[Federal Register Volume 70, Number 165 (Friday, August 26, 2005)]
[Proposed Rules]
[Pages 50442-50677]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-15576]



[[Page 50441]]

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Part II





Nuclear Regulatory Commission





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10 CFR Part 26



Fitness for Duty Programs; Proposed Rule

  Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / 
Proposed Rules  

[[Page 50442]]


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NUCLEAR REGULATORY COMMISSION

10 CFR Part 26

RIN 3150-AF12


Fitness for Duty Programs

AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

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SUMMARY: The Nuclear Regulatory Commission (NRC) is proposing to amend 
its regulations for Fitness for Duty (FFD) programs to update the rule 
and enhance consistency with advances in other relevant Federal rules 
and guidelines, including the U.S. Department of Health and Human 
Services Mandatory Guidelines for Federal Workplace Drug Testing 
Programs (HHS Guidelines), and other Federal drug and alcohol testing 
programs that impose similar requirements on NRC licensees. The 
proposed amendments would require nuclear power plant licensees to 
strengthen the effectiveness of their FFD programs 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; and ensure 
consistency with the NRC's access authorization requirements for 
nuclear power plants. The proposed rule would ensure 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 proposed rule would also grant, 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 would partially grant a 
petition for rulemaking (PRM-26-2) submitted by Barry Quigley on 
December 28, 1999.

DATES: Submit comments on the rule by December 27, 2005. Submit 
comments specific to the information collections aspects of this rule 
by September 26, 2005. Comments received after the above dates will be 
considered if it is practical to do so, but assurance of consideration 
cannot be given to comments received after these dates.

ADDRESSES: You may submit comments on the rule by any one of the 
following methods. Please include the following number (RIN 3150-AF12) 
in the subject line of your comments. Comments on rulemakings submitted 
in writing or in electronic form will be made available to the public 
in their entirety on the NRC rulemaking Web site. Personal information 
will not be removed from your comments.
    Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, Attention: Rulemakings and Adjudications 
Staff.
    E-mail comments to: [email protected]. If you do not receive a reply e-
mail confirming that we have received your comments, contact us 
directly at (301) 415-1966. You may also submit comments via the NRC's 
rulemaking Web site at http://ruleforum.llnl.gov. Address questions 
about our rulemaking Web site to Carol Gallagher (301) 415-5905; e-mail 
[email protected].
    Hand deliver comments to: 11555 Rockville Pike, Rockville, 
Maryland, between 7:30 A.M. and 4:15 P.M. on Federal workdays.
    Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at 
(301) 415-1101.
    You may submit comments on the information collections by the 
methods indicated in the Paperwork Reduction Act Statement.
    Publicly available documents related to this rulemaking may be 
examined and copied for a fee at the NRC's Public Document Room (PDR), 
Public File Area O1-F21, One White Flint North, 11555 Rockville Pike, 
Rockville, Maryland. Copyrighted documents may be viewed at the NRC's 
PDR, but may not be copied. The draft Regulatory Analysis and other 
documents related to this rulemaking, including comments can be viewed 
and downloaded electronically via the NRC rulemaking Web site at http://ruleforum.llnl.gov.
    Publicly available documents created or received at the NRC after 
November 1, 1999, are available electronically at the NRC's Electronic 
Reading Room at http://www.nrc.gov/NRC/ADAMS/index.html. From this 
site, the public can gain entry into the NRC's Agencywide Document 
Access and Management System (ADAMS), which provides text and image 
files of NRC's public documents. If you do not have access to ADAMS or 
if there are problems in accessing the documents located in ADAMS, 
contact the NRC Public Document Room (PDR) Reference staff at 1-800-
397-4209, 301-415-4737 or by e-mail to [email protected].

FOR FURTHER INFORMATION CONTACT: Rebecca L. Karas, Office of Nuclear 
Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 
20555-0001, telephone (301) 415-3711, Timothy S. McCune, Office of 
Nuclear Security and Incident Response, telephone (301) 415-6474, or 
Dr. David R. Desaulniers, Office of Nuclear Reactor Regulation, 
telephone (301) 415-1043. 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. Work Fatigue Provisions
    C. Combined Part 26 Rulemaking
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 Proposed Action
    A. Overview
    B. Goals of the Rulemaking Activity
    C. Overview of Proposed Rule
    D. Inclusion of Worker Fatigue Provisions in 10 CFR Part 26
V. Summary of Public Interactions and Comments
    A. Public Comments Submitted to OMB on 2000 Final Rule and 
Responses
    B. Key Stakeholder Comments not Incorporated into Proposed Rule 
and Responses
VI. Section-by-Section Analysis of Substantive Changes
VII. Issues for Public Comment
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

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 a FFD program for all

[[Page 50443]]

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 literature, as well as initiatives by industry, 
the Substance Abuse and Mental Health Services Administration (SAMHSA, 
formerly the National Institute on Drug Abuse [NIDA]) 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 rulemaking 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 (responses to those 
comments are included in Section V of this document). 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 
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 revised work-hour guidelines. Those guidelines 
were:
    (1) An individual should not be permitted to work more than 16 
hours straight (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 seven 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. 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.
    Soon thereafter, the Commission received a petition for rulemaking 
(PRM-26-2), dated September 28, 1999, from Barry Quigley. (The petition 
is discussed in greater detail in Section II. B.) 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, pursuant to 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 (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). In accordance 
with 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

[[Page 50444]]

adversely affecting public health and safety and the common defense and 
security by establishing clear and enforceable requirements for the 
management worker fatigue.
    During the development of proposed 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. Following 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 use of extended work hours, 
matters unique to security personnel, and stakeholder input obtained 
through public meetings concerning the proposed worker fatigue 
rulemaking and the Order. The requirements in the Order were imposed 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 proposed 10 CFR Part 26, Subpart 
I, Managing Fatigue, for security force personnel would replace the 
requirements imposed by Order. Differences between the proposed 
requirements in Subpart I and the requirements imposed by Order, and 
the rationale for those differences, are discussed in Section IV. D.

C. Combined Part 26 Rulemaking

    On March 29, 2004, in COMSECY-04-0014, the NRC staff informed the 
Commission of the status of both 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 current 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 repropose one 
or both 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 proposed rule withdraws the proposed rule 
published on May 9, 1996.

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 the FFD 
program and 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 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.
    Proposed Sec.  26.41(b) would partially grant two aspects of the 
petition. That is, the required audit frequency for licensees and other 
entities who are subject to 10 CFR Part 26 would be reduced from the 
nominal 1-year frequency in the current 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 would be conducted as part of the 2-year audits of the 
licensee or other entity's FFD program, under proposed Sec.  26.41(b).
    Proposed Sec.  26.41(c)(1) would partially deny two aspects of the 
petition. That is, the nominal annual audit requirement for HHS-
certified laboratories would be retained. In addition, the annual audit 
requirement would be 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 audit requirements in the proposed 
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 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 
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

[[Page 50445]]

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 proposed 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 has evaluated the merits of PRM-26-2, the comments received 
in response to the PRM, and assessed the Policy on Worker Fatigue. The 
NRC has 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 
believes 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. The proposed rule would therefore grant, in part, PRM-26-
2. 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 plans to 
similarly revise the same documents during preparation of the final 
Part 26 rule. The self-disclosure of sleeping disorders by licensed 
operators (item 4) is being addressed by the NRC as a separate effort 
from this proposed 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 current rule requires 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 offsite 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 proposed rule would maintain the current 
requirement for random drug and alcohol testing for 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
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
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

[[Page 50446]]

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 Proposed Action

A. Overview

    A review of FFD program experience confirms that the regulatory 
approach of 10 CFR Part 26 is fundamentally sound and continues to 
provide a means of deterrence and detection of substance abuse at 
licensee facilities. NRC Information Notice 2003-04, ``Summary of 
Fitness-for-Duty Program Performance Reports,'' dated February 6, 2003, 
provides the latest published summary of program performance. 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 ADAMS under Accession No. 
ML030350473.
    Nonetheless, the NRC believes that revisions are needed to improve 
the effectiveness and efficiency of FFD programs; enhance consistency 
with advances in similar rules and guidelines, including 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 Nuclear Regulatory Commission (NRC) proposes to amend 10 CFR 
Part 26, Fitness for Duty Programs. The proposed 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 
U.S. Department of Health and Human Services Mandatory Guidelines for 
Federal Workplace Drug Testing Programs 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.
    (7) Protect the privacy and due process rights 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 proposed rule relate 
to each goal. The major changes for each subpart, and the reasons for 
those changes, are described in Section IV. C and D of this document. 
For each of the many specific changes that are being proposed, 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 proposed changes to the 
rule that would 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 the 
U.S. Department of Health and Human Services Mandatory Guidelines for 
Federal Workplace Drug Testing Programs (referred to in this document 
as 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. Goal 1 
is central to this rulemaking activity. Many changes are included in 
the proposed 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 Guidelines, upon which the current rule is 
based.
    The President of the United States designated HHS as the agency 
responsible for the Federal workplace drug testing program, and HHS' 
Substance Abuse and Mental Health Services Administration (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 HHS' most recent 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 would be 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 instrumented specimen validity tests to 
determine whether a urine specimen has been adulterated, diluted, or 
substituted. This proposed rule would adopt 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 current 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 proposed change 
to 10 CFR Part 26 that was included from the proposed HHS Guidelines is 
permission for licensees to use non-instrumented validity testing 
devices to determine

[[Page 50447]]

whether a urine specimen must be 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 
non-instrumented validity testing devices 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 proposing to 
include 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 proposed changes to 10 CFR Part 26 that 
incorporate the recent revisions to the HHS Guidelines, the Department 
of Transportation (DOT) revised its Procedures for Transportation 
Workplace Drug and Alcohol Testing Programs [49 CFR 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. The proposed 
rule would also reflect 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. 
Proposed Subpart I, Managing Fatigue, would add clear and enforceable 
requirements for licensee management of worker fatigue to 10 CFR Part 
26. The proposed requirements would 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 discusses the specific reasons for each proposed 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 proposing 
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 proposed reduction 
in the period within which pre-access testing must be performed from 60 
days, in current Sec.  26.24(a)(1), to 30 days or less, in proposed 
Subpart C [Granting and Maintaining Authorization]. This proposed 
change would improve the effectiveness of the pre-access test in 
detecting drug and alcohol use by individuals who are applying for 
authorization to perform the types of job duties that require them to 
be subject to Part 26 (see proposed Sec.  26.25 [Individuals subject to 
the fitness-for-duty program]). Reducing the number of breath specimens 
required for alcohol testing from two each for initial and confirmatory 
testing, in current Section 2.4(g)(18) in Appendix A to Part 26, to one 
specimen for the initial test and one for the confirmatory test, if 
required, in proposed Sec.  26.91(d), would increase the efficiency of 
FFD programs without compromising the accuracy and validity of alcohol 
test results.
    Another example would be establishing a regulatory framework for 
the management of worker fatigue that appropriately balances the need 
for flexibility to manage plant exigencies and worker individual 
differences relative to fatigue 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 access 
authorization requirements established in 10 CFR 73.56, as supplemented 
by orders to nuclear power plant licensees dated January 7, 2003. 
Current FFD and access authorization requirements each contain 
provisions that relate to establishing the trustworthiness and 
reliability of personnel prior to granting unescorted access to the 
protected areas of nuclear power plants. The NRC has determined that, 
because both sets of requirements share this same goal, revising Part 
26 would 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 Part 26 address 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 compensatory measures on existing access authorization 
programs. Therefore, it is necessary to revise the related provisions 
in Part 26.
    Goal 5--Improve 10 CFR Part 26 by eliminating or modifying 
unnecessary requirements. The proposed rule would incorporate a number 
of changes to eliminate or modify unnecessary requirements. The 
experience NRC has gained over the years since Part 26 was promulgated 
have enhanced the agency's understanding of implementation by the 
industry, and the NRC now proposes to eliminate or modify some 
provisions, while at the same time maintaining the protection of public 
health and safety and the common defense and security.
    For example, because of inconsistencies in 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. Proposed revisions to 
Part 26 would clarify that licensees may obtain information to satisfy 
FFD

[[Page 50448]]

suitable inquiry requirements and related access authorization 
requirements at the same time when conducting an employment inquiry.
    Goal 6--Improve clarity in the organization and language of the 
rule. The proposed rule is organized to facilitate implementation, as 
compared to the current rule which has generated many questions from 
licensees. Therefore, in the proposed 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 would apply to licensees' FFD processes. In addition, the NRC has 
proposed many language changes to improve clarity. The NRC has 
undertaken this substantial reorganization to improve the protection of 
public health and safety and the common defense and security by 
substantially reducing the likelihood of variations in FFD programs 
across the industry through differing interpretations of the rule. The 
proposed 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 this proposed 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 proposed Part 26 have eliminated the need for a guidance document. 
In the public meetings described in Section V, 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. Industry therefore desired the 
rule to be more specific and detailed, in lieu of a guidance document.
    Goal 7--Protect the privacy and due process rights of individuals 
who are subject to 10 CFR Part 26. This goal is an implicit objective 
of the current rule, and the proposed rule would also continue to 
protect the privacy and due process rights of individuals 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 DOT and HHS to modify many of their 
requirements for such testing to more clearly protect privacy and due 
process rights of individuals. Many of the proposed 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 proposes 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 ``Bottle B'', the 
second portion of a split urine specimen, would now only be tested with 
the donor's written permission.

C. Overview of Proposed Rule

    The proposed rule would be divided into subparts that contain 
related requirements. This proposed change would be made to improve the 
ease of implementing the rule by grouping related requirements and 
presenting them generally in the order in which they would apply to 
licensees' and other entities' FFD processes. Each subpart would be 
assigned a descriptive title to aid users in locating rule provisions 
and to simplify cross-referencing within the proposed rule. The major 
topics addressed in each subpart and the reasons that the major changes 
are being proposed are described below. A detailed cross-reference 
table between the current and proposed Part 26 provisions is included 
at the end of this notice.
Subpart A Administrative Provisions
    The first subpart, proposed Subpart A [Administrative Provisions], 
would replace the General Provisions portion of the current rule, but 
continue to address the same subject matter. Thus, Subpart A would 
address the purpose and scope of the rule, provide definitions of 
important terms used in the proposed rule, and update current 
provisions related to requests for specific exemptions, interpretations 
of the rule, and communications with the NRC.
Subpart B Program Elements
    Subpart B [Program Elements] of the proposed rule would reorganize 
and amend current Sec. Sec.  26.10-26.29, which specify the performance 
objectives that FFD programs would be required to meet and the FFD 
program elements that licensees and other entities must implement to 
meet the performance objectives. However, the proposed rule would not 
include current Sec.  26.27 [Management actions and sanctions to be 
imposed] in Subpart B for two reasons. First, at the public meetings 
described in Section V. B, stakeholders requested that the rule be 
reorganized to be consistent with the order in which licensees and 
other entities would implement their programs. Because Subpart B would 
be 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 proposed rule. Second, the 
stakeholders suggested, and the NRC staff concurred after 
consideration, that the subject matter of current Sec.  26.27 is 
sufficiently important and complex that a separate subpart is 
warranted. Therefore, the proposed rule would present requirements 
related to management actions and sanctions in proposed Subpart D 
[Management Actions and Sanctions to be Imposed].
Subpart C Granting and Maintaining Authorization
    Subpart C [Granting and Maintaining Authorization] of the proposed 
rule would substantially amend current 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 proposed rule would introduce 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 perform the job duties described in proposed Sec.  26.25 
[Individuals subject to the fitness-for-duty program], as a result of 
the process described in this subpart. For example, in the case of 
nuclear power plant personnel, an individual who is ``authorized'' 
under Part 26 may be permitted 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 
authorization to an individual or permit an individual to

[[Page 50449]]

maintain authorization. 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, a credit and criminal history check, and interview 
individuals who have knowledge of the applicant for authorization. 
However, as discussed in Section IV. B, historically there have been 
some inconsistencies and redundancies between the Part 26 requirements 
related to granting and maintaining authorization 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, in other cases, imposed an unnecessary burden on 
licensees. Therefore, a central goal of adding Subpart C to the 
proposed 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 authorization 
under Part 26 and also under other, related requirements, including, 
but not limited to, the access authorization orders issued by the NRC 
to nuclear power plant licensees on January 7, 2003.
    The requirements in proposed Subpart C are based upon several 
fundamental changes to the NRC's approach to the authorization 
requirements in current 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 IV. C with respect to proposed Sec.  26.23(a) in terms of 
the increased insider threat since the terrorist attacks of September 
11, 2001. One change to current Part 26 authorization requirements that 
reflects this concern is the elimination of temporary access 
authorization requirements in the second sentence of current Sec.  
26.27(a)(4). Other changes are discussed in Section IV with respect to 
the specific provisions that would incorporate them.
    A second, related change to the NRC's approach to authorization 
requirements, which has informed proposed Subpart C, is an increased 
concern with the sharing of information about individuals between 
licensees and other entities. At the time the current 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 so 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 upon 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 current FFD regulations were written on the basis that 
individual licensees would maintain independent, site-specific FFD 
programs and would share limited information, and that the majority of 
nuclear personnel would remain at one site for years, the regulations 
do 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, proposed Subpart C would require licensees 
and other entities to collect and share greater amounts of information 
than under the current rule, subject to the protections of individuals' 
privacy that would be specified in proposed Sec.  26.37 [Protection of 
information]. As a result, individuals who are subject to the rule 
would establish a detailed ``track record'' within the industry that 
would 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 would 
contribute to providing reasonable assurance that individuals who are 
granted and maintain authorization 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 hold authorization, 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 and there is 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 that 
would be required under Subpart C has the potential to result in a 
greater number of such individuals being banned from working in the 
industry. Therefore, several requirements would be added to

[[Page 50450]]

proposed Subpart C to minimize such consequences for individuals who 
are able to demonstrate that they have resolved a substance abuse 
problem. Additional requirements for protecting information that would 
be gathered about individuals under proposed Part 26 would be specified 
in proposed Sec.  26.37 [Protection of information]. The detailed 
changes to current requirements are discussed in Section VI with 
respect to the specific provisions that would incorporate them.
    In general, the authorization requirements in proposed Subpart C 
would be 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 proposed rule would require 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 
proposed rule would require licensees and other entities to complete 
before granting authorization to the individual would be reduced. The 
need for original information gathering in these instances would be 
reduced because, under the proposed rule, licensees and other entities 
would have access to all of the information that previous FFD programs 
had collected about the individual.
    For individuals who have established a favorable track record in 
the industry, the steps that licensees and other entities would be 
required to complete in order to grant authorization to an individual 
would also depend 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 proposed rule would require 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 proposed rule would require licensees and 
other entities to complete fewer steps in order to grant authorization 
to the individual. There are several reasons that the proposed rule 
would require 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 would be 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 would have 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.
    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, the less likely it would be that the individual 
could have undergone significant changes in lifestyle or character that 
would be undetected.
    Therefore, the proposed rule would establish categories of 
requirements for granting authorization to an individual that would 
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. Proposed Sec.  26.55 [Initial 
authorization] would establish 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. Proposed Sec.  26.57 [Authorization update] would establish 
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. 
Proposed Sec.  26.59 [Authorization reinstatement] would establish 
authorization requirements for individuals who previously held 
authorization under Part 26 and whose last period of authorization was 
terminated favorably within the past year. Proposed Sec.  26.69 
[Authorization with potentially disqualifying fitness-for-duty 
information] would define 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 would be 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 proposed 
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 proposed rule would incorporate these time 
periods within Part 26.
    In general, the steps that would be required to grant authorization 
to an individual who has recently held authorization and whose most 
recent period of authorization was terminated favorably would be 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 requirements for a rigorous evaluation 
process contained in the current Sec.  26.27(e) would be strengthened 
and licensees and other entities would be required to meet them before 
granting authorization to an individual about whom potentially 
disqualifying FFD information has been disclosed or

[[Page 50451]]

discovered (see proposed Sec.  26.69). The proposed rule would require 
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, with certain 
exceptions. The proposed exceptions to the self-disclosure and 
employment history, suitable inquiry, and pre-access testing 
requirements would be specified in proposed Sec. Sec.  26.61 [Self-
disclosure and employment history], 26.63 [Suitable inquiry], and 26.65 
[Pre-access drug and alcohol testing], respectively. The proposed rule 
would also require licensees and other entities to ensure that 
applicants are subject to random testing, as specified in proposed 
Sec.  26.67 [Random drug and alcohol testing of individuals who have 
applied for authorization].
Subpart D Management Actions and Sanctions
    Subpart D [Management Actions and Sanctions] of the proposed rule 
would replace current Sec.  26.27(b) and (c) and divide the current 
provisions into two separate sections that specify requirements for 
responding to FFD policy violations in proposed Sec.  26.75 
[Sanctions], and indications of impairment in proposed Sec.  26.77 
[Management actions regarding possible impairment]. The current rule 
would be reorganized in response to stakeholder requests that were made 
during the public meetings discussed in Section V. The stakeholders 
requested that the proposed rule generally reflect the order in which 
the requirements apply to licensees' and other entities' FFD processes 
and that related requirements be grouped into separate sections. 
Therefore, this change would be made to meet Goal 6 of this rulemaking, 
which is to improve clarity in the organization and language of the 
rule.
    In general, proposed Subpart D would include three significant 
changes from the related provisions in the current rule that are each 
intended to provide a stronger deterrent to engaging in the unwanted 
actions specified in the proposed subpart. First, the proposed rule 
would increase 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 would be 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 
perform the job duties listed in proposed Sec.  26.25 [Individuals 
subject to the fitness-for-duty program].
    Second, the proposed rule would require 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. Some licensees, however, have 
imposed lesser sanctions for alcohol violations, an approach that is 
inconsistent with the NRC's intent. Therefore, the proposed rule would 
rectify this situation by explicitly requiring the same minimum 
sanctions for abuse of alcohol as currently required for the use of 
illegal drugs.
    Third, the proposed rule would add the sanction of permanent denial 
of authorization for any individuals who subvert or attempt to subvert 
the testing process. The current rule permits 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 have imposed different sanctions and 
some individuals have been granted authorization or permitted to 
maintain authorization when they have 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 proposed 
rule would establish 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 would be made to meet Goal 3 of this 
rulemaking, which is to improve the effectiveness of FFD programs, as 
discussed in Section IV. B. Other changes to current Sec.  26.27(b) and 
(c) in proposed Subpart D would be made primarily to eliminate or 
modify unnecessary requirements and clarify the intent of current 
provisions.
Subpart E Collecting Specimens for Testing
    Subpart E [Collecting specimens for testing] of the proposed rule 
would reorganize and amend the requirements related to collecting 
specimens for drug and alcohol testing that are contained in current 
Sec.  26.24 [Chemical and alcohol testing] and interspersed throughout 
current Appendix A to Part 26. The proposed subpart would group the 
related requirements and present them in the order in which they would 
be implemented by FFD programs. The proposed rule would also eliminate 
some redundancies in the provisions of the current rule that are 
related to specimen collections, as is discussed in Section VI, with 
respect to the specific provisions. These proposed changes would be 
made to meet Goal 6 of the rulemaking, which is to improve clarity in 
the organization and language of the rule, as discussed in Section IV. 
B.
    In general, the procedures in this subpart would be more detailed 
than those in Appendix A to the current rule, and also those NRC 
regulations that are based upon a risk-informed, performance-based 
approach, for several reasons. First, the more detailed procedures in 
proposed Subpart E would increase the consistency of Part 26 drug and 
alcohol specimen collection procedures with those of other Federal 
agencies and therefore would take advantage of the scientific and 
technical advances that have been made in workplace drug and alcohol 
testing programs since the current Part 26 was promulgated, as 
discussed in Section IV. B. Second, the proposed rule would permit Part 
26 FFD programs to accept and rely upon other Part 26 programs, as well 
as the programs of other Federal and State agencies, to a much greater 
extent than is permitted under the current rule. The proposed 
permission to rely on other programs would improve the effectiveness 
and efficiency of FFD programs (Goal 3 of the rulemaking) and improve 
10 CFR Part 26 by eliminating or modifying unnecessary requirements 
(Goal 5 of the rulemaking). For example, under proposed Sec.  
26.69(b)(6), the proposed rule would permit licensees and other 
entities to rely upon 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 
three-year period following the violation, and is transferring from one 
licensee's site to another. The proposed rule would require the 
receiving licensee or other entity to continue the followup testing

[[Page 50452]]

program. However, the proposed rule would permit 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 proposed rule would permit such 
reliance on other programs, more detailed requirements for conducting 
the activities upon 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, at the public 
meetings discussed in Section V, industry stakeholders requested a 
greater level of detail in the specimen collection procedures of the 
proposed rule for the reasons discussed in Section IV. B.
    Other major changes to the current rule's requirements for 
collecting specimens for drug and alcohol testing would be made to 
incorporate specimen validity testing requirements from the HHS 
Guidelines into Part 26 (Goal 1 of this rulemaking) and modify current 
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 [Licensee Testing Facilities] of the proposed rule would 
present 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 current rule and Sec.  26.31(d)(3)(i) of the 
proposed rule. The proposed subpart would be entitled, ``Licensee 
Testing Facilities,'' for brevity, but other entities who are subject 
to the proposed rule would be permitted to establish and operate such 
facilities under the proposed rule.
    This new subpart would be added to group together in a single 
subpart the proposed requirements that are related to licensee testing 
facilities, which are intermixed with requirements related to drug 
testing at HHS-certified laboratories in Appendix A to Part 26 in the 
current rule. During the public meetings discussed in Section V, 
stakeholders requested that the proposed rule present the requirements 
that would be applicable to licensee testing facilities and HHS-
certified laboratories in two separate subparts because, the 
stakeholders noted, it is not always clear which requirements apply to 
which type of testing facility in the current rule. The stakeholders 
also requested that any requirements that apply to both types of 
facilities would be included in both subparts so that it would be 
unnecessary for licensees and other entities who do not operate 
licensee testing facilities to review or implement any provisions in 
Subpart F. Although many of the requirements in this subpart would be 
redundant with similar requirements in proposed Subpart G [Laboratories 
Certified by the Department of Health and Human Services], the proposed 
rule would implement these recommendations to meet Goal 6 of this 
rulemaking, which is to improve clarity in the organization and 
language of the rule.
    The most important changes in proposed Subpart F to the current 
requirements for licensee testing facilities would be the addition of 
new requirements for licensee testing facilities to conduct 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 urine specimen validity testing are 
discussed in Section VI with respect to proposed Sec.  26.31(d)(3)(I). 
As discussed in Section V, stakeholders have objected to the addition 
of requirements for licensee testing facilities to conduct validity 
testing. However, 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, 
licensees and other entities are permitted 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 would not be 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, proposed 
Subpart F would permit licensee testing facilities to use non-
instrumented validity testing devices to conduct ``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 proposed 
Sec.  26.5 [Definitions], the proposed rule would use the term, 
``validity screening test,'' to refer to testing using these non-
instrumented devices. The term, ``initial validity test,'' would refer 
to instrumented validity testing.
    At the same time that the HHS published its final regulations to 
require specimen validity testing, which would be incorporated in the 
proposed 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 proposed Subpart F would 
also incorporate. 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 [Laboratories Certified by the Department of Health and 
Human Services] in the proposed rule would present together in a single 
subpart requirements related to the HHS-certified laboratories that are 
used by

[[Page 50453]]

licensees and other entities who are subject to Part 26 for validity 
and drug testing. The requirements in this subpart would group together 
the current requirements in Appendix A to Part 26, as they relate to 
HHS-certified laboratories. However, the current requirements would be 
updated 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 current rule's requirements for HHS-certified 
laboratories would be the incorporation of extensive requirements for 
urine specimen validity testing.
Subpart H Determining Fitness-for-Duty Policy Violations and 
Determining Fitness
    Subpart H [Determining Fitness-for-Duty Policy Violations and 
Determining Fitness] in the proposed rule would reorganize, clarify, 
and enhance current requirements related to the decisions that 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 
proposed Subpart C [Granting and Maintaining Authorization] and also 
with respect to imposing sanctions and taking actions to prevent an 
individual from performing the job duties that require an individual to 
be subject to this part under proposed Subpart D [Management Actions 
and Sanctions]. The current requirements, which are interspersed 
throughout the rule, would be grouped together in the proposed subpart 
to make them easier to locate within the proposed rule, consistent with 
Goal 6 of this rulemaking, which is to improve clarity in the 
organization and language of the rule, as discussed in Section IV. B. 
The proposed subpart would also make several significant changes to 
current requirements.
    In general, proposed Subpart H would include more detailed 
requirements for determining FFD policy violations and conducting 
determinations of fitness than are included in the current rule. These 
more detailed requirements would be added 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 proposed rule would permit licensees and 
other entities to rely on the determinations made by other Part 26 
programs to a greater extent than the current rule. For example, 
proposed Sec.  26.63(b) would permit 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, for previous periods of authorization. 
The reasons for adding these permissions were discussed previously in 
this section, with respect to proposed Subpart C [Granting and 
Maintaining Authorization]. However, in order 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 current requirements and establish clear minimum 
standards for those processes. Therefore, the proposed subpart would 
include greater detail to meet Goal 3 of this rulemaking, which is to 
improve the effectiveness and efficiency of FFD programs.
    Under the proposed rule, licensees and other entities who are 
subject to the rule would 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 proposed rule would extend this requirement to 
the review of non-negative validity test results, consistent with the 
addition of requirements to conduct validity testing throughout the 
proposed rule, as discussed in Section VI with respect to proposed 
Sec.  26.31(d)(3)(i). An MRO review of non-negative confirmatory 
validity test results 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 non-negative 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. Requiring the MRO to review non-
negative validity test results would be added to meet Goal 7 of this 
rulemaking, which is to protect the due process rights of individuals 
who are subject to Part 26. The HHS Guidelines also require the MRO to 
review non-negative validity test results. Therefore, adding this 
requirement to the proposed rule would also 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.
    Another significant change that the proposed rule would make to 
current requirements is establishing a new position within FFD 
programs--the ``substance abuse expert'' (SAE). The SAE would be 
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 SAE position would be 
added 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 non-
negative 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 
proposed rule would permit MROs to serve as SAEs if they meet the 
qualifications for this role that would be established in this subpart. 
But, licensees and other entities would be required to rely on other 
healthcare professionals who have the necessary qualifications to 
conduct determinations of fitness if the MRO does not meet the proposed 
SAE qualification requirements.
    Second, during the meetings discussed in Section V, stakeholders 
requested that healthcare professionals, other than a licensed 
physician, be permitted to make determinations of fitness under the 
proposed rule. The stakeholders indicated that the costs of using only 
licensed physicians are prohibitive and noted that a license to 
practice medicine does not guarantee that a physician is knowledgeable 
about substance abuse disorders. The NRC concurs that healthcare 
professionals

[[Page 50454]]

other than licensed physicians may have the requisite knowledge and 
skills to serve as SAEs under the proposed rule. Therefore, the 
proposed rule would define the position of SAE in terms of the 
knowledge and skills required, and permit healthcare professionals 
other than licensed physicians to serve in this role.
    Third, under the proposed rule, FFD programs would be 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 would play in 
assuring the common defense and security and public health and safety 
when making a determination of fitness upon 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 judgements in these circumstances.
    Many of the provisions in the proposed subpart would be adapted 
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 current Part 26.
Subpart I Managing Fatigue
    Subpart I [Managing Fatigue] of the proposed rule would 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. Because the overall 
rationale for including Subpart I, Managing Fatigue, in Part 26, is 
detailed and extensive, this discussion is presented separately in 
Section IV. D.
Subpart J Recordkeeping and Reporting Requirements
    Subpart J [Recordkeeping and Reporting Requirements] would be added 
to the proposed rule to reorganize the current rule's requirements for 
maintaining records and submitting reports to the NRC. The new subpart 
would combine and amend two sections of the current rule: Section 26.71 
[Recordkeeping requirements] and Sec.  26.73 [Reporting requirements], 
and would incorporate the record retention requirements of current 
Sec. Sec.  26.21(b), 26.22(c), and 26.80(c). This proposed change would 
be made to meet Goal 6 of this rulemaking, which is to improve clarity 
in the organization and language of the rule, by grouping related 
requirements together in the proposed subpart.
    Major changes to the current rule's requirements for recordkeeping 
and reporting would reflect (1) the addition of requirements for 
specimen validity to the proposed rule; (2) the addition of 
requirements for managing worker fatigue at nuclear power plants; and 
(3) 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 K Inspections, Violations, and Penalties
    Subpart K [Inspections, Violations, and Penalties] would be added 
to the proposed rule to combine into one subpart current Sec. Sec.  
26.70 [Inspections], 26.90 [Violations] and 26.91 [Criminal penalties]. 
These sections would be grouped together in one subpart because they 
each establish requirements related to the NRC's oversight of the 
implementation of FFD programs. Proposed Sec.  26.221 [Inspections] 
would retain the requirements in current Sec.  26.70. Proposed Sec.  
26.223 [Violations] would retain the requirements in current Sec.  
26.90 [Violations]. Proposed Sec.  26.225 [Criminal penalties] would 
retain the requirements in current 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. Subpart I, Managing Fatigue, of the proposed rule would 
include these requirements and establish an integrated approach to 
fatigue management, with fatigue prevention, detection, and mitigation 
as the fundamental components. As discussed further in this section, 
the proposed requirements in Subpart I would provide a substantial 
increase in the protection of public health and safety and common 
defense and security. In determining the provisions of this proposed 
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 current regulatory 
framework; the excessive hours currently worked by many nuclear power 
workers; and the 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 proposed rule. These interactions are discussed in 
detail in Section V of this document.
    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 worker tolerances to these 
conditions also influence worker fitness for duty. As a consequence, 
fatigue is a complex phenomenon that requires an integrated approach to 
be managed effectively. The requirements in proposed Subpart I were 
developed based upon the premise that fatigue management requires the 
collaboration of individual workers and licensees.
    Each of the proposed requirements in Subpart I are discussed in 
detail in Section VI. However, because proposed Subpart I presents an 
integrated fatigue management approach, this section discusses the 
principal findings that led to the 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 proposed rule. The considerations listed in the numbered paragraphs 
that follow summarize the NRC's considerations

[[Page 50455]]

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 prevalence of 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 current regulatory framework does 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 work hours and work-hour 
limit deviations;
    (5) The current regulatory framework includes requirements that are 
inadequate and incomplete for effective fatigue management;
    (6) Ensuring effective management of worker fatigue through 
rulemaking would 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; 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. Such 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 has 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., Proposed 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 safeguards 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 clear decisions, and 
communicate and work as a team. The following effects of fatigue on 
cognitive abilities are the primary focus of the proposed 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 a cornerstone 
of safe nuclear power plant operations. Fatigue has been associated 
with more risky strategies and decreases in the effort individuals 
exert (Schellekens, et al., 2000). Furthermore, Harrison and Horne 
(2000) reviewed the impact of sleep deprivation on decision-making and

[[Page 50456]]

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 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 degrading 
performance, recent research has helped characterize the magnitude of 
these effects relative to a historical FFD concern: impairment from 
alcohol intoxication. The current provisions in 10 CFR Part 26 prohibit 
the use of alcohol on site and within several hours before a tour of 
duty, and establish 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 current provisions of 10 CFR 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 a breath alcohol cutoff level of 0.04 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 is 
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., Proposed Rule, May 2, 2000, 
65 FR 25544). The effects of extended working hours on worker 
performance can be exacerbated when many extended shifts are scheduled 
in succession.
    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 Section V, 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

[[Page 50457]]

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 indicates that 
deviations from the limit of 72 hours in 7 days continue to account for 
more than 80 percent of the deviations authorized. During these 
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 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 a 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. 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 is 
specific to U.S. nuclear power plant workers, in the general U.S. 
population, such 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

[[Page 50458]]

general population. A survey by the NSF of 1,154 adults living in 
households in the continental U.S. 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), and such changes are beyond the individual's control. In 
addition, several studies have suggested caution with regard to the 
ability of individuals to self-monitor their abilities 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, the NRC believes that 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 currently 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 
believes 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 current regulatory framework does not 
include consistent or readily enforceable requirements to address 
worker fatigue.
    The principal components of the current regulatory framework for 
matters pertaining to working hours and fatigue for non-security 
personnel are (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 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 current 
regulatory framework applicable to worker fatigue, including licensee 
technical specification requirements 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 proposed 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, the policy is 
enforceable only to the extent that the guidelines have been 
incorporated into a license condition or technical specification 
requirements. For the three nuclear power plant sites who have not 
incorporated the guidelines from the NRC's Policy on Worker Fatigue 
into a license condition or technical specification requirement, 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 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 is 
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 results 
in inconsistent interpretation and implementation of technical 
specification requirements 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 working 
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 capability.
--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 be 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 is not 
implemented consistently from one nuclear power plant to another. Work 
hours included within the limits at some nuclear power plants are not 
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 Sec.  26.10 require 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.''

[[Page 50459]]

Although 10 CFR Part 26 contains specific requirements pertaining to 
alcohol and drug usage, it does not include prescriptive requirements 
regarding fatigue. Rather, Sec.  26.20 uses 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 is 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, make it difficult for the NRC to enforce worker fatigue 
requirements and working 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 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 includes 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 have 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.
    The Nuclear Energy Institute (NEI) conducted a survey in the summer 
of 2000 concerning industry control of work hours for personnel subject 
to the technical specification requirements (letter dated August 29, 
2000, from J.W. Davis, NEI, to G.T. 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 increased from 7 percent in 1997 to 11 percent in 
1999. The percentage of licensed operators working in excess of 600 
hours increased from 13 percent in 1997 to more than 16 percent in 
1999. The NRC believes these percentages 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 are 
reported in detail in Appendix 3 of the draft Regulatory Analysis. The 
analysis is available as discussed above under the ADDRESSES heading. 
Single copies may be obtained from the contact listed above under the 
FOR FURTHER INFORMATION CONTACT heading. The NRC believes that licensee 
use of deviations and overtime at some sites is excessive, and does not 
represent the intent of the NRC's Policy on Worker Fatigue.
    In addition to excessive work hours and work hour guideline 
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 proposed rule would establish requirements to address this need.
    (5) The current regulatory framework includes requirements that are 
inadequate and incomplete for effective fatigue management.

[[Page 50460]]

    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 
consequence, implementation has been varied across the industry.
    b. Certain policy guidelines and technical specification 
requirements are inadequate for 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 would 
be revised to a 10 hour break. The basis for the need to revise this 
break period is described in detail in Section VI with respect to 
proposed Sec.  26.199(d)(2)(I).
    Further, the specific work hour guidelines of the policy, and most 
technical specification requirements for the administrative control of 
work hours, are principally focused on acute fatigue, and do 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, continuous task demands, or other issues 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 or 
night 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 current regulatory framework for addressing 
cumulative fatigue became particularly apparent in the months following 
the terrorist attacks of September 11, 2001. As described in Section VI 
with respect to proposed Sec.  26.199(f)(2), 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 are 
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, would establish controls to address cumulative 
fatigue. Limits to mitigate cumulative fatigue for security personnel 
were implemented by Order EA-03-038. The proposed rule would codify, 
with limited changes, these requirements. Changes to those limits that 
would be imposed by this rule are discussed in detail in Section VI, 
which also includes a detailed discussion of the proposed limits and 
other controls to mitigate cumulative fatigue for non-security 
personnel.
    c. The existing regulatory framework does not effectively ensure 
that fatigue from causes other than work hours is 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 ability 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). 
Proposed Subpart I, Managing Fatigue, would require a comprehensive 
fatigue management program. One example would be the strengthening of 
FFD training requirements concerning worker fatigue. This would 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.
    (6) Ensuring effective management of worker fatigue through 
rulemaking would 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 are ensured under the current regulatory 
framework, including Order EA-03-038 (for security personnel), the 
NRC's Policy on Worker Fatigue, and licensee technical specification 
requirements. Licensee FFD programs currently include 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 current 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) ensure adequate protection of public health 
and safety and the common defense and security. However, there are 
substantial limitations to the current regulatory framework, as 
detailed in this section. Therefore, although the current regulatory 
framework provides adequate protection, including work hour controls in 
10 CFR Part 26 would provide a substantial increase in public health 
and safety and the common defense and security. The NRC is proposing to 
incorporate worker fatigue provisions into 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 current and proposed Federal limits on work 
hours for nuclear plant workers in eight other countries, as well as 
six other industries in the United States and Canada. Although many 
factors influence specific regulatory limits, and requirements for 
other industries should be considered in context, the NRC found that 
the NRC's current 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. With the exception 
of Spain, which has limits consistent with the NRC's Policy on Worker 
Fatigue, each of the other eight countries has

[[Page 50461]]

more stringent requirements. The more stringent requirements have 
largely 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). Dissatisfied 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) prohibit work after the end of the fourteenth hour after the driver 
began work; and (3) require long break recovery periods to prevent 
cumulative fatigue (68 FR 22456-22517; April 28, 2003).
    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 in paragraph D(1)(d) of 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 job 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 industries, in its use of automated 
safety systems to protect against the

[[Page 50462]]

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. Current NRC requirements, such as the minimum on-site 
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 proposed rule would differ from other 
Federal agencies' requirements with respect to specific work hour 
requirements and would require 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 proposed 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 proposed 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 current 
regulatory framework, the excessive hours currently worked by many 
nuclear power plan 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 proposed rule. These 
interactions are discussed in detail in Section V. The specific basis 
for each provision of the fatigue management portions of the proposed 
rule are discussed in Section VI.
    The proposed 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 would 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.

V. Summary of Public Interactions and Comments

    In preparing this proposed rule, the NRC has considered comments 
received by OMB and the NRC on the prior Part 26 final rule affirmed by 
the Commission in a SRM dated December 4, 2000, and subsequently 
submitted to the Office of Management and Budget (OMB) for a clearance 
under the Paperwork Reduction Act. Those comments and responses to them 
are provided in Section V. A.
    The NRC has also considered feedback received from industry, as 
well as other interested parties and members of the public in preparing 
this proposed rule. The NRC held 11 stakeholder meetings on the drug 
and alcohol testing portions of the rule during 2001-2004, and held 13 
stakeholder meetings on the fatigue portion of the rule during 2002-
2003. Subsequent to the Commission's decision to combine the two 
rulemaking efforts, the NRC held 1 stakeholder meeting on the combined 
rule in July, 2004, and 2 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 (67 FR 7093) on February 15, 
2002. Feedback was received from stakeholders both through the public 
meetings and the NRC's rulemaking Web site at http://ruleforum.llnl.gov. Summaries of these meetings, and any comments provided 
through the Web site are available at http://ruleforum.llnl.gov/cgi-bin/rulemake?source=BQ_PETITION&st=plan plan for meetings and comments on 
the fatigue portions of the rulemaking prior to 2004, and at http://ruleforum.llnl.gov/cgi-bin/rulemake?source=Part26_risk&st=risk for 
meetings and comments on the drug and alcohol testing portions of the 
rulemaking, and on the fatigue portions of the rulemaking subsequent to 
the Commission's decision to combine the rulemakings in 2004. 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 proposed rule in a manner to 
ensure it was clearly understandable, could be consistently 
interpreted, and did not result in unintended consequences. Many of the 
stakeholders' comments directly resulted in proposed changes. Where a 
comment was included in a proposed provision, the comment is discussed 
in Section VI.
    Many comments were received during the years the meetings were 
held, and the draft proposed rule language was

[[Page 50463]]

changed and re-posted to the web numerous times. Each comment received 
during these meetings, but not included in the proposed rule text, is 
not discussed and responded to in detail, given that the NRC is issuing 
a new proposed rule for formal public comment. However, the most 
significant comments that were not incorporated are discussed in 
Section V. B of this document.

A. Public Comments Submitted to OMB on 2000 Final Rule and Responses

    The comments below were received by OMB and the NRC on the prior 
Part 26 final rule affirmed by the Commission in a SRM dated December 
4, 2000, and subsequently submitted to OMB for a clearance under the 
Paperwork Reduction Act. The NRC's responses follow each comment.
    Industry Comment 1: Rule should allow combining partial samples to 
get the required volume for HHS analysis. Otherwise, it [the Regulatory 
Analysis] should reflect an added expense with a reduced gain.
    Response: New provisions in Sec.  26.109, ``Urine specimen 
quantity,'' prohibit licensees from combining partial samples because 
this practice may falsely lower the concentration of a drug or 
adulterant. Further, HHS and DOT do not permit this practice. 
Additionally, comments on the previous proposed rule objected to 
combining specimens for the same reason. However, the proposed rule 
would lower the required specimen quantity from a minimum of 60 
milliliters (mL) to 30 mL. NRC discussions with representatives of HHS-
certified laboratories have indicated that advances in testing 
technologies allow accurate and reliable testing of 15 mL specimens. 
The NRC has proposed 30 mL, which would allow the HHS laboratory 
sufficient specimen quantity for retesting, if needed. Because the 
required specimen quantity has been reduced by at least one-half, there 
should be few instances in which a donor is unable to produce the 
necessary quantity and, therefore, few instances in which additional 
costs would be incurred.
    Industry Comment 2: Medical professionals other than a licensed 
physician should be allowed to determine if a history of substance 
abuse ``raises a concern.''
    Response: The proposed rule in Sec.  26.187 would add a position 
called the ``Substance Abuse Expert'' (SAE), adapted from the related 
DOT regulations. The SAE need not be a licensed physician, but would be 
required to have extensive expertise, such as a licensed or certified 
social worker, psychologist, or others listed in Sec.  26.187(b), and 
additional qualifications specifically related to substance abuse 
disorders. The SAE would be authorized to make a determination of 
fitness in at least circumstances: (1) when an individual has violated 
the substance abuse provisions of a licensee's or C/V's FFD policy, 
including, but not limited to a first positive drug test result; (2) 
when there is a concern that an individual may be impaired by the use 
of a substance; or (3) for an applicant for authorization when the 
self-disclosure, the suitable inquiry, or other sources of information 
identify potentially disqualifying FFD information (PDFFDI) about the 
applicant.
    Industry Comment 3: Reevaluate NRC's regulatory analysis indicating 
a $27 million savings in light of industry's estimate of a $8 million 
cost increase.
    Response: A detailed reevaluation of the drug and alcohol 
provisions, based in part on data obtained from NEI, still indicates a 
savings to industry of $116 million-$183 million (7 percent--3 percent 
discount rate) present value. The evaluation of the proposed Part 26 
provisions as a whole, including the proposed worker fatigue 
provisions, indicates a cost to industry of $469 million-$730 million 
(7 percent--3 percent discount rate) present value. A draft regulatory 
analysis was provided to industry and other stakeholders during the 
public meetings held in 2004. Comments received have been considered in 
developing the regulatory analysis for this proposed rule.
    Industry Comment 4: New rule requires audits of [HHS] certified 
labs.
    Response: The proposed rule includes additional language in 
proposed Sec.  26.41 to clarify the NRC's intent that audits of 
certified labs may be shared among licensees and that licensees are not 
required to audit areas that are covered by the HHS certification 
process. Additionally, organizations that do not routinely provide FFD 
services to a licensee or C/V, such as local hospitals or a substance 
abuse treatment facility, would be exempt from the annual audit 
requirement.
    Industry Comment 5: Rule includes FFD personnel in program.
    Response: The NRC continues to agree with the original intent of 
the rule, which was that personnel who administer FFD programs must be 
covered by 10 CFR Part 26. However, during meetings, stakeholders 
discussed the numerous logistical difficulties associated with covering 
FFD program personnel. As a result, the proposed rule includes a number 
of related language adjustments.
    Specifically, new language in proposed Sec.  26.25(a)(4) would 
clarify the NRC's intent that FFD program personnel must be subject to 
the program. Proposed Sec.  26.25(a)(4)(I) through (v) would be added 
to identify the FFD program personnel who must be subject to the FFD 
program, based upon their job responsibilities. Proposed Sec.  
26.25(b)(1) would exempt individuals who may provide an FFD service to 
a licensee or other entity in special circumstances, and who meet all 
of the following three criteria: (1) They are not employed by the 
licensee or C/V, (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 or other entity's facility. Personnel who meet the 
three criteria specified in proposed Sec.  26.25(b)(1) would be exempt 
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.
    In addition, new language in Sec.  26.31(b)(2) would permit FFD 
program personnel who are distant from a licensee site to be tested at 
a local facility that meets DOT requirements, including audits. 
Permitting these FFD program personnel to be tested at local collection 
sites that follow similar procedures would be adequate to meet the goal 
of ensuring their continuing honesty and integrity, while addressing 
some logistical concerns posed by stakeholders.
    Industry Comment 6: The term, ``history of substance abuse,'' is 
pejorative and may incorrectly label some workers in the nuclear 
industry as substance abusers.
    Response: Based upon further discussions with stakeholders, the NRC 
developed a greater appreciation for the connotations of the term, 
``history of substance abuse,'' and agreed that the term has too many 
pejorative implications. Therefore, the proposed rule would entirely 
eliminate the use of this term. The rule language no longer discusses 
this issue in terms of an individual's personal characteristics. 
Rather, the language focuses on the type of information that would 
trigger a determination of fitness. This information is referred to as 
``potentially disqualifying FFD information'' (PDFFDI), which is 
consistent with terminology used in access authorization programs.
    Industry Comment 7: History of substance abuse creates a new class 
of workers and no relief.
    Response: As noted above, the concept, ``history of substance 
abuse,''

[[Page 50464]]

has been eliminated in the proposed rule. The proposed rule would 
provide relief to individuals with PDFFDI in three ways. First, 
individuals would be required to self-disclose PDFFDI that is related 
to events that occurred only within the past 5 years. This provision 
provides relief from the current rule, which requires individuals to 
self-disclose certain adverse events every time they apply for 
authorization, no matter how long ago the adverse events occurred. 
Second, licensees would be permitted to accept a determination of 
fitness conducted by a previous licensee and a favorable termination of 
authorization for an individual who had any PDFFDI that was addressed 
and resolved under a previous Part 26 program. This provision also 
provides relief from the current rule, which requires the licensee to 
conduct a determination of fitness for any individual who has ever been 
denied access or had access terminated unfavorably, no matter how long 
ago the event occurred or whether there is evidence that the individual 
has been rehabilitated. Licensees would be permitted to conduct another 
determination of fitness, but would not be required to do so, if the 
individual's last period of authorization was terminated favorably. 
Third, licensees would be permitted to accept responsibility for 
continuing any treatment and followup testing plans that a previous 
licensee implemented for an individual, rather than conducting a new 
determination of fitness and developing new treatment and testing 
plans. These provisions protect the rights of individuals who have 
successfully resolved or are resolving a substance abuse-related 
problem as well as reduce the regulatory burden on the individuals and 
licensees.
    Industry Comment 8: History of substance abuse creates a tracking 
burden.
    Response: As noted above, the concept, ``history of substance 
abuse,'' would be eliminated in the proposed rule. Further, the current 
rule requires licensees to maintain records and share information 
related to denials and unfavorable terminations of authorization in 
Sec.  26.27(a)(3). Therefore, the proposed rule's requirements for 
licensees to maintain records and share information related to PDFFDI 
would not create a new tracking burden and are consistent with the 
access authorization Order.
    Industry Comment 9: Change the opiate cutoff level of 300 ng/mL to 
the HHS standard of 2000 ng/mL.
    Response: The proposed rule now includes the 2000 ng/mL HHS cutoff 
level for opiates. Discussions with HHS indicate that the HHS staff's 
rationale for changing the cutoff level to 2000 ng/ML provides 
sufficient protection for public health and safety from individuals who 
may be abusing opiates.
    Industry Comment 10: It is impossible to complete all suitable 
inquiries within 72 hours.
    Response: Consistent with the access authorization Order, which the 
Commission issued to nuclear power reactor licensees on January 7, 
2003, the proposed rule would eliminate provisions for routine 
temporary access. Therefore, the proposed rule would eliminate the 
requirement in the Affirmed Rule for a 72-hour turnaround on a suitable 
inquiry prior to granting temporary access.
    Industry Comment 11: Rule requires verification of all employment 
periods, including less than 30 days.
    Response: The proposed rule incorporates feedback received through 
stakeholder meetings. The revised provisions specify employers required 
to be addressed during the suitable inquiry for several different 
cases, including applicants for initial authorization, updated 
authorization, or reinstated authorization. The employers required to 
be addressed vary for each of these situations, and are specified in 
proposed Sec. Sec.  26.63 and 26.69. In developing this proposed 
section, the NRC took into account documented substance abuse 
recidivism rates (highest within the first year following treatment, 
continuing at a somewhat lower rate for 3 years post-treatment, and 
decreasing again at 5 years) and stakeholder feedback.
    Stakeholders have indicated that employers are generally reluctant 
to provide any information other than dates of employment, but that 
more recent employers are more likely to disclose adverse information 
than employers from previous years. Therefore, the NRC has determined 
that requiring every employer from the past 5 years to be contacted for 
all persons is both unnecessary and an unwarranted regulatory burden. 
Thus, for initial authorization, the employment check is to be 
conducted with every employer, regardless of the length of employment, 
for the past year, and with each employer by whom the individual claims 
to have been employed the longest in each calendar month for the 
previous 2 years. For authorization updates, the employment check is to 
be conducted with every employer, regardless of the length of 
employment, for the past year, and with each employer by whom the 
individual claims to have been employed the longest in each calendar 
month for the remaining time since authorization was terminated. For 
authorization reinstatements, the employment check is to be conducted 
with each employer by whom the individual claims to have been employed 
the longest in each calendar month since authorization was terminated. 
For individuals who have had a substance abuse problem, however, Sec.  
26.69 requires a suitable inquiry for the applicable period specified 
by Sec.  26.63, as well as obtaining any records that other licensees 
or other entities may have developed relating to any potentially 
disqualifying FFD information about the individual.
    Industry Comment 12: Allow credit for prior licensee's suitable 
inquiry.
    Response: Proposed Sec.  26.63(b) would permit licensees to rely 
upon suitable inquiry information that was gathered by other licensees 
and entities. However, for all applicants for authorization, the 
suitable inquiry would be more thorough than previous industry 
practices, in order to increase the likelihood that PDFFDI would be 
identified, if it existed, and to provide reasonable assurance that 
individuals are trustworthy and reliable as demonstrated by the 
avoidance of substance abuse. For individuals who have established a 
recent, favorable work history within the industry, as demonstrated by 
having held authorization that was terminated favorably within the past 
3 three years, the period of time addressed in the suitable inquiry 
would be reduced from the past 5 five years in every case, to the past 
3 three years or less, depending upon how recently the applicant held 
authorization. If PDFFDI within the past 5 five years is identified 
regarding an applicant and the information had not been addressed and 
favorably resolved by a previous licensee or other entity, the suitable 
inquiry requirements would be more extensive, as described in proposed 
Sec.  26.69.
    Industry Comment 13: Allow credit for prior licensee's medical 
determination of fitness.
    Response: The NRC has clarified the qualification requirements for 
the medical personnel who may conduct a determination of fitness and 
believe that these clarifications will provide greater consistency in 
the determinations made across licensees. Therefore, a requirement for 
each new licensee to perform another determination of fitness for 
authorization reinstatements (authorization interrupted for 365 days or 
less) and authorization updates

[[Page 50465]]

(authorization interrupted for >365 days to <3 years) when no new 
PDFFDI has been identified would be unnecessary.
    Industry Comment 14: Requirements for FFD should be consistent with 
access authorization requirements.
    Response: The provisions of the proposed rule are consistent with 
current access authorization requirements, including those in the 
recent access authorization Order, which the Commission issued to 
nuclear power reactor licensees on January 7, 2003.
    Industry Comment 15: Medical determination of fitness for all 
individuals with a history of substance abuse creates an unnecessary 
burden.
    Response: The proposed rule would add Sec.  26.189(b)-(d) to 
clarify the NRC's intent with regard to the circumstances in which a 
determination of fitness is required. Permitting licensees to accept 
the results of a determination of fitness conducted by a previous 
licensee, when no new PDFFDI has been identified, reduces the 
unnecessary burden that stakeholders referenced. However, a 
determination of fitness would continue to be required before an 
individual is granted authorization to perform activities within the 
scope of this part when PDFFDI is identified and has not been 
previously evaluated by another licensee.
    Industry Comment 16: Rule does not allow shared audits of HHS-
certified laboratories.
    Response: The NRC believes that a requirement for independent 
audits by all licensees who rely on a laboratory is a redundant and 
unnecessary requirement. The proposed rule would specify requirements 
for sharing audits in proposed Sec.  26.41(g). This paragraph would 
state that licensees may jointly conduct audits, or accept audits of C/
Vs and HHS-certified laboratories that were conducted by other 
licensees or entities subject to this part, when the services provided 
to the sharing licensees or entities by the C/Vs and HHS-certified 
laboratories are the same. Nonetheless, each sharing licensee is 
responsible for ensuring the correction of any deficiencies identified 
in audit results.

B. Key Stakeholder Comments Not Incorporated Into Proposed Rule and 
Responses

    The headings below provide a listing of the significant comments 
received, but not incorporated, for each subpart in the proposed rule. 
The comments were received from stakeholders during development of this 
proposed rule. Following each comment is a response detailing why the 
comment was not incorporated into the proposed rule.
Subpart A Administrative Provisions
    There are no significant comments that were not incorporated into 
the proposed rule text.
Subpart B Program Elements
    Comment 1 (NEI): The Medical Review Officer should not be included 
in the random testing program.
    Response: Although current Section 2.3 [Preventing subversion of 
testing] in Appendix A to Part 26 requires 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 (including MROs) who the NRC 
originally intended to be subject to testing. The proposed change would 
be made to clarify the NRC's original intent because the actions of 
these individuals have an ongoing effect on public health and safety as 
a result of their responsibility to ensure that the FFD program is 
effective. In addition, these persons' 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, MROs could inadvertently 
commit errors when reviewing test results as a result of being impaired 
from drug or alcohol abuse or because of motives associated with 
maintaining an MRO's substance abuse or empathy with an abuser. 
Furthermore, 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 provided their services to other 
Federally regulated industries were identified as substance abusers. 
Therefore, the proposed rule provision would fulfill the NRC's original 
objective and require 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; (2) make 
determinations of fitness; (3) make authorization decisions; (4) are 
involved in selecting or notifying individuals for testing; or (5) are 
involved in the collection or on-site testing of specimens.
    Comment 2 (NEI): The FFD training requirements are too detailed, 
particularly the requirement for the FFD exam to be a separate exam, 
and for each knowledge and ability (KA) to be covered on each test.
    Response: The proposed rule would require that individuals who are 
subject to the FFD program demonstrate attainment of the specified KAs 
by passing a comprehensive examination. This new requirement would be 
added because there have been several instances since Part 26 was first 
promulgated in which 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 so could not be expected to comply with the requirements of the 
policy. Therefore, the proposed rule would require individuals to 
demonstrate their attainment of the knowledge and abilities to ensure 
that the FFD training has been effective. There would also be a 
requirement for the examination to include a comprehensive random 
sampling of all KAs with questions to test each KA, including at least 
one question for each KA, and establish a minimum passing score of 80 
percent. These requirements would be 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.
    Comment 3 (Quest Diagnostics): Unannounced audits of HHS 
laboratories by the licensee, other entity, or NRC inspectors at any 
time is unreasonable given the other inspections, client tours, 
scheduled department meetings, and off-site requirements for testimony 
that are required of laboratories and their staff. The audits should 
also not be more than 48 hours in duration, and original documents or 
copies should not be allowed to be removed from the laboratory.
    Response: The proposed rule would permit audits to be unannounced 
to enhance the effectiveness of the audit process should unannounced 
audits appear to be necessary. For example, a licensee or other entity 
may receive allegations that a laboratory is falsifying records or that 
laboratory employees are using drugs, and the licensee or other

[[Page 50466]]

entity may determine that an unannounced audit would provide the most 
effective means to investigate such allegations. The proposed rule 
would ensure that the licensee's or other entity's contract with the 
lab would permit the unannounced audit as well as access to any 
information necessary to conduct the audit.
    The NRC has also not proposed limits on the duration of such 
audits, as time limits may decrease the effectiveness and integrity of 
the audit process. Licensees or other entities may determine they 
require more lengthy audits to effectively cover all intended areas, or 
to assess deficiencies.
    The NRC has incorporated a provision to permit an HHS-certified 
laboratory to 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. However, the NRC does not believe auditors should 
be restricted from copying or taking away documents that do not meet 
the above criteria, because doing so would decrease the efficiency and 
effectiveness of audits.
Subpart C Granting and Maintaining Authorization
    Comment 1 (NEI): The process for granting authorization for 
individuals whose prior authorization was terminated unfavorably should 
be an initial.
    Response: The proposed rule would require licensees to follow the 
proposed provisions in Sec.  26.69 for individuals whose prior 
authorization was terminated unfavorably due to an FFD concern. 
Licensees would not be permitted to use the proposed process for 
granting initial authorization for those individuals for several 
reasons. First, if an individual was terminated for a first positive 
drug or alcohol test result, and if it has been any period less than 3 
years since that individual was terminated, then it would be 
unnecessary to require licensees and other entities to perform a 
suitable inquiry of the entire past 3 years (which would be required 
for an initial authorization). In those cases, proposed Sec.  26.69 
would require licensees or other entities to perform a suitable inquiry 
for the period since the individual's authorization was terminated. 
Second, if an individual has had his or her authorization denied for 5 
years, the suitable inquiry should be performed for the entire past 5 
years (as required in proposed Sec.  26.69). The proposed process for 
granting initial authorization would only require a suitable inquiry 
for the past 3 years, and the NRC believes that would not be 
appropriate in these situations. If an individual's prior authorization 
was terminated unfavorably for reasons that are unrelated to an FFD 
concern, the licensee would implement the relevant requirements in the 
access authorization Orders, which the Commission issued to nuclear 
power reactor licensees on January 7, 2003.
    Comment 2 (NEI): There should not be any additional drug and 
alcohol testing for applicants for reinstatement of authorization whose 
last period of authorization ended between 6 and 30 days ago.
    Response: The proposed rule would require licensees and other 
entities to subject applicants whose authorization has been interrupted 
for 6-30 days to the possibility of being selected for pre-access 
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 would be selected for 
testing at some point within a 30-day period. For applicants selected 
for such testing, the licensee or other entity would complete an 
alcohol test and collect a specimen for drug testing before reinstating 
the individual's authorization. The provision would enhance the 
deterrent effect of pre-access testing for individuals who have had a 
very short break in authorization, without imposing the regulatory 
burden of requiring that every individual be tested.
    This is one of many changes to Subpart C that are being proposed to 
emphasize the NRC's intent 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. 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; 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--the same 
individuals who would be subject to the proposed rule. Because these 
individuals have unimpeded access to sensitive information and safety 
equipment and systems, their trustworthiness and reliability are 
essential. The NRC concludes that an increased level of requirements 
are necessary for the new threat environment, such that there remains 
reasonable assurance that individuals who are subject to the rule are 
trustworthy and reliable. Pre-access testing is one important aspect of 
FFD programs designed to deter and detect substance abuse, which 
presents an unacceptable risk to public health and safety and the 
common defense and security in several ways.
    First, substance abuse increases the likelihood that such 
individuals may pose an insider threat by increasing an individual's 
vulnerability to coercion. Under 10 CFR 73.1, 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 such 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 judgement 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 current rule provide 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

[[Page 50467]]

NRC has taken since September 11, 2001, the proposed requirement that 
individuals who have had a break in authorization of between 6-30 days 
must be subject to one-time selection for pre-access testing would 
provide further assurance that those individuals are trustworthy and 
reliable. The NRC believes that implementation of this provision and 
other provisions in the proposed rule, in addition to the other, 
related measures the Agency has taken in the post-September 11, 2001, 
threat environment, would provide reasonable assurance that individuals 
who are subject to the rule are trustworthy and reliable.
Subpart D Management Actions and Sanctions To Be Imposed
    There are no significant comments that were not incorporated into 
the proposed rule text.
Subpart E Collecting Specimens for Testing
    There are no significant comments that were not incorporated into 
the proposed rule text.
Subpart F Licensee Testing Facilities
    Comment 1 (NEI): Significant QA requirements have been added, which 
makes licensee testing facilities perform at the same level as an HHS-
certified laboratory. This will result in licensees closing many of 
their licensee testing facilities.
    Response: New requirements would be added for conducting initial 
urine specimen validity tests at licensee testing facilities. Specimen 
validity testing refers to testing conducted to identify attempts to 
tamper with a specimen. This includes 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; substitution, which includes replacing a 
valid urine specimen with a drug-free specimen; and dilution, which 
includes intentionally diluting a urine specimen with another liquid to 
decrease the concentration of a drug below the cutoff concentration. 
When HHS published its Notice of Proposed Revisions (66 FR 43876; 
August 21, 2001) to the HHS Guidelines to establish requirements for 
specimen validity testing performed by HHS-certified laboratories, the 
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 U.S. Department 
of Transportation (DOT) regulations (49 CFR part 40). Program 
experience gained since Part 26 was first promulgated has also 
indicated an increasing number of adulterated and substituted urine 
specimens. Although current Part 26 contains a number of requirements 
related to specimen validity, the methods available to tamper with 
specimens have become more sophisticated since the rule was first 
published and therefore more sophisticated methods of detecting 
tampering are necessary. The proposed rule would incorporate new 
requirements for conducting specimen validity tests that are consistent 
with similar provisions contained in the most recent revision to the 
HHS Guidelines (69 FR 19643; April 13, 2004). These new requirements 
for specimen validity testing would be added to strengthen FFD programs 
by improving the ability to detect specimens that are adulterated, 
substituted, or diluted.
    The requirements for specimen validity testing are proposed to 
identify individuals who are willing to attempt to subvert the testing 
process, and so may be willing to subvert other rules and regulations 
that are important for public health and safety and the common defense 
and security. Detecting specimen tampering is necessary to identify 
individuals who may attempt to hide drug abuse, because attempts to 
tamper with a specimen provide clear evidence that the individual is 
not trustworthy and reliable.
    The proposed rule would permit licensees to conduct drug and 
validity screening tests, and to grant authorization to individuals 
whose specimens yield negative test results. If the NRC were not to 
include quality assurance and training requirements in conjunction with 
such tests, but still permit licensees to grant authorization on the 
basis of the tests, then the NRC would not have reasonable assurance 
that only individuals who are trustworthy and reliable are granted 
authorization. Therefore, the NRC has included such provisions in this 
proposed rule.
    Comment 2 (NEI): Licensees should be permitted 3 business days to 
send Bottle B of a split specimen to the HHS lab for testing, following 
a request from the donor.
    Response: The proposed rule would extend the time period provided 
to the licensee to send Bottle B to the HHS-certified laboratory. The 
current rule requires that the specimen must be sent the same day as 
the donor request. The proposed rule would allow 1 business day to send 
the specimen. The proposed rule would not allow 3 days, as requested by 
NEI, because the proposed rule would also require licensees to 
administratively withdraw the individual's authorization at the time 
Bottle A is confirmed non-negative. The NRC believes that permitting up 
to 3 days would pose an unnecessary burden on the individual, 
especially because some licensees temporarily remove pay until the 
Bottle B test is complete. The NRC also believes that 1 business day 
would provide sufficient time for the licensee to locate Bottle B, 
prepare it for shipping, and deliver it to the courier.
Subpart G Laboratories Certified by the Department of Health and Human 
Services
    Comment 1 (Quest Diagnostics): If an individual who is the subject 
of a drug test requests in writing to have access to the laboratory's 
records related to his or her drug test, the records released should be 
limited to the laboratory test report and data package, and not include 
the results of any relevant certification, review, or revocation-of-
certification proceedings. Blanket releases by the employee to third 
parties should be prohibited.
    Response: The proposed rule would permit an individual to have 
access to laboratory records, as well as a third party such as an 
attorney to whom the employee has released the information. The records 
that an employee may request include laboratory records beyond the 
individual's drug test results because other records may be relevant to 
litigation. For instance, if a laboratory audit subsequent to the 
individual's test uncovers improper testing that may be relevant to the 
individual's test, that information may be useful in litigation. The 
NRC sees no justification for withholding such information from an 
individual or an authorized third party, and believes access to such 
information to be consistent with protection of the individual's rights 
and with due process. The provision is also consistent with HHS 
guidelines and Section 503 of Public Law 100-71 for Federal workplace 
drug testing.
    Comment 2 (Quest Diagnostics): Cutoff levels should be consistent 
with new HHS proposed Guidelines.
    Response: The NRC typically considers HHS provisions for inclusion 
into a Part 26 proposed rule following the issuance of final HHS 
Guidelines. This is to minimize the possibility that a Part 26 proposed 
rule must be re-proposed due to changes in the HHS Guidelines between 
their proposed and final forms, and to ensure proper stakeholder 
interaction in the technical basis development stage, followed by 
public review and comment of the Part 26 proposed provisions. The NRC 
will consider the proposed HHS Guidelines

[[Page 50468]]

for inclusion into the technical basis development for a future Part 26 
rulemaking once they have been finalized by HHS.
Subpart H Determining Fitness-for-Duty Policy Violations and 
Determining Fitness
    Comment 1 (NEI): The MRO has too much independent responsibility, 
given that the licensee is responsible for the program. The MRO is part 
of the licensee program and should be accountable within the program, 
not independent of the program.
    Response: The proposed rule would require that MRO and MRO staff 
duties must be independent from any other activity or interest of the 
licensee or other entity. Although the NRC is unaware of any instances 
in which the MRO function has been compromised in Part 26 programs, the 
experience of other Federal agencies has indicated that clear limits on 
independence and who may direct MRO staff activities are advisable. 
Further, in contrast to other Federal agencies' regulations, current 
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, which may provide greater opportunities 
for inadvertent compromise of the independence of the MRO function than 
situations in which the MRO and his or her staff are physically co-
located. Independence of the MRO function from the licensee or other 
entity is necessary to ensure that MROs are impartial gatekeepers for 
the accuracy and integrity of the drug testing process and also to 
ensure the confidentiality of medical information.
    Comment 2 (NEI): The SAE requirements for qualification are 
excessive.
    Response: Detailed requirements regarding the qualifications and 
responsibilities of the SAE are necessary to ensure consistency among 
FFD programs. This is because under the proposed rule, FFD programs 
would be 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. In addition, detailed requirements regarding the 
qualifications and responsibilities of the SAE are necessary because of 
the key role the SAE would play in assuring the public health and 
safety and common defense and security when making a determination of 
fitness. The SAE role is not defined in the current rule. Therefore, 
many of the provisions in the proposed subpart would be adapted from 
related DOT requirements regarding the ``substance abuse professional'' 
[49 CFR Part 40, Subpart O; 65 FR 41944; August 9, 2001]. Additionally, 
the NRC has received feedback on implementation of the current rule 
that some MROs do not feel qualified to make decisions on substance 
abuse treatment and rehabilitation. Under the proposed rule, the 
critical tasks of assessing the presence of a substance abuse disorder, 
providing input to authorization decisions, and developing treatment 
plans would be reserved for professionals who have met the specific 
training, clinical experience, and knowledge requirements for an SAE.
Subpart I Managing Fatigue
    Subpart I would establish clear and enforceable requirements 
concerning the management of fatigue at nuclear power plants. Many 
stakeholders took an interest in, and commented on Subpart I through 
the public meetings, including IBEW, UCS, the Nuclear Energy Institute 
(NEI), the Professional Reactor Operator Society (PROS), industry 
representatives, and Barry Quigley, the petitioner, among others. 
Because of the level of interest and commenting on Subpart I, in 
comparison to the other subparts, several key comments that were not 
incorporated, and their responses, are provided below for each of the 
stakeholders listed above.
    Comment 1 (IBEW): Individuals allowed to perform fatigue 
assessments should be trained to a higher level than others.
    Response: The NRC is proposing to train individuals and supervisors 
to the same level because fatigue management is a shared 
responsibility. The proposed level of training would provide the 
knowledge needed to perform a fatigue assessment, including providing 
an understanding of the indications and effects of fatigue, and the 
appropriate use of fatigue countermeasures. This ensures that those 
individuals who may undergo a fatigue assessment have been trained to 
understand the process to which they will be subject and what the 
assessor will be looking for, in addition to being able to recognize 
the signs of fatigue in their coworkers. Because the training on what 
to expect from a fatigue assessment is not substantially different from 
how to conduct one, for simplicity of implementation, all workers would 
be trained to the same level. In addition, the proposed revisions to 
drug and alcohol testing provisions would revise that training such 
that all workers are required to be trained to the same level. The 
fatigue training would therefore be consistent with those provisions as 
well.
    Comment 2 (Patrick Shaffer, Southern California Edison): The 48 
hour/week group average limit is not high enough for groups other than 
security force personnel that would be subject to the proposed work 
hour controls. A 60 hour/week group average limit would be preferable.
    Response: Answered in the response to Comment 4, below.
    Comment 3 (Barry Quigley, petitioner): The group average limit 
should not be increased above a 48 hour/week limit.
    Response: Answered in the response to Comment 4, below.
    Comment 4 (UCS): The proposed rule would permit the entire affected 
workforce to work 53-hour weeks [including shift turnover time], which 
erodes fatigue protection from the 40-hour weeks recommended in NRC's 
Policy on Worker Fatigue.
    Response: The objectives of the 48-hour group limit during normal 
plant operations are to ensure that the amount of overtime typically 
worked by individuals does not adversely affect their abilities to 
safely and competently perform their duties, to define an enforceable 
upper limit to the nominal 40-hour work-week policy in GL 82-12, and to 
permit licensees to manage overtime in a manner that reflects the 
differing desires and capabilities of individuals with respect to work 
hours. A more detailed discussion of the basis for requiring a 48 hour/
week group average limit is provided in Section VI with respect to 
proposed Sec.  26.199(f), and is also summarized below.
    A 40-hour work-week during normal operations is a key objective of 
the NRC's Policy on Worker Fatigue. The policy is intended to ensure 
that there are enough operating personnel to ``maintain adequate shift 
coverage without routine heavy use of overtime.'' However, the policy, 
and the 40-hour work-week objective, are not enforceable.
    Routine overtime can cause cumulative fatigue, which degrades the 
abilities of workers to safely and competently perform their duties. 
The proposed collective work hour controls, including the 48-hour per 
week group limit during normal plant operations, would address 
cumulative fatigue by establishing more readily enforceable 
requirements for the long-term control of work hours, including the 
limited use of overtime for occasional short-term exigent circumstances 
(e.g., equipment failure, personnel illness or attrition). The 48-hour 
group limit would reduce the potential for cumulative fatigue by

[[Page 50469]]

preventing excessive use of the maximum allowable individual limits 
during normal plant operations. The current regulatory framework does 
not contain enforceable requirements to prevent such practices. In 
addition, by limiting work hours during normal conditions, individuals 
would be better rested and less susceptible to cumulative fatigue from 
the long work hours that are common during plant and security system 
outages. Further, it would provide reasonable assurance that 
individuals will be better rested prior to an emergency or increased 
threat condition.
    The proposed requirement would limit groups of individuals to a 48-
hour average, permitting 20 percent overtime in excess of the nominal 
40-hour work week. Consideration of several types and sources of 
information led to the decision to establish a group average limit of 
48 hours for normal plant conditions. These included past 
recommendations from experts and expert panels on work scheduling and 
maintaining worker alertness in the nuclear industry, surveys of 
nuclear power plant workers on their desire and ability to work 
overtime, data and industry practices on the amount of overtime worked 
by security personnel, and requirements and practices in other 
industries. A detailed description of the sources of information is 
included in Section VI with respect to proposed Sec.  26.199(f).
    Comment 5 (NEI): A 56-day outage exclusion from the 48-hour group 
average work hour limits is insufficient.
    Response: Answered in the response to Comment 7, below.
    Comment 6 (UCS): The work hour limits should not be turned off 
based on an unrelated artificial construct, such as outage duration(s) 
and national security levels. Instead, the rule should state the work 
hour limits for short and long terms.
    Response: Answered in the response to Comment 7, below.
    Comment 7 (Barry Quigley, petitioner): Outages should not be 
excluded from the group work hour average limits.
    Response: The collective work hour controls address the long-term 
control of work hours, including the limited use of overtime for 
occasional short-term exigent circumstances (e.g., equipment failure, 
personnel illness or attrition). However, the NRC recognizes the need 
to address separately the control of work hours during outages because 
of the unique staffing and workload demands of this plant state. 
Accordingly, the proposed rule would permit a limited exclusion period 
for plant outages from the collective work hour controls.
    The NRC considered several factors, including current policy, the 
bases for the policy, and lessons learned from the policy 
implementation in developing a provision to permit a limited exclusion 
period for plant outages from the collective work hour controls. 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, plant circumstances involving 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 
degradation of performance for short periods of time, research has 
shown that the ability to sustain performance without adequate rest is 
clearly limited. However, the NRC has never defined the term 
``temporary basis'' as used in the policy. As a consequence, licensees 
have used the guidelines to control working hours for conditions 
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 indicated the need to establish clear and more 
readily enforceable requirements that would limit the sustained use of 
extended work hours.
    The NRC considered several factors in setting the exclusion period 
for plant outages at 8 weeks. First, by the end of 8 weeks of work at 
the limits permitted, individuals will have worked 540 hours, including 
200 hours of overtime. This is 50 percent of the hours that surveys of 
nuclear plant workers have indicated are acceptable on an annual basis. 
Second, by the end of 8 weeks of work at the limits permitted, 
individuals will have missed as many as 17 normally scheduled days off, 
a reduction of 60 percent in the time available to recover and prevent 
cumulative fatigue. In addition, with each passing week of an outage, 
individuals have worked an increasing number of normally scheduled days 
off. The ability to defer daily living obligations becomes increasingly 
difficult, causing increased pressure to reduce sleep time in order to 
meet demands of both work and daily life, and increased potential for 
cumulative fatigue.
    In addition to considering the potential for cumulative fatigue, 
the NRC considered current industry data concerning the duration of 
plant outages. The average refueling outage duration, as indicated by 
outage data from 2000-2002 in the Information System on Occupational 
Exposure database (ADAMS Accession No. ML050190016), is approximately 
39 days. Eighty-nine percent 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 
include a marginal number of additional outages. The NRC believes that 
such an increase in the exclusion period would substantively increase 
the potential for cumulative fatigue and fatigue-related personnel 
errors. By contrast, decreasing the exclusion period to less than 8 
weeks would rapidly increase the number of outages that would, in part, 
be subject to the collective work hour controls, potentially increasing 
the duration and cost of those outages. The NRC acknowledges that 
decreasing the exclusion period by 1 or 2 weeks could decrease the 
potential for cumulative fatigue, but the magnitude of the decrease 
would be difficult to quantify and the benefit would not likely justify 
the costs.
    The NRC believes that an exclusion of the first 8 weeks of an 
outage is consistent with the objective of ensuring that licensees 
provide adequate shift coverage without routine heavy use of overtime. 
The exclusion period would be limited to plant outages, which occur 
regularly, but with limited frequency. In addition, the duration of the 
exclusion period would be limited to 8 weeks, thereby providing 
reasonable assurance that workers would be able to safely and 
competently perform their duties, and not be impaired from cumulative 
fatigue.
    The NRC further considers that the exclusion of security system 
outages and increased threat conditions is appropriate. In these 
conditions, maintaining plant security is of the utmost importance. It 
is specifically during these conditions that the NRC believes that the 
benefits to the common defense and security of augmenting on-shift 
security staffing during those conditions outweigh the potential risk 
from increased fatigue for those time periods.
    Comment 8 (PROS and UCS): Turnover time is excluded from the work 
hour limit calculations, but there is no maximum allowed turnover time. 
This could lead to excessive time allocated to turnovers, and therefore 
hours worked.

[[Page 50470]]

    Response: Although the NRC believes it is necessary and justified 
to limit the number of hours worked by certain individuals to ensure 
public health and safety and the common defense and security, the NRC 
also believes shift turnovers contribute significantly to safety and 
security. If the proposed rule included shift turnover in the work hour 
calculations, licensees may have an incentive to limit turnover time, 
which could have a negative impact on safety and security. The NRC 
believes the importance of an accurate and thorough turnover should not 
be undermined through the imposition of work hour restrictions related 
to turnover.
    The NRC shares the commenters' concern that excessive time 
allocated to turnovers could result in excessive hours worked. 
Therefore, proposed Sec.  26.199(b)(1)(I) would specify the types of 
activities that would and would not be considered shift turnover 
activities under the proposed rule. For example, the proposed paragraph 
would define shift turnover activities as only those activities that 
are necessary to safely transfer information and responsibilities 
between two or more individuals between shifts. By contrast, the early 
arrival of an individual for meetings, training, or pre-shift briefings 
for special evolutions would not be considered shift turnover time. The 
NRC believes that the proposed specifications for shift turnover 
activities would be sufficient to ensure that excluding shift turnover 
time from work hours calculations, combination with the other 
requirements for fatigue management in the proposed rule, would be 
sufficient to prevent individuals from working excessive hours.
    Comment 9 (UCS): The formal determination that a waiver of the 
individual work hour limits and break requirements ``is necessary to 
mitigate or prevent a condition adverse to safety,'' or to ``maintain 
the security of the facility,'' is hardly a robust barrier when one 
considers all the safety-challenged things that have been changed at 
nuclear power plants under the far more restrictive provisions of 10 
CFR 50.59.
    Response: The provisions of 10 CFR 50.59 do permit many minor 
changes to be made at nuclear reactors because the safety criteria are 
stated in the negative. In other words, a licensee is permitted to make 
changes that do not have an adverse impact. In contrast, the proposed 
waiver criteria would work in the positive. Minor safety issues would 
not constitute a valid justification for a waiver of the individual 
limits or break requirements because the criteria are stated in the 
positive. Only work that ``is necessary to mitigate or prevent a 
condition adverse to safety,'' or to ``maintain the security of the 
facility,'' would meet the criteria. This is consistent with the NRC's 
intent that waivers be approved only in very limited circumstances. The 
NRC believes granting of waivers in these extreme cases is justified 
and in the public interest because the gain in safety or security from 
the work being completed in an unimpeded manner would offset the 
potential reduction in safety or security from worker fatigue.
    Comment 10 (NEI): Waivers should be allowed for pressing economic 
concerns.
    Response: The criteria for granting waivers from individual short-
term work hour limits and break requirements were strengthened from 
current plant technical specification requirements to permit the 
granting of waivers only for conditions adverse to safety or security. 
Industry data have shown significant over-use of waivers, mostly for 
commercial reasons, as is detailed in the Regulatory and Backfit 
Analysis prepared for this proposed rule. The NRC believes the 
individual short-term work hour limits and break requirements should 
only be waived in unique circumstances, on a very infrequent basis, and 
only when necessary for safety or security. Permitting waivers for 
economic reasons would increase the potential risk to public health and 
safety and the common defense and security from worker fatigue without 
an off-setting gain to safety or security. As described in this section 
with respect to the individual limits in proposed Sec.  26.199(d)(2) 
and (3), the potential for worker fatigue in conditions that would 
require a waiver is substantial (Baker, et al., 1994; Dawson and Reid, 
1997; Stephens, 1995; Strohl, 1999). As a consequence, the NRC does not 
believe that licensees can reasonably justify the performance of risk 
significant functions at work hours in excess of the proposed limits on 
the basis that the action would not constitute an adverse impact on 
safety or security. During the public meetings described in Section V, 
industry stakeholders proposed that a senior site manager have the 
authority to grant waivers if the manager ``determines that the 
deviation will not have an adverse impact on safety or security.'' The 
NRC does not believe that the criterion proposed by industry 
stakeholders is appropriate for several reasons. The work hour limits 
of proposed Sec.  26.199(d) would apply only to personnel performing 
risk significant functions. If an activity is not risk significant, it 
is not subject to the work hour controls and therefore a waiver is 
unnecessary. The proposed waiver criteria, therefore, do not impose 
unnecessary restrictions in such circumstances. Further, the NRC does 
not believe the proposed work hour limits and minimum break 
requirements are unnecessarily conservative. The criterion proposed by 
industry representatives is also highly subjective. In light of 
concerns regarding industry's past use of deviations that the NRC 
documented in SECY-01-0113, the use of a subjective criterion would not 
be an effective regulatory approach to mitigating the past over-use of 
waivers by certain licensees.
    Comment 11 (NEI): There should not be a reporting requirement for 
the number of waivers granted.
    Response: As detailed in the Regulatory and Backfit Analysis, the 
industry has, and continues to, grant excessive numbers of waivers each 
year. Although the proposed provisions are expected to greatly limit 
the number of waivers licensees can grant each year, the NRC believes 
it is necessary and justified to monitor the number of waivers granted, 
along with other indicators of FFD program performance that are 
proposed to be monitored, to ensure the rule is implemented as intended 
and that the fatigue portions of FFD programs are effective. The NRC 
has weighed the burden introduced in the proposed reporting requirement 
with the burden that would otherwise be required of NRC staff and 
inspectors to perform such monitoring and has determined the burden is 
justified. In that determination, the NRC has also considered that a 
yearly FFD program performance report is currently required for the 
drug and alcohol testing program, and the additional reporting for the 
fatigue programs would merely add to the report, not create a new one.
    Comment 12 (NEI): The fire brigade should not be subject to Subpart 
I requirements.
    Response: The proposed work hour limits would be applicable only to 
those members of the fire brigade who are responsible for understanding 
the effects of fire and fire suppressants on safe shutdown capability 
for the reactor. This knowledge enables them to provide the control 
room operators and fire brigade leader with information that is 
critical to implementing a fire mitigation strategy that maintains safe 
shutdown capability. For application of the collective work hour 
controls specified in Sec.  26.199(f), these fire brigade members could 
be averaged with another work group (e.g., operations) for those 
individuals who perform the duties of both groups.

[[Page 50471]]

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 the cognitive 
ability to be able to think and 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 all activities with control room operators.
    Fatigue can substantially degrade a worker's decision-making and 
communication abilities, cause a worker to take more risks, and cause a 
worker to maintain faulty diagnoses throughout an event, as detailed in 
Section IV. D. These abilities are key to the duties of the fire 
brigade members who are responsible for understanding the effects of 
fire and fire suppressants on 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 
worker 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 
decision-making could lead a worker to improperly control flooding, 
which could impact other needed equipment, or could 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 decision-making of 
those operators. If information known to the impaired worker is not 
properly communicated, operators may not initiate appropriate actions 
to mitigate the fire effects, or effects of suppressant activities, on 
critical equipment. As a consequence, ensuring that the ability of fire 
brigade members to safely and competently assess the effects of a fire 
and fire suppressants on safe shutdown capability is essential to the 
overall success of the fire mitigation strategy and the protection of 
public health and safety.
    Further, the NRC periodically grants exemptions from requirements 
in 10 CFR Part 50, Appendix R [Fire Protection Program for Nuclear 
Power Facilities Operating Prior to January 1, 1979] 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 a fire by the fire brigade.
    Comment 13 (NEI): There should not be requirements for a 48-hour 
break every 14 days and a 24-hour break every 7 days.
    Response: The NRC believes the proposed 24- and 48-hour break 
requirements are necessary to reduce the effects of acute and 
cumulative fatigue. A more detailed discussion of the basis for 
requiring the 24- and 48-hour breaks is provided in Section VI with 
respect to proposed Sec.  26.199(d)(2), and is also summarized below.
    Acute fatigue results from excessive cognitive work and especially 
from significant amounts of missed sleep. It is readily relieved by 
obtaining adequate rest and sleep. Cumulative fatigue results from 
individuals receiving inadequate sleep for successive days. As fatigue 
increases, performance is increasingly impaired, shows greater 
variability, and manifests itself in the form of errors of omission and 
commission. Research has shown that lack of adequate days off and 
extended workdays can result in cumulative sleep debt and performance 
impairment. This research, as well as other considerations, is 
discussed in detail in Section VI with respect to proposed Sec.  
26.199(d)(2).
    Additionally, the NRC considers the 24- and 48-hour breaks to be a 
key component of fatigue mitigation for the transient workforce. 
Contract and other temporary personnel move from one plant outage to 
another within a region or nationally. During most portions of an 
outage, these personnel would be subject only to the proposed 
individual limits and break requirements. The break requirements, in 
conjunction with the consideration that such temporary workers likely 
have periodic seasonal breaks between outages, provides reasonable 
assurance that they will not be impaired from either acute or 
cumulative fatigue.
    Comment 14 (PROS): Utilities should not be allowed to work licensed 
operators up to 16 hours straight, they should be limited to 12 hours.
    Response: Although proposed Subpart I would not prohibit the use of 
16-hour shifts, the proposed rule includes requirements that 
collectively address this concern. The proposed rule would include 
controls that would reduce the frequency of 16-hour shifts. These 
controls include proposed Sec.  26.199(d)(1)(ii), which would limit the 
maximum hours worked in any 48-hour period to no more than 26 hours. 
This limit prohibits individuals from working 16-hour shifts on two 
consecutive days. Proposed Sec.  26.199(d)(2)(I) would require a 
minimum 10-hour break between work periods and provide workers with the 
opportunity for 7-8 hours of sleep. This requirement would create a 
substantial disincentive for using 16-hour shifts. Specifically, 
individuals who work 16-hour shifts would not be eligible to return to 
work at the beginning of the next normally available shift.
    The NRC acknowledges that 16-hour shifts can substantially increase 
the probability for human error. Accordingly, the NRC believes that 
fatigue management must include limiting the use of 16-hour shifts to 
the extent practicable and applying effective behavioral observation 
and fatigue mitigation strategies when such conditions are unavoidable. 
The training requirements in the proposed rule would provide 
individuals and supervisors with the knowledge to make effective 
decisions regarding fatigue, which should result in the scheduling of 
fewer 16-hour shifts. The proposed rule would also require licensees to 
establish a process to be followed if an individual declares that he or 
she is not fit for duty, for any reason, including fatigue. The NRC 
would expect that individuals who believe that they are incapable of 
safely and competently completing a 16-hour shift would make an 
appropriate self-declaration.
    Collectively, the requirements of the proposed rule would be 
expected to: (1) Substantially limit the frequency of 16-hour shifts, 
(2) provide assurance that, when such work hours are necessary, 
licensees have the knowledge and abilities to assess the potential for 
degraded performance and need for fatigue countermeasures, and (3) 
ensure workers have a process for resolving concerns regarding fatigue 
from extended work hours. As a

[[Page 50472]]

consequence, the NRC believes that the proposed requirements are 
appropriate for maintaining worker fitness for duty and, thereby, 
protecting public health and safety and the common defense and 
security.
    Comment 15 (Barry Quigley, petitioner): The work hour controls in 
Subpart I should apply to all individuals performing risk-significant 
work, such as engineers and all fire brigade personnel.
    Response: The proposed requirements would cover all personnel who 
perform duties within one of the following job duty groups: (1) 
Operating or on-site 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 maintenance or 
on-site directing of the maintenance of structures, systems, and 
components that a risk-informed evaluation process has shown to be 
significant to public health and safety; (3) performing Health Physics 
or Chemistry duties required as a member of the on-site emergency 
response organization minimum shift complement; (4) performing the 
duties of a Fire Brigade member who is responsible for understanding 
the effects of fire and fire suppressants on safe shutdown capability; 
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).
    Engineers who direct, on-site, the maintenance or operations of 
risk-significant structures, systems, and components would be subject 
to group work hour controls. The NRC believes those engineers who 
perform such duties should be subject to group work hour controls. A 
few examples of such direction would be engineers who act as test 
directors in the control room, engineers who provide direction to 
maintenance crews (such as during an outage), engineers who provide 
technical direction and guidance for reactivity manipulations and power 
changes, as well as many other similar engineering functions. However, 
the NRC does not believe that engineers, or other individuals, who do 
not perform those duties should be subject to group work hour controls. 
Many engineers do not direct maintenance or operations, and many others 
do not work with risk-significant plant systems, structures, or 
components. A few examples of engineering activities that the NRC does 
not consider direction include design modifications, assisting in 
procedure changes (including writing and modifying procedures for 
covered work groups such as operations), performing technical analyses, 
monitoring the performance of systems and recommend maintenance, as 
well as many other similar engineering functions.
    The NRC is not proposing to require licensees and other entities to 
subject all engineers to work hour controls because many engineering 
tasks, such as modification design, are reviewed by managers, peer 
reviewers, and others before being implemented. The same is the case 
for routine performance monitoring. Any maintenance recommended by an 
engineer as a result of performance monitoring would typically be 
reviewed by managers or work planners in maintenance. Therefore, the 
NRC has reasonable assurance that errors committed by an engineer in 
these circumstances would be found and corrected through the normal 
plant review processes.
    In the case of fire brigade personnel, the NRC is proposing that 
only those fire brigade personnel who are responsible for understanding 
the effects of fire and fire suppressants on safe shutdown capability 
would be subject to work hour controls. The NRC does not propose to 
include other members of the fire brigade because they are principally 
engaged in manual actions. These types of actions do not require 
substantial analysis and decision-making capability, and individuals 
engaged in manual actions would be expected to perform those actions 
without significant degradation from fatigue. Diagnosis and decision-
making functions are affected by fatigue to a much greater extent, and 
are collectively more critical to emergency response. For these 
reasons, the NRC proposes work hour controls on only the fire brigade 
members who are responsible for understanding the effects of fire and 
fire suppressants on safe shutdown capability.
Subpart J Recordkeeping and Reporting Requirements
    There are no significant comments that were not incorporated into 
the proposed rule text.
Subpart K Inspections, Violations, and Penalties
    There are no significant comments that were not incorporated into 
the proposed rule text.

VI. Section-by-Section Analysis of Substantive Changes

    The proposed rule would be organized into eleven 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--Recordkeeping and Reporting Requirements
Subpart K--Inspections, Violations, and Penalties

    A detailed cross-reference table between the current and proposed 
Part 26 provisions is included at the end of this notice.
    Appendix A of the current rule would be deleted and the detailed 
requirements for conducting drug and alcohol testing that are contained 
in Appendix A to 10 CFR Part 26 would be moved 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 proposed rule.

Subpart A--Administrative Provisions

Section 26.1 Purpose

    Section 26.1 [Purpose] of the proposed rule would amend the 
language of the corresponding section of the current rule. The proposed 
paragraph would delete the term, ``certain aspects,'' as unnecessary. 
The proposed paragraph would add the term, ``implementation,'' to the 
phrase in the current rule which states, ``for the establishment and 
maintenance of * * * fitness-for-duty programs,'' in order to convey 
more accurately that the proposed rule includes requirements for 
implementing FFD programs, in addition to requirements for establishing 
and maintaining such programs. The portion of current Sec.  26.1 that 
refers to the entities who are subject to the rule would be moved to 
proposed Sec.  26.3 [Scope] in order to consolidate this information in 
a more appropriate location.

Section 26.3 Scope

    Proposed Sec.  26.3 [Scope] would renumber, reorganize, and amend 
current Sec.  26.2 [Scope]. In general, proposed Sec.  26.3 would 
retain the list of entities who are subject to the current rule and add 
other entities. However, the provisions in current Sec.  26.2 that 
specify the individuals whose job duties require them to be subject to 
the rule and exempt certain other individuals

[[Page 50473]]

would be moved to a new section, proposed Sec.  26.25 [Individuals 
subject to the fitness-for-duty program]. The provisions that would be 
moved to proposed Sec.  26.25 include the second sentence of current 
Sec.  26.2(a), the first sentence of current Sec.  26.2(b), and the 
portion of the second sentence of current Sec.  26.2(d) that pertains 
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 would make the two sets of provisions easier to 
locate within the rule without compromising the intended meaning of 
these provisions.
    Proposed Sec.  26.3(a) would add combined operating license holders 
to be consistent with the revised 10 CFR Part 52 licensing process for 
new reactors.
    Proposed Sec.  26.3(b) would retain the requirement in the first 
sentence of current Sec.  26.2(a) that licensees who are authorized to 
possess or use formula quantities of SSNM or to transport formula 
quantities of SSNM are subject to the regulations in this part. 
However, these licensees would not be subject to the requirements 
contained in proposed Subpart I [Managing Fatigue] for the reasons that 
will be discussed later in this document in relation to proposed Sec.  
26.195 [Applicability].
    Proposed Sec.  26.3(c) would retain the requirements of current 
Sec.  26.2(d) and add references to entities other than a corporation 
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. The proposed 
paragraph would also add a cross-reference to proposed Sec.  
26.25(a)(3), which specifies the individuals who are employed by or 
under contract to these entities who would be subject to Part 26. The 
entities in the proposed paragraph would not be subject to the 
requirements in proposed Subpart I [Managing Fatigue] for the reasons 
that will be discussed later in this document in relation to proposed 
Sec.  26.195 [Applicability].
    Proposed Sec.  26.3(d) would retain the meaning of the portion of 
current Sec.  26.23(a)(1) that requires a contractor/vendor (C/V) FFD 
program to meet the standards of this part if licensees rely upon the 
C/V's FFD program to meet the requirements of this part, but amend some 
of the terminology used in the current rule. The proposed paragraph 
would add C/Vs to the list of entities who are subject to Part 26 in 
proposed Sec.  26.3 in order to more clearly convey that C/Vs may be 
directly subject to NRC inspection and enforcement actions than the 
current rule language implies. The current rule text presents 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, current Sec.  26.23(a)(1) states, ``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 current 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, proposed Sec.  26.3(d) 
would include C/V FFD programs and program elements upon which 
licensees and other entities rely within this section to convey more 
accurately that C/Vs are directly accountable for meeting the 
applicable requirements of Part 26, rather than accountable only 
through their contractual relationships with the licensees and other 
entities who are subject to the rule. This clarification is also 
necessary to maintain the internal consistency of the proposed rule 
because some provisions of the proposed rule apply only to C/Vs, 
including, but not limited to proposed Sec.  26.217(g).
    The phrases, ``program elements'' and ``to the extent that 
licensees and other entities rely upon those C/V FFD programs or 
program elements to meet the requirements of this part,'' would be used 
in proposed Sec.  26.3(d) because C/Vs would 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 proposed rule except 
drug and alcohol testing. In this case, the proposed rule would 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 proposed 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 proposed Sec.  26.31(c) [Conditions for 
testing], such as for-cause testing, and a licensee or other entity who 
is subject to Part 26 relies upon the results of the C/V's tests in 
determining whether to grant authorization to an individual (see 
proposed Subpart C [Granting and Maintaining Authorization]), then the 
use of these two phrases in the proposed paragraph would be correctly 
interpreted as meaning that the C/V's drug and alcohol testing program 
element must meet the proposed rule's requirements related to drug and 
alcohol testing when conducting the tests on which the licensee or 
other entity relies. By 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 who is subject to this part, 
then the proposed paragraph would not require the C/V to meet the 
applicable Part 26 requirements for that FFD program element.
    Proposed Sec.  26.3(d) would require C/Vs to meet the requirements 
of proposed Subpart I [Managing Fatigue], if any nuclear power plant 
licensees rely upon a C/V's fatigue management program element to meet 
the requirements of Subpart I. The applicability of proposed Subpart I 
to C/Vs will be discussed with respect to proposed Sec.  26.195 
[Applicability].
    Other provisions of current Sec.  26.23 [Contractors and vendors] 
would either be eliminated from the proposed rule or moved to other 
sections of the proposed rule. The current requirement for licensees to 
retain written agreements with C/Vs in the second sentence of Sec.  
26.23 would be moved to proposed Subpart J [Recordkeeping and Reporting 
Requirements]. The requirement in current Sec.  26.23(a)(1), which 
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, would be addressed in proposed Subpart C 
[Granting and Maintaining Authorization]. The audit requirement 
contained in current Sec.  26.23(b) would be addressed in proposed 
Sec.  26.41(d) [Contracts]. The current requirements would be moved to 
different sections of the proposed rule to meet Goal 6 of this 
rulemaking, which is to improve clarity in the organization and 
language of the rule, as discussed in Section IV. B, by grouping 
related requirements together in one section or subpart that addresses 
similar topics.

[[Page 50474]]

    Proposed Sec.  26.3(e) would retain and update the requirements of 
current Sec.  26.2(c) to be consistent with revisions to related 
sections of the proposed rule as well as related parts of this chapter. 
Combined operating license holders (under Part 52 of this chapter) 
before the Commission has made the finding under Sec.  52.103 of this 
chapter would continue to be subject to the rule, as well as combined 
license applicants who have received authorization to construct under 
Sec.  50.10(e)(3), construction permit holders (under Part 50 of this 
chapter), construction permit applicants who have received 
authorization to construct under Sec.  50.10(e)(3), and holders of 
manufacturing licenses (under Part 52 of this chapter). For 
consistency, the proposed paragraph would also replace the current 
cross-references to other sections of the rule with updated cross-
references to the related sections in the proposed rule and replace 
some terms used in the current paragraph with new terms that would be 
used throughout the proposed rule. For example, the term, ``chemical 
testing,'' would be replaced with ``drug and alcohol testing,'' and 
``appeals'' would be replaced with ``review'' for reasons that will be 
discussed below related to proposed Sec.  26.31 [Drug and alcohol 
testing] and proposed Sec.  26.39 [Review process for fitness-for-duty 
violations], respectively. Other new terms in the proposed rule that 
would replace some of the terms used in the current rule are discussed 
with respect to proposed Sec.  26.5 [Definitions].
    Proposed Sec.  26.3(f) would retain the second sentence of current 
Sec.  26.2(b) because it addresses entities who would not be subject to 
the proposed rule. The first sentence of current Sec.  26.2(b), which 
addresses individuals who are not subject to the rule, would be moved 
to proposed Sec.  26.25 [Individuals subject to the fitness-for-duty 
program] for organizational clarity in the proposed rule.

