Fitness for Duty Programs, 50442-50677 [05-15576]
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Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules
10 CFR Part 26
RIN 3150–AF12
Fitness for Duty Programs
Nuclear Regulatory
Commission.
ACTION: Proposed rule.
AGENCY:
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.
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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: SECY@nrc.gov. 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 https://ruleforum.llnl.gov.
Address questions about our rulemaking
Web site to Carol Gallagher (301) 415–
5905; e-mail cag@nrc.gov.
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
https://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
https://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 pdr@nrc.gov.
FOR FURTHER INFORMATION CONTACT:
Rebecca L. Karas, Office of Nuclear
ADDRESSES:
NUCLEAR REGULATORY
COMMISSION
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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 FITNESSFORDUTY@NRC.GOV.
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
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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
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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 [§ 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
§ 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
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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 SelfDeclarations 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
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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
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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 1year 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 § 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 § 26.41(b).
Proposed § 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
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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,
https://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 safetyrelated 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
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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
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(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 safetysensitive 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
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50445
1245, which favored it. In SRM–SECY–
04–0229, dated January 10, 2005
(available on the NRC Web site at
https://www.nrc.gov/reading-rm/doccollections/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
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SSNM Strategic special nuclear
material
THC Tetrahydrocannabinol, delta-9tetrahydrocannabinol-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, https://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.
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(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
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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
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whether a urine specimen must be
subject to further testing at an HHScertified 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 noninstrumented 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
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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 § 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 § 26.25
[Individuals subject to the fitness-forduty 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 § 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
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50447
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
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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
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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 §§ 26.10–26.29, which
specify the performance objectives that
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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 § 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 § 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 § 26.25
[Individuals subject to the fitness-forduty 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
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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 § 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 § 26.27(a)(4). Other changes are
discussed in Section IV with respect to
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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
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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 § 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
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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
§ 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
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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 ongoing 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
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any elements of a Part 26 program
during the interruption period.
Proposed § 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 § 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 § 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 § 26.69 [Authorization
with potentially disqualifying fitnessfor-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
§ 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
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discovered (see proposed § 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 §§ 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 § 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 § 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 § 26.75
[Sanctions], and indications of
impairment in proposed § 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
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assurance that only individuals who are
fit for duty are permitted to perform the
job duties listed in proposed § 26.25
[Individuals subject to the fitness-forduty 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
§ 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.
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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 § 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 § 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
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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 § 26.24(d)(1) of the current
rule and § 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
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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 § 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
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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 § 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 noninstrumented 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 HHScertified 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 HHScertified laboratories that are used by
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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-forDuty Policy Violations and Determining
Fitness
Subpart H [Determining Fitness-forDuty 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
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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
§ 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 § 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-
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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
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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.
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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
§ 26.73 [Reporting requirements], and
would incorporate the record retention
requirements of current §§ 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
Penalties
Inspections, Violations, and
Subpart K [Inspections, Violations,
and Penalties] would be added to the
proposed rule to combine into one
subpart current §§ 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 § 26.221 [Inspections] would
retain the requirements in current
§ 26.70. Proposed § 26.223 [Violations]
would retain the requirements in
current § 26.90 [Violations]. Proposed
§ 26.225 [Criminal penalties] would
retain the requirements in current
§ 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
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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
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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
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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.
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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
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reported that, contrary to popular belief,
sleep deprivation impairs decisionmaking 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
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(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
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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
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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 12hour 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 wakesleep 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
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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
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50457
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
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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.
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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
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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 safetyrelated 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 § 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.’’
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Although 10 CFR Part 26 contains
specific requirements pertaining to
alcohol and drug usage, it does not
include prescriptive requirements
regarding fatigue. Rather, § 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 nonprescriptive 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
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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). Fortyseven 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.
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50459
The NRC also reviewed the data
collected by NEI concerning deviations,
which showed that approximately onethird 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 SelfDeclaration 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.
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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 § 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 sleepwake 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 § 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.
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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 countermeasures.
(6) Ensuring effective management of
worker fatigue through rulemaking
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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
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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 offduty 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
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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-ofservice 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
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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
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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
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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 selfmanagement 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
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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 https://ruleforum.llnl.gov.
Summaries of these meetings, and any
comments provided through the Web
site are available at https://ruleforum.
llnl.gov/cgi-bin/rulemake?source=
BQ_PETITION&st=plan for meetings
and comments on the fatigue portions of
the rulemaking prior to 2004, and at
https://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
cag@nrc.gov.
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
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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 § 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
§ 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
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worker, psychologist, or others listed in
§ 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 § 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.
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50463
Specifically, new language in
proposed § 26.25(a)(4) would clarify the
NRC’s intent that FFD program
personnel must be subject to the
program. Proposed § 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
§ 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
§ 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
§ 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,’’
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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 selfdisclose 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 § 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.
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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 §§ 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,
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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, § 26.69 requires a suitable
inquiry for the applicable period
specified by § 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 § 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 § 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
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(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 § 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 § 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.
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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,
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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
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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 § 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
§ 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 § 26.69). The proposed
process for granting initial authorization
would only require a suitable inquiry
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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 preaccess 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 preaccess 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
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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
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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).
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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 HHScertified 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
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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-ofcertification 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 reproposed 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
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for inclusion into the technical basis
development for a future Part 26
rulemaking once they have been
finalized by HHS.
Subpart H Determining Fitness-forDuty 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
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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.
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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 40hour weeks recommended in NRC’s
Policy on Worker Fatigue.
Response: The objectives of the 48hour 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 § 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
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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
§ 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
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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
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50469
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 onshift 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.
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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
§ 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 safetychallenged 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
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‘‘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
§ 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 § 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
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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 § 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.
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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
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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 48hour breaks is provided in Section VI
with respect to proposed § 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
§ 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
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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
§ 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
§ 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 16hour 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 selfdeclaration.
Collectively, the requirements of the
proposed rule would be expected to: (1)
Substantially limit the frequency of 16hour 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
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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 risksignificant 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 risksignificant 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
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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 decisionmaking 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
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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 § 26.1
that refers to the entities who are subject
to the rule would be moved to proposed
§ 26.3 [Scope] in order to consolidate
this information in a more appropriate
location.
Section 26.3 Scope
Proposed § 26.3 [Scope] would
renumber, reorganize, and amend
current § 26.2 [Scope]. In general,
proposed § 26.3 would retain the list of
entities who are subject to the current
rule and add other entities. However,
the provisions in current § 26.2 that
specify the individuals whose job duties
require them to be subject to the rule
and exempt certain other individuals
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would be moved to a new section,
proposed § 26.25 [Individuals subject to
the fitness-for-duty program]. The
provisions that would be moved to
proposed § 26.25 include the second
sentence of current § 26.2(a), the first
sentence of current § 26.2(b), and the
portion of the second sentence of
current § 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 § 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 § 26.3(b) would retain the
requirement in the first sentence of
current § 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
§ 26.195 [Applicability].
Proposed § 26.3(c) would retain the
requirements of current § 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 crossreference to proposed § 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 § 26.195
[Applicability].
Proposed § 26.3(d) would retain the
meaning of the portion of current
§ 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
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would add C/Vs to the list of entities
who are subject to Part 26 in proposed
§ 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 § 26.23(a)(1) states,
‘‘The contractor or vendor is responsible
to the licensee [emphasis added] for
adhering to the licensee’s fitness-forduty 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 § 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
§ 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 § 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 drugtesting 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
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chooses to conduct drug and alcohol
testing under some or all of the
conditions specified in proposed
§ 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 § 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 § 26.195
[Applicability].
Other provisions of current § 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
§ 26.23 would be moved to proposed
Subpart J [Recordkeeping and Reporting
Requirements]. The requirement in
current § 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
§ 26.23(b) would be addressed in
proposed § 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.
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Proposed § 26.3(e) would retain and
update the requirements of current
§ 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
§ 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 § 50.10(e)(3), construction permit
holders (under Part 50 of this chapter),
construction permit applicants who
have received authorization to construct
under § 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 crossreferences 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 § 26.31 [Drug and alcohol
testing] and proposed § 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
§ 26.5 [Definitions].
Proposed § 26.3(f) would retain the
second sentence of current § 26.2(b)
because it addresses entities who would
not be subject to the proposed rule. The
first sentence of current § 26.2(b), which
addresses individuals who are not
subject to the rule, would be moved to
proposed § 26.25 [Individuals subject to
the fitness-for-duty program] for
organizational clarity in the proposed
rule.
Section 26.5 Definitions
Proposed § 26.5 [Definitions] would
amend current § 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
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also eliminate six terms in current § 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
§ 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 § 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
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[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 § 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
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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 § 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
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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 § 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 § 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
§ 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 § 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
§ 26.137 [Quality assurance and quality
control]. The term, ‘‘directing,’’ would
be added to clarify new requirements for
MRO staff under proposed § 26.183(d)
and the scope of individuals who would
be subject to work hour controls in
proposed § 26.199(a). For consistency
with the use of the term in the related
regulations of other Federal agencies,
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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 § 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
§ 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
§ 26.31(d)(3)(i), and new sanctions that
would be imposed on individuals who
are subject to the proposed rule, in
proposed § 26.75(b).
Proposed § 26.5 would also retain and
amend a number of other definitions
currently contained in § 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 § 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
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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
§ 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 § 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 § 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 § 26.7 [Interpretations]
would retain current § 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
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in the organization and language of the
rule, as discussed in Section IV. B.
Section 26.8 Information Collection
Requirements: OMB Approval
Proposed § 26.8 [Information
collection requirements: OMB approval]
would amend current § 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 § 26.9 [Specific Exemptions]
would revise current § 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 § 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 § 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 § 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 § 26.195
[Applicability]. As another example, the
proposed rule would retain the current
requirement in § 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
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§ 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
§ 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
§ 26.23 [Contractors and vendors] are
discussed with respect to proposed
§ 26.23 [Performance objectives].
Section 26.23 Performance Objectives
Proposed § 26.23 [Performance
objectives] would amend current § 26.10
[General performance objectives], as
follows:
The proposed rule would amend
current § 26.10(a). The proposed rule
would divide the performance
objectives contained in current
§ 26.10(a) into two paragraphs
(proposed § 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 § 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 postSeptember 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.
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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
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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
§ 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 § 26.23(b) would retain the
performance objective of providing
reasonable assurance that personnel are
fit for duty, which appears in current
§ 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
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subvert the testing process or
demonstrates a willingness to break the
law by possessing illegal drugs on site,
the proposed rule (under proposed
§§ 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 § 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 § 26.77(b)(3) and
current § 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
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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
§ 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
§ 26.77(b)(3).
Proposed § 26.23(c) would retain the
performance objective in current
§ 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 § 26.25
[Individuals subject to the fitness-forduty 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 § 26.23(d) would amend
current § 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’’
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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 § 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 § 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 § 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
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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 § 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 § 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 § 26.25(a)(1)–(a)(3) would
amend the portions of current § 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 § 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
§ 26.25(a)(4) to clarify the NRC’s original
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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 § 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
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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 § 26.25(a)(4)(i)–(a)(4)(v); the
MRO and MRO staff under proposed
§ 26.25(a)(4)(i); the licensee’s or other
entity’s reviewing officials under
proposed § 26.25(a)(4)(iii); specimen
collectors under proposed
§ 26.25(a)(4)(v); SAEs who are under
contract to or employed by the FFD
program under proposed
§ 26.25(a)(4)(ii); and licensee testing
facility personnel under proposed
§ 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 § 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 § 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
§ 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
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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 nonnegative 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
§ 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
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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 § 26.25(a)(4)
would require MROs and SAEs to be
subject to Part 26 (see the discussion of
proposed § 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 § 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 § 26.25(b)(2) and (3) would
retain the first sentence of current
§ 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 crossreferencing to these paragraphs from
other portions of the rule. The second
sentence of current § 26.2(b) would be
moved to proposed § 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 § 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
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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 § 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
§ 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 HHScertified laboratory conducts the
program’s specimen validity and drug
testing. Similarly, proposed § 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 § 26.103(a).
