFD training and examinations to 
ensure that individuals who are subject to Subpart I have the ability 
to identify symptoms of worker fatigue and contributors to decreased 
alertness in the workplace. Examples of topics that are related to this 
KA will include, but are not limited to, (1) behavioral symptoms of 
fatigue (e.g., yawning, red eyes, prolonged or excessive blinking, 
irritability), (2) task conditions that may contribute to degraded 
alertness and increased fatigue (e.g., repetitive tasks, tasks with 
high cognitive or attentional demands, tasks that require the 
individual to be sedentary, tasks that limit social interaction), and 
(3) environmental conditions that may contribute to degraded alertness 
and increased worker fatigue (e.g., high heat and humidity, low 
lighting, and low-frequency noise/white noise). Requiring individuals 
to be trained on this KA is necessary to ensure that an individual is 
able to determine when it is appropriate to self-declare that he or she 
is unfit for duty because of fatigue, as permitted under Sec.  26.209 
[Self-declarations] and Sec.  26.211(a)(2), and to determine when it is 
appropriate to report an FFD concern about another individual who, 
based on behavioral observations, is exhibiting indications of fatigue, 
as required under Sec.  26.33 [Behavioral observation].
    Section 26.203(d) [Recordkeeping] establishes recordkeeping 
requirements related to the implementation of Subpart I. This section 
includes, with revisions, the requirements presented in Sec.  26.197(d) 
of the proposed rule. Specifically, Sec.  26.203(d)(1), which retains 
Sec.  26.197(d)(1) of the proposed rule without change, requires 
licensees to retain records of the number of hours worked by 
individuals who are subject to the work hour requirements established 
in Sec.  26.205. Section 26.203(d)(2) requires licensees to retain 
records of shift schedules and shift cycles of individuals who are 
subject to the work hour requirements established in Sec.  26.205. The 
NRC added this requirement to the final rule. Section 26.203(d)(3) 
through (d)(5) retains the requirements in proposed Sec.  26.197(d)(2) 
through (d)(4) without changes. Specifically, Sec.  26.203(d)(3) 
requires licensees to retain records of the number of, and the bases 
for, waivers they have granted, Sec.  26.203(d)(4) requires licensees 
to retain documentation of the work hour reviews that are required 
under Sec.  26.205(e)(3) and (e)(4), and

[[Page 17122]]

Sec.  26.203(d)(5) requires retaining documentation of any fatigue 
assessments licensees conduct. The NRC removed the proposed Sec.  
26.197(d)(5) from the final rule because the NRC eliminated the 
collective work hour requirements. The final rule establishes these 
recordkeeping requirements for four reasons: (1) These records are 
necessary to ensure that documentation of the licensee's fatigue 
management program is retained and available for NRC inspectors to 
verify that licensees are complying with the work hour requirements and 
waiver and fatigue assessment provisions, (2) the documentation is 
necessary for a review process under Sec.  26.39 or in legal 
proceedings related to a determination that an individual has violated 
the fatigue provisions of an FFD policy, (3) the documentation is 
necessary to perform the trending and self-assessments that Sec.  
26.205(e) [Reviews] requires; and (4) the documentation is necessary to 
meet the reporting requirements in Sec.  26.203(e) [Reporting]. To 
ensure that the records remain available for NRC inspections and the 
review process or legal proceedings, the final rule requires licensees 
to retain these records for 3 years or until the completion of any 
related legal proceedings, whichever is later.
    Section 26.203(e) [Reporting] requires licensees to report to the 
NRC certain data related to their fatigue management programs as part 
of the annual FFD program performance report, which Sec.  26.717 
[Fitness-for-duty program performance data] requires. This requirement 
replaces, with revisions, Sec.  26.197(e) of the proposed rule. This 
section is revised to specify that reports are required in a standard 
format. The final rule requires licensees to include the following 
information in the annual report: (1) Information on the number of 
waivers granted from work hour requirements in the previous calendar 
year, and (2) a summary of corrective actions, if any, resulting from 
the analyses of these data, including fatigue assessments. This section 
does not retain the requirements in the 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 
limits. In addition, this section does not retain the proposed rule 
requirement for licensees to report a summary of instances of fatigue 
assessments that the licensee conducted.
    The NRC considered comments that the requirements for including 
fatigue management information should be deleted from the rule because 
they will not provide new or unique information to the NRC, are 
unnecessary to protect public health and safety, are unnecessary to 
facilitate NRC oversight of the revised rule, and are 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 at increased potential for impairment, and 
(2) how often a licensee must mitigate or prevent a condition adverse 
to safety while using individuals 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 assessment 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 proposed 
rule requirements are 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 the 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 of the site and 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) or issues (e.g., self-declaration) 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. Furthermore, 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

[[Page 17123]]

improve its effectiveness or reduce unnecessary burden. The NRC notes 
that such information was the basis for reducing the random testing 
rate for drugs and alcohol required in the final rule.
     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 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. Furthermore, 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 
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 Part 26 requirements and performance 
objective--The final rule retains the requirement that licensees 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, respectively). 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. 
Furthermore, 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. The NRC therefore considers the reporting of information 
pertaining to licensee management of worker fatigue to be consistent 
with (1) the requirements for reporting information pertaining to drug 
and alcohol testing, (2) the performance objective of this rulemaking 
for licensees to implement a comprehensive FFD program, and (3) 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) 
requires licensees to report information concerning management of 
worker fatigue 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) 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.
    Section 26.203(e)(1) requires licensees to provide the NRC with an 
annual summary of all instances during the previous calendar year in 
which the licensee waived each of the work hour controls specified in 
Sec.  26.205(d)(1) and (d)(2) for each of the duties listed in Sec.  
26.4(a)(1) through (a)(5). This section revises the requirements in 
proposed Sec.  26.197(e)(1). The agency revised this reporting 
requirement 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.
    Section 26.203(e)(1) revises the reporting requirements in proposed 
rule Sec.  26.197(e)(1) to clarify that licensees are required to 
report the number of waivers for each work hour requirement and not the 
sum total of all waivers for all work hour requirements. For example, 
if the licensee permits an operator to work 18 hours in a 24-hour 
period three times in a year, another operator to work 80 hours in a 7-
day period, and another operator to take a rest break of only 6 hours 
between shifts, then the licensee will report that it granted three 
waivers of Sec.  26.205(d)(1)(i), one waiver of Sec.  
26.205(d)(1)(iii), and one waiver of Sec.  26.205(d)(2)(i), for the 
operations group that year. This clarification ensures that the waiver 
information is reported at a level of detail that will enable the NRC 
to know which limits

[[Page 17124]]

are most frequently exceeded and therefore better understand the 
specific scheduling challenges to licensee management of worker 
fatigue.
    Section 26.203(e)(1) also requires licensees to include only those 
waivers under which work was actually performed in the annual report. 
This section contains requirements presented in Sec.  26.197(e)(1)(i) 
of the proposed rule. The final rule retains this provision of the 
proposed rule because it may sometimes be unnecessary for individuals 
to work the extended hours for which a licensee planned when granting a 
waiver. Licensees may anticipate that it will be necessary to waive one 
or more of the work hour controls listed in Sec.  26.205(d)(1) and 
(d)(2) in order to complete a task and so will implement the process 
specified in Sec.  26.207 [Waivers and exceptions] for granting 
waivers. However, on some occasions, the work will be finished sooner 
than the licensee anticipated with the result that the waiver was 
granted but no one was required to work an extended work period. The 
final rule requires licensees to exclude waivers under which no work 
was performed from the annual report because this circumstance provides 
no meaningful information about the licensee's management of fatigue 
during extended work periods.
    Section 26.203(e)(1) further specifies that licensees shall report 
all waivers granted for each of the work hour controls in Sec.  
26.205(d)(1) through (d)(5) for those instances in which a single 
extended work period required a waiver of more than one work hour 
control. This section contains the requirements presented in Sec.  
26.197(e)(1)(ii) of the proposed rule. For example, if an individual 
works 12 hours on day 1 and on day 2 the licensee needs the individual 
to work more than 16 hours to resolve a condition adverse to safety, 
the licensee would need to authorize and report a waiver of Sec.  
26.205(d)(1)(i), for exceeding 16 hours in a 24-hour period, and 
(d)(1)(ii), for exceeding 26 hours in a 48-hour period. Although this 
example included only one work period, both waivers are required and 
must be reported because the potential for fatigue results not only 
from the length of the workday (e.g., exceeding 16 hours of work in a 
24-hour period) but also the cumulative effect of prior work (e.g., 
exceeding 26 hours of work in a 48-hour period).
    Section 26.203(e)(1)(i) and (e)(1)(ii) requires licensees to report 
whether work hour controls are waived for individuals working on normal 
plant operations or working on outage activities. In establishing this 
requirement the NRC considered comments that the use of waivers should 
be considered in context. 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. This revision will 
enable the NRC to better understand a site's changes in waiver use over 
time and understand why certain annual reports for a given site may 
indicate a heightened level of waiver use relative to the site's other 
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. Furthermore, the NRC intends to 
consider waiver use in conjunction with the reported fatigue assessment 
information. Therefore, the agency will be able to determine whether 
waiver use may be associated with the incidence of fatigue assessments 
conducted for cause, following events, or in response to self-
declarations by individuals asserting that they are not able to safely 
and competently perform their duties because of fatigue. 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.
    Section 26.203(e)(1)(i) requires licensees to report the number of 
instances in which each work hour control specified in Sec.  
26.205(d)(1)(i) through (d)(1)(iii), (d)(2)(i) and (d)(2)(ii), and 
(d)(3)(i) through (d)(3)(iv) was waived for individuals not working on 
outage activities. Section 26.203(e)(1)(ii) requires licensees to 
report the number of instances in which each work hour control 
specified in Sec.  26.205(d)(1)(i) through (d)(1)(iii), (d)(2)(i) and 
(d)(2)(ii), (d)(3)(i) through (d)(3)(iv), and (d)(4) and (d)(5)(i) was 
waived for individuals working on outage activities. The differences 
between Sec.  26.205(e)(1)(i) and (e)(ii) in the work hour requirements 
specified reflects whether requirements are applicable to outage 
activities.
    Section 26.203(e)(1)(iii) requires licensees to report a summary 
that shows the distribution of waiver use among the individuals within 
each category of individuals Sec.  26.4(a) identifies. This summary 
will show, for example, how many individuals received only one waiver 
during the reporting period, how many individuals received two waivers, 
how many received three waivers, and so on. This reporting requirement 
enables the NRC to determine the extent to which waivers are 
concentrated among a few individuals or distributed more broadly within 
a group of individuals who perform the same duties. 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 by indicating if the waivers were 
concentrated among individuals performing a certain duty and if the 
waiver use in a duty group was associated with relatively few 
individuals or distributed among many individuals.
    The waiver data that licensees are required to report to the NRC 
under Sec.  26.203(e)(1)(i) through (e)(1)(iii) are important because 
waivers represent ``assumed risk.'' As discussed in Section IV.D, 
fatigued workers experience impaired cognitive functioning, including 
difficulties in decisionmaking and maintaining attention. If a licensee 
permits an individual to work extended hours that cause the individual 
to become fatigued, the individual may experience momentary lapses in 
attention or degraded decisionmaking from fatigue. These performance 
degradations can be mitigated by establishing controls and conditions

[[Page 17125]]

under which the individual is permitted to work, as required under 
Sec.  26.211(e). However, controls and conditions can reduce, but not 
eliminate, the potential risks from fatigue-induced errors. The more 
often that a licensee permits individuals to exceed work hour limits, 
the more risk from fatigue-induced errors a licensee is assuming. The 
risk of fatigue-induced errors increases further when an individual is 
permitted to exceed more than one of the work hour limits contained in 
Sec.  26.205(d)(1)(i) through (d)(1)(iii) because of the potential for 
the combined effects of both acute and cumulative fatigue. Any waivers 
from the rest breaks that are required under Sec.  26.205(d)(2) or the 
minimum day off requirements of Sec.  26.205(d)(3) through (d)(5) will 
also contribute to the accumulation of a sleep deficit, especially when 
inadequate rest breaks are combined with long work hours. Repeated and 
continual use of waivers may indicate a staffing or other programmatic 
weakness at a site that warrants additional inspection resources. 
Therefore, the NRC considers the number of waivers granted from the 
work hour limits to be a key element in evaluating FFD program 
performance.
    Section 26.203(e)(2) requires that licensees include in the annual 
report the reporting of corrective actions resulting from the analyses 
of waiver and fatigue assessment data. The NRC considers the reporting 
of a summary of corrective actions to be consistent with the 
requirement of Sec.  26.717 for reporting of drug and alcohol test 
results. For example, the NRC views the number of for-cause drug and 
alcohol tests that a licensee conducts each year to be one indicator of 
the health of the licensee's behavioral observation program and its 
effectiveness in meeting the rule's performance objective identified in 
Sec.  26.23(c) to provide for the early detection of individuals who 
are not fit to perform the duties that require them to be subject to 
this part. The NRC similarly views the reporting of corrective actions 
resulting from the analyses of these data, including fatigue 
assessments, to be another indicator of the health of the licensee's 
behavioral observation and self-declaration processes with respect to 
fatigue. Annual reports, which will include the distribution of waiver 
use among individuals performing the same duties, will enable NRC to 
determine the extent to which waivers are concentrated among a few 
individuals or distributed broadly among individuals within each 
category specified in Sec.  26.4.
    Collectively, the reporting of waivers required in Sec.  
26.203(e)(1) and the reporting of corrective actions required in Sec.  
26.203(e)(2) provides important information concerning the 
effectiveness of fatigue management at a licensee site. The reports 
permit the NRC to (1) efficiently monitor the ongoing effectiveness of 
licensees' fatigue management programs by providing interpretable data, 
(2) efficiently allocate inspection resources, (3) track the 
effectiveness of the requirements of Subpart I in controlling the 
fatigue of nuclear power plant workers, (4) assess whether the 
objectives of the final rule are being achieved, and (5) determine 
whether any further changes to the requirements are necessary to ensure 
that worker fatigue is managed consistent with the intent of the 
provisions.
    Section 26.203(f) [Audits] requires the licensee to audit the 
management of worker fatigue as part of the overall FFD program audits 
required in Sec.  26.41 [Audits and corrective action]. This section 
does not add a new requirement, but is included in Subpart I for 
clarity.
Section 26.205 Work Hours
    The NRC substantively revised Sec.  26.199 of the proposed rule in 
response to public comments. The revised provisions are in Sec.  26.205 
of the final rule and establish controls on the work hours of select 
individuals who are subject to nuclear power plant licensees' FFD 
programs, as follows.
    Section 26.205(a) [Individuals subject to work hour controls] 
establishes the scope of individuals who are subject to the work hour 
requirements in Sec.  26.205. These individuals are subject to the work 
hour requirements, in addition to the training, behavioral observation, 
and self-declaration requirements of Subpart I that apply to all 
individuals who are subject to nuclear power plant licensees' FFD 
programs. In determining the scope of personnel who are subject to the 
work hour controls, the NRC considered the burdens on individuals and 
licensees associated with the practical control of work hours in 
conjunction with the potential for individuals' work activities to 
affect public health and safety or the common defense and security if 
their performance is degraded by fatigue. The NRC also considered the 
nature of these individuals' work activities and work environments 
relative to their potential to induce or exacerbate fatigue (e.g., 
whether the work is monotonous or the environment is not stimulating), 
the risk significance of the work, and the potential for other controls 
to prevent or mitigate the consequences of a fatigue-related error. As 
a result of these deliberations, the rule requires that individuals who 
perform the duties specified in Sec.  26.4(a)(1) through (a)(5) must be 
subject to work hour controls. The duties specified in Sec.  26.4(a)(1) 
through (a)(5) are the same as the duties that were specified in Sec.  
26.199(a)(1) through (a)(5) of the proposed rule. Rather than list the 
duties in Sec.  26.205(a), the final rule references Sec.  26.4(a) 
which provides a consolidated list of individuals subject to the 
requirements of Part 26.
    Section 26.205(a) requires that individuals identified in Sec.  
26.4(a)(1) (i.e., individuals who operate or provide onsite direction 
of the operation 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 in this 
section. To implement the work hour requirements, nuclear power plant 
licensees are required to delineate the operations personnel who are 
subject to the work hour requirements, on the basis of the risk 
significance of the safety SSCs being operated. At a minimum, this must 
include personnel who are performing activities on SSCs that are 
determined to be significant to public health and safety. To delineate 
the scope of the operations duty group, licensees can use, for example, 
the risk-significance determination process and criteria that they 
currently employ to meet the requirements of Sec.  50.65(a)(4) of this 
chapter for assessing and managing the risk associated with maintenance 
activities. The work hour requirements of Sec.  26.205 would typically 
apply to individuals who are operating or directing, while on site, the 
operation of SSCs that are included within the scope of an assessment 
required by Sec.  50.65(a)(4). Therefore, the work hour requirements 
would apply to the individuals who most directly affect the operation 
of those SSCs most important to the protection of public health and 
safety. Controlling the work hours of these individuals would achieve 
the NRC's objective to minimize the potential for fatigue-related 
errors in operating these risk-significant SSCs.
    Licensed operators who perform the duties specified in Sec.  
26.4(a)(1) are responsible for correctly performing actions that are 
necessary for the safe operation of nuclear power plants and the 
mitigation of accidents at these facilities. These responsibilities 
include monitoring the plant for off-normal conditions and taking 
appropriate actions to prevent these conditions from challenging the 
reactor core, safety systems, and fission product barriers. The 
importance of licensed operator actions to the protection of public 
health and safety is reflected in the 10

[[Page 17126]]

CFR Part 55, ``Operators' Licenses,'' requirements that are applicable 
to these individuals, including specific licensing, examination and 
testing, requalification, and FFD requirements. In addition to 
performing actions that are necessary for accident mitigation, operator 
actions, if performed incorrectly, can be accident initiators. Section 
IV.D discussed the effects of fatigue on decisionmaking, risk-taking, 
communications, and other key skills. Fatigued operators have an 
increased potential to commit errors, raising the probability of 
component failures, system misalignments, and incorrect execution of 
accident mitigation strategies. Operator actions are highly dependent 
on cognitive skills (e.g., attention, decisionmaking) that are 
susceptible to fatigue, and operators are frequently exposed to 
conditions that can induce fatigue (e.g., long work hours, shiftwork). 
The NRC highlighted this concern in 1982 by issuing its Policy on 
Worker Fatigue. The Policy specifically addressed the need for 
``controls to prevent situations where fatigue could reduce the ability 
of operating personnel to keep the reactor in a safe condition.''
    Despite the NRC's Policy on Worker Fatigue and subsequent technical 
specifications to limit operator work hours, an NRC staff review of 
technical specification implementation from 1997-99 found that a 
significant percentage of licensed and non-licensed operators worked 
more than 600 hours of overtime in a year (Attachment 1 to SECY-01-
0113, ``Rulemaking Plan: Fatigue of Workers at Nuclear Power Plants''). 
This level of overtime is two to three times the level that is 
permitted for operations personnel at some foreign nuclear plants and 
twice the level recommended by a 1985 expert panel (NUREG/CR-4248). In 
addition, the NRC staff has noted that some licensees appeared to be 
abusing the authority to permit deviations from the technical 
specification limits on working hours, including deviations for 
operators. For example, data provided by NEI on August 29, 2000, from 
J. W. Davis, NEI, to G.T. Tracy (ADAMS Accession No. ML003746495), 
indicated that during a sample of 37 refueling outages conducted in 
1999, licensees authorized more than 1,800 deviations for licensed 
operators and more than 1,100 deviations for non-licensed operators. 
This frequency of deviations is inconsistent with the intent of the 
NRC's Policy on Worker Fatigue that deviations should be authorized 
only for ``very unusual circumstances.'' The failure of some licensees 
to limit the work hours of operations personnel, considered together 
with the risk significance of the activities performed by operators, 
indicates the need for more readily enforceable work hour limits for 
operators whose job duties are important to protect public health and 
safety.
    Further, the work hour requirements in Sec.  26.205 also apply to 
individuals who direct risk-significant operations on site. These 
individuals include management on shift, such as shift operations 
management or special outage managers, if those individuals provide 
direction to operators. Individuals to whom the work hour requirements 
apply also include engineers who provide onsite technical direction to 
operations, such as test directors or reactor engineers. These 
individuals perform tasks that are often highly dependent on cognitive 
skills (e.g., problem-solving, decisionmaking, communications) and are 
susceptible to fatigue-induced errors, as described in Section IV.D. 
Incorrect technical direction provided to operators can significantly 
challenge licensed operators and increase the possibility of errors or 
events, particularly when the direction is provided by an individual 
who supervises the operators or an individual who the operator 
reasonably expects to have specialized technical knowledge of the 
system or component being operated.
    Section 26.205(a) requires that individuals identified in Sec.  
26.4(a)(2) (i.e., individuals who perform health physics or chemistry 
duties that are required of the onsite emergency response organization 
minimum shift complement) must be subject to the work hour requirements 
of this section. Although Sec.  26.207(d) [Plant emergencies] exempts 
licensees from applying the work hour controls during declared 
emergencies, the intent of this provision is to provide reasonable 
assurance that the work schedules of these individuals during non-
emergency conditions ensure that fatigue does not compromise their 
abilities to safely and competently perform their duties should an 
emergency occur. NUREG-1465, ``Accident Source Terms for Light-Water 
Nuclear Power Plants,'' concluded that significant fission product 
releases from the bulk of the fuel can occur within 30-60 minutes after 
the onset of an accident. As a function of the accident and its 
severity, certain areas within the plant, while predictable and benign 
during normal operations, could present elevated levels of airborne/
external radiation levels (greater that 300 Rad/hour). Additionally, 
industrial hazards (e.g., explosive mixtures, smoke, toxic gas, oxygen 
deficiency) that may be immediately dangerous to life and health could 
be present. In these circumstances, health physics technicians (HPTs) 
support necessary plant staff actions to assess conditions, perform 
search and rescue missions, and take timely mitigation actions (e.g., 
local manual operations by operators). The overall success of 
responding safely and appropriately to emergencies and the protection 
of public health and safety depends, in part, on the ability of HPTs to 
safely and competently perform their emergency response duties.
    Similarly, NUREG-0654, Revision 1, ``Criteria for Preparation and 
Evaluation of Radiological Emergency Response Plans and Preparedness in 
Support of Nuclear Power Plants,'' issued March 2002, identifies the 
need for an on-shift chemistry/radiochemistry emergency response 
capability. An on-shift chemistry technician(s) provides an important 
component for a successful response at the onset of a radiological 
emergency. The independent and timely actions of the chemistry 
technician(s) in response to a radiological event can provide key 
information for assessing core status and estimating the source term of 
a potential release. By providing defense-in-depth support for 
operations personnel, chemistry technicians also assist with offsite 
dose calculations and ancillary radiological protection tasks, such as 
sampling spaces for toxic gases or explosive mixtures. Chemistry 
technicians may also be needed to conduct analyses for the detection of 
hydrogen and oxygen gas concentrations in both the reactor coolant and 
the containment atmosphere. These analyses support severe accident 
management decisions with respect to minimizing radiological release 
potential. As a consequence, ensuring that chemistry technicians are 
able to safely and competently perform their emergency response duties 
is essential to the overall success of responding safely and 
appropriately to emergencies and to the protection of public health and 
safety.
    Section 26.205(a) requires that individuals identified in Sec.  
26.4(a)(3) (i.e., individuals who are performing the duties of a fire 
brigade member who is responsible for understanding the effects of fire 
and fire suppressants on safe shutdown capability) must be subject to 
the work hour requirements of this section. The work hour requirements 
are applicable to the members of the fire brigade who are responsible 
for providing the control room operators and fire brigade leader with 
information that is critical to implementing a fire mitigation strategy

[[Page 17127]]

to maintain safe shutdown capability for the reactor. Attachment 1 to 
SECY-99-140, ``Recommendation for Reactor Fire Protection 
Inspections,'' dated May 20, 1999, states that ``based on IPEEE 
results, fire events are important contributors to the reported core 
damage frequency (CDF) for a majority of plants. The reported CDF 
contribution from fire events can, in some cases, approach (or even 
exceed) that from internal events.'' Fire brigade members must retain 
their cognitive abilities to be able to determine the best way to 
suppress a fire to prevent additional damage to safety-related 
equipment, evaluate equipment affected by a fire to report to control 
room operators concerning equipment availability, make decisions 
concerning smoke ventilation to prevent the fire effects from affecting 
other plant operations, and coordinate fire brigade activities with 
control room operators.
    As discussed in Section IV.D, fatigue can substantially degrade an 
individual's decisionmaking and communication abilities, cause an 
individual to take more risks, and maintain faulty diagnoses throughout 
an event. The abilities to make accurate and conservative decisions, 
communicate effectively, and accurately diagnose events are key to the 
duties of the fire brigade members who are responsible for providing 
the control room operators and fire brigade leader with information 
that is critical to implementing a fire mitigation strategy to maintain 
the safe-shutdown capability for the reactor. Degradations of these 
abilities could have significant consequences on the outcome of an 
event involving a fire. For instance, a fatigued individual could 
incorrectly decide to vent smoke or toxic gas to an area required for 
alternate shutdown, which could prevent or impair access to equipment 
needed for safe shutdown of the plant. In addition, a fatigued worker 
could incorrectly apply the wrong fire suppressant, which could affect 
additional equipment in the plant. Further, impaired decisionmaking 
could lead a worker to fail to properly control flooding, which could 
impact other needed equipment, or to incorrectly determine whether an 
area contains critical equipment and improperly apply a suppressant in 
that area. Impaired communications could also lead to incomplete 
disclosure of information to licensed operators in the control room, 
which could adversely impact the decisionmaking of those operators. If 
information known to the impaired fire brigade member is not properly 
communicated, operators may not initiate appropriate actions to 
mitigate the fire effects, or the effects of suppressant activities, on 
critical equipment. As a consequence, ensuring that fire brigade 
members, who are responsible for understanding the effects of fire and 
fire suppressants on safe-shutdown capability, are able to safely and 
competently perform their duties is essential to the overall success of 
the fire mitigation strategy and the protection of public health and 
safety.
    In addition, the NRC periodically grants exemptions from the 
requirements of Appendix R [Fire Protection Program for Nuclear Power 
Facilities Operating Prior to January 1, 1979] to 10 CFR Part 50, 
``Domestic Licensing of Production and Utilization Facilities,'' based 
on protection of the levels of defense in depth listed in Section II(A) 
of Appendix R to Part 50, which are ``To prevent fires from starting; 
to detect, rapidly control, and extinguish promptly those fires that do 
occur; to provide protection for structures, systems, and components 
important to safety so that a fire that is not promptly extinguished by 
the fire suppression activities will not prevent the safe shutdown of 
the plant.'' Granting these exemptions is often predicated on effective 
manual suppression of the fire by the fire brigade. Therefore, it is 
necessary to ensure that fire brigade members who are responsible for 
understanding the effects of fire and fire suppressants on safe-
shutdown capability remain rested so that they are able to safely and 
competently perform their duties in plant events involving a fire.
    Section 26.205(a) requires that individuals identified in Sec.  
26.4(a)(4) (i.e., individuals who are performing maintenance or the 
onsite directing of maintenance of systems, structures, or 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 in this section. Section 26.5 [Definitions] includes a 
definition of ``maintenance'' to clarify the scope of individuals 
described by Sec.  26.4(a)(4). To implement this requirement, licensees 
are required to delineate the maintenance personnel, as well as the 
personnel who direct maintenance on site, who would be subject to the 
work hour controls on the basis of the risk significance of the SSCs 
that they maintain. At a minimum, this must include personnel who 
maintain SSCs that are determined to be significant to public health 
and safety. To delineate the scope of the maintenance job duty group, 
licensees can use, for example, the risk-significance determination 
process and criteria that they currently employ to meet the 
requirements of Sec.  50.65(a)(4) for assessing and managing the risk 
associated with maintenance activities. As a consequence, the work hour 
requirements of Sec.  26.205 would typically apply to individuals who 
are maintaining or directing on site the maintenance of SSCs that are 
included within the scope of an assessment required by Sec.  
50.65(a)(4). Therefore, the work hour requirements would apply to the 
individuals who most directly affect the maintenance of SSCs that are 
most important to the protection of public health and safety, which 
would achieve the NRC's objective to minimize the potential for 
fatigue-related errors in maintaining these risk-significant SSCs.
    Nuclear power plant maintenance personnel perform tasks that are 
often highly dependent on cognitive skills (e.g., the ability to 
comprehend oral and written instructions, problem-solving, 
communication) that are susceptible to fatigue, as described in Section 
IV.D. These tasks may require extensive physical effort in high heat, 
humidity, and noise conditions that can exacerbate fatigue. In 
addition, maintenance personnel are subject to the work scheduling 
conditions of round-the-clock operations and emergent work conditions 
that also can exacerbate fatigue (e.g., long work hours, unscheduled 
overtime, shiftwork). Compared to rested workers, fatigued maintenance 
personnel would have a higher probability of (1) taking longer to 
complete maintenance activities or using non-conservative work 
practices, (2) making errors that would increase the risk of failure of 
the affected SSCs to perform their functions or operate for their 
required mission time during post-maintenance testing, thus delaying 
their return to unrestricted service, and (3) making errors that could 
introduce latent defects that may not be readily detected by post-
maintenance testing, but that may cause degraded reliability (i.e., 
degraded performance or failure of the SSCs at a later time). 
Collectively, the effects of fatigue on the performance of maintenance 
personnel have the potential to decrease the availability and 
reliability of SSCs that are important to the protection of public 
health and safety. Therefore, the rule requires these maintenance 
personnel to be subject to the work hour requirements to ensure that 
fatigue does not compromise their abilities to safely and competently 
perform their duties relative to the maintenance of these SSCs.
    The work hour requirements also apply to those who direct risk-
significant maintenance on site. For example, these individuals include 
maintenance supervisors who provide

[[Page 17128]]

direction to maintenance technicians and engineers who provide onsite 
technical direction to maintenance crews, during key outage maintenance 
activities. These individuals perform tasks that are often highly 
dependent on cognitive skills (e.g., problem solving, decisionmaking, 
communications) that are susceptible to fatigue, as discussed in 
Section IV.D. Incorrect technical direction provided to maintenance 
technicians can significantly challenge maintenance technicians and 
increase the possibility of errors or events, particularly when that 
direction is provided by an individual who supervises them or an 
individual who the maintenance technician reasonably expects to have 
specialized technical knowledge of the system or component being 
maintained.
    Section 26.205(a) requires that individuals identified in Sec.  
26.4(a)(5) (i.e., individuals who are performing the duties of an armed 
security force officer, alarm station operator, response team leader, 
or watchperson at a nuclear power plant) must be subject to the work 
hour requirements of this section. Individuals who perform these duties 
are the members of licensees' security forces who are responsible for 
implementing the licensees' physical security plans. To ensure that 
these individuals are able to meet their responsibilities for 
maintaining the common defense and security, it is necessary to ensure 
that they are not subject to fatigue, which could reduce their 
alertness and ability to perform the critical job duties of identifying 
and promptly responding to plant security threats. Security personnel 
are the only individuals at nuclear power plants who are entrusted with 
the authority to apply deadly force. Decisions regarding the use of 
deadly force are not amenable to many of the work controls (e.g., peer 
checks, independent verification, post-maintenance testing) that are 
implemented for other personnel actions at a nuclear plant to ensure 
correct and reliable performance. In contrast to most other nuclear 
power plant job duty groups, security personnel are typically deployed 
in a configuration in which some members of the security force have 
very infrequent contact with other members or with other plant 
personnel. A lack of social contact can exacerbate the effects of 
fatigue on individuals' abilities to remain alert (Horne, 1988). In 
addition, these deployment positions can be fixed posts where very 
little physical activity is required, further promoting an atmosphere 
in which fatigue could transition into sleep. Many security duties are 
largely dependent on maintaining vigilance, and vigilance tasks are 
among the most susceptible to degradation from fatigue (Rosekind, 1997; 
Monk and Carrier, 2003). Finally, unlike operators, security forces 
lack automated backup systems that can prevent or mitigate the 
consequences of an error caused by fatigue. For these reasons, and in 
light of the excessive hours that some security force personnel were 
required to work following the elevated threat condition(s) in effect 
after the terrorist attacks of September 11, 2001, the Commission 
issued orders for Compensatory Measures Related to Fitness-for-Duty 
Enhancements Applicable to Nuclear Facility Security Force Personnel on 
April 23, 2003. The security force personnel who are subject to work 
hour controls in the orders are the same individuals who are subject to 
the work hour requirements in this section.
    Section 26.205(b) [Calculating work hours] specifies the time 
periods that licensees shall include when calculating the work hours of 
the individuals listed in Sec.  26.205(a) for the purposes of this 
subpart. This requirement replaces, with editorial and substantive 
modifications, the requirements presented in Sec.  26.199(b) of the 
proposed rule. The editorial changes are renumbering and reorganization 
of the requirements for clarity. The substantive change is the deletion 
of the provisions concerning the calculation of collective work hours 
as a conforming change resulting from the deletion of the collective 
work hour controls as described with respect to Sec.  26.205(d)(3).
    The NRC's Policy on Worker Fatigue established guidelines for the 
control of work hours but did not define the concept of ``work hours'' 
or establish criteria for calculating them. As a consequence, licensees 
have inconsistently defined and calculated work hours when implementing 
the Policy through their technical specifications and administrative 
procedures. This inconsistency has contributed to some licensees 
permitting individuals to work excessive hours that caused them to 
become fatigued. Therefore, the rule defines work hours and 
requirements for calculating them, as well as certain specific periods 
that may be excluded from the calculation to ensure consistent 
implementation of the work hour controls established in Sec.  26.205(d) 
[Work hour controls].
    The rule requires licensees to calculate work hours as the amount 
of time that an individual performs duties for a licensee, including 
all within-shift break times and rest periods during which there are no 
reasonable opportunities or accommodations appropriate for restorative 
sleep. The rule also details the periods excluded from the calculation.
    The rule specifically does not limit work hours to hours that are 
assigned to an individual by the licensee, that are worked on site, or 
that are worked as part of a scheduled shift, but does require 
licensees to include hours during which an individual performs duties 
for the licensee. The rule defines hours worked in this broad manner 
because the NRC is aware that some licensees permit individuals to 
perform duties on behalf of the licensee from offsite locations and 
during periods when the individual is not assigned to a shift or 
scheduled by the licensee to be working on site. For example, because 
of the large amount of administrative work that is frequently assigned 
to individuals in the shift manager role, some shift managers stay at 
work to review and act upon administrative matters after the end of 
their scheduled shifts in order to complete the reviews and meet 
deadlines. Anecdotal reports from these individuals have indicated that 
they may work for 3-4 hours after going off shift to manage their 
workload, with the result that the hours they have available for 
personal obligations and sleep are reduced. Many licensees operate 
multiple sites and at times send personnel to other sites for short 
periods to fill in or to extend expertise. This time away from their 
normal duty site must be included when calculating work hours. If the 
rule limited the calculation of work hours to only those hours that an 
individual is paid by the licensee, works on shift, works on site, and/
or is scheduled to be working by the licensee, many individuals may 
continue to be permitted to work excessive hours, thereby becoming 
fatigued. Therefore, Sec.  26.205(b) [Calculating work hours] requires 
licensees to include these work hours in their work hour calculations.
    Section 26.205(b)(1) [shift turnover] excludes the time periods 
during which an individual participates in shift turnover from the 
calculation of the individual's work hours. Section 26.199(b)(1) of the 
proposed rule defined the specific shift turnover activities that 
licensees may exclude from their work hour calculations. The final rule 
defines shift turnover as only those activities that are necessary to 
safely transfer information and responsibilities between two or more 
individuals between shifts. Shift turnover is a vital activity, but it 
also contributes to the length of the workday,

[[Page 17129]]

and therefore, to worker fatigue. The NRC understands that shift 
turnovers routinely add approximately 30 minutes to the length of a 
shift and typically no more than 2-2.5 hours to the length of a typical 
work week. Stakeholder comments during the public meetings described in 
the preamble to the proposed rule highlighted the importance of this 
activity for communicating plant status information between work crews 
and expressed concern that including turnover time in work hour 
calculations could cause indirect pressure on individuals to abbreviate 
shift turnovers in order to ensure that work hour limits would not be 
violated. This pressure could compromise the quality of shift turnovers 
and have unintended adverse safety consequences, such as omitting 
important equipment or maintenance status information. Although some 
stakeholders believe that turnover is part of the workday and, 
therefore, should be included in the calculation of hours worked, the 
NRC concluded that the benefit of including turnover for managing 
worker fatigue would be outweighed by the potential adverse consequence 
on the quality of shift turnovers.
    The exclusion of shift turnover from work hour calculations is 
consistent with current requirements in most licensee technical 
specifications for the control of work hours for personnel performing 
safety-related functions and with GL 82-12, ``Nuclear Power Plant Staff 
Working Hours,'' dated June 15, 1982. For example, most technical 
specifications state, ``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'' (see SECY-01-0113, Attachment 1, Table 
2). However, the final rule more clearly describes the activities that 
may be included in turnover and the activities that may not be 
included. This provision addresses the NRC concerns arising from 
observations that some licensees have occasionally excluded 2 or more 
hours from calculated work hours on the basis that the individuals were 
engaged in ``turnover.'' To ensure that turnover is not hurried, the 
rule does not establish a time limit for an acceptable turnover period. 
However, by clearly delineating the activities that licensees may 
consider to be turnover activities, the rule reduces the potential for 
individuals and/or licensees to use the shift turnover exclusion to 
perform other work activities.
    Section 26.205(b)(2) [Within shift break and rest periods] permits 
licensees to exclude within-shift breaks and rest periods from their 
work hour calculations if the individual has both a reasonable 
opportunity and accommodations for restorative sleep. The rule permits 
licensees to exclude breaks from the accounting of work hours only when 
the exclusion can be justified on the basis that the break 
substantively mitigates fatigue. The exclusion allows workers to be 
scheduled for round-the-clock duties (e.g., dedicated fire brigades) 
during which they are on site and available to respond as needed but 
the licensee provides sleeping accommodations and the individuals are 
allowed periods of time to obtain restorative sleep. This exclusion 
also permits licensees to make use of strategic napping, a well-proven 
fatigue countermeasure (McCallum, et al., 2003; Petrie, et al., 2004; 
Rosekind, et al., 1994, 1995; Dinges, et al., 1988; Kemper, 2001; 
Schweitzer, et al., 1992; Sallinen, et al., 1998), without requiring 
the nap period to be included in work hour calculations.
    The exclusion is limited to that portion of a break or rest period 
that provides a reasonable opportunity for restorative sleep. For 
example, a 15-minute coffee break would not provide a reasonable 
opportunity for restorative sleep. The rule limits the exclusion to the 
amount of time the individual has available to actually sleep and does 
not include transit time to and from the sleep accommodations. The term 
``restorative sleep'' means an amount of sleep that mitigates fatigue, 
which is generally considered to be a minimum of approximately 30 
minutes (Buxton, et al., 2002; McCallum, et al., 2003; Sallinen, 1998; 
Rosekind, 1995).
    The final rule also requires that individuals must have reasonable 
accommodations available for sleep in order to exclude the break period 
from the calculation of the individual's work hours. Reasonable 
accommodations would include a sleep surface (e.g., bed, recliner) in a 
darkened, quiet room (Priest, 2000).
    The degree of specificity in this section is necessary because some 
licensees currently exclude within-shift breaks from the calculation of 
work hours required by their technical specifications. Excluding break 
periods from the calculation of work hours can add up to as many as 12 
hours over the course of a week, which permits individuals to work an 
additional 12-hour shift. As a consequence, licensees may assign seven 
consecutive 12-hour shifts to individuals, but only include 72 hours in 
their work hour calculations, rather than the 84 hours that the 
individuals are actually at work. The discussion of Sec.  
26.205(d)(1)(iii) details the basis for limiting individuals to 72 work 
hours per week.
    Although breaks without sleep have some fatigue mitigation value 
(Tucker, Folkard, and Macdonald, 2003), the benefits are principally 
limited to short-term improvements in vigilance. Horne (1988), Mitler 
and Miller (1996), and Dinges, et al. (1997) have pointed out that the 
only non-pharmacological cure for fatigue is sleep. The duration of 
within-shift break times is normally insufficient to allow a worker to 
obtain sleep and, consequently, these periods add to the total amount 
of time an individual remains awake while at work. Time since awakening 
is a principal determinant of worker fatigue (Folkard and Akerstedt, 
1992; NTSB, 1994; Akerstedt, 2004) and performance generally declines 
as a function of the amount of time that an individual remains awake 
(Dawson and Reid, 1997). Because within-shift breaks and rest periods 
provide only short-term mitigation of fatigue (Kruger, 2002; Baker, et 
al., 1990), the rule requires licensees to include short breaks in the 
calculation of work hours.
    Section 26.205(b)(3) [Beginning or resuming duties subject to work 
hour controls] permits licensees to assign individuals, who are 
qualified to perform the duties listed in Sec.  26.4(a), to duties 
other than those listed Sec.  26.4(a), without controlling their work 
hours in accordance with the work hour controls contained in Sec.  
26.205(d). However, if these individuals are assigned or returned to 
performing any duties that are listed in Sec.  26.4(a) during the 
calculation period, the rule requires the licensee to include all of 
the hours that they worked when calculating their work hours and to 
subject the individual to the work hour controls in Sec.  26.205(d). 
For example, if a licensed operator was assigned to training for an 
entire calculation period, then his or her work hours would not be 
subject to Sec.  26.205(d) for that period because he or she would not 
be performing any of the duties listed in Sec.  26.4(a). However, if 
the same individual were assigned to training for only a portion of the 
calculation period and performed the duties listed in Sec.  26.4(a) 
during the remainder of the calculation period, all of his or her 
hours, including those worked while assigned to training, would be 
included in the calculation of the individual's work hours as if the 
individual were performing operations duties for the entire calculation 
period. Licensees would be required to count the hours that the 
individual worked

[[Page 17130]]

performing other duties if an individual begins performing the duties 
listed in Sec.  26.4(a) during the calculation period because the 
individual's level of fatigue is largely dependent on the total number 
of hours he or she has worked, regardless of where the work was 
performed or the nature of the work itself. Therefore, including the 
hours worked performing other duties would provide assurance that 
fatigue would not compromise that individual's ability to safely and 
competently perform the duties that are specified in Sec.  26.4(a).
    Section 26.205(b)(4) [Unannounced emergency preparedness exercise 
and drills] allows licensees to exclude certain time associated with 
unannounced emergency preparedness exercises and drills from the 
calculation of an individual's work hours. Only the time an individual 
works unscheduled work hours for the purpose of participating in the 
actual conduct of an unannounced emergency preparedness exercise or 
drill can be excluded. This exclusion is incorporated in the final rule 
in response to stakeholder comments that adjusting work schedules in 
anticipation of an unscheduled exercise or drill would negate the 
element of surprise for the individuals. The nature of such drills is 
that they are relatively infrequent and short in duration. Therefore, 
they would not have a major impact on individual fatigue and any impact 
would be offset by the potential contribution to safety.
    Section 26.205(b)(5) [Incidental duties performed off site] allows 
licensees to exclude from the calculation of an individual's work hours 
unscheduled work performed off site (e.g., technical assistance 
provided by telephone from an individual's home) provided the total 
duration of the work does not exceed a nominal 30 minutes during any 
single break period. For the purposes of compliance with the minimum 
break requirements of Sec.  26.205(d)(2) and the minimum day off 
requirements of Sec.  26.205(d)(3) through (d)(5), such duties do not 
constitute work periods or work shifts. The final rule includes this 
exclusion in response to stakeholder comments regarding the necessity 
of obtaining expert advice or details on recent operating experience 
that may not have been included in a turnover and the burden that would 
be imposed by resetting the clock to account for the disruption in a 
break period. The nominal 30-minute reduction in the break period is 
not expected to have a detrimental impact on the individual's overall 
fatigue level and would be offset by the potential contribution to 
safety.
    Proposed Sec.  26.199(b)(2) would have established requirements for 
calculating the collective work hours of certain job duty groups that 
would have been subject to the collective work hour limits in proposed 
Sec.  26.199(f). The final rule does not include these requirements 
because the NRC eliminated the concept of collective work hours in the 
final rule, as discussed in Sec.  26.205(d)(3) of this section-by-
section analysis. Therefore, to conform with other changes in the final 
rule, Sec.  26.205(b) does not include those aspects related to 
calculating collective work hours.
    Section 26.205(c) [Work hours scheduling] requires licensees to 
schedule the work hours of individuals who are subject to this section 
in a manner that is consistent with the objective of preventing 
impairment from fatigue resulting from the duration, frequency, or 
sequencing of successive shifts. This section retains the requirement 
presented in Sec.  26.199(c) of the proposed rule. The NRC intends for 
the maximum work hour and minimum break and day off requirements 
specified in Sec.  26.205(d) to apply to infrequent, temporary 
circumstances and not be considered guidelines or limits for routine 
work scheduling. In addition, the work hour controls in Sec.  26.205(d) 
do not address several elements of routine schedules that can 
significantly affect worker fatigue, such as shift length, the number 
of consecutive shifts, the duration of breaks between blocks of shifts, 
and the direction of shift rotation. Therefore, Sec.  26.205(c) 
requires licensees to schedule personnel consistent with preventing 
impairment from fatigue from these scheduling factors.
    The rule requires licensees to address scheduling factors because 
human alertness and the propensity to sleep vary markedly through the 
course of a 24-hour period. These variations are referred to as 
circadian rhythms and are the result of changes in physiology brought 
about by a circadian clock or oscillator inside the human brain that is 
outside the control of the individual. Work may be scheduled, and the 
consequent timing of periods of sleep and wakefulness, in a manner that 
either facilitates an individual's adaptation to the work schedule or 
challenges the individual's ability to get adequate rest. Therefore, 
the duration, frequency, and sequencing of shifts, particularly for 
personnel who work rotating shifts, are critical elements of fatigue 
management. Section IV.D also discusses the effects of circadian 
rhythms on worker fatigue. The importance of these elements for fatigue 
management is reflected in guidelines for work scheduling, such as EPRI 
NP-6748 (Baker, et al., 1990), and in technical reports, such as, 
NUREG/CR-4248 and the Office of Technology Assessment's report, 
``Biological Rhythms: Implications for the Worker'' (Liskowsky, 1991). 
For example, the EPRI guidelines address issues related to the 
sequencing of day, evening, and night shifts and the use of break 
periods between shifts to optimize the ability of personnel to obtain 
adequate sleep and effectively transition from one shift to another. 
Although research provides clear evidence of the importance of these 
factors in developing schedules that support effective fatigue 
management, the NRC also recognizes that the complexity of effectively 
addressing and integrating each of these factors in work scheduling 
decisions precludes a prescriptive requirement. Therefore, Sec.  
26.205(c) establishes a non-prescriptive, performance-based 
requirement.
    Stakeholder interactions have interpreted this requirement as a 
performance-based approach in that licensees' fatigue management 
performance could be assessed in terms of adherence to the schedules 
developed in response to Sec.  26.205(c). Although the NRC had intended 
this requirement to be limited to the development of work schedules, 
the NRC acknowledges the benefit of implementing this provision as a 
performance-based requirement applicable to licensee control of the 
actual hours worked by individuals performing the duties specified in 
Sec.  26.4(a)(1) through (a)(5) and adopts this interpretation for the 
final rule. As a consequence, this provision of the final rule requires 
the work hours of individuals subject to the requirements of this 
section to be controlled in a manner that prevents impairment from 
fatigue resulting from elements of routine schedules that can 
significantly affect worker fatigue, such as shift length, the number 
of consecutive shifts, the duration of breaks between blocks of shifts, 
and the direction of shift rotation.
    Section 26.205(d) [Work hour controls] requires licensees to 
establish work hour controls for individuals who are subject to the 
requirements of Sec.  26.205. The provision requires licensees to 
establish controls that limit work periods and provide for breaks that 
are of sufficient length to allow the individual to obtain restorative 
rest. This requirement replaces Sec.  26.199(d) of the proposed rule, 
with limited editorial changes.
    Section 26.205(d)(1) establishes work hour limits for consecutive, 
rolling periods of 24 and 48 hours and 7 days. The majority of 
licensees have incorporated the work hour controls

[[Page 17131]]

from the NRC's Policy on Worker Fatigue, as disseminated by GL 82-12, 
into either their technical specifications or administrative 
procedures. The Policy (including the bases for the individual 
requirements) has been in place for over 20 years and was the subject 
of a substantive review documented in Attachment 1 to SECY-01-0113. The 
work hour limits from GL 82-12 also were the subject of substantial 
stakeholder comments during the public meetings described in the 
preamble of the proposed rule. In developing the requirements in this 
section, the NRC staff considered the information gained through these 
stakeholder interactions.
    Section 26.205(d)(1)(i) limits the number of hours that an 
individual may work in any 24-hour period. The section permits 
individuals to work no more than 16 hours in any 24-hour period. This 
provision retains without change the requirement in Sec.  
26.199(d)(1)(i) of the proposed rule. This limit is identical to that 
specified in GL 82-12. Attachment 1 to SECY-01-0113 provides the basis 
for this limit, which is summarized as follows. Studies have shown that 
task performance declines after 12 hours on a task (Folkard, 1997; 
Dawson and Reid, 1997; Rosa, 1991). Other studies have shown that the 
relative risk of having an accident increases dramatically after 9 
consecutive hours on the job (Hanecke, et al., 1998; Colquhoun, et al., 
1996; U.S. DOT, 49 CFR Parts 350, et al., Proposed Rule, May 2, 2000, 
65 FR 25544). Further, nine experts who met in 1984 to develop 
recommendations for NUREG/CR-4248 recommended a maximum of 12 work 
hours per day. Therefore, in originally developing its Policy on Worker 
Fatigue, the NRC had planned a 12-hour maximum limit, but revised it to 
16 hours in response to practical concerns raised by the industry that 
the 12-hour limit required personnel who worked 8-hour shifts to split 
shifts when they work overtime. Those practical concerns remain valid, 
and the final rule retains a 16-hour limit.
    Although the rule permits 16-hour shifts, other work hour limits in 
the rule would effectively limit the number of 16-hour shifts that 
licensees could assign. The NRC's response to a comment from PROS on 
this issue is discussed in the preamble to the proposed rule.
    Section 26.205(d)(1)(ii) limits the number of hours that an 
individual may work in any 48-hour period. This provision retains 
without change the requirement presented in Sec.  26.199(d)(1)(ii) of 
the proposed rule. The section permits an individual to work no more 
than 26 work hours in a 48-hour period; by contrast, GL 82-12 limits 
individuals' work hours to 24 work hours in any 48-hour period. This 
change accommodates the fact that most licensee sites are now routinely 
working 12-hour shifts, rather than 8-hour shifts, as was the case when 
the NRC published GL 82-12. At that time, the basis for the 24-hour 
limit was to permit a worker to work one 16-hour double shift, followed 
by an 8-hour break, and then start another 8-hour shift at the worker's 
normal starting time, but only in very unusual circumstances. With the 
majority of plants now routinely working 12-hour shifts, the rule 
increases the maximum work hours in a 48-hour period from 24 to 26 
hours to decrease the burden on licensees by accommodating situations 
in which a worker's relief is delayed or similar circumstances. For 
example, a 12-hour shift worker is able to work up to 14 hours in one 
day and still return to work at his or her normal time the next day, 
but can only work 12 hours that day. In the extreme, the 26-hour limit 
permits an individual to work up to 16 hours one day, followed by a 
minimum 10-hour break, as required in Sec.  26.205(d)(2)(i). The 
individual is then limited to 10 hours of work over the next 22 hours.
    When developing this requirement, which effectively relaxes by 2 
hours the NRC's policy guideline in GL 82-12 for the maximum hours 
individuals should work in 48 hours, the NRC considered: (1) The burden 
associated with granting a waiver for the additional 2 hours; (2) the 
increased stringency of the criteria for granting a waiver of the work 
hour limits in Sec.  26.207 relative to those in plant technical 
specifications; and (3) the increased potential for worker fatigue and 
fatigue-related errors that may accrue from working 26 hours in a 48-
hour period versus working 24 hours in that same period.
    The increase of 2 additional work hours during a 48-hour period 
will likely contribute to some increase in fatigue and fatigue-related 
errors, particularly when these hours come at the end of a work period 
of 12 or more hours or coincide with a decrease in an individual's 
circadian level of alertness, as might be expected at the end of a 12-
hour day shift. However, because the revised criteria for granting a 
waiver of the work hour limits in Sec.  26.207 are expected to 
substantially reduce the number of waivers that are granted, the 
licensee will have to either delay or turn over any work that the 
individual is performing when it is necessary for him or her to go off 
shift. Either delaying or turning over work could contribute to errors. 
In addition, licensees commonly use waivers to exceed the 24-hours of 
work in any 48-hour period limit for short durations. As a result, the 
NRC concluded that the relaxation will principally reduce the paperwork 
burden, rather than increase the hours that individuals would have 
actually worked under the proposed rule. Accordingly, the relaxation 
provides a substantive reduction in burden with a limited net effect on 
human performance reliability.
    Section 26.205(d)(1)(iii) limits the number of hours an individual 
may work in any 7-day period. This section retains without change the 
requirement presented in Sec.  26.199(d)(1)(iii) of the proposed rule. 
The requirement limits an individual to working no more than 72 hours 
in any 7-day period. This limit is identical to the related limit 
specified in GL 82-12. Attachment 1 to SECY-01-0113 provides the basis 
for this limit, which is summarized in this section. In the absence of 
the break and day off requirements in Sec.  26.205(d)(2) and (d)(3), 
respectively, the limit would permit a worker to work six 12-hour 
shifts per week continuously. Studies have shown that longer work 
schedules cause fatigue (Colquhoun, 1996; Rosa, 1995). Human 
reliability analysis experts have recommended that the NRC set ``a 
maximum of 60 hours in any 7-day period and a maximum of 100 hours in 
any 14-day period,'' noting studies indicating that fatigue from long 
work hours can result in personnel developing their own subjective 
standards of what is important in their jobs (NUREG/CR-1278, ``Handbook 
on Human Reliability Analysis with Emphasis on Nuclear Power Plant 
Applications''). Further, NUREG/CR-4248 recommends a limit of 60 hours 
of work in a 7-day period. However, in its Policy on Worker Fatigue, 
the NRC established a 72-hour maximum limit based on the expectation 
that individuals would work up to this limit on an infrequent and 
temporary basis. The rule codifies this expectation, in part, through 
Sec.  26.205(d)(3), which requires licensees to ensure a minimum number 
of days off per week, averaged over a shift cycle, for individuals who 
are subject to the work hour controls. The rule effectively prevents an 
individual from consistently working six 12-hour shifts in a week.
    Section 26.205(d)(2) requires licensees to provide adequate rest 
breaks for individuals who are performing the duties listed in Sec.  
26.4(a). This section contains, with substantial revisions, the 
requirements presented in Sec.  26.199(d)(2) of the proposed rule.

[[Page 17132]]

Although Sec.  26.205(d)(2) retains without change the requirement 
presented in proposed rule Sec.  26.199(d)(2)(i) for a 10-hour break, 
the final rule revises the 24-hour break requirement proposed in Sec.  
26.199(d)(2)(ii) and replaces the 48-hour break requirement proposed in 
Sec.  26.199(d)(2)(iii) with an alternative break requirement. The 
following section-by-section discussion of Sec.  26.205(d)(2) and 
(d)(3) provides a rationale for these specific changes.
    Section 26.205(d)(2) is necessary to ensure that licensees provide 
individuals with sufficient time off between work periods (shifts) to 
permit them to recuperate from fatigue and provide reasonable assurance 
that acute and cumulative fatigue do not compromise the abilities of 
these individuals to safely and competently perform their duties. Acute 
fatigue results from excessive cognitive work, especially if an 
individual is missing significant amounts of sleep, and is readily 
relieved by obtaining adequate rest and sleep. Cumulative fatigue 
results from receiving inadequate amounts or poor quality sleep for 
successive days. An extensive body of research has shown that a lack of 
adequate days off and extended workdays result in a cumulative sleep 
debt and performance impairment (Williamson and Feyer, 2000; Tucker, 
1999; Colquhoun, 1996; Baker, et al., 1994; Webb and Agnew,1974; U.S. 
DOT (65 FR 25546, May 2, 2000)).
    Section 26.205(d)(2) defines a rest break as an interval of time 
that falls between successive work periods during which the individual 
does not perform any duties for the licensee. For example, individuals 
would not perform work-related duties during rest breaks such as 
completing paperwork reviews, mandatory reading, or required self-
study. Rest breaks could include periods during which an individual is 
``on-call'' because actual demands on an individual's time while he or 
she is on-call would be infrequent and of limited duration, such as 
answering a phone call. However, if an individual who is ``on-call'' is 
``called-in'' to report to the site, the licensee would be required to 
include the hours that the individual worked as work hours, not as 
break time, because the individual would be performing duties on behalf 
of the licensee while on site.
    Section 26.205(d)(2)(i) requires licensees to provide a 10-hour 
break between successive work periods, but permits 8-hour breaks in 
limited circumstances in which a shorter break is necessary for a 
crew's scheduled transition between work schedules. Current licensee 
technical specifications and administrative procedures that are based 
on GL 82-12 require a minimum 8-hour break between work periods. 
Section 26.205(d)(2)(i) increases the minimum break period from 8 hours 
to 10 hours to provide greater assurance that individuals have an 
adequate opportunity to obtain the 7-8 hours of sleep that is 
recommended by most experts in work scheduling and fatigue. When 
considering shift turnover and commute times, which do not provide 
individuals with opportunities for rest and recovery, a nominal rest 
break of 8 hours actually leaves the individual with approximately 6 
hours available to meet personal needs, including sleep (8 hours off-
duty minus an average 1.5-hour round-trip commute minus an average 0.5 
hours spent in shift turnover, equaling 6 hours available for personal 
needs). However, individuals typically also require 0.5 hours for 
preparing (or buying) and eating at least one meal off-shift and 0.5 
hours for personal hygiene, which leaves, at best (i.e., assuming no 
social or domestic commitments that day), a total of 5 hours available 
for sleep. By contrast, the 10-hour break ensures that individuals 
generally have 7 hours available each day for sleep, which is close to 
the 7-8 hours of sleep needed by adults in the United States (National 
Sleep Foundation, 2001; Monk, et al., 2000; Rosekind, et al., 1997; 
Rosa, 1995).
    The scientific literature provides strong evidence of the negative 
effects on performance and alertness of a week when sleep is restricted 
to 5 hours per day. Dinges, et al., 1997, and Belenky, et al., 2003, 
who have headed key laboratories in the field of sleep deprivation (the 
University of Pennsylvania and the Walter Reed Army Institute of 
Research, respectively), have conducted studies in this area. Belenky, 
et al. (2003) clearly demonstrates that limiting sleep to 5 hours per 
night leads to significant impairment in both alertness and actual 
performance, which builds up over the week, when compared to the 
alertness and performance of individuals who obtain 7 hours of sleep 
per night. The difference was found to be significant on all days 
during which sleep was restricted to 5 hours. Compared to the research 
subjects' performance after two baseline nights during which they 
obtained 7 hours of sleep, the subjects' performance after nights 
during which they were restricted to 5 hours of sleep showed more than 
twice as many lapses (extra slow responses). Dinges, et al. (1997) 
obtained similar results. From the second baseline day (the last day 
during which a full 7 hours of sleep was obtained) through the 7 
partial sleep restriction days, the research subjects' sleepiness and 
performance became progressively worse and these effects achieved a 
high level of statistical significance. The Dinges, et al. study also 
concluded that ``recovery from these deficits appeared to require two 
full nights of sleep.''
    The importance of adequate sleep and the need to provide adequate 
opportunity for sleep in work schedules are reflected in studies (e.g., 
Kecklund and Akerstedt, 1995; Wylie, et al., 1996), guidelines (Pratt, 
2003; Baker, et al., 1990), handbooks (Tepas and Monk, 1987), and the 
panel recommendations of sleep and fatigue experts (e.g., NUREG/CR-
4248). An EPRI/NEI Work Hours Task Force white paper, ``Managing 
Fatigue in the Nuclear Energy Industry: Challenges and Opportunities'' 
(ADAMS Accession No. ML0221740179), also notes the importance of 
providing an opportunity for at least 8 hours of sleep. The report, 
prepared by Mark Rosekind, states that ``the strongest and most 
extensive data demonstrate that sleep is a critical factor in promoting 
alertness and performance in subsequent wakefulness. Data clearly show 
that acute and cumulative sleep loss degrade subsequent alertness and 
performance. Therefore, any `hours of service' policy should emphasize 
the provision of an appropriate sleep opportunity prior to duty.'' More 
specifically, human reliability analysis experts have recommended that 
the NRC require ``a break of at least 12 hours between all work 
periods'' (NUREG/CR-1278). Similarly, a panel of sleep and fatigue 
experts criticized a DOT requirement for an 8-hour break for motor 
carriers as inadequate because 8 hours of off-duty time does not 
translate into 8 hours of sleep. The DOT has since amended its 
regulations for motor carriers to require 10-hour rest breaks (68 FR 
22456-22517, April 28, 2003).
    Although a longer minimum rest break requirement would provide 
greater assurance that individuals have adequate opportunities for 
sleep, the 10-hour break requirement provides adequate opportunity for 
rest when used infrequently, as is expected given other requirements in 
this rule. For example, Sec.  26.205(d)(1)(ii) limits individuals to 
working 26 hours in any 48-hour period. Although licensees could use 
routine 10-hour breaks in conjunction with atypical shift durations 
(e.g., alternating 12- and 14-hour shifts), the practical implications 
of these schedules, such as varied start times, make their use 
improbable. As a consequence, the 10-hour break requirement is 
sufficient to

[[Page 17133]]

assure adequate rest during infrequent circumstances in which 
individuals work extended hours (e.g., more hours than their typical 8-
,10-, or 12-hour shift) and that rest opportunities will typically vary 
between 12 and 16 hours in duration.
    The minimum 10-hour break duration also accommodates most 
scheduling circumstances for the common shift durations that are 
currently in use in the industry. A notable exception is that the 10-
hour break requirement could potentially prevent an individual who has 
worked 16 hours straight (e.g., two consecutive 8-hour shifts) from 
returning to duty at the start of his or her next regularly scheduled 
shift. However, the 10-hour break requirement appropriately prevents 
the individual from working in this circumstance because the potential 
for degraded job performance resulting from fatigue would be 
substantial given the individual's continuous hours of work and limited 
opportunity to sleep.
    Section 26.205(d)(2)(i) permits licensees to schedule a minimum 8-
hour break in only one circumstance: if the 8-hour break is necessary 
to accommodate a crew's scheduled transition between work schedules. 
During the public meetings described in the preamble of the proposed 
rule, the NRC received comments that a 10-hour break requirement would 
occasionally interfere with a transition from 12-hour shifts to 8-hour 
shifts. This transition typically occurs at the end of an outage for 
individuals who normally work an 8-hour shift, but work a 12-hour shift 
during outages. Although the exception provides individuals with less 
time for recovery, the shorter break is limited to one break occurring 
on a very restricted frequency. Therefore, the permission for an 8-hour 
break for the specific circumstances of a shift transition provides 
scheduling flexibility with minimal potential to adversely affect an 
individual's ability to safely and competently perform his or her 
duties.
    Section 26.205(d)(2)(ii) replaces and revises Sec.  
26.199(d)(2)(ii) of the proposed rule which would have required a 
minimum 24-hour break in any rolling 7-day period. Section 
26.205(d)(2)(ii) of the final rule requires a minimum 34-hour break in 
any rolling 9-day period. This provision requires a periodic long 
duration break thereby preventing an excessive number of consecutive 
work shifts that would not otherwise be prevented by the requirements 
of Sec.  26.205 of this rule.
    Break periods longer than the minimum 10 hours between shifts 
required by Sec.  26.205(d)(2)(i) are necessary on a regular basis in 
order to maintain reliable human performance. For example, Belenky, et 
al. (2003) found that the performance of subjects whose sleep periods 
were restricted to 7 hours per night over 7 consecutive days 
increasingly degraded as the number of sleep-restricted days increased. 
Van Dongen, et al. (2003) similarly found that the performance of 
subjects whose sleep was limited to 8-hours per night also declined 
over a 2-week period. The only subjects in these studies who did not 
show any performance decrements were those who were permitted 9-hour 
sleep periods in the Van Dongen study. These results clearly 
demonstrate that individuals require more rest than a 10-hour break 
provides over time to prevent performance degradation from cumulative 
fatigue, including that which accrues from a series of days of mild 
sleep restriction (e.g., 7 hours per night). Recent changes in the DOT 
regulations for the work hours of commercial truck drivers also reflect 
the need for longer breaks to mitigate fatigue. On April 28, 2003, the 
DOT published final regulations (68 FR 22456-22517) for hours-of-
service for drivers of motor carriers, which amended 49 CFR Parts 385, 
390, and 395. These regulations require a minimum 34-hour break after 
any period of 8 consecutive days with no more than 70 hours on duty. 
The intent of this 34-hour break is to provide for two consecutive 
sleep periods.
    Further, a 10-hour break provides an opportunity for 7 hours of 
sleep only if one assumes the minimal times for meals, hygiene, and 
commuting described with respect to Sec.  26.205(d)(2)(i), with no 
other daily living obligations. These assumptions are realistic only 
for unusual circumstances and limited periods of time during which 
individuals may be able to temporarily defer their other obligations. 
As the number of consecutive days increases in which individuals have 
only a 10-hour break available to meet these other obligations, the 
pressure on individuals to restrict sleep time in order to meet these 
other obligations increases. In addition, after a series of moderately 
restricted sleep periods (i.e., 6 hours per night), individuals' 
subjective feelings of sleepiness stabilize and they report feeling 
only mild sleepiness (Van Dongen, et al., 2003), which may further 
encourage individuals to restrict their sleep periods in order to meet 
daily living obligations. Van Dongen, et al. noted ``the lack of 
reports of intense feelings of sleepiness during chronic sleep 
restriction may explain why sleep restriction is widely practiced--
people have the subjective impression they have adapted to it because 
they do not feel particularly sleepy.'' However, results of the Van 
Dongen study also demonstrated that the performance of subjects in that 
study continued to degrade as the number of consecutive restricted 
sleep periods increased over a 2-week period, including the performance 
of subjects who were permitted 6- and 8-hour sleep periods.
    Section 26.199(d)(2)(ii) of the proposed rule would have 
established a requirement for a minimum 24-hour break in any 7-day 
period. The NRC revised the maximum number of days between the breaks 
in response to stakeholder comments that the proposed requirement would 
have substantially reduced licensee flexibility in scheduling 8-hour 
shifts. Stakeholders noted that many licensees currently use 8-hour 
schedules that include periods of 7 consecutive days. In revising the 
proposed requirement, the NRC considered that, although the final rule 
allows more consecutive days for 8-hour and 10-hour shifts, the final 
rule allows licensees the flexibility to more readily optimize 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, 
individuals on 10-hour shifts typically do not work a rotating schedule 
and thereby do not experience the disruption of their circadian cycle 
that exacerbates the cumulative fatigue effects of consecutive work 
shifts. The final rule also provides flexibility to accommodate other 
practical considerations such as scheduling training on a Monday 
through Friday basis and allows a contingency day in 8-hour shift 
schedules that includes a series of seven consecutive 8-hour shifts as 
part of the routine shift cycle.
    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 34-hour break. The revision more clearly 
states 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 
opportunity for two consecutive sleep periods without an intervening 
work period, 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.

[[Page 17134]]

    Given these considerations, the NRC concluded that Sec.  
26.205(d)(2)(ii) of the final rule provides a level of assurance of 
worker FFD relative to fatigue that is comparable to that which would 
have been achieved through the requirement in Sec.  26.199(d)(2)(ii) of 
the proposed rule. The provision for a 34-hour break in any rolling 9-
day period serves both to prevent and mitigate cumulative fatigue. The 
34-hour break periods will not only provide some opportunity for 
recovery sleep, but also time that individuals need to meet the many 
daily living obligations that they cannot otherwise readily meet. 
Without such long break opportunities, individuals must either forego 
activities that can be important to general mental and physical fitness 
(e.g., family interactions, exercise, recreation, doctor appointments) 
or sacrifice sleep and increase their sleep debt (Presser, 2000), 
resulting in impairment on the job.
    Section 26.205(d)(2) of the final rule does not retain the 
requirement for a minimum 48-hour break in any rolling 14-day period as 
would have been required by Sec.  26.199(d)(2)(iii) of the proposed 
rule. The NRC received many stakeholder comments in opposition to the 
48-hour break requirement. One commenter stated that fixed break 
requirements and collective work hour restrictions will lead to 
significant safety implications and could affect a licensee's ability 
to restore inoperable equipment in a timely manner. This view was 
echoed by many other commenters. Another commenter found fault with 
focusing on days off without considering the number of hours worked in 
a particular day and the breaks between work periods. In addition, many 
commenters raised the issue of work schedule disruption as a result of 
the 48-hour break requirement. They asserted that, for workers on the 
night shift, having one day off provides an additional rest period and 
allows the worker to maintain a consistent pattern of work and sleep 
habits, which reduces the risk of accidents on the job. Two days off, 
however, may interfere with his or her sleep cycle, and as a result, 
the individual would have to readjust to the night shift after the 2-
day break. According to the commenters, some workers have stated that 
having 2 days off is worse than having no days off. They also argued 
that a 1-day break in any 7-day period is more than adequate when 
combined with other rule provisions to address cumulative fatigue. 
Thus, commenters requested that the 48-hour break requirement during 
outage periods be deleted.
    In response to stakeholder comments, the NRC replaced the 
requirement proposed in Sec.  26.199(d)(2)(iii) with alternative 
requirements that ensure that each worker receives a minimum number of 
days off per week, on average, while the plant is operating or receives 
a minimum number of days off in each consecutive 15-day period of a 
plant outage. Security personnel subject to the requirements of Sec.  
26.205 are also subject to requirements for minimum days off in 15-day 
periods during security system outages and increased threat conditions. 
These alternative extended break requirements are in Sec.  26.205(d)(3) 
through (d)(5) of the final rule and are addressed in the section-by-
section analysis applicable to those requirements. In adopting the 
alternative requirement for the final rule, the NRC considered that, 
whereas the alternative requirements assured that workers subject to 
the requirement would receive a minimum number of days off, which would 
serve to limit the potential for cumulative fatigue, the requirements 
would not assure that any of the days off would be consecutive, as 
would have been required by the minimum 48-hour break requirement of 
proposed Sec.  26.199(d)(2)(iii). In proposing the 48-hour break 
requirement, the NRC cited several studies that demonstrate the 
benefits of consecutive days off, noting that one night of unrestricted 
sleep is not sufficient to fully recover from the cumulative fatigue 
that can result from restricted sleep and extended work hours. However, 
the NRC also considered that the minimum day off requirements would, in 
effect, limit each individual's average number of work hours and the 
average number of consecutive work shifts between days off, thereby 
reducing the potential for cumulative fatigue. As a consequence, the 
final rule's requirements reduce the need for consecutive days off to 
prevent or mitigate fatigue. The NRC also expects that common 
scheduling constraints and worker preferences will cause licensees to 
schedule days off in succession. In addition, the NRC considered that 
the alternative requirements of Sec.  26.205(d)(3) and (d)(4) of the 
final rule provides licensees greater flexibility in meeting scheduling 
demands and minimizing circadian disruption for workers.
    Section 26.205(d)(3) requires individuals subject to the 
requirements of Sec.  26.205 to have a minimum average number of days 
off per week. The specific number of days off depends upon the length 
of shifts in the work schedule of the individual. This requirement 
replaces the requirements presented in proposed Sec.  26.199(f) 
[Collective work hour limits], which would have required licensees to 
control the collective work hours of each group of individuals 
performing the duties subject to the work hour requirements and ensure 
that the collective work hours of each job duty group would not have 
exceeded an average of 48 hours per person per week in any averaging 
period. Section 26.205(d)(3), by requiring a minimum number of days 
off, indirectly limits average weekly work hours to levels comparable 
to those that would have been permitted by the collective work hour 
limits of the proposed rule. Consequently, Sec.  26.205(d)(3) of the 
final rule performs the same function as the requirements of proposed 
Sec.  26.199(f), providing reasonable assurance that the FFD of 
individuals subject to the work hour requirements is not impaired by 
cumulative fatigue. As described with respect to Sec.  26.205(d)(2), 
this requirement also addresses an objective of the 48-hour break 
requirement of the proposed rule by limiting the potential for the 
cumulative fatigue of individuals while the plant is operating. The 
provision does not require that days off be provided consecutively, as 
would have been required by proposed Sec.  26.199(d)(2)(iii), but 
rather allows licensees discretion, within the constraints of the other 
work hour limit and break requirements, in distributing days off 
throughout the shift cycle. As a consequence, Sec.  26.205(d)(3), like 
proposed Sec.  26.199(d)(2)(iii), is intended to ensure that 
individuals receive sufficient days off on a periodic basis to prevent 
cumulative fatigue.
    The minimum day off requirements of Sec.  26.205(d)(3) will ensure 
that licensees manage during periods of normal plant operation the 
potential for cumulative fatigue (i.e., fatigue from successive weeks 
of overwork or inadequate rest) to adversely affect the abilities of 
individuals to perform functions that are important to maintaining the 
safety and security of the plant. The requirements prevent excessive 
use of the maximum work hours and minimum rest breaks that are 
permitted under Sec.  26.205(d)(1) and (d)(2). In addition, proactively 
controlling work hours to ensure individuals receive a minimum weekly 
average number of days off while the plant is operating is likely to 
reduce the need for licensees to grant waivers of the work hour 
requirements in Sec.  26.205(d)(1) and (d)(2). Individuals will be 
better rested and less susceptible to cumulative fatigue from the 
increased work hours that are common during outages and that are 
necessary to augment security

[[Page 17135]]

staffing during increased threat conditions. Therefore, the minimum day 
off requirement is essential for limiting cumulative fatigue and 
augments other important elements of licensees' fatigue management 
programs.
    Requiring a minimum number of days off that results in a maximum 
average work week of approximately 48-54 hours per week helps to ensure 
that licensees meet a fundamental objective of the NRC's Policy on 
Worker Fatigue. The Policy, promulgated in GL 82-12, is intended to 
ensure that there are a sufficient number of operating personnel 
available to ``maintain adequate shift coverage without routine heavy 
use of overtime.'' Routine overtime can cause cumulative fatigue, 
thereby degrading workers' abilities to safely and competently perform 
their tasks. Section 26.205(d)(3) establishes requirements that are 
expected to result in maximum average work weeks in the range of 48-54 
hours, thereby ensuring that work hours approaching the limits in Sec.  
26.205(d)(1) and NRC's Policy on Worker Fatigue are the exception and 
not routine.
    The minimum day off requirements of Sec.  26.205(d)(3) also 
address, in part, the cumulative fatigue concerns reported by security 
personnel in the months following the terrorist attacks of September 
11, 2001. These individuals questioned their readiness and ability to 
perform their required job duties because of the adverse effects of 
cumulative fatigue. The NRC reviewed the actual hours worked by 
security personnel and determined that, in the vast majority of cases, 
individual work hours did not exceed the guidelines specified in the 
NRC's Policy on Worker Fatigue. However, the review confirmed that 
individuals had been working up to 60 hours per week for extended 
periods. Individual concerns 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 are inadequate for addressing cumulative fatigue. The NRC 
obtained additional support for this conclusion following 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).
    Through public interactions during the development of order EA-03-
038, the NRC developed a collective work hour requirement, rather than 
a limit on individual work hours, in response to stakeholder comments 
regarding differences among individuals in their abilities and desires 
to work overtime. The proposed rule would have permitted a group of 
workers who perform similar duties to average 48 hours of work over a 
period not to exceed 13 weeks. Because the proposed limit would have 
been imposed on a job duty group's average number of work hours during 
an averaging period, licensees would have been able to distribute 
overtime among their workers based on their assessment of individuals' 
abilities and desires to work overtime. Stakeholder comments on the 
proposed requirement for collective work hour controls raised several 
concerns.
    Some stakeholders expressed the concern that the collective work 
hour controls were not an effective means for addressing fatigue. One 
stakeholder expressed the concern that the collective work hour 
controls would allow licensees to force individuals to work overtime. 
Another stakeholder expressed the opinion that collective work hour 
controls are not an effective means to address the known physiological 
fatigue risks contributed by individual operators. Other stakeholders 
expressed the concern that licensees may be able to manipulate the 
collective work hour calculations. Other commenters asserted that the 
collective work hour controls were unnecessary to mitigate the effects 
of cumulative fatigue and that the controls would limit the flexibility 
to increase work hours in a job-duty group based on operational needs. 
These commenters stated that other rule provisions, such as the work 
schedule, individual work hour limits, and individual break 
requirements, as well as the provisions concerning fatigue assessments 
and the self-declaration process adequately address cumulative fatigue.
    Although the NRC acknowledges that Subpart I provisions concerning 
fatigue assessment and self-declaration are important for the detection 
of cumulative fatigue, these provisions, like the individual work hour 
limit and break requirements of the proposed rule, do not adequately 
address the prevention of cumulative fatigue. Accordingly, the final 
rule addresses the comments on the limitations of the collective work 
hour requirements by replacing the requirements of Sec.  26.199(f) of 
the proposed rule with the minimum day off requirements in Sec.  
26.205(d)(3) of the final rule. The minimum day off requirements were 
largely derived from a work hour control proposal submitted by NEI as a 
comment on the proposed rulemaking. Although in several instances the 
NRC did not adopt the specific minimum number of days off that NEI 
proposed in its comments, Sec.  26.205(d)(3) establishes requirements 
similar to those proposed by NEI by requiring each individual subject 
to the requirements of Sec.  26.205 to have a minimum average numbers 
of days off per week.
    Section 26.205(d)(3) defines, for the purposes of Subpart I, the 
term day off as a calendar day in which an individual does not start a 
work shift. The definition ensures consistent licensee implementation 
of the requirements in Sec.  26.205(d)(3). In developing the 
definition, the NRC considered the alternative of defining the 
requirements of Sec.  26.205(d)(3) in terms of 24-hour break periods. A 
stakeholder at the March 29, 2006, public meeting concerning this 
rulemaking noted that the number of 24-hour breaks in a schedule could 
be readily influenced by the number of rotations between shifts and 
therefore could encourage scheduling practices that achieved compliance 
with the requirement through schedules that were adverse to the 
circadian adjustment of workers. As defined in the final rule, use of 
the term day off does not encourage such adverse scheduling practices 
and results in requirements that establish uniform limits for all 
schedule designs. In addition, the definition enables workers and 
schedulers to readily determine the number of days off in a schedule 
without the need to calculate the duration of break periods.
    Section 26.205(d)(3)(i) through (d)(3)(iv) specifies the minimum 
number of days off for each individual subject to the requirements of 
Sec.  26.205 in terms of a minimum number of days off per week, 
averaged over the shift cycle. The requirements in this section thereby 
allow the number of days off for an individual to vary from week to 
week, but mandate that over the duration of the shift cycle, the 
average number of days off per week meets the specified minimum. 
Section 26.205(d)(3) requires that, for the purposes of calculating the 
average number of days off required in this section, the duration of a 
shift cycle may not exceed 6 weeks. This maximum duration of a shift 
cycle limits the period over which licensees are permitted to average 
the number of days off and thereby limits the potential for cumulative 
fatigue by preventing an excessive number of consecutive weeks in which 
individuals may be working the maximum hours allowed by Sec.  
26.205(d)(1) while having only the minimum breaks required by

[[Page 17136]]