Section 26.5 Definitions

    Proposed Sec.  26.5 [Definitions] would amend current 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 the Substance Abuse and Mental Health 
Services Administration and the Department of Transportation); (3) 
define new terms used in other sections of the proposed rule; and (4) 
move definitions into this section from current Section 1.2 of Appendix 
A to 10 CFR Part 26, which contains definitions of important terms used 
in Appendix A to Part 26. The proposed rule would also eliminate six 
terms in current Sec.  26.3 and Section 1.2 of Appendix A to Part 26 
because they would be fully defined in the text of the proposed rule or 
would no longer be used in the proposed rule. In addition, the proposed 
rule would eliminate redundant definitions of some terms, which appear 
in both current Sec.  26.3 and Section 1.2 in Appendix A to Part 26. 
Finally, some definitions would be revised to make them simpler and 
easier to understand, consistent with the Agency's commitment to using 
plain language. For example, some definitions in the current rule 
include requirements that are also contained in other sections of the 
rule. In these instances, the proposed rule would eliminate the 
requirements that are embedded in the definitions, but retain the 
definitions in this section. The requirements would be moved to the 
related sections of the rule for organizational clarity.
    The majority of the proposed changes to this section would be made 
as a result of adding new requirements for urine drug testing, 
including specimen validity testing, to the proposed rule. The proposed 
rule would incorporate 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 proposed changes would require adding terms to 
proposed Sec.  26.5, modifying a number of the terms that are used in 
the current rule, and revising the definitions of some terms in the 
current rule that would also be used in the proposed rule, as follows:
    The proposed rule would add several new 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 proposed terms would include ``adulterated specimen,'' ``dilute 
specimen,'' ``substituted specimen,'' and ``invalid result.'' The 
proposed rule would also add the term, ``oxidizing adulterant,'' to 
refer to one class of substances that may be used to adulterate urine 
specimens. These new terms and proposed definitions would be adapted 
from the HHS Guidelines.
    The proposed rule also would add 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 proposed rule would also add 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 proposed rule.
    The proposed rule would change certain terms that describe drug and 
alcohol tests to reflect the addition of urine specimen validity 
testing requirements. The changes would include replacing the term, 
``initial or screening test,'' with more specific terms to distinguish 
between drug testing and testing for urine specimen validity. The 
terms, ``validity screening test,'' ``initial drug test,'' and 
``initial validity test,'' would be added to refer to the first tests 
of a urine specimen that would be 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 proposed rule would also modify the 
definition of ``initial drug test'' in the current rule to eliminate 
the requirement that the test must be performed using immunoassay 
techniques because that requirement would be addressed in the text of 
the proposed rule. The proposed rule would replace the general term, 
``confirmatory test,'' in the current rule with the more specific 
terms, ``confirmatory drug or alcohol test'' and ``confirmatory 
validity test.'' In addition, the definitions of these terms in the 
proposed rule would not include requirements for the methods to be used 
in performing confirmatory tests because these requirements would be 
addressed in the text of the proposed rule. Therefore, the requirement 
that confirmatory drug testing be performed using gas chromatography/
mass spectrometry (GC/MS) testing would be removed from the definition. 
The proposed rule would also eliminate the reference to GC/MS testing 
of blood samples for confirmatory alcohol testing in the definition of 
``confirmatory drug or alcohol test'' because the proposed rule would 
no longer give donors the option to provide a blood sample for alcohol 
confirmatory testing, as discussed with respect to proposed Sec.  
26.83(a).
    The proposed rule would modify several terms that are used in the 
current rule 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. Among these changes, the 
proposed rule would add the term ``non-negative test result.'' The 
term, ``non-negative,'' would be used to refer to any adverse test 
result from the different types of testing that would be

[[Page 50475]]

required under the proposed rule. For example, the proposed rule would 
use ``non-negative'' to refer to positive results from alcohol testing 
as well as results of drug and validity tests of urine specimens that 
indicate the presence of drugs or drug metabolites, and/or that the 
specimen may be adulterated, dilute, substituted, or invalid. The term, 
``presumptive positive test result,'' would be eliminated from the 
proposed section because it would no longer be used in the rule text. 
The updated term, ``non-negative initial test result,'' would be used 
in the rule text instead. The proposed rule would also change the term, 
``confirmed positive test,'' to ``confirmed test result'' to clarify 
that this term refers to the results of the MRO's review of drug and 
validity tests of urine specimens and to positive results of a 
confirmatory alcohol test, rather than to a type of testing. The 
proposed rule would also remove the reference to testing of blood 
specimens for alcohol that is contained in the current definition of 
``confirmed positive test'' from the definition of ``confirmed test 
result'' because blood specimens would no longer be collected at the 
donor's request for confirmatory alcohol testing, as discussed with 
respect to proposed Sec.  26.83(a).
    The proposed rule would also add 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 proposed definitions of these terms would be 
adapted from the HHS Guidelines.
    In addition, the definitions of two terms in the current rule would 
be modified to be consistent with the new drug and alcohol testing 
terminology that would be used throughout the proposed rule. The 
proposed rule would amend the definition of ``cutoff level'' to refer 
to ``non-negative,'' rather than ``positive,'' test results to clarify 
that the term is also applicable to the interpretation of results from 
specimen validity testing. And, the definition of ``Medical Review 
Officer'' (MRO) would be amended to refer to a ``non-negative'' test 
result, rather than a ``positive'' test result, to clarify that the MRO 
would review validity test results in addition to drug test results.
    The proposed rule would also add several terms that would be 
necessary to implement the proposed requirements contained in two new 
subparts of the regulation, proposed Subpart C [Granting and 
Maintaining Authorization] and proposed Subpart I [Managing Fatigue]. 
The proposed rule would add six new terms that are related to the 
requirements of proposed Subpart C. The term, ``potentially 
disqualifying fitness-for-duty (FFD) information,'' would be added to 
refer to the types of information that licensees and other entities who 
are subject to the rule would consider when deciding whether to grant 
or maintain an individual's authorization to have the types of access 
or perform the job duties that are listed in proposed Sec.  26.26(a). 
The proposed rule would also add 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 term, ``best 
effort,'' would also be added 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 proposed Sec.  
26.63(a).
    The proposed rule would also add several terms that are necessary 
to implement the requirements of proposed Subpart I [Managing Fatigue]. 
These terms would 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 proposed rule would use 
the term, ``alertness,'' to refer to an individual's ability to remain 
awake and sustain attention, which is adversely affected by fatigue. 
The term, ``circadian variation in alertness and performance,'' would 
be added to define a factor that licensees would consider when 
conducting a fatigue assessment under proposed Sec.  26.201 [Fatigue 
assessments]. The proposed rule would also add the term, ``increase in 
threat condition,'' to refer to circumstances in which the proposed 
rule would provide licensees with some flexibility in implementing the 
work hour controls of proposed Sec.  26.199 [Work hour controls].
    The proposed rule would also add eight new terms related to other 
proposed revisions to the current rule. Specifically, ``analytical 
run'' would be added for use in establishing amended performance 
testing requirements for licensee testing facilities in proposed Sec.  
26.137 [Quality assurance and quality control]. The term, 
``directing,'' would be added to clarify new requirements for MRO staff 
under proposed Sec.  26.183(d) and the scope of individuals who would 
be subject to work hour controls in proposed Sec.  26.199(a). For 
consistency with the use of the term in the related regulations of 
other Federal agencies, the term, ``donor,'' would replace the current 
terms that are used to refer to an individual from whom a specimen is 
collected for drug or alcohol testing. The term, ``nominal,'' would be 
added to refer to the leeway in the time periods within which certain 
requirements must be met, such as the requirement for annual FFD 
refresher training in proposed Sec.  26.29(c)(2). The term, ``other 
entity,'' would be added to refer to organizations who would be 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 proposed Sec.  26.3 [Scope]. The terms, ``formula quantity'' 
and ``strategic special nuclear material'' (SSNM), would be defined 
consistently with the definitions of the same terms in 10 CFR 70.4. The 
term, ``subversion and subvert the testing process,'' would be added to 
clarify the language of new provisions related to urine specimen 
validity testing, as discussed with respect to proposed Sec.  
26.31(d)(3)(i), and new sanctions that would be imposed on individuals 
who are subject to the proposed rule, in proposed Sec.  26.75(b).
    Proposed Sec.  26.5 would also retain and amend a number of other 
definitions currently contained in Sec.  26.3 and Section 1.2 in 
Appendix A to Part 26, as follows.
    The proposed rule would revise the current 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 
would be consistent with the same definition in the HHS Guidelines.
    The proposed rule would simplify the current definition of ``blood 
alcohol concentration'' (BAC) by deleting references to the instruments 
and devices that licensees and other entities are permitted to use for 
alcohol testing. The text of proposed Sec.  26.91 [Acceptable devices 
for conducting initial and confirmatory tests for alcohol and methods 
of use] would specify acceptable devices for alcohol testing under the 
proposed rule.
    The proposed rule would revise the definition of ``category IA 
material'' to conform with the current definition contained in 10 CFR 
74.4.
    The proposed rule would expand the definition of ``chain of 
custody'' to indicate that the terms ``chain of custody'' and ``custody 
and control'' are synonymous. This proposed change would be made in 
response to stakeholder requests during the public meetings discussed 
in Section V.
    The definition of ``collection site'' would be modified to include 
a reference to oral fluids as specimens

[[Page 50476]]

that are acceptable for initial alcohol testing. The basis for 
permitting the use of oral fluids for initial alcohol testing is 
discussed with respect to proposed Sec.  26.83(a).
    The proposed rule would replace 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 would no longer include the qualifications 
required for collectors because they would be specified in proposed 
Sec.  26.85 [Collector qualifications and responsibilities].
    The proposed rule would add the term ``contractor/vendor'' (C/V) 
and combine the definitions of ``contractor'' and ``vendor'' in the 
current rule, because the proposed rule would not distinguish between 
the two types of entities.
    The proposed rule would update 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 proposed rule would simplify the definition of 
``licensee testing facility'' by eliminating the reference to 
collecting specimens for alcohol testing in the current definition, 
because alcohol testing typically occurs at a collection site, rather 
than at the licensee testing facility.
    Finally, the proposed rule would eliminate six terms that are 
defined in current Sec.  26.3 and Section 1.2 in Appendix A to Part 26. 
Specifically, the proposed rule would eliminate ``followup testing,'' 
``random test,'' ``suitable inquiry,'' ``reason to believe,'' and 
``split specimen'' because the text of the proposed rule defines them 
in the section where each term is used. The proposed rule would also 
eliminate the term, ``permanent record book,'' in current Section 1.2 
in Appendix A to Part 26 because laboratories now use other mechanisms 
to maintain testing records. Therefore, this term would no longer be 
used in the proposed rule.

Section 26.7 Interpretations

    Proposed Sec.  26.7 [Interpretations] would retain current Sec.  
26.4 [Interpretations] but move the qualifying phrase, ``other than a 
written interpretation by the General Counsel,'' to the end of the 
sentence to improve the clarity of the sentence. This proposed change 
would be made in keeping with the Commission's commitment to using 
plain language in its regulations and to meet Goal 6 of this 
rulemaking, which is to improve clarity in the organization and 
language of the rule, as discussed in Section IV. B.

Section 26.8 Information Collection Requirements: OMB Approval

    Proposed Sec.  26.8 [Information collection requirements: OMB 
approval] would amend current Sec.  26.8 [Information collection 
requirements: OMB approval] to reflect the modified sections of the 
proposed rule in which recordkeeping requirements would be 
incorporated.

Section 26.9 Specific Exemptions

    Proposed Sec.  26.9 [Specific Exemptions] would revise current 
Sec.  26.6 [Exemptions] to include the citation of 10 CFR 50.12 and 
70.17. This proposed change would be made to ensure consistency between 
Part 26 and these related requirements.

Section 26.11 Communications

    Proposed Sec.  26.11 [Communications] would be added to improve 
consistency with similar sections in other parts of 10 CFR and ensure 
that communications with the NRC are addressed and, therefore, 
processed properly.

Subpart B--Program Elements

Section 26.21 Fitness-for-Duty Program

    Proposed Sec.  26.21 [Fitness-for-duty program] would require that 
licensees and other entities who are subject to the rule must 
establish, implement, and maintain FFD programs that comply with the 
applicable requirements of this part. This statement would be added to 
serve as an introduction to the remaining text of the proposed rule, 
consistent with Goal 6 of this rulemaking, which is to improve clarity 
in the organization and language of the rule, as discussed in Section 
IV. B. The term, ``applicable,'' would be included in this sentence 
because not all the requirements in the proposed regulation would apply 
to all the entities listed in proposed Sec.  26.3(a)-(d). For example, 
the requirements in proposed Subpart I [Managing Fatigue] would apply 
only to nuclear power plant licensees and any C/Vs upon whom they rely 
to meet the requirements of this part, as discussed with respect to 
proposed Sec.  26.195 [Applicability]. As another example, the proposed 
rule would retain the current requirement in Sec.  26.2(c), which 
states that nuclear power plant construction permit holders must 
establish a drug and alcohol testing program that includes random 
testing, but would not require these entities to meet the requirements 
of the proposed regulation related to drug and alcohol testing, 
including, but not limited to, proposed Sec.  26.31 [Drug and alcohol 
testing] and proposed Subpart E [Collecting Specimens for Testing].
    The second sentence of the proposed paragraph, which is based on 
current Sec.  26.23(b), would retain permission for licensees and other 
entities to rely upon a C/V's FFD program or program elements to meet 
the requirements of this part, if the C/V's FFD program or program 
element meets the applicable requirements of this part. The other 
requirements contained in current Sec.  26.23 [Contractors and vendors] 
are discussed with respect to proposed Sec.  26.23 [Performance 
objectives].

Section 26.23 Performance Objectives

    Proposed Sec.  26.23 [Performance objectives] would amend current 
Sec.  26.10 [General performance objectives], as follows:
    The proposed rule would amend current Sec.  26.10(a). The proposed 
rule would divide the performance objectives contained in current Sec.  
26.10(a) into two paragraphs (proposed 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.
    Proposed Sec.  26.23(a) would require 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. This level of emphasis is 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. These are the same individuals 
who would be subject to the proposed rule. Because these individuals 
have unimpeded access to sensitive information and safety equipment and 
systems, their trustworthiness and reliability are essential. Substance 
abuse by such individuals presents an unacceptable risk to public 
health and safety and the common defense and security in several ways.
    First, substance abuse increases the likelihood that such 
individuals may pose an insider threat by increasing an individual's 
vulnerability to coercion.

[[Page 50477]]

Under 10 CFR 73.1, 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 such 
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 judgement 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 current rule provide 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 proposed changes to the current rule would provide further 
assurance that individuals who are subject to the rule are trustworthy 
and reliable. Proposed changes to strengthen the effectiveness of the 
rule in assuring individuals' trustworthiness and reliability include, 
but are not limited to:
    (1) Adding requirements for specimen validity testing to identify 
individuals who are willing to attempt to subvert the testing process, 
and so 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 have the types of access and perform the job 
duties listed in proposed Sec.  26.25(a) to any individual who attempts 
to subvert the drug and alcohol testing process.
    The NRC believes that implementation of these provisions of the 
proposed rule, in addition to the other, 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, such that there remains reasonable assurance that 
individuals who are subject to the rule are trustworthy and reliable.
    Proposed Sec.  26.23(b) would retain the performance objective of 
providing reasonable assurance that personnel are fit for duty, which 
appears in current 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 an individual's fitness at any particular moment 
in time may be affected by many different factors. 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 would 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 reasonable assurance that individuals 
are not impaired. Another example of this is with regard to the 
sanctions that the proposed rule would require licensees and other 
entities to impose on individuals who demonstrate questionable 
trustworthiness and reliability compared to the management actions 
licensees would be 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 
proposed rule (under proposed Sec. Sec.  26.75(b) and 26.75(c), 
respectively) would require the licensee or other entity to terminate 
the individual's authorization to have the types of access and perform 
the job duties that are listed in proposed Sec.  26.25 [Individuals 
subject to the fitness-for-duty program]. Terminating the individual's 
authorization would be necessary to provide reasonable assurance that 
the individual could pose no further risk to public health and safety 
or the common defense and security. By contrast, the current and 
proposed rules would 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 and 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 proposed (and current) 
rule (under proposed Sec.  26.77(b)(3) and current Sec.  26.27(b)(1), 
respectively) would require the licensee or other entity to take action 
to prevent the individual from performing the job 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 would 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 once the headache is resolved.
    Another difference between the performance objectives of providing 
``reasonable'' assurance of trustworthiness and reliability and 
``reasonable'' assurance that the

[[Page 50478]]

individuals who are subject to the proposed 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 proposed Sec.  26.75(b) but would be unlikely to take 
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 proposed Sec.  26.77(b)(3).
    Proposed Sec.  26.23(c) would retain the performance objective in 
current Sec.  26.10(b), which is to ``provide reasonable measures for 
the early detection of persons who are not fit to perform activities 
within the scope of this part,'' but would replace the phrase, 
``perform activities within the scope of this part,'' with the phrase, 
``perform the job duties that require them to be subject to this 
part.'' The proposed rule would make this change for clarity in the 
language of the rule. As discussed further with respect to proposed 
Sec.  26.25 [Individuals subject to the fitness-for-duty program], the 
proposed rule would require that certain individuals must be subject to 
an FFD program based on their job duties, which include not only 
performing activities, such as measuring, guarding, or transporting 
Category IA material, but also 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 who was 
tested before the MRO reviews the drug test results. Therefore, the 
phrase, ``perform the job duties that require them to be subject to 
this part,'' would be more accurate. Replacing the current phrase with 
the more accurate phrase would be consistent with Goal 6 of the 
rulemaking, which is to improve clarity in the organization and 
language of the rule, as discussed in Section IV. B.
    Proposed Sec.  26.23(d) would amend current Sec.  26.10(c) to 
require that FFD programs must provide reasonable assurance that the 
workplaces that are subject to this part are free from the presence and 
effects of illegal drugs and alcohol. The proposed rule would revise 
the current 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 proposed rule would 
replace ``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 
would be proscribed. The proposed revision would clarify 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. This proposed change would be made to 
meet Goal 6 of the rulemaking, which is to improve clarity in the 
organization and language of the rule.
    The proposed performance objective would also replace the phrase, 
``have a goal of,'' in the current rule with the phrase, ``provide 
reasonable assurance,'' which more accurately captures the intent of 
this performance objective. The phrase, ``have a goal of,'' would be 
eliminated because proposed Sec.  26.23(d) is a performance objective 
and, therefore, the phrase is unnecessary. This proposed change would 
be made to meet Goal 6 of the rulemaking, which is to improve clarity 
in the organization and language of the rule, without changing the 
intended meaning of the performance objective.
    Proposed Sec.  26.23(e) would be added 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 proposed performance 
objective would be added to specify the objective of the requirements 
concerning worker fatigue that would be added to the proposed rule. 
Worker fatigue cannot be measured or controlled with precision, and 
licensees and other entities do not have direct control over all 
matters that may influence worker fatigue. Therefore, proposed Sec.  
26.23(e) would establish a ``reasonable assurance'' criterion for the 
proposed performance objective. Worker fatigue 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 from 
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, proposed Sec.  26.23(e) would 
establish a performance objective of reasonable assurance that 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 proposed performance 
objective would permit 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 Individuals Subject to the Fitness-for-Duty Program

    Proposed Sec.  26.25 [Individuals subject to the fitness-for-duty 
program] would be added to group together in one section the provisions 
of the proposed rule that specify the individuals who must be subject 
to the FFD program, based on their job duties, and those who would not 
be subject to the FFD program. This proposed change would be made to 
meet Goal 6 of the rulemaking, which is to improve clarity in the 
organization and language of the rule, by grouping related requirements 
together within the rule.
    Proposed Sec.  26.25(a)(1)-(a)(3) would amend the portions of 
current Sec.  26.2(a) and (d) that describe the individuals whose job 
duties require them to be subject to Part 26 by presenting the 
requirements in separate paragraphs. This organizational change would 
be made to make it easier for users to locate these requirements within 
the rule text and to support cross-referencing to these paragraphs from 
other portions of the rule, so that it is unnecessary to repeat the 
relevant list of job duties each time the rule refers to a specific 
group of individuals, as the organization of the current rule has 
required [see, for example, current Sec.  26.27(a)(1), (b)(2), and 
(b)(3)]. This proposed change would be made to meet Goal 6 of the 
rulemaking, which is to improve clarity in the organization and 
language of the rule, as discussed in Section IV. B.
    The proposed rule would add Sec.  26.25(a)(4) to clarify the NRC's 
original

[[Page 50479]]

intent that FFD program personnel must be subject to the FFD program. 
Although current Section 2.3 in Appendix A to Part 26 requires 
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 
proposed change would be made to clarify 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. 
Furthermore, 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 have also been identified as substance 
abusers. Therefore, the proposed revision to current Sec.  26.2(a) 
would fulfill the NRC's original objective and require 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; (2) make determinations of fitness; (3) make authorization 
decisions; (4) are involved in selecting or notifying individuals for 
testing; or (5) are involved in the collection or on-site testing of 
specimens. Although job titles and responsibilities may differ among 
different Part 26 FFD programs, examples of FFD program personnel who 
would be subject to Part 26 under the proposed rule would include, but 
would not be limited to, the following: The FFD program manager under 
proposed Sec.  26.25(a)(4)(i)-(a)(4)(v); the MRO and MRO staff under 
proposed Sec.  26.25(a)(4)(i); the licensee's or other entity's 
reviewing officials under proposed Sec.  26.25(a)(4)(iii); specimen 
collectors under proposed Sec.  26.25(a)(4)(v); SAEs who are under 
contract to or employed by the FFD program under proposed Sec.  
26.25(a)(4)(ii); and licensee testing facility personnel under proposed 
Sec.  26.25(a)(4)(v). In some cases, information technology personnel 
who design and implement software programs for selecting individuals 
for random testing may also be subject to the rule under proposed Sec.  
26.25(a)(4)(iv) if such personnel have knowledge of who will be 
selected for random testing or the ability to affect the selection of 
specific individuals for random testing.
    Proposed Sec.  26.25(b)(1)-(b)(3) would be added to group together 
in one paragraph the proposed rule's provisions that identify 
individuals who would not be subject to the rule. This proposed change 
would be made to meet Goal 6 of the rulemaking, which is to improve 
clarity in the organization and language of the rule.
    A new provision, proposed Sec.  26.25(b)(1), would be added to the 
rule as a result of extensive discussions with industry stakeholders at 
the public meetings mentioned in Section V. Industry stakeholders 
expressed strong concern that the related language in the Affirmed Rule 
(which was also discussed in Section V), which delineated the FFD 
program personnel who must be subject to the 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 off-site 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 other locations 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 (1) the significant logistical difficulties 
involved in ensuring that these individuals are subject to behavioral 
observation and drug and alcohol testing, and (2) excessive costs to 
hire additional MRO(s) to review any non-negative 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.  
26.25(b)(1) to the proposed rule. The proposed paragraph would exclude 
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 would not be subject to the rule under 
the proposed provision may include, but would not be 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 proposed 
paragraph would be excluded from the FFD program because the limited 
nature of their involvement with the FFD program makes it unlikely that 
they would be

[[Page 50480]]

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. 
Therefore, the NRC concurs with the stakeholders that requiring such 
individuals to be subject to the FFD program would be unnecessary.
    However, proposed Sec.  26.25(a)(4) would require MROs and SAEs to 
be subject to Part 26 (see the discussion of proposed 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 non-
negative drug test result is an FFD policy violation (i.e., the MRO 
under proposed Sec.  26.185) and whether an individual is fit to safely 
and competently perform the job 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 and invites 
further comment on these provisions.
    Proposed Sec.  26.25(b)(2) and (3) would retain the first sentence 
of current Sec.  26.2(b) but divide it into two paragraphs. This 
organizational change would be made to make 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 second sentence 
of current Sec.  26.2(b) would be moved to proposed Sec.  26.3(e) 
rather than retained in this paragraph because it addresses entities 
who would not be subject to the rule, rather than individuals. The 
proposed changes would be made to meet Goal 6 of the rulemaking, which 
is to improve clarity in the organization and language of the rule, as 
discussed in Section IV. B.
    Proposed Sec.  26.25(c) would be added to provide that persons who 
are covered by a program regulated by another Federal or State agency 
that meets the performance objectives of Part 26 need not also be 
covered by 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 Department of 
Transportation's (DOT) drug and alcohol testing requirements [49 CFR 
Part 40--65 FR 41944, August 9; 2001]. This proposed revision would 
reduce 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 would continue 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 would not be 
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 job 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.
    Proposed Sec.  26.25(c)(1)-(c)(6) would list the necessary 
characteristics of an alternative Federal or State program that, under 
the proposed rule, licensees and other entities could rely upon to 
satisfy the requirements of this part for an individual who is subject 
both to Part 26 and an alternative program. Proposed Sec.  26.25(c)(1) 
and (3) would permit licensees and other entities to rely on the 
alternative program to meet the proposed rule's drug testing 
requirements if the alternative program tests for the drugs and drug 
metabolites that are specified in the proposed rule at or below the 
cutoff levels established in the proposed rule and an HHS-certified 
laboratory conducts the program's specimen validity and drug testing. 
Similarly, proposed Sec.  26.25(c)(2) would permit licensees and other 
entities to rely on the alternative program to meet the proposed rule's 
alcohol testing requirements if the alternative program's alcohol 
testing procedures and devices meet the proposed rule's requirements 
and the alternative program uses cutoff levels that are at least as 
stringent as those specified in proposed Sec.  26.103(a). Proposed 
Sec.  26.25(c)(4) would permit the licensee or other entity to rely on 
an alternative program's FFD training if that training addresses the 
knowledge and abilities listed in proposed Sec.  26.29(a)(1)-(a)(10). 
Proposed Sec.  26.25(c)(5) would permit licensees and other entities to 
rely on the alternative program to meet the proposed rule's 
requirements for an impartial and objective procedure for the review 
and reversal of any findings of an FFD violation if the alternative 
program provides such a procedure. And, finally, if the licensee or 
other entity relies on the alternative program, proposed Sec.  
26.25(c)(6) would require the licensee or other entity to ensure that 
the alternative program would inform the licensee or other entity of 
any FFD violations.
    These proposed provisions would be consistent with the current and 
proposed 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 proposed 
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, would fulfill the rule's 
performance objectives and improve Part 26 by eliminating or modifying 
unnecessary requirements, which is Goal 5 of this rulemaking, as 
discussed in Section IV. B. However, an important difference between 
the proposed rule's permission for licensees and other entities to rely 
on the programs of other Federal and State agencies, compared to the 
proposed rule's permission for licensees and other entities to rely on 
C/V programs, is that the proposed rule would not require licensees and 
other entities to audit the alternate Federal and State programs under 
proposed Sec.  26.41 [Audits and corrective action]. Auditing Federal 
and State programs would be 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 would be in keeping with Goal 5 of this 
rulemaking.
    Proposed Sec.  26.25(d) would be added to clarify that individuals 
who have applied for authorization to perform job duties that would 
require them to be subject to Part 26 would also be subject to some 
provisions of the proposed rule. The current Part 26 requires an 
applicant for authorization to provide a written statement related to 
his or her past activities under this part in current Sec.  
26.27(a)(1); provide permission to the

[[Page 50481]]

licensee to conduct a suitable inquiry in current Sec.  26.27(a)(2); 
and submit to pre-access testing in current Sec.  26.24(a)(1). The 
proposed rule would impose similar requirements on applicants and add 
others, such as random testing during the short time period that falls 
between when a licensee or other entity collects specimens for a pre-
access test and then grants authorization to the individual. Therefore, 
proposed Sec.  26.25(d) would ensure the internal consistency of the 
proposed rule and would meet Goal 6 of this rulemaking, which is to 
improve clarity in the organization and language of the rule.

Section 26.27 Written Policy and Procedures

    Proposed Sec.  26.27 [Written policy and procedures] would 
reorganize and amend current Sec.  26.20 [Written policy and 
procedures]. The proposed rule would reorganize the current section to 
divide into separate paragraphs the requirements related to the FFD 
policy and those related to FFD program procedures that are intermixed 
within the current section. The proposed organizational change would be 
made so that the requirements related to the FFD policy and procedures 
would be easier to locate within this section, consistent with Goal 6 
of this rulemaking, which is to improve clarity in the organization and 
language of the rule, as discussed in Section IV. B.
    Proposed Sec.  26.27(a) [General] would amend the first paragraph 
of current Sec.  26.20, which requires 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 proposed 
rule would replace the term, ``licensee,'' in the current rule with the 
phrase, ``licensees and other entities,'' because entities other than 
licensees would be subject to this requirement, as discussed with 
respect to proposed Sec.  26.3 [Scope]. The term, ``maintain,'' would 
be added to the current 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 proposed rule 
would replace ``specific'' with the term, ``applicable,'' in the 
proposed sentence because all the requirements in Part 26 would not 
apply to all the licensees and other entities who would be subject to 
the rule, as discussed with respect to proposed Sec.  26.3 [Scope]. The 
proposed rule would also eliminate ``designed to'' from this sentence 
because it is unnecessary. The records retention requirements contained 
in the second sentence of the current paragraph would be moved to 
proposed Sec.  26.213(d) in Subpart J [Recordkeeping and Reporting 
Requirements], which groups together the recordkeeping and reporting 
requirements that are interspersed throughout the current rule. These 
proposed changes to the organization and language of current Sec.  
26.27 would be made to meet Goal 6 of this rulemaking, which is to 
improve clarity in the organization and language of the rule, as 
discussed in Section IV. B.
    Proposed Sec.  26.27(b) [Policy] would amend current Sec.  
26.20(a), which establishes requirements for the written FFD policy. 
The proposed rule would expand the list of topics that the FFD policy 
must address. The list of topics to be addressed by the FFD policy 
would be expanded as a result of discussions with stakeholders during 
the public meetings described in Section V. Stakeholders noted that the 
list of topics in the current 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 proposed rule would add topics to the policy content 
requirements in current Sec.  26.20(a) to ensure that FFD policies will 
be complete. This proposed change would be made to meet Goal 7 of this 
rulemaking, as it relates to protecting the due process rights of 
individuals who are subject to Part 26, as discussed in Section IV. B.
    Proposed Sec.  26.27(b) would also add 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 current 
nor proposed 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 non-negative 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 the proposed rule, the 
written FFD policy would continue to be the primary means by which a 
licensee or other entity would communicate 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 proposed rule would add 
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. This proposed change 
would be made to meet Goal 7 of this rulemaking, as it relates to 
protecting the due process rights of individuals who are subject to 
Part 26.
    The proposed rule would also add 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. These examples would 
be added at the request of stakeholders during the public meetings 
discussed in Section V, and would meet Goal 6 of this rulemaking, which 
is to improve clarity in the organization and language of the rule.
    Proposed Sec.  26.27(b)(1) would amend the second sentence of 
current Sec.  26.20(a), which requires that ``the policy must address 
the use of illegal drugs and abuse of legal drugs (e.g., alcohol, 
prescription and over-the-counter drugs).'' Proposed Sec.  26.27(b)(1) 
would expand this sentence to require the FFD policy to describe the 
consequences of on-site or off-site use, sale, or possession of illegal 
drugs in proposed Sec.  26.27(b)(i); the abuse of legal drugs and 
alcohol in proposed Sec.  26.27(b)(ii); and the misuse of prescription 
and over-the-counter drugs in proposed Sec.  26.27(b)(iii). The 
proposed rule would replace the phrase, ``must address,'' in the 
current sentence with the phrase, ``must describe the consequences 
of,'' because stakeholders noted that ``must address'' is vague during 
the public meetings discussed in Section V. The phrase, ``must describe 
the consequences of,'' would clarify 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. These proposed changes would 
be made to meet Goal 6 of this rulemaking, which is to improve clarity 
in the organization and language of the rule, as discussed in Section 
IV. B.
    The proposed rule would add a new Sec.  26.27(b)(2), which would 
require the FFD policy to state the time period

[[Page 50482]]

within which individuals must report to the collection site after being 
notified that they have been selected for random testing, as specified 
by the licensee or other entity. The proposed regulation would not 
establish a time limit because there are a variety of circumstances 
among the different 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 would be 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. Further, 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 due to metabolism, with the result that 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 proposed rule would require 
licensees and other entities to establish a time limit within which 
individuals must report for random testing after they have been 
notified to improve the effectiveness of FFD programs, consistent with 
Goal 3 of this rulemaking. The proposed rule would also require 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. This proposed change would be made to meet Goal 7 of this 
rulemaking, as it relates to protecting the due process rights of 
individuals who are subject to Part 26.
    Proposed Sec.  26.27(b)(3) would be added to require the FFD policy 
to inform individuals of the consequences of refusing to be tested and 
attempting to subvert the testing process. This provision would be 
added to ensure that persons who are subject to the rule are aware of 
proposed Sec.  26.75(b), which would require licensees and other 
entities to impose the sanction of permanent denial of authorization 
for these actions. Proposed Sec.  26.27(b)(3) would be added to protect 
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 would meet Goal 7 of this 
rulemaking with respect to protecting the due process rights of 
individuals who are subject to Part 26, as discussed in Section IV. B.
    Proposed Sec.  26.27(b)(4)(i) would amend current Sec.  
26.20(a)(1), which requires the FFD policy to prohibit the consumption 
of alcohol within an abstinence period of at least 5 hours preceding 
``any scheduled working tour.'' The proposed rule would replace 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 current rule at 
the public meetings discussed in Section V. The stakeholders commented 
that the current phrase lacks 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 
language of the proposed rule would be revised to clarify 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 proposed Sec.  26.27(c)(3). This 
proposed change would be made to meet Goal 6 of this rulemaking, which 
is to improve clarity in the organization and language of the rule, as 
discussed in Section IV.B.
    Proposed Sec.  26.27(b)(4)(ii) would retain current Sec.  
26.20(a)(2).
    Proposed Sec.  26.27(b)(5) would be added to require the FFD policy 
to inform individuals that abstinence from alcohol during the 5 hours 
preceding arrival at a licensee's or other entity's site, as required 
in proposed Sec.  26.27(b)(4), 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 proposed Sec.  26.103 when they 
arrive at the licensee's or other entity's facility, depending upon the 
amount of alcohol and food that the individual consumed before the 
abstinence period began, body weight, and other factors. This proposed 
paragraph would be added to meet Goal 7 of this rulemaking with respect 
to protecting the due process rights of individuals who are subject to 
alcohol testing under Part 26 by ensuring that they are aware that the 
required 5-hour abstinence period may be insufficient to assure they 
have a BAC below the cutoff levels in this part when arriving for work.
    Proposed Sec.  26.27(b)(6) would amend the last sentence of current 
Sec.  26.20(a), which requires 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 
proposed provision would add 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 re-assigned to job 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 proposed rule 
would require 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 due 
process rights of individuals who are subject to the policy. The 
addition of this requirement would also increase the internal 
consistency of the rule because other portions of the proposed (and 
current) rule establish requirements related to using prescription and 
over-the-counter medications, including, for example, proposed Sec.  
26.29(a)(6), which would require FFD training to address this topic, 
and proposed Sec.  26.183(j)(2), which would require the MRO to 
determine whether a non-negative confirmatory drug test result that is 
due to using a prescription or over-the-counter medication represents 
substance abuse. Therefore, the proposed requirement for the FFD policy 
to address the use of prescription and over-the-counter medications 
that

[[Page 50483]]

could cause impairment at work would also meet Goal 6 of this 
rulemaking, which is to improve clarity in the organization and 
language of the rule.
    Proposed Sec.  26.27(b)(7) would amend current Sec.  26.20(b), 
which requires 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 job 
duties. Proposed Sec.  26.27(b)(7) would add 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, which 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 the 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 due to sleepiness 
(National Sleep Foundation, 2000). Proposed Sec.  26.27(b)(7) would 
ensure that individuals are aware of the services that are available 
for diagnosing and treating sleep disorders that can adversely affect 
their job performance. This proposed change would be made to meet Goal 
2 of this rulemaking, which is 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 proposed rule would replace the phrase, ``adversely 
affect the performance of activities within the scope of this part,'' 
in the current provision with the phrase, ``could adversely affect an 
individual's ability to safely and competently perform the job duties 
that require an individual to be subject to this part,'' for the 
reasons discussed with respect to proposed Sec.  26.23(c).
    Proposed Sec.  26.27(b)(8) would retain the requirement in current 
Sec.  26.20(d) that the FFD policy must specify the consequences of 
violating the policy. The current requirements in this paragraph that 
are related to the procedures that the licensee or other entity would 
implement if an individual violates the FFD policy would be moved to 
proposed Sec.  26.27(c) [Procedures], which addresses FFD program 
procedures for organizational clarity.
    Proposed Sec.  26.27(b)(9) would add a requirement for licensees' 
and other entities' FFD policies to describe the individual's 
responsibility to report legal actions, as defined in proposed Sec.  
26.5 [Definitions]. The new requirement to report legal actions is 
discussed with respect to proposed Sec.  26.61 [Self-disclosure and 
employment history]. However, the proposed rule would require the FFD 
policy to address the reporting of legal actions to ensure that 
individuals are aware of it and are not at risk of being subject to 
sanctions for failing to report any legal actions. This proposed change 
would be made to meet Goal 7 of this rulemaking with respect to 
protecting the due process rights of individuals who are subject to the 
policy, as discussed in Section IV.B.
    Proposed Sec.  26.27(b)(10) would add a requirement for the FFD 
policy to describe the responsibilities of managers, supervisors, and 
escorts to report FFD concerns. The current rule implies that managers 
and supervisors have the responsibility to report FFD concerns in Sec.  
26.22(a)(5), which requires managers and supervisors to be trained in 
procedures ``for initiating appropriate corrective action.'' Similarly, 
the last phrase of Sec.  26.22(b) requires that escorts be trained in 
procedures ``for reporting problems to supervisory or security 
personnel,'' and, therefore, also implies that escorts have a reporting 
responsibility. However, the current rule does not explicitly state 
that the FFD policy must convey this requirement. Therefore, the 
proposed rule would add Sec.  26.27(b)(10) to enhance the internal 
consistency of the rule. This proposed change would be made to meet 
Goal 6 of this rulemaking, which is to improve clarity in the 
organization and language of the rule.
    Proposed Sec.  26.27(b)(11) would add a requirement for the FFD 
policy to state that individuals who are subject to the rule must 
report FFD concerns. The proposed provision would be added for 
consistency with proposed Sec.  26.33 [Behavioral observation], which 
would require 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. Proposed 
Sec.  26.29 [Training] would establish a requirement for all 
individuals who are subject to the rule to be trained in behavioral 
observation. As a group, these proposed requirements would be added to 
enhance the effectiveness of Part 26 in assuring the early detection of 
individuals who are not fit to perform the job duties that require them 
to be subject to this part, which is one of the performance objectives 
that FFD programs must meet, as discussed with respect to current Sec.  
26.10(b) and proposed Sec.  26.23(c). The proposed provision would also 
be added 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, as 
discussed in Section IV.B. The specific requirement for licensees' and 
other entities' FFD policies to state that individuals must report FFD 
concerns in proposed Sec.  26.27(b)(11) would be 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 with respect to protecting the due process rights of 
individuals who are subject to the policy, as discussed in Section 
IV.B.
    Proposed Sec.  26.27(c) [Procedures] would combine the requirements 
related to procedures contained in current Sec.  26.20(c)-(e), and 
would add other requirements, as follows:
    Proposed Sec.  26.27(c)(1) would retain the requirements in current 
Sec.  26.20(c). The phrase, ``privacy and due process rights of an 
individual,'' would be added to clarify the requirement for 
``protecting the employee,'' contained in current Sec.  26.20(c). For 
example, individuals' privacy rights under the proposed 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. Examples of individuals' rights to 
due process under the proposed 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 non-negative test result. This proposed change would be 
made to meet Goal 6 of this rulemaking, which is to improve clarity in 
the organization and language of the rule.

[[Page 50484]]

    Proposed Sec.  26.27(c)(2)(i) and (c)(2)(ii) would divide current 
Sec.  26.20(d) into separate paragraphs that address different topics. 
Proposed Sec.  26.27(c)(2)(i) would retain the requirement for 
licensees and other entities to 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. Proposed Sec.  26.27(c)(2)(ii) would continue to require 
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 pre-work abstinence 
period, during the mandatory pre-work abstinence period, or while on 
duty, as determined by a test that measures BAC. The proposed rule 
would divide the current paragraph into two paragraphs to meet Goal 6 
of this rulemaking, which is to improve clarity in the organization and 
language of the rule.
    Proposed Sec.  26.27(c)(2)(iii) and (c)(2)(iv) would require that 
licensees and other entities who are subject to the rule must prepare 
written procedures for implementing the FFD program that address 
followup actions for attempted subversion of the testing process. 
Proposed Sec.  26.27(c)(2)(iii) would require 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. Proposed Sec.  
26.27(c)(2)(iv) would require procedures to address the actions to be 
taken if an individual has refused to provide a specimen for testing. 
The proposed rule would add these provisions for consistency with 
proposed Sec.  26.75(b), which would require licensees and other 
entities to terminate an individual's authorization and, thereafter, 
permanently deny authorization to any individual who has committed any 
act or attempted 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 this 
part. Adding the proposed requirements for procedures to address these 
circumstances would meet Goal 6 of this rulemaking, which is to improve 
clarity in the organization and language of the rule.
    Proposed Sec.  26.27(c)(2)(v) would require that the written 
procedures must address immediate and followup actions for individuals 
who have had drug- or alcohol-related legal actions taken against them, 
as defined in proposed Sec.  26.5 [Definitions]. The proposed paragraph 
would support related provisions in proposed Sec.  26.69(d) 
[Maintaining authorization with other potentially disqualifying FFD 
information], which, in general, require 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 job duties that require them to be subject 
to this part. Adding the proposed requirement for procedures to address 
these circumstances would meet Goal 6 of this rulemaking, which is to 
improve clarity in the organization and language of the rule, and 
ensure the internal consistency of the proposed rule.
    Proposed Sec.  26.27(c)(3) would amend current Sec.  26.20(e). The 
proposed paragraph would continue to require 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 proposed 
paragraph would also retain the requirement in the last sentence of 
current Sec.  26.20(e)(3) that consumption of alcohol within the 5-hour 
pre-duty abstinence period may not by itself preclude a licensee or 
other entity from using individuals who are needed to respond to an 
emergency. However, this sentence would be moved from the end of the 
last sentence in the current paragraph to the introductory paragraph of 
proposed Sec.  26.27(c)(3) because it applies generally to the topic of 
this proposed paragraph, rather than only to the topic addressed in 
current Sec.  26.20(e)(3). This proposed change would be made to meet 
Goal 6 of this rulemaking, which is to improve clarity in the 
organization and language of the rule, as discussed in Section IV. B.
    The proposed rule also would retain the other requirements of 
current Sec.  26.20(e), as follows: Proposed Sec.  26.27(c)(3)(i) would 
retain current Sec.  26.20(e)(1), which 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. Proposed Sec.  
26.27(c)(3)(ii)(A) and (c)(3)(ii)(B) would retain current Sec.  
26.20(e)(2) and the first sentence of current Sec.  26.20(e)(3), which 
require that an individual who reports that he or she has used alcohol 
and is called in must be subject to alcohol testing, and that the 
licensee or other entity must establish controls and conditions under 
which an individual who has consumed alcohol may perform work safely.
    The proposed rule would also add a requirement to proposed Sec.  
26.27(c)(3)(i) and (c)(3)(iii). The proposed rule would require an 
individual who is called in 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. The proposed rule would add this 
requirement to recognize that there are conditions other than the 
consumption of alcohol that 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]). 
Therefore, requiring individuals to report other conditions that may 
cause them to be impaired when called in to perform an unscheduled 
working tour, under proposed Sec.  26.27(c)(3)(i), would strengthen 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 
proposed Sec.  26.27(c)(3)(iii). These proposed changes would be made 
to meet Goal 3 of this rulemaking, which is improve the effectiveness 
and efficiency of FFD programs.
    Proposed Sec.  26.27(c)(3)(ii)(C) would be added to clarify that 
licensees and other entities may not impose sanctions if an individual 
is called in for an unscheduled working tour and has consumed alcohol 
during the pre-duty abstinence period specified in the FFD policy. 
During the public meetings discussed in Section V, the stakeholders 
requested this clarification to ensure 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 concurs with this recommendation because sanctions 
for the consumption of alcohol in these circumstances would be 
inappropriate, given that the individual would have been unaware that 
he or she would be called in to work. The proposed revision also would 
be consistent with the original intent of the rule. Therefore, the 
proposed change would be made to meet Goal 6 of this rulemaking, which 
is to improve clarity in the organization and language of the rule.
    Proposed Sec.  26.27(c)(4) would be added to require that FFD 
procedures must describe the process to be followed when another 
individual's behavior

[[Page 50485]]

raises an FFD concern and for reporting the concern. As discussed with 
respect to proposed Sec.  26.27(b)(11), this proposed paragraph would 
be added for consistency with proposed Sec.  26.33 [Behavioral 
observation], which would establish a new requirement that all 
individuals who are subject to the rule must perform behavioral 
observation and report any FFD concerns, and proposed Sec.  26.29 
[Training], which requires that individuals who are subject to this 
part must be trained to perform behavioral observation. The proposed 
requirement would be added to meet Goal 3 of this rulemaking, which is 
to improve the effectiveness and efficiency of FFD programs, and Goal 
4, which is 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.
    Proposed Sec.  26.27(d) would retain the requirements of current 
Sec.  26.20(f).

Section 26.29 Training

    Proposed Sec.  26.29 [Training] would combine and amend current 
Sec.  26.21 [Policy communications and awareness training] and Sec.  
26.22 [Training of supervisors and escorts]. The proposed section would 
require that all individuals who are subject to the rule must receive 
the same training, to include, for example, behavioral observation, 
whereas current Sec.  26.22 requires that only supervisors and escorts 
must receive behavioral observation training. Increasing the number of 
individuals who are trained in behavioral observation would enhance the 
effectiveness of FFD programs by increasing the likelihood of detecting 
potential impairment, consistent with Goal 3 of this rulemaking, as 
discussed in Section IV.B.
    Proposed Sec.  26.29(a) [Training content] would combine the 
training topics listed in current Sec. Sec.  26.21(a)(1)-(a)(5), 
26.22(a)(1)-(a)(5), and 26.22(b). The required training topics would be 
rewritten in terms of knowledge and abilities (KAs) to be consistent 
with terminology used by licensees and other entities in other required 
training programs to meet Goal 6 of this rulemaking, which is to 
improve clarity in the organization and language of the rule.
    Proposed Sec.  26.29(a)(1) would combine current Sec.  26.21(a)(1) 
with the latter portion of current Sec.  26.21(a)(5). Consistent with 
the current training requirements, the proposed paragraph would require 
licensees and other entities to ensure that individuals who are subject 
to the FFD policy 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.
    Proposed Sec.  26.29(a)(2) would retain the requirement in current 
Sec.  26.22(a)(1) that licensees and other entities who are subject to 
the rule 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.
    Proposed Sec.  26.29(a)(3) would amend the terminology used in 
current Sec.  26.22(a)(2), which requires FFD training to address the 
roles and responsibilities of others, such as the personnel, medical, 
and employee assistance program (EAP) staffs. The proposed paragraph 
would replace the references to the ``personnel'' function and 
``medical'' staff in current Sec.  26.22(a)(2) with ``human resources'' 
and ``FFD'' staff, respectively. The proposed rule would also move the 
reference to the MRO into this paragraph from current Sec.  
26.21(a)(3). These proposed changes would be made to update the 
terminology in this paragraph to be consistent with other terms used 
throughout the regulation to meet Goal 6 of this rulemaking, which is 
to improve clarity in the organization and language of the rule.
    Proposed Sec.  26.29(a)(4) and (a)(5) would amend current Sec.  
26.21(a)(4) and (a)(2), respectively, by changing some of the language 
used in the current provisions. Current Sec.  26.29(a)(4) requires FFD 
training to inform individuals who are subject to the rule of any EAPs 
that are available to them. The proposed rule would eliminate the 
reference to EAPs ``provided by the licensee'' in the current provision 
and amend it as ``EAP services available to the individual'' because 
there are other entities who would be subject to this requirement under 
the proposed rule. Proposed Sec.  26.29(a)(5) would amend current 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. These proposed 
changes would be made to meet Goal 6 of this rulemaking, which is to 
improve clarity in the language of the rule.
    Proposed Sec.  26.29(a)(6) would retain the portion of current 
Sec.  26.21(a)(3) which requires licensees to ensure that individuals 
understand the effects of prescription and over-the-counter drugs and 
dietary factors on job performance. The proposed rule would add a 
requirement for FFD training to address the effects of 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 requirement in the last 
sentence of current Sec.  26.20(a) for the FFD policy to address these 
factors would be moved to proposed Sec.  26.27(b)(6) because proposed 
Sec.  26.27(b) would address FFD policy requirements. These proposed 
changes would be made to meet Goal 6 of this rulemaking, which is to 
improve clarity in the organization and language of the rule.
    Proposed Sec.  26.29(a)(7) would retain the portion of current 
Sec.  26.21(a)(3) that requires 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.
    Proposed Sec.  26.29(a)(8) and (a)(9) would retain the requirements 
in current Sec.  26.22(a)(3) and (a)(4), respectively.
    Proposed Sec.  26.29(a)(10) would amend current Sec.  26.22(a)(5). 
The proposed provision would retain the current 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, to include referral to the EAP. The 
proposed rule would add a requirement for FFD training to ensure that 
individuals understand their responsibility to report FFD concerns to 
the person(s) who are designated in FFD program procedures to receive 
such reports. This proposed change would be made for consistency with 
proposed Sec.  26.33 [Behavioral observation], which would require 
individuals to perform behavioral observation and report any FFD 
concerns, as discussed with respect to proposed Sec.  26.27(b)(11), and 
proposed Sec.  26.27(c)(4), which would require procedures for 
implementing the requirement. This group of inter-related proposed 
requirements would be added to meet Goal 3 of this rulemaking, which is 
to improve the effectiveness and efficiency of FFD programs, and Goal 4 
of this rulemaking, which is to improve consistency between FFD

[[Page 50486]]

requirements and access authorization requirements established in 10 
CFR 73.56, as supplemented by orders to nuclear power plant licensees 
dated January 7, 2003.
    A new Sec.  26.29(b) [Comprehensive examination] would require that 
individuals who are subject to the FFD program must demonstrate 
attainment of the KAs specified in proposed Sec.  26.29(a) by passing a 
comprehensive examination. This new requirement would be added because 
there have been several instances since Part 26 was first promulgated 
in which 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 so 
could not be expected to comply with the requirements of the policy. 
Therefore, the proposed rule would require individuals to demonstrate 
their attainment of the KAs listed in proposed Sec.  26.29(a) to ensure 
that the FFD training has been effective. The proposed rule would also 
require remedial training for those who fail to achieve a passing score 
on the examination. Proposed Sec.  26.29(b) would require the 
examination to include at least one question for each KA, and establish 
a minimum passing score of 80 percent. These proposed requirements 
would be 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. The proposed 
paragraph would be added to meet the portion of Goal 3 of this 
rulemaking that relates to improving the effectiveness of FFD programs 
by establishing a method to ensure that individuals understand the 
requirements with which they must comply.
    The proposed paragraph also would permit 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 would meet the portion of Goal 3 of this rulemaking that 
relates to improving the efficiency of FFD programs. The proposed 
permission would also meet Goal 5, which is to improve Part 26 by 
eliminating or modifying unnecessary requirements, by providing 
flexibility in the methods that licensees and other entities may use to 
administer the required examination.
    Proposed Sec.  26.29(c) [Training administration] would combine and 
amend the portions of current Sec.  26.21(b) and Sec.  26.22(c) that 
require FFD training for individuals, supervisors, and escorts before 
they are permitted to perform duties that require them to be subject to 
this part.
    Proposed Sec.  26.29(c)(1) would require that all personnel who are 
subject to this part must complete FFD training before the licensee or 
other entity grants initial authorization to the individual, as defined 
in proposed Sec.  26.55 [Initial authorization]. The proposed rule 
would also require 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 proposed Sec.  26.57 
[Authorization update] and Sec.  26.59 [Authorization reinstatement], 
respectively. The proposed paragraph also would eliminate the 
requirement to upgrade training for newly assigned supervisors within 3 
months of a supervisory assignment in current Sec.  26.22(c), because 
all personnel would receive the same training and be required to 
complete the training before a licensee or other entity grants 
authorization to any individual. The proposed changes would be made for 
consistency with the new requirements related to granting and 
maintaining authorization that would be established in proposed Subpart 
C [Granting and Maintaining Authorization], as discussed with respect 
to that subpart.
    Proposed Sec.  26.29(c)(2) would retain but combine the 
requirements for annual refresher training in current Sec.  26.21(b), 
which addresses individuals who are subject to this part, and Sec.  
26.22(c), which addresses supervisors and escorts. The current 
requirements would be combined because all personnel would receive the 
same training under the proposed rule. The proposed paragraph would 
also permit individuals who pass a comprehensive ``challenge'' 
examination that demonstrates their continued understanding of the FFD 
program requirements to be excused from the refresher training that 
would otherwise be required under the proposed paragraph. The challenge 
examination would be required to meet the examination requirements 
specified in proposed Sec.  26.29(b) [Comprehensive examination] and 
individuals who did not pass would undergo remedial training. 
Permitting individuals to pass a comprehension examination rather than 
take refresher training each year would ensure that they are retaining 
their FFD knowledge and abilities while reducing some costs associated 
with meeting the annual refresher training requirement. Therefore, this 
proposed change would meet Goal 5 of this rulemaking, which is to 
improve Part 26 by eliminating or modifying unnecessary requirements.
    Proposed Sec.  26.29(c)(3) would permit 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 proposed Sec.  
26.29(b) [Comprehensive examination] that would permit licensees and 
other entities to use various media to administer the comprehensive 
examination. The proposed requirements for a licensee or other entity 
to monitor the completion of training and provide access to an 
instructor or subject matter expert should ensure that individuals who 
are trained using different media would achieve the same understanding 
as persons who are trained in a classroom setting with an instructor 
present. This proposed flexibility may reduce the costs associated with 
presenting initial and refresher training only in a classroom setting. 
Therefore, this proposed change would meet Goal 5 of this rulemaking, 
which is to improve Part 26 by eliminating or modifying unnecessary 
requirements.
    To meet the annual refresher training requirement for individuals, 
proposed Sec.  26.29(d) [Acceptance of training] would permit licensees 
and other entities to accept FFD training that was provided by other 
licensees and entities who are subject to the rule. Licensees and other 
entities would also be permitted to accept a passing result from a 
comprehensive examination that was administered by another Part 26 FFD 
program in lieu of refresher training, if the examination meets the 
requirements of proposed Sec.  26.29(b) [Comprehensive examination]. 
Proposed Sec.  26.29(c)(4) would incorporate item 3.3 of NUREG-1385, 
``Fitness for Duty in the Nuclear Power Industry: Responses to 
Implementation Questions,'' which recommends acceptance of prior 
training. The proposed provision would also meet Goal 4 of this 
rulemaking, which is 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 access authorization requirements also permit licensees 
and other entities to rely on training and examinations administered by 
other Part 26 programs.

[[Page 50487]]

Section 26.31 Drug and Alcohol Testing

    Proposed Sec.  26.31 [Drug and alcohol testing] would rename 
current Sec.  26.24 [Chemical and alcohol testing]. The proposed rule, 
in general, would replace the phrase, ``chemical testing,'' with the 
term, ``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. This proposed change would 
be made to meet Goal 6 of this rulemaking, which is to improve clarity 
in the organization and language of the rule.
    Proposed Sec.  26.31(a) [General] would retain but update the 
language in current Sec.  26.24(a) to be consistent with the new 
terminology used throughout the rule, as discussed in proposed Sec.  
26.5 [Definitions]. For example, the proposed rule would replace 
``licensee'' with ``licensees and other entities'' to refer to the 
entities who are subject to the rule. This proposed change would be 
made to meet Goal 6 of this rulemaking, which is to improve clarity in 
the language of the rule.
    Proposed Sec.  26.31(b) [Assuring the honesty and integrity of FFD 
program personnel] would amend current Section 2.3 in Appendix A to 
Part 26, as explained below.
    Proposed Sec.  26.31(b)(1) would amend the first paragraph of 
current Section 2.3 in Appendix A to Part 26, which requires licensees 
to carefully select and monitor persons responsible for administering 
the testing program to assure they meet the highest standards of 
honesty and integrity. The proposed rule would replace the current list 
of individuals who would be subject to this requirement with a cross-
reference to Sec.  26.25(a)(4) of the proposed rule, which specifies, 
in detail, the FFD program personnel who must be subject to the FFD 
program. This cross-reference would be added to avoid repeating the 
list of personnel in this paragraph.
    The proposed paragraph would also add 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 would not be limited to, 
a substance abuse problem [as discussed with respect to proposed Sec.  
26.25(a)(4)] or financial problems. Therefore, the proposed rule would 
add 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 proposed changes would be made 
to meet Goal 6 of this rulemaking, which is to improve clarity in the 
language of the rule.
    Proposed Sec.  26.31(b)(1)(i) would amend current Section 2.3(2) in 
Appendix A to Part 26 in response to implementation questions regarding 
the current requirements that the NRC staff has received since Part 26 
was first promulgated as well as discussions with stakeholders during 
the public meetings discussed in Section V. In response to numerous 
questions from licensees, the proposed paragraph would clarify 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 proposed rule would retain the term, ``appropriate,'' in 
the current rule for two reasons. First, it would be used to indicate 
that, for FFD program personnel who are employed by entities who are 
subject to the rule but are not nuclear power plants, the requirements 
may be met through investigations, checks, and evaluations that provide 
the information needed to determine the honesty and integrity of FFD 
program personnel but may differ from those required under nuclear 
power plant access authorization programs. In addition, the proposed 
rule would retain 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,'' would be 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. These proposed changes would be made to meet the portion of 
Goal 6 of this rulemaking that pertains to improving clarity in the 
language of the rule.
    The requirement in current Section 2.3(2) in Appendix A to Part 26 
for ``appropriate background checks and psychological evaluations'' to 
be ``conducted at least once every three years'' would be relaxed to 
require that credit and criminal history checks and updated 
psychological assessments be conducted nominally every 5 years. The 
proposed rule would relax the current 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 proposed 
rule would retain the current requirement for updated background checks 
and psychological assessments but would reduce the required frequency 
of these updates from every 3 years to every 5 years. This proposed 
change would be made to meet Goal 5 of this rulemaking, which is to 
improve Part 26 by eliminating or modifying unnecessary requirements. 
In addition, the proposed frequency for these updates would increase 
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.
    Proposed Sec.  26.31(b)(1)(ii) would amend current Section 2.3(1) 
in Appendix A to Part 26 for clarification in response to the many 
implementation questions that have arisen since the regulation was 
published. In the current rule, individuals who have a personal 
relationship with the individual being tested (i.e., a donor), such as 
the donor's ``supervisors, coworkers, and relatives,'' are prohibited 
from performing any ``collection, assessment, or evaluation 
procedures'' involving the individual being tested. The restriction on 
``supervisors, coworkers, and relatives'' was included in the current 
rule to provide examples of the ``personal relationships'' referenced 
in the introductory paragraph of current Section 2.3 in Appendix A to 
Part 26. The restriction on coworkers in the current rule has been 
misinterpreted by some licensees as meaning that no one

[[Page 50488]]

who is an employee of the same corporation may be involved in 
collection, assessment, or evaluation procedures. However, in a large 
corporation, there will be many individuals who are employed by the 
same corporation who do not have personal relationships with FFD 
program personnel, specifically, or with other individuals who are 
subject to testing, in general. Therefore, in proposed Sec.  
26.31(b)(1)(ii), the phrase, ``in the same work group,'' would be added 
to clarify that the example regarding coworkers pertains to individuals 
who report to the same manager. For example, FFD program personnel 
report to the FFD program manager and so would be considered 
``coworkers in the same work group'' to whom the proposed restriction 
would apply. In addition, the proposed paragraph would add a reference 
to determinations of fitness (discussed with respect to proposed Sec.  
26.189 [Determination of fitness]) to provide a clarifying example of 
the assessment and evaluation procedures that FFD program personnel 
would be prohibited from performing if the FFD program staff member has 
a personal relationship with the subject individual. These proposed 
changes would be made to meet Goal 6 of this rulemaking, which is to 
improve clarity in the organization and language of the rule.
    Proposed Sec.  26.31(b)(1)(iii) would relax the prohibition on 
individuals who have ``personal relationships'' with the donor from 
performing specimen collection procedures in current Section 2.3(1) in 
Appendix A to Part 26 in response to stakeholder requests during the 
public meetings discussed in Section V. With respect to specimen 
collections, stakeholders were convincing that the current restriction 
imposes an unnecessary burden when the objective of ensuring the 
integrity of specimen collections in these circumstances could be 
achieved by other means. Therefore, in proposed Sec.  26.31(b)(1)(iii), 
individuals who have a personal relationship with a donor would be 
permitted to collect specimens, if the collection and preparation of 
the specimens for shipping is monitored by 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. The proposed rule would require that the independent individual 
who is designated to monitor the collection must be trained to monitor 
specimen collections. The proposed paragraph would also provide 
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. This 
proposed change would be made to meet Goal 5 of this rulemaking, which 
is to improve Part 26 by eliminating or modifying unnecessary 
requirements, by permitting monitored collections in these 
circumstances while continuing to assure the integrity of specimen 
collections from FFD program personnel. The proposed rule would retain 
the prohibition on individuals who have personal relationships with the 
donor from performing assessment and evaluation procedures because 
monitoring of these activities by qualified, independent personnel 
would not be feasible.
    Proposed Sec.  26.31(b)(1)(iv) would be added to prohibit a 
collector who has a personal relationship with the donor from acting as 
a urine collector under monitoring, if a directly observed collection 
is required. This proposed prohibition would be necessary to minimize 
embarrassment to the donor (and the collector) during a directly 
observed collection. The proposed paragraph would be added to meet Goal 
7 of this rulemaking, which is to protect the privacy and due process 
rights of individuals who are subject to Part 26.
    Proposed Sec.  26.31(b)(1)(v) would amend current 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 the proposed paragraph, a ``facility'' 
would include, but is not limited to, a licensee's or other entity's 
corporate offices and any medical facilities that are operated by the 
licensee or other entity. The proposed requirement would be added 
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 proposed 
rule would limit 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 proposed requirement for behavioral observation of MROs to 
those instances in which the MRO is working at a licensee's or other 
entity's facility would be adequate to assure the continuing honesty 
and integrity of these MROs because MROs who work off site would not be 
interacting 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. Further, the proposed 
rule would continue to require all MROs to be subject to the other FFD 
program elements that are required in this proposed Subpart, including 
drug and alcohol testing and regular psychological assessments and 
background investigations, which would permit licensees and other 
entities to monitor off-site MROs' honesty and integrity. This proposed 
relaxation would be added to meet Goal 5 of this rulemaking, which is 
to improve Part 26 by eliminating or modifying unnecessary 
requirements.
    Proposed Sec.  26.31(b)(2) would provide another relaxation related 
to collecting specimens from FFD program personnel. The proposed 
paragraph would permit 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 proposed 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 would 
be adequate to meet the goal of ensuring their continuing honesty and 
integrity. Therefore, the proposed paragraph would be added to meet 
Goal 5 of this rulemaking, which is to improve Part 26 by eliminating 
or modifying unnecessary requirements.
    Proposed Sec.  26.31(c) [Conditions for testing] would replace 
current Sec.  26.24(a)(1)-(a)(4). The proposed paragraph would list 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 current provision in Sec.  26.24(a)(3), in particular, has led to 
confusion and misinterpretation of the regulations, to be corrected as 
noted below. Specific requirements for conducting the testing would be 
addressed in proposed Subparts E [Collecting Specimens for

[[Page 50489]]

Testing], F [Licensee Testing Facilities], and G [Laboratories 
Certified by the Department of Health and Human Services]. The proposed 
rule would reorganize and amend current Sec.  26.24(a)(1)-(a)(4) to 
meet Goal 6 of this rulemaking, which is to improve clarity in the 
organization and language of the rule.
    Proposed Sec.  26.31(c)(1) [Pre-access] would amend current Sec.  
26.24(a)(1), which requires pre-access testing within 60 days before 
the initial granting of unescorted access to protected areas or 
assignment to job duties within the scope of this part. The proposed 
paragraph would introduce 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 job duties which require 
the individual to be subject to Part 26. Section 26.65 [Pre-access drug 
and alcohol testing] in Subpart C [Granting and Maintaining 
Authorization] of the proposed rule would specify detailed requirements 
for conducting pre-access testing.
    Proposed Sec.  26.31(c)(2) [For cause] and Sec.  26.31(c)(3) [Post 
event] would clarify and amend current Sec.  26.24(a)(3), as follows:
    Proposed Sec.  26.31(c)(2) [For cause] would continue to require 
for-cause testing in response to any observed behavior or physical 
condition indicating possible substance abuse. The proposed rule would 
also retain the current requirement for testing if the licensee or 
other entity receives credible information that an individual is 
engaging in substance abuse. The term, ``substance abuse,'' would be 
defined in proposed Sec.  26.3 [Definitions].
    Proposed Sec.  26.31(c)(3) [Post event] would amend the portion of 
current Sec.  26.24(a)(3) that requires drug and alcohol testing when 
an event involving a failure in individual performance leads to 
significant consequences. The proposed rule would amend the current 
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 current 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 the intent of this paragraph. Therefore, to clarify the 
intent of the provision, the proposed rule would eliminate 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, require post-event 
testing as soon as practical after significant events [as listed in 
proposed Sec.  26.31(c)(3)(i)-(c)(3)(iii)] involving a human error that 
may have caused or contributed to the event. The proposed rule would 
use the term, ``human error,'' rather than the current term, ``worker's 
behavior,'' to emphasize that post-event testing would be required for 
acts that unintentionally deviated from what was planned or expected in 
a given task environment (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 would be required 
regardless of whether there was ``reasonable suspicion'' that the 
individual was abusing drugs or alcohol for the consequences listed in 
the proposed paragraph.
    In addition, the second sentence of proposed Sec.  26.31(c)(3) 
would be added in response to stakeholder comments at the public 
meetings discussed in Section V. The stakeholders noted that the 
current provision does not clearly delineate the scope of individuals 
who must be subject to post-event testing. Some licensees have 
misinterpreted the current provision as requiring that all individuals 
who are involved in a significant event must be tested, including 
individuals whose behavior played no causal or contributing role in the 
event. For example, these licensees' FFD programs would require that an 
individual who was exposed to radiation in excess of regulatory limits 
must be tested, 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 
proposed provision would clarify the original intent of this paragraph 
by stating that only the individual(s) who committed the error(s) would 
be subject to post-event testing.
    Proposed Sec.  26.31(c)(3)(i) would provide a threshold for the 
types of workplace personal injuries and illnesses for which post-event 
testing would be required in response to implementation questions 
related to current Sec.  26.24(a)(3). Some licensees have 
misinterpreted the current provision as requiring post-event testing 
for any personal injury, no matter how minor. The proposed paragraph 
would clarify 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 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 proposed rule, these would 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, 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. 
The proposed rule would add this clarification to reduce the number of 
unnecessary post-event tests performed for minor injuries and illnesses 
and meet Goal 3 of this rulemaking, which is to improve the 
effectiveness and efficiency of FFD programs.
    In response to stakeholder comments at the public meetings 
discussed in Section V, proposed Sec.  26.31(c)(3)(i) would also 
include 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 stakeholders noted that, in some cases, 
it is difficult to detect illnesses and injuries that meet the proposed 
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 so it 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

[[Page 50490]]

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 non-negative test 
results reflected the individual's condition at the time the event 
occurred rather than subsequent drug or alcohol use. Therefore, the 
proposed rule would limit post-event testing to situations in which the 
licensee or other entity can determine that an injury or illness meets 
the proposed threshold within 4 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 proposed paragraph should not be misinterpreted as 
requiring post-event testing to be completed within 4 hours after the 
event. The time period after the event within which testing must be 
completed would be defined in proposed Sec.  26.31(c)(3) as ``as soon 
as practical.'' This proposed change would be made to meet Goal 3 of 
this rulemaking, which is to improve the effectiveness and efficiency 
of FFD programs.
    Proposed Sec.  26.31(c)(3)(ii) would carry over the relevant 
language in the corresponding portion of current Sec.  26.24(a)(3), 
without change.
    Proposed Sec.  26.31(c)(3)(iii) would carry over the relevant 
language in the corresponding portion of current Sec.  26.24(a)(3), 
but, as discussed with respect to proposed Sec.  26.31(c)(3), would 
eliminate the current qualifying phrase, ``if there is reasonable 
suspicion that the worker's behavior contributed to the event.''
    Proposed Sec.  26.31(c)(4) [Followup] would retain the intent of 
current Sec.  26.24(a)(4) but amend its language. The proposed rule 
would eliminate the phrase, ``to verify continued abstention from the 
use of substances covered under this part,'' because it could be 
misinterpreted as limiting the substances for which followup testing 
would be permitted to only those listed in proposed Sec.  26.31(d)(1) 
[Substances tested]. The proposed rule would revise this phrase as, 
``to verify continued abstinence from substance abuse,'' to clarify 
that FFD programs would be permitted to conduct followup testing for 
any substances an individual may have abused, subject to certain 
additional requirements discussed with respect to proposed Sec.  
26.31(d)(1)(i). Detailed requirements for conducting followup testing 
would be established in proposed Sec.  26.69 [Authorization with 
potentially disqualifying fitness-for-duty information], where they 
would apply to licensees' and other entities' processes for granting 
and maintaining authorization. The proposed rule would make these 
changes to meet Goal 6 of this rulemaking, which is to improve clarity 
in the organization and language of the rule.
    Proposed Sec.  26.31(c)(5) [Random] would simplify current Sec.  
26.24(a)(2) to define random testing as one of the conditions under 
which testing is required. The detailed requirements for implementing 
random testing that are contained in current Sec.  26.24(a)(2) would be 
moved to proposed Sec.  26.31(d) [General requirements for drug and 
alcohol testing]. The proposed changes would be made to meet Goal 6 of 
this rulemaking, which is to improve clarity in the organization and 
language of the rule.
    Proposed Sec.  26.31(d) [General requirements for drug and alcohol 
testing] would be added to better organize requirements related to the 
general administration of drug and alcohol testing. The proposed rule 
would present more detailed requirements for conducting drug and 
alcohol testing in proposed Subparts E [Collecting Specimens for 
Testing], F [Licensee Testing Facilities], and G [Laboratories 
Certified by the Department of Health and Human Services]. The proposed 
change would be made to meet Goal 6 of this rulemaking, which is to 
improve clarity in the organization and language of the rule.
    Proposed Sec.  26.31(d)(1) [Substances tested] would retain the 
list of drugs for which testing must be conducted in current Section 
2.1(a) in Appendix A to Part 26, but would clarify that, for some 
drugs, the testing is conducted to detect drug metabolites. The 
circumstances in which testing for these substances must be performed 
(i.e., pre-access, post-event, random) would be moved to proposed Sec.  
26.31(c) for organizational clarity. In addition, the proposed 
paragraph would add adulterants to the list of substances for which 
testing must be conducted, consistent with the addition of specimen 
validity testing requirements to the proposed rule, as discussed with 
respect to proposed Sec.  26.31(d)(3)(i).
    Proposed Sec.  26.31(d)(1)(i) would retain the permission in the 
second sentence of current 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.
    Proposed Sec.  26.31(d)(1)(i)(A) would retain the permission in 
current Sec.  26.24(c) for licensees and other entities to add to the 
panel of drugs for which testing is required in proposed 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 proposed paragraph would also require 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 would be 
consistent with the definition of ``illegal drugs'' in current Sec.  
26.3 [Definitions].
    Proposed Sec.  26.31(d)(1)(i)(B) would retain the last sentence in 
current Sec.  26.24(c), which requires licensees and other entities who 
are subject to the rule to establish appropriate cutoff levels for any 
additional substances for which testing will be conducted.
    Proposed Sec.  26.31(d)(1)(i)(C) would retain the requirement in 
current Section 2.1(c) in Appendix A to Part 26, which requires 
licensees and other entities to establish rigorous testing procedures 
for any additional drugs.
    Proposed Sec.  26.31(d)(1)(i)(D) would be added to further clarify 
the requirement in proposed Sec.  26.31(d)(1)(i)(C) for ``rigorous 
testing procedures'' and would replace the portion of current Section 
1.1(2) in Appendix A to Part 26 that requires licensees to obtain 
written approval from the NRC to test for additional drugs. The purpose 
of the current requirement is 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 current requirement also imposes a reporting burden. The 
proposed provision would eliminate this reporting requirement and 
replace it with requirements for an independent forensic toxicologist 
to conduct the review that the NRC currently performs. The proposed 
rule would require 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. The proposed 
paragraph would also specify the required qualifications for the 
forensic toxicologist. Certification of the assay and cutoff levels 
would not be 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 (2) if the licensee or other 
entity has received written approval from the NRC to test for the 
additional drugs or metabolites and to apply the cutoff levels to be 
used in testing for the

[[Page 50491]]

additional drugs or metabolites, as required in current Section 1.1(2) 
in Appendix A to Part 26. Certification would be unnecessary in these 
two circumstances because it would be redundant. This proposed change 
would be made to meet Goal 5 of this rulemaking, which is to improve 
Part 26 by eliminating or modifying unnecessary requirements, while 
continuing to ensure that any drug testing conducted under Part 26 is 
scientifically sound and legally defensible.
    Proposed Sec.  26.31(d)(1)(ii) would amend current Section 2.1(b) 
in Appendix A to Part 26 and would permit 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 CSA that the licensee or 
other entity suspects the individual may have abused, as follows:
    The proposed paragraph would add a reference to post-event testing 
for consistency with the intent of current Section 2.1(b) in Appendix A 
to Part 26, which permits testing for any illegal drugs during a for-
cause test. The current rule includes post-event testing within the 
definition of for-cause testing whereas the proposed rule would use a 
distinct term, ``post-event'' testing, to refer to the testing that is 
required following certain events, as discussed with respect to 
proposed Sec.  26.31(d)(3). Therefore, it would be necessary to add a 
reference to post-event testing to this paragraph to retain the full 
intent of the current provision.
    The proposed paragraph would also add a reference to followup 
testing, which would permit the 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 proposed Sec.  26.189 
[Determination of fitness], found that an individual was abusing 
barbiturates, this provision would permit followup testing to verify 
that the individual is abstaining from such abuse. This proposed change 
would be made to strengthen the followup testing element of FFD 
programs by ensuring that followup testing would detect continued drug 
abuse and would therefore, meet Goal 3 of this rulemaking, which is to 
improve the effectiveness and efficiency of FFD programs.
    The proposed paragraph would retain the limitation in current 
Section 2.1(b) in Appendix A to Part 26, which permits testing only for 
illegal drugs that the individual is suspected of having abused, and 
extend that limitation to followup testing. The proposed rule would 
extend this limitation to followup testing to protect donors' rights to 
privacy, which is the same reason that the limitation was established 
in the current rule with respect to for-cause testing. That is, 
licensees and other entities would be 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 
[Performance objectives]. Thus, extending the current limitation on 
for-cause testing to followup testing would meet Goal 7 of this 
rulemaking, which is to protect the privacy and due process rights of 
individuals who are subject to Part 26.
    The proposed paragraph would replace the term, ``illegal drugs,'' 
in current 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 CSA. 
These schedules list drugs with abuse potential and include many drugs 
with legitimate medical uses that are not ``illegal'' when used in 
accordance with a valid prescription for medical purposes. Therefore, 
replacing the term, ``illegal drugs,'' with the reference to Schedules 
I-V of the CSA would more accurately characterize the specific drugs 
for which testing is permitted. This proposed change would be made to 
meet Goal 6 of this rulemaking, which is to improve clarity in the 
language of the rule.
    Proposed Sec.  26.31(d)(1)(ii) would also apply the new 
requirements in proposed 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 proposed paragraph would 
require the assays and cutoff levels to be used in testing for the 
additional drugs to be certified by a forensic toxicologist in 
accordance with proposed Sec.  26.31(d)(1)(i)(D). The proposed 
provision would provide consistency with proposed Sec.  
26.31(d)(1)(i)(D) and ensure that the testing would be scientifically 
sound and legally defensible. The proposed change would be made to 
protect donors' rights to due process, as it relates to minimizing the 
possibility of false positive test results, and strengthen 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, this proposed change would be made to meet Goal 
7 of this rulemaking, which is to protect the privacy and due process 
rights of individuals who are subject to Part 26, and Goal 3, which is 
to improve the effectiveness and efficiency of FFD programs.
    The last sentence of proposed Sec.  26.31(d)(1)(ii) would be added 
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, 
despite the quantitative test result falling 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 
in the rule, which 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 proposed rule would specifically prohibit these 
practices to meet Goal 7 of this rulemaking, which is to protect the 
privacy and due process rights of individuals 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.
    Proposed Sec.  26.31(d)(2) [Random testing] would reorganize and 
amend the requirements for conducting random testing, which currently 
appear in Sec.  26.24(a)(2), as follows:
    Proposed Sec.  26.31(d)(2)(i) would add a new requirement for 
licensees and other entities to administer random testing in a manner 
that provides reasonable assurance that individuals are unable to 
predict the time periods during which specimens will be collected. This 
proposed provision would be added because the NRC is aware of instances 
in which individuals who believed they would have a non-negative 
result, if tested, have been able to determine the

[[Page 50492]]

days on which collections were being conducted, which 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 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 during which 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 proposed paragraph would require 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 would be 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, proposed Sec.  26.31(d)(2)(i)(A) would be 
added to require licensees and other entities to 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 
four days in each calendar week at each site. This proposed provision 
would require 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 
proposed requirement could include, but would not be limited to, 
stationing a mobile collection facility on site for some part of the 
day on four 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 four days in each 
calendar week. Maintaining the appearance that the collection site is 
active on more than half of the days in each week would make it more 
difficult for individuals to plan to subvert the testing process by 
leaving work when they believe specimens are being collected. The 
requirements in proposed Sec.  26.31(d)(2)(i) and (A) would be added to 
meet Goal 3 of this rulemaking, which is to improve the effectiveness 
of FFD programs, by reducing the opportunities for individuals to 
subvert the testing process by having advanced warning that specimens 
are being collected.
    Proposed Sec.  26.31(d)(2)(i)(B) would amend the third sentence of 
current Sec.  26.24(a)(2), which requires that specimens must be 
collected ``at various times during the day.'' The proposed rule would 
expand the current 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 current and proposed provisions is to 
ensure that individuals cannot predict the times at which they will be 
tested, as well as prevent them from perceiving that there are ``safe'' 
periods during which they will not be tested that 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 would also increase the rule's effectiveness in 
deterring substance abuse. Adding this proposed provision would meet 
Goal 3 of this rulemaking, which is to improve the effectiveness of FFD 
programs.
    Proposed Sec.  26.31(d)(2)(ii) would retain the third sentence of 
current Sec.  26.24(a)(2), which states that random testing must be 
administered on a nominal weekly frequency. The current requirement to 
collect specimens for random testing at ``various times during the 
day'' would be retained in proposed Sec.  26.31(d)(2)(i)(B).
    Proposed Sec.  26.31(d)(2)(iii) would require 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 proposed Sec.  26.27(b)(2). Proposed Sec.  26.31(d)(2)(iii) 
would be added to further clarify 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 in which 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 2 hours to report 
for testing after notification. However, if there are no legitimate 
work, travel, or other demands that prevent an individual from 
immediately reporting for testing, the proposed provision would require 
the individual to report as soon as he or she is notified. This 
provision would strengthen FFD programs by further reducing 
opportunities for individuals to subvert the testing process, as 
discussed with respect to proposed Sec.  26.27(b)(2), and, therefore, 
would meet Goal 3 of this rulemaking, which is to improve the 
effectiveness of FFD programs.
    Proposed Sec.  26.31(d)(2)(iv) would amend the first sentence of 
current Sec.  26.24(a)(2) to clarify that individuals who are off site 
and unavailable for testing when selected for a random test, must be 
tested at the earliest reasonable and practical opportunity. This 
proposed requirement would be added to prohibit licensees and other 
entities from returning these individuals' names to the random testing 
pool without conducting a test, as has been some licensees' practice. 
Returning the individuals' names to the random testing pool without 
conducting a test ensures that they are immediately eligible for 
another unannounced test, as required in proposed Sec.  26.31(d)(2)(v), 
but does not ensure that all individuals who are subject to this part 
have an equal probability of being tested. This proposed revision, 
therefore, would meet Goal 3 of this rulemaking, which is to improve 
the effectiveness of FFD programs.
    The proposed paragraph would include 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 would not be required to call an 
individual back to the site if he

[[Page 50493]]

or she is off site when selected for testing. In addition, the proposed 
provision would 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, which would provide them with an opportunity to 
take actions to subvert the testing process, as discussed with respect 
to proposed Sec.  26.31(d)(2)(i). Therefore, the proposed paragraph 
would require licensees and other entities to collect specimens from an 
individual who is off site when selected for testing, in a manner that 
also ensures the individual does not have advance notification that he 
or she has been selected for testing. This proposed change would be 
made to meet Goal 3 of this rulemaking, which is to improve the 
effectiveness and efficiency of FFD programs.
    Proposed Sec.  26.31(d)(2)(v) would retain the second sentence of 
Sec.  26.24(a)(2), which requires that an individual who has completed 
a test is immediately eligible for another random test.
    Proposed Sec.  26.31(d)(2)(vi) would amend the last sentence of 
current Sec.  26.24(a)(2) in response to licensee implementation 
questions with respect to the meaning of the term, ``workforce,'' in 
the current rule. These questions have 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. The 
proposed paragraph would clarify that the number of random tests that 
must be performed in a year must be equal to 50 percent of the 
population of individuals who are subject to random testing under the 
FFD program. If several sites are covered by a common FFD program, the 
``population'' would include all individuals who are subject to the 
common FFD program. The population would also include individuals who 
have applied for authorization and who are subject to random testing 
under proposed Sec.  26.67 [Random drug and alcohol testing of 
individuals who have applied for authorization]. This proposed change 
would be made to meet Goal 6 of this rulemaking, which is to improve 
clarity in the organization and language of the rule.
    Proposed Sec.  26.31(d)(3) [Drug testing] would be added to group 
requirements in one paragraph that are related to the general 
administration of drug testing. This proposed change would be made 
because requirements that address this topic are dispersed throughout 
the current rule whereas grouping them together in a paragraph would 
make them easier to locate within the proposed rule. The proposed 
reorganization would meet Goal 6 of this rulemaking, which is to 
improve clarity in the organization and language of the rule.
    Proposed Sec.  26.31(d)(3)(i) would combine some of the 
requirements in current Section 1.1(3) in Appendix A to Part 26, Sec.  
26.24(f), the first sentence of current Section 2.8(e)(1) in Appendix 
A, and current Section 4.1(a) and (b) in Appendix A to Part 26, which 
require licensees and other entities to use only HHS-certified 
laboratories to perform drug testing, except if initial tests are 
performed at a licensee testing facility. Other detailed requirements 
in these sections would be retained, but presented in the appropriate 
sections in proposed Subparts E [Collecting specimens for testing], F 
[Licensee Testing Facilities], and G [Laboratories Certified by the 
Department of Health and Human Services]. The proposed rule would use 
the term, ``non-negative,'' to replace the term, ``presumptive 
positive,'' in this paragraph and throughout the remainder of the rule 
to refer collectively to adverse validity and drug test results, as 
discussed with respect to the definition of ``non-negative'' in 
proposed Sec.  26.5 [Definitions]. These proposed changes would be made 
to meet Goal 6 of this rulemaking, which is to improve the 
organizational clarity of the rule.
    The proposed paragraph would also require 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, and any 
specimens that yield non-negative initial validity or drug test results 
must be subject to confirmatory testing by the laboratory, except for 
invalid specimens that cannot be tested. 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, which, by 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 Proposed Revisions (66 FR 43876; August 21, 2001) to the HHS 
Guidelines to establish requirements for specimen validity testing 
performed by HHS-certified laboratories, the 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 U.S. Department of 
Transportation (DOT) regulations (49 CFR part 40). Program experience 
gained since 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 current Part 26 contains a number of requirements related to 
specimen validity (e.g., the fifth sentence of current Section 2.1(e), 
Section 2.4(f)(2), 2.4(g)(14)-(g)(16), and 2.7(d) in Appendix A to Part 
26), the methods available to tamper with specimens have become more 
sophisticated since the rule was first published and more sophisticated 
methods of detecting tampering are necessary. Therefore, the proposed 
rule would incorporate 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). These new requirements for specimen 
validity testing would be added to strengthen FFD programs by improving 
current laboratory procedures to detect specimens that are dilute, 
adulterated, or substituted, consistent with 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. Detecting specimen 
tampering is necessary to identify individuals who may attempt to hide 
drug abuse, because attempts to tamper with a specimen provide clear 
evidence that the individual is not trustworthy and reliable, and 
because these individuals' drug use may pose a risk to public health 
and safety and the common defense and security, as discussed with 
respect to proposed Sec.  26.23 [Performance objectives].
    Proposed Sec.  26.31(d)(3)(ii) would amend the first sentence of 
current Sec.  26.24(d)(1), which permits licensees and other entities 
to conduct initial testing of urine specimens at a licensee

[[Page 50494]]

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 proposed rule would add permission 
for licensees and other entities to perform initial validity testing at 
a licensee testing facility, for the reasons discussed with respect to 
proposed Sec.  26.31(d)(3)(i). Detailed requirements related to 
specimen validity testing at licensee testing facilities would be 
established in proposed Subpart F [Licensee Testing Facilities].
    Proposed Sec.  26.31(d)(3)(iii) would be based upon the portions of 
current Sections 2.7(e)(1) and 2.7(f)(2) in Appendix A to Part 26 that 
establish the cutoff levels for initial and confirmatory drug testing, 
respectively, which licensees must apply under the current rule. 
However, the proposed paragraph would require FFD programs to apply the 
updated cutoff levels specified in proposed Sec.  26.163(a)(1) for 
initial drug testing and proposed Sec.  26.163(b)(1) for confirmatory 
drug testing. Consistent with the first sentence of current Sec.  
26.24(b), the proposed paragraph would also permit FFD programs to 
implement more stringent cutoff levels than specified in the rule, but 
would establish additional requirements related to lower cutoff levels, 
as will be discussed further below. The permission in the first 
sentence of current Sec.  26.24(b) to implement a broader panel of 
drugs would be relocated to proposed Sec.  26.31(d)(1), as discussed 
with respect to that paragraph.
    Proposed Sec.  26.31(d)(3)(iii)(A) would retain the third and 
fourth sentences of current 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 proposed rule 
would add a requirement that the lower cutoff levels must be documented 
in the FFD program's 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 to due process. The proposed change would be made to meet 
Goal 7 of this rulemaking, which is to protect the due process rights 
of individuals who are subject to Part 26.
    Proposed Sec.  26.31(d)(3)(iii)(B) would require that the FFD 
program's cutoff levels for drugs and drug metabolites, including any 
more stringent cutoff levels, must be uniformly applied in all tests 
conducted under this part and equally to all individuals who are 
subject to testing, except as permitted under proposed Sec.  
26.163(a)(2) for dilute specimens and proposed Sec.  26.165(c)(2) for 
retesting specimens. As discussed with respect to proposed 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 proposed paragraph would be added to 
meet Goal 7 of this rulemaking, which is to protect the privacy and due 
process rights of individuals who are subject to Part 26.
    Proposed Sec.  26.31(d)(3)(iii)(C) would be added to specify 
requirements for establishing more stringent cutoff levels. Before 
implementing the more stringent cutoff levels, licensees and other 
entities who are subject to the rule would be required to obtain 
certification from an independent forensic toxicologist that the more 
stringent cutoff levels are technically sound and legally defensible, 
with two exceptions. Certification by a forensic toxicologist would not 
be required if: (1) The U.S. Department of Health and Human Services 
lowers the cutoff levels in the HHS Guidelines for the same drugs or 
drug metabolites and the FFD program adopts the lower HHS cutoffs or 
(2) the licensee or other entity previously received written approval 
from the NRC to apply lower cutoff levels, in accordance with current 
Section 1.1(2) in Appendix A to Part 26. These proposed requirements 
would be consistent with those contained in proposed Sec.  
26.31(d)(1)(i)(D) related to adding drugs to the panel of drugs for 
which testing is required under the rule and would be added here for 
the same reasons discussed with respect to that paragraph. Licensees 
and other entities would no longer be required to inform the NRC, in 
writing, that they have implemented new, lower cutoff levels because 
the purpose of the reporting would be met by the forensic 
toxicologist's review. Therefore, these changes would be made to meet 
Goal 5 of this rulemaking, which is to improve Part 26 by eliminating 
or modifying unnecessary requirements, while continuing to protect 
donors' right to accurate and reliable drug testing.
    Proposed Sec.  26.31(d)(4) [Alcohol testing] would update current 
Sec.  26.24(g), which contains general requirements for conducting 
alcohol testing, to reflect other changes that would be made in the 
proposed rule. The current cross-reference to Section 2.7(o)(3) in 
Appendix A to Part 26 would be amended to refer to Sec.  26.91(a) in 
Subpart E [Collecting Specimens for Testing], which would contain 
detailed requirements for conducting alcohol testing. Reference to oral 
fluids as acceptable specimens for initial alcohol testing would be 
added to this paragraph. The basis for adding oral fluids as acceptable 
specimens for initial alcohol testing is discussed with respect to 
proposed Sec.  26.83 [Specimens to be collected]. The BAC at which a 
confirmatory test is required would be changed to 0.02 percent (from 
0.04 percent) in the proposed paragraph for consistency with the 
revised alcohol cutoff levels in proposed Sec.  26.99 [Determining the 
need for a confirmatory test for alcohol] and proposed 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. Reference to blood testing for alcohol would be deleted 
because donors would no longer be permitted to request blood testing 
for alcohol in the proposed rule, as discussed with respect to proposed 
Sec.  26.83(a).
    Proposed Sec.  26.31(d)(5) [Medical conditions] would be added to 
address circumstances in which 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, in which an individual's medical condition has 
made it inadvisable to implement testing procedures in accordance with 
the relevant requirements. Therefore, proposed Sec.  26.31(d)(5)(i) 
would permit alternative specimen collection and evaluation procedures 
for rare instances in which 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 would be permitted to authorize an 
alternative evaluation procedure, which may include, but is not limited 
to blood testing for alcohol. Proposed Sec.  26.31(d)(5)(ii) would be 
added to clarify that necessary medical treatment may not be delayed in 
order to conduct drug and alcohol testing. These proposed paragraphs 
would be consistent with the requirements of other Federal agencies 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.
    Proposed Sec.  26.31(d)(6) [Limitations of testing] would retain 
and amend current

[[Page 50495]]

Section 2.1(d) in Appendix A to Part 26, which states 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 proposed 
paragraph would add examples of the types of analyses and tests that 
would be prohibited without the donor's written permission. Although 
the NRC is not aware of any instances in which 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. These examples 
would be added to meet Goal 7 of this rulemaking, which is to protect 
the privacy and due process rights of individuals who are subject to 
Part 26.

Section 26.33 Behavioral Observation

    Proposed Sec.  26.33 [Behavioral observation] would be added to 
emphasize that behavioral observation is a required element of FFD 
programs. The first sentence of proposed Sec.  26.33 would require 
behavioral observation of individuals who are subject to this part. The 
second sentence would retain current Sec.  26.22(a)(3), (a)(4), and 
(b), which state that the individuals who perform behavioral 
observation must be trained to do so, and extend the training 
requirement to all individuals who are subject to Part 26. The third 
sentence of the proposed paragraph would require that individuals must 
report FFD concerns arising from behavioral observation to the 
appropriate personnel designated in the FFD program procedures. These 
proposed changes would be made to strengthen the behavioral observation 
element of FFD programs by increasing the likelihood that impairment 
and other adverse behaviors are detected and appropriately addressed by 
the licensees and other entities who are subject to the rule.

Section 26.35 Employee Assistance Programs

    Proposed Sec.  26.35 [Employee assistance programs] would amend 
current Sec.  26.25 [Employee assistance programs (EAP)] for the 
reasons discussed with respect to each paragraph that would be added to 
the proposed rule. Proposed Sec.  26.35(a) would retain the current 
provision.
    In response to implementation questions, proposed Sec.  26.35(b) 
would be added to clarify that licensees and other entities are not 
required to provide EAP services to C/V employees who are working at a 
licensee's or other entity's facility and are subject to this part. 
This proposed provision would be consistent with the interpretation of 
the current rule in item 13.1.4 of NUREG-1354. However, the proposed 
rule would continue to require that C/V employees who are subject to 
Part 26 must have access to an EAP, and licensees and other entities 
who rely upon the C/V's FFD program would continue to be required to 
ensure that the C/V's EAP meets the requirements of this part. The 
proposed paragraph would be added to meet Goal 6 of this rulemaking, 
which is to improve clarity in the organization and language of the 
rule.
    The proposed paragraph would also state that licensees and other 
entities need not provide EAP services to individuals who have applied 
for authorization to perform job duties that would require them to be 
subject to this part. Licensees and other entities would not be 
required to provide an EAP to applicants for authorization because 
these individuals would not yet be performing job duties that could 
affect public health and safety or the common defense and security. 
This proposed clarification would be added because applicants would be 
subject to other requirements under the proposed rule, as discussed 
with respect to proposed Sec.  26.25(d).
    Proposed Sec.  26.35(c) would amend the last sentence of current 
Sec.  26.25 to emphasize that the identity and privacy of an individual 
who seeks EAP services must be protected and clarify the conditions 
under which an individual's confidentiality may or must be violated by 
EAP personnel. The proposed rule would permit 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. The proposed provision would 
clarify the NRC's intent with respect to EAP confidentiality because 
the current provision has been misinterpreted.
    The last sentence of current Sec.  26.25 requires 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 this phrase has been misinterpreted by some 
individuals who are subject to the rule 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 current rule and who 
correctly permit EAP staff to make the determination whether an 
individual's condition should be reported 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 job 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 
proposed paragraph would amend the last sentence of current 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.
    Proposed Sec.  26.35(c)(1) would be added 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 the problems 
that led to the self-referral. The proposed provision would be 
necessary to: (1) Eliminate some licensees' practices of requiring 
these reports, (2) protect individuals' privacy, and (3) strengthen the 
EAP element of FFD programs by eliminating a current barrier to self-
referrals in some FFD programs. The term, ``routinely,'' would be used 
to indicate that the proposed rule would permit 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

[[Page 50496]]

health and safety or the common defense and security. The proposed 
provision would 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 would not compromise individuals' privacy.
    Proposed Sec.  26.35(c)(2) would be added to provide further 
clarity in the language of the rule with respect to the conditions 
under which EAP personnel would be excepted from the confidentiality 
requirement in proposed 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 current and proposed rules in these circumstances. However, the 
proposed rule would include more detail with respect to the conditions 
and actions that an EAP professional would be required to report to 
ensure that licensees, other entities, and individuals who are subject 
to the rule better understand the intent of the current and proposed 
provisions. The proposed rule would require 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 himself or herself or others. The phrase, ``substantive 
reasons to believe,'' would be used to clarify that casual and/or 
contextually appropriate comments made by an individual during a 
counseling session would not be 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. By 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 together constitute substantive reasons 
to believe that the individual's condition poses an immediate hazard 
and must be reported.
    Proposed Sec.  26.35(c)(2)(i)-(c)(2)(iii) would be added to provide 
several examples of conditions and actions that would require EAP 
personnel to provide a report about an individual who has self-referred 
to licensee or other entity management. Proposed Sec.  26.35(c)(2)(i) 
would require 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. Proposed Sec.  
26.35(c)(2)(ii) would require 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 proposed Sec.  
26.35(c)(2). Proposed Sec.  26.35(c)(2)(iii) would require 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 
proposed Sec.  26.219(b)(1)-(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 job duties that require the individual to be subject to this 
part. The examples included in these proposed paragraphs are 
illustrative, but 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 proposed rule.
    For additional clarity, proposed Sec.  26.35(c)(3) would be added 
to cross-reference the provisions in the proposed rule that would 
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 those paragraphs, proposed 
Sec. Sec.  26.69(d) and 26.77(b) would require the licensee or other 
entity to take immediate action to: (1) Prevent the individual from 
performing any job duties that require the individual to be subject to 
this part; (2) ensure that a determination of fitness is performed by a 
professional who has specific qualifications and training to address 
the nature of the individual's problem; and (3) 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 proposed changes to current Sec.  26.25 would be consistent 
with Goal 7 of this rulemaking, which is to protect the privacy and due 
process rights of individuals who are subject to Part 26, as well as 
Goal 3 of this rulemaking, which is to improve the effectiveness and 
efficiency of FFD programs.

Section 26.37 Protection of Information

    Proposed Sec.  26.37 [Protection of information] would amend 
current Sec.  26.29, which contains requirements for protecting the 
personal information that must be collected under Part 26. In general, 
the proposed section would group requirements related to the protection 
of personal information that are dispersed throughout the current rule 
to aid in locating these requirements in the proposed rule. The records 
retention requirement in current Sec.  26.29(a) would be moved to 
proposed Subpart J [Recordkeeping and Reporting Requirements]. These 
proposed changes would be made to meet Goal 6 of this rulemaking, which 
is to improve clarity in the organization of the rule.
    Proposed Sec.  26.37(a) would combine and retain the first sentence 
of current Sec.  26.29(a) and the second sentence of current Section 
3.1 in Appendix A to Part 26. The proposed paragraph would require 
licensees and other entities to establish and maintain a system of 
files and procedures to protect the personal information that is 
collected under this part and maintain and use such records with the 
highest regard for individual privacy.
    Proposed Sec.  26.37(b) would amend current Sec.  26.29(b) and 
would divide it into several paragraphs for clarity. The first sentence 
of the proposed paragraph would amend the first sentence of current 
Sec.  26.29(b), which prohibits licensees and other entities from 
disclosing personal information collected under this part to any 
individuals other than those listed in the sentence. The proposed 
paragraph would continue to permit disclosure of the personal 
information to the listed individuals and would add 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 subject individual. The proposed permission to 
release the personal information to individuals who are not listed in 
the paragraph with the written consent of the subject individual would 
be added because some licensees have misinterpreted the current 
requirement as prohibiting them from releasing the personal information 
under any circumstances, except to the parties listed in this 
paragraph. 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

[[Page 50497]]

explicit permission for licensees and other entities to release 
personal information when an individual consents to the release, in 
writing, would be added to meet Goal 7 of this rulemaking, which is to 
protect the privacy and due process rights of individuals who are 
subject to Part 26.
    Proposed Sec.  26.37(b)(1)-(b)(8) would list in separate paragraphs 
the individuals to whom licensees and other entities would be permitted 
to release personal information about an individual. Proposed Sec.  
26.37(b)(3), (b)(4), and (b)(8) would retain unchanged the current 
permission for the release of information to NRC representatives, 
appropriate law enforcement officials under court order, and other 
persons as required by court order. Proposed Sec.  26.37(b)(1), (b)(2), 
(b)(5), and (b)(6) would amend the related requirements contained in 
current Sec.  26.29(b) to meet Goal 6 of this rulemaking, which is to 
improve clarity in the organization and language of the rule. The 
specific changes to current Sec.  26.29(b) would include the following:
    Proposed Sec.  26.37(b)(1) would retain the current permission for 
the release of information to the subject individual and his or her 
designated representative. The proposed paragraph would add 
requirements for the individual to designate his or her representative 
in writing and specify the FFD matters to be disclosed. The proposed 
changes would be made in response to implementation questions from 
licensees. Licensees have sought guidance from the NRC related to the 
manner in which an individual must ``designate'' a representative.
    Proposed Sec.  26.37(b)(2) would retain the current permission for 
the release of information to the licensee's or other entity's MROs. 
The proposed rule would also permit the release of information to MRO 
staff members for consistency with proposed Sec.  26.183(d), which 
would permit MRO staff to serve some MRO functions under the direction 
of the MRO. MRO staff would require access to the personal information 
in order to perform their job duties. The role of MRO staff in FFD 
programs is further discussed with respect to proposed Sec.  26.183(d).
    Proposed Sec.  26.37(b)(5) would amend the current reference to 
licensee representatives who have a need to have access to the 
information in performing assigned duties. The current rule refers only 
to individuals who are performing audits of FFD programs. As a result, 
the current rule has been misinterpreted by some licensees as limiting 
the release of personal information only to such individuals. This was 
not the intent of the provision. Rather, the intent of the current rule 
was that licensees and other entities would be permitted to release 
information to their representatives who must have access to the 
personal information in order to perform assigned job duties. 
Therefore, the proposed rule would clarify that licensee 
representatives who perform determinations of fitness, such as the SAE 
(see the discussion of proposed Sec.  26.187) and human resources 
functions, as well as auditors and other representatives of the 
licensee or other entity, may be permitted access to personal 
information but only to the extent that such access is required to 
perform their assigned functions.
    Proposed Sec.  26.37(b)(6) and (b)(7) would amend the portion of 
current Sec.  26.29(b) that refers to ``persons deciding matters on 
review or appeal.'' The proposed changes would be made 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 current Sec.  26.28 [Appeals] as 
well as whether information could be released in a judicial proceeding 
that was not initiated by the subject individual. The proposed rule 
would clarify that the permission includes individuals who are 
presiding in a judicial or administrative proceeding, but only if the 
proceeding is initiated by the subject individual in proposed Sec.  
26.37(b)(6). Proposed Sec.  26.37(b)(7) would be added to cover 
``persons deciding matters under review in Sec.  26.39'' [Review 
process for fitness-for-duty policy violations], as discussed with 
respect to that section.
    Proposed Sec.  26.37(c) would be added 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 proposed provision would be added 
to further clarify current Sec.  26.29(b), because some licensees have 
misinterpreted the current 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 
proposed change would be made to meet Goal 6 of this rulemaking, which 
is to improve clarity in the organization and language of the rule.
    Proposed Sec.  26.37(d)-(f) would retain several requirements 
related to the protection of information in the current rule but move 
them into this proposed section for organizational clarity. Proposed 
Sec.  26.37(d) would combine requirements in current 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. The proposed paragraph would retain the current requirements 
for licensees, other entities, HHS-certified laboratories, and MROs to 
provide the information that an individual requests related to a 
determination that the individual has violated the FFD policy on the 
basis of drug test results. Proposed Sec.  26.37(e) and (f) would 
retain current Section 3.1 in Appendix A to Part 26 and the last 
sentence of current Sec.  26.29(b), respectively.

Section 26.39 Review Process for Fitness-for-Duty Policy Violations

    Proposed Sec.  26.39 [Review process for fitness-for-duty policy 
violations] would amend current Sec.  26.28 [Appeals] and separate it 
into several paragraphs. The current section title would be revised to 
eliminate the implication that the internal management review is a 
legal proceeding. Several requirements would be added to clarify and 
strengthen individuals' due process rights during the review, as 
follows:
    Current Sec.  26.28 requires 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. Proposed Sec.  26.39(a) would retain the requirement that the 
review must be impartial and add a requirement that the review must be 
objective. The requirement for an objective review would be added 
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 is required under current 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 proposed requirement for the review 
to be both impartial and objective would emphasize the NRC's intent 
that the review process must be effective.
    In keeping with revisions to several other sections that would be 
intended to counter subversion of the testing process, proposed Sec.  
26.39(a) would extend this opportunity to request a review to all FFD 
violations, including, but not limited to, violations based upon non-
negative validity test results. The proposed paragraph would also 
clarify that applicants for authorization must be given the opportunity 
for a

[[Page 50498]]

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 non-negative 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 would also enhance program 
credibility.
    Proposed Sec.  26.39(b) would specify 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 and state that the individual may submit 
additional relevant information as part of the review process. This 
proposed clarification is necessary because experience with 
implementing current Sec.  26.28 has indicated that, in some cases, 
individuals do not understand the purpose of the review process and 
their associated rights.
    Proposed Sec.  26.39(c) would require that more than one 
representative of the licensee's or other entity's management must 
conduct the review and that the reviewers may not be anyone who was 
involved in the original determination that the individual violated the 
FFD policy. These proposed clarifications are necessary because 
experience with implementing current Sec.  26.28 has indicated that, in 
some instances, the persons who were responsible for the initial 
determinations have been conducting reviews. The proposed requirements 
that the reviewers may not have been involved in the initial 
determination and that more than one management representative must 
conduct the review would strengthen the impartiality and objectivity of 
the review process in order to further enhance individuals' due process 
rights.
    Proposed Sec.  26.39(d) would add 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 would be necessary because the proposed rule permits 
licensees and other entities to share and rely on information gathered 
by other Part 26 programs to a greater extent than currently. 
Therefore, incorrect records related to an FFD policy violation could 
effectively bar an individual from further employment under a Part 26 
program if such information is transmitted to other licensees and 
entities who are considering whether to grant authorization to an 
individual. The proposed requirement to delete or correct any records 
associated with an FFD policy violation that has been overturned would 
protect individuals from such potential adverse consequences.
    Proposed Sec.  26.39(e) would amend the last sentence of current 
Sec.  26.28, which states that licensees and other entities are not 
required to provide a review procedure to a C/V's employees and 
applicants when the C/V is administering its own drug and alcohol 
testing. The proposed rule would amend the current paragraph in 
response to implementation questions from licensees who have asked 
whether the current provision excuses them from providing a review 
process for C/V employees at any time, including situations in which 
the FFD policy violation was determined as a result of testing 
conducted by the licensee. The proposed rule would revise this sentence 
to clarify that the licensee or other entity need not provide a review 
process if the FFD violation to be reviewed was identified through the 
C/V's drug and alcohol testing program. If the FFD violation was 
determined through the licensee's drug and alcohol testing, the 
licensee would continue to be required to provide the impartial and 
objective review.