Proposed § 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
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§ 26.29(a)(1)–(a)(10). Proposed
§ 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
§ 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 § 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
§ 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 § 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
§ 26.27(a)(1); provide permission to the
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licensee to conduct a suitable inquiry in
current § 26.27(a)(2); and submit to preaccess testing in current § 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
§ 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 § 26.27 [Written policy and
procedures] would reorganize and
amend current § 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 § 26.27(a) [General] would
amend the first paragraph of current
§ 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 § 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
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§ 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 § 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 § 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 § 26.27(b) [Policy] would
amend current § 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 § 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 § 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
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50481
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 § 26.27(b)(1) would amend
the second sentence of current
§ 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-thecounter drugs).’’ Proposed § 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 § 26.27(b)(i); the abuse of legal
drugs and alcohol in proposed
§ 26.27(b)(ii); and the misuse of
prescription and over-the-counter drugs
in proposed § 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
§ 26.27(b)(2), which would require the
FFD policy to state the time period
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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 § 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 § 26.75(b), which
would require licensees and other
entities to impose the sanction of
permanent denial of authorization for
these actions. Proposed § 26.27(b)(3)
would be added to protect the due
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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 § 26.27(b)(4)(i) would
amend current § 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 5hour 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 § 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 § 26.27(b)(4)(ii) would
retain current § 26.20(a)(2).
Proposed § 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
§ 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 § 26.103 when
they arrive at the licensee’s or other
entity’s facility, depending upon the
amount of alcohol and food that the
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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 § 26.27(b)(6) would amend
the last sentence of current § 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 § 26.29(a)(6), which would
require FFD training to address this
topic, and proposed § 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-thecounter medication represents
substance abuse. Therefore, the
proposed requirement for the FFD
policy to address the use of prescription
and over-the-counter medications that
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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 § 26.27(b)(7) would amend
current § 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 § 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 twothirds 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
§ 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 § 26.23(c).
Proposed § 26.27(b)(8) would retain
the requirement in current § 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
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to proposed § 26.27(c) [Procedures],
which addresses FFD program
procedures for organizational clarity.
Proposed § 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
§ 26.5 [Definitions]. The new
requirement to report legal actions is
discussed with respect to proposed
§ 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 § 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 § 26.22(a)(5), which requires
managers and supervisors to be trained
in procedures ‘‘for initiating appropriate
corrective action.’’ Similarly, the last
phrase of § 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 § 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 § 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 § 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 § 26.29
[Training] would establish a
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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 § 26.10(b) and
proposed § 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
§ 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 § 26.27(c) [Procedures]
would combine the requirements related
to procedures contained in current
§ 26.20(c)–(e), and would add other
requirements, as follows:
Proposed § 26.27(c)(1) would retain
the requirements in current § 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 § 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.
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Proposed § 26.27(c)(2)(i) and (c)(2)(ii)
would divide current § 26.20(d) into
separate paragraphs that address
different topics. Proposed
§ 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 § 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 § 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 § 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
§ 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 § 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 § 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
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§ 26.5 [Definitions]. The proposed
paragraph would support related
provisions in proposed § 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 § 26.27(c)(3) would amend
current § 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 § 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 § 26.27(c)(3) because it
applies generally to the topic of this
proposed paragraph, rather than only to
the topic addressed in current
§ 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
§ 26.20(e), as follows: Proposed
§ 26.27(c)(3)(i) would retain current
§ 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 § 26.27(c)(3)(ii)(A) and
(c)(3)(ii)(B) would retain current
§ 26.20(e)(2) and the first sentence of
current § 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
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which an individual who has consumed
alcohol may perform work safely.
The proposed rule would also add a
requirement to proposed § 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 § 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 § 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 § 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 § 26.27(c)(4) would be
added to require that FFD procedures
must describe the process to be followed
when another individual’s behavior
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raises an FFD concern and for reporting
the concern. As discussed with respect
to proposed § 26.27(b)(11), this
proposed paragraph would be added for
consistency with proposed § 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 § 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 § 26.27(d) would retain the
requirements of current § 26.20(f).
Section 26.29 Training
Proposed § 26.29 [Training] would
combine and amend current § 26.21
[Policy communications and awareness
training] and § 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 § 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 § 26.29(a) [Training content]
would combine the training topics listed
in current §§ 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 § 26.29(a)(1) would combine
current § 26.21(a)(1) with the latter
portion of current § 26.21(a)(5).
Consistent with the current training
requirements, the proposed paragraph
would require licensees and other
entities to ensure that individuals who
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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 § 26.29(a)(2) would retain
the requirement in current § 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 § 26.29(a)(3) would amend
the terminology used in current
§ 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
§ 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 § 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 § 26.29(a)(4) and (a)(5)
would amend current § 26.21(a)(4) and
(a)(2), respectively, by changing some of
the language used in the current
provisions. Current § 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 § 26.29(a)(5) would amend
current § 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 § 26.29(a)(6) would retain
the portion of current § 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.
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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 § 26.20(a) for the FFD policy to
address these factors would be moved to
proposed § 26.27(b)(6) because proposed
§ 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 § 26.29(a)(7) would retain
the portion of current § 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 § 26.29(a)(8) and (a)(9)
would retain the requirements in
current § 26.22(a)(3) and (a)(4),
respectively.
Proposed § 26.29(a)(10) would amend
current § 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
§ 26.33 [Behavioral observation], which
would require individuals to perform
behavioral observation and report any
FFD concerns, as discussed with respect
to proposed § 26.27(b)(11), and
proposed § 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
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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 § 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
§ 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
§ 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 § 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 computerbased 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.
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Proposed § 26.29(c) [Training
administration] would combine and
amend the portions of current § 26.21(b)
and § 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 § 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 § 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
§ 26.57 [Authorization update] and
§ 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
§ 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 § 26.29(c)(2) would retain
but combine the requirements for
annual refresher training in current
§ 26.21(b), which addresses individuals
who are subject to this part, and
§ 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 § 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
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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 § 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 § 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
§ 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 § 26.29(b)
[Comprehensive examination]. Proposed
§ 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.
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Section 26.31
Testing
Drug and Alcohol
Proposed § 26.31 [Drug and alcohol
testing] would rename current § 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 § 26.31(a) [General] would
retain but update the language in
current § 26.24(a) to be consistent with
the new terminology used throughout
the rule, as discussed in proposed § 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 § 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 § 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 § 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 crossreference 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 § 26.25(a)(4)] or
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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 § 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
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‘‘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 § 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
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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 § 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 § 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 § 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 § 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
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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 § 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 § 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
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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 § 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 § 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 § 26.31(c) [Conditions for
testing] would replace current
§ 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 § 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
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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
§ 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 § 26.31(c)(1) [Pre-access]
would amend current § 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 [Preaccess 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 § 26.31(c)(2) [For cause] and
§ 26.31(c)(3) [Post event] would clarify
and amend current § 26.24(a)(3), as
follows:
Proposed § 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 § 26.3 [Definitions].
Proposed § 26.31(c)(3) [Post event]
would amend the portion of current
§ 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
§ 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,
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‘‘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 postevent testing and, instead, require postevent testing as soon as practical after
significant events [as listed in proposed
§ 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 § 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 § 26.31(c)(3)(i) would
provide a threshold for the types of
workplace personal injuries and
illnesses for which post-event testing
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would be required in response to
implementation questions related to
current § 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 § 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
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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 nonnegative 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
§ 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 § 26.31(c)(3)(ii) would carry
over the relevant language in the
corresponding portion of current
§ 26.24(a)(3), without change.
Proposed § 26.31(c)(3)(iii) would carry
over the relevant language in the
corresponding portion of current
§ 26.24(a)(3), but, as discussed with
respect to proposed § 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 § 26.31(c)(4) [Followup]
would retain the intent of current
§ 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 § 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 § 26.31(d)(1)(i).
Detailed requirements for conducting
followup testing would be established
in proposed § 26.69 [Authorization with
potentially disqualifying fitness-for-duty
information], where they would apply
to licensees’ and other entities’
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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 § 26.31(c)(5) [Random]
would simplify current § 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 § 26.24(a)(2) would
be moved to proposed § 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 § 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 § 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, postevent, random) would be moved to
proposed § 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
§ 26.31(d)(3)(i).
Proposed § 26.31(d)(1)(i) would retain
the permission in the second sentence
of current § 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 § 26.31(d)(1)(i)(A) would
retain the permission in current
§ 26.24(c) for licensees and other
entities to add to the panel of drugs for
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which testing is required in proposed
§ 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 § 26.3 [Definitions].
Proposed § 26.31(d)(1)(i)(B) would
retain the last sentence in current
§ 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 § 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 § 26.31(d)(1)(i)(D) would be
added to further clarify the requirement
in proposed § 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
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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 § 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 § 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 § 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
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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 § 26.23
[Performance objectives]. Thus,
extending the current limitation on forcause 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 § 26.31(d)(1)(ii) would also
apply the new requirements in proposed
§ 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
§ 26.31(d)(1)(i)(D). The proposed
provision would provide consistency
with proposed § 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
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50491
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
§ 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 HHScertified laboratories to test specimens
that are collected for for-cause, postevent, 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 § 26.31(d)(2) [Random
testing] would reorganize and amend
the requirements for conducting random
testing, which currently appear in
§ 26.24(a)(2), as follows:
Proposed § 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
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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
§ 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
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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
§ 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 § 26.31(d)(2)(i)(B) would
amend the third sentence of current
§ 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 § 26.31(d)(2)(ii) would
retain the third sentence of current
§ 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
§ 26.31(d)(2)(i)(B).
Proposed § 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
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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 § 26.27(b)(2). Proposed
§ 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
§ 26.27(b)(2), and, therefore, would meet
Goal 3 of this rulemaking, which is to
improve the effectiveness of FFD
programs.
Proposed § 26.31(d)(2)(iv) would
amend the first sentence of current
§ 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 § 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
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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
§ 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 § 26.31(d)(2)(v) would retain
the second sentence of § 26.24(a)(2),
which requires that an individual who
has completed a test is immediately
eligible for another random test.
Proposed § 26.31(d)(2)(vi) would
amend the last sentence of current
§ 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 § 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 § 26.31(d)(3) [Drug testing]
would be added to group requirements
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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 § 26.31(d)(3)(i) would
combine some of the requirements in
current Section 1.1(3) in Appendix A to
Part 26, § 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, ‘‘nonnegative,’’ 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 § 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 HHScertified 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
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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 HHScertified 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
§ 26.23 [Performance objectives].
Proposed § 26.31(d)(3)(ii) would
amend the first sentence of current
§ 26.24(d)(1), which permits licensees
and other entities to conduct initial
testing of urine specimens at a licensee
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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 § 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 § 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 § 26.163(a)(1) for initial drug
testing and proposed § 26.163(b)(1) for
confirmatory drug testing. Consistent
with the first sentence of current
§ 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 § 26.24(b) to implement a
broader panel of drugs would be
relocated to proposed § 26.31(d)(1), as
discussed with respect to that
paragraph.
Proposed § 26.31(d)(3)(iii)(A) would
retain the third and fourth sentences of
current § 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 § 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
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tests conducted under this part and
equally to all individuals who are
subject to testing, except as permitted
under proposed § 26.163(a)(2) for dilute
specimens and proposed § 26.165(c)(2)
for retesting specimens. As discussed
with respect to proposed
§ 26.31(d)(1)(ii), some FFD programs
have adopted the practice of testing
specimens at the assay’s LOD for forcause, 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 § 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 § 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 § 26.31(d)(4) [Alcohol
testing] would update current § 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 crossreference to Section 2.7(o)(3) in
Appendix A to Part 26 would be
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amended to refer to § 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 § 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 § 26.99
[Determining the need for a
confirmatory test for alcohol] and
proposed § 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
§ 26.83(a).