Sec.  26.205(d)(2). The 6-week maximum for shift cycles also 
corresponds to the longest shift cycle commonly used in the U.S. 
nuclear industry.
    Section 26.205(d)(3)(i) requires individuals who are working 8-hour 
shift schedules to have at least 1 day off per week, averaged over the 
shift cycle. This minimum day off requirement allows an average of 48 
hours of work per week, assuming individuals receive the minimum number 
of days off with no work shifts extended beyond 8 hours. This 
requirement is therefore generally consistent with the 48-hour 
collective work hour requirement of Sec.  26.199(f) of the proposed 
rule, though it imposes the requirement on an individual rather than a 
group basis. This requirement is also consistent with the NEI proposal 
for an average of 1 day off per week, averaged over a shift cycle, for 
predominantly 8-hour shift schedules.
    In developing requirements to address cumulative fatigue, the NRC 
considered several types and sources of information, including (1) past 
recommendations from experts and expert panels on work scheduling and 
maintaining worker alertness in the nuclear industry, (2) surveys of 
nuclear power plant workers on their desire and ability to work 
overtime, (3) data on the amount of overtime worked by security 
personnel, and (4) the requirements and practices in other industries.
    EPRI NP-6748 (Baker, et al., 1990) and NUREG/CR-4248 are two of the 
most comprehensive documents on worker fatigue in the U.S. nuclear 
industry. Like the collective work hour limits of the proposed rule, 
the minimum average number of days off requirement is a new concept 
developed to meet the rule's objectives while also addressing 
stakeholders' unique circumstances and specific concerns. As a 
consequence, neither of the documents provides specific guidelines for 
establishing collective work hour limits. Nevertheless, the documents 
contain information and guidelines relevant to this requirement. 
Collectively, the shift scheduling guidelines of EPRI NP-6748 and 
NUREG/CR-4248 suggest a maximum routine work schedule of 44-46 hours 
per week. This maximum includes an assumed turnover time of 30 minutes 
per shift. The NRC also considered the recommendations of experts 
concerning the use of overtime. The expert panel that developed the 
guidelines for NUREG/CR-4248 also addressed overtime use and 
recommended an individual limit of 213 hours per month, including shift 
turnover time. The expert panel emphasized that overtime should not be 
approved for an entire crew, noting that this individual maximum on 
overtime should not be a group norm. Work schedules that meet the 
minimum day off requirements will result in levels of individual work 
hours that are typically in the middle of the range of work hours 
defined by the maximum routine scheduling limits and maximum individual 
overtime. The expert panel further recommended that the NRC authorize 
no more than 400 hours of overtime in a year. A limit of 400 hours of 
overtime annually is very similar to a 48-hour average (i.e., 52 weeks 
x 8 hours = 416 hours).
    In addition to considering the opinions of experts in work 
scheduling and fatigue, the NRC staff also considered the opinions of 
individuals who work in nuclear power plants. These opinions were 
expressed in surveys conducted by PROS and EPRI.
    In 2002, PROS surveyed the attitudes of its members towards work 
hours and the development of a proposed rule concerning fatigue of 
workers at nuclear power plants (ADAMS Accession No. ML05270310). One 
of the survey questions was, ``What is your personal tolerance for 
overtime?'' The responses indicated that 75 percent of the respondents 
had a ``tolerance'' for up to 350 hours per year. Only 13 percent 
expressed a tolerance for more than 350 hours of overtime.
    The work conducted in the development of EPRI NP-6748 also included 
a survey of operators. The results were consistent with the PROS 
survey, indicating that the amount of overtime that operators wanted to 
work ranged from 100 to 400 hours per year. A survey of nuclear power 
plant personnel in the United Kingdom yielded similar results.
    A minimum day off requirement will limit individuals to 
approximately 400 to 500 hours of overtime in a year. Therefore, the 
minimum day off requirements permit levels of overtime while the plant 
is operating that are at the upper extreme of the number of overtime 
hours for which nuclear power plant personnel have expressed a 
tolerance. In addition, the minimum day off requirements are less 
restrictive than the limit implied by worker opinions because the 
minimum day off requirements of Sec.  26.205(d)(3) would not apply 
during the first 60 days of plant outages, and for security personnel, 
during the first 60 days of plant outages, security system outages, or 
increased threat conditions.
    Together with expert and worker opinions, the NRC considered 
industry practices concerning the use of overtime for security 
personnel. The NRC collected work scheduling data for security 
personnel at all nuclear power plants following the events of September 
11, 2001, as part of the process of evaluating the need to require 
licensees to implement compensatory measures to address security 
personnel fatigue. The NRC's analysis, as described in letters from the 
NRC to licensees (e.g., ADAMS Accession No. ML031880257), indicated 
that at some of the sites (31 percent), security personnel worked more 
than 55 hours per week and at a few sites (11 percent) they worked 60 
hours or more per week. The data also indicated that at the majority of 
the sites (58 percent) security personnel typically worked 50 hours per 
week or less. The NRC also reviewed work hours data collected by NEI 
(ADAMS Accession No. ML003746495) and found that, although individual 
sites varied substantially, the average annual overtime for licensed 
operators was 375 hours and 361 hours for non-licensed operators. These 
findings suggest that an average work week of approximately 48 hours is 
an achievable objective for operations personnel as well, although it 
was not a current practice at a small fraction of nuclear power plants.
    The minimum day off requirements are comparable to, though less 
restrictive than, limits on workers in other industries within the 
United States and the limits imposed by other countries that regulate 
overtime for nuclear power plant workers. The NRC staff noted that 
several other countries address cumulative fatigue of nuclear power 
plant personnel through individual monthly and/or annual work hours 
limits on overtime. These limits, summarized in Table 6 of Attachment 1 
to SECY-01-0113, are generally more restrictive than the minimum day 
off requirements because they directly limit hours of work, rather than 
work days, and permit fewer hours of work (e.g., Finland limits 
overtime to 250 hours per year). Table 5 of Attachment 1 to SECY-01-
0113 includes a summary of limits on work hours in other industries in 
the United States.
    The NRC also considered the requirements of the European Union (EU) 
Working Times Directive (WTD) (Council Directive, 1993). The WTD 
establishes requirements concerning the working hours of workers across 
various industries in EU member nations. The WTD establishes a 
requirement that ``workers cannot be forced to work more than 48 hours 
per week averaged over 17 weeks.''
    Moreover, the amount of overtime permitted by the minimum day off 
requirements would be greater than the

[[Page 17137]]

amount used in most continuous operations. Circadian Technologies, 
Inc., a consulting firm that is expert in fatigue management, regularly 
surveys U.S. and Canadian companies conducting 24/7 operations. Its 
2000 survey of 550 major companies indicates that shift workers at 89 
percent of the companies surveyed averaged less than 400 hours of 
overtime per year (Circadian Technologies, Inc., 2000). Circadian 
Technologies, Inc., noted that the average overtime for workers in 
extended operations in the United States was 12.6 percent above the 
standard work week in the first 8 months of 2003, with utilities 
averaging 14.9 percent (Circadian Technologies, Inc., 2003).
    Therefore, the minimum day off requirements establish appropriate 
limits on work schedules while the plant is operating. The requirements 
would ensure that individuals subject to the work hour requirements of 
Sec.  26.205 have sufficient days off to prevent fatigue. The minimum 
day off requirements will indirectly permit levels of overtime at the 
upper extreme desired by most nuclear power plant workers while 
limiting overtime to levels comparable to those recommended by work 
scheduling and fatigue experts.
    Section 26.205(d)(3)(ii) requires that individuals who are working 
10-hour shift schedules have at least 2 days off per week, averaged 
over a shift cycle. Individuals working schedules that meet the minimum 
day off requirements of this section would therefore be working, on 
average, five 10-hour shifts (50 hours) per week. In developing this 
requirement the NRC considered the NEI proposal for a minimum of 1 day 
off per week average for 10-hour shift schedules. The NRC concluded 
that such a limit would allow excessive work hours (i.e., an average of 
60 hours per week) for routine scheduling, thus creating the potential 
for cumulative fatigue. The NRC would not expect such a limit for long-
term work hour control to prevent fatigue concerns such as those 
reported by security personnel working on the order of 60 hours per 
week in the months following the terrorist attacks of September 11, 
2001. The section-by-section analysis for Sec.  26.205(d)(3)(i) 
addresses in detail the basis for minimum day off requirements that 
effectively limit work schedules to work weeks averaging approximately 
48 hours per week. Section 26.205(d)(3)(i) would permit an average work 
schedule of approximately 50 hours. Although this requirement for 10-
hour schedules would allow 2 more hours per week than the requirement 
for 8-hour schedules, 10-hour schedules are not typically used for 
rotating shift schedules. As a consequence, the individuals on those 
schedules are less likely to experience the disruption of their 
circadian cycles that is caused by rotating shifts and therefore better 
able to cope with the additional work hours.
    Section 26.205(d)(3)(iii) requires that individuals performing the 
duties described in Sec.  26.4(a)(1) through (a)(3) have at least 2.5 
days off per week averaged over a shift cycle and individuals described 
in Sec.  26.4(a)(4) have at least 2 days off per week, averaged over a 
shift cycle. In developing this requirement, the NRC considered NEI's 
proposal to require a minimum of 2 days off per week for all 
individuals working 12-hour shifts subject to the work hour 
requirements, except security personnel. For individuals performing the 
duties described in Sec.  26.4(a)(1) through (a)(3), the NRC judged 2 
days off per week to be insufficient for routine scheduling of 12-hour 
shifts because it would allow an average work week of 60 hours, which 
the NRC expects would lead to cumulative fatigue. Furthermore, such a 
requirement would ensure substantially fewer days off than would be 
recommended by the scheduling guidelines contained in EPRI NP-6748 
(Baker, et al., 1990) and NUREG/CR-4248.
    In developing Sec.  26.205(d)(3)(iii), the NRC also considered the 
effect of scheduled training weeks on the overall work hours of 
operations personnel. Operators have 1 week of requalification training 
in most shift cycles. The training week typically consists of four 9-
hour days or five 8-hour days. As a consequence, Sec.  
26.205(d)(3)(iii) has the effect of limiting covered operations 
personnel to an average work week ranging from 48.8 hours to 52 hours, 
in most shift cycles (i.e., when the shift cycle contains a training 
week). The specific number of hours depends on the number of weeks in 
the shift cycle and the training week schedule. This estimate also 
assumes that individuals do not work longer than their scheduled 12-
hour shift.
    Section 26.205(d)(3)(iv) of the rule requires that licensees ensure 
that individuals who are working 12-hour shifts while performing the 
maintenance duties described in Sec.  26.4(a)(4) have a minimum of at 
least 2 days off per week, averaged over a shift cycle. For individuals 
described in Sec.  26.4(a)(4) the NRC judged 2 days off per week to be 
sufficient for routine scheduling of 12-hour shifts. Relative to the 
duties described in Sec.  26.4(a)(1)-(a)(3) and (a)(5), the duties 
described in Sec.  26.4(a)(4) involve fewer and less prolonged periods 
of sedentary activities, which can contribute to degraded alertness, 
and monitoring activities, which are particularly susceptible to 
degraded vigilance.
    Section 26.205(d)(3)(v) of the rule requires that licensees ensure 
that individuals who are working 12-hour shifts and performing the 
security duties described in Sec.  26.4(a)(5) have a minimum of 3 days 
off per week, averaged over a shift cycle. This requirement limits the 
security personnel who are subject to this requirement to an average 
work week of 48 hours. In developing this requirement the NRC 
considered the technical basis described with respect to Sec.  
26.205(d)(3) and public comment on the collective work hour controls of 
the proposed rule. The NRC also considered its experience with 
implementing the group work hour controls that were required for 
security personnel by the compensatory measures of order EA-03-038. The 
NRC has generally found that licensees have implemented work hour 
controls consistent with the requirements of the compensatory measures. 
However, the NRC has received a limited number of concerns from 
security personnel stating that they are still experiencing excessive 
fatigue leading to the perception that the requirements have not been 
fully protective of all security personnel. The NRC also notes that it 
has received numerous reports of inattentive security personnel at U.S. 
nuclear powerplants within the last 2 years. In addition, the NRC 
considered the critical importance of mental alertness and maintaining 
vigilance to the effective performance of security personnel and the 
unique challenges of security duties and work environments to meeting 
these needs (see the section-by-section analysis of Sec.  26.205(a) for 
a more detailed discussion of the relationship between security duties 
and fatigue). Given these considerations, the NRC concluded that it is 
appropriate to establish more stringent work hour requirements for 
security personnel than other individuals subject to the requirements 
of Sec.  26.205. Accordingly, Sec.  26.205(d)(3)(iv) requires a minimum 
of 3 days off per week, averaged over a shift cycle, for individuals 
working 12-hour shifts who are performing the security duties described 
in Sec.  26.4(a)(5).
    Section 26.205(d)(4) provides a limited exception from the minimum 
day off requirements in Sec.  26.205(d)(3) for individuals performing 
the duties specified in Sec.  26.4(a)(1) through (a)(4) (i.e., certain 
operations, chemistry,

[[Page 17138]]

health physics, fire brigade, and maintenance personnel). The exception 
from the minimum day off requirements is available during the first 60 
days of a unit outage while a subject individual is working on outage 
activities. In these circumstances, Sec.  26.205(d)(4) requires 
licensees to ensure that individuals specified in Sec.  26.4(a)(1) 
through (a)(3) have a minimum of 3 days off in each successive (i.e., 
non-rolling) 15-day period and that individuals specified in Sec.  
26.4(a)(4) (maintenance personnel) have at least 1 day off in any 7-day 
period. If at any time during a unit outage an individual performs 
duties specified in Sec.  26.4(a)(1) through (a)(4) on or for a unit 
that is not disconnected from the electrical grid, the individual is 
subject to the minimum day off requirements of Sec.  26.205(d)(3) while 
the individual is performing those duties, except as permitted by Sec.  
26.205(d)(6). After the first 60 days of a unit outage, regardless of 
whether the individual is working on unit outage activities, the 
individual is again subject to the minimum day off requirements of 
Sec.  26.205(d)(3), except as permitted by Sec.  26.205(d)(6).
    The minimum day off requirements in Sec.  26.205(d)(3) address the 
long-term control of work hours while permitting the occasional use of 
extended work hours for short duration circumstances such as equipment 
failure, personnel illness, or attrition. The requirements in Sec.  
26.205(d)(4) address the control of work hours for unique plant 
conditions (i.e., unit outages) which require extended work hours for a 
more sustained period of time. In developing the minimum day off 
requirements of Sec.  26.205(d)(4), the NRC considered several factors, 
including current policy, the bases for the policy, lessons learned 
from the policy implementation, and public comment on the proposed 
rule.
    The NRC's Policy on Worker Fatigue provides guidelines for 
controlling work hours, ``on a temporary basis,'' during periods 
requiring substantial overtime. The Policy reflects the NRC's 
recognition that outages are unique, relatively short term, and involve 
levels of activity that are substantially higher than most non-outage 
operating periods. The policy also reflects the NRC's understanding 
that, although individuals are capable of working with limited rest 
without degraded performance for short periods of time, research has 
shown that the ability to sustain performance without adequate rest is 
clearly limited (Knauth and Hornberger, 2003; Pilcher and Huffcutt, 
1996; Van Dongen, et al., 2003), as discussed in Section IV.D. However, 
as noted in SECY-01-0113, Attachment 1, the NRC has never defined the 
term ``temporary basis'' as used in the Policy. As a result, licensees 
have relied on this phrase in the guidelines to permit extended work 
hours for periods ranging from a few days to more than a year. Industry 
experience with conditions such as sustained plant shutdowns and the 
increased work hours of security personnel following the terrorist 
attacks of September 11, 2001, have demonstrated the need for the NRC 
to establish clearer and more readily enforceable requirements limiting 
the sustained use of extended work hours.
    Differences between individuals, job demands, and work-rest 
schedules can each have a substantial effect on the period of time that 
an individual can work without compromising his or her ability to 
safely and competently perform duties. As a result, studies of work 
scheduling and fatigue provide insights into the potential for 
cumulative fatigue of workers, but do not provide a direct basis for 
establishing the maximum acceptable period for excluding plant outage 
work hours from the collective work hour controls. In setting the 
maximum duration of the exclusion period, the NRC considered that, by 
the end of 60 days of work at the limits permitted by Sec.  
26.205(d)(1) and (d)(2), individuals who are performing the duties 
specified in Sec.  26.4(a)(1) through (a)(4) will have (1) worked 576 
hours, including more than 200 hours of overtime, and (2) missed as 
many as 17 normally scheduled days off. The loss of the 17 normally 
scheduled days off represents a 60-percent reduction in the time 
available to recover and prevent cumulative fatigue. Further, with each 
passing week of increased work hours and decreased time off, deferring 
daily living obligations becomes increasingly difficult, causing 
increased pressure on individuals to reduce their sleep time in order 
to meet the demands of both work and daily life, resulting in an 
increased potential for cumulative fatigue.
    In addition to considering the potential for cumulative fatigue, 
the NRC considered current industry data on the duration of unit 
outages in determining whether the cost to licensees imposed by 
limiting the exclusion period to 60 days is justified in terms of the 
benefit. The average outage duration, as indicated by outage data from 
2000-2002, is approximately 39 days (Information System on Occupational 
Exposure Database, ADAMS Accession No. ML050190016). Eighty-nine 
percent of plant outages during this period were less than 8 weeks in 
duration. In reviewing the frequency of outages, by duration, the NRC 
found that it would be necessary to increase the exclusion period 
substantially to address a marginal number of additional outages of 
longer lengths. Many comments on the proposed rule recommended that the 
8-week exclusion period be increased to a 10-week exclusion period. 
This increase in the exclusion period would substantially increase the 
period of time that an individual would be working with reduced 
recovery time. During the exclusion period, individuals are permitted 
to work up to 72 hours in a 7-day period and are assured of just 3 days 
off in each 15-day period. Individuals who work 12-hour shifts, which 
is common during outages, will average up to 67.2 hours per week, which 
represents 160 percent of their normally scheduled hours with less than 
half of their normally scheduled days off for recovery, for a period of 
up to 2 months. Extending the outage exclusion period to prolong these 
conditions would substantively increase the potential for cumulative 
fatigue and fatigue-related personnel errors. Therefore, the NRC did 
not adopt the recommendation to increase the duration of the exclusion 
period in the final rule.
    The NRC also received several comments on the proposed rule which 
recommended that the NRC eliminate the exclusion for outage periods. In 
an early phase of developing the work hour requirements in Subpart I, 
the NRC considered establishing a set of uniform requirements that 
would be applicable regardless of whether a unit was operating or shut 
down. However, as noted with respect to Sec.  26.205(d)(4), the NRC 
recognizes that individuals are capable of working with limited rest 
without degraded performance for short periods of time. As a 
consequence, the NRC considers it appropriate to allow flexibility 
within the work hour requirements to accommodate limited periods of 
more intensive work schedules, such as unit outages. However, the NRC 
limits this flexibility to infrequent circumstances, such as unit 
outages, to limit the potential for cumulative fatigue. Further, the 
NRC considered the substantial cost to licensees for meeting the 
requirements applicable to periods of plant operation through either 
increasing staffing (to minimize outage durations) or increasing outage 
durations to accommodate a less intensive work schedule. Given these 
considerations, the NRC concluded that a limited period of less 
restrictive work hour requirements, as included in the final

[[Page 17139]]

rule, is better justified by the costs and benefits.
    The 60-day exclusion period that Sec.  26.205(d)(4) permits from 
the minimum day off requirements of Sec.  26.205(d)(3) replaces the 8-
week exclusion period that proposed Sec.  26.199(f) would have 
permitted from the collective work hour limits. The discussion with 
respect to Sec.  26.205(d)(3) presents the issues the NRC considered in 
deciding to replace the collective work hour limits with minimum day 
off requirements. The NRC revised the maximum duration of the permitted 
exclusion period to a duration that is comparable to the 8-week (56-
day) period of the proposed rule, but better conforms with the minimum 
day off requirements in Sec.  26.205(d)(4) and (d)(5). For most 
categories of individuals, the final rule establishes minimum day off 
requirements in terms of 15-day periods, rather than weeks, as the 
proposed rule would have required. As a consequence, the NRC revised 
the maximum duration of the exclusion period to 60 days (4 x 15) to 
encompass four complete periods of time.
    Section 26.205(d)(4) requires licensees to ensure that individuals 
performing the duties specified in Sec.  26.4(a)(1) through (a)(3) have 
at least 3 days off in each successive (i.e., non-rolling) 15-day 
period during the first 60 days of a unit outage and that individuals 
specified in Sec.  26.4(a)(4) (maintenance personnel) have at least 1 
day off in any 7-day period. This requirement replaces, in part, 
proposed Sec.  26.199(d)(2)(ii), which would have required that these 
individuals have a minimum 24-hour break in any 7-day period. This 
requirement also replaces, in part, proposed Sec.  26.199(d)(2)(iii), 
which would have required that these individuals have a minimum 48-hour 
break in any 14-day period, except during the first 14 days of an 
outage. The NRC is replacing these requirements with Sec.  26.205(d)(4) 
in response to public comment (see the discussion of public comment 
with respect to Sec.  26.205(d)(2)(i) and (d)(3)). The combined effect 
of Sec.  26.199(d)(2)(ii) and (d)(2)(iii) of the proposed rule would 
have been to require 2 days off in the first 2 weeks of the outage and 
3 days off in each subsequent 14-day period. Section 26.205(d)(4) 
establishes a requirement that is similar to, though more flexible and 
less complex than, the requirements it replaces.
    The NRC also received stakeholder comments on the proposed rule 
which recommended that the NRC eliminate the minimum day off 
requirements for outage periods. In additions, the NRC received 
comments asserting that attracting qualified supplemental workers is 
challenging in the entire commercial reactor industry, that for many 
supplemental workers the availability of overtime is a key factor in 
where they decide to work, and that the industry has already 
experienced cases where individuals have left during an outage to go to 
a job that offered more overtime. The final rule partially addresses 
these comments by requiring that maintenance personnel have at least 1 
day off in any 7-day period instead of the requirement for at least 3 
days off in each successive (i.e., nonrolling) 15-day period. The NRC 
notes that critical maintenance tasks performed by individuals within 
the scope of Sec.  26.4(a)(4) are subject to quality assurance and 
corrective action programs and that these programs are subject to NRC 
inspection. In addition, post-maintenance testing provides additional 
assurances of equipment performance.
    As described with respect to Sec.  26.205(d)(2), the NRC received 
many stakeholder comments on the proposed rule regarding the 48-hour 
break requirement. Several commenters asserted 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, which reduces the risk of accidents on the job. However, two 
days off may interfere with his or her sleep cycle and, as a result, 
the individual would have to readjust to the night shift after the 2-
day break. The NRC acknowledges that these concerns may be particularly 
applicable during outage periods when it is common for licensees to 
schedule many individuals on a fixed night shift for the duration of an 
outage. The final rule addresses this concern by providing licensees 
increased flexibility in the distribution of the days off. As a 
consequence, licensees may schedule single days off to limit circadian 
disruption for workers on the night shift. Alternatively, they may 
provide the days off in consolidated blocks to provide extended breaks 
of 2 or more consecutive unrestricted sleep periods which are important 
to reducing cumulative fatigue.
    The objective of the requirement in Sec.  26.205(d)(4) is to ensure 
that individuals performing the duties described in Sec.  26.4(a)(1) 
through (a)(4) have sufficient periodic long-duration breaks to prevent 
cumulative fatigue from degrading their ability to safely and 
competently perform their duties. The minimum day off requirement in 
Sec.  26.205(d)(4) serves the same general function as the minimum day 
off requirements of Sec.  26.205(d)(3). However, whereas Sec.  
26.205(d)(3) is principally applicable to extended periods while a unit 
is operating, Sec.  26.205(d)(4) is applicable to periods of limited 
duration during unit outages. As a consequence, the specific limits and 
details of these requirements differ to accommodate these different 
plant conditions and periods of applicability.
    In its development of Sec.  26.205(d)(4), the NRC considered 
industry work scheduling practices during outages and the applicability 
of other proposed requirements during these periods. In SECY-01-0113 
and NRC staff reviews of records of deviations from technical 
specification work hour controls from 2003 and 2004, the most common 
deviation identified was to permit individuals to work more than 72 
hours in 7 days, frequently by working more than six consecutive 12-
hour days. These reviews also indicated that this practice was used 
extensively at a number of sites. Industry comments at the public 
meetings described in the preamble to the proposed rule also confirmed 
the NRC observation that some licensees were scheduling outages with 
several weeks of 12-hour shifts with no scheduled days off. The NRC 
also considered industry comments submitted during the public comment 
period that asserted 1 day off in 7 is adequate for maintaining worker 
performance and that offering schedules that included these levels of 
overtime is necessary to attract supplemental outage workers. The 
minimum day off requirement of Sec.  26.205(d)(4) is the one 
requirement of this final rule that prevents individuals who perform 
the duties listed in Sec.  26.4(a)(1) through (a)(3) from working 72 
hours per week for the entire first 8 weeks of a unit outage. In 
addition, the minimum day off requirement of Sec.  26.205(d)(4) is the 
one requirement of this final rule that prevents individuals from 
performing the duties listed in Sec.  26.4(a)(4) with no scheduled days 
off for the entire first 8 weeks of a unit outage. In this regard, the 
NRC notes that the duties listed in Sec.  26.4(a)(1) through (a)(4) are 
those the NRC considers most important for fatigue management because 
of their relationship to the protection of public health and safety. In 
particular, these duties include operating and maintaining systems and 
components that a risk-informed process has shown to be significant to 
public health and safety.
    As described with respect to Sec.  26.205(d)(2)(ii), break periods 
longer than the minimum 10 hours required by Sec.  26.205(d)(2)(i) are 
necessary on a regular basis to maintain reliable human

[[Page 17140]]

performance. A 10-hour break provides an adequate opportunity to sleep 
(approximately 7 hours for most individuals) only if one assumes the 
minimal times for meals, hygiene, and commuting, as described with 
respect to Sec.  26.205(d)(2)(i), with no other daily living 
obligations. During unit outages, work schedules of 12-hour shifts and 
limited days off are common. As the ratio of 12-hour work shifts to 
days off increases, the pressure on individuals to restrict sleep time 
in order to meet daily living obligations that cannot be deferred 
increases. Without periodic days off, individuals must either forego 
activities that can be important to general mental and physical fitness 
(e.g., family interactions, exercise, recreation, doctor appointments) 
or sacrifice sleep and increase their sleep debt (Presser, 2000). Such 
sleep restriction will compound the effect of the long (12-hour) work 
shift resulting in impairment on the job.
    The NRC also considered ways to prevent and mitigate cumulative 
fatigue in roving outage crews and other transient workers who 
predominantly work during plant outages in the development of this 
requirement. During the stakeholder meetings discussed in the preamble 
to the proposed rule, many stakeholders expressed a strong desire for 
transient workers to be subject to work hour controls. One stakeholder 
observed that assuring transient outage workers are not impaired by 
fatigue is particularly important because these individuals typically 
do not have the extensive training in methods for maintaining reliable 
human performance that is provided to permanent plant personnel.
    During development of the proposed rule, the NRC staff considered 
establishing long-term work hour controls. However, collective work 
hour controls would not be effective because these individuals 
typically work during outages when the collective work hour controls 
would not be applicable or practical. The NRC staff then considered 
individual long-term (quarterly and yearly) work hour limits for 
transient workers. However, industry representatives strongly objected 
because these transient workers move from one licensee to another, and 
the burden of obtaining work hour information for all of these 
individuals from other licensees would be extremely high. In part 
because of the practical difficulties of controlling long-term work 
hours for transient individuals, the NRC developed the 48-hour break 
requirement as a replacement for long-term work hour limits for 
transient individuals. As noted with respect to Sec.  26.205(d)(4), the 
minimum day off requirement of this section replaces, in part, the 48-
hour break requirement of the proposed rule, and is the single 
requirement that prevents individuals responsible for performing risk-
significant duties from working extended periods of 72-hour work weeks 
or extended periods with no days off.
    The NRC further considered that some transient personnel include 
licensee employees and long-term C/Vs. Many of these individuals may 
move from site to site within a fleet during plant outage periods. For 
large fleets, some individuals may work much of the spring and fall 
outage seasons under only the work hour limits and break requirements 
applicable to unit outage periods. For these individuals, the minimum 
day off requirement of Sec.  26.205(d)(4) is the single requirement 
that will prevent such individuals from performing risk-significant 
duties while working with no days off for substantial portions of a 
year.
    In developing the minimum day off requirements for the final rule, 
the NRC considered scheduling practices during outages and determined 
that it could not practically extend the same approach used in Sec.  
26.205(d)(3) because the requirements of this section are based on 
shift cycles which provide a defined period to which the average day 
off requirement will apply. The length of outages and increased threat 
conditions is variable and therefore does not provide a consistent 
averaging period. The NRC further considered establishing a requirement 
of a minimum of 3 days off in any 14-day period for individuals 
specified in Sec.  26.4(a)(1) through (a)(3) because that would have 
been similar to the requirements it would have replaced. However, the 
NRC ultimately determined that 3 days off within a 15-day period 
provides licensees scheduling flexibility (e.g., establishing a 
schedule comprising a repeating series of 4 work shifts followed by 1 
day off). As a consequence, the rule allows licensees the option to 
establish a schedule that is predictable, a characteristic desired by 
schedulers and workers, and that both mitigates and prevents cumulative 
fatigue by including periodic rest breaks.
    During the development of the final rule the NRC also considered a 
graded approach to the minimum day off requirements for outages. 
Specifically, the staff considered an option which would have allowed 
licensees to defer 1 of the 3 required days off in a 15-day block to 
the subsequent 15-day block (i.e., licensees could provide individuals 
only 2 days off in a 15-day block but would be required to provide 
those individuals 4 days off in the subsequent 15-day block). This 
option would have required fewer days off for outages of less than 15 
days and provided additional scheduling flexibility for longer outages. 
At the March 29, 2006 public stakeholder meeting regarding this 
rulemaking the staff discussed the potential of a graded approach and 
solicited stakeholder comment. Only one licensee representative stated 
that a graded approach may provide useful flexibility. The NRC 
subsequently considered the increased potential for cumulative fatigue 
that would result from deferring days off, the increased complexity of 
the rule and scheduling to meet the requirements, the minimal 
stakeholder interest in a graded approach, and determined that the 
option for deferring a required day off to a subsequent 15-day block 
was not warranted.
    Section 26.205(d)(5) requires that during the first 60 days of unit 
outages, security system outages, and increased threat conditions, 
licensees control the hours worked by individuals performing the 
security duties specified in Sec.  26.4(a)(5) in accordance with the 
requirements in Sec.  26.205(d)(5)(i) and (d)(5)(ii). The effect of 
this section is to provide a 60-day exception from the minimum day off 
requirements in 26.205(d)(3) for these plant conditions. After the 
first 60 days of these periods, these individuals are again subject to 
the minimum day off requirements of Sec.  26.205(d)(3), except as 
permitted by Sec.  26.205(d)(6). The purpose of this exception is to 
allow licensees the flexibility provided by the less stringent day off 
requirements of Sec.  26.205(d)(5)(i) and (d)(5)(ii) to provide the 
increased level of security staffing that is required by these unique 
circumstances. The requirements in Sec.  26.205(d)(5)(i) and (d)(5)(ii) 
provide the restrictions necessary to prevent and mitigate excessive 
cumulative fatigue during these periods.
    Section 26.205(d)(5)(i) provides an exception from the minimum day 
off requirements of Sec.  26.205(d)(3) for personnel performing the 
duties described in Sec.  26.4(a)(5) during unit outages or unplanned 
security system outage. The requirement limits this exception period to 
60 days from the beginning of the outage and requires that individuals 
performing the security duties identified in Sec.  26.4(a)(5) during 
this period have a minimum of 4 days off in each non-rolling 15-day 
period. This requirement replaces the collective work hour limit of 60 
work hours per person per week that Sec.  26.199(f)(2)(i) of

[[Page 17141]]

the proposed rule would have required for these individuals during the 
first 8 weeks of a unit outage or a planned security system outage.
    Section 26.205(d)(5) permits licensees to meet the minimum day off 
requirements of Sec.  26.205(d)(5)(i) as an exception to the more 
stringent minimum day off requirements in Sec.  26.205(d)(3). The rule 
permits this exception for a limited duration, 60 days to accommodate 
the short-term demand for increased work hours associated with these 
outages while limiting cumulative fatigue. Therefore, the requirement 
provides reasonable assurance that security personnel will remain 
capable of safely and competently responding to a security incident or 
an increased security threat condition, should one occur during or 
shortly after a period of increased work hours.
    The basis for limiting the duration of the exception from the 
requirements of Sec.  26.205(d)(3) during unit outages is described 
with respect to Sec.  26.205(d)(4). In addition to establishing a 
minimum day off requirement for personnel performing the security 
duties identified in Sec.  26.4(a)(5) during the first 60 days of a 
unit outage, Sec.  26.205(d)(5) establishes minimum day off 
requirements for these individuals for the first 60 days of a planned 
security system outage. Planned security system outages are typically 
of very short duration relative to unit outages and the NRC does not 
expect that planned security system outages will exceed 60 days. 
However, the rule establishes the 60-day limit for planned security 
system outages to simplify implementation of the rule by applying 
identical exclusion periods for all outages and increased threat 
conditions. Additionally, the ability of security personnel to perform 
their duties safely and competently during these outage and increased 
threat conditions is based on the length of time individuals work 
additional hours, not on the nature of the site condition.
    Section 26.205(d)(5)(i) replaces, in part, the requirements 
limiting work hours of security personnel established by order EA-03-
038 with alternative requirements that will achieve the same objective. 
Collectively, the requirements in Subpart I more effectively achieve 
the objectives of the compensatory measures and therefore the NRC 
intends to revoke order EA-03-038 following implementation of this 
rule. This requirement limits, with the exception specified in Sec.  
26.205(d)(6), the maximum duration of the outage requirements to 60 
days instead of the 120-day period order EA-03-038 permits.
    Since September 11, 2001, the NRC has received several reports of 
nuclear security officers found asleep while on duty. In addition, the 
NRC received numerous allegations from nuclear security officers that 
certain licensees have required them to work excessive amounts of 
overtime over long periods as a result of the post-September 11 threat 
environment. The nuclear security officers questioned their readiness 
and ability to perform their required job duties because of fatigue and 
stated that they feared reprisal if they refused to work assigned 
overtime. The NRC received similar information from newspaper articles 
and from interactions with public stakeholder groups. For example, the 
Project on Government Oversight (POGO) issued a report entitled, 
``Nuclear Power Plant Security: Voices from Inside the Fences,'' and 
submitted this report to the NRC staff (ADAMS Accession No. 
ML031670987). POGO interviewed more than 20 nuclear security officers 
protecting 24 nuclear reactors (at 13 plants) to obtain material for 
its report. POGO reported that the security officers who were 
interviewed said, ``Their plants are heavily relying on increased 
overtime of the existing guard force * * *. These guards raised serious 
concerns about the inability to remain alert.'' After reviewing the 
work hours and FFD concerns of security personnel subsequent to 
September 11, 2001, the NRC issued Order EA-03-038 to limit the work 
hours of security personnel and ensure that they remain capable of 
safely and competently performing their duties. The order requires 
compensatory measures for limiting work hours to a collective work hour 
average of 48 hours per person per week during normal operations, as 
well as limiting work hours to an average of 60 hours per week for 
planned plant outages and planned security system outages.
    Ensuring that work schedules incorporate adequate break periods is 
an important mitigation strategy for cumulative fatigue. The need for 
periodic long breaks was discussed with respect to Sec.  26.205(d)(2) 
and (d)(3). The NRC's initial concept for compensatory measures to 
prevent fatigue of security personnel from the long work hours of 
outages included a feature that required a 48-hour break in any 7-day 
period for periods of increased work hours that exceeded 45 days (ADAMS 
Accession No. ML030300470). Through stakeholder interactions during 
development of the order, the NRC concluded that a 60-hour collective 
work hour limit would be an effective alternative to meet the same 
objective and would also provide more flexibility. The 60-hour limit of 
the proposed rule would have ensured that security force personnel who 
work a 12-hour shift receive, on average, 2 days off in every 7-day 
period, thereby reducing the potential for cumulative fatigue.
    As discussed with respect to Sec.  26.205(d)(3), stakeholder 
comments on the proposed rule expressed a range of concerns regarding 
the need for, and effectiveness of, collective work hour controls. As a 
consequence, the NRC replaced the collective work hour limits of the 
proposed rule with the minimum day off requirements outlined in Sec.  
26.205(d)(3) through (d)(5). More specifically, the requirement for a 
minimum of 4 days off in each 15-day period of the first 60 days of an 
outage required in Sec.  26.205(d)(5)(i) establishes a requirement in 
the final rule that is comparable to the 60-hour collective work hour 
limit of the proposed rule, while addressing stakeholder comments 
regarding the importance of addressing worker fatigue on an individual 
basis. Although Sec.  26.205(d)(5)(i) does not directly limit work 
hours, the requirement has the effect of limiting individuals to an 
average work week of 61.6 hours, assuming no work shifts exceed 12 
hours. The NRC established the minimum day off requirement in terms of 
15-day periods to establish requirements for security personnel in time 
periods consistent with the minimum day off requirements for other 
personnel to simplify licensee implementation of the requirements of 
this section.
    For several reasons, control of work hours for security personnel 
must be more stringent than for other individuals who are subject to 
the work hour controls. First, security personnel are the only 
individuals at nuclear powerplants who are entrusted with the authority 
to apply deadly force. Decisions regarding the use of deadly force are 
not amenable to many of the work controls (e.g., peer checks, 
independent verification, post-maintenance testing) that are 
implemented for other personnel actions at a nuclear plant to ensure 
correct and reliable performance. Second, unlike most other work 
groups, security personnel are typically deployed in a configuration in 
which some members of the security force have very infrequent contact 
with other members of the security force or with other plant personnel. 
A lack of social interaction can exacerbate the effects of fatigue on 
individuals' abilities to remain alert (Horne, 1988). Third, these 
deployment positions can be fixed posts where very little physical 
activity is

[[Page 17142]]

required, further promoting an atmosphere in which fatigue could 
transition into sleep. Fourth, many security duties are largely 
dependent on maintaining vigilance. Vigilance tasks are among the most 
susceptible to degradation from fatigue (Rosekind, 1997; Monk and 
Carrier, 2003). Finally, unlike operators, security forces lack 
automated backup systems that can prevent or mitigate the consequences 
of an error caused by fatigue.
    Consistent with the requirements of the proposed rule, the final 
rule requirement differs from that in Order EA-03-038 by establishing 
more stringent work hour requirements for unplanned plant outages than 
for increased threat conditions. Order EA-03-038 currently does not 
impose collective work hour limits for unplanned plant outages. As 
discussed in the preceding paragraph, security duties are particularly 
susceptible to fatigue. Therefore, the NRC considers that the minimum 
day off requirement for security personnel should only be waived in 
cases in which (1) licensees would be unable to sufficiently plan for 
the increased security demands, and (2) the increased potential for 
fatigue-induced errors is outweighed by the need for a higher 
complement of security personnel on shift to maintain the common 
defense and security. In the case of unplanned plant outages, although 
licensees would be unable to sufficiently plan for the increased 
security demands that typically accompany plant outages, licensees can 
control the demands on the work hours of security personnel by 
controlling the outage activities (e.g., maintenance) that create the 
increased demand for security personnel. As a consequence, work hours 
that may compromise the FFD of security personnel, such as those that 
would be permitted in the absence of the minimum day off requirements 
of Sec.  26.205(d)(5)(i), cannot be justified. The economic benefit 
gained by licensees cannot justify the increased potential for fatigue-
induced errors.
    Section 26.205(d)(5)(ii) provides an exception from the minimum day 
off requirements for security personnel for the first 60 days of an 
unplanned security system outage or an increased threat condition. This 
requirement replaces proposed Sec.  26.199(f)(2)(iii), which would have 
provided an exception to the collective work hour limits for security 
personnel for the first 8 weeks of an unplanned security system outage 
or an increased threat condition. The exception allowed by Sec.  
26.205(d)(5)(ii) is consistent with compensatory measures required by 
Order EA-03-038. However, Order EA-03-038 provides an exception from 
the collective work hour limits in the compensatory measures for these 
conditions for a period of up to 120 days. Section 26.205(d)(5)(ii) 
establishes a more stringent exception period.
    Unplanned security system outages and increased threat conditions 
require extensive increases in security force labor in terms of 
compensatory measures. These increases can make it very difficult to 
maintain work hour controls during these periods, especially because 
licensees are unable to plan in advance for these circumstances. 
Although the increased work hours increase the potential for cumulative 
fatigue, other fatigue management requirements, including the work 
hours controls in Sec.  26.205(d)(1) and (d)(2), provide reasonable 
assurance of guard readiness during the exception period. Therefore, 
the benefit to plant security of ensuring adequate staffing during such 
unplanned conditions outweighs the potential for excessive worker 
fatigue.
    Staffing to a level necessary to meet the minimum day off 
requirements of Sec.  26.205(d)(3) during unplanned security system 
outages or increased threat conditions would not be practical because 
it would require licensees to maintain security staffing in numbers 
that would be excessive for the vast majority of circumstances. 
Limiting periods of extended work hours for security personnel to 60 
days aligns the exception period for security personnel with the 
exception period for other personnel subject to the work hour 
requirements, simplifying the rule and its implementation. Further, the 
cost to licensees of the compensatory measures required to address 
security system outages is significant, and most security systems are 
modular. Therefore, an unplanned security system outage is unlikely to 
exceed 60 days. Outages of this duration have been uncommon. Therefore, 
reducing the exclusion period from 120 days to 60 days is not likely to 
have a practical impact on licensees.
    The Department of Homeland Security has refined its threat system 
to compartmentalize increases in threat conditions for individual 
business sectors and regions of the country. In addition, since the 
inception of the system, the threat level has not been increased for 
any period that exceeded 6 weeks. An event that would cause NRC-
regulated sites to maintain increased protective measures for a period 
of more than 60 days would likely mean a significant domestic attack 
had occurred. In this event, Sec.  26.207(c) [Common defense and 
security] provides a means for extending the proposed 60-day exception 
period, as discussed with respect to that provision.
    Proposed Sec.  26.199(f)(2)(iv) would have clarified the instances 
in which security personnel would be subject to a collective work hour 
limit for certain instances in which multiple plant conditions exist. 
The NRC has not retained this provision for the final rule because 
Sec.  26.205(d)(ii), in conjunction with the definition of increased 
threat condition as described in Sec.  26.5, adequately addresses the 
applicability of the work hour requirements for circumstances in which 
multiple plant conditions (e.g., a unit outage and increased threat 
condition) occur simultaneously. Specifically, Sec.  26.205(d)(ii) 
states that during the first 60 days of an unplanned security system 
outage or increased threat condition, licensees need not meet the 
requirements of either Sec.  26.205(d)(3) or (d)(5)(i). As a 
consequence, should an unplanned security system outage or increased 
threat condition occur at any time during a unit outage, security 
personnel subject to the work hour requirements would not be required 
to meet the minimum day off requirements of Sec.  26.205(d)(3) or 
(d)(5)(i) during the first 60 days of the unplanned security system 
outage or increased threat condition.
    Proposed Sec.  26.199(f)(2)(iv) would have also clarified the 
applicability of the collective work hour controls to instances in 
which a threat level increases and then decreases. In the final rule, 
the NRC has defined an increased threat condition in Sec.  26.5 as ``an 
increase in protective measure level, relative to the lowest level 
applicable to the site during the previous 60 days, as promulgated by 
an NRC advisory.'' Accordingly, any time a threat level changes, 
whether by increasing or decreasing, the determination of whether a 
site is in an increased threat condition, for purposes of applying the 
work hour requirements of Subpart I, is made by comparing the current 
threat level with the lowest level applicable to the site during the 
previous 60 days.
    Proposed Sec.  26.199(f)(2)(v) would have clarified the 
applicability of the collective work hour limits for security personnel 
during multiple consecutive and concurrent plant conditions. The NRC 
has not retained this provision for the final rule because the 
requirements in Sec.  26.205(d)(5) and (d)(7), in conjunction with the 
definition of increased threat condition as described in Sec.  26.5, 
adequately define the requirements applicable to multiple

[[Page 17143]]

consecutive and concurrent plant conditions. In the case of multiple 
consecutive increases in threat conditions, Sec.  26.205(d)(ii) would 
permit a 60-day exception from the minimum day off requirements, with 
the 60 days beginning with each increase. As described in the preceding 
paragraph, should the threat level decrease, the determination of which 
work hour requirements are applicable (i.e., whether the increased 
threat level exception applies) depends upon a comparison of the 
current threat level to the lowest level applicable in the previous 60 
days.
    Proposed Sec.  26.199(f)(2)(vi) would have established requirements 
controlling the exception period from the collective work hour controls 
when a threat condition decreases during an unplanned security system 
outage or increased threat condition. In these circumstances, the 
proposed rule would have established the beginning of the exception 
period based upon the date upon which the current threat condition was 
last entered as a result of a threat condition increase. The NRC has 
not retained this provision for the final rule because the requirement 
in Sec.  26.205(d)(5) in conjunction with the definition of increased 
threat condition as described in Sec.  26.5, adequately define the 
requirements. For example, if the threat level increases at the 
beginning of week 1, increases again at the beginning of week 3, and 
then decreases in week 5 to the level of week 1, the beginning of the 
maximum 60-day exception period would be the beginning of week 1 
because the definition of increased threat condition is based upon an 
increase from the lowest level of protective measures in the past 60 
days. The requirements ensure that the duration of the exception period 
is no longer than necessary based upon the current threat level, 
thereby providing licensees with the flexibility to respond to 
increased threat conditions while minimizing the potential for 
cumulative fatigue of security personnel. As a consequence, Sec.  
26.205(d)(5), in conjunction with the definition of increased threat 
condition in Sec.  26.5, establishes requirements applicable to changes 
in threat conditions that are consistent with the work hour controls 
order EA-03-038 requires.
    Section 26.205(d)(6) permits licensees to extend the 60-day 
exception periods in Sec.  26.205(d)(4) and (d)(5) for each individual 
in 7-day increments for each non-overlapping 7-day period in which the 
individual has worked not more than 48 hours during the unit or 
security system outage or increased threat condition. For example, 
during weeks 5 and 6 of a 10-week outage, an individual may work 42-
hour work weeks because of reduced demand for his or her skills during 
those weeks of the outage. That individual would then be eligible to 
work an additional 2 weeks beyond the 60-day exception period under the 
minimum day off requirements applicable to the first 60 days of an 
outage. The NRC added this provision to the final rule partly in 
response to public comment on the proposed rule that the exception for 
outage periods should be extended to 10 weeks. As described with 
respect to Sec.  26.205(d)(4), the NRC does not believe it is 
appropriate to extend the outage exception period to 10 weeks without 
restriction because of the increased potential for cumulative fatigue 
when individuals work at the limits established by Sec.  26.205(d)(4) 
for extended periods of time. However, during public meetings on the 
proposed rule, stakeholders also commented that during extended outages 
individuals do not always work an outage schedule for the entire outage 
but may have periods of reduced activity that provide opportunity for 
individuals to recover from cumulative fatigue. The break requirements 
exception allowed by Sec.  26.205(d)(6) acknowledges this circumstance. 
The provision accommodates longer outages without increasing the risk 
of worker fatigue by allowing licensees to extend the outage exception, 
and therefore the reduced requirements applicable to outages, by taking 
credit for these periods of reduced work hours. As a result, this 
requirement also provides licensees the flexibility of planning outages 
longer than the normal 60-day exception period by incorporating periods 
of reduced work hours appropriate to maintaining worker FFD over an 
extended duration outage. In addition, this provision also applies to 
increased threat conditions and provides a mechanism for a limited 
extension of the reduced requirements applicable to scheduling 
individuals performing security functions during increased threat 
conditions.
    Proposed Sec.  26.199(f)(3) would have permitted the collective 
work hours of any job duty group specified in proposed Sec.  26.199(a) 
to exceed an average of 48 hours per week in one averaging period if 
all of the conditions specified in Sec.  26.199(f)(3)(i) through 
(f)(3)(iii) of the proposed rule were met. The criteria in proposed 
Sec.  26.199(f)(3)(i) through (f)(3)(iii) would have permitted 
licensees to control work hours to a higher collective work hour limit 
under certain occasional, short-term exigent circumstances. The NRC has 
not retained this provision for the final rule because the requirements 
in Sec.  26.205(d)(3) and (d)(6), and Sec.  26.207 adequately define 
the requirements applicable to these circumstances.
    The objective of proposed Sec.  26.199(f)(3) would have been to 
establish a regulatory framework that accommodated circumstances beyond 
the reasonable control of licensees, while ensuring that licensees 
continue 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. The requirements of the final 
rule provide licensees the flexibility to accommodate these 
circumstances in a manner that is consistent with reasonable assurance 
of worker FFD. Section 26.205(d)(3) establishes minimum day off 
requirements that accommodate variation in workload because it does not 
require a minimum number of days off each week but requires licensees 
to ensure that individuals have an average number of days off over the 
duration of a shift cycle of up to 6 weeks. As a consequence, 
individuals are able to work up to 72 hours in a week, to the extent 
that they are still able to meet the minimum days off requirement for 
the shift cycle. For example, individuals on 12-hour shifts can work 72 
hours per week for 2 weeks, and still have enough days off to work an 
average of 45 hours per week for the remaining 4 weeks of a 6-week 
cycle. Section 26.205(d)(3) also accommodates circumstances that may 
require increased work hours for more extended periods of time. Again, 
as an example, Sec.  26.205(d)(3)(iii) requires an average of 2.5 days 
off per week for individuals performing the job duties specified in 
Sec.  26.4(a)(1) through (a)(4). Individuals can meet this requirement 
while working an average of 54 hours per week. This limit is comparable 
to the limit that would have been required by Sec.  26.199(f)(3)(ii) of 
the proposed rule, which would have restricted the exception allowed by 
Sec.  26.199(f)(3) to a group collective work hour average of not more 
than 54 hours per person per week. Section 26.205(d)(6) can also 
accommodate limited unplanned extensions of an outage beyond the 60-day 
exception period, provided individuals have periods of reduced work 
hours that qualify for the 7-day extensions. Such circumstances may 
arise if unexpected complications in an outage task occur that cause 
the work to be deferred until later in the outage,

[[Page 17144]]

leaving the assigned work crew with a reduced period of activity.
    The NRC also notes that the work hour limits of Subpart I are only 
applicable to a limited scope of personnel and therefore not all 
exigent circumstances would necessarily involve individuals or duties 
subject to these controls. In addition, should the circumstances 
require increased work hours by individuals who perform the duties 
specified in Sec.  26.5(a)(1) through (a)(5), the provisions of Sec.  
26.207 address waivers of the work hour requirements when necessary to 
prevent or mitigate conditions adverse to safety and provide exceptions 
from the requirements when necessary to ensure common defense and 
security and allow adequate staffing during declared plant emergencies.
    Proposed Sec.  26.199(f)(4) would have prohibited licensees from 
repeatedly permitting the collective work hours of any job duty group 
to exceed an average of 48 hours per person per week. The final rule 
does not retain this requirement because the NRC has deleted collective 
work hour control requirements from the final rule. As a consequence, a 
limit on repeatedly exceeding the collective work hour limit is not 
necessary for the final rule.
    Proposed Sec.  26.199(f)(5) would have permitted licensees to 
exceed any collective work hour limit of proposed Sec.  26.199(f) if 
the licensee submitted and obtained advance approval of a written 
request to the NRC that included the information in proposed Sec.  
26.199(f)(5)(i) through (f)(5)(iii). The primary objective of this 
provision was to provide a regulatory framework for addressing unique 
and infrequent circumstances, such as steam generator replacements or 
other extended outages, that would be difficult to manage within the 
collective work hour controls of Sec.  26.199(f) of the proposed rule. 
As described with respect to Sec.  26.205(d)(6), Sec.  26.205(d)(6) 
provides a mechanism in the final rule for licensees to establish work 
hour schedules for extended outages without the need for NRC approval 
of a written request and therefore allows licensees to directly and 
more simply address the circumstances that would have otherwise been 
handled through the process that proposed Sec.  26.199(f)(5) would have 
required.
    Proposed Sec.  26.199(g) [Successive plant outages] would have 
established requirements for the control of work hours during unit and 
security system outages that follow a preceding outage by less than 2 
weeks. The objective of the proposed requirements would have been to 
limit the potential for cumulative fatigue that could result from 
working successive outages in close succession. The final rule does not 
retain these requirements.
    A comment on the proposed rule noted that several companies own and 
operate reactors at multiple sites and it is common for these companies 
to develop outage work groups and deploy these work groups to outages 
in close succession at their sites. Another comment noted that 
recruiting qualified supplemental workers to support outages is 
challenging for the entire commercial reactor industry and that for 
many supplemental workers the availability of overtime is a key factor 
in where they decide to work. This comment further stated that the 
industry has already experienced cases where individuals have left 
during an outage for employment that offered more overtime.
    In determining to eliminate the requirements pertaining to 
successive plant outages the NRC concluded that although reduced work 
hours between successive outages would reduce the potential for 
cumulative fatigue, the NRC expects that in many cases transient 
workers would have days off between outages as they travel between 
nuclear power plant sites or wait for the beginning of the next outage. 
As a result, a rule requirement for reduced work hours between 
successive outages would provide no or limited additional benefit in 
these circumstances. The NRC also considered the limited applicability 
of the requirement, i.e., the requirement would have been limited to 
instances in which individuals worked successive outages for the same 
licensee. As a result, the requirement would have provided a benefit 
for only a limited scope of individuals in these circumstances. The NRC 
also considered the increased challenge licensees would face in 
retaining crews of supplemental workers between outages if these 
workers were required to take a full 2 weeks off between outages. The 
NRC further considered that licensees could have alternatively complied 
with the requirement by employing supplemental workers for a 2 week 
period at the conclusion of an initial outage or the beginning of a 
successive outage at the levels applicable to an operating plant. The 
NRC acknowledges that such a practice would likely extend outages and 
the reduced work hours could cause some individuals to seek alternative 
employment. In addition, the NRC considered the potential for the 
successive outage requirements to adversely affect outage schedules. 
Specifically, if a planned outage must be extended due to unforeseen 
complications, the schedule for subsequent outages could be affected if 
the outage extension affects the ability of individuals to have 2 weeks 
of reduced work hours before the subsequent outage.
    Given the limited scope of individuals that would benefit from the 
requirements in proposed Sec.  26.199(g) and the potential for 
substantial adverse impacts on licensee's ability to plan and conduct 
outages, the NRC has not retained these requirements in the final rule. 
However, the NRC notes that the final rule includes other provisions 
that will reduce the potential for cumulative fatigue from successive 
outages, including more stringent work hour controls, requirements for 
a process through which individuals may self-declare if they believe 
they are not fit for duty because of fatigue, and requirements for 
training in fatigue management.
    Section 26.205(e) [Reviews] has been added to require licensees to 
periodically self-assess their performance with respect to controlling 
the work hours of those individuals who perform the job duties 
specified in proposed Sec.  26.4(a). This section replaces with 
substantive changes the requirements in Sec.  26.199(j) of the proposed 
rule. The NRC revised the review requirements to eliminate reviews 
related to the collective work hour limits that were deleted from the 
final rule and to add a review requirement for the implementation of 
the requirements in Sec.  26.205(d)(3).
    Work hour controls in proposed Sec.  26.205(d) would provide 
licensees with substantial flexibility in controlling work hours. 
Accordingly, periodic self-assessments are needed for the licensee to 
maintain reasonable assurance that they are implementing the specific 
work hour control provisions of Sec.  26.205(d) consistent with the 
general performance objective in Sec.  26.23(e). In addition, it is 
necessary for the self-assessments to be scheduled in a manner that 
ensures corrective action, if necessary.
    Outages and increased threat conditions increase the risk of human 
error as a result of higher workload, the performance of more complex 
and infrequent tasks, and the pressure to meet schedular goals. 
Therefore, it is particularly important to include those periods of 
time in any assessment of the effectiveness of a licensee's work hour 
controls. Accordingly, licensees are required to conduct a review once 
per calendar year. If any plant or security system outages or increased 
threat conditions occurred since the licensee completed the most recent 
review, the licensee shall include in the review an

[[Page 17145]]

evaluation of the control of work hours during the outages or increased 
threat conditions. Licensees shall complete the review within 30 days 
of the end of the review period.
    Section 26.205(e)(1) requires licensees to review the actual work 
hours and performance of individuals who are subject to this section 
for consistency with the requirements of Sec.  26.205(c), so that 
licensees can determine if they are scheduling individuals with the 
objective of preventing impairment from fatigue due to the duration, 
frequency, or sequencing of successive shifts. This review is 
consistent with the performance-based approach in Sec.  26.205(c).
    Section 26.205(e)(1)(i) requires the licensees to assess 
individuals whose actual hours worked during the review period exceeded 
an average of 54 hours per week in any shift cycle while the 
individuals' work hours are subject to the requirements of Sec.  
26.205(d)(3). Individuals that average more than 54 hours over a shift 
cycle have a substantial number of extended work days, or have received 
minimal days off, or both. Although the objective of the minimum day 
off requirements of Sec.  26.205(d)(3) is a maximum average work week 
of 48 hours, the requirements do not prevent individuals from exceeding 
an average of 54 hours per week. The requirement is necessary to ensure 
that licensees fully evaluate the work hours and performance of these 
individuals. Several studies have indicated a tendency for individuals 
to underestimate their levels of fatigue (Wylie, et al., 1996; Dinges, 
1995; Rosekind and Schwartz, 1988). This tendency may cause an 
individual to fail to recognize that his or her ability to perform is 
degraded. The final rule requires licensees to independently evaluate 
the performance of these individuals to determine whether their 
abilities to safely and competently perform their duties had actually 
been compromised.
    Section 26.205(e)(1)(ii) requires that licensee assessments include 
individuals who were granted more than one waiver during the review 
period. This provision requires licensees to assess the work hours and 
performance of these individuals to ensure that licensees adequately 
evaluate whether an individual's abilities to safely and competently 
perform their duties had actually been compromised while working under 
a waiver. This requirement is necessary to ensure that licensees' use 
of waivers did not result in degraded worker fitness-for-duty.
    Section 26.205(e)(1)(iii) requires that the licensee assessments 
include individuals who were assessed for fatigue in accordance with 
Sec.  26.211 during the review period. This section requires licensees 
to evaluate whether these individuals' abilities to safely and 
competently perform their duties had actually been compromised. An 
individual who has been assessed for fatigue may be working above his 
or her tolerance for overtime, and it would be necessary for licensees 
to fully evaluate the individual's overall performance. The requirement 
is necessary to ensure that licensee fatigue assessments are consistent 
with worker performance and are providing an effective basis for 
licensee fatigue management decisions.
    Section 26.205(e)(2) requires licensees to review each individual's 
hours worked and the waivers under which work was performed to assess 
staffing adequacy for all of the jobs that are subject to the work hour 
controls of Sec.  26.205. The minimum day off requirements of Sec.  
26.205(d)(3) through (d)(5) provide assurance that licensees are 
managing cumulative fatigue at a gross level, and an indication of 
whether staffing is adequate to support the objectives of the rule. 
However, there is a potential that individuals with specialized skills 
may work a disproportionate number of hours and, consequently, may be 
more susceptible to fatigue than others. Accordingly, Sec.  
26.205(e)(2) requires licensees to review work hours and waivers of the 
work hour controls to provide assurance that fatigue is properly 
managed for all jobs.
    Section 26.205(e)(3) requires licensees to document the methods 
used to conduct their reviews and the results of the reviews. The NRC 
will use the documentation during site inspections as a means of 
assuring compliance with the regulations. The methods and results of 
the reviews are indicative of a licensee's performance in managing the 
fatigue of its workers who are subject to the requirements of this 
section. Irregularities in the review process may indicate a 
programmatic weakness that might trigger further inspection activities. 
The NRC considers the additional recordkeeping burden for documenting 
this information to be outweighed by the NRC's need to ensure that 
licensees are complying with the proposed requirements of this section 
and maintaining effective fatigue management programs.
    Section 26.205(e)(4) requires licensees to record, trend, and 
correct, under the licensee's corrective action program, any problems 
identified in maintaining control of work hours consistent with the 
specific requirements and performance objectives of Part 26. 
Accordingly, licensees are required to maintain the documentation that 
is necessary for NRC reviews of licensees' compliance with the work 
hour controls within the licensees' existing corrective action 
programs. The requirement is in keeping with the existing requirements 
in 10 CFR Part 50 Appendix B, Criterion XVII, ``Quality Assurance 
Records,'' and Criterion XVI, ``Corrective Action.'' The NRC will use 
the documentation during site inspections as a means of assuring 
compliance with the regulations. The corrective actions and trending 
would be indicative of a licensee's performance in managing the fatigue 
of its workers who are subject to the requirements of this part. 
Irregularities in the corrective action process may indicate a 
programmatic weakness that might trigger further inspection activities. 
The NRC considers the additional recordkeeping burden for documenting 
this information under the existing corrective action program to be 
outweighed by the NRC's need to ensure that licensees are complying 
with the requirements and maintaining effective fatigue management 
programs.
Section 26.207 Waivers and Exceptions
    Section 26.207 permits licensees to authorize waivers from the work 
hour requirements in Sec.  26.205(d)(1) through (d)(5)(i) for 
conditions that meet the two criteria specified in this section. 
Section 26.207 contains the revised requirements in proposed Sec.  
26.199(d)(3) and 26.199(h) and (i) of the proposed rule. The final rule 
consolidates these requirements into a single section to improve the 
organization of Subpart I. Although the provisions are renumbered, the 
NRC made only limited changes to the requirements for the final rule.
    Section 26.207(a) permits licensees to grant a waiver of the work 
hour controls in Sec.  26.205(d)(1) through (d)(5)(i). Exceeding the 
individual work hour limits is justified for limited circumstances in 
which compliance with the work hour requirements could have immediate 
adverse consequences for the protection of public health and safety or 
the common defense and security. Limited use of waivers is also 
consistent with the Commission's position stated in the NRC's Policy on 
Worker Fatigue. However, as specified in Sec.  26.207(a)(2), which 
contains the requirements in proposed Sec.  26.199(d)(3)(ii), the NRC 
expects a licensee to grant waivers only to address circumstances that 
it cannot reasonably control.

[[Page 17146]]

    Section 26.207(a)(1)(i) requires an operations shift manager to 
determine that the waiver is necessary to mitigate or prevent a 
condition adverse to safety, or a security shift manager to determine 
that the waiver is necessary to maintain site security, or a site 
senior-level manager with requisite signature authority to make either 
determination. This section establishes one of two criteria in the 
final rule for granting a waiver from the individual work hours 
requirements. This section replaces proposed Sec.  26.199(d)(3)(i)(A), 
with limited editorial revisions.
    The NRC's Policy on Worker Fatigue recognized that ``very unusual 
circumstances may arise requiring deviation from the above [work hour] 
guidelines.'' In SECY-01-0113, the NRC noted that the frequency of 
guideline deviations at a substantial proportion of sites appeared to 
be inconsistent with the intent of the policy and that some licensees 
abused the authority to grant deviations from the work hour guidelines. 
Section 26.207(a)(1)(i) more clearly articulates the NRC's expectations 
with respect to exceeding the work hour limits; licensees must limit 
the granting of waivers from the work hour limits to circumstances in 
which such a waiver is necessary to prevent or mitigate a condition 
adverse to safety or to maintain the security of the plant. The 
criterion in the final rule limits waivers to conditions that are 
infrequent while still permitting waivers that are necessary for safety 
or security. For example, Sec.  26.207(a)(1)(i) permits a licensee to 
grant a waiver from a work hour requirement if necessary to prevent a 
condition adverse to safety, if compliance with the work hour 
requirement will cause the licensee to violate other NRC requirements, 
such as the minimum onsite staffing requirements in 10 CFR 50.54(m), or 
if a delay in the recovery of failed plant equipment that is necessary 
for maintaining plant safety will occur. Similarly, the NRC considers 
it appropriate to grant a waiver from the work hour requirements if 
necessary to prevent a condition adverse to safety or if compliance 
with the work hour requirements would cause a forced reactor shutdown, 
power reduction, or other similar action, as a result of exceeding a 
time limit for a technical specification limiting condition for 
operation (LCO). LCOs require nuclear power plant licensees to take 
certain actions to maintain the plant in a safe condition under various 
conditions, including malfunctions of key safety systems.
    The criterion for granting waivers in Sec.  26.207(a)(1)(i) was the 
subject of considerable stakeholder comment and discussion during the 
public meetings described in the preamble to the proposed rule. 
Industry representatives stated that the criterion is overly 
restrictive because it would prohibit the granting of waivers for 
conditions that could be cost beneficial to the licensee without a 
substantive decrease in safety. However, the potential for worker 
fatigue in conditions that require a waiver is substantial (Baker, et 
al., 1994; Dawson and Reid, 1997; Stephens, 1995; Strohl, 1999). 
Therefore, the NRC does not believe that licensees can reasonably 
justify the performance of risk-significant functions by individuals 
who have worked hours in excess of the limits on the basis that 
granting the waiver will not have an adverse impact on safety or 
security. The preamble to the proposed rule details the NRC's decision 
not to incorporate industry's comment on this provision.
    Section 26.207(a)(1)(i) further requires that an operations shift 
manager or a senior-level site manager with requisite signature 
authority must make the determination that a waiver is necessary to 
mitigate or prevent a condition adverse to safety. Similarly, the final 
rule requires that a security shift manager, or a senior-level site 
manager with requisite signature authority, must make the determination 
that a waiver is necessary to maintain the security of the facility. 
Operations shift managers and security shift managers have the 
requisite knowledge and qualifications to make the respective safety or 
security determinations and making such determinations is consistent 
with the scope of duties currently performed by individuals in these 
positions. The NRC considered industry stakeholder comments during the 
public meetings described in the preamble to the proposed rule, 
expressing concern that limiting the authority to approve waivers to 
operations shift managers and security shift managers could contribute 
to overburdening individuals in these positions and prevent 
distributing the administrative burden of granting a waiver to other 
qualified individuals. The NRC also considered other stakeholder 
comments concerning the need to ensure that the individuals making 
these determinations are not unduly influenced by schedule pressures. 
The NRC noted that some licensees had delegated the authority to 
authorize deviations to organizational levels that appeared to be 
inconsistent with the guidelines in the NRC's Policy on Worker Fatigue, 
which recommend that the plant manager or plant manager designee 
authorize deviations from the guidelines. Accordingly, Sec.  
26.207(a)(1)(i) permits senior site managers with the signature 
authority of operations shift supervisors to make the safety 
determinations that are required to grant waivers and senior site 
managers with the signature authority of security shift supervisors to 
make the security determinations required to grant waivers.
    Section 26.207(a)(1)(ii) establishes the second of two criteria for 
granting a waiver from the individual work hour controls of Sec.  
26.205(d)(1) through (d)(5)(i). This section contains, with revision, 
the requirements in Sec.  26.199(d)(3)(i)(B) of the proposed rule. 
Section 26.207(a)(1)(ii) requires that a supervisor, who is qualified 
to direct the work to be performed by the individual to whom the waiver 
will be granted and is trained in accordance with the requirements of 
Sec. Sec.  26.29 [Training] and 26.203(c) [Training and examinations], 
must assess the individual face to face and be reasonably sure that the 
individual will be able to safely and competently perform his or her 
duties during the additional work period for which the waiver is 
sought. These determinations require knowledge of the specific skills 
that are necessary to perform the work and the conditions under which 
the work will be performed in order to assess the potential for fatigue 
to adversely affect the ability of an individual to safely and 
competently perform the work. This knowledge is generally limited to 
individuals who are qualified to direct the work. The training required 
by Sec. Sec.  26.29 and 26.203(c) provides the KAs that are essential 
for a supervisor to make valid assessments in this regard. Among other 
FFD topics, the training addresses the contributors to worker fatigue 
and decreased alertness in the workplace, the potential adverse effects 
of fatigue on job performance, and the effective use of fatigue 
countermeasures. Accordingly, the training is necessary for individuals 
to perform these assessments.
    The NRC revised the proposed rule to account for the situation in 
which no supervisor qualified to direct the work is on site. To address 
this circumstance, Sec.  26.207(a)(1)(ii) of the final rule states that 
a supervisor who is qualified to provide oversight of the work to be 
performed by the individual can make the assessment if he or she is 
trained in accordance with the requirements of Sec. Sec.  26.29 and 
26.203(c). Although this individual may be less familiar with the 
details of how the work is to be performed, the exception prevents the 
substantial burden of a licensee requiring a supervisor who is 
qualified

[[Page 17147]]

to direct the work to report to the site to perform the assessment, as 
well as preventing the potential fatigue of the supervisor if called in 
during the night.
    Section 26.207(a)(1)(ii) further requires that supervisors must 
perform the assessment face to face with the individual to which the 
waiver will apply. This requirement ensures that the supervisor who is 
performing the assessment has the opportunity to observe the 
individual's appearance and behavior and note any indications of 
fatigue (e.g., decreased facial tone, rubbing of eyes, slowed speech). 
The supervisor can also interact with the individual to assess his or 
her ability to continue to safely and competently perform his or her 
duties during the period for which the waiver will be granted.
    Section 26.207(a)(1)(ii) also requires that the supervisory 
assessment must address, at a minimum, the potential for acute and 
cumulative fatigue, considering the individual's work history for at 
least the past 14 days, and the potential for circadian degradations in 
alertness and performance, considering the time of day for which the 
waiver will be granted. The potential for acute fatigue can be 
practically assessed by estimating the total number of continuous hours 
that the individual will have worked by the end of the work period for 
which the waiver is being considered. The potential for cumulative 
fatigue can be practically assessed by reviewing the individual's work 
schedule during the past 14 days to determine whether (1) the 
individual had adequate opportunity to obtain sufficient rest, 
considering the length and sequencing of break periods, (2) the 
available sleep periods occurred during the night or at other times 
when sleep quality may be degraded, and (3) the potential exists for 
transitions between shifts (e.g., from days to nights) to have 
interfered with the individual's ability to obtain adequate rest. The 
potential for circadian degradations in alertness and performance can 
be practically assessed by considering the time of day or night during 
which the work would be performed, as well as the times of day of the 
individual's recent shift schedules. Section 26.207(a)(1)(ii) in effect 
requires supervisors to address the three work schedule factors (i.e., 
shift timing, shift duration, and speed of rotation) that are generally 
considered to be the largest determinants of worker fatigue (Akerstedt, 
2004; McCallum, et al., 2003; Mallis, et al., 2002; Folkard and Monk, 
1980; Rosa, 1995; Rosa, et al., 1996). In determining the scope of the 
assessment, the NRC also considered the need for licensees to be able 
to focus the assessment on information that is readily available and 
could be verified.
    Section 26.207(a)(1)(ii) further requires that the supervisory 
assessment for granting a waiver address the potential for fatigue-
related degradations in alertness and performance to affect risk-
significant functions and whether it is necessary to establish controls 
and conditions under which the individual is permitted to perform work. 
This requirement is consistent with the NRC's Policy on Worker Fatigue, 
which states that ``the paramount consideration in such authorizations 
shall be that significant reductions in the effectiveness of operating 
personnel would be highly unlikely.'' However, Sec.  26.207(a)(1)(ii) 
requires the supervisor to identify any risk-significant functions that 
may be compromised by worker fatigue, thereby focusing the assessment 
on worker activities that have the greatest impact on the protection of 
the public, considering the types of skills and abilities that are most 
sensitive to fatigue-related degradations.
    Section 26.207(a)(1)(ii) also requires the supervisor to identify 
any additional controls and conditions that he or she considers 
necessary to grant the individual a waiver from a work hour control. 
For example, applicable controls and conditions may include, but are 
not limited to (1) peer review and approval of assigned job tasks, (2) 
assignment of job tasks that are non-repetitive in nature, (3) 
assignment of job tasks that allow the individual to be physically 
active, and (4) provisions for additional rest breaks. The requirement 
to consider establishing controls and conditions is necessary to ensure 
that licensees take steps to mitigate fatigue from an extended work 
period and reduce the likelihood of fatigue-related errors adversely 
affecting public health and safety or the common defense and security.
    Section 26.207(a)(2) requires licensees, to the extent practical, 
to grant waivers only in circumstances that could not have been 
reasonably controlled. This section contains the requirement presented 
in Sec.  26.199(d)(3)(ii) of the proposed rule. This requirement is 
necessary because conditions for meeting the waiver criteria that are 
specified in Sec.  26.207(a)(1) could routinely result from inadequate 
staffing or work planning. Licensees have authorized deviations from 
their technical specification limits on work hours for such reasons in 
the past. However, because of the significant adverse effects of worker 
fatigue, as detailed in Section IV.D, waivers should be used 
infrequently and only when necessary to protect the public. Licensees 
should take all reasonable care to ensure the use of waivers is 
minimized. Therefore, Sec.  26.207(a)(2) prohibits the use of waivers 
in lieu of adequate staffing or proper work planning, for example, but 
would permit the use of waivers for circumstances that the licensee 
could not have reasonably controlled, which may include, but are not 
limited to, equipment failures or a sudden increase in the personnel 
attrition rate.
    Section 26.207(a)(3) requires that the face-to-face supervisory 
assessment required by Sec.  26.207(a)(1)(ii) be performed sufficiently 
close in time to the period during which the individual will be 
performing work under the waiver to ensure that the assessment will 
provide a valid indication of the potential for worker fatigue during 
the extended work period. This section contains the requirements 
presented in Sec.  26.199(d)(3)(iii) of the proposed rule. This 
requirement is needed because worker alertness and the ability to 
perform can change markedly over several hours (Baker, et al., 1990; 
Dawson and Reid, 1997; Frobert, 1997; Folkard and Monk, 1980; Rosa, 
1995). These changes can be particularly dramatic if fatigue from 
sustained wakefulness coincides with circadian periods of decreased 
alertness (Baker, et al., 1990; Gander, et al., 1998; Rosekind, 1997; 
Folkard and Tucker, 2003; Carrier and Monk, 2000). Therefore, the final 
rule requires licensees to conduct supervisory assessments within a 
time period that provides reasonable assurance that the individual's 
condition will not substantively change before work is performed under 
the waiver.
    Section 26.207(a)(3) also establishes a period of 4 hours before 
the individual begins working under the waiver as the period within 
which the supervisory assessment must be performed. In establishing a 
maximum time period the NRC considered several factors. Conducting the 
assessment as close in time as practical to the period during which the 
individual will perform work under the waiver will provide the greatest 
assurance of a valid assessment. However, conducting the assessment 
immediately before the individual will begin performing work under the 
waiver could, in some circumstances, cause the timing of assessments to 
conflict with the conduct of shift turnovers and other practical 
administrative and operational constraints. Additionally, assessments 
for granting waivers from the longer term individual limits (e.g., the 
maximum number of work hours in 7

[[Page 17148]]

days) would be less sensitive to the specific timing of the assessment. 
However, certain licensees have periodically authorized blanket 
deviations from technical specification work hour limits days and weeks 
in advance of the actual performance of the work. A maximum limit of 4 
hours would address the need for an enforceable requirement that would 
provide reasonable assurance of valid assessments and would take into 
account the relevant technical and practical considerations. An added 
benefit of this requirement is that it would prevent the simultaneous 
granting of blanket waivers for large groups of individuals that do not 
take into account each individual's level of fatigue.
    Section 26.207(a)(4) requires licensees to document the bases for 
granting waivers from the individual work hour controls of Sec.  
26.205(d). This section contains the requirement presented in Sec.  
26.199(d)(3)(iv) of the proposed rule. This section requires licensees 
to document the circumstances that necessitate the waiver, a statement 
of the scope of work and time period for which the waiver is approved, 
and the bases for the determinations required by Sec.  26.207(a)(1). 
This documentation is necessary to support NRC inspections of 
compliance with requirements for granting waivers from the work hour 
limits as well as for the licensee self-assessments of the 
effectiveness of implementing work hour controls that would be required 
under Sec.  26.205(e).
    Section 26.207(b) [Force-on-force tactical exercises] of the final 
rule relieves licensees from the requirements of Sec.  26.205(d)(3) by 
allowing them to exclude shifts worked by security personnel during the 
actual conduct of NRC-evaluated force-on-force tactical exercises when 
calculating the individual's number of days off. This provision is an 
addition to the requirements of the proposed rule and is similar to a 
slightly different exception contained in Order EA-03-08 that applied 
to group work hour controls. The NRC believes this provision is 
appropriate in order to provide licensees flexibility in accommodating 
the NRC-evaluated tactical exercises, which are not under a licensee's 
full control. For example, it allows licensees to use security 
personnel on their normally scheduled days off to support the conduct 
of the exercise without violating the rule. The exception in Order EA-
03-08 also applied to other force-on-force tactical exercises (i.e., 
any not evaluated by the NRC), but the NRC believes this is not an 
appropriate exception for the minimum days off requirement because 
these exercises can be fully planned and scheduled by licensees in 
advance in a manner that complies with the requirements. Nevertheless, 
the more limited exception should provide adequate flexibility to 
licensees given that (1) the final rule removes all restrictions on 
group work hour controls for security personnel, and (2) the exception 
applies to all security personnel working during affected shifts 
(including staff that do not participate in the exercise) even though 
the minimum days off requirement applies to security personnel on an 
individual basis. In contrast, the group work hour controls applied to 
security personnel collectively. During the limited exception period 
for these triennial (every 3 years) NRC-evaluated exercises, the 
requirements in Sec.  26.205(d)(1) and (d)(2) provide reasonable 
assurance that fatigue does not impair the ability of these individuals 
to safely and competently perform their duties.
    Section 26.207(c) [Common defense and security] provides a licensee 
relief from the work hour control requirements of Sec.  26.205(d) upon 
written notification from the NRC, for the purpose of assuring the 
common defense and security for a period the NRC defines. This section 
contains the requirements presented in Sec.  26.199(h) of the proposed 
rule. The exception granted by this section provides necessary relief 
from the requirements of the work hour controls in cases of emergencies 
that are not otherwise covered in this section, including war, in which 
the increased risk from fatigue-induced errors would be outweighed by 
the need to maintain the common defense and security. This section also 
indicates that the NRC would provide such relief in writing.
    Section 26.207(d) [Plant emergencies] adds the potential to 
temporarily waive the requirements of Sec.  26.205(c) and (d) during 
declared emergencies, as defined in the licensee's emergency plan. This 
section contains the requirements presented in Sec.  26.199(i) of the 
proposed rule. Plant emergencies are extraordinary circumstances that 
may be most effectively addressed through staff augmentation that can 
only be practically achieved through the use of work hours in excess of 
the limits of Sec.  26.205(c) and (d). The objective of the temporary 
exemption is to ensure that the control of work hours and management of 
worker fatigue do not impede a licensee's ability to use whatever staff 
resources may be necessary to respond to a plant emergency and ensure 
that the plant reaches and maintains a safe and secure status. At the 
conclusion of the declared emergency, the rule would require licensees 
to again comply with the work hour controls.
Section 26.209 Self-Declarations
    Section 26.209(a) retains, with limited editorial changes, the 
requirements presented in Sec.  26.199(e) of the proposed rule. Section 
26.209(a) requires licensees to take immediate action in response to a 
self-declaration (as discussed with respect to Sec.  26.203(b)(1)) by 
an individual who is working under, or being considered for, a waiver 
from the work hour controls in Sec.  26.205(d)(1) through (d)(5)(i). 
Licensees are required to immediately stop the individual from 
performing any duties listed in Sec.  26.4(a) unless the individual is 
required to continue performing those duties under other requirements 
of 10 CFR Chapter I, such as the minimum control room staffing 
requirements in 10 CFR 50.54(m). If other requirements make it 
necessary for the individual to continue working, this section requires 
the licensee to immediately take action to relieve the individual. For 
example, the licensee should immediately begin a call-in procedure for 
another individual to fill the required position and remove the 
individual from duties as soon as relief becomes available.
    The final rule retains this requirement of the proposed rule 
because correct performance of the duties specified in Sec.  26.4(a) is 
critical to maintaining public health and safety and the common defense 
and security. In addition, there is a significantly increased potential 
for fatigue-related errors when individuals work more than the maximum 
work hours or obtain less rest than the minimum rest requirements of 
Sec.  26.205(d)(1) through (d)(5)(i). Individuals working extended 
hours under a waiver will have a clear and legitimate basis for a self-
declaration of being unfit for duty because of fatigue. Further, by 
self-declaring fatigue, the individual will effectively provide an 
assessment of his or her ability to continue to safely and competently 
perform these critical duties. Several studies indicate a tendency for 
individuals to underestimate their level of fatigue (Wylie et al., 
1996; Dinges, 1995; Rosekind and Schwartz, 1988). Therefore, it is very 
likely that an individual who makes a self-declaration of fatigue is 
potentially more impaired than he or she realizes.
    Section 26.209(a) does not require that licensees immediately 
relieve an individual who self-declares when it is necessary for the 
individual to continue performing his or her duties under other 
requirements of 10 CFR Chapter I. The

[[Page 17149]]

failure to meet minimum staffing or similar requirements will, in the 
majority of cases, have a greater potential to adversely affect public 
health and safety and the common defense and security than permitting a 
fatigued individual to continue performing his or her duties for a 
limited period of time. Further, in these circumstances, licensees can 
implement any fatigue mitigation strategies they deem necessary while 
the individual remains on duty. Fatigue mitigation measures in these 
circumstances include, but are not limited to, controls on the type of 
work that the individual may perform until he or she is relieved (e.g., 
physical or mental, tedious or stimulating, individual or group, risk-
significant or not) and an increased level of supervision (continuous 
or intermittent) and other oversight (e.g., peer checks, independent 
verifications, quality assurance reviews, and operability checks).
    Section 26.209(b) establishes the requirements for returning an 
individual to duty following a self-declaration under the conditions 
described in Sec.  26.209(a). These provisions allow the individual to 
be reassigned to duties that are not subject to work hour requirements, 
if the individual is fit for such duties, and requires that the 
individual have a break of at least 10 hours before returning to duties 
that are subject to the work hour requirements of Subpart I.
    Section 26.209(b)(1) permits licensees to reassign an individual 
who has made a self-declaration of fatigue to perform other duties than 
those specified in Sec.  26.4(a). This section contains with limited 
editorial revisions the requirements presented in Sec.  26.199(e)(1) of 
the proposed rule. The final rule includes this flexibility because, 
although an individual may not be fit to perform the activities 
specified in Sec.  26.4(a), he or she may be able to safely and 
competently perform other duties. Other duties can include, but are not 
limited to, tasks that require skills that are less susceptible to 
degradation from fatigue or do not have the potential to adversely 
affect public health and safety or the common defense and security if 
the individual commits fatigue-related errors. The final rule permits 
licensees to reassign individuals who make a self-declaration of 
fatigue to other duties, if the results of a fatigue assessment (as 
required under Sec.  26.211) indicate that he or she is fit to perform 
them, because permitting the individual to remain at work and continue 
performing such duties will not have the potential to adversely impact 
public health and safety or the common defense and security.
    Section 26.209(b)(2) requires licensees to permit or require an 
individual who has made a self-declaration to take a rest break of at 
least 10 hours before the individual returns to performing any duties 
listed in Sec.  26.4(a). This section contains, with limited editorial 
revisions, the requirements presented in Sec.  26.199(e)(2) of the 
proposed rule. The final rule includes this requirement to ensure that 
individuals who have self-declared are given an opportunity to sleep 
before they are permitted to resume performing any duties that have the 
potential to adversely affect public health and safety or the common 
defense and security. Sleep is widely considered the only non-
pharmacological means of reducing fatigue. As discussed with respect to 
Sec.  26.205(d)(2)(i), a 10-hour rest break generally allows 
individuals to obtain the 7-8 hours of sleep that is recommended by 
most experts for maintaining human performance (National Sleep 
Foundation, 2001; Dinges et al., 1997; Belenky et al., 2003; Akerstedt, 
2003; Monk et al., 2000; Rosekind et al., 1997; Rosa, 1995).
    Although one sleep period of 7-8 hours may be insufficient to 
ensure full recovery from excessive fatigue, nothing in the final rule 
precludes an individual in this circumstance from making a second self-
declaration of fatigue if the individual believes that he or she 
remains unable to safely and competently perform his or her duties 
following the rest break. Section I.B of NRC RIS 2002-07 addressed the 
applicability of the protections of 10 CFR 50.7, [Employee protection] 
to workers who self-declare that they are unfit for duty as a result of 
fatigue.
Section 26.211 Fatigue Assessments
    Section 26.211 requires licensees to conduct fatigue assessments 
under several conditions and contains, with limited editorial changes, 
the requirements presented in proposed Sec.  26.201. The numbering and 
content of the paragraphs in Sec.  26.211 remain consistent with that 
of proposed Sec.  26.201. These conditions, specified in Sec.  
26.211(a)(1) through (a)(4), include for cause, after a self-
declaration, after an event that requires post-event drug and alcohol 
testing, and as a followup to returning an individual to work after a 
self-declaration. The assessments are necessary to determine whether 
individuals who are observed to be in a condition creating a reasonable 
suspicion of impaired individual alertness or have indicated that they 
are not fit for duty because of fatigue can, in fact, safely and 
competently perform their duties. Further, in situations in which a 
plant event requires drug or alcohol testing as specified in Sec.  
26.31(c) [Conditions for testing], this section requires the licensee 
to conduct a fatigue assessment to determine whether fatigue 
contributed to the event.
    Work hour requirements are necessary, but not sufficient, to manage 
worker fatigue effectively. 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). Further, individuals differ substantially 
in their ability to work for extended periods without performance 
degradation from fatigue (Gander, 1998; Jansen et al., 2003; Van Dongen 
et al., 2004a; Van Dongen et al., 2004b). The work hour requirements of 
Sec.  26.205 provide only partial assurance that individuals are not 
fatigued. Therefore, fatigue assessments are essential.
    Appropriately assessing fatigue is also important because workers 
who are experiencing either acute or cumulative fatigue may not be able 
to perform their duties safely and competently, as discussed in Section 
IV.D. A large body of research demonstrates the negative effects of 
fatigue on individuals' abilities to perform. The literature includes 
studies comparing the effects of fatigue with those of alcohol 
intoxication. The effects of both conditions can be expressed in the 
form of performance decrements. Studies have correlated hours of 
wakefulness with equivalent blood alcohol concentrations showing that 
the performance decrements resulting from fatigue are at least as 
severe as the performance decrements observed when individuals consume 
the legal limit of alcohol (Dawson and Reid, 1997; Falleti et al., 
2003). At the extreme, workers who have acute fatigue show symptoms 
that are similar to those of intoxication. Speech is less precise, 
attention may be lacking, and normal body movements and posture may be 
absent. Therefore, it is just as important for a worker to be assessed 
to determine if he or she is unduly impaired from fatigue as it is for 
the worker to be evaluated to determine whether he or she is impaired 
from consuming alcohol.
    The objective of the assessments required by Sec.  26.211(a)(1) 
through (a)(4) is for licensees to address instances of worker fatigue 
appropriately, including those that are not prevented by the work hour 
requirements, regardless of the number of hours that the subject 
individual has worked or rested. As discussed with respect to Sec.  
26.211(c),