Section 26.41 Audits and Corrective Action

    Proposed Sec.  26.41 [Audits and corrective action] would rename 
and amend current Sec.  26.80 [Audits]. The phrase, ``and corrective 
action,'' would be added to the section title 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 proposed rule would reorganize audit 
requirements in current Sec.  26.80, and move several audit and 
inspection requirements that are currently addressed in Appendix A to 
Part 26 into this section. These proposed changes would be made to meet 
Goal 6 of this rulemaking, which is to improve clarity in the 
organization and language of the rule.
    Proposed Sec.  26.41(a) [General] would amend the last sentence in 
current Sec.  26.80(a), which states that licensees retain 
responsibility for the effectiveness of C/V programs and the 
implementation of appropriate corrective action. The proposed paragraph 
would revise this requirement to include HHS-certified laboratories as 
well as any C/V FFD program elements and FFD programs upon which the 
licensee or other entity relies, which is consistent with the original 
intent of the current requirement. The proposed change would be to meet 
Goal 6 of this rulemaking, which is to improve clarity in the language 
of the rule.
    Proposed Sec.  26.41(b) [FFD program] would amend the required 
audit frequency in current Sec.  26.80(a). (The other requirements 
contained in current Sec.  26.80(a) are addressed in other paragraphs 
of proposed Sec.  26.41, as discussed with respect to the paragraphs of 
the proposed rule that address those topics.) The proposed rule would 
decrease the current 12-month FFD program audit frequency to a nominal 
24-month frequency, which would grant 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 proposed audit frequency would be decreased to 
24 months to relieve this burden and to be consistent with the NRC's 
schedule for inspecting FFD programs. The proposed change would be 
consistent with Goal 5 of this rulemaking, which is to improve Part 26 
by eliminating or modifying unnecessary requirements.
    Although the proposed rule would decrease the required audit 
frequency, licensees and other entities would be 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 proposed rule would require licensees and 
other entities to consider the frequency, nature, and severity of 
discovered problems, testing errors, personnel or procedural changes, 
previous audit findings, and ``lessons learned.'' The proposed change 
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.

[[Page 50499]]

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, did not 
take, or changes in processes. The purpose of these focused audits 
would be 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 proposed audit requirement 
would ensure that any programmatic problems that may result from 
significant changes in personnel, procedures, or equipment are detected 
and corrected on a timely basis. This proposed change would be made to 
meet Goal 3 of this rulemaking, which is to improve the effectiveness 
and efficiency of FFD programs, by requiring more frequent audits of 
FFD program elements that may require closer monitoring than a nominal 
24-month frequency would provide.
    Proposed Sec.  26.41(c) [C/Vs and HHS-certified laboratories] would 
amend the audit and inspection requirements for these entities that are 
contained in the second sentence of current Sec.  26.80(a) and the 
third sentence of Section 2.7(m) in Appendix A to Part 26, as follows:
    Proposed Sec.  26.41(c)(1) would further amend the requirement in 
current Sec.  26.80(a) for annual audits of C/V FFD programs and 
program elements and HHS-certified laboratories. The current annual 
audit frequency would be 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 would be audited under proposed Sec.  26.41(b). Retention of 
the annual audit requirement for C/Vs whose personnel work off site is 
necessary to ensure that the services provided continue to be 
effective, given that other means of monitoring their effectiveness, 
such as daily oversight, are unavailable. The proposed paragraph would 
also retain the annual audit requirement for HHS-certified 
laboratories. This audit frequency would be retained because of the key 
role the laboratories play in the overall effectiveness of Part 26 
programs. Retention of these annual audit requirements in the proposed 
paragraph would deny the petition for rulemaking (PRM-26-1) submitted 
by Virginia Power on December 30, 1993.
    Proposed Sec.  26.41(c)(2) would be added to relax some 
requirements related to annual audits and inspections of the HHS-
certified laboratories upon which licensees and other entities rely for 
drug testing services. The proposed rule would permit 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 would no longer require licensees and other entities to audit the 
effectiveness of services that are reviewed by HHS inspectors. The 
current rule contains a number of requirements that are inconsistent 
with the requirements for drug testing of other Federally mandated 
programs. For example, the current rule permits donors to request 
confirmatory alcohol testing of a blood specimen at an HHS-certified 
laboratory, which is not permitted by other Federal agencies, and some 
of the cutoff levels established in the current rule are higher, in the 
case of testing for marijuana metabolite, or lower, in the case of 
testing for opiates, than 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 these services 
are not addressed in the HHS inspections. However, as discussed in 
Section IV.B, the proposed rule would eliminate the majority of such 
discrepancies. Therefore, the annual audits of HHS-certified 
laboratories by licensees that have been necessary under the current 
rule would be redundant under the proposed rule, except in certain 
conditions described below. The proposed change would be made to meet 
Goal 5 of this rulemaking, which is to improve Part 26 by eliminating 
or modifying unnecessary requirements.
    Proposed Sec.  26.41(c)(2) would continue to require licensees and 
other entities to conduct annual audits of any services provided to the 
licensee or other entity that were not addressed in the annual HHS-
certification review. This annual audit requirement would be retained 
because proposed Sec.  26.31(d) would retain the permission in the 
current 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 in the proposed rule, the licensee or other entity would be 
required to ensure that annual audits of the HHS-certified services 
related to those cutoff levels and drug tests are performed.
    The last sentence of proposed Sec.  26.41(c)(2) would be added in 
response to stakeholder comments that were made during the public 
meetings discussed in Section V, related to the scope of the current 
audit requirements. The stakeholders noted that the scope of the 
current audit requirements is ill-defined in the current rule, which 
they believe has resulted in unnecessary variability between FFD 
programs and also an unnecessary burden. For example, the stakeholders 
noted that some FFD programs have interpreted the current rule as 
requiring annual audits of any substance abuse treatment program from 
which individuals who are subject to their FFD program may seek 
services as well as the entire national EAP company with whom the 
licensee or other entity contracts to obtain the services of one 
individual in the local geographical area. The stakeholders suggested 
that such audits are costly and have little relationship to continuing 
FFD program effectiveness. The scope of audit requirements was not 
specified in the current rule because there is a wide variety of 
contractual relationships between licensees, other entities, and C/Vs 
for FFD program services that make it impractical to establish limits 
that would be universally applicable. However, the examples provided by 
the stakeholders at the public meeting were convincing that some 
limitations on the scope of the audit requirements would be appropriate 
in the proposed rule. Therefore, the proposed rule would 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 would be 
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, under proposed Sec.  
26.187 [Substance abuse professional], the SAE would be required to 
monitor the substance abuse treatment of individuals who require it and 
so would have the qualifications and information necessary to assess 
the quality of the treatment services an individual receives. The SAE 
would have the authority to seek other services on behalf of the FFD 
program if he or she identifies weaknesses in a treatment program. 
Therefore, this change would be made to meet Goal 5 of this

[[Page 50500]]

rulemaking, which is to improve Part 26 by eliminating or modifying 
unnecessary requirements.
    Proposed Sec.  26.41(d) [Contracts] would incorporate and amend the 
requirements of current Section 2.7(m) in Appendix A to Part 26 and 
others, which address 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 current Section 2.7(m) in Appendix A to Part 26 
that relate to NRC inspections of HHS-certified laboratories would be 
moved to Sec.  26.221 [Inspections] in Subpart K of the proposed rule, 
consistent with Goal 6 of this rulemaking, which is to improve clarity 
in the organization and language of the rule.
    Proposed Sec.  26.41(d)(1) would amend the second sentence of 
current Section 2.7(m) in Appendix A to Part 26, which requires 
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 proposed rule would retain the current requirement with respect to 
HHS-certified laboratories, and expand 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 proposed 
paragraph would extend the current 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 off-site C/V is falsifying 
records or that a contract MRO or SAE is using drugs, and the licensee 
or other entity may determine that an unannounced audit would provide 
the most effective means to investigate such allegations. The proposed 
paragraph would ensure that the licensee's or other entity's contract 
with the C/V would permit the unannounced audit as well as access to 
any information necessary to conduct the audit. Therefore, this 
proposed change would be made to meet Goal 3 of this rulemaking, which 
is to improve the effectiveness and efficiency of FFD programs.
    Proposed Sec.  26.41(d)(2) would be added 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 proposed provision would respond to several 
incidents in which parties under contract to licensees did not permit 
Part 26 auditors to remove documents from a C/V's premises that were 
necessary to document audit findings, develop corrective actions, and 
ensure that the corrective actions were effective. Therefore, the 
proposed requirement would meet Goal 3 of this rulemaking, which is to 
improve the effectiveness and efficiency of FFD programs.
    The proposed paragraph would permit HHS-certified laboratories to 
reasonably limit the use and dissemination of the documentation that 
auditors copy and take away from the laboratories, in order to protect 
proprietary information and donors' confidentiality. This proposed 
permission would be added in response to stakeholder requests at the 
public meetings discussed in Section V. Because the current and 
proposed rules permit sharing of audit reports among licensees and C/Vs 
who rely on a laboratory, and it may be otherwise difficult to maintain 
appropriate control of proprietary information or donors' personal 
information, the NRC concurred with the stakeholders' request. This 
proposed change would meet Goal 7 of this rulemaking, as it relates to 
the privacy of individuals who are subject to Part 26, and would 
protect the trade secrets of HHS-certified laboratories who would 
continue to be subject to auditing under the proposed rule.
    Proposed Sec.  26.41(d)(3) would amend the third sentence of 
current Section 2.7(m) in Appendix A to Part 26, which requires 
licensees and other entities to carry out inspections and evaluation of 
the procedural aspects of an HHS-certified laboratory's drug testing 
operations before awarding a contract to the laboratory, by adding a 
cross-reference to proposed Sec.  26.41(g). Proposed Sec.  26.41(g) 
would permit licensees and other entities to forgo the otherwise 
required pre-award evaluation under certain specific circumstances, as 
discussed with respect to that paragraph.
    Proposed Sec.  26.41(e) [Conduct of audits] would retain the 
requirements in current Sec.  26.80(b).
    Proposed Sec.  26.41(f) [Audit results] would retain the portion of 
current Sec.  26.80(c) that requires 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 proposed paragraph would also add 
two requirements. The second sentence of proposed Sec.  26.41(f) would 
specify the required content of audit reports to include identification 
of any conditions that are adverse to the proper performance of the FFD 
program, the cause of the condition(s), and, when appropriate, 
recommended corrective actions. The third sentence of the proposed 
paragraph would require licensees and other entities to 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 proposed rule would add these two 
sentences for consistency with Criterion XVI in Appendix B to 10 CFR 
Part 50 to indicate that FFD audit reports are to be included in 
licensees' and other entities' corrective action programs. Some 
licensees have handled FFD audit reports outside of their normal 
corrective action programs, which address other conditions adverse to 
quality. As a result, some corrective actions for FFD program 
weaknesses have not been timely or effective. Therefore, the proposed 
rule would add these requirements to meet Goal 3 of this rulemaking, 
which is to improve the effectiveness and efficiency of FFD programs.
    The last sentence of current Sec.  26.80(c), which refers to the 
requirements for auditing HHS-certified laboratories in Appendix A to 
Part 26, would be deleted as redundant with proposed Sec.  26.41(c). 
This proposed change would be made to meet Goal 6 of this rulemaking, 
which is to improve clarity in the organization of the rule.
    Proposed Sec.  26.41(g) [Sharing of audits] would respond to 
licensees' implementation questions related to the third and fourth 
sentences in current Sec.  26.80(a), which permit licensees and other 
entities to accept audits of C/Vs that are conducted by other FFD 
programs. The proposed paragraph would clarify the current 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.
    Proposed Sec.  26.41(g) would amend the current provision to 
incorporate specific permission for licensees and other entities to 
jointly conduct audits as well

[[Page 50501]]

as rely on one another's audits. Reference to HHS-certified 
laboratories would also be added to indicate the applicability of these 
permissions to licensees' and other entities' audits of HHS-certified 
laboratories. These proposed changes would be consistent with the 
guidance issued by the NRC in the documents referenced above and 
current licensee practices. Therefore, the proposed changes would be 
made to meet Goal 6 of this rulemaking, which is to improve clarity in 
the organization and language of the rule.
    Proposed Sec.  26.41(g)(1) and (g)(2) would be added 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 
would not be permitted to rely on the shared audit with respect to the 
lower cutoff levels and would be 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 who use the same cutoff levels). These proposed provisions 
would be consistent with the guidance issued by the NRC in the 
documents referenced above and current licensee practices. Therefore, 
the proposed changes would be made to meet Goal 6 of this rulemaking, 
which is to improve clarity in the organization and language of the 
rule.
    Proposed Sec.  26.41(g)(3) would retain the portion of the third 
sentence of current Sec.  26.80(a) that states that licensees and other 
entities need not re-audit the same C/V for the same period of time, 
and extend this permission to audits of HHS-certified laboratories. 
Extending the current provision to cover audits of HHS-certified 
laboratories would be consistent with the guidance issued by the NRC in 
the documents referenced above and current licensee practices. 
Therefore, this proposed change would be made to meet Goal 6 of this 
rulemaking, which is to improve clarity in the organization and 
language of the rule.
    Proposed Sec.  26.41(g)(4) would retain the fourth sentence of 
current Sec.  26.80(a), which requires licensees and other entities to 
retain copies of the shared audit reports.
    Proposed Sec.  26.41(g)(5) would be added to permit licensees and 
other entities to immediately obtain drug testing services from another 
HHS-certified laboratory, subject to certain conditions, in the event 
that the laboratory used by the licensee or other entity should lose 
its certification. Within 3 months of obtaining services from the 
replacement laboratory, the proposed paragraph would require the 
licensee or other entity to ensure that an audit is conducted of any 
aspects of the laboratory's services that are used by the licensee or 
other entity that have not been audited within the past 12 months by 
another licensee or entity who is subject to this part. This proposed 
provision would enhance the effectiveness of FFD programs by ensuring 
that drug testing would 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 would be assured 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 proposed change would be made to meet Goal 3 of this rulemaking, 
which is to improve the effectiveness and efficiency of FFD programs.

Subpart C--Granting and Maintaining Authorization

Section 26.51 Purpose

    A new Sec.  26.51 [Purpose] would be added to describe the purpose 
of the proposed subpart. Proposed Sec.  26.51 would emphasize that 
Subpart C contains ``FFD requirements'' for granting and maintaining 
authorization because the NRC has also published other requirements 
that establish additional steps that licensees and other entities must 
take as part of the process of determining whether to grant 
authorization to an individual. These additional requirements, found in 
particular in 10 CFR 73.56 and access authorization orders issued by 
the NRC to nuclear power plant licensees, require the licensee or other 
entity to conduct a psychological assessment and a credit and criminal 
history check of the individual, and to interview persons who have 
knowledge of the applicant for authorization. A central goal of adding 
Subpart C to the proposed rule is to eliminate redundancies and ensure 
consistency between the FFD requirements and these other requirements.

Section 26.53 General Provisions

    A new Sec.  26.53 [General provisions] would provide a generic 
summary of the requirements and process for determining whether 
individuals may be granted and maintain authorization.
    Proposed Sec.  26.53(a) would introduce four new terms to Part 26: 
(1) ``initial authorization,'' (2) ``authorization update,'' (3) 
``authorization reinstatement,'' and (4) ``authorization with 
potentially disqualifying FFD information.'' These terms would be used 
to describe categories of proposed requirements for granting 
authorization. The proposed categories, which are based upon whether an 
individual who has applied for authorization has previously held 
authorization under Part 26 and the length of time that has elapsed 
since the individual's last period of authorization ended, are defined 
in proposed Sec.  26.55 [Initial authorization], proposed Sec.  26.57 
[Authorization update], proposed Sec.  26.59 [Authorization 
reinstatement], and proposed Sec.  26.69 [Authorization with 
potentially disqualifying fitness-for-duty information]. Proposed Sec.  
26.53(a) would direct licensees or other entities to use the criteria 
for granting authorization to individuals found in proposed Sec. Sec.  
26.55, 26.57, 26.59, or 26.69, depending on which of the proposed 
sections would apply to the individual seeking authorization. The 
current rule in Sec.  26.27 discusses actions that the licensee must 
take before the initial granting of access or assignment of specified 
duties to an individual, but does not use the concepts of ``initial 
authorization,'' ``authorization update,'' ``authorization 
reinstatement,'' or ``authorization with potentially disqualifying FFD 
information.'' These concepts would be used in the proposed rule to 
focus the requirements for authorization more precisely on whether the 
individual has established a ``track record'' in the industry, and to 
specify the amount of original information gathering that licensees or 
other entities would be required to perform according to whether 
previous FFD programs have collected information about the individual. 
In addition, the same concepts are used in access authorization 
requirements, so incorporating them into Part 26 would increase the 
consistency between the related regulations.
    Proposed Sec.  26.53(b) would define the meaning of the term, 
``interruption,'' which would be used in proposed Sec.  26.57 
[Authorization update] and

[[Page 50502]]

proposed Sec.  26.59 [Authorization reinstatement] to refer to the 
interval of time between periods during which an individual holds 
authorization under Part 26. Licensees and other entities would 
calculate an interruption in authorization as the total number of days 
falling between the day upon which the individual's last period of 
authorization ended and the day upon which the licensee or other entity 
grants authorization to the individual. Proposed Sec.  26.53(b) would 
also specify that if potentially disqualifying FFD information is 
disclosed or discovered about an individual, licensees and other 
entities must implement the applicable requirements in proposed Sec.  
26.69 [Authorization with potentially disqualifying fitness-for-duty 
information] in order to grant or maintain an individual's 
authorization, rather than relying on the requirements in proposed 
Sec. Sec.  26.55, 26.57, or 26.59, as discussed further with respect to 
proposed Sec.  26.69.
    Proposed Sec.  26.53(c) would reiterate the FFD training 
requirements in proposed Sec.  26.29 [Training] and the fatigue 
training requirements in proposed Sec.  26.197(c) [Training and 
examinations] to clarify that all individuals 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. The proposed paragraph would repeat the training 
requirements for organizational clarity, because they apply to the 
authorization process. As discussed in Section V, stakeholders 
requested that the proposed rule present requirements in the order in 
which they would apply to licensees' and other entities' FFD processes. 
Therefore, the proposed paragraph would be added to meet Goal 6 of this 
rulemaking, which is to improve clarity in the organization and 
language of the rule.
    Proposed Sec.  26.53(d) would permit licensees and other entities 
to rely upon other licensees' or entities' Part 26 programs and program 
elements, as well as licensee-approved Part 26 programs and program 
elements of C/Vs, to meet the requirements of this subpart for granting 
and maintaining authorization. Proposed Sec.  26.53(d) would expand 
upon two sections of the current rule that similarly permit licensees 
and other entities to accept and rely upon other Part 26 programs and 
program elements. Specifically, current Sec.  26.24(a)(1) permits 
licensees to accept results from drug and alcohol tests that were 
administered under another Part 26 program within the past 60 days, and 
current Sec.  26.23 [Contractors and vendors] permits licensees to rely 
upon C/Vs' Part 26 programs that have been formally reviewed and 
approved by the licensee. Consistent with the principle of permitting 
licensees to accept and rely upon other Part 26 programs in their 
authorization decisions, guidance contained in NUREG-1385 also 
indicates that licensees may ``accept'' an authorization granted by a 
previous licensee for individuals who transfer between licensees with 
only a ``short break'' in authorization. The proposed rule would 
substantially increase the specificity of the requirements that must be 
met by licensees or other entities for granting authorization and 
establish detailed minimum standards that all programs must meet. These 
proposed detailed minimum standards are designed to address recent 
changes in industry practices that have resulted in a more transient 
workforce, as noted in the discussion of Subpart C in Section IV. B. 
Because the FFD programs of licensees and other entities would be 
substantially more consistent than in the past under these proposed 
detailed standards, permitting licensees and other entities to rely on 
other Part 26 programs to meet the proposed rule's requirements is 
reasonable and appropriate. In addition, the proposed provision would 
eliminate unnecessary redundancies in the steps required to grant 
authorization to an individual who is transferring from one Part 26 
program to another.

Section 26.55 Initial Authorization

    A new Sec.  26.55 [Initial authorization] would define the category 
of ``initial authorization'' requirements to apply 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 whose last period of authorization ended favorably. Two 
considerations support the proposed requirement 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, requiring individuals whose 
last period of authorization ended 3 or more years previously to 
satisfy the same requirements as individuals who have never held 
authorization would increase the consistency of Part 26 with the 
related access authorization requirements.
    Proposed Sec.  26.55(a)(1) would require the licensee or other 
entity, before granting initial authorization to an individual, to 
obtain and review a self-disclosure in accordance with the applicable 
requirements of proposed Sec.  26.61 [Self-disclosure and employment 
history]. As discussed with respect to proposed Sec.  26.61, the self-
disclosure and employment history would require the individual to 
report violations, if any, involving drugs or alcohol and the 
individual's current and past employment history. The proposed 
requirement is similar to the requirement in Sec.  26.27(a)(1) of the 
current rule that a written statement must be obtained from the 
individual addressing the topics that are specified in current Sec.  
26.27(a)(1). The discussion of proposed Sec.  26.61 compares the topics 
required to be addressed in the written statement under the current 
rule with the topics that would be addressed in the self-disclosure 
under the proposed rule. As discussed with respect to proposed Sec.  
26.61(a)(3), the period of time to be addressed in the self-disclosure 
by an applicant for initial authorization would be the shorter period 
of either the past 5 years or the interval of time since the 
individual's eighteenth birthday.
    Proposed Sec.  26.55(a)(2) would require the licensee or other 
entity, before granting initial authorization to an individual, to 
complete a suitable inquiry in accordance with the applicable 
requirements of proposed Sec.  26.63 [Suitable inquiry]. The proposed 
requirement is similar to the requirement in Sec.  26.27(a)(2) of the 
current rule that a suitable inquiry must be completed addressing the 
topics that are specified in Sec.  26.27(a)(2). The discussion of 
proposed Sec.  26.63 compares the topics that must be addressed in the 
suitable inquiry under the current rule with the topics that would be 
addressed in the suitable inquiry under the proposed rule. Proposed 
Sec.  26.63(f)(1) specifies that the

[[Page 50503]]

period of time that the suitable inquiry would address for an initial 
authorization must be the shorter period of either the past 3 years or 
the interval of time since the individual's eighteenth birthday.
    Proposed Sec.  26.55(a)(3) would require the licensee or other 
entity, before granting initial authorization to an individual, to 
ensure that the individual is subject to pre-access drug and alcohol 
testing in accordance with the applicable requirements of proposed 
Sec.  26.65 [Pre-access drug and alcohol testing]. Current Sec.  
26.24(a)(1) requires testing within 60 days prior to the initial 
granting of unescorted access to protected areas or assignment to 
activities within the scope of Part 26. The discussion of proposed 
Sec.  26.65 compares the proposed pre-access drug and alcohol testing 
requirements for initial authorization to the requirements in the 
current rule. Proposed Sec.  26.65 would require 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, for the reasons 
discussed with respect to that section.
    Proposed Sec.  26.55(a)(4) would require the licensee or other 
entity also to ensure that the individual is subject to random drug and 
alcohol testing in accordance with the applicable requirements of 
proposed Sec.  26.67 [Random drug and alcohol testing of individuals 
who have applied for authorization]. Current Sec.  26.64(a)(2) requires 
unannounced drug and alcohol tests imposed in a statistically random 
and unpredictable manner. The discussion of proposed Sec.  26.67 
compares the proposed random drug and alcohol testing requirements for 
initial authorization to the requirements in the current rule.
    Proposed Sec.  26.55(b) would be added to require that the licensee 
or other entity must meet the requirements in proposed Sec.  26.69 
[Authorization with potentially disqualifying fitness-for-duty 
information] to grant authorization to the individual, if potentially 
disqualifying FFD information is disclosed or discovered about the 
individual who is applying for authorization that has not previously 
been evaluated by another licensee or other entity.

Section 26.57 Authorization Update

    Proposed new Sec.  26.57 [Authorization update] would define 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 proposed requirements for granting an 
authorization update would be less stringent than the proposed 
requirements for granting initial authorization. The proposed 
requirements would be less stringent for two reasons: (1) The 
individual who is applying for an authorization update would have a 
more recent ``track record'' of successful performance within the 
industry, and (2) the licensee or other entity would 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 proposed rule. However, the 
licensee or other entity would not have information about the 
individual's activities during the period of the interruption, so the 
proposed rule's requirements for an authorization update would focus on 
gathering and evaluating information from the interruption period. For 
example, in the case of an individual whose last period of 
authorization ended 2 years ago, the licensee or other entity would 
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 would 
focus on gathering information about the individual's activities within 
those 13 months.
    Proposed Sec.  26.57(a), like proposed Sec.  26.55(a), would 
require the licensee or other entity, before granting authorization, 
to: (1) Obtain and review a self-disclosure in accordance with the 
applicable requirements of proposed Sec.  26.61; (2) complete a 
suitable inquiry in accordance with the applicable requirements of 
proposed Sec.  26.63; (3) ensure that the individual is subject to pre-
access drug and alcohol testing in accordance with the applicable 
requirements of proposed Sec.  26.65; and (4) ensure that the 
individual is subject to random drug and alcohol testing in accordance 
with the applicable requirements of proposed Sec.  26.67. However, 
proposed Sec.  26.61(c)(3)(iii) would limit the period of time to be 
addressed in the self-disclosure and employment history to the 
interruption period. That is, 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, proposed Sec.  
26.63(f)(2) would provide that the suitable inquiry for an 
authorization update must cover the interruption period. The proposed 
rule would require only that the interruption period must be addressed 
in the self-disclosure, employment history, and suitable inquiry 
because the licensee or other entity would obtain information from 
earlier periods in the individual's history from the licensee or other 
entity who had last granted authorization to the individual.
    Proposed Sec.  26.57(b) would be added 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 in 
accordance with proposed Sec.  26.69.

Section 26.59 Authorization reinstatement

    A new Sec.  26.59 [Authorization reinstatement] would establish 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, for the reasons 
discussed in Section IV. C. One category of authorization reinstatement 
requirements would apply to individuals whose authorization has been 
interrupted for more than 30 days but no more than 365 days in proposed 
Sec.  26.59(a), and the other to individuals whose authorization has 
been interrupted for 30 or fewer days in proposed Sec.  26.59(c). The 
proposed steps for reinstating an individual's authorization after an 
interruption of 365 or fewer days would be less stringent than those 
required for initial authorization or an authorization update because 
these individuals have a recent, positive track record within the 
industry and so would pose little risk to public health and safety or 
the common defense and security.
    The proposed requirements that are related to an individual whose 
authorization has been interrupted for more than 30 days but no more 
than 365 days would be more extensive than the requirements for 
granting authorization to an individual whose authorization has been 
interrupted for 30 or fewer days. The proposed requirements for the 31-
365 day category would be consistent with those contained in the access 
authorization orders issued by the NRC to nuclear power plant licensees 
dated January 7, 2003. However, the proposed requirements for 
individuals whose authorization has been interrupted for 30 or fewer 
days

[[Page 50504]]

would be more stringent than those contained in the access 
authorization orders issued by the NRC to nuclear power plant licensees 
dated January 7, 2003. 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 the proposed rule, licensees and other entities 
would also be required to subject the individual to the possibility of 
being selected for pre-access testing in accordance with proposed Sec.  
26.65(e) [Authorization reinstatement after an interruption of 30 days 
or less]. The NRC has determined that this additional proposed 
requirement is necessary to meet the proposed rule's performance 
objective of providing reasonable assurance that individuals are 
trustworthy and reliable, as discussed with respect to proposed Sec.  
26.23(a), 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, proposed Sec.  26.59(a)(1) would require the licensee or other 
entity to obtain and review a self-disclosure and employment history in 
order to reinstate authorization. Consistent with the requirements for 
authorization updates in proposed Sec.  26.57, the proposed rule in 
Sec.  26.61(c)(3)(iii) would limit 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 would be unnecessary because the granting 
licensee or other entity would have access to information about the 
individual from the licensee or other entity who had recently 
terminated the individual's authorization.
    By contrast to the proposed requirements for an initial 
authorization and an authorization update, proposed Sec.  26.59(a)(2) 
would permit the licensee or other entity to reinstate an individual's 
authorization without first completing the suitable inquiry. The 
proposed rule would permit the licensee or other entity to reinstate 
the individual's authorization before completing the suitable inquiry 
because these individuals have a recent, positive track record within 
the industry and would pose little risk to public health and safety or 
the common defense and security. As would be required for an 
authorization update, the proposed rule would limit the period of time 
to be addressed by the suitable inquiry to the interruption period in 
proposed Sec.  26.63(f)(3). However, the proposed paragraph would 
require licensees and other entities to ensure that the suitable 
inquiry is completed within 5 days after reinstating the individual's 
authorization. If the suitable inquiry is not completed within the 5-
day period permitted, the proposed rule would permit the licensee or 
other entity to maintain the individual's authorization for up to 10 
days following the day upon which 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 the 10 days permitted, the proposed rule would 
require the licensee or other entity to administratively withdraw the 
individual's authorization until the suitable inquiry is completed.
    Proposed Sec.  26.59(a)(3) and (a)(4) would require the licensee or 
other entity to ensure that the individual whose authorization has been 
interrupted for 31-365 days is subject to pre-access drug and alcohol 
testing and random testing, respectively. Proposed Sec.  26.65(d) 
[Authorization reinstatement after an interruption of more than 30 
days] would establish pre-access drug and alcohol testing requirements 
for authorization reinstatements. Proposed Sec.  26.67 [Random drug and 
alcohol testing of individuals who have applied for authorization] 
would specify the requirements for random testing of individuals who 
are applying for an authorization reinstatement.
    Proposed Sec.  26.59(b) would be added to ensure that any 
administrative withdrawal of authorization that would be required under 
proposed Sec.  26.59(a)(2) would not be reported or recorded as an 
unfavorable termination of authorization, unless and until the suitable 
inquiry is completed and it indicates that authorization should not be 
granted. This proposed provision would ensure that an individual's 
temporary administrative withdrawal of authorization, caused by a delay 
in completing the suitable inquiry, would not be treated as an 
unfavorable termination caused by an FFD violation. This proposed 
provision would be necessary to meet Goal 7 of this rulemaking, which 
is to protect the due process rights 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.
    Proposed Sec.  26.59(c) would establish authorization requirements 
for individuals whose authorization has been interrupted for 30 or 
fewer days. Proposed Sec.  26.59(c)(1) would require the licensee or 
other entity to obtain and review a self-disclosure from the applicant 
for authorization with certain exceptions that would be specified in 
proposed Sec.  26.61 [Self-disclosure and employment history]. The 
licensee or other entity would be permitted to forego conducting a 
suitable inquiry for individuals whose authorization has been 
interrupted for such a short period. Proposed Sec.  26.59(c)(2) would 
permit 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, but pre-access testing may be required under 
proposed Sec.  26.65(e) for individuals whose authorization has been 
interrupted for 6-30 days. Exceptions to the self-disclosure and pre-
access testing requirements in this proposed paragraph would be 
specified in proposed Sec. Sec.  26.61 and 26.65, respectively.

Section 26.61 Self-Disclosure and Employment History

    A new Sec.  26.61 [Self-disclosure and employment history] would 
replace current Sec.  26.27(a)(1) for the reasons discussed in Section 
IV.C. The proposed rule would replace the term, ``written statement,'' 
in the current rule with the phrase,'' self-disclosure and employment 
history,'' to more accurately characterize the requirement. This 
proposed change would be made to meet Goal 6 of this rulemaking, which 
is to improve clarity in the language of the rule.
    Proposed Sec.  26.61(a) would be added to require licensees and 
other entities to obtain a written self-disclosure and employment 
history from every applicant before granting authorization to the 
individual, except in two circumstances, as follows:
    Proposed Sec.  26.61(a)(1) would permit 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 was subject to a behavioral observation and arrest-reporting 
program that meets the requirements of this part throughout the time 
interval during which the individual's authorization was interrupted. 
The information to be obtained from the self-disclosure and employment 
history would be unnecessary in these circumstances, because it would 
already be available to the granting licensee or

[[Page 50505]]

other entity from the Part 26 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 would 
be redundant and impose an unnecessary burden.
    Proposed Sec.  26.61(a)(2) would permit 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 would be 
unnecessary in this case, because the proposed rule would not require 
licensees or other entities to conduct a suitable inquiry for 
individuals who have had such a short break in authorization.
    Proposed Sec.  26.61(b) would be added to specify the required 
content of the self-disclosure. Affirmative responses to any of the 
questions in proposed Sec.  26.61(b)(1) would be considered potentially 
disqualifying FFD information, as defined in proposed Sec.  26.5 
[Definitions]. The proposed rule would expand the scope of the 
questions to be asked from those required in current Sec.  26.27(a)(1) 
in order to provide greater assurance that individuals would disclose 
information with regard to indicators of an active substance abuse 
problem or an increased risk of recidivism into an active substance 
abuse problem after treatment. Current Sec.  26.27(a)(2) requires 
information about whether the applicant ``tested positive for drugs or 
use of alcohol that resulted in on-duty impairment.'' Proposed Sec.  
26.61(b)(1) would require 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 current Sec.  26.27(a)(2) and proposed 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.
    Proposed Sec.  26.61(b)(2) would be added to require the applicant 
to disclose the circumstances surrounding any potentially disqualifying 
FFD information and the resolution of the matter. For example, proposed 
Sec.  26.61(b)(1) would require an applicant to report an arrest on 
drug-related charges, while proposed Sec.  26.61(b)(2) would require 
the applicant to report the outcome of the arrest (e.g., charges, a 
conviction, a finding of not guilty, the dropping of the charges).
    Proposed Sec.  26.61(b)(3) would define the time period to be 
addressed in the self-disclosure. The proposed rule would establish a 
time limit on the number of years in the past that an individual would 
be 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 there is a decrease in 
post-treatment recidivism (i.e., relapse) rates after 3 years of no 
further substance abuse, and a larger decrease in the recidivism rate 
after 5 years. If no indicators of a substance abuse problem within the 
past 5 years are disclosed (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 proposed Sec.  26.55) would 
not be required to disclose earlier substance-abuse-related events. For 
applicants who held authorization within the past 3 years, the self-
disclosure would address only the time interval since the individual's 
last period of authorization ended. However, the licensee or other 
entity would obtain further information about the applicant over the 
past 5 years from reviewing the information made available by licensees 
or other entities who had granted authorization to the applicant in the 
past. This information would include information developed as part of 
previous suitable inquiries (see proposed Sec.  26.63) as well as 
information from the period(s) during which the individual was subject 
to other Part 26 programs.
    Proposed Sec.  26.61(c) would be added to require applicants to 
provide information about current and past employers, which the 
licensee or other entity would then use for the suitable inquiry, if a 
suitable inquiry is required under proposed Sec.  26.63 [Suitable 
inquiry].
    Proposed Sec.  26.61(d) would replace and expand upon current Sec.  
26.27(a)(4). The proposed rule would add falsification of the self-
disclosure or employment history as sufficient reasons to deny 
authorization to an individual in order to deter falsification 
attempts. Reference to temporary access authorization would be deleted 
from the proposed paragraph because temporary access authorization 
would no longer be permitted under Part 26, for the reasons discussed 
in Section IV.C.

Section 26.63 Suitable Inquiry

    A new Sec.  26.63 [Suitable inquiry] would amend current 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 current Sec.  26.3 [Definitions]. The current 
rule defines 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 
proposed changes to the current requirements are intended to: (1) 
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; (2) 
increase the consistency in implementing suitable inquiries among FFD 
programs by providing more detailed requirements, also as discussed in 
Section IV.C; and (3) improve Part 26 by eliminating or modifying 
unnecessary requirements, which is Goal 5 of this rulemaking, as 
discussed in Section IV.B.
    For all authorization categories, the suitable inquiry would be 
more thorough than previous industry practices, in order to increase 
the likelihood that potentially disqualifying FFD information would be 
identified, if it existed, and to 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 period of time addressed in the suitable inquiry would be reduced 
from the past 5 years in every case, to the past 3 years or less, 
depending upon how recently the applicant held authorization. If 
potentially disqualifying FFD information within the past 5 years is 
identified regarding an applicant and the information has not been 
addressed and favorably resolved by a previous licensee or other 
entity, the suitable inquiry requirements would be more extensive, as 
described in proposed Sec.  26.69 [Authorization with

[[Page 50506]]

potentially disqualifying fitness-for-duty information].
    Proposed Sec.  26.63(a) would be added to require licensees and 
other entities to conduct a suitable inquiry for two purposes. One 
purpose would be to verify the information provided by the applicant in 
the self-disclosure and employment history obtained under proposed 
Sec.  26.61. The second purpose would be to determine whether 
additional potentially disqualifying FFD information is available 
regarding the applicant. The proposed paragraph would also establish 
the circumstances in which a licensee or other entity would be 
permitted to forego the suitable inquiry in order to grant 
authorization to individuals. A licensee or other entity would be 
permitted to forego the suitable inquiry 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 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 would be unnecessary in these 
circumstances, because it would 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.
    Proposed Sec.  26.63(b) would be added to permit licensees and 
other entities to rely upon suitable inquiry information that was 
gathered by previous licensees and other entities who are subject to 
this part. This proposed provision would reduce 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 proposed paragraph would also permit licensees and other 
entities to accept the results of any 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 in accordance with the same requirements 
under another Part 26 program. This proposed change would be made to 
meet Goal 5 of this rulemaking, which is to improve Part 26 by 
eliminating or modifying unnecessary requirements.
    Proposed Sec.  26.63(c) would be added to specify requirements for 
the manner in which licensees and other entities must conduct the 
suitable inquiry. Licensees and other entities would be required to 
demonstrate a ``best effort'' 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 an 
individual was employed by the company, 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 would require licensees and other entities to seek suitable 
inquiry information 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 proposed paragraph 
would be consistent with the ``best-efforts basis'' in current Sec.  
26.27(a)(2), but the proposed rule would provide more detailed 
requirements in response to questions that the NRC has received from 
licensees about implementing a suitable inquiry on a ``best effort'' 
basis since Part 26 was first promulgated.
    Proposed Sec.  26.63(c)(1) would be added to specify the type of 
information that the licensee or other entity must seek from employers 
regarding the applicant for authorization. The proposed paragraph would 
require 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 proposed requirement to obtain 
this information would be 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.
    Proposed Sec.  26.63(c)(2) would specify the type of information 
that licensees and other entities must seek when an applicant's claimed 
periods of employment include military service. The proposed 
requirement would be added 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.
    Proposed Sec.  26.63(c)(3) also would be added to provide 
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 proposed 
paragraph would 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 would be 
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 proposed Sec.  26.63(c)(3), the proposed 
paragraph would require 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 would not be limited to, a co-worker or 
supervisor at the same company who had personal knowledge of the 
applicant, if such an individual could be located. However, the 
proposed rule would prohibit 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 
proposed rule would permit 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. These proposed 
alternative methods of meeting the suitable inquiry requirement are 
necessary because, as discussed with respect to proposed Sec.  
26.63(c), some employers are unwilling or unable to provide suitable 
inquiry information.
    Proposed Sec.  26.63(d) would be added to require licensees and 
other entities who are subject to this part to share suitable inquiry 
information that they have collected when contacted by another licensee 
or entity who has a release that would permit the sharing of that 
information signed by the applicant for authorization. This proposed 
provision would restate the permission to release suitable inquiry 
information in current Sec.  26.29(b) as a requirement that licensees 
and other entities must

[[Page 50507]]

share the information necessary to conduct the suitable inquiry. The 
proposed provision would also clarify that the information must also be 
released to C/Vs who have licensee-approved FFD programs when the C/V 
presents the required signed release from the applicant. This proposed 
clarification is necessary because some licensees have misinterpreted 
current Sec.  26.29(b) as prohibiting the release of suitable inquiry 
information to C/Vs who have licensee-approved FFD programs. The 
proposed paragraph would also permit a licensee or other entity to deny 
authorization to an individual if the individual will not sign the 
release necessary to permit the licensee or other entity to conduct the 
suitable inquiry. The proposed provisions would be consistent with 
access authorization requirements established in 10 CFR 73.56, as 
supplemented by orders to nuclear power plant licensees dated January 
7, 2003.
    Proposed Sec.  26.63(e) would be added to permit licensees and 
other entities to use electronic means of obtaining the suitable 
inquiry information. This proposed permission would be 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 proposed paragraph would also add cross-references to the 
applicable records retention requirements in proposed Sec.  26.211 
[General provisions] and proposed Sec.  26.213 [Recordkeeping 
requirements for licensees and other entities] in proposed Subpart J 
[Recordkeeping and Reporting Requirements] to ensure that licensees and 
other entities are aware of the applicability of these requirements to 
the suitable inquiry information obtained electronically. The proposed 
change would be consistent with Goal 6 of this rulemaking, which is to 
improve clarity in the organization and language of the rule.
    Proposed Sec.  26.63(f) would be added specify the period(s) of 
time that the suitable inquiry must address for applicants for initial 
authorization, authorization update, and authorization reinstatement. 
The proposed paragraph would also specify additional requirements for 
conducting the suitable inquiry for these authorization categories, as 
follows:
    Proposed Sec.  26.63(f)(1) [Initial authorization] would require 
licensees and other entities to conduct a suitable inquiry to address 
the 3-year period preceding the date upon which the individual applies 
for authorization. The period of time to be addressed in the suitable 
inquiry for applicants for initial authorization who do not disclose 
any potentially disqualifying FFD information would be reduced from 5 
years in the current regulation to 3 years for two reasons: First, one 
purpose of the suitable inquiry is to identify indicators of an active 
substance abuse problem or an increased risk of recidivism following 
treatment. Therefore, if no potentially disqualifying FFD information 
is disclosed by an applicant for initial authorization 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 unlikely provide useful information and imposes an 
unnecessary burden. Second, industry experience has shown that 
employers are often reluctant to disclose adverse information to other 
private employers about former employees, and that 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 proposed rule would increase the thoroughness of the 
suitable inquiry into the past 3 years.
    Proposed Sec.  26.63(f)(1) would be added to require the licensee 
or other entity to conduct the suitable inquiry with every employer by 
whom the applicant claims to have been employed within the past year. 
This proposed requirement to conduct the suitable inquiry with every 
claimed employer would be a more rigorous suitable inquiry than was 
common industry practice prior to issuance of the January 7, 2003, 
access authorization orders, which imposed additional compensatory 
measures related to access authorization. The purpose of contacting 
every employer would be to ensure that the licensee or other entity 
sought information related to any active substance abuse problem. For 
the earlier 2 years of the suitable inquiry period, the proposed 
paragraph would require the licensee or other entity to conduct the 
suitable inquiry with every employer by whom the applicant claims to 
have been employed the longest within each calendar month. Contacting 
these employers would increase the likelihood that the employers would 
have knowledge of the applicant and so may provide more useful 
information than contacting employers by whom the applicant was 
employed only briefly.
    Proposed Sec.  26.63(f)(2) [Authorization update] would be added to 
specify 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 proposed paragraph would 
require the licensee or other entity to conduct the suitable inquiry in 
the same manner as described in proposed Sec.  26.63(f)(1). However, 
for an authorization update, the suitable inquiry would address only 
the period that the individual's authorization was interrupted, rather 
than the full 3 years that would be required for initial authorization. 
A 3-year period for the suitable inquiry would be unnecessary for these 
individuals, because the licensee or other entity would 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.
    Proposed Sec.  26.63(f)(3) [Authorization reinstatement after an 
interruption of more than 30 days] would specify 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 proposed rule would require 
licensees and other entities to contact employers by whom the applicant 
claims to have been employed the longest in each calendar month of the 
interruption. The proposed rule would not require licensees and other 
entities to contact every employer by whom the individual claimed to 
have been employed during the interruption for the reasons discussed 
with respect to proposed Sec.  26.59(a)(2). Because these individuals 
have had only a short break in authorization, a sampling of employers 
from the interruption period would be sufficient to determine whether 
any indications exist that the individual had 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 proposed Sec.  26.63(f)(1)-(f)(3) would be consistent 
with those established in the access authorization orders issued to 
nuclear power plant licensees dated January 7, 2003.

[[Page 50508]]

Section 26.65 Pre-Access Drug and Alcohol Testing

    Proposed Sec.  26.65 [Pre-access drug and alcohol testing] would 
amend current Sec.  26.24(a)(1), which requires 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 proposed section would amend the current pre-access 
drug and alcohol testing requirement for individuals who are seeking 
authorization under Part 26 to strengthen the effectiveness of FFD 
programs, as discussed in Section IV. C.
    Proposed Sec.  26.65(a) [Purpose] would be added to describe the 
purpose of the section and identify the individuals to whom the 
requirements in the proposed section would apply. The pre-access 
testing requirements in this section would cover applicants for 
authorization (1) 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 (2) about whom no 
potentially disqualifying FFD information has been discovered or 
disclosed that was not reviewed and favorably resolved by another 
licensee or entity. 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, would be contained in 
proposed Sec.  26.69 [Authorization with potentially disqualifying 
fitness-for-duty information].
    Proposed Sec.  26.65(b) [Accepting tests conducted within the past 
30 days] would be added to permit licensees and other entities to 
forego pre-access testing of an individual who has negative test 
results from drug and alcohol tests that were performed in accordance 
with 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 
proposed rule would permit 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 upon which authorization is granted to the individual. A 
requirement for the licensee or other entity to conduct pre-access 
testing in these circumstances would be redundant and unnecessary.
    Proposed 26.65(c) [Initial authorization and authorization update] 
would be added to establish pre-access testing requirements for 
individuals who are applying for initial authorization and an 
authorization update. The proposed rule would require negative results 
from pre-access testing before the licensee or other entity could grant 
authorization to the individual, except in the two circumstances 
described in proposed Sec.  26.65(c)(1) and (c)(2). In proposed Sec.  
26.65(c)(1), licensees and other entities would be permitted to forego 
pre-access testing if the applicant had been subject to drug and 
alcohol testing (including random testing), behavioral observation, and 
arrest-reporting requirements under a Part 26 FFD program throughout 
the period during which the individual's authorization was interrupted. 
In proposed Sec.  26.65(c)(2), licensees and other entities would be 
permitted to forego pre-access testing of an applicant who had negative 
test results from Part 26 drug and alcohol tests that were performed 
within the past 30 days and was subject to behavioral observation and 
arrest-reporting requirements during the time interval between the day 
upon which the specimens were collected and the day the licensee or 
other entity grants authorization to the individual. Pre-access testing 
in these two circumstances would be unnecessary because there would be 
sufficient opportunity to detect substance abuse without it.
    Proposed paragraphs Sec.  26.65(d) [Authorization reinstatement 
after an interruption of more than 30 days] and (e) [Authorization 
reinstatement after an interruption of 30 days or fewer] would be added 
to establish requirements for pre-access testing of individuals who are 
applying for an authorization reinstatement. The proposed requirements 
for pre-access testing of these individuals would be less stringent 
than the requirements for initial authorization and an authorization 
update. The proposed provision would also relax the pre-access testing 
requirements in current Sec.  26.24(a)(1), which require all applicants 
for authorization to be subject to pre-access testing within 60 days 
before granting authorization. Less stringent pre-access testing 
requirements would be appropriate because these individuals have (1) 
met the rigorous criteria for initial authorization; (2) established a 
recent record of successfully maintaining authorization under Part 26; 
and (3) had only a short break in authorization.
    Proposed Sec.  26.65(d) would specify pre-access testing 
requirements for individuals whose authorization has been interrupted 
for more than 31 days but no more than one year. Proposed Sec.  
26.65(d)(1)(i) would require the licensee or other entity to administer 
an alcohol test and collect a urine specimen for drug testing. The 
licensee or other entity would be permitted to reinstate the 
individual's authorization if the alcohol test results are negative, 
before the drug test results are available. Proposed Sec.  
26.65(d)(1)(ii) would permit the licensee or other entity to maintain 
the individual's authorization for 5 days after reinstatement without 
receiving the drug test results. But, if the licensee or other entity 
does not receive negative drug test results within 5 days of 
reinstating the individual's authorization, the proposed rule would 
require the licensee or other entity to administratively withdraw the 
individual's authorization until negative drug test results are 
received. These proposed requirements would 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 
proposed provisions would not unduly delay authorization reinstatement, 
given that these individuals' recent successful histories of 
maintaining authorization under Part 26 indicates that they are at low 
risk of engaging in substance abuse. Proposed Sec.  26.65(d)(2) would 
permit licensees and other entities to forego pre-access testing of 
these applicants for reinstatement in the circumstances discussed with 
respect to proposed Sec.  26.65(c)(1) and (c)(2).
    Proposed Sec.  26.65(e)(1) would be added to permit licensees and 
other entities to forego pre-access testing of applicants whose 
authorization has been interrupted for 5 or fewer days. This proposed 
provision would be consistent with current licensee practices and 
recommendations regarding ``short breaks'' in authorization in NUREG-
1385 and other access authorization requirements.
    However, proposed Sec.  26.65(e)(2) would require licensees and 
other entities to subject applicants whose authorization has been 
interrupted for 6-30 days to the possibility of being selected for pre-
access testing in order to deter any potential for substance abuse. 
Proposed Sec.  26.65(e)(2)(i) would require the licensee or other 
entity to subject the applicant to a one-time

[[Page 50509]]

chance of being selected for testing at a probability of approximately 
4 percent. This proposed probability approximates the likelihood that 
individuals who are subject to random testing at the 50 percent annual 
testing rate in proposed Sec.  26.31(d)(2)(vi) would be selected for 
testing at some point within a 30-day period. Proposed Sec.  
26.65(e)(2)(ii) would clarify that, if an applicant is not selected for 
pre-access testing under the preceding paragraph, the licensee or other 
entity would not be required to perform a pre-access test. Proposed 
Sec.  26.65(e)(2)(iii)(A) and (B) would specify requirements for 
conducting the pre-access testing, should an individual be selected for 
testing under proposed Sec.  26.65(e)(2)(i). The licensee or other 
entity would 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, the proposed rule 
would require that the licensee or other entity must receive negative 
drug test results within 5 days after reinstatement or administratively 
withdraw the individual's authorization until negative drug test 
results are received. However, proposed Sec.  26.65(e)(3) would permit 
licensees and other entities to forego subjecting an individual to the 
possibility of being selected for pre-access testing, if the applicant 
had 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; because being subject to these program elements during 
the interruption period would be sufficient to deter substance abuse 
and provide assurance that substance abuse would be detected. Proposed 
Sec.  26.65 would enhance 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.
    Proposed Sec.  26.65(f) [Time period for testing] would be added to 
require that specimens that are collected for any pre-access testing 
required in this proposed section must be collected within the 30-day 
period preceding the day upon which the licensee grants authorization 
to an individual. Under current Sec.  26.24(a)(1), licensees and other 
entities are permitted to complete pre-access testing within the 60-day 
period before authorization is granted. The shorter time period within 
which pre-access testing must be conducted, if required, in the 
proposed rule would increase 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 would be performed. In 
addition, the decreased time period for pre-access testing would 
increase the likelihood that recent drug use, particularly marijuana, 
would be detected before the concentration of metabolites in an 
individual's body could decrease below the cutoff levels prescribed in 
the proposed rule. The decreased time period within which pre-access 
testing must be performed in the proposed rule would provide higher 
assurance that individuals subject to this part are trustworthy and 
reliable, as demonstrated by the avoidance of substance abuse, as 
discussed with respect to proposed Sec.  26.23(a).
    Proposed Sec.  26.65(g) [Administrative withdrawal of 
authorization] would be added 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 
proposed paragraphs (d)(1)(ii) or (e)(2)(iii)(B) of this proposed 
section. The point in time at which a licensee or other entity receives 
drug test results would not be under the control of the applicant and 
would not reflect upon 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 would be inappropriate. Should the drug test 
results be non-negative and the licensee or other entity terminates the 
individual's authorization for cause, however, the termination would 
then be recorded as unfavorable.
    Proposed Sec.  26.65(h) [Sanctions for a confirmed non-negative 
pre-access test result] would be added to specify the minimum sanctions 
to be imposed on an individual whose pre-access test results are 
confirmed by the MRO as an FFD policy violation. Proposed Sec.  
26.65(h)(1) and (h)(2) would cross-reference the relevant sanctions 
specified in proposed Subpart D [Management Actions and Sanctions] to 
clarify that those sanctions would 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 would be required to impose the sanction 
for an attempt to subvert the testing process (i.e., permanent denial 
of authorization) in proposed Sec.  26.75(b).
    Proposed Sec.  26.65(h)(3) would be added to permit licensees and 
other entities to grant authorization to an individual whose confirmed 
non-negative test result is a first drug- or alcohol-related violation 
under a Part 26 program, consistent with current Sec.  26.27(b)(2). 
However, the proposed rule would permit authorization to be granted 
only in accordance with the stringent requirements contained in 
proposed Sec.  26.69 [Authorization with potentially disqualifying 
fitness-for-duty information].

Section 26.67 Random Drug and Alcohol Testing of Individuals Who Have 
Applied for Authorization

    A new Sec.  26.67 [Random drug and alcohol testing of individuals 
who have applied for authorization] would be added to extend current 
random testing requirements to individuals who have applied for 
authorization under Part 26 but to whom authorization has not yet been 
granted. The requirements contained the proposed section would be added 
to the access authorization requirements that were established by 
orders to nuclear power plant licensees dated January 7, 2003, for two 
reasons: (1) To enhance the effectiveness of FFD programs by increasing 
the likelihood that substance abuse would be detected before 
authorization is granted, and (2) to deter the potential for substance 
abuse among applicants.
    A new Sec.  26.67(a) would require licensees and other entities to 
conduct random testing of applicants in accordance with the 
requirements of proposed Sec.  26.31(d)(2). That is, the licensee or 
other entity would add applicants 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 would be subject to random testing beginning when the 
licensee or other entity collects the specimens for any required pre-
access test, and continuing thereafter, if the licensee or other entity 
grants authorization to the individual.
    Licensees and other entities would be permitted to forego random 
testing of applicants in the two circumstances described in proposed 
Sec.  26.67(a)(1) and (a)(2). Proposed Sec.  26.67(a)(1) would permit a 
licensee or other entity to discontinue random testing of any applicant 
to whom the licensee or other entity does not grant authorization for

[[Page 50510]]

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. Proposed Sec.  
26.67(a)(2) would address the circumstance described in proposed Sec.  
26.65(b), in which the licensee or other entity is permitted to meet 
pre-access testing requirements by relying upon negative test results 
from specimens collected under another Part 26 program within 30 days 
before granting authorization to the individual. Under proposed Sec.  
26.67(a)(2), the licensee or other entity would 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 actions may include, but are not limited to, the 
point in time at which the licensee or other entity receives the 
individual's signed consent form and begins creating a record of the 
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 upon the licensee's FFD and access 
authorization program procedures, whether the applicant's FFD training 
is up-to-date, and other factors, which, together, make it impractical 
to establish in the proposed rule a single point in the authorization 
process at which random testing must begin. Therefore, the proposed 
paragraph would require 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 would not define a specific 
formal action that would initiate random testing of applicants in all 
cases.
    Proposed Sec.  26.67(b) would be added to permit 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. That is, if the applicant has met all other 
applicable requirements for authorization, licensees and other entities 
need not delay granting authorization to the individual in order to 
conduct and obtain the results from a random test, if the applicant was 
selected for random testing while in applicant status. The proposed 
rule would not require the testing to be completed before the licensee 
or other entity grants authorization to the individual because the 
primary purpose of random testing of applicants would be to deter 
substance abuse rather than to provide information for the 
authorization decision. Pre-access testing provides the necessary 
information for authorization decision-making.
    Proposed Sec.  26.67(c) would cross-reference the minimum sanctions 
to be imposed on an individual whose drug or alcohol test results from 
random testing are confirmed as non-negative. Proposed Sec.  
26.67(c)(1) and (c)(2) would refer to the relevant sanctions specified 
in proposed Subpart D. Proposed Sec.  26.67(c)(3) would continue to 
permit licensees and other entities to grant authorization to an 
individual whose confirmed non-negative test result is a first drug- or 
alcohol-related violation under a Part 26 program, consistent with 
current Sec.  26.27(b)(2), but the proposed rule would permit 
authorization to be granted only in accordance with the stringent 
requirements contained in proposed Sec.  26.69 [Authorization with 
potentially disqualifying fitness-for-duty information].

Section 26.69 Authorization With Potentially Disqualifying Fitness-for-
Duty Information

    A new Sec.  26.69 [Authorization with potentially disqualifying 
fitness-for-duty information] would replace and clarify the existing 
requirements contained in Sec.  26.27(b)(4), which establishes 
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 5 years under the current 
rule. Consistent with Goal 6 of this rulemaking, which is to improve 
clarity in the organization and language of the rule, the proposed 
section would be added to address problems that have arisen in 
implementing the current rule and clarify the NRC's intent with respect 
to several situations that are not addressed in the current rule.
    Proposed Sec.  26.69(a) [Purpose] would be added to describe the 
purpose of the section and the applicants to whom the requirements in 
the proposed section would apply. The proposed rule would require 
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 an 
individual through any means and the information has not been assessed 
and favorably resolved by a previous licensee or other entity. Proposed 
Sec.  26.63(b) would permit licensees and other entities to rely upon 
the results of determinations of fitness that were conducted by 
previous licensees or other entities, 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 under another Part 26 program, licensees and 
other entities would implement the requirements contained in this 
proposed section.
    The proposed paragraph would also revise the language contained in 
current 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, would not be required to implement 
these requirements. At the public meetings discussed in Section V, 
stakeholders noted that some individuals have misinterpreted the 
current 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 current and proposed rules assign the responsibility for 
making authorization decisions to the licensee or other entity. 
Therefore, the proposed paragraph would clarify 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.''
    Proposed Sec.  26.69(b) [Authorization after a first confirmed 
positive drug or alcohol test result or a 5-year denial of 
authorization] would be added 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, as a result, was previously terminated unfavorably 
or denied for 5 years. The requirements in the proposed paragraph would 
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 current Sec.  26.26(b)(2), which 
would be moved to

[[Page 50511]]

proposed 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 proposed Sec.  26.75(c), (d), (e)(2), or (f). The 
proposed paragraph would replace and strengthen the requirements 
contained in current Sec.  26.27(b)(2) and expand them to address 
confirmed positive alcohol test results, which are excluded from this 
process in current Sec.  26.27(b)(5). The proposed paragraph would 
include confirmed positive alcohol test results for the reasons 
discussed with respect to proposed Sec.  26.75(e).
    Proposed Sec.  26.69(b)(1) would require the licensee or other 
entity to obtain and review a self-disclosure from the applicant to 
verify that it does not contain any previously undisclosed potentially 
disqualifying FFD information. Because the individual's last period of 
authorization was terminated unfavorably or denied, licensees and other 
entities would not be permitted to forego obtaining a self-disclosure 
and employment history under any circumstances, because it would be 
important to review the individual's activities during the interruption 
period. The period of time to be addressed in the self-disclosure would 
be the shorter of either the past 5 years or the intervening period 
since the individual last held authorization.
    Proposed Sec.  26.69(b)(2) would increase the scope of the suitable 
inquiry that the licensee or other entity must conduct 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 self-disclosure. This 
extensive suitable inquiry would be necessary to determine whether any 
indications exist that the individual has continued to engage in 
substance abuse. The proposed rule would also required 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 would not be 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. This information would be used by 
the SAE to assess the individual's fitness and the licensee's or other 
entity's reviewing official to determine whether authorization is 
warranted.
    Proposed Sec.  26.69(b)(3) would apply only to individuals whose 
authorization was denied for 5 years under the current rule or in 
accordance with Sec.  26.75(c), (d), (e)(2), or (f) of the proposed 
rule. The proposed paragraph would require 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 proposed requirement would be consistent with the portion of 
current Sec.  26.27(b)(4) that requires licensees to obtain 
``satisfactory medical assurance that the person has abstained from 
drugs for at least three years.'' However, the proposed rule would 
extend the requirement to 5 years to ensure that such an individual 
would be at the lowest risk of recidivism into an active substance 
abuse problem before the licensee or other entity could grant 
authorization to the individual.
    Proposed Sec.  26.69(b)(4) would amend the requirement in current 
Sec.  26.27(b)(2), which mandates 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 proposed paragraph would make 
several changes to the current provision. First, the proposed rule 
would replace the term, ``management and medical assurance of 
fitness,'' which is used in current Sec.  26.27(b)(2) and (b)(4), with 
the term, ``determination of fitness,'' to improve the accuracy of the 
language in the proposed rule. The proposed rule would not use 
``management'' because the licensee's or other entity's reviewing 
official (see the discussion of proposed Sec.  26.69(c)(3) and the 
definition of ``reviewing official'' in proposed Sec.  26.5 
[Definitions]) 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 proposed rule would 
permit professionals other than a licensed physician to conduct a 
determination of fitness, for the reasons discussed with respect to 
proposed Sec.  26.189 [Determination of fitness]. Therefore, this 
proposed change would be made to meet Goal 6 of this rulemaking, which 
is to improve clarity in the organization and language of the rule.
    Consistent with the intent of the current requirement, the proposed 
paragraph would require the licensee or other entity to ensure that a 
``determination of fitness'' is conducted, as defined in proposed Sec.  
26.189 [Determination of fitness], as part of the authorization 
decision. Proposed Sec.  26.187 [Substance abuse expert] would require 
that determinations of fitness that are conducted for authorization 
decisions must be performed by an SAE, whose role, responsibilities, 
and required qualifications would also be defined in proposed Sec.  
26.187. Therefore, proposed Sec.  26.69(b)(4) would require that the 
individual must be referred to an SAE for a determination of fitness, 
but the proposed rule would not require the SAE to be an EAP employee. 
Permitting licensees and other entities to rely upon a professional who 
meets the required qualifications for an SAE, rather than only on EAP 
personnel, would more appropriately focus this requirement on assuring 
that the professional who performs the assessment and treatment 
planning is qualified, rather than on the professional's organizational 
affiliation.
    Proposed Sec.  26.69(b)(4)(i)-(b)(4)(iii) would replace and 
strengthen the requirement in current Sec.  26.27(b)(2), which states 
that ``any rehabilitation program deemed appropriate must be initiated 
during such suspension period.'' The proposed paragraph would require 
that the individual must be in compliance with or have successfully 
completed treatment 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.
    Proposed Sec.  26.69(b)(5) would be added 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 proposed 
paragraph would require negative results from an alcohol test performed 
within 10 business days before authorization is granted. Similarly, the 
proposed paragraph would require negative results from a urine specimen 
that was collected for drug testing within 10 business days before 
authorization is granted, as well as collection of the urine specimen 
under direct observation. The proposed paragraph would prohibit the 
licensee or other entity from granting authorization to the individual 
before the drug test results are reported to the licensee's or other 
entity's MRO so that the MRO may determine whether the drug test 
results indicated that the individual has not engaged in any further 
drug abuse [see the discussion of proposed Sec.  26.69(f)]. Completing 
drug and alcohol testing within 10 days

[[Page 50512]]

before granting authorization, rather than the 30 days that is 
permitted in proposed Sec.  26.65(f) [Time period for testing] for the 
other authorization categories, would provide evidence that the 
individual has abstained from abusing proscribed substances during the 
interruption period and that the individual would be 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 current Sec.  26.27(b)(2) 
and retained in proposed Sec.  26.75(e)(1). Requiring direct 
observation of the urine specimen collection would be necessary to 
provide added assurance that the specimen is valid and yields accurate 
drug test results.
    Proposed Sec.  26.69(b)(6) would apply 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 
proposed paragraph would replace the third sentence of current Sec.  
26.27(b)(4), which establishes requirements and a schedule for followup 
drug and alcohol testing for an individual whose authorization was 
denied for 3 years under the current rule, and apply the requirement 
for followup testing to individuals who have had a first confirmed 
positive test result for drugs or alcohol. The proposed requirement 
would provide greater deterrence of further drug and alcohol use than 
current Sec.  26.27(b)(4), which requires 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 
would provide higher assurance that individuals who are subject to this 
part are trustworthy, reliable, and fit for duty.
    Proposed Sec.  26.69(b)(6) would amend the current 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 
proposed rule would require licensees and other entities to ensure that 
the individual is subject to unannounced testing at least 15 times 
within the 3-year period and verify that the individual's test results 
are negative. Either random or followup tests, which are both 
unannounced, may be used to meet this proposed requirement. The 
proposed rule would require licensees and other entities to distribute 
the unannounced tests over the 3-year period, with at least one 
unannounced test conducted each quarter.
    Proposed Sec.  26.69(b)(6)(i)-(b)(6)(iii) would be added to address 
circumstances in which an individual is not continuously subject to a 
Part 26 program during the 3 years following restoration of 
authorization. Proposed Sec.  26.69(b)(6)(i) would require 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. Proposed Sec.  
26.69(b)(6)(ii) would permit 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 proposed 15-test 
requirement. Proposed Sec.  26.69(b)(6)(iii) would permit 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 due 
to brief and infrequent periods of authorization.
    These proposed changes to the current followup testing requirements 
respond to information provided by stakeholders in the public meetings 
discussed in Section V. Stakeholders reported that some individuals who 
are subject to followup testing have been unable to satisfy the 
requirements of current Sec.  26.27(b)(4) because they are not 
continuously employed in the nuclear industry in job positions that 
require authorization, and, therefore, are not continuously subject to 
a Part 26 FFD program. As a result, these individuals have been unable 
to demonstrate negative test results on tests that are performed ``once 
every month for four months and at least once every three months for 
the next two years and eight months after unescorted access is 
reinstated.'' Stakeholders reported that some individuals have been 
unable to satisfy the current requirement after 10 years, despite 
obtaining negative test results on every pre-access, random, and 
followup test administered during that period, because the individuals 
were not continuously subject to a Part 26 followup testing program for 
the required 3-year period. This was not the intent of the current 
provision. Therefore, the proposed revision to this requirement would 
increase the flexibility with which licensees and other entities may 
implement followup testing requirements, but retain the current 
effectiveness of followup testing in detecting and deterring substance 
abuse.
    Proposed Sec.  26.69(b)(7) would be added to require 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 restoration of the individual's authorization indicate no 
further drug or alcohol abuse. The proposed paragraph would 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 proposed 
Sec.  26.185(o), would be required to determine whether the results 
indicate new drug use or are consistent with results that would be 
expected from the drug use that resulted in the previous confirmed 
positive test result. The proposed rule would add this requirement in 
response to inconsistencies in the manner in which some MROs have 
implemented current 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 proposed change would permit 
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 
proposed Sec.  26.75(e)(2).
    Proposed Sec.  26.69(c) [Granting authorization with other 
potentially disqualifying FFD information] would be added to establish 
requirements for granting authorization to an individual about whom 
potentially disqualifying FFD information is discovered or disclosed 
that was not a confirmed non-negative drug or alcohol test result or 5-
year denial of authorization. For example, this type of potentially

[[Page 50513]]

disqualifying FFD information may include, but would not be limited to: 
(1) A report of an arrest for an alcohol-related traffic violation; (2) 
information from the suitable inquiry that an individual's employment 
was terminated by a previous private-sector employer 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. The 
proposed paragraph would be necessary because the current rule does not 
address the authorization process in such circumstances and the NRC is 
aware that licensees and other entities have handled these 
circumstances inconsistently. Therefore, the proposed rule would add 
these requirements to establish the NRC's intent with respect to these 
circumstances and increase consistency between Part 26 programs.
    Proposed Sec.  26.69(c)(1) would be added to require the licensee 
or other entity to verify that the individual's self-disclosure 
addresses the applicable period specified in proposed Sec.  
26.61(b)(3). The proposed rule would not require the licensee or other 
entity to ``obtain'' a self-disclosure in all circumstances, because 
the individual may have already provided a self-disclosure under 
proposed Sec. Sec.  26.55, 26.57, or 26.59 and an additional self-
disclosure and employment history would be unnecessary.
    Proposed Sec.  26.69(c)(2) would require the licensee or other 
entity to conduct a suitable inquiry with every employer for the period 
that would be addressed in the self-disclosure and employment history. 
If the potentially disqualifying FFD information was identified during 
the course of conducting a suitable inquiry in accordance with proposed 
Sec.  26.63(f) so that the suitable inquiry was partially completed, 
proposed Sec.  26.69(c)(3) would require 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 
proposed paragraph would also require the licensee or entity to 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. This more complete suitable inquiry would be 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.
    Proposed Sec.  26.69(c)(3) would be added and would use the term, 
``reviewing official,'' to refer to the employee who is designated by 
the licensee or other entity to make authorization decisions, as 
discussed with respect to proposed Sec.  26.5 [Definitions]. The 
proposed paragraph would permit 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 proposed paragraph 
also would grant 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, proposed Sec.  26.69(c)(4) would require the licensee or 
other entity to implement the treatment and testing recommendations.
    Proposed Sec.  26.69(c)(5) would be added to require pre-access and 
random testing of the applicant for authorization. The proposed 
paragraph would require 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. The proposed rule would 
require the licensee or other entity to verify that test results are 
negative before granting authorization to the individual to provide 
evidence that the individual is avoiding substance abuse.
    Proposed Sec.  26.69(d) [Maintaining authorization with other 
potentially disqualifying FFD information] would be added to establish 
requirements for maintaining an individual's authorization when new 
potentially disqualifying FFD information is disclosed or discovered 
that was not a confirmed non-negative 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 would not be required because the 
individual would not be applying for authorization. However, the 
proposed paragraph would require the reviewing official to review 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 proposed paragraph 
would require the licensee or other entity to implement any treatment 
or testing requirements resulting from the determination of fitness. 
The proposed paragraph would be added because the current rule does not 
address maintaining an individual's authorization in such circumstances 
and the NRC is aware that licensees and other entities have handled 
these circumstances inconsistently. Therefore, the proposed rule would 
add these requirements to establish the NRC's intent with respect to 
these circumstances and increase consistency between Part 26 programs.
    A new Sec.  26.69(e) [Accepting followup testing and treatment from 
another Part 26 program] would establish continuity of care 
requirements for individuals who were subject to a followup testing and 
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. The proposed paragraph would require the receiving licensee 
other entity to continue the testing and treatment plan to which the 
individual was subject under the previous FFD program. The proposed 
rule would also permit the receiving licensee or other entity to accept 
and rely upon any followup testing that was completed while the 
individual was subject to the previous Part 26 program in determining 
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, then the granting licensee would administer 
the final year of the followup testing, but would not be required to 
``re-start the clock'' and 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, then the proposed paragraph would permit the 
receiving licensee or other entity to accept the previous determination 
of fitness and would not require the granting licensee to develop and 
implement an additional testing and treatment plan.
    Proposed Sec.  26.69(f) [Sanctions for confirmed non-negative drug 
and alcohol test results] would be added to

[[Page 50514]]

clarify the minimum sanctions to be imposed on an individual who has 
confirmed non-negative drug and alcohol test results on any tests that 
may be required under this proposed section. Proposed Sec.  26.69(f)(1) 
and (f)(2) would cross-reference the relevant sanctions specified in 
proposed Subpart D [Management actions and sanctions] to establish that 
those sanctions would apply to individuals about whom potentially 
disqualifying FFD information has been discovered or disclosed.

Section 26.71 Maintaining Authorization

    Proposed Sec.  26.71 [Maintaining authorization] would be added to 
state the requirements for maintaining authorization under this part. 
The proposed section would respond to stakeholder requests for this 
clarification at the public meetings discussed in Section V.
    Proposed Sec.  26.71(a) would provide that individuals may maintain 
authorization under the conditions listed in proposed Sec.  
26.71(a)(1)-(a)(4), as follows:
    Proposed Sec.  26.71(a)(1) would establish that an individual must 
comply with the licensee's or other entity's FFD policies to which the 
individual is subject. This proposed requirement thus relates, although 
it does not refer, to proposed Sec.  26.27 [Written policy and 
procedures], which would require 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 it. The 
proposed rule would require that all individuals who are subject to the 
FFD policy must have information on what is expected of them and what 
consequences may result from a lack of adherence to the policy. 
Proposed Sec.  26.71 would also require that, in order to maintain 
authorization, an individual must report any legal actions, as defined 
in proposed Sec.  26.5 [Definitions]. Finally, although not explicitly 
specified in proposed Sec.  26.71(a)(1), proposed Sec.  26.33 
[Behavioral observation] would require individuals to report any FFD 
concern to the personnel designated in the FFD policy.
    Proposed Sec.  26.71(a)(2) would establish 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 proposed Sec.  26.31 
[Drug and alcohol testing], and 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).] In addition, 
proposed Sec.  26.31 also would place certain responsibilities on 
individuals who are subject to the testing program. In particular, 
under proposed Sec.  26.31(d)(2)(iii), individuals who are selected for 
random testing would be required to report to the collection site as 
soon as reasonably practicable after notification, and 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.
    Proposed Sec.  26.71(a)(3) would establish 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 proposed Sec.  26.33 
[Behavioral observation], would be 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.
    Proposed Sec.  26.71(a)(4) would establish that a condition for 
maintaining authorization is successful completion by the individual of 
required FFD training, according to the schedule in proposed Sec.  
26.29(c). As specified in proposed Sec.  26.29(c)(1), the proposed rule 
would require the individual to complete training before the licensee 
or other entity grants initial authorization. Thereafter, as specified 
in proposed Sec.  26.29(c)(2), the proposed rule would require 
individuals to complete refresher training or pass a comprehensive 
examination on a nominal 12-month frequency. Proposed Sec.  26.29(d) 
would provide that licensees and other entities may accept training of 
individuals who have been subject to another Part 26 program and have, 
within the past 12 months, either had initial or refresher training or 
successfully passed a comprehensive examination that meets the 
requirements of proposed Sec.  26.29.
    Proposed Sec.  26.29(d) would require a licensee or other entity to 
terminate an individual's authorization if the individual, for more 
than 30 [consecutive] days, is not subject to an FFD program that meets 
the requirements of Part 26. The requirements of the proposed paragraph 
would permit 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 would not be reasonably 
available for behavioral observation or to collect specimens for random 
drug and alcohol testing. The proposed paragraph would be added in 
response to stakeholder requests and would be 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

Section 26.75 Sanctions

    The first sentence of proposed Sec.  26.75(a) would introduce the 
purpose of the section, which would be to define the minimum 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 proposed paragraph would restate the second sentence of 
current Sec.  26.27(b), which permits licensees and other entities to 
impose more stringent sanctions than those specified in the rule. The 
proposed rule would add a reference to paragraph (h) of the proposed 
section, which would establish limits on the sanctions that licensees 
and other entities may impose for non-negative validity and drug test 
results, to clarify that there is one exception to the blanket 
permission to impose more stringent sanctions granted in this 
paragraph, as discussed with respect to proposed paragraph (h) of this 
section. These proposed changes would be made to meet Goal 6 of this 
rulemaking, which is to improve clarity in the organization and 
language of the rule.
    Proposed Sec.  26.75(b) would be added 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. The proposed 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

[[Page 50515]]

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, the proposed change would be made to meet Goal 3 
of this rulemaking, which is to improve the effectiveness of FFD 
programs, 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.
    The proposed rule would specify three examples of actions that 
would be 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 had 
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 would expect the 
licensee or other entity to permanently deny authorization to all of 
the individuals who were involved in the collusion.
    The proposed rule would 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 proposed Sec.  26.185(g). Submitting a dilute specimen, in 
itself, would 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 current rule and in proposed Sec.  26.109(b)(1). Therefore, the 
proposed rule would 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 phrase, ``for any test required under this part,'' would be 
added to proposed Sec.  26.75(b) to indicate that applicants for 
authorization who subvert or attempt to subvert a pre-access or random 
test would also be subject to permanent denial of authorization. 
Although these individuals would not yet be performing any job 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 job duties. Therefore, it is necessary to 
ensure that any applicant who subverts or attempts to subvert the 
testing process would be denied authorization.
    Proposed Sec.  26.75(c) would amend current Sec.  26.27(b)(3), 
which establishes 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 proposed paragraph 
would retain the current sanction of a 5-year denial of authorization 
in these instances and add two other instances in which a 5-year denial 
of authorization would be required.
    First, the proposed rule would require 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 proposed change 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 
current sanction to alcohol consumption also would be consistent with 
the revised FFD program performance objective in proposed 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, the proposed change would be made 
to meet Goal 3 of this rulemaking, which is to improve the 
effectiveness of FFD programs, by reducing the risk to public health 
and safety and the common defense and security that on-site use of 
alcohol poses.
    Second, the proposed rule would add the phrase, ``or while 
performing the job duties that require the individual to be subject to 
this part,'' to address circumstances in which an individual may be 
performing job duties that require him or her to be subject to this 
part but is not performing those duties 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 current rule is 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 current 
rule does not specifically address such circumstances. The majority of 
licensees have appropriately interpreted the intent of the current 
rule, but the proposed rule would add this phrase to meet Goal 6 of 
this rulemaking, which is to improve clarity in the organization and 
language of the rule.
    In addition, the list of activities in the current paragraph that 
an individual would be prohibited from performing would be deleted in 
the proposed paragraph and replaced with the summary term, 
``authorization,'' for consistency with the use of this term throughout 
the proposed rule. As discussed with respect to proposed Sec.  26.25 
[Individuals subject to the fitness-for-duty program], the list of job 
duties that require individuals to maintain authorization and to be 
subject to this part would be presented once in proposed Sec.  26.25, 
rather than repeatedly throughout the rule, for consistency with Goal 6 
of this rulemaking, which is to improve clarity in the organization and 
language of the rule.
    Proposed Sec.  26.75(d) would amend the portion of current Sec.  
26.27(c) that requires licensees 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 
current provision has raised implementation questions from licensees 
regarding the appropriate action to take in these circumstances. 
Licensees have questioned whether the intent of the current requirement 
is to deny authorization to an individual for some period of time, as 
required under current Sec.  26.27(b)(2)-(b)(4), permanently deny 
authorization to the individual, or merely to record the resignation. 
Therefore, the proposed rule would clarify the intent of the current 
provision, as follows:

[[Page 50516]]

    The proposed rule would establish 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 
proposed paragraph would establish a 5-year denial of authorization 
because the confirmed positive drug or alcohol test result, in 
combination with such a resignation, would be 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 proposed Sec.  
26.189 [Determination of fitness]. Therefore, prohibiting the 
individual from being granted authorization for a 5-year period would 
give the individual an opportunity to seek treatment and establish a 5-
year history of sobriety, which would be required to regain 
authorization under proposed Sec.  26.69 [Authorization with 
potentially disqualifying fitness-for-duty information], while also 
ensuring that such an individual is not granted authorization without 
having demonstrated that he or she has overcome the substance abuse 
problem.
    In addition, for any type of FFD policy violation, the proposed 
paragraph would require 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 would be necessary to 
ensure that any licensees or other entities who may consider granting 
authorization to the individual in the future would be aware of the 
individual's behavior and the nature of the FFD policy violation. 
Subsequent licensees and other entities would 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, proposed Sec.  26.75(g) would prohibit a subsequent 
licensee or other entity from granting authorization to the individual 
under any circumstances.
    The portion of current Sec.  26.27(c) that refers to a refusal to 
provide a specimen for testing would be moved to proposed Sec.  
26.75(b) for organizational clarity, as discussed with respect to that 
paragraph.
    Proposed Sec.  26.75(e) would amend current Sec.  26.27(b)(2) and 
expand its scope to include alcohol. Abuse of alcohol would no longer 
be excluded from the sanctions specified in this proposed 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 job 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 job duties under this part, the proposed rule would impose the 
same sanctions for abusing alcohol as those required for abusing drugs 
in the proposed paragraph. The proposed change would be made to meet 
Goal 3 of this rulemaking, which is to improve the effectiveness of FFD 
programs.
    Proposed Sec.  26.75(e)(1) would retain the intent of the second 
sentence of current Sec.  26.27(b)(2), which states 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 proposed paragraph would require 
licensees and other entities to terminate the individual's 
authorization for at least 14 days, rather than ``remove'' the 
individual. At the public meetings discussed in Section V, 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, with which the NRC concurred.
    The stakeholders also requested that the requirements in the 
current paragraph related to referring the individual to the EAP for 
assessment and counseling be eliminated from proposed Sec.  
26.75(e)(1). 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 current provision as requiring them to 
provide EAP services to individuals who are no longer in their employ. 
The NRC concurs that the intent of the current rule is for licensees 
and other entities to provide assessment and counseling services only 
in those instances in which the licensee or other entity desires to 
reinstate the individual's authorization. Therefore, the proposed 
change would be made to clarify the intent of the provision.
    The proposed rule would also move the requirements in the current 
paragraph that are related to permitting the individual to regain 
authorization from this section to proposed Subpart C [Granting and 
Maintaining Authorization], because this section would address 
sanctions for FFD policy violations, rather than FFD requirements for 
granting authorization. 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 
would be addressed in proposed Sec.  26.69(b) [Authorization after a 
first confirmed positive drug or alcohol test result or a 5-year denial 
of authorization] of proposed Subpart C. This proposed change would be 
made for organizational clarity in the rule.
    Proposed Sec.  26.75(e)(2) would increase the length of the period 
for which licensees and other entities must deny an individual's 
authorization for a second confirmed positive test result from 3 years 
in current Sec.  26.27(b)(vii) to 5 years. This proposed change would 
be made to provide higher assurance that individuals who have had a 
second confirmed positive 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 upon the research literature indicating that individuals who 
abstain from substance abuse for 5 years after

[[Page 50517]]

treatment are less likely to relapse than individuals who have been 
able to abstain for 3 years. In addition, the proposed more stringent 
sanction for a second confirmed positive test result would provide 
greater deterrence to recidivism than the current 3-year period.
    Proposed Sec.  26.75(f) would amend current Sec.  26.27(b)(5), 
which states that the sanctions for confirmed positive drug test 
results in current Sec.  26.27 do not apply to the misuse of alcohol, 
valid prescriptions, and over-the-counter drugs, but requires 
licensees' FFD policies to establish sanctions that are sufficient to 
deter misuse of those substances. The proposed rule would require 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. Some licensees, however, have imposed lesser 
sanctions for alcohol violations, an approach that is inconsistent with 
the NRC's intent. Therefore, the proposed rule would rectify this 
situation by explicitly requiring the same minimum sanctions for abuse 
of alcohol as currently required for the use of illegal drugs.
    In addition, proposed Sec.  26.75(f) would require licensees and 
other entities to impose the same sanctions as required for abuse of 
illegal drugs if the MRO determines that misuse of prescription drugs 
or over-the-counter medications that results in a positive drug or 
alcohol test result represents substance abuse. The MRO would make this 
determination in accordance with proposed 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 cold and cough preparations available over-the-
counter containing alcohol or other active ingredients that may cause 
impairment. However, the same substances may be used by an individual 
who has a substance abuse problem. 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 the proposed paragraph, 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 would be 
required to impose the minimum sanctions specified in this proposed 
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 
proposed rule would require the licensee or other entity to impose the 
sanctions for substance misuse that the licensee or entity would 
specify in the FFD policy.
    The proposed rule would also revise but retain the requirement in 
the last sentence of current Sec.  26.27(b)(5), which states that 
sanctions for the misuse of prescription and over-the-counter drugs 
must be sufficient to ``deter abuse of legally obtainable substances.'' 
These sanctions must be sufficient to deter the misuse of prescription 
and over-the-counter medications because such misuse may lead to 
impairment on the job. However, the proposed rule would eliminate the 
phrase, ``as a substitute for abuse of proscribed drugs,'' in the last 
sentence of current Sec.  26.27(b)(5) because it unnecessarily limits 
the circumstances in which sanctions for the misuse of prescription and 
over-the-counter drugs would be imposed.
    Proposed Sec.  26.75(g) would amend current Sec.  26.27(b)(4). The 
portions of the current paragraph that establish requirements for 
granting authorization to an individual who has violated the licensee's 
or other entity's FFD policy would be moved to proposed Sec.  26.69 
[Authorization with potentially disqualifying fitness-for-duty 
information] in Subpart C [Granting and Maintaining Authorization] for 
organizational clarity because proposed Sec.  26.75(g) would only 
address sanctions for FFD policy violations. The proposed paragraph 
would retain the portion of the current paragraph that requires 
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 proposed rule would require an individual's 
authorization to be denied permanently if he or she has another 
confirmed positive drug or alcohol test result after he or she has had 
authorization denied for 5 years in accordance with other paragraphs in 
this proposed section. This proposed more stringent sanction would 
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 perform the job duties listed in proposed Sec.  26.25 
[Individuals subject to the fitness-for-duty program].
    Proposed Sec.  26.75(h) and (i) would amend current Sec.  
26.24(d)(2), which permits 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, the proposed rule would 
divide the current paragraph into two paragraphs to separate the 
requirements related to the conditions under which licensees and other 
entities may and may not take action on the basis of initial test 
results.
    Proposed Sec.  26.75(h) would continue to prohibit licensees and 
other entities from taking administrative actions or imposing sanctions 
on an individual based on an positive initial drug test result reported 
by an HHS-certified laboratory. The proposed paragraph would also 
continue to permit 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 proposed 
rule would require that the urine specimen that yields a non-negative 
drug test result(s) must also appear to be a valid specimen, based upon 
the results of validity screening or initial validity test results at 
the licensee testing facility. In addition, the proposed paragraph 
would prohibit licensees and other entities from imposing sanctions or 
taking other actions in response to non-negative validity screening or 
initial validity test results from a specimen in which no drug 
metabolites were detected. This proposed prohibition would be added 
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 would risk imposing substantial burdens 
on individuals from false non-negative test results. Therefore, this 
prohibition would be added to meet Goal 7 of this rulemaking, which is 
to protect the due process rights of individuals who are subject to 
Part 26.
    Proposed Sec.  26.75(i)(1)-(4) would retain the requirements in 
current Sec.  26.24(d)(2)(i)-(iv) that establish the conditions under 
which licensees and other entities may take administrative

[[Page 50518]]

actions on the basis of a positive initial drug test result for 
marijuana or cocaine metabolites from a licensee testing facility. The 
proposed rule would add a requirement for specimen validity testing 
(see the discussion of proposed Sec.  26.31(d)(3)(i) with respect to 
the addition of validity testing requirements in the proposed rule) and 
require 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 proposed rule would also revise 
the terminology used in the current paragraph to be consistent with the 
terminology used throughout the proposed rule (see the discussion of 
proposed Sec.  26.5 [Definitions] with respect to the new terminology 
adopted in the proposed rule) and update the cross-references to other 
sections of the rule to be consistent with the organization of the 
proposed rule.

Section 26.77 Management Actions Regarding Possible Impairment

    A new Sec.  26.77 [Management actions regarding possible 
impairment] would amend the requirements of current Sec.  26.27(b)(1). 
The current paragraph requires licensees and other entities to remove 
impaired workers, or those whose fitness may be questionable, from 
performing activities within the scope of this part, and permits them 
to return the individuals to duty only after the individuals are 
determined to be fit to safely and competently perform their duties. 
The proposed section would retain the intent of the current provision, 
but the terminology used in the proposed section would be revised to be 
consistent with the terminology used throughout the proposed rule. 
Cross-references to other sections of the rule would be updated to be 
consistent with the organization of the proposed rule. In addition, 
several new requirements would be added.
    Proposed Sec.  26.77(a) would be added to describe the purpose of 
the proposed 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 
the duties that require the individual to be subject to this part. The 
proposed paragraph would be added to introduce the section and to meet 
Goal 6 of this rulemaking, which is to improve clarity in the 
organization and language of the rule.
    Proposed Sec.  26.77(b) would retain the portion of current Sec.  
26.27(b)(1) that requires the licensee or other entity to take 
immediate action to prevent an individual from performing the job 
duties that require the individual to be subject to this part if an 
individual appears to be impaired, or his or her fitness is 
questionable. The proposed paragraph would add cross-references to 
proposed Sec.  26.27(c)(3), and Sec.  26.199(h) and (i), because the 
proposed provisions would provide exceptions to the requirement for 
immediate action. Proposed Sec.  26.27(c)(3) would permit 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. Proposed Sec.  26.199(h) and (i) would also permit 
licensees who are subject to proposed Subpart I [Managing Fatigue] to 
use fatigued individuals to perform work if the licensee determines 
that they are needed to protect the common defense and security or 
respond to an emergency and establishes controls and conditions under 
which the individual may perform work safely. The cross-references 
would be added to meet Goal 6 of this rulemaking, which is to improve 
clarity in the organization and language of the rule.
    The proposed rule would also revise some terminology used in the 
current paragraph in response to stakeholder requests during the public 
meetings discussed in Section V. The stakeholders indicated that, 
because the current rule requires them to ``remove'' individuals whose 
fitness may be questionable, some FFD programs have interpreted the 
current paragraph as requiring them to terminate the individual's 
authorization. This was not the intent of the current provision. In 
this instance, the intent of the rule was for licensees and other 
entities to prevent the individual from performing the job 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 proposed rule would replace the 
phrase, ``removed from activities within the scope of this part,'' with 
the phrase, ``prevent the individual from performing the job duties,'' 
and make other minor changes to the wording of the current requirement 
to clarify the intent of the provision. The proposed changes would be 
made to meet Goal 6 of this rulemaking, which is to improve clarity in 
the language of the rule.
    Proposed Sec.  26.77(b)(1) would retain the intent of current Sec.  
26.24(a)(3), which requires licensees and other entities to conduct 
drug and alcohol testing for cause. The proposed rule would require 
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 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 
would be required, but the proposed rule would not require the licensee 
or other entity to perform a drug test unless other indicators of 
possible impairment are present.
    The proposed rule would not require drug testing without other 
indicators of impairment in response to stakeholder comments made 
during the public meetings discussed in Section V. The stakeholders 
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 yield 
negative results, including those instances in which the alcohol test 
results are positive. The stakeholders suggested that the current 
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 job 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 the 
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 so would eliminate it from the proposed rule. The 
proposed rule would continue to require drug testing if there are 
behavioral or physical indications of impairment in addition to the 
smell of alcohol.
    Proposed Sec.  26.77(b)(2) would be added but would apply only to 
nuclear power plant licensees who would be subject to proposed Subpart 
I [Managing Fatigue]. The proposed paragraph would permit these 
licensees to forego drug and alcohol testing and a

[[Page 50519]]

determination of fitness, if the licensee is certain that the 
individual's observed behavior or physical condition is solely due to 
fatigue. In this case, the proposed rule would require the licensee to 
conduct a fatigue assessment, as defined in proposed Sec.  26.201 
[Fatigue assessments], before permitting the individual to return to 
performing his or her job duties.
    Proposed Sec.  26.77(b)(3) would be added 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 proposed Subpart 
I). Consistent with current Sec.  26.27(b)(1), the proposed rule would 
permit 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 proposed Sec.  26.189 [Determination of fitness] 
for a more detailed discussion of the determination of fitness 
process). The proposed paragraph would 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 would prohibit 
the licensee or other entity from assigning the impaired individual to 
perform job duties that require the individual to be subject to this 
part until a determination is made that the individual is fit to return 
to duty.
    Proposed Sec.  26.77(c) would update current Sec.  26.27(d) to be 
consistent with current NRC notification procedures.

Subpart E--Collecting Specimens for Testing

Section 26.81 Purpose

    Proposed Sec.  26.81 [Purpose] would be added to describe the 
purpose of proposed Subpart E, which would be to establish requirements 
for collecting specimens for drug and alcohol testing. Adding the 
proposed section at the beginning of the proposed subpart would assist 
in locating provisions within the rule and so would be consistent with 
Goal 6 of the rulemaking, which is to improve clarity in the 
organization and language of the rule.

Section 26.83 Specimens To Be Collected

    A new Sec.  26.83 [Specimens to be collected] would specify the 
types of specimens that licensees and other entities must collect for 
initial and confirmatory drug and alcohol testing.
    Proposed Sec.  26.83(a) would require licensees and other entities 
to collect either breath or oral fluids (i.e., saliva) for initial 
tests for alcohol. The proposed rule would continue to require 
collecting only breath specimens for confirmatory alcohol testing. The 
proposed rule would add permission to use 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. Further, there may be circumstances, such as collecting a 
specimen of oral fluids from a donor who has impaired lung functioning, 
in which the use of such devices is more efficient for both donors and 
the FFD program than collecting breath specimens. Therefore, the 
proposed permission to collect oral fluids for initial alcohol testing 
would meet Goal 3 of this rulemaking, which is 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 proposed rule would also be 
consistent with Goal 1 of the rulemaking, which is to update and 
enhance the consistency of Part 26 with advances in other relevant 
Federal rules and guidelines.
    The proposed rule would eliminate the use of blood as a specimen 
for alcohol testing at the donor's discretion, which is permitted in 
current Sec.  26.24(g) and Section 2.2(d)(4) in Appendix A to Part 26. 
The proposed rule would eliminate the current provisions related to 
blood alcohol testing for several reasons. Since the current 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 
have 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 would explain 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 was envisioned when the 
provisions for voluntary testing of blood specimens were incorporated 
into the current rule has not been realized in practice. The current 
requirement has also been costly for licensees, who are required to 
ensure that an individual who is trained to draw blood is available to 
do so, should a donor request blood testing. Based upon information 
provided by stakeholders at the public meetings discussed in Section V, 
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, references to 
collecting and testing blood specimens for alcohol would be deleted 
from the proposed rule.
    Proposed Sec.  26.83(b) would retain but make explicit the implied 
requirement in the first sentence of current Sec.  26.24(b) (and other 
provisions that are interspersed throughout the current rule) for 
licensees and other entities to collect only urine specimens for drug 
testing. At the time the current 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 the HHS has published proposed revisions to 
its Guidelines (69 FR 19673; April 13, 2004) that would permit the use 
of such alternate specimens for drug testing in Federal workplace drug 
testing programs. The NRC is considering

[[Page 50520]]

permitting the use of alternate specimens for drug testing when the HHS 
has published final revisions to its Guidelines related to these types 
of specimens. The revised HHS Guidelines will identify 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 
proposed 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 proposed Sec.  26.31(d)(5) 
[Medical conditions] for the reasons discussed with respect to that 
paragraph.

Section 26.85 Collector Qualifications and Responsibilities

    A new Sec.  26.85 [Collector qualifications and responsibilities] 
would replace the collector qualifications and training requirements 
that are specified in the definition of ``collection site person'' in 
current Sections 1.2, 2.2(d), and 2.4(b) in Appendix A to Part 26. The 
intent of the current provisions would be retained in the proposed 
section, but the proposed rule would group the requirements together 
within this section for organizational clarity in the rule. In 
addition, as will be described below, the proposed rule would amend the 
current collector qualifications and training requirements to increase 
the consistency of Part 26 with the requirements of other Federal 
agencies and incorporate the lessons learned from those programs, as 
discussed in Section IV. B with respect to Goal 1 of this rulemaking.
    Proposed Sec.  26.85(a) [Urine collector qualifications] would be 
added to provide more detailed requirements for urine collector 
qualifications and training than are contained in the current 
definition of ``collection site person'' and current Section 2.2(d) in 
Appendix A to Part 26. The proposed paragraph would require urine 
collectors to be knowledgeable of the requirements of this part, the 
FFD policy and procedures of the licensees or other entities for whom 
collections are performed, and keep current on any changes to urine 
collection procedures. The proposed changes would increase the 
consistency of urine collector qualification requirements with those of 
other Federal workplace drug testing programs as well as consistency 
between Part 26 urine collection procedures. These more detailed 
requirements would be added for the reasons discussed in Section IV.C.
    Proposed Sec.  26.85(a) would retain the requirements in current 
Section 2.2(d) that urine collectors must receive training to perform 
their duties and demonstrate proficiency in applying the requirements 
of the proposed paragraph before serving as a collector. Proposed Sec.  
26.85(a)(1)-(a)(3) would list the topics that the proposed rule would 
require collector training to address. Proposed Sec.  26.85(a)(1) would 
require collectors to be trained in the steps that are necessary to 
complete a collection correctly and the proper completion and 
transmission of the custody-and-control form to the licensee testing 
facility or HHS-certified laboratory, as appropriate. Proposed Sec.  
26.85(a)(2) would require training in methods to address ``problem'' 
collections, which may include, but would not be 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. Proposed Sec.  26.85(a)(3) would require the training 
to instruct collectors on how to correct problems in collections, which 
may include, but would not be limited to, a donor refusing to cooperate 
with the collection process or an incident in which a urine specimen is 
spilled. These proposed requirements would be added to 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.
    Proposed Sec.  26.85(a)(4) would retain the portion of current 
Section 2.2(d)(1) in Appendix A to Part 26 that requires collector 
training to emphasize the collector's responsibility for maintaining 
the integrity of the specimen collection and transfer process, to 
carefully ensure the modesty and privacy of the donor, and avoid any 
conduct or remarks that might be construed as accusatorial or otherwise 
offensive or inappropriate.
    Proposed Sec.  26.85(b) [Alcohol collector qualifications] would be 
added to specify requirements related to alcohol collector 
qualifications and training. Portions of this paragraph would be the 
same as the requirements for urine collectors in proposed Sec.  
26.85(a), including the first three sentences of proposed Sec.  
26.85(b) and proposed Sec.  26.85(b)(4) and (b)(5), and would be added 
here for the same reasons discussed above with respect to the first 
three sentences of proposed Sec.  26.85(a), and proposed Sec.  
26.85(a)(3) and (a)(4), respectively. The proposed rule would repeat 
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 would make it easier to locate the requirements that 
apply to urine or alcohol collectors, respectively, to meet Goal 6 of 
the rulemaking, which is to improve clarity in the organization of the 
rule.
    Proposed Sec.  26.85(b)(1) and (b)(3) would require alcohol 
collectors to receive training that addresses the alcohol testing 
requirements of this part and methods to address ``problem'' 
collections, including, but not limited to, collections involving ``shy 
lung'' problems or attempts by a donor to tamper with a specimen. By 
contrast to proposed Sec.  26.85(a)(2), which addresses ``shy bladder'' 
problems in urine collections, the proposed rule would not incorporate 
the related DOT procedures for determining ``shy lung'' problems in 
alcohol collections. During the public meetings discussed in Section V, 
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 proposed rule is necessary. The stakeholders 
reported that ``shy lung'' has not been a problem for donors, based on 
their experience implementing the breath testing requirements of Part 
26 since the rule was first promulgated. Therefore, proposed paragraph 
Sec.  26.85(b)(3) would require 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 would 
not establish requirements for responding to ``shy lung'' problems in 
the rule. The NRC invites comment on this omission.
    Proposed Sec.  26.85(b)(2) would be added to require alcohol 
collectors to be trained in the operation of the particular alcohol 
testing device(s) [i.e., the alcohol screening devices (ASDs) and 
evidential breath testing devices (EBTs)] to be used in conducting 
alcohol tests, consistent with the most recent version of the 
manufacturers' instructions. The proposed rule would add a requirement 
for alcohol collectors to be trained to follow the most recent version 
of the testing device manufacturers' instructions 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

[[Page 50521]]

of the device manufacturer's instructions, the proposed rule would add 
this requirement to ensure that alcohol test results continue to be 
accurate and cannot be challenged on this basis. The proposed changes 
would also be consistent with the alcohol collector training 
requirements of other Federal agencies.
    Proposed Sec.  26.85(c) [Alternative collectors] would amend the 
last sentence of current Section 2.2(d)(2) in Appendix A to Part 26, 
which permits medical personnel to perform specimen collections without 
receiving the training that is required for non-medical collectors. The 
proposed rule would permit medical personnel to conduct specimen 
collections for the purposes of this part only under the conditions 
that would be specified in proposed Sec.  26.85(c)(1)-(c)(5), which may 
include, but would not be limited to the collection of specimens for 
post-event testing by a nurse or medical technician at a hospital. The 
proposed rule would limit 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 upon such individuals to 
collect specimens for drug and alcohol testing, as discussed with 
respect to proposed Sec.  26.25(b)(1). Therefore, the proposed rule 
would permit 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 would otherwise require medical personnel 
who do not meet the criteria specified in proposed Sec.  26.85(c)(1)-
(c)(5) to receive the same training as non-medical collectors. The 
proposed change would be made to meet Goal 3 of the rulemaking, which 
is to improve the effectiveness and efficiency of FFD programs, by 
reducing the likelihood of errors and legal challenges to test results.
    The proposed rule would eliminate current Section 2.2(d)(4) in 
Appendix A to Part 26, which requires that donors must be informed of 
the option to request blood testing. The current requirement would be 
eliminated because blood specimens would no longer be used for alcohol 
testing, as discussed with respect to current Sec.  26.83(a).
    Proposed Sec.  26.85(d) would amend current Section 2.7(o)(5) 
[Personnel available to testify at proceedings] in Appendix A to Part 
26, which requires that the licensee testing facility and HHS-certified 
laboratory must make available qualified individuals to testify in 
administrative or disciplinary proceedings related to drug and alcohol 
test results. The proposed rule would add an explicit requirement for 
collection site personnel to be available to testify at proceedings 
because this requirement is implied but not explicitly stated in the 
current provision. At the time the rule was first published, licensee 
testing facilities and collection sites were 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, which may not be co-located with the 
collection site. Therefore, the proposed rule would add this paragraph 
to retain the NRC'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 requirements in the 
current paragraph that address the availability of personnel to testify 
in proceedings related to drug test results from the licensee testing 
facility would be moved to Sec.  26.139(c) of proposed Subpart F 
[Licensee Testing Facilities] and those related to HHS-certified 
laboratories would be moved to Sec.  26.153(f)(2) of proposed Subpart G 
[Laboratories Certified by the Department of Health and Human 
Services].

Section 26.87 Collection Sites

    A new Sec.  26.87 [Collection sites] would be added to reorganize 
current requirements related to specimen collection sites. In general, 
the proposed rule would group together in this section the requirements 
that are related to collection sites, which are currently distributed 
among several different sections in Appendix A to Part 26. The proposed 
change would be made to meet Goal 6 of this rulemaking, which is to 
improve organizational clarity in the rule.
    Proposed Sec.  26.87(a) would amend current Section 2.4(a) in 
Appendix A to Part 26, which requires FFD programs to designate 
collection sites and ensure that they are fully equipped to collect 
specimens for testing. The proposed paragraph would delete reference to 
blood specimens because the proposed rule would no longer provide 
donors with the option to request blood testing for alcohol for the 
reasons discussed with respect to proposed Sec.  26.83(a). The proposed 
paragraph would add a requirement for collection sites to be capable of 
alcohol testing, which was implied in the current paragraph but not 
explicitly stated. This proposed change would be made to meet Goal 6 of 
this rulemaking, which is to improve clarity in the language of the 
rule. The proposed paragraph would retain the current permission for 
licensees and other entities to use properly equipped mobile collection 
facilities.
    Proposed Sec.  26.87(b) would revise the first sentence of current 
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 retain the current 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 would 
increase the consistency of Part 26 with the alcohol testing procedures 
of other Federal agencies and assure greater privacy for donors who are 
subject to FFD programs who do not provide visual privacy under the 
current rule. This proposed change would be made to meet Goal 7 of this 
rulemaking, which is to protect the privacy of individuals who are 
subject to Part 26. For organizational clarity, the proposed rule would 
move the current requirements in Section 2.4(f) in Appendix A to Part 
26 that are related to collecting a specimen under direction 
observation to proposed Sec.  26.115 [Collecting a urine specimen under 
direct observation].
    Proposed Sec.  26.87(c) would retain only the portion of current 
Section 2.7(m) in Appendix A to Part 26 that requires licensees' and 
other entities' contracts for collection site services to permit 
unfettered NRC, licensee, and other entity access to collection sites 
for unannounced inspections. For organizational clarity, the 
requirements in the current paragraph related to licensee testing 
facilities would be relocated to proposed Subpart K [Inspections, 
Violations, and Penalties] and subsumed under proposed Sec.  26.221(a). 
The portions of the current paragraph that apply to HHS-certified 
laboratories would be moved to Sec.  26.153(f) of proposed Subpart G 
[Laboratories Certified by the Department of Health and Human 
Services], also for organizational clarity.