Proposed § 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
§ 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
§ 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 § 26.31(d)(6) [Limitations of
testing] would retain and amend current
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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 § 26.33 [Behavioral
observation] would be added to
emphasize that behavioral observation
is a required element of FFD programs.
The first sentence of proposed § 26.33
would require behavioral observation of
individuals who are subject to this part.
The second sentence would retain
current § 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 § 26.35 [Employee
assistance programs] would amend
current § 26.25 [Employee assistance
programs (EAP)] for the reasons
discussed with respect to each
paragraph that would be added to the
proposed rule. Proposed § 26.35(a)
would retain the current provision.
In response to implementation
questions, proposed § 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
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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
§ 26.25(d).
Proposed § 26.35(c) would amend the
last sentence of current § 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 § 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
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50495
to the EAP would remain confidential
and that EAP staff always report selfreferrals 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 § 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 § 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 selfreferrals 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
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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 § 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
§ 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 § 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
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management. Proposed § 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
§ 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 § 26.35(c)(2).
Proposed § 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 § 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
§ 26.35(c)(3) would be added to crossreference 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 §§ 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
§ 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.
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Section 26.37 Protection of
Information
Proposed § 26.37 [Protection of
information] would amend current
§ 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
§ 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 § 26.37(a) would combine
and retain the first sentence of current
§ 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 § 26.37(b) would amend
current § 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 § 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
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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 § 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 § 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 § 26.37(b)(1), (b)(2),
(b)(5), and (b)(6) would amend the
related requirements contained in
current § 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
§ 26.29(b) would include the following:
Proposed § 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 § 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 § 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 § 26.183(d).
Proposed § 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
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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
§ 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 § 26.37(b)(6) and (b)(7)
would amend the portion of current
§ 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 § 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
§ 26.37(b)(6). Proposed § 26.37(b)(7)
would be added to cover ‘‘persons
deciding matters under review in
§ 26.39’’ [Review process for fitness-forduty policy violations], as discussed
with respect to that section.
Proposed § 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
§ 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 § 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.
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Proposed § 26.37(d) would combine
requirements in current § 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 § 26.37(e)
and (f) would retain current Section 3.1
in Appendix A to Part 26 and the last
sentence of current § 26.29(b),
respectively.
Section 26.39 Review Process for
Fitness-for-Duty Policy Violations
Proposed § 26.39 [Review process for
fitness-for-duty policy violations] would
amend current § 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 § 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
§ 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 § 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 § 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
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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 nonnegative 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 § 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
§ 26.28 has indicated that, in some
cases, individuals do not understand the
purpose of the review process and their
associated rights.
Proposed § 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 § 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 § 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
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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 § 26.39(e) would amend the
last sentence of current § 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 § 26.41 [Audits and
corrective action] would rename and
amend current § 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 § 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 § 26.41(a) [General] would
amend the last sentence in current
§ 26.80(a), which states that licensees
retain responsibility for the
effectiveness of C/V programs and the
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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 § 26.41(b) [FFD program]
would amend the required audit
frequency in current § 26.80(a). (The
other requirements contained in current
§ 26.80(a) are addressed in other
paragraphs of proposed § 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.
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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 § 26.41(c) [C/Vs and HHScertified laboratories] would amend the
audit and inspection requirements for
these entities that are contained in the
second sentence of current § 26.80(a)
and the third sentence of Section 2.7(m)
in Appendix A to Part 26, as follows:
Proposed § 26.41(c)(1) would further
amend the requirement in current
§ 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
§ 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 HHScertified 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.
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Proposed § 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 HHScertification 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 § 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 § 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
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the HHS-certified services related to
those cutoff levels and drug tests are
performed.
The last sentence of proposed
§ 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 illdefined 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 § 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
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rulemaking, which is to improve Part 26
by eliminating or modifying
unnecessary requirements.
Proposed § 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 HHScertified laboratories would be moved to
§ 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 § 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 HHScertified 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 HHScertified 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 § 26.41(d)(2) would be
added to ensure that licensees’ and
other entities’ contracts with C/Vs and
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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 HHScertified 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 § 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 HHScertified laboratory’s drug testing
operations before awarding a contract to
the laboratory, by adding a crossreference to proposed § 26.41(g).
Proposed § 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 § 26.41(e) [Conduct of
audits] would retain the requirements in
current § 26.80(b).
Proposed § 26.41(f) [Audit results]
would retain the portion of current
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§ 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 § 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 § 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
§ 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 § 26.41(g) [Sharing of
audits] would respond to licensees’
implementation questions related to the
third and fourth sentences in current
§ 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 § 26.41(g) would amend the
current provision to incorporate specific
permission for licensees and other
entities to jointly conduct audits as well
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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 § 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 HHScertified 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 § 26.41(g)(3) would retain
the portion of the third sentence of
current § 26.80(a) that states that
licensees and other entities need not reaudit 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 § 26.41(g)(4) would retain
the fourth sentence of current § 26.80(a),
which requires licensees and other
entities to retain copies of the shared
audit reports.
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Proposed § 26.41(g)(5) would be
added to permit licensees and other
entities to immediately obtain drug
testing services from another HHScertified 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 HHScertified 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 § 26.51 [Purpose] would be
added to describe the purpose of the
proposed subpart. Proposed § 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
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requirements and these other
requirements.
Section 26.53 General Provisions
A new § 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 § 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 § 26.55 [Initial
authorization], proposed § 26.57
[Authorization update], proposed
§ 26.59 [Authorization reinstatement],
and proposed § 26.69 [Authorization
with potentially disqualifying fitnessfor-duty information]. Proposed
§ 26.53(a) would direct licensees or
other entities to use the criteria for
granting authorization to individuals
found in proposed §§ 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 § 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 § 26.53(b) would define the
meaning of the term, ‘‘interruption,’’
which would be used in proposed
§ 26.57 [Authorization update] and
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proposed § 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 § 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 § 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 §§ 26.55, 26.57, or 26.59, as
discussed further with respect to
proposed § 26.69.
Proposed § 26.53(c) would reiterate
the FFD training requirements in
proposed § 26.29 [Training] and the
fatigue training requirements in
proposed § 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 § 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 § 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 § 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 § 26.23 [Contractors and
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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 § 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
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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 § 26.55(a)(1) would require
the licensee or other entity, before
granting initial authorization to an
individual, to obtain and review a selfdisclosure in accordance with the
applicable requirements of proposed
§ 26.61 [Self-disclosure and
employment history]. As discussed with
respect to proposed § 26.61, the selfdisclosure 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 § 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 § 26.27(a)(1). The discussion
of proposed § 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 § 26.61(a)(3), the period of
time to be addressed in the selfdisclosure 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 § 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
§ 26.63 [Suitable inquiry]. The proposed
requirement is similar to the
requirement in § 26.27(a)(2) of the
current rule that a suitable inquiry must
be completed addressing the topics that
are specified in § 26.27(a)(2). The
discussion of proposed § 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 § 26.63(f)(1) specifies that the
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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 § 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
§ 26.65 [Pre-access drug and alcohol
testing]. Current § 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 § 26.65
compares the proposed pre-access drug
and alcohol testing requirements for
initial authorization to the requirements
in the current rule. Proposed § 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 § 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 § 26.67
[Random drug and alcohol testing of
individuals who have applied for
authorization]. Current § 26.64(a)(2)
requires unannounced drug and alcohol
tests imposed in a statistically random
and unpredictable manner. The
discussion of proposed § 26.67
compares the proposed random drug
and alcohol testing requirements for
initial authorization to the requirements
in the current rule.
Proposed § 26.55(b) would be added
to require that the licensee or other
entity must meet the requirements in
proposed § 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 § 26.57 [Authorization
update] would define the category of
‘‘authorization update’’ requirements for
granting authorization to individuals
whose authorization has been
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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 informationsharing 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 § 26.57(a), like proposed
§ 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
§ 26.61; (2) complete a suitable inquiry
in accordance with the applicable
requirements of proposed § 26.63; (3)
ensure that the individual is subject to
pre-access drug and alcohol testing in
accordance with the applicable
requirements of proposed § 26.65; and
(4) ensure that the individual is subject
to random drug and alcohol testing in
accordance with the applicable
requirements of proposed § 26.67.
However, proposed § 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 § 26.63(f)(2)
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50503
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 § 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 § 26.69.
Section 26.59 Authorization
reinstatement
A new § 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
§ 26.59(a), and the other to individuals
whose authorization has been
interrupted for 30 or fewer days in
proposed § 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
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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 preaccess testing in accordance with
proposed § 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
§ 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 § 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 § 26.57, the proposed rule
in § 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
§ 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
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Jkt 205001
§ 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 § 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
§ 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
§ 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 § 26.59(b) would be added
to ensure that any administrative
withdrawal of authorization that would
be required under proposed § 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 § 26.59(c) would establish
authorization requirements for
individuals whose authorization has
been interrupted for 30 or fewer days.
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Proposed § 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 § 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 § 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
§ 26.65(e) for individuals whose
authorization has been interrupted for
6–30 days. Exceptions to the selfdisclosure and pre-access testing
requirements in this proposed
paragraph would be specified in
proposed §§ 26.61 and 26.65,
respectively.
Section 26.61 Self-Disclosure and
Employment History
A new § 26.61 [Self-disclosure and
employment history] would replace
current § 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 § 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 § 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 selfdisclosure and employment history
would be unnecessary in these
circumstances, because it would already
be available to the granting licensee or
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other entity from the Part 26 program
that had been implementing the
behavioral observation and arrestreporting 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 § 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 § 26.61(b) would be added
to specify the required content of the
self-disclosure. Affirmative responses to
any of the questions in proposed
§ 26.61(b)(1) would be considered
potentially disqualifying FFD
information, as defined in proposed
§ 26.5 [Definitions]. The proposed rule
would expand the scope of the
questions to be asked from those
required in current § 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 § 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 § 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
§ 26.27(a)(2) and proposed § 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 § 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
§ 26.61(b)(1) would require an applicant
to report an arrest on drug-related
charges, while proposed § 26.61(b)(2)
would require the applicant to report
the outcome of the arrest (e.g., charges,
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Jkt 205001
a conviction, a finding of not guilty, the
dropping of the charges).
Proposed § 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 § 26.55)
would not be required to disclose earlier
substance-abuse-related events. For
applicants who held authorization
within the past 3 years, the selfdisclosure 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 § 26.63) as well as information
from the period(s) during which the
individual was subject to other Part 26
programs.
Proposed § 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 § 26.63 [Suitable
inquiry].
Proposed § 26.61(d) would replace
and expand upon current § 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.
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Section 26.63
50505
Suitable Inquiry
A new § 26.63 [Suitable inquiry]
would amend current § 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 § 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 § 26.69 [Authorization with
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potentially disqualifying fitness-for-duty
information].
Proposed § 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 § 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 § 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 § 26.63(c) would be added
to specify requirements for the manner
in which licensees and other entities
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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
§ 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 § 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 § 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
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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 § 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
§ 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 § 26.63(c), some
employers are unwilling or unable to
provide suitable inquiry information.
Proposed § 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 § 26.29(b) as a requirement
that licensees and other entities must
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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 licenseeapproved 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
§ 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 § 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 crossreferences to the applicable records
retention requirements in proposed
§ 26.211 [General provisions] and
proposed § 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 § 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 § 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.