[[Page 17150]]

these assessments provide the basis for subsequent management actions 
for fatigue management (e.g., relieving an individual of duties or 
requiring additional fatigue mitigation actions). Therefore, fatigue 
assessments are important for effective fatigue management because they 
provide the basis for any short-term corrective actions that may be 
necessary to ensure that individuals are able to safely and competently 
perform their duties and any long-term corrective actions that may be 
necessary to address individual or programmatic issues contributing to 
recurring instances of fatigue.
    Section 26.211(a)(1) specifies that licensees must perform a 
fatigue assessment, in addition to any other testing that is required 
under Sec. Sec.  26.31(c) and 26.77, if a worker is observed to be in a 
condition of impaired alertness and there is a reasonable suspicion 
that he or she may not be fit to safely and competently perform his or 
her duties. The objective of the requirement is to ensure that fatigue 
is considered, in addition to drugs or alcohol, as a cause for impaired 
alertness. As noted in SECY-01-0113, approximately 80 percent of all 
for-cause FFD tests conducted annually yield negative results for drugs 
and alcohol. A fatigue assessment will help to determine if fatigue was 
the cause for the perceived impairment when testing does not support 
drugs or alcohol as the probable cause.
    Common indications of impaired alertness include yawning, red eyes, 
prolonged or excessive blinking, rubbing of the face with the hands, 
and gross body movements to maintain alertness. Individuals may take 
substantially longer to complete routine tasks, exhibit difficultly 
processing written or oral communications, and may become less 
talkative. At the extreme, workers who are experiencing acute fatigue 
have symptoms that are similar to those of intoxication. Individuals 
who are fatigued are more likely to complain of illness, pain, or 
discomfort. In addition to decreased vigor, fatigued individuals may be 
more irritable, engage in inappropriate humor, exhibit less 
conservative decisionmaking, and persevere in using ineffective problem 
solutions (Horne, 1988; Harrison and Horne, 2000; Dinges et al., 1997; 
Pilcher and Huffcutt, 1996; Belenky et al., 2003; Monk, 2003).
    Section 26.211(a)(1) does not require licensees to conduct a 
fatigue assessment if indications of impaired individual alertness are 
observed during an individual's break period. The NRC considered a 
comment from the IBEW at a September 14, 2004, public meeting 
expressing concern with for-cause assessments for work performed 
outside of the protected area (PA). Although whether a worker is inside 
the PA is not a criterion for being subject to Part 26 requirements, 
the NRC recognizes that napping is an effective means for reducing 
worker fatigue. Therefore, Sec.  26.211(a)(1) excludes napping during a 
break period as a condition for which the final provision requires a 
for-cause fatigue assessment.
    Section 26.211(a)(1) also permits licensees to conduct a fatigue 
assessment, without drug and alcohol testing, if the observed condition 
is impaired alertness with no other indication of possible substance 
abuse. In developing the requirement related to for-cause fatigue 
assessments, the NRC considered stakeholder comments during the public 
meetings described in the preamble to the proposed rule. Stakeholders 
expressed concern that testing for drugs and alcohol, in addition to 
fatigue, when the only apparent cause of impairment was decreased 
alertness, would cause stigma, burden, and reluctance to raise FFD 
concerns that may result in for-cause testing. Accordingly, the 
requirement permits licensees to assess only fatigue if there are no 
indications of possible substance abuse.
    Section 26.211(a)(1) also permits licensees to conduct drug and 
alcohol testing, without a fatigue assessment, when the licensee has 
reason to believe that the observed condition is not caused by fatigue. 
The NRC considered stakeholder comments at the public meetings 
described in the preamble to the proposed rule that a requirement to 
perform a fatigue assessment when the licensee has a reasonable basis 
for believing that the condition is from causes other than fatigue is 
an undue burden. In many cases, an observed condition may clearly 
relate to drugs or alcohol only (such as the smell of alcohol on an 
individual), and in such cases, a fatigue assessment will have no 
benefit.
    Section 26.211(a)(2) requires licensees to conduct a fatigue 
assessment if an individual makes a self-declaration that he or she is 
not fit to safely and competently perform his or her duties because of 
fatigue, except if the licensee permits or requires the individual to 
take a rest break of at least 10 hours. Self-declarations provide 
assurance that instances of worker fatigue, including those that are 
not prevented by the work hour requirements in Sec.  26.205, are 
appropriately addressed, regardless of the number of hours the 
individual has worked or rested. Former Sec.  26.27(b)(1) required that 
``impaired workers, or those whose fitness may be questionable, shall 
be removed from activities within the scope of this part, and may be 
returned only after determined to be fit to safely and competently 
perform activities within the scope of this part.'' A statement by an 
individual to his or her supervisor that he or she is not fit to safely 
and competently perform his or her duties because of fatigue is an 
indication that the individual's FFD is questionable, and that an 
assessment, or a rest break of at least 10 hours, is necessary before 
the individual may be returned to duty. Therefore, in circumstances in 
which an individual requests to be relieved of duties because of 
fatigue and the individual is relieved of duties for at least 10 hours, 
the final rule does not require the licensee to conduct another fatigue 
assessment before permitting the individual to return to duty, 
consistent with current industry practice. Providing a 10-hour break is 
consistent with Sec.  26.205(d)(2)(i), which establishes required break 
times between work periods, and is generally considered sufficient to 
address most acute fatigue conditions.
    As discussed with respect to Sec.  26.211(c), a fatigue assessment 
provides a basis for a licensee to determine whether the individual is 
able to safely and competently perform his or her duties and what, if 
any, subsequent management actions for fatigue management are necessary 
(e.g., relieving an individual of duties or requiring additional 
fatigue mitigation actions). As discussed with respect to Sec.  
26.203(b)(1)(ii), licensees are required to establish controls and 
conditions under which an individual may be permitted or required to 
perform work after that individual declares that he or she is not fit 
because of fatigue.
    In developing the final requirement for fatigue assessments of 
individuals who have self-declared, the NRC considered research on 
subjective assessments of alertness. Self-declarations are generally 
based on an individual's subjective evaluation of his or her alertness. 
Studies have indicated that individuals often misjudge their own 
fatigue, typically by underestimating their level of fatigue and 
propensity for uncontrolled sleep episodes. This effect is widely 
recognized by scientists who study sleep and fatigue. Rosekind, et al. 
(1997) noted that ``An important phenomenon, highly relevant to 
operational environments, is that there is a discrepancy between 
subjective reports of sleepiness/alertness and physiological measures. 
In general, individuals will report higher levels of

[[Page 17151]]

alertness than indicated by physiological measures.'' As a consequence, 
individuals who self-declare will tend to be more impaired than they 
realize. An exception to this tendency has been noted by Dinges, et al. 
(1988) who noted that naps can benefit the performance of those 
experiencing sleep loss, without that benefit being apparent in 
subjective measures. Therefore, it is not only important to assess 
self-declarations as an indicator that an individual may not be able to 
safely and competently perform his or her duties, but also to consider 
factors in addition to a self-declaration as part of the fatigue 
assessment.
    Section 26.211(a)(2) also specifies that licensees must perform 
fatigue assessments for self-declarations made to an individual's 
supervisor. The NRC considered stakeholder comments at public meetings 
that the final rule should be clear with respect to the behavior that 
constitutes a self-declaration. For example, stakeholders expressed 
concern that an individual's off-hand remark to a co-worker that he or 
she is groggy would be considered a self-declaration under the final 
rule and, therefore, require a fatigue assessment in conditions that 
could be satisfactorily addressed through less formal processes. The 
NRC's objective is not to supplant these normal processes for licensee 
workforce management, but to ensure that formal declarations of fatigue 
are appropriately evaluated and addressed. Therefore, the requirement 
specifies that fatigue assessments must be conducted for self-
declarations concerning an individual's ability to ``safely and 
competently perform his or her duties'' and require that the self-
declaration must be made to the individual's supervisor. However, as 
discussed with respect to Sec.  26.211(a)(1), a fatigue assessment must 
be performed in response to an observed condition of impaired 
alertness. If, in the preceding example, the groggy individual remains 
on duty and is observed to exhibit impaired alertness, a fatigue 
assessment is required for cause in accordance with Sec.  26.211(a)(1).
    Section 26.211(a)(3) specifies that licensees must perform a 
fatigue assessment after an event that requires drug or alcohol 
testing, as required in Sec.  26.31(c)(3). Section 26.31(c)(3)(i) 
through (c)(3)(iii) specifies the events and conditions requiring post-
event drug and alcohol testing. A fatigue assessment is also necessary 
in these circumstances to determine whether worker fatigue contributed 
to the event and, if so, to identify the need for any corrective 
actions to prevent similar future events. The assessment will also 
provide the basis for subsequent management actions for fatigue 
management, as required by Sec.  26.211(c) (e.g., relieving an 
individual of duties or requiring additional fatigue mitigation 
actions). Further, the fatigue assessment will provide insights 
concerning the effectiveness of the licensee's fatigue management 
program.
    Consistent with Sec.  26.31(d)(5)(ii), the requirement specifies 
that licensees may not delay necessary medical treatment in order to 
conduct a fatigue assessment, if the event involved physical harm to 
the individual. The NRC considers the immediate medical needs of the 
individual to be paramount. In these circumstances, it is reasonable to 
presume that the individual has been removed from duty and consequently 
the individual's level of fatigue is irrelevant to the immediate 
protection of public health and safety or the common defense and 
security.
    Section 26.211(a)(4) requires licensees to perform a followup 
fatigue assessment if an individual is returned to work after a break 
of fewer than 10 hours following a fatigue assessment that was 
performed for cause or in response to a self-declaration. Although 
sleep periods of less than 8 hours (e.g., naps) can mitigate some 
effects of fatigue, such sleep periods are typically insufficient to 
provide complete recovery from fatigue (McCallum, et al., 2003; Dinges, 
et al., 1997; Totterdell, et al., 1995). As a consequence, the 
objective of this provision is to ensure that, in circumstances of 
sleep periods of less than 8 hours (e.g., if a licensee provides an 
individual an opportunity for a nap rather than a 10-hour break), the 
short rest break has provided sufficient rest to mitigate the 
individual's fatigue and that the individual is not still groggy from 
sleep inertia. Sleep inertia is the grogginess that an individual 
experiences in the transition from sleep to wakefulness that can 
temporarily affect an individual's ability to safely and competently 
perform his or her duties (Bruck and Pisani, 1999; Sallinen, et al., 
1998). Further, the assessment ensures that the individual is capable 
of performing his or her duties safely and competently during the 
upcoming work period. It also provides the information necessary for 
the licensee to determine whether any controls or conditions must be 
implemented during the work period (Priest, 2000; Baker, et al., 1990; 
Sallinen, 1998; Kruger, 2002).
    Section 26.211(b) requires that either a supervisor or a staff 
member of the FFD program, who is trained in accordance with the 
requirements of Sec. Sec.  26.29 and 26.203(c), must conduct any 
fatigue assessment that is required under Sec.  26.211. Under Sec.  
26.211(c), fatigue assessments provide the basis for subsequent actions 
for fatigue management (e.g., relieving an individual of duties or 
requiring additional fatigue mitigation actions). In addition, the NRC 
recognizes that fatigue assessments may be used by some licensees as a 
basis for imposing sanctions on individuals. Therefore, the authority 
to perform fatigue assessments should be limited to supervisors or 
staff members of the FFD program. The training required by Sec. Sec.  
26.29 and 26.203(c) provides the KAs that are essential to a 
supervisor's or FFD program staff member's ability to make valid 
assessments in this regard. Among other FFD program topics, the 
training addresses (1) the contributors to worker fatigue and decreased 
alertness in the workplace, (2) symptoms of worker fatigue, (3) 
indications and risk factors for common sleep disorders, and (4) the 
effective use of fatigue countermeasures. Section 26.29(b) [Policy] 
also requires individuals to demonstrate successful completion of the 
training by passing a comprehensive examination that addresses the KAs.
    Section 26.211(b) further requires that supervisors or FFD program 
staff members must perform the fatigue assessment face to face with the 
subject individual. This requirement ensures that the individual 
performing the assessment has the opportunity to (1) observe the 
subject individual's appearance and behavior to note indications of 
fatigue (e.g., decreased facial tone, rubbing of eyes, slowed speech), 
(2) interact with the individual to understand the individual's self-
assessment of his or her ability to safely and competently perform his 
or her duties, and (3) understand any factors in addition to the 
individual's work schedule that may have contributed to fatigue.
    Section 26.211(b)(1) prohibits individuals who observe another 
individual exhibiting indications of impaired alertness from performing 
the for-cause fatigue assessment of that individual. Without this 
prohibition, a single supervisor could potentially both observe a 
worker exhibiting indications of impairment from fatigue and also 
conduct the for-cause assessment of that worker. In accordance with 
Sec.  26.211(c), fatigue assessments provide the basis for subsequent 
management actions for fatigue management. In addition, some licensees 
may use fatigue assessments as a basis for imposing sanctions on 
individuals, if, for example, a licensee believes that an individual 
has been

[[Page 17152]]

negligent in maintaining his or her FFD. Therefore, in the case of 
fatigue assessments that are conducted for cause, an independent third 
party shall perform the fatigue assessment to provide reasonable 
assurance of an objective assessment.
    Section 26.211(b)(2) prohibits individuals from performing a post-
event fatigue assessment in those circumstances specified in Sec.  
26.211(b)(2)(i) through (b)(2)(iii), in which a conflict of interest 
may be present. An individual who has a conflict of interest may not 
provide an objective assessment of the subject individual's fatigue. 
This requirement provides assurance of an objective fatigue assessment 
by prohibiting individuals from performing the assessment who were 
directly responsible for performing the work or assessing the 
individuals who were involved in the event.
    Section 26.211(b)(2)(i) prohibits individuals from performing a 
post-event fatigue assessment if they performed or directed the work 
activities during which the event occurred. A supervisor who performed 
some of the work activities during which the event occurred may benefit 
from either positive or negative results from a fatigue assessment of 
another individual, depending on the circumstances. Similarly, a 
supervisor who directed the work activities of an individual may avoid 
an adverse action against himself or herself for the actions of a 
fatigued individual under his or her supervision if the supervisor 
erroneously assessed the individual as not fatigued. Therefore, the 
final rule prohibits these individuals from performing fatigue 
assessments under the specified conditions.
    Section 26.211(b)(2)(ii) prohibits individuals from performing a 
post-event fatigue assessment if they performed a fatigue assessment of 
the individuals who were performing or directing the work activities 
during which the event occurred within 24 hours before the event 
occurred. These individuals may have a conflict of interest. For 
example, if an individual previously self-declared fatigue, but a 
fatigue assessment determined he or she was fit to continue work and an 
event subsequently occurred that required the subject individual to be 
assessed again, then the supervisor who performed the first assessment 
may avoid adverse action for the previous determination by performing 
the post-event fatigue assessment and erroneously determining that the 
individual was not fatigued. The final rule prohibits these individuals 
from performing fatigue assessments under the specified conditions.
    Section 26.211(b)(2)(iii) prohibits individuals from performing a 
post-event fatigue assessment if they evaluated or approved a waiver of 
the limits specified in Sec.  26.205(d)(1) through (d)(5)(i) for any of 
the individuals who were performing or directing the work activities 
during which the event occurred if the event occurred while such 
individuals were performing work under that waiver. This provision 
limits the potential for bias in assessments that can result from prior 
involvement in assessing the individual or responsibility for the work 
activities associated with the event.
    Section 26.211(c) requires that fatigue assessments must provide 
the information necessary for management decisions and actions in 
response to the circumstance that initiated the assessment. This 
information is necessary to determine the subject individual's ability 
to safely and competently perform his or her duties, as well as any 
controls or conditions that must be implemented. Section 26.211(c) 
provides assurance that fatigue assessments include sufficient and 
appropriate information to support a valid assessment of the individual 
relative to fatigue and therefore an appropriate basis for management 
decisions and actions. The criteria listed in Sec.  26.211(c)(1)(i) 
through (c)(1)(iii) specify the minimum considerations for fatigue 
assessments.
    In determining the scope of the assessments, the NRC considered the 
need for licensees to be able to focus the assessment on information 
that is readily available and verifiable. Section 26.211(c) requires 
the assessment to address the three work schedule factors described in 
Sec.  26.211(c)(1) through (c)(3), which are generally considered to be 
the largest determinants of worker fatigue (Akerstedt, 2003, 2004; 
McCallum, et al., 2003; Mallis, et al., 2002; Folkard and Monk, 1980; 
Rosa, 1995; Rosa, et al., 1996), as follows.
    Section 26.211(c)(1)(i) specifies the first criterion that fatigue 
assessments will address, acute fatigue. Acute fatigue directly affects 
an individual's ability to safely and competently perform his or her 
duties, as discussed in Section IV.D. Licensees will assess the 
potential for acute fatigue by estimating, at a minimum, the total 
number of continuous hours the individual has been awake, as well as 
considering other individual factors or information provided by the 
individual (such as his or her ability to obtain rest during break 
periods).
    Section 26.211(c)(1)(ii) specifies the second criterion that 
fatigue assessments will address, cumulative fatigue. Cumulative 
fatigue also directly affects an individual's ability to safely and 
competently perform his or her duties, as discussed in Section IV.D. 
Licensees will assess the potential for cumulative fatigue by 
reviewing, at a minimum, (1) the individual's work schedule during the 
past 14 days to assess whether the individual had adequate opportunity 
to obtain sufficient rest, considering the length and sequencing of 
break periods, (2) whether the available sleep periods occurred during 
the night or at other times when sleep quality may be degraded, (3) the 
potential for transitions between shifts (e.g., from days to nights) to 
have interfered with the ability of the individual to obtain adequate 
rest, and (4) other individual factors or information provided by the 
individual (such as any personal issues that may impact his or her 
ability to obtain adequate sleep). For cumulative fatigue, the sleep 
medicine scientific establishment uses the concept of a ``sleep debt,'' 
which is analogous to a bank account becoming overdrawn, and is a 
measure of how much an individual's sleep is being cumulatively reduced 
from his or her everyday sleep need. Many individuals build up a slight 
sleep debt during the working week, dissipating it by ``catch-up'' 
sleep on weekends (National Sleep Foundation, 2000; Monk, et al., 
2001). Therefore, in evaluating cumulative fatigue, how much of a 
``sleep debt'' the worker has accrued in the preceding week needs to be 
evaluated. Dinges and colleagues (1997) noted a five- to seven-fold 
increase in the percentage of subjects noting a significant ``illness, 
infection, pain, discomfort, worry or problem'' in their daily logs as 
they progressed from baseline through the 7 nights of restricted sleep. 
In addition to the expected decrements in vigor over the restricted 
sleep days, subjects' ratings indicated increases in confusion-
bewilderment, tension-anxiety, and total mood disturbance.
    Symptoms of cumulative fatigue are in some ways similar to those of 
acute fatigue, but in other ways quite different. The term ``burnout'' 
has been used to describe workers experiencing cumulative fatigue. 
Similar to burnout from other sources, burnout from cumulative fatigue 
is often characterized by a lack of initiative and/or creativity, with 
the individual just ``going through the motions like a zombie'' without 
being actively engaged or involved in the job he or she is being asked 
to

[[Page 17153]]

perform. Harrison and Horne (2000) advanced the view that the more 
creative thought processes are those most likely to be impaired by the 
individual receiving insufficient amounts of the ``core'' sleep needed 
for cognitive restitution. They note ``[sleep deprivation] presents 
particular difficulties for decisionmaking involving the unexpected, 
innovation, revising plans, competing distraction and effective 
communication.''
    Section 26.211(c)(1)(iii) specifies the third criterion that 
fatigue assessments will address, circadian variations in alertness and 
performance. Section IV.D discusses the impact of such variations on an 
individual's ability to safely and competently perform his or her 
duties. Licensees can assess the potential for circadian degradations 
in alertness and performance by considering the time of day or night 
during which the work was or will be performed and whether the time 
period coincides with a circadian variation through in the individual's 
level of alertness.
    Section 26.211(c)(2) requires that individuals must provide 
complete and accurate information that may be required by the licensee 
to address the factors listed in Sec.  26.20(c)(1) (i.e., acute 
fatigue, cumulative fatigue, and circadian variations in alertness and 
performance). Although work hours are an important determinant of 
worker fatigue, many other factors can affect worker fatigue, not all 
of which may be readily apparent to a licensee. As a consequence, 
individuals and licensees share the responsibility for effective 
assessment and management of fatigue which depends upon complete and 
accurate communication between the individual and the licensee 
concerning matters that may influence an individual's level of fatigue. 
For example, licensees may be able to estimate the total number of 
continuous hours that an individual has been awake through review of 
the individual's work schedule and assumptions regarding typical waking 
times for individuals on that schedule. However, individuals can 
provide information to better approximate the number of hours they have 
been continuously awake and facilitate a more accurate assessment of 
acute fatigue. Additionally, individuals may be able to provide 
information about their general level of work- and non-work-related 
activities, as well as opportunities for rest during the period 
addressed in the fatigue assessment.
    Licensees can practically assess the potential for cumulative 
fatigue by reviewing the individual's work schedule during the past 14 
days to identify schedule features that typically influence whether an 
individual has had adequate opportunity to obtain sufficient rest. 
However, individuals differ substantially in their ability to adapt to 
various schedules (Monk and Folkard, 1985). Therefore, individuals can 
provide general information related to the quality and quantity of 
sleep that they actually obtained during this period, which 
substantively improves the licensee's assessment of the potential for 
cumulative fatigue.
    Licensees can practically assess the potential for circadian 
degradations in alertness and performance by considering the time of 
day or night during which the work is or will be performed and whether 
the time period coincides with a circadian trough in alertness for the 
individual. However, individuals differ in the extent and rate at which 
they adapt to work during periods in which they would otherwise be 
asleep (Folkard and Tucker, 2003; Carrier and Monk, 2000) and can 
provide information (e.g., the timing of their sleep periods) that can 
better inform a licensee's assessment of the potential for circadian 
degradations in alertness.
    Section 26.211(c)(2) also limits licensees' inquiries to only 
obtaining information from the subject individual that is necessary to 
assess the factors listed in Sec.  26.211(c)(1). The fatigue assessment 
will provide a valid basis for licensee decisions and actions for 
fatigue management without undue invasion of an individual's privacy. 
For example, inquiries limited to the amount, quality, and timing of 
sleep and general activity level of the individual can support an 
accurate fatigue assessment without the need for an individual to 
divulge personal details about the reasons for missed sleep or abnormal 
timings for sleep. Consistent with Sec.  26.37 [Protection of 
information], licensees are required to keep any information from the 
individual's self-disclosures confidential.
    Section 26.211(d) prohibits licensees from concluding that fatigue 
had not or will not degrade the individual's ability to safely and 
competently perform his or her duties solely on the basis that the 
individual's work hours have not exceeded any of the limits specified 
in Sec.  26.205(d)(1) or that the individual has had the minimum rest 
breaks required in Sec.  26.205(d)(2) or the minimum days off required 
in 26.205(d)(3) through (d)(5). The work hour controls of Sec.  
26.205(d)(1) and (d)(2) provide reasonable measures to prevent fatigue 
resulting from excessive work hours. However, these controls address 
only work hours and work schedules, and as a consequence, compliance 
with these controls may not prevent an individual from experiencing 
fatigue from one or more of the many other factors that can cause 
fatigue, some of which may not be readily apparent to an employer. 
Workload and the type of work an individual performs, home stresses, 
sleep disorders, and differences in an individual's ability to work 
extended hours or adapt to certain schedules can all substantively 
affect worker fatigue (Rosa, 1995; Totterdell, et al., 1995; Knauth and 
Hornberger, 2003). Although the NRC considered the findings from 
studies of work hours and worker fatigue in developing the work hours 
requirements of Sec.  26.205(d)(1) through (d)(5), it is neither 
practical nor possible to establish limits that will prevent fatigue 
for all individuals. Therefore, the final rule requires licensees to 
consider factors in addition to work hours and rest breaks when 
determining whether an individual is fit to safely and competently 
perform duties.
    Section 26.211(e) requires that, following a fatigue assessment, 
the licensee must decide whether the individual may perform duties 
without a rest break, and, if so, whether controls and conditions must 
be established under which the individual may perform those duties. 
Examples of controls and conditions include, but are not limited to (1) 
a rest break, (2) peer review and approval of assigned job tasks, (3) 
assignment of job tasks that are non-repetitive in nature, (4) 
assignment of job tasks that are simple in nature, and (5) assignment 
to duties that are not important to the protection of public health and 
safety or common defense and security. Section 26.211(e) also requires 
licensees to ensure that any controls and conditions that they 
determine to be necessary to return an individual to duty will be 
implemented.
    Section 26.211(f) requires that licensees document the results of 
any fatigue assessments that were performed, the circumstances that 
necessitated the fatigue assessments, and any controls and conditions 
that were implemented. The documentation is necessary for NRC 
inspectors to evaluate the fatigue assessment component of licensees' 
FFD programs and for the licensee to conduct the reviews required under 
Sec.  26.205(e). The information that the final rule requires licensees 
to document will indicate how well a licensee's fatigue mitigation 
program at a site is performing.
    Section 26.211(g) requires that licensees prepare an annual summary 
for each nuclear power plant site of instances of fatigue assessments 
that were conducted during the previous

[[Page 17154]]

calendar year for any individual identified in Sec.  26.4(a) through 
(c). The NRC revised the reporting provisions in Sec.  26.197(e)(3) of 
the proposed rule to eliminate the requirement to include information 
regarding fatigue assessments in an annual report to the NRC. However, 
the NRC concluded that the fatigue assessment information that would 
have been required in the annual report should be documented in an 
annual summary available on site for NRC inspection. Specifically, 
Sec.  26.211(g)(1) requires that the summary include the conditions 
under which each fatigue assessment was conducted (i.e., whether the 
assessment was conducted for cause, for a self-declaration, after an 
event, or as a followup, as described in Sec.  26.211(a)(1) through 
(a)(4)). As a result, the annual reports will indicate the means by 
which licensees are identifying potential instances of worker 
impairment from fatigue, including whether these instances are 
identified through plant events. Section 26.211(g)(2) requires that the 
annual summaries include a statement for each fatigue assessment of 
whether or not the assessed individual was working on outage activities 
at the time of the self-declaration or condition resulting in the 
fatigue assessment. The annual summaries will therefore show the 
incidence of fatigue assessments during known periods of increased work 
hours (i.e., outage periods) relative to other times during the 
reporting period. Section 26.211(g)(3) requires that the annual summary 
indicate for each fatigue assessment the category of duties that the 
individual was performing, if the individual was performing the duties 
described in Sec.  26.4(a)(1) through (a)(5) at the time of the self-
declaration or condition resulting in the fatigue assessment. 
Accordingly, the annual summaries will show the relative incidence of 
fatigue assessments for each category of duties subject to the work 
hour requirements of Sec.  26.205 in addition to the incidence of 
fatigue assessments for individuals subject to the FFD requirements of 
Part 26 but not subject to the work hour controls of Sec.  26.205. 
Section 26.211(g)(4) requires that the annual summaries include for 
each fatigue assessment the management actions, if any, resulting from 
each fatigue assessment. The annual summaries will therefore show the 
incidence of fatigue assessments that warranted management actions, and 
the nature of those actions.

Subpart J--[Reserved]

    As a result of reorganization of the proposed rule, the provisions 
contained in Subpart J of the proposed rule have been moved to Subpart 
N of the final rule. This section is currently reserved.

Subpart K--FFD Programs for Construction

Section 26.401 General
    Section 26.401(a) provides that a licensee or other entity 
specified in Sec.  26.3(c) may, at its discretion, establish, 
implement, and maintain an FFD program that meets the requirements of 
Subpart K for those individuals who are specified in Sec.  26.4(f). 
Alternatively, if an FFD program for those individuals that meets the 
requirements of Subpart K is not established, those individuals must be 
subject to an FFD program that meets the requirements of Subparts A 
[Administrative Provisions] through H [Determining Fitness-for-Duty 
Policy Violations and Determining Fitness], N [Recordkeeping and 
Reporting Requirements], and O [Inspections, Violations, and Penalties] 
of Part 26. The NRC recognizes that some new plants will be constructed 
near existing nuclear power plants, and it may be more efficient for 
the licensees of those plants to extend their existing FFD programs to 
cover the individuals specified in Sec.  26.4(f). Therefore, this 
section of the final rule provides licensees and other entities 
flexibility to implement either the Subpart K program or a program 
meeting all of the requirements of Subparts A through H, N, and O. 
Subparts A through H, N, and O include all elements of the FFD program 
that apply to operating nuclear power plant licensees, except fatigue 
management requirements. This section meets Goal 3 of this rulemaking 
to improve the effectiveness and efficiency of FFD programs. It also 
meets Goal 6 to improve clarity in the organization and language of the 
rule.
    This section of the final rule differs in several respects from 
those sections of the former rule and the proposed rule that 
established the general applicability requirements for FFD programs 
during construction. The former rule did not specify the construction 
activities that would be subject to the FFD program. Consequently, it 
applied to all workers performing any construction activities, whether 
or not the SSCs under construction could have an impact on public 
health and safety or the common defense and security. In addition, it 
did not provide a choice between applying the FFD program in Sec.  
26.2(c) of the former rule or a complete Part 26 program to the new 
reactor construction workforce (although the former Sec.  26.2(c) could 
have been interpreted as requiring a complete Part 26 program). The 
proposed rule also did not specify the individuals to whom the program 
would apply, thus making it applicable to the entire new reactor 
construction workforce. The proposed rule also did not provide the 
option that is included in Sec.  26.401(a) of the final rule. The final 
rule provides greater flexibility to licensees and other entities than 
either the former rule or the proposed rule by giving them an option 
concerning the type of FFD program to apply. It also clarifies and 
narrows the scope of the group to which Subpart K applies. This is 
consistent with Goal 6 of this rulemaking to improve clarity in the 
organization and language of the rule.
    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, and the Part 52 final rule made these 
changes to the former Sec.  26.2(c). 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 final rule clarifies 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, the FFD program for construction in the final rule 
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 in Sec.  
26.5 of the final rule 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, state, or country would not be subject to 
Subpart K, whereas producing (i.e., ``fabricating'') 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

[[Page 17155]]

(although the construction of the cement mixing facility would not). 
The NRC anticipates that the focus of the Subpart K program on 
construction activities performed 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 NRC considered whether the FFD program for construction should 
also cover individuals who construct safety- and security-related SSCs 
at a vendor's or manufacturer's facility that is geographically remote 
from the location where the new plant will be operated. Because of the 
modular design of new reactors, many of the safety-related SSCs that 
will be relied on to protect public health and safety will be 
fabricated by vendor personnel at remote locations and transported to 
the site for installation and integration. Similarly, the small, 
complete nuclear reactors that may be constructed by manufacturing 
licensees under Part 52 will also be constructed at remote locations 
and transported to the site for installation and integration. However, 
because of the complexity of the technical and regulatory issues raised 
by imposing FFD requirements on these entities, the staff has decided 
to defer adopting requirements for reactor manufacturing facilities, 
which were included in the proposed rule, and has declined to impose a 
Subpart K program on modular fabrication facilities located at a 
distance from the site where the nuclear power plant will be 
constructed and operated at this time. Although the Part 52 final rule 
added manufacturing licensees to the scope of Part 26, this final rule 
removes holders of manufacturing licenses from regulation under Part 
26.
    The former rule and the proposed rule also did not limit the 
applicability of the FFD program to individuals who are constructing 
only safety- or security-related SSCs. However, the NRC recognizes that 
there will be other construction work being 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 or 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 limits the scope of the 
requirements to cover only those individuals who are constructing 
(i.e., fabricating, erecting, integrating, testing, and installing 
foundations of) these specific SSCs. 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.
    Section 26.401(b) provides that licensees and other entities who 
intend to implement an FFD program under Subpart K shall submit a 
description of the FFD program and its implementation as part of the 
license, permit, or limited work authorization application. The former 
rule and the proposed rule did not contain a reference to a limited 
work authorization application, because the requirements in 10 CFR 
parts 50 and 52 pertaining to limited work authorization had not yet 
been developed. The reference to a limited work authorization 
application in Sec.  26.401(b) is consistent with Goal 6 of this 
rulemaking to improve clarity in the organization and language of the 
rule.
    Licensees and other entities who intend to implement an FFD program 
for construction that meets all of the requirements of Subparts A 
through H, N, and O are not required under Part 26 to submit a 
description of their FFD program and its implementation because the 
details of the program are specified by 10 CFR Part 26, Subparts A 
through H, N, and O.
    Submittal of a description of the FFD program and its 
implementation was not required by Sec.  26.2(c) of the former rule or 
Sec.  26.3(e) of the proposed rule, but is a logical and necessary 
component of Subpart K because of the flexibility that Subpart K 
provides in Sec.  26.401(a) and (d). The description of the FFD program 
and its implementation will provide the information that the NRC needs 
to enable it to review as a part of the license, permit, or limited 
work authorization application the particular FFD requirements that are 
selected for implementation by licensees and other entities. Subpart K 
provides licensees and other entities substantial flexibility in the 
design of the program to accommodate local circumstances and the 
logistical challenges associated with construction. The NRC believes 
this flexibility is necessary because it cannot reasonably anticipate 
all of the circumstances that may affect implementation of an FFD 
program for construction (e.g., proximity to a licensee testing 
facility, proximity to a population center that offers alternative 
collection sites, stability in the composition of the workforce at a 
specific site, variations in the need for an FFD program during 
different construction stages based on the potential risks imposed by 
the construction activities at each stage) and, therefore, could not 
develop prescriptive requirements that would be appropriate for all 
potential circumstances. However, because Subpart K is not prescriptive 
and includes several new concepts (e.g., the fitness monitoring 
program, permission to use specimens other than urine for drug 
testing), the NRC believes that it is necessary to verify that a 
licensee or other entity has understood the intent of the Subpart K 
provisions and will implement a program that meets that intent, 
including ensuring that any procedures used for testing specimens other 
than urine for drugs will be scientifically sound and legally 
defensible.
    Requiring a Part 50 applicant to submit a description of its FFD 
program for construction and its implementation is also consistent with 
the Part 52 license application requirements. In the Part 52 
rulemaking, the NRC implemented the Commission's SRM-SECY-02-0067, 
dated September 11, 2002, in which the Commission disapproved the use 
of ITAAC for operational programs such as FFD as long as combined 
license applicants provide descriptions of the operational programs in 
their applications:

    [A]n ITAAC for a program should not be necessary if the program 
and its implementation are fully described in the application and 
found to be acceptable by the NRC at the COL stage. The burden is on 
the applicant to provide the necessary and sufficient programmatic 
information for approval of the COL without ITAAC.

This requirement to include descriptions of operational programs in 
combined license applications was reiterated in the Commission's SRM-
SECY-04-0032, ``Programmatic

[[Page 17156]]

Information Needed for Approval of a Combined License Application 
Without Inspections, Tests, Analyses, and Acceptance Criteria,'' dated 
May 14, 2004:

    In this context, ``fully described'' should be understood to 
mean that the program is clearly and sufficiently described in terms 
of the scope and level of detail to allow a reasonable assurance 
finding of acceptability. Required programs should always be 
described at a functional level and at an increased level of detail 
where implementation choices could materially and negatively affect 
the program effectiveness and acceptability.

Accordingly, Part 52 requires a combined license applicant to include a 
description of its FFD program and its implementation, including the 
FFD program to be implemented during construction. Similarly, Sec.  
26.401(b) requires license, permit, or LWA applicants under Part 50 to 
submit a description of their FFD programs during construction and 
their implementation. The NRC believes that prior review of the 
description of the FFD program for construction and its implementation 
will be more efficient than inspecting FFD programs for construction 
because it will significantly reduce the inspection resources necessary 
to ensure proper program implementation once construction has begun. In 
addition, delaying an evaluation of the program until an inspection can 
be scheduled, which may occur after construction has begun, could mean 
that an ineffective FFD program may be in place during early 
construction, when important tasks are being performed and errors 
resulting in faults could not be easily detected and corrected (e.g., 
the pouring of concrete). Finally, the emphasis on performance 
objectives in Subpart K, compared to the specific, prescriptive 
requirements in the remainder of the rule, means that the Subpart K 
requirements will be difficult to enforce without prior NRC knowledge 
of a licensee's FFD program secured through the description of the FFD 
program and its implementation.

    Consistent with the Part 52 final rule, the NRC expects a Part 50 
applicant's FFD program for construction and its implementation to be 
``fully described,'' as explained by the Commission in SRM-SECY-04-
0032. The applicant should provide a description of the FFD policy and 
procedures prepared by licensees or other entities, including, but not 
limited to, procedures for implementing either random testing or 
fitness monitoring and for performing drug and alcohol testing, and 
identification of the personnel covered by the FFD program. This 
requirement meets Goal 3 of the rulemaking to improve the effectiveness 
and efficiency of FFD programs.
    Section 26.401(c) provides that nothing prohibits the licensees and 
other entities listed in Sec.  26.3(c) from subjecting the individuals 
described in Sec.  26.4(f) to an FFD program that meets all of the 
requirements of Part 26, or program elements that meet all of the 
applicable requirements of Part 26. This provision provides flexibility 
to licensees and other entities to cover all individuals with an FFD 
program that includes all the requirements of Part 26 or to adopt 
certain FFD requirements for individuals described in Sec.  26.4(f) 
from Subpart K and certain FFD requirements from other subparts of Part 
26, as long as the latter meet all of the applicable requirements of 
Part 26. In either case, workers conducting preliminary work that does 
not involve building any safety-or security-related SSCs of a facility 
are not required to be subject to an FFD program. This section allows 
licensees and other entities, if they so choose, to include fatigue 
management requirements under Subpart I in their FFD programs for 
reactor construction. It also allows licensees to mingle elements of 
the requirements of Subpart K and program elements under Subparts A 
through H, N, and O, as long as the elements selected from Subparts A 
through H, N, and O meet all of the requirements in Part 26 for that 
element. Because neither the former rule nor the proposed rule included 
this provision, the final rule provides greater flexibility than either 
the former rule or the proposed rule. This section achieves Goals 3 and 
5 of the rulemaking to improve the effectiveness and efficiency of FFD 
programs and 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 26.403 Written Policy and Procedures
    Section 26.403 addresses the requirements related to the FFD policy 
for personnel listed in Sec.  26.4(f) and the requirements related to 
the procedures for such FFD programs. These requirements are presented 
in separate sections to ensure that the requirements related to FFD 
policy and procedures are easy to locate within this section. This is 
consistent with Goal 6 of this rulemaking to improve clarity in the 
organization and language of the rule.
    Section 26.403(a) requires FFD programs under Subpart K to ensure 
that a clear, concise, written FFD policy statement is provided to 
individuals who are subject to the program. Section 26.403(a) specifies 
that the policy statement must be written in sufficient detail to 
provide affected individuals with information on the program's 
expectations of them and the consequences that may result from a lack 
of adherence to the policy. Because Subpart K does not require 
licensees and other entities to provide site-specific FFD training to 
individuals, the FFD policy statement will be the primary means for 
communicating information with respect to, for example, the sanctions 
that are applied for confirmed positive, adulterated, substituted, or 
invalid test results, the types of specimens and 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, if the program includes random testing. Because of the likely 
large numbers and transient nature of construction workers involved in 
new reactor plant construction, requiring each of them to be provided 
with a copy of the FFD policy statement is the most effective and 
efficient means of ensuring that each individual listed under Sec.  
26.4(f) is informed of the contents of the policy. A clear and concise 
FFD policy statement that is provided to individuals subject to the 
program will promote their awareness of the site-specific FFD policy to 
which they are subject. This section satisfies Goal 3 of the rulemaking 
to improve the effectiveness and efficiency of FFD programs, as well as 
Goal 7 to protect the privacy and other rights (including due process) 
of individuals who are subject to the rule.
    If a licensee or other entity chooses, under Sec.  26.401(d), to 
adopt FFD elements from Subparts A through H, N, and O of Part 26, the 
requirements established by those elements will need to be documented 
in the FFD policy and procedures, and in the FFD program plan. Also, 
notice will need to be provided to the relevant workers falling under 
the scope of the program, as required by this section of the rule.
    The final rule differs in several other respects from the former 
rule and the proposed rule. The former rule contained a simple cross-
reference to the section of the former rule pertaining to the 
requirement to adopt an FFD policy and procedures in writing and did 
not describe or circumscribe the requirement. Thus, the policy and 
procedures requirement for FFD programs applicable to only the reactor 
construction workforce was the same as

[[Page 17157]]

the requirement for other FFD programs. In contrast, the proposed rule 
did not contain any explicit cross-reference to the requirement 
pertaining to FFD program and procedures. However, the program and 
procedures section could be interpreted to apply to FFD programs 
applicable to the reactor construction workforce. The final rule both 
clarifies and adds flexibility to the requirement for an FFD policy 
statement and FFD procedures for FFD programs for construction by 
explaining the limited nature of the Subpart K FFD policy and 
procedures and indicating that they need to be provided only to those 
persons subject to the Subpart K FFD program. This is consistent with 
Goal 6 of this rulemaking to improve clarity in the organization and 
language of the rule.
    Section 26.403(b) requires FFD programs under Subpart K to develop, 
implement, and maintain written procedures that address the topics 
specified in section (b)(1) through (b)(3). However, the procedures 
must address a more limited set of topics than specified in Sec.  26.27 
[Written policy and procedures], the section of Part 26 that deals with 
policy and procedures for FFD programs generally. Thus, the final rule 
reduces the scope of the FFD procedures that are required for FFD 
programs applicable to the individuals listed in Sec.  26.4(f), 
compared to the scope of the former rule and the proposed rule. This 
section implements Goal 3 of the rulemaking to improve the 
effectiveness and efficiency of FFD programs.
    Section 26.403(b)(1) requires the written procedures to address the 
methods and techniques to be used in testing for drugs and alcohol, 
including procedures for protecting the privacy of the individual who 
provides a specimen, procedures for protecting the integrity of the 
specimen, and procedures for ensuring that the test results are valid 
and attributable to the correct individual.
    Section 26.403(b)(2) requires the procedures to describe the 
immediate and followup actions that must be taken if an individual is 
determined to have: (1) Been involved in the use, sale, or possession 
of illegal drugs; (2) consumed alcohol to excess before or while 
constructing safety-or security-related SSCs, as determined by a test 
that accurately measures BAC; (3) attempted to subvert the testing 
process by adulterating or diluting specimens (in vivo or in vitro), 
substituting specimens, or by any other means; (4) refused to provide a 
specimen for testing; or (5) had legal action taken relating to drug or 
alcohol use.
    Section 26.403(b)(3) requires the procedures to describe the 
process to be followed if an individual's behavior raises a concern 
regarding the possible use, sale, or possession of illegal drugs on or 
off site; the possible possession or consumption of alcohol while 
constructing safety-or security-related SSCs; or impairment from any 
cause which in any way could adversely affect the individual's ability 
to safely and competently perform his or her duties.
    The NRC considers the procedures specified in Sec.  26.403(b)(1) to 
(b)(3) to be the minimum set of procedures necessary to implement an 
effective FFD program meeting the requirements of Subpart K. Those 
sections clarify the requirements in the former rule and the proposed 
rule for FFD policy and procedures by explaining what is meant by the 
requirements and limiting them to the listed topics. The section 
satisfies Goal 3 of the rulemaking to improve the effectiveness and 
efficiency of FFD programs, and Goal 6 of the rulemaking to improve 
clarity in the organization and language of the rule. As specified in 
Sec.  26.401(c), licensees and other entities are free to adopt 
procedures for other aspects of their FFD programs that are applicable 
to the individuals listed in Sec.  26.4(f).
Section 26.405 Drug and Alcohol Testing
    The former rule required reactor construction permit holders to 
implement a chemical testing program, including random tests. The 
proposed rule made the requirement more explicit, by requiring the 
implementation of a drug and alcohol testing program, including random 
testing, during construction. The final rule requires pre-assignment, 
for-cause, post-accident, and followup testing, as discussed with 
respect to Sec.  26.405(c), but does not require random testing of all 
individuals who are constructing safety- or security-related SSCs, as 
discussed with respect to Sec.  26.405(b), if a licensee or other 
entity implements a fitness monitoring program, as discussed with 
respect to Sec.  26.406.
    The NRC concludes that there is a strong empirical basis for 
requiring drug and alcohol testing for construction. SAMHSA conducts 
annual surveys that investigate the prevalence, patterns, and 
consequences of alcohol and illegal drug use and abuse in the general 
U.S. civilian population. Its National Household Survey on Drug Abuse 
(NHSDA) covering the years 2000-2001, for example, indicated that over 
23 percent of male construction workers aged 18-24 and over 11 percent 
of those 25 and older admitted to the use of an illicit drug within the 
month previous to the survey, while over 75 percent of the 18-24 age 
group and almost 55 percent of the over 25 group admitted to binge 
drinking or heavy use of alcohol at least once during the prior month. 
Because of the relatively small number of female construction workers, 
the data pertain only to male construction workers. A study based on 
the results of the SAMHSA NHSDA conducted in 1994 and in 1997 showed 
that in 1994 15.6 percent of full-time construction workers, ages 18-
49, reported current illicit drug use and 17.6 percent reported heavy 
alcohol use, while in 1997 14.1 percent and 12.4 percent reported such 
drug and alcohol use, respectively. The report of the 2000 SAMHSA NHSDA 
stated that ``workers in the construction and mining industries 
reported the highest rates'' of heavy alcohol use, illicit drug use, 
dependence on or abuse of alcohol, and dependence on or abuse of 
illicit drugs among full time workers aged 18 through 49 in the U.S. 
labor force. SMHSA's 2004 National Survey on Drug Use and Health 
indicated that from 2002-2004, past month illicit drug use among full-
time construction and extraction workers aged 18 to 64 was 15.1 
percent, and past month heavy alcohol use among this same group was 
17.8 percent, which was the highest level among surveyed occupational 
groups. Also, construction industry groups, such as the Construction 
Safety and Drug Abuse Executive Roundtable, also have concluded that 
``drug abuse continues to be widespread in the construction industry,'' 
affecting up to 25 percent of the workforce. Finally, data collected 
annually through the FFD program performance reports and evaluated by 
the NRC show a consistent pattern of substantially higher incidence of 
detections of drugs and/or alcohol in the population of short-term 
contractors, which includes construction workers who seek employment or 
are employed during outages, who are given pre-access, random, for-
cause, and post-event drug and alcohol tests by the FFD programs of 
reactor licensees, compared to long-term permanent employees at 
reactors.
    To clarify that the drug and alcohol testing requirements under 
Subpart K are not intended to incorporate all of the requirements in 
Subparts C [Granting and Maintaining Authorization], E [Collecting 
Specimens for Testing], F [Licensee Testing Facilities], and G 
[Laboratories Certified by the Department of Health and Human Services] 
of Part 26, but at the same time to ensure that the drug and alcohol

[[Page 17158]]

testing requirements of Subpart K are clear, the final rule clarifies 
the proposed rule by substantially expanding the description of the 
program requirements in Sec.  26.405. This section meets 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 26.405(a) requires Subpart K FFD programs to provide a 
means to deter and detect substance abuse. The FFD programs must 
include drug and alcohol testing that complies with the requirements of 
Sec.  26.405. The final rule clarifies that if a licensee or other 
entity complies with the requirements of Sec.  26.405 with respect to 
drug and alcohol testing, it is not required to meet the drug and 
alcohol testing requirements in the balance of Part 26.
    Section 26.405(b) specifies that if the licensee or other entity 
elects to impose random testing for drugs and alcohol on individuals 
who are constructing safety- or security-related SSCs, the random 
testing must meet the requirements specified in Sec.  26.405(b)(1) 
through (b)(4). Random testing must--
    (1) Be administered in a manner that provides reasonable assurance 
that individuals are unable to predict the time periods during which 
specimens will be collected.
    (2) Require individuals who are selected for random testing to 
report to the collection site as soon as reasonably practicable after 
notification, within the time period specified in the FFD program 
policy.
    (3) Ensure that all individuals in the population that is subject 
to testing on a given day have an equal probability of being selected 
and tested.
    (4) Provide that an individual completing a test is immediately 
eligible for another unannounced test.
    The random testing requirements in Subpart K are considerably more 
flexible than the random testing requirements in Sec.  26.31 [Drug and 
alcohol testing]. These requirements represent those elements of the 
random testing requirements under Sec.  26.31 that the NRC has 
concluded are necessary and appropriate for random testing of 
individuals identified in Sec.  26.4(f). They are intended to ensure 
randomness of selection for testing but also take into account the 
potentially difficult logistical problems associated with testing at 
such large and diverse locations. Licensees and other entities who 
adopt random testing will need, in particular, to develop a system for 
tracking individuals who are subject to the random testing program to 
identify when they are physically present and therefore available and 
eligible for testing. Licensees and other entities may also need to 
develop programs to ensure that subcontractors who operate 
independently also implement random testing programs, and it will be 
necessary for licensees and other entities to conduct audits of 
subcontractor programs. Section 26.405 provides licensees and other 
entities flexibility to design their random testing programs to address 
those problems. For example, the final rule in Subpart K does not 
specify that random testing must take place at times including 
weekends, backshifts, and holidays, and at various times during a shift 
because the construction schedule may not in all cases include work 
during those periods. The final rule also provides flexibility for 
licensees and other entities to determine the number of random tests to 
be performed annually and the probability that a member of the 
population that is subject to the FFD program will be selected for 
random testing. Because of the likely fluctuations in the numbers of 
reactor construction workers over the course of a year, the NRC cannot 
specify that the number of random tests performed annually must be 
equal to at least 50 percent of the population that is subject to the 
FFD program, as it does under Sec.  26.31. Finally, Subpart K provides 
licensees and other entities with the flexibility to adopt a fitness 
monitoring program under Sec.  26.406 to detect and deter substances 
abuse, rather than conducting random testing of individuals identified 
in Sec.  26.4(f).
    Section 26.405(c) specifies that the individuals who are 
constructing safety- and security-related SSCs shall be subject to drug 
and alcohol testing under the following four conditions: (1) Before 
assignment to construct safety-or security-related SSCs; (2) When the 
licensee or other entity has adequate cause, arising either in response 
to an individual's observed behavior or physical condition indicating 
possible substance abuse or after the licensee or other entity has 
received credible information that an individual is engaging in 
substance abuse, as defined in Sec.  26.5; (3) Following an accident in 
which the individual was involved. Post-accident testing should be 
conducted as soon as practical after an event involving a human error 
that was committed by an individual specified in Sec.  26.4(f), where 
the human error may have caused or contributed to the accident. The 
licensee or other entity is not required to test individuals who were 
affected by the event but whose actions likely did not cause or 
contribute to the event. Post-accident testing may involve more than 
one individual, and should be conducted if the event resulted in 
either: (i) A significant illness or personal injury to the individual 
to be tested or another individual, which within 4 hours after the 
event is recordable under the U.S. Department of Labor standards 
contained in 29 CFR 1904.7, and subsequent amendments, and results in 
death, days away from work, restricted work, transfer to another job, 
medical treatment beyond first aid, loss of consciousness, or other 
significant illness or injury as diagnosed by a physician or other 
licensed health care professional, even if it does not result in death, 
days away from work, restricted work or job transfer, medical treatment 
beyond first aid, or loss of consciousness; or (ii) Significant damage 
to any safety-related SSC of a facility that is required by the 
Commission's rules and regulations to be described in the site safety 
analysis report or preliminary or final safety analysis report. 
Finally, (4) followup testing should be conducted as part of a followup 
plan to verify an individual's continued abstinence from substance 
abuse.
    The conditions that can lead to drug and alcohol testing of an 
individual specified in Sec.  26.405(c)(1) through (c)(4) parallel 
generally the conditions listed in Sec.  26.31(c)(1) through (c)(4), 
with changes to reflect the different reasons for testing individuals 
identified in Sec.  26.4(f) under Subpart K and testing individuals at 
an operating nuclear reactor under Part 26. Thus, pre-assignment 
testing is limited to those individuals who will construct safety-or 
security-related SSCs. Because the NRC has concluded that there is no 
basis to distinguish between for-cause testing under Subpart K and for-
cause testing under Part 26 generally, the final rule in Subpart K and 
Sec.  26.31(c)(2) provide the same basis for for-cause testing. 
Similarly, Sec.  26.405(c)(3)(i) requires post-accident testing for 
exactly the same significant illness and personal injury situations as 
required under Sec.  26.31(c)(3)(i). However, the Subpart K post-
accident testing requirement that is triggered by property damage is 
limited to damage to any safety-or security-related SSC of a facility. 
The NRC recognizes that in the context of reactor plant construction, 
damage incidents can occur in a number of contexts that are not related 
to the impairment or potential sabotage bases for FFD programs under 
Subpart K (e.g., vehicle accidents, injuries to persons not working on 
safety-or security-related

[[Page 17159]]

SSCs). Followup testing under Sec.  26.405(c)(4) is defined exactly the 
same as followup testing under Sec.  26.31(c)(4). In the NRC's view, 
the purpose of the testing, to verify an individual's continued 
abstinence from substance abuse, is exactly the same in both cases. 
These requirements 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 26.405(d) specifies that, at a minimum, FFD programs under 
Subpart K shall test specimens for marijuana metabolite, cocaine 
metabolite, opiates (codeine, morphine, 6-acetylmorphine), amphetamines 
(amphetamine, methamphetamine), phencyclidine, adulterants, and alcohol 
at the cutoff levels specified in this part for testing the respective 
specimens, or comparable cutoff level, if alternate specimens, such as 
oral fluids, are used for drug screening. The list of substances for 
which testing must be conducted under Subpart K exactly parallels the 
list in Sec.  26.31(d)(1). The NRC considers this the minimum set of 
substances that an effective and adequate FFD program must include for 
both construction and operation. However, this section does not 
prohibit Subpart K programs from testing for additional drugs, 
consistent with the permission in Sec.  26.31(d)(1)(i)(A) for licensees 
and other entities who are implementing an FFD program for operating 
plants to test for additional drugs.
    The NRC is not prohibiting drug testing of specimens other than 
urine under Subpart K because it recognizes that there may be 
circumstances during construction where waiting for the results of 
urine drug tests could unacceptably delay the assignment of individuals 
to construct safety-or security-related SSCs. For example, for some 
construction activities or in some locations, licensees and other 
entities may rely on craftspersons from a local union hall and may not 
know in advance which specific individuals will be assigned to work on 
a particular day. If the union local does not offer pre-employment 
testing to its members, a licensee or other entity may elect to conduct 
an oral fluids drug screen, for example, that provides very rapid 
results, as long as the collection procedures and testing of oral 
fluids meet the criteria established in Sec.  26.405(e) by protecting 
the donor's privacy and the integrity of the specimen, and stringent 
quality controls are implemented to ensure that test results are valid 
and attributable to the correct individual. The NRC does not permit 
testing of oral fluids for drugs in FFD programs for other licensees 
and entities who are subject to Part 26 because the window of detection 
for marijuana use when testing for oral fluids is very short compared 
to the window of detection for marijuana use when testing urine 
specimens, and the NRC has a higher expectation that individuals will 
be trustworthy and reliable, as demonstrated by the avoidance of 
substance abuse, for the categories of individuals who are subject to 
Part 26 under the licensees' and entities' FFD program for operating 
plants. However, the NRC believes that oral fluids drug test results 
would be adequate to demonstrate that an individual who will be 
constructing safety- and security-related SSCs is not impaired that day 
from recent marijuana use or the other substances for which testing is 
required under Sec.  26.405(d). Permitting testing of alternate 
specimens under FFD programs for construction is consistent with Goal 3 
of the rulemaking to improve the effectiveness and efficiency of FFD 
programs. This permission is also consistent with Sec.  26.2(c) of the 
former rule and Sec.  26.3(e)(2) of the proposed rule that required 
drug and alcohol testing during construction, but did not specify the 
specimens to be tested.
    Section 26.405(d) also requires that urine specimens collected for 
drug testing must be subject to validity testing. Although Sec.  
26.405(d) specifies that urine specimens collected for drug testing 
must be subject to validity testing and does not further elaborate on 
the validity testing requirement, the NRC considers the regulatory 
detail found in Sec.  26.31 to provide useful guidance to licensees and 
other entities on the agency's expectations. However, Subpart K also 
provides flexibility to licensees and other entities with respect to 
this requirement by not specifying that they are required to meet the 
standards of Sec.  26.31. This section limits the requirement for 
validity testing to urine specimens because the final rule does not 
prohibit the use of specimens other than urine for drug testing under 
Subpart K and scientifically sound and legally defensible means of 
testing the validity of other types of specimens are not yet available 
for some alternate specimens. The requirements in this section 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 26.405(e) specifies that the specimen collection and drug 
and alcohol testing procedures of FFD programs under this subpart must 
protect the donor's privacy and the integrity of the specimen and 
implement stringent quality controls to ensure that test results are 
valid and attributable to the correct individual. At the licensee's or 
other entity's discretion, specimen collections and alcohol testing may 
be conducted at a local hospital or other facility in accordance with 
the specimen collection and alcohol testing requirements of 49 CFR Part 
40, ``Procedures for Department of Transportation Workplace Drug and 
Alcohol Testing Programs'' (65 FR 41944; August 9, 2001), and 
subsequent amendments. This section of the final rule is intended to 
provide licensees and other entities with additional flexibility about 
the locations where specimen collections and alcohol testing may be 
carried out and to help ensure that licensees will not be required, 
before construction can begin, to build specimen collection and alcohol 
testing facilities at sites that are distant from a current licensee's 
specimen collection facilities for drug and alcohol testing. This 
provision is consistent with the former and proposed rules, which also 
did not require the construction of specimen collection and alcohol 
testing facilities. This requirement meets 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 26.405(f) specifies that testing of urine specimens for 
drugs and validity, except validity screening and initial drug and 
validity tests that may be performed by licensee testing facilities, 
must be performed in a laboratory that is certified by HHS for that 
purpose, consistent with its standards and procedures for 
certification. This section requires that urine specimens collected for 
drug testing must be subject to initial validity and drug testing by 
the laboratory because means to attempt to adulterate or substitute a 
urine specimen are readily available, but does not apply these 
requirements to drug testing of other specimens for two reasons: (1) 
Some HHS-certified laboratories may not have the capability to perform 
tests of alternate specimens, such as oral fluids, or validity testing 
of alternate specimens, and (2) means for attempting to adulterate or 
substitute some alternative specimens (e.g., oral fluids) are not 
readily available. However, any initial drug test performed by a 
licensee or other entity subject to Subpart K, including tests of 
alternate specimens, must use an immunoassay that meets

[[Page 17160]]

the requirements of the Food and Drug Administration for commercial 
distribution. Urine specimens that yield positive, adulterated, 
substituted, or invalid initial validity or drug test results must be 
subject to confirmatory testing by an HHS-certified laboratory, except 
for invalid specimens that cannot be tested. Alternate specimens that 
yield positive drug test results must be subject to confirmatory 
testing by a laboratory that meets quality control requirements that 
are at least as stringent as the requirements those laboratories are 
required to meet for HHS-certification, such as the accreditation 
process of the American College of Pathologists. These requirements 
constitute the general administrative procedures that the NRC considers 
necessary for drug testing. Licensees and other entities would be 
allowed to conduct initial testing of urine or alternate specimens at a 
licensee testing facility, provided that the licensee testing facility 
staff members possess the necessary training and skills for the tasks 
assigned, the staff's qualifications are documented, and adequate 
quality controls for testing are implemented. However, in parallel with 
Sec.  26.31, Subpart K requires licensees and other entities to use 
only HHS-certified laboratories to perform drug testing of urine 
specimens, except if a licensee testing facility performs initial 
tests. This requirement is consistent with the former and proposed 
rules, which also required the use of only HHS-certified laboratories 
for testing urine specimens for drugs.
    Section 26.405(g) requires FFD programs under Subpart K to provide 
for an MRO review of positive, adulterated, substituted, and invalid 
drug and validity test results from confirmatory testing to determine 
whether the donor has violated the FFD policy, before reporting the 
results to the individual designated by the licensee or other entity to 
perform the suitability and fitness evaluations required under Sec.  
26.419. This requirement in Subpart K parallels the requirement in 
Sec.  26.169 [Reporting results] of the final rule. This requirement is 
an integral component of all Federally-mandated drug and alcohol 
testing programs, and required by the Department of Health and Human 
Services Mandatory Guidelines for Federal Workplace Drug Testing 
Programs. It is fully consistent with the former and proposed rules, 
which also followed the HHS Guidelines. This requirement meets 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 26.406 Fitness Monitoring
    Section 26.406(a) of Subpart K specifies that the requirements in 
Sec.  26.406 apply only if a licensee or other entity does not elect to 
subject the individuals specified in Sec.  26.4(f) to random testing 
for drugs and alcohol under Sec.  26.405(b). The NRC considers fitness 
monitoring of the individuals who are constructing safety- and 
security-related SSCs, as specified in Sec.  26.406, to be a means of 
detecting and deterring substance abuse that can function as 
effectively as random testing, given the logistical and other issues 
associated with random testing. Daily monitoring of individuals by 
trained personnel provides a constant source of information about their 
fitness, in contrast to the sporadic information provided by random 
testing during construction. Fitness monitoring can immediately detect 
situations where for-cause testing is required as well as provide a 
degree of deterrence comparable to the deterrence provided by the 
potential for a random test. Subpart K gives a licensee or other entity 
the flexibility to adopt either random testing under Sec.  26.405(b), 
or fitness monitoring under Sec.  26.406, or to implement both if the 
licensee or other entity chooses. Neither the former rule nor the 
proposed rule explicitly required fitness monitoring. However, both 
listed the performance objective standards section as one of the 
specific rule sections that an FFD program applicable to individuals 
involved with the construction of a new reactor plant was required to 
satisfy. Attainment of the performance objectives clearly implied that 
licensees and other entities would undertake a program to deter 
substance abuse and detect impairment. Section 26.406(b) described 
below contains a similar performance objective. The requirement for 
fitness monitoring in Sec.  26.406, if a licensee or other entity does 
not implement random testing of individuals who construct safety- and 
security-related SSCs, meets 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 26.406(b) establishes the performance objective for a 
fitness monitoring program. It requires licensees and other entities to 
implement a program to deter substance abuse and detect indications of 
possible use, sale, or possession of illegal drugs, use or possession 
of alcohol while constructing safety-or security-related SSCs, and 
impairment from any cause that if left unattended may result in a risk 
to public health and safety or the common defense and security. Both 
the former rule and the proposed rule included a cross-reference to the 
performance objectives standard. Thus, Sec.  26.406(b) of the final 
rule extends and clarifies the former and proposed rules.
    Section 26.406(c) requires licensees and other entities to 
establish procedures that fitness monitors shall follow in response to 
the indications and actions specified in Sec.  26.406(b) and to train 
the monitors to implement the program. Section 26.406(d) provides 
licensees and other entities with significant flexibility in 
determining the number of individuals required to monitor fitness and 
the procedures they are required to follow, commensurate with the 
potential risk. Development of fitness monitoring procedures and 
training of monitors in those procedures as well as the licensee's or 
other entity's requirements for program implementation will ensure that 
fitness monitors know what is meant by the requirement and are informed 
about the procedures for implementing this requirement.
    Section 26.406(d) requires licensees and other entities to ensure 
that the fitness of individuals who are constructing safety- and 
security-related SSCs is monitored effectively, commensurate with the 
potential risk to public health and safety and the common defense and 
security imposed by the construction activity. To achieve this 
objective, the rule requires licensees and other entities to consider 
the number and placement of monitors required, the necessary ratio of 
monitors to individuals specified in Sec.  26.4(f), and the frequency 
with which the individuals shall be monitored while performing each 
construction activity. The NRC does not expect that the individuals 
designated as fitness monitors will be dedicated solely to the task of 
fitness monitoring. Licensees and other entities may assign fitness 
monitoring responsibilities to first-line supervisors, security 
personnel, and others who are performing other activities for the 
licensee or other entity while monitoring the fitness of individuals 
who are constructing safety- and security-related SSCs. In determining 
the number of such monitors licensees and other entities may need to 
consider how to ensure that equipment, walls, and other temporary or 
permanent barriers do not interfere with the monitors' abilities to 
maintain visual contact with individuals performing the construction 
activity and whether monitoring will be conducted

[[Page 17161]]

continuously until completion of the construction activity, 
continuously only at critical points during a construction activity, 
once at the beginning of a shift and again after a lunch break, or at a 
frequency of every few hours on an irregular schedule. Licensees and 
other entities thus have considerable flexibility in designing their 
fitness monitoring program. However, they must ensure that the program 
meets the performance objective stated in Sec.  26.406(b). This 
requirement is consistent with the requirement in the former rule that 
FFD programs pertaining to licensees actively constructing nuclear 
power plants satisfy former Sec.  26.10(b), calling for measures for 
the early detection of persons who are not fit to perform activities 
within the scope of Part 26.
Section 26.407 Behavioral Observation
    Section 26.407 provides that individuals in Sec.  26.4(f) shall be 
subject to behavioral observation while they are constructing safety- 
and security-related SSCs at the location where a nuclear power plant 
is under construction and will be operated. However, if these 
individuals are subject to a fitness monitoring program under Sec.  
26.406, they are not required to be subject to behavioral observation 
under Sec.  26.407. Thus, this section provides licensees and other 
entities with the flexibility of subjecting the individuals specified 
in Sec.  26.4(f) to either fitness monitoring under Sec.  26.406 or to 
a combination of random drug and alcohol testing under Sec.  26.405(b) 
and behavioral observation under Sec.  26.407.
    Behavioral observation is an important component of an FFD program 
because it increases the likelihood that the licensees and other 
entities who are subject to the rule detect and appropriately address 
impairment and other adverse behaviors. The individuals listed under 
Sec.  26.4(e) will be trained in behavioral observation, because Sec.  
26.4(e) specifies that they shall be subject to an FFD program that 
meets all of the requirements of Part 26, except Subparts I and K, and 
such a program includes behavioral observation training. The 
individuals who will perform the behavioral observation are specified 
under Sec.  26.4(e) as including any individual whose duties for the 
licensees and other entities in Sec.  26.3(c) require him or her to 
perform the following activities at the location where the nuclear 
power plant will be constructed and operated: (1) Serves as a security 
officer under NRC requirements; (2) performs quality assurance 
activities, as specified in Appendix B to Part 50; (3) based on a 
designation under Sec.  26.406 by a licensee or other entity, monitors 
the fitness of the individuals specified in Sec.  26.4(f) (and thus has 
also received fitness monitoring training); (4) determines that 
inspections, tests, and analyses, or parts thereof, required under 10 
CFR Part 52 have been successfully completed; (5) supervises or manages 
the construction of safety-or security-related SSCs; or (6) directs, as 
defined in Sec.  26.5, or implements the licensee's or other entity's 
access authorization program. Because of their important oversight 
responsibilities, these individuals will be subject to an FFD program 
that meets the requirements for Subparts A through H, N, and O of 
Subpart 26. In addition to behavioral observation training, they will 
be subject to random testing at the 50 percent annual rate and a 
suitable inquiry/employment history check.
    Neither the former rule nor the proposed rule explicitly required 
behavioral observation. However, both listed the performance objective 
standards section as one of the specific rule sections that an FFD 
program applicable to individuals involved with the construction of a 
new reactor plant was required to satisfy, and attainment of the 
performance objectives clearly implied the use of behavioral 
observation. The final rule clarifies the requirement and adds 
flexibility. This requirement is consistent with the requirement in the 
former rule that FFD programs pertaining to licensees actively 
constructing nuclear power plants satisfy former Sec.  26.10(b), 
calling for measures for the early detection of persons who are not fit 
to perform activities within the scope of Part 26. Section 26.407 meets 
Goal 3, to improve the effectiveness and efficiency of FFD programs, 
and Goal 6 to improve clarity in the organization and language of the 
rule.
Section 26.409 Sanctions
    Section 26.409 requires FFD programs under Subpart K to establish 
sanctions for FFD policy violations that, at a minimum, prohibit the 
individuals specified in Sec.  26.4(f) from being assigned to or 
performing the duties specified in that section until the licensee or 
other entity determines that the individual's behavior does not pose a 
threat to public health and safety or the common defense and security. 
This section meets 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.
    The former rule provided for flexibility in the development and 
application of sanctions by specifying only that an FFD program 
applicable to individuals involved in the construction of a new reactor 
plant should make provision for the imposition of sanctions but did not 
otherwise specify the level or type of sanctions to be applied. The 
proposed rule, in Sec.  26.3(e)(3), included an identical provision, 
also without specifying the level or type of sanctions to be included 
in the FFD program. By adding explicit criteria for the types of FFD 
policy violations to which sanctions shall be applied, the final rule 
clarifies the sanctions provision of the former and proposed rules. 
This provision in the final rule adds flexibility because it does not 
require FFD programs under Subpart K to implement the minimum 
requirements for sanctions in Sec.  26.75 [Sanctions] or to apply the 
specific procedures for conducting a determination of fitness in Sec.  
26.189. Subpart K also allows licensees and other entities the 
flexibility to assign individuals who violate the FFD policy under 
Subpart K to other duties at the site not covered by the FFD program, 
depending on the licensee's assessment of the violation and the other 
duties involved.
Section 26.411 Protection of Information
    Section 26.411(a) requires FFD programs that collect personal 
information about an individual for the purpose of complying with 
Subpart K to establish and maintain a system of files and procedures to 
protect the personal information. It also requires FFD programs to 
maintain and use such records with the highest regard for individual 
privacy. This requirement exactly parallels the requirement in Sec.  
26.37 [Protection of information] of the final rule pertaining to 
protection of information under Part 26 generally. The NRC does not 
believe that any lesser standard of protection can be justified for 
personal information collected under Subpart K than is required for 
personal information collected under Part 26 generally. This section 
meets Goal 3 of this rulemaking to improve the effectiveness and 
efficiency of FFD programs, Goal 6 to improve clarity in the 
organization and language of the rule, and Goal 7 to protect the 
privacy of individuals.
    The final Subpart K rule parallels the requirements in the former 
rule and in the proposed rule. Both included a requirement that FFD 
programs applicable to individuals involved with the construction of a 
new reactor plant make provisions for the protection of information. 
Section 26.411(a) provides

[[Page 17162]]

additional detail about the level of protection (the highest regard for 
individual privacy) required of FFD programs that maintain and use 
records of personal information. Thus, this final rule provides 
additional clarity, compared to the former rule or the proposed rule, 
that the program should achieve the necessary protection through a 
system of files and procedures.
    Section 26.411(b) requires licensees and other entities to obtain a 
signed consent that authorizes the disclosure of the personal 
information collected and maintained under Subpart K before disclosing 
the personal information, except for disclosures to the individuals and 
entities specified in Sec.  26.37(b)(1) through (b)(6), (b)(8), and 
persons deciding matters under review in Sec.  26.413 [Review process]. 
These persons include the subject individual or his or her 
representative, when the individual has designated the representative 
in writing for specified FFD matters; assigned MROs and MRO staff; NRC 
representatives; appropriate law enforcement officials under court 
order; a licensee's or other entity's representatives who have a need 
to access the information to perform assigned duties, including 
determinations of fitness, audits of FFD programs, and human resources 
functions; the presiding officer in a judicial or administrative 
proceeding that the subject individual initiates; and other persons 
pursuant to court order. The NRC did not include a reference to Sec.  
26.37(b)(7) because it refers to persons deciding matters under another 
section of Part 26 that Subpart K does not include. Instead, this 
section adds a new reference to persons deciding matters under review 
in Sec.  26.413. The requirement to obtain permission to release the 
personal information to individuals who are not specified in Sec.  
26.37(b)(1) through (b)(6), (b)(8), and persons deciding matters under 
review in Sec.  26.413 is necessary because licensees have 
misinterpreted the former requirement as prohibiting them from 
releasing the personal information under any circumstances. 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 final rule 
includes the explicit permission for licensees and other entities to 
release personal information when an individual consents to the 
release, in writing. This requirement precisely parallels the 
requirement in Sec.  26.37, except for the differences noted, because 
the NRC does not believe that any different procedures for handling 
personal information can be justified for personal information 
collected under Subpart K than are required for personal information 
collected under Part 26 generally.
Section 26.413 Review Process
    Section 26.413 requires FFD programs under Subpart K to establish 
and implement procedures for the review of a determination that an 
individual listed in Sec.  26.4(f) has violated the FFD policy. The 
procedure must provide for an objective and impartial review of the 
facts related to the determination that the individual has violated the 
FFD policy. This requirement parallels the one in Sec.  26.39(a) of the 
final rule. Because the NRC recognizes that much of the construction 
workforce will be transient and rapidly changing, it is leaving 
licensees and other entities the flexibility to adopt the additional 
review procedures found in Sec.  26.39(b) through (e), but is not 
mandating their adoption by including them in the review process 
requirements in Sec.  26.413. This section meets 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.
    The final rule is more explicit than the former rule, which 
specified only that the FFD program for the reactor construction 
workforce should make provisions for appeals procedures. The proposed 
rule in Sec.  26.3(e)(3) similarly required FFD program for 
construction to make provisions for procedures for the objective and 
impartial review of authorization decisions. This final rule more 
clearly requires FFD programs under Subpart K to establish and 
implement procedures and more clearly specifies that the procedures are 
for the review of the facts related to the determination that an 
individual has violated the FFD policy. However, the basic requirement 
in this final rule is the same as that in the former rule and the 
proposed rule. The requirement for an objective and impartial review 
establishes the same criteria for the review as did the proposed rule, 
which also mandated an impartial and objective review.
Section 26.415 Audits
    Section 26.415 establishes audit requirements for Subpart K FFD 
programs. Section 26.415(a) requires licensees and other entities to 
ensure that audits are performed to assure the continuing effectiveness 
of the FFD program, including FFD program elements that C/Vs provide, 
and the FFD programs of C/Vs that are accepted by the licensee or other 
entity. This requirement parallels the audit requirement in Sec.  
26.41(a) of the final rule. The agency has not identified any 
circumstances relating to the reactor construction workforce that would 
support different auditing requirements for Subpart K FFD programs than 
for FFD programs under the other subparts of Part 26. The criterion to 
be applied for each audit program is that it must assure the continuing 
effectiveness of the FFD program. Although the former rule did not 
contain a requirement for audits of the FFD programs for construction, 
the proposed rule referred explicitly to Sec.  26.41 [Audits and 
corrective action] as one of the requirements to be complied with by 
licensees authorized to construct a nuclear power plant. Thus, Sec.  
26.415 extends and clarifies the requirement in the proposed rule, 
meets Goal 3 of this rulemaking to improve the effectiveness and 
efficiency of FFD programs, and satisfies Goal 6 to improve clarity in 
the organization and language of the rule.
    Section 26.415(b) requires each licensee and other entity who 
implements an FFD program under Subpart K to ensure that these programs 
are audited at a frequency that ensures their continuing effectiveness 
and that corrective actions are taken to resolve any problems 
identified. The section also provides that licensees and entities may 
conduct joint audits, or accept audits of C/Vs conducted by others, so 
long as the audit addresses the relevant services of the C/V. The NRC 
expects that in determining the frequency of audits, licensees and 
other entities will consider the frequency, nature, and severity of 
discovered problems, testing errors, personnel or procedural changes, 
previous audit findings, and lessons learned. The requirement is 
intended to promote performance-based rather than compliance-based 
audit activities. By allowing joint audits, the final rule creates 
additional flexibility for Subpart K FFD programs.
    Section 26.415(c) provides that licensees and other entities who 
implement FFD programs under Subpart K need not audit the HHS-certified 
laboratories or specimen collection and alcohol testing services that 
meet the requirements of 49 CFR Part 40, ``Procedures for Department of 
Transportation Workplace Drug and Alcohol Testing Programs'' (65 FR 
41944, August 9, 2001) upon which licensees and other entities may rely 
to meet the drug and alcohol testing requirements of Subpart K. Because 
the

[[Page 17163]]

DOT conducts audits of collection sites that the agency's grantees use, 
the NRC has concluded that audits of those sites when they are used by 
NRC licensees and other entities are unnecessary.
Section 26.417 Recordkeeping and Reporting
    Section 26.417(a) of the final rule provides that FFD programs 
shall ensure that records pertaining to the administration of the 
program, which may be stored and archived electronically, are 
maintained so that they are available for NRC inspection purposes and 
for any legal proceedings resulting from the administration of the 
program. This recordkeeping provision provides more extensive detail 
than the equivalent recordkeeping sections of the former rule or the 
proposed rule, both of which provided only that the FFD program for the 
reactor construction workforce should make provisions for 
recordkeeping. This final rule provides notice that records may be 
stored and archived electronically, which clarifies the requirement and 
provides flexibility to licensees and other entities. This rule also 
incorporates standard language pertaining to the availability of 
records for NRC inspection purposes and for any legal proceedings 
resulting from the administration of the program. These provisions are 
inherent to the NRC's recordkeeping requirements. While adding clarity, 
they do not significantly change the recordkeeping requirement from 
that in the former or proposed rule. Both the former rule and the 
proposed rule contained an explicit requirement for recordkeeping by 
the FFD program applicable to reactor construction workers. This 
section meets 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 26.417(b) requires licensees and other entities that 
implement FFD programs under Subpart K to make the reports described in 
Sec.  26.417(b)(1) and (b)(2). Section 26.417(b)(1) requires reports to 
the NRC Operations Center by telephone within 24 hours after the 
licensee or other entity discovers any intentional act that casts doubt 
on the integrity of the FFD program and any programmatic failure, 
degradation, or discovered vulnerability of the FFD program that may 
permit undetected drug or alcohol use or abuse by individuals who are 
subject to Subpart K. This provision also specifies that these events 
must be reported under Subpart K, rather than under the provisions of 
10 CFR 73.71 [Reporting of safeguards events]. Section 26.417(b)(2) 
requires annual program performance reports for the FFD program. The 
former rule contained detailed reporting requirements similar to those 
in the final rule. In addition, the NRC considers the reporting of acts 
that cast doubt on the integrity of the FFD program and any 
programmatic failure, degradation, or discovered vulnerability of the 
FFD program that may permit undetected drug or alcohol use or abuse by 
individuals subject to Subpart K, as well as annual program performance 
reports, to be clearly logical and necessary components of the program 
and outgrowths of the recordkeeping requirements.
Section 26.419 Suitability and Fitness Evaluations
    Section 26.419 requires licensees and other entities who implement 
FFD programs under Subpart K to develop, implement, and maintain 
procedures for evaluating whether to assign individuals to the duties 
specified in Sec.  26.4(f). These procedures must provide reasonable 
assurance that such individuals are fit to safely and competently 
perform their duties and are trustworthy and reliable, as demonstrated 
by the avoidance of substance abuse. This section provides flexibility 
for Subpart K programs to develop procedures for determining 
suitability. The requirement that licensees and other entities develop, 
implement, and maintain procedures for evaluating whether to assign 
individuals to the duties specified in Sec.  26.4(f) is necessary to 
enable licensees and other entities to implement Subpart K. These 
procedures will allow licensees, other entities, and the individuals 
who are subject to the FFD program to know who the Subpart K 
requirements cover. This section meets 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.
    Although neither the former rule nor the proposed rule contained an 
explicit requirement for suitability and fitness evaluations, each 
contained a cross-reference to the general performance objectives 
sections of their respective rules (Sec.  26.10 of the former rule and 
Sec.  26.23 of the proposed rule). Section 26.10 required the FFD 
programs applicable to reactor construction workers to provide 
reasonable assurance that personnel would perform their tasks in a 
reliable and trustworthy manner and that they are not under the 
influence of any substance, legal or illegal, or mentally or physically 
impaired from any cause, which in any way would affect their ability to 
safely and competently perform their duties. Section 26.23 of the 
proposed rule used language similar to that in this final rule, 
requiring FFD programs to provide reasonable assurance that individuals 
who are subject to Part 26 are trustworthy and reliable, as 
demonstrated by the avoidance of substance abuse, and to provide 
reasonable assurance that individuals who are subject to Part 26 are 
not under the influence of any substance, legal or illegal, or mentally 
or physically impaired from any cause, which in any way adversely 
impairs their ability to safely and competently perform their duties.