[[Page 50522]]

In addition, proposed Sec.  26.87(c) would add 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. This proposed requirement for access to 
documentation would be added for consistency with the HHS Guidelines, 
which also require collection sites to provide information and 
documentation as part of inspections and audits. Therefore, this 
proposed change would 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 term, ``audit,'' would be 
added to the proposed paragraph because, although the NRC conducts 
inspections, licensees and other entities would be required to conduct 
audits under proposed Sec.  26.41 [Audits and corrective action]. 
Adding this term to the proposed paragraph would increase the clarity 
of its language, consistent with Goal 6 of the rulemaking.
    Proposed Sec.  26.87(d) would revise current Section 2.4(c) in 
Appendix A to Part 26 to clarify current requirements for assuring 
collection site security and the integrity of specimen collection 
procedures. The proposed rule would group requirements related to 
assuring the security of a licensee's or other entity's designated 
collection site in this proposed paragraph for organizational clarity. 
The requirements contained in current 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 would be moved to proposed Sec.  26.87(f), 
also for organizational clarity. The proposed paragraph would include 
other clarifying changes to current Section 2.4(c) in Appendix A to 
Part 26, in response to stakeholder requests for such clarifications at 
the public meetings discussed in Section V, as follows:
    Proposed Sec.  26.87(d)(1) would retain the first sentence of 
current Section 2.4(e) in Appendix A to Part 26, which requires that 
only authorized personnel may have access to any part of a collection 
site in which specimens are collected and stored. This requirement 
would be moved to the proposed paragraph because it addresses the topic 
of collection site security. Therefore, this change would be made for 
organizational clarity.
    Proposed Sec.  26.87(d)(2) would amend the second sentence of 
current Section 2.4(c) in Appendix A to Part 26, which requires 
collection sites to be secure, by providing examples of acceptable 
methods to assure collection site security. The proposed rule would add 
these examples in response to stakeholder requests during the public 
meetings discussed in Section V. The stakeholders noted that the 
requirement that collection sites ``must be secure'' has raised many 
implementation questions. Therefore, the proposed rule would add 
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 proposed change would be made to meet 
Goal 6 of this rulemaking, which is to improve clarity in the language 
of the rule.
    Proposed Sec.  26.87(d)(3) would amend the third sentence in 
current Section 2.4(c) in Appendix A to Part 26, which requires that 
the portion of any facility that is not dedicated solely to drug and 
alcohol testing must be secured during testing, and combine it with the 
third sentence of current Section 2.4(c)(1) in Appendix A to Part 26, 
which requires posting the facility against unauthorized access during 
the collection. The proposed rule would replace the phrase, ``in the 
case of a public restroom,'' in the last sentence of current 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 proposed changes would be made to meet Goal 6 of this 
rulemaking, which is to improve clarity in the organization and 
language of the rule.
    Proposed Sec.  26.87(e) would be added to specify the steps that 
licensees and other entities must take to deter dilution and 
adulteration of specimens during urine collections. The proposed 
paragraph would retain and amend portions of current Section 2.4(g) in 
Appendix A to Part 26, as explained below:
    Proposed Sec.  26.87(e)(1) would relax the requirement for use of a 
bluing agent in any source of standing water, such as a toilet bowl or 
tank, in current Section 2.4(g)(1) of Appendix A to Part 26. The 
proposed rule would permit licensees and other entities to use colors 
other than blue. A yellow coloring agent would not be permitted because 
it would preclude 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 proposed 
relaxation would not affect the accuracy of drug tests, but would give 
FFD programs increased flexibility in the choice of coloring agents. 
The proposed rule would make this change in response to stakeholder 
requests during the public meetings discussed in Section V and to meet 
Goal 5 of this rulemaking, which is to improve Part 26 by eliminating 
or modifying unnecessary requirements.
    Proposed Sec.  26.87(e)(1) would also add a requirement that the 
coloring agents that are added to any source of standing water in the 
stall or room in which the donor is to provide a specimen cannot 
interfere with drug or validity tests. The proposed requirement would 
be necessary to ensure that, if a donor attempted to subvert the 
testing process through diluting his or her specimen, the coloring 
agent would not interfere with testing assays and, therefore, would 
permit the detection of prohibited drug use. The proposed requirement 
would meet Goal 3 of this rulemaking, which is to improve the 
effectiveness of FFD programs, by deterring dilution attempts using 
sources of standing water and increasing the likelihood that dilution 
attempts of this type would be detected.
    Proposed Sec.  26.87(e)(2) would retain the second sentence of 
current Section 2.4(g)(1) in Appendix A to Part 26, which requires 
sources of standing water to be secured, but shorten it without 
changing the intended meaning of the requirement. The proposed change 
would be made to improve clarity in the language of the rule.
    Proposed Sec.  26.87(e)(3) would be added 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 collector would also 
be required to inspect the enclosure to ensure that no potential 
adulterants are available before the donor would enter the stall or 
enclosure. These requirements would be added to prevent possible donor 
attempts to subvert the testing process by adulterating a urine 
specimen with materials that are available at the collection site. The 
proposed rule would add this provision to meet Goal 3 of this 
rulemaking, which is to improve the effectiveness of FFD programs. The 
proposed provision would also be consistent with the related 
requirements of other Federal agencies.
    Proposed Sec.  26.87(f) would reorganize current 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

[[Page 50523]]

designated collection site in unusual circumstances, such as a specimen 
collection for post-event testing at a hospital. The proposed rule 
would group these requirements together in a single paragraph and 
separate them from those related to collecting specimens at a 
designated collection site in proposed Sec.  26.87(d) and (e) to make 
it easier to locate these requirements within the rule. The proposed 
change would be made to improve organizational clarity in the rule.
    Proposed Sec.  26.87(f)(1) would amend current Section 2.4(c)(1) in 
Appendix A to Part 26, which establishes requirements for securing a 
location that is not a designated collection site but will be used for 
a specimen collection(s). The proposed rule would require 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 current rule 
requires only the posting of a sign, but stationing an individual to 
guard access would be at least as effective. The proposed rule would 
permit an individual to guard access to the collection area in response 
to stakeholder requests for this flexibility during the public meetings 
discussed in Section V. The proposed change would be made to meet Goal 
5 of this rulemaking, which is to improve Part 26 by eliminating or 
modifying unnecessary requirements.
    Proposed Sec.  26.87(f)(2) would retain the third sentence of 
current Section 2.4(g)(10) in Appendix A to Part 26 that requires a 
water-coloring agent to be used, 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.
    Proposed Sec.  26.87(f)(3) would amend the second sentence of 
current Section 2.4(g)(10), which requires that the collector must be 
the same gender as the donor. If a collector of the same gender is 
unavailable, the proposed paragraph would permit another person of the 
same gender who is instructed in the requirements of proposed Subpart E 
[Collecting specimens for testing] to assist in the collection. The 
proposed paragraph would require 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 proposed rule would require the observer's 
identity to be documented 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 proposed 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, would be 
consistent with the procedures of other Federal agencies and reduce 
potential embarrassment to the donor. Therefore, this proposed change 
would 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, and Goal 7, which is to protect the privacy of 
individuals who are subject to Part 26.
    Proposed Sec.  26.87(f)(4) would require 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. The proposed paragraph would amend the fifth and 
sixth sentences of current Section 2.4(g)(10) in Appendix A to Part 26 
that describe the required sequence of actions during a specimen 
collection and specify that a donor is permitted to flush the toilet 
after a specimen donation. The proposed rule would eliminate the option 
for the donor to flush the toilet and would direct the collector to 
instruct the donor not to flush the toilet. The proposed change would 
reduce the possibility that a donor could dispose of evidence of a 
subversion attempt by flushing it down the toilet. Proposed Sec.  
26.87(f)(4) would direct the collector to inspect the toilet bowl and 
area once he or she receives the specimen from the donor. The proposed 
rule would add these provisions to reduce the opportunities for a donor 
to subvert the testing process and to meet Goal 3 of this rulemaking, 
which is to improve the effectiveness of FFD programs. The proposed 
requirement would also 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.
    Proposed Sec.  26.87(f)(5) would amend the portions of current 
Section 2.4(c)(2) in Appendix A to Part 26 that define requirements for 
maintaining control of specimens that are not collected at a designated 
collection site. An ``authorized individual,'' including, for example, 
a security officer or hospital medical technician, would be permitted 
to maintain physical custody and control of specimens in the proposed 
paragraph, rather than only the collector, as is required in the 
current rule. The ``authorized individual'' would be designated by the 
licensee or other entity and instructed in his or her responsibilities 
for maintaining custody and control of the specimen. The authorized 
individual's custody of the specimen would 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 proposed Sec.  26.39 [Review process for fitness-for-
duty policy violations] or legal proceedings. The proposed change would 
continue to ensure specimen integrity and security, but would respond 
to industry experience, as described by stakeholders at the public 
meetings discussed in Section V. 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 
proposed change would be made to meet Goal 5 of this rulemaking, which 
is to improve Part 26 by eliminating or modifying unnecessary 
requirements, while continuing to protect the privacy and due process 
rights of individuals who are subject to Part 26.

Section 26.89 Preparing to Collect Specimens for Testing

    A new Sec.  26.89 [Preparing to collect specimens for testing] 
would describe the preliminary steps to be taken by the collector and 
donor before specimens are collected for drug and alcohol testing. The 
proposed section would reorganize and amend portions of the current 
Appendix A to Part 26, and add several new requirements, as explained 
below. The proposed rule would present these requirements in a new 
section to facilitate locating them within the proposed rule to meet 
Goal 6 of this rulemaking, which is to improve clarity in the 
organization of the rule.
    Proposed Sec.  26.89(a) would provide more detailed requirements 
than those contained in current 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 current rule requires 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 
Section V, some stakeholders indicated that the lack of specificity in 
the current 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

[[Page 50524]]

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 is not the intent of the current provision. 
Therefore, under the proposed paragraph, when informed that an 
individual who was selected for testing has not appeared at the 
required time, FFD program management would be required to 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 proposed rule 
would require the licensee or other entity to impose the sanctions 
specified in proposed 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 evidence of a 
subversion attempt is not identified, the proposed rule would prohibit 
the licensee or other entity from imposing sanctions and require the 
individual to be tested at the earliest reasonable and practical 
opportunity after the individual is located. These more detailed 
requirements would be added to strengthen the rule's effectiveness in 
preventing subversion by ensuring that a failure to appear for testing 
is investigated, which would increase the likelihood of detecting a 
willful attempt to avoid testing. In addition, the proposed 
requirements would prevent an individual from being subject to a 
permanent denial of authorization, as would be required under proposed 
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. These proposed changes would be made 
to meet Goal 3 of this rulemaking, which is to improve the 
effectiveness of FFD programs, and Goal 7, which is to protect the due 
process rights of individuals who are subject to Part 26.
    Proposed Sec.  26.89(b) would reorganize and expand current Section 
2.4(g)(2) in Appendix A to Part 26, which requires the collector to 
ensure that an individual who arrives at the collection site for 
testing is positively identified. The proposed rule would add more 
detailed requirements for the reasons discussed with respect to each 
requirement in the proposed paragraph.
    Proposed Sec.  26.89(b)(1) would specify the types of photo 
identification that the licensee or other entity may accept to identify 
the donor. Identification of the donor by the employer's representative 
would no longer be permitted. The NRC is not aware of any incidents in 
which an employer's representative has inaccurately identified an 
individual who appeared for testing without acceptable identification. 
However, permitting collectors to rely on identification by an 
employer's representative provides an opportunity for individuals to 
conspire to subvert the testing process by substituting the designated 
donor, who may have engaged in substance abuse, with another individual 
who has not abused illegal drugs or alcohol. Such a conspiracy could 
prevent an individual's substance abuse from being detected through 
testing. Therefore, this proposed revision would be made to provide 
greater assurance that the individual who appears for testing is the 
designated donor and, thereby, strengthen the effectiveness of FFD 
programs in detecting substance abuse. The proposed change would also 
increase 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.
    Proposed Sec.  26.89(b)(2) would amend the portion of current 
Section 2.4(g)(2) in Appendix A to Part 26 that directs the collector 
to stop the collection if the individual cannot be positively 
identified. By contrast, the proposed paragraph would direct the 
collector to proceed with the collection and inform FFD program 
management that the donor did not present acceptable photo 
identification. The proposed paragraph would require FFD management to 
take the necessary steps to determine whether the lack of 
identification is an attempt to subvert the testing process. However, 
the proposed paragraph would retain the current requirement for the 
collector to delay the collection until the individual can be 
identified if it a pre-access test. The proposed changes would be made 
for several reasons:
    First, lessons learned from implementing the current rule have 
indicated that the large majority of failures to present acceptable 
identification are the result of 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 would assure that test results would be available 
and accurate from donors who are currently authorized and whose 
identity has previously been confirmed by the licensee or other entity. 
Therefore, this proposed change would meet Goal 3 of this rulemaking, 
which is to improve the effectiveness and efficiency of FFD programs.
    Second, the current 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 would 
provide 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 
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 proposed requirement 
would strengthen the effectiveness of FFD programs in detecting 
attempts to subvert the testing process.
    The requirement to delay the collection until the individual 
presents acceptable identification if it is a pre-access test would be 
retained from the current rule at the request of stakeholders during 
the public meetings discussed in Section V. The stakeholders noted that 
the current 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 would not yet 
have access to sensitive information, radiological materials, or safety 
systems and equipment. Further, stakeholders noted that retaining the 
current provision would save them the expense associated with 
collecting and testing a specimen that may be collected from the wrong 
individual. The NRC concurs that it is reasonable to retain the current 
requirement as it relates to pre-access tests for the reasons given by 
the stakeholders.

[[Page 50525]]

    Proposed Sec.  26.89(b)(3) would update current Sections 2.4(g)(4) 
and 2.4(g)(23)(ii) in Appendix A to Part 26, in which, before any 
specimens are collected, donors are required to list the prescription 
and over-the-counter medications they have 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 
proposed rule would eliminate the requirement to list medications prior 
to specimen collection and testing. The proposed rule would require 
donors to provide medication information to the MRO only in the event 
of non-negative confirmatory validity or drug test results in order to 
enhance their rights to privacy under the rule. This revised 
requirement would also be consistent with the procedures of other 
Federal agencies and would 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.
    Proposed Sec.  26.89(b)(3) would also add a requirement for the 
collector to explain the testing procedure to the donor. Current 
Section 2.2(d)(3) in Appendix A to Part 26 requires that individuals 
who are subject to testing must be provided with standard written 
instructions setting forth their responsibilities. However, the NRC is 
aware that these instructions are typically provided to individuals as 
part of the training that is required under current Sec.  26.21 [Policy 
communications and awareness training] rather than at the collection 
site before starting the specimen collection process, which was not the 
intent of Section 2.2(d)(3) in Appendix A to Part 26. Rather than 
retaining and clarifying the current provision for standard written 
instructions, which some individuals have may difficulty comprehending, 
the proposed rule would adopt the related practices of other Federal 
agencies, which require the collector to explain the testing procedure 
to the donor. This proposed change would ensure that individuals are 
informed of the testing process in which they must participate and 
their responsibilities within it to meet Goal 7 of this rulemaking, 
which is to protect the due process rights of individuals who are 
subject to Part 26. In addition, the proposed revision would enhance 
the consistency of Part 26 with the requirements of other Federal 
agencies.
    Proposed Sec.  26.89(c) would be added to ensure that the donor is 
aware of his or her responsibilities to cooperate with the specimen 
collection process. The proposed paragraph would respond to reports 
from stakeholders at the public meetings discussed in Section V that 
some donors have attempted to obstruct or delay the collection process 
on the basis that the donor's responsibility to cooperate with the 
collection process is implied, but not clearly specified, in the 
current rule. Therefore, the proposed paragraph would eliminate that 
basis for obstructing or delaying collections, which would improve the 
effectiveness and efficiency of FFD programs, consistent with Goal 3 of 
this rulemaking.
    The proposed paragraph would also require the collector to inform 
the donor that a failure to cooperate in the specimen collection 
process would be considered a refusal to test and may result in the 
permanent denial of authorization under proposed Sec.  26.75(b). 
Informing donors of the potential consequences of failing to cooperate 
in the collection process, in advance, would be consistent with Goal 7 
of this rulemaking, which is to protect the due process rights of 
individuals who are subject to Part 26. The requirements of this 
proposed paragraph would also be consistent with the practices of other 
Federal agencies.
    Proposed Sec.  26.89(d) would retain the last two sentences of 
current Section 2.4(e) in Appendix A to Part 26. These sentences 
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 proposed paragraph 
would be retained in this section because it relates to the topic of 
the proposed section, which is preparing for specimen collections, to 
ensure that collectors are aware of this requirement before they begin 
collecting any specimens. The proposed change would improve the 
organizational clarity of the rule.

Section 26.91 Acceptable Devices for Conducting Initial and 
Confirmatory Tests for Alcohol and Methods of Use

    A new Sec.  26.91 [Acceptable devices for conducting initial and 
confirmatory tests for alcohol and methods of use] would amend current 
requirements for alcohol testing devices and methods of use. The 
requirements in the current rule that are related to this topic appear 
in current Sec.  26.24(g) and Sections 2.4(g)(18) and 2.7(o)(3)(ii) in 
Appendix A to Part 26. The proposed section would combine these 
requirements into one section, amend the current requirements, and add 
others, as explained below. The proposed rule would group these 
requirements in one section to meet Goal 6 of this rulemaking, which is 
to improve clarity in the organization of the rule.
    Proposed Sec.  26.91(a) [Acceptable alcohol screening devices] 
would be added to permit the use of alcohol screening devices (ASDs) 
for initial testing and establish requirements for the ASDs that may be 
used. Acceptable ASDs would 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 (May 4, 2001, 66 FR 
22639, and subsequent amendments thereto). Current Section 
2.7(o)(3)(ii) in Appendix A to Part 26 limits 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 
would be consistent with other Federal agencies' procedures for 
workplace alcohol testing. Therefore, the proposed change would 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.
    Further, permitting the use of some ASDs for initial alcohol 
testing would provide 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 
proposed rule's permission to use ASDs that are listed on NHTSA's CPL 
for ASDs for initial alcohol testing would meet Goal 5 of this 
rulemaking, which is to improve Part 26 by eliminating or modifying 
unnecessary requirements, by increasing FFD programs' flexibility in 
administering initial alcohol tests.
    A new Sec.  26.91(b) [Acceptable evidential breath testing devices] 
would amend current Section 2.7(o)(3)(ii) in Appendix A to Part 26 and 
establish new requirements for the EBTs that licensees and other 
entities must use for confirmatory alcohol breath testing. The proposed 
paragraph would require licensees and other entities to use EBTs that 
are listed on the most recent version of NHTSA's CPL for evidential 
breath testing devices (October 3, 2002, 67 FR 62091, and subsequent 
amendments thereto) when conducting confirmatory alcohol tests, and 
permit licensees and other entities to use these EBTs for conducting 
initial alcohol tests. These EBTs incorporate many improvements in EBT 
technology and

[[Page 50526]]

have been shown to accurately detect BACs at the 0.02 percent level. 
Therefore, they are the appropriate instruments to use for testing at 
the revised alcohol cutoff levels specified in proposed 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 proposed requirement to use 
these EBTs would permit two additional proposed changes to the alcohol 
testing procedures contained in current 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 proposed Sec. Sec.  
26.95(c) and 26.101(c), rather than the two specimens that are 
currently required for each test; and (2) conducting both the initial 
and confirmatory tests (if a confirmatory test is required) using the 
same EBT in proposed Sec.  26.101(d). As discussed further with respect 
to proposed Sec. Sec.  26.95(c) and 26.101(c) and (d), these proposed 
changes to the current alcohol testing requirements would 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, 
``Procedures for Department of Transportation Workplace Drug and 
Alcohol Testing Programs' (65 FR 41944; August 9, 2001). Therefore, 
this proposed change would also 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; Goal 3, which is to 
improve the efficiency of FFD programs; and Goal 5, which is to improve 
Part 26 by eliminating or modifying unnecessary requirements.
    Proposed Sec.  26.91(c) [EBT capabilities] would be added 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 proposed 
Sec.  26.91(c)(1)-(c)(3) are necessary to ensure that a test result can 
be uniquely associated with the instrument used, the time of testing, 
and the donor. These capabilities are necessary in order to establish 
an unimpeachable chain of custody for 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 proposed Sec.  26.91(c)(4)-(c)(6) would ensure that test 
results will be accurate by permitting collectors to verify that the 
instrument is functioning properly before each test and there will be 
no carryover effects from previous testing. These capabilities would 
improve the effectiveness and efficiency of confirmatory alcohol 
testing by limiting the need to cancel test results due to instrument 
errors, as required under proposed Sec.  26.91(e)(3). Using EBTs that 
have the required capabilities for confirmatory alcohol tests would 
protect donors' rights to accurate test results, provide greater 
assurance that test results will withstand any legal challenges, and 
improve an FFD programs' ability to identify tests that may have been 
affected by instrument errors. Therefore, the proposed requirements 
would meet Goal 3 of this rulemaking, which is to improve the 
effectiveness and efficiency of FFD programs.
    Proposed Sec.  26.91(d) [Quality assurance and quality control of 
ASDs] would be added to establish quality assurance and quality control 
requirements for ASDs. These proposed 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, a donor who has a BAC that exceeds the cutoff levels 
established in this part would not be detected by the test and may be 
permitted to perform the job duties that require him or her to be 
subject to this part, thereby creating an unacceptable risk to public 
health and safety or the common defense and security. The proposed (and 
current) rule would require confirmatory testing if initial alcohol 
test results are positive, so false positive test results from an ASD 
would lead to confirmatory testing, which would provide accurate test 
results. False positive test results 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 proposed paragraph would 
be necessary to maintain the effectiveness of FFD programs, which is 
Goal 3 of this rulemaking.
    Proposed Sec.  26.91(d)(1) would be added 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. In order 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. The 
proposed paragraph would require 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 proposed Sec.  26.91(d), the proposed 
provision would be necessary to maintain the effectiveness of FFD 
programs that rely on ASDs for initial alcohol testing.
    Proposed Sec.  26.91(d)(2) would be added to prohibit licensees and 
other entities from using an ASD that fails the quality control checks 
that would be specified in the most recent version of the 
manufacturer's quality assurance plan or that has passed its expiration 
date. This proposed prohibition would be 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.
    Proposed Sec.  26.91(d)(3) would be added to require licensees and 
other entities to follow the device use and care requirements that 
would be specified in proposed paragraph (e) of this section for an ASD 
that tests breath specimens. The proposed requirement would be added 
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 (October 3, 2002, 
67 FR 62091, and subsequent amendments thereto). Those ASDs that do 
test breath specimens and would be used for confirmatory testing have 
more detailed quality assurance and quality control

[[Page 50527]]

provisions because their results must be legally defensible.
    Proposed Sec.  26.91(e) [Quality assurance and quality control of 
EBTs] would establish new quality assurance and quality control 
requirements for EBTs. The proposed requirements would be consistent 
with those of other Federal agencies that require workplace alcohol 
testing and, therefore, would update and enhance the consistency of 
Part 26 with advances in other relevant Federal rules and guidelines, 
as follows:
    Proposed Sec.  26.91(e)(1) would add 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 frequency of 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 proposed rule would require licensees and other entities 
to perform external calibration checks 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 proposed provision would ensure 
that the EBT will not provide false test results from improper storage 
or use.
    Proposed Sec.  26.91(e)(2) would add 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 proposed requirement is necessary to 
ensure that the calibrating units used by licensees and other entities 
meet minimum standards and provide accurate results.
    Proposed Sec.  26.91(e)(3) would be added to address circumstances 
in which an EBT fails an external calibration check. The proposed 
paragraph would require the licensee or other entity to cancel any 
positive test results from tests that were conducted during the period 
since the EBT last passed an external calibration check. This proposed 
requirement would protect donors' right to due process under the rule 
because 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. Because most EBT 
manufacturers' recommended intervals are one month, licensees and other 
entities may choose to conduct the calibration checks more frequently 
in order to avoid the proposed test cancellations, should an EBT fail 
an external calibration check. The proposed paragraph would also 
require the licensee or other entity to take the EBT out of service. 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.
    Proposed Sec.  26.91(e)(4) would be added to require that 
inspection, maintenance, and calibration of the EBT must be performed 
by its manufacturer or a maintenance representative who is certified by 
the manufacturer, a State health agency, or other appropriate State 
agency. This proposed provision would ensure that inspection, 
maintenance, and calibration of EBTs are performed by qualified 
personnel for two reasons: (1) To ensure that 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.

Section 26.93 Preparing for Alcohol Testing

    A new Sec.  26.93 [Preparing for alcohol testing] would expand on 
current Section 2.4(g)(18) in Appendix A to Part 26, which specifies 
procedures for alcohol testing. The proposed rule would provide more 
detailed procedures than the current 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. These more detailed 
requirements would be added for the reasons discussed in Section IV. B.
    Proposed Sec.  26.93(a) would contain more detailed procedures for 
implementing the current requirement in the first sentence of current 
Section 2.4(g)(18) in Appendix A, which instructs 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). Proposed Sec.  26.93(a)(1)-(a)(6) would 
require the collector to provide the donor with more detailed 
information about mouth alcohol and the testing process than is 
currently required and document that the information is provided. 
Providing more detailed requirements for the 15-minute waiting period 
would improve 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. Proposed Sec.  26.93(a)(1) would 
retain the current requirement for the collector to ask the donor about 
behaviors such as eating and drinking that have may have occurred 
within the 15 minutes before an alcohol test and add a requirement for 
the collector to advise the donor to avoid these activities during the 
collection process. Proposed Sec.  26.93(a)(2) would permit alcohol 
testing to proceed if the donor states that none of the activities 
listed in Sec.  26.93(a)(1) had occurred, while proposed Sec.  
26.93(a)(3) would retain the current requirement for a 15-minute 
waiting period before a donor could be tested if he or she had engaged 
in the activities listed in proposed Sec.  26.93(a)(1). Proposed Sec.  
26.93(a)(4) would add 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. Proposed Sec.  26.93(a)(5) 
would add 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). Proposed Sec.  
26.93(a)(6) would add a requirement for the collector to document that 
the instructions were communicated to the donor. The proposed 
additional requirements for the collector to communicate with the donor 
about the potential effects on test results of the activities listed in 
proposed Sec.  26.93(a)(1) would ensure that donors clearly understand 
the reasons for avoiding those activities and the potential 
consequences of engaging in them in order to protect their rights to 
due process under the rule. The proposed requirement for the collector 
to document that the instructions were communicated to the donor would 
be necessary to ensure that the collector does not inadvertently omit 
the instructions and improve the legal defensibility of the collection 
procedure, should a donor challenge it.

[[Page 50528]]

    Proposed Sec.  26.93(b) would be added 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 proposed requirements would decrease the likelihood that a 
donor's test results would fall below the program's cutoff levels as a 
result of metabolic processes over time, which could prevent the 
detection of proscribed alcohol consumption or drug use. Delays between 
the time at which a donor reports for testing and the time at which 
testing occurs would continue to be permitted for tests conducted under 
conditions other than for cause, because, in contrast to for-cause 
testing, there would be no reason to believe that an individual may 
have used drugs or alcohol in violation of the FFD policy. Therefore, 
there would be no basis for a concern that metabolic processes may 
cause inaccurate test results. The proposed provision would be 
consistent with the related regulations of other Federal agencies.

Section 26.95 Conducting an Initial Test for Alcohol Using a Breath 
Specimen

    Proposed Sec.  26.95 [Conducting an initial test for alcohol using 
a breath specimen] would replace the portions of current Section 
2.4(g)(18) in Appendix A to Part 26 that specify procedures for 
conducting an initial test for alcohol. Collectors would follow the 
procedures in this section when using ASDs that test breath specimens 
and EBTs. The proposed section would increase the consistency of Part 
26 with the procedures of other Federal agencies for workplace alcohol 
testing. Consistent with other agencies' procedures, the proposed rule 
would eliminate the requirement in current 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 current 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 proposed section are 
followed. Therefore, the proposed rule would amend the current 
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.
    Proposed Sec.  26.95(a) would be added 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 phrase, ``as soon as reasonably practical,'' 
would be added to the proposed paragraph in response to stakeholder 
comments at the public meetings discussed in Section V. 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 
proposed Sec.  26.93 [Preparing for alcohol testing] in order to ensure 
the accuracy of the test result, because 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 proposed 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 proposed rule would add the 
phrase, ``as soon as reasonably practical,'' to permit reasonable 
delays in testing associated with outage planning.
    Proposed Sec.  26.95(b)(1) would permit the donor to select the 
mouthpiece to be used for testing, at the collector's discretion. 
Permitting the donor to select the mouthpiece would not be required, 
but 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 would attempt to 
subvert the testing process by, for example, 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.
    Proposed Sec.  26.95(b)(2) would instruct the collector to open the 
mouthpiece packaging and insert it into the device in view of the 
donor. The proposed requirement to insert the mouthpiece into the 
device in the view of the donor would be added for the same reason 
described with respect to proposed Sec.  26.95(b)(1).
    Proposed Sec.  26.95(b)(3) would require the donor to blow into the 
mouthpiece for at least 6 seconds in order to obtain an adequate breath 
sample. The requirement to obtain the specimen from the end of the 
breath exhalation in current Section 2.4(g)(18) in Appendix A to Part 
26 would be deleted as unnecessary based upon improvements to breath-
testing technology.
    Proposed Sec.  26.95(b)(4) would require the collector to show the 
test result to the donor. This proposed 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 proposed requirement is consistent with Goal 7 of this 
rulemaking, which is to protect the due process rights 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.
    Proposed Sec.  26.95(b)(5) would require the collector to ensure 
that the test result record can be associated with the donor and is 
maintained secure, consistent with the many provisions throughout the 
current and proposed rules that the chain-of-custody must be maintained 
for specimens and the associated documentation of test results. 
Proposed Sec. Sec.  26.129 and 26.159 [Assuring specimen security, 
chain of custody, and preservation] would establish similar 
requirements for urine specimens at licensee testing facilities and 
HHS-certified laboratories, respectively.
    Proposed Sec.  26.95(c) would be added to require the collection of 
only one breath specimen for the initial test, unless problems in the 
collection require that the collection must be repeated. Problems in 
the collection may include, but would not be 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 would rely on the result from the first successful collection 
in determining the need for confirmatory alcohol testing. If the 
procedures specified in this proposed section are followed, relying on 
one breath specimen for the initial test, rather than the two required 
in the current rule, would increase the consistency of Part 26 
collection procedures with those of other Federal

[[Page 50529]]

agencies, consistent with Goal 1 of this rulemaking. The proposed 
provision would also reduce the time required for breath specimen 
collections without compromising the accuracy, validity, or reliability 
of the test results. Therefore, the proposed provision would also meet 
Goal 3 of this rulemaking, which is to improve the efficiency of FFD 
programs.

Section 26.97 Conducting an Initial Test for Alcohol Using a Specimen 
of Oral Fluids

    A new Sec.  26.97 [Conducting an initial test for alcohol using a 
specimen of oral fluids] would establish requirements for conducting 
initial alcohol tests using an ASD for testing oral fluids specimens. 
The proposed rule would permit licensees and other entities to rely on 
ASDs that test oral fluids for the reasons discussed with respect to 
proposed Sec.  26.83(a). The proposed procedures for conducting alcohol 
testing with an ASD for testing oral fluids would incorporate the 
related requirements from 49 CFR Part 40, ``Procedures for Department 
of Transportation Workplace Drug and Alcohol Testing Programs'' (65 FR 
41944; August 9, 2001) and would be added to the proposed rule to 
ensure that initial alcohol tests of oral fluids provide accurate and 
legally defensible test results.
    Proposed Sec.  26.97(a) would be added to specify the procedures 
that the collector would follow in using an ASD for testing oral 
fluids, as follows:
    Proposed Sec.  26.97(a)(1) would require the collector to check the 
expiration date on the device and show it to the donor. Some devices 
degrade during storage. Therefore, this step would be necessary to 
assure both the donor and the collector that the device can be expected 
to function properly.
    Proposed Sec.  26.97(a)(2) would require the collector to open an 
individually wrapped or sealed package containing the device in the 
presence of the donor. The proposed rule would add the requirement for 
the collector to open the package in the presence of the donor for the 
reasons discussed with respect to proposed Sec.  26.95(b)(1).
    Proposed Sec.  26.97(a)(3) would require 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 would be required to 
provide instructions for its proper use. The proposed rule would 
require 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 proposed Sec.  26.95(b)(1).
    Proposed Sec.  26.97(a)(4) would require 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 would be required 
to wear single-use examination or similar gloves while doing so and 
change them following each test. Proposed Sec.  26.97(a)(5) would 
require the collector to follow the manufacturer's instructions to 
ensure that the device has activated. The proposed requirements in 
these paragraphs to follow the device manufacturer's instructions for 
collecting the specimen and verify that the device has activated would 
be added to ensure that the collection is properly conducted. The 
proposed requirement to use single-use examination gloves would ensure 
that the collector and donor are protected from possible infection from 
exposure to body fluids.
    Proposed Sec.  26.97(b) would be added to specify the procedures 
that the collector would 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 the device is dropped on the floor.
    Proposed Sec.  26.97(b)(1) would require 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 proposed 
rule would require the second device used to have been under the 
collector's control to ensure that there have been no opportunities for 
the donor or another individual to substitute the new device with 
another that has been altered to provide a false negative test result. 
This proposed requirement would be necessary to protect the integrity 
of the collection process.
    Proposed Sec.  26.97(b)(2) would require the collector to record 
the reason for the new test. The proposed rule would require 
documentation of the reason for the new test to ensure that the 
information is available, should any questions arise with respect to 
the collection procedure in a review conducted under proposed Sec.  
26.39 [Review process for fitness-for-duty policy violations] or legal 
proceedings.
    Proposed Sec.  26.97(b)(3) would require 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 proposed rule would require the 
collector to offer the donor the choice of using the device for the 
reasons discussed with respect to proposed 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 would enhance the efficiency of the collection procedure by 
ensuring that the second collection is conducted properly.
    Proposed Sec.  26.97(b)(4) would require the collector to repeat 
the collection procedures outlined in proposed Sec.  26.97(a) for the 
second collection.
    If the second collection attempt fails, proposed Sec.  26.97(c) 
would be added to direct the collector to use an EBT to perform the 
initial alcohol test instead. The proposed rule would require 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, proposed Sec.  26.97(d) would instruct the collector to 
follow the device manufacturer's instructions for reading the result 
and show the result to the donor. The proposed rule would prohibit 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 proposed 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. The proposed paragraph would also 
require the collector to record the test result and that an ASD was 
used to document the collection and test and ensure that the 
information is available, should any questions arise with respect to 
the collection procedure in a review conducted under proposed Sec.  
26.39 [Review process for fitness-for-duty policy violations], or legal 
proceedings.
    In order to protect collectors and donors from any possible 
biohazards, proposed Sec.  26.97(e) would be added 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

    A new Sec.  26.99 [Determining the need for a confirmatory test for 
alcohol] would amend the existing requirements in current Sec.  
26.24(g) and the portion of

[[Page 50530]]

Section 2.7(e)(1) in Appendix A to Part 26 that addresses cutoff levels 
for alcohol testing. The proposed rule would amend the current 
requirements for consistency with a new approach to determining 
positive alcohol test results in proposed Sec.  26.103 [Determining a 
confirmed positive test result for alcohol]. The proposed approach 
would be adopted because some licensees have not taken appropriate 
action when a donor has obtained alcohol test results just below the 
current 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, new cutoff levels for alcohol 
testing would be established in proposed Sec. Sec.  26.99 and 26.103 
that would take into account the average rate at which individuals 
metabolize alcohol over time. In proposed Sec.  26.99(a), the cutoff 
level for the initial alcohol test result would be decreased from 0.04 
to 0.02 percent BAC and a confirmatory alcohol test would be required 
if a donor's initial test result is 0.02 percent BAC or higher. In 
addition, in proposed Sec.  26.99(b), the collector would be required 
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 could be calculated to determine whether a confirmatory 
test result is positive, in accordance with proposed Sec.  26.103. The 
proposed changes in the initial alcohol test cutoff level and testing 
procedure are necessary to support the provisions of proposed Sec.  
26.103, which would 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 one 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 would 
permit licensees and other entities to identify donors who 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

    A new Sec.  26.101 [Conducting a confirmatory test for alcohol] 
would be added to provide detailed procedures for conducting 
confirmatory breath alcohol tests. These proposed procedures would 
incorporate the related requirements from 49 CFR Part 40, ``Procedures 
for Department of Transportation Workplace Drug and Alcohol Testing 
Programs'' (65 FR 41944; August 9, 2001), which would be added to the 
proposed rule to ensure that confirmatory breath alcohol tests provide 
accurate and legally defensible test results when using the EBTs that 
would be required in proposed Sec.  26.91(b) [Acceptable evidential 
breath testing devices] and relying upon one breath specimen for 
confirmatory testing, as would be required in proposed paragraph (c) of 
this section.
    Proposed Sec.  26.101(a) would require 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 proposed rule would add this requirement to 
reduce the possibility that alcohol metabolism will cause a 
confirmatory test to provide a result falling below the applicable 
cutoff level. Current Section 2.4(g)(18) in Appendix A to Part 26 does 
not require that confirmatory testing must be conducted as soon as 
possible after a positive initial alcohol test result is obtained, 
although licensees follow this practice. However, the 30-minute limit 
would be added because some FFD program personnel may be tested under 
DOT procedures, as permitted in proposed 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 would be 
unnecessary at licensees' and other entities' collection sites because 
licensees' and other entities' collection sites would have the 
capability to conduct confirmatory tests with an EBT, as required under 
proposed Sec.  26.87(a). Therefore, except in these unusual 
circumstances, licensees and other entities would be expected to 
continue their current practice of conducting the confirmatory test 
immediately after a donor's initial test result is determined to be 
positive.
    Proposed Sec.  26.101(b) would be added to specify procedures for 
conducting a confirmatory alcohol test.
    Proposed Sec.  26.101(b)(1) and (b)(2) would require the collector 
to conduct an air blank before beginning the confirmatory test and 
verify that the air blank reading is 0.00. These proposed steps are 
necessary to ensure that the EBT is functioning properly before the 
test begins.
    Proposed Sec.  26.101(b)(3) would require the collector to take the 
EBT out of service if a second air blank test reading is above 0.00. 
This proposed 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.
    Proposed Sec.  26.101(b)(4)-(b)(7) would be added 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 
necessity for these steps would be the same as for those discussed with 
respect to the related steps in proposed Sec.  26.95 [Conducting an 
initial test for alcohol using a breath specimen]. However, the 
proposed rule would 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 would be necessary if any questions arise 
with respect to the collection procedure in a review conducted under 
proposed Sec.  26.39 [Review process for fitness-for-duty policy 
violations], or legal proceedings.
    Proposed Sec.  26.101(c) would be added to require 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 would rely 
upon the result from the first successful collection in determining the 
confirmatory test result. As discussed with respect to proposed Sec.  
26.95(c), if the procedures specified this proposed section are 
followed, relying on one breath specimen for the initial test, rather 
than the two required in the current rule, would increase the 
consistency of Part 26 collection procedures with those of other 
Federal agencies, and reduce the time required for breath specimen 
collections without compromising the accuracy, validity, or reliability 
of the test results. The proposed paragraph would also prohibit 
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, which are required in current Section 2.4(g)(18) in 
Appendix A to Part 26, would no longer be necessary with use of the 
EBTs specified in proposed Sec.  26.91(b). The proposed change would 
meet Goal 3 of this rulemaking, which is to improve the efficiency of 
FFD programs.
    Proposed Sec.  26.101(d) would amend the portion of current Section 
2.4(g)(18) in Appendix A of Part 26 that requires using a different EBT 
for conducting the confirmatory alcohol test than the EBT that the 
collector used for initial alcohol

[[Page 50531]]

testing. The proposed rule would permit the use of the same EBT for 
both initial and confirmatory alcohol testing, rather than require the 
use of two different EBTs. The licensee or other entity would obtain 
one breath specimen for initial alcohol testing and one for 
confirmatory testing, if necessary, but would be permitted to conduct 
both tests using the same EBT. This proposed change would be made 
because improvements in EBT technology assure that valid and reliable 
test results may be obtained from a single EBT, if the proposed 
specimen collection and quality assurance procedures in this part are 
followed. Reducing the number of breath specimens required for alcohol 
testing would not only reduce the costs associated with alcohol 
testing, but would also reduce the burden on donors that is imposed by 
the collection process. 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

    A new Sec.  26.103 [Determining a confirmed positive test result 
for alcohol] would amend the current cutoff level for determining 
whether a confirmatory alcohol test result is positive, as specified in 
current Sec.  26.24(g) and Section 2.7(f)(2) in Appendix A to Part 26. 
The proposed rule would establish 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 proposed Sec.  26.99 [Determining the 
need for a confirmatory test for alcohol]. Proposed Sec.  26.103(a)(1) 
would retain the 0.04 percent BAC in current 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. Proposed Sec.  26.103(a)(2) 
and (a)(3) would 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 upon 
confirmatory testing, but indicate that the donor had a BAC of 0.04 
percent or greater while in a work status or had consumed alcohol while 
on duty. The cutoff levels and time periods in proposed Sec.  
26.103(a)(2) and (a)(3) are based upon 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 
one hour would have had a BAC of approximately 0.04 percent when he or 
she reported for work an hour ago. 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 proposed changes would 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.
    Proposed Sec.  26.103(b) would be added 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 proposed 
Sec.  26.103(a). The proposed rule would require the collector to 
declare the test as negative because some of the EBTs that licensees 
and other entities would be permitted to use for confirmatory alcohol 
testing under the proposed rule have not been thoroughly evaluated by 
NHTSA 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 would 
provide a reason to believe that the individual has been impaired while 
on duty. Therefore, the proposed provision would require the licensee 
or other entity to ensure that the donor's alcohol use is evaluated, a 
determination of fitness is performed, and that the results of the 
determination of fitness indicate 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 after testing. This proposed change would strengthen 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.
    Current Section 2.4(g)(19) in Appendix A to Part 26, which 
establishes requirements for collecting a blood specimen for alcohol 
testing, would be deleted in its entirety because blood testing for 
alcohol, at the donor's discretion, would no longer be permitted in the 
proposed rule. The reasons for eliminating blood testing for alcohol 
from the proposed rule discussed with respect to proposed Sec.  
26.83(a).

Section 26.105 Preparing for Urine Collection

    A new Sec.  26.105 [Preparing for urine collection] would be added 
to describe the preliminary steps for collecting a urine specimen for 
drug testing. This proposed section would reorganize the requirements 
in current Section 2.4(g)(5)-(g)(7) in Appendix A to Part 26 by 
separating alcohol and urine specimen collection procedures into 
separate sections of the proposed rule for organizational clarity. The 
proposed section would also establish several new requirements that 
would be added to 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.
    Proposed Sec.  26.105(a) would revise current Section 2.4(g)(5) in 
Appendix A to Part 26, which requires 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. The proposed paragraph would eliminate the references to 
blood and breath specimens in the current paragraph. Reference to blood 
specimens would be eliminated because blood testing for alcohol, at the 
donor's discretion, would no longer be permitted in the proposed rule, 
as discussed with respect to proposed Sec.  26.83(a). Reference to 
breath specimens would be eliminated in the proposed paragraph because 
the proposed rule would present requirements related to preparing for 
alcohol testing in a separate section, proposed Sec.  26.93 [Preparing 
for alcohol testing], for organizational clarity.
    Proposed Sec.  26.105(b) would be added to require the donor to 
empty his or her pockets and display the items contained in them. The 
proposed requirement for the collector to examine the contents of the 
donor's pockets would increase 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 collector would be 
required 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

[[Page 50532]]

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, the proposed paragraph would require 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 
would secure the item and continue with the collection. These proposed 
requirements would be added to 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, as well as Goal 3 of this 
rulemaking, which is to improve the effectiveness of FFD programs, by 
improving the ability of the collector to identify attempts to subvert 
the drug testing process. The proposed requirement for the donor to 
permit the collector to make this examination would be added in 
response to stakeholder requests at the public meetings discussed in 
Section V to ensure that donors understand that they must cooperate 
with the examination.
    Proposed Sec.  26.105(c) would retain current Section 2.4(g)(6) in 
Appendix A to Part 26, which requires the individual to be instructed 
to wash his or her hands prior to urination. The proposed rule would 
make two minor editorial changes to the current provision for clarity 
in the language of the proposed rule. The proposed rule would clarify 
that the collector is to instruct the donor to wash and dry his or her 
hands and would replace the term, ``individual,'' with the term, 
``donor.''
    Proposed Sec.  26.105(d) would retain current Section 2.4(g)(7) in 
Appendix A to Part 26, which 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 proposed rule would make two minor editorial changes 
to the current provision for clarity in the language of the rule. The 
proposed rule would replace the term, ``collection site person,'' with 
the simpler term, ``collector,'' and the term, ``individual,'' with the 
term, ``donor.''
    Proposed Sec.  26.105(e) would be added 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 would not be required, but 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 would attempt to subvert the testing process by, for 
example, selecting a kit that had been contaminated with a substance 
that would produce a positive or adulterated 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 proposed Sec.  26.95(b)(1). The proposed paragraph would 
also prohibit the donor from taking collection kit materials (such as 
the specimen label) other than the collection container into the 
private area used for urination in order to ensure that a donor could 
not tamper with the other collection kit materials and thereby disrupt 
the chain of custody for the urine specimen. The proposed paragraph 
would be consistent with the related requirements of other Federal 
agencies and so would 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.

Section 26.107 Collecting a Urine Specimen

    Proposed Sec.  26.107 [Collecting a urine specimen] would amend 
current Section 2.4(g)(8), (g)(9), and (g)(12) in Appendix A to Part 26 
to update Part 26 urine specimen collection procedures and incorporate 
advances in other relevant Federal rules and guidelines, consistent 
with Goal 1 of this rulemaking.
    Proposed Sec.  26.107(a)(1) would be added to specify the 
instructions that the collector would be required to provide to the 
donor. The proposed paragraph would require the collector to instruct 
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, not flush the toilet, and return with the specimen as 
soon as the donor has completed the void. The proposed rule would 
require the collector to provide these instructions to the donor so 
that the donor would understand his or her responsibilities with 
respect to the urine collection procedure. In addition, the 
instructions would be necessary to implement other provisions of the 
proposed rule, as follows: The quantity of urine that the collector 
would instruct the donor to provide would be based upon the 
requirements of the licensee's or other entity's drug testing program, 
as discussed with respect to proposed Sec.  26.109 [Urine specimen 
quantity]. The collector would instruct 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 
proposed paragraph (c) of this section. The collector would 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 would cool and its temperature would fall below the acceptable 
specimen temperature range specified in proposed Sec.  26.111(b).
    Proposed Sec.  26.107(a)(1) would further amend current Section 
2.4(g)(8) in Appendix A to Part 26, which states that the individual 
may provide his/her urine specimen in the privacy of a stall or 
otherwise partitioned area that protects individual privacy. For 
clarity, the proposed paragraph would replace ``may'' in the current 
rule with ``shall'' to indicate that the area in which the donor will 
urinate must provide for individual privacy. The proposed rule would 
also add an exception to the current requirement for privacy in the 
case of a directly observed collection. This proposed change would be 
made for greater accuracy in the language of the rule, because the 
requirement for individual privacy would not apply in the case of a 
directly observed collection, as discussed with respect to proposed 
Sec.  26.115 [Collecting a urine specimen under direct observation].
    Proposed Sec.  26.107(a)(2) would be added to further emphasize the 
requirement in current Section 2.4(g)(8) in Appendix A to Part 26 that 
donors must be provided with individual privacy when providing a urine 
specimen. The proposed paragraph would require 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 current requirement for individual privacy has been 
compromised, the experience of other Federal agencies has indicated 
that such emphasis is necessary.
    Proposed Sec.  26.107(a)(3) would permit the collector to set a 
reasonable time limit for the donor to urinate. Rather than 
establishing a specific time limit, the proposed rule would permit 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

[[Page 50533]]

permitting collectors to prevent donors from disrupting the testing 
process by taking an unduly long time to provide a specimen. Proposed 
training and qualification requirements to ensure that collectors are 
able to exercise professional judgment appropriately would be specified 
in proposed Sec.  26.85 (a). At the public meetings discussed in 
Section V, 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 proposed paragraph would clarify that collectors 
have the authority to set a reasonable time limit for voiding. In 
addition, the proposed paragraph would increase the consistency of Part 
26 with the procedures implemented by other Federal agencies, 
consistent with Goal 1 of this rulemaking.
    Proposed Sec.  26.107(b) would amend current Section 2.4(g)(9) in 
Appendix A to Part 26, which requires the collector to note any unusual 
behavior or appearance in the permanent record book and on the custody-
and-control form. The proposed paragraph would clarify the intent of 
the current requirement, which has raised implementation questions from 
licensees, by specifying that the collector must pay careful attention 
to the donor during the collection process for the purpose of noting 
any conduct that may indicate an attempt to tamper with the specimen. 
The proposed paragraph would also provide examples of the types of 
behavior that may indicate a subversion attempt and require the 
collector to contact FFD program management if such behavior is 
observed. The proposed rule would require FFD program management to 
determine whether a directly observed collection is necessary under 
proposed Sec.  26.115 [Collecting a urine specimen under direct 
observation].
    Proposed Sec.  26.107(c) would be added to specify the actions to 
be taken by the collector and donor to complete the specimen collection 
procedure. The first sentence of proposed Sec.  26.107(c) would retain 
the existing instruction in current Section 2.4(g)(12) in Appendix A to 
Part 26, which prohibits the donor from washing his or her hands until 
the specimen has been delivered to the collector. The proposed 
paragraph would also add a requirement for the collector to inspect the 
private area for any evidence of a subversion attempt prior to flushing 
the toilet. This proposed additional requirement would be consistent 
with existing industry practices and the procedures of other Federal 
agencies. In addition, it may increase the likelihood of detecting 
subversion attempts from which physical evidence may remain in the 
toilet bowl or private area where the donor voided, which could 
include, but would not be 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

    A new Sec.  26.109 [Urine specimen quantity] would amend current 
Section 2.4(g)(11) in Appendix A to Part 26, which establishes 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.
    Proposed Sec.  26.109(a) would introduce a new term, ``the 
predetermined quantity.'' The predetermined quantity of urine that a 
donor would be requested to provide would be established by the 
licensee or other entity, depending upon the characteristics of the 
licensee's or other entity's testing program. The proposed rule would 
require the predetermined quantity to include at least 30 milliliters 
(mL) of urine, but licensees and other entities could request a larger 
quantity of urine, if the specimen will be initially tested at a 
licensee testing facility, if testing will be conducted for additional 
drugs beyond those required in proposed Sec.  26.31(d)(1), if split 
specimen procedures will be followed, and if the licensee's or other 
entity's program includes some combination of these characteristics.
    The proposed paragraph would establish 30 mL as the basic quantity 
of urine that donors must provide for a testing program that does not 
include initial tests at a licensee testing facility, does not test for 
additional drugs, and does not follow split specimen procedures. The 60 
mL quantity that is required in current Section 2.4(g)(11) in Appendix 
A to Part 26 would be reduced 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 proposed 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 would no longer be 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 proposed Sec.  
26.31(d)(1), as well as retesting of the specimen, if required.
    Proposed Sec.  26.109(a) would also specify the additional quantity 
of urine, above the basic 30 mL, to be collected when the testing 
program follows split specimen procedures. Licensees and other entities 
would be required 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 proposed Sec.  26.113(b), the proposed rule 
would replace the terms, ``primary specimen'' and ``split specimen,'' 
in the current 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 
would be 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 proposed Sec.  
26.31(d)(1), then the predetermined quantity for this testing program 
would be 45 mL (30 mL for basic testing + 15 mL for the split 
specimen). The predetermined quantity would be larger than 45 mL if the 
testing program also includes initial tests at a licensee testing 
facility and testing for additional drugs.
    Proposed Sec.  26.109(a) would also permit licensees and other 
entities to include in the predetermined quantity the additional amount 
of urine that would be necessary to support testing for additional 
drugs beyond those specified in proposed Sec.  26.31(d)(1). Licensees 
and other entities would 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 would consist 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

[[Page 50534]]

licensee testing facility, follows split specimen procedures, and tests 
for additional drugs, then the predetermined quantity would consist of 
the 30 mL basic quantity plus 15 mL for the split specimen plus the 
additional amount required to test for additional drugs.
    Proposed Sec.  26.109(a) would also permit 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 at the 
licensee testing facility. 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 additional drugs 
or follow split specimen procedures. In this program, the predetermined 
quantity that collectors would 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 could 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 could be larger than 55 mL.
    Proposed Sec.  26.109(b) would be added 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 proposed Sec.  26.31(d)(1). The 30 mL quantity would also 
ensure 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 proposed Sec.  26.165(b). 
However, the 30 mL basic quantity would be insufficient to permit 
testing for additional drugs, initial testing at licensee testing 
facilities, or splitting the specimen, which are not required under 
this part.
    Proposed Sec.  26.109(b)(1) would amend the portions of current 
Section 2.4(g)(11) in Appendix A to Part 26 that relate to collector 
actions if a donor provides an insufficient specimen. The proposed 
paragraph would require 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 currently required. This proposed change would be made 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, 
the proposed paragraph would establish a limit on the amount of liquid 
that the individual would be 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. The 
proposed limit of 24 ounces of water over a 3-hour period would be the 
same limit imposed in the HHS Guidelines, and would be conservative, in 
order 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 taking some medications, would not be placed at-risk. 
The proposed rule would retain the current requirement in Section 
2.4(g)(11) in Appendix A to Part 26 to collect successive specimens in 
separate containers.
    Proposed Sec.  26.109(b)(2) would be added 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 proposed 
requirement would reduce 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.
    Proposed Sec.  26.109(b)(2) would also specify 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. 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 would be 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.
    Proposed Sec.  26.109(b)(2) would also require 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 proposed 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. If the 
subsequent specimen is equal to or greater than the licensee's or other 
entity's predetermined quantity, however, the licensee or other entity 
would be permitted to follow the FFD program's normal testing 
procedures. Following normal testing procedures in this instance would 
be permissible because there would be 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.
    Proposed Sec.  26.109(b)(3) would be added 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 proposed 
Sec.  26.119 [Determining shy bladder]. Requirements for implementing 
``shy bladder'' procedures would be contained in that proposed section.
    Proposed Sec.  26.109(b)(4) would be added to establish additional 
requirements for specimen collections when a donor provides a specimen 
of less than 30 mL, as follows:
    The proposed paragraph would eliminate the requirement in current 
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 
proposed rule would prohibit the practice of combining specimens to 
ensure that successive specimens neither contaminate nor dilute a 
specimen that will be tested. In addition, the proposed prohibition 
would increase the consistency of Part 26 with the related requirements 
of other Federal agencies, which is Goal 1 of this rulemaking.
    Proposed Sec.  26.109(b)(4) would also require 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 could 
include, but would not be limited to: (1) Observation of powder (that 
could be an adulterant or powdered urine) spilled in the private

[[Page 50535]]

area in which the donor urinated or on the donor's clothing; (2) 
unexpected sounds from the private area while the donor should be 
urinating, 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 proposed rule would require the collector to discard 
specimens of less than 30 mL when there is no reason to believe that 
the specimens had been subject to tampering because they would not be 
used for testing and there would be no reason to retain them.
    If the collector suspects that a specimen has been altered and the 
suspect specimen is greater than 15 mL, the proposed rule would require 
the collector to forward the suspect specimen to the HHS-certified 
laboratory for testing, consistent with current 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 would be insufficient to support retesting of the 
specimen at the donor's request. In these circumstances, in which 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 would take precedence over the individual'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, would provide clear 
evidence that a donor had tampered with the specimen and had thereby 
attempted to subvert the testing process.
    The proposed paragraph would also amend current Section 2.4(g)(17) 
in Appendix A to Part 26, which requires a directly observed collection 
whenever there is a reason to believe that a donor has or may attempt 
to alter a specimen. The proposed paragraph would require the collector 
to contact FFD program management to determine whether a directly 
observed collection is required, but would not require a directly 
observed collection. At the public meetings discussed in Section V, the 
stakeholders requested flexibility in the decision to collect another 
specimen under direct observation. They noted that there have been 
numerous instances 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 would establish a 
clear motive for an alleged attempt to tamper with a specimen and would 
add further evidence supporting the imposition of sanctions on the 
donor for attempting to subvert the testing process. However, the NRC 
agrees with the stakeholders 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 
proposed rule would permit FFD program management to determine whether 
an additional specimen collection under direct observation would be 
conducted. This proposed change would be made to meet Goal 3 of this 
rulemaking, which is to improve the efficiency of FFD programs, by 
reducing the number of directly observed collections required under the 
rule.

Section 26.111 Checking the Validity of the Urine Specimen

    A new Sec.  26.111 [Checking the validity of the urine specimen] 
would amend current requirements for assessing specimen validity at the 
collection site, which appear in Section 2.4(g)(13)-(g)(17) in Appendix 
A to Part 26. In general, the changes contained in the proposed section 
would be made to 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.
    Proposed Sec.  26.111(a) would amend current Section 2.4(g)(13) in 
Appendix A to Part 26, which requires the collector to measure the 
temperature of the specimen immediately after the urine specimen is 
collected. The proposed paragraph would require the collector to 
measure the temperature of any specimen that is 15 mL or more. The 
proposed rule would not require measuring the temperature of smaller 
specimens because the collector would be required to discard them, as 
discussed with respect to proposed Sec.  109(b)(4). The proposed 
paragraph would also amend the third sentence of current Section 
2.4(g)(13) to indicate that, if the ambient temperature is low or the 
specimen is small, it may be necessary to measure the specimen 
temperature sooner than 4 minutes after the collector receives the 
specimen from the donor. A low ambient temperature could cool the 
specimen more rapidly than normal room temperatures, resulting in an 
inaccurate temperature reading. Specimens of less than 30 mL will cool 
more rapidly than specimens of 30 mL or more, so that smaller specimens 
may also produce inaccurate temperature readings. Therefore, the 
proposed rule would add an admonition for the collector to expedite the 
temperature measurement process if the collection is occurring in an 
environment below normal room temperatures or the specimen is small.
    Proposed Sec.  26.111(b) would replace current Section 2.4(g)(14) 
in Appendix A to Part 26, which establishes the acceptable specimen 
temperature range and requires conducting a second specimen collection 
under direct observation if a specimen's temperature falls outside the 
acceptable range. The proposed rule would increase the range of 
acceptable specimen temperatures from 90.5[deg]F-99.8[deg]F in the 
current provision to 90[deg]F-100[deg]F for consistency with the 
temperature range specified in the HHS Guidelines. The proposed wider 
acceptable temperature range would provide increased protection against 
false low or false high temperature readings and, therefore, would 
protect donors from the imposition of sanctions based upon inaccurate 
specimen temperature readings. The proposed paragraph would retain the 
requirement in the current rule for the collector to offer the donor 
the opportunity to provide a measurement of body temperature, but a 
measure of oral temperature would no longer be specified. New 
technologies for obtaining body temperature, such as digital 
measurement in the ear canal, would also be permitted, because the new 
technologies provide results more quickly that are at least as accurate 
as oral thermometers. The portion of current Section 2.4(g)(14) that 
specifies collector actions if there is a reason to believe that the 
individual may have tampered with the specimen would be moved to 
proposed Sec.  26.111(d) for organizational clarity.
    Proposed Sec.  26.111(c) would amend current Section 2.4(g)(15) in 
Appendix A to Part 26, which requires the collector to inspect the 
specimen's color, determine whether there are any signs of 
contaminants, and record any unusual findings in the permanent

[[Page 50536]]

record book. The proposed rule would amend this requirement by deleting 
reference to the permanent record book and requiring the collector to 
use the custody-and-control form for recording this information. This 
change would be made because the proposed rule would no longer require 
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 proposed rule would also make minor 
editorial revisions to the current provision by incorporating the 
related language from the HHS Guidelines. These proposed changes would 
be made to meet Goal 1 of this rulemaking, which is to update and 
enhance the consistency of Part 26 with the regulations of other 
Federal agencies.
    Proposed Sec.  26.111(d) would replace and revise the first 
sentence of current Section 2.4(g)(14) in Appendix A to Part 26, which 
requires a second specimen to be collected under direct observation if 
the temperature of the first specimen submitted by a donor falls 
outside of the acceptable specimen temperature range. The proposed 
paragraph would eliminate 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 
proposed provision would require 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 upon observed donor 
behavior, the specimen temperature, unusual specimen characteristics, 
or other observations. The FFD program manager, at his or her 
discretion, would 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 licensee or 
other entity would be permitted to impose the sanctions for a 
subversion attempt in proposed 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 proposed rule would permit the 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 was collected under direct observation would provide 
additional evidence that the donor had attempted to tamper with his or 
her first specimen to hide drug use. This proposed change would be made 
in response to stakeholder requests, for the reasons discussed with 
respect to proposed Sec.  26.109(b)(4).
    Proposed Sec.  26.111(e) would revise current Section 2.4(g)(16) in 
Appendix A to Part 26, which requires that all urine specimens that are 
suspected of being adulterated or diluted must be forwarded to the HHS-
certified laboratory for testing. The proposed paragraph would add 
suspicion that a specimen has been substituted as a third reason for 
forwarding the specimen to the HHS-certified laboratory. As discussed 
with respect to proposed Sec.  26.31(d)(3)(i), substitution entails 
replacing a valid urine specimen with a drug-free specimen. This 
proposed addition would be made for consistency with the addition of 
substitution to the proposed rule as another method of attempting to 
subvert the testing process for which licensees and other entities 
would be required to impose sanctions, as discussed with respect to 
proposed Sec.  26.75(b).
    The proposed paragraph would also specifically prohibit testing the 
suspect specimen at a licensee testing facility for three reasons, 
which are 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 proposed Sec.  26.161(g)]. Only suspect specimens 
of 15 mL or more would be sent for testing, rather than all specimens. 
This proposed lower limit on specimen quantity would be added in order 
to ensure that there would be sufficient urine available for the HHS-
certified laboratory to conduct all of the validity and drug tests on 
the specimen that would required under this part.
    Proposed Sec.  26.111(f) would require collectors and the HHS-
certified laboratory to preserve as much of the specimen as possible. 
This proposed requirement would be added to provide increased assurance 
that a sufficient quantity of urine would be 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.
    Proposed Sec.  26.111(g) would be added to inform donors and 
collectors of the characteristics of a specimen that is acceptable for 
testing at an HHS-certified laboratory. The proposed paragraph would 
incorporate the related provision from the HHS Guidelines.

Section 26.113 Splitting the Urine Specimen

    Proposed Sec.  26.113 [Splitting the urine specimen] would update 
the requirements in current Sections 2.4(g)(20) and 2.7(j) in Appendix 
A to Part 26, which address collection site procedures for split 
specimens, and group them together in one section within the proposed 
rule for organizational clarity.
    Proposed Sec.  26.113(a) would retain the first sentence of current 
Section 2.7(j) in Appendix A to Part 26, which permits licensees to 
follow split specimen procedures. The proposed rule would revise the 
current sentence in the active voice for increased clarity in the 
language of the rule.
    Proposed Sec.  26.113(b) would be added to group together in one 
paragraph, for organizational clarity, the steps that the collector and 
donor must follow for the split-specimen collection procedure, which 
are embedded in current Section 2.4(g)(20) and portions of Section 
2.7(j) in Appendix A to Part 26. The proposed rule would also replace 
the terminology used in the current rule that refers to the split 
specimen as an ``aliquot,'' and use the terms, ``Bottle A'' and 
``Bottle B,'' to refer to the primary and split specimen, respectively. 
This proposed change would be made for increased clarity in the 
language of the rule and consistency with the terminology used in other 
relevant Federal rules and guidelines.
    Proposed Sec.  26.113(b)(1) would require the collector to instruct 
the donor to urinate into either a specimen bottle or a specimen 
container. This step would be added to clarify that the donor is not 
required to divide a specimen into Bottle A and Bottle B while 
urinating. The proposed paragraph would incorporate the related 
provision in the HHS Guidelines.
    Proposed Sec.  26.113(b)(2) would amend the portions of current 
Section 2.7(j) in Appendix A to Part 26 that specify the amount of 
urine to be contained in the split specimen bottles. The proposed rule 
would replace the implied requirements in the second and third 
sentences of Section 2.4(j), which refer to the split specimens as 
``halves'' of the specimen that was collected, with

[[Page 50537]]

updated requirements that would be consistent with those established in 
proposed Sec.  26.109 [Urine specimen quantity] and the related 
provisions in the HHS Guidelines. The proposed paragraph would require 
the collector to ensure that Bottle A contains 30 mL of urine and that 
Bottle B contains 15 mL. As discussed with respect to proposed Sec.  
26.109, advances in urine testing technologies since Part 26 was first 
promulgated permit a reduction in the quantities of urine that must be 
collected from donors in order to conduct the testing that would be 
required under this part. Therefore, 30 mL of urine is now a sufficient 
quantity for conducting all of the testing that may be required under 
this part, while 15 mL is sufficient for any retesting that a donor may 
request.
    The proposed paragraph would also specify that the specimen in 
Bottle A would be used for drug and validity testing and that, even if 
there is less than 15 mL of urine available for Bottle B after the 
collector ensures that Bottle A contains 30 mL, the specimen in Bottle 
A must be subject to testing anyway. These clarifications would be 
added to the proposed 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. Should any Part 26 
programs follow this practice, the efficiency of FFD programs would be 
reduced and the burden on donors from being subject to testing would be 
unnecessarily increased. The 30 mL quantity is sufficient to permit 
retesting of the specimen in Bottle A, at the donor's discretion, and, 
therefore, having 15 mL of urine available for Bottle B is unnecessary 
to ensure donors' rights to retesting. The proposed rule would 
incorporate these clarifications from the HHS Guidelines to ensure that 
Part 26 programs do not adopt this inefficient and burdensome practice.
    Proposed Sec.  26.113(b)(3) would retain the portion of current 
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.
    Proposed Sec.  26.113(c) would be added to establish priorities for 
using the specimen that has been collected. The proposed paragraph 
would permit 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 proposed 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 proposed Sec.  26.109 [Urine specimen 
quantity]. As discussed with respect to proposed Sec.  26.113(b)(2), 
the proposed rule would require 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 proposed rule would permit 
the remaining amount of urine, above the 45 mL required for Bottles A 
and B, to be subject to such testing. However, if the donor has 
provided only 45 mL of urine, the proposed rule would require 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 proposed 
rule would establish the priority of using the 15 mL of urine for 
Bottle B, rather than for testing at a licensee testing facility or 
additional drugs, because the FFD program has established the 
expectation among donors in this instance that the FFD program will 
follow split specimen procedures and that Bottle B will be available 
for retesting at the donor's request. Reserving the 15 mL of urine for 
Bottle B would also be consistent with the principle that would be 
established in the last sentences of proposed Sec. Sec.  26.135(b) and 
26.165(a)(4) that control over testing of the specimen contained in 
Bottle B would reside with the donor.

Section 26.115 Collecting a Urine Specimen Under Direct Observation

    Proposed Sec.  26.115 [Collecting a urine specimen under direct 
observation] would group together in one section the requirements of 
the proposed rule that apply to collecting a urine specimen under 
direct observation. This organizational change would be made because 
requirements that address this topic are dispersed throughout the 
current rule. The proposed section would also incorporate more detailed 
procedures for collecting specimens under direct observation, based 
upon 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 proposed changes would be made to 
increase the likelihood of detecting such 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.
    Proposed Sec.  26.115(a) would amend and combine current Section 
2.4(f), 2.4(g)(17), and (g)(25) in Appendix A to Part 26, which 
establish requirements for collecting a urine specimen under direct 
observation. The proposed paragraph would assign responsibility for 
approving a directly observed collection to the MRO or FFD program 
manager, rather than a ``higher level supervisor'' of the collector in 
current Section 2.4(b)(25) in Appendix A to Part 26. This proposed 
change would ensure that the decision to conduct a directly observed 
collection is made by 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. The proposed change would 
also be consistent with revised requirements in the HHS Guidelines 
related to who may authorize a directly observed collection.
    The proposed rule would also list the circumstances that constitute 
a reason to believe that a donor may dilute, substitute, adulterate, or 
otherwise alter a specimen, and that would, therefore, warrant the 
invasion of individual privacy associated with a directly observed 
collection, as follows:
    Proposed Sec.  26.115(a)(1) would amend current Section 2.4(f)(2) 
in Appendix A to Part 26, which specifies that a directly observed 
collection may be performed if the last urine specimen provided by 
donor yielded specific gravity and creatinine concentration results 
that are inconsistent with normal human urine. The proposed paragraph 
would amend the current provision in several ways.
    First, the proposed rule would eliminate the limitation in the 
current 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 proposed rule would permit 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 proposed change would be necessary for

[[Page 50538]]

consistency with proposed Sec.  26.75(b), which would require 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 proposed Sec.  26.75(b) would require 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 would not be subject to further 
testing under the rule. However, there may be instances in which a 
licensee or other entity is aware that an individual has engaged in a 
subversion attempt under a drug testing program that is not regulated 
by the NRC. If the licensee or other entity is considering granting 
authorization under Part 26 to the individual, then a directly observed 
collection would be warranted to ensure that the donor did not have an 
opportunity to tamper with the specimen and, therefore, that drug test 
results would be accurate. The amended language of the proposed 
provision would permit collecting a specimen under direct observation 
in such circumstances.
    Second, the proposed rule would update the current provision by 
replacing the specific gravity and creatinine concentration values that 
are included in the current 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.'' This proposed change would be made for 
consistency with the addition of more detailed requirements for 
validity testing throughout the proposed rule, as discussed with 
respect to proposed Sec.  26.31(d)(3)(i). The cutoff concentrations and 
specimen characteristics that would lead the HHS-laboratory to report a 
specimen as substituted, adulterated, or invalid would be specified in 
proposed Sec.  26.161 [Cutoff levels for validity testing]. 
Requirements for the MRO's review of the test results would be 
specified in proposed Sec.  26.185 [Determining a fitness-for-duty 
policy violation].
    Proposed Sec.  26.115(a)(2) would combine and update current 
Sections 2.4(f)(1) and 2.4(g)(14) in Appendix A to Part 26, which 
establish that the presentation of a specimen that falls outside of the 
required temperature range is sufficient grounds to conduct a directly 
observed collection. The proposed paragraph would retain the 
requirement in current Section 2.4 (f)(1) in Appendix A to Part 26, 
which specifies that a directly observed collection may be conducted at 
any time the specimen's temperature falls outside of the required 
temperature range. However, the proposed paragraph would amend the 
current requirement for the collector to take an oral measure of 
temperature with a sterile thermometer to permit other means of 
measuring the donor's body temperature, for the reasons discussed with 
respect to proposed Sec.  26.111(a). The proposed rule would also 
retain the current requirement that a directly observed collection may 
be conducted if the specimen's temperature falls outside of the 
required range and the donor declines to provide a measurement of body 
temperature, in proposed Sec.  26.115(a)(2)(i). However, proposed Sec.  
26.115(a)(2)(ii) would eliminate the current permission to conduct a 
directly observed collection in those instances in which the donor's 
body temperature does not equal or exceed that of the specimen. The 
proposed rule would establish a range of acceptable variability between 
the donor's measured temperature and the specimen's temperature of 1EC/
1.8EF. If the donor's temperature differs from the specified 
temperature by more than the specified amount, a directly observed 
collection would be permitted. This proposed change would be made for 
consistency with the related provision in the HHS Guidelines and to 
recognize that a specimen temperature that is either much higher or 
lower than the donor's body temperature may indicate that the donor has 
attempted to subvert the testing process.
    Proposed Sec.  26.115(a)(3) would update current Section 2.4(f)(3) 
in Appendix A to Part 26, which permits a directly observed collection 
if a collector observes donor conduct that clearly and unequivocally 
demonstrates an attempt by the donor to substitute the specimen. The 
proposed rule would add 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 for 
ensuring specimen validity in the proposed rule, as discussed with 
respect to proposed Sec.  26.31(d)(3)(i). As discussed with respect to 
proposed 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 proposed Sec.  26.87(e)(1)] discolors the 
specimen.
    Proposed Sec.  26.115(a)(4) would update current Section 2.4(f)(4) 
in Appendix A to Part 26, which permits directly observed collections 
if a donor has previously been determined to have engaged in substance 
abuse and the specimen is being collected as part of a rehabilitation 
program and/or pre-access testing following a confirmed positive test 
result. The proposed paragraph would update the current requirement by 
adding a cross-reference to proposed Sec.  26.69 [Authorization with 
potentially disqualifying fitness-for-duty information], which would 
establish requirements for granting or maintaining the authorization of 
an individual about whom potentially disqualifying FFD information has 
been discovered or disclosed. Several provisions in proposed Sec.  
26.69 would permit or require directly observed collections, including 
proposed Sec.  26.69(b)(5), which would require 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, the proposed paragraph would replace the 
current requirement with a cross-reference to proposed Sec.  26.69, 
rather than repeat the applicable requirements in this section.
    Proposed Sec.  26.115(b) would amend the requirement in current 
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 proposed 
Sec.  26.115(a). The second sentence of the proposed paragraph would be 
added 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 proposed requirement would ensure 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

[[Page 50539]]

FFD program and, therefore, not be detected by testing. Non-negative 
test results from testing a specimen collected under direct observation 
would 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 would ensure that test results from the specimen provide 
relevant and useful information. The proposed requirement would also be 
consistent with the requirements of other relevant Federal rules and 
guidelines.
    Proposed Sec.  26.115(c) would be added 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. This proposed requirement 
would be added to the proposed rule 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 would meet Goal 7 of this rulemaking, which is to 
protect donors' right to due process, by ensuring that the donor is 
aware of the concern that has initiated the collection. The proposed 
paragraph would also be consistent with the requirements of other 
relevant Federal rules and guidelines.
    Proposed Sec.  26.115(d) would be added to establish recordkeeping 
requirements related to the directly observed collection. The proposed 
paragraph would require the collector to record on the specimen's 
custody-and-control form that the specimen was collected under direct 
observation and the reason for the directly observed collection. The 
proposed requirement is necessary to ensure 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 would be required under proposed Sec.  26.185 [Determining 
a fitness-for-duty policy violation]. This information would be 
important, for example, in an MRO's decision to request the laboratory 
to test a specimen at the LOD that appeared to have been diluted, as 
permitted under proposed 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. Non-
negative test results from the dilute specimen and the presence of the 
same drugs or drug metabolites in the specimen collected under direct 
observation would provide clear evidence that the donor had diluted the 
first specimen in an attempt to mask drug use. The proposed paragraph 
would also be consistent with the requirements of other relevant 
Federal rules and guidelines.
    Proposed Sec.  26.115(e) would retain and combine the existing 
requirements in Sections 1.2, 2.4(b), 2.4(g)(14), (g)(17), and (g)(25) 
in Appendix A to Part 26, which require that the individual who 
observes the specimen collection must be of the same gender as the 
donor. Consistent with the current requirements, the proposed rule 
would permit 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 proposed Sec.  26.115(f). The proposed rule would combine the 
current requirements in the proposed paragraph for organizational 
clarity.
    Proposed Sec.  26.115(f) would be added to specify the procedures 
that must be followed in conducting a directly observed collection. The 
procedures in the proposed paragraph would be followed 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 proposed changes 
would be made to increase the likelihood of detecting such 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.
    Proposed Sec.  26.115(f)(1) would be added 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 proposed requirement would be added to ensure that the 
observer could detect the use of an anatomically correct urine delivery 
device.
    Proposed Sec.  26.115(f)(2) would be added to specify the action to 
be observed during the collection. This proposed requirement would be 
consistent with the requirements of other Federal agencies and is 
intended to ensure that the urine specimen is obtained from the donor's 
body.
    Proposed Sec.  26.115(f)(3) would be added to prohibit an observer 
who is not the collector from touching the specimen container. The 
proposed provision would be 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.
    Proposed Sec.  26.115(f)(4) would be added to require the collector 
to record the observer's name on the custody-and-control form, if the 
observer is not the collector. The proposed requirement would be 
consistent with the related requirements of other Federal agencies and 
is intended to ensure that the observer's identity is documented, 
should future questions arise regarding the collection.
    Proposed Sec.  26.115(g) would be added to clarify that a donor's 
refusal to participate in the directly observed collection would 
constitute a refusal to test and, therefore, would be considered to be 
an act to subvert the testing process, under proposed Sec.  26.75(b). 
Current Section 2.4(j) in Appendix A to Part 26 requires the collector 
to inform the MRO, and the MRO to inform licensee management, if a 
donor fails 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 
current requirement does 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 current rule does not require 
the licensee or other entity to impose sanctions on a donor for 
refusing to be tested. Therefore, the proposed paragraph would both 
clarify the NRC's original intent by stating that a refusal to 
participate in a directly observed collection constitutes a refusal to 
test and update the current requirement by adding a cross-reference to 
the proposed sanction of permanent denial of authorization that would 
be required in such circumstances under proposed Sec.  26.75(b).
    Proposed Sec.  26.115(h) would be added to specify the actions that 
a collector must take, if a directly observed collection was required, 
but was not performed. The collector would inform the FFD program 
manager or designee of the omission, who would ensure 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

[[Page 50540]]

cutoff levels that would be 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 would increase 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 may reduce 
the concentrations of drugs, drug metabolites, or blood alcohol in the 
donor's specimens, the proposed rule would require a directly observed 
collection to be performed immediately. The proposed provision would 
use 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 proposed requirement 
would increase consistency with the related requirements of other 
Federal agencies and is intended to provide instructions for correcting 
an oversight, which are not addressed in the current rule.

Section 26.117 Preparing Urine Specimens for Storage and Shipping

    A new Sec.  26.117 [Preparing urine specimens for storage and 
shipping] would reorganize and present together in one section current 
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. This organizational change would be 
made because requirements that address these topics are dispersed 
throughout the current rule whereas grouping them together in a single 
section would make them easier to locate within the proposed rule.
    Proposed Sec.  26.117(a) would amend current Section 2.4(g)(20) in 
Appendix A to Part 26, which requires the donor and collector to 
maintain visual contact with specimens until they are sealed and 
labeled. The proposed paragraph would eliminate reference to blood 
specimens because donors would no longer be permitted to volunteer to 
provide a blood specimen for alcohol testing under the proposed rule, 
as discussed with respect to proposed Sec.  26.83(a). The proposed 
paragraph would also amend the requirements in the second sentence of 
the current provision. Procedural requirements for observing the 
splitting of a specimen and sealing the split specimen bottles would be 
moved to proposed Sec.  26.113 [Splitting the urine specimen] for 
organizational clarity. However, the proposed paragraph would broaden 
the current requirement, which addresses 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 proposed requirement would be 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 proposed rule would 
require the donor to observe these actions in order 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.
    Proposed Sec.  26.117(b) would retain current Section 2.4(g)(21) in 
Appendix A to Part 26, which 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.
    Proposed Sec.  26.117(c) would retain the meaning of current 
Section 2.4(g)(22) in Appendix A to Part 26, which establishes 
requirements for labeling and sealing the specimen(s), but split the 
current requirement into several sentences for increased clarity in the 
language of the provision.
    For organizational clarity, proposed Sec.  26.117(d) would combine 
current Section 2.4(g)(23) and 2.4(g)(23)(i) in Appendix A to Part 26, 
which require the donor to certify that the specimen was collected from 
him or her. However, the proposed rule would delete current Section 
2.4(g)(23)(ii), which requires the donor to have an opportunity to list 
on the custody-and-control form any medications he or she has taken 
within the past 30 days, for the reasons discussed with respect to 
proposed Sec.  26.89(b)(3).
    The proposed rule would delete current Section 2.4(g)(24) in 
Appendix A to Part 26, which requires the collector to enter into the 
permanent record book all information identifying the specimen. This 
requirement would be eliminated because the proposed rule would no 
longer require 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 would be 
permitted to use other means of tracking specimen identity, including, 
but not limited to bar coding.
    Proposed Sec.  26.117(e) would amend current Section 2.4(g)(26) in 
Appendix A to Part 26, which requires 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 proposed rule would 
eliminate reference to the aliquot and split sample in the current 
paragraph 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. The proposed paragraph 
would retain the current requirement for the collector to certify 
proper completion of the collection.
    Proposed Sec.  26.117(f) would amend current Section 2.4(g)(27) in 
Appendix A to Part 26, which states that the specimens and chain-of-
custody forms are now ready for transfer and must be appropriately 
safeguarded if they are not immediately prepared for shipment. The 
proposed rule would replace the first sentence of the current 
provision, which states 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 proposed change would improve 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. The proposed paragraph would retain the second 
sentence of the current provision.
    Proposed Sec.  26.117(g) would retain current Section 2.4(g)(28) in 
Appendix A to Part 26, which 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 proposed paragraph would make minor editorial changes to some of 
the terminology used in the current paragraph for consistency with the 
terminology used throughout the proposed rule, as discussed with 
respect to proposed Sec.  26.5 [Definitions], but retain the intended 
meaning of the current requirements.

[[Page 50541]]

    Proposed Sec.  26.117(h) would retain the requirements in current 
Section 2.4(c)(2) in Appendix A to Part 26 related to maintaining 
specimen security until the specimens are sent to the licensee testing 
facility or the HHS-certified laboratory for testing from the 
collection site. The current paragraph would be moved to this section 
of the proposed rule for organizational clarity because this is the 
point in the specimen collection procedures at which requirements for 
maintaining specimen security would apply. The portion of the current 
paragraph that applies to situations in which it is impractical to 
maintain continuous physical security of a collection site would be 
moved to proposed Sec.  26.87(f)(5) for organizational clarity because 
proposed Sec.  26.87(f) addresses those circumstances.
    Proposed Sec.  26.117(i) would update the specimen packaging 
requirements in current Section 2.4(i) in Appendix A to Part 26 by 
replacing the current paragraph with the related provision from the HHS 
Guidelines. The first sentence of the current paragraph, which directs 
collection site personnel to arrange to transfer the specimens to the 
licensee testing facility or HHS-certified laboratory, would be moved 
to proposed Sec.  26.117(j) for organizational clarity. Proposed Sec.  
26.117(j) would address transfer and storage requirements, while 
proposed Sec.  26.117(i) would address packaging requirements. The 
proposed paragraph would also eliminate the initial phrases in the 
second sentence of the current paragraph, which list the conditions 
under which specimens will be 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 would be redundant with other portions of the 
proposed rule. Proposed requirements related to transferring specimens 
from a licensee testing facility to an HHS-certified laboratory for 
further testing would be moved to proposed Sec.  26.129(g) in Subpart F 
[Licensee Testing Facilities] for organizational clarity. The proposed 
rule would also eliminate the third sentence of the current paragraph, 
which requires the collector to sign and date the tape used to seal the 
container. This requirement would be eliminated because licensees and 
other entities now rely upon courier services to transfer specimens who 
offer other means of tracking the date that a container of specimens is 
shipped and the sender that program experience has shown are equally 
effective. The proposed paragraph would retain the intended meaning of 
the current 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 Section 
V, the proposed rule would add shipping bags to the current set of 
examples of acceptable shipping containers that protect the specimens 
from damage. Also at the request of stakeholders, the proposed rule 
would delete the last sentence of the current paragraph, which requires 
the collector to ensure that chain-of-custody documents are attached to 
the container that is used to ship the specimens to the licensee 
testing facility or laboratory. The stakeholders requested this change 
because their practice is to seal the specimens' 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, proposes this change.
    Proposed Sec.  26.117(j) would amend and combine the first sentence 
of current Section 2.4(i) in Appendix A to Part 26 with the 
requirements applicable to short-term storage of specimens at 
collection sites in current Section 2.7(c) in Appendix A to Part 26. 
The first sentence of current Section 2.4(i) in Appendix A to Part 26 
would be moved to the proposed paragraph for the reasons discussed with 
respect to proposed Sec.  26.117(i). Under the proposed paragraph, 
short-term refrigerated storage of specimens within 6 hours of 
collection would no longer be required for all specimens, as a result 
of advances in testing technologies. However, the proposed rule would 
continue to require licensees and other entities to protect specimens 
from any conditions that could cause specimen degradation. Collection 
site personnel would be 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 proposed rule 
would also require 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 proposed rule would establish 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.
    Proposed Sec.  26.117(k) would amend the portions of current 
Section 2.4(h) in Appendix A to Part 26 that require every individual 
in the chain of custody to be identified on a specimen's custody-and-
control form. The proposed rule would not require couriers to meet the 
requirements in current Section 2.4(h), which state 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 would 
not be required to meet these requirements because custody-and-control 
forms for individual specimens would be packaged inside the shipping 
container where they are inaccessible to couriers so that it is 
impractical to expect them to sign them when handling the specimen 
shipping containers. The proposed paragraph would codify licensees' and 
other entities' current practices of relying upon 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 proposed rule would also eliminate the 
current 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

    A new Sec.  26.119 [Determining ``shy'' bladder] would be adapted 
from the DOT Procedures at 49 CFR 40.193 to specify procedures for 
determining whether a donor who does not provide a urine specimen of 30 
mL within the 3 hours that would be permitted for a specimen collection 
is refusing to test or has a medical reason for being unable to provide 
the required 30 mL specimen. The proposed section would be respond to 
stakeholder requests during the public meetings discussed in Section V. 
The stakeholders reported that some donors have had difficulty 
providing the 60 mL of urine that was required in current Section 
2.4(g)(11) for medical reasons, but the current rule does not establish 
procedures for handling such circumstances. As a result, some FFD 
programs have adopted the DOT ``shy bladder'' procedures, but the 
stakeholders preferred that the proposed rule incorporate the 
requirements to (1) clarify that the NRC accepts the procedures; (2) 
inform donors of the procedures that they are required to

[[Page 50542]]

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 proposed rule because 
proposed Sec.  26.109 [Urine specimen quantity] would reduce the 
minimum quantity of urine required from 60 mL in the current rule to 30 
mL. However, because some donors' medical problems may also interfere 
with their ability to provide 30 mL of urine, the proposed rule would 
incorporate the DOT procedures. In general, the purpose of these 
proposed procedures is to protect the due process rights of individuals 
who are subject to Part 26. That is, the proposed section would 
establish 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 would be authorized to devise alternative methods of drug testing, 
if it appears that the donor's medical problem would prevent him or her 
from being able to provide sufficient urine for drug testing in future 
tests.
    Proposed Sec.  26.119(a) would be added 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 MRO would be permitted to perform the evaluation, if the MRO 
possesses the appropriate expertise. If not, the MRO would be required 
to review the qualifications of the physician and agree to the 
selection of that physician. These proposed requirements for the 
physician who performs the evaluation to be qualified in the relevant 
medical issues are necessary to ensure that the results of the 
evaluation would be valid.
    The proposed paragraph would also require that the evaluation must 
be completed within 5 days of the unsuccessful collection. The 5-day 
time limit would be established on the basis of a trade-off between the 
necessity 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. The DOT's experience has indicated that 5 days is 
sufficient to complete the evaluation.
    Proposed Sec.  26.119(b) would be added 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. Proposed Sec.  
26.119(b)(1) and (b)(2) would 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 proposed requirements would ensure that the evaluating physician 
understands the context in which he or she is being asked to perform 
the evaluation. Proposed Sec.  26.119(b)(3) would also require the MRO 
to inform the physician that he or she must agree to follow the 
procedures specified in proposed Sec.  26.119(c)-(f) if he or she 
performs the evaluation. This proposed requirement would ensure that 
the physician understands and consents to follow the proposed 
procedures specified in this section.
    Proposed Sec.  26.119(c) would be added to describe the conclusions 
that the physician must provide to the MRO following the evaluation. 
Under proposed 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 proposed 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 proposed rule 
would limit the physician's conclusions to one of these two 
alternatives in order 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.
    Proposed Sec.  26.119(d) would be added to define the physical and 
psychological conditions that would constitute a medical condition that 
could have precluded the donor from providing a 30 mL specimen and 
provide examples of conditions that would not constitute a legitimate 
medical condition. Legitimate medical conditions would 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 would 
be examples of conditions that could not be considered legitimate 
medical conditions. The proposed rule would add this paragraph to 
provide necessary guidance to the evaluating physician.
    Proposed Sec.  26.119(e) would be added 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 would provide this written statement. The written 
statement would be necessary to communicate the results of the 
evaluation and create a record of it, should any question arise later 
with respect to the determination.
    The proposed paragraph would also require that the physician must 
provide only the information that is necessary to support the 
physician's conclusion. This proposed requirement would be added to 
protect the donor's privacy by ensuring that the only medical 
information documented is information that is necessary to support the 
determination.
    Proposed Sec.  26.119(f) would be added to require the physician to 
inform the MRO, in the written statement, whether any medical condition 
that may be identified would also preclude the donor from providing 
specimens of 30 mL or more in future collections. This information 
would be necessary for the MRO to determine whether alternative methods 
of drug testing must be implemented for the donor, as required under 
proposed Sec.  26.119(g)(3).
    Proposed Sec.  26.119(g) would be added to prescribe the actions to 
be taken by the MRO based on the results of the evaluation, as follows:
    Proposed Sec.  26.119(g)(1) would require 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 would not impose sanctions on the donor 
because the donor had not violated the FFD policy by refusing to test.
    Proposed Sec.  26.119(g)(2) would require 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 would impose the sanction of a permanent denial of 
authorization for an attempt to subvert the testing process, as 
required under proposed Sec.  26.75(b).

[[Page 50543]]

    Proposed Sec.  26.119(g)(3) would require the MRO to devise an 
alternative method of collecting specimens for drug testing, if the 
donor's medical condition would, over the long-term, consistently 
prevent the donor from providing urine specimens of 30 mL or more. For 
example, the proposed provision would permit 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 
would be scientifically defensible and forensically sound. The proposed 
paragraph would grant flexibility to the MRO in exercising his or her 
professional judgment in determining an alternative method of 
conducting drug testing, rather than establish detailed requirements 
which may not appropriately address the range of possible medical 
conditions that could arise.

Subpart F--Licensee Testing Facilities

Section 26.121 Purpose

    A new Sec.  26.121 [Purpose] would be added to provide an overview 
of the contents of the proposed subpart, consistent with Goal 6 of this 
rulemaking, which is to improve clarity in the organization and 
language of the rule.

Section 26.123 Testing Facility Capabilities

    Proposed Sec.  26.123 [Testing facility capabilities] would amend 
the second sentence of current Section 2.7(l)(2) in Appendix A to Part 
26 as it relates to the capabilities of licensee testing facilities. 
The proposed paragraph would retain the current 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 would add a requirement for licensee testing facilities 
to have the capability to perform either validity screening tests, 
initial validity tests, or both. The first sentence of current Section 
2.7(l)(2), which establishes requirements for the capabilities of HHS-
certified laboratories would be moved to proposed Subpart G 
[Laboratories Certified by the Department of Health and Human 
Services]. The last sentence of the current paragraph, which permits 
the testing of breath specimens for alcohol at the collection site, 
would be deleted here because the proposed rule would address alcohol 
testing in Subpart E [Collecting Specimens for Testing]. These proposed 
organizational changes to the current paragraph would be made to meet 
Goal 6 of this rulemaking, which is to improve organizational clarity 
in the rule.

Section 26.125 Licensee Testing Facility Personnel

    Proposed Sec.  26.125 [Licensee testing facility personnel] would 
amend current Section 2.6 in Appendix A to Part 26, as follows:
    Proposed Sec.  26.125(a) would retain current Section 2.6(a) in 
Appendix A to Part 26, which 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 proposed paragraph would make minor 
changes in the language of this paragraph, which would be consistent 
with amended language in the related portion of the HHS Guidelines.
    Proposed Sec.  26.125(b) would amend current Section 2.6(b) in 
Appendix A to Part 26, which requires laboratory technicians and 
nontechnical staff to have the necessary training and skills for the 
tasks assigned to them. The proposed rule would retain the first 
sentence of the current provision, but would add another. The proposed 
rule would require laboratory technicians who perform urine specimen 
testing to demonstrate proficiency in operating the testing instruments 
and devices used at the licensee testing facility. This proficiency 
requirement would be added to ensure that technicians are capable of 
correctly using the instruments and devices that the licensee testing 
facility has selected for validity and drug testing. This proposed 
change is necessary for several reasons. First, the proposed rule would 
add new requirements for licensee testing facilities to conduct 
validity testing, and the instruments and devices that the technicians 
would be using are likely to differ from those previously used at 
licensee testing facilities. Therefore, additional training and 
proficiency testing would be required to ensure that validity testing 
would be conducted properly. Second, proposed 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 
current 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 proposed requirement 
for technicians to demonstrate proficiency, then, would contribute 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.
    Proposed Sec.  26.125(c) would amend current Section 2.6(c) in 
Appendix A to Part 26, which establishes recordkeeping requirements for 
the personnel files of licensee testing facility personnel. The current 
requirement for records of tests for color blindness would be 
eliminated here, consistent with a similar change to the HHS 
Guidelines. Tests for color blindness would no longer be necessary 
because current testing technologies provide means other than color for 
reading test results.

Section 26.127 Procedures

    Proposed Sec.  26.127 [Procedures] would combine, reorganize, and 
amend requirements for procedures that are interspersed throughout 
Appendix A to Part 26, including requirements in current Sections 2.2 
and 2.7. These organizational changes would be made to improve clarity 
in the organization of the rule by grouping procedural requirements for 
licensee testing facilities in one section.
    Proposed Sec.  26.127(a) would make minor editorial changes to the 
first sentence of current Section 2.2 in Appendix A to Part 26, which 
requires licensee testing facilities and HHS-certified laboratories to 
have detailed procedures for conducting testing. The proposed rule 
would delete the current reference to blood samples because donors 
would no longer have the option to request blood testing for alcohol, 
as discussed with respect to proposed Sec.  26.83(a). Reference to HHS-
certified laboratories would be moved to proposed Sec.  26.157(a) in 
Subpart G [Laboratories Certified by the Department of Health and Human 
Services] to improve the organizational clarity of the rule. The 
proposed rule would also delete the current reference to procedures for 
specimen collections, because procedural requirements for specimen 
collections would be relocated to proposed Subpart E [Collecting 
Specimens for Testing].
    Proposed Sec.  26.127(b) would combine and amend portions of the 
requirements in the first sentence of current 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 proposed 
paragraph would retain the portions of the current paragraphs that 
require 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

[[Page 50544]]

testing and reporting of results, during storage and shipping to the 
HHS-certified laboratory, and continuing until final disposition of the 
specimens. The current requirements related to HHS-certified 
laboratories would be moved to proposed Sec.  26.157(b) in Subpart G 
[Laboratories Certified by the Department of Health and Human Services] 
to improve organizational clarity. The proposed rule would also remove 
references to custody-and-control procedures for blood specimens 
because donors would no longer have the option to request blood testing 
for alcohol, as discussed with respect to proposed Sec.  26.83(a).
    Proposed Sec.  26.127(c) would retain the portions of current 
Section 2.7(o)(1) in Appendix A to Part 26 that address the required 
content of procedures for licensee testing facilities and amend the 
current requirements. The proposed paragraph would retain the portions 
of the current provision that require 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 
proposed paragraph would present the required topics of the procedures 
in a list format in proposed Sec.  26.127(c)(1)-(c)(12) to clarify that 
each topic stands on its own, and to improve clarity in the 
organization of the rule.
    Proposed Sec.  26.127(c) would also amend current Section 2.7(o)(1) 
in Appendix A to Part 26 in several ways. First, the proposed paragraph 
would eliminate the current requirement for the procedures to be 
maintained in a laboratory manual as unnecessarily restrictive. 
Licensee testing facilities would be permitted to use other means to 
maintain their procedures. Second, the proposed paragraph would add a 
requirement for the development, implementation, and maintenance of 
written standard operating procedures for validity testing instruments 
and devices, consistent with the addition of requirements to conduct 
validity testing throughout the proposed rule. Third, two portions of 
the current provision would be moved to other subparts of the proposed 
rule that address related topics to improve clarity in the organization 
and language of the rule, as follows: The last two sentences of current 
Section 2.7(o)(1) in Appendix A to Part 26, which address requirements 
for retaining copies of superceded procedures, would be relocated to 
Sec.  26.215(a) of Subpart J [Recordkeeping and Reporting Requirements] 
of the proposed rule. Procedural requirements for HHS-certified 
laboratories would be moved to Sec.  26.157(b) in proposed Subpart G 
[Laboratories Certified by the Department of Health and Human 
Services].
    Proposed Sec.  26.127(d) would amend current Section 2.7(o)(3)(iii) 
in Appendix A to Part 26, which 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 proposed paragraph would extend the 
current requirements to non-instrumented devices (such as some validity 
screening devices), if the licensee testing facility uses such devices, 
consistent with the addition of requirements to conduct validity 
testing throughout the proposed rule. The proposed rule would also make 
three organizational changes to the current provision. The proposed 
paragraph would present the required topics of the procedures in a list 
format in proposed Sec.  26.127(d)(1)-(d)(3) to clarify that each topic 
stands on its own. The current requirement to maintain records of 
preventative maintenance would be relocated to Sec.  26.215(b)(10) in 
Subpart J [Recordkeeping and Reporting Requirements] of the proposed 
rule. And, the current requirements that apply to HHS-certified 
laboratories would be moved to Sec.  26.157(d) in proposed Subpart G 
[Laboratories Certified by the Department of Health and Human 
Services]. These proposed changes would made to improve clarity in the 
organization of the rule.
    Proposed Sec.  26.127(e) would reorganize and amend current Section 
2.7(o)(4) in Appendix A to Part 26, which requires documented 
corrective actions if systems are out of acceptable limits or errors 
are detected. The proposed paragraph would extend the current 
requirement to non-instrumented validity screening devices, if the 
licensee testing facility uses such devices, consistent with the 
addition of requirements to conduct validity testing throughout the 
proposed rule. The requirements in the current paragraph that apply to 
HHS-certified laboratories would be moved to Sec.  26.157(e) in 
proposed Subpart G [Laboratories Certified by the Department of Health 
and Human Services] for organizational clarity.

Section 26.129 Assuring Specimen Security, Chain of Custody, and 
Preservation

    Proposed Sec.  26.129 [Assuring specimen security, chain of 
custody, and preservation] would be added to group together in one 
section the requirements of the proposed rule that apply to licensee 
testing facilities with respect to the safeguarding of specimen 
identity, integrity, and security. This proposed organizational change 
would be made because requirements that address these topics are 
dispersed throughout the current rule whereas grouping them together in 
a single section would make them easier to locate within the proposed 
rule.
    Proposed Sec.  26.129(a) would retain the first four sentences of 
current Section 2.7(a)(1) in Appendix A to Part 26, which require 
licensee testing facilities to be secure and accessible only to 
authorized personnel. These requirements as they apply to HHS-certified 
laboratories would be moved to proposed Sec.  26.159(a). The last 
sentence of the current paragraph, which establishes recordkeeping 
requirements, would be moved to Sec.  26.215(b)(13) in proposed Subpart 
J [Recordkeeping and Reporting Requirements]. The proposed changes 
would be made for organizational clarity.
    Proposed Sec.  26.129(b) would amend current Section 2.7(b)(1) in 
Appendix A to Part 26, which establishes requirements for receiving 
specimens at the licensee testing facility and assuring their integrity 
and identity. The proposed rule would move the current requirements 
related to HHS-certified laboratories to Sec.  26.159(b) in proposed 
Subpart G [Laboratories Certified by the Department of Health and Human 
Services] for organizational clarity. Several requirements would also 
be added to the proposed paragraph, as follows:
    The proposed paragraph would add requirements for licensee or other 
entity management personnel to investigate any indications of specimen 
tampering and take corrective actions if tampering is confirmed. The 
proposed rule would add these requirements because some licensees have 
not investigated or taken corrective actions in response to indications 
of tampering with specimens under the current rule. The appropriate 
corrective actions that management personnel would take would depend 
upon 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 proposed Sec.  26.75(b) for a subversion attempt. 
Management personnel would also be required to correct any systematic 
weaknesses in specimen custody-and-control procedures that may be

[[Page 50545]]

identified in the investigation, such as inadequate safeguarding of 
specimen shipping containers.
    The proposed paragraph would also add 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 would work with collection site personnel to attempt 
to identify the collector and obtain the collector's signature on the 
form if possible. This proposed requirement would reduce 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 proposed requirements would also improve the efficiency 
of FFD programs by avoiding the need to conduct additional specimen 
collections when discrepancies can be corrected. The proposed provision 
would also 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 proposed paragraph would also add a prohibition on testing of 
any specimens if the licensee or other entity has reason to believe 
that the specimens that were subject to tampering had been altered in 
such a manner as to affect specimen identity and integrity. In these 
circumstances, the MRO would cancel testing of the specimens or any 
test results from those specimens, and require the licensee or other 
entity to retest the donors who had submitted them. Although the NRC is 
not aware of any instances in which these circumstances have arisen in 
Part 26 programs, the experience of other Federal agencies indicates 
such tampering is possible. Therefore, this requirement would be 
necessary to ensure that individuals are not subject to sanctions for a 
non-negative test result from a specimen that may not have been theirs. 
The proposed change would be made to meet Goal 7 of this rulemaking, 
which is to protect the due process rights of individuals who are 
subject to Part 26. The additional provision would also be consistent 
with the requirements of other Federal agencies.
    Proposed Sec.  26.129(c) would amend current Section 2.7(b)(2) in 
Appendix A to Part 26, which establishes requirements for chain-of-
custody procedures for specimens and aliquots at licensee testing 
facilities. The proposed rule would move the requirements in the 
current paragraph that are related to HHS-certified laboratories to 
proposed Subpart G [Laboratories Certified by the Department of Health 
and Human Services] to improve organizational clarity. In addition, the 
proposed paragraph would add a reference to specimen validity testing 
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).
    The proposed paragraph would incorporate two additional changes to 
the current provision at the request of stakeholders at the public 
meetings discussed in Section V. The stakeholders requested that the 
proposed rule 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 proposed change would be incorporated 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. Continuing to 
permit such flexibility would be consistent with Goal 5 of this 
rulemaking, which is to improve Part 26 by eliminating or modifying 
unnecessary requirements.
    The stakeholders also requested that the proposed paragraph specify 
the conditions under which specimens and aliquots may be discarded 
because the current rule does not address discarding of negative 
specimens. Therefore, the proposed rule would permit licensee testing 
facilities to discard specimens and aliquots as soon as practical after 
validity screening or initial validity tests have demonstrated that the 
specimen appears to be valid and initial test results for drugs and 
drug metabolites are negative. The proposed clarification would codify 
current licensee practices. This permission would have no impact on 
donors' rights under the rule, because donors are not at risk of 
management actions or sanctions as a result of negative test results 
and, therefore, would not need the licensee testing facility to retain 
the specimen for additional testing for review or litigation purposes. 
The proposed change would be made to meet Goal 6 of this rulemaking, 
which is to improve clarity in the language of the rule.
    Proposed Sec.  26.129(d) would update current Section 2.7(a)(2) in 
Appendix A to Part 26, which requires licensee testing facility 
personnel to maintain and document the chain of custody for specimens 
and aliquots. The proposed paragraph would incorporate the simpler 
language of the related provision from the HHS Guidelines while 
retaining the intent of the current paragraph. The proposed rule would 
relocate the requirements in the current paragraph that are related to 
HHS-certified laboratories to Sec.  26.159(d) and (e) in proposed 
Subpart G [Laboratories Certified by the Department of Health and Human 
Services] to improve organizational clarity.
    Proposed Sec.  26.129(e) would amend the first sentence of current 
Section 2.7(d) in Appendix A to Part 26, which requires specimens that 
test as ``presumptive positive'' at the licensee testing facility to be 
shipped to the HHS-certified laboratory for further testing. The 
proposed rule would replace the term, ``presumptive positive,'' with 
the term, ``non-negative,'' in order to address validity testing 
results, 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). For organizational clarity, 
the requirements in current Section 2.7(d) in Appendix A to Part 26 
that relate to quality control procedures for testing at licensee 
testing facilities and HHS-certified laboratories would be moved to 
proposed Sec. Sec.  26.137 [Quality assurance and quality control] and 
26.167 [Quality assurance and quality control], respectively.
    Proposed Sec.  26.129(f) would clarify and revise current Section 
2.7(c) in Appendix A to Part 26, as it relates to refrigerating urine 
specimens to protect them from degradation. For organizational clarity, 
the proposed rule would move the current requirements that apply to 
HHS-certified laboratories to proposed Sec.  26.159(h) in Subpart G 
[Laboratories Certified by the Department of Health and Human 
Services]. The proposed paragraph would restate portions of the current 
provision and add a performance standard regarding ``appropriate and 
prudent actions'' to minimize specimen degradation. For the reasons 
discussed with respect to proposed Sec.  26.117(j), the proposed rule 
would no longer require all specimens to be refrigerated within 6 hours 
after collection, but would add a requirement that any specimen that 
has not been tested within 24 hours of receipt at the licensee testing 
facility

[[Page 50546]]

must be refrigerated. The proposed paragraph would continue 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 non-negative results from initial drug 
testing at the licensee testing facility. The proposed rule would also 
add a requirement for refrigerating any specimen (and the associated 
Bottle B) that yields non-negative results from validity screening or 
initial validity testing at the licensee testing facility. 
Refrigerating these specimens would be necessary because some 
adulterants have been shown to interfere with drug test results more 
rapidly if the specimen remains at room temperature.
    The proposed rule would eliminate as unnecessary the last sentence 
of the current paragraph, which requires licensee testing facilities to 
ensure that emergency power equipment is available to maintain the 
specimens cooled in the event of a power failure. With improvements in 
the courier services available to licensee testing facilities since 
Part 26 was first published, licensee testing facilities are typically 
able to ship specimens to the HHS-certified laboratory on the same day 
that specimens are tested. Further, program experience since the rule 
was implemented indicates that the periods of time that licensee 
testing facilities are without off-site power are typically limited to 
a few hours at most, which would not be long enough for specimen 
degradation to occur. Therefore, the proposed change would be made to 
meet Goal 5 of this rulemaking, which is to improve Part 26 by 
eliminating or modifying unnecessary requirements.
    The proposed rule would also update the terminology used in the 
current paragraph to be consistent with the new terminology adopted 
throughout the proposed rule for referring to split specimens. 
Therefore, in the proposed paragraph, the licensee testing facility 
would continue 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 
licensee testing facility would also be required to refrigerate any 
specimen that yields non-negative test results, Bottle B of any 
specimen in Bottle A that tests as non-negative, and any specimen that 
is not tested within 24 hours of receipt at the licensee testing 
facility. These changes in the terminology of the proposed paragraph 
would be made to improve clarity in the language of the proposed rule.
    Proposed Sec.  26.129(g) and (h) would separate current Section 
2.4(i) in Appendix A to Part 26 into two paragraphs for organizational 
clarity and amend the current provision for the reasons previously 
discussed with respect to proposed Sec.  26.117(i) and (k). Proposed 
Sec.  26.129(g) and (h), which repeat the requirements for packaging 
and shipping specimens contained in proposed Sec.  26.117(i) and (k) of 
Subpart E [Collecting specimens for testing], would apply these 
requirements to packaging and shipping specimens from licensee testing 
facilities to HHS-certified laboratories. The bases for these 
requirements are discussed with respect to proposed Sec. Sec.  
26.117(i) and (k).