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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 5year suitable inquiry in all cases, the
proposed rule would increase the
thoroughness of the suitable inquiry
into the past 3 years.
Proposed § 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.
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Proposed § 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 § 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 § 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 § 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 § 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.
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Section 26.65 Pre-Access Drug and
Alcohol Testing
Proposed § 26.65 [Pre-access drug and
alcohol testing] would amend current
§ 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 § 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 § 26.69
[Authorization with potentially
disqualifying fitness-for-duty
information].
Proposed § 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 30day 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
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authorization is granted to the
individual. A requirement for the
licensee or other entity to conduct preaccess 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
§ 26.65(c)(1) and (c)(2). In proposed
§ 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 § 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 § 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 preaccess testing requirements in current
§ 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
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record of successfully maintaining
authorization under Part 26; and (3) had
only a short break in authorization.
Proposed § 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
§ 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 § 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 § 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
§ 26.65(c)(1) and (c)(2).
Proposed § 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 § 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 § 26.65(e)(2)(i) would
require the licensee or other entity to
subject the applicant to a one-time
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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
§ 26.31(d)(2)(vi) would be selected for
testing at some point within a 30-day
period. Proposed § 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
§ 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
§ 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
§ 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 § 26.65 would
enhance the deterrent effect of preaccess 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 § 26.65(f) [Time period for
testing] would be added to require that
specimens that are collected for any preaccess testing required in this proposed
section must be collected within the 30day period preceding the day upon
which the licensee grants authorization
to an individual. Under current
§ 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
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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 § 26.23(a).
Proposed § 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 § 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
§ 26.65(h)(1) and (h)(2) would crossreference 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
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50509
(i.e., permanent denial of authorization)
in proposed § 26.75(b).
Proposed § 26.65(h)(3) would be
added to permit licensees and other
entities to grant authorization to an
individual whose confirmed nonnegative test result is a first drug- or
alcohol-related violation under a Part 26
program, consistent with current
§ 26.27(b)(2). However, the proposed
rule would permit authorization to be
granted only in accordance with the
stringent requirements contained in
proposed § 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 § 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 § 26.67(a) would require
licensees and other entities to conduct
random testing of applicants in
accordance with the requirements of
proposed § 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 § 26.67(a)(1) and
(a)(2). Proposed § 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
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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
§ 26.67(a)(2) would address the
circumstance described in proposed
§ 26.65(b), in which the licensee or
other entity is permitted to meet preaccess 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 § 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 § 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
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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 decisionmaking.
Proposed § 26.67(c) would crossreference the minimum sanctions to be
imposed on an individual whose drug
or alcohol test results from random
testing are confirmed as non-negative.
Proposed § 26.67(c)(1) and (c)(2) would
refer to the relevant sanctions specified
in proposed Subpart D. Proposed
§ 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 § 26.27(b)(2), but the
proposed rule would permit
authorization to be granted only in
accordance with the stringent
requirements contained in proposed
§ 26.69 [Authorization with potentially
disqualifying fitness-for-duty
information].
Section 26.69 Authorization With
Potentially Disqualifying Fitness-forDuty Information
A new § 26.69 [Authorization with
potentially disqualifying fitness-for-duty
information] would replace and clarify
the existing requirements contained in
§ 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 § 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
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any means and the information has not
been assessed and favorably resolved by
a previous licensee or other entity.
Proposed § 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
§ 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 § 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
§ 26.26(b)(2), which would be moved to
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proposed § 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
§ 26.75(c), (d), (e)(2), or (f). The
proposed paragraph would replace and
strengthen the requirements contained
in current § 26.27(b)(2) and expand
them to address confirmed positive
alcohol test results, which are excluded
from this process in current
§ 26.27(b)(5). The proposed paragraph
would include confirmed positive
alcohol test results for the reasons
discussed with respect to proposed
§ 26.75(e).
Proposed § 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 selfdisclosure 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 § 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
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entity’s reviewing official to determine
whether authorization is warranted.
Proposed § 26.69(b)(3) would apply
only to individuals whose authorization
was denied for 5 years under the current
rule or in accordance with § 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 § 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 § 26.69(b)(4) would amend
the requirement in current § 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 § 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
§ 26.69(c)(3) and the definition of
‘‘reviewing official’’ in proposed § 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 § 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 § 26.189
[Determination of fitness], as part of the
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authorization decision. Proposed
§ 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 § 26.187. Therefore,
proposed § 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 § 26.69(b)(4)(i)–(b)(4)(iii)
would replace and strengthen the
requirement in current § 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 § 26.69(b)(5) would be
added to impose more stringent preaccess 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 § 26.69(f)]. Completing drug
and alcohol testing within 10 days
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before granting authorization, rather
than the 30 days that is permitted in
proposed § 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
§ 26.27(b)(2) and retained in proposed
§ 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 § 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
§ 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 § 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 § 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
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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 § 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
§ 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 § 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 § 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 § 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
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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 § 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 § 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
§ 26.75(e)(2).
Proposed § 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 nonnegative drug or alcohol test result or 5year denial of authorization. For
example, this type of potentially
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disqualifying FFD information may
include, but would not be limited to: (1)
A report of an arrest for an alcoholrelated 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 alcoholrelated 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 § 26.69(c)(1) would be
added to require the licensee or other
entity to verify that the individual’s selfdisclosure addresses the applicable
period specified in proposed
§ 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 selfdisclosure under proposed §§ 26.55,
26.57, or 26.59 and an additional selfdisclosure and employment history
would be unnecessary.
Proposed § 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
§ 26.63(f) so that the suitable inquiry
was partially completed, proposed
§ 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
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authorization was terminated favorably
in order to make an appropriate
authorization decision.
Proposed § 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 § 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
§ 26.69(c)(4) would require the licensee
or other entity to implement the
treatment and testing recommendations.
Proposed § 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 preaccess 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 § 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 selfdisclosure, suitable inquiry, and preaccess 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
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50513
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 § 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 § 26.69(f) [Sanctions for
confirmed non-negative drug and
alcohol test results] would be added to
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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 § 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 § 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 § 26.71(a) would provide
that individuals may maintain
authorization under the conditions
listed in proposed § 26.71(a)(1)–(a)(4), as
follows:
Proposed § 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 § 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
§ 26.71 would also require that, in order
to maintain authorization, an individual
must report any legal actions, as defined
in proposed § 26.5 [Definitions]. Finally,
although not explicitly specified in
proposed § 26.71(a)(1), proposed § 26.33
[Behavioral observation] would require
individuals to report any FFD concern
to the personnel designated in the FFD
policy.
Proposed § 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
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with the requirements in proposed
§ 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 § 26.71(b).] In addition,
proposed § 26.31 also would place
certain responsibilities on individuals
who are subject to the testing program.
In particular, under proposed
§ 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 § 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
§ 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 § 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 § 26.29(c). As
specified in proposed § 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 § 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
§ 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 § 26.29.
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Proposed § 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
§ 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 § 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 § 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
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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 § 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 § 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
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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 § 26.75(b) to indicate that
applicants for authorization who
subvert or attempt to subvert a preaccess 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 § 26.75(c) would amend
current § 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 § 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
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50515
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
§ 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 § 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 § 26.75(d) would amend the
portion of current § 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 § 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:
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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 5year 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 § 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 § 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 § 26.75(g)
would prohibit a subsequent licensee or
other entity from granting authorization
to the individual under any
circumstances.
The portion of current § 26.27(c) that
refers to a refusal to provide a specimen
for testing would be moved to proposed
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§ 26.75(b) for organizational clarity, as
discussed with respect to that
paragraph.
Proposed § 26.75(e) would amend
current § 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 § 26.75(e)(1) would retain
the intent of the second sentence of
current § 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
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paragraph related to referring the
individual to the EAP for assessment
and counseling be eliminated from
proposed § 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
§ 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 § 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 § 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
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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 § 26.75(f) would amend
current § 26.27(b)(5), which states that
the sanctions for confirmed positive
drug test results in current § 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 § 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 § 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
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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 § 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-thecounter 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 § 26.27(b)(5) because
it unnecessarily limits the
circumstances in which sanctions for
the misuse of prescription and over-thecounter drugs would be imposed.
Proposed § 26.75(g) would amend
current § 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 § 26.69
[Authorization with potentially
disqualifying fitness-for-duty
information] in Subpart C [Granting and
Maintaining Authorization] for
organizational clarity because proposed
§ 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 § 26.25
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50517
[Individuals subject to the fitness-forduty program].
Proposed § 26.75(h) and (i) would
amend current § 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 § 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 § 26.75(i)(1)–(4) would
retain the requirements in current
§ 26.24(d)(2)(i)–(iv) that establish the
conditions under which licensees and
other entities may take administrative
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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
§ 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 § 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 § 26.77 [Management actions
regarding possible impairment] would
amend the requirements of current
§ 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 § 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 § 26.77(b) would retain the
portion of current § 26.27(b)(1) that
requires the licensee or other entity to
take immediate action to prevent an
individual from performing the job
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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 § 26.27(c)(3), and § 26.199(h)
and (i), because the proposed provisions
would provide exceptions to the
requirement for immediate action.
Proposed § 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
§ 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 crossreferences 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 § 26.77(b)(1) would retain
the intent of current § 26.24(a)(3), which
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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 forcause 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 § 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
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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 § 26.201 [Fatigue
assessments], before permitting the
individual to return to performing his or
her job duties.
Proposed § 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
§ 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 § 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 § 26.77(c) would update
current § 26.27(d) to be consistent with
current NRC notification procedures.
Subpart E—Collecting Specimens for
Testing
Section 26.81
Purpose
Proposed § 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.
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Section 26.83 Specimens To Be
Collected
A new § 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 § 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 § 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
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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 § 26.83(b) would retain but
make explicit the implied requirement
in the first sentence of current § 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
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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
§ 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 § 26.31(d)(5) [Medical
conditions] for the reasons discussed
with respect to that paragraph.
Section 26.85 Collector Qualifications
and Responsibilities
A new § 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 § 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.
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Proposed § 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
§ 26.85(a)(1)–(a)(3) would list the topics
that the proposed rule would require
collector training to address. Proposed
§ 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
§ 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 § 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 § 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 § 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 § 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 § 26.85(a),
including the first three sentences of
proposed § 26.85(b) and proposed
§ 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 § 26.85(a),
and proposed § 26.85(a)(3) and (a)(4),
respectively. The proposed rule would
repeat the requirements that are
applicable to both urine and alcohol
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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 § 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 § 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 § 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 § 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
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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 § 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
§ 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
§ 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 § 26.85(c)(1)–(c)(5) to
receive the same training as nonmedical 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
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discussed with respect to current
§ 26.83(a).
Proposed § 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 colocated 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 § 26.139(c) of proposed Subpart F
[Licensee Testing Facilities] and those
related to HHS-certified laboratories
would be moved to § 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 § 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 § 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
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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 § 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 § 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
§ 26.115 [Collecting a urine specimen
under direct observation].
Proposed § 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
§ 26.221(a). The portions of the current
paragraph that apply to HHS-certified
laboratories would be moved to
§ 26.153(f) of proposed Subpart G
[Laboratories Certified by the
Department of Health and Human
Services], also for organizational clarity.
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In addition, proposed § 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 § 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 § 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 § 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 § 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 § 26.87(d)(2) would amend
the second sentence of current Section
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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 § 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 § 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 § 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.
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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 § 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 § 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 § 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 § 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
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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 § 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 § 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 § 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 § 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
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to the collection in a review under
proposed § 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 § 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 § 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 § 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
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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 § 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 § 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 § 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
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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
§ 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 § 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 § 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 § 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
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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 § 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
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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 preaccess 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.
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Proposed § 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 § 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 § 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 § 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
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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
§ 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 § 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 § 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 § 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
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rulemaking, which is to improve clarity
in the organization of the rule.