Subpart L--[Reserved]

Subpart M--[Reserved]

Subpart N--Recordkeeping and Reporting Requirements

    As a result of the reorganization of the proposed rule, the NRC has 
moved the provisions from Subpart J of the proposed rule to a new 
Subpart N of the final rule. The final rule includes minor 
clarifications of the language of the proposed rule that are discussed 
with respect to those sections. The NRC has also made more substantive 
changes to the proposed rule in Sec.  26.711(c) and (d). Otherwise, the 
provisions in this subpart have been adopted as proposed without 
change.
Section 26.709 Applicability
    The NRC has added Sec.  26.709 to the final rule to specify the 
licensees and other entities to whom the requirements of this subpart 
apply.
Section 26.711 General Provisions
    The NRC has added Sec.  26.711 to the final rule to define general 
requirements related to recordkeeping and reporting under Part 26.
    Section 26.711(a) of the final rule establishes a requirement that 
licensees and other entities must maintain records and submit certain 
reports to the NRC, consistent with Goal 6 of this rulemaking to 
improve clarity in the organization and language of the rule. In 
addition, this section requires that licensees and other entities 
retain the records required under this part for either the periods that 
are specified in Subpart N or for the life of the facility's license, 
certificate, or other regulatory approval, if no records retention 
requirement is specified. This general records retention requirement 
clarifies the language of the rule and is a standard administrative 
provision that is used in all other parts of 10 CFR that contain 
substantive requirements applicable to licensees and applicants, such 
as 10 CFR 50.71(c).

[[Page 17164]]

    The NRC has added Sec.  26.711(b) to the final rule to permit 
records to be stored and archived electronically if the method used to 
create the electronic records (1) provides an accurate representation 
of the original records, (2) prevents the alteration of any archived 
information and/or data once it has been committed to storage, and (3) 
allows easy retrieval and re-creation of the original records. This 
provision recognizes that most records are now stored electronically 
and must be protected to ensure the integrity of the data. The 
requirements are consistent with related requirements in the access 
authorization orders issued to nuclear power plant licensees dated 
January 7, 2003. Therefore, these requirements meet Goal 4 of this 
rulemaking to improve consistency between FFD requirements and access 
authorization requirements established in 10 CFR 73.56 [Personal access 
authorization requirements for nuclear power plants], 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.  
26.711(c). This provision requires licensees and other entities to 
inform individuals of the right to review and correct the records 
maintained about the individual under this part and imposes a 
requirement on licensees and other entities to ensure that the 
information they maintain and share with other licensees and entities 
is correct and complete. The NRC added this provision to provide 
further assurance that individuals who are subject to an FFD program 
under this part are not unjustly or inaccurately portrayed as having 
violated FFD requirements in any written documentation that licensees 
and other entities rely on when making authorization decisions. 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. This provision is also meets Goal 4 of this rulemaking to 
improve consistency between this rule 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.  26.711(d) to the final rule to require 
licensees and other entities to ensure that only correct and complete 
information about individuals is retained and shared. This provision 
specifies that licensees and other entities shall correct or augment 
shared information contained in the records if this information changes 
or new information is developed. Also, if the changed or new 
information has implications for adversely affecting an individual's 
eligibility for authorization, the final rule requires that the 
licensee or other entity who discovers the incorrect information or 
developed new information shall inform the reviewing official of the 
updated information. The NRC has added this provision 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. This provision also 
meets Goal 4 of this rulemaking to improve consistency between this 
rule and access authorization requirements established in 10 CFR 73.56, 
as supplemented by orders to nuclear power plant licensees dated 
January 7, 2003.
Section 26.713 Recordkeeping Requirements for Licensees and Other 
Entities
    Section 26.713 of the final rule amends former Sec.  26.71 
[Recordkeeping requirements]. Former Sec.  26.71(d), which established 
requirements for FFD program performance reports, is retained in Sec.  
26.717 [Fitness-for-duty program performance data], a separate section 
that focuses only on those reports. Section 26.713 retains but amends 
former Sec.  26.71(a) through (c) and adds other requirements that are 
interspersed throughout the former 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 by grouping recordkeeping 
requirements that apply to licensees and other entities in one section.
    Section 26.713(a) of the final rule requires licensees and other 
entities to retain certain records related to authorization 
decisionmaking for at least 5 years after an individual's authorization 
has been terminated or denied, or until the completion of all related 
legal proceedings, whichever is later. The agency has added the 
requirement to retain records until the completion of all related legal 
proceedings at the suggestion of stakeholders during the public 
meetings discussed in Section I.D. The stakeholders noted that some 
legal proceedings involving records of the type specified in the 
paragraph have continued longer than the 5 years that the former rule 
required these records to be retained and that adding a requirement in 
the final rule to retain the records until all legal proceedings are 
complete protects an individual's right to due process under the rule. 
This provision 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 and Goal 3 to improve the effectiveness and 
efficiency of FFD programs.
    Section 26.713(a)(1) amends former Sec.  26.71(a). Former Sec.  
26.71(a) required licensees to retain records of the inquiries that 
licensees conduct in granting unescorted access to an individual for 5 
years following the termination of such access authorizations. The 
final rule updates the terminology used in the former paragraph for 
consistency with the revised language used throughout the rule. For 
example, the paragraph refers to ``self-disclosures,'' ``employment 
histories,'' ``suitable inquiries,'' and ``granting authorization,'' 
but retains the intent of the former paragraph. The NRC has made the 
changes in terminology for the reasons discussed with respect to 
Sec. Sec.  26.61 [Self-disclosure and employment history] and 26.63 
[Suitable inquiry]. In addition, the agency has updated the former 
cross-reference to Sec.  26.27(a) to reflect the new organization of 
the rule.
    Section 26.713(a)(2) amends former Sec.  26.71(b). Former Sec.  
26.71(b) required licensees to retain records that are related to 
positive drug test results that the MRO has confirmed. The final rule 
revises the former requirement by mandating that licensees and other 
entities retain records related to any violation of the FFD policy, 
which includes confirmed positive drug and alcohol test results. This 
change ensures that licensees and other entities who may be considering 
granting authorization to an individual who has previously violated any 
aspect of an FFD policy can obtain these records for review as part of 
the authorization decisionmaking process specified in Sec.  26.69 
[Authorization with potentially disqualifying fitness-for-duty 
information].
    The NRC has added Sec.  26.713(a)(3) to the final rule to require 
licensees and other entities to retain records that are related to the 
granting and termination of an individual's authorization. This 
provision ensures that licensees and other entities who may be 
considering granting authorization to an individual under Subpart C 
[Granting and Maintaining Authorization] can determine which category 
of authorization requirements in Subpart C applies to the individual, 
based upon the length of time that has elapsed since the termination of 
the individual's last period of authorization and whether it was 
terminated favorably. The new section discusses the categories of 
authorization requirements with respect to Sec. Sec.  26.55 [Initial 
authorization], 26.57

[[Page 17165]]

[Authorization update], 26.59 [Authorization reinstatement], and 26.69.
    The NRC has added Sec.  26.713(a)(4) to the final rule to require 
licensees and other entities to retain records that are related to any 
determination of fitness that was conducted under Sec.  26.189 
[Determination of fitness]. The final rule, with respect to the 
proposed rule, clarifies that the records to be retained include any 
recommendations for treatment and followup testing plans. This 
provision ensures that licensees and other entities who may be 
considering granting authorization to an individual who has previously 
undergone a determination of fitness can obtain these records for 
review as part of the authorization decisionmaking process specified in 
Sec.  26.69. In addition, if an individual who is subject to followup 
testing and a treatment plan transfers to another FFD program, the 
reviewing official and SAE of the receiving FFD program, which takes 
responsibility for implementing the testing and treatment plans, are 
required to have access to this information under Sec.  26.69(e).
    Section 26.713(b)(1) and (b)(2) of the final rule requires 
licensees and other entities to retain records related to FFD training, 
examinations, audits, audit findings, and corrective actions for at 
least 3 years, or until the completion of all related legal 
proceedings, whichever is later. These paragraphs retain the 3-year 
recordkeeping requirements of the former rule in Sec. Sec.  26.21(b) 
and 26.22(c) for training records, and Sec.  26.80(c) for audit 
findings and corrective action records.
    Section 26.713(c) of the final rule amends former Sec.  26.71(c). 
Former Sec.  26.71(c) required licensees to retain records related to 
any individual who was made ineligible for authorization for 3 years or 
longer under former Sec.  26.27 [Management actions and sanctions to be 
imposed] until the Commission terminates each license under which the 
records were created. However, the final rule requires licensees and 
other entities to retain records concerning 5-year and permanent 
denials of authorization for 40 years or until, upon application, the 
NRC determines that the records are no longer needed. The requirement 
to retain records related to 5-year denials of authorization is 
consistent with the more stringent sanctions established in Sec.  
26.75(c), (d), and (e)(2), in which the NRC has eliminated the sanction 
of a 3-year denial of authorization, as discussed with respect to those 
paragraphs. The 40-year retention requirement is based on the longest 
expected working life of an individual, rather than on the period of 
the license. The termination of a license by the Commission does not 
mean that individuals whose authorizations were denied for 5 years or 
permanently denied under the licensee' FFD program would necessarily 
leave the industry. Requiring retention of the records pertaining to 
those individuals ensures that the records of the 5-year and permanent 
denials are available, should the individual seek authorization from 
another licensee or other entity. This amendment 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 and 
Goal 3 to improve the effectiveness and efficiency of FFD programs.
    Section 26.713(d) of the final rule replaces the recordkeeping 
requirement in former Sec.  26.20 [Written policy and procedures]. This 
paragraph requires licensees and other entities to retain superseded 
FFD policies and procedures for at least 5 years, or until completion 
of all legal proceedings related to an FFD violation that may have 
occurred under the policy and procedures, whichever is later. The NRC 
has increased the required period for retaining superseded materials 
from 3 to 5 years to ensure that the materials are available if 
subsequent licensees and other entities require the information in 
making a determination of fitness. The requirement to retain the policy 
and procedures related to any matter under legal challenge until the 
matter is resolved ensures that the materials remain available if an 
individual, the NRC, a licensee, or another entity who is subject to 
this rule require access to them in a legal or regulatory proceeding. 
This provision 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, and Goal 3 to improve the effectiveness and 
efficiency of FFD programs.
    Section 26.713(e) of the final rule amends the requirement in 
former Sec.  26.23(a) pertaining to the retention of written agreements 
for the provision of FFD program services. This provision requires 
licensees and other entities to retain the written agreement for the 
life of the agreement (as in the former rule), or until completion of 
all legal proceedings related to an FFD violation that involved the 
services, whichever is later. This requirement ensures that the 
materials remain available should an individual, the NRC, a licensee, 
or another entity who is subject to the rule require access to them in 
a legal or regulatory proceeding. This amendment 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, and 
Goal 3 to improve the effectiveness and efficiency of FFD programs.
    The NRC has added Sec.  26.713(f) to the final rule to require 
licensees and other entities to retain records related to the 
background investigations, credit and criminal history checks, and 
psychological assessments of FFD program personnel, conducted under 
Sec.  26.31(b)(1)(i), for the length of the individual's employment by 
or contractual relationship with the licensee or other entity, or until 
the completion of all related legal proceedings, whichever is later. 
This requirement is consistent with the last phrase of former Section 
2.6(c) in Appendix A to Part 26, which required licensee testing 
facilities to retain personnel files that include ``appropriate data to 
support determinations of honesty and integrity conducted in accordance 
with Section 2.3 of this appendix.'' The required period during which 
these records must be maintained is based on the NRC's need to have 
access to the records for inspection purposes and the potential need 
for the records to remain available if an individual, the NRC, a 
licensee, or another entity who is subject to this rule requires access 
to them in a legal or regulatory proceeding. However, the final rule 
establishes a new limit on the period during which the records must be 
retained in order to reduce the burden associated with storing such 
records indefinitely. This new provision 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, and Goal 3 to 
improve the effectiveness and efficiency of FFD programs.
    The NRC has added Sec.  26.713(g) to the final rule to require 
licensees and other entities to retain records of the certification, 
provided by a qualified forensic toxicologist, as required under Sec.  
26.31(d)(1)(i) and (d)(3)(iii)(C), of the scientific and technical 
suitability of any assays and cutoff levels used for drug testing that 
this part does not address. This provision requires the licensee or 
other entity to retain these records for the period of time during 
which the FFD program continues to test for drugs for which this part 
does not require testing, uses more stringent cutoff levels than those 
specified in this part, or until the completion of all related legal 
proceedings, whichever is later. This new requirement ensures that the 
NRC has access to the records for inspection purposes and that the

[[Page 17166]]

records remain available if an individual, the NRC, a licensee, or 
another entity who is subject to this rule requires access to them in a 
legal or regulatory proceeding. This provision 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, and Goal 3 to 
improve the effectiveness and efficiency of FFD programs.
Section 26.715 Recordkeeping Requirements for Collection Sites, 
Licensee Testing Facilities, and Laboratories Certified by The 
Department of Health and Human Services
    The NRC has added Sec.  26.715 to the final rule to group together 
in one section the recordkeeping requirements that apply to collection 
sites, licensee testing facilities, and HHS-certified laboratories.
    Section 26.715(a) of the final rule retains the requirement in 
former Section 2.7(n) in Appendix A to Part 26. This provision mandates 
that collection sites, HHS-certified laboratories and licensee testing 
facilities must maintain documentation of all aspects of the testing 
process for at least two years. The final rule includes collection 
sites within this provision because licensee testing facilities and 
collection sites may not be co-located, as was typically the case when 
the former rule was first published. This section retains the provision 
in former Section 2.7(n) that the two-year period may be extended upon 
written notification by the NRC or any licensee or other entity for 
whom services are being provided. The final rule also adds a 
requirement to retain the documentation until completion of all legal 
proceedings related to an FFD violation to ensure that the records 
remain available if an individual, the NRC, a licensee, or another 
entity who is subject to this rule requires access to them in a legal 
or regulatory proceeding. This change 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, and Goal 3 to 
improve the effectiveness and efficiency of FFD programs.
    The NRC has added Sec.  26.715(b)(1) through (b)(14) to the final 
rule to list in a single paragraph the documents that collection sites, 
licensee testing facilities, and HHS-certified laboratories must 
retain. Specifically, those documents include personnel files of 
individuals who are no longer working at a collection site, licensee 
testing facility, or HHS-certified laboratory; on chain-of-custody 
documents; quality assurance/quality control records; superseded 
procedures; all test data; test reports; records on performance 
testing; records on testing errors or unsatisfactory performance, and 
the investigation and correction of the errors or unsatisfactory 
performance; performance records on certification inspections; records 
on preventative maintenance; records on negative test results based on 
scientific insufficiency; computer-generated data, printed or 
electronic copies of computer-generated data; records of individuals 
accessing secured areas in licensee testing facilities and HHS-
certified laboratories; and records of EBT maintenance, inspection, and 
calibration. This listing of records to be retained comes from 
provisions of the former rule in Sec. Sec.  26.20 and 26.71(a) and 
Sections 2.7(a)(1), 2.7(f)(2), 2.7(g)(8), 2.7(n), 2.7(o)(1), 2.7(o)(3), 
2.8(e)(4), 2.9(g), and 3.1 of Appendix A to Part 26. The final rule 
groups them together in a single paragraph to make them easier to 
locate within the rule, consistent with Goal 6 of this rulemaking to 
improve clarity in the organization and language of the rule.
Section 26.717 Fitness-for-Duty Program Performance Data
    The NRC has added Sec.  26.717 to the final rule to amend the 
requirements in former Sec.  26.71(d) for collecting, compiling, and 
submitting FFD program performance data to reduce the burden on 
licensees and other entities and to make the reporting time consistent 
with the NRC's need for the information. Specifically, this paragraph 
requires licensees and other entities to submit program performance 
data to the NRC every 12 months, rather than every 6 months. The NRC 
has made the additional conforming changes described below to former 
Sec.  26.71 for consistency with other revisions to the rule.
    Section 26.717(a) of the final rule retains the requirement in 
former Sec.  26.71(d) that each FFD program subject to Part 26 must 
collect and compile FFD performance data.
    Section 26.717(b)(1) through (b)(9) of the final rule amends the 
second sentence of former Sec.  26.71(d). The provision specifies the 
FFD program performance data that a licensee or other entity must 
report, including the random testing rate, the drugs for which testing 
is conducted and their cutoff levels, workforce populations tested, 
numbers of tests administered and results, conditions under which the 
tests were performed, substances identified, number of subversion 
attempts by type, summary of management actions; and the information 
required under Sec.  26.203(e)(1) and (e)(2). With respect to the 
proposed rule, the final rule clarifies Sec.  26.717(b)(2) to be 
consistent with the changes the NRC has made to procedures for dilute 
specimens, as discussed with regard to Sec.  26.163(a)(2). This 
paragraph is identical to the requirements of the former provision with 
two exceptions: (1) the final rule requires reporting the number of 
subversion attempts by type, and (2) does not require a list of events 
reported during the reporting period.
    Concerning the first exception, the final rule adds a requirement 
for licensees and other entities to report the number of subversion 
attempts by type. This new requirement is necessary to enable the NRC 
to monitor the ongoing integrity and effectiveness of FFD programs in 
detecting subversion attempts, consistent with the NRC's heightened 
concern with this issue, as discussed with respect to Sec. Sec.  
26.31(d)(3)(i) and 26.75(b). Although this information is available to 
NRC inspection personnel at each site, it would be costly and an 
inefficient use of resources for inspectors to aggregate and report it 
annually. Under the former rule, licensees typically reported 
subversion attempts they detected under the requirement to summarize 
``events reported'' in former Sec.  26.71(d). Therefore, the NRC 
expects that the reporting requirement imposes minimal additional 
burden. The agency has added this requirement to meet Goal 3 of the 
rulemaking to improve the effectiveness and efficiency of FFD programs.
    Second, the final rule eliminates the former requirement to include 
the number of events reported to the NRC during the reporting period. 
The NRC eliminated the former reporting requirement because it has 
access to this information through other avenues and reporting it twice 
is unnecessary. Eliminating this requirement meets Goal 5 of the 
rulemaking to improve Part 26 by eliminating or modifying unnecessary 
requirements.
    The final rule also adds a requirement in Sec.  26.717(b)(9) that 
the FFD program performance data must include the information required 
under Sec.  26.203(e)(1) and (e)(2), which includes (1) a summary of 
all instances during the past calendar year when certain work hour 
controls were waived, and (2) a summary of corrective actions taken, 
resulting from the analysis of the data collected under Sec.  
26.203(e), respectively.
    Section 26.717(c) of the final rule amends the portions of former 
Sec.  26.71(d)

[[Page 17167]]

that required licensees and other entities to analyze the FFD program 
performance data semiannually. Instead, this provision requires 
licensees and other entities to analyze FFD program performance data 
annually and retains the requirement that actions must be taken to 
correct program weaknesses. NRC experience in reviewing FFD program 
performance reports since it first promulgated the rule has shown that 
reporting twice per year is unnecessary to ensure the continuing 
effectiveness of FFD programs. Therefore, the final rule relaxes the 
semiannual analysis and reporting requirement, consistent with Goal 5 
of the rulemaking to improve Part 26 by eliminating or modifying 
unnecessary requirements. Furthermore, the provision requires licensees 
and other entities to retain for 3 years records of the data, analysis, 
and corrective actions taken, which is the same as the former 
requirement in Sec.  26.71(d). However, the rule adds a requirement to 
retain the documentation until completion of any legal proceedings 
related to an FFD violation to ensure that the records remain available 
if an individual, the NRC, a licensee, or another entity who is subject 
to this rule requires access to them in a legal or regulatory 
proceeding. The agency has added this requirement to meet Goal 3 of the 
rulemaking to improve the effectiveness and efficiency of FFD programs.
    Section 26.717(d) of the final rule retains the last sentence of 
former Sec.  26.71(d). The former provision required any licensee who 
temporarily suspends an individual's authorization or takes 
administrative actions on the basis of an initial positive marijuana or 
cocaine drug test result (under the provisions of former Sec.  
26.24(d)) to report the results in the annual summary by processing 
stage (i.e., initial testing at the licensee testing facility, testing 
at the HHS-certified laboratory, MRO determination). The final rule 
continues to require that the report include the number of 
administrative actions taken against individuals for the reporting 
period. However, the agency has eliminated the term ``temporarily 
suspend'' from the provision and replaced it with the term 
``administratively withdraw authorization,'' in response to stakeholder 
requests at the public meetings discussed in Section I.D. The 
stakeholders noted that an individual is either authorized to perform 
job duties under Part 26 or not, and that the concept of suspending an 
individual's authorization is conceptually inconsistent. The NRC 
concurred with this observation and, therefore, has eliminated the 
inaccurate phrase from the final rule. The agency made this change to 
meet Goal 6 of the rulemaking relating to improving clarity in the 
language of the rule.
    Section 26.717(e) of the final rule amends portions of former Sec.  
26.71(d). It requires licensees and other entities to submit the annual 
summary to the NRC by March 1 of the following year, rather than the 
former requirement to provide a semiannual summary within 60 days of 
the end of each six-month reporting period. The agency made this change 
for consistency with the requirement in Sec.  26.717(c) to submit the 
report annually, as discussed with respect to that paragraph, and to 
meet Goal 5 of the rulemaking to improve Part 26 by eliminating or 
modifying unnecessary requirements.
    Section 26.717(f) of the final rule retains the requirement in 
former Sec.  26.71(d) that program performance data may be submitted in 
a consolidated report as long as the data are reported separately for 
each site.
    The NRC has added Sec.  26.717(g) to the final rule to require that 
C/Vs who maintain an approved drug and alcohol testing program must 
submit to the NRC the same program performance data that are required 
from licensees and other entities who are subject to the final rule, 
either directly or via the licensee or other entity to whom the C/V 
provides services, ensuring that duplicate reports are not provided to 
the NRC. This requirement is necessary because the final rule applies 
directly to C/Vs who maintain licensee-approved programs, rather than 
applying only to licensees under the former rule, as discussed with 
respect to Sec.  26.3(d). The agency has added this requirement to meet 
Goal 3 of the rulemaking to improve the effectiveness and efficiency of 
FFD programs.
Section 26.719 Reporting Requirements
    The NRC has added Sec.  26.719 to the final rule to replace former 
Sec.  26.73 and combines it with former Section 2.8(e)(4), (e)(5), and 
(e)(6) in Appendix A to Part 26. The final rule groups into one section 
reporting requirements that are interspersed throughout the former rule 
to meet Goal 6 of this rulemaking to improve clarity in the 
organization and language of the rule.
    The NRC added Sec.  26.719(a) to the final rule to introduce the 
section, consistent with Goal 6 of this rulemaking to improve clarity 
in the organization and language of the rule. This provision specifies 
the categories of significant events that licensees and other entities 
must report to the NRC (i.e., significant violations of the FFD policy, 
significant FFD program failures, and errors in drug and alcohol 
testing). The second sentence of the paragraph retains the requirement 
in former Sec.  26.73(c) that significant events must be reported under 
this section, rather than under the provisions of 10 CFR 73.71 
[Reporting of safeguards events].
    Section 26.719(b) of the final rule reorganizes and amends former 
Sec.  26.73(a)(1), (a)(2), and (b), consistent with Goal 6 of this 
rulemaking to improve clarity in the organization and language of the 
rule. Paragraph 26.719(b) retains the requirement in former Sec.  
26.73(b) that notifications of events must be made to the NRC 
Operations Center within 24 hours of their discovery. However, the 
final rule presents this requirement at the beginning of the paragraph 
to clarify that it applies to all of the events that are listed in the 
paragraph.
    Section 26.719(b)(1) amends former Sec.  26.73(a)(1). The former 
provision required licensees to report the sale, use, or possession of 
illegal drugs within a protected area. The final rule adds a 
requirement for licensees and other entities also to report the 
consumption or presence of alcohol in a protected area. This change is 
consistent with the NRC's increased concern with the adverse effects of 
alcohol abuse on safe performance, as discussed with respect to Sec.  
26.75(e). The agency has made the change for consistency with the 
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 illegal drugs and alcohol, as discussed with 
respect to that paragraph. This change also meets Goal 3 of the 
rulemaking to improve the effectiveness and efficiency of FFD programs, 
as the consumption or presence of alcohol in a protected area 
constitutes a significant programmatic failure in achieving this 
performance objective.
    Section 26.719(b)(2) amends former Sec.  26.73(a)(2). Former Sec.  
26.73(a)(2) required licensees to report any acts by licensed operators 
and supervisory personnel involving the sale, use, or possession of a 
controlled substance; resulting in confirmed positive test results for 
such persons; involving the use of alcohol within the protected area; 
or resulting in a determination of unfitness for scheduled work because 
of the consumption of alcohol. The final rule expands the former 
reporting requirement to include SSNM transporter personnel and FFD 
program personnel. The NRC has made this

[[Page 17168]]

change to ensure that it is informed of events involving these 
individuals because of the important roles they play in assuring public 
health and safety and the common defense and security, in the former 
case, and the integrity of the FFD program, in the latter. The agency's 
change meets Goal 3 of the rulemaking to improve the effectiveness and 
efficiency of FFD programs.
    Section 26.719(b)(2)(i) retains former Sec.  26.73(a)(2)(i). The 
provision requires licensees and other entities to report any acts by 
the subject individuals that involve the use, sale, or possession of a 
controlled substance.
    Section 26.719(b)(2)(ii) combines and amends former Sec.  
26.73(a)(2)(ii) and (a)(2)(iv). The former section required licensees 
and other entities to report any confirmed positive test results for 
such persons and any acts by the subject individuals that result in a 
determination of unfitness for scheduled work because of the 
consumption of alcohol, respectively. The final rule amends the former 
requirements by mandating that licensees and other entities report any 
acts by the subject individuals that result in a determination that the 
individual has violated the licensee's or other entity's FFD policy 
(including subversion as defined in Sec.  26.5 [Definitions]). This 
change is consistent with two other changes to the rule: (1) the 
addition of validity testing requirements to the final rule, as 
discussed with respect to Sec.  26.31(d)(3)(i), and (2) the addition of 
new requirements in Subpart D [Management Actions and Sanctions to be 
Imposed] that impose the same sanctions for confirmed positive alcohol 
test results as those required for confirmed positive drug test 
results, as discussed with respect to Sec.  26.75(e). Therefore, the 
final rule requires licensees and other entities to report confirmed 
positive drug test results, any other acts to subvert or attempt to 
subvert the testing process, and confirmed positive alcohol test 
results for these individuals.
    Section 26.719(b)(2)(iii) amends former Sec.  26.73(a)(2)(iii). The 
former provision required licensees and other entities to report any 
events involving the consumption of alcohol within the protected area 
by the subject individuals. The final rule adds the requirement to 
report any acts involving the consumption of alcohol while performing 
the duties that require these individuals to be subject to this part. 
This change is consistent with the addition of SSNM transporters and 
FFD program personnel to this paragraph, as discussed with respect to 
Sec.  26.719(b)(2), because transporter and FFD program personnel 
typically do not work within a protected area. However, the NRC 
maintains an interest in the consumption of alcohol by the individuals 
listed in Sec.  26.719(b)(2) while they are performing the duties 
specified in Sec.  26.4 at any location.
    Section 26.719(b)(3) establishes a new requirement for licensees 
and other entities to report any intentional act that casts doubt on 
the integrity of the FFD program. Because of the wide array of possible 
acts that could fit this definition and be of concern to the NRC, the 
final rule does not specify the acts that licensees and other entities 
must report. However, such intentional acts may include, but are not 
limited to:
    (1) Notifying individuals, outside of the FFD program's normal 
notification procedures, that they will be selected for random or 
followup testing on a particular date or at a specific time so that the 
individuals have sufficient time available to attempt to mask drug use 
by, for example, obtaining a substitute urine specimen or an 
adulterant, drinking large amounts of liquid in order to provide a 
dilute urine specimen, or leaving the site to avoid testing;
    (2) Attempting to divert or tamper with urine specimens that are 
being prepared for transfer to a licensee testing facility or HHS-
certified laboratory by stealing the specimens, substituting specimens 
in the package, or altering the specimens' custody-and-control 
documentation;
    (3) Attempting to tamper with testing instruments so that they 
provide false negative test results;
    (4) Collusion by collection site personnel, an MRO, or MRO staff 
with an individual who is subject to testing to alter the individual's 
test results; and
    (5) Attempts by information technology personnel to alter the 
software that the FFD program uses to randomly select individuals for 
testing to ensure that specific individuals are not selected.
    The intentional acts that this final rule requires licensees and 
other entities to report could involve any aspect of the operations of 
the FFD program and the testing process.
    The final rule adds this reporting requirement because of other 
changes to the final rule that permit licensees and other entities to 
rely on other Part 26 programs to a much greater extent than under the 
former requirement. The final rule permits licensees and other entities 
to rely on testing performed by another Part 26 program, FFD training, 
other programs' suitable inquiries and determinations of fitness, and 
audits. Therefore, intentional acts that cast doubt on the integrity of 
one FFD program may also indirectly affect the integrity and 
effectiveness of other FFD programs. The NRC requires reporting of 
these acts in order to monitor their impacts and ensure that other FFD 
programs that may be affected are informed of the problem so that they 
can take corrective actions, if necessary. The agency has made this 
change to meet Goal 3 of the rulemaking to improve the effectiveness 
and efficiency of FFD programs.
    The NRC has added Sec.  26.719(b)(4) to the final rule to require 
licensees and other entities to report any programmatic failure, 
degradation, or discovered vulnerability of an FFD program that may 
permit undetected drug or alcohol use or abuse by individuals within a 
protected area, or by individuals who are assigned to perform the 
duties that require them to be subject to the FFD program. In Item 10.1 
of NUREG-1385, ``Fitness for Duty in the Nuclear Power Industry: 
Responses to Implementation Questions,'' the NRC emphasized that it 
expects licensees to exercise prudent judgment in determining whether 
to report unusual situations and that the significant events the 
licensees must report are not limited to the examples contained in the 
rule. However, the NRC understands that licensees have not reported 
many significant events that would be useful for formulating public 
policy or that the NRC should respond to in a timely fashion because 
licensee management decided not to do so unless the rule specifically 
required this reporting. Therefore, this final rule adds Sec.  
26.719(b)(4) to clarify that significant events and programmatic 
failures are not limited to those listed in Sec.  26.719(b), but 
include any programmatic failures or weaknesses that potentially could 
permit substance abuse to be undetected. The agency has made this 
change to meet Goal 3 of the rulemaking to improve the effectiveness 
and efficiency of FFD programs.
    Section 26.719(c) of the final rule reorganizes and amends former 
requirements for reporting errors in drug and alcohol testing, 
consistent with Goal 6 of the rulemaking to improve clarity in the 
organizational of the rule. The final rule retains the former 
requirements for licensees and other entities to investigate and take 
corrective actions for drug and alcohol testing errors in Sec. Sec.  
26.137(f) and 26.167(g) for licensee testing facilities and HHS-
certified laboratories, respectively, but moves the reporting 
requirements to this section.

[[Page 17169]]

    Section 26.719(c)(1) updates the portion of former Sec.  2.8(e)(4) 
in Appendix A to Part 26 that mandated that licensees and other 
entities must report within 30 days of completing an investigation any 
testing errors or unsatisfactory performance in performance testing at 
either a licensee testing facility or an HHS-certified laboratory. This 
section amends the former requirement by specifying that the report of 
the incident must describe the corrective actions taken or planned. 
Although licensees and other entities have consistently described 
corrective actions in such reports, the agency has added this new 
requirement to meet Goal 6 of the rulemaking to improve clarity in the 
language of the rule.
    In addition, this section adds cross-references to other sections 
of the final rule that define processes that may also result in the 
identification of errors, including the reviews required under Sec.  
26.39 [Review process for fitness-for-duty policy violations] and Sec.  
26.185 [Determining a fitness-for-duty policy violation]. In the 
original rule, the NRC intended that testing or process errors 
discovered in any part of the program, including these review 
processes, would be investigated as an unsatisfactory performance of a 
test. 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. Therefore, this change, 
consistent with Goal 6 of the rulemaking to improve clarity in the 
language of the rule, clarifies that the requirement to investigate, 
correct, and report errors is not limited only to errors identified 
through blind performance testing in licensee testing facilities and 
HHS-certified laboratories but also applies to errors identified 
through any means.
    Section 26.719(c)(2) amends the portion of former Section 2.8(e)(5) 
in Appendix A to Part 26 that required licensees to promptly notify the 
NRC if a false positive error occurs on a blind performance test 
sample. This section replaces the former requirement that the report 
must be made ``promptly'' with one to report the false positive error 
within 24 hours of the discovery. The agency has made this change as a 
result of the public meetings discussed in Section I.D, during which 
the stakeholders noted that the term ``promptly'' is vague. Therefore, 
the final rule clarifies the former requirement by establishing a 24-
hour time limit for the notification, consistent with Goal 6 of this 
rulemaking to improve clarity in the language of the rule.
    The rule establishes a 24-hour time limit because false positive 
test results would cause licensees and other entities to impose 
sanctions on individuals who have not, in fact, abused drugs and/or 
attempted to subvert the testing process. HHS may decertify a 
laboratory as a result of false positive test results. The 24-hour time 
limit ensures that the NRC can quickly notify HHS of the problem so 
that HHS may initiate the applicable steps required under its 
guidelines for such circumstances. In addition, the NRC may use the 
information to inform other licensees and entities who rely on the same 
HHS-certified laboratory of the problem, so that they may determine 
whether to require the laboratory or a second laboratory to retest any 
specimens a licensee or other entity has submitted. The agency has 
established the 24-hour time limit to meet Goal 7 of the rulemaking to 
protect the privacy and other rights (including due process) of 
individuals who are subject to Part 26.
    The NRC has added Sec.  26.719(c)(3) to the final rule to require 
licensees and other entities to report any false negative errors 
identified through quality assurance checks of validity screening tests 
within 24 hours of the discovery if the licensee or other entity uses 
these tests for validity screening at a licensee testing facility. This 
reporting requirement ensures that the NRC is aware of any testing 
failures, so that other Part 26 programs that rely on the tests may be 
informed of the error and stop using them until the cause of the error 
is identified and the problem is resolved. Continued use of unreliable 
tests may permit attempts to subvert the testing process to go 
undetected, with the result that individuals who have engaged in a 
subversion attempt may be granted or allowed to maintain authorization. 
The agency has added this requirement to meet Goal 3 of the rulemaking 
to improve the effectiveness and efficiency of FFD programs.
    The final rule does not require licensees and other entities to 
report false positive errors identified through quality assurance 
checks of validity screening tests for two reasons. First, other 
provisions of the rule prohibit licensees and other entities from 
taking management actions or imposing sanctions on individuals on the 
basis of validity screening test results, as discussed with respect to 
Sec.  26.75(h). Second, donors are protected from the adverse 
consequences of false positive validity screening test results because 
these specimens are forwarded to an HHS-certified laboratory for 
initial and confirmatory testing, if required, before a licensee or 
other entity is permitted to act, as discussed with respect to Sec.  
26.137(c). Therefore, reporting of false positive errors is unnecessary 
to protect the interests of either donors or the public.
    The NRC has added Sec.  26.719(d) to the final rule to require 
licensees and other entities to document, trend, and correct 
nonreportable FFD issues that identify programmatic weaknesses under 
the licensee's or other entity's corrective action program. The final 
rule includes this requirement because some licensees have not 
documented, trended, or corrected programmatic weaknesses, while others 
have created separate systems, with the result that corrective actions 
for FFD program weaknesses have not been timely or effective. 
Therefore, the final rule adds these requirements for consistency with 
Criterion XVI in Appendix B to 10 CFR Part 50 [Domestic licensing of 
production and utilization facilities] and to meet Goal 3 of this 
rulemaking to improve the effectiveness and efficiency of FFD programs.
    This section also requires licensees and other entities to 
document, trend, and correct any programmatic weaknesses in a manner 
that protects individuals' privacy. For example, this section prohibits 
licensees and other entities from documenting a single confirmed 
positive, adulterated, substituted, or invalid drug test result in the 
corrective action program, because such documentation, along with other 
cues in the work environment, may permit any individual who has access 
to the corrective action system easily to identify the donor. However, 
under the final rule, the NRC expects licensees and other entities to 
document, trend, analyze, and take corrective actions for an increase 
in the rate of confirmed positive, adulterated, substituted, or invalid 
test results in the aggregate if the licensee or other entity 
determines that the increasing trend indicates programmatic weaknesses 
rather than improved effectiveness of the FFD program or some other 
factor. The agency has added the requirement to protect individuals' 
privacy within the corrective action program 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.

Subpart O--Inspections, Violations, and Penalties

    As a result of the reorganization of the proposed rule, the 
provisions contained in Subpart K of the proposed rule have been moved 
to Subpart O of the final rule. The NRC received no public comment on 
Subpart O, and the final

[[Page 17170]]

rule adopts the provisions in Subpart O as proposed without change.
    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], consistent with Goal 6 of the rulemaking to 
improve clarity in the organization of the rule, by grouping related 
sections into one subpart. Section 26.821 [Inspections] retains the 
requirements in former Sec.  2626.70. Section 26.823 [Violations] 
retains the requirements in former Sec.  2626.90. Section 26.825 
[Criminal penalties] retains the requirements in former Sec.  2626.91.
    The NRC has deleted Appendix A to Part 26 ``Guidelines for Drug and 
Alcohol Testing Programs'' in its entirety and has incorporated its 
requirements into Subparts E [Collecting Specimens for Testing], F 
[Licensee Testing Facilities], and G [Laboratories Certified by the 
Department of Health and Human Services].

VII. Availability of Documents

    The NRC is making the documents identified below available to 
interested persons through one or more of the following methods as 
indicated.
    Public Document Room (PDR). The NRC Public Document Room is located 
at 11555 Rockville Pike, Rockville, Maryland.
    Regulations.gov Web site (Web). The federal government's rulemaking 
portal is located at http://www.regulations.gov/.
    NRC's Public Electronic Reading Room (EPDR). The NRC's electronic 
public reading room is located at http://www.nrc.gov/reading-rm.html.
    The NRC staff contact. David Diec, Mail Stop O-12D3, Washington, DC 
20555-0001, 301-415-2834.

----------------------------------------------------------------------------------------------------------------
               Document                    PDR                Web                      EPDR            NRC staff
----------------------------------------------------------------------------------------------------------------
Part 26 Derivation and Distribution            X   ........................  ML080570421............          X
 Tables.
Comments received....................          X   NRC--2002--0002.........  .......................          X
Analysis of comments received (when            X   ........................  X......................          X
 available).
Regulatory Analysis..................          X   ........................  ML080580135............          X
----------------------------------------------------------------------------------------------------------------

VIII. Criminal Penalties

    For the purpose of Section 223 of the Atomic Energy Act (AEA), the 
Commission is amending 10 CFR Part 26 under one or more of Sections 
161b, 161i, or 161o of the AEA. Willful violations of the rule are 
subject to criminal enforcement.

IX. Agreement State Compatibility

    Under the ``Policy Statement on Adequacy and Compatibility of 
Agreement State Programs'' approved by the Commission on June 30, 1997, 
and published in the Federal Register on September 3, 1997 (62 FR 
46517), this rule is classified as Compatibility Category ``NRC.'' 
Compatibility is not required for Category ``NRC'' regulations. The NRC 
program elements in this category are those that relate directly to 
areas of regulation reserved to the NRC by the Atomic Energy Act of 
1954, as amended (AEA), or the provisions of Title 10 of the Code of 
Federal Regulations. Although an Agreement State may not adopt program 
elements reserved to the NRC, it may wish to inform its licensees of 
certain requirements via a mechanism that is consistent with the 
particular States's administrative procedure laws but does not confer 
regulatory authority on the State.

X. Plain Language

    The Presidential memorandum dated June 1, 1998, entitled ``Plain 
Language in Government Writing'' directed that the Government's writing 
be in plain language. This memorandum was published on June 10, 1998 
(63 FR 31883). In complying with this directive, editorial changes have 
been made in these revisions to improve the organization and 
readability of the former language of the paragraphs being revised.

XI. Voluntary Consensus Standards

    The National Technology Transfer and Advancement Act of 1995, Pub. 
L. 104-113, requires that Federal agencies use technical standards 
developed or adopted by voluntary consensus standards bodies unless the 
use of such a standard is inconsistent with applicable law or otherwise 
impractical. There are no consensus standards regarding the methods for 
performing drug and alcohol testing, fatigue assessments, or other 
aspects of FFD programs, that would apply to the requirements imposed 
by this rule, with the exception of short-term work hour limits for 
licensed operators, senior operators, and the shift technical advisor. 
The NRC notes the inclusion of these limits in a 1988 American Nuclear 
Society standard on administrative controls and quality assurance for 
the operational phase of nuclear power plants, ANSI/ANS-3.2-1998.
    The NRC does not believe that this standard is sufficient, as it 
does not apply to other categories of workers who would be subject to 
the provisions of this rule, such as maintenance, health physics, 
chemistry, fire brigade, and security force personnel. Additionally, 
the standard is insufficient because it does not provide the 
comprehensive fatigue management approach that this rule does, and 
lacks provisions to mitigate long-term fatigue, provide a process for 
self-declarations of fatigue by workers, and provide for rest breaks.
    Further, the standard does not adequately mitigate short-term 
fatigue, because it does not restrict deviations from the short-term 
limits to only those unique instances necessary for the safety and 
security of the plant. The standard only requires that exceptions be 
minimized and that they be approved by the plant manager or designee. 
The provisions in the standard are identical to those currently 
incorporated as requirements in some nuclear power plants' technical 
specifications. Section IV.D explains that enforcement of the technical 
specification requirements is complicated by the fact that the language 
is largely advisory, and key terms have not been defined, with the 
result that the requirements have been interpreted inconsistently.
    For the reasons noted above, the ANS standard cannot be used in 
lieu of the provisions of this rule to meet the objective of 
comprehensive fatigue management.

XII. Finding of No Significant Environmental Impact: Environmental 
Assessment

    The Commission has determined under the National Environmental 
Policy Act of 1969, as amended, and the Commission's regulations in 
Subpart A of 10 CFR Part 51, that this rule is not a major Federal 
action significantly affecting the quality of the human environment 
and, therefore, an environmental impact statement is not required. The 
basis for this determination reads as follows:

[[Page 17171]]

    The final rule amends the NRC's requirements for FFD programs which 
are contained in 10 CFR Part 26 to address the following needs: (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 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 10 CFR Part 26 by eliminating or modifying unnecessary 
requirements; (6) improve clarity in the organization and language of 
the rule; and (7) protect the privacy rights and other rights 
(including due process) of individuals who are subject to 10 CFR Part 
26.
    It also grants, in part, a December 30, 1993, petition for 
rulemaking (PRM-26-1) from Virginia Electric and Power Company (now 
Dominion Virginia Power) which requested a relaxation in required audit 
frequencies, and a petition for rulemaking (PRM-26-2), dated December 
28, 1999, from Barry Quigley, by establishing clear and enforceable 
requirements concerning the management of worker fatigue. In addition, 
the rule continues to apply to all personnel with unescorted access to 
the protected area of a nuclear power plant, consistent with the 
Commission's denial (SRM-SECY-04-0229) of an exemption request by IBEW 
Local 1245 dated March 13, 1990, and renewed on January 26 and December 
6, 1993.
    This rule does not significantly increase the probability or 
consequences of an accident. No changes have been made in the types or 
quantities of radiological effluents that may be released offsite, and 
there is no significant increase in public or occupational radiation 
exposure since there is no change to facility operations that could 
create a new or affect a previously analyzed accident or release path.
    With regard to non-radiological impacts, no changes have been made 
to non-radiological plant effluents and there are no changes in 
activities that would adversely affect the environment. Therefore, 
there are no significant non-radiological impacts associated with this 
action.
    The primary alternative to this action is the no action 
alternative. The no action alternative would result in continued 
inconsistencies between FFD and access authorization requirements, 
continued difficulties in implementation of the regulation due to the 
current organization of the rule, continued use of less current 
technologies and advances in testing and a continued lack of a 
comprehensive fatigue management program. The no action alternative 
would provide little or no safety, risk, or environmental benefit.
    No outside agencies or persons were consulted, or outside sources 
used or relied upon, in the preparation of this environmental 
assessment. The NRC received no comments on this environmental 
assessment.
    The determination of this environmental assessment is that there 
will be no significant environmental impact from this action.

XIII. Paperwork Reduction Act Statement

    The final rule contains new or amended information collection 
requirements that are subject to the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501 et seq.). These requirements were approved by the 
Office of Management and Budget, approval number 3150-0146.
    The burden to the public for these information collections is 
estimated to average 1.5 hours per response, including the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing the 
information collection. Send comments on any aspect of these 
information collections, including suggestions for reducing the burden, 
to the Records and FOIA/Privacy Services Branch (T-5 F52), U.S. Nuclear 
Regulatory Commission, Washington DC 20555-0001, or by Internet 
electronic mail to [email protected]; and to the Desk Officer, 
Office of Information and Regulatory Affairs, NEOB-10202, (3150-0146), 
Office of Management and Budget, Washington, DC 20503.

Public Protection Notification

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

XIV. Regulatory Analysis

    The NRC has prepared a final Regulatory Analysis on this 
regulation. The final regulatory analysis was prepared under the NRC's 
Regulatory Analysis Guidelines (RA Guidelines), NUREG/BR-0058, Revision 
4, dated September 2004. The Regulatory Analysis consists of three 
parts. First, an aggregate analysis of the entire rule was performed. 
Second, a screening review for disaggregation was performed to identify 
any individual provisions that could impose costs disproportionate to 
the benefits attributable to each provision. Finally, a separate 
analysis of the rule's provisions addressing worker fatigue was 
performed. A description of each of these three elements is discussed 
below. Single copies may be obtained from the contact listed above 
under the FOR FURTHER INFORMATION CONTACT heading.

A. Aggregate Analysis

    Consistent with the RA Guidelines, an aggregate analysis of the 
entire rulemaking was performed. The provisions of the rule relating to 
drug and alcohol testing (and other general FFD program requirements) 
are estimated to result in net present value savings to industry of 
$129 million-$204 million (using 7 percent and 3 percent real discount 
rates), consisting of $2 million in one-time costs and $10 million in 
annual net savings. The worker fatigue portions of the final rule are 
estimated to cost industry $439 million--$685 million net present value 
(using the 7 percent and 3 percent real discount rates, respectively), 
consisting of $12 million in one-time costs and $32 million in annual 
net costs. The net present value of the entire rule, including both the 
worker fatigue and drug and alcohol testing portions, is estimated to 
be a cost to industry of $310 million--$481 million (using 7 percent 
and 3 percent real discount rates), which consists of $14 million in 
one-time costs and $22 million in annual costs. In addition, the rule 
is estimated to be a cost to the NRC of $665,000--$1,025,000 net 
present value (using 7 percent and 3 percent real discount rates), 
consisting of $28,000 in one-time costs and $47,000 in annual net 
costs.
    The NRC concludes that the costs of the rule are justified in view 
of the qualitative benefits evaluated in Section 4.1.2 of the 
Regulatory Analysis. The basic analysis measures the incremental 
impacts of the rule relative to a baseline that assumes full licensee 
compliance

[[Page 17172]]

with existing NRC requirements, including current regulations and any 
relevant orders or enforcement discretion. The aggregate analysis is 
contained in Section 4.1 of the regulatory analysis.

B. Screening Review for Disaggregation

    The regulatory analysis also discusses the screening review for 
disaggregation performed by the staff. The analysis was performed 
consistent with Section 4.3.2 of the RA Guidelines to determine if 
there are provisions whose costs are disproportionate to the benefits 
and whose inclusion in the aggregate analysis could obscure their 
impact, but also responds to the Commission's direction in SRM-01-0134 
dated July 23, 2001, that, ``If there is a reasonable indication that a 
change imposes costs disproportionate to the safety benefit 
attributable to that change, as part of the final rule package the 
Commission will perform an analysis of that change in addition to the 
aggregate analysis of the entire rulemaking to determine whether this 
change should be aggregated with the other change for the purposes of 
the backfit analysis. That analysis will need to show that the 
individual change is integral to achieving the purpose of the rule, has 
costs that are justified in view of the benefits that would be provided 
or qualifies for one of the exceptions in 10 CFR Sec.  50.109(a)(4).'' 
These results are described in Sections 4.1.4.1 and 4.4.2 of the 
regulatory analysis.

C. Dissaggregation of Worker Fatigue Provisions

    Section 4.1.4.2 of the Regulatory Analysis summarizes the division 
of costs and savings of the fatigue management portions of the rule, in 
comparison with the rest of the rule. The worker fatigue portions of 
the rule are estimated to cost industry $439 million--$685 million net 
present value (using the 7 percent and 3 percent real discount rates, 
respectively), consisting of $12 million in one-time costs and $32 
million in annual net costs. The NRC considers fatigue management to be 
an integral and necessary aspect of FFD. Fatigue was considered to be 
part of FFD under former Sec.  26.10(a) and Sec.  26.20(a)(2). However, 
the NRC included a summary of the costs associated with the fatigue 
management requirements in the aggregate as a courtesy to stakeholders 
in Section 4.1.4.2 of the Regulatory Analysis.

XV. Regulatory Flexibility Act Certification

    As required by the Regulatory Flexibility Act, as amended, 5 U.S.C. 
605(b), the Commission certifies that this rule will not have a 
significant economic impact on a substantial number of small entities. 
This rule affects only licensees authorized to operate nuclear power 
reactors; licensees authorized to possess, use, or transport formula 
quantities of SSNM; corporations who obtain certificates of compliance 
or approved compliance plans under Part 76 involving formula quantities 
of SSNM; combined license holders; holders of construction permits; 
combined license and construction permit holders and combined license 
and construction permit applicants with authorization to construct; and 
C/Vs who implement FFD programs or program elements, to the extent that 
licensees and other entities rely upon those C/V FFD programs or 
program elements to meet the requirements of Part 26. Those above do 
not fall within the scope of the definition of ``small entities'' set 
forth in the Regulatory Flexibility Act, or the Size Standards 
established by the Nuclear Regulatory Commission (10 CFR 2.810).

XVI. Backfit Analysis

    The rule constitutes backfitting as defined in 10 CFR 50.109(a)(1). 
The NRC has performed a backfit analysis, as described in Sec.  
50.109(c) [which applies to power reactors], Sec.  70.76(b) [which 
applies to formula quantity strategic special nuclear material 
licensees], and Sec.  76.76(b) [which applies to gaseous diffusion 
plants], consistent with the NRC's Regulatory Analysis Guidelines (RA 
Guidelines) in NUREG/BR-0058, Revision 4, dated September 2004. The 
Backfit Analysis is included in the Regulatory Analysis.

A. Consideration of Fuel Fabrication Facilities and Gaseous Diffusion 
Plants

    The backfit provision of 10 CFR 70.76 applies to currently licensed 
fuel fabrication facilities. Although gas centrifuge facilities are 
licensed under Part 70, these facilities have not been considered in 
the analysis because NRC has not granted authorization to possess 
formula quantities of SSNM at these facilities. These facilities have 
been considered in the aggregate backfit analysis. The planned mixed-
oxide fuel fabrication facility also would be licensed under Part 70, 
but has not yet submitted a Part 26 program description. Therefore, the 
consideration of the costs to the mixed-oxide fuel fabrication facility 
in the regulatory analysis is sufficient for consideration of the 
impacts to that facility. Although the backfit provision of 10 CFR 
76.76 applies to gaseous diffusion plants, there are no backfit impacts 
because the gaseous diffusion plants certified by the NRC are not 
currently authorized to possess formula quantities of strategic special 
nuclear material.

B. Aggregate Backfit Analysis

    The NRC performed an aggregate backfit analysis of all backfits 
consistent with Section 4.3.2 of the RA Guidelines. Because the changes 
associated with the rule are interrelated and deal with a single 
subject area (FFD), the NRC followed its ordinary practice of assessing 
the backfitting implications in an aggregate manner, consistent with 
the RA Guidelines. The aggregate analysis is provided in Section 4.4.1 
of the Part 26 Regulatory Analysis. The aggregate analysis also 
includes a list of all changes that constitute backfits, in Exhibits 4-
14 and 4-15 of the analysis. Exhibit 4-16 of the analysis also includes 
a list of all changes that were evaluated for potential cost 
implications, but were determined to not constitute backfits, as well 
as a list of the reasons those changes were determined to not 
constitute backfits. In addition, the NRC prepared a supplemental 
backfit analysis for the requirements in Subpart K of Part 26. A 
summary of the results of the aggregate analysis follows.
    The NRC determined the backfitting is justified under Sec.  
50.109(a)(3) and Sec.  70.76(a)(3) because: (1) There is a substantial 
increase in the overall level of protection afforded for the public 
health and safety or the common defense and security to be derived from 
the backfitting; and (2) the costs of implementation and the annual 
costs are justified in view of this increase. The estimated cost of 
implementation would be $14 million and the annual net costs would be 
$42 million, resulting in a net present value cost of $582 million-$911 
million (using 7 percent and 3 percent real discount rates, 
respectively).
    In determining that the substantial increase standard is met, the 
NRC considered safety benefits qualitatively. In this qualitative 
consideration, the NRC determined that the FFD rule, considered in the 
aggregate, constitutes a substantial increase in protection to public 
health and safety by addressing the following six key areas that have 
been identified as posing recurring and, in some cases, significant 
problems with respect to the effectiveness, integrity, and efficiency 
of FFD programs at nuclear facilities.
    1. Subversion of the detection/testing process;

[[Page 17173]]

    2. Regulatory efficiency between 10 CFR Part 26 and other related 
Federal rules and guidelines;
    3. Ineffective/unnecessary FFD requirements;
    4. Ambiguous or imprecise regulatory language in 10 CFR Part 26;
    5. Technical developments; and
    6. FFD program integrity and protection of individual rights.
    In addition to the six areas above, the NRC noted in its analysis a 
significant qualitative benefit in the management of worker fatigue for 
key personnel at nuclear power plants.

C. Screening Review for Disaggregation

    The NRC also performed a screening review, consistent with Section 
4.3.2 of the RA Guidelines, to determine if there are provisions 
constituting backfits whose costs are disproportionate to the benefits 
and whose inclusion in the aggregate analysis could obscure their 
impact. The NRC identified 17 backfits with reasonable indications that 
the costs associated with the backfit may be disproportional to the 
safety benefit attributable to the change. The NRC determined that all 
of the 17 backfits were necessary to meet the objectives of the rule. 
Therefore, the staff did not disaggregate any of those individual 
provisions and perform a separate backfit analysis for each provision. 
A detailed discussion of the screening review, including the reasons 
why each of the 17 backfits were determined to be necessary to meet the 
objectives of the rule is described in Section 4.4.2 of the Regulatory 
Analysis.

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    Copies of publicly available reference items are available for 
inspection and/or copying for a fee in the NRC Public Document Room, 
One White Flint North, 11555 Rockville Pike, Room O-F21, Rockville, MD 
20852-2738. Copyrighted materials may be viewed at the NRC Public 
Document Room, but may not be copied.

List of Subjects in 10 CFR Part 26

    Alcohol abuse, Alcohol testing, Appeals, Chemical testing, Drug 
abuse, Drug testing, Employee assistance programs, Fitness for duty, 
Management actions, Nuclear power reactors, Protection of information, 
Reporting and recordkeeping requirements.


0
For the reasons set out in the preamble and under the authority of the 
Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 
1974, as amended; and 5 U.S.C. 552 and 553; the NRC is revising 10 CFR 
Part 26.
0
1. 10 CFR Part 26 is revised to read as follows:

PART 26--FITNESS FOR DUTY PROGRAMS

Subpart A--Administrative Provisions
Sec.
26.1 Purpose.
26.3 Scope.
26.4 FFD program applicability to categories of individuals.
26.5 Definitions.
26.7 Interpretations.
26.8 Information collection requirements: OMB approval.
26.9 Specific exemptions.
26.11 Communications.
Subpart B--Program Elements
26.21 Fitness-for-duty program.
26.23 Performance objectives.
26.25 [Reserved]
26.27 Written policy and procedures.
26.29 Training.
26.31 Drug and alcohol testing.
26.33 Behavioral observation.
26.35 Employee assistance programs.
26.37 Protection of information.
26.39 Review process for fitness-for-duty policy violations.
26.41 Audits and corrective action.
Subpart C--Granting and Maintaining Authorization
26.51 Applicability.
26.53 General provisions.
26.55 Initial authorization.
26.57 Authorization update.
26.59 Authorization reinstatement.
26.61 Self-disclosure and employment history.
26.63 Suitable inquiry.
26.65 Pre-access drug and alcohol testing.
26.67 Random drug and alcohol testing of individuals who have 
applied for authorization.
26.69 Authorization with potentially disqualifying fitness-for-duty 
information.
26.71 Maintaining authorization.
Subpart D--Management Actions and Sanctions To Be Imposed
26.73 Applicability.
26.75 Sanctions.
26.77 Management actions regarding possible impairment.
Subpart E--Collecting Specimens for Testing
26.81 Purpose and applicability.
26.83 Specimens to be collected.
26.85 Collector qualifications and responsibilities.
26.87 Collection sites.
26.89 Preparing to collect specimens for testing.
26.91 Acceptable devices for conducting initial and confirmatory 
tests for alcohol and methods of use.
26.93 Preparing for alcohol testing.
26.95 Conducting an initial test for alcohol using a breath 
specimen.
26.97 Conducting an initial test for alcohol using a specimen of 
oral fluids.
26.99 Determining the need for a confirmatory test for alcohol.
26.101 Conducting a confirmatory test for alcohol.
26.103 Determining a confirmed positive test result for alcohol.
26.105 Preparing for urine collection.
26.107 Collecting a urine specimen.
26.109 Urine specimen quantity.
26.111 Checking the acceptability of the urine specimen.
26.113 Splitting the urine specimen.
26.115 Collecting a urine specimen under direct observation.
26.117 Preparing urine specimens for storage and shipping.
26.119 Determining ``shy'' bladder.
Subpart F--Licensee Testing Facilities
26.121 Purpose.
26.123 Testing facility capabilities.
26.125 Licensee testing facility personnel.
26.127 Procedures.
26.129 Assuring specimen security, chain of custody, and 
preservation.
26.131 Cutoff levels for validity screening and initial validity 
tests.
26.133 Cutoff levels for drugs and drug metabolites.
26.135 Split specimens.
26.137 Quality assurance and quality control.

[[Page 17177]]

26.139 Reporting initial validity and drug test results.
Subpart G--Laboratories Certified by the Department of Health and Human 
Services
26.151 Purpose.
26.153 Using certified laboratories for testing urine specimens.
26.155 Laboratory personnel.
26.157 Procedures.
26.159 Assuring specimen security, chain of custody, and 
preservation.
26.161 Cutoff levels for validity testing.
26.163 Cutoff levels for drugs and drug metabolites.
26.165 Testing split specimens and retesting single specimens.
26.167 Quality assurance and quality control.
26.168 Blind performance testing.
26.169 Reporting results.
Subpart H--Determining Fitness-for-Duty Policy Violations and 
Determining Fitness
26.181 Purpose.
26.183 Medical review officer.
26.185 Determining a fitness-for-duty policy violation.
26.187 Substance abuse expert.
26.189 Determination of fitness.
Subpart I--Managing Fatigue.
26.201 Applicability.
26.203 General provisions.
26.205 Work hours.
26.207 Waivers and exceptions.
26.209 Self-declarations.
26.211 Fatigue assessments.
Subpart J--[Reserved]
Subpart K--FFD Programs for Construction
26.401 General.
26.403 Written policy and procedures.
26.405 Drug and alcohol testing.
26.406 Fitness monitoring.
26.407 Behavioral observation.
26.409 Sanctions.
26.411 Protection of information.
26.413 Review process.
26.415 Audits.
26.417 Recordkeeping and reporting.
26.419 Suitability and fitness evaluations.
Subpart L--[Reserved]
Subpart M--[Reserved]
Subpart N--Recordkeeping and Reporting Requirements
26.709 Applicability.
26.711 General provisions.
26.713 Recordkeeping requirements for licensees and other entities.


Sec.  26.715  Recordkeeping requirements for collection sites, licensee 
testing facilities, and laboratories certified by the Department of 
Health and Human Services.


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


Sec.  26.719  Reporting requirements.

Subpart O--Inspections, Violations, and Penalties


Sec.  26.821  Inspections.


Sec.  26.823  Violations.


Sec.  26.825  Criminal penalties.

    Authority: Secs. 53, 81, 103, 104, 107, 161, 68 Stat. 930, 935, 
936, 937, 948, as amended, sec. 1701, 106 Stat. 2951, 2952, 2953 (42 
U.S.C. 2073, 2111, 2112, 2133, 2134, 2137, 2201, 2297f); secs. 201, 
202, 206, 88 Stat. 1242, 1244, 1246, as amended (42 U.S.C. 5841, 
5842, 5846).

Subpart A--Administrative Provisions


Sec.  26.1  Purpose.

    This part prescribes requirements and standards for the 
establishment, implementation, and maintenance of fitness-for-duty 
(FFD) programs.


Sec.  26.3  Scope.

    (a) Licensees who are authorized to operate a nuclear power reactor 
under 10 CFR 50.57, and holders of a combined license under 10 CFR Part 
52 after the Commission has made the finding under 10 CFR 52.103(g) 
shall comply with the requirements of this part, except for subpart K 
of this part. Licensees who receive their authorization to operate a 
nuclear power reactor under 10 CFR 50.57 after the date of publication 
of this final rule in the Federal Register and holders of a combined 
license under 10 CFR Part 52 after the Commission has made the finding 
under 10 CFR 52.103(g) shall implement the FFD program before the 
receipt of special nuclear material in the form of fuel assemblies.
    (b) Licensees who are authorized to possess, use, or transport 
formula quantities of strategic special nuclear material (SSNM) under 
Part 70 of this chapter, and any corporation, firm, partnership, 
limited liability company, association, or other organization who 
obtains a certificate of compliance or an approved compliance plan 
under Part 76 of this chapter, only if the entity elects to engage in 
activities involving formula quantities of SSNM shall comply with the 
requirements of this part, except for subparts I and K of this part.
    (c) Before the receipt of special nuclear material in the form of 
fuel assemblies, the following licensees and other entities shall 
comply with the requirements of this part, except for subpart I of this 
part; and, no later than the receipt of special nuclear material in the 
form of fuel assemblies, the following licensees and other entities 
shall comply with the requirements of this part:
    (1) Combined license applicants (under Part 52 of this chapter) 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 structures, systems, and components (SSCs) under the 
limited work authorization;
    (2) Combined license holders (under Part 52 of this chapter) before 
the Commission has made the finding under Sec.  52.103(g);
    (3) Construction permit applicants (under Part 50 of this chapter) 
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;
    (4) Construction permit holders (under Part 50 of this chapter); 
and
    (5) 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.
    (d) Contractor/vendors (C/Vs) who implement FFD programs or program 
elements, to the extent that the licensees and other entities specified 
in paragraphs (a) through (c) of this section rely on those C/V FFD 
programs or program elements to meet the requirements of this part, 
shall comply with the requirements of this part.
    (e) This part does not apply to either spent fuel storage facility 
licensees or non-power reactor licensees who possess, use, or transport 
formula quantities of irradiated SSNM.


Sec.  26.4  FFD program applicability to categories of individuals.

    (a) All persons who are granted unescorted access to nuclear power 
reactor protected areas by the licensees in Sec.  26.3(a) and, as 
applicable, (c) and perform the following duties shall be subject to an 
FFD program that meets all of the requirements of this part, except 
subpart K of this part:
    (1) Operating or onsite directing of the operation of systems and 
components that a risk-informed evaluation process has shown to be 
significant to public health and safety;
    (2) Performing health physics or chemistry duties required as a 
member of the onsite emergency response organization minimum shift 
complement;
    (3) Performing the duties of a fire brigade member who is 
responsible for understanding the effects of fire and fire suppressants 
on safe shutdown capability;
    (4) Performing maintenance or onsite directing of the maintenance 
of SSCs that a risk-informed evaluation process

[[Page 17178]]

has shown to be significant to public health and safety; and
    (5) Performing security duties as an armed security force officer, 
alarm station operator, response team leader, or watchperson, 
hereinafter referred to as security personnel.
    (b) All persons who are granted unescorted access to nuclear power 
reactor protected areas by the licensees in Sec.  26.3(a) and, as 
applicable, (c) and who do not perform the duties described in 
paragraph (a) of this section shall be subject to an FFD program that 
meets all of the requirements of this part, except Sec. Sec.  26.205 
through 26.209 and subpart K of this part.
    (c) All persons who are required by a licensee in Sec.  26.3(a) 
and, as applicable, (c) to physically report to the licensee's 
Technical Support Center or Emergency Operations Facility by licensee 
emergency plans and procedures shall be subject to an FFD program that 
meets all of the requirement of this part, except Sec. Sec.  26.205 
through 26.209 and subpart K of this part.
    (d) Any individual whose duties for the licensees and other 
entities in Sec.  26.3(b) require him or her to have the following 
types of access or perform the following activities shall be subject to 
an FFD program that meets all of the requirements of this part, except 
subparts I and K of this part:
    (1) All persons who are granted unescorted access to Category IA 
material;
    (2) All persons who create or have access to procedures or records 
for safeguarding SSNM;
    (3) All persons who measure Category IA material;
    (4) All persons who transport or escort Category IA material; and
    (5) All persons who guard Category IA material.
    (e) When construction activities begin, any individual whose duties 
for the licensees and other entities in Sec.  26.3(c) require him or 
her to have the following types of access or perform the following 
activities at the location where the nuclear power plant will be 
constructed and operated shall be subject to an FFD program that meets 
all of the requirements of this part, except subparts I and K of this 
part:
    (1) Serves as security personnel required by the NRC, 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;
    (2) Performs quality assurance, quality control, or quality 
verification activities related to safety- or security-related 
construction activities;
    (3) Based on a designation under Sec.  26.406 by a licensee or 
other entity, monitors the fitness of the individuals specified in 
paragraph (f) of this section;
    (4) Witnesses or determines inspections, tests, and analyses 
certification required under Part 52 of this chapter;
    (5) Supervises or manages the construction of safety- or security-
related SSCs; or
    (6) Directs, as defined in Sec.  26.5, or implements the access 
authorization program, including--
    (i) Having access to the information used by the licensee or other 
entity to make access authorization determinations, including 
information stored in electronic format;
    (ii) Making access authorization determinations;
    (iii) Issuing entry-control picture badges in accordance with 
access authorization determinations;
    (iv) Conducting background investigations or psychological 
assessments used by the licensee or other entity to make access 
authorization determinations, except that 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;
    (v) Adjudicating reviews or appeals of access authorization 
determinations;
    (vi) Auditing the access authorization program; or
    (vii) Performing any of the activities or having any of the duties 
listed in paragraph (e)(6) of this section for any C/V upon whom the 
licensee's or other entity's access authorization program will rely.
    (f) Any individual who is constructing or directing the 
construction of safety- or security-related SSCs shall be subject to an 
FFD program that meets the requirements of subpart K of this part, 
unless the licensee or other entity subjects these individuals to an 
FFD program that meets all of the requirements of this part, except for 
subparts I and K of this part.
    (g) All FFD program personnel who are involved in the day-to-day 
operations of the program, as defined by the procedures of the 
licensees and other entities in Sec.  26.3(a) through (c), and, as 
applicable, (d), and whose duties require them to have the following 
types of access or perform the following activities shall be subject to 
an FFD program that meets all of the requirements of this part, except 
subparts I and K of this part, and, at the licensee's or other entity's 
discretion, subpart C of this part:
    (1) All persons who 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;
    (2) All persons who make determinations of fitness;
    (3) All persons who make authorization decisions;
    (4) All persons involved in selecting or notifying individuals for 
testing; and
    (5) All persons involved in the collection or onsite testing of 
specimens.
    (h) Individuals who have applied for authorization to have the 
types of access or perform the activities described in paragraphs (a) 
through (d) of this section shall be subject to Sec. Sec.  26.31(c)(1), 
26.35(b), 26.37, 26.39, and the applicable requirements of subparts C, 
and E through H of this part.
    (i) The following individuals are not subject to an FFD program 
under this part:
    (1) Individuals who are not employed by a licensee or other entity 
in this part, who do not routinely provide FFD program services to a 
licensee or other entity in this part, and whose normal workplace is 
not at the licensee's or other entity's facility, but who may be called 
on to provide an FFD program service, including, but not limited to, 
collecting specimens for drug and alcohol testing, performing 
behavioral observation, or providing input to a determination of 
fitness. Such individuals may include, but are not limited to, 
hospital, employee assistance program (EAP) or substance abuse 
treatment facility personnel, or other medical professionals;
    (2) NRC employees, law enforcement personnel, or offsite emergency 
fire and medical response personnel while responding on site;
    (3) SSNM transporter personnel who are subject to U.S. Department 
of Transportation drug and alcohol FFD programs that require random 
testing for drugs and alcohol; and
    (4) The FFD program personnel of a program that is regulated by 
another Federal agency or State on which a licensee or other entity 
relies to meet the requirements of this part, as

[[Page 17179]]

permitted under Sec. Sec.  26.4(j), 26.31(b)(2), and 26.405(e), 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's 
facility.
    (j) Individuals who are subject to this part and who are also 
subject to a program regulated by another Federal agency or State need 
be covered by only those elements of an FFD program that are not 
included in the Federal agency or State program, as long as all of the 
following conditions are met:
    (1) The individuals are subject to pre-access (or pre-employment), 
random, for-cause, and post-event testing for the drugs and drug 
metabolites specified in Sec.  26.31(d)(1) at or below the cutoff 
levels specified in Sec.  26.163(a)(1) for initial drug testing and in 
Sec.  26.163(b)(1) for confirmatory drug testing;
    (2) The individuals are subject to pre-access (or pre-employment), 
random, for-cause, and post-event testing for alcohol at or below the 
cutoff levels specified in Sec.  26.103(a) and breath specimens are 
subject to confirmatory testing, if required, with an EBT that meets 
the requirements specified in Sec.  26.91;
    (3) Urine specimens are tested for validity and the presence of 
drugs and drug metabolites at a laboratory certified by the Department 
of Health and Human Services (HHS);
    (4) Training is provided to address the knowledge and abilities 
(KAs) listed in Sec.  26.29(a)(1) through (a)(10); and
    (5) Provisions are made to ensure that the testing agency or 
organization notifies the licensee or other entity granting 
authorization of any FFD policy violation.


Sec.  26.5  Definitions.

    Acute fatigue means fatigue from causes (e.g., restricted sleep, 
sustained wakefulness, task demands) occurring within the past 24 
hours.
    Adulterated specimen means a urine specimen that has been altered, 
as evidenced by test results showing either a substance that is not a 
normal constituent of urine or showing an abnormal concentration of an 
endogenous substance.
    Alertness means the ability to remain awake and sustain attention.
    Aliquot means a portion of a specimen that is used for testing. It 
is taken as a sample representing the whole specimen.
    Analytical run means the process of testing a group of urine 
specimens for validity or for the presence of drugs and/or drug 
metabolites. For the purposes of defining the periods within which 
performance testing must be conducted by any licensee testing facility 
or HHS-certified laboratory that continuously processes specimens, an 
analytical run is defined as no more than an 8-hour period. For a 
facility that analyzes specimens in batches, an analytical run is 
defined as a group of specimens that are handled and tested together.
    Authorization means that a licensee or other entity in Sec.  26.3 
has determined that an individual has met the requirements of this part 
to be granted or maintain the types of access or perform the duties 
specified in Sec.  26.4(a) through (e), and, at the licensee's or other 
entity's discretion, Sec.  26.4(f) or (g).
    Best effort means documented actions that a licensee or other 
entity who is subject to subpart C of this part takes to obtain 
suitable inquiry and employment information in order to determine 
whether an individual may be granted authorization, when the primary 
source of information refuses or indicates an inability or 
unwillingness to provide the information within 3 business days of the 
request and the licensee or other entity relies on a secondary source 
to meet the requirement.
    Blood alcohol concentration (BAC) means the mass of alcohol in a 
volume of blood.
    Calibrator means a solution of known concentration which is used to 
define expected outcomes of a measurement procedure or to compare the 
response obtained with the response of a test specimen/sample. The 
concentration of the analyte of interest in the calibrator is known 
within limits ascertained during its preparation. Calibrators may be 
used to establish a cutoff concentration and/or a calibration curve 
over a range of interest.
    Category IA material means SSNM that is directly usable in the 
manufacture of a nuclear explosive device, except if the material meets 
any of the following criteria:
    (1) The dimensions are large enough (at least 2 meters in one 
dimension, greater than 1 meter in each of two dimensions, or greater 
than 25 centimeters in each of three dimensions) to preclude hiding the 
item on an individual;
    (2) The total weight of an encapsulated item of SSNM is such that 
it cannot be carried inconspicuously by one person (i.e., at least 50 
kilograms gross weight); or
    (3) The quantity of SSNM (less than 0.05 formula kilograms) in each 
container requires protracted diversions to accumulate 5 formula 
kilograms.
    Chain of custody means procedures to account for the integrity of 
each specimen or aliquot by tracking its handling and storage from the 
point of specimen collection to final disposition of the specimen and 
its aliquots. ``Chain of custody'' and ``custody and control'' are 
synonymous and may be used interchangeably.
    Circadian variation in alertness and performance means the 
increases and decreases in alertness and cognitive/motor functioning 
caused by human physiological processes (e.g., body temperature, 
release of hormones) that vary on an approximately 24-hour cycle.
    Collection site means a designated place where individuals present 
themselves for the purpose of providing a specimen of their urine, oral 
fluids, and/or breath to be analyzed for the presence of drugs or 
alcohol.
    Collector means a person who is trained in the collection 
procedures of subpart E, instructs and assists a specimen donor at a 
collection site, and receives and makes an initial examination of the 
specimen(s) provided by the donor.
    Commission means the U.S. Nuclear Regulatory Commission (NRC) or 
its duly authorized representatives.
    Confirmatory drug or alcohol test means a second analytical 
procedure to identify the presence of alcohol or a specific drug or 
drug metabolite in a specimen. The purpose of a confirmatory test is to 
ensure the reliability and accuracy of an initial test result.
    Confirmatory validity test means a second test performed on a 
different aliquot of the original urine specimen to further support a 
validity test result.
    Confirmed test result means a test result that demonstrates that an 
individual has used drugs and/or alcohol in violation of the 
requirements of this part or has attempted to subvert the testing 
process by submitting an adulterated or substituted urine specimen. For 
drugs, adulterants, and substituted specimens, a confirmed test result 
is determined by the Medical Review Officer (MRO), after discussion 
with the donor subsequent to the MRO's receipt of a positive 
confirmatory drug test result from the HHS-certified laboratory and/or 
a confirmatory substituted or adulterated validity test result from the 
HHS-certified laboratory for that donor. For alcohol, a confirmed test 
result is based on a positive confirmatory alcohol test result from an 
evidential breath testing device (EBT) without MRO review of the test 
result.
    Constructing or construction activities mean, for the purposes of 
this part, 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. These

[[Page 17180]]

tasks include fabricating, erecting, integrating, and testing safety- 
and security-related SSCs, and the installation of their foundations, 
including the placement of concrete.
    Contractor/vendor (C/V) means any company, or any individual not 
employed by a licensee or other entity specified in Sec.  26.3(a) 
through (c), who is providing work or services to a licensee or other 
entity covered in Sec.  26.3(a) through (c), either by contract, 
purchase order, oral agreement, or other arrangement.
    Control means a sample used to monitor the status of an analysis to 
maintain its performance within predefined limits.
    Cumulative fatigue means the increase in fatigue over consecutive 
sleep-wake periods resulting from inadequate rest.
    Cutoff level means the concentration or decision criteria 
established for designating and reporting a test result as positive, of 
questionable validity (referring to validity screening or initial 
validity test results from a licensee testing facility), or 
adulterated, substituted, dilute, or invalid (referring to initial or 
confirmatory test results from an HHS-certified laboratory).
    Dilute specimen means a urine specimen with creatinine and specific 
gravity concentrations that are lower than expected for human urine.
    Directing means the exercise of control over a work activity by an 
individual who is directly involved in the execution of the work 
activity, and either makes technical decisions for that activity 
without subsequent technical review, or is ultimately responsible for 
the correct performance of that work activity.
    Donor means the individual from whom a specimen is collected.
    Eight (8)-hour shift schedule means a schedule that averages not 
more than 9 hours per workday over the entire shift cycle.
    Employment action means a change in job responsibilities or removal 
from a job, or the employer-mandated implementation of a plan for 
substance abuse treatment in order to avoid a change in or removal from 
a job, because of the individual's use of drugs or alcohol.
    Fatigue means the degradation in an individual's cognitive and 
motor functioning resulting from inadequate rest.
    Formula quantity means SSNM in any combination in a quantity of 
5000 grams or more computed by the formula, grams=(grams contained U-
235)+2.5 (grams U-233+grams plutonium). This class of material is 
sometimes referred to as a Category I quantity of material.
    HHS-certified laboratory means a laboratory that is certified to 
perform urine drug testing under the Department of Health and Human 
Services Mandatory Guidelines for Federal Workplace Drug Testing 
Programs (the HHS Guidelines), which were published in the Federal 
Register on April 11, 1988 (53 FR 11970), and as amended, June 9, 1994 
(59 FR 29908), November 13, 1998 (63 FR 63483), and April 13, 2004 (69 
FR 19643).
    Illegal drug means, for the purposes of this regulation, any drug 
that is included in Schedules I to V of section 202 of the Controlled 
Substances Act [21 U.S.C. 812], but not when used pursuant to a valid 
prescription or when used as otherwise authorized by law.
    Increased threat condition means an increase in the protective 
measure level, relative to the lowest protective measure level 
applicable to the site during the previous 60 days, as promulgated by 
an NRC Advisory.
    Initial drug test means a test to differentiate ``negative'' 
specimens from those that require confirmatory drug testing.
    Initial validity test means a first test used to determine whether 
a specimen is adulterated, dilute, substituted, or invalid, and may 
require confirmatory validity testing.
    Invalid result means the result reported by an HHS-certified 
laboratory for a specimen that contains an unidentified adulterant, 
contains an unidentified interfering substance, has an abnormal 
physical characteristic, contains inconsistent physiological 
constituents, or has an endogenous substance at an abnormal 
concentration that prevents the laboratory from completing testing or 
obtaining a valid drug test result.
    Legal action means a formal action taken by a law enforcement 
authority or court of law, including an arrest, an indictment, the 
filing of charges, a conviction, or the mandated implementation of a 
plan for substance abuse treatment in order to avoid a permanent record 
of an arrest or conviction, in response to any of the following 
activities:
    (1) The use, sale, or possession of illegal drugs;
    (2) The abuse of legal drugs or alcohol; or
    (3) The refusal to take a drug or alcohol test.
    Licensee testing facility means a drug and specimen validity 
testing facility that is operated by a licensee or other entity who is 
subject to this part to perform tests of urine specimens.
    Limit of detection (LOD) means the lowest concentration of an 
analyte that an analytical procedure can reliably detect, which could 
be significantly lower than the established cutoff levels.
    Limit of quantitation (LOQ) means the lowest concentration of an 
analyte at which the concentration of the analyte can be accurately 
determined under defined conditions.
    Maintenance means, for the purposes of Sec.  26.4(a)(4), the 
following onsite maintenance activities: Modification, surveillance, 
post-maintenance testing, and corrective and preventive maintenance.
    Medical Review Officer (MRO) means a licensed physician who is 
responsible for receiving laboratory results generated by a Part 26 
drug testing program and who has the appropriate medical training to 
properly interpret and evaluate an individual's drug and validity test 
results together with his or her medical history and any other relevant 
biomedical information.
    Nominal means the limited flexibility that is permitted in meeting 
a scheduled due date for completing a recurrent activity that is 
required under this part, such as the nominal 12-month frequency 
required for FFD refresher training in Sec.  26.29(c)(2) and the 
nominal 12-month frequency required for certain audits in Sec.  
26.41(c)(1). Completing a recurrent activity at a nominal frequency 
means that the activity may be completed within a period that is 25 
percent longer or shorter than the period required in this part. The 
next scheduled due date would be no later than the current scheduled 
due date plus the required frequency for completing the activity.
    Other entity means any corporation, firm, partnership, limited 
liability company, association, C/V, or other organization who is 
subject to this part under Sec.  26.3(a) through (c), but is not 
licensed by the NRC.
    Oxidizing adulterant means a substance that acts alone or in 
combination with other substances to oxidize drugs or drug metabolites 
to prevent the detection of the drugs or drug metabolites, or a 
substance that affects the reagents in either the initial or 
confirmatory drug test. Examples of these agents include, but are not 
limited to, nitrites, pyridinium chlorochromate, chromium (VI), bleach, 
iodine/iodide, halogens, peroxidase, and peroxide.
    Positive result means, for drug testing, the result reported by a 
licensee testing facility or HHS-certified laboratory when a specimen 
contains a drug or drug metabolite equal to or greater than the cutoff 
concentration. A result reported by an HHS-certified laboratory

[[Page 17181]]

that a specimen contains a drug or drug metabolite below the cutoff 
concentration is also a positive result when the laboratory has 
conducted the special analysis permitted in Sec.  26.163(a)(2). For 
alcohol testing, a positive result means the result reported by a 
collection site when the BAC indicated by testing a specimen exceeds 
the cutoff concentrations established in this part.
    Potentially disqualifying FFD information means information 
demonstrating that an individual has--
    (1) Violated a licensee's or other entity's FFD policy;
    (2) Had authorization denied or terminated unfavorably under 
Sec. Sec.  26.35(c)(2), 26.53(i), 26.63(d), 26.65(g), 26.67(c), 
26.69(f), or 26.75(b) through (e);
    (3) Used, sold, or possessed illegal drugs;
    (4) Abused legal drugs or alcohol;
    (5) Subverted or attempted to subvert a drug or alcohol testing 
program;
    (6) Refused to take a drug or alcohol test;
    (7) Been subjected to a plan for substance abuse treatment (except 
for self-referral); or
    (8) Had legal action or employment action, as defined in this 
section, taken for alcohol or drug use.
    Protected area has the same meaning as in Sec.  73.2(g) of this 
chapter: An area encompassed by physical barriers and to which access 
is controlled.
    Quality control sample means a sample used to evaluate whether an 
analytical procedure is operating within predefined tolerance limits. 
Calibrators, controls, negative samples, and blind samples are 
collectively referred to as ``quality control samples'' and each is 
individually referred to as a ``sample.''
    Questionable validity means 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.
    Reviewing official means an employee of a licensee or other entity 
specified in Sec.  26.3(a) through (c), who is designated by the 
licensee or other entity to be responsible for reviewing and evaluating 
any potentially disqualifying FFD information about an individual, 
including, but not limited to, the results of a determination of 
fitness, as defined in Sec.  26.189, in order to determine whether the 
individual may be granted or maintain authorization.
    Safety-related structures, systems, and components (SSCs) mean, for 
the purposes of this part, those structures, systems, and components 
that are relied on to remain functional during and following design 
basis events to ensure the integrity of the reactor coolant pressure 
boundary, the capability to shut down the reactor and maintain it in a 
safe shutdown condition, or the capability to prevent or mitigate the 
consequences of accidents that could result in potential offsite 
exposure comparable to the guidelines in 10 CFR 50.34(a)(1).
    Security-related SSCs mean, for the purposes of this part, those 
structures, systems, and components that the licensee will rely on to 
implement the licensee's physical security and safeguards contingency 
plans that either are required under Part 73 of this chapter if the 
licensee is a construction permit applicant or holder or an early site 
permit holder, as described in Sec.  26.3(c)(3) through (c)(5), 
respectively, or are included in the licensee's application if the 
licensee is a combined license applicant or holder, as described in 
Sec.  26.3(c)(1) and (c)(2), respectively.
    Shift cycle means 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.
    Standard means a reference material of known purity or a solution 
containing a reference material at a known concentration.
    Strategic special nuclear material (SSNM) means uranium-235 
(contained in uranium enriched to 20 percent or more in the uranium-235 
isotope), uranium-233, or plutonium.
    Substance abuse means the use, sale, or possession of illegal 
drugs, or the abuse of prescription and over-the-counter drugs, or the 
abuse of alcohol.
    Substituted specimen means a specimen with creatinine and specific 
gravity values that are so diminished or so divergent that they are not 
consistent with normal human physiology.
    Subversion and subvert the testing process mean a willful act to 
avoid being tested or to bring about an inaccurate drug or alcohol test 
result for oneself or others at any stage of the testing process 
(including selection and notification of individuals for testing, 
specimen collection, specimen analysis, and test result reporting), and 
adulterating, substituting, or otherwise causing a specimen to provide 
an inaccurate test result.
    Supervises or manages means the exercise of control over a 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.
    Ten (10)-hour shift schedule means a schedule that averages more 
than 9 hours, but not more than 11 hours, per workday over the entire 
shift cycle.
    Transporter means a general licensee, under 10 CFR 70.20(a), who is 
authorized to possess formula quantities of SSNM, in the regular course 
of carriage for another or storage incident thereto, and includes the 
driver or operator of any conveyance, and the accompanying guards or 
escorts.
    Twelve (12)-hour shift schedule means a schedule that averages more 
than 11 hours, but not more than 12 hours, per workday over the entire 
shift cycle.
    Unit outage means, for the purposes of this part, that the reactor 
unit is disconnected from the electrical grid.
    Validity screening test means a test to determine the need for 
initial validity testing of a urine specimen, using a non-instrumented 
test in which the endpoint result is obtained by visual evaluation 
(read by the human eye), or a test that is instrumented to the extent 
that results are machine-read.
    Validity screening test lot means a group of validity screening 
tests that were made from the same starting material.