Section 26.131 Cutoff Levels for Validity Screening and Initial 
Validity Tests

    A new Sec.  26.131 [Cutoff levels for validity screening and 
initial validity tests] would be added to establish cutoff levels for 
validity screening and initial validity tests at licensee testing 
facilities for creatinine, pH, and oxidizing adulterants. The 
procedures, substances, and cutoff levels for initial validity testing 
in the proposed section would incorporate the related requirements from 
the HHS Guidelines (69 FR 19643; April 13, 2004). The proposed validity 
screening test requirements would be adapted from the HHS proposed 
revision to the Guidelines that was also published in the Federal 
Register on April 13, 2004 (69 FR 19673).
    By contrast to the requirements for initial validity testing in the 
HHS Guidelines, the proposed rule would not require licensee testing 
facilities to evaluate the specific gravity of a specimen that has a 
creatinine concentration of less than 20 milligrams (mg) per deciliter 
(dL). Specimens with a low creatinine concentration may be dilute or 
substituted. Instead, if the specimen's creatinine concentration is 
less than 20 mg/dL, the proposed rule would require the licensee 
testing facility to forward the specimen to the HHS-certified 
laboratory to complete the testing, where the specimen's specific 
gravity would be measured. The proposed rule would differ 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 proposed rule would require licensee 
testing facilities to ship specimens with low creatinine concentrations 
to the HHS-laboratory to complete the initial testing process and would 
not include cutoff levels for specific gravity or quality control 
requirements for measuring specific gravity in this proposed subpart. 
The NRC invites comment on this issue.
    Proposed Sec.  26.131(a) would be 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 specimens that yield drug-positive results from initial 
testing at a licensee testing facility, the proposed rule would also 
require licensee testing facilities to forward specimens that yield 
non-negative validity testing results 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 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 
protect donors' rights to due process under Part 26, 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 upon more 
complex testing technologies. The proposed rule would permit licensee 
testing facilities to perform validity screening tests before 
performing initial validity tests, but would not require them to do so, 
because validity screening tests would be unnecessary if the licensee 
testing facility will perform initial validity testing.
    Proposed Sec.  26.131(b) would be added to require licensee testing 
facilities to test each urine specimen for its creatinine 
concentration, pH, and the presence of one or more oxidizing 
adulterants, such as nitrite or bleach. Abnormal creatinine 
concentrations and pH values, and the presence of oxidizing adulterants 
are indicators that a specimen has been adulterated or substituted. The 
proposed rule would permit the FFD program to choose the oxidizing 
adulterant(s) for which testing would be conducted. The requirements in 
this proposed paragraph would be consistent with the related 
requirements in the current HHS Guidelines.

[[Page 50547]]

    Proposed Sec.  26.131(b) would also establish the criteria for 
determining whether a specimen must be forwarded to the HHS-certified 
laboratory for further validity testing. The proposed criteria would be 
incorporated from the current HHS Guidelines. Because validity testing 
is complex and the methods for testing are relatively new, the proposed 
rule would not permit an FFD program to establish more stringent cutoff 
levels for validity screening and initial validity testing. This 
proposed prohibition is necessary to decrease the risk of obtaining 
false non-negative test results and would ensure that donors are not 
subject to sanctions on the basis of inaccurate test results.

Section 26.133 Cutoff Levels for Drugs and Drug Metabolites

    A new Sec.  26.133 [Cutoff levels for drugs and drug metabolites] 
would amend current Section 2.7(e)(1) in Appendix A to Part 26, which 
establishes cutoff levels for initial testing for drugs and drug 
metabolites. Proposed Sec.  26.133 would replace and amend some cutoff 
levels for initial tests for drugs and drug metabolites in current 
Section 2.7(e)(1) in Appendix A to Part 26 to be consistent with the 
HHS cutoff levels for the same substances.
    The initial test cutoff level for marijuana metabolites would be 
decreased from 100 nanograms (ng) per milliliter (mL) to 50 ng/mL. 
Current immunoassay techniques can now reliably detect the presence of 
marijuana metabolites at this cutoff level. As discussed in Section IV. 
B, this proposed change would strengthen the effectiveness of FFD 
programs by increasing the likelihood of detecting marijuana use.
    The proposed rule would increase the initial test cutoff level for 
opiate metabolites from 300 ng/mL in the current rule to 2,000 ng/mL. 
The proposed change in the cutoff level for opiate metabolites would 
substantially reduce the number of positive opiate test results that 
are reported to MROs by HHS-certified laboratories that MROs ultimately 
verify as negative.
    The proposed rule would continue to permit licensees and other 
entities to establish more stringent cutoff levels for initial drug 
tests, subject to the requirements specified in proposed Sec.  
26.31(d)(3)(iii), for the reasons discussed with respect to that 
paragraph.
    The current requirement for licensees and other entities to report 
drug test results for both the cutoff levels in the rule and more 
stringent cutoff levels would be eliminated in the proposed rule. The 
reason that the current rule requires FFD programs to report test 
results for the cutoff levels specified in this part, when the licensee 
is using more stringent cutoff levels, is that it provides means for 
the NRC to monitor licensees' implementation of the permission to use 
more stringent cutoff levels. The proposed rule would eliminate this 
requirement, because proposed Sec.  26.31(d)(3)(iii)(C) would require 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 would no 
longer be needed to assure licensee testing facility performance in 
this area. Eliminating this requirement would meet Goal 5 of this 
rulemaking, which is to improve Part 26 by eliminating or modifying 
unnecessary requirements.

Section 26.135 Split Specimens

    A new Sec.  26.135 [Split specimens] would reorganize and amend the 
requirements contained in current Section 2.7(j) in Appendix A to Part 
26 that relate to licensee testing facility handling of split 
specimens. The proposed requirements would apply only if the FFD 
program follows split specimen procedures. The current paragraph would 
be divided into separate paragraphs in the proposed section to indicate 
that each requirement stands on its own. This proposed change would be 
made to meet Goal 6 of this rulemaking, which is to improve clarity in 
the organization and language of the rule.
    Proposed Sec.  26.135(a) would amend the second, third, and fourth 
sentences of current Section 2.7(j) in Appendix A to Part 26. The 
proposed rule would revise the terminology used in these sentences 
(e.g., ``Bottle A'' rather than ``primary specimen,'' ``Bottle B'' 
rather than ``split specimen,'' ``non-negative'' rather than 
``presumptive positive'') to be consistent with terminology used in 
other parts of the proposed regulation without amending the meaning of 
the sentences. The requirement in the third sentence of current Section 
2.7(j) to seal the split specimen prior to placing it in secure storage 
would be deleted in the proposed rule, because Bottles A and B would 
have already been sealed at the collection site, as required in 
proposed Sec.  26.113(b)(3). The proposed paragraph would add a 
requirement to forward Bottle A of the split specimen to the HHS-
certified laboratory, in the case of any non-negative validity test 
results at the licensee testing facility. This proposed requirement 
would be 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).
    Proposed Sec.  26.135(b) would amend the requirements in current 
Section 2.7(j) in Appendix A to Part 26 related to donor requests for 
testing of the specimen in Bottle B. The proposed paragraph would add 
non-negative 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 proposed rule, 
as discussed with respect to proposed Sec.  26.31(d)(3)(i). The 
proposed paragraph would also add a requirement that the donor must 
request testing of the Bottle B specimen within 3 business days of 
being notified by the MRO that the specimen in Bottle A has yielded 
confirmed non-negative test results. Since 1994, the HHS Guidelines 
have allowed up to 72 hours for a donor to make this request, so the 
proposed change would increase the consistency of Part 26 with the HHS 
Guidelines to 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 proposed paragraph would also eliminate the requirement in the 
fourth sentence of current Section 2.7(j) in Appendix A to Part 26, 
which requires that the split specimen must be forwarded to another 
HHS-certified laboratory for testing on the same day of the donor 
request. Licensees and other entities would be permitted up to one 
business day to forward Bottle B to a second HHS-certified laboratory 
following the donor request. This proposed change would respond to 
stakeholder feedback provided during the public meetings discussed in 
Section V. The stakeholders reported that implementing the same-day 
requirement has often been 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 upon the nature of the 
non-negative test result. The proposed rule would alleviate some of 
these types of logistical difficulties (e.g., logistical problems 
associated with weekends and holidays) while continuing to provide the 
donor with timely test results. Therefore, this proposed change would 
be made to meet Goal 5 of this rulemaking, which is to improve Part 26 
by eliminating or modifying unnecessary requirements.

[[Page 50548]]

    The proposed paragraph would also require the donor to provide 
written permission to the licensee or other entity for testing of the 
specimen contained in Bottle B and clarify that only the donor may 
authorize testing of Bottle B. Stakeholders have indicated that the 
requirement for a written request from donors would impose a 
substantial logistical burden for donors who may not be working on site 
when contacted by the MRO. However, the NRC believes that the proposed 
requirement is necessary to ensure that the donor's right to privacy 
and control of the specimen would be protected, consistent with Goal 7 
of this rulemaking, which is to protect the privacy and due process 
rights of individuals who are subject to Part 26.
    Proposed Sec.  26.135(c) would update the terminology used in the 
portions of current Section 2.7(h) in Appendix A to Part 26 that apply 
to storing specimens at licensee testing facilities. For example, the 
proposed provision would replace the term, ``split specimen,'' with the 
term, ``Bottle B.'' The proposed paragraph would continue to require 
licensee testing facilities who retain Bottle B of a confirmed non-
negative split specimen to store it in long-term frozen storage for at 
least one year before discarding it, or longer if the specimen is under 
legal challenge, or at the request of the NRC. The proposed rule would 
extend the current requirement to apply to Bottle B of any specimen 
that has yielded non-negative validity test results, 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). The portions of current Section 2.7(h) in Appendix A to 
Part 26 that apply to HHS-certified laboratories would be moved to 
Sec.  26.159(i) in proposed Subpart G [Laboratories Certified by the 
Department of Health and Human Services] to improve the organizational 
clarity of the rule.

Section 26.137 Quality Assurance and Quality Control

    A new Sec.  26.137 [Quality assurance and quality control] would 
amend current Section 2.8 in Appendix A to Part 26. The proposed 
section would add 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 
to be discussed with respect to each proposed paragraph. The portions 
of current Section 2.8 in Appendix A to Part 26 that establish 
requirements for HHS-certified laboratories would be moved to Sec.  
26.167 in proposed Subpart G [Laboratories Certified by the Department 
of Health and Human Services] for organizational clarity.
    Proposed Sec.  26.137(a) [Quality assurance program] would amend 
current Section 2.8(a) in Appendix A to Part 26, which requires 
licensee testing facilities and HHS-certified laboratories to have a 
quality assurance program for all aspects of the testing process. The 
requirements for HHS-certified laboratories would be moved to Sec.  
26.167(a) in proposed Subpart G [Laboratories Certified by the 
Department of Health and Human Services] to improve organizational 
clarity. The proposed paragraph would extend the current requirements 
for licensee testing facilities to have a quality assurance program and 
procedures 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).
    Proposed Sec.  26.137(b) [Performance testing and quality control 
requirements for validity screening tests] would be added to establish 
requirements for conducting validity screening tests for the reasons 
discussed with respect to proposed Sec.  26.31(d)(3)(i). The proposed 
requirements in this paragraph are based upon requirements that have 
been proposed by HHS in a Notice of Proposed Revisions to the Mandatory 
Guidelines dated April 13, 2004 (69 FR 19673).
    Proposed Sec.  26.137(b)(1) would permit licensee testing 
facilities to use non-instrumented devices, such as dipsticks, to 
determine whether a specimen appears to be valid or must be subject to 
further validity testing. However, in proposed Sec.  26.137(b)(1)(i) 
and (ii), licensee testing facilities would be permitted to use only 
non-instrumented devices that either have been cleared by the U.S. Food 
and Drug Administration and 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 proposed 
Sec.  26.137(b)(1)(ii). SAMHSA has yet to publish a list of certified 
devices, but, in order to be added to SAMHSA's list, SAMHSA will 
require that a device must meet the performance testing requirements 
that are contained in proposed Sec.  26.137(b)(1)(ii). Therefore, 
adding these requirements to the proposed rule would permit licensee 
testing facilities to conduct the required performance testing and 
begin using any devices that meet the criteria before SAMHSA's list is 
published.
    The NRC is aware that the performance testing requirements in 
proposed 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 non-negative initial drug 
test result for marijuana or cocaine from a specimen that appears to be 
valid [see proposed Sec.  26.75(i)], it is critical that any validity 
screening devices used in Part 26 programs provide accurate results. 
The proposed performance testing requirements would be necessary to 
protect donors from inaccurate results, as well as ensure that 
specimens of questionable validity would be detected.
    Proposed Sec.  26.137(b)(1)(iii) and (b)(1)(iv) would require 
licensee testing facilities to ensure that any validity screening 
devices placed into service continue to be effective in determining the 
validity of urine specimens. Proposed Sec.  26.137(b)(1)(iii) would 
require licensee testing facilities to ensure that the device(s) either 
remains on the SAMHSA list of certified devices (when it becomes 
available) or continues to meet the performance testing criteria in 
proposed Sec.  26.137(b)(1)(ii)(A)-(b)(1)(ii)(C) by conducting further 
performance testing on a nominal yearly schedule. The proposed 
requirement would be consistent with the related requirement in HHS's 
proposed revisions to the Guidelines. Proposed Sec.  26.137(b)(1)(iv) 
would require licensee testing facilities to ensure that the 
manufacturer of any validity screening device used informs the licensee 
or other entity of modifications to the device, so that the licensee or 
other entity may determine whether additional performance testing is 
required to demonstrate that the modified device continues to be 
effective. These proposed provisions would be necessary to protect 
donors from inaccurate results, as well as provide assurance that 
specimens of questionable validity are detected.
    Proposed Sec.  26.137(b)(2) would require licensee testing facility 
personnel to use the validity screening device to test quality control 
samples at the beginning of any 8-hour period during which validity 
screening tests will be performed. The proposed rule would require the 
quality control samples to consist of one sample that is certified as 
negative and one that is non-negative for the specific validity test 
for which the device is designed. For example, if the device tests for 
nitrite, licensee testing

[[Page 50549]]

facility personnel would use a certified quality control sample 
containing nitrite. If the device fails to perform correctly when 
testing the quality control samples, the proposed rule would require 
the licensee testing facility to stop using it immediately and initiate 
the investigation required in proposed Sec.  26.137(f). If the test 
result is a false negative, the last sentence of the proposed paragraph 
would require the licensee or other entity to notify the NRC. The 
proposed rule would not require notifying the NRC of a false positive 
result because any specimen that yields a non-negative validity 
screening test result would be forwarded to the HHS-certified 
laboratory for further testing, and licensees and other entities would 
be prohibited from taking any management actions until the HHS-
certified laboratory completes testing of the specimen and the MRO has 
reviewed the results. Therefore, false positive test results from the 
device would not impose a burden on donors. These proposed procedures 
are necessary to protect donors from inaccurate test results, as well 
as to provide assurance that specimens of questionable validity are 
detected.
    Proposed Sec.  26.137(b)(3) would require licensee testing facility 
personnel to submit 1 out of every 10 donor specimens that yield 
negative results using the device to the HHS-certified laboratory. If 
the HHS-certified laboratory's results indicate that the device had 
provided a false negative result, the proposed rule would require the 
licensee testing facility to stop using the device immediately, 
initiate the investigation required in proposed Sec.  26.137(f), and 
notify the NRC.
    The NRC notifications that would be required in proposed Sec.  
26.137(a) and (b) would be necessary because false negative results 
from a validity screening device 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, the 
individual, who has demonstrated that he or she is not trustworthy and 
reliable, would be permitted to perform job duties under this part and 
pose a risk to public health and safety and the common defense and 
security. The NRC would use the information to ensure that HHS is 
notified of the device failure as well as inform other licensees and 
entities who may also be using the device of the false negative results 
to prevent additional testing errors. Therefore, the proposed 
notifications would be 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 device are detected 
and corrected as soon as possible.
    Proposed Sec.  26.137(b)(4) would require that any non-instrumented 
validity screening device used by a licensee testing facility must be 
capable of measuring creatinine to 1 decimal place. This proposed 
requirement would be necessary to ensure that the device can support 
the creatinine cutoff levels established in the HHS Guidelines, as 
incorporated into the proposed rule.
    Proposed Sec.  26.137(b)(5) and (b)(6) would establish quality 
control requirements for performing validity screening tests for pH and 
oxidizing adulterants, respectively. These proposed requirements would 
incorporate the related requirements in the proposed HHS Guidelines.
    Proposed Sec.  26.137(c) [Non-negative validity screening test 
results] would be added to specify the actions that the licensee 
testing facility must take if the results of validity screening tests 
are non-negative. If validity screening test results are non-negative, 
the proposed rule would require instrumented initial validity testing 
either at the licensee testing facility or the HHS-certified 
laboratory. This proposed provision would be consistent with current 
requirements for handling specimens that test as drug-positive on 
initial tests at a licensee testing facility. The proposed requirement 
would be 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 
proposed rule.
    Proposed Sec.  26.137(d) [Quality control requirements for 
performing initial validity tests] would be added to specify the 
required methods for performing initial validity tests at a licensee 
testing facility to ensure that initial validity testing at the 
licensee testing facility would provide accurate results. The proposed 
requirements in this paragraph would incorporate the related 
requirements in the HHS Guidelines as revised on April 13, 2004 (69 FR 
19644). The proposed paragraph would be added to 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.
    Proposed Sec.  26.137(d)(1) would require licensee testing 
facilities to measure creatinine concentration to 1 decimal place and 
would establish requirements for the controls to be used in initial 
tests for creatinine concentration.
    Proposed Sec.  26.137(d)(2) would establish quality control 
requirements for performing initial pH tests. Proposed Sec.  
26.137(b)(2)(i)-(b)(2)(v) would specify the required calibrators and 
controls for initial pH testing, based upon the type of testing 
instrument used and whether a pH validity screening test has been 
performed.
    Proposed Sec.  26.137(d)(3) would establish quality control 
requirements for performing initial tests for oxidizing adulterants, 
including nitrite, and proposed Sec.  26.137(d)(4) would establish 
quality control requirements for performing initial tests for ``other'' 
adulterants at the licensee testing facility.
    Proposed Sec.  26.137(e) [Quality control requirements for initial 
drug tests] would amend and combine portions of current Sections 
2.7(d), 2.7(e)(1), and 2.8(b) in Appendix A to Part 26, which establish 
quality control requirements for performing initial tests for drugs and 
drug metabolites at licensee testing facilities. The proposed paragraph 
would group together in one paragraph the current requirements that are 
dispersed throughout the rule to meet Goal 6 of this rulemaking, which 
is to improve clarity in the organization of the rule.
    Proposed Sec.  26.137(e)(1) would amend the first sentence of 
current Section 2.7(e)(1) in Appendix A to Part 26 but retain the 
intent of the current provision as it applies to licensee testing 
facilities. The current and proposed paragraphs require licensee 
testing facilities to use only immunoassay tests that meet the 
requirements of the Food and Drug Administration for commercial 
distribution. The requirements in the current paragraph related to 
initial drug testing at HHS-certified laboratories would be moved to 
Sec.  26.167(d)(1) of proposed Subpart G [Laboratories Certified by the 
Department of Health and Human Services] to improve organizational 
clarity in the rule.
    In addition, the proposed paragraph would prohibit licensee testing 
facilities from relying on drug test results from any devices they may 
use to perform validity screening tests. This proposed prohibition 
would be added 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 proposed

[[Page 50550]]

rule would permit licensee testing facilities to use such combination 
devices for validity screening tests, if the devices meet the 
requirements of proposed Sec.  26.137(b)(1). However, the drug testing 
capabilities of these devices are not yet sufficiently accurate and 
sensitive to be used in Part 26 programs, in which licensees and other 
entities would be 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 
devices 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 
proposed rule would retain the current prohibition on using such 
devices for drug testing at licensee testing facilities.
    Proposed Sec.  26.137(e)(2) would be added 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 drug negative and valid by an HHS-certified 
laboratory. The proposed paragraph would incorporate the related 
provision from the HHS Guidelines and would be added to 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.
    Proposed Sec.  26.137(e)(3) would permit licensee testing 
facilities to conduct multiple tests of a single specimen for the same 
drug or drug class. The requirements in the proposed paragraph would 
also be consistent with a similar provision in the HHS Guidelines and 
would be added for the same reasons discussed with respect to Sec.  
26.137(e)(2).
    Proposed Sec.  26.137(e)(4) would amend the first sentence of 
current Section 2.8(b) in Appendix A to Part 26, which states that 
licensee testing facilities are not required to assess their false 
positive rates in drug testing. The proposed paragraph would retain the 
intent of the current requirement, but the terminology used in the 
paragraph would be revised to use the new terms that are used 
throughout the proposed rule, e.g., ``initial'' rather than 
``screening,'' as discussed with respect to proposed Sec.  26.5 
[Definitions].
    Proposed Sec.  26.137(e)(5) would amend the second sentence of 
current Section 2.8(b) in Appendix A to Part 26, which requires 
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 proposed paragraph would retain the intent of the current 
provision but make several changes to the specific requirements.
    The proposed paragraph would use the term, ``analytical run,'' 
rather than the current term, ``test run,'' to reflect changes in 
testing technologies that some licensee testing facilities have adopted 
since the current rule was published. Requirements for blind 
performance and other quality control testing in the current 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 
proposed rule would use the term, ``analytical run,'' to refer to both 
batch and continuous processing, as defined in proposed Sec.  26.5 
[Definitions]. This proposed change would be made to meet Goal 6 of 
this rulemaking, which is to improve clarity in the language of the 
rule.
    The current rule does not establish a number or percentage of 
negative specimens that licensee testing facilities are required to 
submit to the HHS-certified laboratory for performance testing, which 
has raised implementation questions from licensees who have wanted to 
know how many specimens must be submitted. Therefore, to clarify the 
current requirement to ``submit a sampling of specimens,'' the proposed 
rule would require 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 
proposed paragraph would also establish 5 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 5 percent of an analytical run would 
be a number less than one specimen. In the latter case, the licensee 
testing facility would submit at least one negative specimen from the 
analytical run. The proposed requirement would ensure the ongoing 
evaluation of the accuracy of the licensee testing facility's initial 
drug testing without imposing a large performance testing burden.
    The proposed rule would move the requirement for testing blind 
performance test samples in current Section 2.8(b) in Appendix A to 
Part 26 to proposed Sec.  26.137(d)(7). The last sentence of the 
current paragraph, which addresses performance testing of breath 
analysis equipment for alcohol testing, would be moved to proposed 
Sec.  26.91(e) in Subpart E [Collecting Specimens for Testing]. The 
proposed rule would reorganize the current requirements and group them 
with related requirements to meet Goal 6 of this rulemaking, which is 
to improve clarity in the organization of the rule.
    Proposed Sec.  26.137(e)(6) would amend the requirements of current 
Section 2.8(c) in Appendix A to Part 26 and apply them to licensee 
testing facilities. The proposed rule would apply requirements for 
quality controls to licensee testing facilities to provide greater 
assurance that initial drug tests performed by these facilities provide 
accurate results. The increased performance testing would be necessary 
because the proposed rule permits licensees and other entities to rely 
on test results from other Part 26 programs to a greater extent than 
the current rule. Therefore, it is necessary to ensure that any tests 
performed at licensee testing facilities meet minimum standards. This 
proposed change would meet Goal 3 of this rulemaking, which is to 
improve the effectiveness of FFD programs.
    Proposed Sec.  26.137(e)(6)(i)-(e)(6)(iii) would be added to 
describe the required characteristics of the quality control samples 
that the licensee testing facility must include in each analytical run 
of specimens. The proposed paragraphs would 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 
75 percent of the cutoff level for each drug and drug metabolite for 
which testing is conducted. The proposed requirements would be 
consistent with the requirements for processing quality control samples 
during initial drug testing in the HHS Guidelines.
    Proposed Sec.  26.137(e)(7) would establish requirements for the 
number of quality control samples to be included in each analytical run 
at the licensee testing facility. The proposed rule would require that 
a minimum of 10 percent of the specimens in each analytical run must be 
quality control samples. The quality control samples included in the 
run could be any combination of the types of quality control samples 
specified in proposed Sec.  26.137(d)(6)(i)-(d)(6)(iii). However, the 
proposed paragraph would require that one percent or at least one of 
the quality control samples included in each run must be a blind 
performance test sample. For example, if an analytical run tested 50 
donor specimens, the

[[Page 50551]]

licensee testing facility would include 5 quality control samples in 
the run. At least one of the 5 would be required to be a blind test 
sample, and it could be either a blank or a sample fortified with a 
drug or metabolite at either 25 percent above the FFD program's cutoff 
level or at 75 percent of the cutoff level. The remaining 4 samples 
could include any combination of blanks and fortified samples. Licensee 
testing facilities would be expected to vary the drugs and drug 
metabolites used to fortify the quality control samples. The licensee 
testing facility would not send the quality control samples to the HHS-
certified laboratory for testing, but use them for internal quality 
control purposes only. The proposed requirements in this paragraph 
would incorporate the related requirements in the HHS Guidelines and 
would 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.
    Proposed Sec.  26.137(e)(8) would extend to licensee testing 
facilities the existing requirement in the third sentence of the last 
paragraph of current Section 2.8(c) in Appendix A to Part 26, which 
requires 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 proposed rule would extend this 
requirement to licensee testing facilities because it is a standard 
forensic practice that is necessary to ensure the integrity of the 
testing process.
    Proposed Sec.  26.137(f) [Errors in testing] would be added 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 proposed rule would require the licensee or other entity to 
document the investigation and any corrective actions taken. The 
proposed revision would clarify that licensees must investigate any 
testing errors or unsatisfactory performance identified throughout the 
testing process or during the review process that would be required 
under proposed 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. 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 proposed paragraph 
would also require the cause of the condition be determined and 
corrective action be taken and documented for consistency with 
Criterion XVI in Appendix B of 10 CFR Part 50.
    Proposed Sec.  26.137(g) [Accuracy] would retain current Section 
2.7(o)(3)(i) in Appendix A to Part 26, which requires checking the 
instruments used in testing for accuracy, as it applies to licensee 
testing facilities. The proposed rule would move the current 
requirement as it relates to HHS-certified laboratories to Sec.  
26.167(h) in proposed Subpart G [Laboratories Certified by the 
Department of Health and Human Services] for organizational clarity.
    Proposed Sec.  26.137(h) [Calibrators and controls] would update 
current Section 2.7(o)(2) in Appendix A to Part 26, which establishes 
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. The proposed paragraph would update 
the existing 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 proposed requirements in 
this paragraph would incorporate the related requirements in the HHS 
Guidelines and would 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.

Section 26.139 Reporting Initial Validity and Drug Test Results

    A new Sec.  26.139 [Reporting initial validity and drug test 
results] would combine existing requirements related to the reporting 
and management of test results from the licensee testing facility that 
are interspersed throughout current Appendix A to Part 26. This 
proposed change would be made to meet Goal 6 of this rulemaking, which 
is to improve clarity in the organization of the rule, by grouping 
related requirements together in a single section.
    Proposed Sec.  26.139(a) would amend current Section 2.7(g)(2) in 
Appendix A to Part 26, which establishes requirements for the manner in 
which HHS-certified laboratories and licensee testing facilities must 
report test results to licensee management. The requirements in the 
current paragraph that are related to reporting test results from HHS-
certified laboratories would be moved to Sec.  26.169(b) of proposed 
Subpart G [Laboratories Certified by the Department of Health and Human 
Services] for organizational clarity. The proposed paragraph would 
delete the current reference to ``special processing'' and replace it 
with reference to validity test results, 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).
    Proposed Sec.  26.139(b) would amend the last sentence of current 
Sec.  26.24(d)(1), which specifies the individuals to whom results of 
initial tests from the licensee testing facility may be released. The 
proposed paragraph would add the MRO's staff to the list of individuals 
who would be 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 proposed rule. Individuals who are serving as 
MRO staff members would require access to initial test results from a 
licensee's testing facility in the course of performing their 
administrative duties for the MRO.
    Proposed Sec.  26.139(c) would amend current Section 2.7(o)(5) in 
Appendix A to Part 26. The requirements in the current paragraph that 
address the availability of personnel to testify in proceedings related 
to drug test results from an HHS-certified laboratory would be moved to 
Sec.  26.153(f)(2) of proposed Subpart G [Laboratories Certified by the 
Department of Health and Human Services] for organizational clarity. 
The proposed rule would move the current requirement for licensee 
testing facility personnel to be available to testify at any 
proceedings with respect to breath analysis test results to proposed 
Sec.  26.85(d) because licensee testing facilities are typically not 
responsible for quality control of alcohol testing, which is conducted 
at the collection site.
    Proposed Sec.  26.139(d) would amend the portions of current 
Section 2.7(g)(6) in Appendix A to Part 26 that apply to the summary 
report that licensee testing facilities must provide to FFD program 
management. The current requirement for the licensee testing facility 
to prepare a monthly report of test results would be replaced with a 
proposed requirement for the licensee testing facility to summarize the 
data annually in the FFD program performance report required in 
proposed Sec.  26.217(b). Experience implementing the current 
requirement for a monthly statistical

[[Page 50552]]

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 
requirement in proposed Sec.  26.139(f) for FFD program management to 
monitor the ongoing effectiveness of the licensee testing facility 
testing program would replace the monthly reporting requirement in 
Section 2.7(g)(6). This proposed change would meet Goal 5 of this 
rulemaking, which is to improve Part 26 by eliminating or modifying 
unnecessary requirements. The requirements in the current paragraph 
that address summary reports from HHS-certified laboratories would be 
moved to Sec.  26.169(k) of proposed Subpart G [Laboratories Certified 
by the Department of Health and Human Services] for organizational 
clarity.
    Proposed Sec.  26.139(e) would amend current Section 2.7(g)(7) in 
Appendix A to Part 26, which requires licensee testing facilities and 
HHS-certified laboratories to report test results for both the cutoff 
levels specified in this part and any more stringent cutoff levels used 
by the FFD program. The current requirement related to HHS-certified 
laboratories would be relocated to Sec.  26.169(c) of proposed Subpart 
G [Laboratories Certified by the Department of Health and Human 
Services] for organizational clarity. The proposed rule would require 
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 proposed 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 current 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 proposed rule would eliminate this 
requirement, because proposed Sec.  26.31(d)(3)(iii)(C) would require 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 testing and reporting requirement 
would no longer be needed to monitor licensee testing facility 
performance in this area. The proposed rule would continue 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 proposed Sec.  26.31(b)(1).
    Proposed Sec.  26.139(f) would be added to require FFD program 
management to monitor the ongoing effectiveness of the licensee testing 
facility testing program. The proposed rule would provide examples of 
the types of information and possible program performance indicators 
that licensees and other entities may use for program monitoring. The 
proposed rule would also require FFD program management to make 
adjustments to the testing program in response to information gained 
from the ongoing monitoring. The proposed requirements would replace 
the current monthly summary reporting requirement in current 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 proposed paragraph also would be consistent with the NRC's 
performance-based approach to regulation. This proposed change would 
meet Goal 3 of this rulemaking, which is 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

    Proposed Sec.  26.151 [Purpose] would be added to introduce the 
purpose of the proposed 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. This proposed section would be added to meet Goal 
6 of this rulemaking, which is to improve clarity in the organization 
and language of the rule. The majority of the requirements in this 
proposed subpart would be based upon the current requirements in 
Appendix A to Part 26, as they relate to HHS-certified laboratories. 
However, the current requirements would be updated to be consistent 
with the Department of Health and Human Services' revisions to the 
Mandatory Guidelines for Federal Workplace Drug Testing Programs (HHS 
Guidelines), as published in the Federal Register on April 13, 2004 (69 
FR 19643).

Section 26.153 Using Certified Laboratories for Testing Urine Specimens

    A new Sec.  26.153 [Using certified laboratories for testing urine 
specimens] would be added to present together requirements related to 
the use of HHS-certified laboratories by licensees and other entities 
who would be subject to the rule.
    Proposed Sec.  26.153(a) would combine and update current 
requirements for licensees and other entities to use HHS-certified 
laboratories for initial and confirmatory drug testing of urine 
specimens. The proposed paragraph would relocate and combine current 
Sec.  26.24(f), the second sentence of Section 1.1(3), and Section 
4.1(a) in Appendix A to Part 26, which require licensees and other 
entities to use HHS-certified laboratories for drug testing. The 
proposed change would be made to eliminate redundancies in the current 
rule and improve organizational clarity. The proposed paragraph would 
update the current citations for the HHS Guidelines because the 
Guidelines have been amended several times since the current rule was 
published. In addition, the proposed rule would provide current contact 
information for obtaining information about the certification status of 
HHS-certified laboratories because the contact information also has 
changed since the current rule was published. The proposed paragraph 
would also add 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 proposed rule, as discussed with respect to 
proposed Sec.  26.31(d)(3)(i). The cross-reference to current Sec.  
26.24(d), which permits licensee testing facilities to conduct initial 
drug tests, would be updated to reference the related provision in the 
proposed rule, proposed Sec.  26.31(d)(3)(ii).
    Proposed Sec.  26.153(b) would amend the first sentence of current 
Section 2.7(l)(2) in Appendix A to Part 26, which requires 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 current requirement for HHS-
certified laboratories to be capable of conducting confirmatory alcohol 
testing of blood would be deleted for the reasons discussed with 
respect to proposed Sec.  26.83(a). The proposed paragraph would add 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

[[Page 50553]]

addition of requirements to perform validity testing to the proposed 
rule, as discussed with respect to proposed Sec.  26.31(d)(3)(i). The 
second sentence of current Section 2.7(l)(2), which establishes 
requirements for the capabilities of licensee testing facilities, would 
be moved to proposed Sec.  26.123 [Licensee testing facility 
capabilities] of Subpart F [Licensee Testing Facilities] for 
organizational clarity. The last sentence of the current paragraph, 
which permits the testing of breath specimens for alcohol at the 
collection site, would be deleted because the proposed rule would 
address alcohol testing in Subpart E [Collecting Specimens for 
Testing]. These organizational changes to the current paragraph would 
be made to meet Goal 6 of this rulemaking, which is to improve clarity 
in the organization and language of the rule.
    Proposed Sec.  26.153(c) would amend the first sentence of current 
Section 2.7(k) in Appendix A to Part 26, which restricts HHS-certified 
laboratories from subcontracting unless authorized by the licensee. The 
proposed rule would extend this restriction to subcontracting for 
specimen validity testing for consistency with the addition of 
requirements to perform validity testing to the proposed rule, as 
discussed with respect to proposed Sec.  26.31(d)(3)(i). The second 
sentence of current Section 2.7(k) would be deleted from the proposed 
paragraph for several reasons: First, the requirement to have the 
capability to test for marijuana, cocaine, opiates, phencyclidine, and 
amphetamines would be deleted because it is redundant with proposed 
Sec.  26.31(d)(1). The requirement to be capable of testing whole blood 
would be deleted because the proposed rule would no longer permit 
donors to request confirmatory alcohol testing of blood for the reasons 
discussed with respect to proposed Sec.  26.83(a). Finally, the 
requirement for laboratories to be capable of conducting GC/MS testing 
would be eliminated because HHS-certified laboratories would be 
permitted to use other methods of confirmatory testing, consistent with 
related revisions to the HHS Guidelines.
    Proposed Sec.  26.153(d) would amend current Section 4.1(b) in 
Appendix A to Part 26, which requires 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 is required under Part 26, and blood. The proposed paragraph 
would eliminate reference to testing for blood because the proposed 
rule would no longer permit donors to request confirmatory alcohol 
testing of blood for the reasons discussed with respect to proposed 
Sec.  26.83(a).
    Proposed Sec.  26.153(e) would amend the third sentence of current 
Section 2.7(m) in Appendix A to Part 26, which requires 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 current 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 
proposed paragraph would revise the current requirement to indicate 
that licensees and other entities would be 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 proposed rule would clarify that the pre-award inspection and 
evaluation must be performed by qualified individuals.
    Proposed Sec.  26.153(e) also would permit 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 proposed rule would 
require that the replacement laboratory must be in use by another Part 
26 program. The proposed rule would add this provision to ensure that 
testing can continue, in the event that the HHS-certified laboratory 
upon which a licensee or other entity relies loses its certification, 
as some licensees have experienced. Related requirements for auditing 
the replacement laboratory would be specified in proposed Sec.  
26.41(g)(5).
    Proposed Sec.  26.153(f) would be added 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.
    Proposed Sec.  26.153(f)(1) would retain the requirement in current 
Section 2.7(l)(1) in Appendix A to Part 26, which states that HHS-
certified laboratories must comply with applicable State licensor 
requirements. The proposed paragraph would replace the term, ``HHS-
certified laboratories,'' with the term, ``laboratory facilities,'' to 
clarify that State requirements apply to laboratory facilities rather 
than to the HHS-certified laboratory as a corporate entity. The 
proposed clarification would be 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 would be required to meet the requirements of that 
State. The proposed change would be made for clarity in the language of 
the proposed rule as well as consistency with the HHS Guidelines.
    Proposed Sec.  26.153(f)(2) would amend current Section 2.7(o)(5) 
in Appendix A to Part 26, which requires that HHS-certified 
laboratories must make available qualified personnel to testify in 
proceedings based on urinalysis results reported by the laboratory. 
Reference to licensee testing facilities would be moved to Sec.  
26.139(c) in proposed Subpart F [Licensee Testing Facilities] for 
organizational clarity. The requirement for qualified personnel to be 
available to testify in proceedings related to breath analysis results 
would be moved to proposed Sec.  26.85(d) in proposed Subpart E 
[Collecting Specimens for Testing] for organizational clarity and 
because responsibility for testifying with respect to breath analysis 
results would reside with the licensee's or other entity's collection 
site personnel.
    Proposed Sec.  26.153(f)(3) would update current Section 3.1 in 
Appendix A to Part 26, which requires HHS-certified laboratories to 
protect donors' records. The current requirement for licensee testing 
facilities to protect donors' records would be subsumed within the 
second sentence of proposed Sec.  26.37(a) for organizational clarity. 
The cross-reference to current Sec.  26.29 would be updated to 
reference proposed Sec.  26.39 [Protection of information].
    Proposed Sec.  26.153(f)(4) would update current Section 3.2 in 
Appendix A to Part 26. Specifically, the proposed rule would add a 
reference to Section 503 of Public Law 100-71 to document the basis for 
this requirement, which would be adapted from the HHS Guidelines. The 
proposed paragraph would add 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 proposed 
rule, as discussed with respect to proposed Sec.  26.31(d)(3)(i). The

[[Page 50554]]

proposed paragraph would delete the current reference to records 
related to alcohol test results because HHS-certified laboratories 
would no longer be testing blood specimens for alcohol, as discussed 
with respect to proposed Sec.  26.83(a).
    Proposed Sec.  26.153(f)(5) would be added 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 proposed paragraph would respond 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 
would be warranted to prevent potential conflict of interest concerns. 
The proposed paragraph would be consistent with the related provision 
in the HHS Guidelines.
    Proposed Sec.  26.153(f)(6) would amend the requirements in the 
first two sentences of current Section 2.7(m) in Appendix A to Part 26, 
which require HHS-certified laboratories to permit the NRC, licensees, 
and other entities to conduct inspections at any time, including 
unannounced inspections. The proposed rule would delete, for 
organizational clarity, the existing references to collection site 
services and licensee testing facilities, which would be covered under 
proposed Sec.  26.221 [Inspections]. The proposed paragraph would also 
delete reference to confirmatory testing of blood specimens for alcohol 
because HHS-certified laboratories would no longer be testing blood 
specimens for alcohol, as discussed with respect to proposed Sec.  
26.83(a).
    Proposed Sec.  26.153(g) would require 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 proposed 
paragraph would be necessary to prevent licensee's and other entity's 
specimens from being rejected.

Section 26.155 Laboratory Personnel

    Proposed Sec.  26.155 [Laboratory personnel] would update current 
Section 2.5 in Appendix A to Part 26 to be consistent with revisions to 
the HHS Mandatory Guidelines for Federal Workplace Drug Testing 
Programs (HHS Guidelines) published in the Federal Register on April 
13, 2004 (69 FR 19643).
    Proposed Sec.  26.155(a) [Day-to-day management of the HHS-
certified laboratory] would amend current Section 2.5(a)(1) in Appendix 
A to Part 26, which requires the HHS-certified laboratory to have a 
qualified individual to assume responsibility for day-to-day management 
of the HHS-certified laboratory. Specifically, the proposed paragraph 
would replace the term, ``qualified individual,'' with the term, 
``responsible person,'' for consistency with terminology that other 
Federal agencies use to refer to this job role.
    Proposed Sec.  26.155(a) would retain the majority of Section 
2.5(a)(2), which establishes qualification requirements for the 
responsible person. Proposed Sec.  26.155(a)(1)(i)-(a)(1)(iv) would 
retain current Section 2.5(a)(2)(i)-(a)(2)(iv) in Appendix A to Part 
26, with minor grammatical changes that would be consistent with 
similar changes to the related provisions in the HHS Guidelines.
    Proposed Sec.  26.155(a)(2) and (a)(3), which establish minimum 
day-to-day management responsibilities of the responsible person, would 
retain current Section 2.5(a)(4) and (a)(5) in Appendix A to Part 26.
    Proposed Sec.  26.155(a)(4) would amend current Section 2.5(a)(5) 
in Appendix A to Part 26, which relates to the responsible person's 
responsibility to maintain the laboratory's procedures manual. The 
proposed paragraph would eliminate the current requirement for the 
procedures to be maintained in a laboratory manual as unnecessarily 
restrictive. Laboratories would be permitted to use other means to 
maintain their procedures. The proposed paragraph would retain the 
current requirements in the second and third sentences of Section 
2.5(a)(5) in Appendix A to Part 26, which require 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, and maintain copies of them. The current 
cross-reference to Section 2.7(o) in Appendix A to Part 26 would be 
updated to reference proposed Sec.  26.157 [Procedures], consistent 
with the organizational changes made to the rule.
    Proposed Sec.  26.155(a)(5) and (a)(6) would retain current Section 
2.5(a)(6) and (a)(7) in Appendix A to Part 26, which define the 
responsible person's responsibilities with respect to maintaining a 
quality assurance program and taking remedial actions to maintain 
satisfactory laboratory operations.
    Proposed Sec.  26.155(b) [Certifying scientist] would amend current 
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 proposed rule would provide more detailed 
requirements with respect to the individual who validates test results 
at the HHS-certified laboratory before they are transmitted to the 
licensee's or other entity's MRO. In proposed Sec.  26.155(b)(1), a new 
job title, ``certifying scientist,'' would replace the term, 
``qualified individual(s),'' in the first sentence of current Section 
2.5(b) in Appendix A to Part 26 for consistency with a related change 
in the HHS Guidelines. Proposed Sec.  26.155(b)(2) would specify the 
required qualifications of individuals who serve as certifying 
scientists. Proposed Sec.  26.155(b)(3) would permit laboratories to 
use more than one certifying scientist with differing responsibilities.
    Proposed Sec.  26.155(c) [Day-to-day operations and supervision of 
analysts] would retain current Section 2.5(c) in Appendix A to Part 26. 
The proposed rule would make minor wording changes to the current 
paragraph to increase the consistency of the wording in this provision 
with that of the related provision in the HHS Guidelines.
    Proposed Sec.  26.155(d) [Other personnel] and (e) [Training] would 
retain current Section 2.5(d) and (e) in Appendix A to Part 26, 
respectively.
    Proposed Sec.  26.155(f) [Files] would amend current Section 2.5(f) 
in Appendix A to Part 26. The proposed revisions would be consistent 
with related requirements in the HHS Guidelines. The current 
requirement for records of tests for color blindness would be 
eliminated, consistent with a similar change to the HHS Guidelines. 
Tests for color blindness would no longer be necessary because current 
testing technologies provide means, other than color, for reading test 
results.

Section 26.157 Procedures

    A new Sec.  26.157 [Procedures] would reorganize and amend 
requirements for procedures, which are interspersed throughout current 
Appendix A to Part 26, including requirements contained in current 
Sections 2.2 and 2.7 in Appendix A to Part 26. The proposed changes 
would be made to meet Goal 6 of this rulemaking, which is to improve 
organizational clarity by grouping

[[Page 50555]]

procedural requirements for HHS-certified laboratories in one section.
    Proposed Sec.  26.157(a) would make minor editorial changes to the 
first sentence of current Section 2.2 in Appendix A to Part 26, which 
requires licensee testing facilities and HHS-certified laboratories to 
have detailed procedures for conducting testing. The proposed rule 
would delete the current reference to blood samples because donors 
would no longer have the option to request blood testing for alcohol, 
as discussed with respect to proposed Sec.  26.83(a). Reference to 
licensee testing facilities would be moved to proposed Sec.  26.127(a) 
in Subpart F [Licensee Testing Facilities] for organizational clarity. 
The proposed rule would also delete reference to procedures for 
specimen collections, because procedural requirements for specimen 
collections would be relocated to proposed Subpart E [Collecting 
Specimens for Testing].
    Proposed Sec.  26.157(b) would combine and amend portions of the 
requirements in the first sentence of current 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 proposed 
paragraph would retain the portions of the current paragraphs that 
require 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 current requirements related to licensee testing 
facilities would be moved to proposed Sec.  26.127(b) in Subpart F 
[Licensee Testing Facilities] for organizational clarity. The proposed 
rule would also remove references to custody-and-control procedures for 
blood specimens because donors would no longer have the option to 
request blood testing for alcohol, as discussed with respect to 
proposed Sec.  26.83(a).
    Proposed Sec.  26.157(c) would amend the portions of current 
Section 2.7(o)(1) in Appendix A to Part 26 that address the required 
content of procedures for HHS-certified laboratories. The proposed 
paragraph would retain the portions of the current provision that 
require laboratories 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 proposed paragraph would present the required topics 
of the procedures in a list format in proposed Sec.  26.157(c)(1)-
(c)(12) to clarify that each topic stands on its own. The proposed 
paragraph would eliminate the current requirement for the procedures to 
be maintained in a laboratory manual, which is unnecessarily 
restrictive. HHS-certified laboratories would be permitted to use other 
means to maintain their procedures. For organizational clarity, two 
portions of the current provision would be moved to other subparts of 
the proposed rule that address related topics. Requirements for 
licensee testing facility procedures would be moved to Sec.  26.127(c) 
in proposed Subpart F [Licensee Testing Facilities]. In addition, the 
proposed rule would move the last two sentences of current Section 
2.7(o)(1), which specify records retention requirements, to Sec.  
26.215(b)(4) of proposed Subpart J [Recordkeeping and Reporting 
Requirements].
    Proposed Sec.  26.157(d) would amend current Section 2.7(o)(3)(iii) 
in Appendix A to Part 26, which 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 proposed rule would make three changes 
to the current provision for organizational clarity. The proposed 
paragraph would present the required topics of the procedures in a list 
format in proposed Sec.  26.157(d)(1)-(d)(3) to clarify that each topic 
stands on its own. The current requirement to maintain records of 
preventative maintenance would be relocated to proposed Sec.  
26.215(b)(10) in Subpart J [Recordkeeping and Reporting Requirements]. 
And, the current requirements that apply to licensee testing facilities 
would be moved to Sec.  26.127(d) in proposed Subpart F [Licensee 
Testing Facilities].
    Proposed Sec.  26.157(e) would amend current Section 2.7(o)(4) in 
Appendix A to Part 26, which requires documented corrective actions if 
systems are out of acceptable limits or errors are detected. The 
requirements in the current paragraph that apply to licensee testing 
facilities would be moved to Sec.  26.127(e) in proposed Subpart F 
[Licensee Testing Facilities] for organizational clarity.

Section 26.159 Assuring Specimen Security, Chain of Custody, and 
Preservation

    Proposed Sec.  26.159 [Assuring specimen security, chain of 
custody, and preservation] would be added to present in one section the 
requirements of the proposed rule that apply to HHS-certified 
laboratories with respect to the safeguarding of specimen identity, 
integrity, and security. The proposed organizational change would be 
made because requirements that address these topics are dispersed 
throughout the current rule and grouping them together in a single 
section would make them easier to locate.
    Proposed Sec.  26.159(a) would amend current Section 2.7(a)(1) in 
Appendix A to Part 26. Proposed Sec.  26.159(a) would retain the first 
three sentences of current Section 2.7(a)(1) in Appendix A to Part 26, 
which require HHS-certified laboratories to be secure and accessible 
only to authorized personnel. For organizational clarity, the 
requirements that apply to licensee testing facilities would be moved 
to proposed Sec.  26.129(a) in Subpart F [Licensee Testing Facilities], 
and the last sentence of the current paragraph, which establishes 
recordkeeping requirements, would be moved to Sec.  26.215(b)(13) in 
proposed Subpart J [Recordkeeping and Reporting Requirements]. In 
addition, the last sentence of the proposed paragraph would be revised 
for increased clarity in the requirement and would expand the list of 
persons who would be authorized to have access to the laboratory to 
include representatives of the Secretary of the Department of Health 
and Human Services and emergency responders. This proposed change would 
be made for consistency with the related provision in the HHS 
Guidelines.
    Proposed Sec.  26.159(b) would amend current Section 2.7(b)(1) in 
Appendix A to Part 26, which establishes requirements for receiving 
specimens at the HHS-certified laboratory and assuring their integrity 
and identity. The proposed rule would retain the existing 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 proposed 
rule would move the current requirements related to licensee testing 
facilities to Sec.  26.129(b) in proposed Subpart F [Licensee Testing 
Facilities] for organizational clarity. Several requirements would also 
be added to the proposed paragraph.
    The proposed paragraph would require 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 would depend upon

[[Page 50556]]

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, licensee and other entity management 
personnel would impose the sanctions in proposed Sec.  26.75(b) for a 
subversion attempt. The proposed paragraph would also require the 
licensee, other entity, or HHS-certified laboratory 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. The proposed rule would add this 
provision because some licensees have not investigated or taken 
corrective actions in response to indications of tampering with 
specimens under the current rule.
    The proposed paragraph would also prohibit testing specimens if 
there is a reason to believe that the specimens have been altered in 
such a manner as to affect specimen identity and integrity. In these 
circumstances, the proposed rule would require the licensee or other 
entity to collect another specimen from the donors. Although the NRC is 
not aware of any instances in which such circumstances have arisen in 
Part 26 programs, the experience of other Federal agencies indicates 
such tampering is possible. Therefore, the proposed requirement would 
ensure that individuals would not be subject to sanctions for a non-
negative test result from a specimen that may not have been theirs. The 
proposed change would meet Goal 7 of this rulemaking, which is to 
protect the due process rights of individuals who are subject to Part 
26. The additional provision would also be consistent with the 
requirements of other Federal agencies.
    Proposed Sec.  26.159(c) would update and combine current Section 
2.7(b)(2) with portions of current Sections 2.9(n) and 3.1 in Appendix 
A to Part 26, which establish requirements for chain-of-custody 
procedures for specimens and aliquots at licensee testing facilities 
and HHS-certified laboratories. The proposed rule would move the 
requirements in the current paragraphs that are related to licensee 
testing facilities to Sec.  26.129(c) in proposed Subpart F [Licensee 
Testing Facilities] for organizational clarity. Proposed Sec.  
26.159(c) would also include the requirements in current Sections 
2.9(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 proposed changes 
would be made to reduce redundancies and improve the organization 
clarity of the rule.
    Proposed Sec.  26.159(d) and (e) would update the portions of 
current Section 2.7(a)(2) in Appendix A to Part 26 that establish 
requirements for HHS-certified laboratory personnel to maintain and 
document the chain of custody for specimens and aliquots, by replacing 
the current paragraph with two related provisions from the HHS 
Guidelines. Proposed paragraph (d) in this section would require the 
laboratory's internal custody-and-control form to allow for 
identification of the donor, and documentation of the testing process 
and transfers of custody of the specimen. The phrase, ``within the 
laboratory,'' would be added to proposed paragraph (e) to clarify that 
the requirement to document each instance of the handling and transfer 
of specimens applies to internal laboratory activities and does not 
apply to transfers involving couriers. The proposed rule would relocate 
the requirements in the current paragraph that are related to licensee 
testing facilities to Sec.  26.129(d) and (e) in proposed Subpart G 
[Laboratories Certified by the Department of Health and Human Services] 
for organizational clarity.
    Proposed Sec.  26.159(f) and (g) would separate current Section 
2.4(i) in Appendix A to Part 26 into two paragraphs, for the reasons 
discussed with respect to the similar provisions of proposed Sec.  
26.117(i) and (k) and Sec.  26.129(g) and (h). The proposed paragraphs 
would repeat the requirements for packaging and shipping non-negative 
specimens that would be presented in proposed Sec.  26.117(i) and (k) 
of Subpart E [Collecting specimens for testing] and Sec.  26.129(g) and 
(h) in Subpart F [Licensee Testing Facilities], 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 
proposed Sec.  26.117(i) and (k).
    Proposed Sec.  26.159(h) [Short-term refrigerated storage] would 
replace current Section 2.7(c) in Appendix A to Part 26, which 
establishes requirements for refrigerating urine specimens at the HHS-
certified laboratory and licensee testing facility to protect them from 
degradation. The proposed rule would replace the current paragraph with 
the simplified language of the related provision in the HHS Guidelines. 
Requirements related to short-term refrigerated storage at licensee 
testing facilities would be moved to Sec.  26.129(f) in proposed 
Subpart F [Licensee Testing Facilities] for organizational clarity.
    Proposed Sec.  26.159(i) [Long-term storage] would amend current 
Section 2.7(h) in Appendix A to Part 26, which establishes requirements 
for long-term frozen storage of positive urine specimens at HHS-
certified laboratories and licensee testing facilities. Requirements 
related to long-term storage of specimens by licensee testing 
facilities would be moved to proposed Sec.  26.135(c) in Subpart F 
[Licensee Testing Facilities] for organizational clarity. The proposed 
paragraph would add requirements for storing specimens that yield non-
negative validity test results, 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). The 
reference to ``administrative or disciplinary proceedings'' in the 
first sentence of the current paragraph would be eliminated 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 proposed Sec.  26.161(g) [Additional testing by a 
second laboratory]. The proposed rule would also update the terminology 
used in the current paragraph by adding a reference to ``Bottle B'' of 
a split specimen and replacing the term, ``positive,'' with the term, 
``non-negative,'' to be consistent with the new terminology adopted 
throughout the proposed rule. As discussed with respect to proposed 
Sec.  26.5 [Definitions], these proposed changes in terminology would 
be made to improve clarity in the language of the proposed rule.
    Proposed Sec.  26.159(j) would be added to incorporate related 
changes to the HHS Guidelines. The proposed paragraph would permit the 
HHS-certified laboratory to discard negative specimens. The proposed 
paragraph also would permit 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.

Section 26.161 Cutoff Levels for Validity Testing

    A new Sec.  26.161 [Cutoff levels for validity testing] would be 
added to establish 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 proposed rule, as discussed with respect to proposed 
Sec.  26.31(d)(3)(i). The proposed rule would incorporate these

[[Page 50557]]

requirements from the HHS Guidelines as revised on April 13, 2004 (69 
FR 19644) to meet, in part, 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.
    Proposed Sec.  26.161(a) [Validity test results] would be added to 
specify that laboratories must conduct initial and confirmatory 
validity testing using two different aliquots of a urine specimen.
    Proposed Sec.  26.161(b) [Initial validity testing] would be added 
to establish requirements and cutoff levels for initial validity tests 
to be performed at HHS-certified laboratories.
    Proposed Sec.  26.161(b)(1)-(b)(6) would establish requirements for 
validity tests that HHS-certified laboratories must conduct on a 
primary specimen, which would be 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 would 
determine the creatinine concentration of each specimen in proposed 
Sec.  26.161(b)(1)(i). If the creatinine concentration is less than 20 
mg/dL, the laboratory would determine the specimen's specific gravity 
in proposed Sec.  26.161(b)(1)(ii). Proposed Sec.  26.161(b)(1)(iii) 
would require the laboratory to determine each specimen's pH. Proposed 
Sec.  26.161(b)(1)(iv) would require the laboratory to test the 
specimen for the presence of oxidizing adulterants, and proposed Sec.  
26.161(b)(1)(v) would require additional validity testing, depending 
upon the characteristics of the specimen.
    Proposed Sec.  26.161(b)(2)(i)-(b)(2)(ix) would establish the 
criteria for determining whether a specimen must be subject to 
confirmatory validity testing.
    Proposed Sec.  26.161(c) [Results indicating an adulterated 
specimen] would be added 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. Proposed Sec.  
26.161(c)(1)-(c)(7) would specify results from initial and confirmatory 
validity testing that would indicate that a specimen is adulterated. 
The proposed paragraphs would also specify the appropriate testing 
devices and instruments to be used for initial and confirmatory 
validity tests. In general, the proposed paragraphs would 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 completely inconsistent with human 
physiology; or (3) it presents an acid/base balance (pH) that appears 
to be inconsistent with human life. The proposed paragraphs would 
address several substances 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 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 as the HHS-
certified laboratories develop methods to detect them. Proposed Sec.  
26.131(c)(8) would recognize that new adulterants will be found and, 
therefore, would require 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.
    Proposed Sec.  26.161(d) [Results indicating a substituted 
specimen] and (e) [Results indicating a dilute specimen] would 
establish cutoff levels and criteria for a determination by the 
laboratory that a specimen has been substituted or is dilute, 
respectively. In proposed Sec.  26.161(d), the HHS-certified laboratory 
would 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 1.001 or equal to or greater than 1.020. These low 
creatinine concentrations combined with the highly skewed specific 
gravity values indicate that the specimen is not human urine. In 
proposed Sec.  26.161(e), the HHS-certified laboratory would be 
required to report to the MRO that a specimen is dilute if it contains 
2-20 mg/dL of creatinine and has a specific gravity of less than or 
equal to 1.001 or equal to or greater than 1.020.
    Proposed Sec.  26.161(f)(1)-(f)(10) [Results indicating an invalid 
specimen] would be added to establish the criteria that HHS-certified 
laboratories would 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-inflammatories 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 which the laboratory could not specifically identify with 
scientific certainty (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 proposed rule would adopt 
the term, ``invalid specimen,'' with the same meaning.
    Proposed Sec.  26.161(g) [Additional testing by a second 
laboratory] would be added to address circumstances in which an HHS-
certified laboratory suspects that a specimen is adulterated but cannot 
identify the adulterant. The proposed paragraph would permit 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 would consult with the licensee's or 
other entity's MRO to determine whether to transfer the specimen to a 
second laboratory for additional testing.
    Proposed Sec.  26.161(h) [More stringent validity test cutoff 
levels are prohibited] would be added 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 proposed rule would 
not permit an FFD program to establish more stringent cutoff levels for 
validity testing. The proposed prohibition would be necessary to 
decrease the risk of obtaining false non-negative test results and 
ensure that donors are not subject

[[Page 50558]]

to sanctions on the basis of inaccurate test results.

Section 26.163 Cutoff Levels for Drugs and Drug Metabolites

    Proposed Sec.  26.163 [Cutoff levels for drugs and drug 
metabolites] would group together in one section, for organizational 
clarity, the proposed requirements for conducting initial and 
confirmatory tests for drugs and drug metabolites at HHS-certified 
laboratories. The proposed section would also update requirements 
related to cutoff levels for drugs and drug metabolites in the current 
rule to 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.
    Proposed Sec.  26.163(a) [Initial drug testing] would amend current 
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), proposed Sec.  26.163(a)(1) would require HHS-certified 
laboratories to apply the same cutoff levels that licensee testing 
facilities would be required to use in proposed Sec.  26.133 [Cutoff 
levels for drugs and drug metabolites], except if the FFD program 
specifies more stringent cutoff levels or the specimen is dilute, as 
discussed further with respect to proposed Sec.  26.163(a)(2). The 
proposed paragraph would reiterate the current permission for licensees 
and other entities to establish lower cutoff levels. In addition, 
proposed Sec.  26.163(a)(1) would decrease the initial test cutoff 
level for marijuana metabolites from 100 nanograms (ng) per milliliter 
(mL) to 50 ng/mL and increase the initial test cutoff level for opiate 
metabolites from 300 ng/mL to 2,000 ng/mL for the reasons discussed 
with respect to proposed Sec.  26.133. The proposed changes would be 
consistent with the HHS cutoff levels for the same substances.
    Proposed Sec.  26.163(a)(2) would be added to establish 
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 
proposed rule would add special testing procedures and criteria for 
determining which dilute specimens must be subject to confirmatory drug 
testing.
    The proposed paragraph would require HHS-certified laboratories to 
conduct initial drug testing of dilute specimens using FDA-approved 
analytical kits that have the lowest concentration levels available for 
the initial testing technologies used. If responses from the dilute 
specimen on the initial drug test are within 50 percent of the 
established cutoff level for the drug or drug metabolite, the proposed 
rule would require the HHS-certified laboratory to report this result 
to the licensee's or other entity's MRO. If the FFD program's policy 
specifies this requirement, the proposed rule would permit the MRO to 
direct the HHS-certified laboratory to test the specimen at the 
confirmatory assay's LOD for that drug or drug class and report the 
results to the MRO. This special processing of dilute specimens would 
increase the likelihood that any drugs and drug metabolites in the 
specimen would be detected. Therefore, this proposed requirement would 
meet Goal 3 of this rulemaking, which is to improve the effectiveness 
of FFD programs, by increasing the likelihood that testing of dilute 
specimens would reveal drug use, if the donor had engaged in substance 
abuse.
    As discussed with respect to proposed Sec.  26.133 [Cutoff levels 
for drugs and drug metabolites], the proposed rule would eliminate the 
requirement in the last sentence of current Section 2.7(e)(1) 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 current 
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 proposed rule would eliminate 
this requirement, because proposed Sec.  26.31(d)(3)(iii)(C) would 
require a qualified forensic toxicologist to certify the scientific and 
technical validity of any testing at lower cutoff levels. Therefore, 
the current reporting requirement is no longer needed to assure 
laboratory performance in this area. Eliminating this requirement would 
meet Goal 5 of this rulemaking, which is to improve Part 26 by 
eliminating or modifying unnecessary requirements.
    The proposed rule would also eliminate current Section 2.7(e)(2), 
which states that the list of substances and cutoff levels contained in 
Appendix A to Part 26 are subject to change by the NRC. At the time the 
current rule was published, the NRC expected to be able to amend the 
list of substances and cutoff levels in Appendix A to Part 26 without 
additional rulemaking. However, the NRC has determined that rulemaking 
is required to make such changes. Therefore, the proposed rule would 
delete this paragraph because it is unnecessary.
    The proposed rule would replace current Section 2.7(f) in Appendix 
A to Part 26, which establishes cutoff levels and requirements related 
to confirmatory testing for drugs and drug metabolites at the HHS-
certified laboratory, with proposed Sec.  26.163(b) [Confirmatory drug 
testing]. The proposed rule would also make a number of changes to the 
current paragraph.
    The proposed rule would move current Section 2.7(f)(1) in Appendix 
A to Part 26 to proposed Sec.  26.169(b). Current Section 2.7(f)(1) 
requires 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. This requirement would 
be moved to proposed Sec.  26.169(b) for organizational clarity because 
proposed Sec.  26.169 [Reporting results] addresses the topic of 
reporting test results by the HHS-certified laboratory to the MRO.
    The proposed rule would also eliminate the requirement in current 
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 current 
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 proposed rule would eliminate 
this requirement, because proposed Sec.  26.31(d)(3)(iii)(C) would 
require 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 would no longer be needed 
to assure laboratory performance in this area.
    For organizational clarity, the requirement in the first sentence 
of current Section 2.7(f)(2) in Appendix A

[[Page 50559]]

to Part 26 that the laboratory must use GC/MS techniques for 
confirmatory testing would be moved to proposed Sec.  26.167(e)(1) 
[Quality control requirements for performing confirmatory drug tests], 
which would establish quality control requirements for conducting 
confirmatory drug tests.
    The proposed rule would eliminate current Section 2.7(f)(3) in 
Appendix A to Part 26, which requires HHS-certified laboratories to use 
GC analysis of blood specimens in testing for alcohol, and the 
confirmatory alcohol cutoff level in current Section 2.7(f)(1) in 
Appendix A to Part 26. These provisions would be eliminated because the 
proposed rule would no longer permit donors to request confirmatory 
testing of a blood specimen for alcohol, as discussed with respect to 
proposed Sec.  26.83(a).
    In addition, the proposed rule would eliminate current Section 
2.7(f)(4) in Appendix A to Part 26 for the same reasons discussed with 
respect to current Section 2.7(e)(2) in Appendix A to Part 26.
    Proposed Sec.  26.163(b)(1) would amend several of the cutoff 
levels in current 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 proposed rule would increase the 
confirmatory test cutoff levels for morphine and codeine to 2,000 ng/
mL. This proposed change in the cutoff levels for opiate metabolites 
would substantially reduce the number of positive opiate test results 
that are reported to MROs by HHS-certified laboratories that MROs 
ultimately verify as negative and would be consistent with the opiate 
cutoff levels contained in the HHS Guidelines.
    Proposed Sec.  26.163(b)(1) would also amend two of the testing 
procedures in current Section 2.7(f) in Appendix A to Part 26. The 
proposed rule would amend Section 2.7(f)(5) in Appendix A to Part 26, 
which requires the laboratory to test for 6-acetylmorphine (6-AM) if a 
specimen tests positive for opiates on the initial drug test. The 
proposed rule would require 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 establish a cutoff level of 10 ng/mL for determining 
that a specimen is positive for 6-AM. In addition, proposed Sec.  
26.163(b)(1) would add a requirement that a specimen must 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 
proposed changes would be made for consistency with the related 
provisions in the HHS Guidelines.
    Proposed Sec.  26.163(b)(1) would update the terminology used in 
current Section 2.7(f)(1) in Appendix A to Part 26. As discussed with 
respect to proposed Sec.  26.5 [Definitions], the proposed paragraph 
would replace the term, ``presumptive positive,'' with the phrase, 
``positive on an initial drug test,'' to increase clarity in the 
language of the rule.
    Proposed Sec.  26.163(b)(2) would amend the second sentence of 
current Section 2.7(f) in Appendix A to Part 26, which requires 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 proposed rule would replace the current 
sentence with a new 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 proposed change would be made to 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.

Section 26.165 Testing Split Specimens and Retesting Single Specimens

    A new Sec.  26.165 [Split specimens] would reorganize and amend the 
requirements currently found in Sec.  26.24(f), and Section 2.7(i) and 
(j) in Appendix A to Part 26 that are related to testing split 
specimens and retesting specimens at HHS-certified laboratories. These 
requirements would be presented together in a single section to make 
them easier to locate in the proposed rule for organizational clarity. 
The proposed section would also add several new requirements.
    Proposed Sec.  26.165(a) [Split specimens] would combine and amend 
current Sec.  26.24(f) and Section 2.7(j) in Appendix A to Part 26, 
which establish requirements for HHS-certified laboratories when 
testing split specimens. The proposed paragraph would use 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 proposed rule. The proposed paragraph would also 
require specimen validity testing, 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).
    Proposed Sec.  26.165(a)(1) would retain the portions of current 
Section 2.7(j) in Appendix A to Part 26 that require the HHS-certified 
laboratory to analyze the primary specimen of a split specimen. The 
current requirements that relate to licensee testing facilities would 
be moved to Sec.  26.135 [Split specimens] in proposed Subpart F 
[Licensee Testing Facilities] for organizational clarity. The proposed 
paragraph would retain the requirement that the primary specimen 
(Bottle A) must be subject to initial testing by the HHS-certified 
laboratory, and confirmatory testing, if the specimen yields non-
negative results from initial testing. The proposed paragraph would 
specify that the HHS-certified laboratory must conduct validity tests 
on the specimen contained in Bottle A, as well as drug tests, 
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).
    Proposed Sec.  26.165(a)(2) would retain the portion of the second 
sentence of current Sec.  26.24(f) that requires the HHS-certified 
laboratory to perform initial and confirmatory tests, if required, on 
the specimen in Bottle A if any initial test results from a licensee 
testing facility are non-negative. This requirement would be moved to 
the proposed section for organizational clarity. In addition, the term, 
``positive,'' in the current sentence would be replaced with the term, 
``non-negative,'' to indicate that the HHS-certified laboratory must 
conduct confirmatory testing of any specimens that yield non-negative 
initial validity or drug test results 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).
    Proposed Sec.  26.165(a)(3) would retain the permission in the 
second sentence of current Section 2.7(j) in Appendix A to Part 26 for 
licensees and other entities 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 proposed 
paragraph would also retain the current permission for the specimen in 
Bottle B to be discarded if test results from the HHS-certified 
laboratory are negative.
    Proposed Sec.  26.165(a)(4) would amend the requirements in current 
Section 2.7(j) in Appendix A to Part 26, as they relate to donor 
requests to test the specimen in Bottle B. The proposed

[[Page 50560]]

paragraph would add non-negative 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 
proposed rule, as discussed with respect to proposed Sec.  
26.31(d)(3)(i). The proposed paragraph would also add a requirement 
that the donor must request testing of the Bottle B specimen within 3 
business days after notification by the MRO that the specimen in Bottle 
A has yielded non-negative test results. Since 1994, the HHS Guidelines 
have allowed up to 72 hours for a donor to make this request, so the 
proposed change would increase the consistency of Part 26 with the HHS 
Guidelines.
    The proposed paragraph would also require the donor to provide 
written permission to the licensee or other entity for testing of the 
specimen contained in Bottle B and clarify that only the donor may 
authorize testing of Bottle B. At the public meetings discussed in 
Section V, stakeholders indicated that the proposed requirement for a 
written request from donors would impose a substantial logistical 
burden on donors who may not be working on site when contacted by the 
MRO. However, the NRC believes that the proposed requirement is 
necessary to ensure that the donor's right to privacy and control of 
the specimen is protected, consistent with Goal 7 of this rulemaking, 
which is to protect the privacy and due process rights of individuals 
who are subject to Part 26.
    Proposed Sec.  26.165(a)(5) would require the HHS-certified 
laboratory to forward Bottle B to a second HHS-certified laboratory for 
testing within one business day of the donor's request for testing. The 
proposed paragraph would eliminate the requirement in the fourth 
sentence of current Section 2.7(j) in Appendix A to Part 26, which 
requires that the split specimen must be forwarded to another HHS-
certified laboratory for testing on the same day of the donor request. 
The proposed change would respond to stakeholder feedback during the 
public meetings discussed in Section V. The stakeholders reported that 
implementing the same-day requirement has often been difficult for a 
number of reasons, including, for example, communication delays among 
donors, MROs, the HHS-certified laboratories, 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 upon the nature of the non-negative test 
result. The proposed change would alleviate some of these types of 
logistical difficulties (e.g., logistical problems associated with 
weekends and holidays) while continuing to provide the donor with 
timely test results. Therefore, this proposed change would meet Goal 5 
of this rulemaking, which is to improve Part 26 by eliminating or 
modifying unnecessary requirements.
    Proposed Sec.  26.165(a)(6) would retain the last sentence of 
current Section 2.7(j) in Appendix A to Part 26, which requires the 
second HHS-certified laboratory to provide quantitative test results 
from Bottle B to the MRO, who would provide them to the donor. The 
proposed paragraph would adopt the simpler language from the related 
provision in the HHS Guidelines, consistent with Goal 6 of this 
rulemaking, which is to improve clarity in the language of the rule.
    Proposed Sec.  26.165(b) [Donor request to MRO for a retest of a 
single specimen] would be added to permit donors to request retesting 
of an aliquot from a single specimen, if the FFD program does not 
follow split specimen procedures. The proposed paragraph would assure 
that donors who are subject to a program that does not follow split 
specimen procedures have the right to request additional testing. The 
proposed change would be consistent with related provisions in the HHS 
Guidelines. However, in order to have sufficient urine to support 
retesting, the proposed paragraph would apply only if the donor had 
submitted a specimen of 30 mL or more. Specimens that the HHS-certified 
laboratory determines to be invalid would not be 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 proposed procedures for requesting and 
conducting the retest of a single specimen would be consistent with 
those for requesting and conducting tests on the specimen in Bottle B 
of a split specimen.
    Proposed Sec.  26.165(c) [Retesting a specimen for drugs] would 
amend current Section 2.7(i) in Appendix A to Part 26, which specifies 
that retesting of a specimen is not subject to cutoff requirements. The 
proposed paragraph would update and expand current 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:
    Proposed Sec.  26.165(c)(1) would be added to require the second 
HHS-certified laboratory to use the laboratory's standard confirmatory 
test for the drug or drug metabolite for which the specimen tested 
positive at the first laboratory. Initial tests, and tests for other 
drugs or drug metabolites, would not be performed, consistent with the 
related requirements in the HHS Guidelines.
    Proposed Sec.  26.165(c)(2) would amend current Section 2.7(i) in 
Appendix A to Part 26, which specifies that retesting of a specimen is 
not subject to cutoff requirements. The proposed paragraph would retain 
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 add permission to test the specimen down to the assay's LOD. Adding 
permission to test down to the assay's LOD would be consistent with the 
related requirement in the HHS Guidelines and would ensure that the 
second laboratory's testing is as sensitive to the presence of the 
drug(s) or drug metabolite(s) as scientifically and legally defensible.
    Proposed Sec.  26.165(c)(3) would be added to require the second 
laboratory to attempt to determine the reason if retesting fails to 
confirm the presence of the drug(s) or drug metabolite(s) that was 
identified by the first HHS-certified laboratory. The proposed 
paragraph would require 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.
    Proposed Sec.  26.165(c)(4) would retain the requirement in the 
last sentence of current Section 2.7(j) in Appendix A to Part 26 that 
requires the second laboratory to report the test results to the MRO. 
The proposed rule would extend this requirement to retesting of a 
single specimen, consistent with the explicit permission added in 
proposed 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 proposed requirement would be consistent with the related 
requirements in the HHS Guidelines.
    Proposed Sec.  26.165(d) [Retesting a specimen for adulterants] and 
(e) [Retesting a specimen for substitution] would be added to 
incorporate related requirements in the HHS Guidelines for performing 
retests for adulterants and substituted specimens at a second HHS-
certified laboratory. Retesting for adulterants would be limited to 
conducting confirmatory testing only for the adulterant(s) identified 
by the first laboratory. Retesting for specimen substitution would be 
limited to

[[Page 50561]]

conducting confirmatory testing only for creatinine and specific 
gravity. These proposed limitations would be consistent with 
limitations on retesting specimens for drugs and drug metabolites.
    Proposed Sec.  26.165(f) [Management actions and sanctions] would 
be added to specify the 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 proposed paragraph would respond to 
stakeholder comments at the public meetings discussed in Section V. The 
stakeholders noted that the current rule does not address required 
management actions when an individual has had a confirmed non-negative 
test result and requests a retest of a single specimen or Bottle B of a 
split specimen. Therefore, the proposed paragraph would be added to 
establish such requirements.
    Proposed Sec.  26.165(f)(1) would be added to address circumstances 
in which the MRO has confirmed a non-negative test result from the HHS-
certified laboratory 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. The proposed paragraph would 
require the licensee or other entity to take the same actions in 
response to the confirmed non-negative test result(s) from the first 
HHS-certified laboratory as the actions that licensees and other 
entities would be permitted to take under proposed 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, proposed Sec.  
26.165(f) would require 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 
confirm any non-negative test results from the first HHS-certified 
laboratory, the proposed paragraph would require the licensee or other 
entity to impose the appropriate sanctions that are specified in 
proposed Subpart D [Management actions and sanctions] for the non-
negative test results that were confirmed by the second laboratory. If 
the test results from the second laboratory do not confirm any non-
negative test results, the proposed rule would (1) prohibit the 
licensee or other entity from imposing any sanctions on the individual; 
(2) require the licensee or other entity to eliminate any records of 
the first confirmed non-negative test results; and (3) require 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 
proposed requirements would 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 protecting the donor's right to due process.
    Proposed Sec.  26.165(f)(2) would be added 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, for example, an insufficient quantity of urine in 
the single specimen 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 misplaced.
    The proposed paragraph would require the MRO to cancel the original 
test result, prohibit the licensee or other entity from imposing any 
sanctions on the donor, and require the licensee or other entity to 
ensure that any records are expunged that could link the donor to the 
original non-negative test result and the administrative action 
required under proposed Sec.  26.165(f)(1). The proposed paragraph 
would require the licensee or other entity to document that the test 
was performed and cancelled, if the original specimen was collected for 
random, for-cause, or post-event testing. However, the MRO would direct 
the licensee or other entity to collect another specimen from the donor 
as soon as reasonably practical, if the original specimen was collected 
for pre-access or followup testing. The proposed paragraph would not 
require a second collection for a random test because a second 
collection could not satisfy the requirements for random testing [i.e., 
the donor would not have the same probability of being selected for 
testing as all other donors who are subject to the FFD program, as 
required under proposed Sec.  26.31(c)(iv)]. The proposed rule also 
would not require a second collection when the original test was 
conducted for cause or post event because test results from a second 
collection could not accurately measure the presence of drugs or drug 
metabolites under the conditions that required the original collection 
due to the passage of time. The proposed paragraph would require a 
second collection as soon as reasonably practical for pre-access and 
followup testing because other provisions of the proposed regulation 
(see proposed Subpart C [Granting and Maintaining Authorization]) 
require negative test results in order for the licensee or other entity 
to grant or maintain the donor's authorization.
    The last sentence of proposed Sec.  26.165(f)(2) would require the 
licensee or other entity to impose the appropriate sanctions, as 
specified in proposed Subpart D [Management actions and sanctions], if 
the results of testing the specimen from a second collection are non-
negative and confirmed by the MRO to be an FFD policy violation. 
However, the proposed rule would prohibit 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 proposed Sec.  26.165(f) would be generally 
consistent with related requirements in the HHS Guidelines. The 
differences from the HHS Guidelines' requirements in the proposed rule 
would be 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 proposed rule.

Section 26.167 Quality Assurance and Quality Control

    Proposed Sec.  26.167 [Quality assurance and quality control] would 
update current Section 2.8 in Appendix A to Part 26, which establishes 
quality assurance and quality control requirements for drug testing at 
HHS-certified laboratories. The proposed section would provide more 
detailed requirements for the quality assurance and quality control 
programs of HHS-certified laboratories for consistency with related 
provisions in the HHS Guidelines, and add new requirements for validity 
testing, 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).
    Proposed Sec.  26.167(a) [Quality assurance program] would amend 
and combine current Section 2.8(a) and the last two sentences of 
Section 2.8(d) in Appendix A to Part 26, which require HHS-certified 
laboratories and licensee testing facilities to have quality assurance 
programs. For increased clarity in the language of the rule, the 
proposed rule would replace the term, ``specimen acquisition,'' with 
the term, ``specimen accessioning,'' in the first

[[Page 50562]]

sentence of current Section 2.8(a), which is the more accurate term. 
The proposed rule would also add a requirement for the quality 
assurance program to encompass the certification of calibrators and 
controls to ensure that calibrators and controls are accurate, which 
would be consistent with the related provision in the HHS Guidelines.
    In addition, the proposed rule would move to proposed Sec.  
26.167(a) and amend the requirements in the last two sentences of 
current Section 2.8(d) in Appendix A to Part 26, which require 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 proposed rule would update these 
requirements for consistency with the HHS Guidelines and require 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. 
These requirements would be moved to proposed Sec.  26.167(a) for 
organizational clarity because they are aspects of the laboratory's 
quality assurance program.
    The requirements in current Section 2.8(a) in Appendix A to Part 26 
that apply to licensee testing facilities would be moved to Sec.  
26.137(a) [Quality assurance program] in proposed Subpart F [Licensee 
Testing Facilities] for organizational clarity. The second sentence of 
current 2.8(a) would be retained in proposed Sec.  26.167(a).
    The quality control requirements for initial tests at licensee 
testing facilities in current Section 2.8(b) in Appendix A to Part 26 
would be relocated to Sec.  26.137 [Quality assurance and quality 
control] in proposed Subpart F [Licensee Testing Facilities]. The 
proposed change would be made for organizational clarity.
    Proposed Sec.  26.167(b) [Calibrators and controls required] would 
retain the portions of current Section 2.8(c) and (d) in Appendix A to 
Part 26 that require HHS-certified laboratories to use appropriate 
calibrators and controls for initial and confirmatory drug testing. The 
proposed rule would add 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 proposed rule, as discussed with respect to 
proposed Sec.  26.31(d)(3)(i). The more detailed requirements for 
calibrators and controls in current Section 2.8(c) and (d) would be 
amended and presented in this section of the proposed rule in separate 
paragraphs that address each type of test to be performed by the HHS-
certified laboratory. The proposed changes would be made for increased 
consistency with the HHS Guidelines and to improve the organizational 
clarity of the proposed rule.
    Proposed Sec.  26.167(c) [Quality control requirements for 
performing initial and confirmatory validity tests] would be added 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 proposed paragraph 
would incorporate the related provisions of the HHS Guidelines.
    Proposed Sec.  26.167(c)(1) [Requirements for performing creatinine 
tests] would be added to require HHS-certified laboratories to measure 
creatinine concentration to 1 decimal place on initial and confirmatory 
creatinine tests and establish requirements for the quality control 
samples to be used in initial and confirmatory tests for creatinine 
concentration.
    Proposed Sec.  26.167(c)(2) [Requirements for performing specific 
gravity tests] would be added to establish the required characteristics 
of the refractometers used by HHS-certified laboratories 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.
    Proposed Sec.  26.167(c)(3) [Requirements for performing pH tests] 
would be added to establish quality control requirements for performing 
initial and confirmatory pH tests. Proposed Sec.  26.167(c)(3)(i)-
(c)(3)(v) would specify the required calibrators and controls for pH 
testing, based upon the type of testing instrument used and whether a 
pH validity screening test has been performed.
    The proposed rule would add three additional paragraphs related to 
quality control of initial and confirmatory validity testing: proposed 
Sec.  26.167(c)(4) [Requirements for performing oxidizing adulterant 
tests], proposed Sec.  26.167(c)(5) [Requirements for performing 
nitrite tests], and proposed Sec.  26.167(c)(6) [Requirements for 
performing ``other'' adulterant tests]. The proposed paragraphs would 
establish quality control requirements for performing initial and 
confirmatory tests for oxidizing adulterants, among which nitrites are 
one example, and for ``other'' adulterants.
    Proposed Sec.  26.167(d) [Quality control requirements for initial 
drug tests] would amend and combine portions of current Sections 2.7(d) 
and (e)(1), and 2.8(c) in Appendix A to Part 26, which establish 
quality control requirements for performing initial tests for drugs and 
drug metabolites at HHS-certified laboratories. The proposed paragraph 
would group together the current requirements that are dispersed 
throughout the rule to meet Goal 6 of this rulemaking, which is to 
improve clarity in the organization and language of the rule. In 
addition, the proposed rule would amend a number of the current 
requirements, as follows:
    Proposed Sec.  26.167(d)(1) would amend the first sentence of 
current Section 2.7(e)(1) in Appendix A to Part 26 but retain the 
intent of the current provision as it applies to HHS-certified 
laboratories. The current and proposed paragraphs require laboratories 
to use only immunoassay tests that meet the requirements of the Food 
and Drug Administration for commercial distribution. The requirements 
in the current paragraph related to initial drug testing at licensee 
testing facilities would be moved to Sec.  26.137(e)(1) of proposed 
Subpart F [Licensee Testing Facilities] to improve organizational 
clarity in the rule.
    Proposed Sec.  26.167(d)(2) would permit HHS-certified laboratories 
to conduct multiple tests of a single specimen for the same drug or 
drug class. The requirements in this paragraph would be consistent with 
a similar provision in the HHS Guidelines and would be added to 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.
    Proposed Sec.  26.167(d)(3)(i)-(d)(3)(vi) would update current 
Section 2.8(c) in Appendix A to Part 26, which requires HHS-certified 
laboratories to include quality control samples in each analytical run 
of specimens for initial drug testing. Proposed Sec.  26.167(d)(3)(i)-
(d)(3)(vi) would specify the number and characteristics of the quality 
control samples to be included in each analytical run of specimens. 
These proposed requirements would be the same as those contained in 
proposed Sec.  26.137(e)(6) and (e)(7) for initial drug tests at 
licensee testing facilities and would be added for consistency with the 
related provisions in the HHS Guidelines.
    Proposed Sec.  26.167(e) [Quality control requirements for 
performing confirmatory drug tests] would update and combine portions 
of current Sections 2.7(f)(2) and 2.8(d) in

[[Page 50563]]

Appendix A to Part 26, which address quality control requirements for 
performing confirmatory drug tests. In general, the proposed changes to 
the current requirements would be made for organizational clarity in 
the proposed rule and to incorporate the related provisions in the HHS 
Guidelines.
    Proposed Sec.  26.167(e)(1) would amend current Section 2.7(f)(2) 
in Appendix A to Part 26, which requires that confirmatory drug tests 
must be performed using gas chromatography/mass spectrometry (GC/MS). 
The proposed paragraph would permit HHS-certified laboratories to use 
other techniques for confirmatory drug testing that the HHS Guidelines 
approve for use in Federal workplace drug testing programs.
    Proposed Sec.  26.167(e)(2)(i)-(e)(2)(iv) would amend the 
requirements for quality control samples in current Section 2.8(d) in 
Appendix A to Part 26. Proposed Sec.  26.167(e)(2)(i) and (e)(2)(ii) 
would retain the current requirements for laboratories to include blank 
samples and samples that contain known standards in each analytical 
run. The proposed requirements would 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 proposed paragraph would provide more detailed 
requirements for ``positive controls with the drug or metabolite at or 
near the threshold'' in current Section 2.8(d)(1) in Appendix A to Part 
26. The proposed rule would require, in proposed Sec.  
26.167(e)(2)(iii), at least one control fortified with a drug or drug 
metabolite targeted at 25 percent above the cutoff and, in proposed 
Sec.  26.167(e)(2)(iv), at least one calibrator or control that is 
targeted at or below 40 percent of the cutoff.
    Proposed Sec.  26.167(f) [Blind performance testing] would amend 
current Section 2.8(e) in Appendix A to Part 26, which establishes 
requirements for licensees and other entities to conduct blind 
performance testing of HHS-certified laboratories, as follows:
    Proposed Sec.  26.167(f)(1) would amend the portion of current 
Section 2.8(e)(2) in Appendix A to Part 26 that establishes 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 proposed paragraph would decrease the 
percentage of blind performance test samples that licensees and other 
entities would submit to the HHS-certified laboratory during the 
initial 90-day period of any contract (not including rewritten or 
renewed contracts). Specifically, the proposed rule would reduce 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 
current rule. This proposed decrease in the blind performance testing 
rate would increase the consistency of Part 26 requirements with the 
related provisions in the HHS Guidelines. In addition, since the NRC 
published the current rule, the number and size of Federal agencies who 
conduct drug testing has substantially increased, and these agencies 
are also required to submit blind performance test samples under the 
HHS Guidelines. As a result, the burden on Part 26 programs to conduct 
performance tests of the HHS-certified laboratories may be reduced 
without affecting the likelihood that errors in testing will be 
detected.
    The proposed rule would also add a requirement for licensees and 
other entities to submit a minimum of 30 blind performance test 
specimens in the 90-day period. This proposed minimum would be 
established 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 90-day period could be less than one blind 
performance test sample. Establishing a minimum number of samples would 
provide assurance that the HHS-certified laboratories used by these 
Part 26 programs are providing accurate test results.
    Proposed Sec.  26.167(f)(2) would amend the portion of current 
Section 2.8(e)(2) in Appendix A to Part 26 that addresses ongoing blind 
performance testing after the first 90 days of an initial contract with 
an HHS-certified laboratory. The proposed rule would decrease 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 current rule to 1 percent, 
or a total of 10 samples, whichever is greater. The proposed rule would 
also decrease the maximum number of samples to be submitted per quarter 
from 250 to 100 samples. The rationale for these proposed changes would 
be the same as discussed with respect to proposed Sec.  26.167(f)(1).
    Proposed Sec.  26.167(f)(3) would decrease the proportion of spiked 
blind samples that licensees and other entities would submit each 
quarter from 20 percent in Section 2.8(e)(3) in Appendix A to Part 26 
to 15 percent. The proposed rule would retain the current requirement 
that samples must be spiked with only the drugs that are included in 
the licensee's or other entity's panel of drugs. The proposed rule 
would add a requirement that the spiked samples must be spiked to 
between 60-80 percent of the initial cutoff levels used by the licensee 
or other entity to be consistent with related requirements in the HHS 
Guidelines. In addition, the proposed rule would add a requirement for 
licensees and other entities to submit samples that meet the criteria 
for adulteration, dilution, and substitution, in order to challenge the 
laboratory's validity testing. Licensees and other entities would be 
required to submit blind samples each quarter that are appropriately 
adulterated, diluted, or substituted, in the amount of 5 percent of the 
specimens submitted that quarter or at least 3 samples per quarter (one 
each that is adulterated, diluted, or substituted), whichever is 
greater. This proposed change would be made 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), and would be necessary to challenge the accuracy of the 
HHS-certified laboratory's specimen validity testing.
    Proposed Sec.  26.167(f)(4) would retain current Section 2.8(e)(3) 
in Appendix A to Part 26, which requires 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).
    Proposed Sec.  26.167(f)(5) would be added to establish detailed 
requirements for the blind performance test samples that licensees and 
other entities must submit to the HHS-certified laboratories. The 
proposed rule would require the supplier of the blind samples to 
certify and provide an expiration date for each sample. Proposed Sec.  
26.167(f)(i) and (f)(ii) would specify the characteristics of the 
samples that licensees and other entities would be required to use to 
challenge the HHS-certified laboratory's drug and validity testing, 
respectively. The proposed quality control requirements would be 
necessary to ensure the effectiveness of the blind performance testing 
process and would incorporate the related requirements in the HHS 
Guidelines.
    Proposed Sec.  26.167(g) [Errors in testing] would amend current 
Section 2.8(e)(4)-(e)(6) in Appendix A to Part 26, which establishes 
requirements for licensees, other entities, and HHS-

[[Page 50564]]

certified laboratories related to unsatisfactory performance, including 
false positive and false negative test results, by the HHS-certified 
laboratory. The proposed paragraph would require 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 proposed rule would no longer require the licensee to perform the 
investigation, but rather to ``ensure'' that the laboratory completes 
an investigation. This change is proposed 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 the HHS-certified laboratories. The requirement for 
documentation of the investigation, which currently appears in Section 
2.8(e)(4) in Appendix A to Part 26, would be moved to Sec.  
26.215(b)(8) in proposed Subpart J [Recordkeeping and Reporting 
Requirements] for organizational clarity.
    Proposed Sec.  26.167(g)(1) would explicitly state the requirements 
that are implied in current 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 proposed rule would expand these requirements 
to include the licensee or other entity, as well as the HHS-certified 
laboratory, depending upon the causes identified and the extent to 
which the causes are within each entity's control. The proposed 
requirement would be added to recognize that some testing errors are 
not attributable to the HHS-certified laboratory.
    Proposed Sec.  26.167(g)(2) would amend current Section 2.8(e)(5) 
in Appendix A to Part 26, which requires the licensee to notify the NRC 
if a false positive error occurs on a blind performance test sample and 
the error is determined to be administrative. The proposed paragraph 
would require 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 proposed Sec.  26.167(i). The 
proposed rule would continue 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 proposed rule would also delete reference to 
administrative errors, which appears in current Section 2.8(e)(5), so 
that any type of errors would fall under the requirements of the 
proposed paragraph. The reporting requirement in current Section 
2.8(e)(5) would be moved to Sec.  26.219(c)(2) in proposed Subpart J 
[Recordkeeping and Reporting Requirements] for organizational clarity.
    Proposed Sec.  26.167(g)(3) would amend current Section 2.8(e)(6) 
in Appendix A to Part 26, which addresses false positive errors 
resulting from methodological errors by the laboratory. The proposed 
rule would incorporate reference to validity testing, consistent with 
the addition of requirements to conduct validity testing throughout the 
proposed rule, as previously discussed with respect to Sec.  
26.31(d)(3)(i). The proposed rule would also replace the reference to 
the individual who is responsible for day-to-day management of the 
laboratory with a requirement for the laboratory's certifying scientist 
to document the retesting of specimens that may be required under this 
paragraph. This proposed change would be made for consistency with the 
related provision of the HHS Guidelines. The proposed paragraph would 
delete the last sentence of the current paragraph because it addresses 
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 proposed 
paragraph would retain the other provisions of current Section 
2.8(e)(6), but adopt the simpler language of the related provision in 
the HHS Guidelines for increased clarity in the language of the 
proposed rule.
    Proposed Sec.  26.167(h) [Accuracy] would retain current Section 
2.7(o)(3)(i) in Appendix A to Part 26 with minor editorial revisions. 
The current paragraph would be relocated to proposed Sec.  26.167 
because it is related to quality control of the HHS-certified 
laboratory's drug testing processes. These proposed changes would be 
made to meet Goal 6 of this rulemaking, which is to improve clarity in 
the organization and language of the rule.
    Proposed Sec.  26.167(i) [Calibrators and controls] would update 
current 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 
proposed paragraph would update current 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 
proposed requirements in this paragraph incorporate the related 
requirements in the HHS Guidelines and would 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 
labeling requirements in the second sentence of current Section 
2.7(o)(2) would be retained.

Section 26.169 Reporting Results

    Proposed Sec.  26.169 [Reporting results] would amend current 
Section 2.7(g) in Appendix A to Part 26, which contains requirements 
for HHS-certified laboratories' reporting of test results to the 
licensee's or other entity's MRO. The proposed rule would update the 
current requirements for consistency with the HHS Guidelines. In 
addition, the proposed rule would add requirements for reporting the 
results of validity testing, 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).
    Proposed Sec.  26.169(a) would amend current Section 2.7(g)(1) in 
Appendix A to Part 26, which establishes 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 proposed 
rule would retain the requirement for the laboratory to report results 
to the MRO within 5 business days of receiving the specimen at the 
laboratory. Under the proposed rule, the HHS-certified laboratory's 
``certifying scientist,'' rather than the laboratory's ``responsible 
individual,'' would certify the test results. This proposed change 
would be made for consistency with the updated term used to refer to 
this individual, as discussed with respect to proposed Sec.  26.155(b). 
The proposed rule would add 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 
proposed Sec.  26.31(d)(3)(i). The proposed rule would delete the 
current 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 current rule was based upon 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

[[Page 50565]]

identity may be lost, and, therefore, have substantially reduced the 
need for the requirement in the current rule.
    Proposed Sec.  26.169(b) would amend current Section 2.7(g)(2) in 
Appendix A to Part 26, which establishes requirements for the manner in 
which HHS-certified laboratories and licensee testing facilities must 
report test results to licensee management. The requirements in the 
current paragraph that are related to reporting test results from the 
licensee testing facility would be moved to Sec.  26.139(a) of proposed 
Subpart F [Licensee Testing Facilities] for organizational clarity. The 
proposed paragraph would delete the current reference to ``special 
processing'' and replace it with reference to validity test results, 
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). In addition, the proposed rule would 
make minor changes in terminology, such as referring to a ``drug or 
drug metabolite,'' rather than a ``substance,'' for clarity in the rule 
language.
    Proposed Sec.  26.169(c) would amend portions of current Section 
2.7(f)(2) in Appendix A to Part 26 by deleting 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. Under the 
proposed rule, if the FFD program specifies cutoff levels that are more 
stringent than those specified in this part, the laboratory need only 
conduct testing using those more stringent cutoff levels, and need only 
report results from those tests to the MRO. This proposed change would 
be made for the reasons discussed with respect to proposed Sec.  
26.31(d)(1)(i)(D).
    Proposed Sec.  26.169(d) would be added to establish requirements 
for the laboratory's reporting of the results of validity testing. 
Under the proposed rule, HHS-certified laboratories would be required 
to report to the MRO quantitative results for any specimen that is 
found to be dilute, adulterated, or substituted. The MRO would be 
prohibited from reporting the quantitative validity test results to the 
licensee or other entity, except as permitted with a signed consent 
from the donor under proposed Sec.  26.37(b). The proposed paragraph 
also would require the HHS-certified laboratory to contact the 
licensee's or other entity's MRO when the laboratory concludes that a 
specimen is invalid, and consult with the MRO to determine whether 
additional testing by a second HHS-certified laboratory would be useful 
in being able to report an adulterated or substituted test result. The 
proposed rule would permit the laboratory's contact with the MRO to 
occur using electronic means, such as telephone, fax, and e-mail. These 
proposed reporting requirements would be added for consistency with the 
related provisions in the HHS Guidelines.
    Proposed Sec.  26.169(e) would be added to require the HHS-
certified laboratory to report more than one test result for a single 
specimen, if the laboratory obtains more than one non-negative test 
result from testing of the specimen. This proposed provision would 
require the laboratory to report any drug-positive test results, as 
well as any non-negative validity test results from the same specimen. 
This proposed change is necessary because sanctions for the different 
test results would differ under proposed Sec.  26.75 [Sanctions]. 
Reporting multiple test results for a single specimen would be 
consistent with related requirements in the HHS Guidelines.
    Proposed Sec.  26.169(f) would update current Section 2.7(g)(3) in 
Appendix A to Part 26, which permits the MRO routinely to obtain 
quantitative test results from the HHS-certified laboratory. 
Specifically, the proposed rule would revise the first sentence of 
current Section 2.7(g)(3) by stating that the HHS-certified laboratory 
shall provide quantitative test results to the MRO upon request. The 
proposed paragraph would clarify the current 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 proposed 
clarification would be necessary because the current sentence has 
raised questions from HHS-certified laboratories to the HHS. In 
addition, the proposed rule would add the third sentence of proposed 
Sec.  26.169(f) to clarify requirements for reporting drug test results 
when the concentration of a drug, metabolite, or adulterant exceeds the 
linear range of the standard curve. The proposed rule would also delete 
the existing reference to test results from blood specimens for the 
reasons discussed with respect to proposed Sec.  26.83(a). Disclosure 
of quantitative test results to licensees and other entities would 
continue to be subject to the requirements in proposed Sec.  26.37(b). 
The proposed changes to this paragraph would be consistent with the 
related provisions in the HHS Guidelines.
    Proposed Sec.  26.169(g) would require HHS-certified laboratories 
to report to the MRO quantitative values for confirmatory opiate test 
results for morphine or codeine that are equal to or greater than 
15,000 ng/mL. The proposed rule would add this requirement for 
consistency with the related provision in the HHS Guidelines and 
because the MRO would not be required to perform an assessment for 
clinical signs of opiate abuse in this instance, as discussed with 
respect to proposed Sec.  26.185(f)(1).
    Proposed Sec.  26.169(h) would amend current Section 2.7(g)(4) in 
Appendix A to Part 26, which establishes requirements for the 
electronic transmission of test results from the HHS-certified 
laboratory to the MRO. Specifically, the proposed rule would clarify 
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 current 
requirement. The proposed change would respond 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. The proposed revision would more accurately 
characterize these relationships without changing the intent of the 
current provision.
    Proposed Sec.  26.169(i) would update current Section 2.7(g)(5) in 
Appendix A to Part 26, which establishes requirements for transmitting 
chain-of-custody documentation with test results to the MRO. The 
proposed rule would permit HHS-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 
non-negative test results, the proposed rule would require the 
laboratory to transmit a legible image or copy of the completed 
custody-and-control form to the MRO. The proposed change would be made 
for consistency with the related provision in the HHS Guidelines.
    Proposed Sec.  26.169(j) would further amend current Section 
2.7(g)(5) in Appendix A to Part 26. The proposed paragraph would 
continue to require that the HHS-certified laboratory must retain the 
original custody-and-control form for any non-negative specimens. 
However, the proposed paragraph would assign 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

[[Page 50566]]

reports.'' The proposed change would be made for consistency with the 
updated terminology used to refer to this individual in the HHS 
Guidelines, as discussed with respect to proposed Sec.  26.155(b).
    Proposed Sec.  26.169(k) would combine and amend current Section 
2.7(g)(6) and (g)(7) in Appendix A to Part 26, which require the 
laboratory to submit a monthly statistical summary of drug test results 
to the licensee or other entity. The proposed rule would reduce 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 proposed requirement for annual reporting 
would make 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 would be required under 
proposed Sec.  26.217 [Fitness-for-duty program performance data], for 
the reasons discussed with respect to that section. The proposed rule 
would also delete the existing reference to blood specimens because the 
option for donors to request blood testing for alcohol would be 
eliminated from the proposed rule, as discussed with respect to 
proposed Sec.  26.83(a). The proposed rule would also delete 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 proposed Sec.  26.169(c). The 
proposed rule would add 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-acetylmorphine (6-AM) 
test results. (The proposed rule would include testing for 6-AM, 
because the presence of 6-AM in a specimen uniquely identifies heroin 
use.) In addition, the proposed rule would add requirements to report 
the results of validity testing. These proposed changes would be made 
to conform the laboratory's annual summary report to other changes in 
the proposed rule, as discussed with respect to proposed Sec. Sec.  
26.217(b)(2), Sec.  26.185(f)(1), and 26.31(d)(3)(i).