Proposed § 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 § 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
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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 § 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
§§ 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 § 26.101(d). As discussed
further with respect to proposed
§§ 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 § 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
§ 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
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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
§ 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 § 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 § 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
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to maintain the effectiveness of FFD
programs, which is Goal 3 of this
rulemaking.
Proposed § 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 § 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 § 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 § 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
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provisions because their results must be
legally defensible.
Proposed § 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 § 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 § 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 § 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
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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 § 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 § 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 § 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 § 26.93(a)(1)–(a)(6)
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50527
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
§ 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
§ 26.93(a)(2) would permit alcohol
testing to proceed if the donor states
that none of the activities listed in
§ 26.93(a)(1) had occurred, while
proposed § 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
§ 26.93(a)(1). Proposed § 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 § 26.93(a)(1) during the
collection process. Proposed
§ 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 § 26.93(a)(1).
Proposed § 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 § 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.
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Proposed § 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 § 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 § 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
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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 § 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
§ 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 § 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 § 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
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into the device in the view of the donor
would be added for the same reason
described with respect to proposed
§ 26.95(b)(1).
Proposed § 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 § 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 § 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 §§ 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 § 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
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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 § 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
§ 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 § 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 § 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 § 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 § 26.95(b)(1).
Proposed § 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
§ 26.95(b)(1).
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Proposed § 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
§ 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 § 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 § 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 § 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 § 26.39
[Review process for fitness-for-duty
policy violations] or legal proceedings.
Proposed § 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
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50529
reasons discussed with respect to
proposed § 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 § 26.97(b)(4) would require
the collector to repeat the collection
procedures outlined in proposed
§ 26.97(a) for the second collection.
If the second collection attempt fails,
proposed § 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 § 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 § 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 § 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 § 26.99 [Determining the need
for a confirmatory test for alcohol]
would amend the existing requirements
in current § 26.24(g) and the portion of
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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 § 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 §§ 26.99 and
26.103 that would take into account the
average rate at which individuals
metabolize alcohol over time. In
proposed § 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 § 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 § 26.103. The proposed
changes in the initial alcohol test cutoff
level and testing procedure are
necessary to support the provisions of
proposed § 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 § 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
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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
§ 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 § 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 § 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 § 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 § 26.101(b) would be added
to specify procedures for conducting a
confirmatory alcohol test.
Proposed § 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 § 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
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EBT is not functioning properly and
may provide inaccurate test results.
Proposed § 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 § 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 § 26.39
[Review process for fitness-for-duty
policy violations], or legal proceedings.
Proposed § 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 § 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 § 26.91(b). The proposed
change would meet Goal 3 of this
rulemaking, which is to improve the
efficiency of FFD programs.
Proposed § 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
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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 § 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
§ 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 § 26.99 [Determining the need
for a confirmatory test for alcohol].
Proposed § 26.103(a)(1) would retain the
0.04 percent BAC in current § 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 § 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 § 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
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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 § 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
§ 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
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reasons for eliminating blood testing for
alcohol from the proposed rule
discussed with respect to proposed
§ 26.83(a).
Section 26.105 Preparing for Urine
Collection
A new § 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 § 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
§ 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 § 26.93 [Preparing for alcohol
testing], for organizational clarity.
Proposed § 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
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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 § 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 § 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 § 26.105(e) would be added
to permit the donor, at the collector’s
discretion, to select the specimen
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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
§ 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 § 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 § 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
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testing program, as discussed with
respect to proposed § 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 § 26.111(b).
Proposed § 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 § 26.115 [Collecting a urine
specimen under direct observation].
Proposed § 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 § 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
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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 § 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 § 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
§ 26.115 [Collecting a urine specimen
under direct observation].
Proposed § 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 § 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
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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 § 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 § 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 § 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
§ 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
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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
§ 26.31(d)(1), as well as retesting of the
specimen, if required.
Proposed § 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
§ 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 § 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 § 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 § 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
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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 § 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 § 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 § 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 § 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 § 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
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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 atrisk. 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 § 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 § 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 § 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
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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 § 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
§ 26.119 [Determining shy bladder].
Requirements for implementing ‘‘shy
bladder’’ procedures would be
contained in that proposed section.
Proposed § 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 § 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
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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 HHScertified 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
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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 § 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 § 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
§ 109(b)(4). The proposed paragraph
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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 § 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°F–99.8°F in the current
provision to 90°F–100°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 § 26.111(d) for
organizational clarity.
Proposed § 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
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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 § 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 § 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
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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 § 26.109(b)(4).
Proposed § 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
§ 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
§ 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 § 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 HHScertified laboratory to conduct all of the
validity and drug tests on the specimen
that would required under this part.
Proposed § 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
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further testing of the specimen is
necessary, and to enhance the
consistency of Part 26 with the related
provisions of other Federal agencies.
Proposed § 26.111(g) would be added
to inform donors and collectors of the
characteristics of a specimen that is
acceptable for testing at an HHScertified laboratory. The proposed
paragraph would incorporate the related
provision from the HHS Guidelines.
Section 26.113 Splitting the Urine
Specimen
Proposed § 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 § 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 § 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 § 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 § 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
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updated requirements that would be
consistent with those established in
proposed § 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
§ 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 § 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 § 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
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§ 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 § 26.109 [Urine
specimen quantity]. As discussed with
respect to proposed § 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 §§ 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 § 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
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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 § 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 § 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
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consistency with proposed § 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 § 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
§ 26.31(d)(3)(i). The cutoff
concentrations and specimen
characteristics that would lead the HHSlaboratory to report a specimen as
substituted, adulterated, or invalid
would be specified in proposed § 26.161
[Cutoff levels for validity testing].
Requirements for the MRO’s review of
the test results would be specified in
proposed § 26.185 [Determining a
fitness-for-duty policy violation].
Proposed § 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)
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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 § 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
§ 26.115(a)(2)(i). However, proposed
§ 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 § 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
§ 26.31(d)(3)(i). As discussed with
respect to proposed § 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
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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
§ 26.87(e)(1)] discolors the specimen.
Proposed § 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
§ 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 § 26.69 would
permit or require directly observed
collections, including proposed
§ 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 § 26.69, rather than repeat the
applicable requirements in this section.
Proposed § 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 § 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
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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 § 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 § 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 § 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
§ 26.185(g)(2), in order to compare the
results from testing the dilute specimen
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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 § 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 § 26.115(f). The
proposed rule would combine the
current requirements in the proposed
paragraph for organizational clarity.
Proposed § 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 § 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 § 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
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to ensure that the urine specimen is
obtained from the donor’s body.
Proposed § 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 § 26.115(f)(4) would be
added to require the collector to record
the observer’s name on the custody-andcontrol 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 § 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 § 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 § 26.75(b).
Proposed § 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
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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 § 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 § 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
§ 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
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and sealing the split specimen bottles
would be moved to proposed § 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 § 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 § 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
§ 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-andcontrol form any medications he or she
has taken within the past 30 days, for
the reasons discussed with respect to
proposed § 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
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identity, including, but not limited to
bar coding.
Proposed § 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-ofcustody 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 § 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 § 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 § 26.5 [Definitions], but
retain the intended meaning of the
current requirements.
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Proposed § 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 § 26.87(f)(5) for organizational
clarity because proposed § 26.87(f)
addresses those circumstances.
Proposed § 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 HHScertified laboratory, would be moved to
proposed § 26.117(j) for organizational
clarity. Proposed § 26.117(j) would
address transfer and storage
requirements, while proposed
§ 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 § 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
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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 § 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 § 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
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collection site, to further protect against
potential specimen degradation.
Proposed § 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-andcontrol 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 § 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
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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 § 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 § 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
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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 § 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
§ 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
§ 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 § 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 § 26.119(c) would be added
to describe the conclusions that the
physician must provide to the MRO
following the evaluation. Under
proposed § 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 § 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 § 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
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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 § 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 § 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 § 26.119(g)(3).
Proposed § 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 § 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 § 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 § 26.75(b).
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Proposed § 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 § 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 § 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
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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 § 26.125 [Licensee testing
facility personnel] would amend current
Section 2.6 in Appendix A to Part 26,
as follows:
Proposed § 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 § 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
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50543
demonstrate proficiency assist in any
litigation that may occur with respect to
urine test results.
Proposed § 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 § 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 § 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 HHScertified 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
§ 26.83(a). Reference to HHS-certified
laboratories would be moved to
proposed § 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 § 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-ofcustody procedures. The proposed
paragraph would retain the portions of
the current paragraphs that require
licensee testing facilities to develop,
implement, and maintain written chainof-custody procedures to maintain
control and accountability of specimens
from receipt through completion of
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testing and reporting of results, during
storage and shipping to the HHScertified laboratory, and continuing
until final disposition of the specimens.
The current requirements related to
HHS-certified laboratories would be
moved to proposed § 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-andcontrol procedures for blood specimens
because donors would no longer have
the option to request blood testing for
alcohol, as discussed with respect to
proposed § 26.83(a).
Proposed § 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
§ 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 § 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
§ 26.215(a) of Subpart J [Recordkeeping
and Reporting Requirements] of the
proposed rule. Procedural requirements
for HHS-certified laboratories would be
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moved to § 26.157(b) in proposed
Subpart G [Laboratories Certified by the
Department of Health and Human
Services].
Proposed § 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 noninstrumented 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
§ 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 § 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 § 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 § 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 noninstrumented 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 § 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 § 26.129 [Assuring
specimen security, chain of custody,
and preservation] would be added to
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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 § 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 HHScertified laboratories would be moved to
proposed § 26.159(a). The last sentence
of the current paragraph, which
establishes recordkeeping requirements,
would be moved to § 26.215(b)(13) in
proposed Subpart J [Recordkeeping and
Reporting Requirements]. The proposed
changes would be made for
organizational clarity.
Proposed § 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 § 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
§ 26.75(b) for a subversion attempt.
Management personnel would also be
required to correct any systematic
weaknesses in specimen custody-andcontrol procedures that may be
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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-ofcustody 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.
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Proposed § 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
§ 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
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50545
rulemaking, which is to improve clarity
in the language of the rule.
Proposed § 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 HHScertified laboratories to § 26.159(d) and
(e) in proposed Subpart G [Laboratories
Certified by the Department of Health
and Human Services] to improve
organizational clarity.
Proposed § 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, ‘‘nonnegative,’’ 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 § 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 §§ 26.137
[Quality assurance and quality control]
and 26.167 [Quality assurance and
quality control], respectively.
Proposed § 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 § 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 § 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
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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 § 26.129(g) and (h) would
separate current Section 2.4(i) in
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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 § 26.117(i) and (k).
Proposed § 26.129(g) and (h), which
repeat the requirements for packaging
and shipping specimens contained in
proposed § 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 HHScertified laboratories. The bases for
these requirements are discussed with
respect to proposed §§ 26.117(i) and (k).
Section 26.131 Cutoff Levels for
Validity Screening and Initial Validity
Tests
A new § 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
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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 § 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 drugpositive 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 § 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.
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Proposed § 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 § 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 § 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
§ 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
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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 § 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 § 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 § 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
§ 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
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throughout the proposed rule, as
discussed with respect to proposed
§ 26.31(d)(3)(i).
Proposed § 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
§ 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.
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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 § 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 § 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
§ 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 § 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
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moved to § 26.167 in proposed Subpart
G [Laboratories Certified by the
Department of Health and Human
Services] for organizational clarity.
Proposed § 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
§ 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 § 26.31(d)(3)(i).
Proposed § 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 § 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 § 26.137(b)(1) would permit
licensee testing facilities to use noninstrumented devices, such as dipsticks,
to determine whether a specimen
appears to be valid or must be subject
to further validity testing. However, in
proposed § 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
§ 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 § 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
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devices that meet the criteria before
SAMHSA’s list is published.