Sec.  26.7  Interpretations.

    Except as specifically authorized by the Commission in writing, no 
interpretation of the meaning of the regulations in this part by any 
officer or employee of the Commission other than a written 
interpretation by the General Counsel will be recognized to be binding 
on the Commission.


Sec.  26.8  Information collection requirements: OMB approval.

    (a) The NRC has submitted the information collection requirements 
contained in this part for approval by the Office of Management and 
Budget (OMB), as required by the Paperwork Reduction Act (44 U.S.C. 
3501 et seq.). The NRC may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number. OMB has approved the information 
collection requirements contained in this part under control number 
3150-0146.
    (b) The approved information collection requirements contained in 
this part appear in Sec. Sec.  26.9, 26.27, 26.29, 26.31, 26.33, 26.35, 
26.37, 26.39, 26.41, 26.53, 26.55, 26.57, 26.59, 26.61, 26.63, 26.65, 
26.67, 26.69, 26.75, 26.77, 26.85, 26.87, 26.89, 26.91, 26.93, 26.95, 
26.97, 26.99, 26.101, 26.103, 26.107, 26.109,

[[Page 17182]]

26.111, 26.113, 26.115, 26.117, 26.119, 26.125, 26.127, 26.129, 26.135, 
26.137, 26.139, 26.153, 26.155, 26.157, 26.159, 26.163, 26.165, 26.167, 
26.168, 26.169, 26.183, 26.185, 26.187, 26.189, 26.203, 26.205, 26.207, 
26.211, 26.401, 26.403, 26.405, 26.406, 26.407, 26.411, 26.413, 26.415, 
26.417, 26.711, 26.713, 26.715, 26.717, 26.719, and 26.821.


Sec.  26.9  Specific exemptions.

    Upon application of any interested person or on its own initiative, 
the Commission may grant such exemptions from the requirements of the 
regulations in this part as it determines are authorized by law and 
will not endanger life or property or the common defense and security, 
and are otherwise in the public interest.


Sec.  26.11  Communications.

    Except where otherwise specified in this part, all communications, 
applications, and reports concerning the regulations in this part must 
be sent either by mail addressed to ATTN: NRC Document Control Desk, 
U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; by hand 
delivery to the NRC's offices at 11555 Rockville Pike, Rockville, 
Maryland, between the hours of 8:15 a.m. and 4 p.m. eastern time; or, 
where practicable, by electronic submission, for example, via 
Electronic Information Exchange, e-mail, or CD-ROM. Electronic 
submissions must be made in a manner that enables the NRC to receive, 
read, authenticate, distribute, and archive the submission, and process 
and retrieve it a single page at a time. Detailed guidance on making 
electronic submissions can be obtained by visiting the NRC's Web site 
at http://www.nrc.gov/site-help/eie.html, by calling (301) 415-6030, by 
e-mail to [email protected], or by writing to the Office of Information 
Services, U.S. Nuclear Regulatory Commission, Washington, DC 20555-
0001. The guidance discusses, among other topics, the formats the NRC 
can accept, the use of electronic signatures, and the treatment of 
nonpublic information. Copies of all communications must be sent to the 
appropriate regional office and resident inspector (addresses for the 
NRC Regional Offices are listed in Appendix D to Part 20 of this 
chapter).

Subpart B--Program Elements


Sec.  26.21  Fitness-for-duty program.

    The licensees and other entities specified in Sec.  26.3(a) through 
(c) shall establish, implement, and maintain FFD programs that, at a 
minimum, comprise the program elements contained in this subpart. The 
individuals specified in Sec.  26.4(a) through (e) and (g), and, at the 
licensee's or other entity's discretion, Sec.  26.4(f), and, if 
necessary, Sec.  26.4(j) shall be subject to these FFD programs. 
Licensees and other entities may rely on the FFD program or program 
elements of a C/V, as defined in Sec.  26.5, if the C/V's FFD program 
or program elements meet the applicable requirements of this part.


Sec.  26.23  Performance objectives.

    Fitness-for-duty programs must--
    (a) Provide reasonable assurance that individuals are trustworthy 
and reliable as demonstrated by the avoidance of substance abuse;
    (b) Provide reasonable assurance that individuals are not under the 
influence of any substance, legal or illegal, or mentally or physically 
impaired from any cause, which in any way adversely affects their 
ability to safely and competently perform their duties;
    (c) Provide reasonable measures for the early detection of 
individuals who are not fit to perform the duties that require them to 
be subject to the FFD program;
    (d) Provide reasonable assurance that the workplaces subject to 
this part are free from the presence and effects of illegal drugs and 
alcohol; and
    (e) 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.


Sec.  26.25  [Reserved]


Sec.  26.27  Written policy and procedures.

    (a) General. Each licensee and other entity shall establish, 
implement, and maintain written policies and procedures to meet the 
general performance objectives and applicable requirements of this 
part.
    (b) Policy. The FFD policy statement must be clear, concise, and 
readily available, in its most current form, to all individuals who are 
subject to the policy. Methods of making the statement readily 
available include, but are not limited to, posting the policy in 
multiple work areas, providing individuals with brochures, or allowing 
individuals to print the policy from a computer. The policy statement 
must be written in sufficient detail to provide affected individuals 
with information on what is expected of them and what consequences may 
result from a lack of adherence to the policy. At a minimum, the 
written policy statement must--
    (1) Describe the consequences of the following actions:
    (i) The use, sale, or possession of illegal drugs on or off site;
    (ii) The abuse of legal drugs and alcohol; and
    (iii) The misuse of prescription and over-the-counter drugs;
    (2) Describe the requirement that individuals who are notified that 
they have been selected for random testing must report to the 
collection site within the time period specified by the licensee or 
other entity;
    (3) Describe the actions that constitute a refusal to provide a 
specimen for testing, the consequences of a refusal to test, as well as 
the consequences of subverting or attempting to subvert the testing 
process;
    (4) Prohibit the consumption of alcohol, at a minimum--
    (i) Within an abstinence period of 5 hours preceding the 
individual's arrival at the licensee's or other entity's facility, 
except as permitted in Sec.  26.27(c)(3); and
    (ii) During the period of any tour of duty;
    (5) Convey that abstinence from alcohol for the 5 hours preceding 
any scheduled tour of duty is considered to be a minimum that is 
necessary, but may not be sufficient, to ensure that the individual is 
fit for duty;
    (6) Address other factors that could affect FFD, such as mental 
stress, fatigue, or illness, and the use of prescription and over-the-
counter medications that could cause impairment;
    (7) Provide a description of any program that is available to 
individuals who are seeking assistance in dealing with drug, alcohol, 
fatigue, or other problems that could adversely affect an individual's 
ability to safely and competently perform the duties that require an 
individual to be subject to this subpart;
    (8) Describe the consequences of violating the policy;
    (9) Describe the individual's responsibility to report legal 
actions, as defined in Sec.  26.5;
    (10) Describe the responsibilities of managers, supervisors, and 
escorts to report FFD concerns; and
    (11) Describe the individual's responsibility to report FFD 
concerns.
    (c) Procedures. Each licensee and other entity shall prepare, 
implement, and maintain written procedures that describe the methods to 
be used in implementing the FFD policy and the requirements of this 
part. The procedures must--
    (1) Describe the methods and techniques to be used in testing for 
drugs and alcohol, including procedures for protecting the privacy and 
other rights (including due process) of an individual who provides a 
specimen, procedures for protecting the integrity of

[[Page 17183]]

the specimen, and procedures used to ensure that the test results are 
valid and attributable to the correct individual;
    (2) Describe immediate and followup actions that will be taken, and 
the procedures to be used, in those cases in which individuals are 
determined to have--
    (i) Been involved in the use, sale, or possession of illegal drugs;
    (ii) Consumed alcohol to excess before the mandatory pre-work 
abstinence period, or consumed any alcohol during the mandatory pre-
work abstinence period or while on duty, as determined by a test that 
measures BAC;
    (iii) Attempted to subvert the testing process by adulterating or 
diluting specimens (in vivo or in vitro), substituting specimens, or by 
any other means;
    (iv) Refused to provide a specimen for analysis; or
    (v) Had legal action taken relating to drug or alcohol use, as 
defined in Sec.  26.5;
    (3) 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. At a minimum--
    (i) The procedure must require 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 policy;
    (ii) If the individual has consumed alcohol within this period and 
the individual is called in for an unscheduled working tour, including 
an unscheduled working tour to respond to an emergency, the procedure 
must--
    (A) Require a determination of fitness by breath alcohol analysis 
or other means;
    (B) Permit the licensee or other entity to assign the individual to 
duties that require him or her to be subject to this subpart, if the 
results of the determination of fitness indicate that the individual is 
fit to safely and competently perform his or her duties;
    (C) Prohibit the licensee or other entity from assigning the 
individual to duties that require him or her to be subject to this 
subpart, 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;
    (D) 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. However, if the determination of 
fitness indicates that an individual who has been called in for an 
unscheduled working tour to 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; and
    (E) State that no sanctions may be imposed on an individual who is 
called in to perform any unscheduled working tour for having consumed 
alcohol within the pre-duty abstinence period stated in the policy.
    (iii) If the individual reports that he or she considers himself or 
herself to be unfit for duty for other reasons, including illness, 
fatigue, or other potentially impairing conditions, and the individual 
is called in, the procedure must require the establishment of controls 
and conditions under which the individual can perform work, if 
necessary;
    (4) Describe the process to be followed if an individual's behavior 
raises a concern regarding the possible use, sale, or possession of 
illegal drugs on or off site; the possible possession or consumption of 
alcohol on site; or impairment from any cause which in any way could 
adversely affect the individual's ability to safely and competently 
perform his or her duties. The procedure must require that individuals 
who have an FFD concern about another individual's behavior shall 
contact the personnel designated in the procedures to report the 
concern.
    (d) Review. The NRC may, at any time, review the written policy and 
procedures to assure that they meet the performance objectives and 
requirements of this part.


Sec.  26.29  Training.

    (a) Training content. Licensees and other entities shall ensure 
that the individuals who are subject to this subpart have the following 
KAs:
    (1) Knowledge of the policy and procedures that apply to the 
individual, the methods that will be used to implement them, and the 
consequences of violating the policy and procedures;
    (2) Knowledge of the individual's role and responsibilities under 
the FFD program;
    (3) Knowledge of the roles and responsibilities of others, such as 
the MRO and the human resources, FFD, and EAP staffs;
    (4) Knowledge of the EAP services available to the individual;
    (5) Knowledge of the personal and public health and safety hazards 
associated with abuse of illegal and legal drugs and alcohol;
    (6) Knowledge of the potential adverse effects on job performance 
of prescription and over-the-counter drugs, alcohol, dietary factors, 
illness, mental stress, and fatigue;
    (7) Knowledge of the prescription and over-the-counter drugs and 
dietary factors that have the potential to affect drug and alcohol test 
results;
    (8) Ability to recognize illegal drugs and indications of the 
illegal use, sale, or possession of drugs;
    (9) Ability to observe and detect performance degradation, 
indications of impairment, or behavioral changes; and
    (10) Knowledge of the individual's responsibility to report an FFD 
concern and the ability to initiate appropriate actions, including 
referrals to the EAP and person(s) designated by the licensee or other 
entity to receive FFD concerns.
    (b) Comprehensive examination. Individuals who are subject to this 
subpart shall demonstrate the successful completion of training by 
passing a comprehensive examination that addresses the KAs in paragraph 
(a) of this section. The examination must include a comprehensive 
random sampling of all KAs with questions that test each KA, including 
at least one question for each KA. The minimum passing score required 
must be 80 percent. Remedial training and testing are required for 
individuals who fail to answer correctly at least 80 percent of the 
test questions. The examination may be administered using a variety of 
media, including, but not limited to, hard-copy test booklets with 
separate answer sheets or computer-based questions.
    (c) Training administration. Licensees and other entities shall 
ensure that individuals who are subject to this subpart are trained, as 
follows:
    (1) Training must be completed before the licensee or other entity 
grants initial authorization, as defined in Sec.  26.55, and must be 
current before the licensee or other entity grants an authorization 
update, as defined in Sec.  26.57, or authorization reinstatement, as 
defined in Sec.  26.59;
    (2) Individuals shall complete refresher training on a nominal 12-
month frequency, or more frequently where the need is indicated. 
Indications of the need for more frequent training include, but are not 
limited to, an individual's failure to properly implement FFD program 
procedures and the frequency, nature, or severity of problems 
discovered through audits or the administration of the program. 
Individuals who pass a comprehensive annual examination that meets the 
requirements in paragraph (b) of this

[[Page 17184]]

section may forgo the refresher training; and
    (3) Initial and refresher training may be delivered using a variety 
of media (including, but not limited to, classroom lectures, required 
reading, video, or computer-based training systems). The licensee or 
other entity shall monitor the completion of training and provide a 
qualified instructor or designated subject matter expert to answer 
questions during the course of training.
    (d) Acceptance of training. Licensees and other entities may accept 
training of individuals who have been subject to another training 
program that meets the requirements of this section and who have, 
within the past 12 months, either had initial or refresher training, or 
have successfully passed a comprehensive examination that meets the 
requirements in paragraph (b) of this section.


Sec.  26.31  Drug and alcohol testing.

    (a) General. To provide a means to deter and detect substance 
abuse, licensees and other entities who are subject to this part shall 
implement drug and alcohol testing programs for individuals who are 
subject to this subpart.
    (b) Assuring the honesty and integrity of FFD program personnel. 
(1) Licensees and other entities who are subject to this subpart shall 
carefully select and monitor FFD program personnel, as defined in Sec.  
26.4(g), based on the highest standards of honesty and integrity, and 
shall implement measures to ensure that these standards are maintained. 
The measures must ensure that the honesty and integrity of these 
individuals are not compromised and that FFD program personnel are not 
subject to influence attempts attributable to personal relationships 
with any individuals who are subject to testing, an undetected or 
untreated substance abuse problem, or other factors. At a minimum, 
these measures must include the following considerations:
    (i) Licensees and other entities shall complete appropriate 
background investigations, credit and criminal history checks, and 
psychological assessments of FFD program personnel before assignment to 
tasks directly associated with administration of the FFD program. The 
background investigations, credit and criminal history checks, and 
psychological assessments that are conducted to grant unescorted access 
authorization to individuals under a nuclear power plant licensee's 
access authorization program are acceptable to meet the requirements of 
this paragraph. The credit and criminal history checks and 
psychological assessments must be updated nominally every 5 years;
    (ii) Individuals who have personal relationships with a donor may 
not perform any assessment or evaluation procedures, including, but not 
limited to, determinations of fitness. These personal relationships may 
include, but are not limited to, supervisors, coworkers within the same 
work group, and relatives of the donor;
    (iii) Except if a directly observed collection is required, a 
collector who has a personal relationship with the donor may collect 
specimens from the donor only if the integrity of specimen collections 
in these instances is assured through the following means:
    (A) The collection must be monitored by an individual who does not 
have a personal relationship with the donor and who is designated by 
the licensee or other entity for this purpose, including, but not 
limited to, security force or quality assurance personnel; and
    (B) Individuals who are designated to monitor collections in these 
instances shall be trained to monitor specimen collections and the 
preparation of specimens for transfer or shipping under the 
requirements of this part;
    (iv) If a specimen must be collected under direct observation, the 
collector or an individual who serves as the observer, as permitted 
under Sec.  26.115(e), may not have a personal relationship with the 
donor; and
    (v) FFD program personnel shall be subject to a behavioral 
observation program designed to assure that they continue to meet the 
highest standards of honesty and integrity. When an MRO and MRO staff 
are on site at a licensee's or other entity's facility, the MRO and MRO 
staff shall be subject to behavioral observation.
    (2) 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 
specimens for drug and alcohol testing from the FFD program personnel 
listed in Sec.  26.4(g).
    (c) Conditions for testing. Licensees and other entities shall 
administer drug and alcohol tests to the individuals who are subject to 
this subpart under the following conditions:
    (1) Pre-access. In order to grant initial, updated, or reinstated 
authorization to an individual, as specified in subpart C of this part;
    (2) For cause. In response to an individual's observed behavior or 
physical condition indicating possible substance abuse or after 
receiving credible information that an individual is engaging in 
substance abuse, as defined in Sec.  26.5;
    (3) Post-event. As soon as practical after an event involving a 
human error that was committed by an individual who is subject to this 
subpart, where the human error may have caused or contributed to the 
event. The licensee or other entity shall test the individual(s) who 
committed the error(s), and need not test individuals who were affected 
by the event whose actions likely did not cause or contribute to the 
event. The individual(s) who committed the human error(s) shall be 
tested if the event resulted in--
    (i) A significant illness or personal injury to the individual to 
be tested or another individual, which within 4 hours after the event 
is recordable under the Department of Labor standards contained in 29 
CFR 1904.7, ``General Recording Criteria,'' and subsequent amendments 
thereto, and results in death, days away from work, restricted work, 
transfer to another job, medical treatment beyond first aid, loss of 
consciousness, or other significant illness or injury as diagnosed by a 
physician or other licensed health care professional, even if it does 
not result in death, days away from work, restricted work or job 
transfer, medical treatment beyond first aid, or loss of consciousness;
    (ii) A radiation exposure or release of radioactivity in excess of 
regulatory limits; or
    (iii) Actual or potential substantial degradations of the level of 
safety of the plant;
    (4) Followup. As part of a followup plan to verify an individual's 
continued abstinence from substance abuse; and
    (5) Random. On a statistically random and unannounced basis, so 
that all individuals in the population subject to testing have an equal 
probability of being selected and tested.
    (d) General requirements for drug and alcohol testing. (1) 
Substances tested. At a minimum, licensees and other entities shall 
test for marijuana metabolite, cocaine metabolite, opiates (codeine, 
morphine, 6-acetylmorphine), amphetamines (amphetamine, 
methamphetamine), phencyclidine, adulterants, and alcohol.
    (i) In addition, licensees and other entities may consult with 
local law enforcement authorities, hospitals, and drug counseling 
services to determine whether other drugs with abuse potential are 
being used in the

[[Page 17185]]

geographical locale of the facility and by the local workforce that may 
not be detected in the panel of drugs and drug metabolites specified in 
paragraph (d)(1) of this section.
    (A) When appropriate, the licensee or other entity may add other 
drugs identified under paragraph (d)(1)(i) of this section to the panel 
of substances for testing, but only if the additional drugs are listed 
in Schedules I through V of section 202 of the Controlled Substances 
Act [21 U.S.C. 812].
    (B) The licensee or other entity shall establish appropriate cutoff 
limits for these substances.
    (C) The licensee or other entity shall establish rigorous testing 
procedures for these substances that are consistent with the intent of 
this part, so that the MRO can evaluate the use of these substances.
    (D) The licensee or other entity may not conduct an analysis for 
any drug or drug metabolites except those identified in paragraph 
(d)(1) of this section unless the assay and cutoff levels to be used 
are certified in writing as scientifically sound and legally defensible 
by an independent, qualified forensic toxicologist who has no 
relationships with manufacturers of the assays or instruments to be 
used or the HHS-certified laboratory that will conduct the testing for 
the licensee or other entity, which could be construed as a potential 
conflict of interest. The forensic toxicologist may not be an employee 
of the licensee or entity, and shall either be a Diplomate of the 
American Board of Forensic Toxicology or currently holds, has held, or 
is eligible to hold, the position of Responsible Person at an HHS-
certified laboratory, as specified in Sec.  26.155(a). All new assays 
and cutoff levels must be properly validated consistent with 
established forensic toxicological standards before implementation. 
Certification of the assay and cutoff levels is not required if the HHS 
Guidelines are revised to authorize use of the assay in testing for the 
additional drug or drug metabolites and the licensee or other entity 
uses the cutoff levels established in the HHS Guidelines for the drug 
or drug metabolites, or if the licensee or other entity received 
written approval of the NRC to test for the additional drug or drug 
metabolites before April 30, 2008.
    (ii) When conducting post-event, followup, and for-cause testing, 
as defined in Sec.  26.31(c), licensees and other entities may test for 
any drugs listed on Schedules I through V of section 202 of the 
Controlled Substances Act [21 U.S.C. 812] that an individual is 
suspected of having abused, and may consider any drugs or metabolites 
so detected when determining appropriate action under subpart D of this 
part. If the drug or metabolites for which testing will be performed 
under this paragraph are not included in the FFD program's drug panel, 
the assay and cutoff levels to be used in testing for the additional 
drugs must be certified by a forensic toxicologist under paragraph 
(d)(1)(i)(D) of this section. Test results that fall below the 
established cutoff levels may not be considered when determining 
appropriate action under subpart D of this part, except if 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) or 26.185(g)(3).
    (iii) The licensee or other entity shall document the additional 
drug(s) for which testing will be performed in written policies and 
procedures in which the substances for which testing will be performed 
are described.
    (2) Random testing. Random testing must--
    (i) Be administered in a manner that provides reasonable assurance 
that individuals are unable to predict the time periods during which 
specimens will be collected. At a minimum, the FFD program shall--
    (A) 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. 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; and
    (B) Collect specimens on an unpredictable schedule, including 
weekends, backshifts, and holidays, and at various times during a 
shift;
    (ii) At a minimum, be administered by the FFD program on a nominal 
weekly frequency;
    (iii) Require individuals who are selected for random testing to 
report to the collection site as soon as reasonably practicable after 
notification, within the time period specified in the FFD program 
policy;
    (iv) Ensure that all individuals in the population subject to 
testing have an equal probability of being selected and tested;
    (v) Require that individuals who are off site when selected for 
testing, or who are on site and are not reasonably available for 
testing when selected, shall be tested at the earliest reasonable and 
practical opportunity when both the donor and collectors are available 
to collect specimens for testing and without prior notification to the 
individual that he or she has been selected for testing;
    (vi) Provide that an individual completing a test is immediately 
eligible for another unannounced test; and
    (vii) Ensure that the sampling process used to select individuals 
for random testing provides that the number of random tests performed 
annually is equal to at least 50 percent of the population that is 
subject to the FFD program.
    (3) Drug testing. (i) Testing of urine specimens for drugs and 
validity, except validity screening and initial drug and validity tests 
performed by licensee testing facilities under paragraph (d)(3)(ii) of 
this section, must be performed in a laboratory that is certified by 
HHS for that purpose, consistent with its standards and procedures for 
certification. Specimens sent to HHS-certified laboratories must be 
subject to initial validity and initial drug testing by the laboratory. 
Specimens that yield positive initial drug test results or are 
determined by initial validity testing to be of questionable validity 
must be subject to confirmatory testing by the laboratory, except for 
invalid specimens that cannot be tested. Licensees and other entities 
shall ensure that laboratories report results for all specimens sent 
for testing, including blind performance test samples.
    (ii) Licensees and other entities may conduct validity screening, 
initial validity, and initial drug tests of urine aliquots to determine 
which specimens are valid and negative and need no further testing, 
provided that the licensee's or other entity's 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.
    (iii) At a minimum, licensees and other entities shall apply the 
cutoff levels specified in Sec.  26.163(a)(1) for initial drug testing 
at either the licensee testing facility or HHS-certified laboratory, 
and in Sec.  26.163(b)(1) for confirmatory drug testing at the HHS-
certified laboratory. At their discretion, licensees and other entities 
may implement programs with lower cutoff levels in testing for drugs 
and drug metabolites.
    (A) If a licensee or other entity implements lower cutoff levels, 
and the MRO determines that an individual has violated the FFD policy 
using the licensee's or other entity's more stringent cutoff levels, 
the individual shall be subject to all management actions and sanctions 
required by the licensee's or other entity's FFD policy

[[Page 17186]]

and this part, as if the individual had a confirmed positive drug test 
result using the cutoff levels specified in this subpart. The licensee 
or other entity shall document the more stringent cutoff levels in any 
written policies and procedures in which cutoff levels for drug testing 
are described.
    (B) The licensee or other entity shall uniformly apply the cutoff 
levels listed in Sec.  26.163(a)(1) for initial drug testing and in 
Sec.  26.163(b)(1) for confirmatory drug testing, or any more stringent 
cutoff levels implemented by the FFD program, to all tests performed 
under this part and equally to all individuals who are tested under 
this part, except as permitted in Sec. Sec.  26.31(d)(1)(ii), 
26.163(a)(2), and 26.165(c)(2).
    (C) In addition, the scientific and technical suitability of any 
more stringent cutoff levels must be evaluated and certified, in 
writing, by a forensic toxicologist who meets the requirements set 
forth in Sec.  26.31(d)(1)(i)(D). Certification of the more stringent 
cutoff levels is not required 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 if the 
licensee or other entity received written approval of the NRC to test 
for lower cutoff levels before April 30, 2008.
    (4) Alcohol testing. Initial tests for alcohol must be administered 
by breath or oral fluids analysis using alcohol analysis devices that 
meet the requirements of Sec.  26.91(a). If the initial test shows a 
BAC of 0.02 percent or greater, a confirmatory test for alcohol must be 
performed. The confirmatory test must be performed with an EBT that 
meets the requirements of Sec.  26.91(b).
    (5) Medical conditions. (i) If an individual has a medical 
condition that makes collection of breath, oral fluids, or urine 
specimens difficult or hazardous, the MRO may authorize an alternative 
evaluation process, tailored to the individual case, to meet the 
requirements of this part for drug and alcohol testing. The alternative 
process must include measures to prevent subversion and achieve results 
that are comparable to those produced by urinalysis for drugs and 
breath analysis for alcohol.
    (ii) If an individual requires medical attention, including, but 
not limited to, an injured worker in an emergency medical facility who 
is required to have a post-event test, treatment may not be delayed to 
conduct drug and alcohol testing.
    (6) Limitations of testing. Specimens collected under NRC 
regulations may only be designated or approved for testing as described 
in this part and may not be used to conduct any other analysis or test 
without the written permission of the donor. Analyses and tests that 
may not be conducted include, but are not limited to, DNA testing, 
serological typing, or any other medical or genetic test used for 
diagnostic or specimen identification purposes.


Sec.  26.33  Behavioral observation.

    Licensees and other entities shall ensure that the individuals who 
are subject to this subpart are subject to behavioral observation. 
Behavioral observation must be performed by individuals who are trained 
under Sec.  26.29 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, may constitute a risk to public health and safety or 
the common defense and security. Individuals who are subject to this 
subpart shall report any FFD concerns about other individuals to the 
personnel designated in the FFD policy.


Sec.  26.35  Employee assistance programs.

    (a) Each licensee and other entity who is subject to this part 
shall maintain an EAP to strengthen the FFD program by offering 
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. Employee assistance programs must be designed to 
achieve early intervention and provide for confidential assistance.
    (b) Licensees and other entities need not provide EAP services to a 
C/V's employees, including those whose work location is a licensee's or 
other entity's facility, or to individuals who have applied for, but 
have not yet been granted, authorization under subpart C of this part.
    (c) The EAP staff shall protect the identity and privacy of any 
individual (including those who have self-referred) seeking assistance 
from the EAP, except if the individual waives the right to privacy in 
writing or a determination is made that the individual's condition or 
actions pose or have posed an immediate hazard to himself or herself or 
others.
    (1) Licensees and other entities may not require the EAP to 
routinely report the names of individuals who self-refer to the EAP or 
the nature of the assistance the individuals sought.
    (2) If EAP personnel determine that an individual poses or has 
posed an immediate hazard to himself or herself or others, EAP 
personnel shall so inform FFD program management, and need not obtain a 
written waiver of the right to privacy from the individual. The 
individual conditions or actions that EAP personnel shall report to FFD 
program management include, but are not limited to, substantive reasons 
to believe that the individual--
    (i) Is likely to commit self-harm or harm to others;
    (ii) Has been impaired from using drugs or alcohol while in a work 
status and has a continuing substance abuse disorder that makes it 
likely he or she will be impaired while in a work status in the future; 
or
    (iii) Has ever engaged in any acts that would be reportable under 
Sec.  26.719(b)(1) through (b)(3).
    (3) If a licensee or other entity receives a report from EAP 
personnel under paragraph (c)(2) of this section, the licensee or other 
entity shall ensure that the requirements of Sec. Sec.  26.69(d) and 
26.77(b) are implemented, as applicable.


Sec.  26.37  Protection of information.

    (a) Each licensee or other entity who is subject to this subpart 
who collects personal information about an individual for the purpose 
of complying with this part, shall establish, use, and maintain a 
system of files and procedures that protects the individual's privacy.
    (b) Licensees and other entities shall obtain a signed consent that 
authorizes the disclosure of the personal information collected and 
maintained under this part before disclosing the personal information, 
except for disclosures to the following individuals:
    (1) The subject individual or his or her representative, when the 
individual has designated the representative in writing for specified 
FFD matters;
    (2) Assigned MROs and MRO staff;
    (3) NRC representatives;
    (4) Appropriate law enforcement officials under court order;
    (5) A licensee's or other entity's representatives who have a need 
to have access to the information to perform their assigned duties 
under the FFD program, including determinations of fitness, FFD program 
audits, or some human resources functions;
    (6) The presiding officer in a judicial or administrative 
proceeding that is initiated by the subject individual;
    (7) Persons deciding matters under review in Sec.  26.39; and
    (8) Other persons pursuant to court order.
    (c) Personal information that is collected under this subpart must 
be

[[Page 17187]]

disclosed to other licensees and entities, including C/Vs, or their 
authorized representatives, who are legitimately seeking the 
information for authorization decisions as required by this part and 
who have obtained a signed release from the subject individual.
    (d) Upon receipt of a written request by the subject individual or 
his or her designated representative, the FFD program, including but 
not limited to, the collection site, HHS-certified laboratory, 
substance abuse expert (SAE), or MRO, possessing such records shall 
promptly provide copies of all FFD records pertaining to the 
individual, including, but not limited to, records pertaining to a 
determination that the individual has violated the FFD policy, drug and 
alcohol test results, MRO reviews, determinations of fitness, and 
management actions pertaining to the subject individual. The licensee 
or other entity shall obtain records related to the results of any 
relevant laboratory certification, review, or revocation-of-
certification proceedings from the HHS-certified laboratory and provide 
them to the subject individual on request.
    (e) A licensee's or other entity's contracts with HHS-certified 
laboratories and C/Vs providing specimen collection services, and 
licensee testing facility procedures, must require test records to be 
maintained in confidence, except as provided in paragraphs (b), (c), 
and (d) of this section.
    (f) This section does not authorize the licensee or other entity to 
withhold evidence of criminal conduct from law enforcement officials.


Sec.  26.39  Review process for fitness-for-duty policy violations.

    (a) Each licensee and other entity who is subject to this subpart 
shall establish procedures for the review of a determination that an 
individual who they employ or who has applied for authorization has 
violated the FFD policy. The procedure must provide for an objective 
and impartial review of the facts related to the determination that the 
individual has violated the FFD policy.
    (b) The procedure must provide notice to the individual of the 
grounds for the determination that the individual has violated the FFD 
policy, and must provide an opportunity for the individual to respond 
and submit additional relevant information.
    (c) The procedure must ensure that the individual who conducts the 
review is not associated with the administration of the FFD program 
[see the description of FFD program personnel in Sec.  26.4(g)]. 
Individuals who conduct the review may be management personnel.
    (d) If the review finds in favor of the individual, the licensee or 
other entity shall update the relevant records to reflect the outcome 
of the review and delete or correct all information the review found to 
be inaccurate.
    (e) When a C/V is administering an FFD program on which licensees 
and other entities rely, and the C/V determines that its employee, 
subcontractor, or applicant has violated its FFD policy, the C/V shall 
ensure that the review procedure required in this section is provided 
to the individual. Licensees and other entities who rely on a C/V's FFD 
program need not provide the review procedure required in this section 
to a C/V's employee, subcontractor, or applicant when the C/V is 
administering its own FFD program and the FFD policy violation was 
determined under the C/V's program.


Sec.  26.41   Audits and corrective action.

    (a) General. Each licensee and other entity who is subject to this 
subpart is responsible for the continuing effectiveness of the FFD 
program, including FFD program elements that are provided by C/Vs, the 
FFD programs of any C/Vs that are accepted by the licensee or other 
entity, any FFD program services that are provided to the C/V by a 
subcontractor, and the programs of the HHS-certified laboratories on 
whom the licensee or other entity and its C/Vs rely. Each licensee and 
other entity shall ensure that these programs are audited and that 
corrective actions are taken to resolve any problems identified.
    (b) FFD program. Each licensee and other entity who is subject to 
this subpart shall ensure that the entire FFD program is audited as 
needed, but no less frequently than nominally every 24 months. 
Licensees and other entities are responsible for determining the 
appropriate frequency, scope, and depth of additional auditing 
activities within the nominal 24-month period based on the review of 
FFD program performance, including, but not limited to, the frequency, 
nature, and severity of discovered problems, testing errors, personnel 
or procedural changes, and previous audit findings.
    (c) C/Vs and HHS-certified laboratories. (1) FFD services that are 
provided to a licensee or other entity by C/V personnel who are off 
site or are not under the direct daily supervision or observation of 
the licensee's or other entity's personnel and HHS-certified 
laboratories must be audited on a nominal 12-month frequency.
    (2) Audits of HHS-certified laboratories that are conducted for 
licensees and other entities who are subject to this subpart need not 
duplicate areas inspected in the most recent HHS certification 
inspection. However, the licensee and other entity shall review the HHS 
certification inspection records and reports to identify any areas in 
which the licensee or other entity uses services that the HHS 
certification inspection did not address. The licensee or other entity 
shall ensure that any such areas are audited on a nominal 12-month 
frequency. Licensees and other entities need not audit organizations 
and professionals who may provide an FFD program service to the 
licensee or other entity, but who are not routinely involved in 
providing services to a licensee's or other entity's FFD program, as 
specified in Sec.  26.4(i)(1).
    (d) Contracts. (1) The contracts of licensees and other entities 
contracts with C/Vs and HHS-certified laboratories must reserve the 
right to audit the C/V, the C/V's subcontractors providing FFD program 
services, and the HHS-certified laboratories at any time, including at 
unannounced times, as well as to review all information and 
documentation that is reasonably relevant to the audits.
    (2) Licensees' and other entities' contracts with C/Vs and HHS-
certified laboratories must also permit the licensee or other entity to 
obtain copies of and take away any documents, including reviews and 
inspections pertaining to a laboratory's certification by HHS, and any 
other data that may be needed 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. In a contract with a licensee or other entity who is 
subject to this subpart, an HHS-certified laboratory may reasonably 
limit the use and dissemination of any documents copied or taken away 
by the licensee's or other entity's auditors in order to ensure the 
protection of proprietary information and donors' privacy.
    (3) In addition, before awarding a contract, the licensee or other 
entity shall ensure completion of pre-award inspections and/or audits 
of the procedural aspects of the HHS-certified laboratory's drug-
testing operations, except as provided in paragraph (g)(5) of this 
section.
    (e) Conduct of audits. Audits must focus on the effectiveness of 
the FFD program or program element(s), as appropriate, and must be 
conducted by individuals who are qualified in the

[[Page 17188]]

subject(s) being audited. The individuals performing the audit of the 
FFD program or program element(s) shall be independent from both the 
subject FFD program's management and from personnel who are directly 
responsible for implementing the FFD program.
    (f) Audit results. The result of the audits, along with any 
recommendations, must be documented and reported to senior corporate 
and site management. Each audit report must identify conditions that 
are adverse to the proper performance of the FFD program, the cause of 
the condition(s), and recommended corrective actions. The licensee or 
other entity shall review the audit findings and take corrective 
actions, including re-auditing of the deficient areas where indicated, 
to preclude, within reason, repetition of the condition. The resolution 
of the audit findings and corrective actions must be documented.
    (g) Sharing of audits. Licensees and other entities may jointly 
conduct audits, or may accept audits of C/Vs and HHS-certified 
laboratories that were conducted by other licensees and entities who 
are subject to this subpart, if the audit addresses the services 
obtained from the C/V or HHS-certified laboratory by each of the 
sharing licensees and other entities.
    (1) Licensees and other entities shall review audit records and 
reports to identify any areas that were not covered by the shared or 
accepted audit.
    (2) Licensees and other entities shall ensure that FFD program 
elements and services on which the licensee or entity relies are 
audited, if the program elements and services were not addressed in the 
shared audit.
    (3) Sharing licensees and other entities need not re-audit the same 
C/V or HHS-certified laboratory for the same period of time.
    (4) Each sharing licensee and other entity shall maintain a copy of 
the shared audit and HHS certification inspection records and reports, 
including findings, recommendations, and corrective actions.
    (5) If an HHS-certified laboratory loses its certification, in 
whole or in part, a licensee or other entity is permitted to 
immediately use another HHS-certified laboratory that has been audited 
within the previous 12 months by another NRC licensee or entity who is 
subject to this subpart. Within 3 months after the change, the licensee 
or other entity shall ensure that an audit is completed of any areas 
that have not been audited by another licensee or entity who is subject 
to this subpart within the past 12 months.

Subpart C--Granting and Maintaining Authorization


Sec.  26.51   Applicability.

    The requirements in this subpart apply to the licensees and other 
entities identified in Sec.  26.3(a), (b), and, as applicable, (c) for 
the categories of individuals in Sec.  26.4(a) through (d), and, at the 
licensee's or other entity's discretion, in Sec.  26.4(g) and, if 
necessary, Sec.  26.4(j). The requirements in this subpart also apply 
to the licensees and other entities specified in Sec.  26.3(c), as 
applicable, for the categories of individuals in Sec.  26.4(e). At the 
discretion of a licensee or other entity in Sec.  26.3(c), the 
requirements of this subpart also may be applied to the categories of 
individuals identified in Sec.  26.4(f). In addition, the requirements 
in this subpart apply to the entities in Sec.  26.3(d) to the extent 
that a licensee or other entity relies on the C/V to meet the 
requirements of this subpart. Certain requirements in this subpart also 
apply to the individuals specified in Sec.  26.4(h).


Sec.  26.53   General provisions.

    (a) In order to grant authorization to an individual, a licensee or 
other entity shall ensure that the requirements in this subpart have 
been met for either initial authorization, authorization update, 
authorization reinstatement, or authorization with potentially 
disqualifying FFD information, as applicable.
    (b) For individuals who have previously held authorization under 
this part but whose authorization has since been favorably terminated, 
the licensee or other entity shall implement the requirements for 
either initial authorization, authorization update, or authorization 
reinstatement, based on the total number of days that the individual's 
authorization is interrupted, to include the day after the individual's 
last period of authorization was terminated and the intervening days 
until the day on which the licensee or other entity grants 
authorization to the individual. If potentially disqualifying FFD 
information is disclosed or discovered about an individual, licensees 
and other entities shall implement the applicable requirements in Sec.  
26.69 in order to grant or maintain an individual's authorization.
    (c) The licensee or other entity shall ensure that an individual 
has met the applicable FFD training requirements in Sec. Sec.  26.29 
and 26.203(c) before granting authorization to the individual.
    (d) Licensees and other entities who are seeking to grant 
authorization to an individual who is maintaining authorization under 
another FFD program that is implemented by a licensee or entity who is 
subject to this subpart may rely on the transferring FFD program to 
satisfy the requirements of this subpart. The individual may maintain 
his or her authorization if he or she continues to be subject to either 
the receiving FFD program or the transferring FFD program, or a 
combination of elements from both programs that collectively satisfy 
the applicable requirements of this part. The receiving FFD program 
shall ensure that the program elements to which the individual is 
subject under the transferring FFD program remain current.
    (e) Licensees and other entities in Sec.  26.3(a) through (c) may 
also rely on a C/V's FFD program or program elements when granting or 
maintaining the authorization of an individual who is or has been 
subject to the C/V's FFD program, if the C/V's program or program 
elements meet the applicable requirements of this part.
    (1) A C/V's FFD program may grant and maintain an individual's 
authorization, as defined in Sec.  26.5, under the C/V's FFD program. 
However, only a licensee or other entity in Sec.  26.3(a) through (c) 
may grant or maintain an individual's authorization to have the types 
of access or perform the duties specified in Sec.  26.4(a) through (e) 
and (g), and, at the licensee's or other entity's discretion, Sec.  
26.4(f).
    (2) If a C/V's FFD program denies or unfavorably terminates an 
individual's authorization, and the individual is performing any duties 
for a licensee or other entity that are specified in Sec.  26.4(a) 
through (e) and (g), or, at the licensee's or other entity's 
discretion, Sec.  26.4(f), then the C/V shall inform the affected 
licensee or other entity of the denial or unfavorable termination. The 
licensee or other entity shall deny or unfavorably terminate the 
individual's authorization to perform those duties on the day that the 
licensee or other entity receives the information from the C/V, or 
implement the applicable process in Sec.  26.69 to maintain the 
individual's authorization.
    (3) If an individual is maintaining authorization under a C/V's FFD 
program, a licensee or other entity in Sec.  26.3(a) through (c) may 
grant authorization to the individual to have the types of access and 
perform the duties specified in Sec.  26.4(a) through (e) and (g), and, 
at the licensee's or other entity's discretion, Sec.  26.4(f), and 
maintain his or her authorization, if the individual continues to be 
subject to either the receiving FFD program or a combination of 
elements from the

[[Page 17189]]

receiving FFD program and the C/V's program that collectively satisfy 
the applicable requirements of this part. 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.
    (f) Licensees and other entities who are seeking to grant 
authorization to an individual who has been subject to an FFD program 
under subpart K may not rely on that program or its program elements to 
meet the requirements of this subpart, except if the program or program 
element(s) of the FFD program for construction satisfy the applicable 
requirements of this part.
    (g) The licensees and other entities specified in Sec.  26.3(a) 
and, as applicable, (c) and (d), shall identify any violation of any 
requirement of this part to any licensee who has relied on or intends 
to rely on the FFD program element that is determined to be in 
violation of this part.
    (h) The licensees and other entities specified in Sec.  26.3(a) 
and, as applicable, (c) and (d), may not initiate any actions under 
this subpart without the knowledge and written consent of the subject 
individual. The individual may withdraw his or her consent at any time. 
If an individual withdraws his or her consent, the licensee or other 
entity may not initiate any elements of the authorization process 
specified in this subpart that were not in progress at the time the 
individual withdrew his or her consent, but shall complete and document 
any elements that are in progress at the time consent is withdrawn. The 
licensee or other entity shall record the individual's application for 
authorization; his or her withdrawal of consent; the reason given by 
the individual for the withdrawal, if any; and any pertinent 
information gathered from the elements that were completed (e.g., the 
results of pre-access drug tests, information obtained from the 
suitable inquiry). The licensee or other entity to whom the individual 
has applied for authorization shall inform the individual that--
    (1) Withdrawal of his or her consent will withdraw the individual's 
current application for authorization under the licensee's or other 
entity's FFD program; and
    (2) Other licensees and entities will have access to information 
documenting the withdrawal as a result of the information sharing that 
is required under this part.
    (i) The licensees and other entities specified in Sec.  26.3(a) 
and, as applicable, (c) and(d), shall inform, in writing, any 
individual who is applying for authorization that the following actions 
related to providing and sharing the personal information required 
under this subpart are sufficient cause for denial or unfavorable 
termination of authorization:
    (1) Refusal to provide written consent for the suitable inquiry;
    (2) Refusal to provide or the falsification of any personal 
information required under this part, including, but not limited to, 
the failure to report any previous denial or unfavorable termination of 
authorization;
    (3) Refusal to provide written consent for the sharing of personal 
information with other licensees or other entities required under this 
part; and
    (4) Failure to report any legal actions, as defined in Sec.  26.5.


Sec.  26.55   Initial authorization.

    (a) Before granting authorization to an individual who has never 
held authorization under this part or whose authorization has been 
interrupted for a period of 3 years or more and whose last period of 
authorization was terminated favorably, the licensee or other entity 
shall 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 is subject to random drug and alcohol testing 
under the applicable requirements of Sec.  26.67.
    (b) If potentially disqualifying FFD information is disclosed or 
discovered, the licensee or other entity may not grant authorization to 
the individual, except under Sec.  26.69.


Sec.  26.57   Authorization update.

    (a) Before granting authorization to an individual whose 
authorization has been interrupted for more than 365 days but less than 
3 years and whose last period of authorization was terminated 
favorably, the licensee or other entity shall 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 is subject to random drug and alcohol testing 
under the applicable requirements of Sec.  26.67.
    (b) If potentially disqualifying FFD information is disclosed or 
discovered, the licensee or other entity may not grant authorization to 
the individual, except under Sec.  26.69.


Sec.  26.59   Authorization reinstatement.

    (a) In order to grant authorization to an individual whose 
authorization has been interrupted for a period of more than 30 days 
but no more than 365 days and whose last period of authorization was 
terminated favorably, the licensee or other entity shall 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 requirements of 
Sec.  26.63 within 5 business days of reinstating authorization. If the 
suitable inquiry is not completed within 5 business days due to 
circumstances that are outside of the licensee's or other entity's 
control and the licensee or other entity is not aware of any 
potentially disqualifying information regarding the individual within 
the past 5 years, the licensee or other entity may maintain the 
individual's authorization for an additional 5 business days. If the 
suitable inquiry is not completed within 10 business days of 
reinstating authorization, the licensee or other entity shall 
administratively withdraw the individual's authorization until the 
suitable inquiry is completed;
    (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 is subject to random drug and alcohol testing 
under the applicable requirements of Sec.  26.67.
    (b) If a licensee or other entity administratively withdraws an 
individual's authorization under paragraph (a)(2) of this section, and 
until the suitable inquiry is completed, the licensee or other entity 
may not record the administrative action to withdraw authorization as 
an unfavorable termination and may not disclose it in response to a 
suitable inquiry conducted under the provisions of Sec.  26.63, a 
background investigation conducted under the provisions of this 
chapter, or any other inquiry or investigation. The individual may not 
be required to disclose the administrative action in response to 
requests for self-disclosure of potentially disqualifying FFD 
information, except if the individual's authorization was subsequently 
denied or terminated unfavorably by the licensee or other entity.
    (c) Before granting authorization to an individual whose 
authorization has

[[Page 17190]]

been interrupted for a period of no more than 30 days and whose last 
period of authorization was terminated favorably, the licensee or other 
entity shall ensure that--
    (1) A self-disclosure has been obtained and reviewed under the 
applicable requirements of Sec.  26.61;
    (2) The individual has been subject to pre-access drug and alcohol 
testing under the applicable requirements of Sec.  26.65, if the 
individual's authorization was interrupted for more than 5 days; and
    (3) The individual is subject to random drug and alcohol testing 
under the applicable requirements of Sec.  26.67.
    (d) If potentially disqualifying FFD information is disclosed or 
discovered, the licensee or other entity may not grant authorization to 
the individual, except under Sec.  26.69.


Sec.  26.61   Self-disclosure and employment history.

    (a) Before granting authorization, the licensee or other entity 
shall ensure that a written self-disclosure and employment history has 
been obtained from the individual who is applying for authorization, 
except as follows:
    (1) If an individual previously held authorization under this part, 
and the licensee or other entity has verified that the individual's 
last period of authorization was terminated favorably, and the 
individual has been subject to a behavioral observation program that 
includes arrest reporting, which meets the requirements of this part, 
throughout the period since the individual's last authorization was 
terminated, the granting licensee or other entity need not obtain the 
self-disclosure or employment history in order to grant authorization; 
and
    (2) If the individual's last period of authorization was terminated 
favorably within the past 30 days, the licensee or other entity need 
not obtain the employment history.
    (b) The written self-disclosure must--
    (1) State whether the individual has--
    (i) Violated a licensee's or other entity's FFD policy;
    (ii) Had authorization denied or terminated unfavorably under 
Sec. Sec.  26.35(c)(2), 26.53(i), 26.63(d), 26.65(g), 26.67(c), 
26.69(f), or 26.75(b) through (e);
    (iii) Used, sold, or possessed illegal drugs;
    (iv) Abused legal drugs or alcohol;
    (v) Subverted or attempted to subvert a drug or alcohol testing 
program;
    (vi) Refused to take a drug or alcohol test;
    (vii) Been subject to a plan for substance abuse treatment (except 
for self-referral); or
    (viii) Had legal action or employment action, as defined in Sec.  
26.5, taken for alcohol or drug use;
    (2) Address the specific type, duration, and resolution of any 
matter disclosed, including, but not limited to, the reason(s) for any 
unfavorable termination or denial of authorization; and
    (3) Address the shortest of the following periods:
    (i) The past 5 years;
    (ii) Since the individual's eighteenth birthday; or
    (iii) Since the individual's last period of authorization was 
terminated, if authorization was terminated favorably within the past 3 
years.
    (c) The individual shall provide a list of all employers, including 
the employer by whom the individual claims to have been employed on the 
day before he or she completes the employment history, if any, with 
dates of employment, for the shortest of the following periods:
    (1) The past 3 years;
    (2) Since the individual's eighteenth birthday; or
    (3) Since authorization was last terminated, if authorization was 
terminated favorably within the past 3 years.


Sec.  26.63  Suitable inquiry.

    (a) In order to grant authorization, licensees and other entities 
shall ensure that a suitable inquiry has been conducted, on a best 
effort basis, to verify the individual's self-disclosed information and 
determine whether any potentially disqualifying FFD information is 
available, except if all of the following conditions are met:
    (1) The individual previously held authorization under this part;
    (2) The licensee or other entity has verified that the individual's 
last period of authorization was terminated favorably; and
    (3) The individual has been subject to a behavioral observation 
program that includes arrest reporting, which meets the requirements of 
this part, throughout the period of interruption.
    (b) To meet the suitable inquiry requirement, licensees and other 
entities may rely on the information that other licensees and entities 
who are subject to this subpart have gathered for previous periods of 
authorization. Licensees and other entities may also rely on those 
licensees' and entities' determinations of fitness that were conducted 
under Sec.  26.189, as well as their reviews and resolutions of 
potentially disqualifying FFD information, for previous periods of 
authorization.
    (c) The licensee or other entity shall ensure that the suitable 
inquiry has been conducted, on a best effort basis, by questioning 
former employers, and the employer by whom the individual claims to 
have been employed on the day before he or she completes the employment 
history, if an employment history is required under Sec.  26.61.
    (1) For the claimed employment period, the suitable inquiry must 
ascertain the reason for termination, eligibility for rehire, and other 
information that could reflect on the individual's fitness to be 
granted authorization.
    (2) If the claimed employment was military service, the licensee or 
other entity who is conducting the suitable inquiry shall request a 
characterization of service, reason for separation, and any 
disciplinary actions related to potentially disqualifying FFD 
information. If the individual's last duty station cannot provide this 
information, the licensee or other entity may accept a hand-carried 
copy of the DD 214 presented by the individual which on face value 
appears to be legitimate. The licensee or other entity may also accept 
a copy of a DD 214 provided by the custodian of military records.
    (3) If a company, previous employer, or educational institution to 
whom the licensee or other entity has directed a request for 
information refuses to provide information or indicates an inability or 
unwillingness to provide information within 3 business days of the 
request, the licensee or other entity shall document this refusal, 
inability, or unwillingness in the licensee's or other entity's record 
of the investigation, and obtain a confirmation of employment or 
educational enrollment and attendance from at least one alternate 
source, with suitable inquiry questions answered to the best of the 
alternate source's ability. This alternate source may not have been 
previously used by the licensee or other entity to obtain information 
about the individual's character. If the licensee or other entity uses 
an alternate source because employer information is not forthcoming 
within 3 business days of the request, the licensee or other entity 
need not delay granting authorization to wait for any employer 
response, but shall evaluate and document the response if it is 
received.
    (d) When any licensee or other entity in Sec.  26.3(a) through (d) 
is legitimately seeking the information required for an authorization 
decision under this subpart and has obtained a signed release from the 
subject individual authorizing the disclosure of information, any 
licensee or other entity who is subject to this part shall disclose 
whether the subject individual's authorization was denied or terminated

[[Page 17191]]

unfavorably as a result of a violation of an FFD policy and shall make 
available the information on which the denial or unfavorable 
termination of authorization was based, including, but not limited to, 
drug or alcohol test results, treatment and followup testing 
requirements or other results from a determination of fitness, and any 
other information that is relevant to an authorization decision.
    (e) In conducting a suitable inquiry, a licensee or other entity 
may obtain information and documents by electronic means, including, 
but not limited to, telephone, facsimile, or e-mail. The licensee or 
other entity shall make a record of the contents of the telephone call 
and shall retain that record, and any documents or electronic files 
obtained electronically, under Sec. Sec.  26.711 and 26.713(a), (b), 
and (c), as applicable.
    (f) For individuals about whom no potentially disqualifying FFD 
information is known (or about whom potentially disqualifying FFD 
information is known, but it has been resolved by a licensee or other 
entity who is subject to this subpart) at the time at which the 
suitable inquiry is initiated, the licensee or other entity shall 
ensure that a suitable inquiry has been conducted as follows:
    (1) Initial authorization. The period of the suitable inquiry must 
be the past 3 years or since the individual's eighteenth birthday, 
whichever is shorter. For the 1-year period immediately preceding the 
date on which the individual applies for authorization, the licensee or 
other entity shall ensure that the suitable inquiry has been conducted 
with every employer, regardless of the length of employment. For the 
remaining 2-year period, the licensee or other entity shall ensure that 
the suitable inquiry has been conducted with the employer by whom the 
individual claims to have been employed the longest within each 
calendar month, if the individual claims employment during the given 
calendar month.
    (2) Authorization update. The period of the suitable inquiry must 
be the period since authorization was terminated. For the 1-year period 
immediately preceding the date on which the individual applies for 
authorization, the licensee or other entity shall ensure that the 
suitable inquiry has been conducted with every employer, regardless of 
the length of employment. For the remaining period since authorization 
was terminated, the licensee or other entity shall ensure that the 
suitable inquiry has been conducted with the employer by whom the 
individual claims to have been employed the longest within each 
calendar month, if the individual claims employment during the given 
calendar month.
    (3) Authorization reinstatement after an interruption of more than 
30 days. The period of the suitable inquiry must be the period since 
authorization was terminated. The licensee or other entity shall ensure 
that the suitable inquiry has been conducted with the employer by whom 
the individual claims to have been employed the longest within the 
calendar month, if the individual claims employment during the given 
calendar month.


Sec.  26.65  Pre-access drug and alcohol testing.

    (a) Purpose. This section contains pre-access testing requirements 
for granting authorization to an individual who either has never held 
authorization or whose last period of authorization was terminated 
favorably and about whom no potentially disqualifying FFD information 
has been discovered or disclosed that was not previously reviewed and 
resolved by a licensee or other entity under the requirements of this 
subpart.
    (b) Accepting tests conducted within the past 30 days. If an 
individual has negative results from drug and alcohol tests that were 
conducted under the requirements of this part before the individual 
applied for authorization from the licensee or other entity, and the 
specimens for such testing were collected within the 30-day period 
preceding the day on which the licensee or other entity grants 
authorization to the individual, the licensee or other entity may rely 
on the results of those drug and alcohol tests to meet the requirements 
for pre-access testing in this section.
    (c) Initial authorization and authorization update. Before granting 
authorization to an individual who has never held authorization or 
whose authorization has been interrupted for a period of more than 365 
days, the licensee or other entity shall verify that the results of 
pre-access drug and alcohol tests, which must be performed within the 
30-day period preceding the day the licensee or other entity grants 
authorization to the individual, are negative. The licensee or other 
entity need not conduct pre-access testing if--
    (1) The individual previously held authorization under this part 
and has been subject to a drug and alcohol testing program that 
includes random testing and a behavioral observation program that 
includes arrest reporting, which both meet the requirements of this 
part, from the date the individual's last authorization was terminated 
through the date the individual is granted authorization; or
    (2) The licensee or other entity relies on negative results from 
drug and alcohol tests that were conducted under the requirements of 
this part at any time before the individual applied for authorization, 
and the individual has remained subject to a drug and alcohol testing 
program that includes random testing and a behavioral observation 
program that includes arrest reporting, which both meet the 
requirements of this part, beginning on the date the drug and alcohol 
testing was conducted through the date the individual is granted 
authorization and thereafter.
    (d) Authorization reinstatement after an interruption of more than 
30 days. (1) To reinstate authorization for an individual whose 
authorization has been interrupted for a period of more than 30 days 
but no more than 365 days, except as permitted in paragraph (d)(2) of 
this section, the licensee or other entity shall--
    (i) Verify that the individual has negative results from alcohol 
testing and collect a specimen for drug testing within the 30-day 
period preceding the day the licensee reinstates the individual's 
authorization; and
    (ii) Verify that the drug test results are negative within 5 
business days of specimen collection or administratively withdraw 
authorization until the drug test results are received.
    (2) The licensee or other entity need not conduct pre-access 
testing of these individuals if--
    (i) The individual previously held authorization under this part 
and has been subject to a drug and alcohol testing program that 
includes random testing and a behavioral observation program that 
includes arrest reporting, which both meet the requirements of this 
part, beginning on the date the individual's last authorization was 
terminated through the date the individual is granted authorization; or
    (ii) The licensee or other entity relies on negative results from 
drug and alcohol tests that were conducted under the requirements of 
this part at any time before the individual applied for authorization, 
and the individual remains subject to a drug and alcohol testing 
program that includes random testing and a behavioral observation 
program that includes arrest reporting, which both meet the 
requirements of this part, beginning on the date the drug and alcohol 
testing was conducted through the date the individual is granted 
authorization.

[[Page 17192]]

    (e) Authorization reinstatement after an interruption of 30 or 
fewer days. (1) The licensee or other entity need not conduct pre-
access testing before granting authorization to an individual whose 
authorization has been interrupted for 5 or fewer days. In addition, 
the licensee or other entity need not conduct pre-access testing if the 
individual has been subject to a drug and alcohol testing program that 
includes random testing and a behavioral observation program that 
includes arrest reporting, which both meet the requirements of this 
part, from the date the individual's last authorization was terminated 
through the date the individual is granted authorization.
    (2) In order to reinstate authorization for an individual whose 
authorization has been interrupted for a period of more than 5 days but 
not more than 30 days, except as permitted in paragraph (e)(1) of this 
section, the licensee or other entity shall take the following actions:
    (i) The licensee or other entity shall subject the individual to 
random selection for pre-access drug and alcohol testing at a one-time 
probability that is equal to or greater than the normal testing rate 
specified in Sec.  26.31(d)(2)(vii) calculated for a 30-day period;
    (ii) If the individual is not selected for pre-access testing under 
paragraph (e)(2)(i) of this section, the licensee or other entity need 
not perform pre-access drug and alcohol tests; or
    (iii) If the individual is selected for pre-access testing under 
this paragraph, the licensee or other entity shall--
    (A) Verify that the individual has negative results from alcohol 
testing and collect a specimen for drug testing before reinstating 
authorization; and
    (B) Verify that the drug test results are negative within 5 
business days of specimen collection or administratively withdraw 
authorization until negative drug test results are received.
    (f) Administrative withdrawal of authorization. If a licensee or 
other entity administratively withdraws an individual's authorization 
under paragraphs (d)(1)(ii) or (e)(2)(iii)(B) of this section, and 
until the drug test results are known, the licensee or other entity may 
not record the administrative action to withdraw authorization as an 
unfavorable termination. The individual may not be required to disclose 
the administrative action in response to requests for self-disclosure 
of potentially disqualifying FFD information, except if the 
individual's authorization was subsequently denied or terminated 
unfavorably by a licensee or entity. Immediately on receipt of negative 
test results, the licensee or other entity shall ensure that any matter 
that could link the individual to the temporary administrative action 
is eliminated from the donor's personnel record and other records.
    (g) Sanctions. If an individual has confirmed positive, 
adulterated, or substituted test results from any drug, validity, or 
alcohol tests that may be required in this section, the licensee or 
other entity shall, at a minimum and as appropriate--
    (1) Deny authorization to the individual, as required by Sec.  
26.75(b), (d), (e)(2), or (g);
    (2) Terminate the individual's authorization, if it has been 
reinstated, under Sec.  26.75(e)(1) or (f); or
    (3) Grant authorization to the individual under Sec.  26.69.


Sec.  26.67   Random drug and alcohol testing of individuals who have 
applied for authorization.

    (a) When the licensee or other entity collects specimens from an 
individual for any pre-access testing that may be required under 
Sec. Sec.  26.65 or 26.69, and thereafter, the licensee or other entity 
shall subject the individual to random testing under Sec.  26.31(d)(2), 
except if--
    (1) The licensee or other entity does not grant authorization to 
the individual; or
    (2) The licensee or other entity relies on drug and alcohol tests 
that were conducted before the individual applied for authorization to 
meet the applicable requirements for pre-access testing. If the 
licensee or other entity relies on drug and alcohol tests that were 
conducted before the individual applied for authorization, the licensee 
or other entity shall subject the individual to random testing when the 
individual arrives at a licensee's or other entity's facility for in-
processing and thereafter.
    (b) If an individual is selected for one or more random tests after 
any applicable requirement for pre-access testing in Sec. Sec.  26.65 
or 26.69 has been met, the licensee or other entity may grant 
authorization before random testing is completed, if the individual has 
met all other applicable requirements for authorization.
    (c) If an individual has confirmed positive, adulterated, or 
substituted test results from any drug, validity, or alcohol test 
required in this section, the licensee or other entity shall, at a 
minimum and as appropriate--
    (1) Deny authorization to the individual, as required by Sec.  
26.75(b), (d), (e)(2), or (g);
    (2) Terminate the individual's authorization, if it has been 
granted, as required by Sec.  26.75(e)(1) or (f); or
    (3) Grant authorization to the individual under Sec.  26.69.


Sec.  26.69  Authorization with potentially disqualifying fitness-for-
duty information.

    (a) Purpose. This section defines the management actions that 
licensees and other entities who are subject to this subpart shall take 
to grant or maintain, at the licensee's or other entity's discretion, 
the authorization of an individual who is in the following 
circumstances:
    (1) Potentially disqualifying FFD information within the past 5 
years has been disclosed or discovered about the individual by any 
means, including, but not limited to, the individual's self-disclosure, 
the suitable inquiry, drug and alcohol testing, the administration of 
any FFD program under this part, a self-report of a legal action, 
behavioral observation, or other sources of information, including, but 
not limited to, any background investigation or credit and criminal 
history check conducted under the requirements of this chapter; and
    (2) The potentially disqualifying FFD information has not been 
reviewed and favorably resolved by a previous licensee or other entity 
under this section.
    (b) Authorization after a first confirmed positive drug or alcohol 
test result or a 5-year denial of authorization. The requirements in 
this paragraph apply to individuals whose authorization was denied or 
terminated unfavorably for a first violation of an FFD policy involving 
a confirmed positive drug or alcohol test result and individuals whose 
authorization was denied for 5 years under Sec.  26.75(c), (d), (e)(2), 
or (f). To grant, and subsequently maintain, the individual's 
authorization, the licensee or other entity shall--
    (1) Obtain and review a self-disclosure and employment history from 
the individual that addresses the shorter period of either the past 5 
years or since the individual's last period of authorization was 
terminated, and verify that the self-disclosure does not contain any 
previously undisclosed potentially disqualifying FFD information before 
granting authorization;
    (2) Complete a suitable inquiry with every employer by whom the 
individual claims to have been employed during the period addressed in 
the employment history obtained under paragraph (b)(1) of this section, 
and obtain and review any records that other licensees or entities who 
are subject to this part may have developed related to the unfavorable 
termination or denial of authorization;

[[Page 17193]]

    (3) If the individual was subject to a 5-year denial of 
authorization under this part, verify that he or she has abstained from 
substance abuse for at least the past 5 years;
    (4) Ensure that an SAE has conducted a determination of fitness and 
concluded that the individual is fit to safely and competently perform 
his or her duties.
    (i) If the individual's authorization was denied or terminated 
unfavorably for a first confirmed positive drug or alcohol test result, 
ensure that clinically appropriate treatment and followup testing plans 
have been developed by an SAE before granting authorization;
    (ii) If the individual was subject to a 5-year denial of 
authorization, ensure that any recommendations for treatment and 
followup testing from an SAE's determination of fitness are initiated 
before granting authorization; and
    (iii) Verify that the individual is in compliance with, and 
successfully completes, any followup testing and treatment plans.
    (5) Within 10 business days before granting authorization, perform 
a pre-access alcohol test, collect a specimen for drug testing under 
direct observation, and ensure that the individual is subject to random 
testing thereafter. Verify that the pre-access drug and alcohol test 
results are negative before granting authorization.
    (6) If the individual's authorization was denied or terminated 
unfavorably for a first confirmed positive drug or alcohol test result 
and a licensee or other entity grants authorization to the individual, 
ensure that the individual is subject to unannounced testing at least 
quarterly for 3 calendar years after the date the individual is granted 
authorization. Both random and followup tests, as defined in Sec.  
26.31(c), satisfy this requirement. Verify that the individual has 
negative test results from a minimum of 15 tests distributed over the 
3-year period, except as follows:
    (i) If the individual does not continuously hold authorization 
during the 3-year period, the licensee or other entity shall ensure 
that at least one unannounced test is conducted in any quarter during 
which the individual holds authorization;
    (ii) If the 15 tests are not completed within the 3-year period 
specified in this paragraph due to periods during which the individual 
does not hold authorization, the followup testing program may be 
extended up to 5 calendar years to complete the 15 tests;
    (iii) If the individual does not hold authorization during the 5-
year period a sufficient number of times or for sufficient periods of 
time to complete the 15 tests required in this paragraph, the licensee 
or other entity shall ensure that an SAE conducts a determination of 
fitness to assess whether further followup testing is required and 
implement the SAE's recommendations; and
    (7) Verify that any drug and alcohol tests required in this 
paragraph, and any other drug and alcohol tests that are conducted 
under this part since authorization was terminated or denied, yield 
results indicating no further drug abuse, as determined by the MRO 
after review, or alcohol abuse, as determined by the result of 
confirmatory alcohol testing.
    (c) Granting authorization with other potentially disqualifying FFD 
information. The requirements in this paragraph apply to an individual 
who has applied for authorization, and about whom potentially 
disqualifying FFD information has been discovered or disclosed that is 
not a first confirmed positive drug or alcohol test result or a 5-year 
denial of authorization. If potentially disqualifying FFD information 
is obtained about an individual by any means, including, but not 
limited to, the individual's self-disclosure, the suitable inquiry, the 
administration of any FFD program under this part, a self-report of a 
legal action, behavioral observation, or other sources of information, 
including, but not limited to, any background investigation or credit 
and criminal history check conducted under the requirements of this 
chapter, before granting authorization to the individual, the licensee 
or other entity shall--
    (1) Obtain and review a self-disclosure and employment history that 
addresses the shortest of the following periods:
    (i) The past 5 years;
    (ii) Since the individual's eighteenth birthday; or
    (iii) Since the individual's last period of authorization was 
terminated;
    (2) Complete a suitable inquiry with every employer by whom the 
individual claims to have been employed during the period addressed in 
the employment history required under paragraph (c)(1) of this section. 
If the individual held authorization within the past 5 years, 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;
    (3) If the designated reviewing official determines that a 
determination of fitness is required, verify that a professional with 
the appropriate qualifications, as specified in Sec.  26.187(a), has 
indicated that the individual is fit to safely and competently perform 
his or her duties;
    (4) Ensure that the individual is in compliance with, or has 
completed, any plans for treatment and drug and alcohol testing from 
the determination of fitness, which may include the collection of a 
urine specimen under direct observation; and
    (5) Verify that the results of pre-access drug and alcohol tests 
are negative before granting authorization, and that the individual is 
subject to random testing after the specimens have been collected for 
pre-access testing and thereafter.
    (d) Maintaining authorization with other potentially disqualifying 
FFD information. If an individual is authorized when other potentially 
disqualifying FFD information is disclosed or discovered, in order to 
maintain the individual's authorization, the licensee or other entity 
shall--
    (1) Ensure that the licensee's or other entity's designated 
reviewing official completes a review of the circumstances associated 
with the information;
    (2) If the designated reviewing official concludes that a 
determination of fitness is required, verify that a professional with 
the appropriate qualifications, as specified in Sec.  26.187(a), has 
indicated that the individual is fit to safely and competently perform 
his or her duties; and
    (3) If the reviewing official determines that maintaining the 
individual's authorization is warranted, implement any recommendations 
for treatment and followup drug and alcohol testing from the 
determination of fitness, which may include the collection of urine 
specimens under direct observation, and ensure that the individual 
complies with and successfully completes the treatment plans.
    (e) Accepting followup testing and treatment plans from another FFD 
program. Licensees and other entities may rely on followup testing, 
treatment plans, and determinations of fitness that meet the 
requirements of Sec.  26.189 and were conducted under the FFD program 
of another licensee or entity who is subject to this subpart.
    (1) If an individual leaves the FFD program in which a treatment 
and/or followup testing plan was required under paragraphs (b), (c), or 
(d) of this section, 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

[[Page 17194]]

authorization to the individual. If the individual is granted 
authorization by the same or another licensee or entity, the licensee 
or other entity who grants authorization to the individual shall ensure 
that any followup testing requirements are met and that the individual 
complies with any treatment plan, with accountability assumed by the 
granting licensee or other entity. If it is impractical for the 
individual to comply with a treatment plan that was developed under 
another FFD program because of circumstances that are outside of the 
individual's or licensee's or other entity's control (e.g., 
geographical distance, closure of a treatment facility), then the 
granting FFD program shall ensure that an SAE develops a comparable 
treatment plan, with accountability for monitoring the individual's 
compliance with the plan assumed by the granting licensee or other 
entity.
    (2) If the previous licensee or other entity determined that the 
individual successfully completed any required treatment and followup 
testing, and the individual's last period of authorization was 
terminated favorably, the receiving licensee or entity may rely on the 
previous determination of fitness and no further review or followup is 
required.
    (f) Sanctions. If an individual has confirmed positive, 
adulterated, or substituted test results from any drug, validity, or 
alcohol test required in this section, the licensee or other entity 
shall, at a minimum and as appropriate--
    (1) Deny authorization to the individual, as required by Sec.  
26.75(b), (d), (e)(2), or (g); or
    (2) Terminate the individual's authorization, if it has been 
granted, as required by Sec.  26.75(e)(1) or (f).


Sec.  26.71  Maintaining authorization.

    (a) Individuals may maintain authorization under the following 
conditions:
    (1) The individual complies with the licensee's or other entity's 
FFD policies and procedures, as described in Sec.  26.27, including the 
responsibility to report any legal actions, as defined in Sec.  26.5;
    (2) The individual remains subject to a drug and alcohol testing 
program that meets the requirements of Sec.  26.31, including random 
testing;
    (3) The individual remains subject to a behavioral observation 
program that meets the requirements of Sec.  26.33; and
    (4) The individual successfully completes required FFD training on 
the schedule specified in Sec.  26.29(c).
    (b) If an authorized individual is not subject to an FFD program 
that meets the requirements of this section for more than 30 continuous 
days, then the licensee or other entity shall terminate the 
individual's authorization and the individual shall meet the 
requirements in this subpart, as applicable, to regain authorization.

Subpart D--Management Actions and Sanctions To Be Imposed


Sec.  26.73  Applicability.

    The requirements in this subpart apply to the licensees and other 
entities identified in Sec.  26.3(a), (b), and, as applicable, (c) for 
the categories of individuals specified in Sec.  26.4(a) through (d) 
and (g). The requirements in this subpart also apply to the licensees 
and other entities specified in Sec.  26.3(c), as applicable, for the 
categories of individuals in Sec.  26.4(e). At the discretion of a 
licensee or other entity in Sec.  26.3(c), the requirements of this 
subpart also may be applied to the categories of individuals identified 
in Sec.  26.4(f). In addition, the requirements in this subpart apply 
to the entities in Sec.  26.3(d) to the extent that a licensee or other 
entity relies on the C/V to meet the requirements of this subpart. The 
regulations in this subpart also apply to the individuals specified in 
Sec.  26.4(h) and (j), as appropriate.


Sec.  26.75  Sanctions.

    (a) This section defines the minimum sanctions that licensees and 
other entities shall impose when an individual has violated the drug 
and alcohol provisions of an FFD policy. A licensee or other entity may 
impose more stringent sanctions, except as specified in paragraph (h) 
of this section.
    (b) Any act or attempted act to subvert the testing process, 
including, but not limited to, 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) must result in the 
immediate unfavorable termination of the individual's authorization and 
permanent denial of authorization thereafter.
    (c) Any individual who is determined to have been involved in the 
sale, use, or possession of illegal drugs or the consumption of alcohol 
within a protected area of any nuclear power plant, within a facility 
that is licensed to possess or use formula quantities of SSNM, within a 
transporter's facility or vehicle, or while performing the duties that 
require the individual to be subject to this subpart shall immediately 
have his or her authorization unfavorably terminated and denied for a 
minimum of 5 years from the date of the unfavorable termination of 
authorization.
    (d) Any individual who resigns or withdraws his or her application 
for authorization before authorization is terminated or denied for a 
first violation of the FFD policy involving a confirmed positive drug 
or alcohol test result shall immediately have his or her authorization 
denied for a minimum of 5 years from the date of termination or denial. 
If an individual resigns or withdraws his or her application for 
authorization before his or her authorization is terminated or denied 
for any violation of the FFD policy, the licensee or other entity shall 
record the resignation or withdrawal, the nature of the violation, and 
the minimum sanction that would have been required under this section 
had the individual not resigned or withdrawn his or her application for 
authorization.
    (e) Lacking any other evidence to indicate the use, sale, or 
possession of illegal drugs or consumption of alcohol on site, a 
confirmed positive drug or alcohol test result must be presumed to be 
an indication of offsite drug or alcohol use in violation of the FFD 
policy.
    (1) The first violation of the FFD policy involving a confirmed 
positive drug or alcohol test result must, at a minimum, result in the 
immediate unfavorable termination of the individual's authorization for 
at least 14 days from the date of the unfavorable termination.
    (2) Any subsequent confirmed positive drug or alcohol test result, 
including during an assessment or treatment period, must result in the 
denial of authorization for a minimum of 5 years from the date of 
denial.
    (f) Paragraph (e) of this section does not apply to the misuse of 
prescription and over-the-counter drugs, except if the MRO determines 
that misuse of the prescription or over-the-counter drug represents 
substance abuse. Sanctions for misuse of prescription and over-the-
counter drugs must be sufficient to deter misuse of those substances.
    (g) For individuals whose authorization was denied for 5 years 
under paragraphs (c), (d), (e)(2), or (f) of this section, any 
subsequent violation of the drug and alcohol provisions of an FFD 
policy must immediately result in permanent denial of authorization.
    (h) A licensee or other entity may not terminate an individual's 
authorization and may not subject the individual to other 
administrative action based solely on a positive test result from any 
initial drug test, other than positive initial test results for 
marijuana or cocaine metabolites from a specimen that is

[[Page 17195]]

reported to be valid on the basis of either validity screening or 
initial validity testing performed at a licensee testing facility, 
unless other evidence, including information obtained under the process 
set forth in Sec.  26.189, indicates that the individual is impaired or 
might otherwise pose a safety hazard. The licensee or other entity may 
not terminate an individual's authorization or subject an individual to 
any other administrative action under this section based on the results 
of validity screening or initial validity testing performed at a 
licensee testing facility indicating that a specimen is of questionable 
validity.
    (i) With respect to positive initial drug test results from a 
licensee testing facility for marijuana and cocaine metabolites from a 
valid specimen, licensee testing facility personnel may inform licensee 
or other entity management of the positive initial drug test result and 
the specific drugs or metabolites identified, and licensees or other 
entities may administratively withdraw the donor's authorization or 
take lesser administrative actions against the donor, provided that the 
licensee or other entity complies with the following conditions:
    (1) For the drug for which action will be taken, at least 85 
percent of the specimens that were determined to be positive as a 
result of initial drug tests at the licensee testing facility during 
the past 12-month data reporting period submitted to the NRC under 
Sec.  26.717 were subsequently reported as positive by the HHS-
certified laboratory as the result of confirmatory testing;
    (2) There is no loss of compensation or benefits to the donor 
during the period of temporary administrative action;
    (3) Immediately on receipt of a negative report from the HHS-
certified laboratory or MRO, any matter that could link the donor to 
the temporary administrative action is eliminated from the donor's 
personnel record and other records; and
    (4) Licensees and other entities may not disclose the temporary 
administrative action against an individual whose initial drug test 
result is not subsequently confirmed by the MRO as a violation of the 
FFD policy in response to a suitable inquiry conducted under the 
provisions of Sec.  26.63, a background investigation conducted under 
the provisions of this chapter, or to any other inquiry or 
investigation.
    (i) To ensure that no records are retained, access to the system of 
files and records must be provided to personnel who are conducting 
reviews, inquiries into allegations, or audits under the provisions of 
Sec.  26.41, and to NRC inspectors.
    (ii) The licensee or other entity shall provide the donor with a 
written statement that the records specified in Sec. Sec.  26.713 and 
26.715 have not been retained with respect to the temporary 
administrative action and shall inform the donor in writing that the 
temporary administrative action that was taken will not be disclosed 
and need not be disclosed by the individual in response to requests for 
self-disclosure of potentially disqualifying FFD information.


Sec.  26.77  Management actions regarding possible impairment.

    (a) This section defines management actions that licensees and 
other entities who are subject to this subpart must take when an 
individual who is subject to this subpart shows indications that he or 
she may not be fit to safely and competently perform his or her duties.
    (b) If an individual appears to be impaired or the individual's 
fitness is questionable, except as permitted under Sec. Sec.  
26.27(c)(3), 26.207, and 26.209, the licensee or other entity shall 
take immediate action to prevent the individual from performing the 
duties that require him or her to be subject to this subpart.
    (1) If an observed behavior or physical condition creates a 
reasonable suspicion of possible substance abuse, the licensee or other 
entity shall perform drug and alcohol testing. The results must be 
negative before the individual returns to performing the duties that 
require the individual to be subject to this subpart. However, if the 
physical condition is the smell of alcohol with no other behavioral or 
physical indications of impairment, then only an alcohol test is 
required and the results must be negative before the individual returns 
to performing his or her duties.
    (2) If a licensee or C/V who is subject to subpart I of this part 
is certain that the observed behavior or physical condition is the 
result solely of fatigue, the licensee or C/V shall ensure that a 
fatigue assessment is conducted under Sec.  26.211. If the results of 
the fatigue assessment confirm that the observed behavior or physical 
condition is the result solely of fatigue, the licensee or C/V need not 
perform drug and alcohol tests or implement the determination of 
fitness process otherwise required by Sec.  26.189.
    (3) For other indications of possible impairment that do not create 
a reasonable suspicion of substance abuse (or fatigue, in the case of 
licensees and C/Vs who are subject to subpart I of this part), the 
licensee or other entity may permit the individual to return to 
performing his or her duties only after the impairing or questionable 
conditions are resolved and a determination of fitness indicates that 
the individual is fit to safely and competently perform his or her 
duties.
    (c) If a licensee or other entity has a reasonable belief that an 
NRC employee or NRC contractor may be under the influence of any 
substance, or is otherwise unfit for duty, the licensee or other entity 
may not deny access but shall escort the individual. In any such 
instance, the licensee or other entity shall immediately notify the 
appropriate Regional Administrator by telephone, followed by written 
notification (e.g., e-mail or fax) to document the oral notification. 
If the Regional Administrator cannot be reached, the licensee or other 
entity shall notify the NRC Operations Center.

Subpart E--Collecting Specimens for Testing


Sec.  26.81  Purpose and applicability.