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

Section 26.181 Purpose

    Proposed Sec.  26.181 [Purpose] would describe the purpose of 
Subpart H, which is to establish requirements for MRO reviews of non-
negative confirmatory drug test results and for making determinations 
of fitness. This proposed section would provide an overview of the 
contents of the proposed subpart, consistent with Goal 6 of this 
rulemaking, which is to improve clarity in the organization and 
language of the rule.

Section 26.183 Medical review officer

    Proposed Sec.  26.183 [Medical review officer] would be added to 
present requirements related to the qualifications, relationships, 
staff, and responsibilities of the MRO to meet Goal 6 of this 
rulemaking, which is to improve clarity in the organization and 
language of the rule, by grouping these requirements together in a 
single section.
    Proposed Sec.  26.183(a) [Qualifications] would combine and amend 
the requirements in current Sec.  26.3 [Definitions] and Section 1.2 of 
Appendix A to Part 26, as well as portions of current Section 2.9(b) in 
Appendix A to Part 26. The proposed rule would reorganize the current 
requirements to eliminate redundancies and group together in one 
paragraph the related provisions in the current rule to meet Goal 6 of 
this rulemaking, which is to improve clarity in the organization and 
language of the rule.
    The proposed paragraph would amend portions of the current 
requirements related to MRO qualifications. The proposed paragraph 
would continue to provide that the MRO must be a licensed physician, 
but would clarify 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 proposed rule would add 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 proposed 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 proposed provision would ensure 
that an MRO is able to perform his or her function appropriately under 
this part. In addition, the proposed rule would add 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 proposed requirement would increase consistency in the 
performance of the MRO function among FFD programs, given that 
licensees and other entities would be permitted to accept test results 
and the results of determinations of fitness conducted by other 
licensees and entities who are subject to the rule. The 2-year 
implementation date would provide MROs who are not currently certified 
with an opportunity to pass the required examination. With the 
exception of the first sentence of this proposed paragraph, which 
specifically relates to the MRO function under Part 26, these MRO 
qualification requirements would be consistent with those of other 
Federal agencies.
    Proposed Sec.  26.183(b) [Relationships] would establish 
requirements related to the relationships that would be permitted or 
prohibited between the MRO, the licensee or other entity, and HHS-
certified laboratories. The first sentence of the proposed paragraph 
would retain the portion of the first sentence of current Section 
2.9(b) in Appendix A to Part 26 that permits the MRO to be an employee 
of a licensee or other entity, or a contractor. The remaining sentences 
of the proposed paragraph would be added 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 proposed prohibition would be added based upon the 
experiences of other Federal agencies and would be consistent with the 
related provision in the HHS Guidelines.
    Proposed Sec.  26.183(c) [Responsibilities] would reorganize and 
update the requirements in current Sec.  26.3 [Definitions] as well as 
Sections 1.2, 2.4(j), 2.7(d), and 2.9(a) and (b) in Appendix A to Part 
26 as they relate to the responsibilities of the MRO in Part 26 
programs. The proposed rule would reorganize the current provisions and 
combine them in one paragraph. In addition, the terminology used in the 
proposed paragraph would be revised to be consistent with that used 
throughout the proposed rule (e.g., ``non-negative''). The proposed 
changes would meet Goal 6 of this rulemaking, which is to improve 
clarity in the organization and language of the rule.
    Proposed Sec.  26.183(c) would retain the requirement in current 
Section 2.9(a) in Appendix A to Part 26 for the MRO to review positive 
confirmatory drug test results and add a requirement for the MRO to 
review non-negative results from validity testing, 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). The proposed

[[Page 50567]]

paragraph would also require the MRO to (1) identify evidence of 
subversion of the testing process; (2) identify issues or problems 
associated with the collection and testing of specimens; and (3) work 
with FFD program management to assure the overall effectiveness of the 
FFD program. The proposed rule would add 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 proposed 
additional responsibilities would strengthen the effectiveness of FFD 
programs by ensuring that the MRO's expertise is brought to bear in the 
management of FFD programs. The proposed paragraph would also increase 
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 proposed changes would 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, 
and Goal 3, which is to improve the effectiveness and efficiency of FFD 
programs.
    Proposed Sec.  26.183(c)(1) would retain and update the 
requirements contained in the current definitions of the term, 
``Medical Review Officer,'' in Sec.  26.3 and Sections 1.2 and 2.9(b) 
in Appendix A to Part 26. The proposed rule would continue to require 
the MRO to examine alternate medical explanations for any non-negative 
test result, which would include non-negative results of confirmatory 
validity testing as well as positive confirmatory drug test results. 
The proposed paragraph would also retain the current requirement for 
the MRO to interview the donor and review the donor's medical history 
and any other relevant biomedical factors as well as all medical 
records that the donor may make available to the MRO. In addition to 
the responsible use of legally prescribed medication, the proposed rule 
would require the MRO to consider a documented condition or disease 
state and the demonstrated physiology of the donor in determining 
whether a non-negative test result is an FFD policy violation. The 
proposed rule would require the MRO to consider the latter factors 
because they may cause some non-negative validity test results. The 
proposed changes would be necessary 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), as 
well as to increase the consistency of Part 26 with advances in other 
relevant Federal rules and guidelines, which is Goal 1 of this 
rulemaking.
    Proposed Sec.  26.183(c)(2) would retain the meaning of the last 
sentence of current Section 2.9(b) in Appendix A to Part 26 with minor 
editorial revisions for consistency with the terminology used 
throughout the proposed rule. For example, the proposed rule would 
replace the term,'' split samples,'' in the current sentence with the 
term, ``split specimens.'' The proposed changes would be made for 
increased clarity in the language of the rule.
    Proposed Sec.  26.183(d) [MRO staff] would be added 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. The proposed rule would add requirements related to MRO staff 
because these individuals (1) have access to drug test results that are 
forwarded to an MRO from the HHS-certified laboratory; (2) perform some 
administrative functions for MROs that permit them to view donors' 
private medical information; and (3) often have contact with donors. 
The NRC is not aware of any instances in which 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, the proposed rule would adopt 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 proposed requirement would also 
ensure that information related to non-negative test results is not 
released to licensee or other entity management personnel until the MRO 
has determined that a donor has violated the FFD policy. These proposed 
changes would 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, and Goal 7, which is to protect the 
privacy and due process rights of individuals who are subject to Part 
26.
    Proposed Sec.  26.183(d)(1) [Direction of MRO staff activities] 
would be added to require an MRO to be directly responsible for the 
administrative, technical, and professional activities of individuals 
who perform MRO staff duties. The NRC does not intend, through use of 
this language, 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. 
Direction may also take place through using a variety of electronic 
communications. However, the proposed rule would require that the MRO's 
direction of staff must be meaningful. Meaningful direction would 
involve (1) personal oversight of staff members' work; (2) personal 
involvement in their performance evaluation, hiring, and firing; (3) 
line authority over the staff for decisions, direction and control; and 
(4) regular contact and oversight concerning drug testing program 
matters. The proposed rule would also require 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 
proposed rule would require that MROs must personally review a 
confirmed positive drug test result that is received from the HHS-
certified laboratory, as well an adulterated or substituted result, 
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).
    Proposed Sec.  26.183(d)(1)(i) would require that MRO staff duties 
must be independent from any other activity or interest of the licensee 
or other entity. The proposed rule would add this requirement because, 
by 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 in which the MRO and his or her staff are 
physically co-located, such as the inadvertent release of non-negative 
test results before the MRO has reviewed the results with the donor. 
Therefore, the NRC believes that the proposed requirement is necessary 
to protect the integrity of the MRO function and donors' privacy.
    Proposed Sec.  26.183(d)(ii) would be added to further specify the 
MRO's responsibilities for directing MRO staff. These responsibilities 
would include, but would not be limited to, ensuring that the 
procedures that must be

[[Page 50568]]

followed by MRO staff meet the regulations of this part and HHS' and 
professional standards of practice, and that personal information about 
the donor is maintained confidential with the highest regard for 
individual privacy. The proposed requirements would meet Goal 7 of this 
rulemaking, which is to protect the privacy and due process rights of 
individuals who are subject to Part 26.
    Proposed Sec.  26.183(d)(1)(iii) would also be added 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 in which 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, proposed Sec.  
26.183(d)(1)(iii) would establish these clear limits.
    Proposed Sec.  26.183(d)(2) [MRO staff responsibilities] would be 
added to specify the job duties that MRO staff may and may not perform. 
The proposed provisions would also be based on the experience of other 
Federal agencies, which has indicated that clear limits on MRO staff 
job duties are necessary to protect donor confidentiality and the 
integrity of the MRO process. Proposed Sec.  26.183(d)(2)(i) would 
permit MRO staff to receive from the HHS-certified laboratory, review, 
and report negative test results to the licensee's or other entity's 
designated reviewing official, under the MRO's direction. Proposed 
Sec.  26.183(c)(2)(ii) would permit MRO staff to review the custody-
and-control forms for specimens that the laboratory reports as non-
negative and correct errors, but would require the MRO to review and 
approve the corrections. Proposed Sec.  26.183(d)(2)(iii) would 
prohibit staff from conducting interviews with donors to discuss non-
negative test results and requesting or reviewing medical information 
from donors related to any non-negative test results. Proposed Sec.  
26.183(c)(2)(iv) would prohibit MRO staff from reporting or discussing 
non-negative test results received from the HHS-certified laboratory 
with any individuals other than the MRO and other MRO staff. The 
proposed provisions would be necessary to protect donor confidentiality 
and the integrity of the MRO review process while permitting licensees 
and other entities to realize the cost efficiencies associated with the 
MRO delegating some tasks to staff.

Section 26.185 Determining a Fitness-for-Duty Policy Violation

    Proposed Sec.  26.185 [Determining a fitness-for-duty policy 
violation] would amend requirements related to the MRO's determination 
that a non-negative test result constitutes an FFD policy violation, as 
follows:
    Proposed Sec.  26.185(a) [MRO review required] would amend portions 
of current Section 2.9(a) in Appendix A to Part 26, which establishes 
requirements for the MRO's review of test results from the HHS-
certified laboratory. The term, ``non-negative test result,'' would be 
used in the proposed paragraph to indicate that the MRO's review would 
encompass validity test results, as well as drug test results, 
consistent with the addition of validity testing requirements in the 
proposed rule. The proposed paragraph would also expand 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 would not be limited 
to, reviewing non-negative validity 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 proposed change would be consistent 
with the NRC's increased concern with potential subversion of the 
testing process, as discussed with respect to proposed Sec.  
26.31(d)(3)(i). The proposed rule would also delete the current 
reference to ``nuclear power plant worker'' and replace it with 
``individual,'' because persons other than nuclear power plant workers 
would be subject to the proposed requirement. In addition, the proposed 
rule would eliminate the current requirement for the MRO to review 
blood test results from the HHS-certified laboratory because the 
proposed rule would no longer permit donors to request testing of a 
blood specimen for alcohol, as discussed with respect to proposed Sec.  
26.83(a). However, the proposed paragraph would retain the current 
requirement that the MRO must complete the review of any non-negative 
test results before transmitting results to a licensee's or other 
entity's designated representative.
    Proposed Sec.  26.185(b) [Reporting of initial test results 
prohibited] would retain the intent of the requirement in the last 
sentence of current Section 2.9(a) in Appendix A to Part 26. 
Specifically, the proposed rule would continue to prohibit the MRO from 
communicating to licensees and other entities any non-negative 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, the proposed rule would extend this prohibition 
to MRO staff, consistent with the addition of requirements related to 
MRO staff in proposed Sec.  26.183(d), as discussed with respect to 
that paragraph.
    Proposed Sec.  26.185(c) [Discussion with the donor] would amend 
current Section 2.9(c) in Appendix A to Part 26. The proposed rule 
would continue to require the MRO to discuss a positive confirmatory 
drug test result with the donor before determining that the FFD policy 
had been violated. The proposed rule would add a requirement for the 
MRO to discuss non-negative 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 proposed rule, 
as discussed with respect to proposed Sec.  26.31(d)(3)(i). The 
proposed rule would add a reference to ``other occurrence'' to address 
circumstances in which 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 proposed Subpart E 
[Collecting Specimens for Testing]. The proposed rule would eliminate 
the current requirement for the MRO to contact the EAP. Under the 
proposed rule, referral to the EAP would be at the licensee's or other 
entity's discretion, as documented in FFD procedures. The current 
requirement would be eliminated because most licensees terminate the 
employment of individuals who have a confirmed non-negative drug test 
result, and it would be 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, the proposed rule would 
require the licensee or other entity to meet the applicable 
requirements of proposed Sec.  26.69 [Authorization with potentially 
disqualifying fitness-for-duty information]. The changes in the 
proposed paragraph would be made for consistency with other proposed 
changes to the regulation.
    Proposed Sec.  26.185(d) [Donor unavailability] would be added to 
clarify the circumstances in which the MRO may confirm a non-negative 
test

[[Page 50569]]

result or other occurrence as an FFD policy violation without having 
first discussed the test result or occurrence with the donor. These 
circumstances would include (1) the donor expressly declining the 
opportunity to discuss the possible FFD policy violation with the MRO 
in proposed Sec.  26.185(d)(1); (2) the donor failing to contact the 
MRO within one business day after being contacted by the licensee or 
other entity or an MRO staff member in proposed Sec.  26.185(d)(2); and 
(3) the MRO being unable to contact the donor after making a reasonable 
effort to do so in proposed Sec.  26.185(d)(2). The proposed paragraphs 
would provide more detailed guidance than the first sentence of current 
Section 2.9(c) in Appendix A to Part 26, in response to the many 
questions that have arisen regarding implementation of the requirement 
for MROs to discuss test results with the donor. The proposed revisions 
would also respond to stakeholders requests during the public meetings 
discussed in Section V. In questions to the NRC staff and during the 
public meetings, licensees have pointed out that the current rule makes 
no provision for these circumstances, which do occasionally arise. 
Therefore, the proposed paragraphs would address these circumstances.
    For the same reasons, proposed Sec.  26.185(e) [Additional 
opportunity for discussion] would specify procedures for addressing a 
circumstance in which the donor was unable to contact the MRO to 
discuss a non-negative test result or other occurrence. The proposed 
paragraph would permit 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 would permit the MRO 
to reopen the procedure for determining whether the donor had violated 
the FFD policy. The proposed paragraph would also permit the MRO to 
modify the initial determination based on the information that the 
donor provides.
    The requirements in proposed Sec.  26.185(d) and (e) would 
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 proposed provisions would 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.
    Proposed Sec.  26.185(f)-(i) would be added to establish 
requirements for the MRO's review of validity test results. These 
proposed paragraphs would be added 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).
    Proposed Sec.  26.185(f) [Review of invalid specimens] would 
clarify the MRO's responsibilities in the event that the HHS-certified 
laboratory reports that a specimen is invalid. The proposed paragraph 
would be consistent with related provisions in the HHS Guidelines, and 
would be necessary because MRO actions in response to an invalid 
specimen are not specified in the current rule. Proposed Sec.  
26.185(f) would provide the MRO with several alternative courses of 
action if a specimen is declared to be invalid by the laboratory, as 
follows:
    Proposed Sec.  26.185(f)(1) would require 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 would direct the laboratory 
to forward an aliquot of the specimen to a second HHS-certified 
laboratory for further testing.
    Proposed Sec.  26.185(f)(2) would require 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, the proposed paragraph would also require 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 affect a second specimen, he or she would 
direct the licensee or other entity to collect another specimen from 
the donor and the licensee or other entity would then rely upon the 
results of the second test to make an authorization decision. The 
proposed rule would not require the second specimen to be collected 
under direct observation in this situation, because there would be 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 proposed 
paragraph would permit the MRO to 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 would not be 
limited to, testing of alternate specimens, such as hair, oral fluids, 
or sweat. The NRC would leave the selection of an alternative method to 
the professional judgement of the MRO. The proposed rule also would 
prohibit 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.
    Proposed Sec.  26.185(f)(3) would require 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 would be warranted in 
this situation because the invalid specimen may be the result of a 
subversion attempt. The proposed rule would require the licensee or 
other entity to rely upon the test results from the directly observed 
collection in authorization decision-making because the result from the 
invalid specimen would be neither negative or non-negative, and so 
could not meet the requirements for granting authorization to an 
individual in proposed Subpart C [Granting and Maintaining 
Authorization] or serve as the basis for imposing the sanctions 
specified in proposed Subpart D [Management Actions and Sanctions].
    Proposed Sec.  26.185(g) [Review of dilute specimens] would be 
added to establish requirements for the MRO's review of positive 
confirmatory drug test results from dilute specimens. The proposed 
paragraph would be added because reviewing test results from a dilute 
specimen is complex and MRO actions in response to a dilute specimen 
are not addressed in the current rule.
    Proposed Sec.  26.185(g)(1) would require the MRO to confirm a 
drug-positive FFD

[[Page 50570]]

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. 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 would be required in proposed 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.
    Proposed Sec.  26.185(g)(2) would permit the MRO to require the 
HHS-certified laboratory to test a dilute specimen for drugs and drug 
metabolites at the LOD of the confirmatory assay used, if the MRO has 
reason to believe that the donor may have attempted to subvert the 
testing process. The proposed rule would authorize the MRO to request 
testing at the LOD for any drugs or drug metabolites for which testing 
would be permitted in this part. The MRO would be permitted to request 
testing at the LOD in these circumstances because the immunoassay tests 
used for initial drug testing may not be sufficiently sensitive to 
detect very low concentrations of drugs or metabolites in a dilute 
specimen. However, confirmatory testing at the LOD may detect very low 
concentrations of drugs or metabolites in a dilute specimen and, 
therefore, would ensure that an attempt to hide drug abuse through 
specimen dilution is unsuccessful.
    Proposed Sec.  26.185(g)(2)(i)-(g)(2)(iii) would define the 
circumstances that 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 proposed 
Sec.  26.185(g)(2). These circumstances would be the same as those 
specified in proposed Sec.  26.115(a)(1)-(a)(3), as discussed with 
respect to those provisions.
    Proposed Sec.  26.185(g)(3) would clarify that the MRO may also 
require the additional testing of a dilute specimen that would be 
permitted in proposed Sec.  26.185(g)(2), if the specimen was collected 
under direct observation, or if such testing is required by the SAE as 
a result of a determination of fitness conducted under proposed Sec.  
26.69 [Authorization with potentially disqualifying fitness-for-duty 
information]. The proposed paragraph would add these permissions for 
consistency with the related provisions in the proposed rule.
    Proposed Sec.  26.185(g)(4) would require the MRO to determine 
whether there is clinical evidence of the illegal use of opiates, 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. The proposed rule would not require an evaluation for clinical 
evidence of illegal use of opiates for 6-AM, because it's presence in a 
specimen is proof of heroin use. However, the proposed paragraph would 
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 proposed paragraph (j) of this section), because the 
concentration of opiates in a dilute specimen would not bear any known 
relationship to the concentration of opiates in vivo (i.e., in the 
donor's body). For similar reasons, the proposed rule would also 
require 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.
    Proposed Sec.  26.185(h) [Review of substituted specimens] would be 
added to establish requirements for the MRO review of substituted test 
results. The proposed provisions would be added because MRO actions in 
determining an FFD policy violation for a substituted specimen are not 
addressed in the current rule. The proposed provisions would be 
consistent with the related provisions in the HHS Guidelines.
    Proposed Sec.  26.185(h)(1) would require the MRO to contact the 
donor to determine whether there is a legitimate medical reason for the 
substituted result. The proposed paragraph would require the MRO to 
give the donor the opportunity to provide legitimate medical evidence, 
within 5 business days of being contacted by the MRO, that the 
individual's normal physiology produced the substituted result and 
would establish requirements for the medical evidence that would be 
necessary. The proposed rule would also provide 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.
    Proposed Sec.  26.185(h)(2) would direct 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.
    Proposed Sec.  26.185(h)(3) would direct 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.
    Proposed Sec.  26.185(i) [Review of adulterated specimens] would 
establish requirements for the MRO's review of adulterated test 
results. The proposed provisions would be added because MRO actions in 
determining an FFD policy violation for an adulterated specimen are not 
addressed in the current rule. Proposed Sec.  26.185(i)(1) would 
require the MRO to contact the donor and offer him or her the 
opportunity to provide an acceptable medical explanation for the 
adulterated result. The proposed rule would also specify the procedures 
that the donor must follow in providing the medical explanation. If the 
donor does not provide an acceptable medical explanation for the 
adulterated result, proposed Sec.  26.185(i)(2) would require the MRO 
to report to the licensee or other entity that the specimen is 
adulterated. If the donor provides an acceptable medical explanation, 
proposed Sec.  26.185(j)(3) would require the MRO to report that no FFD 
policy violation had occurred. These proposed requirements would be 
consistent with the related provisions in the HHS Guidelines.
    Proposed Sec.  26.185(j) [Review for opiates, prescription and 
over-the-counter medications] would amend current Section 2.9(d) in 
Appendix A to Part 26 to address circumstances that have arisen since 
Part 26 was first published and about which licensees have sought 
guidance from the NRC. The proposed paragraph would amend the current 
requirements in Section 2.9(d) in Appendix A to Part 26 and add others, 
as follows:
    Proposed Sec.  26.185(j)(1) would incorporate updated requirements 
from the HHS Guidelines related to the MRO's review of a positive drug 
test result for opiates. The proposed rule would revise, but retain the 
meaning of the requirement for the MRO to determine that there is 
clinical evidence of illegal use of opiates, which appears in current 
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

[[Page 50571]]

the required assessment, the proposed rule would permit the MRO to 
designate another licensed physician who has knowledge of the clinical 
signs of drug abuse to conduct the evaluation. The proposed change 
would continue to ensure 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 proposed 
change would meet Goal 5 of this rulemaking, which is to improve Part 
26 by eliminating or modifying unnecessary requirements.
    The proposed rule would make other changes to current Section 
2.9(d) in Appendix A to Part 26. The proposed paragraph would eliminate 
the examples of clinical signs of opiate abuse in current Section 
2.9(d), because these signs are addressed as part of the training that 
MROs would obtain in order to pass the comprehensive certification 
examination required in proposed Sec.  26.183(a) [Qualifications]. The 
proposed rule would retain the provision in current 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 
proposed rule would add 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 proposed 
change would be made because, in the experience of other Federal 
programs, such concentrations without a legitimate medical explanation 
can only indicate substance abuse. In addition, the proposed rule would 
prohibit 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, given that food 
consumption could not result in a concentration at this level.
    Proposed Sec.  26.185(j)(2) would retain the last sentence of 
current Section 2.9(d) in Appendix A to Part 26, which requires the MRO 
to determine whether there is clinical evidence, in addition to the 
positive drug test result, of abuse of these substances or their 
derivatives.
    Proposed Sec.  26.185(j)(3) would be added 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 the determination they make as to 
whether the use of another person's prescription medication is an FFD 
policy violation. The proposed paragraph would clarify the NRC's intent 
with respect to these circumstances. In the proposed rule, if a donor 
claims, and the MRO confirms, that a non-negative drug test result is 
due to the unauthorized use of another person's prescription 
medication, the proposed rule would require 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 would 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 would confirm that the test 
results are positive for the drug or metabolites detected.
    Proposed Sec.  26.185(j)(4) would be added 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 the determination they make as to 
whether the use of medications legally obtained in a foreign county is 
an FFD policy violation. The proposed paragraph would clarify 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 proposed rule would permit 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 country and the 
donor has used it properly for its intended medical purpose. The 
proposed rule would prohibit 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.
    Proposed Sec.  26.185(j)(5) would be added 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 proposed Sec.  26.163, including, 
but not limited to hemp products and coca leaf tea. In so doing, the 
proposed rule would provide 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 Department of Transportation, 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 proposed Sec.  
26.29(a)(6) and (a)(7), individuals who are subject to Part 26 would 
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.
    Proposed Sec.  26.185(j)(6) would be added 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 proposed 
prohibition would primarily be 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 proposed requirement would be 
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.
    Proposed Sec.  26.185(k) [Results consistent with legitimate drug 
use] would amend current Section 2.9(f) in Appendix A to Part 26. The 
current

[[Page 50572]]

paragraph instructs 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 current 
provision does 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 proposed 
rule would require that a determination of fitness must be performed. 
Because the MRO determined that the drug test result was negative, the 
licensee or other entity would 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 job 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. The 
proposed provision would meet Goal 3 of this rulemaking, which is to 
improve the effectiveness of FFD programs, by providing greater 
assurance that individuals who are subject to the rule are fit to 
safely and competently perform their duties.
    Proposed Sec.  26.185(l) [Retesting authorized] would amend current 
Section 2.9(e) in Appendix A to Part 26, which permits the MRO to 
authorize retesting of an aliquot of a specimen if there is any 
question about the accuracy or validity of a drug test result. The 
proposed rule would retain the provisions in current Section 2.9(e) 
that permit 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 proposed rule would update the current 
requirement for consistency with the terminology used throughout the 
proposed rule (e.g., ``Bottle B'' to refer to a split specimen), as 
discussed with respect to proposed Sec.  26.5 [Definitions]. The 
proposed rule would also add a requirement that the retesting must be 
conducted at a second HHS-certified laboratory that did not conduct the 
original tests. The proposed requirement that retesting must be 
performed at a second HHS-certified laboratory would ensure the 
independence of the second testing and provide additional protection of 
donors' due process rights under the proposed rule. In addition, the 
proposed requirement would increase the consistency of Part 26 with 
related provisions in the HHS Guidelines. The proposed rule would also 
require the donor to request the retest in writing, in order to ensure 
donors' control over the specimen and rights to privacy, as discussed 
with respect to Sec.  26.135(b).
    Proposed paragraph Sec.  26.185(m) [Results scientifically 
insufficient] would amend current Section 2.9(g) in Appendix A to Part 
26, which permits the MRO to determine that a positive drug test result 
is scientifically insufficient and declare it negative. The proposed 
paragraph would change some of the terminology used in the current 
paragraph (e.g., ``samples'' would be changed to ``specimens'') for 
consistency with the terminology used throughout the proposed rule, as 
discussed with respect to proposed Sec.  26.5 [Definitions]. The 
proposed rule would also make other changes to this paragraph, as 
follows:
    The proposed paragraph would amend the first sentence of the 
current requirement, which permits the MRO to report to the licensee or 
other entity that a test result is negative if he or she determines 
that it is scientifically insufficient for further action. The proposed 
rule would instruct the MRO to report that the test result is ``not an 
FFD policy violation'' in these circumstances, rather than a negative 
test result. The proposed change would be made for consistency with 
other changes in the proposed rule related to invalid test results, as 
discussed with respect to proposed Sec.  26.185(f). That is, a test 
result that the MRO determines to 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 non-negative test 
result. Therefore, the proposed change would meet Goal 6 of this 
rulemaking, which is to improve clarity in the language of the rule.
    The proposed rule would also add a statement to the current 
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 proposed rule would add 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 non-negative. Although the NRC is not aware of any such instances 
in Part 26 programs, the proposed rule would clarify that the MRO, 
alone, is authorized to request retesting to further protect the 
independence of the MRO function.
    In addition, the last sentence of current Section 2.9(g), which 
contains records retention requirements, would be moved to Sec.  
26.215(b)(11) of proposed Subpart J [Recordkeeping and Reporting 
Requirements] and grouped with other records retention requirements in 
the proposed rule for organizational clarity.
    Proposed Sec.  26.185(n) [Evaluating results from a second 
laboratory] would establish 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. The 
proposed paragraph would specify that the test result(s) from the 
second HHS-certified laboratory would supersede the confirmatory test 
results provided by the HHS-certified laboratory that performed the 
original testing of the specimen. The proposed rule would incorporate 
these requirements from the HHS Guidelines because the current rule 
does not address MRO actions in response to test results from a second 
laboratory. Therefore, the proposed paragraph would be consistent with 
the related provisions in the HHS Guidelines and would 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.
    Proposed Sec.  26.185(o) [Re-authorization after a first violation] 
would be added to address 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 current rule does not require the MRO to 
evaluate whether drug test results in these instances indicate 
subsequent drug use after a first confirmed positive drug test result, 
and MROs from different FFD programs have implemented different 
policies. Specifically, the proposed paragraph would require 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 
proposed provision would prohibit the MRO from determining that a 
second FFD policy violation for

[[Page 50573]]

marijuana had occurred, if the quantitative results from confirmatory 
testing of the second specimen are positive for marijuana metabolites, 
but at a concentration that would be inconsistent with additional 
marijuana use since the first non-negative 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 
proposed provision would prevent individuals from being subject to a 5-
year denial of authorization for a second confirmed positive drug test 
result under proposed Sec.  26.57(e), when the donor has not engaged in 
further drug use, consistent with Goal 7 of this rulemaking, which is 
to protect the privacy and due process rights of individuals who are 
subject to Part 26.
    Proposed Sec.  26.185(p) [Time to complete MRO review] would amend 
current Sec.  26.24(e), which 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 days after an initial presumptive positive 
screening test result. The proposed rule would replace the current 
phrase, ``initial presumptive positive screening test result,'' with 
the phrase, ``initial non-negative test result,'' for consistency with 
the terminology used throughout the proposed rule, as discussed with 
respect to proposed Sec.  26.5 [Definitions]. The proposed paragraph 
would also require the MRO to report his or her determination that a 
non-negative 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 proposed changes would be made 
for consistency with the related provisions in the HHS Guidelines.

Section 26.187 Substance Abuse Expert

    A new Sec.  26.187 [Substance abuse expert] would be added to 
establish minimum requirements for a new position within FFD programs, 
the ``substance abuse expert'' (SAE), for the reasons discussed in 
Section IV. C.
    Proposed Sec.  26.187(a) [Implementation] would be added to require 
SAEs to meet the requirements of this proposed section within 2 years 
of the date on which the final rule is published in the Federal 
Register. The 2-year period would be proposed 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.
    Proposed Sec.  26.187(b) [Credentials] would be added to establish 
the credentials required for an individual to serve as an SAE under 
this part. The proposed rule would require that the SAE must possess 
the extensive education, training, and supervised clinical experience 
that are prerequisites for obtaining the professional credentials 
listed in proposed Sec.  26.187(b)(1)-(b)(5). However, proposed Sec.  
26.187(c)-(e) would require an SAE to possess additional knowledge and 
experience directly related to substance abuse disorders and the 
requirements of this part.
    Proposed Sec.  26.187(c) [Basic knowledge] and (d) [Qualification 
training] would be added to establish the specific areas of expertise 
and training that would be required for an individual to serve as an 
SAE under this part. The proposed knowledge and training requirements 
in these two paragraphs would be necessary to ensure that SAEs possess 
the knowledge and clinical experience required to perform the SAE 
function effectively in a Part 26 program.
    Proposed Sec.  26.187(c) would require 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 proposed Sec.  26.187(c)(1); (2) knowledge of the 
SAE function as it relates to individuals who perform the job duties 
that require an individual to be subject to this part, in proposed 
Sec.  26.187(c)(2); and (3) knowledge of this part and any changes to 
its requirements, in proposed Sec.  26.187(c)(3).
    Proposed Sec.  26.187(d) would establish the topical areas in which 
an SAE must be trained. The proposed qualification training 
requirements would include training in the following areas: (1) The 
background, rationale, and scope of this part, in proposed Sec.  
26.187(d)(1); (2) key drug and alcohol testing requirements of this 
part, in proposed Sec.  26.187(d)(2) and (d)(3), respectively; (3) SAE 
qualifications and prohibitions, in proposed 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 proposed Sec.  
26.187(d)(5); (5) procedures for consulting and communicating with 
licensee or other entity officials and the MRO, in proposed Sec.  
26.187(d)(6); (6) reporting and recordkeeping requirements of this part 
as they related to the SAE function, in proposed Sec.  26.187(d)(7); 
and (7) appropriate methods for addressing issues that SAEs confront in 
carrying out their duties under this part, in proposed Sec.  
26.187(d)(8).
    Proposed Sec.  26.187(e) [Continuing education] would be added to 
ensure that SAEs maintain the knowledge and skills required to perform 
the SAE function under this part. The proposed paragraph would require 
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. Proposed Sec.  
26.187(e)(1) would describe 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 proposed Sec.  26.187(d). Proposed Sec.  26.187(e)(2) 
would require 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 proposed continuing 
educations requirements would necessary to ensure that SAEs maintain 
updated knowledge and skills to continue performing the SAE function 
effectively under this part.
    Proposed Sec.  26.187(f) [Documentation] would be added to specify 
the records that the SAE must maintain in order to demonstrate that he 
or she meets the proposed requirements of this section. The SAE would 
be required to provide the documentation, as requested, to NRC 
representatives, and to licensees or other entities who would 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 would also be required to have access to this 
documentation. These proposed requirements would be 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.
    Proposed Sec.  26.187(g) [Responsibilities and prohibitions] would 
be added to specify the responsibilities of SAEs within a licensee's or 
other entity's FFD program and their limitations.

[[Page 50574]]

    Proposed Sec.  26.187(g)(1) would specify at least three 
circumstances in which the SAE would be responsible for making a 
determination of fitness under the proposed rule. In proposed 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 proposed 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 proposed Sec.  26.69 [Authorization with 
potentially disqualifying FFD information] would 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 proposed 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 proposed Sec.  26.77 [Management actions regarding 
possible impairment] would 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 job duties that require the 
individual to be subject to this part. Therefore, the proposed 
paragraph would be added for consistency with other, related provisions 
in the proposed rule.
    Proposed Sec.  26.187(g)(2) would be added to require the SAE to 
act as a referral source to assist an individual's entry into an 
appropriate treatment or education program and prohibit the SAE from 
engaging in any activities that could create the appearance of a 
conflict of interest. Proposed Sec.  26.187(g)(2)(i) would prohibit 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, 
proposed Sec.  26.187(g)(2)(ii)(A)-(g)(2)(ii)(D) would specify 
circumstances in which the prohibition in proposed Sec.  
26.187(g)(2)(i) would not apply. In general, the proposed rule would 
permit 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 proposed provisions would be 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

    Proposed Sec.  26.189 [Determination of fitness] would be added to 
present together in one section and amend current requirements related 
to the determination that an individual is fit to safely and 
competently perform the job duties that require individuals to be 
subject to this part. The terms, ``medical assurance'' and ``medical 
determination of fitness,'' used in various sections of the current 
rule [e.g., Sec.  26.27(a)(3), (b)(2) and (b)(4)] would be replaced 
with the term, ``determination of fitness,'' as defined in this 
proposed section. This proposed change in terminology would be made 
because the rule would permit healthcare professionals other than 
licensed physicians to conduct determinations of fitness, as discussed 
with respect to proposed Sec.  26.187 [Substance abuse expert]. 
Therefore, the proposed change would meet Goal 6 of this rulemaking, 
which is to improve clarity in the organization and language of the 
rule.
    Proposed Sec.  26.189(a) would be added. The first sentence of the 
proposed paragraph would define the term, ``determination of fitness.'' 
This term would refer to the process followed to determine 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 general, the proposed rule would require 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 proposed 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 proposed Sec.  26.69(b)(4)] or 
whether the individual is a licensed physician. Therefore, proposed 
Sec.  26.189(a)(1)-(a)(5) would provide examples of the healthcare 
professionals who would be 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 would be 
permitted to make determinations of fitness under proposed Sec.  
26.189(a)(1). The proposed rule would permit 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 proposed Sec.  26.189(a)(2), 
psychiatrists in proposed Sec.  26.189(a)(3), physicians in proposed 
Sec.  26.189(a)(4), or an MRO in proposed Sec.  26.189(a)(5), 
consistent with their professional qualifications. The proposed rule 
would also permit other licensed and certified professionals who are 
not listed in the proposed 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 would be reserved for healthcare 
professionals who have met the specific training, clinical experience, 
and knowledge requirements for an SAE under proposed Sec.  26.187 
[Substance abuse expert] for the reasons discussed with respect to that 
proposed section.
    The proposed rule would also prohibit 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 proposed rule 
would add 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 proposed prohibition would be 
necessary to meet Goal 3 of this rulemaking, which is to improve the 
effectiveness and efficiency of FFD programs, as well as Goal 7, which 
is to

[[Page 50575]]

protect the privacy and due process rights of individuals who are 
subject to Part 26.
    Proposed Sec.  26.189(b)(1)-(b)(4) would list and present together 
the circumstances in which a determination of fitness must be 
performed, as required in other sections of the proposed rule. Although 
this proposed paragraph would be redundant with other sections of the 
proposed rule, these circumstances would be listed in the proposed 
paragraph to meet Goal 6 of this rulemaking, which is 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.
    Proposed Sec.  26.189(b)(1) would reiterate the requirement in 
current Section 2.9(f) in Appendix A to Part 26 and proposed Sec.  
26.185(k) that a determination of fitness must be performed when there 
is a medical explanation for a non-negative 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.
    Proposed Sec.  26.189(b)(2) would reiterate requirements in current 
Sec.  26.27(b)(1) and (b)(4) and proposed Sec.  26.69(b) [Authorization 
after a first confirmed positive drug or alcohol test result or a 5-
year denial of authorization] 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.
    Proposed Sec.  26.189(b)(3) would reiterate the requirement in 
proposed 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 a Part 26 FFD program.
    Proposed 26.189(b)(4) would address 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 proposed Sec.  26.27(c)(4), and if a 
licensee's or other entity's reviewing official requires one, in 
accordance with proposed Sec.  26.69(c)(3) and (d)(2).
    Proposed Sec.  26.189(c) would be added to establish requirements 
for a determination of fitness that is conducted ``for cause.'' 
Specifically, proposed Sec.  26.189(c) would require that a 
determination of fitness that is conducted for cause must be conducted 
through face-to-face interaction to ensure 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 immediacy of 
the decision would limit the amount of information that could be 
gathered and made available to the professional by others. Conversely, 
the proposed paragraph would not require that determinations of fitness 
for other purposes be conducted face-to-face. These other purposes may 
include, but would not limited to, the determination of fitness that 
would be 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. The professional would 
have access to information that could be gathered by others about the 
individual, and no time urgency would be involved in the evaluation. 
Therefore, the proposed paragraph would be added to meet Goal 3 of this 
rulemaking, which is to improve the effectiveness and efficiency of FFD 
programs, by requiring a face-to-face assessment in some circumstances 
where electronic means of communication could not provide the requisite 
information for the evaluation, and permitting 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.
    Proposed Sec.  26.189(c)(1)-(c)(4) would be added to specify the 
required outcomes of a for-cause determination of fitness. The proposed 
rule would provide 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 proposed Sec.  26.187 [Substance abuse expert].
    Proposed Sec.  26.189(c)(1) would require 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 and the licensee or 
other entity must permit the individual to perform the job duties that 
require the individual to be subject to this part.
    Proposed Sec.  26.189(c)(2) would require 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 would not constitute a violation of Part 26 or the 
licensee's or other entity's FFD policy; therefore, no sanctions would 
be applied. Examples of circumstances in which an individual may be 
determined to be unfit under the proposed 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 job duties that require the individual to be subject to 
this part. In addition, the proposed rule would require 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.
    Proposed Sec.  26.189(d) would be added 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 proposed paragraph would also require 
that the professional who made the initial determination must be 
responsible for modifications to the initial determination based on new 
or additional information. If the initial professional is no longer 
available, then the licensee or other entity would be required to 
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. The proposed paragraph would be necessary to 
ensure consistency and continuity in the treatment of an individual who 
may be undergoing treatment, aftercare, and followup testing.

[[Page 50576]]

Subpart I--Managing Fatigue

Section 26.195 Applicability

    A new Sec.  26.195 [Applicability] would be added to specify the 
licensees and other entities to whom the requirements in proposed 
Subpart I would apply. Proposed Subpart I would apply only to licensees 
who are authorized to operate a nuclear power reactor (under Sec.  
50.57 of this chapter) and holders of a combined license after the 
Commission has made the finding under Sec.  52.103 of this chapter, as 
specified in proposed Sec.  26.3(a), and C/Vs who implement FFD 
programs or program elements upon which such licensees rely, as 
specified in proposed Sec.  26.3(d).
    As discussed in Section IV. D, the proposed rule would require 
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 NRC's current regulatory framework does not 
include consistent requirements to prevent worker fatigue from 
adversely impacting safe operations and enforcement of the current 
requirements is complex;
    (4) Reviews of nuclear power plant licensees' controls on work 
hours have repeatedly identified practices that are inconsistent with 
the NRC's Policy on Worker Fatigue, including excessive work hours and 
the overuse of work-hour limit deviations;
    (5) The current regulatory framework is comprised of requirements 
that are inadequate and incomplete for effective fatigue management;
    (6) Ensuring effective management of worker fatigue through 
rulemaking would 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; 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 U.S.
    The proposed requirements also would 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 proposed provision would 
permit licensees to rely on a C/V's fatigue management program, 
consistent with the permission for licensees to rely on licensee-
approved FFD programs and program elements in current Sec.  26.23(a), 
as retained in proposed Sec.  26.3 [Scope].
    Proposed Subpart I would not apply to the materials licensees who 
are otherwise subject to Part 26 (see proposed Sec.  26.3 [Scope]) for 
two reasons. First, NRC analyses have indicated 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 are required under NRC regulations. 
Second, there is no evidence of excessive overtime use by the materials 
licensees who are subject to Part 26. Therefore, applying the 
requirements in Subpart I to these licensees would be unnecessary. The 
costs associated with establishing work hour controls to meet the 
proposed Subpart I requirements would not be commensurate with a 
corresponding benefit to the protection of public health and safety and 
the environment. However, requirements to prevent fatigue from 
adversely affecting the job performance of security personnel at 
materials facilities may provide a substantial enhancement to the 
security of these facilities. In SRM-COMSECY-04-0037, dated September 
1, 2004, the Commission determined that FFD 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. That activity is scheduled to 
begin in FY 2006. Publication of a proposed rule related to fatigue of 
security forces for these materials facilities would not occur until 
the final rule is published from this rulemaking.

Section 26.197 General Provisions

    Proposed Sec.  26.197 [General provisions] would be added to 
establish fatigue management requirements for licensees' FFD programs. 
The general provisions in this section would establish requirements for 
licensees' fatigue management policies, procedures, training, 
examinations, recordkeeping, and reporting. The NRC's objective in 
establishing these general provisions would be to facilitate 
integrating fatigue management into licensees' FFD programs, as 
discussed in Section IV. D.
    Proposed Sec.  26.197(a) [Policy] would be added to require 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. The NRC believes that 
the responsibility for ensuring that each individual is fit to safely 
and competently perform his or her duties is shared between the 
licensee and the individuals who perform duties on the licensee's 
behalf. Therefore, the proposed rule would require each licensee's FFD 
policy to set forth the licensee's fatigue management policy, so that 
individuals who are subject to it will be aware of and may comply with 
the fatigue management requirements for which they will be held 
accountable. The proposed rule would require each licensee to 
incorporate the fatigue management policy statement into the written 
FFD policy that would be required under proposed Sec.  26.27(b). As 
discussed with respect to proposed Sec.  26.27(b), the proposed rule 
would require 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 there is a need for 
individuals to clearly understand their fatigue management 
responsibilities and those of the licensee. These responsibilities 
would include the individual's responsibility 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 job duties, as 
well as concerns related to others, and the licensee's responsibility 
to assess such fatigue-related FFD concerns. Further, the proposed rule 
would not prohibit licensees from imposing sanctions on individuals for 
failing to comply with the portions of the licensees' fatigue 
management policies that assign certain responsibilities to 
individuals. For example, some licensees 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 proposed Sec.  26.189 [Determination of fitness], a healthcare 
professional has

[[Page 50577]]

determined is adversely affecting the individual's job performance and 
potentially could be medically resolved. The proposed rule would not 
establish minimum sanctions for individual 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, in order to protect individuals' 
rights to due process under the rule, it would be necessary for 
licensees' fatigue management policies to communicate any sanctions 
that a licensee may impose on an individual for failing to comply with 
the policy's requirements.
    Proposed Sec.  26.197(b) [Procedures] would be added to require 
licensees to develop, implement, and maintain procedures to implement 
the fatigue management policy that would be required under proposed 
Sec.  26.197(b). Procedures would be necessary to ensure that 
licensees' fatigue management programs are properly and consistently 
implemented.
    Proposed Sec.  26.197(b)(1) would require licensees to develop, 
implement, and maintain procedures that describe the process to be 
followed any time an individual who is subject to the licensee's FFD 
program reports to a supervisor that he or she is unfit for duty 
because of fatigue (i.e., makes a self-declaration). The NRC previously 
noted in RIS 2002-007 that self-declaration is an important adjunct to 
behavioral observation in meeting the requirements of the performance 
objective in current Sec.  26.10(b) [as retained in proposed Sec.  
26.23(c)], which is ``to provide reasonable measures for the early 
detection of persons who are not fit to perform the job 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 
fitness for duty (e.g., formally stating to a supervisor, ``I am too 
tired right now to check these valve lineups accurately'').
    Proposed Sec.  26.197(b)(1)(i) would require the licensee's self-
declaration procedure to describe the responsibilities of individuals 
and licensees and the actions they must take with respect to an 
individual's self-declaration of fatigue. The NRC has considered 
industry experience with individuals refusing to report to work on the 
basis that they were too tired, and has concluded that detailed 
procedures are necessary to specify: (1) The individual's 
responsibility to be available at work for a fatigue assessment, which 
must be conducted face-to-face under proposed Sec.  26.201(b) for the 
reasons discussed with respect to that paragraph; (2) the individual's 
responsibility to cooperate with the fatigue assessment process by 
providing the necessary information [see the discussion of proposed 
Sec.  26.201(c)(2)]; and (3) the licensee's responsibility for 
conducting a fatigue assessment in response to an individual's self-
declaration, as required under proposed Sec.  26.201(a)(2), to 
determine whether, and under what controls and conditions, if any, the 
individual may be permitted or required to work.
    Proposed Sec.  26.197(b)(1)(ii) would require the licensee's self-
declaration procedure to 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 for duty as a result of fatigue. This portion of the 
procedure would be necessary to ensure correct and consistent 
implementation of the requirements in proposed Sec.  26.201(b), which 
would require that a supervisor or staff member of the FFD program must 
conduct the fatigue assessment and make a determination whether, and 
under what conditions, an individual who has self-declared may be 
returned to duty. For example, the licensee's procedure would 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 may include, but would 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 would be 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.
    Proposed Sec.  26.197(b)(1)(iii) would be added to require licensee 
procedures to describe the processes to be followed if an individual 
disagrees with the results of a fatigue assessment that was conducted 
in response to the individual's self-declaration. These procedures 
would 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 job duties listed in proposed Sec.  26.199(a) 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 proposed rule would add this requirement for several reasons. 
First, in RIS 2002-007, the NRC documented concerns associated with 
past instances of self-declaration. The NRC believes that these 
instances indicated 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 Section V, several stakeholders requested that 
this provision be added to the proposed rule to ensure that individuals 
have recourse if they disagree with the results of a fatigue assessment 
that was 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 concurs that licensee policies and procedures related to 
implementing the requirements of this proposed subpart must address 
these potential issues in order to protect the due process rights of 
individuals who would be subject to the rule. However, the proposed 
rule would not establish specific requirements for the process(es) to 
be followed in such instances for two reasons: (1) Licensees have 
already

[[Page 50578]]

implemented a number of processes for addressing similar safety and 
employment issues that provide appropriate mechanisms for resolving 
fatigue-related issues, and (2) there is such a wide variety of 
possible issues that may arise that establishing one mechanism in the 
proposed rule could not be expected to appropriately address them all. 
Therefore, the proposed rule would require licensees to have procedures 
for addressing situations in which an individual who has self-declared 
disagrees with the outcome of a fatigue assessment, but would not 
require a new process nor specify the required characteristics of the 
process(es) the licensees would use.
    Proposed Sec.  26.197(b)(2) would be added to require that licensee 
procedures must describe the process for implementing the work hour 
controls that would be required under proposed Sec.  26.199 [Work hour 
controls]. For example, the procedures would detail individual and 
organizational responsibilities and requirements, including items such 
as: Scheduling; tracking and calculating work hours; granting waivers 
of the individual work hour controls; reviewing the implementation of 
the work hour controls; documenting the results of the reviews; and 
implementing any necessary corrective actions. These procedures would 
be necessary to ensure that individuals understand the work hour 
controls to which they are subject and that licensees consistently 
implement the work hour controls required in proposed Sec.  26.199 and 
as the NRC intends.
    Proposed Sec.  26.197(b)(3) would be added to require that licensee 
procedures must describe the process(es) to be followed in conducting a 
fatigue assessment, as required under proposed Sec.  26.201(a). The 
proposed procedures would establish the methods through which the 
licensee would determine whether an individual who may be fatigued 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 would address fatigue 
assessments that are conducted following an individual's self-
declaration, 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 proposed rule would require licensees to 
conduct fatigue assessments are discussed with respect to proposed 
Sec.  26.201(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 determined to have been asleep 
while on duty), comprehensive procedures would be necessary to ensure 
consistent implementation of the fatigue assessment requirements in 
proposed Sec.  26.201 [Fatigue assessments]. Therefore, the NRC expects 
that these procedures would 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 may 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 
proposed Sec.  26.199(j)(1). These procedures would be necessary to 
implement the proposed requirements in this subpart and protect the due 
process and privacy rights of individuals, consistent with Goal 7 of 
this rulemaking.
    Proposed Sec.  26.197(b)(4) would be added to require licensees to 
describe in a procedure the sanctions they may impose on individuals, 
if any, following a fatigue assessment (e.g., termination or leave 
without pay). During the public meetings discussed in Section V, 
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 fitness for duty. Although the NRC neither endorses nor 
prohibits the imposition of sanctions in cases of fatigue, licensees 
have an obligation to provide due process to individuals who are 
subject to their FFD policy. For this reason, procedures would be 
necessary to ensure that licensees fully disclose the conditions under 
which sanctions would be considered; the nature of the possible 
sanctions; and the process for administering and imposing the 
sanctions, 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 proposed Sec.  26.39 [Review process for 
fitness-for-duty policy violations].
    Proposed Sec.  26.197(c) [Training and examinations] would 
establish additional fatigue-related training and examination 
requirements, in addition to those required under proposed Sec.  
26.29(a) and (b). Several of the knowledge and abilities (KAs) 
requirements that are listed in proposed Sec.  26.29(a) would ensure 
that individuals are familiar with a licensee's or other entity's 
fatigue policies and procedures, which may include the consequences of 
violating them under proposed Sec.  26.29(a)(1), and individuals' and 
others' responsibilities under the licensee's FFD program in proposed 
Sec.  26.29(a)(2) and (a)(3). However, individuals who would be 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 proposed rule would require licensees 
to address the topics specified in proposed Sec.  26.197(c)(1) and 
(c)(2) in their FFD training and testing programs.
    Proposed Sec.  26.197(c)(1) would require FFD training and 
examinations to ensure that individuals who are subject to the proposed 
subpart 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 would address that are 
related to this KA would 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

[[Page 50579]]

stable workforce by reducing worker turnover. A survey by Circadian 
Technologies Incorporated of 550 facilities in the U.S. 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 
Incorporated, 2004).
    Proposed Sec.  26.197(c)(2) would require FFD training and 
examinations to ensure that individuals who are subject to proposed 
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 would 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 would be 
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 proposed Sec. Sec.  26.199(e) and 
26.201(a)(2), and identify other individuals who are exhibiting 
indications of fatigue through behavioral observation to determine when 
it is appropriate to report an FFD concern about another individual, as 
required under proposed Sec.  26.33 [Behavioral observation].
    Proposed Sec.  26.197(d) [Recordkeeping] would be added to 
establish recordkeeping requirements related to the implementation of 
proposed Subpart I. Specifically, proposed Sec.  26.197(d)(1) would 
require licensees to retain records of the number of hours worked by 
individuals who are subject to the work hour controls established in 
proposed Sec.  26.199 [Work hour controls]; proposed Sec.  26.197(d)(2) 
would require licensees to retain records of the number of waivers they 
have granted and the bases for those waivers; proposed Sec.  
26.197(d)(3) would require licensees to retain documentation of the 
work hour reviews that would be required under proposed Sec.  
26.199(j)(3); proposed Sec.  26.197(d)(4) would require retaining 
documentation of any fatigue assessments that would be conducted, as 
required by proposed Sec.  26.201(g); and proposed Sec.  26.197(d)(5) 
would require licensees to retain documentation of each job duty 
group's collective work hours. The proposed rule would establish these 
recordkeeping requirements for four reasons: (1) These records would be 
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 proposed work hour 
controls, and waiver and fatigue assessment provisions; (2) the 
documentation may be necessary for a review process under proposed 
Sec.  26.39 [Review process for fitness-for-duty policy violations] or 
in legal proceedings related to a determination that an individual has 
violated the fatigue provisions of an FFD policy; (3) the documentation 
would be necessary to perform the trending and self-assessments that 
would be required under proposed Sec.  26.199(j) [Reviews]; and (4) the 
documentation would be necessary to meet the reporting requirements in 
proposed Sec.  26.197(e) [Reporting]. In order to ensure that the 
records remain available for NRC inspections and for the review process 
or legal proceedings, the proposed paragraph would require licensees to 
retain these records for 3 years or until the completion of any related 
legal proceedings, whichever is later.
    Proposed Sec.  26.197(e) [Reporting] would be added to require 
licensees to report to the NRC certain data related to their fatigue 
management programs as part of the annual FFD program performance 
report, which licensees would be required to submit under proposed 
Sec.  26.217 [Fitness-for-duty program performance data]. The proposed 
rule would require licensees to include the following information in 
the annual report: (1) Information on the number of waivers granted 
from work hour controls from the previous calendar year; (2) the 
collective work hours for any job duty group whose average work hours 
exceeds 48 hours per week; and (3) the number of fatigue assessments 
conducted during the year, the management actions that resulted, and 
the conditions under which the fatigue assessments were conducted. The 
NRC would use the information in these annual reports for several 
purposes.
    The primary reason for requiring licensees to submit this 
information annually would be that, as discussed in Section IV. D, 
certain nuclear power plant licensees have permitted individuals to 
work hours that are significantly in excess of those intended under the 
NRC's Policy on Worker Fatigue and abused the waiver provisions of the 
Policy by granting blanket waivers to large groups of plant personnel 
for extended periods of time. It is the intent of the requirements in 
proposed Subpart I to ensure that such abuses do not recur under the 
proposed rule. However, the NRC does not have the resources to inspect 
every licensee's fatigue management program each year and collect this 
information by relying solely on NRC inspection personnel. Therefore, 
the proposed requirement for licensees to submit this information would 
be necessary to ensure that it would be available for the NRC's review 
and evaluation to identify licensees whose fatigue management programs 
do not appear to be meeting the objectives of this proposed subpart.
    In addition, the proposed reports would permit the NRC to more 
efficiently focus its inspection resources on those licensees' fatigue 
management programs that do not appear to be meeting the objectives of 
this proposed subpart, and thereby maximize the efficiency of the 
inspection process. Obtaining information about significant fatigue-
management issues and events (e.g., events resulting in fatigue 
assessments, or plant events occurring while work hour limits are 
waived) would permit the NRC to evaluate situations that may indicate 
inadequate licensee performance. Inadequate licensee performance may 
require action by the NRC staff to ensure that public health and safety 
and the common defense and security are not compromised.
    The NRC also requires the information to: (1) Track the 
effectiveness of the requirements of proposed Subpart I in controlling 
the fatigue of nuclear power plant workers; (2) assess whether the 
objectives of the proposed requirements are being achieved; and (3) 
determine whether any further changes to the requirements are necessary 
to ensure that worker fatigue is managed consistent with the intent of 
the provisions. As a hypothetical example, if analyses of the data 
obtained from the annual reports show that, across the industry, (1) 
licensees generally grant significantly more waivers for operations 
personnel than any other job duty groups, (2) operations job duty 
groups exceed the 48-hour per person per week work

[[Page 50580]]

group average limit significantly more often than any other job duty 
groups, and (3) operations personnel are subject to more for-cause 
fatigue assessments than individuals in any other work groups, the NRC 
may determine that it is necessary to further evaluate the causes for 
these findings and potentially revise the requirements of Subpart I as 
they relate to the operations job duty group.
    In summary, because the information that licensees would be 
required to report would be central to assessing licensee performance, 
efficiently allocating NRC inspection resources, and evaluating the 
effectiveness of the proposed Subpart I requirements, the reporting 
burden that these requirements would impose on licensees is warranted. 
However, the NRC expects that the additional burden associated with the 
proposed requirements for licensees to add this information to their 
annual reports would be minimal because proposed Sec.  26.199(j) 
[Reviews] would require licensees to aggregate and review this 
information after each averaging period for the reasons discussed with 
respect to that proposed provision. Therefore, the proposed requirement 
to include the information in the annual FFD program performance report 
would not impose a significant additional burden.
    Proposed Sec.  26.197(e)(1) would require licensees to provide the 
NRC with an annual summary of the number of instances during the 
previous calendar year in which the licensee waived each of the work 
hour controls specified in proposed Sec.  26.199(d)(1) and (d)(2) for 
each of the job duty groups listed in proposed Sec.  26.199(a). 
(Waivers of the work hour controls in proposed Sec.  26.199(d)(1) and 
(d)(2) would be permitted under proposed Sec.  26.199(d)(3) for the 
reasons discussed with respect to proposed Sec.  26.199(d)(3).) For 
example, if a licensee granted 10 waivers to one operator that 
permitted him or her to work 18 hours in a 24-hour period [see proposed 
Sec.  26.199(d)(1)(i)] on 10 separate occasions during the calendar 
year, the licensee would report that the work hour limit in proposed 
Sec.  26.199(d)(1)(i) was waived 10 times in the operations job duty 
group that year. The job duty groups who would be subject to work hour 
controls are discussed with respect to proposed Sec.  26.199(a). 
Similarly, if the licensee granted one waiver to each of 10 different 
operators to permit the operators to work 18 hours in a 24-hour period, 
the licensee would also report that the work hour limit in proposed 
Sec.  26.199(d)(1)(i) was waived 10 times in the operations job duty 
group that year. As another example, if the licensee permitted 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 would report that the operations job duty group was granted 
three waivers of proposed Sec.  26.199(d)(1)(i), one waiver of proposed 
Sec.  26.199(d)(1)(iii), and one waiver of proposed Sec.  
26.199(d)(2)(i) for the year.
    As a fourth and more complex example, if a licensee permitted an 
operator who normally works 12-hour shifts to work a seventh 12-hour 
consecutive shift, followed by a second waiver on the eighth day to 
work another 12-hour shift, then the licensee would report multiple 
waivers. In this example, on the seventh day, the licensee would grant 
one waiver of proposed Sec.  26.199(d)(1)(iii) for working 84 hours in 
a 7-day period and one waiver of proposed Sec.  26.199(d)(2)(ii) for 
not receiving the required 24-hour break in a 7-day period. On the 
eighth day, the individual would be granted those same two waivers 
again. So, the licensee would report the instances on the seventh and 
eighth days as two waivers of proposed Sec.  26.199(d)(1)(iii) and two 
waivers of proposed Sec.  26.199(d)(2)(ii). This example presumes that 
the individual received the 48-hour break required by proposed Sec.  
26.199(d)(2)(iii) within the 6 days preceding day 1, otherwise 
additional waivers from that provision would also be required and 
reported.
    The proposed rule would also establish additional requirements 
related to aggregating and reporting the waiver data, as follows:
    Proposed Sec.  26.197(e)(1)(i) would require licensees to include 
in the annual report only those waivers under which work was actually 
performed. The proposed rule would add this provision 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 work hour 
control in proposed Sec.  26.199(d)(1) and (d)(2) in order to complete 
a task, and so implement the process specified in proposed Sec.  
26.199(d)(3) 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 proposed rule would require licensees to exclude 
waivers under which no work was performed from the annual report 
because the granting of a waiver provides would provide no meaningful 
information about the licensee's management of fatigue during extended 
work periods.
    In addition, proposed Sec.  26.197(e)(1)(ii) would require 
licensees to report all waivers granted of each of the work hour 
controls in proposed Sec.  26.199(d)(1) and (d)(2) for each job duty 
group, to include all of the waivers that were granted for those 
instances in which a single extended work period required waiving more 
than one of the work hour controls. For example, if a component failure 
creates a condition adverse to safety, the licensee may determine that 
a waiver of the work hour controls for a four-person crew of 
maintenance technicians would be necessary to resolve the adverse 
safety condition in a timely manner. Assuming that the results of 
fatigue assessments of the individuals involved indicated that they 
were able to continue working, the licensee may decide to waive two of 
the limits on individual work hours in proposed Sec.  26.199(d)(1) for 
each of four crew members to enable them to complete the repair. 
Therefore, depending upon the actual circumstances, proposed Sec.  
26.199(e)(1)(ii) would require the licensee's annual summary to report, 
for example, that waivers were granted to four maintenance technicians 
of the ``16 work hours in any 24-hour period'' individual work hour 
limit in proposed Sec.  26.199(d)(1)(i) as well as four waivers of the 
``26 work hours in any 48-hour period'' requirement in proposed Sec.  
26.199(d)(1)(ii). Although the maintenance crew may have worked for 
only a single extended work period, the licensee's annual summary would 
include all eight of the waivers that the licensee would grant in this 
example.
    The waiver data that licensees would be required to report to the 
NRC under proposed Sec.  26.197(e)(1)(i) and (e)(1)(ii) would be 
important because waivers represent ``assumed risk.'' For example, as 
discussed in Section IV. D, fatigued workers have impaired cognitive 
functioning, including difficulties in maintaining attention and 
alertness. 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 decision-making 
from fatigue that could cause him or her to commit errors that may pose 
risks to public health and safety and the common defense and security. 
These performance degradations can be mitigated by establishing 
controls and conditions under which the individual is permitted to 
work, as would be required under proposed Sec.  26.201(e). However, 
controls and conditions

[[Page 50581]]

cannot eliminate errors altogether and would reduce, but not eliminate, 
the potential risks to public health and safety or the common defense 
and security from fatigue-induced errors. The more often that a 
licensee permits individuals to exceed work hour limits, the more risk 
from fatigue-induced errors that a licensee would be assuming. The risk 
of fatigue-induced errors increases further when an individual is 
permitted to exceed more than one of the work hour limits in proposed 
Sec.  26.199(d)(1)(i)-(d)(1)(iii) because of the potential for combined 
effects of both acute and cumulative fatigue. Any waivers from the rest 
breaks that would be required under proposed Sec.  26.199(d)(2)(i)-
(d)(2)(iii) would 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 
of FFD program performance.
    During the September 14, 2004 public meeting, NEI commented that 
the number of waivers granted would not give meaningful information 
about the health of a licensee's program. However, as discussed in 
Section IV. D, certain nuclear power plant licensees have granted 
thousands of waivers each year under the current Policy on Worker 
Fatigue. This level of waiver use is inconsistent with the intent of 
the NRC's Policy and provides a clear indication that these licensees 
have not been effectively managing fatigue. If a licensee continued to 
grant thousands of waivers each year under the requirements of this 
proposed subpart, the sheer number of waivers granted in this case 
would provide meaningful information about the licensee's fatigue 
management program as well as the effectiveness of these proposed 
requirements. In less extreme circumstances, the NRC concurs that a 
simple summary of the number of waivers granted during the year would 
not provide sufficient information for the NRC to evaluate a licensee's 
practices with respect to granting waivers. It is for this reason that 
the proposed rule would require licensees to report additional 
information about their fatigue management practices in the annual 
summary report under proposed Sec.  26.197(e)(2) and (e)(3) to provide 
the contextual information necessary to properly interpret the waiver 
data that proposed Sec.  26.197(e)(1) would require. When considered in 
conjunction with number of instances in which collective work hour 
limits [in proposed Sec.  26.197(e)(2)] are exceeded and the number of 
fatigue assessments that a licensee conducts each year and their 
outcomes [in proposed Sec.  26.197(e)(3)], the number of waivers 
granted in a year provides an important indicator of the health of the 
licensee's fatigue management program. Therefore, the proposed 
requirement for licensees to report the number of waivers granted each 
year would be necessary to: (1) Evaluate the effectiveness of the more 
stringent requirements for granting waivers in proposed Sec.  
26.199(d)(3), which will be discussed further with respect to that 
paragraph; and (2) monitor the ongoing effectiveness of licensees' 
fatigue management programs, when considered together with the other 
information that licensees would be required to report in this proposed 
paragraph.
    Proposed Sec.  26.197(e)(2) would be added to require licensees to 
report the collective work hours of any job duty group listed in 
proposed Sec.  26.199(a) that exceeded the applicable collective work 
hour limits in any averaging period during the previous calendar year 
under the conditions specified in proposed Sec.  26.199(f)(3) and 
(f)(5). As discussed with respect to proposed Sec.  26.199(f)(3), the 
proposed rule would permit a job duty group's collective work hours to 
exceed 48 hours per person per week during one averaging period if all 
of the following conditions are met: (1) The circumstances that caused 
the group's collective work hours to exceed 48 hours per person per 
week could not be reasonably controlled; (2) the group's collective 
work hours did not exceed 54 hours per person per week; and (3) the 
additional work hours were worked only to address the circumstances 
that the licensee could not have reasonably controlled. Proposed Sec.  
26.199(f)(5) would also permit licensees to exceed any of the 
collective work hour limits in proposed Sec.  26.199(f), if the 
licensee receives prior approval from the NRC of a written request to 
exceed the work hour limits.
    Proposed Sec.  26.197(e)(2) would require licensees to report the 
collective work hours of any job duty group whose collective work hours 
exceeded the specified collective work hour limits during the previous 
year because this information would be necessary for the NRC to monitor 
the effectiveness of licensees' ongoing compliance with the proposed 
collective work hour limits that would be established in proposed Sec.  
26.199(f) [Collective work hour limits]. The number of times that 
collective work hour limits are exceeded in a year would be indicative 
of a licensee's effectiveness in managing the fatigue of its workers 
who would be subject to the proposed requirements of proposed Sec.  
26.199. Exceeding the collective work hour limits on repeated occasions 
may indicate a programmatic weakness that would necessitate further NRC 
inspection activities to address questions related to, for example, the 
adequacy of licensee staffing within specific job duty groups, overall 
management of cumulative fatigue, or corrective actions for fatigue 
management weaknesses. Collectively, information concerning instances 
in which collective work hour limits are exceeded, in conjunction with 
information concerning the number of waivers granted [in proposed Sec.  
26.197(e)(1)] and the number of fatigue assessments that a licensee 
conducts each year and their outcomes (in proposed Sec.  26.197(e)(3)), 
provide a strong indicator of the health of the licensee's fatigue 
management program.
    The NRC believes that the additional burden of including these 
instances in the annual report to be minimal, as the intent of the 
provisions is that the collective work hour limits in proposed Sec.  
26.199(f) would be exceeded only under very infrequent circumstances. 
Further, the NRC considers the burden to be significantly outweighed by 
the need to effectively use NRC inspection resources. The proposed 
paragraph would limit the reporting of occasions on which a job duty 
group exceeds collective work hour limits to those specified in 
proposed Sec.  26.199(f)(3) and (f)(5) because the proposed rule would 
establish other reporting requirements for other instances in which a 
job duty group's collective work hours may exceed the proposed 
collective work hour limits, as discussed further with respect to the 
relevant provisions.
    Proposed Sec.  26.197(e)(3) would be added to require that 
licensees include in the annual report the number of fatigue 
assessments conducted, the conditions under which each assessment was 
conducted [i.e., whether the assessment was conducted for-cause, for a 
self-declaration, post-event, or as a followup, as described in 
proposed Sec.  26.201(a)(1)-(a)(4)], and the management actions that 
resulted from each assessment. The NRC considers that the reporting of 
the fatigue assessments and their outcomes is similar to the reporting 
of drug and alcohol tests results, which is also a part of the annual 
report. For example, the NRC views the number of for-cause drug and 
alcohol tests that a licensee

[[Page 50582]]

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, in proposed Sec.  26.23(c), to provide 
for the early detection of individuals who are not fit to perform the 
job duties that require them to be subject to this part. The NRC would 
similarly view the number of for-cause fatigue assessments that a 
licensee conducts each year to be one factor indicating the health of 
the licensee's behavioral observation and self-declaration processes 
with respect to fatigue.
    Collectively, the reporting of waivers that would be required in 
proposed Sec.  26.197(e)(1), the number of instances in which a 
licensee exceeds the 48-hour per person collective work hour limit that 
would be required in proposed Sec.  26.197(e)(2), and the number of 
fatigue assessments conducted and their outcomes that would be required 
in Sec.  26.197(e)(3), would provide important information concerning 
the effectiveness of fatigue management at a licensee site. Together, 
the proposed reports would 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 proposed 
Subpart I in controlling the fatigue of nuclear power plant workers; 
(4) assess whether the objectives of the proposed rule are being 
achieved; and (5) determine whether any further changes to the 
requirements would be necessary to ensure that worker fatigue is 
managed consistent with the intent of the provisions.

Section 26.199 Work Hour Controls

    Proposed Sec.  26.199 [Work hour controls] would be added to 
establish controls on the work hours of select individuals who are 
subject to nuclear power plant licensees' FFD programs, as follows:
    Proposed Sec.  26.199(a) [Individuals subject to work hour 
controls] would be added to establish the scope of individuals who 
would be subject to the work hour controls in proposed Sec.  26.199. 
These individuals would be subject to the proposed work hour controls, 
in addition to the proposed training, behavioral observation, and self-
declaration requirements of Subpart I that would apply to all 
individuals who are subject to nuclear power plant licensees' FFD 
programs. In determining the scope of personnel who would be subject to 
the proposed 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 proposed rule 
would require that individuals who perform the types of job duties 
specified in proposed Sec.  26.199(a)(1)-(a)(5) must be subject to the 
proposed work hour controls.
    Proposed Sec.  26.199(a)(1) would require that 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 
proposed work hour controls in this section. In order to implement the 
proposed work hour controls, nuclear power plant licensees would be 
required to delineate the operations personnel who would be subject to 
the proposed work hour controls, based upon the risk significance of 
the safety systems and components (SSCs) being operated, including, at 
a minimum, 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 job duty group, licensees could use, for 
example, the risk significance determination process and criteria that 
they currently use 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 controls of proposed Sec.  26.199 
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 proposed 
work hour controls would apply to the individuals who most directly 
affect the operation of SSCs that are 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 job duties specified in 
proposed Sec.  26.199(a), 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 CFR Part 55 
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. The effects of fatigue on decision-making, risk-
taking, communications, and other key skills were discussed in Section 
IV. D. Fatigued operators have an increased potential to commit errors, 
increasing 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, 
decision-making) 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 1997-1999 found that a 
significant percentage of licensed and non-licensed operators worked 
more the 600 hours of overtime in a year (SECY-01-0113, Attachment 1). 
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 37 refueling outages

[[Page 50583]]

conducted in 1999, more than 1,800 deviations were authorized for 
licensed operators and more than 1,100 deviations were authorized 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 controls in proposed Sec.  26.199 would also 
apply to individuals who direct risk-significant operations onsite. 
These individuals would 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 
controls would 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, decision-making, 
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, especially 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.
    Proposed Sec.  26.199(a)(2) would be added to require the control 
of work hours for individuals who are maintaining, or providing onsite 
direction of maintenance of systems and components that ``a risk 
informed evaluation process has shown to be significant to public 
health and safety.'' To implement this proposed requirement, licensees 
would be required to delineate the maintenance personnel, and personnel 
who are directing maintenance onsite, who would be subject to the work 
hour controls, based upon the risk significance of the SSCs that they 
maintain, including, at a minimum, 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 could use, for 
example, the risk significance determination process and criteria that 
they currently use to meet the requirements of Sec.  50.65(a)(4) of 
this chapter for assessing and managing the risk associated with 
maintenance activities. As a consequence, the work hour controls of 
proposed Sec.  26.199 would typically apply to individuals who are 
maintaining or directing onsite the maintenance of SSCs that are 
included within the scope of an assessment required by Sec.  
50.65(a)(4). Therefore, the proposed work hour controls 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; (2) making errors that would increase 
the risk of failure of the affected SSCs to perform their function(s) 
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 proposed rule 
would require these maintenance personnel to be subject to the proposed 
work hour limits to ensure that fatigue does not compromise their 
abilities to safely and competently perform their duties relative to 
the maintenance of these SSCs.
    The proposed work hour controls would also apply to those who 
direct risk-significant maintenance onsite. For example, these 
individuals would include maintenance supervisors who provide direction 
to maintenance technicians, and engineers who provide onsite technical 
direction to maintenance crews, such as during key outage maintenance 
activities. These individuals perform tasks that are often highly 
dependent on cognitive skills (e.g., problem-solving, decision-making, 
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, especially 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.
    Proposed Sec.  26.199(a)(3) would be added to require work hour 
controls for individuals who perform health physics or chemistry duties 
that are required of the on-site Emergency Response Organization (ERO) 
minimum shift complement. Although proposed Sec.  26.199(f) would 
exempt licensees from applying the work hour controls during declared 
emergencies, the intent of this proposed provision would be 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 (IDLH) 
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

[[Page 50584]]

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, Rev. 1, ``Criteria for Preparation and 
Evaluation of Radiological Emergency Response Plans and Preparedness in 
Support of Nuclear Power Plants,'' identifies the need for an on-shift 
chemistry/radio-chemistry emergency response capability. On-shift 
chemistry technician(s) provide 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 off-site 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.
    Proposed Sec.  26.199(a)(4) would be added to require work hour 
controls for 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. The proposed work 
hour controls would be 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 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 decision-making 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 that 
maintains 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 decision-making 
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 decision-making 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.
    Further, the NRC periodically grants exemptions from requirements 
in 10 CFR Part 50, Appendix R [Fire Protection Program for Nuclear 
Power Facilities Operating Prior to January 1, 1979] 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 and so are able to safely and 
competently perform their duties in plant events involving a fire.
    Proposed Sec.  26.199(a)(5) would be added to require work hour 
controls for 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. Individuals who perform these 
duties are the members of licensees' security forces who are 
responsible for implementing the licensees' physical security plans. In 
order 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. By contrast to most 
other nuclear power plant job duty groups, security personnel are 
typically deployed in a configuration such that some have very 
infrequent contact with other members of the security force, or 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

[[Page 50585]]

required, further promoting an atmosphere in which fatigue could 
transition into sleep. Many security duties are largely dependent on 
maintaining vigilance, whereas 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 since 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 would be the same individuals who would be 
subject to the proposed work hour controls in this section.
    Proposed Sec.  26.199(b) [Calculating work hours] would be added to 
specify the time periods that licensees would include when calculating 
the work hours of the individuals listed in proposed Sec.  26.199(a) 
for the purposes of this subpart. 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 proposed rule would define work hours and requirements for 
calculating them to ensure consistent implementation of the work hour 
controls established in this proposed section.
    Proposed Sec.  26.199(b)(1) [Individual work hours] would be added 
to specify those portions of a shift that a licensee must include in 
work hour calculations. The proposed rule would define ``work hours'' 
as the amount of time that an individual performs any duties for a 
licensee who is subject to this section, including all within-shift 
break times and rest periods during which there are no reasonable 
opportunities or accommodations appropriate for restorative sleep, but 
excluding shift turnover.
    The proposed rule specifically would not limit the definition of 
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 rather would require licensees to include hours during which 
an individual performs any duties for the licensee. The proposed rule 
defines work hours in this broad manner because the NRC is aware that 
some licensees permit individuals to perform duties on behalf of the 
licensee from off-site 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, often, sleep 
are reduced. If the proposed rule limited the calculation of work hours 
to only those hours that an individual is paid by the licensee, works 
on shift, and/or is scheduled to be working by the licensee, many 
individuals may continue to be permitted to work excessive hours and 
thereby become fatigued. Therefore, proposed Sec.  26.199(b)(1) would 
require licensees to include these work hours in their work hour 
calculations.
    The proposed rule would not require licensees to include the time 
periods during which an individual participates in shift turnover in 
the calculation of the individual's work hours. Proposed Sec.  
26.199(b)(1)(i) would be added to define the specific shift turnover 
activities that licensees may exclude from their work hour 
calculations. The proposed rule would define 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 work day, 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 Section V highlighted the importance of this activity for 
communicating plant status information between work crews as well as 
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 believes 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 proposed exclusion of shift turnover from the work hour 
calculations would be consistent with the current requirements in most 
licensee technical specifications for the control of work hours for 
personnel performing safety-related functions, and with GL 82-12. 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, 
Fatigue of Workers at Nuclear Power Plants, Attachment 1, Table 2). 
However, the proposed rule would more clearly describe the activities 
may be included in turnover and the activities that may not be 
included. The proposed provision would address NRC concerns arising 
from observations that licensees have occasionally excluded 2 or more 
hours from calculated work hours on the basis that the individuals were 
engaged in ``turnover.'' In order to ensure that turnover is not 
hurried, the proposed rule would 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 
proposed rule would reduce the potential for individuals and/or 
licensees to use the proposed shift turnover exclusion to perform other 
work activities.
    Proposed Sec.  26.199(b)(1)(ii) would be added to permit licensees 
to exclude within-shift breaks and rest periods from their work hour 
calculations only if the individual has both a reasonable opportunity 
and accommodations for restorative sleep. The proposed rule would 
permit licensees to exclude breaks from the accounting of work hours 
only when the exclusion can be

[[Page 50586]]

justified on the basis that the break substantively mitigates fatigue. 
The proposed exclusion would be added to address circumstances in which 
workers may 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 proposed exclusion would also permit 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 proposed exclusion would be limited to that portion of a break 
or rest period in which there is reasonable opportunity for restorative 
sleep. For example, a 15-minute coffee break would not provide a 
reasonable opportunity for restorative sleep. The proposed requirement 
would be worded to limit the exclusion to the amount of the time the 
individual has available to actually sleep, and would 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 proposed provision would also require that individuals must 
have available reasonable accommodations 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 in a darkened, 
quiet room (e.g., bed, recliner) (Priest, 2000).
    This degree of specificity in the proposed paragraph would be 
necessary because presently some licensees 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. 
This practice permits individuals to work continuous 12-hour shifts 
without the licensee having to authorize a deviation from technical 
specification requirements. The discussion of proposed Sec.  
26.199(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 proposed rule would require licensees to include short 
breaks in the calculation of work hours.
    Proposed Sec.  26.199(b)(1)(iii) would be added to permit licensees 
to assign individuals, who are qualified to perform the duties listed 
in proposed Sec.  26.199(a), to other duties than those listed in 
proposed Sec.  26.199(a), without controlling their work hours in 
accordance with the work hour controls contained in proposed Sec.  
26.199(d). However, if these individuals would be assigned or returned 
to performing any duties that are listed in proposed Sec.  26.199(a) 
during the averaging period, the proposed paragraph would require the 
licensee to include all of the hours that they worked when calculating 
the individuals' work hours for the averaging period and to subject the 
individuals to the work hour controls in proposed Sec.  26.199(d). For 
example, if a licensed operator was assigned to training for an entire 
averaging period, then his or her work hours would not be subject to 
proposed Sec.  26.199(d) for that period because he or she would not be 
performing any of the duties listed in proposed Sec.  26.199(a)(1). 
However, if the same individual was assigned to training for only a 
portion of the averaging period and performed the duties listed in 
proposed Sec.  26.199(a)(1) during the remainder of the averaging 
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 for the period and would be included in the operations job 
duty group collective work hours average, as if the individual was 
performing operations duties for the entire averaging period. Licensees 
would be required to count the hours that the individual worked 
performing other duties if an individual begins performing the duties 
listed in proposed Sec.  26.199(a) during the averaging 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 proposed Sec.  
26.199(a).
    Proposed Sec.  26.199(b)(2) [Collective work hours] would be added 
to establish requirements for calculating the collective work hours of 
the job duty groups that would be subject to the collective work hour 
limits in proposed Sec.  26.199(f) [Collective work hour limits]. (The 
collective work hour limits and the bases for establishing them are 
discussed with respect to proposed Sec.  26.199(f).) Specifically, the 
proposed rule would require licensees to calculate, at a minimum, a 
separate work hour average for each job duty group in proposed Sec.  
26.199(a). (Appropriate methods for defining job duty groups to which 
the collective work hour limits would be applied are discussed with 
respect to proposed Sec.  26.199(b)(3).)
    Proposed Sec.  26.199(b)(2) would limit the length of any averaging 
period that licensees may use for calculating collective work hours to 
no more than 13 weeks. In proposing to limit the averaging period to no 
more than 13 weeks, the NRC considered the need to account for periods 
of elevated work hours, which have the potential to cause fatigue, as 
well as the need for an averaging period that would not be unduly 
influenced by short-term variations in work hours. The NRC also 
considered industry comments during the stakeholder meetings discussed 
in Section V expressing a desire for an averaging period that is 
consistent with other surveillance or assessment requirements. The 
proposed requirement would provide the flexibility for licensees to use 
a 13-week averaging period that may be aligned with quarterly reviews 
or shorter periods that coincide with existing time-keeping practices 
(e.g., a multiple of pay periods). The proposed flexibility to use 
shorter averaging periods would also

[[Page 50587]]

accommodate other circumstances, such as an outage period that occurs 
within a 13-week averaging period, during which the proposed rule would 
not require licensees to implement the collective work hour controls, 
as permitted in proposed Sec.  26.199(f)(2)(iii). Licensees may choose 
to define shorter averaging periods in these circumstances in order to 
synchronize subsequent averaging periods with their other scheduling 
demands (e.g., quarterly reviews, pay periods, the calendar or fiscal 
year).
    The NRC considered both shorter and longer periods in determining 
the proposed maximum duration for an averaging period. The NRC rejected 
requiring a shorter maximum averaging period because it would increase 
the potential for short-term (e.g., 2-3 weeks) emergent work conditions 
to cause group averages to exceed the 48-hour collective work hours 
limit in proposed Sec.  26.199(f), if overtime is required to respond 
to the emergent work. These short-term work periods of high overtime 
use have limited potential for causing cumulative fatigue, considering 
the individual work hour controls in proposed Sec.  26.199(d). 
Therefore, group averages that are based on shorter averaging periods 
may overestimate the cumulative fatigue of a job duty group. By 
contrast, increasing the averaging period to more than 13 weeks would 
permit a job duty group to work for more than three weeks at the 
individual limit of 72 hours in 7 days in proposed Sec.  
26.199(d)(1)(iii) without raising the group average above the 48-hour 
limit. Therefore, repeated periods of elevated group work hours would 
not be reflected in the job duty group average and may cause a licensee 
to delay taking any short-term or long-term corrective actions that may 
be necessary to control cumulative fatigue within a job duty group. 
Therefore, the NRC determined that the 13-week averaging period would 
provide the appropriate level of sensitivity for licensees to identify 
and respond to conditions that present a significant potential for 
cumulative fatigue.
    Proposed Sec.  26.199(b)(2)(i) would be added to permit licensees 
to calculate collective work hours for each of the broad job duty 
groups that is listed in proposed Sec.  26.199(a) or smaller sub-groups 
that would be comprised of individuals who are performing similar 
duties within any of these broad job duty groups. However, the proposed 
rule would also require that licensees who elect to calculate 
collective work hours for smaller sub-groups must ensure that the work 
hours of all individuals in the broader job duty groups listed in 
proposed Sec.  26.199(a) are included in the collective work hour 
calculations of a smaller job duty group. That is, the proposed rule 
would require licensees to ensure that the work hours of all 
individuals who perform job duties that require them to be subject to 
the proposed work hour controls of this section are counted. The 
proposed rule would not permit licensees to combine the broad job duty 
groups into a larger group (e.g., combining the operations and 
maintenance groups) because doing so may mask excessive work hours in 
one of the job duty groups. Separate calculations for each job duty 
group would be necessary to ensure that the work hours of each job duty 
group as a whole would be maintained at a level that is consistent with 
the proper management of cumulative fatigue.
    In establishing the requirements for calculating collective 
averages in proposed Sec.  26.199(b)(2)(i) (i.e., determining how many 
job functions may be included in a collective average), the NRC weighed 
the merits of limiting the job duty groups to narrow collections of 
similarly qualified individuals who are capable of performing each 
other's duties, and therefore sharing workload and work hours. 
Requiring licensees to calculate collective work hours for smaller sub-
groups would provide a more precise indication of work hours. Defining 
smaller sub-groups would also provide greater assurance of identifying 
groups of individuals who may be working excessive hours because of 
inadequate staffing for specific job skills.
    However, the proposed rule would not require licensees to calculate 
collective work hours for smaller sub-groups for several practical 
reasons:
    (1) It would be difficult to define such groups in the rule in a 
manner that licensees could interpret and implement consistently, 
considering the diversity of their organizational structures and 
nomenclature for job duties;
    (2) Individuals within the broad job duty groups may be qualified 
to perform functions in multiple sub-groups. Therefore, assigning these 
individuals to an appropriate sub-group would be challenging and likely 
to result in inconsistent implementation of the proposed rule; and
    (3) Individuals would be likely to transition between sub-groups 
within an averaging period due to changes in their work focus or 
qualifications, which would impose a significant burden on licensees to 
track each individual's sub-group membership.
    For these reasons, the proposed rule would not require licensees to 
define narrower sub-groups, although it would permit licensees to 
define such sub-groups for calculating collective work hours.
    The proposed requirements for defining groups for calculating 
collective work hours would ensure that, at a minimum, collective work 
hour calculations would provide an indication of a licensee's control 
of work hours for broad licensee functions (e.g., operations, 
maintenance, security) that are important to the protection of public 
health and safety and the common defense and security. Further, 
proposed Sec.  26.199(j)(2) and (4) would require licensees to identify 
and take corrective action for instances of excessive work hours 
indicating inadequate staffing for any job that would be subject to the 
work hour controls of proposed Sec.  26.199(f). Therefore, collective 
work hour calculations for broad job duty groups would appropriately 
support the objectives of the collective work hour controls, when 
implemented in conjunction with the requirements of proposed Sec.  
26.199(j)(2) and (4), and provide assurance that the work hours of each 
job duty group as a whole would be maintained at a level that is 
consistent with the proper management of cumulative fatigue.
    Proposed Sec.  26.199(b)(2)(ii) would be added to require licensees 
to include, in the calculation of collective work hours for each job 
duty group, the work hours of any individual who performs the job 
duties of the job duty group, as determined by the licensee in 
accordance with proposed Sec.  26.199(b)(2)(i). The NRC intends the 
term, ``any individual who performs,'' as used in proposed Sec.  
26.199(b)(2)(ii), to mean individuals who are qualified to perform the 
specified duties.
    The NRC considered limiting the calculation of collective work 
hours to individuals who actually performed the duties of the job duty 
group during the averaging period. However, during the stakeholder 
meetings discussed in Section V, industry representatives indicated 
that this alternative would result in a substantial administrative 
burden associated with tracking whether each individual actually 
performed any duties of the group during the averaging period. The NRC 
considered this comment, as well as the increased volatility of group 
size and membership that would result from the alternative approach, 
and concluded that the administrative simplification of defining group 
membership based on qualifications would substantially reduce the 
burden of the proposed requirement without a commensurate reduction in 
the effectiveness of the

[[Page 50588]]

collective work hour controls in addressing cumulative fatigue. The 
proposed approach that is based on qualifications would require 
licensees to expend significantly fewer resources than tracking which 
individuals are performing specific tasks on a constantly changing 
basis. The effectiveness of the work hour controls would not be reduced 
because the number of individuals who are qualified to perform most of 
these job duties is not substantially greater than the size of each job 
duty group. Therefore, the effect of including the work hours of a few 
individuals who are qualified to perform the groups' job duties but did 
not actually perform any of those duties during an averaging period 
would be minimal.
    Proposed Sec.  26.199(b)(2)(ii) would also require the licensee to 
include in the calculations the work hours of ``any individual'' who 
performs the specified job duties, regardless of the individual's 
employer. The NRC recognizes that many of the job functions in the job 
duty groups listed in proposed Sec.  26.199(a) are performed by C/Vs, 
as well as by direct employees of the licensee. It is important to 
provide reasonable assurance that fatigue does not impair the job 
performance of any individual who performs these duties, irrespective 
of the individual's organizational affiliation. Therefore, the proposed 
rule would require licensees to include in the collective work hours 
calculations for the appropriate job duty group any work hours of C/V 
personnel who perform the specified job duties.
    Proposed Sec.  26.199(b)(2)(ii) would require licensees to include 
in their calculations only the hours that individuals worked ``at the 
licensee's site'' during the averaging period, but not any hours that 
the individuals may have worked at other facilities. Therefore, 
collective work hour calculations would not include any work hours that 
an individual may have worked during the averaging period, for example, 
at another nuclear plant, at a non-nuclear power plant, or in any other 
place or form of employment. The NRC acknowledges that hours worked, 
irrespective of whether the work is performed at a nuclear power plant 
or any other place of employment, can contribute to worker fatigue, and 
that consideration of all hours worked would provide a more complete 
basis for assessing the potential for worker fatigue. However, in 
establishing the requirement to include only hours worked at the 
licensee's site in the collective work hours calculations, the NRC also 
considered the practical constraints on the ability of licensees to 
obtain complete and reliable work hours information from other 
employers. In addition, the NRC anticipates that licensees would comply 
with the collective work hour controls of proposed Sec.  26.199(f) 
[Collective work hour limits] by continuing to distribute work hours 
and rest days among individuals in accordance with the capabilities and 
needs of the individuals, consistent with most licensees' current 
practices. Accordingly, the proposed work hour requirements would apply 
only to those work hours which the licensee can directly control and 
manage, which are the hours that an individual works for the licensee.
    A second implication of adding the phrase, ``at the licensee's 
site,'' to the proposed paragraph is that the proposed rule would 
prohibit licensees from combining all of the individuals across a fleet 
of plants who may be subject to the same FFD program into one of the 
broad job duty groups listed in proposed Sec.  26.199(a). For example, 
if one licensee operates units at four different sites, proposed Sec.  
26.199(b)(2)(ii) would permit the licensee to create an operations job 
duty group for multiple units at one site, but would prohibit the 
licensee from combining the work hours of all operations personnel 
across the four different sites to calculate a fleet-wide group 
average. The proposed prohibition would be necessary to ensure that the 
size of the job duty groups is not so large that excessive work hours 
in a job duty group at one site would be masked by lower work hours in 
the same job duty group at another site, with the result that the group 
average would be insensitive to local variations in work hours.
    Proposed Sec.  26.199(b)(2)(ii) would also require licensees to 
include in their collective work hours calculations only the work hours 
of individuals who worked at least 75 percent of the normally scheduled 
hours of the job duty group. This proposed limitation would ensure that 
job duty group averages are not artificially suppressed by including 
the work hours of individuals who worked part-time or substantially 
less than full-time during the averaging period. For example, the 
proposed rule would prohibit licensees from including in their 
calculations the work hours of individuals who were on disability or 
maternity leave for more than 25 percent of the averaging period, or 
entered or left the job duty group as a result of a personnel action, 
without working 75 percent of the group's normally scheduled hours. The 
proposed limitation would be necessary to ensure that the collective 
average would actually represent the work hours of the individuals who 
comprised the job duty group for the majority of the averaging period.
    Proposed Sec.  26.199(b)(2)(iii) would be added to require that the 
licensee-defined averaging periods must comprise consecutive days or 
days that are separated only by days that licensees would be permitted 
to exclude from the collective work hour calculations in proposed Sec.  
26.199(f)(1)-(f)(3) and (f)(5), (h), and (i). That is, the proposed 
rule would require that the averaging period must comprise consecutive 
days unless outages, increased threat conditions, plant emergencies, 
and the other conditions that are specified in proposed Sec.  
26.199(f)(1)-(f)(3) and (f)(5), (h), and (i) occur during the averaging 
period. This proposed requirement would be necessary to prevent 
licensees from selectively constituting averaging periods to meet the 
collective work hour limits by combining work hours during disparate 
time periods.
    However, if any of the conditions arise that are specified in 
proposed Sec.  26.199(f)(1)-(f)(3) and (f)(5), (h), and (i) (e.g., 
outages, increased threat conditions, plant emergencies) during an 
averaging period, the proposed paragraph would permit licensees to 
combine consecutive days immediately preceding and following the 
excluded period(s) to constitute a complete averaging period. For 
example, if the length of a licensee's averaging period is 13 weeks and 
two weeks of an averaging period had elapsed before an increased threat 
condition occurred (or an outage period began), the licensee could 
define an averaging period as including those two weeks and the 11 
weeks that followed the end of the increased threat condition.
    The objective of proposed Sec.  26.199(b)(2)(iii) would be to 
ensure that collective work hour calculations are representative of 
typical work hours during a distinct period, to the extent practicable, 
while recognizing that there may be intervening periods that would be 
excluded from the collective work hour controls that would disrupt the 
licensee's normal averaging period schedule. The proposed rule would 
permit licensees flexibility in comprising their averaging periods in 
these instances in order to minimize a potential administrative burden 
that could result from averaging periods that, because of the exclusion 
period, are no longer synchronized with other needs (e.g., pay periods, 
the fiscal year). Because the exclusion periods would occur 
infrequently, the NRC anticipates that permitting licensees flexibility 
in constituting averaging periods around

[[Page 50589]]

an excluded period would not mask any systemic or programmatic 
weaknesses in the licensees' work hour controls over the long-term.
    Proposed Sec.  26.199(b)(2)(iv) would be added to require licensees 
to include in an averaging period all days that are not excluded from 
the collective work hour controls under proposed Sec.  26.199(f))(1)-
(f)(3) and (f)(5), (h), and (i). Proposed Sec.  26.199(b)(2) would 
provide licensees substantial flexibility in comprising averaging 
periods that include, or are contiguous with, periods that would be 
excluded from the collective work hour controls. However, the proposed 
rule would add this proposed provision to ensure that licensees' 
collective work hour calculations are complete and represent the 
typical work hours of individuals by requiring that all days not 
specifically excluded from collective work hour requirements would be 
included in at least one averaging period.
    Proposed Sec.  26.199(b)(2)(v) would be added to prohibit licensees 
from including any individual's work hours in more than one averaging 
period. The proposed rule would prohibit double-counting of work hours 
to ensure that each collective work hours average would represent the 
work hours of each job duty group during a discrete period of time.
    Proposed Sec.  26.199(c) [Work hours scheduling] would be added to 
require licensees to schedule the work hours of individuals who are 
subject to this proposed section in a manner that is consistent with 
the objective of preventing impairment from fatigue due to the 
duration, frequency, or sequencing of successive shifts. The maximum 
work hour and minimum break requirements that are specified in proposed 
Sec.  26.199(d) [Work hour controls for individuals] would be intended 
for infrequent, temporary circumstances, and not as guidelines or 
limits for routine work scheduling. In addition, the work hour controls 
in proposed Sec.  26.199(d) would 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, proposed Sec.  26.199(c) would require licensees to schedule 
personnel consistent with preventing impairment from fatigue from these 
scheduling factors.
    The proposed rule would require 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. The effect of 
circadian rhythms on worker fatigue is also discussed in Section IV. D. 
The importance of these elements for fatigue management is reflected in 
guidelines for work scheduling, such as NUREG/CR-4248 and EPRI NP-6748 
(Baker, et al., 1990), and in technical reports, such as the Office of 
Technology Assessment's report, Biological Rhythms: Implications for 
the Worker (Liskowsky, 1991). The EPRI report, for example, addresses 
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, proposed Sec.  26.199(c) would establish a non-
prescriptive, performance-based requirement.
    Proposed Sec.  26.199(d) [Work hour controls for individuals] would 
be added to specify that licensees must establish work hour controls 
for each individual who performs the duties listed in proposed Sec.  
26.199(a). The proposed rule would require licensees to establish 
controls that would limit work periods and provide for breaks that are 
of sufficient length to allow the individual to obtain restorative 
rest.
    Proposed Sec.  26.199(d)(1) would be added to establish work hour 
limits for consecutive, rolling periods of 24 and 48 hours and seven 
days. The majority of licensees have incorporated the work hour 
controls 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 that is documented in Attachment 1 to SECY-01-
0113. The work hour limits from GL 82-12 also were the subject of 
substantial stakeholder comment during the public meetings described in 
Section V. In developing the proposed requirements in this paragraph, 
the NRC staff considered the information gained through these 
stakeholder interactions.
    Proposed Sec.  26.199(d)(1)(i) would limit the number of hours that 
an individual may work in any 24-hour period. The proposed paragraph 
would permit individuals to work no more than 16 work hours in any 24-
hour period. This proposed limit would be identical to that specified 
in GL 82-12. Attachment 1 to SECY-01-0113 provides the basis for this 
proposed 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, a maximum of 12 work hours per day was the 
limit recommended by nine experts who met in 1984 to develop 
recommendations for NUREG/CR-4248. Therefore, in originally developing 
the NRC's Policy on Worker Fatigue, the NRC had planned a 12-hour 
maximum limit, but revised it to 16 hours in response to practical 
concerns from 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 proposed rule would retain a 
16-hour limit.
    Although the proposed rule would permit 16-hour shifts, other work 
hour limits in the proposed rule would effectively limit the number of 
16-hour shifts that licensees could assign. This issue is discussed in 
greater detail in Section V, with respect to a comment on proposed 
Subpart I by PROS.
    Proposed Sec.  26.199(d)(1)(ii) would limit the number of hours 
that an individual may work in any 48-hour period. The proposed 
paragraph would permit an individual to work no more than 26 work hours 
in a 48-hour period, by contrast to the related limit in GL 82-12, 
which limits individuals' work hours to 24 work hours in any 48-hour 
period. This proposed change would be made to accommodate the fact that 
most licensee sites are now working routine 12-hour shifts, rather than 
routine 8-hour shifts, as was the case when GL 82-12 was published. At 
that time, the

[[Page 50590]]

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 most plants now routinely working 12-hour 
shifts, the proposed rule would increase the maximum work hours in a 
48-hour period from 24 to 26 hours to decrease the burden on licensees 
that would be imposed by accommodating situations in which a worker's 
relief is delayed, or similar circumstances. For example, a 12-hour 
shift worker could work up to 14 hours in one day and still return to 
work at his or her normal time the next day, but could only work 12 
hours that day. In the extreme, the proposed 26-hour limit would permit 
an individual to work up to 16 hours one day, followed by a minimum 10-
hour break, as required in proposed Sec.  26.199(d)(2)(i). The 
individual would then be limited by the proposed requirement to 10 
hours of work over the next 22 hours.
    In developing the proposed relaxation of the previous 24-hour limit 
on the number of hours that individuals can work in 48 hours, the NRC 
considered several factors. These factors include:
    (1) The burden associated with granting a waiver for the additional 
two hours;
    (2) The increased stringency of the criteria for granting a waiver 
of the work hour limits in proposed Sec.  26.199(d)(3) 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 two additional work hours during a 48-hour period 
would 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 proposed Sec.  26.199(d)(3) are 
expected to substantially reduce the number of waivers that would be 
granted, the licensee would 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, licensee use of waivers to exceed the 24-hours 
of work in any 48-hour period limit for short durations is common 
practice. As a result, the NRC believes that the proposed relaxation 
would principally reduce the paperwork burden, rather than result in an 
increase in the hours that individuals would actually work under the 
proposed rule. Accordingly, the proposed relaxation would provide a 
substantive reduction in burden with a limited net effect on human 
performance reliability.
    Proposed Sec.  26.199(d)(1)(iii) would be added to limit the number 
of hours an individual may work in any 7-day period. The proposed 
paragraph would limit an individual to working no more than 72 hours in 
any 7-day period. This proposed limit would be identical to the related 
limit specified in GL 82-12. Attachment 1 to SECY-01-0113 provides the 
basis for the proposed limit, which is summarized in this paragraph: In 
the absence of the break requirements in proposed Sec.  26.199(d)(2), 
the proposed limit could potentially 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 the NRC's 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 proposed rule would codify this 
expectation, in part, through proposed Sec.  26.199(d)(2)(iii), which 
would require licensees to schedule a 48-hour break every 14 days for 
individuals who are subject to the proposed work hour controls, and 
would, thereby, effectively prevent an individual from working six 12-
hour shifts for more than 1 week at a time.
    Proposed Sec.  26.199(d)(2) would be added to require licensees to 
provide adequate rest breaks for individuals who are performing the 
duties listed in proposed Sec.  26.199(a). This proposed requirement 
would be necessary to ensure that licensees provide individuals with 
sufficient time off between work periods (shifts) to permit the 
individuals 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)].
    Proposed Sec.  26.199(d)(2) would define 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, during rest breaks, individuals would not be performing work-
related duties 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, rather than as break time, because the individual would be 
performing duties on behalf of the licensee while on site. The proposed 
rule would permit individuals to conduct shift turnovers within rest 
break periods, as discussed with respect to proposed Sec.  
26.199(b)(1)(i).
    Proposed Sec.  26.199(d)(2)(i) would be added to require licensees 
to provide a 10-hour break between successive work periods, but would 
permit 8-hour breaks in limited circumstances in which a shorter break 
would be 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. Proposed Sec.  26.199(d)(2)(i) would increase the 
minimum break period from 8 hours to 10 hours in order to provide 
greater assurance that individuals have an adequate opportunity to 
obtain the 7-8 hours of sleep that are recommended by most experts in 
work scheduling and fatigue. When considering shift turnover and 
commute times, which do not provide individuals with opportunities

[[Page 50591]]

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 (8.0 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 would ensure that individuals would generally have 7 hours 
available each day for sleep, which is close to the 7-8 hours of sleep 
needed by adults in the U.S. (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 of sleep restriction to 
5 hours. Dinges, et al., 1997, and Belenky, et al., 2003, who both 
represent 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, 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 seven 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). The importance of providing an opportunity for at least 8 hours 
of sleep is also noted in an EPRI/NEI Work Hours Task Force white 
paper, Managing Fatigue in the Nuclear Energy Industry: Challenges and 
Opportunities (ADAMS Accession No. ML0221740179). 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 proposed 10-hour break requirement would provide adequate 
opportunity for rest when used infrequently, as would be expected given 
other requirements in this proposed rule. For example, proposed Sec.  
26.199(d)(1)(ii) would limit 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 would be sufficient to assure adequate rest 
during infrequent circumstances in which individuals may work extended 
hours (e.g., more hours than their typical 8-, 10-, or 12-hour shift) 
and that rest opportunities would typically vary between 12 and 16 
hours in duration.
    The proposed minimum 10-hour break duration would also accommodate 
most scheduling circumstances for the common shift durations that are 
currently in use in the industry. A notable exception is that the 
proposed 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 would 
appropriately prevent 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.
    Proposed Sec.  26.199(d)(2)(i) would permit a minimum 8-hour break 
in only one circumstance. That is, the proposed paragraph would permit 
licensees to schedule an 8-hour break, if the 8-hour break is necessary 
to accommodate a crew's scheduled transition between work schedules. 
During the public meetings described in Section V, the NRC received 
comments that the proposed 10-hour break would occasionally interfere 
with a transition from 12-hour shifts to 8-hour shifts. This transition 
would typically occur 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 proposed exception would provide individuals with less 
time for recovery, the shorter break would be limited to one break 
occurring on a very restricted frequency. Therefore, the proposed 
permission for an 8-hour break in the circumstances of a shift 
transition would provide scheduling flexibility with minimal potential 
to adversely affect an individual's ability to safely and competently 
perform his or her duties.
    Proposed Sec.  26.199(d)(2)(ii) would be added to require a 24-hour 
break in any rolling 7-day period. Break periods longer than 10 hours 
between shifts 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 two-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

[[Page 50592]]

which accrues from a series of days of mild sleep restriction (e.g., 7 
hours per night).
    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 proposed Sec.  26.199(d)(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 on 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 two-week period, including the 
performance of subjects who were permitted 6- and 8-hour sleep periods.
    Therefore, the proposed provision for a 24-hour break in any 
rolling 7-day period would serve both to prevent and mitigate 
cumulative fatigue. The proposed 24-hour break periods would 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.
    Significant considerations in the NRC's development of proposed 
Sec.  26.199(d)(2)(ii) and (d)(2)(iii) were 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 Section V also 
confirmed the NRC observation that some licensees were scheduling 
outages with several weeks of 12-hour shifts with no scheduled days 
off. This practice would be inconsistent with the findings of the 
studies and recommendations cited in the discussions of proposed Sec.  
26.199(d)(1)(iii) and (d)(2)(ii).
    Although the NRC expects that the proposed criteria for granting 
waivers from the individual work hour controls in proposed Sec.  
26.199(d)(3) would significantly reduce the granting of waivers, the 
proposed maximum individual work hour requirements of proposed Sec.  
26.199(d)(1) would not preclude licensees from scheduling consecutive 
10-hour shifts with no days off. In addition, although the collective 
work hour controls in proposed Sec.  26.199(f) would limit cumulative 
fatigue from broad and extended use of such schedules while plants are 
operating, these controls would not apply during the first 8 weeks of 
plant outages, and in other circumstances for security personnel, as 
detailed in proposed Sec.  26.199(f)(2). Therefore, the proposed work 
hour controls of Sec.  26.199(d)(1) and (f) would not effectively 
prevent cumulative fatigue for roving outage crews and other transient 
workers who predominantly work during plant outages.
    By contrast, the long break requirement of proposed Sec.  
26.199(d)(2)(ii) would provide an important protection against 
cumulative fatigue for individuals who work consecutive outages, as 
well as for all individuals who perform the duties listed in proposed 
Sec.  26.199(a) during extended plant outages. One stakeholder observed 
during one of the public meetings described in Section V 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.
    Proposed Sec.  26.199(d)(2)(iii) would be added to further require 
licensees to provide individuals with a 48-hour break in any rolling 
14-day period. A detailed discussion of the bases for requiring 
extended breaks is provided with respect to proposed Sec.  
26.199(d)(2)(ii). In addition to the bases for the 24-hour break 
requirement, the details of which also apply to this proposed 
requirement, a 48-hour break every 14 days is further justified because 
the maximum individual work hour requirements of proposed Sec.  
26.199(d)(1) and the 24-hour break requirement in proposed Sec.  
26.199(d)(2)(ii) would not preclude licensees from scheduling a series 
of weeks that required individuals to work six consecutive 12-hour 
shifts with only one day off. However, only one day off is insufficient 
to recover completely from chronic sleep restriction.
    The need for at least two consecutive unrestricted sleep periods to 
recover from restricted sleep and periods of extended work hours has 
been demonstrated in several studies. Surveys (National Sleep 
Foundation, 2001, 2002) and studies (Monk, et al., 2001) of actual 
sleep patterns of shiftworkers show that shiftworkers sleep longer on 
``weekends'' (i.e., periods of two or more days off), indicating a need 
for recovery sleep that is not being met during the workweek. In the 
Belenky, et al. (2003) study that was discussed with respect to 
proposed Sec.  26.199(d)(2)(ii), the performance of the sleep-
restricted subjects, including those whose sleep periods were 
restricted to 7 hours, did not return to baseline levels on all 
performance measures, even after 3 recovery nights of 8-hour sleep 
periods. Further, in a personal communication on March 22, 2005 (ADAMS 
Accession No. ML050870172), Dr. David Dinges stated that he and his 
colleagues at the sleep lab at University of Pennsylvania Medical 
School are currently conducting large-scale studies of the recovery 
process and that preliminary results from these studies appear to 
confirm the Belenky, et al. findings. He noted that one night of 
unrestricted sleep is generally insufficient because individuals' 
circadian rhythms will not permit them to sleep for the 12-14 hours 
that may be required to recover from a series of days on which sleep 
has been moderately restricted. In addition, Dr. Dinges reported that a 
scientific consensus has emerged within the research community that at 
least two consecutive nights of unrestricted sleep periods are the 
minimum essential for recovery. Two consecutive nights' are required 
because, as discussed in Section IV D(2)(c), individuals' circadian 
rhythms decrease the length of

[[Page 50593]]

daytime sleep periods and daytime sleep interruptions are common.
    The need for longer breaks to mitigate fatigue was also reflected 
in recent changes to DOT's regulations for the work hours of commercial 
truck drivers. 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 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. The regulations also limit 
drivers to 11 hours of driving and 14 hours on duty with 10 consecutive 
hours off duty each day.
    The importance of long breaks is also reflected in work scheduling 
guidelines such as EPRI NP-6748, ``Control Room Operator Alertness and 
Performance in Nuclear Power Plants.'' With respect to the number of 
consecutive shifts, EPRI recommends no more than 6-7 consecutive 8-hour 
shifts and no more than 3-4 consecutive 12-hour shifts. With respect to 
the number of consecutive days off, EPRI recommends a break of at least 
48 hours between any two blocks of shifts and at least one 3-4 day 
break every few weeks. Similarly, a panel of independent experts in 
fatigue and work scheduling, convened by the NRC (NUREG/CR-4248), 
recommended that work schedules should include no more than 7 
consecutive 8-hour shifts and at least 2 consecutive days off in any 9 
days and a maximum of 4 consecutive 12-hour shifts followed by no fewer 
than 4 days off. Proposed Sec.  26.199(d)(2)(iii) would establish a 
minimum break requirement that would be somewhat less stringent than 
these scheduling guidelines.
    In many nations a routine 72-hour work week would be illegal (OTA, 
1991). As a consequence, studies of the effects of continuous weeks of 
working six consecutive 12-hour shifts are sparse. However, there are a 
few studies concerning the work hours and performance of medical 
residents who, like many nuclear power plant personnel, perform largely 
cognitive tasks. By contrast to the majority of individuals working at 
nuclear power plants, medical residents are typically young adults with 
few family commitments. This characteristic is important because social 
and domestic commitments inevitably limit sleep time (Presser, 2000) 
and there are significant decrements in the abilities of middle-aged 
men to adapt to the changes in sleep schedules required by shiftwork 
compared to younger adults (Monk, Moline and Graeber, 1988; Carrier, et 
al., 1997; Dawson and Campbell, 1991). However, despite lifestyle and 
age differences between medical residents and nuclear power plant 
workers, the underlying physiological processes affected by fatigue are 
the same in both groups. Therefore, research on the effects of 
cumulative fatigue on the job performance of medical residents is 
useful in understanding the potential effects of fatigue on nuclear 
power plant personnel, although generalizing the findings of research 
conducted with medical residents to nuclear power plant workers likely 
underestimates the effects of fatigue on nuclear power plant workers' 
job performance because of their greater average age.
    Two key publications, (Baldwin, et al., 2003; Baldwin and 
Daugherty, 2004) report survey data from more than 3,600 medical 
residents. These studies found that almost half of the sample worked 
more than 80 hours per week. When the residents who worked more than 80 
hours per week were compared to those working fewer than 80 hours, it 
was found that the former group had a statistically higher likelihood 
of (1) having a serious accident or injury; (2) having a serious 
conflict with a co-worker; and (3) making a significant medical error. 
Work hours were also significantly correlated with sleep loss and 
ratings of stress.
    Similarly, two studies were conducted comparing the performance of 
medical interns on their traditional schedule, which totaled 77-81 
hours per week and included on-call shifts that extended up to 30 
hours, with the performance of these same interns during an 
intervention schedule. The intervention schedule averaged approximately 
65 hours per week and reduced shift lengths to a maximum of 16 hours. 
Lockley and colleagues found that interns on the intervention schedule 
had less than half the rate of attentional failures during on-call 
night shifts compared with their rate of attentional failures while 
working on the traditional schedule (Lockley, et al., 2004). In another 
study, Landrigan and colleagues found that interns on the traditional 
schedule made 35.9 percent more serious medical errors and 56.5 percent 
more serious, non-intercepted errors than interns working on the 
intervention schedule. The rate of serious errors on the critical care 
unit was 22 percent higher during the traditional schedule. Interns 
made 20.8 percent more serious medication errors and 5.6 times as many 
serious diagnostic errors on the traditional schedule (Landrigan, et 
al., 2004).
    These studies suggest that nuclear power plant workers who work 
long shifts over extended periods are substantially more likely to 
commit errors on the job. Fatigue from extended periods of working long 
shifts is likely to lead to serious errors, impaired teamwork, and an 
increased potential for personal injuries.
    Except during the first 2 weeks of a plant outage, proposed Sec.  
26.199(d)(2)(iii), in conjunction with the other proposed work hour 
limits, would require a schedule very similar to the intervention 
schedule for the medical interns. Specifically, proposed Sec.  
26.199(d)(2)(iii) would require a 48-hour break in every rolling 14-day 
period, effectively limiting individuals who perform the job duties 
listed in proposed Sec.  26.199(a)(1)-(a)(4) from working six 12-hour 
shifts for more than one week at a time. For example, individuals on 
12-hour shifts could work six 12-hour shifts during week 1, followed by 
five 12-hour shifts during week 2. As a result, these individuals would 
average 66 hours over the two-week period, and would be limited by 
proposed Sec.  26.199(d)(1)(i) to working no more than 16 hours in any 
24-hour period.
    In addition to being important for permanent workers at nuclear 
power plants, the 48-hour break requirement would be critical to 
prevent and mitigate cumulative fatigue in roving outage crews and 
other transient workers who predominantly work during plant outages 
when the collective work hour controls in proposed Sec.  26.199(f) 
would not frequently apply. During the stakeholder meetings discussed 
in Section V, many stakeholders expressed a strong desire for transient 
workers to be subject to work hour controls. The NRC staff considered 
subjecting transient workers to long-term work hour controls. However, 
collective work hour controls and 48-hour average group limits would 
not be practical, because these individuals typically work during 
outages when significant workloads occur. The NRC staff further 
considered individual long-term (quarterly and yearly) work hour limits 
for transient workers. However, industry representatives strongly 
objected because these transient individuals 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.