The NRC is aware that the
performance testing requirements in
proposed § 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 § 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 § 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 § 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
§ 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 § 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 § 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
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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 § 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 § 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
§ 26.137(f), and notify the NRC.
The NRC notifications that would be
required in proposed § 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
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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 § 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 § 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 § 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 § 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.
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Proposed § 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 § 26.137(d)(2) would
establish quality control requirements
for performing initial pH tests. Proposed
§ 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 § 26.137(d)(3) would
establish quality control requirements
for performing initial tests for oxidizing
adulterants, including nitrite, and
proposed § 26.137(d)(4) would establish
quality control requirements for
performing initial tests for ‘‘other’’
adulterants at the licensee testing
facility.
Proposed § 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 § 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 § 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
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rule would permit licensee testing
facilities to use such combination
devices for validity screening tests, if
the devices meet the requirements of
proposed § 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 § 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 § 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 § 26.137(e)(2).
Proposed § 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 § 26.5 [Definitions].
Proposed § 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
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submit specimens that yield negative
results from initial testing to the HHScertified 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 § 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 HHScertified 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 HHScertified 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 § 26.137(d)(7). The last
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sentence of the current paragraph,
which addresses performance testing of
breath analysis equipment for alcohol
testing, would be moved to proposed
§ 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 § 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 § 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 § 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
§ 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
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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 HHScertified 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 § 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 § 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 § 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
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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 § 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 HHScertified laboratories to § 26.167(h) in
proposed Subpart G [Laboratories
Certified by the Department of Health
and Human Services] for organizational
clarity.
Proposed § 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 § 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 § 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
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requirements in the current paragraph
that are related to reporting test results
from HHS-certified laboratories would
be moved to § 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
§ 26.31(d)(3)(i).
Proposed § 26.139(b) would amend
the last sentence of current § 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 § 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 § 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
§ 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 § 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 § 26.217(b).
Experience implementing the current
requirement for a monthly statistical
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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 § 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 § 26.169(k) of
proposed Subpart G [Laboratories
Certified by the Department of Health
and Human Services] for organizational
clarity.
Proposed § 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
§ 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 § 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 § 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
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testing for additional drugs and drug
metabolites, beyond those specified in
proposed § 26.31(b)(1).
Proposed § 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 § 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 § 26.153 [Using certified
laboratories for testing urine specimens]
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would be added to present together
requirements related to the use of HHScertified laboratories by licensees and
other entities who would be subject to
the rule.
Proposed § 26.153(a) would combine
and update current requirements for
licensees and other entities to use HHScertified laboratories for initial and
confirmatory drug testing of urine
specimens. The proposed paragraph
would relocate and combine current
§ 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 HHScertified 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
§ 26.31(d)(3)(i). The cross-reference to
current § 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
§ 26.31(d)(3)(ii).
Proposed § 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 § 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
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addition of requirements to perform
validity testing to the proposed rule, as
discussed with respect to proposed
§ 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 § 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 § 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 § 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
§ 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 § 26.83(a). Finally,
the requirement for laboratories to be
capable of conducting GC/MS testing
would be eliminated because HHScertified laboratories would be
permitted to use other methods of
confirmatory testing, consistent with
related revisions to the HHS Guidelines.
Proposed § 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
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because the proposed rule would no
longer permit donors to request
confirmatory alcohol testing of blood for
the reasons discussed with respect to
proposed § 26.83(a).
Proposed § 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 § 26.153(e) also would
permit a licensee or other entity to begin
using the services of another HHScertified 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
§ 26.41(g)(5).
Proposed § 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 § 26.153(f)(1) would retain
the requirement in current Section
2.7(l)(1) in Appendix A to Part 26,
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50553
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 HHScertified 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 § 26.153(f)(2) would amend
current Section 2.7(o)(5) in Appendix A
to Part 26, which requires that HHScertified 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 § 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 § 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 § 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 § 26.37(a)
for organizational clarity. The crossreference to current § 26.29 would be
updated to reference proposed § 26.39
[Protection of information].
Proposed § 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 § 26.31(d)(3)(i). The
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proposed paragraph would delete the
current reference to records related to
alcohol test results because HHScertified laboratories would no longer be
testing blood specimens for alcohol, as
discussed with respect to proposed
§ 26.83(a).
Proposed § 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 § 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 § 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
§ 26.83(a).
Proposed § 26.153(g) would require
licensees and other entities to provide a
memorandum for the record to the HHScertified laboratories that they use to
document why the licensee or other
entity is using a non-Federal custodyand-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 § 26.155 [Laboratory
personnel] would update current
Section 2.5 in Appendix A to Part 26 to
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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 § 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 § 26.155(a) would retain the
majority of Section 2.5(a)(2), which
establishes qualification requirements
for the responsible person. Proposed
§ 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 § 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 § 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 § 26.157
[Procedures], consistent with the
organizational changes made to the rule.
Proposed § 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
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maintaining a quality assurance
program and taking remedial actions to
maintain satisfactory laboratory
operations.
Proposed § 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 HHScertified laboratory before they are
transmitted to the licensee’s or other
entity’s MRO. In proposed
§ 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
§ 26.155(b)(2) would specify the
required qualifications of individuals
who serve as certifying scientists.
Proposed § 26.155(b)(3) would permit
laboratories to use more than one
certifying scientist with differing
responsibilities.
Proposed § 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 § 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 § 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 § 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
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procedural requirements for HHScertified laboratories in one section.
Proposed § 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 HHScertified 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
§ 26.83(a). Reference to licensee testing
facilities would be moved to proposed
§ 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 § 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-ofcustody procedures. The proposed
paragraph would retain the portions of
the current paragraphs that require
HHS-certified laboratories to develop,
implement, and maintain written chainof-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 HHScertified laboratory, and continuing
until final disposition of the specimens.
The current requirements related to
licensee testing facilities would be
moved to proposed § 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 § 26.83(a).
Proposed § 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
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procedures in a list format in proposed
§ 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. HHScertified 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
§ 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 § 26.215(b)(4)
of proposed Subpart J [Recordkeeping
and Reporting Requirements].
Proposed § 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 § 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
§ 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
§ 26.127(d) in proposed Subpart F
[Licensee Testing Facilities].
Proposed § 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 § 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 § 26.159 [Assuring
specimen security, chain of custody,
and preservation] would be added to
present in one section the requirements
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of the proposed rule that apply to HHScertified 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 § 26.159(a) would amend
current Section 2.7(a)(1) in Appendix A
to Part 26. Proposed § 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 § 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 § 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 § 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 § 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
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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 § 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 § 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-ofcustody 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 § 26.129(c) in proposed
Subpart F [Licensee Testing Facilities]
for organizational clarity. Proposed
§ 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-andcontrol form in secure storage at the
HHS-certified laboratory. The proposed
changes would be made to reduce
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redundancies and improve the
organization clarity of the rule.
Proposed § 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 § 26.129(d)
and (e) in proposed Subpart G
[Laboratories Certified by the
Department of Health and Human
Services] for organizational clarity.
Proposed § 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 § 26.117(i) and (k) and
§ 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
§ 26.117(i) and (k) of Subpart E
[Collecting specimens for testing] and
§ 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 § 26.117(i) and (k).
Proposed § 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 § 26.129(f)
in proposed Subpart F [Licensee Testing
Facilities] for organizational clarity.
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Proposed § 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
§ 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
§ 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 § 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, ‘‘nonnegative,’’ to be consistent with the new
terminology adopted throughout the
proposed rule. As discussed with
respect to proposed § 26.5 [Definitions],
these proposed changes in terminology
would be made to improve clarity in the
language of the proposed rule.
Proposed § 26.159(j) would be added
to incorporate related changes to the
HHS Guidelines. The proposed
paragraph would permit the HHScertified 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 § 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 § 26.31(d)(3)(i). The proposed
rule would incorporate these
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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 § 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 § 26.161(b) [Initial validity
testing] would be added to establish
requirements and cutoff levels for initial
validity tests to be performed at HHScertified laboratories.
Proposed § 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 § 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 § 26.161(b)(1)(ii).
Proposed § 26.161(b)(1)(iii) would
require the laboratory to determine each
specimen’s pH. Proposed
§ 26.161(b)(1)(iv) would require the
laboratory to test the specimen for the
presence of oxidizing adulterants, and
proposed § 26.161(b)(1)(v) would
require additional validity testing,
depending upon the characteristics of
the specimen.
Proposed § 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 § 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
§ 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
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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
§ 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 § 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 § 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 § 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 § 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
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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 § 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 HHScertified 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 § 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
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to sanctions on the basis of inaccurate
test results.
Section 26.163 Cutoff Levels for Drugs
and Drug Metabolites
Proposed § 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 § 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
§ 26.163(a)(1) would require HHScertified laboratories to apply the same
cutoff levels that licensee testing
facilities would be required to use in
proposed § 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 § 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
§ 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 § 26.133. The
proposed changes would be consistent
with the HHS cutoff levels for the same
substances.
Proposed § 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.
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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 HHScertified 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
§ 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
§ 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.
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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 § 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 § 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 § 26.169(b)
for organizational clarity because
proposed § 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 § 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
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to Part 26 that the laboratory must use
GC/MS techniques for confirmatory
testing would be moved to proposed
§ 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 § 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 § 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 § 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
§ 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
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changes would be made for consistency
with the related provisions in the HHS
Guidelines.
Proposed § 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
§ 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 § 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 § 26.165 [Split specimens]
would reorganize and amend the
requirements currently found in
§ 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 § 26.165(a) [Split
specimens] would combine and amend
current § 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
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discussed with respect to proposed
§ 26.31(d)(3)(i).
Proposed § 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 § 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 HHScertified 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
§ 26.31(d)(3)(i).
Proposed § 26.165(a)(2) would retain
the portion of the second sentence of
current § 26.24(f) that requires the HHScertified 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 nonnegative 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
§ 26.31(d)(3)(i).
Proposed § 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 § 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
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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
§ 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 nonnegative 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 § 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
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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 § 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 § 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 § 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 § 26.165(c)(1) would be
added to require the second HHScertified laboratory to use the
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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 § 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 § 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 § 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
§ 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 § 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 HHScertified 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
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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 § 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 § 26.165(f)(1) would be
added to address circumstances in
which the MRO has confirmed a nonnegative test result from the HHScertified 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 § 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 § 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 nonnegative test results from the first HHScertified 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
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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 § 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 § 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 preaccess 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 § 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
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50561
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
§ 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
§ 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 crossreferences to other portions of the
proposed rule.
Section 26.167 Quality Assurance and
Quality Control
Proposed § 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 HHScertified laboratories. The proposed
section would provide more detailed
requirements for the quality assurance
and quality control programs of HHScertified 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 § 26.31(d)(3)(i).
Proposed § 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
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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 § 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 § 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 § 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 § 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 § 26.137
[Quality assurance and quality control]
in proposed Subpart F [Licensee Testing
Facilities]. The proposed change would
be made for organizational clarity.
Proposed § 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 § 26.31(d)(3)(i). The more
detailed requirements for calibrators
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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 § 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 HHScertified laboratory. The quality control
requirements for validity tests in this
proposed paragraph would incorporate
the related provisions of the HHS
Guidelines.
Proposed § 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 § 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 § 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 § 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 § 26.167(c)(4)
[Requirements for performing oxidizing
adulterant tests], proposed § 26.167(c)(5)
[Requirements for performing nitrite
tests], and proposed § 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.
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Proposed § 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 § 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 § 26.137(e)(1) of
proposed Subpart F [Licensee Testing
Facilities] to improve organizational
clarity in the rule.