    This subpart contains requirements for collecting specimens for 
drug testing and conducting alcohol tests by or on behalf of the 
licensees and other entities in Sec.  26.3(a) through (d) for the 
categories of individuals specified in Sec.  26.4(a) through (d) and 
(g). At the discretion of a licensee or other entity in Sec.  26.3(c), 
specimen collections and alcohol tests must be conducted either under 
this subpart for the individuals specified in Sec.  26.4(e) and (f) or 
the licensee or other entity may rely on specimen collections and 
alcohol tests conducted under the requirements of 49 CFR Part 40 for 
the individuals specified in Sec.  26.4(e) and (f). The requirements of 
this subpart do not apply to specimen collections and alcohol tests 
that are conducted under the requirements of 49 CFR Part 40, as 
permitted in this paragraph and under Sec. Sec.  26.4(j) and 
26.31(b)(2) and Subpart K.


Sec.  26.83  Specimens to be collected.

    Except as permitted under Sec.  26.31(d)(5), licensees and other 
entities who are subject to this subpart shall--
    (a) Collect either breath or oral fluids for initial tests for 
alcohol. Breath must be collected for confirmatory tests for alcohol; 
and
    (b) Collect only urine specimens for both initial and confirmatory 
tests for drugs.


Sec.  26.85  Collector qualifications and responsibilities.

    (a) Urine collector qualifications. Urine collectors shall be 
knowledgeable of the requirements of this part and the FFD policy and 
procedures of the

[[Page 17196]]

licensee or other entity for whom collections are performed, and shall 
keep current on any changes to urine collection procedures. Collectors 
shall receive qualification training that meets the requirements of 
this paragraph and demonstrate proficiency in applying the requirements 
of this paragraph before serving as a collector. At a minimum, 
qualification training must provide instruction on the following 
subjects:
    (1) All steps necessary to complete a collection correctly and the 
proper completion and transmission of the custody-and-control form;
    (2) Methods to address ``problem'' collections, including, but not 
limited to, collections involving ``shy bladder'' and attempts to 
tamper with a specimen;
    (3) How to correct problems in collections; and
    (4) 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.
    (b) Alcohol collector qualifications. Alcohol collectors shall be 
knowledgeable of the requirements of this part and the FFD policy and 
procedures of the licensee or other entity for whom collections are 
performed, and shall keep current on any changes to alcohol collection 
procedures. Collectors shall receive qualification training meeting the 
requirements of this paragraph and demonstrate proficiency in applying 
the requirements of this paragraph before serving as a collector. At a 
minimum, qualification training must provide instruction on the 
following subjects:
    (1) The alcohol testing requirements of this part;
    (2) Operation of the particular alcohol testing device(s) [i.e., 
the alcohol screening devices (ASDs) or EBTs] to be used, consistent 
with the most recent version of the manufacturers' instructions;
    (3) Methods to address ``problem'' collections, including, but not 
limited to, collections involving ``shy lung'' and attempts to tamper 
with a specimen;
    (4) How to correct problems in collections; and
    (5) The collector's responsibility for maintaining the integrity of 
the specimen collection process, carefully ensuring the privacy of the 
donor, and avoiding any conduct or remarks that might be construed as 
accusatorial or otherwise offensive or inappropriate.
    (c) Alternative collectors. A medical professional, technologist, 
or technician may serve as a collector without meeting the collector 
qualification requirements in paragraphs (a) or (b) of this section, as 
applicable, only if all of the following conditions are met:
    (1) A collector who meets the requirements of paragraphs (a) or (b) 
of this section cannot reasonably be made available at the time the 
collection must occur;
    (2) The individual is not employed by the licensee's or other 
entity's FFD program and his or her normal workplace is not at the 
licensee's or other entity's facility;
    (3) The individual does not routinely provide FFD program services 
to the licensee or other entity;
    (4) The individual is licensed or otherwise approved to practice in 
the jurisdiction in which the collection occurs; and
    (5) The individual is provided with detailed, clearly-illustrated, 
written instructions for collecting specimens under this subpart and 
follows those instructions.
    (d) Personnel available to testify at proceedings. The licensee or 
other entity shall ensure that qualified collection site personnel, 
when required, are available to testify in an administrative or 
disciplinary proceeding against an individual when that proceeding is 
based on positive drug or alcohol test results or adulterated or 
substituted test results from specimens collected by or under contract 
to the licensee or other entity.
    (e) Files. Collection site personnel files must include each 
individual's resume of training and experience; certification or 
license, if any; references; job descriptions; records of performance 
evaluations and advancement; incident reports, if any; results of tests 
to establish employee competency for the position he or she holds, 
including, but not limited to, certification that collectors are 
proficient in administering alcohol tests consistent with the most 
recent manufacturer's instructions for the instruments and devices 
used; and appropriate data to support determinations of honesty and 
integrity conducted under Sec.  26.31(b).


Sec.  26.87  Collection sites.

    (a) Each FFD program must have one or more designated collection 
sites that have all necessary personnel, materials, equipment, 
facilities, and supervision to collect specimens for drug testing and 
to perform alcohol testing. Each collection site must provide for the 
collection, security, temporary storage, and shipping or transportation 
of urine specimens to a drug testing laboratory; the collection of oral 
fluids or breath specimens; and the security of alcohol testing devices 
and test results. A properly equipped mobile facility that meets the 
requirements of this section is an acceptable collection site.
    (b) The collection site must provide for the donor's visual privacy 
while the donor and collector are viewing the results of an alcohol 
test, and for individual privacy while the donor is submitting a urine 
specimen, except if a directly observed urine specimen collection is 
required. Unauthorized personnel may not be present for the specimen 
collection.
    (c) Contracts for collection site services must permit 
representatives of the NRC, licensee, or other entity to conduct 
unannounced inspections and audits and to obtain all information and 
documentation that is reasonably relevant to the inspections and 
audits.
    (d) Licensees and other entities shall take the following measures 
to prevent unauthorized access to the collection site that could 
compromise the integrity of the collection process or the specimens.
    (1) Unauthorized personnel may not be permitted in any part of the 
designated collection site where specimens are collected or stored;
    (2) A designated collection site must be secure. If a collection 
site is dedicated solely to specimen collection, it must be secure at 
all times. Methods of assuring security may include, but are 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; and
    (3) If a collection site cannot be dedicated solely to collecting 
specimens, the portion of the facility that is used for specimen 
collection must be secured and, during the time period during which a 
specimen is being collected, a sign must be posted to indicate that 
access is permitted only for authorized personnel.
    (e) The following steps must be taken to deter the dilution and 
adulteration of urine specimens at the collection site:
    (1) Agents that color any source of standing water in the stall or 
room in which the donor will provide a specimen, including, but not 
limited to, the toilet bowl or tank, must be placed in the source of 
standing water, so that the reservoirs of water are neither yellow nor 
colorless;
    (2) There must be no other source of water (e.g., no shower or 
sink) in the enclosure where urination occurs, or the source of water 
must be rendered unusable; and

[[Page 17197]]

    (3) Chemicals or products that could be used to contaminate or 
otherwise alter the specimen must be removed from the collection site 
or secured. The collector shall inspect the enclosure in which 
urination will occur before each collection to ensure that no materials 
are available that could be used to subvert the testing process.
    (f) In the exceptional event that a designated collection site is 
inaccessible and there is an immediate requirement to collect a urine 
specimen, including, but not limited to, an event investigation, then 
the licensee or other entity may use a public rest room, onsite rest 
room, or hospital examining room according to the following procedures:
    (1) The facility must be secured by visual inspection to ensure 
that no unauthorized persons are present, and that undetected access 
(e.g., through a rear door not in the view of the collector) is 
impossible. Security during the collection may be maintained by 
restricting access to collection materials and specimens. In the case 
of a public rest room, a sign must be posted or an individual assigned 
to ensure that no unauthorized personnel are present during the entire 
collection procedure to avoid embarrassment of the donor and 
distraction of the collector.
    (2) If practical, a water coloring agent that meets the 
requirements of Sec.  26.87(e)(1) must be placed in the toilet bowl to 
be used by the donor and in any other accessible source of standing 
water, including, but not limited to, the toilet tank. The collector 
shall instruct the donor not to flush the toilet.
    (3) A collector of the same gender as the donor shall accompany the 
donor into the area that will be used for specimen collection, but 
remain outside of the stall, if it is a multi-stalled rest room, or 
outside of the door to the room, if it is a single rest room, in which 
the donor will provide the specimen. If a collector of the same gender 
is not available, the collector shall select a same-gender person to 
accompany the donor. This person shall be instructed on the collection 
procedures specified in this subpart and his or her identity must be 
documented on the custody-and-control form.
    (4) After the collector has possession of the specimen, the 
collector shall inspect the toilet bowl and area to ensure that there 
is no evidence of a subversion attempt and shall then flush the toilet. 
The collector shall instruct the donor to participate with the 
collector in completing the chain-of-custody procedures.
    (5) If it is impractical to maintain continuous physical security 
of a collection site from the time a urine specimen is presented until 
the sealed container is transferred for shipment, the specimen must 
remain under the direct control of an individual who is authorized by 
the licensee or other entity until the specimen is prepared for 
transfer, storage, or shipping, as required by Sec.  26.117. The 
authorized individual shall be instructed on his or her 
responsibilities for maintaining custody and control of the specimen 
and his or her custody of the specimen must be documented on the 
custody-and-control form.


Sec.  26.89  Preparing to collect specimens for testing.

    (a) When an individual has been notified of a requirement for 
testing and does not appear at the collection site within the time 
period specified by FFD program procedures, the collector shall inform 
FFD program management that the individual has not reported for 
testing. FFD program management shall ensure that the necessary steps 
are taken to determine whether the individual's undue tardiness or 
failure to appear for testing constitutes a violation of the licensee's 
or other entity's FFD policy. If FFD program management determines that 
the undue tardiness or failure to report for testing represents an 
attempt to subvert the testing process, the licensee or other entity 
shall impose on the individual the sanctions in Sec.  26.75(b). If FFD 
program management determines that the undue tardiness or failure to 
report does not represent a subversion attempt, the licensee or other 
entity may not impose sanctions but shall ensure that the individual is 
tested at the earliest reasonable and practical opportunity after 
locating the individual.
    (b) Donors shall provide acceptable identification before testing.
    (1) Acceptable identification includes photo-identification issued 
by a licensee or other entity who is subject to this part, or by the 
Federal, State, or local government. Licensees and other entities may 
not accept faxes or photocopies of identification.
    (2) If the donor cannot produce acceptable identification before 
any testing that is required under this part other than pre-access 
testing, the collector shall proceed with the test and immediately 
inform FFD program management that the donor did not present acceptable 
identification. When so informed, FFD program management shall contact 
the individual's supervisor to verify in-person the individual's 
identity, or, if the supervisor is not available, take other steps to 
establish the individual's identity and determine whether the lack of 
identification was an attempt to subvert the testing process. The donor 
may not leave the collection site except under supervision until his or 
her identity has been established.
    (3) If the donor is scheduled for pre-access testing and cannot 
produce acceptable identification, the collector may not proceed with 
the collection, and shall inform FFD program management that the 
individual did not present acceptable identification. When so informed, 
FFD program management will take the necessary steps to determine 
whether the lack of identification was an attempt to subvert the 
testing process.
    (4) The collector shall explain the testing procedure to the donor, 
show the donor the form(s) to be used, and ask the donor to sign a 
consent-to-testing form. The donor may not be required to list 
prescription medications or over-the-counter preparations that he or 
she has recently used.
    (c) The collector shall inform the donor that, if the donor refuses 
to cooperate in the specimen collection process (including, but not 
limited to, behaving in a confrontational manner that disrupts the 
testing process; admitting to the collector that he or she adulterated, 
diluted, or adulterated the specimen; is found to have a device, such 
as a prosthetic appliance, the purpose of which is to interfere with 
providing an actual urine specimen; or leaving the collection site 
before all of the collection procedures are completed), it will be 
considered a refusal to test, and sanctions for subverting the testing 
process will be imposed under Sec.  26.75(b). If the donor refuses to 
cooperate in the collection procedures, the collector shall inform FFD 
program management to obtain guidance on the actions to be taken.
    (d) In order to promote the security of specimens, avoid 
distraction of the collector, and ensure against any confusion in the 
identification of specimens, a collector shall conduct only one 
collection procedure at any given time. For this purpose, a urine 
collection procedure is complete when the urine specimen container has 
been sealed and initialed, the chain-of-custody form has been executed, 
and the donor has departed the collection site.


Sec.  26.91  Acceptable devices for conducting initial and confirmatory 
tests for alcohol and methods of use.

    (a) Acceptable alcohol screening devices. Alcohol screening devices 
(ASDs), including devices that test specimens of oral fluids or breath, 
must be approved by the National Highway

[[Page 17198]]

Traffic Safety Administration (NHTSA) and listed in the most current 
version of NHTSA's Conforming Products List (CPL) for such devices. An 
ASD that is listed in the NHTSA CPL may be used only for initial tests 
for alcohol, and may not be used for confirmatory tests.
    (b) Acceptable evidential breath testing devices. Evidential breath 
testing devices listed in the NHTSA CPL for evidential devices that 
meet the requirements of paragraph (c) of this section must be used to 
conduct confirmatory alcohol tests, and may be used to conduct initial 
alcohol tests. Note that, among the devices listed in the CPL for EBTs, 
only those devices listed without an asterisk (*) may be used for 
confirmatory alcohol testing under this subpart.
    (c) EBT capabilities. An EBT that is listed in the NHTSA CPL for 
evidential devices that has the following capabilities may be used for 
conducting initial alcohol tests and must be used for confirmatory 
alcohol tests under this subpart:
    (1) Provides a printed result of each breath test;
    (2) Assigns a unique number to each completed test, which the 
collector and donor can read before each test and which is printed on 
each copy of the test result;
    (3) Prints, on each copy of the test result, the manufacturer's 
name for the device, its serial number, and the time of the test;
    (4) Distinguishes alcohol from acetone at the 0.02 alcohol 
concentration level;
    (5) Tests an air blank; and
    (6) Permits performance of an external calibration check.
    (d) Quality assurance and quality control of ASDs. (1) Licensees 
and other entities shall implement the most recent version of the 
quality assurance plan submitted to NHTSA for any ASD that is used for 
initial alcohol testing.
    (2) Licensees and other entities may not use an ASD that fails the 
specified quality control checks or that has passed its expiration 
date.
    (3) For ASDs that test breath specimens and meet EBT requirements 
for confirmatory testing, licensees and other entities shall also 
follow the device use and care requirements specified in paragraph (e) 
of this section.
    (e) Quality assurance and quality control of EBTs. (1) Licensees 
and other entities shall implement the most recent version of the 
manufacturer's instructions for the use and care of the EBT 
consistently with the quality assurance plan submitted to NHTSA for the 
EBT, including performing external calibration checks no less 
frequently than at the intervals specified in the manufacturer's 
instructions.
    (2) When conducting external calibration checks, licensees and 
other entities shall use only calibration devices appearing on NHTSA's 
CPL for ``Calibrating Units for Breath Alcohol Tests.''
    (3) If an EBT fails an external check of calibration, the licensee 
or other entity shall take the EBT out of service. The EBT may not be 
used again for alcohol testing under this subpart until it is repaired 
and passes an external calibration check.
    (4) In order to ensure that confirmed positive alcohol test results 
are derived from an EBT that is calibrated, the licensee or other 
entity shall implement one of the following procedures:
    (i) If an EBT fails any external check of calibration, cancel every 
confirmed positive test result that was obtained using the EBT from any 
tests that were conducted after the EBT passed the last external 
calibration check; or
    (ii) After every confirmed positive test result obtained from using 
an EBT, conduct an external check of calibration of the EBT in the 
presence of the donor. If the EBT fails the external calibration check, 
cancel the donor's test result and conduct another initial and 
confirmatory test on a different EBT as soon as practicable.
    (5) Inspection, maintenance, and calibration of the EBT must be 
performed by its manufacturer or a maintenance representative or other 
individual who is certified either by the manufacturer or by a State 
health agency or other appropriate State agency.


Sec.  26.93  Preparing for alcohol testing.

    (a) Immediately before collecting a specimen for alcohol testing, 
the collector shall--
    (1) Ask the donor whether he or she, in the past 15 minutes, has 
had anything to eat or drink, belched, or put anything into his or her 
mouth (including, but not limited to, a cigarette, breath mint, or 
chewing gum), and instruct the donor that he or she should avoid these 
activities during the collection process;
    (2) If the donor states that he or she has not engaged in the 
activities listed in paragraph (a)(1) of this section, alcohol testing 
may proceed;
    (3) If the donor states that he or she has engaged in any of the 
activities listed in paragraph (a)(1) of this section, inform the donor 
that a 15-minute waiting period is necessary to prevent an accumulation 
of mouth alcohol from leading to an artificially high reading;
    (4) Explain that it is to the donor's benefit to avoid the 
activities listed in paragraph (a)(1) of this section during the 
collection process;
    (5) Explain that the initial and confirmatory tests, if a 
confirmatory test is necessary, will be conducted at the end of the 
waiting period, even if the donor has not followed the instructions; 
and
    (6) Document that the instructions were communicated to the donor.
    (b) With the exception of the 15-minute waiting period, if 
necessary, the collector shall begin for-cause alcohol and/or drug 
testing as soon as reasonably practical after the decision is made that 
for-cause testing is required. When for-cause alcohol testing is 
required, alcohol testing may not be delayed by collecting a specimen 
for drug testing.


Sec.  26.95  Conducting an initial test for alcohol using a breath 
specimen.

    (a) The collector shall perform the initial breath test as soon as 
practical after the donor indicates that he or she has not engaged in 
the activities listed in Sec.  26.93(a)(1) or after the 15-minute 
waiting period has elapsed, if required.
    (b) To perform the initial test, the collector shall--
    (1) Select, or allow the donor to select, an individually wrapped 
or sealed mouthpiece from the testing materials;
    (2) Open the individually wrapped or sealed mouthpiece in view of 
the donor and insert it into the device as required by the 
manufacturer's instructions;
    (3) Instruct the donor to blow steadily and forcefully into the 
mouthpiece for at least 6 seconds or until the device indicates that an 
adequate amount of breath has been obtained;
    (4) Show the donor the displayed or printed test result; and
    (5) Ensure that the test result record can be associated with the 
donor and is maintained secure.
    (c) Unless problems in administering the breath test require an 
additional collection, only one breath specimen may be collected for 
the initial test. If an additional collection(s) is required, the 
collector shall rely on the test result from the first successful 
collection to determine the need for confirmatory testing.


Sec.  26.97  Conducting an initial test for alcohol using a specimen of 
oral fluids.

    (a) To perform the initial test, the collector shall--
    (1) Check the expiration date on the device and show it to the 
donor (the device may not be used after its expiration date);
    (2) Open an individually wrapped or sealed package containing the 
device in the presence of the donor;

[[Page 17199]]

    (3) Offer the donor the choice of using the device or having the 
collector use it. If the donor chooses to use it, instruct the donor to 
insert the device into his or her mouth and use it in the manner 
described by the device's manufacturer;
    (4) If the donor chooses not to use the device, or in all cases 
when a new test is necessary because the device failed to activate, 
insert the device into the donor's mouth, and gather oral fluids in the 
manner described by the device's manufacturer (wear single-use 
examination or similar gloves while doing so and change them following 
each test); and
    (5) When the device is removed from the donor's mouth, follow the 
manufacturer's instructions regarding necessary next steps to ensure 
that the device has activated.
    (b) If the steps in paragraph (a) of this section could not be 
completed successfully (e.g., the device breaks, the device is dropped 
on the floor, the device fails to activate), the collector shall--
    (1) Discard the device and conduct a new test using a new device. 
The new device must be one that has been under the collector's control 
before the test;
    (2) Record the reason for the new test;
    (3) Offer the donor the choice of using the device or having the 
collector use it unless the donor, in the opinion of the collector, was 
responsible for the new test needing to be conducted. If the collector 
concludes that the donor was responsible, then the collector shall use 
the device to conduct the test; and
    (4) Repeat the procedures in paragraph (a) of this section.
    (c) If the second collection attempt in paragraph (b) of this 
section could not be completed, the collector shall--
    (1) End the collection of oral fluids and document the reason(s) 
that the collection could not be completed; and
    (2) Immediately conduct another initial test using an EBT.
    (d) The collector shall read the result displayed on the device no 
sooner than the device's manufacturer instructs. In all cases, the 
collector shall read the result within 15 minutes of the test. The 
collector shall then show the device and its reading to the donor, 
record the result, and record that an ASD was used.
    (e) Devices, swabs, gloves, and other materials used in collecting 
oral fluids may not be re-used.


Sec.  26.99  Determining the need for a confirmatory test for alcohol.

    (a) If the initial test result is less than 0.02 percent BAC, the 
collector shall declare the test result as negative.
    (b) If the initial test result is 0.02 percent BAC or higher, the 
collector shall ensure that the time at which the test was concluded 
(i.e., the time at which the test result was known) is recorded and 
inform the donor that a confirmatory test for alcohol is required.


Sec.  26.101  Conducting a confirmatory test for alcohol.

    (a) The confirmatory test must begin as soon as possible, but no 
more than 30 minutes after the conclusion of the initial test.
    (b) To complete the confirmatory test, the collector shall--
    (1) In the presence of the donor, conduct an air blank on the EBT 
before beginning the confirmatory test and show the result to the 
donor;
    (2) Verify that the reading is 0.00. If the reading is 0.00, the 
test may proceed. If not, then conduct another air blank;
    (3) If the reading on the second air blank is 0.00, the test may 
proceed. If the reading is greater than 0.00, take the EBT out of 
service and proceed with the test using another EBT. If an EBT is taken 
out of service for this reason, the EBT may not be used for further 
testing until it is found to be within tolerance limits on an external 
check of calibration;
    (4) Open an individually wrapped or sealed mouthpiece in view of 
the donor and insert it into the device as required by the 
manufacturer's instructions;
    (5) Read the unique test number displayed on the EBT, and ensure 
that the donor reads the same number;
    (6) Instruct the donor to blow steadily and forcefully into the 
mouthpiece for at least 6 seconds or until the device indicates that an 
adequate amount of breath has been obtained; and
    (7) Show the donor the result displayed on or printed by the EBT, 
record the result, and document the time at which the confirmatory test 
result was known.
    (c) Unless there are problems in administering the breath test that 
require an additional collection, the collector shall collect only one 
breath specimen for the confirmatory test. If an additional 
collection(s) is required because of problems in administering the 
breath test, the collector shall rely on the breath specimen from the 
first successful collection to determine the confirmatory test result. 
Collection procedures may not require collectors to calculate an 
average or otherwise combine results from two or more breath specimens 
to determine the confirmatory test result.
    (d) If an EBT that meets the requirements of Sec.  26.91(b) and (c) 
was used for the initial alcohol test, the same EBT may be used for 
confirmatory testing.


Sec.  26.103  Determining a confirmed positive test result for alcohol.

    (a) A confirmed positive test result for alcohol must be declared 
under any of the following conditions:
    (1) When the result of the confirmatory test for alcohol is 0.04 
percent BAC or higher;
    (2) When the result of the confirmatory test for alcohol is 0.03 
percent BAC or higher and the donor had been in a work status for at 
least 1 hour at the time the initial test was concluded (including any 
breaks for rest, lunch, dental/doctor appointments, etc.); or
    (3) When the result of the confirmatory test for alcohol is 0.02 
percent BAC or higher and the donor had been in a work status for at 
least 2 hours at the time the initial test was concluded (including any 
breaks for rest, lunch, dental/doctor appointments, etc.).
    (b) When the result of the confirmatory test for alcohol is equal 
to or greater than 0.01 percent BAC but less than 0.02 percent BAC and 
the donor has been in a work status for 3 hours or more at the time the 
initial test was concluded (including any breaks for rest, lunch, 
dental/doctor appointments, etc.), the collector shall declare the test 
result as negative and inform FFD program management. The licensee or 
other entity shall prohibit the donor from performing any duties that 
require the individual to be subject to this subpart and may not return 
the individual to performing such duties until a determination of 
fitness indicates that the donor is fit to safely and competently 
perform his or her duties.


Sec.  26.105  Preparing for urine collection.

    (a) The collector shall ask the donor to remove any unnecessary 
outer garments, such as a coat or jacket, which might conceal items or 
substances that the donor could use to tamper with or adulterate his or 
her urine specimen. The collector shall ensure that all personal 
belongings such as a purse or briefcase remain with the outer garments 
outside of the room or stall in which the urine specimen is collected. 
The donor may retain his or her wallet.
    (b) The collector shall also ask the donor to empty his or her 
pockets and display the items in them to enable the collector to 
identify items that the donor could use to adulterate or substitute his 
or her urine specimen. The donor shall permit the collector to make 
this observation. If the donor refuses to show the collector the items 
in his or her

[[Page 17200]]

pockets, this is considered a refusal to test. If an item is found that 
appears to have been brought to the collection site with the intent to 
adulterate or substitute the specimen, the collector shall contact the 
MRO or FFD program manager to determine whether a directly observed 
collection is required. If the item appears to have been inadvertently 
brought to the collection site, the collector shall secure the item and 
continue with the normal collection procedure. If the collector 
identifies nothing that the donor could use to adulterate or substitute 
the specimen, the donor may place the items back into his or her 
pockets.
    (c) The collector shall instruct the donor to wash and dry his or 
her hands before urinating.
    (d) After washing his or her hands, the donor shall remain in the 
presence of the collector and may not have access to any water 
fountain, faucet, soap dispenser, cleaning agent, or other materials 
that he or she could use to adulterate the urine specimen.
    (e) The collector may select, or allow the donor to select, an 
individually wrapped or sealed collection container from the collection 
kit materials. Either the collector or the donor, with both present, 
shall unwrap or break the seal of the collection container. With the 
exception of the collection container, the donor may not take anything 
from the collection kit into the room or stall used for urination.


Sec.  26.107  Collecting a urine specimen.

    (a) The collector shall direct the donor to go into the room or 
stall used for urination, provide a specimen of the quantity that has 
been predetermined by the licensee or other entity, as defined in Sec.  
26.109(a), not flush the toilet, and return with the specimen as soon 
as the donor has completed the void.
    (1) The donor shall provide his or her urine specimen in the 
privacy of a room, stall, or otherwise partitioned area (private area) 
that allows for individual privacy, except if a directly observed 
collection is required, as described in Sec.  26.115;
    (2) Except in the case of a directly observed collection, no one 
may go with the donor into the room or stall in which the donor will 
provide his or her specimen; and
    (3) The collector may set a reasonable time limit for voiding.
    (b) The collector shall pay careful attention to the donor during 
the entire collection process to note any conduct that clearly 
indicates an attempt to tamper with a specimen (e.g., substitute urine 
is in plain view or an attempt to bring an adulterant or urine 
substitute into the private area used for urination). If any such 
conduct is detected, the collector shall document the conduct on the 
custody-and-control form and contact FFD program management to 
determine whether a directly observed collection is required, as 
described in Sec.  26.115.
    (c) After the donor has provided the urine specimen and submitted 
it to the collector, the donor shall be permitted to wash his or her 
hands. The collector shall inspect the toilet bowl and room or stall in 
which the donor voided to identify any evidence of a subversion 
attempt, and then flush the toilet.


Sec.  26.109  Urine specimen quantity.

    (a) Licensees and other entities who are subject to this subpart 
shall establish a predetermined quantity of urine that donors are 
requested to provide when submitting a specimen. At a minimum, the 
predetermined quantity must include 30 milliliters (mL) to ensure that 
a sufficient quantity of urine is available for initial and 
confirmatory validity and drug tests at an HHS-certified laboratory, 
and for retesting of an aliquot of the specimen if requested by the 
donor under Sec.  26.165(b). The licensee's or other entity's 
predetermined quantity may include more than 30 mL, if the testing 
program follows split specimen procedures, tests for additional drugs, 
or performs initial testing at a licensee testing facility. Where 
collected specimens are to be split under the provisions of this 
subpart, the predetermined quantity must include an additional 15 mL.
    (b) If the quantity of urine in the first specimen provided by the 
donor is less than 30 mL, the collector shall take the following steps:
    (1) The collector shall encourage the donor to drink a reasonable 
amount of liquid (normally, 8 ounces of water every 30 minutes, but not 
to exceed a maximum of 40 ounces over 3 hours) until the donor provides 
a specimen containing at least 30 mL. The collector shall provide the 
donor with a separate collection container for each successive 
specimen;
    (2) Once the donor provides a specimen of at least 30 mL, the 
collection must end. If the specimen quantity is at least 30 mL but is 
less than the licensee's or other entity's predetermined quantity, the 
licensee or other entity may not require the donor to provide 
additional specimens and may not impose any sanctions on the donor. If 
the donor provides a specimen of 30 mL or more, but the specimen 
quantity is less than the predetermined quantity, the collector shall 
forward the specimen to the HHS-certified laboratory for testing. If 
the donor provides a specimen of at least the predetermined quantity, 
the specimen may be processed under the FFD program's usual testing 
procedures;
    (3) If the donor has not provided a specimen of at least 30 mL 
within 3 hours of the first unsuccessful attempt to provide a specimen 
of the predetermined quantity, the collector shall discontinue the 
collection and notify the FFD program manager or MRO to initiate the 
``shy bladder'' procedures in Sec.  26.119; and
    (4) Neither the donor nor the collector may combine specimens. The 
collector shall discard specimens of less than 30 mL, except if there 
is reason to believe that the donor has diluted, adulterated, 
substituted, or otherwise tampered with the specimen, based on the 
collector's observations of the donor's behavior during the collection 
process or the specimen's characteristics, as specified in Sec.  
26.111. If the collector has a reason to believe that a specimen that 
is 15 mL or more, but less than 30 mL, has been diluted, adulterated, 
substituted, or altered, the collector shall prepare the suspect 
specimen for shipping to the HHS-certified laboratory and contact FFD 
program management to determine whether a directly observed collection 
is required, as described in Sec.  26.115.


Sec.  26.111  Checking the acceptability of the urine specimen.

    (a) Immediately after the donor provides the urine specimen to the 
collector, including specimens of less than 30 mL but greater than 15 
mL, the collector shall measure the temperature of the specimen. The 
temperature-measuring device used must accurately reflect the 
temperature of the specimen and not contaminate the specimen. The time 
from urination to temperature measurement may not exceed 4 minutes. If 
the temperature of a urine specimen is outside the range of 90 [deg]F 
to 100 [deg]F (32 [deg]C to 38 [deg]C), that is a reason to believe the 
donor may have altered or substituted the specimen.
    (b) Immediately after the donor provides a urine specimen, 
including specimens of less than 30 mL but equal to or greater than 15 
mL, the collector shall also inspect the specimen to determine its 
color and clarity and look for any signs of contaminants or 
adulteration. The collector shall note any unusual findings on the 
custody-and-control form.
    (c) If there is reason to believe that the donor may have attempted 
to dilute, substitute, or adulterate the specimen based on specimen 
temperature or other observations made during the collection, the 
collector shall contact the

[[Page 17201]]

designated FFD program manager, who may consult with the MRO, to 
determine whether the donor has attempted to subvert the testing 
process or whether other circumstances may explain the observations. 
The FFD program manager or MRO may require the donor to provide a 
second specimen as soon as possible under direct observation. In 
addition, the collector shall inform the donor that he or she may 
volunteer to submit a second specimen under direct observation to 
counter the reason to believe the donor may have altered or substituted 
the specimen.
    (d) Any specimen of 15 mL or more that the collector suspects has 
been diluted, substituted, or adulterated, and any specimen of 15 mL or 
more that has been collected under direct observation under paragraph 
(c) of this section, must be sent directly to the HHS-certified 
laboratory for initial and, if required, confirmatory testing, and may 
not be subject to initial testing at a licensee testing facility.
    (e) As much of the suspect specimen as possible must be preserved.
    (f) An acceptable specimen is free of any apparent contaminants, 
meets the required basic quantity of at least 30 mL, and is within the 
acceptable temperature range.


Sec.  26.113  Splitting the urine specimen.

    (a) Licensees and other entities may, but are not required to, use 
split-specimen methods of collection.
    (b) If the urine specimen is to be split into two specimen bottles, 
hereinafter referred to as Bottle A and Bottle B, the collector shall 
take the following steps:
    (1) The collector shall instruct the donor to urinate into a 
specimen container;
    (2) The collector, in the presence of the donor and after 
determining specimen temperature as described in Sec.  26.111(a), shall 
split the urine specimen. The collector shall pour 30 mL of urine into 
Bottle A and a minimum of 15 mL of urine into Bottle B. If the quantity 
of urine available for Bottle B is less than 15 mL, the collector shall 
pour the remaining urine into Bottle B and forward the specimens in 
Bottles A and B to the HHS-certified laboratory for drug and validity 
testing; and
    (3) The collector shall ask the donor to observe the splitting of 
the urine specimen and to maintain visual contact with both specimen 
bottles until the custody-and-control form(s) for both specimens are 
completed, the specimens are sealed, and the specimens and form(s) are 
prepared for secure storage or shipping.
    (c) Licensees and other entities may use aliquots of the specimen 
collected for validity screening and initial validity and drug testing 
at the licensee testing facility, as permitted under Sec.  
26.31(d)(3)(ii), or to test for additional drugs, as permitted under 
Sec.  26.31(d)(1)(i)(A), but only if sufficient urine is available for 
this testing after the specimen has been split into Bottle A and Bottle 
B.


Sec.  26.115  Collecting a urine specimen under direct observation.

    (a) Procedures for collecting urine specimens must provide for the 
donor's privacy unless directed by this subpart or the MRO or FFD 
program manager determines that a directly observed collection is 
warranted. The following circumstances constitute the exclusive grounds 
for performing a directly observed collection:
    (1) The donor has presented, at this or a previous collection, 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;
    (2) The donor has presented, at this collection, a urine specimen 
that falls outside the required temperature range;
    (3) The collector observes conduct clearly and unequivocally 
indicating an attempt to dilute, substitute, or adulterate the 
specimen; and
    (4) A directly observed collection is required under Sec.  26.69.
    (b) Before collecting a urine specimen under direct observation, 
the collector shall obtain the agreement of the FFD program manager or 
MRO to obtain a urine specimen under direct observation. After 
obtaining agreement, the collector shall ensure that a specimen is 
collected under direct observation as soon as reasonably practicable.
    (c) The collector shall explain to the donor the reason for direct 
observation of the collection under paragraph (a) of this section.
    (d) The collector shall complete a new custody-and-control form for 
the specimen that is obtained from the directly observed collection. 
The collector shall record that the collection was observed and the 
reason(s) for the directly observed collection on the form.
    (e) The collector shall ensure that the observer is the same gender 
as the individual. A person of the opposite gender may not act as the 
observer under any conditions. The observer may be a different person 
from the collector and need not be a qualified collector.
    (f) If someone other than the collector is to observe the 
collection, the collector shall instruct the observer to follow the 
procedures in this paragraph. The individual who observes the 
collection shall follow these procedures:
    (1) The observer shall instruct the donor to adjust his or her 
clothing to ensure that the area of the donor's body between the waist 
and knees is exposed;
    (2) The observer shall watch the donor urinate into the collection 
container. Specifically, the observer shall watch the urine go from the 
donor's body into the collection container;
    (3) If the observer is not the collector, the observer may not take 
the collection container from the donor, but shall observe the specimen 
as the donor takes it to the collector; and
    (4) If the observer is not the collector, the collector shall 
record the observer's name on the custody-and-control form.
    (g) If a donor declines to allow a directly observed collection 
that is required or permitted under this section, the donor's refusal 
constitutes an act to subvert the testing process.
    (h) If a collector learns that a directly observed collection 
should have been performed but was not, the collector shall inform the 
FFD program manager, or his or her designee. The FFD program manager or 
designee shall ensure that a directly observed collection is 
immediately performed.


Sec.  26.117   Preparing urine specimens for storage and shipping.

    (a) Both the donor and the collector shall keep the donor's urine 
specimen(s) in view at all times before the specimen(s) are sealed and 
labeled. If any specimen or aliquot is transferred to another 
container, the collector shall ask the donor to observe the transfer 
and sealing of the container with a tamper-evident seal.
    (b) Both the collector and the donor shall be present (at the same 
time) during the procedures outlined in this section.
    (c) The collector shall place an identification label securely on 
each container. The label must contain the date, the donor's specimen 
number, and any other identifying information provided or required by 
the FFD program. The collector shall also apply a tamper-evident seal 
on each container if it is separate from the label. The specimen bottle 
must be securely sealed to prevent undetected tampering.
    (d) The donor shall initial the identification label(s) on the 
specimen bottle(s) for the purpose of certifying that the specimen was 
collected from him or her. The collector shall also ask

[[Page 17202]]

the donor to read and sign a statement on the custody-and-control form 
certifying that the specimen(s) identified as having been collected 
from the donor is, in fact, the specimen(s) that he or she provided.
    (e) The collector shall complete the custody-and-control form(s) 
and shall certify proper completion of the collection.
    (f) The specimens and chain-of-custody forms must be packaged for 
transfer to the HHS-certified laboratory or the licensee's testing 
facility. If the specimens are not immediately prepared for transfer, 
they must be appropriately safeguarded during temporary storage.
    (g) While any part of the chain-of-custody procedures is being 
performed, the specimens and custody documents must be under the 
control of the involved collector. The collector may not leave the 
collection site during the interval between presentation of the 
specimen by the donor and securing of the specimens with identifying 
labels bearing the donor's specimen identification numbers and seals 
initialed by the donor. If the involved collector momentarily leaves 
his or her workstation, the sealed specimens and custody-and-control 
forms must be secured or taken with him or her. If the collector is 
leaving for an extended period of time, the specimens must be packaged 
for transfer to the HHS-certified laboratory or the licensee testing 
facility and secured before the collector leaves the collection site.
    (h) The specimen(s) sealed in a shipping container must be 
immediately transferred, appropriately safeguarded during temporary 
storage, or kept under the personal control of an authorized individual 
until transferred. These minimum procedures apply to the transfer of 
specimens to licensee testing facilities from collection sites (except 
where co-located) as well as to the shipping of specimens to HHS-
certified laboratories. As an option, licensees and other entities may 
ship several specimens via courier in a locked or sealed shipping 
container.
    (i) Collection site personnel shall ensure that a custody-and-
control form is packaged with its associated urine specimen bottle. 
Unless a collection site and a licensee testing facility are co-
located, the sealed and labeled specimen bottles, with their associated 
custody-and-control forms that are being transferred from the 
collection site to the drug testing laboratory must be placed in a 
second, tamper-evident shipping container. The second container must be 
designed to minimize the possibility of damage to the specimen during 
shipment (e.g., specimen boxes, shipping bags, padded mailers, or bulk 
insulated shipping containers with that capability), so that the 
contents of the shipping containers are no longer accessible without 
breaking a tamper-evident seal.
    (j) Collection site personnel shall arrange to transfer the 
collected specimens to the HHS-certified laboratory or the licensee 
testing facility. Licensees and other entities shall take appropriate 
and prudent actions to minimize false negative results from specimen 
degradation. Specimens that have not been shipped to the HHS-certified 
laboratory or the licensee testing facility within 24 hours of 
collection and any specimen that is suspected of having been 
substituted, adulterated, or tampered with in any way must be 
maintained cooled to not more than 6[deg]C (42.8 [deg]F) until they are 
shipped to the HHS-certified laboratory. Specimens must be shipped from 
the collection site to the HHS-certified laboratory or the licensee 
testing facility as soon as reasonably practical but, except under 
unusual circumstances, the time between specimen shipment and receipt 
of the specimen at the licensee testing facility or HHS-certified 
laboratory should not exceed 2 business days.
    (k) Couriers, express carriers, and postal service personnel do not 
have direct access to the custody-and-control forms or the specimen 
bottles. Therefore, there is no requirement that such personnel 
document chain of custody on the custody-and-control forms during 
transit. Custody accountability of the shipping containers during 
shipment must be maintained by a tracking system provided by the 
courier, express carrier, or postal service.


Sec.  26.119   Determining ``shy'' bladder.

    (a) When a donor has not provided a specimen of at least 30 mL 
within the 3 hours permitted for urine collection, FFD program 
personnel shall direct the donor to obtain, within 5 business days, an 
evaluation from a licensed physician who is acceptable to the MRO and 
has expertise in the medical issues raised by the donor's failure to 
provide a sufficient specimen. The MRO may perform this evaluation if 
the MRO has the appropriate expertise.
    (b) If another physician will perform the evaluation, the MRO shall 
provide the other physician with the following information and 
instructions:
    (1) The donor was required to take a drug test, but was unable to 
provide a sufficient quantity of urine to complete the test;
    (2) The potential consequences of refusing to take the required 
drug test; and
    (3) The physician must agree to follow the requirements of 
paragraphs (c) through (f) of this section.
    (c) The physician who conducts this evaluation shall make one of 
the following determinations:
    (1) A medical condition has, or with a high degree of probability 
could have, precluded the donor from providing a sufficient amount of 
urine; or
    (2) 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.
    (d) For purposes of this section, a medical condition includes an 
ascertainable physiological condition (e.g., a urinary system 
dysfunction) or a medically documented pre-existing psychological 
disorder, but does not include unsupported assertions of ``situational 
anxiety'' or dehydration.
    (e) The physician who conducts this evaluation shall provide a 
written statement of his or her determination and the basis for it to 
the MRO. This statement may not include detailed information on the 
donor's medical condition beyond what is necessary to explain the 
determination.
    (f) If the physician who conducts this evaluation determines that 
the donor's medical condition is a serious and permanent or long-term 
disability that is highly likely to prevent the donor from providing a 
sufficient amount of urine for a very long or indefinite period of 
time, the physician shall set forth this determination and the reasons 
for it in the written statement to the MRO.
    (g) The MRO shall seriously consider and assess the information 
provided by the physician in deciding whether the donor has a medical 
condition that has, or with a high degree of probability could have, 
precluded the donor from providing a sufficient amount of urine, as 
follows:
    (1) If the MRO concurs with the physician's determination, then the 
MRO shall declare that the donor has not violated the FFD policy and 
the licensee or other entity shall take no further action with respect 
to the donor;
    (2) If the MRO determines that the medical condition has not, or 
with a high degree of probability could not have, precluded the donor 
from providing a sufficient amount of urine, then the MRO shall declare 
that there has been a refusal to test; or
    (3) If the MRO determines that the medical condition is highly 
likely to prevent the donor from providing a sufficient amount of urine 
for a very

[[Page 17203]]

long or indefinite period of time, then the MRO shall authorize an 
alternative evaluation process, tailored to the individual case, for 
drug testing.

Subpart F--Licensee Testing Facilities


Sec.  26.121   Purpose.

    This subpart contains requirements for facilities that are operated 
by licensees and other entities who are subject to this part to perform 
initial tests of urine specimens for validity, drugs, and drug 
metabolites.


Sec.  26.123   Testing facility capabilities.

    Each licensee testing facility shall have the capability, at the 
same premises, to perform either validity screening tests or initial 
validity tests or both, and initial drug tests for each drug and drug 
metabolite for which testing is conducted.


Sec.  26.125  Licensee testing facility personnel.

    (a) Each licensee testing facility shall have one or more 
individuals who are responsible for day-to-day operations and 
supervision of the testing technicians. The designated individual(s) 
shall have at least a bachelor's degree in the chemical or biological 
sciences, medical technology, or equivalent. He or she shall also have 
training and experience in the theory and practice of the procedures 
used in the licensee testing facility, and a thorough understanding of 
quality control practices and procedures, the review, interpretation, 
and reporting of test results, and proper remedial actions to be taken 
in response to detection of abnormal test or quality control results.
    (b) Other technicians or non-technical staff shall have the 
necessary training and skills for their assigned tasks. Technicians who 
perform urine specimen testing shall have documented proficiency in 
operating the testing instruments and devices used at the licensee 
testing facility.
    (c) Licensee testing facility personnel files must include each 
individual's resume of training and experience; certification or 
license, if any; references; job descriptions; records of performance 
evaluations and advancement; incident reports, if any; results of tests 
that establish employee competency for the position he or she holds, 
including, but not limited to, certification that personnel are 
proficient in conducting testing in accordance with manufacturer's most 
recent instructions for the instruments and devices used and tests for 
color blindness; and appropriate data to support determinations of 
honesty and integrity required by this part.


Sec.  26.127  Procedures.

    (a) Licensee testing facilities shall develop, implement, and 
maintain clear and well-documented procedures for accession, shipment, 
and testing of urine specimens.
    (b) Written chain-of-custody procedures must describe the methods 
to be used 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.
    (c) Licensee testing facilities shall develop, implement, and 
maintain written standard operating procedures for each assay performed 
for drug and specimen validity testing. If a licensee testing facility 
performs validity screening tests, the licensee testing facility shall 
develop, implement, and maintain written standard operating procedures 
for each test. The procedures must include, but are not limited to, 
detailed descriptions of--
    (1) The principles of each test;
    (2) Preparation of reagents, standards, and controls;
    (3) Calibration procedures;
    (4) Derivation of results;
    (5) Linearity of the methods;
    (6) Sensitivity of the methods;
    (7) Cutoff values;
    (8) Mechanisms for reporting results;
    (9) Controls;
    (10) Criteria for unacceptable specimens and results;
    (11) Reagents and expiration dates; and
    (12) References.
    (d) Licensee testing facilities shall develop, implement, and 
maintain written procedures for instrument and test setup and normal 
operation, including the following:
    (1) A schedule for checking critical operating characteristics for 
all instruments and validity screening tests;
    (2) Tolerance limits for acceptable function checks; and
    (3) Instructions for major troubleshooting and repair.
    (e) Licensee testing facilities shall develop, implement, and 
maintain written procedures for remedial actions to be taken when 
systems, and instrumented and non-instrumented tests are out of 
acceptable limits or errors are detected. Each facility shall maintain 
documentation that these procedures are followed and that all necessary 
corrective actions are taken. In addition, each facility shall have 
systems in place to verify all stages of testing and reporting and to 
document the verification.


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

    (a) Each licensee testing facility must be secure at all times. 
Each licensee or other entity shall have sufficient security measures 
in place to control access to the licensee testing facility and to 
ensure that no unauthorized personnel handle specimens or gain access 
to the licensee testing facility's processes or areas where records are 
stored. Access to these secured areas must be limited to specifically 
authorized individuals whose authorization is documented. All 
authorized visitors and maintenance and service personnel shall be 
escorted at all times while in the licensee testing facility.
    (b) When specimens are received, licensee testing facility 
personnel shall inspect each package for evidence of possible tampering 
and shall compare information on the specimen containers within each 
package to the information on the accompanying custody-and-control 
forms. Licensee testing facility personnel shall attempt to resolve any 
discrepancies identified in the information on specimen bottles or on 
the accompanying custody-and-control forms. When resolving any 
discrepancies, licensee testing facility personnel shall obtain a 
memorandum for the record from the specimen collector involved in the 
discrepancy to document correction of the discrepancy. This memorandum 
must accompany the specimen(s) and custody-and-control forms to the 
HHS-certified laboratory if the specimen(s) must be transferred.
    (1) Indications of tampering with specimens in transit from the 
collection site, or at a licensee testing facility, must be reported to 
senior licensee or other entity management as soon as practical and no 
later than 8 hours after the indications are identified. In response to 
a report, licensee or other entity management personnel shall initiate 
an investigation to determine whether tampering has occurred.
    (i) If the investigation determines that tampering has occurred, 
licensee or other entity management shall ensure that corrective 
actions are taken.
    (ii) If there is reason to believe that the integrity or identity 
of a specimen is in question (as a result of tampering or discrepancies 
between the information on the specimen bottle and on the accompanying 
custody-and-control forms that cannot be resolved), the specimen may 
not be tested and the licensee or other entity shall ensure that 
another collection occurs as soon as reasonably practical, except if a 
split specimen collection was performed, either the Bottle A or Bottle 
B seal

[[Page 17204]]

remains intact, and the intact specimen contains at least 15 mL of 
urine. In this instance, the licensee testing facility shall forward 
the intact specimen for testing to the HHS-certified laboratory and may 
not conduct any testing at the licensee testing facility.
    (2) The following are exclusive grounds requiring the MRO to cancel 
the testing of a donor's urine specimen:
    (i) 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;
    (ii) The identification numbers on the specimen bottle seal(s) do 
not match the identification numbers on the custody-and-control form;
    (iii) 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;
    (iv) 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; or
    (v) As required under Sec.  26.165(f)(2).
    (c) The licensee testing facility shall retain specimen containers 
within the testing facility's accession area until all analyses have 
been completed. Testing facility personnel shall use aliquots of the 
specimen and licensee testing facility chain-of-custody forms, or other 
appropriate methods of tracking aliquot custody and control, when 
conducting validity screening and initial validity and drug tests. The 
original specimen bottles and the original custody-and-control forms 
must remain in secure storage. Licensee testing facility personnel may 
discard specimens and aliquots as soon as practical after validity 
screening or initial validity tests have demonstrated that the specimen 
appears valid and initial test results for drugs and drug metabolites 
are negative.
    (d) The licensee testing facility's procedure for tracking custody 
and control of specimens and aliquots must protect the identity of the 
donor, and provide documentation of the testing process and transfers 
of custody of the specimen and aliquots. Each time a specimen or 
aliquot is handled or transferred within the licensee testing facility, 
testing facility personnel shall document the date and purpose and 
every individual in the chain of custody must be identified.
    (e) Urine specimens identified as positive or of questionable 
validity at a licensee testing facility must be shipped to an HHS-
certified laboratory for testing as soon as reasonably practical.
    (f) Licensee testing facility personnel shall take appropriate and 
prudent actions to minimize false negative results from specimen 
degradation. If validity screening or initial validity testing indicate 
that the specimen is of questionable validity, or initial drug test 
results are positive, or if a specimen has not been tested within 24 
hours of receipt at the licensee testing facility, then the facility 
shall maintain the specimen cooled to not more than 6 [deg]C (42.8 
[deg]F) until it is forwarded to the HHS-certified laboratory for 
further testing, if required. Split specimens in Bottle B that are 
associated with positive specimens or specimens of questionable 
validity in Bottle A must also be maintained cooled (as previously 
specified) until test results from the HHS-certified laboratory are 
known to be negative for Bottle A; until the MRO informs the licensee 
testing facility that Bottle B must be forwarded to an HHS-certified 
laboratory for testing; or until the specimen is moved to long-term, 
frozen storage, under Sec.  26.135(c).
    (g) Licensee testing facility personnel shall ensure that the 
original custody-and-control form is packaged with its associated urine 
specimen bottle. Sealed and labeled specimen bottles, with their 
associated custody-and-control forms, being transferred from the 
licensee testing facility to the HHS-certified laboratory must be 
placed in a second, tamper-evident shipping container designed to 
minimize the possibility of damage to the specimen during shipment 
(e.g., specimen boxes, padded mailers, or bulk insulated shipping 
containers with that capability) so that the contents of the shipping 
containers are no longer accessible without breaking a tamper-evident 
seal.
    (h) Couriers, express carriers, and postal service personnel do not 
have direct access to the custody-and-control forms or the specimen 
bottles. Therefore, such personnel are not required to document chain 
of custody on the custody-and-control forms during transit. Custody 
accountability of the shipping containers during shipment must be 
maintained by a tracking system provided by the courier, express 
carrier, or postal service.


Sec.  26.131  Cutoff levels for validity screening and initial validity 
tests.

    (a) Each validity test result from the licensee testing facility 
must be based on performing either a validity screening test or an 
initial validity test, or both, on one or more aliquots of a urine 
specimen. The licensee testing facility shall forward any specimen that 
yields a questionable validity screening or initial validity test 
result to the HHS-certified laboratory for further testing. Licensee 
testing facilities need not perform validity screening tests before 
conducting initial validity tests of a specimen.
    (b) At a minimum, the licensee testing facility shall test each 
urine specimen for creatinine, pH, and one or more oxidizing 
adulterants. Licensees and other entities may not specify more 
stringent cutoff levels for validity screening and initial validity 
tests than those specified in this section. If tests or observations 
indicate one or more of the following from either a validity screening 
test or an initial validity test, the licensee testing facility shall 
forward the specimen to the HHS-certified laboratory for additional 
testing:
    (1) Creatinine is less than 20 milligrams (mg) per deciliter (dL);
    (2) The pH of the specimen is either less than 4.5 or equal to or 
greater than 9, using either a colorimetric pH test with a dynamic 
range of 2 to 12 or pH meter that is capable of measuring pH to one 
decimal place (for initial validity tests), or colorimetric pH tests, 
dipsticks, and pH paper (for pH validity screening tests) that have a 
narrow dynamic range;
    (3) Nitrite or other oxidant concentration is equal to or greater 
than 200 micrograms (mcg) per mL or equal to or greater than 200 mcg/mL 
nitrite-equivalents using either a nitrite colorimetric test or a 
general oxidant colorimetric test;
    (4) The possible presence of an oxidizing adulterant (e.g., 
chromium (VI), pyridine (pyridinium chlorochromate)) is determined 
using either a general oxidant colorimetric test (with a cutoff equal 
to or greater than 50 mcg/mL chromium (VI)-equivalents) or a chromium 
(VI) colorimetric test (chromium (VI) concentration equal to or greater 
than 50 mcg/mL);
    (5) The possible presence of halogen (e.g., bleach, iodine, 
fluoride) is determined using a general oxidant colorimetric test (with 
a cutoff equal to or greater than 200 mcg/mL nitrite-equivalents or 
equal to or greater than 50 mcg/mL chromium (VI)-equivalents), a 
halogen colorimetric test (halogen concentration equal to or greater 
than the limit of detection (LOD)), or the odor of the specimen;
    (6) The possible presence of glutaraldehyde is determined using 
either an aldehyde test (aldehyde present) or the characteristic 
immunoassay response is observed on one or more drug immunoassay tests;
    (7) The possible presence of a surfactant is determined by using a 
surfactant colorimetric test with a cutoff

[[Page 17205]]

equal to or greater than 100 mcg/mL dodecylbenzene sulfonate-equivalent 
or a foam/shake test; or
    (8) The specimen shows evidence of adulterants, including, but not 
limited to, the following:
    (i) Abnormal physical characteristics;
    (ii) Reactions or responses characteristic of an adulterant 
obtained during the validity screening or initial test; or
    (iii) A possible unidentified interfering substance or adulterant, 
demonstrated by interference occurring on the immunoassay drug tests on 
two separate aliquots (i.e., valid immunoassay drug test results cannot 
be obtained).


Sec.  26.133  Cutoff levels for drugs and drug metabolites.

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

        Initial Test Cutoff Levels for Drugs and Drug Metabolites
------------------------------------------------------------------------
                                                           Cutoff level
                   Drug or metabolites                      [nanograms
                                                             (ng)/mL]
------------------------------------------------------------------------
Marijuana metabolites...................................              50
Cocaine metabolites.....................................             300
Opiate metabolites......................................            2000
Phencyclidine (PCP).....................................              25
Amphetamines............................................            1000
------------------------------------------------------------------------

Sec.  26.135  Split specimens.

    (a) If the FFD program follows split-specimen procedures, as 
described in Sec.  26.113, the licensee testing facility shall analyze 
aliquots of the specimen for the licensee's or other entity's purposes 
as described in this part. Except as provided in paragraph (b) in this 
section, the licensee testing facility shall store Bottles A and B of 
the specimen in a secure manner until the facility has finished 
testing. If the initial validity and drug test results are negative and 
the specimen in Bottle A will not be forwarded to the HHS-certified 
laboratory, the licensee testing facility may discard both Bottle A and 
Bottle B. If any test results are positive or indicate that the 
specimen is of questionable validity, the licensee testing facility 
shall forward Bottle A to the HHS-certified laboratory for testing and 
shall retain Bottle B in secure storage, under the requirements of 
Sec.  26.159(i), or may forward it to the HHS-certified laboratory for 
storage.
    (b) If the MRO confirms any positive, adulterated, or substituted 
result for a specimen in Bottle A, based on the results of confirmatory 
testing at an HHS-certified laboratory, and the licensee testing 
facility has elected to retain Bottle B of the specimen, and the donor 
requests testing of the specimen in Bottle B, as permitted under Sec.  
26.165(b), the MRO shall ensure that Bottle B is forwarded to an HHS-
certified laboratory other than the laboratory that tested the specimen 
in Bottle A, under the procedures specified in Sec.  26.165(b).
    (c) If the MRO confirms that the specimen in Bottle A is positive, 
adulterated, substituted, or invalid and the donor does not request 
that Bottle B be tested, the licensee or other entity shall ensure that 
Bottle B is maintained in long-term, frozen storage (-20 [deg]C/-68 
[deg]F or less) for a minimum of 1 year. If a licensee testing facility 
elects to retain the specimen in Bottle B, rather than forwarding it to 
the HHS-certified laboratory with Bottle A, the licensee testing 
facility shall ensure proper storage conditions in the event of a 
prolonged power failure. After the end of 1 year, the licensee or other 
entity may discard Bottle B, with the exception that the licensee 
testing facility shall retain any specimens under legal challenge, or 
as requested by the NRC, until the specimen is no longer needed.


Sec.  26.137  Quality assurance and quality control.

    (a) Quality assurance program. Each licensee testing facility shall 
have a quality assurance program that encompasses all aspects of the 
testing process including, but not limited to, specimen acquisition, 
chain of custody, security and reporting of results, validity screening 
(if validity screening tests are performed), initial validity and drug 
testing, and validation of analytical procedures. Quality assurance 
procedures must be designed, implemented, and reviewed to monitor the 
conduct of each step of the process of validity testing and testing for 
drugs and drug metabolites.
    (b) Performance testing and quality control requirements for 
validity screening tests. (1) Licensee testing facilities may rely on 
validity screening tests to determine the need for initial tests of 
specimen validity either at the licensee testing facility or HHS-
certified laboratory. Licensees and other entities shall ensure that 
the HHS-certified laboratory is capable of conducting confirmatory 
testing for any adulterant for which the licensee testing facility 
conducts validity screening tests. Licensee testing facilities shall 
use only validity screening tests that meet the following criteria:
    (i) Either the test, by lot number, has been placed on the 
Substance Abuse and Mental Health Services Administration (SAMHSA) list 
of point-of-collection tests that are approved for use in the Federal 
Workplace Drug Testing Program; or
    (ii) Before using the test, the licensee or other entity has 
ensured that the validity screening test, by lot number, effectively 
identifies specimens of questionable validity by meeting the following 
performance testing and quality control requirements:
    (A) The creatinine validity screening test must use a 20 mg/dL 
cutoff concentration;
    (B) A pH specimen validity screening test must be able to determine 
if pH is less than 4.5 and if pH is equal to or greater than 9; and
    (C) An oxidant validity screening test must be able to determine if 
an oxidant concentration is equal to or greater than a 200 mcg/mL 
nitrite-equivalent cutoff, and/or a chromium screening test must be 
able to determine concentrations equal to or greater than a 50 mcg/mL 
chromium(VI)-equivalent cutoff, and/or a halogen screening test must be 
able to determine the halogen concentration is equal to or greater than 
the LOD. Licensees and other entities who use validity screening tests 
for additional adulterants shall establish performance testing 
requirements to challenge the licensee testing facility and the HHS-
certified laboratory for the additional validity screening test(s);
    (D) The manufacturer has conducted validation studies to document 
the validity screening test's performance characteristics around each 
applicable cutoff specified in this section, using performance testing 
samples that have been formulated to challenge the validity screening 
test around the applicable cutoffs. These validation studies must 
demonstrate the validity screening test's ability to differentiate 
valid samples from those of questionable validity and the performance 
of the validity screening test(s) around the applicable cutoffs 
specified in this section; and
    (E) The licensee testing facility shall submit three consecutive 
sets of performance testing samples to the manufacturer, using 
performance testing samples that have been formulated to challenge the 
validity screening test around the applicable cutoffs specified

[[Page 17206]]

in this paragraph and whose formulation levels have been confirmed by 
an HHS-certified laboratory. For example, one set of performance 
testing samples used to challenge a creatinine validity screening test 
must include at least six samples formulated at different 
concentrations ranging from 0 to 20 mg/dL. A set of performance testing 
samples used to challenge a pH validity screening test must include at 
least six samples formulated with different pH levels that are equal to 
or less than 4.5, and six samples formulated with different pH levels 
that are equal to or greater than 9. And, a set of performance testing 
samples used to challenge an oxidizing adulterant validity screening 
test must include at least six samples to challenge each validity 
screening test used. The performance testing samples for oxidizing 
adulterants must contain nitrite and other oxidizing adulterant 
concentrations in a range of less than or equal to a 200 mcg/mL 
nitrite-equivalent cutoff to a 500 mcg/mL nitrite-equivalent cutoff; 
chromium samples formulated in a range less than or equal to a 50 mcg/
mL chromium(VI)-equivalent cutoff to 100 mcg/mL chromium(VI)-equivalent 
cutoff; or halogen samples formulated in a concentration at or near the 
LOD and 25 percent above the LOD. The results of analyzing the three 
consecutive sets of performance test samples for each validity 
screening test (i.e., creatinine, pH, nitrite and general oxidants, 
chromium, or halogen) must demonstrate that the validity screening 
test, by lot number, correctly identified at least 90 percent of the 
total validity performance test challenges on each of three sets of 
performance testing samples, and, for each individual specimen validity 
screening test, the test, by lot number, correctly identified at least 
90 percent of the validity performance test challenges on each of three 
sets of performance testing samples; and
    (iii) After the licensee testing facility has placed a validity 
screening test in service, the licensee or other entity shall verify 
that the test, by lot number, remains on the SAMHSA-approved list. Or, 
if the SAMHSA-approved list is unavailable, the licensee or other 
entity shall ensure that the test continues to identify specimens of 
questionable validity, as demonstrated by documentation from the 
manufacturer that a set of validity screening tests from each lot in 
use by the licensee testing facility correctly identified at least 90 
percent of the total validity test challenges on a set of performance 
testing samples, and, for each individual specimen validity screening 
test, that the test, by lot number, correctly identified at least 90 
percent of the validity test challenges. This performance testing must 
be performed at a nominal annual frequency after the date on which the 
manufacturer completed the initial validation studies required under 
paragraph (b)(1)(ii)(D) of this section. The performance testing 
samples used must be formulated to challenge the validity screening 
test around the applicable cutoffs of this subpart.
    (2) In addition, licensee testing facility personnel who perform 
the validity screening tests shall conduct quality control testing of 
validity screening tests as follows:
    (i) At the beginning of any 8-hour period during which the licensee 
testing facility will perform validity screening tests, licensee 
testing facility personnel shall test a minimum of one quality control 
sample that is negative for each specific validity test to be performed 
(e.g., creatinine, pH, nitrites, chromium) during the 8-hour period, 
and one quality control sample that is formulated to challenge the 
validity screening test(s) around the cutoffs specified in this subpart 
for each specific validity test to be performed during the 8-hour 
period. The results of these quality control tests must be correct 
before any donor specimens may be tested.
    (ii) After screening every ten donor specimens during the 8-hour 
period, licensee testing facility personnel shall also challenge each 
validity screening test with at least one quality control sample that 
is formulated to challenge the validity screening test(s) around the 
cutoffs specified in this subpart. If fewer than ten donor specimens 
were screened during the 8-hour period or the number of donor specimens 
tested exceeds a multiple of ten but is less than the next multiple of 
ten (e.g., 24 donor specimens, 48 donor specimens), licensee testing 
facility personnel shall challenge each validity screening test at the 
end of the 8-hour period during which the validity screening tests were 
performed.
    (3) The licensee testing facility shall also submit at least one 
specimen out of every ten donor specimens that test negative using each 
validity screening test that the licensee testing facility uses to an 
HHS-certified laboratory as part of the licensee testing facility's 
quality assurance program.
    (4) Licensee testing facilities shall store specimen validity tests 
as specified by the manufacturer's instructions and may not use such 
tests after the manufacturer's expiration date.
    (c) Validity screening test results. If the results of a validity 
screening test indicate that the specimen is of questionable validity, 
the licensee testing facility may either perform initial validity 
testing or shall forward the specimen to the HHS-certified laboratory 
for further testing.
    (d) Quality control requirements for performing initial validity 
tests. Licensees and other entities shall ensure that the HHS-certified 
laboratory is capable of conducting confirmatory testing for any 
adulterant for which the licensee testing facility conducts initial 
validity tests.
    (1) Creatinine. Creatinine concentration must be measured to 1 
decimal place. The initial creatinine test must have a control in the 
range of 3 to 20 mg/dL and a control in the range of 21 to 25 mg/dL.
    (2) Requirements for performing initial pH tests are as follows:
    (i) Colorimetric pH tests that have a dynamic range of 2 to 12 and 
pH meters and must be capable of measuring pH to one decimal place.
    (ii) An initial colorimetric pH test must have the following 
calibrators and controls:
    (A) One calibrator at 3;
    (B) One calibrator at 11;
    (C) One control in the range of 2 to 2.8;
    (D) One control in the range of 3.2 to 4;
    (E) One control in the range of 4.5 to 9;
    (F) One control in the range of 10 to 10.8; and
    (G) One control in the range of 11.2 to 12.
    (iii) If a pH screening test is not used, an initial pH meter test 
must have the following calibrators and controls:
    (A) One calibrator at 4;
    (B) One calibrator at 7;
    (C) One calibrator at 10;
    (D) One control in the range of 2 to 2.8;
    (E) One control in the range of 3.2 to 4;
    (F) One control in the range of 10 to 10.8; and
    (G) One control in the range of 11.2 to 12.
    (iv) If a pH screening test is used, an initial pH meter test must 
have the following calibrators and controls when the screening result 
indicates that the pH is below the lower decision point in use:
    (A) One calibrator at 4;
    (B) One calibrator at 7;
    (C) One control in the range of 2 to 2.8; and
    (D) One control in the range of 3.2 to 4.

[[Page 17207]]

    (v) If a pH screening test is used, an initial pH meter test must 
have the following calibrators and controls when the screening test 
result indicates that the pH is above the upper decision point in use:
    (A) One calibrator at 7;
    (B) One calibrator at 10;
    (C) One control in the range of 10 to 10.8; and
    (D) One control in the range of 11.2 to 12.
    (3) Oxidizing adulterants. Initial tests for oxidizing adulterants 
must include a calibrator at the appropriate cutoff concentration for 
the compound of interest, a control without the compound of interest 
(i.e., a certified negative control), and a control with at least one 
of the compounds of interest at a measurable concentration. For 
nitrite, the licensee testing facility shall have one control in the 
range of 200 to 400 mcg/mL, one control in the range of 500 to 625 mcg/
mL, and a control without nitrite (i.e., a certified negative control).
    (4) Other adulterants. Initial tests for other adulterants must 
include an appropriate calibrator, a control without the compound of 
interest (i.e., a certified negative control), and a control with the 
compound of interest at a measurable concentration.
    (5) Each analytical run performed to conduct initial validity 
testing shall include at least one quality control sample that appears 
to be a donor specimen to the laboratory analysts.
    (6) The licensee testing facility shall also submit at least one 
specimen out of every 10 donor specimens that test negative on the 
initial validity tests performed by the licensee testing facility to an 
HHS-certified laboratory as part of the licensee testing facility's 
quality assurance program.
    (e) Quality control requirements for initial drug tests. (1) Any 
initial drug test performed by a licensee testing facility must use an 
immunoassay that meets the requirements of the Food and Drug 
Administration for commercial distribution. Licensee testing facilities 
may not use non-instrumented immunoassay testing devices that are 
pending HHS/SAMHSA review and approval for initial drug testing under 
this part. In addition, licensees and other entities may not take 
management actions on the basis of any drug test results obtained from 
non-instrumented devices that may be used for validity screening tests.
    (2) Licensee testing facilities shall discard negative specimens or 
may pool them for use in the licensee testing facility's internal 
quality control program after certification by an HHS-certified 
laboratory that the specimens are negative and valid. Licensee testing 
facilities may not retain any information linking donors to specimens 
that are pooled for use in the internal quality control program.
    (3) Licensee testing facilities may perform multiple initial drug 
tests for the same drug or drug class, provided that all tests meet the 
cutoffs and quality control requirements of this part. For example, a 
licensee testing facility may use immunoassay technique ``A'' for all 
drugs using the licensee's or other entity's cutoff levels, but 
specimens testing positive for amphetamines may also be tested using 
immunoassay technique ``B'' to eliminate any possible positives due to 
structural analogues; or, a valid analytical result cannot be obtained 
using immunoassay technique ``A'' and immunoassay technique ``B'' is 
used in an attempt to obtain a valid analytical result.
    (4) Licensee testing facilities need not assess their false 
positive testing rates for drugs, because all specimens that test as 
positive on the initial tests for drugs and drug metabolites must be 
forwarded to an HHS-certified laboratory for initial and confirmatory 
testing.
    (5) To ensure that the rate of false negative drug tests is kept to 
the minimum that the immunoassay technology supports, licensee testing 
facilities shall submit to the HHS-certified laboratory a minimum of 5 
percent (or at least one) of the donor specimens screened as negative 
from every analytical run.
    (6) A minimum of 10 percent of all specimens in each analytical run 
of specimens to be initially tested for drugs by the licensee testing 
facility must be quality control samples, which the licensee testing 
facility shall use for internal quality control purposes. (These 
samples are not forwarded to the HHS-certified laboratory for further 
testing, other than for performance testing of the samples.) Licensee 
testing facilities shall ensure that quality control samples that are 
positive for each drug and metabolite for which the FFD program 
conducts testing are included in at least one analytical run each 
calendar quarter. The quality control samples for each analytical run 
must include--
    (i) Sample(s) certified by an HHS-certified laboratory to contain 
no drugs or drug metabolites (i.e., negative urine samples);
    (ii) At least one positive control with drug(s) or drug 
metabolite(s) targeted at 25 percent above the cutoff;
    (iii) At least one positive control with drug(s) or drug 
metabolite(s) targeted at 25 percent below the cutoff;
    (iv) A sufficient number of calibrators to ensure and document the 
linearity of the assay method over time in the concentration area of 
the cutoff (after acceptable values are obtained for the known 
calibrators, those values will be used to calculate sample data); and
    (v) At least one positive control, certified to be positive by an 
HHS-certified laboratory, that appears to be a donor specimen to the 
laboratory analysts.
    (7) Licensee testing facilities shall document the implementation 
of procedures to ensure that carryover does not contaminate the testing 
of a donor's specimen.
    (f) Errors in testing. Each licensee testing facility shall 
investigate any testing errors or unsatisfactory performance discovered 
in the testing of quality control samples, in the testing of actual 
specimens, or through the processing of management reviews and/or MRO 
reviews, as well as any other errors or matters that could adversely 
reflect on the licensee testing facility's testing process.
    (1) Whenever possible, the investigation must determine relevant 
facts and identify the root cause(s) of the testing or process error.
    (2) The licensee testing facility shall take action to correct the 
cause(s) of any errors or unsatisfactory performance that are within 
the licensee testing facility's control.
    (3) If false negative results are obtained in any analytical run 
from testing the quality control samples specified in paragraphs (b), 
(d), and (e) of this section at the licensee testing facility, the 
licensee testing facility shall forward all donor specimens from that 
analytical run to the HHS-certified laboratory for additional testing 
and implement corrective actions before resuming testing of donor 
specimens for the drug(s), drug metabolite(s), adulterant(s), or other 
specimen characteristics (i.e., creatinine, pH) associated with the 
quality control sample that yielded the false negative result(s).
    (4) If a donor specimen that yielded negative validity or drug test 
results at the licensee testing facility yields positive, substituted, 
adulterated, or invalid results after confirmatory testing by the HHS-
certified laboratory under paragraphs (b)(3), (d)(6), or (e)(5) of this 
section, the licensee or other entity shall implement corrective 
actions before resuming testing of donor specimens for the drug(s), 
drug metabolite(s), adulterant(s), or other specimen

[[Page 17208]]

characteristics (i.e., creatinine, pH) associated with the donor 
specimen that yielded the false negative result(s). In addition to 
resolving any technical, methodological, or administrative errors in 
the licensee testing facility's testing process, the licensee or other 
entity may re-collect and test specimens from any donor whose test 
results from the licensee testing facility may have been inaccurate.
    (5) A record of the investigative findings and the corrective 
actions taken, where applicable, must be dated and signed by the 
individuals who are responsible for the day-to-day management of the 
licensee testing facility and reported to appropriate levels of 
management.
    (g) Accuracy. Volumetric pipettes and measuring devices must be 
certified for accuracy or be checked by gravimetric, colorimetric, or 
other verification procedure. Automatic pipettes and dilutors must be 
checked for accuracy and reproducibility before being placed in 
service, and periodically thereafter.
    (h) Calibrators and controls. Calibrators and controls must be 
prepared using pure drug reference materials, stock standard solutions 
obtained from other laboratories, or standard solutions that are 
obtained from commercial manufacturers and are properly labeled as to 
content and concentration. Calibrators and controls may not be prepared 
from the same stock solution. The standards and controls must be 
labeled with the following dates: when received; when prepared or 
opened; when placed in service; and when scheduled for expiration.


Sec.  26.139  Reporting initial validity and drug test results.

    (a) The licensee testing facility shall report as negative all 
specimens that are valid on the basis of validity screening or initial 
validity tests, or both, and are negative on the initial tests for 
drugs and drug metabolites. Except as permitted under Sec.  26.75(h), 
positive test results from initial drug tests at the licensee testing 
facility may not be reported to licensee or other entity management. In 
addition, the licensee testing facility may not report results from 
validity screening or initial validity testing indicating that a 
specimen is of questionable validity or positive initial drug test 
results from specimens that are of questionable validity.
    (b) Except as provided in Sec. Sec.  26.37 and 26.75(h), access to 
the results of initial tests must be limited to the licensee testing 
facility's staff, the MRO and MRO staff, the FFD program manager, and, 
when appropriate, EAP staff and the SAE.
    (c) The licensee testing facility shall provide qualified 
personnel, when required, to testify in an administrative or 
disciplinary proceeding against an individual when that proceeding is 
based on urinalysis results reported by the licensee testing facility.
    (d) The licensee testing facility shall prepare the information 
required for the annual report to the NRC, as required in Sec.  26.717.
    (e) The data in the annual report to the NRC must be presented for 
either the cutoff levels specified in this part, or for more stringent 
cutoff levels, if the FFD program uses more stringent cutoff levels for 
drugs and drug metabolites. If the FFD program tests for drugs and drug 
metabolites that are not specified in Sec.  26.31(d)(1), the summary 
must also include the number of positive test results and the cutoff 
levels used for those drugs and drug metabolites.
    (f) The designated FFD program official shall use the available 
information from the licensee testing facility's validity and drug test 
results, the results of quality control testing performed at the 
licensee testing facility, and the results from testing the quality 
control samples that the licensee testing facility submits to the HHS-
certified laboratory to evaluate continued testing program 
effectiveness and detect any local trends in drugs of abuse that may 
require management action or FFD program adjustments. FFD program 
adjustments may include, but are not limited to, training enhancements, 
procedure changes, the expansion of the FFD program's drug panel to 
include additional drugs to be tested, or changes in the types of 
assays, validity screening tests, or instruments used.

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


Sec.  26.151  Purpose.

    This subpart contains requirements for the HHS-certified 
laboratories that licensees and other entities who are subject to this 
part use for testing urine specimens for validity and the presence of 
drugs and drug metabolites.


Sec.  26.153  Using certified laboratories for testing urine specimens.

    (a) Licensees and other entities who are subject to this part shall 
use only laboratories certified under the Department of Health and 
Human Services (HHS) Mandatory Guidelines for Federal Workplace Drug 
Testing Programs [published in the Federal Register on April 11, 1988 
(53 FR 11970), and as amended, June 9, 1994 (59 FR 29908), November 
13,1998 (63 FR 63483), and April 13, 2004 (69 FR 19643)] for specimen 
validity and drug testing, except as permitted under Sec.  
26.31(d)(3)(ii). Information concerning the current certification 
status of laboratories is available from the Division of Workplace 
Programs, Center for Substance Abuse Prevention, Substance Abuse and 
Mental Health Services Administration, Room 815, 5600 Fishers Lane, 
Rockwall 2 Bldg., Rockville, Maryland 20857.
    (b) HHS-certified laboratories shall have the capability, at the 
same premises, to perform both initial and confirmatory tests for 
specimen validity and for each drug and drug metabolite for which the 
HHS-certified laboratory provides services to the licensee or other 
entity.
    (c) An HHS-certified laboratory may not subcontract and shall 
perform all work with its own personnel and equipment unless otherwise 
authorized by the licensee or other entity.
    (d) Licensees and other entities shall use only HHS-certified 
laboratories that agree to follow the same rigorous specimen testing, 
quality control, and chain-of-custody procedures when testing for more 
stringent cutoff levels as may be specified by licensees and other 
entities for the classes of drugs identified in this part, and for any 
other substances included in the licensees' or other entities' panels.
    (e) Before awarding a contract to an HHS-certified laboratory, the 
licensee or other entity shall ensure that qualified personnel conduct 
a pre-award inspection and evaluation of the procedural aspects of the 
laboratory's drug testing operations. However, if an HHS-certified 
laboratory loses its certification, in whole or in part, a licensee or 
other entity may immediately begin using another HHS-certified 
laboratory that is being used by another licensee or entity who is 
subject to this part, as permitted by Sec.  26.41(g)(5).
    (f) All contracts between licensees or other entities who are 
subject to this part and HHS-certified laboratories must require the 
laboratory to implement all applicable requirements of this part. At a 
minimum, licensees' and other entities' contracts with HHS-certified 
laboratories must include the following requirements:
    (1) Laboratory facilities shall comply with the applicable 
provisions of any State licensor requirements;
    (2) The laboratory shall make available qualified personnel to 
testify in an administrative or disciplinary

[[Page 17209]]

proceeding against an individual when that proceeding is based on 
urinalysis results reported by the HHS-certified laboratory;
    (3) The laboratory shall maintain test records in confidence, 
consistent with the requirements of Sec.  26.39, and use them with the 
highest regard for individual privacy;
    (4) Consistent with the principles established in section 503 of 
Public Law 100-71, any employee of a licensee or other entity who is 
the subject of a drug test (or his or her representative designated 
under Sec.  26.37(d)) shall, on written request, have access to the 
laboratory's records related to his or her validity and drug test and 
any records related to the results of any relevant certification, 
review, or revocation-of-certification proceedings;
    (5) The laboratory may not enter into any relationship with the 
licensee's or other entity's MRO(s) that may be construed as a 
potential conflict of interest, including, but not limited to, the 
relationships described in Sec.  26.183(b), and may not derive any 
financial benefit by having a licensee or other entity use a specific 
MRO; and
    (6) The laboratory shall permit representatives of the NRC and any 
licensee or other entity using the laboratory's services to inspect the 
laboratory at any time, including unannounced inspections.
    (g) If licensees or other entities use a form other than the 
current Federal custody-and-control form, licensees and other entities 
shall provide a memorandum to the laboratory explaining why a non-
Federal form was used, but must ensure, at a minimum, that the form 
used contains all the required information on the Federal custody-and-
control form.


Sec.  26.155  Laboratory personnel.

    (a) Day-to-day management of the HHS-certified laboratory. HHS-
certified laboratories shall have a responsible person to assume 
professional, organizational, educational, and administrative 
responsibility for the laboratory's drug testing facilities.
    (1) This individual shall have documented scientific qualifications 
in analytical forensic toxicology. Minimum qualifications are as 
follows:
    (i) Certification by the appropriate State as a laboratory director 
in forensic or clinical laboratory toxicology; or
    (ii) A PhD in one of the natural sciences with an adequate 
undergraduate and graduate education in biology, chemistry, and 
pharmacology or toxicology; or
    (iii) Training and experience comparable to a Ph.D. in one of the 
natural sciences, such as a medical or scientific degree with 
additional training and laboratory/research experience in biology, 
chemistry, and pharmacology or toxicology; and
    (iv) In addition to the requirements in paragraphs (a)(1)(i) 
through (a)(1)(iii) of this section, the responsible person shall also 
have the following minimum qualifications:
    (A) Appropriate experience in analytical forensic toxicology 
including experience with the analysis of biological material for drugs 
of abuse; and
    (B) Appropriate training and/or experience in forensic applications 
of analytical toxicology (e.g., publications, court testimony, research 
concerning analytical toxicology of drugs of abuse, or other factors 
that qualify the individual as an expert witness in forensic 
toxicology).
    (2) This individual shall be engaged in and responsible for the 
day-to-day management of the testing laboratory, even if another 
individual has overall responsibility for an entire multi-specialty 
laboratory.
    (3) This individual shall be responsible for ensuring that there 
are enough personnel with adequate training and experience to supervise 
and conduct the work of the drug testing laboratory. He or she shall 
ensure the continued competency of laboratory personnel by documenting 
their in-service training, reviewing their work performance, and 
verifying their skills.
    (4) This individual shall be responsible for ensuring that the 
laboratory has a manual of standard operating procedures that are 
complete, up-to-date, available for personnel performing tests, and 
followed by those personnel. The procedures must be reviewed, signed, 
and dated by this responsible person whenever the procedures are first 
placed into use or changed or when a new individual assumes 
responsibility for management of the laboratory. This individual shall 
ensure that copies of all procedures and records of the dates on which 
they are in effect are maintained. (Specific contents of the procedures 
are described in Sec.  26.157.)
    (5) This individual shall be responsible for maintaining a quality 
assurance program to assure the proper performance and reporting of all 
test results; maintaining acceptable analytical performance for all 
controls and standards; maintaining quality control testing; and 
assuring and documenting the validity, reliability, accuracy, 
precision, and performance characteristics of each test and test 
system.
    (6) This individual shall be responsible for taking all remedial 
actions that may be necessary to maintain satisfactory operation and 
performance of the laboratory in response to quality control systems 
not being within performance specifications, including errors in result 
reporting or in the analysis of performance testing results. This 
individual shall ensure that test results are not reported until all 
corrective actions have been taken and he or she can assure that the 
test results provided are accurate and reliable.
    (b) Certifying scientist. (1) HHS-certified laboratories shall have 
one or more certifying scientists who review all pertinent data and 
quality control results to certify the laboratory's test results.
    (2) A certifying scientist shall be an individual with at least a 
bachelor's degree in the chemical or biological sciences, medical 
technology, or an equivalent field who reviews all pertinent data and 
quality control results. The individual shall have training and 
experience in the theory and practice of all methods and procedures 
used in the laboratory, including a thorough understanding of chain-of-
custody procedures, quality control practices, and analytical 
procedures relevant to the results that the individual certifies. 
Relevant training and experience must also include the review, 
interpretation, and reporting of test results; maintenance of chain of 
custody; and proper remedial action to be taken in response to aberrant 
test or quality control results, or a determination that test systems 
are out of control limits.
    (3) A laboratory may designate certifying scientists who only 
certify results that are reported negative and certifying scientists 
who certify results that are reported both negative and adulterated, 
substituted, dilute, or invalid.
    (c) Day-to-day operations and supervision of analysts. HHS-
certified laboratories shall assign one or more individuals who are 
responsible for day-to-day operations and supervision of the technical 
analysts. The designated individual(s) shall have at least a bachelor's 
degree in the chemical or biological sciences, medical technology, or 
an equivalent field. The individual(s) shall also have training and 
experience in the theory and practice of the procedures used in the 
laboratory, resulting in his or her thorough understanding of quality 
control practices and procedures; review, interpretation, and reporting 
of test results; maintenance of the chain of

[[Page 17210]]

custody; and proper remedial actions to be taken in response to 
aberrant test or quality control results, or the finding that test 
systems are out of control limits.
    (d) Other personnel. Other technicians or nontechnical staff shall 
have the necessary training and skills for their assigned tasks.
    (e) Training. HHS-certified laboratories shall make available 
continuing education programs to meet the needs of laboratory 
personnel.
    (f) Files. At a minimum, each laboratory personnel file must 
include a r[eacute]sum[eacute], any professional certification(s) or 
license(s), a job description, and documentation to show that the 
individual has been properly trained to perform his or her job.