[[Page 50594]]

    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 individual work hour limits and break 
requirements in proposed Sec.  26.199(d). The proposed 48-hour break 
requirement would be the single requirement that would prevent such 
individuals from working 72 hours per week for extended periods. The 
proposed 48-hour break requirement would also provide necessary breaks 
for all individuals who perform the duties listed in proposed Sec.  
26.199(a) during extended plant outages of more than 2 weeks in 
duration. In this case, the proposed 48-hour break requirement would 
again be the single requirement that would prevent individuals from 
working 72 hours per week for the entire first 8 weeks of any plant 
outage [collective work hour limits would apply after the first 8 weeks 
of any plant outage, as discussed with respect to proposed Sec.  
26.199(f)]. Working 72 hours per week for extended periods is 
inconsistent with the research cited in this section with respect to 
proposed Sec.  26.199(d)(2)(i) and (d)(2)(ii), nor does the NRC believe 
it is consistent with providing reasonable assurance that individuals 
are fit to perform their duties. The 48-hour break requirement of 
proposed Sec.  26.199(d)(2)(ii) would provide an important protection 
against cumulative fatigue for individuals who work consecutive outages 
and outages that are longer than two weeks.
    Proposed Sec.  26.199(d)(3) would be added to permit licensees to 
authorize waivers from the work hour controls for individuals in 
proposed Sec.  26.199(d)(1) and (d)(2) for conditions that meet two 
criteria, which would be specified in the proposed paragraph. Exceeding 
the individual work hour limits would be justified for limited 
circumstances in which compliance with the work hour controls could 
have immediate adverse consequences for the protection of public health 
and safety or the common defense and security. Limited use of waivers 
also would be consistent with the Commission's position stated in the 
NRC's Policy on Worker Fatigue. However, as specified in proposed Sec.  
26.199(d)(3)(ii), the NRC would expect licensees to grant waivers only 
to address circumstances that the licensee could not have reasonably 
controlled.
    Proposed Sec.  26.199(d)(3)(i)(A) would be added to establish one 
of two criteria in the proposed rule for granting a waiver from the 
individual work hours controls. Specifically, proposed Sec.  
26.199(d)(3)(i)(A) would require that an operations shift manager must 
determine that the waiver is necessary to mitigate or prevent a 
condition adverse to safety, or a security shift manager must determine 
that the waiver is necessary to maintain the security of the facility, 
or a site senior-level manager with requisite signature authority must 
make either determination.
    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. The NRC believes that 
the authority to grant deviations from the work hour guidelines was 
abused by some licensees. Proposed Sec.  26.199(d)(3)(i)(A) would more 
clearly articulate the NRC's expectations with respect to exceeding the 
work hour limits, which are that licensees must limit the granting of 
waivers from the work hour limits to circumstances in which it is 
necessary to prevent or mitigate a condition adverse to safety or to 
maintain the security of the plant. The proposed criterion would limit 
waivers to conditions that are infrequent while permitting waivers that 
are necessary for safety or security. For example, proposed Sec.  
26.199(d)(3)(i)(A) would permit a licensee to grant a waiver from a 
work hour control on the basis that the waiver is necessary to prevent 
a condition adverse to safety, if compliance with the work hour 
controls would cause the licensee to be in violation of other NRC 
requirements, such as the minimum on-site staffing requirements in 10 
CFR 50.54(m), or would delay the recovery of failed plant equipment 
that is necessary for maintaining plant safety. Similarly, the NRC 
would consider it appropriate to grant a waiver from the proposed work 
hour controls on the basis that it is necessary to prevent a condition 
adverse to safety, if compliance with the work hour controls 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 proposed Sec.  
26.199(d)(3)(i)(A) was the subject of considerable stakeholder comment 
and discussion during the public meetings described in Section V. 
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, as discussed with respect to 
proposed Sec.  26.199(d)(2) and (d)(3), the potential for worker 
fatigue in conditions that would 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 proposed limits on 
the basis that granting the waiver would not have an adverse impact on 
safety or security. The basis for not incorporating industry's comment 
on this provision is detailed in Section V.
    Proposed Sec.  26.199(d)(3)(i)(A) would further require 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 proposed rule would require 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 would be 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 Section V, 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 would 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 determinations are made by individuals who would not be unduly 
influenced by schedule pressures. The NRC noted that authority to 
authorize deviations had been delegated by some licensees to 
organizational levels that appeared to be inconsistent with the 
guidelines in the

[[Page 50595]]

NRC's Policy on Worker Fatigue for work hour deviation authorizations, 
which indicate that deviations from the guidelines should be authorized 
by the plant manager or plant manager designee. Accordingly, proposed 
Sec.  26.199(d)(3)(i)(A) would permit senior site managers with the 
signature authority of operations shift supervisors to make the safety 
determinations that would be required to grant waivers and senior site 
managers with the signature authority of security shift supervisors to 
make security determinations required to grant waivers.
    Proposed Sec.  26.199(d)(3)(i)(B) would be added to establish the 
second of two proposed criteria for granting a waiver from the 
individual work hour controls of proposed Sec.  26.199(d)(1) and 
(d)(2). Proposed Sec.  26.199(d)(3)(i)(B) would require 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 proposed Sec. Sec.  26.29 and 
26.197(c), must assess the individual face to face and determine 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.
    These determinations would 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 proposed Sec. Sec.  26.29 and 26.197(c) would provide the knowledge 
and abilities that would be essential for a supervisor to make valid 
assessments in this regard. Among other FFD topics, the proposed 
training would address 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 proposed training would be necessary for individuals 
to perform these assessments.
    Proposed Sec.  26.199(d)(3)(i)(B) would further require that 
supervisors must perform the assessment face to face with the 
individual that he or she is assessing for the waiver. This proposed 
requirement would ensure that the supervisor who is performing the 
assessment has the opportunity to observe the individual's appearance 
and behavior to note indications of fatigue (e.g., decreased facial 
tone, rubbing of eyes, slowed speech) and interact with the individual 
to assess the individual's ability to continue to safely and 
competently perform his or her duties during the period for which the 
waiver would be granted.
    Proposed Sec.  26.199(d)(3)(i)(B) would also require 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 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 (1) 
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; and (3) the potential 
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. Proposed Sec.  26.199(d)(3)(i)(B) 
would in effect require 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 proposed assessment, the NRC also considered the need 
for licensees to be able to focus the assessment on information that 
would be readily available and could be verified.
    Proposed Sec.  26.199(d)(3)(i)(B) would further require that the 
supervisory assessment for granting a waiver must address the potential 
for fatigue-related degradations in alertness and performance to affect 
risk-significant functions, and whether it would be necessary to 
establish controls and conditions under which the individual will be 
permitted to perform work. This proposed 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, proposed Sec.  26.199(d)(3)(i)(B) would require 
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.
    Proposed Sec.  26.199(d)(3)(i)(B) would also require 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 would not be 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 
proposed requirement to consider establishing controls and conditions 
would be 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.
    Proposed Sec.  26.199(d)(3)(ii) would be added to require 
licensees, to the extent practicable, to grant waivers only in 
circumstances that the licensee could not have reasonably controlled. 
This proposed requirement would be necessary because conditions meeting 
the waiver criteria that are specified in proposed Sec.  
26.199(d)(3)(i) could routinely result from inadequate staffing or work 
planning. Licensees have authorized deviations from their technical 
specification limits on work hours for these 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, 
proposed Sec.  26.199(d)(3)(ii) would prohibit 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

[[Page 50596]]

not have reasonably controlled, which may include, but would not be 
limited to, equipment failures or a sudden increase in the personnel 
attrition rate.
    Proposed Sec.  26.199(d)(3)(iii) would be added to require that the 
face-to-face supervisory assessment required in proposed Sec.  
26.199(d)(3)(i)(B) must 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 would provide a valid assessment 
of the potential for worker fatigue during the extended work period. 
This proposed requirement would be necessary 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 proposed rule would require 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.
    Proposed Sec.  26.199(d)(3)(iii) would establish 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 would 
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 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 the proposed 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.
    Proposed Sec.  26.199(d)(3)(iv) would be added to require licensees 
to document the bases for granting waivers from the individual work 
hour controls of proposed Sec.  26.199(d)(1) and (d)(2). The proposed 
paragraph would require 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 that would be required by proposed Sec.  
26.199(d)(3)(i). The proposed documentation would be 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 proposed Sec.  26.199(j) [Reviews].
    Proposed Sec.  26.199(e) [Self-declarations during extended work 
hours] would be added to require licensees to take immediate action in 
response to a self-declaration [as discussed with respect to proposed 
Sec.  26.197(b)(1)] by an individual who is working under, or being 
considered for, a waiver from the work hour controls in proposed Sec.  
26.199(d)(1) and (d)(2). Licensees would be required to immediately 
stop the individual from performing any duties listed in proposed Sec.  
26.199(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, 
the proposed paragraph would require the licensee to immediately take 
action to relieve the individual. For example, the licensee would 
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 proposed rule would add this requirement because correct 
performance of the job duties specified in proposed Sec.  26.199(a) is 
of critical importance in 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 proposed Sec.  26.199(d)(1) and (d)(2). 
Individuals who would be working extended hours under a waiver would 
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 would have effectively provided an assessment of his or her 
ability to continue to safely and competently perform these critical 
duties. Several studies have indicated 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 would make a self-declaration of fatigue is 
potentially more impaired than he or she realizes.
    The proposed rule would not require licensees immediately to 
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, because the failure to meet minimum 
staffing or similar requirements would, 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 could implement any fatigue 
mitigation strategies they deem necessary while the individual remains 
on duty. Fatigue mitigation measures in these circumstances may 
include, but would not be 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).
    Proposed Sec.  26.199(e)(1) would be added to permit licensees to 
reassign an individual who has made a self-declaration of fatigue to 
perform other duties than those specified in proposed Sec.  26.199(a). 
The proposed rule would include this flexibility because, although an 
individual may not be fit to perform the activities specified in 
proposed Sec.  26.199(a), the individual may be able to safely and 
competently perform other duties. Other duties may include, but would 
not be limited to, tasks that require skills that are less

[[Page 50597]]

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 proposed 
rule would permit licensees to reassign individuals who have made a 
self-declaration of fatigue to other duties, if the results of a 
fatigue assessment (as would be required under proposed Sec.  26.201 
[Fatigue assessments]) indicate that he or she is fit to perform them, 
because permitting the individual to remain at work and continue 
performing such duties would not have the potential to adversely impact 
public health and safety or the common defense and security.
    However, proposed Sec.  26.199(e)(2) would be added to require the 
licensee 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 proposed Sec.  
26.199(a). The proposed rule would include this requirement to ensure 
that individuals who have self-declared would be 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 
proposed Sec.  26.199(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 proposed 
rule would preclude 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 the May 10, 2002, NRC 
Regulatory Issue Summary (RIS) 2002-07: ``Clarification of NRC 
Requirements Applicable to Worker Fatigue and Self-Declarations of 
Fitness-for-Duty,'' 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.
    Proposed Sec.  26.199(f) [Collective work hour limits] would be 
added to require licensees to control the collective work hours of each 
group of individuals who are performing the job duties listed in 
proposed Sec.  26.199(a) and ensure that the collective work hours of 
each job duty group do not exceed an average of 48 hours per person per 
week in any averaging period. (The proposed rule's requirements for 
calculating collective work hours are discussed with respect to 
proposed Sec.  26.195(b)(2) [Collective work hours].) The requirements 
of proposed Sec.  26.199(f) would address the control of work hours 
over extended periods of time, by contrast to the short-term work hour 
controls in proposed Sec.  26.199(d) [Work hour controls for 
individuals].
    The objectives of the 48-hour collective limit during normal plant 
operations would be to: (1) ensure that the routine work hours of 
individuals who are performing the duties listed in proposed Sec.  
26.199(a)(1)-(a)(5) do not adversely affect their abilities to safely 
and competently perform their duties; (2) define an enforceable upper 
limit for the nominal 40-hour work-week policy stated in GL 82-12; and 
(3) continue to permit licensees to manage overtime in a manner that 
reflects the differing desires and capabilities of individuals with 
respect to work hours.
    The proposed collective work hour controls would ensure that 
licensees manage the potential for cumulative fatigue (i.e., fatigue 
from successive weeks or months 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 
48-hour collective work hour limit would prevent excessive use of the 
maximum work hours and minimum rest breaks that would be permitted 
under the proposed individual work hour controls. In addition, 
proactively controlling work hours to a group average of no more than 
48 hours per week would likely reduce the need for licensees to grant 
waivers of the individual limits in proposed Sec.  26.199(d)(1) and 
(d)(2). Individuals would be better rested and less susceptible to 
cumulative fatigue from the increased work hours that are common during 
outages and are necessary to augment security staffing during increased 
threat conditions, during which times licensees would not be required 
to implement group work hour controls, subject to the restrictions 
listed in proposed Sec.  26.199(f)(1)-(f)(5). Therefore, the 48-hour 
collective work hour limit would be essential for limiting cumulative 
fatigue and would augment other important elements of licensees' 
fatigue management programs.
    The collective work hour control concept would be consistent with a 
fundamental objective of the NRC's Policy on Worker Fatigue. The 
Policy, promulgated via 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. The 
proposed requirement would, in effect, limit groups of individuals to 
no more than 20 percent overtime in excess of the nominal 40-hour work 
week objective of the NRC's Policy on Worker Fatigue during the periods 
in which the proposed requirement would be applicable (typically during 
normal plant operations).
    The collective work hour controls of proposed Sec.  26.199(f) would 
also codify, in part, the requirements established by Order EA-03-038 
for the control of work of hours for specified nuclear power plant 
security personnel (SRM-COMSECY-03-0012, dated March 31, 2003). As 
described with respect to Sec.  26.199(f)(2), the NRC has received 
numerous allegations from nuclear security officers that certain 
licensees have 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 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 fitness for duty, 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

[[Page 50598]]

hour requirement, rather than a limit on individual work hours, in 
response to stakeholder input regarding differences among individuals 
in their abilities and desires to work overtime. Similarly, the 
proposed rule would permit a group of workers who are performing 
similar duties to average 48 hours of work over a period not to exceed 
13 weeks [proposed requirements for calculating collective work hours 
are discussed with respect to proposed Sec.  26.199(b)(2)]. Because the 
proposed limit would be imposed on a job duty group's average number of 
work hours during an averaging period, licensees would continue to be 
permitted to distribute overtime among their workers based on their 
assessment of individuals' abilities and desires to work overtime. The 
proposed averaging methodology would not unduly limit individuals from 
working voluntary overtime, and would effectively result in adequate 
opportunities for days off and limited forced overtime. As discussed 
with respect to proposed Sec.  26.199(b)(2), requiring licensees to 
average collective work hours over a period up to 13 weeks in length 
would establish a limit on the long-term scheduling of work hours that 
would support timely identification and corrective action for 
conditions that could contribute to cumulative fatigue, but would not 
be overly sensitive to short-term variations in workload. Short-term 
variations in workload have limited potential for causing cumulative 
fatigue.
    The NRC considered several types and sources of information in 
deciding to propose a collective work hour limit of 48 hours per person 
per week. These included: (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.
    Two of the most comprehensive documents on worker fatigue in the 
U.S. nuclear industry are EPRI NP-6748 (Baker, et al., 1990) and NUREG/
CR-4248. The collective work hour limit is a new concept developed to 
meet the NRC's objectives, while also addressing the unique 
circumstances and specific concerns of the stakeholders. 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 the proposed 
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 use of overtime 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, indicating that this individual maximum on 
overtime should not be a group norm. The collective work hour limit of 
48 hours per person per week would establish a requirement that is in 
the middle of the range of work hours defined by the maximum routine 
scheduling limits and maximum individual overtime, and also provides 
for individual differences with respect to vulnerability to fatigue. 
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 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. Similar results were 
obtained in a survey of nuclear power plant personnel in the United 
Kingdom.
    A 48 hour per person per week collective work hour limit would 
permit job duty groups to average approximately 400 hours of overtime, 
or 2400 hours of work, in a year. Therefore, the proposed collective 
work hour limit would be consistent with the upper extreme of overtime 
hours for which nuclear power plant personnel have expressed a 
tolerance. In addition, the proposed collective work hour limit would 
be less restrictive than the limit implied by worker opinions because 
the 48-hour average would exclude hours worked during the first 8 weeks 
of outages.
    In addition to 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 fewer. The NRC also reviewed work hours data collected by NEI 
(ADAMS Accession No. ML003746495) and found that, although there was 
substantial variation among sites, 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 48 hours 
is an achievable objective for security personnel as well, although it 
was not a current practice at a small fraction of nuclear power plants.
    The proposed 48-hour per person per week collective work hour limit 
would be comparable to restrictions on workers in other industries 
within the U.S. and the limits imposed by other countries that regulate 
overtime for nuclear power plant workers. The NRC staff considered that 
cumulative fatigue of nuclear power plant personnel is addressed in 
several other countries 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 
proposed 48-hour collective work hour limit because they permit fewer 
hours of work and provide less flexibility because the limits apply to 
individuals rather than groups (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 U.S.

[[Page 50599]]

    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.''
    In addition, the amount of overtime permitted by the proposed 48-
hour collective work hour limit would be greater than the amount used 
in most continuous operations. Circadian Technologies Incorporated, a 
consulting firm that is expert in fatigue management, regularly surveys 
U.S. and Canadian companies conducting 24/7 operations. Their 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 Incorporated, 2000). 
Circadian Technologies Incorporated noted that average overtime for 
workers in extended operations in the U.S. was 12.6 percent above the 
standard work-week in the first 8 months of 2003, with utilities 
averaging 14.9 percent (Circadian Technologies Incorporated, 2003).
    Therefore, the proposed 48-hour collective work hour requirement 
would establish an appropriate upper limit on work hours while the 
plant is operating. The proposed limit would be consistent with expert 
and worker opinions concerning work hours, provide substantial licensee 
flexibility, and recognize individual differences in the ability to 
work overtime while remaining fit to safely and competently perform 
duties.
    Proposed Sec.  26.199(f)(1) would be added to exclude the first 8 
weeks of plant outages from the collective work limit in proposed Sec.  
26.199(f) for the job duty groups that are specified in proposed Sec.  
26.199(a)(1)-(a)(4) (i.e., certain operations, maintenance, chemistry, 
health physics, and fire brigade personnel). During the first 8 weeks 
of a plant outage, proposed Sec.  26.199(d) would require these 
individuals to be subject to individual work hour controls. After the 
first 8 weeks of a plant outage, proposed Sec.  26.199(f)(1) would 
require licensees to resume controlling the work hours of these 
individuals in accordance with the collective work hour limit in 
proposed Sec.  26.199(f).
    The collective work hour limits of proposed Sec.  26.199(f) would 
address the long-term control of work hours while permitting the 
occasional use of limited overtime for circumstances such as equipment 
failure, personnel illness, or attrition. The NRC proposes to address 
the control of work hours during short- and medium-length outages 
separately and permit licensees to waive the collective work hour 
controls for the first 8 weeks of an outage in proposed Sec.  
26.199(f)(1). In developing the proposed permission to exclude the 
first 8 weeks of an outage from the collective work hour limits, the 
NRC considered several factors, including current policy, the bases for 
the policy, and lessons learned from the policy implementation.
    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 
exclusion period for plant outages at 8 weeks, the NRC considered that, 
by the end of 8 weeks of work at the limits permitted by proposed Sec.  
26.199(d), individuals who are performing the duties specified in 
proposed Sec.  26.199(a)(1)-(a)(4) will have (1) worked 540 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 would be a reduction of 60 percent in the time available to recover 
and prevent cumulative fatigue. Further, with each passing week of an 
outage involving 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 plant 
outages in determining whether the cost to licensees imposed by the 
proposed 8-week outage exclusion period are 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. This increase in the exclusion period would 
substantially increase the period of time that work hours would not be 
controlled by the proposed 48-hour collective work hour limit, which 
would be the proposed rule's principal requirement to prevent 
cumulative fatigue. During the exclusion period, individuals would only 
be assured of a 24-hour break every 7 days and a 48-hour break every 14 
days, under the individual work hour limits in proposed Sec.  
26.199(d)(1) and (d)(2). Individuals who work 12-hour shifts would 
average 66 hours per week, a rate of more than 150 percent of their 
normally scheduled hours with less than half of their normally 
scheduled days off for recovery, for a period that would exceed 2 
months. These extended work hours would substantively increase the 
potential for cumulative fatigue and fatigue-related personnel errors. 
By contrast, decreasing the exclusion period to less than 8 weeks would 
increase the number of

[[Page 50600]]

outages that would be, in part, subject to the collective work hour 
controls, potentially increasing the duration and cost of those 
outages. Decreasing the exclusion period by 1 or 2 weeks could also 
decrease the potential for cumulative fatigue, but the magnitude of the 
decrease would be difficult to quantify and the benefit would unlikely 
justify the costs.
    Excluding the first 8 weeks of an outage would be consistent with 
the NRC's objective of ensuring that licensees provide adequate shift 
coverage without routine heavy use of overtime. The proposed exclusion 
period would be limited to plant outages, which occur regularly, but 
with limited frequency. In addition, the proposed rule would limit the 
duration of the exclusion period to 8 weeks in order to limit the 
potential for cumulative fatigue.
    Proposed Sec.  26.199(f)(2)(i) would be added to establish a 
collective work hour limit of 60 work hours per person per week for 
personnel who are performing the job duties specified in proposed Sec.  
26.199(a)(5) (i.e., security personnel) during the first 8 weeks of a 
plant outage or a planned security system outage. The proposed rule 
would permit a 60-hour per person per week collective work hour limit 
as an exception to the 48-hour collective work hour limit in proposed 
Sec.  26.199(f). The proposed exception for security personnel would 
accommodate the short-term demand for increased work hours associated 
with these outages while limiting cumulative fatigue. Therefore, the 
proposed requirement would provide reasonable assurance that security 
personnel would 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 excluding work hours during the first 8 weeks of an 
outage from the proposed requirement for a 48-hour group average is 
discussed with respect to proposed Sec.  26.199(f)(1). However, that 
exclusion would be only applicable to individuals who are performing 
the duties listed in proposed Sec.  26.199(a)(1)-(a)(4) during plant 
outages. During the first 8 weeks of a plant outage, those individuals 
would remain subject to the proposed individual work hour controls but 
their work hours would not be limited by any collective work hour 
requirement. By contrast, proposed Sec.  26.199(f)(2)(i) would require 
security personnel to be subject to a 60-hour per person per week 
collective work hour limit, in addition to the proposed individual work 
hour limits, during the first 8 weeks of a plant outage.
    Proposed Sec.  26.199(f)(2)(i) also would permit licensees to 
exclude security personnel from the 48-hour per person per week 
collective work hour limit during the first 8 weeks of a planned 
security system outage, during which time they would be subject to a 
60-hour per person per week collective work hour limit. Planned 
security system outages are typically of very short duration (days), 
and the NRC does not expect that planned security system outages will 
exceed 8 weeks in length. However, the proposed rule would establish 
the 8-week limit for planned security system outages in order 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 safely and competently perform 
their duties during these varying outages and increased threat 
conditions is based on the length of time individuals work additional 
overtime, not on the nature of the site condition.
    The proposed provision would codify, in part, requirements 
established by Order EA-03-038, although it would limit the exclusion 
period to 8 weeks instead of the 120-day exclusion period that is 
permitted in Order EA-03-038, for the reasons discussed above. Since 
September 11, 2001, the NRC has received 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 due to the post-September 11 threat environment. The 
nuclear security officers questioned their readiness and ability to 
perform their required job duties because of the adverse effects of 
cumulative 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 
required 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 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 elevated overtime 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 also 
provided more flexibility. The proposed 60-hour limit would ensure 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. The need for periodic long breaks was discussed 
with respect to proposed Sec.  26.199(d)(2)(ii) and (d)(2)(iii).
    For several reasons, control of work hours for security personnel 
must be more stringent than for other individuals who would be subject 
to the proposed work hour controls. First, 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. Second, unlike most other work 
groups, security personnel are typically deployed in a configuration 
such that some have very infrequent contact with other members of the 
security force, or other plant personnel. A lack of social contact can 
exacerbate the effects of fatigue on individuals' abilities to remain 
alert (Horne, 1988). Third, these

[[Page 50601]]

deployment positions can be fixed posts where very little physical 
activity is 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.
    The proposed requirement would also differ from that in Order EA-
03-038 by requiring licensees to meet 60-hour per person per week 
collective work hour limit during unplanned plant outages. Order EA-03-
038 currently does not impose collective work hour limits for these 
conditions. As discussed in the preceding paragraph, security duties 
are particularly susceptible to fatigue. Therefore, the NRC considers 
that the proposed 60-hour per person per week collective work hour 
limit 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 security system outages, although licensees would be 
unable to sufficiently plan for the increased security demands that 
typically accompany plant outages, the increase in those demands is 
directly due to the need to return the plant to operation (such as 
additional guards needed to support maintenance activities), not the 
need to maintain the common defense and security (as is the case with 
security system outages). The increased potential for fatigue-induced 
errors under the greatly increased work hours that would be permitted 
in the absence of collective work hour controls could not be justified 
by the economic benefit gained by licensees.
    Proposed Sec.  26.199(f)(2)(ii) would be added to establish a 
collective work hour limit of 60 hours per person per week for security 
personnel during the actual conduct of Force-on-Force (FOF) exercises. 
The proposed rule would include a 60-hour per week collective work hour 
limit for security personnel as an exception to the 48-hour collective 
work hour limit in proposed Sec.  26.199(f). The proposed exception 
would accommodate the short-term demand for increased work hours 
associated with FOF exercises while limiting cumulative fatigue, 
thereby providing reasonable assurance that security personnel will 
remain capable of safely and competently responding to a security 
incident or increased threat condition, should one occur during or 
shortly after the conduct of FOF exercises. The basis for requiring 
security personnel to be subject to a 60-hour per person per week 
collective work hour limit, in addition to the individual work hour 
limits, in lieu of waiving the group average limits completely, is 
discussed with respect to proposed Sec.  26.199(f)(2)(i).
    The proposed 60-hour collective work hour limit during FOF 
exercises would be consistent with the relaxation to Order EA-03-038, 
granted October 23, 2003. During public meetings concerning Order EA-
03-038, industry stakeholders commented that the FOF exercises warrant 
special consideration because NRC participation in the exercises causes 
some aspects of the exercises to be outside industry control, and 
because of the short-term and unique staffing demands imposed on 
licensees during the exercises. In addition, industry stakeholders have 
commented that: (1) Hiring extra security officers for such short-term 
demands would be inefficient and injurious to workforce stability; (2) 
imposing a staffing level requirement on licensees sufficient to 
support the FOF exercises would result in staff levels greater than 
those routinely needed; and (3) the benefit of conducting these 
exercises far outweighs the additional burden of the person-hours 
expended. The NRC agrees that the conduct of the pilot and annual FOF 
exercises warrant special consideration because: (1) The benefits of 
conducting a FOF exercise outweigh concerns regarding work-hour limits; 
(2) the exercises are infrequent and intensive efforts conducted over a 
short-term period; and (3) the burden to meet the significant staffing 
demands during the exercises would be very high if work hours were 
limited to a collective average of 48 hours per person per week.
    Proposed Sec.  26.199(f)(2)(iii) would be added to provide 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 proposed exception would codify, in 
part, the 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 
up to 120 days. Proposed Sec.  26.199(f)(2)(iii) would establish 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 proposed fatigue management requirements, including the 
individual work hour controls in proposed Sec.  26.199(d)(1) and 
(d)(2), would provide reasonable assurance of guard readiness during 
the exception period. Therefore, the benefit to plant security of 
ensuring adequate staffing during such unplanned conditions would 
outweigh the potential for excessive worker fatigue.
    Staffing to maintain work hours within the limits of the proposed 
collective work hour controls would not be practical because it would 
require licensees to maintain security staffing at levels that would be 
excessive for the vast majority of circumstances. Limiting periods of 
extended work hours for security personnel to 8 weeks brings security 
personnel closer to the requirements for the other proposed exclusion 
periods, 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 8 
weeks. Outages of this duration have been uncommon. Therefore, reducing 
the exclusion period from 120 days to 8 weeks would be unlikely to have 
a practical impact on licensees.
    In the case of an increased threat condition, the Department of 
Homeland Security has refined their threat system to compartmentalize 
increases in threat conditions for individual business sectors and 
regions of the country. Also, since the inception of the system, there 
has never been an increase for any period that exceeded 6 weeks. An 
event that would cause NRC-regulated sites to adopt an increase over 8 
weeks would likely mean a significant domestic attack had occurred. In 
this event, proposed Sec.  26.199(f)(5) would provide a means for 
extending the proposed 8-week exclusion period, as discussed with 
respect to that provision.
    Proposed Sec.  26.199(f)(2)(iv) would be added to clarify the 
instances in which security personnel would be subject to a collective 
work hour limit for certain instances in which multiple plant 
conditions exist. As discussed with

[[Page 50602]]

respect to proposed Sec.  26.199(f)(2)(iii), licensees would not be 
required to control the collective work hours of security personnel 
during the first 8 weeks of an increased threat condition. Proposed 
Sec.  26.199(f)(2)(iv) would establish requirements for implementing 
this exception should an increased threat condition occur concurrently 
with a plant outage or planned security system outage. The proposed 
exception would codify, in part, an exception to group work hour 
controls permitted by Order EA-03-038.
    As would be required by proposed Sec.  26.199(f)(2)(i), the 
collective work hours of security personnel would be limited to an 
average of not more than 60 hours per person per week during any plant 
outage or planned security system outage. If an increase in threat 
condition occurs during such a period, and the increased threat 
condition persists for a period of 8 weeks or fewer, proposed Sec.  
26.199(f)(iv) would establish an exception for the collective work hour 
controls on security personnel for the duration of the increased threat 
condition. However, if during any such outage, the threat condition 
returned to the least significant threat condition that was in effect 
at any time within the past 8 weeks, then the licensee would be 
required to limit the collective work hours of security personnel to an 
average of 60 hours per person per week for the first 8 weeks of the 
outage for the periods that occurred before and after the increased 
threat condition. For example, if, during an 8-week outage, the threat 
level increased at the beginning of week 3 and returned to the original 
or a lower threat level at the conclusion of week 4, then the licensee 
would be required to limit the collective work hours of security 
personnel to a group average of no more than 60 hours per person per 
week during weeks 1-2 and 5-8 of the outage. Outage weeks 3-4 would not 
be subject to the proposed work hour controls because of the increased 
threat condition. As such, proposed Sec.  26.199(f)(2)(iv) would 
clarify the limits to be applied when multiple plant conditions occur 
at the same time. Consistent with the requirements of proposed Sec.  
26.199(f)(2)(i), licensees would be required to limit the collective 
work hours of security personnel to an average of 48 hours per person 
per week following the first 8 weeks of the outage.
    This proposed exception to the collective work hour controls would 
be necessary to ensure that licensees have the flexibility to take any 
immediate actions necessary for maintaining plant security. The 
proposed exception would be limited in duration to ensure that 
licensees take appropriate long-term actions to prevent cumulative 
fatigue should the increased threat condition be sustained for a period 
that is longer than 8 weeks.
    Proposed Sec.  26.199(f)(2)(v) would be added to further clarify 
the applicability of the collective work hour limits for security 
personnel during multiple consecutive and concurrent plant conditions. 
Licensees would be permitted to relax collective work hour controls in 
situations in which additional increases in threat condition occur 
during an unplanned security system outage or increased threat 
condition, but only for a period that is the shorter of either the 
duration of the increased threat condition or 8 weeks. The proposed 
exception would codify, in part, an exception to collective work hour 
controls that is permitted by Order EA-03-038. The proposed exception 
to the collective work hour controls would be necessary to ensure that 
licensees have the flexibility to take any immediate actions necessary 
for maintaining plant security in response to increasing security 
threat levels. The proposed exception would be limited in duration to 
ensure that licensees take appropriate long-term actions to prevent 
cumulative fatigue should an increased threat condition be sustained 
for a period of more than 8 weeks.
    Proposed Sec.  26.199(f)(2)(vi) would be added to establish 
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 establish 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. 
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, the beginning of the maximum 8-week exception period would be the 
beginning of week 1. The proposed requirement would 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. Proposed 
Sec.  26.199(f)(2)(vi) would codify, in part, an exception to the work 
hour controls that is permitted by Order EA-03-038.
    Proposed Sec.  26.199(f)(3) would be added to permit 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 proposed Sec.  26.199(f)(3)(i)-
(f)(3)(iii) are met. The collective work hour controls of proposed 
Sec.  26.199(f) would address the long-term control of work hours, 
including the limited use of overtime for occasional, short-term, 
exigent circumstances. The primary objective of proposed Sec.  
26.199(f) would be to ensure that fatigue resulting from the routine 
work hours of individuals performing the functions listed in proposed 
Sec.  26.199(a)(1)-(a)(5) would not adversely affect their abilities to 
safely and competently perform their duties, and therefore that 
licensees maintain adequate shift coverage without routine heavy use of 
overtime. The objective of proposed Sec.  26.199(f)(3) would be to 
establish a regulatory framework that would accommodate 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 criteria in proposed Sec.  
26.199(f)(3)(i)-(f)(3)(iii) would permit licensees to control work 
hours to a higher collective work hour limit under certain occasional, 
short-term, exigent circumstances.
    Proposed Sec.  26.199(f)(3)(i) would be added to establish the 
first criterion for permitting a higher collective work hour limit by 
requiring that the circumstances that cause collective work hours to 
exceed 48 hours per person per week cannot be reasonably controlled. 
Unusual circumstances (e.g., strikes, hurricanes, outage extensions for 
reasons that licensees cannot reasonably control, extremely high 
employee turnover) may require increased work hours for a short period 
of time, and licensees cannot practically maintain staffing reserves to 
avoid using overtime in such unusual circumstances. These unusual 
circumstances would place licensees in jeopardy of violating the 
requirements of proposed Sec.  26.199(f). However, temporarily 
exceeding the proposed collective work hour limits in circumstances 
that could not be reasonably controlled by a licensee generally would 
not indicate that the licensee's fatigue management program was 
ineffective.
    Proposed Sec.  26.199(f)(3)(ii) would be added to establish the 
second criterion for permitting a higher collective work hour limit in 
unusual circumstances that could not be reasonably controlled. The 
proposed rule would prohibit collective work hours from exceeding 54

[[Page 50603]]

hours per person per week in these circumstances. This proposed limit 
would be necessary to ensure that workers do not become unacceptably 
fatigued during the exigent circumstances. In some instances, licensees 
may rely on this provision to permit a 54-hour per person per week 
collective work hour limit during the averaging period following an 8-
week outage that was extended for reasons beyond the licensee's 
reasonable control (e.g., defects in new equipment that were only 
detectable following installation, late delivery of key equipment or 
parts). Limiting collective work hours to 54 hours per person per week 
would provide a substantial increase in the hours that would be 
available to address the emergent circumstance(s) [equivalent to 
approximately one month of work at the maximum hours permitted by the 
individual work hour controls of proposed Sec. Sec.  26.199(d)(1) and 
(d)(2)] while continuing to ensure the availability of some recovery 
days.
    Proposed Sec.  26.199(f)(3)(iii) would be added to establish the 
third criterion for permitting a higher collective work hour limit. The 
proposed rule would require that the additional work hours that result 
in the group average exceeding 48 hours per person per week would be 
worked only to address the circumstances that the licensee could not 
have reasonably controlled. This proposed provision would require 
licensees to use relief from the 48-hour collective work hour limit 
only to the extent necessary, and not as an opportunity to increase 
work hours for unrelated activities performed by the group. For 
example, the proposed provision would permit a maintenance job duty 
group's collective work hours to average 50 hours per person per week 
in one averaging period if a crew of maintenance technicians worked 
excess hours in order to exit an LCO on time. However, the proposed 
provision would not permit the licensee to assign unrelated work 
activities to other maintenance technicians, and thereby increase the 
group's collective work hours to the 54 hours per person per week that 
the proposed rule would permit in the specified circumstances.
    Proposed Sec.  26.199(f)(4) would be added to prohibit licensees 
from repeatedly permitting the collective work hours of any job duty 
group to exceed an average of 48 hours per person per week. As 
discussed with respect to proposed Sec.  26.199(f)(3), the NRC 
recognizes that, because of circumstances that a licensee cannot 
reasonably control, there may be averaging periods in which a job duty 
group's collective work hours exceed the 48-hour collective limit. 
However, the primary objective of the collective work hour limit would 
be to prevent cumulative fatigue that can result from sustained 
extended work hours. The repeated use of the accommodations afforded by 
proposed Sec.  26.199(f)(3) to exceed the 48-hours per person per week 
collective work hour limit in proposed Sec.  26.199(f) would be 
inconsistent with the objective of preventing cumulative fatigue. Both 
increased workload and decreased opportunity for rest can contribute to 
cumulative fatigue (Baker, et al., 1994; Rosekind, 1997; Totterdell, et 
al., 1995; Knauth and Hornberger, 2003; Rosa, 1995). With each passing 
week of an extended work schedule, individuals have worked an 
increasing number of their normally scheduled days off. Deferring daily 
living obligations becomes increasingly difficult, causing increased 
pressure to reduce sleep time in order to meet the demands of both work 
and daily life, thereby increasing the potential for cumulative 
fatigue. Therefore, it would be necessary to ensure that licensees do 
not permit any job duty group to exceed the collective work hour limits 
in the proposed rule repeatedly.
    Proposed Sec.  26.199(f)(4)(i) would be added to prohibit licensees 
from permitting the collective work hours of any job duty group to 
exceed the 48-hour limit in any two consecutive averaging periods. This 
proposed requirement would ensure that individuals in a job duty group 
who worked extended hours during one averaging period have recovery 
time during the subsequent averaging period, during which they would 
resume working normal work hours.
    Proposed Sec.  26.199(f)(4)(ii) would prohibit licensees from 
permitting the collective work hours of any job duty group to exceed 
the 48-hour limit in more than one averaging period during any 26-week 
period. This proposed requirement would be necessary because the 
proposed rule permits licensees to establish averaging periods of any 
length less than 14 weeks in proposed Sec.  26.199(b)(2) [Collective 
work hours]. By manipulating the lengths of averaging periods, for 
example, a licensee could require a job duty group to work hours in 
excess of the 48-hour collective limit during one 13-week averaging 
period, reduce the group's collective work hours to 48 hours or fewer 
during a subsequent 1-week averaging period, and still be in compliance 
with proposed Sec.  26.199(f)(4)(ii). This schedule manipulation could 
result in individuals working 48 weeks of extended work hours in a 
calendar year, punctuated only by four, 1-week periods of normal work 
hours, which would lead to extreme levels of cumulative fatigue. 
Therefore, in order to ensure that the 48-hour collective work hour 
limit achieves the objective of preventing cumulative fatigue, proposed 
Sec.  26.199(f)(4)(ii) would require that any averaging periods in 
which a job duty group works extended hours during normal operations 
would be widely separated in time and occur no more frequently than 
twice in one rolling year.
    Proposed Sec.  26.199(f)(5) would be added to permit licensees to 
exceed any collective work hour limit of proposed Sec.  26.199(f) if 
the licensee submits a written request to the NRC and obtains advance 
approval of a written request that includes the information in proposed 
Sec.  26.199(f)(5)(i)-(f)(5)(iii). Proposed Sec.  26.199(f)(5) would 
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 proposed Sec.  26.199(f), but that licensees could 
effectively manage using comparable work scheduling controls and 
fatigue mitigation strategies. For example, an extended outage of 
longer than 8 weeks may have a high workload at the beginning and end 
of the outage, with limited use of extended hours in the intervening 
period. The potential for cumulative fatigue may be minimal in such 
circumstances. However, the use of extended work hours after the first 
8 weeks of the outage would be subject to collective work hour controls 
and could challenge the ability of the licensee to limit collective 
work hour averages to no more than 48 hours per person per week in the 
subsequent averaging period. Proposed Sec.  26.199(f)(5) would permit 
licensees to obtain approval for alternative approaches to work 
scheduling controls and fatigue mitigation strategies that the licensee 
could tailor to these unique and infrequent circumstances.
    Proposed Sec.  26.199(f)(5)(i) would be added to require that the 
written request to the NRC must include a description of the specific 
circumstances that would require the licensee to exceed the applicable 
collective work hour limit, the job duty group(s) affected, and the 
collective work hour limit(s) to be exceeded. The information regarding 
the specific circumstances would be necessary for the NRC to determine 
whether the circumstances warrant special consideration and whether the

[[Page 50604]]

fatigue mitigation strategies that the licensee would be required to 
establish in proposed Sec.  26.199(f)(5)(iii) would be appropriate for 
those circumstances. The information on the job duty group(s) affected 
would be necessary for the NRC to determine whether the licensee's 
proposed fatigue mitigation strategies are appropriate for those job 
duty group(s) and also to ensure that NRC resident inspectors would be 
aware of which job duty group(s) would be working under the revised 
work hour controls, if approved. Information on the collective work 
hour limit(s) to be exceeded would be necessary for the NRC to evaluate 
whether the fatigue mitigation strategies would provide an effective 
alternative to the limit(s) to be exceeded.
    Proposed Sec.  26.199(f)(5)(ii) would be added to require the 
written request to include a statement of the period of time during 
which it would be necessary to exceed the collective work hour 
limit(s). This information would be necessary for the NRC to evaluate 
whether the fatigue mitigation strategies that the licensee would be 
required to establish in proposed Sec.  26.199(f)(5)(iii) are 
appropriate for the time period requested.
    Proposed Sec.  26.199(f)(5)(iii) would be added to require the 
written request to include a description of the fatigue mitigation 
strategies, including, but not limited to, rest break requirements and 
work hour limits, that the licensee would implement to ensure that the 
individuals affected would be fit to safely and competently perform 
their duties. This information would be necessary for the NRC to 
evaluate whether these strategies would provide an effective 
alternative to the work hour limits to be exceeded.
    Proposed Sec.  26.199(g) [Successive plant outages] would be added 
to establish requirements for the control of work hours during plant 
outages that closely follow a preceding plant outage. At the conclusion 
of an outage, individuals are likely to be fatigued from working 
extended hours and the increased workload associated with the outage 
and plant restart preparations. The objective of the proposed 
requirement would be to provide adequate opportunity for individuals to 
recover and transition to an operating schedule, and thereby reduce the 
potential for cumulative fatigue of individuals that can result from 
outages that occur in close succession. The proposed requirement would 
apply to outages that follow the preceding outage by less than 2 weeks. 
A minimum of 2 weeks under normal workloads and the collective work 
hour requirements of proposed Sec.  26.199(f), which are generally only 
applicable during non-outage periods, would be necessary to provide 
reasonable assurance that individuals have the opportunity for 
successive days of rest to reduce the potential for cumulative fatigue. 
For purposes of work hour control, the proposed provision would require 
licensees in effect, to treat outages that follow a preceding outage by 
less than 2 weeks as a continuation of the first outage. Specifically, 
licensees would be required to apply the requirements of proposed Sec.  
26.199(d)(2)(iii), (f)(1), (f)(2)(i), and (f)(2)(iv) based upon the 
number of days that have elapsed since the first plant outage in the 
series began. For example, if a refueling outage lasts 6 weeks, but the 
plant encounters difficulties during power ascension a day after 
exiting the refueling outage, and enters a new outage, then the 8-week 
exclusion period must be calculated from the beginning of the refueling 
outage.
    Proposed Sec.  26.199(h) [Common defense and security] would be 
added to relieve a licensee from the proposed collective work hour 
controls when written notification is received from the NRC for the 
purpose of assuring the common defense and security for a period 
defined by the NRC. This proposed paragraph would provide necessary 
relief from the requirements of this proposed section 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. The 
proposed provision would define the process by which the NRC would 
provide such relief.
    Proposed Sec.  26.199(i) [Plant emergencies] would be added to 
temporarily waive the requirements of proposed Sec.  26.199(c)-(f) 
during declared emergencies, as defined in the licensee's emergency 
plan. 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 proposed Sec.  26.199(c)-(f). The objective of the proposed 
temporary exemption would be 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 
proposed rule would require licensees to again comply with the work 
hour controls.
    Proposed Sec.  26.199(j) [Reviews] would be 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.  26.199(a). The work hour controls in 
proposed Sec.  26.199(a) would provide licensees with substantial 
flexibility in controlling work hours. Accordingly, periodic self-
assessments would be necessary to maintain reasonable assurance that 
the licensee is implementing the specific work hour control provisions 
of proposed Sec.  26.199 consistent with the general performance 
objective in proposed Sec.  26.23(e). In addition, it would be 
necessary for the self-assessments to be scheduled in a manner that 
would ensure timely 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 would be particularly important to include those periods of time in 
any assessment of the effectiveness of a licensee's work hour controls.
    Proposed Sec.  26.199(j)(1) would be added to require licensees to 
focus their assessments on those individuals who were at the greatest 
risk of committing performance errors, including, but not limited to, 
those individuals listed in proposed Sec.  26.199(j)(1)(i)-(j)(1)(iv). 
These individuals would have worked the most hours when compared with 
their peers during the same averaging period; have been granted the 
most work-hour waivers; and were subject to fatigue assessments under 
proposed Sec.  26.201 (i.e., were assessed for fatigue for cause, post-
event, or in response to a self-declaration of being unfit for duty 
because of fatigue). Requiring licensees to consider individual 
performance, as indicated by operating events or other errors, for 
those individuals listed in proposed Sec.  26.199(j)(1)(i)-(j)(1)(iii), 
would provide an indication of whether those individuals' abilities to 
safely and competently perform their duties had actually been 
compromised.
    Proposed Sec.  26.199(j)(1)(i) would be added to require the 
assessments to include individuals who were granted more than one 
waiver during the review period. The proposed provision would require 
licensees to assess the work hours and performance of these individuals 
to ensure that licensees evaluate whether the individuals' abilities to 
safely and competently perform their duties had actually been

[[Page 50605]]

compromised. The proposed requirement would be necessary to ensure that 
licensees' use of waivers did not result in degraded worker fitness-
for-duty.
    Proposed Sec.  26.199(j)(1)(ii) would be added to require the 
assessments to include individuals who were assessed for fatigue in 
accordance with Sec.  26.201 [Fatigue assessments] during the review 
period. The proposed paragraph would require 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 proposed requirement would be 
necessary to ensure that licensee fatigue assessments are consistent 
with worker performance and are providing an effective basis for 
licensee fatigue management decisions.
    Proposed Sec.  26.199(j)(1)(iii) would be added to require the 
assessments to include individuals who performed the job duties listed 
in proposed Sec.  26.199(a) whose average individual work hours per 
week exceeded 54 hours during any averaging period for which the 
collective work hours limit would be 48 hours in this proposed section. 
These individuals worked significantly more hours than others in their 
job duty group. The proposed requirement would be necessary to ensure 
that licensees fully evaluate the work hours and performance of these 
individuals, who are at a much higher risk for cumulative fatigue than 
their peers. As noted with respect to proposed Sec.  26.199(j)(1)(iii), 
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 proposed rule would require 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.
    Proposed Sec.  26.199(j)(1)(iv) would be added to require that the 
assessments must include security personnel whose average individual 
work hours per week exceeded 66 hours in any averaging periods for 
which the collective work hour limit in this proposed section would be 
60 hours per person per week. The proposed rule would require licensees 
to evaluate the work hours and performance of these individuals for the 
same reasons discussed with respect to the individuals who would be 
evaluated under proposed Sec.  26.199(j)(1)(iii).
    Proposed Sec.  26.199(j)(2) would be added to require licensees to 
review individuals' 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 proposed Sec.  26.199. The 
proposed collective work hour controls of Sec.  26.199(f) would provide 
assurance that licensees are managing cumulative fatigue at a gross 
level for broad job duty groups, and an indication of whether staffing 
is adequate to support this objective. However, the use of broad job 
duty groups creates a potential that sub-groups of individuals (e.g., 
those with specialized skills) may work a disproportionate number of 
hours and, consequently, may be more susceptible to fatigue than 
otherwise indicated by the collective averages. Accordingly, proposed 
Sec.  26.199(j)(2) would require licensees to review work hours and 
waivers of the work hour controls to provide assurance that cumulative 
fatigue is properly managed for all jobs.
    Proposed Sec.  26.199(j)(3) would be added to require licensees to 
document the methods used to conduct their reviews and the results of 
the reviews. The NRC would use the documentation during site 
inspections as a means of assuring compliance with the regulations. The 
methods and results of the reviews would be indicative of a licensee's 
performance in managing the fatigue of its workers who would be subject 
to the requirements of this proposed 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.
    Proposed Sec.  26.199(j)(4) would be added to require 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 would be required to maintain the 
documentation that would be necessary for NRC reviews of licensees' 
compliance with the proposed work hour controls within the licensees' 
existing corrective action programs. The proposed requirement would be 
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 would 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 would be 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 proposed requirements 
and maintaining effective fatigue management programs.

Section 26.201 Fatigue Assessments

    A new Sec.  26.201 [Fatigue Assessments] would be added to require 
licensees to conduct fatigue assessments under several conditions. 
These conditions, which would be specified in proposed Sec.  
26.201(a)(1)-(a)(4), would include for cause, after a self-declaration, 
after an event that would require post-event drug and alcohol testing, 
and as a followup to returning an individual to work after a self-
declaration. The proposed assessments would be 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 where 
there has been a plant event that would require drug or alcohol testing 
as specified in proposed Sec.  26.31(c), this proposed section would 
require the licensee to conduct a fatigue assessment in order to 
determine whether fatigue contributed to the event.
    Work hour controls are necessary, but not sufficient, to 
effectively manage worker fatigue. 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, there are 
substantial individual differences in the 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 hours controls of proposed Sec.  26.199 would provide 
only partial assurance that individuals are not

[[Page 50606]]

fatigued. Therefore, fatigue assessments would be 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. There is a large body of research that 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 proposed Sec.  
26.201(a)(1)-(a)(4) would be for licensees to appropriately address 
instances of worker fatigue, including those that are not prevented by 
the work hour controls, regardless of the number of hours that the 
subject individual has worked or rested. As discussed with respect to 
proposed Sec.  26.201(c), these assessments would 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.
    Proposed Sec.  26.201(a)(1) would specify that licensees must 
perform a fatigue assessment, in addition to any other testing that 
would be required under proposed 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 proposed 
requirement would be 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 would help to determine if fatigue was the cause for 
the perceived impairment in circumstances where 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, as discussed 
with respect to proposed Sec.  26.201. 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 decision-making, 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).
    Proposed Sec.  26.201(a)(1) would 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 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, proposed Sec.  26.201(a)(1) would exclude napping during a 
break period as a condition for which the proposed provision would 
require a for-cause fatigue assessment.
    Proposed Sec.  26.201(a)(1) would also permit 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 proposed requirement for for-cause 
fatigue assessments, the NRC considered stakeholder comments during the 
public meetings described in Section V. 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 proposed requirement would permit 
licensees to assess only fatigue, if there are no indications of 
possible substance abuse.
    Proposed Sec.  26.201(a)(1) would also permit licensees to conduct 
drug and alcohol testing, without a fatigue assessment, when the 
licensee has reason to believe that the observed condition is not due 
to fatigue. The NRC considered stakeholder comments at the public 
meetings described in Section V 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 would be 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 there would be no benefit from requiring a fatigue 
assessment.
    Proposed Sec.  26.201(a)(2) would be added to require licensees to 
conduct a fatigue assessment if an individual makes a self-declaration 
that he or she may not be 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 controls in 
proposed Sec.  26.199, are appropriately addressed, regardless of the 
number of hours the individual has worked or rested. Current Sec.  
26.27(b)(1) requires 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 may not be 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, would be 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

[[Page 50607]]

proposed rule would 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 
would be consistent with proposed Sec.  26.199(b)(2)(i), which would 
establish required break times between work periods, and is generally 
considered sufficient to address most acute fatigue conditions.
    As discussed with respect to proposed Sec.  26.201(c), a fatigue 
assessment would provide 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 proposed Sec.  6.197(b)(1)(ii), licensees would be 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 proposed requirement for fatigue assessments of 
individuals who have self-declared, the NRC considered research 
concerning subjective assessments of alertness. Self-declarations would 
generally be 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 alertness than 
indicated by physiological measures.'' As a consequence, individuals 
who self-declare would 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.
    Proposed Sec.  26.201(a)(2) would also specify 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 proposed requirement 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 proposed 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 proposed requirement would specify 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 proposed 
Sec.  26.201(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 would be required 
``for-cause'' in accordance with proposed Sec.  26.201(a)(1).
    Proposed Sec.  26.201(a)(3) would be added to specify that 
licensees must perform a fatigue assessment after an event that would 
require drug or alcohol testing, as required in proposed Sec.  
26.31(c)(3). Proposed Sec.  26.31(c)(3)(i)-(c)(3)(iii) would specify 
the events and conditions requiring post-event drug and alcohol 
testing. A fatigue assessment would also be 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 would also provide the 
basis for subsequent management actions for fatigue management, as 
required by proposed Sec.  26.201(c) (e.g., relieving an individual of 
duties or requiring additional fatigue mitigation actions). Further, 
the fatigue assessment may provide insights concerning the 
effectiveness of the licensee's fatigue management program.
    Consistent with proposed Sec.  26.31(d)(5)(ii), the proposed 
requirement would specify 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 
would be irrelevant to the immediate protection of public health and 
safety or the common defense and security.
    Proposed Sec.  26.201(a)(4) would be added to require licensees to 
perform a followup fatigue assessment if an individual is to be 
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 proposed provision would be 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 would ensure 
that the individual is capable of performing his or her duties safely 
and competently during the upcoming work period. It would also provide 
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).
    Proposed Sec.  26.201(b) would be added to require that either a 
supervisor or a staff member of the FFD program, who is trained in 
accordance with the requirements of proposed Sec. Sec.  26.29 and 
26.197(c), must conduct any fatigue assessment that would be required 
under proposed Sec.  26.201. In accordance with proposed Sec.  
26.201(c), fatigue assessments would provide the basis for subsequent 
actions for fatigue management (e.g., relieving an individual of duties 
or requiring

[[Page 50608]]

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 
26.197(c) would provide the knowledge and abilities that are essential 
to a supervisor's or FFD program staff member's ability to make valid 
assessments in this regard. Among other FFD topics, the proposed 
training would address: (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. Individuals would also be 
required by proposed Sec.  26.29(b) to demonstrate successful 
completion of the training by passing a comprehensive examination that 
addresses the KAs.
    Proposed Sec.  26.201(b) would further require that supervisors or 
FFD program staff members must perform the fatigue assessment face to 
face with the subject individual. This proposed requirement would 
ensure 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.
    Proposed Sec.  26.201(b)(1) would be added to prohibit individuals 
who observe another individual who is exhibiting indications of 
impaired alertness from performing the for-cause fatigue assessment of 
that individual. Without this proposed 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 proposed Sec.  26.201(c), fatigue 
assessments would 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 negligent in 
maintaining his or her FFD. Therefore, in the case of fatigue 
assessments that would be conducted for cause, the fatigue assessment 
should be performed by an independent third party to provide reasonable 
assurance of an objective assessment.
    Proposed Sec.  26.201(b)(2) would be added to prohibit individuals 
from performing a post-event fatigue assessment in those circumstances 
specified in proposed Sec.  26.201(b)(2)(i)-(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. The proposed requirement would provide 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.
    Proposed Sec.  26.201(b)(2)(i) would be added to prohibit 
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 proposed rule would prohibit these 
individuals from performing fatigue assessments under the specified 
conditions.
    Proposed Sec.  26.201(b)(2)(ii) would be added to prohibit 
individuals from performing a post-event fatigue assessment if they 
performed, within 24 hours before the event occurred, a fatigue 
assessment of the individuals who were performing or directing the work 
activities during which the event occurred. These individuals may have 
a conflict of interest. For example, if an individual had previously 
self-declared fatigue, but a fatigue assessment determined he or she 
was fit to continue work, and an event subsequently occurred that would 
require the subject individual to be assessed again, then the 
supervisor who performed the first assessment may avoid adverse action 
for their previous determination by performing the post-event fatigue 
assessment and erroneously determining the individual was not fatigued. 
Therefore, the proposed rule would prohibit these individuals from 
performing fatigue assessments under the specified conditions.
    Proposed Sec.  26.201(b)(2)(iii) would be added to prohibit 
individuals from performing a post-event fatigue assessment if they 
evaluated or approved a waiver of the limits specified in proposed 
Sec.  26.199(d)(1) and (d)(2) 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. For example, a supervisor who previously 
assessed an individual such that the individual would be permitted to 
perform work under a waiver would benefit from an assessment that the 
individual was not fatigued if an event occurred while the individual 
was working under the waiver. Therefore, the proposed rule would 
prohibit these individuals from performing fatigue assessments under 
the specified conditions.
    Proposed Sec.  26.201(c) would be added to require that fatigue 
assessments must provide the information necessary for management 
decisions and actions in response to the circumstance that initiated 
the assessment. This information would be 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. Proposed Sec.  26.201(c) would provide 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 proposed Sec.  26.201(c)(1)(i)-(c)(1)(iii) would 
specify the minimum considerations for fatigue assessments.
    In determining the scope of the proposed assessments, the NRC 
considered the need for licensees to be able to focus the assessment on 
information that would be readily available and verifiable. Proposed 
Sec.  26.201(c) would require the assessment to address the three work 
schedule factors that 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:
    Proposed Sec.  26.201(c)(1)(i) would be added to specify the first 
criterion that fatigue assessments would address, which is 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 could assess the potential for acute fatigue 
by estimating, at a

[[Page 50609]]

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).
    Proposed Sec.  26.201(c)(1)(ii) would be added to specify the 
second criterion that fatigue assessments would address, which is 
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 could 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; as well as (4) other 
individual factors or information provided by the individual (such as 
any personal issues that 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 had 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 seven 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 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 decision-making 
involving the unexpected, innovation, revising plans, competing 
distraction and effective communication.''
    Proposed Sec.  26.201(c)(1)(iii) would be added to specify the 
third criterion that fatigue assessments would be required to address, 
which is circadian variations in alertness and performance. The impact 
of such variations on an individual's ability to safely and competently 
perform his or her duties is discussed in Section IV. D. Licensees 
could assess the potential for circadian degradations in alertness and 
performance by considering the time of day or night during which the 
work was or would be performed and whether the time period coincides 
with a circadian trough in the individual's level of alertness.
    Proposed Sec.  26.201(c)(2) would be added to require that 
individuals must provide complete and accurate information that may be 
required by the licensee to address the factors listed in proposed 
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, there are many other 
factors that can affect worker fatigue, not all of which may be readily 
apparent to a licensee. As a consequence, effective assessment and 
management of fatigue is a shared responsibility of individuals and 
licensees, and 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, and 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, there are substantial individual differences in the 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 
would substantively improve 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 has been or would be performed and 
whether the time period would coincide 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.
    Proposed Sec.  26.201(c)(2) would also limit licensees' inquiries 
to obtaining from the subject individual only the information that is 
necessary to assess the factors listed in proposed Sec.  26.201(c)(1). 
The fatigue assessment should 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 proposed 
Sec.  26.37 [Protection of information], licensees would be required to 
keep any information from the individual's self-disclosures 
confidential.
    Proposed Sec.  26.201(d) would be added to prohibit 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

[[Page 50610]]

work hours have not exceeded any of the limits specified in proposed 
Sec.  26.199(d)(1) or that the individual has had the minimum rest 
breaks required in proposed Sec.  26.199(d)(2). The individual work 
hour controls of proposed Sec.  26.199(d)(1) and (d)(2) would be 
intended to provide reasonable measures to prevent fatigue due to 
excessive work hours. However, the proposed controls address only work 
hours and the length of rest breaks, 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 proposed 
maximum work hours and minimum rest requirements of proposed Sec.  
26.199(d)(1) and (d)(2), it is neither practical nor possible to 
establish limits that would prevent fatigue for all individuals. 
Therefore, the proposed rule would require 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.
    Proposed Sec.  26.201(e) would be added to require that, following 
a fatigue assessment, the licensee must decide whether the individual 
may perform job duties without a rest break, and, if so, whether 
controls and conditions must be established under which the individual 
may perform those duties. Controls and conditions may be necessary to 
ensure that the duties are performed in a safe and competent manner. 
Examples of controls and conditions would include, but would not be 
limited to: (1) A rest break; (2) 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 are simple in nature; and (4) 
assignment to job duties that are not important to the protection of 
public health and safety or common defense and security. Proposed Sec.  
26.201(e) would also require licensees to ensure that any controls and 
conditions that have been determined to be necessary to return an 
individual to duty would be implemented.
    Proposed Sec.  26.201(f) would be added to require that licensees 
must document the results of any fatigue assessments that are 
performed, the circumstances that necessitated the fatigue assessments, 
and any controls and conditions that were implemented. The proposed 
documentation would be necessary for NRC inspectors to evaluate the 
fatigue assessment component of licensees' FFD programs and for the 
licensee to conduct the reviews required under proposed Sec.  26.199(j) 
[Reviews]. The information that the proposed rule would require 
licensees to document would provide indicators of how well a licensee's 
fatigue mitigation program at a site is performing.

Subpart J--Recordkeeping and Reporting Requirements

Section 26.211 General Provisions

    Proposed Sec.  26.211 [General provisions] would be added to define 
general requirements related to recordkeeping and reporting under Part 
26.
    Proposed Sec.  26.211(a) would establish a requirement that 
licensees and other entities who are subject to this part must maintain 
records and submit certain reports to the NRC, consistent with Goal 6 
of this rulemaking, which is to improve clarity in the organization and 
language of the rule. In addition, the proposed paragraph would require 
that licensees and other entities retain the records required under the 
proposed rule for either the periods that are specified in proposed 
Subpart J 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 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), and would be added for clarity in 
the language of the rule.
    Proposed Sec.  26.211(b) would be added 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. The 
proposed paragraph would be added to recognize that most records are 
now stored electronically and must be protected to ensure the integrity 
of the data. The proposed requirements would be consistent with related 
requirements in the access authorization orders issued to nuclear power 
plant licensees dated January 7, 2003, and would, therefore, meet Goal 
4 of this rulemaking, which is 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 26.213 Recordkeeping Requirements for Licensees and Other 
Entities

    Proposed Sec.  26.213 [Recordkeeping requirements for licensees and 
other entities] would amend current Sec.  26.71 [Recordkeeping 
requirements]. Current Sec.  26.71(d), which establishes requirements 
for FFD program performance reports, would be retained in a separate 
section that would focus only on those reports in proposed Sec.  26.217 
[Fitness-for-duty program performance data]. Proposed Sec.  26.213 
would retain but amend current Sec.  26.71(a)-(c) and add other 
requirements that are interspersed throughout the current rule. These 
proposed changes would be made to meet Goal 6 of this rulemaking, which 
is 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.
    Proposed Sec.  26.213(a) would require licensees and other entities 
to retain certain records related to authorization decision-making 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 proposed requirement to retain 
records until the completion of all related legal proceedings would be 
added at the suggestion of stakeholders during the public meetings 
discussed in Section V. The stakeholders noted that some legal 
proceedings involving records of the type specified in the proposed 
paragraph have continued longer than the 5 years that the current rule 
requires these records to be retained and that adding a requirement to 
retain the records until all legal proceedings are complete would 
protect individuals' right to due process under the rule. The proposed 
change would be consistent with Goal 7 of this rulemaking, which is to 
protect the privacy and due process rights of individuals who are 
subject to Part 26.
    Proposed Sec.  26.213(a)(1) would amend current Sec.  26.71(a), 
which requires 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 
proposed paragraph

[[Page 50611]]

would update the terminology used in the current paragraph for 
consistency with the revised language used throughout the proposed 
rule. For example, the proposed paragraph would refer to ``self-
disclosures,'' ``employment histories,'' ``suitable inquiries,'' and 
``granting authorization,'' but retain the intent of the current 
paragraph. The proposed changes in terminology would be made for the 
reasons discussed with respect to proposed Sec. Sec.  26.61 [Self-
disclosure and employment history] and 26.63 [Suitable inquiry]. In 
addition, the current cross-reference to Sec.  26.27(a) would be 
updated to cross-reference the related portions of the proposed rule.
    Proposed Sec.  26.213(a)(2) would amend current Sec.  26.71(b), 
which requires licensees to retain records that are related to 
confirmed positive test results that have been confirmed by the MRO. 
The proposed paragraph would revise the current requirement by 
requiring licensees and other entities to retain records that are 
related to any violation of the FFD policy, which would include 
confirmed positive drug and alcohol test results. This proposed change 
would be made to ensure 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 decision-making process specified 
in proposed Sec.  26.69 [Authorization with potentially disqualifying 
fitness-for-duty information].
    Proposed Sec.  26.213(a)(3) would be added to require licensees and 
other entities to retain records that are related to the granting and 
termination of an individual's authorization. The proposed paragraph 
would be necessary to ensure that licensees and other entities who may 
be considering granting authorization to an individual under proposed 
Subpart C [Granting and Maintaining Authorization] can determine which 
category of authorization requirements in proposed Subpart C would 
apply to the individual, based upon the length of time that has elapsed 
since the individual's last period of authorization was terminated and 
whether the individual's last period of authorization was terminated 
favorably. The proposed categories of authorization requirements are 
discussed in Section IV. C and in this section, with respect to 
proposed Subpart C.
    Proposed Sec.  26.213(a)(4) would be added to require licensees and 
other entities to retain records that are related to any determination 
of fitness that was conducted under proposed Sec.  26.189 
[Determination of fitness]. The proposed requirement would be necessary 
to ensure 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 decision making process specified in proposed Sec.  
26.69 [Authorization with potentially disqualifying fitness-for-duty 
information]. In addition, if an individual who is subject to a 
followup testing and treatment plan transfers to another FFD program, 
the reviewing official and SAE of the receiving FFD program, which 
would take responsibility for implementing the testing and treatment 
plans, would require access to this information.
    Proposed Sec.  26.213(b)(1) and (b)(2) would require 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. The proposed paragraphs would retain the 3-year recordkeeping 
requirements of the current 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.
    Proposed Sec.  26.213(c) would amend current Sec.  26.71(c), which 
requires licensees to retain records related to any individual who was 
made ineligible for authorization for 3 years or longer under current 
Sec.  26.27 [Management actions and sanctions to be imposed] until the 
Commission terminates each license under which the records were 
created. The proposed paragraph would require 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 proposed 
paragraph would add the requirement to retain records related to 5-year 
denials of authorization for consistency with the more stringent 
sanctions established in proposed Sec.  26.75(c), (d), and (e)(2), in 
which the sanction of a 3-year denial of authorization has been 
eliminated, as discussed with respect to those proposed paragraphs. The 
40-year retention requirement would be 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 would not mean 
that the individuals whose authorization was denied for 5 years or 
permanently denied under the licensee's FFD program would necessarily 
leave the industry. Requiring retention of the records pertaining to 
those individuals would ensure that the records of the 5-year and 
permanent denials are available, should the individual seek 
authorization from another licensee or other entity.
    Proposed Sec.  26.213(d) would replace the recordkeeping 
requirement in current Sec.  26.20 [Written policy and procedures]. The 
proposed paragraph would require licensees and other entities to retain 
superseded FFD policies and procedures for at least 5 years or until 
they would no longer be needed to respond to a legal challenge. The 
period of time that superseded materials would be retained would be 
increased 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 proposed requirement to retain 
the policy and procedures related to any matter under legal challenge 
until the matter is resolved would be added to ensure that the 
materials remain available, should 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.
    Proposed Sec.  26.213(e) would amend the requirement in current 
Sec.  26.23(a) pertaining to the retention of written agreements for 
the provision of FFD program services. The proposed paragraph would 
require licensees and other entities to retain the written agreement 
for the life of the agreement (as in the current rule) or until 
completion of all legal proceedings related to an FFD violation that 
involved the services, whichever is later. The proposed requirement to 
retain the written agreements for any matter under legal challenge 
until the matter is resolved would be added to ensure that the 
materials remain available, should an individual, the NRC, a licensee, 
or another entity who would be subject to the rule require access to 
them in a legal or regulatory proceeding.
    Proposed Sec.  26.213(f) would be added 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 proposed Sec.  
26.31(b)(1)(ii), 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. 
The proposed paragraph would be consistent with the last phrase of 
current Section 2.6(c) in Appendix A to Part 26, which requires 
licensee testing facilities to

[[Page 50612]]

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 proposed period during which these 
records must be maintained would be 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 should an individual, the NRC, a 
licensee, or another entity who would be subject to this rule require 
access to them in a legal or regulatory proceeding. However, the 
proposed rule would establish 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.
    Proposed Sec.  26.213(g) would be added to require licensees and 
other entities to retain records of the certification of the scientific 
and technical suitability of any assays and cutoff levels used for drug 
testing that are not addressed in this part, provided by a qualified 
forensic toxicologist, as required under proposed Sec.  26.31(d)(1)(i) 
and (d)(3)(iii)(C). The proposed paragraph would require 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 testing is 
not required under this part, uses more stringent cutoff levels than 
those specified in this part, or until the completion of all related 
legal proceedings, whichever is later. This proposed requirement would 
be necessary to ensure the NRC's access to the records for inspection 
purposes and that the records remain available should an individual, 
the NRC, a licensee, or another entity who would be subject to this 
rule require access to them in a legal or regulatory proceeding.

Section 26.215 Recordkeeping Requirements for Collection Sites, 
Licensee Testing Facilities, and Laboratories Certified by the 
Department of Health and Human Services

    A new Sec.  26.215 [Recordkeeping requirements for collection 
sites, licensee testing facilities, and laboratories certified by the 
Department of Health and Human Services] would be added to group 
together in one section the recordkeeping requirements that apply to 
collection sites, licensee testing facilities, and HHS-certified 
laboratories contained in current Sec. Sec.  26.20 and 26.71, and, 
Sections 2.5(f), 2.6 (c), 2.7(a)(1), 2.7(f)(2), 2.7(g)(8), 2.7(n), 
2.7(o)(1) and (o)(3), 2.8(e)(4), 2.9(g), and 3.1 in Appendix A to Part 
26. The proposed rule would group these requirements in one section to 
make them easier to locate within the proposed rule, consistent with 
Goal 6 of this rulemaking, which is to improve clarity in the 
organization and language of the rule.
    Proposed Sec.  26.215(a) would retain the requirement in current 
Section 2.7(n) in Appendix A to Part 26, which mandates that HHS-
certified laboratories and licensee testing facilities must maintain 
documentation of all aspects of the testing process for at least 2 
years, and would extend this requirement to collection sites. The 
proposed rule would include collection sites within this provision 
because licensee testing facilities and collection sites may not be co-
located, as was typically the case when the current rule was first 
published. The proposed paragraph would retain the provision in current 
Section 2.7(n) that the 2-year period may be extended upon written 
notification by the NRC or any licensee or other entity for whom 
services are being provided. The proposed rule would also add a 
requirement to retain the documentation until completion of all legal 
proceedings related to an FFD violation to ensure that the records 
remain available should an individual, the NRC, a licensee, or another 
entity who would be subject to this rule require access to them in a 
legal or regulatory proceeding.
    Proposed Sec.  26.215(b)(1)-(b)(14) would be added to list in a 
single paragraph the documents that must be retained by collection 
sites, licensee testing facilities, and HHS-certified laboratories. 
Specifically, those documents would include personnel files of 
individuals who are no longer working at a collection site, licensee 
testing facility or HHS-certified laboratory, 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 current rule in Sec.  26.20 and Sec.  26.71(a); and 
in Appendix A to Part 26, 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. The proposed 
rule would group them together in a single paragraph to make them 
easier to locate within the rule, consistent with Goal 6 of this 
rulemaking, which is to improve clarity in the organization and 
language of the rule.

Section 26.217 Fitness-for-Duty Program Performance Data

    A new Sec.  26.217 [Fitness-for-duty program performance data] 
would amend the requirements in current 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, the 
proposed rule would require licensees and other entities to submit 
program performance data to the NRC every 12 months, rather than every 
6 months. The proposed rule would make additional conforming changes to 
current Sec.  26.71 for consistency with other revisions to the rule, 
as follows:
    Proposed Sec.  26.217(a) would retain the requirement in current 
Sec.  26.71(d) that each FFD program subject to Part 26 must collect 
and compile FFD performance data.
    Proposed Sec.  26.217(b)(1)-(b)(8) would amend the second sentence 
of current Sec.  26.71(d) to specify the FFD program performance data 
that a licensee or other entity must report, including the random 
testing rate, the drugs for which is conducted and 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, and summary of 
management actions. The proposed paragraph is identical to the 
requirements of the current provision with two exceptions: (1) The 
current rule does not require reporting the number of subversion 
attempts by type and (2) the proposed rule would not require a list of 
events reported during the reporting period.
    The proposed rule would add a requirement for licensees and other 
entities to report the number of subversion attempts by type. This 
proposed reporting requirement would be 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 proposed 
Sec. Sec.  26.31(d)(3)(i) and 26.75(b). Although this information would 
be available to NRC inspection personnel at each site,

[[Page 50613]]

it would be costly and an inefficient use of inspection resources for 
inspectors to aggregate and report it annually. Under the current rule, 
licensees typically report subversion attempts they have detected under 
the requirement to summarize ``events reported'' in current Sec.  
26.71(d). Therefore, the NRC expects that the proposed reporting 
requirement would impose a minimal additional burden.
    The proposed rule would eliminate the current requirement to 
include the number of events reported to the NRC during the reporting 
period. The current reporting requirement would be eliminated because 
the NRC has access to this information through other avenues and 
reporting it twice would be unnecessary.
    Proposed Sec.  26.217(c) would amend the portions of current Sec.  
26.71(d) that require licensees and other entities to analyze the FFD 
program performance data semi-annually. The proposed paragraph would 
require licensees and other entities to analyze FFD program performance 
data annually, rather than semi-annually, and retain the requirement 
that actions must be taken to correct program weaknesses. NRC 
experience in reviewing FFD program performance reports since the rule 
was first promulgated has shown that reporting twice per year is 
unnecessary to ensure the continuing effectiveness of FFD programs. 
Therefore, the proposed rule would relax the semi-annual analysis and 
reporting requirement. Further, the proposed paragraph would require 
licensees and other entities to retain for 3 years records of the data, 
analysis, and corrective actions taken, which is the same as the 
current requirement in Sec.  26.71(d). However, the proposed rule would 
add a requirement to retain the documentation until completion of any 
legal proceedings related to an FFD violation to ensure that the 
records remain available should an individual, the NRC, a licensee, or 
another entity who would be subject to this rule require access to them 
in a legal or regulatory proceeding.
    Proposed Sec.  26.217(d) would retain the last sentence of current 
Sec.  26.71(d), which requires that any licensee who temporarily 
suspends an individual's authorization or takes administrative actions 
on the basis of a non-negative initial test result for marijuana or 
cocaine [under the provisions of current Sec.  26.24(d)] must 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 proposed paragraph would continue 
to require that the report must include the number of administrative 
actions taken against individuals for the reporting period. However, 
the term, ``temporarily suspend,'' would be eliminated from the 
proposed paragraph and replaced with the term, ``administratively 
withdraw authorization,'' in response to stakeholder requests at the 
public meetings discussed in Section V. 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, eliminated the inaccurate phrase from the proposed 
rule.
    Proposed Sec.  26.217(e) would amend portions of current Sec.  
26.71(d) to require licensees and other entities to submit the annual 
summary to the NRC by March 1 of the following year, rather than the 
current requirement of a semi-annual summary to be reported within 60 
days of the end of each 6-month reporting period. This proposed change 
would be made for consistency with the revised requirement to submit 
the report semi-annually in proposed Sec.  26.217(c), as discussed with 
respect to that paragraph.
    Proposed Sec.  26.217(f) would retain the requirement in current 
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.
    Proposed Sec.  26.217(g) would introduce a new requirement that C/
Vs who maintain an approved drug and alcohol testing program must 
submit to the NRC the same program performance data that would be 
required from licensees and other entities who would be subject to the 
proposed 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 proposed requirement is needed because the 
proposed rule would apply directly to C/Vs who maintain licensee-
approved programs, rather than applying only to licensees under the 
current rule, as discussed with respect to proposed Sec.  26.3(d).

Section 26.219 Reporting Requirements

    A new Sec.  26.219 [Reporting requirements] would replace current 
Sec.  26.73 [Reporting requirements] and combine them with current 
Section 2.8(e)(4), (e)(5), and (e)(6) in Appendix A to Part 26. The 
proposed section would group into one section reporting requirements 
that are interspersed throughout the current rule to meet Goal 6 of 
this rulemaking, which is to improve clarity in the organization and 
language of the rule.
    Proposed Sec.  26.219(a) [Required reports] would be added to 
introduce the proposed section, consistent with Goal 6 of this 
rulemaking, which is to improve clarity in the organization and 
language of the rule, by specifying the categories of significant 
events that licensees and other entities would 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 proposed paragraph would retain the requirement in current Sec.  
26.73(c) that significant events must be reported under this section, 
rather than under the provisions of 10 CFR 73.71.
    Proposed Sec.  26.219(b) [Significant FFD policy violations or 
programmatic failures] would reorganize and amend current Sec.  
26.73(a)(1), (a)(2), and (b). Proposed Sec.  26.219(b) would retain the 
requirement in current Sec.  26.73(b) that notifications of events must 
be made to the NRC Operations Center within 24 hours of their 
discovery, but the proposed rule would present this requirement at the 
beginning of the paragraph to clarify that it applies to all of the 
events that are listed in the proposed paragraph.
    Proposed Sec.  26.219(b)(1) would amend current Sec.  26.73(a)(1), 
which requires licensees to report the sale, use, or possession of 
illegal drugs within a protected area. The proposed paragraph would add 
a requirement for licensees and other entities also to report the 
consumption or presence of alcohol in a protected area. This proposed 
change would be made for consistency with the NRC's increased concern 
with the adverse effects of alcohol abuse on safe performance, as 
discussed with respect to proposed Sec.  26.75(e). The proposed change 
would also be consistent with the revised performance objective in 
proposed 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. The consumption or presence of alcohol in a protected area 
would constitute a significant programmatic failure in achieving this 
performance objective.
    Proposed Sec.  26.219(b)(2) would amend current Sec.  26.73(a)(2), 
which requires 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 tests on such 
persons; involving consumption of alcohol within the protected area; or 
resulting in a determination of unfitness

[[Page 50614]]

for scheduled work due to the consumption of alcohol. The proposed rule 
would expand the current reporting requirement to include SSNM 
transporter personnel and FFD program personnel. The proposed change 
would be made to ensure that the NRC 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.
    Proposed Sec.  26.219(b)(2)(i) would retain current Sec.  
26.73(a)(2)(i), which requires licensees and other entities to report 
any acts by the subject individuals that involve the use, sale, or 
possession of a controlled substance.
    Proposed Sec.  26.219(b)(2)(ii) would combine and amend current 
Sec.  26.73(a)(2)(ii) and (a)(2)(iv), which require licensees and other 
entities to report any confirmed positive tests on such persons and any 
acts by the subject individuals that result in a determination of 
unfitness for scheduled work due to the consumption of alcohol, 
respectively. The proposed paragraph would amend the current 
requirements by requiring licensees and other entities to 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 proposed Sec.  26.5 [Definitions]). 
This proposed change would be made for consistency with two other 
changes to the proposed rule: (1) The addition of validity testing 
requirements to the proposed rule, as discussed with respect to 
proposed Sec.  26.31(d)(3)(i), and (2) the new requirements in proposed 
Subpart D [Management actions and sanctions] to impose the same 
sanctions for confirmed positive alcohol test results as those required 
for confirmed positive drug test results, as discussed with respect to 
proposed Sec.  26.75(e). Therefore, the proposed rule would require 
licensees and other entities to report confirmed non-negative validity 
test results, any other acts to subvert or attempt to subvert the 
testing process, and confirmed positive alcohol test results for these 
individuals.
    Proposed Sec.  26.219(b)(2)(iii) would amend current Sec.  
26.73(a)(2)(iii), which requires licensees and other entities to report 
any events involving the consumption of alcohol within the protected 
area by the subject individuals, by adding the requirement to report 
any acts involving the consumption of alcohol while performing the job 
duties that require these individuals to be subject to this part. This 
proposed change would be made for consistency with the proposed 
addition of SSNM transporters and FFD program personnel to this 
paragraph, as discussed with respect to proposed Sec.  26.219(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 proposed Sec.  
26.219(b)(2) while they are performing the duties that require them to 
be subject to this part at any location.
    Proposed Sec.  26.219(b)(3) would be added to establish 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 intentional acts that could cast doubt on 
the integrity of the FFD program and would be of concern to the NRC, 
the proposed rule would not specify the acts that licensees and other 
entities must report. However, such intentional acts may include, but 
would not be 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 devices and 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 is used by 
the FFD program to randomly select individuals for testing to ensure 
that specific individuals are not selected. The intentional acts that 
the proposed rule would require licensees and other entities to report 
could involve any aspect of the operations of the FFD program and the 
testing process.
    The proposed rule would add this new reporting requirement because 
of other changes to the proposed rule that would permit licensees and 
other entities to rely on other Part 26 programs to a much greater 
extent than currently. The proposed rule would permit 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 would require 
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 may take corrective actions, if necessary.
    Proposed Sec.  26.219(b)(4) would be added 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 job duties that require them 
to be subject to this part. In Item 10.1 of NUREG-1385, the NRC 
emphasized that the NRC expects licensees to exercise prudent judgment 
in determining whether unusual situations should be reported and that 
the significant events the licensees must report are not limited to the 
examples contained in the rule. However, the NRC understands that many 
significant events that would be useful for formulating public policy 
or that the NRC should respond to in a timely fashion have not been 
reported because licensee management decided not to report the event 
unless it was specifically required by the rule. Therefore, the 
proposed rule would add Sec.  26.219(b)(4) to clarify that significant 
events and programmatic failures are not limited to those listed in 
proposed Sec.  26.219(b), but would include any programmatic failures 
or weaknesses that potentially could permit substance abuse to be 
undetected.
    Proposed Sec.  26.219(c) [Drug and alcohol testing errors] would 
reorganize and amend current requirements for reporting errors in drug 
and alcohol testing for organizational clarity. The proposed rule would 
retain the current requirements for licensees and other entities to 
investigate and take corrective actions for drug and alcohol testing 
errors in proposed Sec. Sec.  26.137(f) and 26.167(g) for licensee 
testing facilities and HHS-certified laboratories, respectively, but 
would move the reporting requirements to this proposed paragraph.

[[Page 50615]]

    Proposed Sec.  26.219(c)(1) would update the portion of current 
Section 2.8(e)(4) in Appendix A to Part 26 that mandates that licensees 
and other entities must report within 30 days of completing an 
investigation of any testing errors or unsatisfactory performance in 
blind performance testing at either a licensee testing facility or an 
HHS-certified laboratory. The proposed paragraph would amend the 
current requirement by specifying that the report of the incident must 
include a description of the corrective actions taken or planned. 
Although licensees and other entities have consistently included a 
description of corrective actions in such reports, the proposed rule 
would add this as a requirement to clarify the NRC's intent in the 
language of the rule.
    In addition, the proposed paragraph would add cross-references to 
other sections of the proposed rule that define processes that may also 
result in the identification of errors, including the reviews required 
under proposed Sec.  26.39 [Review process for fitness-for-duty 
violations] and proposed Sec.  26.185 [Determining a fitness-for-duty 
policy violation]. The NRC intended, in the original rule, 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 proposed change would be made to clarify that the 
requirement to investigate, correct, and report errors would not be 
limited only to errors identified through blind performance testing in 
licensee testing facilities and HHS-certified laboratories but also 
would apply to errors identified through any means.
    Proposed Sec.  26.219(c)(2) would amend the portion of current 
Section 2.8(e)(5) in Appendix A to Part 26 that requires licensees to 
promptly notify the NRC if a false positive error occurs on a blind 
performance test sample. The proposed paragraph would replace the 
current requirement that the report must be made ``promptly'' with a 
requirement to report the false positive error within 24 hours of the 
discovery. This proposed change would be made as a result of the public 
meetings discussed in Section V, during which the stakeholders noted 
that ``promptly'' is vague. Therefore, the proposed rule would clarify 
the current requirement by establishing a 24-hour time limit for the 
notification to meet Goal 6 of this rulemaking, which is to improve 
clarity in the language of the rule.
    The proposed rule would establish 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. 
The HHS views false positive test results very seriously and may de-
certify a laboratory as a result. The 24-hour time limit would be 
necessary to ensure that the NRC can quickly notify the HHS of the 
problem so that the HHS may initiate the applicable steps required 
under the HHS 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 they have submitted.
    Proposed Sec.  26.219(c)(3) would be added to require licensees and 
other entities to report, within 24 hours of the discovery, any false 
negative errors identified through quality assurance checks of validity 
screening devices, if the licensee or other entity uses these devices 
for validity testing at a licensee testing facility. The proposed 
reporting requirement would be necessary to ensure that the NRC is 
aware of any device failures, so that other Part 26 programs that rely 
on the devices 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 devices 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 proposed rule would not require licensees and other entities to 
report false positive errors identified through quality assurance 
checks of validity screening devices for two reasons. First, other 
provisions of the proposed rule would 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 proposed Sec.  26.75(h). Second, donors would 
be protected from adverse consequences of false positive errors because 
any specimen that yields a non-negative validity screening test result 
would be forwarded to an HHS-certified laboratory for initial and 
confirmatory testing, if required, before a licensee or other entity 
would be permitted to act, as discussed with respect to proposed Sec.  
26.137(c). Therefore, reporting of false positive errors would be 
unnecessary to protect the interests of either donors or the public.
    Proposed Sec.  26.219(d) [Indicators of programmatic weaknesses] 
would be added to require licensees and other entities to document, 
trend, and correct non-reportable FFD issues that identify programmatic 
weaknesses under the licensee's or other entity's corrective action 
program. The proposed rule would add 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 proposed rule would add these requirements 
for consistency with Criterion XVI in Appendix B to 10 CFR Part 50 to 
FFD programs and to meet Goal 3 of this rulemaking, which is to improve 
the effectiveness and efficiency of FFD programs.
    The proposed paragraph would also require licensees and other 
entities to document, trend, and correct any programmatic weaknesses in 
a manner that protects individuals' privacy. For example, the proposed 
paragraph would prohibit licensees and other entities from documenting 
a single non-negative drug test result in the corrective action 
program, because such documentation, along with other cues in the work 
environment, would permit any individual who has access to the 
corrective action system easily to identify the donor. However, under 
the proposed rule, the NRC would expect licensees and other entities to 
document, trend, analyze, and take corrective actions for an increase 
in the rate of confirmed non-negative 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. The proposed requirement to protect individuals' 
privacy within the corrective action program would be added to meet 
Goal 7 of this rulemaking, which is to protect the privacy and due 
process rights of individuals who are subject to Part 26.

Subpart K--Inspections, Violations, and Penalties

    A new Subpart K [Inspections, Violations, and Penalties] would be 
added to the proposed rule to combine into one subpart current 
Sec. Sec.  26.70 [Inspections], 26.90 [Violations] and 26.91 [Criminal 
penalties]. Proposed Sec.  26.221 [Inspections] would retain the 
requirements in current Sec.  26.70.

[[Page 50616]]

Proposed Sec.  26.223 [Violations] would retain the requirements in 
current Sec.  26.90 [Violations]. Proposed Sec.  26.225 [Criminal 
penalties] would retain the requirements in current Sec.  26.91 
[Criminal penalties].
    Appendix A would be deleted in its entirety.

VII. Issues for Public Comment

    The NRC seeks public comment on the following issues. Public 
comments should be submitted to the NRC as indicated under the heading 
ADDRESSES.
    1. Proposed Sec.  26.75 in Subpart D would increase the sanctions 
for certain testing-related actions by requiring that: ``Any act or 
attempted 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 this part must 
result in permanent denial of authorization,'' and ``for individuals 
whose authorization was denied for 5 years * * * any subsequent 
violation of the drug and alcohol provisions of an FFD policy must 
immediately result in permanent denial of authorization.'' The NRC 
requests comments regarding these proposed changes specifically when 
compared to the 5-year ban available through the agency's enforcement 
policy for other acts of deliberate misconduct.
    2. Proposed Sec.  26.119 [Determining ``shy'' bladder] would 
establish a process for determining whether there is a medical reason 
that a donor is unable to provide a urine specimen of at least 30 mL. 
The NRC added this proposed section in response to stakeholder requests 
and adapted the process from the DOT's Procedures for Transportation 
Workplace Drug and Alcohol Testing Programs (49 CFR 40.197). The DOT 
Procedures also include processes for determining whether there is a 
medical reason that a donor is unable to provide a specimen of oral 
fluids (49 CFR 40.263) or a breath specimen (49 CFR 40.265) of 
sufficient quantity to support alcohol testing. The NRC invites 
comments on whether the NRC should consider incorporating these 
processes for insufficient oral fluids and breath specimens in Part 26.
    3. Proposed Sec.  26.31(d)(3)(iii)(C) would permit licensees and 
other entities to specify more stringent cutoff levels for the panel of 
drugs for which testing is required under this part without informing 
the NRC within 60 days and without obtaining the written approval of 
the NRC. Proposed Sec.  26.31(d)(1)(i)(D) and (d)(1)(ii) would also 
permit licensees and other entities to test for drugs and drug 
metabolites in addition to those specified in proposed Sec.  
26.31(d)(1) without informing or obtaining the written approval of the 
NRC. However, the proposed paragraphs would require that the scientific 
and technical suitability of the more stringent cutoff levels and of 
the assays and cutoff levels used to test for additional drugs or drug 
metabolites must be evaluated and certified, in writing, by a 
qualified, independent forensic toxicologist. Certification by a 
forensic toxicologist would not be required in three circumstances: (1) 
If the HHS issues more stringent cutoff levels in the HHS Guidelines 
and the licensee or other entity adopts the revised HHS cutoffs; (2) 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; and (3) if the licensee or other entity 
received written approval from the NRC for the lower cutoff levels and/
or for testing for the additional drugs or drug metabolites, under 
current Section 1.1(2) in Appendix A to Part 26. The proposed 
paragraphs differ from the current requirement in Section 1.1(2) of 
Appendix A to Part 26. The NRC requests comments regarding these 
proposed changes.
    4. Proposed Sec. Sec.  26.133 and 26.163 would raise the cutoff 
levels for initial and confirmatory tests for opiates from 300 
nanograms (ng) per milliliter (mL) to 2,000 ng/mL. The proposed rule 
would also require testing for 6-acetylmorphine (6-AM), a metabolite 
that comes only from heroin, using a 10 ng/mL confirmatory cutoff level 
for specimens that tested positive on the initial test. The proposed 
cutoff levels and new test would be consistent with those used by HHS 
and DOT, and would reduce the number of specimens in Part 26 programs 
that test positive for opiates at an HHS-certified laboratory but are 
subsequently determined to be negative by the MRO after consultation 
with the donor. The NRC invites comment on these proposed changes.
    5. In proposed Sec. Sec.  26.131, 26.137, 26.161, and 26.167, the 
NRC would add new requirements for validity testing of urine specimens 
to detect specimens that may have been adulterated, substituted, or 
diluted. The new requirements are adapted from practices the HHS 
published in the Federal Register on April 13, 2004 (69 FR 19643) as a 
final rule. The NRC invites public comment on the following issues 
related to the proposed validity testing requirements.
    a. Proposed Sec.  26.137 would establish quality assurance and 
quality control requirements for conducting validity and drug tests of 
urine specimens. The NRC seeks input regarding any technical and 
methodological barriers to implementing these requirements at licensee 
testing facilities.
    b. Proposed Sec. Sec.  26.161(d) and 26.185(h) would establish 
criteria and procedures for determining whether a specimen has been 
substituted. A specimen would be reported by the HHS-certified 
laboratory to the MRO as substituted if it has a creatinine 
concentration of less than 2 mg/dL and specific gravity of less than or 
equal to 1.0010, or equal to or greater than 1.0200. For the HHS-
certified laboratory to report a specimen as substituted, results in 
these ranges would be necessary on both the initial and confirmatory 
creatinine and specific gravity tests on two separate aliquots of the 
specimen. The NRC invites comments on the proposed provisions.
    6. Proposed Sec.  26.183(a) requires that ``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 NRC invites 
comments on whether Part 26 should establish specific training 
requirements for the MRO related to this part and the licensee's or 
other entity's programs for which the MRO provides services.
    7. The NRC is considering incorporating future changes to the draft 
HHS Guidelines that were published as a proposed rule for public 
comment in the Federal Register on April 13, 2004 (69 FR 19672) 
relating to the permission in this proposed Part 26 rule for licensees 
and other entities to use non-instrumented validity tests to determine 
whether a urine specimen appears to be adulterated, diluted, or 
substituted and requires further testing at an HHS-certified 
laboratory. Proposed Part 26 would permit licensees and other entities 
to use these devices for validity screening tests, in lieu of the 
instrumented validity testing required in the April 13, 2004, final 
version of the HHS Guidelines. Should any changes be made to those 
draft HHS Guidelines between issuing this proposed rule and issuing the 
final 10 CFR Part 26 rule, those changes would be considered for 
incorporation. Any comments related to the potential incorporation of 
those changes are of interest.
    8. Proposed Subpart I, Managing Fatigue, includes many requirements 
related to worker fatigue at nuclear power plants. The NRC is 
especially interested in comments on the following provisions:

[[Page 50617]]

    a. Proposed Sec.  26.199(d)(2)(ii) and (d)(2)(iii) would require 
licensees to provide individuals who are subject to the proposed work 
hour limits with at least one 24-hour rest break in any 7-day period 
and at least one 48-hour rest break in any 14-day period, except during 
the first 14 days of any outage, as well as certain other circumstances 
for security force personnel.
    b. Proposed Sec.  26.199(d)(3) would permit licensees to waive 
individual work hour limits and rest break requirements only in 
circumstances in which it is necessary to mitigate or prevent a 
condition adverse to safety, or to maintain the security of the 
facility. Proposed Sec.  26.197(e)(1) would require licensees to report 
the number of waivers granted in a year.
    c. Proposed Sec.  26.199(f) would prohibit job duty groups that are 
subject to work hour controls from working more than a maximum 
collective average of 48 hours per person per week, except during the 
first 8 weeks of any outage, as well as certain other circumstances for 
security force personnel.
    9. As a means of determining the flexibility of the proposed rule 
work hour controls in Sec.  26.199, the NRC is seeking public comment 
on work-scheduling examples that meet the requirements of the proposed 
rule and whether such schedules afford a reasonable degree of 
flexibility to licensee management.
    10. The NRC is seeking comment on the exclusions from certain work 
hour controls that would be allowed by proposed Sec. Sec.  
26.199(d)(2)(iii), (f)(1) and (f)(2) during maintenance and refueling 
outages, and how these exclusions could affect human error. The NRC is 
specifically interested in whether a more precisely defined rule scope 
with more limited outage exclusions would better meet the stated 
objectives of the rule.
    11. The NRC is seeking public comment on alternatives to the group 
work hour controls that could also address cumulative fatigue, such as 
individual work hour limits based on a longer term (e.g., monthly or 
quarterly).
    12. Proposed Sec.  26.199(a) would require any individual who 
performs duties within specified job duty groups to be subject to the 
work hour control provisions in Sec.  26.199. Other individuals, beyond 
those specified within the scope of Sec.  26.199(a), might 
substantially impact the outcome of risk-significant work, such as 
certain engineers (e.g., Shift Technical Advisors). The NRC requests 
comment on the inclusion of other individuals in the scope of Sec.  
26.199(a). The NRC is also seeking comments on an alternative approach 
for identifying the specific job functions that would be subject to 
these requirements. Specifically, the NRC is interested in whether, as 
an alternative, the scope should instead be structured to define 
attributes of the job functions (e.g., time-critical nature of 
decisions needed to ensure public health and safety, operational 
control of risk-important equipment) that would fall within the scope 
of the proposed work hour control provisions in Sec.  26.199. Under 
such an alternative, the licensee would then be required to identify 
the specific job functions that fit the defined attributes.
    13. The NRC is considering amending 10 CFR 50.109, 70.76, and 76.76 
to exclude certain future changes to Part 26 from current backfit 
requirements. The scope of the exclusions would be limited to only 
those changes to Part 26 that would be necessary to incorporate 
relevant revisions to the HHS Guidelines when they are published by HHS 
as final rules. Examples of changes to the HHS Guidelines that may be 
incorporated into Part 26 in future rulemakings may include, but would 
not be limited to (1) Adopting changes to the cutoff levels established 
in the Guidelines; (2) the addition or deletion of drugs and 
adulterants for which testing would be required; and (3) changes in the 
specimens, instruments, or assays used in drug and validity testing. 
The NRC requests comment on excluding such future changes to Part 26 
from backfit analysis requirements.
    14. Proposed Sec. Sec.  26.135(b) and 26.165(a)(4) and (b)(1) would 
prohibit licensees and other entities, the MRO, and the NRC from 
initiating testing of the specimen in Bottle B or retesting an aliquot 
from a single specimen without the donor's written permission. The NRC 
is considering an alternative approach that would permit a licensee or 
other entity to initiate testing of the specimen in Bottle B or 
retesting an aliquot from a single specimen without the donor's written 
permission only if all of the following conditions are met: (1) The 
first results from testing the specimen were confirmed as non-negative 
by the MRO; (2) the donor has requested a review under proposed Sec.  
26.39 or initiated legal proceedings; and (3) the testing is conducted 
in accordance with proposed Sec.  26.165(c)-(e), as applicable. Under 
either the proposed provisions or the alternative approach, the 
proposed rule would require the licensee or other entity to 
administratively withdraw the donor's authorization until the results 
from Bottle B or the retest results are available and to rely only on 
those results in determining whether the licensee or other entity would 
be required to take management actions or impose sanctions on the 
donor. The NRC is seeking an appropriate balance between protecting 
donors' rights to privacy and due process under the rule and the 
protection of public health and safety and the common defense and 
security, and invites public comment on the proposed and alternative 
approaches.
    15. The NRC is seeking comment regarding the administrative 
reporting burden that the proposed rule provisions would create. 
Provide any comments as described in Section XIII, Paperwork Reduction 
Act Statement, of this notice.