Proposed § 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 § 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 § 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
§ 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 § 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
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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 § 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 HHScertified laboratories to use other
techniques for confirmatory drug testing
that the HHS Guidelines approve for use
in Federal workplace drug testing
programs.
Proposed § 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 § 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
§ 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 § 26.167(e)(2)(iv), at
least one calibrator or control that is
targeted at or below 40 percent of the
cutoff.
Proposed § 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 § 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
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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 § 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 § 26.167(f)(1).
Proposed § 26.167(f)(3) would
decrease the proportion of spiked blind
samples that licensees and other entities
would submit each quarter from 20
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50563
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
§ 26.31(d)(3)(i), and would be necessary
to challenge the accuracy of the HHScertified laboratory’s specimen validity
testing.
Proposed § 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 § 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 § 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 § 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-
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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 § 26.215(b)(8) in
proposed Subpart J [Recordkeeping and
Reporting Requirements] for
organizational clarity.
Proposed § 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 HHScertified laboratory.
Proposed § 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 § 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
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would fall under the requirements of the
proposed paragraph. The reporting
requirement in current Section 2.8(e)(5)
would be moved to § 26.219(c)(2) in
proposed Subpart J [Recordkeeping and
Reporting Requirements] for
organizational clarity.
Proposed § 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 § 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 § 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 § 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 § 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
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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 § 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 § 26.31(d)(3)(i).
Proposed § 26.169(a) would amend
current Section 2.7(g)(1) in Appendix A
to Part 26, which establishes a timelimit 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
§ 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
§ 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
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identity may be lost, and, therefore,
have substantially reduced the need for
the requirement in the current rule.
Proposed § 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 § 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
§ 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 § 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 § 26.31(d)(1)(i)(D).
Proposed § 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 § 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 HHScertified laboratory would be useful in
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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 § 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 § 26.75 [Sanctions]. Reporting
multiple test results for a single
specimen would be consistent with
related requirements in the HHS
Guidelines.
Proposed § 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 § 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
§ 26.83(a). Disclosure of quantitative test
results to licensees and other entities
would continue to be subject to the
requirements in proposed § 26.37(b).
The proposed changes to this paragraph
would be consistent with the related
provisions in the HHS Guidelines.
Proposed § 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
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50565
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 § 26.185(f)(1).
Proposed § 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 § 26.169(i) would update
current Section 2.7(g)(5) in Appendix A
to Part 26, which establishes
requirements for transmitting chain-ofcustody 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 nonnegative 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 § 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
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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
§ 26.155(b).
Proposed § 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 § 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 § 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 § 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 6acetylmorphine (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 §§ 26.217(b)(2),
§ 26.185(f)(1), and 26.31(d)(3)(i).
Subpart H—Determining Fitness-forDuty Policy Violations and Determining
Fitness
Section 26.181 Purpose
Proposed § 26.181 [Purpose] would
describe the purpose of Subpart H,
which is to establish requirements for
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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 § 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 § 26.183(a) [Qualifications]
would combine and amend the
requirements in current § 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
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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 § 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 § 26.183(c)
[Responsibilities] would reorganize and
update the requirements in current
§ 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 § 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 § 26.31(d)(3)(i). The proposed
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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 § 26.183(c)(1) would retain
and update the requirements contained
in the current definitions of the term,
‘‘Medical Review Officer,’’ in § 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 nonnegative 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
§ 26.31(d)(3)(i), as well as to increase the
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consistency of Part 26 with advances in
other relevant Federal rules and
guidelines, which is Goal 1 of this
rulemaking.
Proposed § 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 § 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 HHScertified 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 § 26.183(d)(1) [Direction of
MRO staff activities] would be added to
require an MRO to be directly
responsible for the administrative,
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50567
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
§ 26.31(d)(3)(i).
Proposed § 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 nonnegative 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 § 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
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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 § 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 § 26.183(d)(1)(iii)
would establish these clear limits.
Proposed § 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 § 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 § 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
§ 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
§ 26.183(c)(2)(iv) would prohibit MRO
staff from reporting or discussing nonnegative 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.
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Section 26.185 Determining a Fitnessfor-Duty Policy Violation
Proposed § 26.185 [Determining a
fitness-for-duty policy violation] would
amend requirements related to the
MRO’s determination that a nonnegative test result constitutes an FFD
policy violation, as follows:
Proposed § 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 nonnegative validity test results and
authorizing the testing at an HHScertified 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 § 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 § 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 § 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
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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
§ 26.183(d), as discussed with respect to
that paragraph.
Proposed § 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
§ 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 § 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 § 26.185(d) [Donor
unavailability] would be added to
clarify the circumstances in which the
MRO may confirm a non-negative test
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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 § 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
§ 26.185(d)(2); and (3) the MRO being
unable to contact the donor after making
a reasonable effort to do so in proposed
§ 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
§ 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
§ 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.
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Proposed § 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
§ 26.31(d)(3)(i).
Proposed § 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 § 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 § 26.185(f)(1) would require
the MRO to consult with the HHScertified 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 § 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 HHScertified 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
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50569
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 § 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 nonnegative, 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 § 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 § 26.185(g)(1) would require
the MRO to confirm a drug-positive FFD
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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 § 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 § 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 § 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 § 26.185(g)(2). These
circumstances would be the same as
those specified in proposed
§ 26.115(a)(1)-(a)(3), as discussed with
respect to those provisions.
Proposed § 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
§ 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
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conducted under proposed § 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 § 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 § 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 § 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.
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Proposed § 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 § 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 § 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 § 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 § 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 § 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 § 26.185(j) [Review for
opiates, prescription and over-thecounter 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 § 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
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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 § 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 § 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 § 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
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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 § 26.185(j)(4) would be
added to assure greater consistency in
MRO determinations related to a
donor’s use of a prescription or overthe-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 § 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-thecounter as a legitimate medical
explanation for the specimen having
drugs or drug metabolites above the
cutoff levels specified in proposed
§ 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
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50571
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 § 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 § 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 § 26.185(k) [Results
consistent with legitimate drug use]
would amend current Section 2.9(f) in
Appendix A to Part 26. The current
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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 § 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 § 26.5
[Definitions]. The proposed rule would
also add a requirement that the retesting
must be conducted at a second HHScertified 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
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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 § 26.135(b).
Proposed paragraph § 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
§ 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 § 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
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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 § 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 § 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 HHScertified 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 § 26.185(o) [Reauthorization 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
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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 § 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 § 26.185(p) [Time to
complete MRO review] would amend
current § 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
§ 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 § 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 § 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
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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 § 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
§ 26.187(b)(1)–(b)(5). However,
proposed § 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 § 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 § 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 controlledsubstance abuse disorders, in proposed
§ 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 § 26.187(c)(2); and (3)
knowledge of this part and any changes
to its requirements, in proposed
§ 26.187(c)(3).
Proposed § 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 § 26.187(d)(1); (2) key
drug and alcohol testing requirements of
this part, in proposed § 26.187(d)(2) and
(d)(3), respectively; (3) SAE
qualifications and prohibitions, in
proposed § 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 § 26.187(d)(5); (5)
procedures for consulting and
communicating with licensee or other
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50573
entity officials and the MRO, in
proposed § 26.187(d)(6); (6) reporting
and recordkeeping requirements of this
part as they related to the SAE function,
in proposed § 26.187(d)(7); and (7)
appropriate methods for addressing
issues that SAEs confront in carrying
out their duties under this part, in
proposed § 26.187(d)(8).
Proposed § 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 § 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 § 26.187(d). Proposed
§ 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 § 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 § 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.
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Proposed § 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
§ 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 § 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 § 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 § 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 § 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 § 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 § 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
§ 26.187(g)(2)(ii)(A)–(g)(2)(ii)(D) would
specify circumstances in which the
prohibition in proposed § 26.187(g)(2)(i)
would not apply. In general, the
proposed rule would permit the SAE to
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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 § 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., § 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 § 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 § 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
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§ 26.69(b)(4)] or whether the individual
is a licensed physician. Therefore,
proposed § 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 § 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 § 26.189(a)(2), psychiatrists in
proposed § 26.189(a)(3), physicians in
proposed § 26.189(a)(4), or an MRO in
proposed § 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 § 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
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protect the privacy and due process
rights of individuals who are subject to
Part 26.
Proposed § 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 § 26.189(b)(1) would
reiterate the requirement in current
Section 2.9(f) in Appendix A to Part 26
and proposed § 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 § 26.189(b)(2) would
reiterate requirements in current
§ 26.27(b)(1) and (b)(4) and proposed
§ 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 § 26.189(b)(3) would
reiterate the requirement in proposed
§ 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 § 26.27(c)(4), and if a
licensee’s or other entity’s reviewing
official requires one, in accordance with
proposed § 26.69(c)(3) and (d)(2).
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Proposed § 26.189(c) would be added
to establish requirements for a
determination of fitness that is
conducted ‘‘for cause.’’ Specifically,
proposed § 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 selfdisclosed 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-toface 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 § 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 forcause determination of fitness process
among FFD programs for the reasons
discussed with respect to proposed
§ 26.187 [Substance abuse expert].
Proposed § 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
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50575
require the individual to be subject to
this part.
Proposed § 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 § 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.
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Subpart I—Managing Fatigue
Section 26.195 Applicability
A new § 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 § 50.57
of this chapter) and holders of a
combined license after the Commission
has made the finding under § 52.103 of
this chapter, as specified in proposed
§ 26.3(a), and C/Vs who implement FFD
programs or program elements upon
which such licensees rely, as specified
in proposed § 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 workhour 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
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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 § 26.23(a),
as retained in proposed § 26.3 [Scope].
Proposed Subpart I would not apply
to the materials licensees who are
otherwise subject to Part 26 (see
proposed § 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 § 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
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licensees’ FFD programs, as discussed
in Section IV. D.
Proposed § 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 § 26.27(b). As
discussed with respect to proposed
§ 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 FitnessFor-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 § 26.189 [Determination of
fitness], a healthcare professional has
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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 § 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 § 26.197(b).
Procedures would be necessary to
ensure that licensees’ fatigue
management programs are properly and
consistently implemented.
Proposed § 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 selfdeclaration is an important adjunct to
behavioral observation in meeting the
requirements of the performance
objective in current § 26.10(b) [as
retained in proposed § 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 fatiguerelated 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 selfdeclaration 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
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supervisor, ‘‘I am too tired right now to
check these valve lineups accurately’’).
Proposed § 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 selfdeclaration 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 § 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 § 26.201(c)(2)];
and (3) the licensee’s responsibility for
conducting a fatigue assessment in
response to an individual’s selfdeclaration, as required under proposed
§ 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 § 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 § 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
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50577
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 § 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 § 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
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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 selfdeclared 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 § 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 § 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 § 26.199 and as the
NRC intends.
Proposed § 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 § 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 selfdeclaration, an event, for cause, or to
reassess an individual after returning
the individual to work despite a selfdeclaration of fatigue [the situations in
which the proposed rule would require
licensees to conduct fatigue assessments
are discussed with respect to proposed
§ 26.201(a)]. Because of the potentially
subjective and personal nature of the
fatigue assessment task and the
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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
§ 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 § 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 § 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 § 26.39
[Review process for fitness-for-duty
policy violations].
Proposed § 26.197(c) [Training and
examinations] would establish
additional fatigue-related training and
examination requirements, in addition
to those required under proposed
§ 26.29(a) and (b). Several of the
knowledge and abilities (KAs)
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requirements that are listed in proposed
§ 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
§ 26.29(a)(1), and individuals’ and
others’ responsibilities under the
licensee’s FFD program in proposed
§ 26.29(a)(2) and (a)(3). However,
individuals who would be subject to
Subpart I should also have a workinglevel knowledge of specific, fatiguerelated 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
§ 26.197(c)(1) and (c)(2) in their FFD
training and testing programs.