Sec.  26.157  Procedures.

    (a) HHS-certified laboratories shall develop, implement, and 
maintain clear and well-documented procedures for accession, receipt, 
shipment, and testing of urine specimens.
    (b) Written chain-of-custody procedures must describe the methods 
to be used 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, if required, 
and continuing until final disposition of specimens.
    (c) HHS-certified laboratories shall develop, implement, and 
maintain a written manual of standard operating procedures for each 
assay performed for licensees and other entities for drug and specimen 
validity testing. The procedures must include, but are not limited to, 
detailed descriptions of--
    (1) The principles of each test;
    (2) Preparation of reagents, standards, and controls;
    (3) Calibration procedures;
    (4) Derivation of results;
    (5) Linearity of methods;
    (6) Sensitivity of the methods;
    (7) Cutoff values;
    (8) Mechanisms for reporting results;
    (9) Controls;
    (10) Criteria for unacceptable specimens and results;
    (11) Reagents and expiration dates; and
    (12) References.
    (d) HHS-certified laboratories shall develop, implement, and 
maintain written procedures for instrument setup and normal operation, 
including the following:
    (1) A schedule for checking critical operating characteristics for 
all instruments;
    (2) Tolerance limits for acceptable function checks; and
    (3) Instructions for major troubleshooting and repair.
    (e) HHS-certified laboratories shall develop, implement, and 
maintain written procedures for remedial actions to be taken when 
errors are detected or systems are out of acceptable limits.

The laboratory shall maintain documentation that its personnel follow 
these procedures and take all necessary corrective actions. In 
addition, the laboratory shall have systems in place to verify all 
stages of testing and reporting and to document the verification.


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

    (a) The HHS-certified laboratories performing services for 
licensees and other entities under this part shall be secure at all 
times. Each laboratory shall have in place sufficient security measures 
to control access to the premises and to ensure that no unauthorized 
personnel handle specimens or gain access to the laboratory processes 
or areas where records are stored. Access to these secured areas must 
be limited to specially authorized individuals whose authorization is 
documented. All authorized visitors, and maintenance and service 
personnel, shall be escorted at all times in the laboratory, except 
personnel who are authorized to conduct inspections and audits on 
behalf of licensees, other entities, the NRC, or the HHS Secretary, and 
emergency personnel (including but not limited to firefighters and 
medical rescue teams).
    (b) When a shipment of specimens is received, laboratory personnel 
shall inspect each package for evidence of possible tampering and shall 
compare information on specimen bottles within each package to the 
information on the accompanying custody-and-control forms.
    (1) Any direct evidence of tampering or discrepancies in the 
information on the specimen bottles and the custody-and-control forms 
attached to the shipment must be reported to the licensee or other 
entity within 24 hours of the discovery and must be noted on the 
custody-and-control forms for each specimen contained in the package. 
When notified, the licensee or other entity shall ensure that an 
investigation is initiated to determine whether tampering has occurred.
    (i) If the investigation determines that tampering has occurred, 
the licensee or other entity shall ensure that corrective actions are 
taken.
    (ii) If the licensee or other entity has reason to question the 
integrity and identity of the specimens, the specimens may not be 
tested and the licensee or other entity shall ensure that another 
collection occurs as soon as reasonably practical, except if a split 
specimen collection was performed, either the Bottle A or Bottle B seal 
remains intact, and the intact specimen contains at least 15 mL of 
urine. In this instance, if the licensee testing facility has retained 
the specimen in Bottle B, the licensee testing facility shall forward 
the intact specimen for testing to the HHS-certified laboratory and may 
not conduct any testing at the licensee testing facility.
    (2) The following are exclusive grounds requiring the MRO to cancel 
the testing of a donor's urine specimen:
    (i) 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;
    (ii) The identification numbers on the specimen bottle seal(s) do 
not match the identification numbers on the custody-and-control form;
    (iii) 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;
    (iv) 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; or
    (v) As required under Sec.  26.165(f)(2).
    (c) The HHS-certified laboratory shall retain specimen bottles 
within the laboratory's accession area until all analyses have been 
completed. Laboratory personnel shall use aliquots and laboratory 
internal custody-and-control forms when conducting initial and 
confirmatory tests. The original specimen and the original custody-and-
control form must remain in secure storage.
    (d) The laboratory's internal custody-and-control form must allow 
for identification of the donor, and documentation of the testing 
process and transfers of custody of the specimen.
    (e) Each time a specimen is handled or transferred within the 
laboratory, laboratory personnel shall document the date and purpose on 
the custody-and-control form and every individual in the chain shall be 
identified. Authorized technicians are responsible for each urine 
specimen or aliquot in their possession and shall sign and complete 
custody-and-control forms for those specimens or aliquots as they are 
received.

[[Page 17211]]

    (f) If a specimen is to be transferred to a second HHS-certified 
laboratory, laboratory personnel shall ensure that a copy of the 
custody-and-control form is packaged with the aliquot of a single 
specimen or Bottle B of a split specimen, as appropriate. Sealed and 
labeled specimen bottles and aliquots, with their associated custody-
and-control forms, being transferred from one laboratory to another 
must be placed in a second, tamper-evident shipping container designed 
to minimize the possibility of damage to the specimen during shipment 
(e.g., specimen boxes, padded mailers, or bulk insulated shipping 
containers with that capability) so that the contents of the shipping 
containers are inaccessible without breaking a tamper-evident seal.
    (g) Couriers, express carriers, and postal service personnel do not 
have direct access to the custody-and-control forms or the specimen 
bottles. Therefore, such personnel are not required to document chain 
of custody on the custody-and-control forms during transit. Custody 
accountability of the shipping containers during shipment must be 
maintained by a tracking system provided by the courier, express 
carrier, or postal service.
    (h) Specimens that do not receive an initial test within 7 days of 
arrival at the laboratory must be placed in secure refrigeration units 
for short-term storage. Temperatures may not exceed 6 [deg]C (42.8 
[deg]F). The laboratory shall ensure proper storage conditions in the 
event of a prolonged power failure.
    (i) Long-term frozen storage at a temperature of -20 [deg]C (-68 
[deg]F) or less ensures that positive, adulterated, substituted, and 
invalid urine specimens and Bottle B of a split specimen will be 
available for any necessary retests. Unless otherwise authorized in 
writing by the licensee or other entity, laboratories shall retain and 
place in properly secured long-term frozen storage all specimens 
reported as positive, adulterated, substituted, or invalid. At a 
minimum, such specimens must be stored for 1 year. Within this 1-year 
period, a licensee, other entity, or the NRC may ask the laboratory to 
retain the specimen for an additional period of time. If no retention 
request is received, the laboratory may discard the specimen after the 
end of 1 year. However, the laboratory shall retain any specimens under 
review or legal challenge until they are no longer needed.
    (j) The laboratory shall discard a valid specimen that tests 
negative on initial or confirmatory drug tests or may pool such 
specimens for use in the laboratory's internal quality control program 
after certifying that the specimens are negative and valid. The 
laboratory may not retain any information linking donors to specimens 
that are pooled for use in the internal quality control program.


Sec.  26.161  Cutoff levels for validity testing.

    (a) Validity test results. Each validity test result for a specimen 
that the HHS-certified laboratory reports to the MRO as adulterated, 
substituted, dilute, or invalid must be based on performing an initial 
validity test on one aliquot and a confirmatory validity test on a 
second aliquot. Licensees and other entities shall ensure that the HHS-
certified laboratory is capable of conducting, and conducts, 
confirmatory testing for at least one oxidizing adulterant and any 
other adulterants specified by the licensee's or other entity's testing 
program. If initial validity test results indicate that the specimen is 
valid under the criteria in paragraphs (c) through (f) of this section, 
the HHS-certified laboratory need not perform confirmatory validity 
testing of the specimen.
    (b) Initial validity testing. The HHS-certified laboratory shall 
perform initial validity testing of each specimen as follows:
    (1) Determine the creatinine concentration;
    (2) Determine the specific gravity of every specimen for which the 
creatinine concentration is less than 20 mg/dL;
    (3) Determine the pH;
    (4) Perform one or more initial validity tests for oxidizing 
adulterants; and
    (5) Perform additional validity tests, the choice of which depends 
on the observed indicators or characteristics below, when the following 
conditions are observed:
    (i) Abnormal physical characteristics;
    (ii) Reactions or responses characteristic of an adulterant 
obtained during initial or confirmatory drug tests (e.g., non-recovery 
of internal standards, unusual response); or
    (iii) Possible unidentified interfering substance or adulterant.
    (c) Results indicating an adulterated specimen. The laboratory 
shall report a specimen as adulterated when the specimen yields any one 
or more of the following validity testing results:
    (1) The pH is less than 3, or equal to or greater than 11, using 
either a pH meter or a colorimetric pH test for the initial test on the 
first aliquot and a pH meter for the confirmatory test on the second 
aliquot;
    (2) The nitrite concentration is equal to or greater than 500 mcg/
mL using either a nitrite colorimetric test or a general oxidant 
colorimetric test for the initial test on the first aliquot and a 
different confirmatory test (e.g., multi-wavelength spectrophotometry, 
ion chromatography, capillary electrophoresis) on the second aliquot;
    (3) The presence of chromium (VI) is verified using either a 
general oxidant colorimetric test (with a cutoff equal to or greater 
than 50 mcg/mL chromium (VI)-equivalents) or a chromium (VI) 
colorimetric test (chromium (VI) concentration equal to or greater than 
50 mcg/mL) for the initial test on the first aliquot and a different 
confirmatory test (e.g., multi-wavelength spectrophotometry, ion 
chromatography, atomic absorption spectrophotometry, capillary 
electrophoresis, inductively coupled plasma-mass spectrometry) with the 
chromium (VI) concentration equal to or greater than the LOD of the 
confirmatory test on the second aliquot;
    (4) The presence of halogen (e.g., bleach, iodine, fluoride) is 
verified using either a general oxidant colorimetric test (with a 
cutoff equal to or greater than 200 mcg/mL nitrite-equivalents or a 
cutoff equal to or greater than 50 mcg/mL chromium (VI)-equivalents) or 
a halogen colorimetric test (halogen concentration equal to or greater 
than the LOD) for the initial test on the first aliquot and a different 
confirmatory test (e.g., multi-wavelength spectrophotometry, ion 
chromatography, inductively coupled plasma-mass spectrometry) with a 
specific halogen concentration equal to or greater than the LOD of the 
confirmatory test on the second aliquot;
    (5) The presence of glutaraldehyde is verified using either an 
aldehyde test (aldehyde present) or the specimen yields the 
characteristic immunoassay response on one or more drug immunoassay 
tests for the initial test on the first aliquot and gas chromatography/
mass spectrometry (GC/MS) for the confirmatory test with the 
glutaraldehyde concentration equal to or greater than the LOD of the 
analysis on the second aliquot;
    (6) The presence of pyridine (pyridinium chlorochromate) is 
verified using either a general oxidant colorimetric test (with a 
cutoff equal to or greater than 200 mcg/mL nitrite-equivalents or a 
cutoff equal to or greater than 50 mcg/mL chromium (VI)-equivalents) or 
a chromium (VI) colorimetric test (chromium (VI) concentration equal to 
or greater than 50 mcg/mL) for the initial test on the first aliquot 
and GC/MS for the confirmatory test with the pyridine concentration 
equal to or greater than the LOD of the analysis on the second aliquot;

[[Page 17212]]

    (7) The presence of a surfactant is verified by using a surfactant 
colorimetric test with a cutoff equal to or greater than 100 mcg/mL 
dodecylbenzene sulfonate-equivalent for the initial test on the first 
aliquot and a different confirmatory test (e.g., multi-wavelength 
spectrophotometry) with a cutoff equal to or greater than 100 mcg/mL 
dodecylbenzene sulfonate equivalent on the second aliquot; or
    (8) The presence of any other adulterant not specified in 
paragraphs (c)(3) through (c)(7) of this section is verified using an 
initial test on the first aliquot and a different confirmatory test on 
the second aliquot.
    (d) Results indicating a substituted specimen. The laboratory shall 
report a specimen as substituted when the specimen's creatinine 
concentration is less than 2 mg/dL and its specific gravity is less 
than or equal to 1.0010, or equal to or greater than 1.0200, on both 
the initial and confirmatory creatinine tests (i.e., the same 
colorimetric test may be used to test both aliquots) and on both the 
initial and confirmatory specific gravity tests (i.e., a refractometer 
is used to test both aliquots) on two separate aliquots.
    (e) Results indicating a dilute specimen. The laboratory shall 
report a specimen as dilute when the specimen's creatinine 
concentration is equal to or greater than 2 mg/dL but less than 20 mg/
dL and its specific gravity is greater than 1.0010 but less than 1.0030 
on a single aliquot.
    (f) Results indicating an invalid specimen. The laboratory shall 
report a specimen as invalid when the laboratory obtains any one or 
more of the following validity testing results:
    (1) Inconsistent creatinine concentration and specific gravity 
results are obtained (i.e., the creatinine concentration is less than 2 
mg/dL on both the initial and confirmatory creatinine tests and the 
specific gravity is greater than 1.0010 but less than 1.0200 on the 
initial and/or confirmatory specific gravity test, the specific gravity 
is less than or equal to 1.0010 on both the initial and confirmatory 
specific gravity tests and the creatinine concentration is equal to or 
greater than 2 mg/dL on either or both the initial or confirmatory 
creatinine tests);
    (2) The pH is equal to or greater than 3 and less than 4.5, or 
equal to or greater than 9 and less than 11, using either a 
colorimetric pH test or pH meter for the initial test and a pH meter 
for the confirmatory test on two separate aliquots;
    (3) The nitrite concentration is equal to or greater than 200 mcg/
mL using a nitrite colorimetric test, or equal to or greater than the 
equivalent of 200 mcg/mL nitrite using a general oxidant colorimetric 
test for both the initial test and the confirmatory test, or, using 
either initial test, the nitrite concentration is equal to or greater 
than 200 mcg/mL but less than 500 mcg/mL using a different confirmatory 
test (e.g., multi-wavelength spectrophotometry, ion chromatography, 
capillary electrophoresis) on two separate aliquots;
    (4) The possible presence of chromium (VI) is determined using the 
same chromium (VI) colorimetric test with a cutoff equal to or greater 
than 50 mcg/mL chromium (VI) for both the initial test and the 
confirmatory test on two separate aliquots;
    (5) The possible presence of a halogen (e.g., bleach, iodine, 
fluoride) is determined using the same halogen colorimetric test with a 
cutoff equal to or greater than the LOD for both the initial test and 
the confirmatory test on two separate aliquots or relying on the odor 
of the specimen as the initial test;
    (6) The possible presence of glutaraldehyde is determined using the 
same aldehyde test (aldehyde present) or the characteristic immunoassay 
response is observed on one or more drug immunoassay tests for both the 
initial test and the confirmatory test on two separate aliquots;
    (7) The possible presence of an oxidizing adulterant is determined 
by using the same general oxidant colorimetric test (with cutoffs equal 
to or greater than 200 mcg/mL nitrite-equivalents, equal to or greater 
than 50 mcg/mL chromium (VI)-equivalents, or a halogen concentration 
equal to or greater than the LOD) for both the initial test and the 
confirmatory test on two separate aliquots;
    (8) The possible presence of a surfactant is determined using the 
same surfactant colorimetric test with a cutoff equal to or greater 
than 100 mcg/mL dodecylbenzene sulfonate-equivalent for both the 
initial test and the confirmatory test on two separate aliquots or a 
foam/shake test for the initial test;
    (9) Interference occurs on the immunoassay drug tests on two 
separate aliquots (i.e., valid immunoassay drug test results cannot be 
obtained);
    (10) Interference with the drug confirmation assay occurs on at 
least two separate aliquots of the specimen, and the laboratory is 
unable to identify the interfering substance;
    (11) The physical appearance of the specimen indicates that testing 
may damage the laboratory's equipment; or
    (12) The physical appearances of Bottles A and B (when a split 
specimen collection is used) are clearly different, and either the test 
result for Bottle A indicated it is an invalid specimen or the specimen 
in Bottle A was screened negative for drugs, or both.
    (g) Additional testing by a second laboratory. If the presence of 
an interfering substance/adulterant is suspected that could make a test 
result invalid, but it cannot be identified (e.g., a new adulterant), 
laboratory personnel shall consult with the licensee's or other 
entity's MRO and, with the MRO's agreement, shall send the specimen to 
another HHS-certified laboratory that has the capability to identify 
the suspected substance.
    (h) More stringent validity test cutoff levels are prohibited. 
Licensees and other entities may not specify more stringent cutoff 
levels for validity tests than those specified in this section.


Sec.  26.163  Cutoff levels for drugs and drug metabolites.

    (a) Initial drug testing. (1) HHS-certified laboratories shall 
apply the following cutoff levels for initial testing of specimens to 
determine whether they are negative for the indicated drugs and drug 
metabolites, except if validity testing indicates that the specimen is 
dilute or the licensee or other entity has established more stringent 
cutoff levels:

        Initial Test Cutoff Levels for Drugs and Drug Metabolites
------------------------------------------------------------------------
                                                           Cutoff level
                   Drug or metabolites                      [nanograms
                                                             (ng)/mL]
------------------------------------------------------------------------
Marijuana metabolites...................................              50
Cocaine metabolites.....................................             300
Opiate metabolites......................................            2000
Phencyclidine (PCP).....................................              25
Amphetamines............................................            1000
------------------------------------------------------------------------

    (2) At the licensee's or other entity's discretion, as documented 
in the FFD program policies and procedures, the licensee or other 
entity may require the HHS-certified laboratory to conduct special 
analyses of dilute specimens as follows:
    (i) If initial validity testing indicates that a specimen is 
dilute, the HHS-certified laboratory shall compare the responses of the 
dilute specimen to the cutoff calibrator in each of the drug classes;
    (ii) If any response is equal to or greater than 50 percent of the 
cutoff, the HHS-certified laboratory shall conduct confirmatory testing 
of the specimen down to the LOD for those drugs and/or drug 
metabolites; and
    (iii) The laboratory shall report the numerical values obtained 
from this special analysis to the MRO.

[[Page 17213]]

    (b) Confirmatory drug testing. (1) A specimen that is identified as 
positive on an initial drug test must be subject to confirmatory 
testing for the class(es) of drugs for which the specimen initially 
tested positive. The HHS-certified laboratory shall apply the 
confirmatory cutoff levels specified in this paragraph, except if the 
licensee or other entity requires the special analysis of dilute 
specimens permitted in paragraph (a)(2) of this section or the licensee 
or other entity has established more stringent cutoff levels.

     Confirmatory Test Cutoff Levels for Drugs and Drug Metabolites
------------------------------------------------------------------------
                                                                 Cutoff
                     Drug or metabolites                         level
                                                                (ng/mL)
------------------------------------------------------------------------
Marijuana metabolite\1\......................................         15
Cocaine metabolite \2\.......................................        150
Opiates:
    Morphine.................................................       2000
    Codeine..................................................       2000
    6-acetylmorphine \3\.....................................         10
Phencyclidine (PCP)..........................................         25
Amphetamines:
    Amphetamine..............................................        500
    Methamphetamine \4\......................................       500
------------------------------------------------------------------------
\1\ As delta-9-tetrahydrocannabinol-9-carboxylic acid.
\2\ As benzoylecgonine.
\3\ Test for 6-AM when the confirmatory test shows a morphine
  concentration exceeding 2,000 ng/mL.
\4\ Specimen must also contain amphetamine at a concentration equal to
  or greater than 200 ng/mL.

    (2) Each confirmatory drug test must provide a quantitative result. 
When the concentration of a drug or metabolite exceeds the linear range 
of the standard curve, the laboratory may record the result as 
``exceeds the linear range of the test'' or as ``equal to or greater 
than ,'' or 
may dilute an aliquot of the specimen to obtain an accurate 
quantitative result when the concentration is above the upper limit of 
the linear range.


Sec.  26.165  Testing split specimens and retesting single specimens.

    (a) Testing split specimens. (1) If a specimen has been split into 
Bottle A and Bottle B at the collection site, and the specimen was not 
initially tested at a licensee testing facility, then the HHS-certified 
laboratory shall perform initial and confirmatory validity and drug 
testing, if required, of the specimen in Bottle A.
    (2) If a specimen was initially tested at a licensee testing 
facility and positive or questionable validity test results were 
obtained, then the HHS-certified laboratory shall perform initial and 
confirmatory testing, if required, of the specimen in Bottle A.
    (3) At the licensee's or other entity's discretion, Bottle B must 
either be forwarded to the HHS-certified laboratory or maintained in 
secure storage at the licensee testing facility, as required by Sec.  
26.135(a) and (c), as applicable. If the specimen in Bottle A is free 
of any evidence of drugs or drug metabolites, and is a valid specimen, 
then the licensee testing facility or HHS-certified laboratory may 
discard the specimens in Bottles A and B.
    (b) Donor request to MRO for a retest of a single specimen or 
testing Bottle B of a split specimen. (1) For a confirmed positive, 
adulterated, or substituted result reported on a single specimen of 30 
mL or more, or a specimen in Bottle A of a split specimen which the 
donor submitted to the licensee or other entity, a donor may request 
(through the MRO) that an aliquot from the single specimen or the split 
(Bottle B) specimen be tested by a second HHS-certified laboratory to 
verify the result reported by the first laboratory. For an invalid test 
result, a donor may not request that an aliquot from the single 
specimen or the split specimen in Bottle B be tested by a second HHS-
certified laboratory.
    (2) The MRO shall inform the donor that he or she may, within 3 
business days of notification by the MRO of the confirmed positive, 
adulterated, or substituted test result, request the retesting of an 
aliquot of the single specimen or the testing of the Bottle B split 
specimen. The MRO shall provide the donor with specific instructions 
for making this request (i.e., providing telephone numbers or other 
contact information). The MRO shall have the ability to receive the 
donor's calls at all times during the 3-day period (e.g., by use of an 
answering machine with a ``time stamp'' feature when there is no one in 
the MRO's office to answer the phone). The donor's request may be oral 
or in writing.
    (3) The donor shall provide his or her permission for retesting an 
aliquot of the single specimen or the testing of Bottle B. Neither the 
licensee, MRO, NRC, nor any other entity may order retesting of the 
single specimen or testing of the specimen in Bottle B without the 
donor's written permission, except as permitted in Sec.  26.185(l).
    (4) If the donor has not requested a retest of an aliquot of a 
single specimen or a test of the split specimen (Bottle B) within 3 
business days, the donor may present to the MRO information documenting 
that serious injury, illness, lack of actual notice of the confirmed 
test result, inability to contact the MRO (e.g., there was no one in 
the MRO's office and the answering machine was not working), or other 
circumstances unavoidably prevented the donor from making a timely 
request. If the MRO concludes from the donor's information that there 
was a legitimate reason for the donor's failure to contact the MRO 
within the 3 business days permitted, the MRO shall direct the 
retesting of an aliquot of the single specimen or the test of the split 
specimen (Bottle B) take place, as if the donor had made a timely 
request.
    (5) As soon as reasonably practical and not more than 1 business 
day following the day of the donor's request, as permitted in paragraph 
(b)(3) or (b)(4) of this section, the MRO shall ensure that the HHS-
certified laboratory forwards an aliquot of a single specimen, or that 
the HHS-certified laboratory (or licensee testing facility, as 
appropriate) forwards Bottle B of a split specimen, to a second HHS-
certified laboratory that did not test the specimen in Bottle A.
    (6) The HHS-certified laboratory that retests an aliquot of a 
single specimen or tests the specimen in Bottle B shall provide 
quantitative test results to the MRO and the MRO shall provide them to 
the donor.
    (c) Retesting a specimen for drugs. (1) The second laboratory shall 
use its confirmatory drug test when retesting an aliquot of a single 
specimen or testing Bottle B of a split specimen for the drug(s) or 
drug metabolite(s) for which the first laboratory reported a positive 
result(s), including retesting specimens that have been subject to the 
special analysis permitted in Sec.  26.163(a)(2).
    (2) Because some drugs or drug metabolites may deteriorate during 
storage, the retest by the second laboratory is not subject to a 
specific drug cutoff level, but must provide data sufficient to 
reconfirm the presence of the drug(s) or drug metabolite(s) down to the 
assay's LOD.
    (3) If the second laboratory fails to reconfirm the presence of the 
drug(s) or drug metabolite(s) for which the first laboratory reported a 
positive result(s), the second laboratory shall attempt to determine 
the reason for not reconfirming the first laboratory's findings by 
conducting specimen validity tests. The second laboratory shall conduct 
the same specimen validity tests it would conduct on a single specimen 
or the specimen in Bottle A of a split specimen.
    (4) The second laboratory shall report all results to the 
licensee's or other entity's MRO.
    (d) Retesting a specimen for adulterants. A second laboratory shall 
use the required confirmatory validity

[[Page 17214]]

test and criteria in Sec.  26.161(c) to reconfirm an adulterant result 
when retesting an aliquot from a single specimen or when testing Bottle 
B of a split specimen. The second laboratory may only conduct the 
confirmatory validity test needed to reconfirm the adulterant result 
reported by the first laboratory.
    (e) Retesting a specimen for substitution. A second laboratory 
shall use its confirmatory creatinine and confirmatory specific gravity 
tests, when retesting an aliquot of a single specimen or testing Bottle 
B of a split specimen, to reconfirm that the creatinine concentration 
was less than 2 mg/dL and the specific gravity was less than or equal 
to 1.0010 or equal to or greater than 1.0200. The second laboratory may 
only conduct the confirmatory creatinine and specific gravity tests to 
reconfirm the substitution result reported by the first laboratory.
    (f) Management actions and sanctions. (1) If the MRO confirms a 
positive, adulterated, or substituted test result(s) from the first 
HHS-certified laboratory and the donor requests testing of Bottle B of 
a split specimen or retesting of an aliquot from a single specimen, the 
licensee or other entity shall administratively withdraw the 
individual's authorization on the basis of the first confirmed 
positive, adulterated, or substituted test result until the results of 
testing Bottle B or retesting an aliquot of the single specimen are 
available and have been reviewed by the MRO. If the MRO reports that 
the results of testing Bottle B or retesting the aliquot of a single 
specimen reconfirm any of the original positive, adulterated, or 
substituted test result(s), the licensee or other entity shall impose 
the appropriate sanctions specified in subpart D. If the results of 
testing Bottle B or retesting the aliquot of a single specimen are 
negative, the licensee or other entity--
    (i) May not impose any sanctions on the individual;
    (ii) Shall eliminate from the donor's personnel file and other 
records any matter that could link the individual to the temporary 
administrative action;
    (iii) May not disclose the temporary administrative action in 
response to a suitable inquiry conducted under the provisions of Sec.  
26.63 or to any other inquiry or investigation required in this 
chapter. To ensure that no records have been retained, access to the 
system of files and records must be provided to personnel conducting 
reviews, inquiries into allegations, or audits under the provisions of 
Sec.  26.41, or to NRC inspectors; and
    (iv) Shall provide the tested individual with a written statement 
that the records specified in Sec. Sec.  26.713 and 26.715 have not 
been retained and shall inform the individual in writing that the 
temporary administrative action that was taken will not be disclosed 
and need not be disclosed by the individual in response to requests for 
self-disclosure of potentially disqualifying FFD information.
    (2) If a donor requests that Bottle B be tested or that an aliquot 
of a single specimen be retested, and either Bottle B or the single 
specimen are not available due to circumstances outside of the donor's 
control (including, but not limited to, circumstances in which there is 
an insufficient quantity of the single specimen or the specimen in 
Bottle B to permit retesting, either Bottle B or the original single 
specimen is lost in transit to the second HHS-certified laboratory, or 
Bottle B has been lost at the HHS-certified laboratory or licensee 
testing facility), the MRO shall cancel the test and inform the 
licensee or other entity that another collection is required under 
direct observation as soon as reasonably practical. The licensee or 
other entity shall eliminate from the donor's personnel and other 
records any matter that could link the donor to the original positive, 
adulterated, or substituted test result(s) and any temporary 
administrative action, and may not impose any sanctions on the donor 
for a cancelled test. If test results from the second specimen 
collected are positive, adulterated, or substituted and the MRO 
determines that the donor has violated the FFD policy, the licensee or 
other entity shall impose the appropriate sanctions specified in 
subpart D of this part, but may not consider the original confirmed 
positive, adulterated, or substituted test result in determining the 
appropriate sanctions.


Sec.  26.167   Quality assurance and quality control.

    (a) Quality assurance program. Each HHS-certified laboratory shall 
have a quality assurance program that encompasses all aspects of the 
testing process, including, but not limited to, specimen accessioning, 
chain of custody, security and reporting of results, initial and 
confirmatory testing, certification of calibrators and controls, and 
validation of analytical procedures. The performance characteristics 
(e.g., accuracy, precision, LOD, limit of quantitation (LOQ), 
specificity) of each test must be validated and documented for each 
test. Validation of procedures must document that carryover does not 
affect the donor's specimen results. Periodic re-verification of 
analytical procedures is required. Quality assurance procedures must be 
designed, implemented, and reviewed to monitor the conduct of each step 
of the testing process.
    (b) Calibrators and controls required. Each analytical run of 
specimens for which an initial or confirmatory validity test, or an 
initial or confirmatory drug test, is being performed must include the 
appropriate calibrators and controls.
    (c) Quality control requirements for performing initial and 
confirmatory validity tests. (1) Requirements for performing creatinine 
tests:
    (i) The creatinine concentration must be measured to one decimal 
place on both the initial and the confirmatory creatinine tests;
    (ii) The initial creatinine test must have a calibrator at 2 mg/dL;
    (iii) The initial creatinine test must have a control in the range 
of 1 to 1.5 mg/dL, a control in the range of 3 to 20 mg/dL, and a 
control in the range of 21 to 25 mg/dL; and
    (iv) The confirmatory creatinine test (performed on those specimens 
with a creatinine concentration less than 2 mg/dL on the initial test) 
must have a calibrator at 2 mg/dL, a control in the range of 1.0 to 1.5 
mg/dL, and a control in the range of 3 to 4 mg/dL.
    (2) Requirements for performing specific gravity tests:
    (i) The refractometer must report and display the specific gravity 
to four decimal places, and must be interfaced with a laboratory 
information management system, or computer, and/or generate a hard copy 
or digital electronic display to document the numerical result;
    (ii) The initial and confirmatory specific gravity tests must have 
a calibrator or control at 1.0000; and
    (iii) The initial and confirmatory specific gravity tests must have 
the following controls:
    (A) One control targeted at 1.0020;
    (B) One control in the range of 1.0040 to 1.0180; and
    (C) One control equal to or greater than 1.0200 but not greater 
than 1.0250.
    (3) Requirements for performing pH tests:
    (i) Colorimetric pH tests that have the dynamic range of 2 to 12 to 
support the 3 and 11 pH cutoffs and pH meters must be capable of 
measuring pH to one decimal place. Dipsticks, colorimetric pH tests, 
and pH paper that have a narrow dynamic range and do not support the 2 
to 12 pH cutoffs may be used only to determine whether initial validity 
tests must be performed;
    (ii) At a minimum, pH screening tests must have the following 
controls:

[[Page 17215]]

    (A) One control below the lower decision point in use;
    (B) One control between the decision points in use; and
    (C) One control above the upper decision point in use;
    (iii) If a pH screening test is not used, an initial pH meter test 
must have the following calibrators and controls:
    (A) One calibrator at 4;
    (B) One calibrator at 7;
    (C) One calibrator at 10;
    (D) One control in the range of 2 to 2.8;
    (E) One control in the range of 3.2 to 4;
    (F) One control in the range of 10 to 10.8; and
    (G) One control in the range of 11.2 to 12;
    (iv) If a pH screening test is used, an initial or confirmatory pH 
meter test must have the following calibrators and controls when the 
screening result indicates that the pH is below the lower decision 
point in use:
    (A) One calibrator at 4;
    (B) One calibrator at 7;
    (C) One control in the range of 2 to 2.8; and
    (D) One control in the range of 3.2 to 4;
    (v) If a pH screening test is used, an initial or confirmatory pH 
meter test must have the following calibrators and controls when the 
screening result indicates that the pH is above the upper decision 
point in use:
    (A) One calibrator at 7;
    (B) One calibrator at 10;
    (C) One control in the range of 10 to 10.8; and
    (D) One control in the range of 11.2 to 12; and
    (vi) An initial colorimetric pH test must have the following 
calibrators and controls:
    (A) One calibrator at 3;
    (B) One calibrator at 11;
    (C) One control in the range of 2 to 2.8;
    (D) One control in the range of 3.2 to 4;
    (E) One control in the range of 4.5 to 9;
    (F) One control in the range of 10 to 10.8;
    (G) One control in the range of 11.2 to 12.
    (4) Requirements for performing oxidizing adulterant tests:
    (i) Initial tests for oxidizing adulterants must include a 
calibrator at the appropriate cutoff concentration for the compound of 
interest as specified in Sec.  26.161(c) and (f), a control without the 
compound of interest (i.e., a certified negative control), and at least 
one control with one of the compounds of interest at a measurable 
concentration; and
    (ii) A confirmatory test for a specific oxidizing adulterant must 
use a different analytical method than that used for the initial test. 
Each confirmatory analytical run must include a calibrator at the 
appropriate cutoff concentration for the compound of interest as 
specified in Sec.  26.161(c) and (f), a control without the compound of 
interest (i.e., a certified negative control), and a control with the 
compound of interest at a measurable concentration.
    (5) Requirements for performing nitrite tests: The initial and 
confirmatory nitrite tests must have a calibrator at the cutoff 
concentration, a control without nitrite (i.e., certified negative 
urine specimen), one control in the range of 200 to 400 mcg/mL, and one 
control in the range of 500 to 625 mcg/mL.
    (6) Requirements for performing ``other'' adulterant tests:
    (i) The initial and confirmatory tests for any ``other'' adulterant 
that may be identified in the future must satisfy the requirements in 
Sec.  26.161(a);
    (ii) The confirmatory test for ``other'' adulterants must use a 
different analytical principle or chemical reaction than that used for 
the initial test; and
    (iii) The initial and confirmatory tests for ``other'' adulterants 
must include an appropriate calibrator, a control without the compound 
of interest (i.e., a certified negative control), and a control with 
the compound of interest at a measurable concentration.
    (d) Quality control requirements for performing initial drug tests. 
(1) Any initial drug test performed by an HHS-certified laboratory must 
use an immunoassay that meets the requirements of the Food and Drug 
Administration for commercial distribution. Non-instrumented 
immunoassay testing devices that are pending HHS/SAMHSA review and 
approval may not be used for initial drug testing under this part.
    (2) HHS-certified laboratories may perform multiple initial drug 
tests for the same drug or drug class, provided that all tests meet the 
cutoffs and quality control requirements of this part. For example, an 
HHS-certified laboratory may use immunoassay technique ``A'' for all 
drugs using the licensee's or other entity's cutoff levels, but 
specimens testing positive for amphetamines may also be tested using 
immunoassay technique ``B'' to eliminate any possible positives due to 
structural analogues; or, a valid analytical result cannot be obtained 
using immunoassay technique ``A'' and immunoassay technique ``B'' is 
used in an attempt to obtain a valid analytical result.
    (3) Quality control samples for each analytical run of specimens 
for initial testing must include--
    (i) Sample(s) certified to contain no drugs or drug metabolites 
(i.e., negative urine samples);
    (ii) At least one positive control with a drug(s) or drug 
metabolite(s) targeted at 25 percent above the cutoff;
    (iii) At least one positive control with a drug(s) or drug 
metabolite(s) targeted at 25 percent below the cutoff;
    (iv) A sufficient number of calibrators to ensure and document the 
linearity of the assay method over time in the concentration area of 
the cutoff (after acceptable values are obtained for the known 
calibrators, those values will be used to calculate sample data); and
    (v) At least one control that appears to be a donor specimen to the 
laboratory analysts.
    (4) A minimum of 10 percent of the total specimens in each 
analytical run must be quality control samples, as defined by 
paragraphs (d)(3)(i) through (iv) of this section.
    (e) Quality control requirements for performing confirmatory drug 
tests. (1) Confirmatory tests for drugs and drug metabolites must be 
performed using gas chromatography/mass spectrometry (GC/MS) or other 
confirmatory test methodologies that HHS-certified laboratories are 
permitted to use in Federal workplace drug testing programs for this 
purpose.
    (2) At least 10 percent of the samples in each analytical run of 
specimens must be calibrators and controls.
    (3) Each analytical run of specimens that are subjected to 
confirmatory testing must include--
    (i) Sample(s) certified to contain no drug (i.e., negative urine 
samples);
    (ii) Positive calibrator(s) and control(s) with a drug(s) or drug 
metabolite(s);
    (iii) At least one positive control with a drug(s) or drug 
metabolite(s) targeted at 25 percent above the cutoff; and
    (iv) At least one calibrator or control that is targeted at or 
below 40 percent of the cutoff.
    (f) Errors in testing. The licensee or other entity shall ensure 
that the HHS-certified laboratory investigates any testing errors or 
unsatisfactory performance discovered in blind performance testing, as 
required under Sec.  26.168, in the testing of actual specimens, or 
through the processing of reviews, as well as any other errors or 
matters that could adversely reflect on the testing process.
    (1) Whenever possible, the investigation must determine relevant

[[Page 17216]]

facts and identify the root cause(s) of the testing or process error. 
The licensee or other entity, and the HHS-certified laboratory, shall 
take action to correct the causes of any errors or unsatisfactory 
performance that are within each entity's control. Sufficient records 
shall be maintained to furnish evidence of activities affecting 
quality. The licensee or other entity shall assure that the cause of 
the condition is determined and that corrective action is taken to 
preclude repetition. The identification of the significant condition, 
the cause of the condition, and the corrective action taken shall be 
documented and reported to appropriate levels of management.
    (2) If a false positive error occurs on a blind performance test 
sample or on a regular specimen, the licensee or other entity shall 
require the laboratory to take corrective action to minimize the 
occurrence of the particular error in the future. If there is reason to 
believe that the error could have been systematic, the licensee or 
other entity may also require review and re-analysis of previously run 
specimens.
    (3) If a false positive error occurs on a blind performance test 
sample and the error is determined to be technical or methodological, 
the licensee or other entity shall instruct the laboratory to provide 
all quality control data from the batch or analytical run of specimens 
that included a false positive sample. In addition, the licensee or 
other entity shall require the laboratory to retest all specimens that 
analyzed as positive for that drug or metabolite, or as adulterated, 
substituted, dilute, or invalid in validity testing, from the time of 
final resolution of the error back to the time of the last satisfactory 
performance test cycle. This retesting must be documented by a 
statement signed by the laboratory's responsible person. The licensee 
or other entity and the NRC also may require an onsite review of the 
laboratory, which may be conducted unannounced during any hours of 
operation of the laboratory.
    (g) Accuracy. Volumetric pipettes and measuring devices must be 
certified for accuracy or be checked by gravimetric, colorimetric, or 
other verification procedures. Automatic pipetttes and dilutors must be 
checked for accuracy and reproducibility both before being placed in 
service and periodically thereafter.
    (h) Calibrators and controls. Laboratory calibrators and controls 
must be prepared using pure drug reference materials, stock standard 
solutions obtained from other laboratories, or standard solutions that 
are obtained from commercial manufacturers and are properly labeled as 
to content and concentration. Calibrators and controls may not be 
prepared from the same stock solution. The standards and controls must 
be labeled with the following dates: when received; when prepared or 
opened; when placed in service; and when scheduled for expiration.


Sec.  26.168   Blind performance testing.

    (a) Each licensee and other entity shall submit blind performance 
test samples to the HHS-certified laboratory.
    (1) During the initial 90-day period of any contract with an HHS-
certified laboratory (not including rewritten or renewed contracts), 
each licensee or other entity shall submit blind performance test 
samples to each HHS-certified laboratory with whom it contracts in the 
amount of at least 20 percent of the total number of specimens 
submitted (up to a maximum of 100 blind performance specimens) or 30 
blind performance test samples, whichever is greater.
    (2) Following the initial 90-day period, the number of blind 
performance test samples submitted per quarter must be a minimum of one 
percent of all specimens (up to a maximum of 100) or ten blind 
performance test samples, whichever is greater.
    (3) Both during the initial 90-day period and quarterly thereafter, 
licensees and other entities should attempt to submit blind performance 
test samples at a frequency that corresponds to the submission 
frequency for other specimens.
    (b) Approximately 60 percent of the blind performance test samples 
submitted to the laboratory must be positive for one or more drugs or 
drug metabolites per sample and submitted so that all of the drugs for 
which the FFD program is testing are included at least once each 
calendar quarter, except as follows:
    (1) Licensees and other entities shall submit blind performance 
test samples that are positive for marijuana metabolite at least two 
times each quarter; and
    (2) In at least two quarters each year, licensees and other 
entities shall submit an additional blind performance test sample that 
is positive for cocaine instead of the required sample that is positive 
for PCP.
    (c) The positive blind performance test samples must be positive 
for only those drugs for which the FFD program is testing and 
formulated at concentrations established in paragraph (g)(2) of this 
section.
    (d) To challenge the HHS-certified laboratory's ability to limit 
false negatives, approximately 10 percent of the blind performance test 
samples submitted to the laboratory each quarter must be formulated at 
the concentrations established in paragraph (g)(3) of this section.
    (e) To challenge the HHS-certified laboratory's ability to 
determine specimen validity, the licensee or other entity shall submit 
blind samples each quarter that are appropriately adulterated, diluted, 
or substituted, in the amount of 20 percent of the specimens submitted 
that quarter or at least three samples per quarter (one each that is 
adulterated, diluted, or substituted), whichever is greater. These 
samples must be formulated at the concentrations established in 
paragraphs (g)(4) through (g)(6) of this section.
    (f) Approximately 10 percent of the blind performance test samples 
submitted to the laboratory each quarter must be negative, as specified 
in paragraph (g)(1) of this section.
    (g) Licensees and other entities shall use only blind performance 
test samples that have been certified by the supplier to be--
    (1) Negative. A negative blind performance test sample may not 
contain a measurable amount of a target drug analyte and must be 
certified by immunoassay and confirmatory testing;
    (2) Drug positive. These samples must contain a measurable amount 
of the target drug or analyte in concentrations ranging between 150 and 
200 percent of the initial cutoff values and be certified by 
immunoassay and confirmatory testing to contain one or more drug(s) or 
drug metabolite(s);
    (3) A false negative challenge. This blind performance test sample 
must contain a measurable amount of the target drug or analyte in 
concentrations ranging between 130 and 155 percent of the initial 
cutoff values;
    (4) Adulterated. The adulterated blind performance test sample must 
have a pH of less than or equal to 2, or greater than or equal to 12, 
or a nitrite or other oxidant concentration equal to or greater than 
500 mcg/mL, equal to or greater than 50 mcg/mL chromium (VI)-
equivalents, or a halogen concentration equal to or greater than the 
LOD. Blind performance test samples for other adulterants must have 
adulterant concentrations equal to or greater than (or equal to or less 
than, as appropriate) the initial cutoff levels used by the licensee's 
or other entity's HHS-certified laboratory;
    (5) Dilute. The dilute blind performance test sample must contain a

[[Page 17217]]

creatinine concentration that is equal to or greater than 5 mg/dL but 
less than 20 mg/dL, and the specific gravity must be greater than 
1.0010 but less than 1.0030; or
    (6) Substituted. The substituted blind performance test sample must 
contain less than 2 mg/dL of creatinine, and the specific gravity must 
be less than or equal to 1.0010, or equal to or greater than 1.0200.
    (h) In order to ensure that blind performance test samples continue 
to meet the criteria set forth in paragraph (g) of this section, 
licensees and other entities shall--
    (1) Ensure that all blind performance test sample lots are placed 
in service by the supplier only after confirmation by an HHS-certified 
laboratory, and for no more than 6 months;
    (2) Ensure that the supplier provides the expiration date for each 
blind performance test sample to ensure that each sample will have the 
expected value when it is submitted to and tested by a laboratory; and
    (3) At a minimum, require the supplier to check each open lot bi-
monthly (i.e., every two months) to ensure that samples remaining in 
the lot do not fall below 130 percent of the initial cutoff test 
concentration established by the assay manufacturer. Thus, for example, 
a lot that was certified by an HHS-certified laboratory at 155 percent 
of the manufacturer's assay cutoff level, and was reported by the 
licensee's or other entity's HHS-certified laboratory to be at or above 
130 percent of that standard is acceptable. A test that indicated a 
result below 130 percent of that standard would be unacceptable. 
Licensees and other entities shall discard blind performance test 
samples from any lot that is outside of these parameters and may not 
use any further samples from that lot.
    (i) Licensees and other entities shall ensure that each blind 
performance test sample is indistinguishable to laboratory personnel 
from a donor's specimen, as follows:
    (1) The licensee or other entity shall submit blind performance 
test samples to the laboratory using the same channels (i.e., from the 
licensee's or other entity's collection site or licensee testing 
facility, as appropriate) through which donors' specimens are sent to 
the laboratory;
    (2) The collector and licensee testing facility personnel, as 
appropriate, shall use a custody-and-control form, place fictional 
initials on the specimen bottles' labels/seals, and indicate for the 
MRO on the MRO's copy that the specimen is a blind performance test 
sample; and
    (3) The licensee or other entity shall ensure that all blind 
performance test samples include split samples, when the FFD program 
includes split specimen procedures.


Sec.  26.169  Reporting Results.

    (a) The HHS-certified laboratory shall report test results to the 
licensee's or other entity's MRO within 5 business days after receiving 
the specimen from the licensee or other entity. Before reporting any 
test result to the MRO, the laboratory's certifying scientist shall 
certify the result as correct. The report must identify the substances 
for which testing was performed; the results of the validity and drug 
tests; the cutoff levels for each; any indications of tampering, 
adulteration, or substitution that may be present; the specimen 
identification number assigned by the licensee or other entity; and the 
specimen identification number assigned by the laboratory.
    (b) If licensees or other entities specify cutoff levels for drugs 
or drug metabolites that are more stringent than those specified in 
this part, the laboratory need only conduct the more stringent tests 
and shall report the results of the initial and confirmatory tests only 
for the more stringent cutoff levels.
    (c) The HHS-certified laboratory shall report as negative all 
specimens that are negative on the initial or confirmatory drug and 
validity tests. Specimens that test as positive, adulterated, 
substituted, dilute, or invalid on the confirmatory analysis must be 
reported to the MRO as positive for a specific drug(s) or drug 
metabolite(s), or as meeting the criteria for an adulterated, 
substituted, dilute, or invalid specimen.
    (1) The laboratory shall report all positive, adulterated, 
substituted, dilute, and invalid test results for each specimen to the 
MRO. For example, a specimen may be both adulterated and positive for 
one or more specific drugs.
    (2) For a specimen that has a positive test result, the laboratory 
shall provide numerical values if the MRO requests such information. 
The MRO's request for positive confirmatory test results may be either 
a general request covering all such results or a specific case-by-case 
request. The laboratory shall routinely provide quantitative values for 
confirmatory opiate test results for morphine or codeine that are 
greater than or equal to 15,000 ng/mL, even if the MRO has not 
requested quantitative values for the test result.
    (3) For a specimen that has an adulterated or substituted test 
result, the laboratory shall provide the MRO with the numerical values 
that support the reported result. The MRO may not disclose the 
numerical values to the licensee or other entity, except as permitted 
in Sec.  26.37(b). If the numerical values for creatinine are below the 
LOD, the laboratory shall report to the MRO ``creatinine: none 
detected'' (i.e., substituted) along with the numerical values of the 
specific gravity test.
    (4) For a specimen that has an invalid result, the laboratory shall 
contact the MRO and both will decide whether testing by another 
certified laboratory would be useful in being able to report a positive 
or adulterated result. This contact may occur through any secure 
electronic means (e.g., telephone, fax, e-mail). If no further testing 
is necessary, the laboratory shall report the invalid result to the 
MRO.
    (5) When the concentration of a drug, metabolite, or adulterant 
exceeds the linear range of the standard curve, the laboratory may 
report to the MRO that the quantitative value ``exceeds the linear 
range of the test,'' that the quantitative value is ``equal to or 
greater than ,'' or may report an accurate quantitative value above the upper 
limit of the linear range that was obtained by diluting an aliquot of 
the specimen.
    (d) The MRO and MRO staff may not disclose quantitative test 
results to a licensee or other entity, but shall report only whether 
the specimen was positive (and for which analyte), adulterated, 
substituted, dilute, invalid, or negative, except as permitted under 
Sec.  26.37(b). This paragraph does not preclude either the HHS-
certified laboratory or the MRO from providing program performance 
data, as required under Sec.  26.717.
    (e) The laboratory may transmit results to the MRO by various 
electronic means (e.g., teleprinters, facsimile, or computer) in a 
manner designed to ensure the confidentiality of the information. The 
laboratory may not provide results orally by telephone. The licensee or 
other entity, directly or through the HHS-certified laboratory, shall 
ensure the security of the data transmission and ensure only authorized 
access to any data transmission, storage, and retrieval system.
    (f) For negative test results, the HHS-certified laboratory may 
fax, courier, mail, or electronically transmit a computer-generated 
electronic report and/or a legible image or copy of the completed 
custody-and-control form to the MRO. However, for positive, 
adulterated, substituted, dilute, and invalid results, the laboratory 
shall fax, courier, mail, or electronically transmit

[[Page 17218]]

a legible image or copy of the completed custody-and-control form to 
the MRO.
    (g) For a specimen that has a positive, adulterated, substituted, 
dilute, or invalid result, the laboratory shall retain the original 
custody-and-control form and transmit to the MRO a copy of the original 
custody-and-control form signed by a certifying scientist.
    (h) The HHS-certified laboratory shall provide to the licensee's or 
other entity's official responsible for coordination of the FFD program 
an annual statistical summary of urinalysis testing, which may not 
include any personal identifying information. To avoid sending data 
from which it is likely that information about a donor's test result 
can be readily inferred, the laboratory may not send a summary report 
if the licensee or other entity has fewer than 10 specimen test results 
in a 1-year period. The summary report must include test results that 
were reported within the year period. The laboratory shall send the 
summary report to the licensee or other entity within 14 calendar days 
after the end of the 1-year period covered by the report. The 
statistics must be presented either for the cutoff levels specified in 
this part or for any more stringent cutoff levels that the licensee or 
other entity may specify. The HHS-certified laboratory shall make 
available quantitative results for all specimens tested when requested 
by the NRC, licensee, or other entity for whom the laboratory is 
performing drug-testing services. If the FFD program tests for 
additional drugs beyond those listed in Sec.  26.31(d), the summary 
must include drug test results for the additional drugs. The summary 
report must contain the following information:
    (1) Total number of specimens received;
    (2) Number of specimens reported as--
    (i) Negative, and
    (ii) Negative and dilute;
    (3) Number of specimens reported as positive on confirmatory tests 
by drug or drug metabolite for which testing is conducted, including, 
but not limited to--
    (i) Marijuana metabolite;
    (ii) Cocaine metabolite;
    (iii) Opiates (total);
    (A) Codeine;
    (B) Morphine; and
    (C) 6-AM;
    (iv) Phencyclidine;
    (v) Amphetamines (total);
    (A) Amphetamine; and
    (B) Methamphetamine;
    (4) Total number of specimens reported as adulterated;
    (5) Total number of specimens reported as substituted;
    (6) Total number of specimens reported as positive and dilute 
[including an indication as to whether the specimen was subject to the 
special analysis permitted in Sec.  26.163(a)(2)];
    (7) Total number of specimens reported as invalid; and
    (8) Number of specimens reported as rejected for testing and the 
reason for the rejection.

Subpart H--Determining Fitness-for-Duty Policy Violations and 
Determining Fitness


Sec.  26.181  Purpose.

    This subpart contains requirements for determining whether a donor 
has violated the FFD policy and for making a determination of fitness.


Sec.  26.183  Medical review officer.

    (a) Qualifications. The MRO shall be knowledgeable of this part and 
of the FFD policies of the licensees and other entities for whom the 
MRO provides services. The MRO shall be a physician holding either a 
Doctor of Medicine or Doctor of Osteopathy degree who is licensed to 
practice medicine by any State or Territory of the United States, the 
District of Columbia, or the Commonwealth of Puerto Rico. By March 31, 
2010, the MRO shall have passed an examination administered by a 
nationally-recognized MRO certification board or subspecialty board for 
medical practitioners in the field of medical review of Federally 
mandated drug tests.
    (b) Relationships. The MRO may be an employee of the licensee or 
other entity or a contractor. However, the MRO may not be an employee 
or agent of, or have any financial interest in, an HHS-certified 
laboratory or a contracted operator of a licensee testing facility for 
whom the MRO reviews drug test results. Additionally, the MRO may not 
derive any financial benefit by having the licensee or other entity use 
a specific drug testing laboratory or licensee testing facility 
operating contractor and may not have any agreement with such parties 
that may be construed as a potential conflict of interest. Examples of 
relationships between laboratories and MROs that create conflicts of 
interest, or the appearance of such conflicts, include, but are not 
limited to--
    (1) The laboratory employs an MRO who reviews test results produced 
by the laboratory;
    (2) The laboratory has a contract or retainer with the MRO for the 
review of test results produced by the laboratory;
    (3) The laboratory designates which MRO the licensee or other 
entity is to use, gives the licensee or other entity a slate of MROs 
from which to choose, or recommends certain MROs;
    (4) The laboratory gives the licensee or other entity a discount or 
other incentive to use a particular MRO;
    (5) The laboratory has its place of business co-located with that 
of an MRO or MRO staff who review test results produced by the 
laboratory; or
    (6) The laboratory permits an MRO, or an MRO's organization, to 
have a financial interest in the laboratory.
    (c) Responsibilities. The primary role of the MRO is to review and 
interpret positive, adulterated, substituted, invalid, and at the 
licensee's or other entity's discretion, dilute test results obtained 
through the licensee's or other entity's testing program and to 
identify any evidence of subversion of the testing process. The MRO is 
also responsible for identifying any issues associated with collecting 
and testing specimens, and for advising and assisting FFD program 
management in planning and overseeing the overall FFD program.
    (1) In carrying out these responsibilities, the MRO shall examine 
alternate medical explanations for any positive, adulterated, 
substituted, invalid, or, at the licensee's or other entity's 
discretion, dilute test result. This action may include, but is not 
limited to, conducting a medical interview with the donor, reviewing 
the donor's medical history, or reviewing any other relevant biomedical 
factors. The MRO shall review all medical records that the donor may 
make available when a positive, adulterated, substituted, invalid, or 
dilute test result could have resulted from responsible use of legally 
prescribed medication, a documented condition or disease state, or the 
demonstrated physiology of the donor.
    (2) The MRO may only consider the results of tests of specimens 
that are collected and processed under this part, including the results 
of testing split specimens, in making his or her determination, as long 
as those split specimens have been stored and tested under the 
procedures described in this part.
    (d) MRO staff. Individuals who provide administrative support to 
the MRO may be employees of a licensee or other entity, employees of 
the MRO, or employees of an organization with whom a licensee or other 
entity contracts for MRO services. Employees of a licensee or other 
entity who serve MRO staff functions may also perform other duties for 
the licensee or other entity and need not be under the

[[Page 17219]]

direction of the MRO while performing those other duties.
    (1) Direction of MRO staff activities. MROs shall be directly 
responsible for all administrative, technical, and professional 
activities of individuals who are serving MRO staff functions while 
they are performing those functions, and those functions must be under 
the MRO's direction.
    (i) The duties of MRO staff must be maintained independent from any 
other activity or interest of a licensee or other entity, in order to 
protect the integrity of the MRO function and donors' privacy.
    (ii) An MRO's responsibilities for directing MRO staff must 
include, but are not limited to, ensuring that--
    (A) The procedures being performed by MRO staff meet NRC 
regulations and HHS' and professional standards of practice;
    (B) Records and other donor personal information are maintained 
confidential by MRO staff and are not released to other individuals or 
entities, except as permitted under this part;
    (C) Data transmission is secure; and
    (D) Drug test results are reported to the licensee's or other 
entity's designated reviewing official only as required by this part.
    (iii) The MRO may not delegate any of his or her responsibilities 
for directing MRO staff to any other individual or entity, except 
another MRO.
    (2) MRO staff responsibilities. MRO staff may perform routine 
administrative support functions, including receiving test results, 
reviewing negative test results, and scheduling interviews for the MRO.
    (i) The staff under the direction of the MRO may receive, review, 
and report negative test results to the licensee's or other entity's 
designated representative.
    (ii) The staff reviews of positive, adulterated, substituted, 
invalid, and, at the licensee's or other entity's discretion, dilute 
test results must be limited to reviewing the custody-and-control form 
to determine whether it contains any errors that may require corrective 
action and to ensure that it is consistent with the information on the 
MRO's copy. The staff may resolve errors in custody-and-control forms 
that require corrective action(s), but shall forward the custody-and-
control forms to the MRO for review and approval of the resolution.
    (iii) The staff may not conduct interviews with donors to discuss 
positive, adulterated, substituted, invalid, or dilute test results nor 
request medical information from a donor. Only the MRO may request and 
review medical information related to a positive, adulterated, 
substituted, or invalid test result or other matter from a donor.
    (iv) Staff may not report nor discuss with any individuals other 
than the MRO and other MRO staff any positive, adulterated, 
substituted, invalid, or dilute test results received from the HHS-
certified laboratory before those results have been reviewed and 
confirmed by the MRO. Any MRO staff discussions of confirmed positive, 
adulterated, substituted, invalid, or dilute test results must be 
limited to discussions only with the licensee's or other entity's FFD 
program personnel and may not reveal quantitative test results or any 
personal medical information about the donor that the MRO may have 
obtained in the course of reviewing confirmatory test results from the 
HHS-certified laboratory.


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

    (a) MRO review required. A positive, adulterated, substituted, 
dilute, or invalid drug test result does not automatically identify an 
individual as having used drugs in violation of the NRC's regulations, 
or the licensee's or other entity's FFD policy, or as having attempted 
to subvert the testing process. An individual who has a detailed 
knowledge of possible alternate medical explanations is essential to 
the review of the results. The MRO shall review all positive, 
adulterated, substituted, and invalid test results from the HHS-
certified laboratory to determine whether the donor has violated the 
FFD policy before reporting the results to the licensee's or other 
entity's designated representative.
    (b) Reporting of initial test results prohibited. Neither the MRO 
nor MRO staff may report positive, adulterated, substituted, dilute, or 
invalid initial test results that are received from the HHS-certified 
laboratory to the licensee or other entity.
    (c) Discussion with the donor. Before determining that a positive, 
adulterated, substituted, dilute, or invalid test result or other 
occurrence is an FFD policy violation and reporting it to the licensee 
or other entity, the MRO shall give the donor an opportunity to discuss 
the test result or other occurrence with the MRO, except as described 
in paragraph (d) of this section. After this discussion, if the MRO 
determines that a positive, adulterated, substituted, dilute, or 
invalid test result or other occurrence is an FFD policy violation, the 
MRO shall immediately notify the licensee's or other entity's 
designated representative.
    (d) Donor unavailability. The MRO may determine that a positive, 
adulterated, substituted, dilute, or invalid test result or other 
occurrence is an FFD policy violation without having discussed the test 
result or other occurrence directly with the donor in the following 
three circumstances:
    (1) The MRO has made and documented contact with the donor and the 
donor expressly declined the opportunity to discuss the test result or 
other occurrence that may constitute an FFD policy violation;
    (2) A representative of the licensee or other entity, or an MRO 
staff member, has successfully made and documented contact with the 
donor and has instructed him or her to contact the MRO, and more than 1 
business day has elapsed since the date on which the licensee's 
representative or MRO's staff member successfully contacted the donor; 
or
    (3) The MRO, after making all reasonable efforts and documenting 
the dates and time of those efforts, has been unable to contact the 
donor. Reasonable efforts include, at a minimum, three attempts, spaced 
reasonably over a 24-hour period, to reach the donor at the day and 
evening telephone numbers listed on the custody-and-control form.
    (e) Additional opportunity for discussion. If the MRO determines 
that the donor has violated the FFD policy without having discussed the 
positive, adulterated, substituted, dilute, or invalid test result or 
other occurrence directly with the donor, the donor may, on subsequent 
notification of the MRO determination and within 30 days of that 
notification, present to the MRO information documenting the 
circumstances, including, but not limited to, serious illness or 
injury, which unavoidably prevented the donor from being contacted by 
the MRO or a representative of the licensee or other entity, or from 
contacting the MRO in a timely manner. On the basis of this 
information, the MRO may reopen the procedure for determining whether 
the donor's test result or other occurrence is an FFD policy violation 
and permit the individual to present information related to the issue. 
The MRO may modify the initial determination based on an evaluation of 
the information provided.
    (f) Review of invalid specimens. (1) If the HHS-certified 
laboratory reports an invalid result, the MRO shall consult with the 
laboratory to determine whether additional testing by another HHS-
certified laboratory may be useful in determining and reporting a 
positive or adulterated test result. If the MRO and the laboratory 
agree that further

[[Page 17220]]

testing would be useful, the HHS-certified laboratory shall forward the 
specimen to a second laboratory for additional testing.
    (2) If the MRO and the laboratory agree that further testing would 
not be useful and there is no technical explanation for the result, the 
MRO shall contact the donor and determine whether there is an 
acceptable medical explanation for the invalid result. If there is an 
acceptable medical explanation, the MRO shall report to the licensee or 
other entity that the test result is not an FFD policy violation, but 
that a negative test result was not obtained. If the medical reason for 
the invalid result is, in the opinion of the MRO, a temporary 
condition, the licensee or other entity shall collect a second urine 
specimen from the donor as soon as reasonably practical and rely on the 
MRO's review of the test results from the second collection. The second 
specimen collected for the purposes of this paragraph may not be 
collected under direct observation. If the medical reason for the 
invalid result would similarly affect the testing of another urine 
specimen, the MRO may authorize an alternative method for drug testing. 
Licensees and other entities may not impose sanctions for an invalid 
test result due to a medical condition.
    (3) If the MRO and the laboratory agree that further testing would 
not be useful and there is no legitimate technical or medical 
explanation for the invalid test result, the MRO shall require that a 
second collection take place as soon as practical under direct 
observation. The licensee or other entity shall rely on the MRO's 
review of the test results from the directly observed collection.
    (g) Review of dilute specimens. (1) If the HHS-certified laboratory 
reports that a specimen is dilute and that drugs or drug metabolites 
were detected in the specimen at or above the cutoff levels specified 
in this part or the licensee's or other entity's more stringent cutoff 
levels, and the MRO determines that there is no legitimate medical 
explanation for the presence of the drugs or drug metabolites in the 
specimen, and a clinical examination, if required under paragraph 
(g)(4) of this section, has been conducted, the MRO shall determine 
that the drug test results are positive and that the donor has violated 
the FFD policy.
    (2) If the licensee or other entity requires the HHS-certified 
laboratory to conduct the special analysis of dilute specimens 
permitted in Sec.  26.163(a)(2), the results of the special analysis 
are positive, the MRO determines that there is no legitimate medical 
explanation for the presence of the drug(s) or drug metabolite(s) in 
the specimen, and a clinical examination, if required under paragraph 
(g)(4) of this section, has been conducted under paragraph (j) of this 
section, the MRO shall determine whether the positive and dilute 
specimen is a refusal to test. If the MRO does not have sufficient 
reason to believe that the positive and dilute specimen is a subversion 
attempt, he or she shall determine that the drug test results are 
positive and that the donor has violated the FFD policy. When 
determining whether the donor has diluted the specimen in a subversion 
attempt, the MRO shall also consider the following circumstances, if 
applicable:
    (i) The donor has presented, at this or a previous collection, a 
urine specimen that the HHS-certified laboratory reported as being 
substituted, adulterated, or invalid to the MRO and the MRO determined 
that there is no adequate technical or medical explanation for the 
result;
    (ii) The donor has presented a urine specimen of 30 mL or more that 
falls outside the required temperature range, even if a subsequent 
directly observed collection was performed; or
    (iii) The collector observed conduct clearly and unequivocally 
indicating an attempt to dilute the specimen.
    (3) If a dilute specimen was collected under direct observation, 
the MRO may require the laboratory to conduct confirmatory testing at 
the LOD for any drugs or drug metabolites, as long as each drug class 
is evaluated as required by Sec.  26.31(d)(1)(ii).
    (4) If the drugs detected in a dilute specimen are any opium, 
opiate, or opium derivative (e.g., morphine/codeine), or if the drugs 
or metabolites detected indicate the use of prescription or over-the-
counter medications, before determining that the donor has violated the 
FFD policy under paragraph (a) of this section, the MRO or his/her 
designee, who shall also be a licensed physician with knowledge of the 
clinical signs of drug abuse, shall conduct the clinical examination 
for abuse of these substances that is required in paragraph (j) of this 
section. An evaluation for clinical evidence of abuse is not required 
if the laboratory confirms the presence of 6-AM (i.e., the presence of 
this metabolite is proof of heroin use) in the dilute specimen.
    (5) An MRO review is not required for specimens that the HHS-
certified laboratory reports as negative and dilute. The licensee or 
other entity may not take any administrative actions or impose any 
sanctions on a donor who submits a negative and dilute specimen.
    (h) Review of substituted specimens. (1) If the HHS-certified 
laboratory reports a specimen as substituted (i.e., the creatinine 
concentration is less than 2 mg/dL and the specific gravity is less 
than or equal to 1.0010 or equal to or greater than 1.0200), the MRO 
shall contact the donor and offer the donor an opportunity to provide a 
legitimate medical explanation for the substituted result. The burden 
of proof resides solely with the donor, who must provide legitimate 
medical evidence within 5 business days that he or she produced the 
specimen for which the HHS-certified laboratory reported a substituted 
result. Any medical evidence must be submitted through a physician who 
is experienced and qualified in the medical issues involved, as 
verified by the MRO. Claims of excessive hydration, or claims based on 
unsubstantiated personal characteristics, including, but not limited 
to, race, gender, diet, and body weight, are not acceptable evidence 
without medical studies which demonstrate that the donor did produce 
the laboratory result.
    (2) If the MRO determines that there is no legitimate medical 
explanation for the substituted test result, the MRO shall report to 
the licensee or other entity that the specimen was substituted.
    (3) If the MRO determines that there is a legitimate medical 
explanation for the substituted test result and no drugs or drug 
metabolites were detected in the specimen, the MRO shall report to the 
licensee or other entity that no FFD policy violation has occurred.
    (i) Review of adulterated specimens. (1) If the HHS-certified 
laboratory reports a specimen as adulterated with a specific substance, 
the MRO shall contact the donor and offer the donor an opportunity to 
provide a legitimate medical explanation for the adulterated result. 
The burden of proof resides solely with the donor, who must provide 
legitimate medical evidence within 5 business days that he or she 
produced the adulterated result. Any medical evidence must be submitted 
through a physician experienced and qualified in the medical issues 
involved, as verified by the MRO.
    (2) If the MRO determines there is no legitimate medical 
explanation for the adulterated test result, the MRO shall report to 
the licensee or other entity that the specimen is adulterated.
    (3) If the MRO determines that there is a legitimate medical 
explanation for the adulterated test result and no drugs or drug 
metabolites were detected in the specimen, the MRO shall report to the

[[Page 17221]]

licensee or other entity that no FFD policy violation has occurred.
    (j) Review for opiates, prescription and over-the-counter 
medications. (1) If the MRO determines that there is no legitimate 
medical explanation for a positive confirmatory test result for opiates 
and before the MRO determines that the test result is a violation of 
the FFD policy, the MRO or his/her designee, who shall also be a 
licensed physician with knowledge of the clinical signs of drug abuse, 
shall determine that there is clinical evidence, in addition to the 
positive confirmatory test result, that the donor has illegally used 
opium, an opiate, or an opium derivative (e.g., morphine/codeine). This 
requirement does not apply if the laboratory confirms the presence of 
6-AM (i.e., the presence of this metabolite is proof of heroin use), or 
the morphine or codeine concentration is equal to or greater than 
15,000 ng/mL and the donor does not present a legitimate medical 
explanation for the presence of morphine or codeine at or above this 
concentration. The MRO may not determine that the consumption of food 
products is a legitimate medical explanation for the presence of 
morphine or codeine at or above this concentration.
    (2) If the MRO determines that there is no legitimate medical 
explanation for a positive confirmatory test result for drugs other 
than opiates that are commonly prescribed or included in over-the-
counter preparations (e.g., benzodiazepines in the first case, 
barbiturates in the second) and are listed in the licensee's or other 
entity's panel of substances to be tested, the MRO shall determine 
whether there is clinical evidence, in addition to the positive 
confirmatory test result, of abuse of any of these substances or their 
derivatives.
    (3) If the MRO determines that the donor has used another 
individual's prescription medication, including a medication containing 
opiates, and no clinical evidence of drug abuse is found, the MRO shall 
report to the licensee or other entity that the donor has misused a 
prescription medication. If the MRO determines that the donor has used 
another individual's prescription medication and clinical evidence of 
drug abuse is found, the MRO shall report to the licensee that the 
donor has violated the FFD policy.
    (4) In determining whether a legitimate medical explanation exists 
for a positive confirmatory test result for opiates or prescription or 
over-the-counter medications, the MRO may consider the use of a 
medication from a foreign country. The MRO shall exercise professional 
judgment consistently with the following principles:
    (i) There can be a legitimate medical explanation only with respect 
to a drug that is obtained legally in a foreign country;
    (ii) There can be a legitimate medical explanation only with 
respect to a drug that has a legitimate medical use. Use of a drug of 
abuse (e.g., heroin, PCP) or any other substance that cannot be viewed 
as having a legitimate medical use can never be the basis for a 
legitimate medical explanation, even if the drug is obtained legally in 
a foreign country; and
    (iii) Use of the drug can form the basis of a legitimate medical 
explanation only if it is used consistently with its proper and 
intended medical purpose.
    (5) The MRO may not consider consumption of food products, 
supplements, or other preparations containing substances that may 
result in a positive confirmatory drug test result, including, but not 
limited to supplements containing hemp products or coca leaf tea, as a 
legitimate medical explanation for the presence of drugs or drug 
metabolites in the urine specimen above the cutoff levels specified in 
Sec.  26.163 or a licensee's or other entity's more stringent cutoff 
levels.
    (6) The MRO may not consider the use of any drug contained in 
Schedule I of section 202 of the Controlled Substances Act [21 U.S.C. 
812] as a legitimate medical explanation for a positive confirmatory 
drug test result, even if the drug may be legally prescribed and used 
under State law.
    (k) Results consistent with legitimate drug use. If the MRO 
determines that there is a legitimate medical explanation for a 
positive confirmatory drug test result, and that the use of a drug 
identified through testing was in the manner and at the dosage 
prescribed, and the results do not reflect a lack of reliability or 
trustworthiness, then the donor has not violated the licensee's or 
other entity's FFD policy. The MRO shall report to the licensee or 
other entity that no FFD policy violation has occurred. The MRO shall 
further evaluate the positive confirmatory test result and medical 
explanation to determine whether use of the drug and/or the medical 
condition poses a potential risk to public health and safety as a 
result of the individual being impaired while on duty. If the MRO 
determines that such a risk exists, he or she shall ensure that a 
determination of fitness is performed.
    (l) Retesting authorized. Should the MRO question the accuracy or 
scientific validity of a positive, adulterated, substituted, or invalid 
test result, only the MRO is authorized to order retesting of an 
aliquot of the original specimen or the analysis of any split specimen 
(Bottle B) in order to determine whether the FFD policy has been 
violated. Retesting must be performed by a second HHS-certified 
laboratory. The MRO is also the only individual who may authorize a 
reanalysis of an aliquot of the original specimen or an analysis of any 
split specimen (Bottle B) in response to a request from the donor 
tested.
    (m) Result scientifically insufficient. Based on the review of 
inspection and audit reports, quality control data, multiple specimens, 
and other pertinent results, the MRO may determine that a positive, 
adulterated, substituted or invalid test result is scientifically 
insufficient for further action and may declare that a drug or validity 
test result is not an FFD policy violation, but that a negative test 
result was not obtained. In this situation, the MRO may request 
retesting of the original specimen before making this decision. The MRO 
is neither expected nor required to request such retesting, unless in 
the sole opinion of the MRO, such retesting is warranted. The MRO may 
request that the reanalysis be performed by the same laboratory, or 
that an aliquot of the original specimen be sent for reanalysis to 
another HHS-certified laboratory. The licensee testing facility and the 
HHS-certified laboratory shall assist in this review process, as 
requested by the MRO, by making available the individual(s) responsible 
for day-to-day management of the licensee testing facility or the HHS-
certified laboratory, or other individuals who are forensic 
toxicologists or who have equivalent forensic experience in urine drug 
testing, to provide specific consultation as required by the MRO.
    (n) Evaluating results from a second laboratory. After a second 
laboratory tests an aliquot of a single specimen or the split (Bottle 
B) specimen, the MRO shall take the following actions if the second 
laboratory reports the following results:
    (1) If the second laboratory reconfirms any positive test results, 
the MRO may report an FFD policy violation to the licensee or other 
entity;
    (2) If the second laboratory reconfirms any adulterated, 
substituted, or invalid validity test results, the MRO may report an 
FFD policy violation to the licensee or other entity;
    (3) If the second laboratory does not reconfirm the positive test 
results, the MRO shall report that no FFD policy violation has 
occurred; or
    (4) If the second laboratory does not reconfirm the adulterated, 
substituted,

[[Page 17222]]

or invalid validity test results, the MRO shall report that no FFD 
policy violation has occurred.
    (o) Re-authorization after a first violation for a positive test 
result. The MRO is responsible for reviewing drug test results from an 
individual whose authorization was terminated or denied for a first 
violation of the FFD policy involving a confirmed positive drug test 
result and who is being considered for re-authorization. In order to 
determine whether subsequent positive confirmatory drug test results 
represent new drug use or remaining metabolites from the drug use that 
initially resulted in the FFD policy violation, the MRO shall request 
from the HHS-certified laboratory, and the laboratory shall provide, 
quantitation of the test results and other information necessary to 
make the determination. If the drug for which the individual first 
tested positive was marijuana and the confirmatory assay for delta-9-
tetrahydrocannabinol-9-carboxylic acid yields a positive result, the 
MRO shall determine whether the confirmatory test result indicates 
further marijuana use since the first positive test result, or whether 
the test result is consistent with the level of delta-9-
tetrahydrocannabinol-9-carboxylic acid that would be expected if no 
further marijuana use had occurred. If the test result indicates that 
no further marijuana use has occurred since the first positive test 
result, then the MRO shall declare the drug test result as negative.
    (p) Time to complete MRO review. The MRO shall complete his or her 
review of positive, adulterated, substituted, and invalid test results 
and, in instances when the MRO determines that there is no legitimate 
medical explanation for the test result(s), notify the licensee's or 
other entity's designated representative within 10 business days of an 
initial positive, adulterated, substituted, or invalid test result. The 
MRO shall notify the licensee or other entity of the results of his or 
her review in writing and in a manner designed to ensure the 
confidentiality of the information.


Sec.  26.187  Substance abuse expert.

    (a) Implementation. By March 31, 2010, any SAEs on whom licensees 
and other entities rely to make determinations of fitness under this 
part shall meet the requirements of this section. An MRO who meets the 
requirements of this section may serve as both an MRO and as an SAE.
    (b) Credentials. An SAE shall have at least one of the following 
credentials:
    (1) A licensed physician;
    (2) A licensed or certified social worker;
    (3) A licensed or certified psychologist;
    (4) A licensed or certified employee assistance professional; or
    (5) An alcohol and drug abuse counselor certified by the National 
Association of Alcoholism and Drug Abuse Counselors Certification 
Commission or by the International Certification Reciprocity 
Consortium/Alcohol and Other Drug Abuse.
    (c) Basic knowledge. An SAE shall be knowledgeable in the following 
areas:
    (1) Demonstrated knowledge of and clinical experience in the 
diagnosis and treatment of alcohol and controlled-substance abuse 
disorders;
    (2) Knowledge of the SAE function as it relates to the public's 
interests in the duties performed by the individuals who are subject to 
this subpart; and
    (3) Knowledge of this part and any changes thereto.
    (d) Qualification training. SAEs shall receive qualification 
training on the following subjects:
    (1) Background, rationale, and scope of this part;
    (2) Key drug testing requirements of this part, including specimen 
collection, laboratory testing, MRO review, and problems in drug 
testing;
    (3) Key alcohol testing requirements of this part, including 
specimen collection, the testing process, and problems in alcohol 
tests;
    (4) SAE qualifications and prohibitions;
    (5) The role of the SAE in making determinations of fitness and the 
return-to-duty process, including the initial evaluation, referrals for 
education and/or treatment, the followup evaluation, continuing 
treatment recommendations, and the followup testing plan;
    (6) Procedures for SAE consultation and communication with 
licensees or other entities, MROs, and treatment providers;
    (7) Reporting and recordkeeping requirements of this part; and
    (8) Issues that SAEs confront in carrying out their duties under 
this part.
    (e) Continuing education. During each 3-year period following 
completion of initial qualification training, the SAE shall complete 
continuing education consisting of at least 12 continuing professional 
education hours relevant to performing SAE functions.
    (1) This continuing education must include material concerning new 
technologies, interpretations, recent guidance, rule changes, and other 
information about developments in SAE practice pertaining to this part, 
since the time the SAE met the qualification training requirements of 
this section.
    (2) Continuing education activities must include documented 
assessment tools to assist in determining that the SAE has learned the 
material.
    (f) Documentation. The SAE shall maintain documentation showing 
that he or she currently meets all requirements of this section. The 
SAE shall provide this documentation on request to NRC representatives, 
licensees, or other entities who are relying on or contemplating 
relying on the SAE's services, and to other individuals and entities, 
as required by Sec.  26.37.
    (g) Responsibilities and prohibitions. The SAE shall evaluate 
individuals who have violated the substance abuse provisions of an FFD 
policy and make recommendations concerning education, treatment, return 
to duty, followup drug and alcohol testing, and aftercare. The SAE is 
not an advocate for the licensee or other entity, or the individual. 
The SAE's function is to protect public health and safety and the 
common defense and security by professionally evaluating the individual 
and recommending appropriate education/treatment, follow-up tests, and 
aftercare.
    (1) The SAE is authorized to make determinations of fitness in at 
least the following three circumstances:
    (i) When potentially disqualifying FFD information has been 
identified regarding an individual who has applied for authorization 
under this part;
    (ii) When an individual has violated the substance abuse provisions 
of a licensee's or other entity's FFD policy; and
    (iii) When an individual may be impaired by alcohol, prescription 
or over-the-counter medications, or illegal drugs.
    (2) After determining the best recommendation for assisting the 
individual, the SAE shall serve as a referral source to assist the 
individual's entry into an education and/or treatment program.
    (i) To prevent the appearance of a conflict of interest, the SAE 
may not refer an individual requiring assistance to his or her private 
practice or to a person or organization from whom the SAE receives 
payment or in which the SAE has a financial interest. The SAE is 
precluded from making referrals to entities with whom the SAE is 
financially associated.
    (ii) There are four exceptions to the prohibitions contained in the 
preceding paragraph. The SAE may refer an individual to any of the 
following providers of assistance, regardless of his or her 
relationship with them:

[[Page 17223]]

    (A) A public agency (e.g., treatment facility) operated by a state, 
county, or municipality;
    (B) A person or organization under contract to the licensee or 
other entity to provide alcohol or drug treatment and/or education 
services (e.g., the licensee's or other entity's contracted treatment 
provider);
    (C) The sole source of therapeutically appropriate treatment under 
the individual's health insurance program (e.g., the single substance 
abuse in-patient treatment program made available by the individual's 
insurance coverage plan); or
    (D) The sole source of therapeutically appropriate treatment 
reasonably available to the individual (e.g., the only treatment 
facility or education program reasonably located within the general 
commuting area).


Sec.  26.189  Determination of fitness.