VIII. Criminal Penalties

    For the purpose of Section 223 of the Atomic Energy Act (AEA), the 
Commission is proposing to amend 10 CFR Part 26 under one or more of 
Sections 161b, 161i, or 161o of the AEA. Willful violations of the rule 
would be 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 State'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 proposed revisions to improve the organization and 
readability of the existing language of the paragraphs being revised. 
The NRC requests comments on the proposed rule specifically with 
respect to the clarity

[[Page 50618]]

and reflectiveness of the language used. Comments should be sent to the 
address listed under the ADDRESSES caption of the preamble.

XI. Voluntary Consensus Standards

    The National Technology Transfer and Advancement Act of 1995, 
Public Law 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 Fitness For Duty Programs, that would 
apply to the requirements that would be 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 proposed 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 proposed rule 
would, and is lacking 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 proposed rule provisions 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, if adopted, would not be 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:
    The proposed rule, if adopted, would amend 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 U.S. Department of Health and Human Services Mandatory 
Guidelines for Federal Workplace Drug Testing Programs (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 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 and due process rights of individuals who are subject to 10 CFR 
Part 26.
    It would also grant, 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 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 proposed rule would 
continue 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.
    The proposed rule would not significantly increase the probability 
or consequences of an accident. No changes are being made in the types 
or quantities of radiological effluents that may be released off site, 
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 are being 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 the 
proposed action.
    The primary alternative to this action would be 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 determination of this environmental assessment is that there 
will be no significant environmental impact from this action. However, 
the general public should note that the NRC is seeking public 
participation. Comments on any aspect of the environmental assessment, 
provided above, may be submitted to the NRC as indicated under the 
ADDRESSES heading.
    The NRC has sent a copy of this proposed rule to every State 
Liaison Officer and requested their comments on the environmental 
assessment.

XIII. Paperwork Reduction Act Statement

    This proposed 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). This rule has been submitted to the Office of 
Management and Budget for review and approval of the information 
collection requirements.

[[Page 50619]]

    Type of submission, new or revision: New.
    The title of the information collection: 10 CFR Part 26, ``Fitness 
for Duty Programs.''
    The form number if applicable: Not applicable.
    How often the collection is required:
    On occasion: Significant FFD policy violations or programmatic 
failures; drug and alcohol testing errors; indicators of programmatic 
weaknesses; possible impairment of an NRC employee or NRC contractor;
    Annually: FFD program performance data.
    Who will be required or asked to report:
    --Licensees authorized to operate a nuclear power reactor;
    --Licensees authorized to possess, use, or transport formula 
quantities of strategic special nuclear material (SSNM) under 10 CFR 
Part 70;
    --Corporations, firms, partnerships, limited liability companies, 
associations, or other organizations that obtain a certificate of 
compliance or an approved compliance plan under 10 CFR Part 76, if the 
entity engages in activities involving formula quantities of SSNM; and
    --Contractor/vendors (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 
this part.
    An estimate of the number of annual responses: 5,540 (5,504 
responses plus 36 recordkeepers).
    The estimated number of annual respondents: 36 FFD programs (used 
by 65 nuclear power plants, 2 fuel cycle facilities, 2 C/Vs, and one 
mixed-oxide fuel fabrication facility), of which 31 FFD programs (used 
by 65 nuclear power plant facilities) are also required to include 
fatigue management programs with additional reporting and recordkeeping 
requirements.
    An estimate of the total number of hours needed annually to 
complete the requirement or request: 545,942 hours, including 125,239 
hours for one-time program implementation, 25,727 hours annually for 
reporting (an average of 715 hours per respondent) + 394,976 hours 
annually for recordkeeping (an average of 10,972 hours per 
recordkeeper).
    Abstract: The Nuclear Regulatory Commission (NRC) is proposing to 
amend its regulations for its Fitness for Duty (FFD) programs to 
completely revise 10 CFR Part 26 to update and clarify the regulations, 
and also add requirements for fatigue management at nuclear power 
plants. The proposed rule would ensure that individuals subject to 
these regulations are trustworthy and reliable, as demonstrated by 
avoiding substance abuse, and are otherwise fit for duty. The proposed 
rule would also ensure that workplaces subject to these regulations are 
free of the presence and effects of illegal drugs and alcohol.
    The recordkeeping and reporting requirements in the proposed rule 
include provisions requiring licensees and other entities to develop 
and maintain policies and procedures; retain records of training, 
qualification and authorization of individuals; retain records related 
to drug and alcohol collections and tests; retain other records related 
to the collection, testing and review processes; report FFD program 
performance and significant violations, program failures and testing 
errors; and retain records related to employee assistance programs. 
Records and reports are also required under the proposed new fatigue 
management component of the FFD program.
    The recordkeeping and reporting requirements would be mandatory for 
licensees and other entities subject to the rule. The NRC would use the 
reports to assess the effectiveness of FFD programs for those subject 
to the rule, and whether the provisions are implemented as the NRC 
intends.
    The U.S. Nuclear Regulatory Commission is seeking public comment on 
the potential impact of the information collections contained in this 
proposed rule and on the following issues:
    1. Is the proposed information collection necessary for the proper 
performance of the functions of the NRC, including whether the 
information will have practical utility?
    2. Is the estimate of burden accurate?
    3. Is there a way to enhance the quality, utility, and clarity of 
the information to be collected?
    4. How can the burden of the information collection be minimized, 
including the use of automated collection techniques?
    A copy of the OMB clearance package may be viewed free of charge at 
the NRC Public Document Room, One White Flint North, 11555 Rockville 
Pike, Room O1-F21, Rockville, MD 20852. The OMB clearance package and 
rule are available at the NRC worldwide Web site: http://www.nrc.gov/public-involve/doc-comment/omb/index.html for 60 days after the 
signature date of this proposed rule and are also available at the rule 
forum site, http://ruleforum.llnl.gov.
    Send comments on any aspect of these proposed information 
collections, including suggestions for reducing the burden and on the 
above issues, by September 26, 2005, to the Records and FOIA/Privacy 
Services Branch (T-5 F53), 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. Comments received after this date will be 
considered if it is practical to do so, but assurance of consideration 
cannot be given to comments received after this date. You may also 
comment by telephone at (202) 395-3087.

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 draft Regulatory Analysis on this proposed 
regulation. The draft regulatory analysis was prepared in accordance 
with the NRC's Regulatory Analysis Guidelines (RA Guidelines), NUREG/
BR-0058, Revision 4, dated September 2004. The draft 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 proposed rule's 
provisions addressing worker fatigue was performed. A description of 
each of these three elements is discussed below. The analysis is 
available as discussed above under the ADDRESSES heading. Single copies 
may be obtained from the contact listed above under the FOR FURTHER 
INFORMATION CONTACT heading. The Commission requests public comment on 
the draft Regulatory Analysis. Comments on the draft analysis may be 
submitted to the NRC as indicated under the ADDRESSES 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 
$116 million-

[[Page 50620]]

$183 million (using 7 percent and 3 percent real discount rates), 
consisting of $2 million in one-time costs and $9 million in annual net 
savings. The worker fatigue portions of the proposed rule are estimated 
to cost industry $585 million-$913 million net present value (using the 
7 percent and 3 percent real discount rates, respectively), consisting 
of $19 million in one-time costs and $42 million in annual net costs. 
The net present value of the entire proposed rule, including both the 
worker fatigue and drug and alcohol testing portions, is estimated to 
be a cost to industry of $469 million-$730 million (using 7 percent and 
3 percent real discount rates), which consists of $21 million in one-
time costs and $33 million in annual costs. In addition, the proposed 
rule is estimated to be a cost to the NRC of $615,000-$947,000 net 
present value (using 7 percent and 3 percent real discount rates), 
consisting of $30,000 in one-time costs and $45,000 in annual net 
costs.
    The NRC also separately evaluated the improvement in worker 
performance expected from the impact of selected fatigue management 
provisions on unplanned reactor scrams, reactor accidents, lost and 
restricted work cases (injuries), fire mitigation, and security. Those 
present value savings are estimated to be $103 million-$167 million 
(using 7 percent and 3 percent real discount rates), and have not been 
subtracted from the net present value of the entire proposed rule 
listed above because the NRC considers the costs of the proposed rule 
to be justified without these quantitative savings, which are only 
included to illustrate further justification for the rulemaking.
    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 draft 
Regulatory Analysis. The basic analysis measures the incremental 
impacts of the proposed rule relative to a baseline that assumes full 
licensee compliance 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 draft 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 
proposed 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 proposed change in addition 
to the aggregate analysis of the entire rulemaking to determine whether 
this proposed change should be aggregated with the other proposed 
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 draft regulatory analysis.

C. Dissaggregation of Worker Fatigue Provisions

    Section 4.1.4.2 of the draft Regulatory Analysis summarizes the 
division of costs and savings of the fatigue management portions of the 
proposed rule, in comparison with the rest of the rule. The worker 
fatigue portions of the proposed rule are estimated to cost industry 
$585 million-$913 million net present value (using the 7 percent and 3 
percent real discount rates, respectively), consisting of $19 million 
in one-time costs and $42 million in annual net costs. The NRC 
considers fatigue management to be an integral and necessary aspect of 
FFD. Fatigue currently is considered to be part of FFD under current 
Sec.  26.10(a) and Sec.  26.20(a)(2). However, the NRC included a 
summary of the costs associated with the proposed fatigue management 
requirements in the aggregate as a courtesy to stakeholders in Section 
4.1.4.2 of the draft 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 proposed rule, if adopted, 
would not have a significant economic impact on a substantial number of 
small entities. This proposed rule would affect only licensees 
authorized to operate nuclear power reactors; licensees authorized to 
possess, use, or transport formula quantities of strategic special 
nuclear material (SSNM); corporations who obtain certificates of 
compliance or approved compliance plans under Part 76 involving formula 
quantities of SSNM; combined license holders; holders of manufacturing 
licenses; holders of construction permits; combined license holders and 
construction permit applicants with authorization to construct; and 
contractor/vendors (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 proposed rule would constitute 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 
Commission requests public comment on the draft Backfit Analysis. The 
draft Backfit Analysis is included in the draft Regulatory Analysis, 
which is available as discussed under the ADDRESSES heading. Single 
copies may be obtained from the contact listed under the FOR FURTHER 
INFORMATION CONTACT heading. Comments on the draft analysis may be 
submitted to the NRC as indicated under the ADDRESSES heading.

A. Consideration of Fuel Fabrication Facilities and Gaseous Diffusion 
Plants

    The backfit provision of 10 CFR 70.76 applies to currently 
operational fuel fabrication facilities. These facilities have been 
considered in the aggregate backfit analysis. The planned mixed-oxide 
fuel fabrication facility would also 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 would apply to gaseous diffusion plants, there are no backfit 
impacts because the gaseous diffusion plants licensed by the NRC are 
not currently authorized to possess formula quantities of strategic 
special nuclear material.

[[Page 50621]]

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 proposed 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 draft Part 26 Regulatory Analysis, which is 
available as discussed under the ADDRESSES heading. The aggregate 
analysis also includes a list of all changes that constitute backfits, 
in Exhibits 4-14 and 4-15 of the draft analysis. Exhibit 4-16 of the 
draft 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. A summary of the results of the 
aggregate analysis follows.
    The NRC determined the backfitting is justified under Sec.  
50.109(a)(3), Sec.  70.76(a)(3) and Sec.  76.76(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 $21 million and 
the annual net costs would be $42 million, resulting in a net present 
value cost of $594 million-$927 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 proposed FFD rule, 
considered in the aggregate, would constitute 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;
    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 draft 
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 15 proposed backfits with reasonable 
indications that the costs associated with the proposed backfit may be 
disproportional to the safety benefit attributable to the change. The 
NRC determined that all of the 15 proposed 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 15 proposed 
backfits were determined to be necessary to meet the objectives of the 
proposed rule is described in Section 4.4.2 of the draft Regulatory 
Analysis.

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limitation of sleep length. Psychophysiology, 11, 265-274.
Williams, H.L., Lubin, A. and Goodnow, J.J. (1959). Impaired 
performance with acute sleep loss. Psychological Monographs, No. 
484, 73, 1-26.
Williamson, A.M. and Feyer, A. (2000). Moderate sleep deprivation 
produces impairments in cognitive and motor performance equivalent 
to legally prescribed levels of alcohol intoxication. Occupational 
and Environmental Medicine, 57, 649-655.
Wu, J.C., Gillin, J.C., Buchsbaum, M.S., Hershey, T., Hazlett, E., 
Sicotte, N. and Bunney, W.E. (1991). The effect of sleep deprivation 
on cerebral glucose metabolic rate in normal humans assessed with 
positron emission tomography. Sleep, 156:1149-1158.
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.
    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. 553, the NRC is proposing to 
revise 10 CFR Part 26 in its entirety to read as follows:

PART 26--FITNESS FOR DUTY PROGRAMS

Subpart A--Administrative Provisions
Sec.
26.1 Purpose.
26.3 Scope.
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 Individuals subject to the fitness-for-duty program.
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 Purpose.
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
26.75 Sanctions.
26.77 Management actions regarding possible impairment.
Subpart E--Collecting Specimens for Testing
26.81 Purpose.
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 validity 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.
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.
26.169 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
26.195 Applicability.
26.197 General provisions.
26.199 Work hour controls.
26.201 Fatigue assessments.
Subpart J--Recordkeeping and Reporting Requirements
26.211 General provisions.
26.213 Recordkeeping requirements for licensees and other entities.
26.215 Recordkeeping requirements for collection sites, licensee 
testing facilities, and laboratories certified by the Department of 
Health and Human Services.
26.217 Fitness-for-duty program performance data.
26.219 Reporting requirements.
Subpart K--Inspections, Violations, and Penalties
26.221 Inspections.
26.223 Violations.
26.225 Criminal penalties.


[[Page 50625]]


    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) The regulations in this part apply to licensees who are 
authorized to operate a nuclear power reactor (under Sec.  50.57 of 
this chapter) and holders of a combined license after the Commission 
has made the finding under Sec.  52.103 of this chapter.
    (b) The regulations in this part, except those contained in Subpart 
I, also apply to licensees who are authorized to possess, use, or 
transport formula quantities of strategic special nuclear material 
(SSNM) under Part 70 of this chapter.
    (c) In addition, the regulations in this part, except those 
contained in Subpart I, apply to a corporation, firm, partnership, 
limited liability company, association, or other organization that 
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. When applicable, the 
requirements apply only to the entity and personnel specified in Sec.  
26.25(a)(3).
    (d) The regulations in this part also apply to contractor/vendors 
(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 this part.
    (e) Combined license holders (under Part 52 of this chapter) before 
the Commission has made the finding under Sec.  52.103 of this chapter, 
combined license applicants who have received authorization to 
construct under Sec.  50.10(e)(3), construction permit holders (under 
Part 50 of this chapter), construction permit applicants who have 
received authorization to construct under Sec.  50.10(e)(3), and 
holders of manufacturing licenses (under Part 52 of this chapter) 
shall--
    (1) Comply with Sec. Sec.  26.23, 26.41, and 26.189;
    (2) Implement a drug and alcohol testing program, including random 
testing; and
    (3) Make provisions for employee assistance programs, imposition of 
sanctions, procedures for the objective and impartial review of 
authorization decisions, protection of information, and recordkeeping.
    (f) The regulations in this part do not apply to either spent fuel 
storage facility licensees or non-power reactor licensees who possess, 
use, or transport formula quantities of irradiated SSNM because these 
materials are exempt from the Category I physical protection 
requirements set forth in 10 CFR 73.6.


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 contains a 
substance that is not a normal constituent, or one that contains an 
endogenous substance at a concentration that is not a normal 
physiological concentration.
    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 licensee testing facilities 
and HHS-certified laboratories who continuously process 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.
    Best effort means documented actions that a licensee or other 
entity who is subject to this part takes to obtain suitable inquiry and 
employment information in order to determine whether an individual may 
be authorized to have the types of access or to perform the activities 
specified in Sec.  26.25(a), 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 upon 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 cm 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 this part, 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 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.

[[Page 50626]]

    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 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 non-
negative confirmatory validity test result from the HHS-certified 
laboratory for that donor. For alcohol, a confirmed test result is 
based upon a positive confirmatory alcohol test result from an 
evidential breath testing device without MRO review of the test result.
    Contractor/vendor (C/V) means any company, or any individual not 
employed by a licensee or other entity who is subject to this part, who 
is providing work or services to a licensee or other entity subject to 
this part, either by contract, purchase order, verbal 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 established for designating 
and reporting a test result as non-negative.
    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, capable of making technical 
decisions, and ultimately responsible for the correct performance of 
that work activity.
    Donor means the individual from whom a specimen is collected.
    Employment action means a change in job responsibilities or removal 
from a job, or the 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 strategic special nuclear material 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 most recent version of the 
Department of Health and Human Services Mandatory Guidelines for 
Federal Workplace Drug Testing Programs. 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.
    Illegal drug means, for the purposes of this regulation, any drug 
that is included in Schedules I-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.
    Increase in threat condition means an increase in the protective 
measure level 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, diluted, or substituted, 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 testing facility that is 
operated by a licensee or other entity who is subject to this part to 
perform initial 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.
    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 non-negative 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.
    Non-negative test result means a report by the licensee testing 
facility or the HHS-certified laboratory that a urine specimen meets 
the criteria for substitution established in this part or is positive 
for a drug, drug metabolite, or adulterant at a concentration equal to 
or greater than the designated cutoff levels, or the results of a test 
of oral fluids or breath that indicate the presence of alcohol at a 
concentration equal to or greater than the cutoff levels established by 
the FFD program or as specified in this part. A non-negative test 
result may be obtained from any initial or confirmatory drug, validity, 
or alcohol test.
    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(c) and (d), but is not licensed 
by the NRC.

[[Page 50627]]

    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.
    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.  26.61(d), 26.63(d), 26.65(h), 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.''
    Reviewing official means the designated licensee or other entity's 
employee who is 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.
    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 U-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, test result reporting), and 
adulterating, substituting, or otherwise causing a specimen to provide 
an inaccurate test result.
    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.
    Validity screening test means the use of a non-instrumented testing 
device to determine the need for initial validity testing of a urine 
specimen.


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 
upon 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, 26.55, 26.57, 26.59, 26.61, 26.63, 26.65, 26.69, 
26.75, 26.77, 26.85, 26.87, 26.91, 26.93, 26.95, 26.97, 26.99, 26.101, 
26.103, 26.107, 26.109, 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, 26.169, 26.183, 26.185, 26.187, 26.189, 26.197, 
26.199, 26.201, 26.211, 26.213, 26.215, 26.217, 26.219, and 26.221.


Sec.  26.9  Specific exemptions.

    Upon application of any interested person or upon 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: 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 at [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.

    Licensees and other entities who are subject to this part must 
establish, implement, and maintain FFD programs in accordance with the 
applicable requirements of this part. Fitness-for-duty programs subject 
to this part may rely upon 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.

[[Page 50628]]

Sec.  26.23  Performance objectives.

    Fitness-for-duty programs must--
    (a) Provide reasonable assurance that individuals who are subject 
to this part are trustworthy and reliable as demonstrated by the 
avoidance of substance abuse;
    (b) Provide reasonable assurance that individuals who are subject 
to this part 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 job duties that require them 
to be subject to this part;
    (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  Individuals subject to the fitness-for-duty program.

    (a) Individuals whose job duties require them to have the following 
types of access, or to perform the following activities are subject to 
the FFD program:
    (1) All persons who are granted unescorted access to nuclear power 
plant protected areas;
    (2) All persons who are required by a licensee to physically report 
to the licensee's Technical Support Center or Emergency Operations 
Facility, in accordance with licensee emergency plans and procedures;
    (3) SSNM licensee and transporter personnel who--
    (i) Are granted unescorted access to Category IA Material;
    (ii) Create or have access to procedures or records for 
safeguarding SSNM;
    (iii) Measure Category IA Material;
    (iv) Transport or escort Category IA Material; or
    (v) Guard Category IA Material;
    (4) All FFD program personnel who are involved in the day-to-day 
operations of the program, as defined by the licensee's or other 
entity's procedures, and who--
    (i) 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;
    (ii) Make determinations of fitness;
    (iii) Make authorization decisions;
    (iv) Are involved in selecting or notifying individuals for 
testing; or
    (v) Are involved in the collection or on-site testing of specimens.
    (b) The following individuals are not subject to the FFD program:
    (1) Individuals who are not employed by the licensee's or other 
entity's FFD program, who do not routinely provide FFD program 
services, and whose normal workplace is not at the licensee's or other 
entity's facility, but who may be called upon 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; and
    (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.
    (c) 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 a Part 26 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 evidential breath 
testing device 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 HHS;
    (4) Training is provided to address the knowledge and abilities 
listed in Sec.  26.29(a)(1) through (10);
    (5) An impartial and objective procedure is provided for the review 
and reversal of any findings of an FFD policy violation; and
    (6) Provisions are made to ensure that the testing agency or 
organization notifies the licensee or other entity granting 
authorization of any FFD policy violation.
    (d) Individuals who have applied for authorization to have the 
types of access or perform the activities described in paragraph (a) of 
this section shall be subject to the applicable requirements of this 
part and provided with the applicable protections of this part.


Sec.  26.27  Written policy and procedures.

    (a) General. Each licensee and other entity who is subject to this 
part 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 consequences of refusals to provide a specimen for 
testing, 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;

[[Page 50629]]

    (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 job duties that require 
an individual to be subject to this part;
    (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 who is subject to 
this part 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 
due process rights 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) Describe immediate and followup actions that will be taken, and 
the procedures to be used, in those cases in which individuals who are 
subject to this part 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, 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. 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. 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, the procedure must--
    (A) Require a determination of fitness by breath alcohol analysis 
or other means;
    (B) Require the establishment of controls and conditions under 
which the individual who has been called in can perform work, if 
necessary; and
    (C) State that no sanctions may be imposed on an individual who is 
called in to perform an unscheduled working tour and has 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 individuals who are subject to this part have the following 
knowledge and abilities (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 
part 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 part 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;

[[Page 50630]]

    (2) Individuals shall complete refresher training on a nominal 12-
month frequency, or more frequently where the need is indicated. 
Individuals who pass a comprehensive annual examination that meets the 
requirements in paragraph (b) of this 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 Part 26 
program 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 part.
    (b) Assuring the honesty and integrity of FFD program personnel. 
(1) Licensees and other entities who are subject to this part shall 
carefully select and monitor FFD program personnel, as defined in Sec.  
26.25(a)(4), based upon the highest standards for 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 conducted in order 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 the 
individual being tested 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 in accordance with 
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 who are subject to this part may 
rely upon 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.  26.25(a)(4).
    (c) Conditions for testing. Licensees and other entities shall 
administer drug and alcohol tests to individuals who are subject to 
this part 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 
part, 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 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 1907.4, 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

[[Page 50631]]

drug counseling services to determine whether other drugs with abuse 
potential are being used in the geographical locale of the facility and 
by the local workforce that may not be detected in the 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 in accordance with 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-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. 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 hold, or would be eligible to hold, the 
position of Responsible Person at an HHS-certified laboratory, as 
specified in Sec.  26.155(a) of this part. All new assays and cutoff 
levels must be properly validated in accordance 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 [Insert implementation date of final rule].
    (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-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 in accordance with 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.
    (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; 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. 
Individuals who are off site when selected for testing, and 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;
    (v) Provide that an individual completing a test is immediately 
eligible for another unannounced test; and
    (vi) 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, except 
initial 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 drug testing by 
the laboratory. Specimens that yield non-negative initial validity or 
drug test results 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 
and initial validity and 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 
and in Sec.  26.163(b)(1) for confirmatory drug testing. At their 
discretion, licensees and other entities may implement programs with 
lower cutoff levels for drug testing.
    (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 and this part, 
as if the individual had a confirmed positive drug test result using 
the cutoff levels specified in this part. 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) and 
26.163(a)(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).

[[Page 50632]]

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 [Insert 
implementation date of final rule].
    (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 evidential 
breath testing device 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 who are subject to this part shall 
ensure that the individuals listed in Sec.  26.25(a) and (c), if 
necessary, are subject to behavioral observation. Behavioral 
observation must be performed by individuals who are trained in 
accordance with 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 the health and 
safety of the public. Individuals who are subject to this part shall 
report any FFD concerns about other individuals who are subject to this 
part 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 its employees who have problems that could 
adversely affect the employees' 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 and individuals who have applied for, but have not yet 
been granted, authorization.
    (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.  26.219(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 part who 
collects personal information about an individual for the purpose of 
complying with this part, shall establish and maintain a system of 
files and procedures to protect the personal information. Licensees and 
other entities shall 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 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 in performing assigned duties, 
including determinations of fitness, audits of FFD programs, and 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 part must be 
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 licensee, other entity, HHS-
certified laboratory, or MRO possessing such records shall promptly 
provide copies of all records pertaining to the determination of a 
violation of the FFD policy, including test results, MRO reviews, 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-

[[Page 50633]]

certified laboratory and provide them to the subject individual upon 
request.
    (e) A licensee's or other entity's contracts with HHS-certified 
laboratories and licensee testing facility procedures must require that 
test records 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 part 
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 review is conducted by more 
than one individual and that the individuals who conduct the review are 
not associated with the administration of the FFD program (see the 
description of FFD program personnel in Sec.  26.25(a)(4)). The 
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) Licensees and other entities need not provide a review 
procedure to a C/V's employee 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 
part 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, and the programs of the HHS-certified laboratories upon 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 part 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 
program performance indicators, such as the frequency, nature, and 
severity of discovered problems, testing errors, personnel or 
procedural changes, previous audit findings, and ``lessons learned.''
    (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 part 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.  26.25(b)(1).
    (d) Contracts. (1) 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 part, 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 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, when appropriate, 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 part, 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 upon which the licensee or

[[Page 50634]]

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 part. 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 part within the past 12 months.

Subpart C--Granting and Maintaining Authorization


Sec.  26.51  Purpose.

    This subpart contains FFD requirements for granting and maintaining 
authorization to have the types of access and be assigned to perform 
the job duties that are specified in Sec.  26.25(a).


Sec.  26.53  General provisions.

    (a) In order to grant authorization to individuals, a licensee or 
other entity who is subject to this part shall meet the requirements in 
this subpart for 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 upon 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 upon 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 26.197(c) before granting authorization to the individual.
    (d) Licensees and other entities who are seeking to grant 
authorization to an individual who is subject to another FFD program 
that complies with this part may rely on the transferring FFD program 
to satisfy the requirements of this part. 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 requirements of this part.


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--
    (1) Obtain and review a self-disclosure in accordance with the 
applicable requirements of Sec.  26.61;
    (2) Complete a suitable inquiry in accordance with the applicable 
requirements of Sec.  26.63;
    (3) Ensure that the individual is subject to pre-access drug and 
alcohol testing in accordance with the applicable requirements of Sec.  
26.65; and
    (4) Ensure that the individual is subject to random drug and 
alcohol testing in accordance with 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 in accordance with 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--
    (1) Obtain and review a self-disclosure in accordance with the 
applicable requirements of Sec.  26.61;
    (2) Complete a suitable inquiry in accordance with the applicable 
requirements of Sec.  26.63;
    (3) Ensure that the individual is subject to pre-access drug and 
alcohol testing in accordance with the applicable requirements of Sec.  
26.65; and
    (4) Ensure that the individual is subject to random drug and 
alcohol testing in accordance with 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 in accordance with 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--
    (1) Obtain and review a self-disclosure in accordance with the 
applicable requirements of Sec.  26.61;
    (2) Complete a suitable inquiry in accordance with 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) Ensure that the individual is subject to pre-access drug and 
alcohol testing in accordance with the applicable requirements of Sec.  
26.65; and
    (4) Ensure that the individual is subject to random drug and 
alcohol testing in accordance with 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.

[[Page 50635]]

    (c) Before granting authorization to an individual whose 
authorization has 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--
    (1) Obtain and review a self-disclosure in accordance with the 
applicable requirements of Sec.  26.61;
    (2) If the individual's authorization was interrupted for more than 
5 days, ensure that the individual is subject to pre-access drug and 
alcohol testing in accordance with the applicable requirements of Sec.  
26.65; and
    (3) Ensure that the individual is subject to random drug and 
alcohol testing in accordance with 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 in accordance with Sec.  26.69.


Sec.  26.61  Self-disclosure and employment history.

    (a) Before granting authorization, the licensee or other entity 
shall obtain a written self-disclosure and employment history 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 and arrest-
reporting program that 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.  26.61(d), 26.63(d), 26.65(h), 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 current employer, 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.
    (d) Falsification of the self-disclosure statement or employment 
history is sufficient cause for denial of authorization.


Sec.  26.63  Suitable inquiry.

    (a) The licensee or other entity shall conduct a suitable inquiry, 
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 and 
arrest-reporting program that meets the requirements of this part 
throughout the period of interruption.
    (b) To meet the suitable inquiry requirement, licensees and other 
entities may rely upon the information that other licensees and 
entities who are subject to this part have gathered for previous 
periods of authorization. Licensees and other entities may also rely 
upon those licensees' and entities' determinations of fitness, as well 
as their reviews and resolutions of potentially disqualifying FFD 
information, for previous periods of authorization.
    (c) The licensee or other entity shall conduct the suitable 
inquiry, on a best effort basis, by questioning both present and former 
employers.
    (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.
    (d) In response to another licensee's or other entity's inquiry and 
presentation of an individual's signed release authorizing the 
disclosure of information, a licensee or other entity shall disclose 
whether the subject individual's authorization was denied or terminated 
unfavorably as a result of a violation of an FFD policy and shall make 
available the information upon which the denial or unfavorable 
termination of authorization was based, including, but not limited to, 
drug or alcohol test results. The failure of an

[[Page 50636]]

individual to authorize the release of information for the suitable 
inquiry is sufficient cause to deny authorization.
    (e) In conducting a suitable inquiry, the 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, in accordance with Sec. Sec.  26.211 and 
26.213(a), (b), and (c), as applicable.
    (f) The licensee or other entity shall conduct the suitable inquiry 
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 upon which the individual applies for authorization, the licensee 
or other entity shall conduct the suitable inquiry with every employer, 
regardless of the length of employment. For the remaining 2-year 
period, the licensee or other entity shall conduct the suitable inquiry 
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 upon which the individual applies for 
authorization, the licensee or other entity shall conduct the suitable 
inquiry with every employer, regardless of the length of employment. 
For the remaining period since authorization was terminated, the 
licensee or other entity shall conduct the suitable inquiry 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 
conduct the suitable inquiry 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 who is subject to this part.
    (b) Accepting tests conducted within the past 30 days. If an 
individual has negative results from drug and alcohol tests that were 
conducted in accordance with 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 upon which the licensee or other entity grants 
authorization to the individual, the licensee or other entity may rely 
upon 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 been authorized 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 are negative. The licensee or other 
entity need not conduct pre-access testing if--
    (1) An individual previously held authorization under this part and 
has been subject to both a drug and alcohol testing program that 
includes random testing and a behavioral observation and arrest 
reporting program which meet the requirements of this part from the 
date upon which the individual's last authorization was terminated 
through the date upon which the individual is granted authorization; or
    (2) The licensee or other entity relies upon negative results from 
drug and alcohol tests that were conducted before the individual 
applied for authorization, as permitted under paragraph (b) of this 
section, and the individual remains subject to a behavioral observation 
and arrest reporting program that meets the requirements of this part, 
beginning on the date upon which the drug and alcohol testing was 
conducted through the date upon which the individual is granted 
authorization and thereafter.
    (d) Authorization reinstatement after an interruption of more than 
30 days. (1) In order 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 before reinstating 
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 both to a drug and alcohol testing program that 
includes random testing and a behavioral and arrest-reporting program 
that meet the requirements of this part from the date upon which the 
individual's last authorization was terminated through the date upon 
which the individual is granted authorization; or
    (ii) The licensee or other entity relies upon negative results from 
drug and alcohol tests that were conducted before the individual 
applied for authorization, as permitted under paragraph (b) of this 
section, and the individual remains subject to a behavioral observation 
and arrest reporting program that meets the requirements of this part, 
beginning on the date upon which the drug and alcohol testing was 
conducted through the date upon which the individual is granted 
authorization.
    (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.
    (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)(3) 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)(vi) calculated for a 30-day period;
    (ii) If the individual is not selected for pre-access testing under 
this paragraph, the licensee or other entity need not perform pre-
access drug and alcohol tests; or

[[Page 50637]]

    (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.
    (3) If the individual previously held authorization under this part 
and has been subject to both a drug and alcohol testing program that 
included random testing and a behavioral observation and arrest 
reporting program that meet the requirements of this part from the date 
upon which the individual's last authorization was terminated through 
the date upon which the individual is granted authorization, then the 
granting licensee or other entity need not conduct pre-access testing 
of the individual.
    (f) Time period for testing. If pre-access testing is required 
under this section, the licensee or other entity must collect the 
specimens within the 30-day period that precedes the date upon which 
the licensee or entity grants authorization to an individual.
    (g) 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. Immediately upon 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 tested individual's 
personnel record and other records.
    (h) Sanctions for a confirmed non-negative pre-access test result. 
If an individual has confirmed non-negative 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. Sec.  
26.75(b), (d), (e)(2), or (g);
    (2) Terminate the individual's authorization, if it has been 
reinstated, in accordance with Sec. Sec.  26.75(e)(1) or (f); or
    (3) Grant authorization to the individual only in accordance with 
the requirements of 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 in accordance with 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 upon drug and alcohol tests 
to meet the applicable requirements for pre-access testing that were 
conducted before the individual applied for authorization. If the 
licensee or other entity relies upon 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 in accordance with 
Sec.  26.31(d)(2), if the individual has met all other applicable 
requirements for authorization.
    (c) If an individual has confirmed non-negative 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. Sec.  
26.75(b), (d), (e)(2), or (g);
    (2) Terminate the individual's authorization, if it has been 
granted, as required by Sec. Sec.  26.75(e)(1) or (f); or
    (3) Grant authorization to the individual only in accordance with 
the requirements of 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 part shall take in 
order 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 
the FFD program, 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 
who is subject to this part.
    (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). In order to grant, and subsequently maintain, the individual's 
authorization, the licensee or other entity shall--
    (1) Obtain and review a self-disclosure from the individual that 
addresses the shorter period of either the past 5 years or since the 
individual last held authorization, 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 self-disclosure in accordance with the requirements of Sec.  26.63, 
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;
    (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 conducts a determination of fitness and 
indicates 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 plans are developed by the 
SAE before granting authorization;

[[Page 50638]]

    (ii) If the individual was subject to a 5-year denial of 
authorization, ensure that any recommendations for treatment and 
followup testing from the 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 a period of 3 calendars years after the date upon which 
the individual is again 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 testing program may be extended up to 
5 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. Before granting authorization to the 
individual, the licensee or other entity shall--
    (1) Verify that the individual's self-disclosure and employment 
history addresses the applicable period in Sec.  26.61(b)(3);
    (2) Complete a suitable inquiry with every employer by whom the 
individual claims to have been employed during the period addressed in 
the self-disclosure in accordance with the requirements of Sec.  26.63, 
and 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 urine 
specimens 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 
successfully completes the treatment plans.
    (e) Accepting followup testing and treatment plans from another 
Part 26 program. Licensees and other entities may rely upon followup 
testing, treatment plans, and determinations of fitness that were 
conducted in accordance with this part by another licensee or entity.
    (1) If an individual leaves the FFD program in which a treatment 
and followup testing plan was required under paragraphs (b), (c), or 
(d) of this section, and 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 treatment and 
followup testing requirements are met, with accountability 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 upon 
the previous determination of fitness and no further review or followup 
is required.
    (f) Sanctions for confirmed non-negative drug and alcohol test 
results. If an individual has confirmed non-negative 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. 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. 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 to which he or she is subject, 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

[[Page 50639]]

complies with the requirements of this part, including random testing;
    (3) The individual remains subject to a behavioral observation 
program that complies with the requirements of this part; and
    (4) The individual successfully completes required FFD training, in 
accordance with 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 part 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.  26.75  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 who 
is subject to this part 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 this part 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 job duties 
that require the individual to be subject to this part shall 
immediately have his or her authorization unfavorably terminated and 
denied thereafter 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 part 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 off-site 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.
    (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), 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 who is subject to this part may not 
terminate an individual's authorization and may not subject the 
individual to other administrative action based solely on a non-
negative test result from any validity screening, initial validity, or 
initial drug test, other than positive initial test results for 
marijuana or cocaine metabolites from a specimen that appears 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.
    (i) With respect to initial drug test results from a licensee 
testing facility for marijuana and cocaine metabolites from a specimen 
that appears to be valid, licensee testing facility personnel may 
inform licensee or other entity management of the non-negative 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 
based on a positive initial drug test result from a specimen that 
appears to be valid, 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.  26.217 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 upon 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.  26.213 and Sec.  
26.215 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.

[[Page 50640]]

Sec.  26.77  Management actions regarding possible impairment.

    (a) This section defines management actions that licensees and 
other entities must take when an individual who is subject to this part 
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.  26.27(c)(3) 
and Sec.  26.199(e) and (f), the licensee or other entity shall take 
immediate action to prevent the individual from performing the job 
duties that require him or her to be subject to this part.
    (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 tests and the results must be 
negative before the individual returns to performing the job duties 
that require the individual to be subject to this part. 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 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 in accordance with Sec.  26.201 and need not perform drug 
and alcohol tests nor a determination of fitness under 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), the licensee or other 
entity may permit the individual to return to performing his or her job 
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 verbal 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.

    This subpart contains requirements for collecting specimens for 
drug and alcohol testing.


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 part 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, the FFD policy and 
procedures of the 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, 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 evidential breath testing 
devices (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, if the individual's normal workplace is not at the 
licensee's or other entity's facility and he or she--
    (1) Is not employed by the licensee's or other entity's FFD 
program;
    (2) Does not routinely provide FFD program services to the licensee 
or other entity;
    (3) Is licensed or otherwise approved to practice in the 
jurisdiction in which the collection occurs;
    (4) Is provided with detailed, clearly-illustrated, written 
instructions for collecting specimens in accordance with this subpart; 
and
    (5) Performs collections in accordance with 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 non-negative alcohol, validity, or drug test results from 
specimens collected by or under contract to the licensee or other 
entity.


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

[[Page 50641]]

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, and for 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 part 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. Coloring agents may not interfere with drug or validity 
tests;
    (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
    (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, on-site 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 in accordance with 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

[[Page 50642]]

present acceptable identification. 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.
    (3) 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 leaves 
the collection site before all of the collection procedures are 
completed or refuses to cooperate in the specimen collection process, 
it will be considered a refusal to test, and sanctions for subverting 
the testing process will be imposed in accordance with Sec.  26.75(b). 
If the donor fails to remain present through the completion of the 
collection procedures or 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 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 (EBTs) 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 part.
    (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 part:
    (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) Performs 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 and cancel every 
positive test result that was obtained using the EBT from any tests 
that were conducted after the EBT passed the last external calibration 
check. The EBT may not be used again for alcohol testing under this 
part until it is repaired and passes an external calibration check.
    (4) Inspection, maintenance, and calibration of the EBT must be 
performed by its manufacturer or a maintenance representative 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

[[Page 50643]]

in paragraph 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 in accordance with 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 upon 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;
    (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 in 
which 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 in accordance with 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 upon 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

[[Page 50644]]

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 him or her to be subject to this part 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 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 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 part 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 in accordance with 
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 part, 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 24 oz. 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 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 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 
in accordance with 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 upon the 
collector's observations of the donor's behavior during the collection 
process or the

[[Page 50645]]

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 validity 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, and 
may need to be less if the ambient temperature is low or the specimen 
quantity is less than 30 mL.
    (b) If the temperature of a urine specimen is outside the range of 
90 [deg]F to 100 [deg]F, the collector shall inform the donor that he 
or she may volunteer to have his or her temperature taken to provide 
evidence to counter the reason to believe the donor may have altered or 
substituted the specimen.
    (c) Immediately after the donor provides a urine specimen, 
including specimens of less than 30 mL but 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.
    (d) If there is reason to believe that the donor may have attempted 
to dilute, substitute, or adulterate the specimen based upon specimen 
temperature or other observations made during the collection, the 
collector shall contact the 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, including under 
direct observation.
    (e) Any specimen of 15 mL or more that the collector suspects has 
been diluted, substituted, or adulterated must be sent directly to the 
HHS-certified laboratory for initial and confirmatory testing, if 
required, and may not be subject to initial testing at a licensee 
testing facility.
    (f) As much of the suspect specimen as possible must be preserved.
    (g) 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 who are subject to this part 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 either a 
specimen bottle or 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. Bottle A must contain a minimum of 30 mL of 
urine and Bottle B must contain 15 mL. The Bottle A specimen must be 
used for drug and validity testing at the HHS-certified laboratory. If 
there is less than 15 mL of urine available for Bottle B, the specimen 
in Bottle A must nevertheless be processed for 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 
such 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 part 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, and
    (i) Either the donor declines to provide a measurement of body 
temperature; or
    (ii) The donor's measured body temperature varies by more than 1EC/
1.8EF from the temperature of the specimen;
    (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 verbally 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

[[Page 50646]]

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, this constitutes a 
refusal to test.
    (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 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.

[[Page 50647]]

    (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 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; 
and appropriate data to support determinations of honesty and integrity 
conducted in accordance with 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 with non-instrumented devices, the 
licensee testing facility shall develop, implement, and maintain 
written standard operating procedures for each device. 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 device setup and normal 
operation, including the following:
    (1) A schedule for checking critical operating characteristics for 
all instruments and devices;
    (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 non-instrumented testing devices (if used for validity 
screening 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 shall be secure at all times. 
Each facility 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 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

[[Page 50648]]

inspect each package for evidence of possible tampering and shall 
compare information on 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. 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 such reports, licensee or 
other entity management personnel shall initiate an investigation to 
determine whether tampering has occurred. If the investigation 
determines that tampering has occurred, licensee or other entity 
management shall ensure that corrective actions are taken. 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 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.
    (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 non-negative 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, initial validity, or initial drug 
test results are non-negative 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 non-negative specimens 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, in accordance with 
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 non-negative 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) Using either a colorimetric pH test or pH meter, the pH of the 
specimen meets either of the following criteria:
    (i) pH less than 3, or
    (ii) pH equal to or greater than 9.
    (3) Nitrite concentration is equal to or greater than 500 
micrograms (mcg) per milliliter (mL) using either a nitrite 
colorimetric test or a general oxidant colorimetric test;
    (4) Presence of chromium (VI) is indicated 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) Presence of halogen (e.g., bleach, iodine, fluoride) is 
indicated using either 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) or a halogen 
colorimetric test (halogen concentration equal to or greater than the 
LOD);
    (6) Presence of glutaraldehyde is indicated using either an 
aldehyde test (aldehyde present) or the characteristic immunoassay 
response is observed on one or more drug immunoassay tests;
    (7) Presence of pyridine (pyridinium chlorochromate) is indicated 
using either 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) or a chromium (VI) 
colorimetric test (chromium (VI) concentration equal to or greater than 
50 mcg/mL);
    (8) Presence of a surfactant is indicated by using a surfactant 
colorimetric test with a cutoff equal to

[[Page 50649]]

or greater than 100 mcg/mL dodecylbenzene sulfonate equivalent; or
    (9) 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 initial test; or
    (iii) A possible unidentified interfering substance or adulterant, 
demonstrated by interference occurring on the immunoassay drug tests on 
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                        (ng/mL)
------------------------------------------------------------------------
 (a) Marijuana metabolites................................            50
(b) Cocaine metabolites...................................           300
(c) Opiate metabolites....................................         2,000
(d) Phencyclidine.........................................            25
(e) Amphetamines..........................................         1,000
------------------------------------------------------------------------

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 
B. If any test results are non-negative, the licensee testing facility 
shall forward Bottle A to the HHS-certified laboratory for testing and 
shall retain Bottle B in secure storage or may forward it to the HHS-
certified laboratory for storage.
    (b) Within 3 business days (Monday through Friday, excluding 
holidays) of being notified by the MRO that the HHS-laboratory reported 
that donor's specimen yielded a non-negative test result, the donor may 
request that the split specimen in Bottle B be tested by another HHS-
certified laboratory. The MRO shall inform the donor of this option, 
and the specimen in Bottle B may be tested only at the request of 
donor. When requested, the licensee or other entity shall ensure that 
Bottle B is forwarded to an HHS-certified laboratory other than the 
laboratory that tested the specimen in Bottle A as soon as practical, 
and not later than one business day following the day of the donor's 
request to have Bottle B tested. The donor shall provide his or her 
written permission for the testing of Bottle B and neither the 
licensee, MRO, NRC, nor any other entity may order testing of Bottle B 
without the donor's written permission.
    (c) If the MRO confirms that the specimen in Bottle A is non-
negative 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 or less) for a minimum of 1 year. 
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, 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 upon 
non-instrumented devices to perform validity screening tests to 
determine the need for initial tests of specimen validity. Licensee 
testing facilities shall use only non-instrumented devices to perform 
validity screening tests that meet the following criteria:
    (i) Either the device has been cleared by the U.S. Food and Drug 
Administration and placed upon the SAMHSA list of point-of-collection 
testing devices that are certified for use in the Federal Workplace 
Drug Testing Program in the Federal Register; or
    (ii) Before using the device, the licensee or other entity has 
ensured that the device effectively determines the validity of a 
specimen, as demonstrated by documentation that the device meets the 
following performance testing requirements:
    (A) A total of 100 devices in representative numbers from all 
currently available manufactured lots of the device have been 
performance tested by the licensee testing facility or an HHS-certified 
laboratory following the manufacturer-specified testing procedures;
    (B) The performance testing samples used to test the 100 devices 
included samples with a nitrite concentration in the ranges of 650 mcg/
mL-800 mcg/mL or 250 mcg/mL-400 mcg/mL; a creatinine concentration in 
the ranges of 5 mg/dL-20 mg/dL or 1 mg/dL-5 mg/dL; and pH in the ranges 
of 1-3 or 10-12; and
    (C) Test results from the performance testing required in this 
paragraph show that the device correctly identified at least 80 percent 
of the total validity test challenges or correctly identified at least 
80 percent of the challenges for a specific validity test, and did not 
report any sample as adulterated with a compound that was not present 
in the sample.
    (iii) After the licensee testing facility has placed the device in 
service, the licensee or other entity shall verify either that the 
device remains on the SAMHSA-certified list, or that the device 
continues to effectively determine the validity of a specimen by 
conducting, or requesting the HHS-certified laboratory to conduct 
performance testing of 50 of the devices in representative numbers from 
all currently available manufactured lots of the device in accordance 
with the criteria specified in paragraphs (b)(1)(ii)(A) through 
(b)(1)(ii)(C) of this section. This performance testing must be 
performed at a nominal annual frequency.
    (iv) In addition, the licensee or other entity shall ensure that 
the manufacturer informs the licensee or other entity of any design 
changes or alterations made to the device. If so informed, the licensee 
or other entity shall consult with the MRO or the HHS-certified 
laboratory to determine whether additional performance testing is 
required to ensure that the modified device continues to be effective. 
If the MRO or HHS-certified laboratory

[[Page 50650]]

recommends additional performance testing, the licensee or other entity 
shall ensure that it is completed in accordance with paragraph 
(b)(1)(iii) of this section.
    (2) 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 1 quality control 
sample that is negative for each specific validity test to be performed 
(e.g., nitrites, chromium) during the 8-hour period, and 1 quality 
control sample that is non-negative for the specific validity test to 
be performed during the 8-hour period. The results of these tests must 
be correct before any donor specimens may be tested. If correct results 
are not obtained (i.e., the device provided either false positive or 
false negative results), the licensee testing facility shall 
immediately stop using the device and conduct the investigation 
required in paragraph (f) of this section. If the incorrect result is a 
false negative result, licensees and other entities shall notify the 
NRC in accordance with Sec.  26.219(c)(3).
    (3) The licensee testing facility shall also submit at least 1 
specimen out of every 10 specimens that test negative using the non-
instrumented validity screening device to an HHS-certified laboratory 
as part of the licensee testing facility's quality assurance program. 
If results from the HHS-certified laboratory indicate that a device 
failed to perform correctly (i.e., provided either false positive or 
false negative results), the licensee or other entity shall immediately 
stop using the device and conduct the investigation required in 
paragraph (f) of this section. If the incorrect result is a false 
negative result, licensees and other entities shall notify the NRC in 
accordance with Sec.  26.219(c)(3).
    (4) Validity screening tests must measure a specimen's creatinine 
concentration to 1 decimal place.
    (5) Dipsticks, colorimetric pH tests that have a narrow dynamic 
range and do not support the 2-12 pH cutoffs, and pH paper may be used 
only for validity screening tests to determine whether initial validity 
tests must be performed. The pH screening tests must have, at a 
minimum, the following controls:
    (i) One control below the lower decision point in use;
    (ii) One control between the decision points in use; and
    (iii) One control above the upper decision point in use.
    (6) Licensee testing facilities may use either a general oxidizing 
adulterant test or one or more specific oxidizing adulterant tests for 
validity screening tests. When a general oxidizing adulterant test is 
used, the test must be able to detect at least the activity equivalent 
of 500 mcg/mL of nitrite. Dipsticks that meet the performance testing 
requirements in paragraph (b)(1) through (b)(3) of this section may be 
used to determine the presence of nitrite or other oxidizing 
adulterants at a concentration sufficient to require initial validity 
testing.
    (c) Non-negative validity screening test results. If the results of 
a validity screening test indicate that the specimen may be 
adulterated, substituted, dilute, or invalid, 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.
    (1) Creatinine. Creatinine concentration must be measured to 1 
decimal place. The initial creatinine test must have a control in the 
range of 3-20 mg/dL and a control in the range of 21-25 mg/dL.
    (2) Requirements for performing initial pH tests are as follows:
    (i) Colorimetric pH tests that have a dynamic range of 2-12 and pH 
meters must be capable of measuring pH to 1 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 2-2.8;
    (D) One control in the range of 3.2-4;
    (E) One control in the range of 4.5-9;
    (F) One control in the range of 10-10.8; and
    (G) One control in the range of 11.2-12.
    (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 2-2.8;
    (E) One control in the range of 3.2-4;
    (F) One control in the range of 10-10.8; and
    (G) One control in the range of 11.2-12.
    (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 2-2.8; and
    (D) One control in the range of 3.2-4.
    (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 10-10.8; and
    (D) One control in the range of 11.2-12.
    (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 200-400 mcg/mL, one control in the range of 500-625 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.
    (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.
    (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.
    (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

[[Page 50651]]

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 a minimum of 5 percent (or at least 1) of the 
specimens screened as negative from every analytical run to the HHS-
certified laboratory.
    (6) Quality control samples for each analytical run of specimens to 
be initially tested for drugs by the licensee testing facility must 
include--
    (i) Sample(s) certified to contain no drug (i.e., negative urine 
samples);
    (ii) At least one control fortified with a drug or drug metabolite 
targeted at 25 percent above the cutoff;
    (iii) At least one control fortified with a drug or drug metabolite 
targeted at 75 percent of the cutoff.
    (7) A minimum of 10 percent of all specimens in each analytical run 
must be quality control samples, as defined in paragraph (e)(6) of this 
section, that the licensee testing facility shall use for internal 
quality control purposes. One percent of each run or at least 1 sample 
(whichever is greater), must be blind performance test samples that 
appear as normal samples to the licensee testing facility technicians. 
Quality control samples are not forwarded to the HHS-certified 
laboratory for testing.
    (8) 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. Whenever 
possible, the investigation must determine relevant facts and identify 
the root cause(s) of the testing or process error. 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. 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 appear to be 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 provided in this part, non-
negative test results from validity screening and initial validity and 
drug tests at the licensee testing facility may not be reported to 
licensee or other entity management.
    (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.
    (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.  26.217.
    (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 
validity and drug testing devices, assays, 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 HHS-certified laboratories for specimen validity and drug 
testing, except as permitted under Sec.  26.31(d)(3)(ii).
    (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-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

[[Page 50652]]

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, in 
accordance with the requirements of 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 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 shall, upon 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, 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 PhD 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 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 attest to the validity of 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 tests 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

[[Page 50653]]

that are reported both negative and non-negative.
    (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 chain-of-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 resume, 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, 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 written 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 Secretary of the 
Department of Health and Human Services, 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. 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. Upon notification, 
the licensee or other entity shall ensure that an investigation is 
initiated to determine whether tampering has occurred. If the 
investigation determines that tampering has occurred, the licensee or 
other entity shall ensure that corrective actions are taken. 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.
    (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.
    (f) If a specimen is to be transferred to a second HHS-certified 
laboratory, laboratory 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 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

[[Page 50654]]

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 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. 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 or less 
ensures that drug-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 
drug 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.


Sec.  26.161  Cutoff levels for validity testing.

    (a) Validity test results. Each validity test result must be based 
on performing an initial validity test on one aliquot and a 
confirmatory validity test on a second aliquot.
    (b) Initial validity testing. (1) The HHS-certified laboratory 
shall test each specimen as follows:
    (i) Determine the creatinine concentration;
    (ii) Determine the specific gravity of every specimen for which the 
creatinine concentration is less than 20 mg/dL;
    (iii) Determine the pH;
    (iv) Perform one or more initial validity tests for oxidizing 
adulterants; and
    (v) Perform additional validity tests, the choice of which depends 
upon the observed indicators or characteristics below, when the 
following conditions are observed:
    (A) Abnormal physical characteristics;
    (B) Reactions or responses characteristic of an adulterant obtained 
during initial or confirmatory drug tests (e.g., non-recovery of 
internal standards, unusual response); or
    (C) Possible unidentified interfering substance or adulterant.
    (2) If tests or observations indicate one or more of the following, 
there is reason to believe the donor may have diluted, substituted, or 
adulterated the specimen, and the laboratory shall subject the specimen 
to confirmatory validity testing:
    (i) Creatinine is less than 20 mg/dL;
    (ii) Using either a colorimetric pH test or pH meter, the pH of the 
specimen is found to meet any one of the following criteria:
    (A) pH less than 3,
    (B) pH equal to or greater than 11,
    (C) pH equal to or greater than 3 and less than 4.5, or
    (D) pH equal to or greater than 9 and less than 11;
    (iii) The nitrite concentration is equal to or greater than 500 
mcg/mL using either a nitrite colorimetric test or a general oxidant 
colorimetric test;
    (iv) The presence of chromium (VI) is indicated 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) with a cutoff concentration equal to 
or greater than 50 mcg/mL);
    (v) The presence of halogen (e.g., bleach, iodine, fluoride) is 
indicated using either 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) or a halogen 
colorimetric test (halogen cutoff concentration equal to or greater 
than the LOD);
    (vi) The presence of glutaraldehyde is indicated using either an 
aldehyde test (aldehyde present) or the characteristic immunoassay 
response is observed on one or more drug immunoassay tests;
    (vii) The presence of pyridine (pyridinium chlorochromate) is 
indicated using either 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) or a chromium 
(VI) colorimetric test (chromium (VI) concentration equal to or greater 
than 50 mcg/mL);
    (viii) The presence of a surfactant is indicated by using a 
surfactant colorimetric test with a cutoff equal to or greater than 100 
mcg/mL dodecylbenzene sulfonate equivalent; or
    (ix) The specimen provides evidence of adulterants, including, but 
not limited to the following:
    (A) Abnormal physical characteristics,
    (B) Reactions or responses characteristic of an adulterant obtained 
during the initial test, or
    (C) 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).
    (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

[[Page 50655]]

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 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;
    (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 200 
mcg/mL nitrite equivalents 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:

[[Page 50656]]



        Initial Test Cutoff Levels for Drugs and Drug Metabolites
------------------------------------------------------------------------
                                                           Cutoff level
                   Drug or metabolites                        (ng/mL)
------------------------------------------------------------------------
(i) Marijuana metabolites...............................              50
(ii) Cocaine metabolites................................             300
(iii) Opiate metabolites................................           2,000
(iv) Phencyclidine......................................              25
(v) Amphetamines........................................           1,000
------------------------------------------------------------------------

    (2) If confirmatory validity testing indicates that a specimen is 
dilute, the HHS-certified laboratory shall use analytical kits approved 
by the Food and Drug Administration that have the lowest concentration 
levels marketed for the technology(ies) being used to conduct initial 
testing of the specimen for drugs or drug metabolites. The laboratory 
shall compare the responses of the dilute specimen to the cutoff 
calibrator in each of the drug classes. If the response is within 50 
percent of the cutoff, the HHS-certified laboratory shall inform the 
licensee's or other entity's MRO. At the licensee's or other entity's 
discretion, as documented in the FFD program policies and procedures, 
the MRO may direct the laboratory to test the specimen for drugs and/or 
drug metabolites down to the confirmatory assay's limit of detection 
(LOD). The laboratory shall report the results of the special analysis, 
if requested, to the MRO.
    (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 
confirmatory validity testing indicates that the specimen is dilute or 
the licensee or other entity has established more stringent cutoff 
levels.

     Confirmatory Test Cutoff Levels for Drugs and Drug Metabolites
------------------------------------------------------------------------
                                                           Cutoff level
                   Drug or metabolites                        (ng/mL)
------------------------------------------------------------------------
(i) Marijuana metabolite \1\............................              15
(ii) Cocaine metabolite \2\.............................             150
(iii) Opiates:
    (A) Morphine........................................            2000
    (B) Codeine.........................................            2000
    (C) 6-acetylmorphine \3\............................              10
(iv) Phencyclidine......................................              25
(v) Amphetamines:
    (A) Amphetamine.....................................             500
    (B) 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) 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 non-negative 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 laboratory or maintained in secure storage 
by the licensee or other entity. If the specimen in Bottle A is free of 
any evidence of drugs or drug metabolites, and is a valid specimen, 
then the licensee, other entity, or laboratory may discard the specimen 
in Bottle B.
    (4) If initial and confirmatory test results from the specimen in 
Bottle A are positive for one or more drugs or drug metabolites, or if 
validity testing at the HHS-certified laboratory shows that the 
specimen has been subject to adulteration, substitution, or other means 
of subversion, the laboratory shall report the results to the MRO. 
Within 3 business days (Monday through Friday, excluding holidays) of 
being notified by the MRO that the donor's specimen yielded a non-
negative test result, the donor may request that the split specimen in 
Bottle B be tested by another HHS-certified laboratory. The MRO shall 
inform the donor of this option, and the specimen in Bottle B may be 
tested only at the donor's request. The donor shall provide his or her 
written permission for the testing of Bottle B and neither the 
licensee, MRO, NRC, nor any other entity may order testing of Bottle B 
without the donor's written permission.
    (5) If the donor requests that the specimen in Bottle B be tested, 
the HHS-certified laboratory shall forward Bottle B to a second HHS-
certified laboratory that did not test the specimen in Bottle A as soon 
as reasonably practical and not more than one business day following 
the day of the donor's request.
    (6) The HHS-certified laboratory that tests the specimen in Bottle 
B shall provide quantitative test results to the MRO and the MRO shall 
provide them to the donor.
    (b) Donor request to MRO for a retest of a single specimen. (1) For 
a drug-positive, adulterated, or substituted result reported on a 
single specimen of 30 mL or more which the donor submitted to the 
licensee or other entity, a donor may request (through the MRO) that an 
aliquot from the single specimen be tested by a second HHS-certified 
laboratory to verify the result reported by the first laboratory. The 
MRO shall inform the donor of the option for a retest and the donor 
shall request the retest within 3 business days after notification by 
the MRO of the non-negative test result. The donor shall provide his or 
her written permission for the retest and neither the licensee, MRO, 
NRC, nor any other entity may order retesting of the specimen without 
the donor's written permission, except as provided in Sec.  26.185(m).
    (2) For a single specimen that the laboratory has reported as 
invalid, a donor may not request that an aliquot from the single 
specimen be tested by a second HHS-certified laboratory. If the donor 
requests testing of the specimen, the HHS-certified laboratory shall 
forward the specimen to a second HHS-certified laboratory that did not 
test the specimen as soon as reasonably practical and not more than one 
business day following the day of the donor's request.
    (c) Retesting a specimen for drugs. (1) The second laboratory shall 
use its standard 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).
    (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 confirm 
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

[[Page 50657]]

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 appropriate confirmatory validity test and criteria specified 
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. However, the second 
laboratory shall apply the cutoff levels for a substituted result in 
this part and shall report the results as non-confirmed if the second 
laboratory's results exceed the original test cutoff parameters. 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 
non-negative 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 non-negative 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 confirm any of the original non-negative test result(s), the 
licensee or other entity shall impose the appropriate sanctions 
specified in Subpart D of this part. 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 tested individual's personnel 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.  26.213 and 26.215 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 to permit retesting, 
either Bottle B or the original single specimen is lost in transit to 
the second HHS-certified laboratory, Bottle B has been lost), the MRO 
shall cancel the test. 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 non-negative test result(s) and any temporary 
administrative action, and may not impose any sanctions on the donor 
for a cancelled test. If the original specimen was collected for 
random, for-cause, or post-event testing, the licensee or other entity 
shall document only that the test was performed and cancelled. If the 
original specimen was collected for pre-access or followup testing, the 
MRO shall direct the licensee or other entity to collect another 
specimen for testing as soon as reasonably practical. If test results 
from the second specimen collected are non-negative 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 
non-negative 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 1 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 1-1.5 mg/dL, a control in the range of 3-20 mg/dL, and a control in 
the range of 21-25 mg/dL.
    (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 1-1.5 mg/
dL, and a control in the range of 3-4 mg/dL.
    (2) Requirements for performing specific gravity tests.
    (i) The refractometer must report and display the specific gravity 
to 4 decimal places, and must be interfaced with a laboratory 
information management system (LIMS), 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.

[[Page 50658]]

    (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 1.0040-1.0180; 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 2-12 to 
support the 3 and 11 pH cutoffs and pH meters must be capable of 
measuring pH to 1 decimal place. Dipsticks, colorimetric pH tests, and 
pH paper that have a narrow dynamic range and do not support the 2-12 
pH cutoffs may be used only to determine whether initial validity tests 
must be performed. At a minimum, pH screening tests must have the 
following controls:
    (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.
    (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 2-2.8;
    (D) One control in the range 3.2-4;
    (E) One control in the range of 4.5-9;
    (F) One control in the range of 10-10.8;
    (G) One control in the range of 11.2-12.
    (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 2-2.8;
    (E) One control in the range 3.2-4;
    (F) One control in the range of 10-10.8; and
    (G) One control in the range of 11.2-12.
    (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 2-2.8; and
    (D) One control in the range 3.2-4.
    (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 10-10.8; and
    (D) One control in the range of 11.2-12.
    (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, 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.
    (ii) A confirmatory test for a specific oxidizing adulterant must 
use a different analytical method than that used for the initial test. 
Each analytical run 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) 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), one control in the range of 200-400 mcg/mL, and one control in 
the range of 500-625 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.
    (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/Substance Abuse and 
Mental Health Services Administration (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.
    (3) Each analytical run of specimens for initial testing must 
include--
    (i) Sample(s) certified to contain no drug (i.e., negative urine 
samples);
    (ii) At least one control fortified with a drug or drug metabolite 
targeted at 25 percent above the cutoff;
    (iii) At least one control fortified with a drug or drug metabolite 
targeted at 75 percent of 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);
    (v) A minimum of 10 percent of the total specimens in each 
analytical run must be quality control samples; and
    (vi) One percent of each run, with a minimum of at least one 
sample, must be the laboratory's blind quality control samples to 
appear as routine specimens to the laboratory analysts.
    (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. 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) fortified with a drug or 
drug metabolite;
    (iii) At least one control fortified with a drug or drug metabolite 
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) Blind performance testing. 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

[[Page 50659]]

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 1 
percent of all specimens (up to a maximum of 100) or 10 blind 
performance test samples, whichever is greater. 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.
    (3) Approximately 15 percent of the blind performance test samples 
submitted to the laboratory must be positive for one or more drugs per 
sample so that all of the drugs for which the FFD program is testing 
are included each quarter. The positive samples must be spiked only 
with those drugs for which the FFD program is testing and spiked with 
concentrations between 60-80 percent of the initial cutoff values for 
the panel of drugs established herein, or of any lower cutoff values 
established by the licensee or other entity. 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 5 percent of the specimens submitted that quarter or at least 3 
samples per quarter (one each that is adulterated, diluted, or 
substituted), whichever is greater.
    (4) Approximately 80 percent of the blind performance test samples 
submitted to the laboratory each quarter must be blank (i.e., certified 
to contain no drug).
    (5) Licensees and other entities shall use only blind performance 
test samples that have been certified by the supplier to be negative 
(i.e., as certified by immunoassay and confirmatory testing), drug 
positive [i.e., certified by immunoassay and confirmatory testing to 
contain one or more drug(s) or drug metabolite(s)], adulterated (i.e., 
certified to be adulterated with a specific adulterant using an 
appropriate confirmatory validity test), or substituted (i.e., the 
creatinine concentration and specific gravity satisfy the criteria for 
a substituted specimen using confirmatory creatinine and specific 
gravity tests, respectively). The supplier shall also provide the 
expiration date for each blind performance test sample to ensure that 
each quality control sample will give the expected result when it is 
submitted and correctly tested by a laboratory before the expiration 
date. In addition--
    (i) Drug performance testing samples must satisfy, but are not 
limited to, one of the following criteria:
    (A) The drug or drug metabolite concentration in the sample must be 
at least 20 percent above the designated cutoff for either the initial 
drug test or the confirmatory drug test, depending upon which is to be 
evaluated;
    (B) For retest samples, the drug or drug metabolite concentration 
may be as low as 40 percent of the cutoff;
    (C) For routine samples, the drug or drug metabolite concentration 
may be below the cutoff for special purposes;
    (D) A negative sample may not contain the target drug analyte at a 
concentration greater than 10 percent of the confirmatory cutoff; and
    (E) Samples may be fortified with interfering substances.
    (ii) Validity performance testing samples must satisfy, but are not 
limited to, one of the following criteria:
    (A) The nitrite concentration must be at least 20 percent above the 
cutoff;
    (B) The pH must be less than 2.75 or greater than 11.25;
    (C) The concentration of an oxidant will be at a level sufficient 
to challenge a laboratory's ability to identify and confirm the 
oxidant;
    (D) The creatinine concentration must be between 0 and 20 mg/dL; 
and
    (E) The specific gravity must be less than or equal to 1.0050 or 
between 1.0170 and 1.0230.
    (g) 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, 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 
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 their 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 the corrective action 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) Should a false positive error occur 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) Should a false positive error occur 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 non-negative 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 
certifying scientist. 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.
    (h) Accuracy. Volumetric pipettes and measuring devices must be 
certified for accuracy or be checked by gravimetric, colorimetric, or 
other verification procedures. Automatic pipettes and dilutors must be 
checked for accuracy and reproducibility both before being placed in 
service and periodically thereafter.
    (i) 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.  26.169  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

[[Page 50660]]

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) 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 non-negative 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, or dilute specimen.
    (c) 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.
    (d) For a specimen that is found to be dilute, adulterated, or 
substituted, the laboratory shall report the specimen as dilute, 
adulterated, or substituted and, when applicable, 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. 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. Such 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.
    (e) The laboratory shall report all non-negative test results for a 
specimen to the MRO. For example, a specimen may be both adulterated 
and positive for one or more specific drugs.
    (f) The laboratory shall provide numerical values for non-negative 
confirmatory test results when the MRO requests such information. The 
MRO's request may be either a general request covering all such results 
or a specific case-by-case request. 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. The MRO may not disclose quantitative test 
results to the licensee or other entity, but shall report only whether 
the specimen was drug-positive (and for which analyte), adulterated, 
substituted, invalid, or negative, except as permitted under Sec.  
26.37(b). This paragraph does not preclude either the laboratory or the 
MRO from providing program performance data, as required under Sec.  
26.217.
    (g) 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.
    (h) 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 verbally 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.
    (i) 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 non-negative results, 
the laboratory shall fax, courier, mail, or electronically transmit a 
legible image or copy of the completed custody-and-control form to the 
MRO.
    (j) For a specimen that has a non-negative 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.
    (k) 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. In order 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 drug positive and dilute; 
and
    (7) Total number of specimens reported as invalid.

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

[[Page 50661]]

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 [insert date 2 years after publication of the final rule in 
the Federal Register], 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.
    (c) Responsibilities. The primary role of the MRO is to review and 
interpret non-negative 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 non-negative 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 non-
negative 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 in accordance with 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 in accordance with 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.
    (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 under his 
or her 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 in accordance with the 
requirements of 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 non-negative drug 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 
non-negative drug test results nor request medical information from a 
donor. Only the MRO may request and review medical information related 
to a non-negative drug test result or other matter from a donor.
    (iv) Staff may not report nor discuss any non-negative test results 
received from the HHS-certified laboratory with any individuals other 
than the MRO and other MRO staff.


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

    (a) MRO review required. A non-negative 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 non-negative 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 non-negative initial test results to the 
licensee or other entity that are received from the HHS-certified 
laboratory.
    (c) Discussion with the donor. Before determining that a non-
negative 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 non-negative 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 non-negative 
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 
one business day has elapsed since the date on which the

[[Page 50662]]

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 
non-negative test result or other occurrence directly with the donor, 
the donor may, upon 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 drug-
positive, adulterated, or substituted test result. If the MRO and the 
laboratory agree that further 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 upon 
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 upon 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, the MRO shall determine that the drug test results are 
positive and that the donor has violated the FFD policy.
    (2) If the MRO has reason to believe that the donor may have 
diluted a specimen in a subversion attempt, the MRO may require the 
laboratory to conduct confirmatory testing of the specimen at the LOD 
for any drugs or drug metabolites as long as each drug class is 
evaluated in accordance with Sec.  26.31(c)(1)(ii). For purposes of 
this paragraph, the following circumstances are the exclusive grounds 
constituting a reason to believe that the donor may have diluted the 
specimen in a subversion attempt:
    (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; and
    (iii) The collector observed conduct clearly and unequivocally 
indicating an attempt to dilute the specimen.
    (3) If the dilute specimen was collected under direct observation 
as required under Sec.  26.69, 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 in accordance with 
Sec.  26.31(c)(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.
    (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 referral 
physician who is experienced and qualified in the medical issues 
involved. Claims of excessive hydration, or claims based upon 
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.

[[Page 50663]]

    (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 through normal human physiology. Any 
medical evidence must be submitted through a referral physician 
experienced and qualified in the medical issues involved.
    (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 no 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 
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 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 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 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 test result for opiates, 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 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 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 
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 any question arise as to the 
accuracy or validity of a non-negative test result, only the MRO is 
authorized to order retesting of an aliquot of the original specimen. 
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 written 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 non-negative 
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

[[Page 50664]]

shall take the following actions if the second laboratory reports the 
following results:
    (1) If the second laboratory reconfirms any drug-positive test 
results, the MRO may report an FFD policy violation to the licensee or 
other entity;
    (2) If the second laboratory reconfirms any non-negative 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 drug-positive 
test results, the MRO shall report that no FFD policy violation has 
occurred; or
    (4) If the second laboratory does not reconfirm the non-negative 
validity test results, the MRO shall report that no FFD policy 
violation has occurred.
    (o) Re-authorization after a first violation for a drug-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 non-negative test results and, in those instances in which 
the MRO determines that the donor has violated the licensee's or other 
entity's FFD policy, notify licensee or other entity's designated 
representative within 10 days of an initial non-negative test result. 
The MRO shall notify the licensee or other entity of the FFD policy 
violation in writing and in a manner designed to ensure the 
confidentiality of the information.


Sec.  26.187  Substance abuse expert.

    (a) Implementation. By [insert date 2 years after publication of 
the final rule in the Federal Register], substance abuse experts (SAEs) 
upon whom licensees and other entities rely to make determinations of 
fitness under this part shall meet the requirements of this section.
    (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 (NAADAC) or by the International Certification Reciprocity 
Consortium/Alcohol and Other Drug Abuse (ICRC).
    (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 job duties performed by individuals who are subject to 
this part; 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 upon request to NRC 
representatives, licensees, or other entities who are relying upon or 
contemplating relying upon the SAE's services.
    (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) Upon 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.

[[Page 50665]]

    (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:
    (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 individuals' 
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 whereby it is 
determined 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. 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 upon 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 in accordance 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 in accordance with 
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 non-
negative 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 in 
accordance with a licensee's or other entity's FFD policy;
    (3) Before an individual is granted authorization when potentially 
disqualifying FFD information is identified and has not previously been 
evaluated by another licensee or entity who is subject to this part; 
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'' 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

[[Page 50666]]

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.

Subpart I--Managing Fatigue


Sec.  26.195  Applicability.

    The requirements in this subpart apply only to the licensees and 
other entities identified in Sec.  26.3(a) and (d).


Sec.  26.197  General provisions.

    (a) Policy. Licensees shall establish a policy for the management 
of fatigue 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 who is 
subject to an FFD program under Sec.  26.25(a)(1) or (2) 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 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.  26.201(a)(2);
    (2) Describe the process for implementing the work hour controls 
required under Sec.  26.199 for the individuals who are performing the 
duties listed in Sec.  26.199(a);
    (3) Describe the process to be followed in conducting fatigue 
assessments under Sec.  26.201; and
    (4) Describe the sanctions, if any, that the licensee may impose on 
an individual following a fatigue assessment.
    (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.  26.199;
    (2) The documentation of waivers that is required in Sec.  
26.199(d)(3)(iv), including the bases for granting the waivers;
    (3) The documentation of work hour reviews that is required in 
Sec.  26.199(j)(3);
    (4) The documentation of fatigue assessments that is required in 
Sec.  26.201(g); and
    (5) Documentation of the collective work hours of each job duty 
group, as calculated in accordance with Sec.  26.199(b)(2).
    (e) Reporting. Licensees shall include the following information in 
the annual FFD program performance report required under Sec.  26.217:
    (1) A summary of the number of instances during the previous 
calendar year in which the licensee waived any of the work hour 
controls specified in Sec.  26.199(d)(1) and (d)(2) for individuals 
within each job duty group in Sec.  26.199(a). The report must 
include--
    (i) Only those waivers under which work was performed; and
    (ii) Each work hour control that was waived in Sec.  26.199(d)(1) 
and (d)(2), including all of the work hour controls that were waived 
for any single extended work period for which it was necessary to waive 
more than one work hour control;
    (2) The collective work hours of any job duty group listed in Sec.  
26.199(a) that exceeded an average of 48 hours per person per week in 
any averaging period during the previous calendar year, in accordance 
with Sec.  26.199(f)(3) and (f)(5). The report must also include--
    (i) The dates that defined the averaging period(s) during which 
collective work hours exceeded 48 hours per person per week;
    (ii) The job duty group that exceeded the collective work hours 
limit; and
    (iii) The conditions that caused the job duty group's collective 
work hours to exceed the collective work hours limit; and
    (3) The number of fatigue assessments conducted during the previous 
calendar year, the conditions under which each fatigue assessment was 
conducted (i.e., self-declaration, for cause, post-event, followup), 
and the management actions, if any, resulting from each fatigue 
assessment.


Sec.  26.199  Work hour controls.

    (a) Individuals subject to work hour controls. Any individual who 
performs duties within the following job duty groups is subject to the 
requirements of this section:
    (1) Operating or on-site 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 maintenance or on-site directing of the maintenance 
of structures, systems, and components that a risk-informed evaluation 
process has shown to be significant to public health and safety;
    (3) Performing Health Physics or Chemistry duties required as a 
member of the on-site emergency response organization minimum shift 
complement;
    (4) Performing the duties of a Fire Brigade member who is 
responsible for understanding the effects of fire and fire suppressants 
on safe shutdown capability; 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) Calculating work hours. (1) Individual work hours. For the 
purposes of this subpart, licensees shall calculate an individual's 
work hours as the amount of time that an individual performs any duties 
for a licensee who is subject to this subpart, including all within-
shift break times and rest periods during which there are no reasonable 
opportunities or accommodations appropriate for restorative sleep, but 
excluding shift turnover.
    (i) 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;

[[Page 50667]]

and holdovers for interviews needed for event investigations.
    (ii) Other than shift turnover, only that portion of a break or 
rest period during which there is a reasonable opportunity and 
accommodations for restorative sleep may be excluded from the 
licensee's calculation of an individual's work hours.
    (iii) Licensees need not calculate the work hours of an individual 
who is qualified to perform the job duties listed in paragraph (a) of 
this section but has not performed such duties during the applicable 
calculation period. However, if the individual begins or resumes 
performing any of the job duties listed in paragraph (a) of this 
section, the licensee shall include in the calculation of the 
individual's work hours all work hours worked, including hours worked 
performing duties that are not listed in paragraph (a) of this section, 
and control the individual's work hours in accordance with the 
requirements of paragraph (d) of this section.
    (2) Collective work hours. For the purposes of this subpart, 
licensees shall calculate collective work hours as the average number 
of work hours worked among each group of individuals who perform the 
duties listed in paragraph (a) of this section, within an averaging 
period that may not exceed 13 weeks, as follows:
    (i) Licensees may define broad job duty groups comprised of 
individuals who perform the job duties listed in paragraph (a) of this 
section, or may define smaller groups of individuals who perform 
similar duties. The groups must collectively include all individuals 
who perform the job duties listed in paragraph (a) of this section;
    (ii) Licensees shall include in the average for each job duty group 
the work hours of any individual who performs the job duties of the 
group at the licensee's site, except if, during the averaging period 
the individual worked less than 75 percent of the group's normally 
scheduled hours;
    (iii) The days included in an averaging period must be consecutive 
or separated only by days that licensees are permitted to exclude from 
the collective work hour calculation under Sec.  26.199(f)(1) through 
(f)(3) and (f)(5), (h), and (i);
    (iv) Licensees shall include within an averaging period all days 
that are not excluded from collective work hour controls under Sec.  
26.199(f)(1) through (f)(3) and (f)(5), (h), and (i); and
    (v) Licensees may not include in the collective work hour 
calculation for an averaging period any work hours that are included in 
a collective work hour calculation for any other averaging period.
    (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 for individuals. Licensees shall control the 
work hours of individuals, as follows:
    (1) Except as permitted under paragraph (d)(3) of this section, 
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 adequate rest 
breaks. 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 shift turnover. At a minimum, licensees shall ensure that 
individuals who are subject to this section have the following breaks:
    (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;
    (ii) A 24-hour break in any 7-day period; and
    (iii) A 48-hour break in any 14-day period, except during the first 
14 days of any plant outage if the individual is performing the job 
duties listed in paragraph (a)(1) through (a)(4) of this section.
    (3) Licensees may grant a waiver of the individual work hour 
controls in paragraphs (d)(1) and (d)(2) of this section, as follows:
    (i) In order to grant a waiver, the licensee shall meet both of the 
following requirements:
    (A) 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 the security of the facility, or a site senior-level manager 
with requisite signature authority makes either determination; and
    (B) A supervisor, who is qualified to direct the work to be 
performed by the individual and trained in accordance with the 
requirements of Sec. Sec.  26.29 and 26.197(c), 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. 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;
    (ii) To the extent practicable, licensees shall rely upon the 
granting of waivers only to address circumstances that could not have 
been reasonably controlled;
    (iii) Licensees shall ensure that the timing of the face-to-face 
supervisory assessment that is required in paragraph (d)(3)(i)(B) 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 four hours before the individual begins performing any work under 
the waiver; and
    (iv) 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 paragraph (d)(3)(i) of this section.
    (e) Self-declarations during extended work hours. If an individual 
is performing, or being assessed for, work under a waiver of the 
requirements contained in paragraphs (d)(1) and (d)(2) of this section 
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 paragraph (a) 
of this section, 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 
paragraph (a) of this section until relieved, the licensee shall 
immediately take action to relieve the individual. Following the self-
declaration or relief

[[Page 50668]]

from performing the duties listed in paragraph (a) of this section, as 
applicable, the licensee--
    (1) May reassign the individual to duties other than those listed 
in paragraph (a) of this section, but only if the results of a fatigue 
assessment, conducted in accordance with the requirements of Sec.  
26.201, 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 rest break of 
at least 10 hours before the individual returns to performing any 
duties listed in paragraph (a) of this section.
    (f) Collective work hour limits. In addition to controlling 
individuals' work hours in accordance with paragraph (d) of this 
section, licensees shall control the collective work hours of each 
group of individuals who are performing similar job duties, as listed 
in paragraph (a) of this section. Licensees shall ensure that the 
collective work hours of each job duty group do not exceed an average 
of 48 hours per person per week in any averaging period, except as 
follows:
    (1) The licensee need not impose the collective work hour controls 
required in this paragraph on the job duty groups specified in 
paragraphs (a)(1) through (a)(4) of this section during the first 8 
weeks of a plant outage;
    (2) For job duty groups comprised of security personnel--
    (i) The group work hour average(s) may not exceed 60 hours per 
person per week during the first 8 weeks of a plant outage or a planned 
security system outage;
    (ii) The group work hour average(s) may not exceed 60 hours per 
person per week during the actual conduct of force-on-force tactical 
exercises (i.e., licensee exercises and NRC-observed exercises);
    (iii) The licensee need not impose any collective work hour 
controls for the first 8 weeks of an unplanned security system outage 
or an increased threat condition;
    (iv) If an increase in threat condition occurs while the site is in 
any plant outage or a planned security system outage and the increased 
threat condition persists for a period of 8 weeks or less, the licensee 
need not impose collective work hour controls on security personnel for 
the duration of the increased threat condition. However, if during any 
such outage, the threat condition returns to the least significant 
threat condition that was in effect at any time within the past 8 
weeks, then the licensee shall limit the collective work hours of 
security personnel to an average of 60 hours per person per week for 
the first 8 weeks of the outage for the periods prior to and following 
the increased threat condition, and shall limit the collective work 
hours of security personnel to an average of 48 hours per person per 
week following the first 8 weeks of the outage;
    (v) If additional increases in threat condition occur during an 
unplanned security system outage or increased threat condition, the 
relaxation of the collective work hour limits that is permitted in 
paragraph (f)(2)(iii) of this section may be extended with each 
increase in the threat condition, but only for a period that is the 
shorter of either the duration of the increased threat condition or 8 
weeks;
    (vi) If the threat condition decreases during an unplanned security 
system outage or increased threat condition, the applicability of the 
relaxation of the collective work hour limits that is permitted in 
paragraph (f)(2)(iii) of this section must based upon the date upon 
which the current threat condition was last entered as a result of an 
increase;
    (3) The collective work hours of any job duty group listed in 
paragraph (a) of this section may exceed an average of 48 hours per 
person per week in one averaging period if all of the following 
conditions are met:
    (i) The circumstances that cause the group's collective work hours 
to exceed 48 hours per person per week cannot be reasonably controlled;
    (ii) The group's collective work hours do not exceed 54 hours per 
person per week; and
    (iii) The additional work hours that result in the group's 
collective work hours exceeding 48 hours per person per week are worked 
only to address the circumstances that the licensee could not have 
reasonably controlled.
    (4) The collective work hours of any job duty group may not exceed 
48 hours per person per week if the collective work hours for the job 
duty group exceeded 48 hours per person per week--
    (i) In the previous averaging period; or
    (ii) In any other averaging period that ended within the past 26 
weeks.
    (5) Licensees may also exceed any collective work hour limits in 
this paragraph if the licensee has received prior approval from the NRC 
of a written request that includes, at a minimum,--
    (i) A description of the specific circumstances that require the 
licensee to exceed the applicable collective work hour limit, the job 
duty group(s) affected, and the collective work hours limit(s) to be 
exceeded;
    (ii) A statement of the period of time during which it will be 
necessary to exceed the collective work hour limit(s); and
    (iii) A description of the fatigue mitigation strategies, 
including, but not limited to, rest break requirements and work hour 
limits, that the licensee will implement to ensure that the individuals 
affected will be fit to safely and competently perform their duties.
    (g) Successive plant outages. If two or more plant outages occur at 
the licensee's site and the interval(s) between successive outages is 
less than 2 weeks, the licensee shall apply the requirements in 
paragraphs (d)(2)(iii), (f)(1), (f)(2)(i), and (f)(2)(iv) of this 
section based upon the number of days that have elapsed since the first 
plant outage in the series began.
    (h) Common defense and security. Licensees need not meet the 
requirements of this section when informed in writing by the NRC that 
these requirements, or any subset thereof, are waived for security 
personnel in order to assure the common defense and security, for the 
duration of the period defined by the NRC.
    (i) Plant emergencies. Licensees need not meet the requirements of 
paragraphs (c) through (f) of this section during declared emergencies, 
as defined in the licensee's emergency plan.
    (j) Reviews. Licensees shall review the control of work hours for 
individuals who are subject to this subpart for each averaging period. 
Licensees shall complete this review within 30 days of the end of the 
averaging period. If any outages or increased threat conditions 
occurred since the licensee completed the most recent review, the 
licensee shall include in the review an assessment of the control of 
work hours during the outages or increased threat conditions. Licensees 
shall--
    (1) Review the work hours and performance of individuals to assess 
the effectiveness of the licensee's work hour controls in achieving the 
objective of reasonable assurance that fatigue due to work hours does 
not compromise individuals' abilities to safely and competently perform 
their duties. At a minimum, the licensee's review must address--
    (i) Individuals who were granted more than one waiver during the 
review period;
    (ii) Individuals who were assessed for fatigue in accordance with 
Sec.  26.201 during the review period;
    (iii) Individuals who performed the job duties listed in paragraph 
(a) of this section whose average work hours per week exceeded 54 hours 
during any averaging period for which the

[[Page 50669]]

collective work hour limit is 48 hours in this section; and
    (iv) Any security personnel whose average work hours per week 
exceeded 66 hours in any averaging periods for which the collective 
work hours limit in this section is 60 hours per person per week;
    (2) Review individuals' hours worked and the waivers under which 
work was performed to assess staffing adequacy for all jobs subject to 
the work hour controls of this section;
    (3) Document the methods used to conduct these reviews and the 
results of the reviews; 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.


Sec.  26.201  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 rest 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 job duties.
    (b) Either a supervisor or a staff member of the FFD program, who 
is trained in accordance with the requirements of Sec.  26.29 and Sec.  
26.197(c), shall conduct the fatigue assessment 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--
    (i) Performed or directed 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 
the work activities during which the event occurred; and
    (iii) Evaluated or approved a waiver of the limits specified in 
Sec.  26.199(d)(1) and (2) 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.
    (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 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.  26.199(d)(1) or that 
the individual has had the minimum rest breaks required in Sec.  
26.199(d)(2), 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 rest 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.

Subpart J--Recordkeeping and Reporting Requirements


Sec.  26.211  General provisions.

    (a) Each licensee and other entity who is subject to this part 
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.


Sec.  26.213  Recordkeeping requirements for licensees and other 
entities.

    (a) Each licensee and other entity who is subject to this part 
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.
    (b) Each licensee and other entity who is subject to this part 
shall retain the

[[Page 50670]]

following records for at least 3 years or until the completion of all 
related legal proceedings, whichever is later:
    (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, upon 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 26.197(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)(ii), 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 period of time during which the FFD program 
follows these practices or until the completion of all related legal 
proceedings, whichever is later.


Sec.  26.215  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, 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 upon 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 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.  26.217  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 
part.
    (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 and tests for 
drugs not included in the HHS panel;
    (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; and
    (8) Summary of management actions.
    (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.
    (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

[[Page 50671]]

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.  26.219  Reporting requirements.

    (a) Required reports. Each licensee and entity who is subject to 
this part 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 job duties that require the individual to be 
subject to this part;
    (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 job duties that require them to 
be subject to this part.
    (c) Drug and alcohol testing errors. (1) Within 30 days of 
completing an investigation of any testing errors or unsatisfactory 
performance discovered in blind performance testing at either a 
licensee testing facility or an HHS-certified laboratory, in the 
testing of 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) Should a false positive error occur 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) Should a false negative error occur on a quality assurance 
check of validity screening devices, as required in Sec.  26.137(b)(2) 
and (3), 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 K--Inspections, Violations, and Penalties


Sec.  26.221  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 in accordance with 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.  26.223  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.


Sec.  26.225  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 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, 26.195, 26.223, and 26.225.

    Dated at Rockville, Maryland, this 2nd day of August 2005.

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

Appendix--Tables 1 and 2

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


    Note: The Proposed Rule constitutes a complete revision of Part 
26. Substantial changes frequently have been made between the new 
section in the proposed rule and the derivation listed in Table 1.


[[Page 50672]]



                 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).
26.3(c)................................  26.2(d).
26.3(d)................................  26.23(a)(1).
26.3(e)................................  26.2(c).
26.3(f)................................  26.2(b).
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.
26.25(a)(1)............................  26.2(a) and 26.2(d).
26.25(a)(2)............................  26.2(a) and 26.2(d).
26.25(a)(3)............................  26.2(a) and 26.2(d).
26.25(a)(4)............................  NEW.
26.25(b)(1)............................  NEW.
26.25(b)(2)............................  26.2(b).
26.25(b)(3)............................  26.2(b).
26.25(c)...............................  NEW.
26.25(d)...............................  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)...............................  26.20(d).
26.29..................................  26.21.
26.31..................................  26.24.
26.33..................................  26.22.
26.35..................................  26.25.
26.37..................................  26.29.
26.39..................................  26.27.
26.41..................................  26.80.
26.51..................................  26.1.
26.53..................................  NEW.
26.55(a)...............................  26.27(a).
26.55(b)...............................  NEW.
26.57(a)...............................  NEW.
26.57(b)...............................  NEW.
26.59..................................  NEW.
26.61(a)...............................  26.27(a)(1).
26.61(b)...............................  26.27(a)(2).
26.61(c)...............................  NEW.
26.61(d)...............................  26.27(a)(4).
26.63(a)...............................  NEW.
26.63(b)...............................  NEW.
26.63(c)...............................  NEW.
26.63(d)...............................  26.27(a)(3).
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(a)...............................  NEW.
26.65(b)...............................  NEW.
26.65(c)(1)............................  26.24(a)(1).
26.65(c)(2)............................  NEW.
26.65(d)...............................  NEW.

[[Page 50673]]

 
26.65(e)...............................  NEW.
26.65(f)...............................  NEW.
26.65(g)...............................  NEW.
26.65(h)...............................  Appendix A Subpart B 2.9(c) and
                                          26.27(a)(2).
26.67(a)...............................  NEW.
26.67(b)...............................  NEW.
26.67(c)...............................  Appendix A Subpart B 2.9(c) and
                                          26.27(a)(2).
26.69(a)...............................  NEW.
26.69(b)(1)............................  26.27(b)(4).
26.69(b)(2)............................  NEW.
26.69(b)(3)............................  26.27(b)(4).
26.69(b)(4)............................  NEW.
26.69(b)(5)............................  NEW.
26.69(b)(6)............................  26.27(b)(4).
26.69(b)(7)............................  26.27(b)(4).
26.69(c)(1)............................  26.27(a)(3).
26.69(c)(2)............................  NEW.
26.69(c)(3)............................  26.27(a)(3).
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.
26.75(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).
26.77(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).
26.81..................................  NEW.
26.83(a)...............................  NEW.
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).
26.87(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)...............................  Appendix A Subpart B 2.4(g)(1).
26.87(f)(1)............................  Appendix A Subpart B 2.4(c).
26.87(f)(2)............................  Appendix A Subpart B 2.4(c).
26.87(f)(3)............................  Appendix A Subpart B 2.4(c).
26.87(f)(4)............................  NEW.
26.87(f)(5)............................  Appendix A Subpart B 2.4(c)(2).
26.89..................................  NEW.
26.91..................................  NEW.
26.93..................................  Appendix A Subpart B 2.4 and
                                          new material.
26.95..................................  NEW.
26.97..................................  NEW.
26.99..................................  Appendix A Subpart B 2.4 and
                                          new material.
26.101.................................  Appendix A Subpart B 2.4 and
                                          new material.
26.103.................................  NEW.
26.105.................................  Appendix A Subpart B 2.4 and
                                          new material.
26.107.................................  Appendix A Subpart B 2.4 and
                                          new material.
26.109.................................  NEW.
26.111.................................  NEW.
26.113.................................  Appendix A Subpart B 2.4 and
                                          new material.
26.115.................................  Appendix A Subpart B 2.4 and
                                          new material.
26.117.................................  Appendix A Subpart B 2.4 and
                                          new material.

[[Page 50674]]

 
26.119.................................  Appendix A Subpart B 2.4 and
                                          new material.
26.121.................................  NEW.
26.123.................................  NEW.
26.133.................................  Appendix A Subpart B 2.7(e)(1).
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 2.2(a) and
                                          2.4(d).
26.127(b)..............................  Appendix A Subpart B 2.4(d).
26.127(c)..............................  Appendix A Subpart B 2.7(o)(1).
26.127(d)..............................  Appendix A Subpart B 2.2(d).
26.127(e)..............................  Appendix A Subpart B
                                          2.7(o)(3)(iii).
26.129(a)..............................  Appendix A Subpart B 2.4(c) and
                                          2.7(a)(1).
26.129(b)..............................  Appendix A Subpart B 2.2(b).
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)..............................  NEW.
26.131.................................  Appendix A Subpart B 2.4(e).
26.133.................................  Appendix A Subpart B 2.7.
26.135.................................  Appendix A Subpart B 2.7(j).
26.137.................................  Appendix A Subpart B 2.8(a).
26.137(e)(4-5).........................  Appendix A Subpart B 2.8(b).
26.137(e)(6-8).........................  Appendix A Subpart B 2.8(c).
26.137(f)..............................  Appendix A Subpart B 2.8(e)(6).
26.137(g)..............................  Appendix A Subpart B 2.7(o).
26.137(h)..............................  Appendix A Subpart B 2.7(o).
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) and Appendix A Subpart
                                          D 4.1.
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 A 1.1(2).
26.153(f)(5)...........................  Appendix A Subpart B 2.3(1).
26.153(f) 1st paragraph................  Appendix A Subpart B 2.3 1st
                                          paragraph.
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 2.2(a) and
                                          2.4(d).
26.157(c)..............................  Appendix A Subpart B 2.7(o)(1).
26.157(d)..............................  Appendix A Subpart B 2.2(d).
26.157(e)..............................  Appendix A Subpart B
                                          2.7(o)(3)(iii).
26.159(a)..............................  Appendix A Subpart B 2.4(c) and
                                          2.7(a)(1).
26.159(b)..............................  Appendix A Subpart B 2.2(b).
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)..............................  NEW.
26.161.................................  NEW.
26.163.................................  Appendix A Subpart B 2.7(e)(1)
                                          (substantially revised).
26.165.................................  Appendix A Subpart B 2.7(j)
                                          (substantially revised).
26.167(a) through (g)..................  Appendix A Subpart B 2.8
                                          (substantially revised).
26.167(h)..............................  Appendix A Subpart B
                                          2.7(o)(3)(i).
26.167(i)..............................  Appendix A Subpart B 2.8(d).
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)..............................  NEW.
26.183(b)1st sentence..................  Appendix A Subpart B 2.9(b) 1st
                                          sentence.
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(a)
                                          last sentence.
26.185(c)..............................  Appendix A Subpart B 2.9(c).

[[Page 50675]]

 
26.185(d)..............................  NEW (more detailed than
                                          Appendix A Subpart B 2.9(c)).
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.
26.195.................................  NEW.
26.197.................................  NEW.
26.199.................................  NEW.
26.201.................................  NEW.
26.211(a)..............................  NEW.
26.211(b)..............................  NEW.
26.213(a)(1)...........................  26.71(a).
26.213(a)(2)...........................  26.71(b).
26.213(a)(3)...........................  NEW.
26.213(a)(4)...........................  NEW.
26.213(b)(1)...........................  26.21(b), 26.22(c), and
                                          26.80(c).
26.213(b)(2)...........................  26.21(b), 26.22(c), and
                                          26.80(c).
26.213(c)..............................  26.71(c).
26.213(d)..............................  26.2.
26.213(e)..............................  26.23(a).
26.213(f)..............................  NEW.
26.213(g)..............................  NEW.
26.215(a)..............................  Appendix A Subpart B 2.7(n).
26.215(b)..............................  NEW.
26.217(a)..............................  26.71(d).
26.217(b)..............................  26.71(d).
26.217(c)..............................  26.71(d).
26.217(d)..............................  26.71(d).
26.217(e)..............................  26.71(d).
26.217(f)..............................  26.71(d).
26.217(g)..............................  NEW.
26.219(a)..............................  NEW.
26.219(b)(1)...........................  26.73(a)(1).
26.219(b)(2)(i)........................  26.73(a)(2)(i).
26.219(b)(2)(ii).......................   26.73(a)(2)(ii) + (iv)
                                          combined.
26.219(b)(2)(iii)......................  26.73(a)(2)(iii).
26.219(b)(3)...........................  NEW.
26.219(b)(4)...........................  NEW.
26.219(c)(1)...........................  Appendix A Subpart B 2.8(e)(4).
26.219(c)(2)...........................  Appendix A Subpart B 2.8(e)(5).
26.219(c)(3)...........................  NEW.
26.219(d)..............................  NEW.
------------------------------------------------------------------------


                Table 2.--Distribution Table for Part 26
------------------------------------------------------------------------
            Current section                        Replaced by:
------------------------------------------------------------------------
26.1 (from beginning to ``programs'')..  26.1.
26.1 (following ``programs'')..........  Deleted.
26.2(a) (first clause).................  26.2(a) (to ``and'').
26.2(a) (balance of 1st sentence)......  26.2(b) (from ``to'' to end).
26.2(a) (2nd sentence).................  26.21 (1st sentence).
26.2(a) (3rd sentence to end)..........  26.25(a) (1)(2) and (3).
26.2(b) (1st sentence).................  26.25(a).
26.2(b) (2nd sentence to end)..........  26.3(f).
26.2(c) (1st sentence).................  26.3(e).

[[Page 50676]]

 
26.2(c) (from ``shall implement'' to     26.3(f).
 end).
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       26.213(d).
 sentence).
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)...............  26.213(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) (balance of paragraph)........  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)(3) 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..................................  26.221.
26.71..................................  26.211, 26.213, and 26.215.
26.73..................................  26.219 (substantially revised).
26.80..................................  26.41 (substantially revised).
26.90..................................  26.223.
26.91..................................  26.225.
Appendix A Subpart A, 1.1(1)...........  26.3.
Appendix A Subpart A, 1.1(2)...........  26.31(d) (substantially
                                          revised).
Appendix A Subpart A, 1.1(3)...........  Subparts F and G.
Appendix A Subpart A, 1.2..............  26.5.
Appendix A Subpart B, 2.1(a)...........  26.31(d)(1).
Appendix A Subpart B, 2.1(b)...........  26.31(d)(1).
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    26.115, 26.117, 26.129, 26.159,
 (c).                                     26.169.
Appendix A Subpart B.2.2(d)(1), (2),     26.85.
 and (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.
Appendix A Subpart B.2.4(c)............  26.87(d) and (f).
Appendix A Subpart B 2.4(d)............  26.117.
Appendix A Subpart B 2.4(e)............  26.87(d)(1).
Appendix A Subpart B 2.4(f) 1st          26.87(b).
 sentence.
Appendix A Subpart B 2.4(f)(1) through   26.95 through 26.115 and
 (f)(4).                                  Subparts F and G.
Appendix A Subpart B 2.4(g)(1) through   Subparts E, F, and G.
 (g)(24).
Appendix A Subpart B 2.4(h) (1st         26.87(f)(5).
 sentence).
Appendix A Subpart B 2.4(h) (balance of  26.113, 26.117, and 26.135.
 section).
Appendix A Subpart B 2.4(i)............  26.117.
Appendix A Subpart B 2.4(j) (first two   26.115 and 26.185.
 sentences).

[[Page 50677]]

 
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.
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(b).
Appendix A Subpart B 2.7(c)............  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)............  26.163(b).
Appendix A Subpart B 2.7(g)(1) through   26.169.
 (5).
Appendix A Subpart B 2.7(g)(6) and (7).  Requirement for annual summary
                                          in 26.169(k).
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)............  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)............  26.153((f)(1) and 26.153(b).
Appendix A Subpart B 2.7(m)............  26.87(c) 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),  26.137 and 26.167.
 and (o)(4).
Appendix A Subpart B 2.7(o)(5).........  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        26.137.
 (e)(3).
Appendix A Subpart B 2.8(e)(4), (e)(5),  26.137 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), 26.165(f).
Appendix A Subpart D 4.1...............  26.153.
------------------------------------------------------------------------

[FR Doc. 05-15576 Filed 8-25-05; 8:45 am]
BILLING CODE 7590-01-P