    (a) A determination of fitness is the process entered when there 
are indications that an individual specified in Sec.  26.4(a) through 
(e), and at the licensee's or other entity's discretion as specified in 
Sec.  26.4(f) and (g), 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. A determination of fitness must be made by a 
licensed or certified professional who is appropriately qualified and 
has the necessary clinical expertise, as verified by the licensee or 
other entity, to evaluate the specific fitness issues presented by the 
individual. A professional called on by the licensee or other entity 
may not perform a determination of fitness regarding fitness issues 
that are outside of his or her specific areas of expertise. The types 
of professionals and the fitness issues for which they are qualified to 
make determinations of fitness include, but are not limited to, the 
following:
    (1) An SAE who meets the requirements of Sec.  26.187 may determine 
the fitness of an individual who may have engaged in substance abuse 
and shall determine an individual's fitness to be granted authorization 
following an unfavorable termination or denial of authorization under 
this part, but may not be qualified to assess the fitness of an 
individual who may have experienced mental illness, significant 
emotional stress, or other mental or physical conditions that may cause 
impairment but are unrelated to substance abuse, unless the SAE has 
additional qualifications for addressing those fitness issues;
    (2) A clinical psychologist may determine the fitness of an 
individual who may have experienced mental illness, significant 
emotional stress, or cognitive or psychological impairment from causes 
unrelated to substance abuse, but may not be qualified to assess the 
fitness of an individual who may have a substance abuse disorder, 
unless the psychologist is also an SAE;
    (3) A psychiatrist may determine the fitness of an individual who 
is taking psychoactive medications consistently with one or more valid 
prescription(s), but may not be qualified to assess potential 
impairment attributable to substance abuse, unless the psychiatrist has 
had specific training to diagnose and treat substance abuse disorders;
    (4) A physician may determine the fitness of an individual who may 
be ill, injured, fatigued, taking medications in accordance with one or 
more valid prescriptions, or using over-the-counter medications, but 
may not be qualified to assess the fitness of an individual who may 
have a substance abuse disorder, unless the physician is also an SAE; 
and
    (5) As a physician with specialized training, the MRO may determine 
the fitness of an individual who may have engaged in substance abuse or 
may be ill, injured, fatigued, taking medications under one or more 
valid prescriptions, and/or using over-the-counter medications, but may 
not be qualified to assess an individual's fitness to be granted 
authorization following an unfavorable termination or denial of 
authorization under this part, unless the MRO is also an SAE.
    (b) A determination of fitness must be made in at least the 
following circumstances:
    (1) When there is an acceptable medical explanation for a positive, 
adulterated, substituted, or invalid test result, but there is a basis 
for believing that the individual could be impaired while on duty;
    (2) Before making return-to-duty recommendations after an 
individual's authorization has been terminated unfavorably or denied 
under a licensee's or other entity's FFD policy;
    (3) Before an individual is granted authorization when potentially 
disqualifying FFD information is identified that has not previously 
been evaluated by another licensee or entity who is subject to this 
subpart; and
    (4) When potentially disqualifying FFD information is otherwise 
identified and the licensee's or other entity's reviewing official 
concludes that a determination of fitness is warranted under Sec.  
26.69.
    (c) A determination of fitness that is conducted for cause (i.e., 
because of observed behavior or a physical condition) must be conducted 
through face-to-face interaction between the subject individual and the 
professional making the determination. Electronic means of 
communication may not be used.
    (1) If there is neither conclusive evidence of an FFD policy 
violation nor a significant basis for concern that the individual may 
be impaired while on duty, then the individual must be determined to be 
fit for duty.
    (2) If there is no conclusive evidence of an FFD policy violation 
but there is a significant basis for concern that the individual may be 
impaired while on duty, then the subject individual must be determined 
to be unfit for duty. This result does not constitute a violation of 
this part nor of the licensee's or other entity's FFD policy, and no 
sanctions may be imposed. However, the professional who made the 
determination of fitness shall consult with the licensee's or other 
entity's management personnel to identify the actions required to 
ensure that any possible limiting condition does not represent a threat 
to workplace or public health and safety. Licensee or other entity 
management personnel shall implement the required actions. When 
appropriate, the subject individual may also be referred to the EAP.
    (d) Neither the individual nor licensees and other entities may 
seek a second determination of fitness if a determination of fitness 
under this part has already been performed by a qualified professional 
employed by or under contract to the licensee or other entity. After 
the initial determination of fitness has been made, the professional 
may modify his or her evaluation and recommendations based on new or 
additional information from other sources including, but not limited 
to, the subject individual, another licensee or entity, or staff of an 
education or treatment program. Unless the professional who made the 
initial determination of fitness is no longer employed by or under 
contract to the licensee or other entity, only that professional is 
authorized to modify the evaluation and recommendations. When 
reasonably practicable, licensees and other entities shall assist in 
arranging for consultation between the new professional and the 
professional who is no longer employed by or under contract to the 
licensee or other entity, to ensure continuity and consistency in the 
recommendations and their implementation.

[[Page 17224]]

Subpart I--Managing Fatigue


Sec.  26.201  Applicability.

    The requirements in this subpart apply to the licensees and other 
entities identified in Sec.  26.3(a), and, if applicable, (c) and (d). 
The requirements in Sec. Sec.  26.203 and 26.211 apply to the 
individuals identified in Sec.  26.4 (a) through (c). In addition, the 
requirements in Sec.  26.205 through Sec.  26.209 apply to the 
individuals identified in Sec.  26.4(a).


Sec.  26.203  General provisions.

    (a) Policy. Licensees shall establish a policy for the management 
of fatigue for all individuals who are subject to the licensee's FFD 
program and incorporate it into the written policy required in Sec.  
26.27(b).
    (b) Procedures. In addition to the procedures required in Sec.  
26.27(c), licensees shall develop, implement, and maintain procedures 
that--
    (1) Describe the process to be followed when any individual 
identified in Sec.  26.4(a) through (c) makes a self-declaration that 
he or she is not fit to safely and competently perform his or her 
duties for any part of a working tour as a result of fatigue. The 
procedure must--
    (i) Describe the individual's and licensee's rights and 
responsibilities related to self-declaration;
    (ii) Describe requirements for establishing controls and conditions 
under which an individual may be permitted or required to perform work 
after that individual declares that he or she is not fit due to 
fatigue; and
    (iii) Describe the process to be followed if the individual 
disagrees with the results of a fatigue assessment that is required 
under Sec.  26.211(a)(2);
    (2) Describe the process for implementing the controls required 
under Sec.  26.205 for the individuals who are performing the duties 
listed in Sec.  26.4(a);
    (3) Describe the process to be followed in conducting fatigue 
assessments under Sec.  26.211; and
    (4) Describe the disciplinary actions that the licensee may impose 
on an individual following a fatigue assessment, and the conditions and 
considerations for taking those disciplinary actions.
    (c) Training and examinations. Licensees shall add the following 
KAs to the content of the training that is required in Sec.  26.29(a) 
and the comprehensive examination required in Sec.  26.29(b):
    (1) Knowledge of the contributors to worker fatigue, circadian 
variations in alertness and performance, indications and risk factors 
for common sleep disorders, shiftwork strategies for obtaining adequate 
rest, and the effective use of fatigue countermeasures; and
    (2) Ability to identify symptoms of worker fatigue and contributors 
to decreased alertness in the workplace.
    (d) Recordkeeping. Licensees shall retain the following records for 
at least 3 years or until the completion of all related legal 
proceedings, whichever is later:
    (1) Records of work hours for individuals who are subject to the 
work hour controls in Sec.  26.205;
    (2) Records of shift schedules and shift cycles of individuals who 
are subject to the work hour controls in Sec.  26.205;
    (3) The documentation of waivers that is required in Sec.  
26.207(a)(4), including the bases for granting the waivers;
    (4) The documentation of work hour reviews that is required in 
Sec.  26.205(e)(3) and (e)(4); and
    (5) The documentation of fatigue assessments that is required in 
Sec.  26.211(g).
    (e) Reporting. Licensees shall include the following information in 
a standard format in the annual FFD program performance report required 
under Sec.  26.717:
    (1) A summary for each nuclear power plant site of all instances 
during the previous calendar year when the licensee waived the work 
hour controls specified in Sec.  26.205(d)(1) through (d)(5)(i) for 
individuals described in Sec.  26.4(a). The summary must include only 
those waivers under which work was performed. If it was necessary to 
waive more than one work hour control during any single extended work 
period, the summary of instances must include each of the work hour 
controls that were waived during the period. For each category of 
individuals specified in Sec.  26.4(a), the licensee shall report--
    (i) The number of instances when each applicable work hour control 
specified in Sec.  26.205(d)(1)(i) through (d)(1)(iii), (d)(2)(i) and 
(d)(2)(ii), and (d)(3)(i) through (d)(3)(v) was waived for individuals 
not working on outage activities;
    (ii) The number of instances when each applicable work hour control 
specified in Sec.  26.205(d)(1)(i) through (d)(1)(iii), (d)(2)(i) and 
(d)(2)(ii), (d)(3)(i) through (d)(3)(v), and (d)(4) and (d)(5)(i) was 
waived for individuals working on outage activities; and
    (iii) A summary that shows the distribution of waiver use among the 
individuals within each category of individuals identified in Sec.  
26.4(a) (e.g., a table that shows the number of individuals who 
received only one waiver during the reporting period, the number of 
individuals who received a total of two waivers during the reporting 
period).
    (2) A summary of corrective actions, if any, resulting from the 
analyses of these data, including fatigue assessments.
    (f) Audits. Licensees shall audit the management of worker fatigue 
as required by Sec.  26.41.


Sec.  26.205  Work hours.

    (a) Individuals subject to work hour controls. Any individual who 
performs duties identified in Sec.  26.4(a)(1) through (a)(5) shall be 
subject to the requirements of this section.
    (b) Calculating work hours. For the purposes of this section, a 
licensee shall calculate the work hours of individuals who are subject 
to this section as the amount of time the individuals perform duties 
for the licensee. Except as permitted by paragraphs (b)(1) through 
(b)(5) of this section, the calculated work hours must include all time 
performing duties for the licensee, including all within-shift break 
times and rest periods during which there are no reasonable 
opportunities or accommodations appropriate for restorative sleep.
    (1) Shift turnover. Licensees may exclude shift turnover from the 
calculation of an individual's work hours. Shift turnover includes only 
those activities that are necessary to safely transfer information and 
responsibilities between two or more individuals between shifts. Shift 
turnover activities may include, but are not limited to, discussions of 
the status of plant equipment, and the status of ongoing activities, 
such as extended tests of safety systems and components. Licensees may 
not exclude work hours worked during turnovers between individuals 
within a shift period due to rotations or relief within a shift. 
Activities that licensees may not exclude from work hours calculations 
also include, but are not limited to, shift holdovers to cover for late 
arrivals of incoming shift members; early arrivals of individuals for 
meetings, training, or pre-shift briefings for special evolutions; and 
holdovers for interviews needed for event investigations.
    (2) Within-shift break and rest periods. Licensees may exclude from 
the calculation of an individual's work hours only that portion of a 
break or rest period during which there is a reasonable opportunity and 
accommodations for restorative sleep (e.g., a nap).

[[Page 17225]]

    (3) Beginning or resuming duties subject to work hour controls. If 
an individual begins or resumes performing for the licensee any of the 
duties listed in Sec.  26.4(a) during the calculation period, the 
licensee shall include in the calculation of the individual's work 
hours all work hours worked for the licensee, including hours worked 
performing duties that are not listed in Sec.  26.4(a), and control the 
individual's work hours under the requirements of paragraph (d) of this 
section.
    (4) Unannounced emergency preparedness exercises and drills. 
Licensees may exclude from the calculation of an individual's work 
hours the time the individual works unscheduled work hours for the 
purpose of participating in the actual conduct of an unannounced 
emergency preparedness exercise or drill.
    (5) Incidental duties performed off site. Licensees may exclude 
from the calculation of an individual's work hours unscheduled work 
performed off site (e.g., technical assistance provided by telephone 
from an individual's home) provided the total duration of the work does 
not exceed a nominal 30 minutes during any single break period. For the 
purposes of compliance with the minimum break requirements of paragraph 
(d)(2) of this section and the minimum day off requirements of 
paragraph (d)(3) through (d)(5) of this section, such duties do not 
constitute work periods or work shifts.
    (c) Work hours scheduling. Licensees shall schedule the work hours 
of individuals who are subject to this section consistent with the 
objective of preventing impairment from fatigue due to the duration, 
frequency, or sequencing of successive shifts.
    (d) Work hour controls. Licensees shall control the work hours of 
individuals who are subject to this section.
    (1) Except as permitted in Sec.  26.207, licensees shall ensure 
that any individual's work hours do not exceed the following limits:
    (i) 16 work hours in any 24-hour period;
    (ii) 26 work hours in any 48-hour period; and
    (iii) 72 work hours in any 7-day period.
    (2) Licensees shall ensure that individuals have, at a minimum, the 
rest breaks specified in this paragraph. For the purposes of this 
subpart, a break is defined as an interval of time that falls between 
successive work periods, during which the individual does not perform 
any duties for the licensee other than one period of shift turnover at 
either the beginning or end of a shift but not both. Except as 
permitted in Sec.  26.207, licensees shall ensure that individuals 
have, at a minimum--
    (i) A 10-hour break between successive work periods or an 8-hour 
break between successive work periods when a break of less than 10 
hours is necessary to accommodate a crew's scheduled transition between 
work schedules or shifts; and
    (ii) A 34-hour break in any 9-day period.
    (3) Licensees shall ensure that individuals have, at a minimum, the 
number of days off specified in this paragraph. For the purposes of 
this subpart, a day off is defined as a calendar day during which an 
individual does not start a work shift. For the purposes of calculating 
the average number of days off required in this paragraph, the duration 
of the shift cycle may not exceed 6 weeks.
    (i) Individuals who are working 8-hour shift schedules shall have 
at least 1 day off per week, averaged over the shift cycle;
    (ii) Individuals who are working 10-hour shift schedules shall have 
at least 2 days off per week, averaged over the shift cycle;
    (iii) Individuals who are working 12-hour shift schedules while 
performing the duties described in Sec.  26.4(a)(1) through (a)(3) 
shall have at least 2.5 days off per week, averaged over the shift 
cycle;
    (iv) Individuals who are working 12-hour shift schedules while 
performing the duties described in Sec.  26.4(a)(4) shall have at least 
2 days off per week, averaged over the shift cycle; and
    (v) Individuals who are working 12-hour shift schedules while 
performing the duties described in Sec.  26.4(a)(5) shall have at least 
3 days off per week, averaged over the shift cycle.
    (4) During the first 60 days of a unit outage, licensees need not 
meet the requirements of paragraph (d)(3) of this section for 
individuals specified in Sec.  26.4(a)(1) through (a)(4), while those 
individuals are working on outage activities. However, the licensee 
shall ensure that the individuals specified in Sec.  26.4(a)(1) through 
(a)(3) have at least 3 days off in each successive (i.e., non-rolling) 
15-day period and that the individuals specified in Sec.  26.4(a)(4) 
have at least 1 day off in any 7-day period;
    (5) During the first 60 days of a unit outage, security system 
outage, or increased threat condition, licensees shall control the 
hours worked by individuals specified in Sec.  26.4(a)(5) as follows:
    (i) During the first 60 days of a unit outage or a planned security 
system outage, licensees need not meet the requirements of paragraph 
(d)(3) of this section. However, licensees shall ensure that these 
individuals have at least 4 days off in each successive (i.e., non-
rolling) 15-day period; and
    (ii) During the first 60 days of an unplanned security system 
outage or increased threat condition, licensees need not meet the 
requirements of either paragraph (d)(3) or (d)(5)(i) of this section.
    (6) The 60-day periods in paragraphs (d)(4) and (d)(5) of this 
section may be extended for each individual in 7-day increments for 
each non-overlapping 7-day period the individual has worked not more 
than 48 hours during the unit or security system outage or increased 
threat condition, as applicable.
    (e) Reviews. Licensees shall evaluate the effectiveness of their 
control of work hours of individuals who are subject to this section. 
Licensees shall conduct the reviews once per calendar year. If any 
plant or security system outages or increased threat conditions 
occurred since the licensee completed the most recent review, the 
licensee shall include in the review an evaluation of the control of 
work hours during the outages or increased threat conditions. Licensees 
shall complete the review within 30 days of the end of the review 
period. Licensees shall--
    (1) Review the actual work hours and performance of individuals who 
are subject to this section for consistency with the requirements of 
Sec.  26.205(c). At a minimum, this review must address--
    (i) Individuals whose actual hours worked during the review period 
exceeded an average of 54 hours per week in any shift cycle while the 
individuals' work hours are subject to the requirements of Sec.  
26.205(d)(3);
    (ii) Individuals who were granted more than one waiver during the 
review period; and
    (iii) Individuals who were assessed for fatigue under Sec.  26.211 
during the review period.
    (2) Review individuals' hours worked and the waivers under which 
work was performed to evaluate staffing adequacy for all jobs subject 
to the work hour controls of this section;
    (3) Document the methods used to conduct the review and the results 
of the review; and
    (4) Record, trend, and correct, under the licensee's corrective 
action program, any problems identified in maintaining control of work 
hours consistent with the specific requirements and performance 
objectives of this part.

[[Page 17226]]

Sec.  26.207  Waivers and exceptions.

    (a) Waivers. Licensees may grant a waiver of the work hour controls 
in Sec.  26.205(d)(1) through (d)(5)(i), as follows:
    (1) To grant a waiver, the licensee shall meet both of the 
following requirements:
    (i) An operations shift manager determines that the waiver is 
necessary to mitigate or prevent a condition adverse to safety, or a 
security shift manager determines that the waiver is necessary to 
maintain site security, or a site senior-level manager with requisite 
signature authority makes either determination; and
    (ii) A supervisor assesses the individual face to face and 
determines that there is reasonable assurance that the individual will 
be able to safely and competently perform his or her duties during the 
additional work period for which the waiver will be granted. The 
supervisor performing the assessment shall be trained as required by 
Sec. Sec.  26.29 and 26.203(c) and shall be qualified to direct the 
work to be performed by the individual. If there is no supervisor on 
site who is qualified to direct the work, the assessment may be 
performed by a supervisor who is qualified to provide oversight of the 
work to be performed by the individual. At a minimum, the assessment 
must address the potential for acute and cumulative fatigue considering 
the individual's work history for at least the past 14 days, the 
potential for circadian degradations in alertness and performance 
considering the time of day for which the waiver will be granted, the 
potential for fatigue-related degradations in alertness and performance 
to affect risk-significant functions, and whether any controls and 
conditions must be established under which the individual will be 
permitted to perform work.
    (2) To the extent practicable, licensees shall rely on the granting 
of waivers only to address circumstances that could not have been 
reasonably controlled;
    (3) Licensees shall ensure that the timing of the face-to-face 
supervisory assessment that is required by paragraph (a)(1)(ii) of this 
section supports a valid assessment of the potential for worker fatigue 
during the time the individual will be performing work under the 
waiver. Licensees may not perform the face-to-face assessment more than 
4 hours before the individual begins performing any work under the 
waiver; and
    (4) Licensees shall document the bases for individual waivers. The 
documented basis for a waiver must include a description of the 
circumstances that necessitate the waiver, a statement of the scope of 
work and time period for which the waiver is approved, and the bases 
for the determinations required in paragraphs (a)(1)(i) and (ii) of 
this section.
    (b) Force-on-force tactical exercises. For the purposes of 
compliance with the minimum days off requirements of Sec.  
26.205(d)(3), licensees may exclude shifts worked by security personnel 
during the actual conduct of NRC-evaluated force-on-force tactical 
exercises when calculating the individual's number of days off.
    (c) Common defense and security. When informed in writing by the 
NRC that the requirements of Sec.  26.205, or any subset thereof, are 
waived for security personnel to ensure the common defense and 
security, licensees need not meet the specified requirements of Sec.  
26.205 for the duration of the period defined by the NRC.
    (d) Plant emergencies. Licensees need not meet the requirements of 
Sec.  26.205(c) and (d) during declared emergencies, as defined in the 
licensee's emergency plan.


Sec.  26.209  Self-declarations.

    (a) If an individual is performing, or being assessed for, work 
under a waiver of the requirements contained in Sec.  26.205(d)(1) 
through (d)(5)(i) and declares that, due to fatigue, he or she is 
unable to safely and competently perform his or her duties, the 
licensee shall immediately stop the individual from performing any 
duties listed in Sec.  26.4(a), except if the individual is required to 
continue performing those duties under other requirements of this 
chapter. If the subject individual must continue performing the duties 
listed in Sec.  26.4(a) until relieved, the licensee shall immediately 
take action to relieve the individual.
    (b) Following a self-declaration, as described in paragraph (a) of 
this section, the licensee--
    (1) May reassign the individual to duties other than those listed 
in Sec.  26.4(a), but only if the results of a fatigue assessment, 
conducted under the requirements of Sec.  26.211, indicate that the 
individual is fit to safely and competently perform those other duties; 
and
    (2) Shall permit or require the individual to take a break of at 
least 10 hours before the individual returns to performing any duties 
listed in Sec.  26.4(a).


Sec.  26.211  Fatigue assessments.

    (a) Licensees shall ensure that fatigue assessments are conducted 
under the following conditions:
    (1) For cause. In addition to any other test or determination of 
fitness that may be required under Sec. Sec.  26.31(c) and 26.77, a 
fatigue assessment must be conducted in response to an observed 
condition of impaired individual alertness creating a reasonable 
suspicion that an individual is not fit to safely and competently 
perform his or her duties, except if the condition is observed during 
an individual's break period. If the observed condition is impaired 
alertness with no other behaviors or physical conditions creating a 
reasonable suspicion of possible substance abuse, then the licensee 
need only conduct a fatigue assessment. If the licensee has reason to 
believe that the observed condition is not due to fatigue, the licensee 
need not conduct a fatigue assessment;
    (2) Self-declaration. A fatigue assessment must be conducted in 
response to an individual's self-declaration to his or her supervisor 
that he or she is not fit to safely and competently perform his or her 
duties for any part of a working tour because of fatigue, except if, 
following the self-declaration, the licensee permits or requires the 
individual to take a rest break of at least 10 hours before the 
individual returns to duty;
    (3) Post-event. A fatigue assessment must be conducted in response 
to events requiring post-event drug and alcohol testing as specified in 
Sec.  26.31(c). Licensees may not delay necessary medical treatment in 
order to conduct a fatigue assessment; and
    (4) Followup. If a fatigue assessment was conducted for cause or in 
response to a self-declaration, and the licensee returns the individual 
to duty following a break of less than 10 hours in duration, the 
licensee shall reassess the individual for fatigue as well as the need 
to implement controls and conditions before permitting the individual 
to resume performing any duties.
    (b) Only supervisors and FFD program personnel who are trained 
under Sec. Sec.  26.29 and 26.203(c) may conduct a fatigue assessment. 
The fatigue assessment must be conducted face to face with the 
individual whose alertness may be impaired.
    (1) In the case of a fatigue assessment conducted for cause, the 
individual who observed the condition of impaired alertness may not 
conduct the fatigue assessment.
    (2) In the case of a post-event fatigue assessment, the individual 
who conducts the fatigue assessment may not have--

[[Page 17227]]

    (i) Performed or directed (on site) the work activities during 
which the event occurred;
    (ii) Performed, within 24 hours before the event occurred, a 
fatigue assessment of the individuals who were performing or directing 
(on site) the work activities during which the event occurred; and
    (iii) Evaluated or approved a waiver of the limits specified in 
Sec.  26.205(d)(1) through (d)(5)(i) for any of the individuals who 
were performing or directing (on site) the work activities during which 
the event occurred, if the event occurred while such individuals were 
performing work under that waiver.
    (c) A fatigue assessment must provide the information necessary for 
management decisions and actions in response to the circumstance that 
initiated the assessment.
    (1) At a minimum, the fatigue assessment must address the following 
factors:
    (i) Acute fatigue;
    (ii) Cumulative fatigue; and
    (iii) Circadian variations in alertness and performance.
    (2) Individuals shall provide complete and accurate information 
that may be required by the licensee to address the factors listed in 
paragraph (c)(1) of this section. Licensees shall limit any inquiries 
to obtaining from the subject individual only the personal information 
that may be necessary to assess the factors listed in paragraph (c)(1) 
of this section.
    (d) The licensee may not conclude that fatigue has not or will not 
degrade the individual's ability to safely and competently perform his 
or her duties solely on the basis that the individual's work hours have 
not exceeded any of the limits specified in Sec.  26.205(d)(1) or that 
the individual has had the minimum breaks required in Sec.  
26.205(d)(2) or minimum days off required in Sec.  26.205(d)(3) through 
(d)(5), as applicable.
    (e) Following a fatigue assessment, the licensee shall determine 
and implement the controls and conditions, if any, that are necessary 
to permit the individual to resume performing duties for the licensee, 
including the need for a break.
    (f) Licensees shall document the results of any fatigue assessments 
conducted, the circumstances that necessitated the fatigue assessment, 
and any controls and conditions that were implemented.
    (g) Licensees shall also prepare an annual summary for each nuclear 
power plant site of instances of fatigue assessments that were 
conducted during the previous calendar year for any individual 
identified in Sec.  26.4(a) through (c). Each summary must include--
    (1) The conditions under which each fatigue assessment was 
conducted (i.e., self-declaration, for cause, post-event, followup);
    (2) A statement of whether or not the individual was working on 
outage activities at the time of the self-declaration or condition 
resulting in the fatigue assessment;
    (3) The category of duties the individual was performing, if the 
individual was performing the duties described in Sec.  26.4(a)(1) 
through (a)(5) at the time of the self-declaration or condition 
resulting in the fatigue assessment; and
    (4) The management actions, if any, resulting from each fatigue 
assessment.

Subpart J--[Reserved]

Subpart K--FFD Program for Construction


Sec.  26.401  General.

    (a) At the licensee's or other entity's discretion, a licensee or 
other entity in Sec.  26.3(c) may establish, implement, and maintain an 
FFD program that meets the requirements of this subpart to apply to the 
individuals specified in Sec.  26.4(f). If a licensee or other entity 
in Sec.  26.3(c) does not elect to implement an FFD program that meets 
the requirements of this subpart, the individuals specified in Sec.  
26.4(f) shall be subject to an FFD program that meets the requirements 
of subparts A through H, N, and O of this part.
    (b) Entities who intend to implement an FFD program under this 
subpart shall submit a description of the FFD program and its 
implementation as part of the license, permit, or limited work 
authorization application.
    (c) Nothing in this subpart prohibits the licensees and other 
entities in Sec.  26.3(c) from subjecting the individuals in Sec.  
26.4(f) to an FFD program that meets all of the requirements of this 
part or FFD program elements that meet all of the applicable 
requirements of this part.


Sec.  26.403  Written policy and procedures.

    (a) Licensees and other entities who implement an FFD program under 
this subpart shall ensure that a clear, concise, written FFD policy 
statement is provided to individuals who are subject to the program. 
The policy statement must be written in sufficient detail to provide 
affected individuals with information on what is expected of them and 
what consequences may result from a lack of adherence to the policy.
    (b) Licensees and other entities shall develop, implement, and 
maintain written procedures that address the following topics:
    (1) The methods and techniques to be used in testing for drugs and 
alcohol, including procedures for protecting the privacy of an 
individual who provides a specimen, procedures for protecting the 
integrity of the specimen, and procedures used to ensure that the test 
results are valid and attributable to the correct individual;
    (2) The immediate and followup actions that will be taken, and the 
procedures to be used, in those cases in which individuals who are 
subject to the FFD program are determined to have--
    (i) Been involved in the use, sale, or possession of illegal drugs;
    (ii) Consumed alcohol to excess before or while constructing 
safety-or security-related SSCs, as determined by a test that 
accurately measures BAC;
    (iii) Attempted to subvert the testing process by adulterating or 
diluting specimens (in vivo or in vitro), substituting specimens, or by 
any other means;
    (iv) Refused to provide a specimen for analysis; or
    (v) Had legal action taken relating to drug or alcohol use.
    (3) The process to be followed if an individual's behavior or 
condition raises a concern regarding the possible use, sale, or 
possession of illegal drugs on or off site; the possible use or 
possession of alcohol while constructing safety-or security-related 
SSCs; or impairment from any cause which in any way could adversely 
affect the individual's ability to safely and competently perform his 
or her duties.


Sec.  26.405  Drug and alcohol testing.

    (a) To provide means to deter and detect substance abuse, licensees 
and other entities who implement an FFD program under this subpart 
shall perform drug and alcohol testing that complies with the 
requirements of this section.
    (b) If the licensee or other entity elects to impose random testing 
for drugs and alcohol on the individuals identified in Sec.  26.4(f), 
random testing must--
    (1) Be administered in a manner that provides reasonable assurance 
that individuals are unable to predict the time periods during which 
specimens will be collected;
    (2) Require individuals who are selected for random testing to 
report to the collection site as soon as reasonably practicable after 
notification, within the time period specified in the FFD program 
policy;
    (3) Ensure that all individuals in the population that is subject 
to random

[[Page 17228]]

testing on a given day have an equal probability of being selected and 
tested; and
    (4) Provide that an individual completing a test is immediately 
eligible for another random test.
    (c) Individuals identified in Sec.  26.4(f) shall be subject to 
drug and alcohol testing under the following conditions:
    (1) Pre-assignment. Before assignment to construct safety-or 
security-related SSCs;
    (2) For-cause. In response to an individual's observed behavior or 
physical condition indicating possible substance abuse or after 
receiving credible information that an individual is engaging in 
substance abuse, as defined in Sec.  26.5;
    (3) Post-accident. As soon as practical after an event involving a 
human error that was committed by an individual specified in Sec.  
26.4(f), where the human error may have caused or contributed to the 
accident. The licensee or other entity shall test the individual(s) who 
committed the error(s), and need not test individuals who were affected 
by the event but whose actions likely did not cause or contribute to 
the event. The individual(s) who committed the human error(s) shall be 
tested if the event resulted in--
    (i) A significant illness or personal injury to the individual to 
be tested or another individual, which within 4 hours after the event 
is recordable under the Department of Labor standards contained in 29 
CFR 1904.7, and subsequent amendments thereto, and results in death, 
days away from work, restricted work, transfer to another job, medical 
treatment beyond first aid, loss of consciousness, or other significant 
illness or injury as diagnosed by a physician or other licensed health 
care professional, even if it does not result in death, days away from 
work, restricted work or job transfer, medical treatment beyond first 
aid, or loss of consciousness; or
    (ii) Significant damage, during construction, to any safety-or 
security-related SSC; and
    (4) Followup. As part of a followup plan to verify an individual's 
continued abstinence from substance abuse.
    (d) At a minimum, licensees and other entities shall test specimens 
for marijuana metabolite, cocaine metabolite, opiates (codeine, 
morphine, 6-acetylmorphine), amphetamines (amphetamine, 
methamphetamine), phencyclidine, adulterants, and alcohol at the cutoff 
levels specified in this part, or comparable cutoff levels if specimens 
other than urine are collected for drug testing. Urine specimens 
collected for drug testing must be subject to validity testing.
    (e) The specimen collection and drug and alcohol testing procedures 
of FFD programs under this subpart must protect the donor's privacy and 
the integrity of the specimen, and implement stringent quality controls 
to ensure that test results are valid and attributable to the correct 
individual. At the licensee's or other entity's discretion, specimen 
collections and alcohol testing may be conducted at a local hospital or 
other facility under the specimen collection and alcohol testing 
requirements of 49 CFR Part 40 and subsequent amendments thereto.
    (f) Testing of urine specimens for drugs and validity, except 
validity screening and initial drug and validity tests that may be 
performed by licensee testing facilities, must be performed in a 
laboratory that is certified by HHS for that purpose, consistent with 
its standards and procedures for certification. Any initial drug test 
performed by a licensee or other entity subject to this subpart must 
use an immunoassay that meets the requirements of the Food and Drug 
Administration for commercial distribution. Urine specimens that yield 
positive, adulterated, substituted, or invalid initial validity or drug 
test results must be subject to confirmatory testing by the HHS-
certified laboratory, except for invalid specimens that cannot be 
tested. Other specimens that yield positive initial drug test results 
must be subject to confirmatory testing by a laboratory that meets 
stringent quality control requirements that are comparable to those 
required for certification by the HHS.
    (g) Licensees and other entities shall provide for an MRO review of 
positive, adulterated, substituted, and invalid confirmatory drug and 
validity test results to determine whether the donor has violated the 
FFD policy, before reporting the results to the individual designated 
by the licensee or other entity to perform the suitability and fitness 
evaluations required under Sec.  26.419.


Sec.  26.406  Fitness monitoring.

    (a) The requirements in this section apply only if a licensee or 
other entity does not elect to subject the individuals specified in 
Sec.  26.4(f) to random testing for drugs and alcohol under Sec.  
26.405(b).
    (b) Licensees and other entities shall implement a fitness 
monitoring program to deter substance abuse and detect indications of 
possible use, sale, or possession of illegal drugs; use or possession 
of alcohol while constructing safety-or security-related SSCs; or 
impairment from any cause that if left unattended may result in a risk 
to public health and safety or the common defense and security.
    (c) Licensees and other entities shall establish procedures that 
monitors shall follow in response to the indications and actions 
specified in paragraph (b) of this section and train the monitors to 
implement the program.
    (d) Licensees and other entities shall ensure that the fitness of 
individuals specified in Sec.  26.4(f) is monitored effectively while 
the individuals are constructing safety- and security-related SSCs, 
commensurate with the potential risk to public health and safety and 
the common defense and security imposed by the construction activity. 
To achieve this objective, licensees and other entities shall consider 
the number and placement of monitors required, the necessary ratio of 
monitors to individuals specified in Sec.  26.4(f), and the frequency 
with which the individuals specified in Sec.  26.4(f) shall be 
monitored while constructing each safety- or security-related SSC.


Sec.  26.407  Behavioral observation.

    While the individuals specified in Sec.  26.4(f) are constructing 
safety- or security-related SSCs, licensees and other entities shall 
ensure that these individuals are subject to behavioral observation, 
except if the licensee or other entity has implemented a fitness 
monitoring program under Sec.  26.406.


Sec.  26.409  Sanctions.

    Licensees and other entities who implement an FFD program under 
this subpart shall establish sanctions for FFD policy violations that, 
at a minimum, prohibit the individuals specified in Sec.  26.4(f) from 
being assigned to construct safety- or security-related SSCs unless or 
until the licensee or other entity determines that the individual's 
condition or behavior does not pose a potential risk to public health 
and safety or the common defense and security.


Sec.  26.411  Protection of information.

    (a) Licensees and other entities who collect personal information 
about an individual for the purpose of complying with this subpart 
shall establish and maintain a system of files and procedures to 
protect the personal information. FFD programs must maintain and use 
such records with the highest regard for individual privacy.
    (b) Licensees and other entities shall obtain a signed consent that 
authorizes the disclosure of the personal information collected and 
maintained under this subpart before disclosing the

[[Page 17229]]

personal information, except for disclosures to the individuals and 
entities specified in Sec.  26.37(b)(1) through (b)(6), (b)(8), and 
persons deciding matters under review in Sec.  26.413.


Sec.  26.413  Review process.

    Licensees and other entities who implement an FFD program under 
this subpart shall establish and implement procedures for the review of 
a determination that an individual in Sec.  26.4(f) has violated the 
FFD policy. The procedure must provide for an objective and impartial 
review of the facts related to the determination that the individual 
has violated the FFD policy.


Sec.  26.415  Audits.

    (a) Licensees and other entities who implement an FFD program under 
this subpart shall ensure that audits are performed to assure the 
continuing effectiveness of the FFD program, including FFD program 
elements that are provided by C/Vs, and the FFD programs of C/Vs that 
are accepted by the licensee or other entity.
    (b) Each licensee and other entity shall ensure that these programs 
are audited at a frequency that assures their continuing effectiveness 
and that corrective actions are taken to resolve any problems 
identified. Licensees and entities may conduct joint audits, or accept 
audits of C/Vs conducted by others, so long as the audit addresses the 
relevant C/Vs' services.
    (c) Licensees and other entities need not audit HHS-certified 
laboratories or the specimen collection and alcohol testing services 
that meet the requirements of 49 CFR Part 40, ``Procedures for 
Department of Transportation Workplace Drug and Alcohol Testing 
Programs'' (65 FR 41944; August 9, 2001), on which licensees and other 
entities may rely to meet the drug and alcohol testing requirements of 
this subpart.


Sec.  26.417  Recordkeeping and reporting.

    (a) Licensees and other entities who implement FFD programs under 
this subpart shall ensure that records pertaining to the administration 
of the program, which may be stored and archived electronically, are 
maintained so that they are available for NRC inspection purposes and 
for any legal proceedings resulting from the administration of the 
program.
    (b) Licensees and other entities shall make the following reports:
    (1) Reports to the NRC Operations Center by telephone within 24 
hours after the licensee or other entity discovers any intentional act 
that casts doubt on the integrity of the FFD program and any 
programmatic failure, degradation, or discovered vulnerability of the 
FFD program that may permit undetected drug or alcohol use or abuse by 
individuals who are subject to this subpart. These events must be 
reported under this subpart, rather than under the provisions of 10 CFR 
73.71; and
    (2) Annual program performance reports for the FFD program.


Sec.  26.419  Suitability and fitness evaluations.

    Licensees and other entities who implement FFD programs under this 
subpart shall develop, implement, and maintain procedures for 
evaluating whether to assign individuals to construct safety- and 
security-related SSCs. These procedures must provide reasonable 
assurance that the individuals are fit to safely and competently 
perform their duties, and are trustworthy and reliable, as demonstrated 
by the avoidance of substance abuse.

Subpart L--[Reserved]

Subpart M--[Reserved]

Subpart N--Recordkeeping and Reporting Requirements


Sec.  26.709  Applicability.

    The requirements of this subpart apply to the FFD programs of 
licensees and other entities specified in Sec.  26.3, except for FFD 
programs that are implemented under subpart K of this part.


Sec.  26.711  General provisions.

    (a) Each licensee and other entity shall maintain records and 
submit certain reports to the NRC. Records that are required by the 
regulations in this part must be retained for the period specified by 
the appropriate regulation. If a retention period is not otherwise 
specified, these records must be retained until the Commission 
terminates the facility's license, certificate, or other regulatory 
approval.
    (b) All records may be stored and archived electronically, provided 
that the method used to create the electronic records meets the 
following criteria:
    (1) Provides an accurate representation of the original records;
    (2) Prevents the alteration of any archived information and/or data 
once it has been committed to storage; and
    (3) Permits easy retrieval and re-creation of the original records.
    (c) The licensees and other entities specified in Sec.  26.3(a) 
and, as applicable, (c) and (d), shall inform each individual of his or 
her right to review information about the individual that is collected 
and maintained under this part to assure its accuracy. Licensees and 
other entities shall provide the individual with an opportunity to 
correct any inaccurate or incomplete information that is documented by 
licensees and other entities about the individual.
    (d) Licensees and other entities shall ensure that only correct and 
complete information about individuals is retained and shared with 
other licensees and entities. If, for any reason, the shared 
information used for determining an individual's eligibility for 
authorization under this part changes or new information is developed 
about the individual, licensees and other entities shall correct or 
augment the shared information contained in the records. If the changed 
or developed information has implications for adversely affecting an 
individual's eligibility for authorization, a licensee and other entity 
specified in Sec.  26.3(a) and, as applicable, (c) and (d), who has 
discovered the incorrect information, or develops new information, 
shall inform the reviewing official of any FFD program under which the 
individual is maintaining authorization of the updated information on 
the day of discovery. The reviewing official shall evaluate the 
information and take appropriate actions, which may include denial or 
unfavorable termination of the individual's authorization.


Sec.  26.713  Recordkeeping requirements for licensees and other 
entities.

    (a) Each licensee and other entity who is subject to this subpart 
shall retain the following records for at least 5 years after the 
licensee or other entity terminates or denies an individual's 
authorization or until the completion of all related legal proceedings, 
whichever is later:
    (1) Records of self-disclosures, employment histories, and suitable 
inquiries that are required under Sec. Sec.  26.55, 26.57, 26.59, and 
26.69 that result in the granting of authorization;
    (2) Records pertaining to the determination of a violation of the 
FFD policy and related management actions;
    (3) Documentation of the granting and termination of authorization; 
and
    (4) Records of any determinations of fitness conducted under Sec.  
26.189, including any recommendations for treatment and followup 
testing plans.
    (b) Each licensee and other entity who is subject to this subpart 
shall retain the following records for at least 3 years or until the 
completion of all related legal proceedings, whichever is later:

[[Page 17230]]

    (1) Records of FFD training and examinations conducted under Sec.  
26.29; and
    (2) Records of audits, audit findings, and corrective actions taken 
under Sec.  26.41.
    (c) Licensees and other entities shall ensure the retention and 
availability of records pertaining to any 5-year denial of 
authorization under Sec.  26.75(c), (d), or (e)(2) and any permanent 
denial of authorization under Sec.  26.75(b) and (g) for at least 40 
years or until, on application, the NRC determines that the records are 
no longer needed.
    (d) Licensees and other entities shall retain any superseded 
versions of the written FFD policy and procedures required under 
Sec. Sec.  26.27, 26.39, and 26.203(b) for at least 5 years or until 
completion of all legal proceedings related to an FFD violation that 
may have occurred under the policy and procedures, whichever is later.
    (e) Licensees and other entities shall retain written agreements 
for the provision of services under this part for the life of the 
agreement or until completion of all legal proceedings related to an 
FFD policy violation that involved those services, whichever is later.
    (f) Licensees and other entities shall retain records of the 
background investigations, credit and criminal history checks, and 
psychological assessments of FFD program personnel, conducted under 
Sec.  26.31(b)(1)(i), for the length of the individual's employment by 
or contractual relationship with the licensee or other entity, or until 
the completion of all related legal proceedings, whichever is later.
    (g) If a licensee's or other entity's FFD program includes tests 
for drugs in addition to those specified in this part, as permitted 
under Sec.  26.31(d)(1), or uses more stringent cutoff levels than 
those specified in this part, as permitted under Sec.  26.31(d)(3), the 
licensee or other entity shall retain documentation certifying the 
scientific and technical suitability of the assays and cutoff levels 
used, as required under Sec.  26.31(d)(1)(i) and (d)(3)(iii)(C), 
respectively, for the time the FFD program follows these practices or 
until the completion of all related legal proceedings, whichever is 
later.


Sec.  26.715  Recordkeeping requirements for collection sites, licensee 
testing facilities, and laboratories certified by the Department of 
Health and Human Services.

    (a) Collection sites providing services to licensees and other 
entities who are subject to this subpart, licensee testing facilities, 
and HHS-certified laboratories shall maintain and make available 
documentation of all aspects of the testing process for at least 2 
years or until the completion of all legal proceedings related to a 
determination of an FFD violation, whichever is later. This 2-year 
period may be extended on written notification by the NRC or by any 
licensee or other entity for whom services are being provided.
    (b) Documentation that must be retained includes, but is not 
limited to, the following:
    (1) Personnel files, including training records, for all 
individuals who have been authorized to have access to specimens, but 
are no longer under contract to or employed by the collection site, 
licensee testing facility, or HHS-certified laboratory;
    (2) Chain-of-custody documents (other than forms recording 
specimens with negative test results and no FFD violations or 
anomalies, which may be destroyed after appropriate summary information 
has been recorded for program administration purposes);
    (3) Quality assurance and quality control records;
    (4) Superseded procedures;
    (5) All test data (including calibration curves and any 
calculations used in determining test results);
    (6) Test reports;
    (7) Records pertaining to performance testing;
    (8) Records pertaining to the investigation of testing errors or 
unsatisfactory performance discovered in quality control or blind 
performance testing, in the testing of actual specimens, or through the 
processing of appeals and MRO reviews, as well as any other errors or 
matters that could adversely reflect on the integrity of the testing 
process, investigation findings, and corrective actions taken, where 
applicable;
    (9) Performance records on certification inspections;
    (10) Records of preventative maintenance on licensee testing 
facility instruments;
    (11) Records that summarize any test results that the MRO 
determined to be scientifically insufficient for further action;
    (12) Either printed or electronic copies of computer-generated 
data;
    (13) Records that document the dates, times of entry and exit, 
escorts, and purposes of entry of authorized visitors, maintenance 
personnel, and service personnel who have accessed secured areas of 
licensee testing facilities and HHS-certified laboratories; and
    (14) Records of the inspection, maintenance, and calibration of 
EBTs.


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

    (a) Licensees and other entities shall collect and compile FFD 
program performance data for each FFD program that is subject to this 
subpart.
    (b) The FFD program performance data must include the following 
information:
    (1) The random testing rate;
    (2) Drugs for which testing is conducted and cutoff levels, 
including results of tests using lower cutoff levels, tests for drugs 
not included in the HHS panel, and any special analyses of dilute 
specimens permitted under Sec.  26.163(a)(2);
    (3) Populations tested (i.e., individuals in applicant status, 
permanent licensee employees, C/Vs);
    (4) Number of tests administered and results of those tests sorted 
by population tested (i.e., individuals in applicant status, permanent 
licensee employees, C/Vs);
    (5) Conditions under which the tests were performed, as defined in 
Sec.  26.31(c);
    (6) Substances identified;
    (7) Number of subversion attempts by type;
    (8) Summary of management actions; and
    (9) The information required under Sec.  26.203(e)(1) and (e)(2).
    (c) Licensees and other entities who have a licensee-approved FFD 
program shall analyze the data at least annually and take appropriate 
actions to correct any identified program weaknesses. Records of the 
data, analyses, and corrective actions taken must be retained for at 
least 3 years or until the completion of any related legal proceedings, 
whichever is later.
    (d) Any licensee or other entity who terminates an individual's 
authorization or takes administrative action on the basis of the 
results of a positive initial drug test for marijuana or cocaine shall 
also report these test results in the annual summary by processing 
stage (i.e., initial testing at the licensee testing facility, testing 
at the HHS-certified laboratory, and MRO determinations). The report 
must also include the number of terminations and administrative actions 
taken against individuals for the reporting period.
    (e) Licensees and other entities shall submit the FFD program 
performance data (for January through December) to the NRC annually, 
before March 1 of the following year.
    (f) Licensees and other entities may submit the FFD program 
performance data in a consolidated report, as long as the report 
presents the data separately for each site.

[[Page 17231]]

    (g) Each C/V who maintains a licensee-approved drug and alcohol 
testing program is subject to the reporting requirements of this 
section and shall submit the required information either directly to 
the NRC or through the licensee's) or other entities to whom the C/V 
provided services during the year. Licensees, other entities, and C/Vs 
shall share information to ensure that the information is reported 
completely and is not duplicated in reports submitted to the NRC.


Sec.  26.719  Reporting requirements.

    (a) Required reports. Each licensee and entity who is subject to 
this subpart shall inform the NRC of significant violations of the FFD 
policy, significant FFD program failures, and errors in drug and 
alcohol testing. These events must be reported under this section, 
rather than under the provisions of 10 CFR 73.71.
    (b) Significant FFD policy violations or programmatic failures. The 
following significant FFD policy violations and programmatic failures 
must be reported to the NRC Operations Center by telephone within 24 
hours after the licensee or other entity discovers the violation:
    (1) The use, sale, distribution, possession, or presence of illegal 
drugs, or the consumption or presence of alcohol within a protected 
area;
    (2) Any acts by any person licensed under 10 CFR parts 52 and/or 55 
to operate a power reactor, as well as any acts by SSNM transporters, 
FFD program personnel, or any supervisory personnel who are authorized 
under this part, if such acts--
    (i) Involve the use, sale, or possession of a controlled substance;
    (ii) Result in a determination that the individual has violated the 
licensee's or other entity's FFD policy (including subversion as 
defined in Sec.  26.5); or
    (iii) Involve the consumption of alcohol within a protected area or 
while performing the duties that require the individual to be subject 
to the FFD program;
    (3) Any intentional act that casts doubt on the integrity of the 
FFD program; and
    (4) Any programmatic failure, degradation, or discovered 
vulnerability of the FFD program that may permit undetected drug or 
alcohol use or abuse by individuals within a protected area, or by 
individuals who are assigned to perform duties that require them to be 
subject to the FFD program.
    (c) Drug and alcohol testing errors. (1) Within 30 days of 
completing an investigation of any testing errors or unsatisfactory 
performance discovered in performance testing at either a licensee 
testing facility or an HHS-certified laboratory, in the testing of 
quality control or actual specimens, or through the processing of 
reviews under Sec.  26.39 and MRO reviews under Sec.  26.185, as well 
as any other errors or matters that could adversely reflect on the 
integrity of the random selection or testing process, the licensee or 
other entity shall submit to the NRC a report of the incident and 
corrective actions taken or planned. If the error involves an HHS-
certified laboratory, the NRC shall ensure that HHS is notified of the 
finding.
    (2) If a false positive error occurs on a blind performance test 
sample submitted to an HHS-certified laboratory, the licensee or other 
entity shall notify the NRC within 24 hours after discovery of the 
error.
    (3) If a false negative error occurs on a quality assurance check 
of validity screening tests, as required in Sec.  26.137(b), the 
licensee or other entity shall notify the NRC within 24 hours after 
discovery of the error.
    (d) Indicators of programmatic weaknesses. Licensees and other 
entities shall document, trend, and correct non-reportable indicators 
of FFD programmatic weaknesses under the licensee's or other entity's 
corrective action program, but may not track or trend drug and alcohol 
test results in a manner that would permit the identification of any 
individuals.

Subpart O--Inspections, Violations, and Penalties


Sec.  26.821  Inspections.

    (a) Each licensee and other entity who is subject to this part 
shall permit duly authorized NRC representatives to inspect, copy, or 
take away copies of its records and to inspect its premises, 
activities, and personnel as may be necessary to accomplish the 
purposes of this part.
    (b) Written agreements between licensees or other entities and 
their C/Vs must clearly show that--
    (1) The licensee or other entity is responsible to the NRC for 
maintaining an effective FFD program under this part; and
    (2) Duly authorized NRC representatives may inspect, copy, or take 
away copies of any licensee's, other entity's, or C/V's documents, 
records, and reports related to implementation of the licensee's or 
other entity's FFD program under the scope of the contracted 
activities.


Sec.  26.823  Violations.

    (a) An injunction or other court order may be obtained to prohibit 
a violation of any provision of--
    (1) The Atomic Energy Act of 1954, as amended;
    (2) Title II of the Energy Reorganization Act of 1974; or
    (3) Any regulation or order issued under these Acts.
    (b) A court order may be obtained for the payment of a civil 
penalty imposed under section 234 of the Atomic Energy Act of 1954, for 
violations of--
    (1) Section 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of 
the Act;
    (2) Section 206 of the Energy Reorganization Act of 1974;
    (3) Any rule, regulation, or order issued under these sections;
    (4) Any term, condition, or limitation of any license issued under 
these sections; or
    (5) Any provisions for which a license may be revoked under section 
186 of the Atomic Energy Act of 1954.


 26.825  Criminal penalties.

    (a) Section 223 of the Atomic Energy Act of 1954, as amended, 
provides for criminal sanctions for willful violation of, attempted 
violation of, or conspiracy to violate, any regulation issued under 
sections 161b, 161i, or 161o of the Act. For the purposes of section 
223, all of the regulations in Part 26 are issued under one or more of 
sections 161b, 161i, or 161o, except for the sections listed in 
paragraph (b) of this section.
    (b) The regulations in Part 26 that are not issued under sections 
161b, 161i, or 161o for the purposes of section 223 are as follows: 
Sec. Sec.  26.1, 26.3, 26.5, 26.7, 26.8, 26.9, 26.11, 26.51, 26.81, 
26.121, 26.151, 26.181, 26.201, 26.823, and 26.825.
* * * * *

    Dated at Rockville, Maryland, this 7th day of March, 2008.

    For the Nuclear Regulatory Commission.
Annette Vietti-Cook,
Secretary of the Commission.

    Note: This Appendix will not appear in The Code of Federal 
Regulations.

Appendix A to This Document--Derivation and Distribution Tables for 
Part 26.

                 Table 1.--Derivation Table for Part 26
------------------------------------------------------------------------
                New section                           Based on
------------------------------------------------------------------------
26.1......................................  26.1 first sentence.
26.3(a)...................................  26.2(a).
26.3(b)...................................  26.1 (2nd sentence) and
                                             26.2(a) (1st sentence).

[[Page 17232]]

 
26.3(c)...................................  26.2(c).
26.3(d)...................................  26.23(a)(1).
26.3(e)...................................  26.2(b).
26.4(a)...................................  26.2(a) and 26.2(d).
26.4(b)...................................  26.2(a) and 26.2(d).
26.4(c)...................................  26.2(a) and 26.2(d).
26.4(d)...................................  26.2(a) and 26.2(d).
26.4(e)...................................  NEW.
26.4(f)...................................  NEW.
26.4(g)...................................  NEW.
26.4(h)...................................  NEW.
26.4(i)(1)................................  26.20(a).
26.4(i)(2)................................  26.2(b) first sentence.
26.4(i)(3)................................  26.2(b) first sentence.
26.4(i)(4)................................  NEW.
26.4(j)...................................  NEW.
26.5......................................  26.3 and Appendix A Subpart
                                             1.2.
26.7......................................  26.4.
26.8......................................  26.8.
26.9......................................  26.6.
26.11.....................................  NEW.
26.21.....................................  26.23(b).
26.23(a)..................................  26.10(a).
26.23(b)..................................  26.10(a).
26.23(c)..................................  26.10(b).
26.23(d)..................................  26.10(c).
26.23(e)..................................  NEW.
26.27(a)..................................  26.20 1st paragraph.
26.27(b)(1)...............................  26.20(a).
26.27(b)(2)...............................  NEW.
26.27(b)(3)...............................  NEW.
26.27(b)(4)(i)............................  26.20(a)(1).
26.27(b)(4)(ii)...........................  26.20(a)(2).
26.27(b)(5)...............................  NEW.
26.27(b)(6)...............................  26.20(a).
26.27(b)(7)...............................  26.20(b).
26.27(b)(8)...............................  26.20(d).
26.27(b)(9)...............................  NEW.
26.27(b)(10)..............................  NEW.
26.27(b)(11)..............................  NEW.
26.27(c)(1)...............................  26.20(c).
26.27(c)(2)...............................  26.20(d).
26.27(c)(3)...............................  26.20(e).
26.27(c)(4)...............................  NEW.
26.27(d)..................................  26.20(f).
26.29(a)..................................  26.21(a)(1)-(5); 26.22(a)(1)-
                                             (5); 26.22(b).
26.29(b)..................................  NEW.
26.29(c)..................................  26.21(b) and 26.21(c).
26.31.....................................  26.24.
26.31(a)..................................  26.24(a).
26.31(b)..................................  Section 2.3 in Appendix A to
                                             Part 26.
26.31(b)(1)...............................  First paragraph, Section 2.3
                                             in Appendix A to Part 26.
26.31(b)(1)(i)............................  Section 2.3(2).
26.31(b)(1)(ii)...........................  Section 2.3(1).
26.31(b)(1)(iii)..........................  Section 2.3(1).
26.31(b)(1)(iv)...........................  NEW.
26.31(b)(1)(v)............................  Section 2.3(3).
26.31(b)(2)...............................  NEW.
26.31(c)..................................  26.24(a)(1)-(4).
26.31(c)(1)...............................  26.24(a)(1).
26.31(c)(2)...............................  26.24(a)(3).
26.31(c)(3)...............................  26.24(a)(3).
26.31(c)(4)...............................  26.24(a)(4).
26.31(c)(5)...............................  26.24(a)(2).
26.31(d)..................................  NEW.
26.31(d)(1)...............................  Section 2.1(a) in Appendix A
                                             to Part 26.
26.31(d)(1)(i)(A).........................  26.24(c).
26.31(d)(1)(i)(B).........................  26.24(c).
26.31(d)(1)(i)(C).........................  Section 2.1(c).
26.31(d)(1)(i)(D).........................  26.31(d)(1)(i)(C).
26.31(d)(1)(ii)...........................  Section 2.1(b) and
                                             26.31(d)(1)(i)(D).
26.31(d)(1)(iii)..........................  NEW.
26.31(d)(2)...............................  26.24(a).
26.31(d)(3)...............................  NEW.
26.31(d)(3)(i)............................  Appendix A Subpart A 1.1(3);
                                             26.24(f); Appendix A
                                             Subpart B 2.8(e); 2.8(a)
                                             and (b).
26.31(d)(3)(ii)...........................  26.24(d)(1).
26.31(d)(3)(iii)..........................  Sections 2.7(e)(1) and
                                             (f)(2).
26.31(d)(3)(iii)(A).......................  26.24(b).
26.31(d)(3)(iii)(B).......................  NEW.
26.31(d)(3)(iii)(C).......................  NEW.
26.31(d)(4)...............................  26.24(g).
26.31(d)(5)...............................  NEW.
26.31(d)(6)...............................  Section 2.1(d).
26.33.....................................  26.22.
26.35.....................................  26.25.
26.37.....................................  26.29.
26.39.....................................  26.27.
26.41(a)..................................  26.80(a).
26.41(b)..................................  26.80(a).
26.41(c)..................................  26.80(a); Appendix A Subpart
                                             B 2.7(m).
26.41(d)..................................  Section 2.7(m).
26.41(e)..................................  26.80(b).
26.41(f)..................................  26.80(c).
26.41(g)..................................  26.80(a).
26.51.....................................  26.1.
26.53.....................................  NEW.
26.55(a)..................................  NEW.
26.55(b)..................................  NEW.
26.57(a)..................................  NEW.
26.57(b)..................................  NEW.
26.59.....................................  NEW.
26.61.....................................  26.27(a)(1).
26.61(a)..................................  NEW.
26.61(b)..................................  NEW.
26.61(c)..................................  NEW.
26.61(d)..................................  26.27(a)(4).
26.63.....................................  26.27(a)(2).
26.63(a)..................................  NEW.
26.63(b)..................................  NEW.
26.63(c)..................................  NEW.
26.63(d)..................................  NEW.
26.63(e)..................................  NEW.
26.63(f)(1)...............................  26.71(c) and
                                             26.27(b)(2)(vii).
26.63(f)(2)...............................  NEW.
26.63(f)(3)...............................  NEW.
26.65.....................................  26.24(a)(1).
26.65(a)..................................  NEW.
26.65(b)..................................  NEW.
26.65(c)..................................  NEW.
26.65(d)..................................  NEW.
26.65(e)..................................  NEW.
26.65(f)..................................  NEW.
26.65(g)..................................  NEW.
26.67(a)..................................  NEW.
26.67(b)..................................  NEW.
26.67(c)..................................  NEW.
26.69.....................................  26.27(b)(4).
26.69(a)..................................  NEW. 26.27(b)(2).
26.69(b)(1)...............................  NEW.
26.69(b)(2)...............................  NEW. 26.27(b)(2).
26.69(b)(3)...............................  26.27(b)(4).
26.69(b)(4)...............................  26.27(b)(2).
26.69(b)(5)...............................  NEW.
26.69(b)(6)...............................  26.27(b)(4).
26.69(b)(7)...............................  NEW.
26.69(c)(1)...............................  NEW.
26.69(c)(2)...............................  NEW.
26.69(c)(3)...............................  NEW.
26.69(c)(4)...............................  NEW.
26.69(c)(5)...............................  NEW.
26.69(d)..................................  NEW.
26.69(e)..................................  NEW.
26.69(f)..................................  26.27(a)(2).
26.71.....................................  NEW.
26.73.....................................  NEW.
26.75(a) (1st sentence)...................  NEW.
26.75(a) (2nd sentence)...................  26.27(b) (1st sentence).
26.75(b)..................................  NEW.
26.75(c)..................................  26.27(b)(3).
26.75(d)..................................  26.27(c).
26.75(e)..................................  26.27(b)(2).
26.75(f)..................................  26.27(b)(5).
26.75(g)..................................  26.27(b)(4).
26.75(h)..................................  26.24(d)(2).
26.75(i)..................................  26.24(d)(2).
26.77.....................................  26.26(b)(1).
26.77(a)..................................  NEW.
26.77(b)(1)...............................  26.27(b)(1).
26.77(b)(2)...............................  NEW.
26.77(b)(3)...............................  NEW.
26.77(c)..................................  26.27(d).
26.83(b)..................................  26.24(b).
26.85(a)..................................  Appendix A Subpart B 2.2(d).
26.85(b)..................................  NEW.
26.85(c)..................................  Appendix A Subpart B
                                             2.2(d)(2) (last sentence).
26.85(d)..................................  Appendix A Subpart B
                                             2.7(o)(5).
26.85(e)..................................  NEW.
26.87(a)..................................  Appendix A Subpart B 2.4(a).
26.87(b)..................................  Appendix A Subpart B 2.4(f)
                                             (1st sentence).
26.87(c)..................................  Appendix A Subpart B 2.7(m).
26.87(d)..................................  Appendix A Subpart B 2.4(c).
26.87(d)(1)...............................  Appendix A Subpart B 2.4(e).
26.87(d)(2)...............................  Appendix A Subpart B 2.4(c)
                                             (2nd sentence).
26.87(d)(3)...............................  Appendix A Subpart B 2.4(c).
26.87(e)..................................  NEW.
26.87(e)(2)...............................  Appendix A Subpart B
                                             2.4(g)(1) (2nd sentence).
26.87(e)(3)...............................  NEW.
26.87(f)(1)...............................  Appendix A Subpart B
                                             2.4(c)(1).

[[Page 17233]]

 
26.87(f)(2)...............................  Appendix A Subpart B
                                             2.4(g)(10) (3rd sentence).
26.87(f)(3)...............................  Appendix A Subpart B
                                             2.4(g)(10) (2nd sentence).
26.87(f)(4)...............................  Appendix A Subpart B
                                             2.4(g)(10) and new
                                             material.
26.87(f)(5)...............................  Appendix A Subpart B
                                             2.4(c)(2).
26.89(a)..................................  Appendix A Subpart B
                                             2.4(g)(3).
26.89(b)..................................  Appendix A Subpart B
                                             2.4(g)(2).
26.89(b)(1)...............................  Appendix A Subpart B
                                             2.4(g)(2).
26.89(b)(2)...............................  Appendix A Subpart B
                                             2.4(g)(2).
26.89(b)(3)...............................  NEW.
26.89(b)(4)...............................  Appendix A Subpart B
                                             2.4(g)(4) and (g)(23)(ii).
26.89(c)..................................  NEW.
26.89(d)..................................  Appendix A Subpart B 2.4(e).
26.91(a)..................................  Appendix A Subpart B
                                             2.7(o)(3)(ii).
26.91(b)..................................  Appendix A Subpart B
                                             2.7(o)(3)(ii).
26.91(c)..................................  NEW.
26.91(d)..................................  NEW.
26.91(e)..................................  NEW.
26.93.....................................  Appendix A Subpart B
                                             2.4(g)(18) and new
                                             material.
26.95.....................................  Appendix A Subpart B
                                             2.4(g)(18) and new
                                             material.
26.97.....................................  NEW.
26.99.....................................  26.24(g) and Appendix A
                                             Subpart B 2.7(e)(1).
26.101....................................  Appendix A Subpart B
                                             2.4(g)(18) and new
                                             material.
26.103....................................  26.24(g), Appendix A Subpart
                                             B 2.7(f)(2), and new
                                             material.
26.105(a).................................  Appendix A Subpart B
                                             2.4(g)(5).
26.105(b).................................  NEW.
26.105(c).................................  Appendix A Subpart B
                                             2.4(g)(6).
26.105(d).................................  Appendix A Subpart B
                                             2.4(g)(7).
26.105(e).................................  NEW.
26.107....................................  Appendix A Subpart B 2.4(g)
                                             and new material.
26.109....................................  Appendix A Subpart B 2.4 and
                                             new material.
26.111(a).................................  Appendix A Subpart B
                                             2.4(g)(13) and (g)(14).
26.111(b).................................  Appendix A Subpart B
                                             2.4(g)(15).
l26.111(c)................................  NEW.
26.111(d).................................  Appendix A Subpart B
                                             2.4(g)(16).
26.111(e).................................  NEW.
26.111(f).................................  NEW.
26.113(a).................................  NEW.
26.113(b).................................  Appendix A Subpart B
                                             2.4(g)(20) and 2.7(j).
26.113(c).................................  NEW.
26.115(a)(1)..............................  Appendix A Subpart B
                                             2.4(f)(2).
26.115(a)(2)..............................  Appendix A Subpart B
                                             2.4(f)(1) and (g)(14).
26.115(a)(3)..............................  Appendix A Subpart B
                                             2.4(f)(3).
26.115(a)(4)..............................  Appendix A Subpart B
                                             2.4(f)(4).
26.115(b).................................  Appendix A Subpart B
                                             2.4(g)(25).
26.115(c).................................  NEW.
26.115(d).................................  NEW.
26.115(e).................................  Appendix A Subpart A 1.2 and
                                             Subpart B 2.4.
26.115(f).................................  NEW.
26.117(a).................................  Appendix A Subpart B
                                             2.4(g)(20).
26.117(b).................................  Appendix A Subpart B
                                             2.4(g)(21).
26.117(c).................................  Appendix A Subpart B
                                             2.4(g)(22).
26.117(d).................................  Appendix A Subpart B
                                             2.4(g)(23).
26.117(e).................................  Appendix A Subpart B
                                             2.4(g)(26).
26.117(f).................................  Appendix A Subpart B
                                             2.4(g)(27).
26.117(g).................................  Appendix A Subpart B
                                             2.4(g)(28).
26.117(h).................................  Appendix A Subpart B
                                             2.4(c)(2).
26.117(i).................................  Appendix A Subpart B 2.7(i).
26.117(j).................................  Appendix A Subpart B 2.4(1)
                                             and 2.7(c).
26.117(k).................................  Appendix A Subpart B 2.4(h).
26.119....................................  NEW.
26.121....................................  NEW.
26.123....................................  Appendix A Subpart B
                                             2.7(l)(2).
26.125(a).................................  Appendix A Subpart B 2.6(a).
26.125(b).................................  Appendix A Subpart B 2.6(b).
26.125(c).................................  Appendix A Subpart B 2.6(c).
26.127(a).................................  Appendix A Subpart B 2.2 1st
                                             paragraph.
26.127(b).................................  Appendix A Subpart B
                                             2.7(a)(2) and 2.4(d).
26.127(c).................................  Appendix A Subpart B
                                             2.7(o)(1).
26.127(d).................................  Appendix A Subpart B
                                             2.7(o)(3)(iii).
26.127(e).................................  Appendix A Subpart B
                                             2.7(o)(4).
26.129(a).................................  Appendix A Subpart B
                                             2.7(a)(1).
26.129(b).................................  Appendix A Subpart B
                                             2.2(b)(1).
26.129(c).................................  Appendix A Subpart B
                                             2.7(b)(2).
26.129(d).................................  Appendix A Subpart B
                                             2.7(a)(2).
26.129(e).................................  Appendix A Subpart B 2.7(d)
                                             1st sentence.
26.129(f).................................  Appendix A Subpart B 2.7(c).
26.129(g).................................  Appendix A Subpart B 2.4(i).
26.129(h).................................  Appendix A Subpart B 2.4(i).
26.131....................................  NEW.
26.133....................................  Appendix A Subpart B
                                             2.7(e)(1).
26.135(a).................................  Appendix A Subpart B 2.7(j).
26.135(b).................................  Appendix A Subpart B 2.7(j).
25.135(c).................................  Appendix A Subpart B 2.7(h).
26.137....................................  Appendix A Subpart B 2.8(a).
26.137(e)(4-5)............................  Appendix A Subpart B 2.8(b).
26.137(e)(6-7)............................  Appendix A Subpart B 2.8(c).
26.137(f).................................  NEW.
26.137(g).................................  Appendix A Subpart B
                                             2.7(o)(3)(i).
26.137(h).................................  Appendix A Subpart B
                                             2.7(o)(2).
26.139(a).................................  Appendix A Subpart B
                                             2.7(g)(2).
26.139(b).................................  26.24(d)(1).
26.139(c).................................  Appendix A Subpart B
                                             2.7(o)(5).
26.139(d).................................  Appendix A Subpart B
                                             2.7(g)(6).
26.139(e).................................  Appendix A Subpart B
                                             2.7(g)(7).
26.139(f).................................  NEW.
26.151....................................  NEW.
26.153(a).................................  26.24(f), Appendix A Subpart
                                             A 1.1(3) and Subpart D
                                             4.1(a).
26.153(b).................................  Appendix A Subpart B
                                             2.7(l)(2).
26.153(c).................................  Appendix A Subpart B 2.7(k).
26.153(d).................................  Appendix A Subpart D 4.1(b).
26.153(e).................................  Appendix A Subpart B 2.7(m).
26.153(f)(1)..............................  Appendix A Subpart B
                                             2.7(l)(1).
26.153(f)(2)..............................  Appendix A Subpart B
                                             2.7(o)(5).
26.153(f)(3)..............................  Appendix A Subpart C 3.1.
26.153(f)(4)..............................  Appendix A Subpart C 3.2.
26.153(f)(5)..............................  NEW.
26.153(f)(6)..............................  Appendix A Subpart B 2.7(m).
26.153(g).................................  NEW.

[[Page 17234]]

 
26.155....................................  Appendix A Subpart B 2.5.
26.157(a).................................  Appendix A Subpart B 2.2 1st
                                             paragraph.
26.157(b).................................  Appendix A Subpart B 2.4(d)
                                             and 2.7(a)(2).
26.157(c).................................  Appendix A Subpart B
                                             2.7(o)(1).
26.157(d).................................  Appendix A Subpart B
                                             2.2(o)(3)(iii).
26.157(e).................................  Appendix A Subpart B
                                             2.7(o)(4).
26.159(a).................................  Appendix A Subpart B
                                             2.7(a)(1).
26.159(b).................................  Appendix A Subpart B
                                             2.7(b)(1).
26.159(c).................................  Appendix A Subpart B
                                             2.7(b)(2).
26.159(d).................................  Appendix A Subpart B
                                             2.7(a)(2).
26.159(e).................................  Appendix A Subpart B
                                             2.7(a)(2).
26.159(f).................................  Appendix A Subpart B 2.4(i).
26.159(g).................................  Appendix A Subpart B 2.4(i).
26.159(h).................................  NEW.
26.159(i).................................  Appendix A Subpart B 2.7(h).
26.159(j).................................  NEW.
26.161....................................  NEW.
26.163(a).................................  Appendix A Subpart B 2.7(e).
26.163(a)(2)..............................  NEW.
26.163(b).................................  Appendix A Subpart B 2.7(f).
26.165(a).................................  26.24(f) and Appendix A
                                             Subpart B 2.7(j).
26.165(b).................................  Appendix A Subpart B 2.7(j)
                                             and new material.
26.165(c).................................  Appendix A Subpart B 2.7(i).
26.165(c)(1)..............................  NEW.
26.165(c)(2)..............................  Appendix A Subpart B 2.7(i).
26.165(c)(3)..............................  NEW.
26.165(c)(4)..............................  Appendix A Subpart B 2.7(j)
                                             (last sentence).
26.165(d).................................  NEW.
26.165(e).................................  NEW.
26.165(f).................................  NEW.
26.167(a).................................  Appendix A Subpart B 2.8(a)
                                             and (d).
26.167(b).................................  Appendix A Subpart B 2.8(c)
                                             and (d) and new material.
26.167(c).................................  NEW.
26.167(d)(1)..............................  Appendix A Subpart B
                                             2.7(e)(1).
26.167(d)(2)..............................  NEW.
26.167(d)(3)..............................  Appendix A Subpart B 2.8(c).
26.167(e).................................  Appendix A Subpart B
                                             2.7(f)(2) and 2.8(d).
26.167(f).................................  Appendix A Subpart B
                                             2.8(e)(4)-(e)(6).
26.167(g).................................  Appendix A Subpart B
                                             2.7(o)(3)(i).
26.167(h).................................  Appendix A Subpart B
                                             2.7(o)(2).
26.168....................................  Appendix A Subpart B 2.8(e)
                                             and new material.
26.169....................................  Appendix A Subpart B 2.7(g)
                                             (substantially revised).
26.181....................................  NEW.
26.183(a).................................  26.3 and Appendix A Subpart
                                             A 1.2 and Appendix A
                                             Subpart B 2.9(b).
26.183(b).................................  Appendix A Subpart B 2.9(b).
26.183(c).................................  26.3 and Appendix A Subparts
                                             A 1.2, B 2.4(j), B 2.9(a),
                                             and B 2.9(b).
26.183(d).................................  NEW.
26.185(a).................................  Appendix A Subpart B 2.9(a).
26.185(b).................................  Appendix A Subpart B 2.9(b).
26.185(c).................................  Appendix A Subpart B 2.9(c).
26.185(d).................................  NEW.
26.185(e).................................  NEW.
26.185(f).................................  NEW.
26.185(g).................................  NEW.
26.185(h).................................  NEW.
26.185(i).................................  NEW.
26.185(j)(1)..............................  Appendix A Subpart B 2.9(d).
26.185(j)(2)..............................  Appendix A Subpart B 2.9(d).
26.185(j)(3)..............................  NEW.
26.185(j)(4)..............................  NEW.
26.185(j)(5)..............................  NEW.
26.185(j)(6)..............................  NEW.
26.185(k).................................  Appendix A Subpart B 2.9(f).
26.185(l).................................  Appendix A Subpart B 2.9(e).
26.185(m).................................  Appendix A Subpart B 2.9(g).
26.185(n).................................  NEW.
26.185(o).................................  NEW.
26.185(p).................................  26.24(e).
26.187....................................  NEW.
26.189....................................  NEW.
26.201....................................  NEW.
26.203....................................  NEW.
26.205....................................  NEW.
26.207....................................  NEW.
26.209....................................  NEW.
26.211....................................  NEW.
26.401....................................  26.2(c).
26.403....................................  26.2(c).
26.405....................................  26.2(c).
26.407....................................  26.2(c).
26.409....................................  26.2(c).
26.411....................................  26.2(c).
26.413....................................  26.2(c).
26.415....................................  26.2(c).
26.417....................................  26.2(c).
26.419....................................  26.2(c).
26.709....................................  NEW.
26.711....................................  NEW.
26.713(a)(1)..............................  26.71(a).
26.713(a)(2)..............................  26.71(b).
26.713(a)(3)..............................  NEW.
26.713(a)(4)..............................  NEW.
26.713(b).................................  26.21(b); 26.22(c);
                                             26.80(c).
26.713(c).................................  26.71(c).
26.713(d).................................  26.20.
26.713(e).................................  26.23(a).
26.713(f).................................  NEW.
26.713(g).................................  NEW.
26.715(a).................................  Appendix A, Section 2.7(n).
26.715(b)(1)-(14).........................  NEW.
26.717....................................  26.71(d).
26.719(a)-(b).............................  26.73.
26.719(c)(1)..............................  Appendix A Subpart B
                                             2.8(e)(4).
26.719(c)(2)..............................  Appendix A Subpart B
                                             2.8(e)(5).
26.719(c)(3)..............................  NEW.
26.719(d).................................  NEW.
26.821....................................  26.70.
26.823....................................  26.90.
26.825....................................  26.91.
------------------------------------------------------------------------


                Table 2.--Distribution Table for Part 26
------------------------------------------------------------------------
              Former section                         Replaced by
------------------------------------------------------------------------
26.1 (from beginning to ``programs'').....  26.1.
26.1 (following ``programs'').............  Deleted.
26.2(a) (first clause)....................  26.3(a).
26.2(a) (balance of 1st sentence).........  26.3(b) first clause.
26.2(a) (2nd sentence)....................  26.21 (1st sentence).
26.2(a) (3rd sentence to end).............  26.4(a), (b), (c), and (d).
26.2(b) (1st sentence)....................  26.4(i) (2) and (3).
26.2(b) (2nd sentence to end).............  26.3(e).
26.2(c) (1st sentence)....................  26.3(c); Subpart K.
26.2(c) (from ``shall implement'' to end).  Subpart K.
26.2(d)...................................  26.3(c).
26.3......................................  26.5.
26.4......................................  26.7.
26.6......................................  26.9.
26.8......................................  26.13.
26.10(a) (from beginning through            26.23(a).
 ``manner'').
26.10(a) (balance of 1st sentence)........  26.23(b).
26.10(b)..................................  26.23(c).
26.10(c)..................................  26.23(d).
26.20 (introductory paragraph, 1st          26.27(a).
 sentence).
26.20 (introductory paragraph, 2nd          26.713(d).
 sentence).

[[Page 17235]]

 
26.20 (introductory paragraph, final        26.27(b) (sentence before
 sentence).                                  ``(1)'').
26.20(a)..................................  26.27(b).
26.20(b)..................................  26.27(b)(7).
26.20(c)..................................  26.27(c)(1).
26.20(d)..................................  26.27(c)(2).
26.20(e)..................................  26.27(c)(3).
26.20(f)..................................  26.27(d).
26.21(a)..................................  26.29(a).
26.21(b)..................................  26.29(c).
26.21(b) (last sentence)..................  26.713(b)(1).
26.22.....................................  Deleted.
26.23(a)..................................  26.3(d) and 26.21.
26.23(b)..................................  26.21.
26.24(a) (first sentence to ``(1)'')......  26.31(a).
26.24(a)(1)-(4)...........................  26.31(c) (substantially
                                             revised).
26.24(b)..................................  Subparts E, F, and G.
26.24(c)..................................  26.31(d).
26.24(d)..................................  Subparts E, F, and G.
26.24(e)..................................  Subpart H.
26.24(f)..................................  26.31(d)(2) and requirements
                                             in Subpart G.
26.24(g)..................................  26.31(d)(4) and Subparts E,
                                             F, and G.
26.25.....................................  26.35.
26.27(a)..................................  Subpart C.
26.27(b)..................................  Subpart D.
26.27(c)..................................  Subpart D.
26.27(d)..................................  26.77(c).
26.28.....................................  26.39.
26.29.....................................  26.37.
26.70.....................................  26.721.
26.71.....................................  26.711, 26.713, and 26.715.
26.73.....................................  26.719 (substantially
                                             revised).
26.80.....................................  26.41 (substantially
                                             revised).
26.90.....................................  26.723.
26.91.....................................  26.725.
Appendix A Subpart A, 1.1(1)..............  26.3.
Appendix A Subpart A, 1.1(3)..............  Subparts F and G.
Appendix A Subpart A, 1.2.................  26.5, and 26.115(e).
Appendix A Subpart B, 2.1(a)..............  26.31(d)(1).
Appendix A Subpart B, 2.1(b)..............  26.31(d)(1)(ii).
Appendix A Subpart B.2.1(c)...............  Subparts E, F, and G.
Appendix A Subpart B.2.1(d)...............  26.31(d)(6).
Appendix A Subpart B.2.1(e)...............  26.31.
Appendix A Subpart B.2.2 (Initial           Subparts F and G.
 paragraph).
Appendix A Subpart B.2.2 (a), (b), and (c)  26.115, 26.117, 26.129,
                                             26.159, 26.169.
Appendix A Subpart B.2.2 (d)(1), (2), and   26.85 and 26.157(b).
 (3).
Appendix A Subpart B.2.2(d)(4)............  Deleted.
Appendix A Subpart B.2.3..................  26.31(b), and requirements
                                             in Subparts E, F, and G.
Appendix A Subpart B.2.4(a)...............  26.87(a).
Appendix A Subpart B.2.4(b)...............  26.85 and 26.115(e).
Appendix A Subpart B.2.4(c)...............  26.87 (d) and (f),
                                             26.117(h).
Appendix A Subpart B 2.4(d)...............  26.117 and 26.127(b).
Appendix A Subpart B 2.4(e)...............  26.87(d)(1).
Appendix A Subpart B 2.4(f) 1st sentence..  26.87(b).
Appendix A Subpart B 2.4(f)(1) through      26.95 through 26.115 and
 (f)(4).                                     Subparts Fand G.
Appendix A Subpart B 2.4(g)(1) through      Subparts E, F, and G.
 (g)(25).
Appendix A Subpart B 2.4(h) (1st sentence)  26.87(f)(5).
Appendix A Subpart B 2.4(h) (balance of     26.129(d) and 26.157.
 section).
Appendix A Subpart B 2.4(i)...............  26.117(j), 26.129(h) and
                                             26.159.
Appendix A Subpart B 2.4(j) (first two      26.115 and 26.185.
 sentences).
Appendix A Subpart B 2.4(j) (final          Deleted.
 sentence).
Appendix A Subpart B 2.5(a)...............  26.155(a).
Appendix A Subpart B 2.5(b)...............  26.153(c) and 26.155(c).
Appendix A Subpart B 2.5(c)...............  26.155(c).
Appendix A Subpart B 2.5(d)...............  26.155(d).
Appendix A Subpart B 2.5(e)...............  26.155(e).
Appendix A Subpart B 2.5(f)...............  26.155(f).
Appendix A Subpart B 2.6(a)...............  26.125(a).
Appendix A Subpart B 2.6(b)...............  26.125(b).
Appendix A Subpart B 2.6(c)...............  26.125(c).
Appendix A Subpart B 2.7(a)...............  26.127, 26.129, 26.157, and
                                             26.159.
Appendix A Subpart B 2.7(b)...............  26.129(b) and 26.159.
Appendix A Subpart B 2.7(c)...............  26.117(j), 26.129(f) and
                                             26.159(h).
Appendix A Subpart B 2.7(d)...............  26.157 and 26.159.
Appendix A Subpart B 2.7(e)...............  Validity screening and
                                             initial validity test
                                             requirements in 26.131 and
                                             26.161 and initial cutoff
                                             levels in 26.133 and
                                             26.163(a).
Appendix A Subpart B 2.7(f)...............  26.103, 26.115(a),
                                             26.163(b), 26.167 and
                                             26.169.
Appendix A Subpart B 2.7(g)(1) through (5)  26.169.
Appendix A Subpart B 2.7(g)(6) and (7)....  Requirement for annual
                                             summary in 26.169(h).
Appendix A Subpart B 2.7(g)(8)............  26.215.
Appendix A Subpart B 2.7(h)...............  26.159(i) and by 26.135(c).
Appendix A Subpart B 2.7(i)...............  26.117(i) and Subparts F and
                                             G.
Appendix A Subpart B 2.7(j)...............  26.113, 26.135, 26.165.
Appendix A Subpart B 2.7(k)...............  26.153(c).
Appendix A Subpart B 2.7(l)...............  26.123 and 26.153.
Appendix A Subpart B 2.7(m)...............  26.87(c), 26.153 and 26.221.
Appendix A Subpart B 2.7(n)...............  26.215(a).
Appendix A Subpart B 2.7(o)(1)............  26.127(c) and 26.157(c).
Appendix A Subpart B 2.7(o)(2), (o)(3),     26.91, 26.127, 26.137,
 and (o)(4).                                 26.157 and 26.167.
Appendix A Subpart B 2.7(o)(5)............  26.85(d), 26.139(c) and
                                             26.153(f)(2).
Appendix A Subpart B 2.8(a)...............  26.137(a) and 26.167(a).
Appendix A Subpart B 2.8(b)...............  26.137.
Appendix A Subpart B 2.8(c)...............  26.167.
Appendix A Subpart B 2.8(d)...............  26.137 and 26.167.
Appendix A Subpart B 2.8(e)(1) to (e)(3)..  26.137 and 26.167.
Appendix A Subpart B 2.8(e)(4), (e)(5),     26.137, 26.167, and 26.219.
 and (e)(6).
Appendix A Subpart B 2.9 (a) and (b)        26.183.
 (through ``contract employee'').
Appendix A Subpart B 2.9(b) (balance of     26.185.
 section), (c), (d), (e), (f), and (g).
Appendix A Subpart C 3.1..................  26.37(e) and 26.153(f)(3).
Appendix A Subpart C 3.2..................  26.75(I)(4), 26.153(f)(4),
                                             and 26.165(f).
Appendix A Subpart D 4.1..................  26.153(d).
------------------------------------------------------------------------

[FR Doc. E8-4998 Filed 3-28-08; 8:45 am]
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