Proposed § 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
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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 § 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, redeyes, 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
§§ 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 § 26.33
[Behavioral observation].
Proposed § 26.197(d) [Recordkeeping]
would be added to establish
recordkeeping requirements related to
the implementation of proposed Subpart
I. Specifically, proposed § 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 § 26.199 [Work hour controls];
proposed § 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
§ 26.197(d)(3) would require licensees to
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retain documentation of the work hour
reviews that would be required under
proposed § 26.199(j)(3); proposed
§ 26.197(d)(4) would require retaining
documentation of any fatigue
assessments that would be conducted,
as required by proposed § 26.201(g); and
proposed § 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 § 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
§ 26.199(j) [Reviews]; and (4) the
documentation would be necessary to
meet the reporting requirements in
proposed § 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 § 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 § 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.
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50579
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
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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
§ 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 § 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 § 26.199(d)(1) and (d)(2) for
each of the job duty groups listed in
proposed § 26.199(a). (Waivers of the
work hour controls in proposed
§ 26.199(d)(1) and (d)(2) would be
permitted under proposed § 26.199(d)(3)
for the reasons discussed with respect to
proposed § 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 § 26.199(d)(1)(i)] on 10
separate occasions during the calendar
year, the licensee would report that the
work hour limit in proposed
§ 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
§ 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
§ 26.199(d)(1)(i) was waived 10 times in
the operations job duty group that year.
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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
§ 26.199(d)(1)(i), one waiver of proposed
§ 26.199(d)(1)(iii), and one waiver of
proposed § 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 § 26.199(d)(1)(iii) for working
84 hours in a 7-day period and one
waiver of proposed § 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 § 26.199(d)(1)(iii) and two
waivers of proposed § 26.199(d)(2)(ii).
This example presumes that the
individual received the 48-hour break
required by proposed § 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 § 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 § 26.199(d)(1)
and (d)(2) in order to complete a task,
and so implement the process specified
in proposed § 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
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provide no meaningful information
about the licensee’s management of
fatigue during extended work periods.
In addition, proposed
§ 26.197(e)(1)(ii) would require
licensees to report all waivers granted of
each of the work hour controls in
proposed § 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
§ 26.199(d)(1) for each of four crew
members to enable them to complete the
repair. Therefore, depending upon the
actual circumstances, proposed
§ 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
§ 26.199(d)(1)(i) as well as four waivers
of the ‘‘26 work hours in any 48-hour
period’’ requirement in proposed
§ 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 § 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 decisionmaking 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 § 26.201(e).
However, controls and conditions
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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 § 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 § 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 § 26.197(e)(2) and (e)(3) to
provide the contextual information
necessary to properly interpret the
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waiver data that proposed § 26.197(e)(1)
would require. When considered in
conjunction with number of instances in
which collective work hour limits [in
proposed § 26.197(e)(2)] are exceeded
and the number of fatigue assessments
that a licensee conducts each year and
their outcomes [in proposed
§ 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 § 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 § 26.197(e)(2) would be
added to require licensees to report the
collective work hours of any job duty
group listed in proposed § 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
§ 26.199(f)(3) and (f)(5). As discussed
with respect to proposed § 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 § 26.199(f)(5)
would also permit licensees to exceed
any of the collective work hour limits in
proposed § 26.199(f), if the licensee
receives prior approval from the NRC of
a written request to exceed the work
hour limits.
Proposed § 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
§ 26.199(f) [Collective work hour limits].
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50581
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
§ 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
§ 26.197(e)(1)] and the number of fatigue
assessments that a licensee conducts
each year and their outcomes (in
proposed § 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
§ 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 § 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 § 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 forcause, for a self-declaration, post-event,
or as a followup, as described in
proposed § 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
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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
§ 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 forcause fatigue assessments that a licensee
conducts each year to be one factor
indicating the health of the licensee’s
behavioral observation and selfdeclaration processes with respect to
fatigue.
Collectively, the reporting of waivers
that would be required in proposed
§ 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
§ 26.197(e)(2), and the number of fatigue
assessments conducted and their
outcomes that would be required in
§ 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 § 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 § 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
§ 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
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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 fatiguerelated error. As a result of these
deliberations, the proposed rule would
require that individuals who perform
the types of job duties specified in
proposed § 26.199(a)(1)–(a)(5) must be
subject to the proposed work hour
controls.
Proposed § 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
§ 50.65(a)(4) of this chapter for assessing
and managing the risk associated with
maintenance activities. The work hour
controls of proposed § 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 § 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
§ 26.199(a), are responsible for correctly
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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 offnormal 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
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conducted in 1999, more than 1,800
deviations were authorized for licensed
operators and more than 1,100
deviations were authorized for nonlicensed 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 § 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, decisionmaking, communications) and are
susceptible to fatigue-induced errors, as
described in Section IV. D. Incorrect
technical direction provided to
operators can significantly challenge
licensed operators and increase the
possibility of errors or events, 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 § 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
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group, licensees could use, for example,
the risk significance determination
process and criteria that they currently
use to meet the requirements of
§ 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 § 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 § 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 fatiguerelated 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-theclock 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 postmaintenance 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
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50583
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 § 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
§ 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
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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/radiochemistry 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 § 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
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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
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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 § 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, postmaintenance 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
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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 § 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 § 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 § 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.
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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 offsite locations and during periods when
the individual is not assigned to a shift
or scheduled by the licensee to be
working on site. For example, because
of the large amount of administrative
work that is frequently assigned to
individuals in the shift manager role,
some shift managers stay at work to
review and act upon administrative
matters after the end of their scheduled
shifts in order to complete the reviews
and meet deadlines. Anecdotal reports
from these individuals have indicated
that they may work for 3–4 hours after
going off shift to manage their workload,
with the result that the hours they have
available for personal obligations and,
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 § 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
§ 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
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50585
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 § 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
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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 wellproven 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
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having to authorize a deviation from
technical specification requirements.
The discussion of proposed
§ 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 shortterm 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 § 26.199(b)(1)(iii) would be
added to permit licensees to assign
individuals, who are qualified to
perform the duties listed in proposed
§ 26.199(a), to other duties than those
listed in proposed § 26.199(a), without
controlling their work hours in
accordance with the work hour controls
contained in proposed § 26.199(d).
However, if these individuals would be
assigned or returned to performing any
duties that are listed in proposed
§ 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 § 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 § 26.199(d) for
that period because he or she would not
be performing any of the duties listed in
proposed § 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 § 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
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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
§ 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
§ 26.199(a).
Proposed § 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
§ 26.199(f) [Collective work hour limits].
(The collective work hour limits and the
bases for establishing them are
discussed with respect to proposed
§ 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 § 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
§ 26.199(b)(3).)
Proposed § 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 timekeeping practices (e.g., a multiple of pay
periods). The proposed flexibility to use
shorter averaging periods would also
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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 § 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
§ 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 § 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
§ 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 § 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 § 26.199(a) or smaller subgroups 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
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groups listed in proposed § 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 § 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 subgroups 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 subgroups 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 subgroup membership.
For these reasons, the proposed rule
would not require licensees to define
narrower sub-groups, although it would
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50587
permit licensees to define such subgroups 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 § 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 § 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 § 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 § 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
§ 26.199(b)(2)(i). The NRC intends the
term, ‘‘any individual who performs,’’
as used in proposed § 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
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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 § 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
§ 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 § 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
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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 § 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
§ 26.199(a). For example, if one licensee
operates units at four different sites,
proposed § 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 § 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
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would actually represent the work hours
of the individuals who comprised the
job duty group for the majority of the
averaging period.
Proposed § 26.199(b)(2)(iii) would be
added to require that the licenseedefined 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 § 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 § 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
§ 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
§ 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
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an excluded period would not mask any
systemic or programmatic weaknesses
in the licensees’ work hour controls
over the long-term.
Proposed § 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 § 26.199(f))(1)–
(f)(3) and (f)(5), (h), and (i). Proposed
§ 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 § 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 doublecounting 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 § 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 § 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 § 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 § 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.
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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
§ 26.199(c) would establish a nonprescriptive, performance-based
requirement.
Proposed § 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 § 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 § 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
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50589
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 § 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 § 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 8hour shifts, as was the case when GL
82–12 was published. At that time, the
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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 12hour 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
§ 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 § 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 12hour day shift. However, because the
revised criteria for granting a waiver of
the work hour limits in proposed
§ 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 24hours of work in any 48-hour period
limit for short durations is common
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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 § 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 § 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
§ 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 § 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 § 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
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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 § 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 oncall 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 § 26.199(b)(1)(i).
Proposed § 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
§ 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
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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.,
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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 § 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 14hour 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 12hour 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
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50591
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 § 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 § 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 8hours 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 10hour break provides over time to
prevent performance degradation from
cumulative fatigue, including that
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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
§ 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 8hour 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
§ 26.199(d)(2)(ii) and (d)(2)(iii) were
industry work scheduling practices
during outages and the applicability of
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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 12hour 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
§ 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 § 26.199(d)(3) would
significantly reduce the granting of
waivers, the proposed maximum
individual work hour requirements of
proposed § 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
§ 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 § 26.199(f)(2). Therefore, the
proposed work hour controls of
§ 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
§ 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 § 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 § 26.199(d)(2)(iii) would be
added to further require licensees to
provide individuals with a 48-hour
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break in any rolling 14-day period. A
detailed discussion of the bases for
requiring extended breaks is provided
with respect to proposed
§ 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
§ 26.199(d)(1) and the 24-hour break
requirement in proposed
§ 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
§ 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
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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 § 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 middleaged men to adapt to the changes in
sleep schedules required by shiftwork
compared to younger adults (Monk,
Moline and Graeber, 1988; Carrier, et
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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 coworker; 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
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50593
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
§ 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
§ 26.199(d)(2)(iii) would require a 48hour break in every rolling 14-day
period, effectively limiting individuals
who perform the job duties listed in
proposed § 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 twoweek period, and would be limited by
proposed § 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 § 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 longterm work hour limits for transient
individuals.
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The NRC further considered that some
transient personnel include licensee
employees and long-term C/Vs. Many of
these individuals may move from siteto-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
§ 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 § 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 § 26.199(f)]. Working 72 hours
per week for extended periods is
inconsistent with the research cited in
this section with respect to proposed
§ 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 § 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 § 26.199(d)(3) would be
added to permit licensees to authorize
waivers from the work hour controls for
individuals in proposed § 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
§ 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 § 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
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controls. Specifically, proposed
§ 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 § 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 § 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 § 26.199(d)(3)(i)(A) was the
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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
§ 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 § 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
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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
§ 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 § 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 § 26.199(d)(1) and (d)(2).
Proposed § 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 §§ 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 §§ 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 § 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
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(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 § 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 § 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 § 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
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50595
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 § 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 § 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 § 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 § 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
§ 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
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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 § 26.199(d)(3)(iii) would be
added to require that the face-to-face
supervisory assessment required in
proposed § 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 § 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 longerterm 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
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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 § 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 § 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 § 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 selfassessments of the effectiveness of
implementing work hour controls that
would be required under proposed
§ 26.199(j) [Reviews].
Proposed § 26.199(e) [Selfdeclarations 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
§ 26.197(b)(1)] by an individual who is
working under, or being considered for,
a waiver from the work hour controls in
proposed § 26.199(d)(1) and (d)(2).
Licensees would be required to
immediately stop the individual from
performing any duties listed in
proposed § 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 § 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
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fatigue-related errors when individuals
work more than the maximum work
hours or obtain less rest than the
minimum rest requirements of proposed
§ 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 selfdeclaration 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 § 26.199(e)(1) would be
added to permit licensees to reassign an
individual who has made a selfdeclaration of fatigue to perform other
duties than those specified in proposed
§ 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 § 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
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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 § 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 § 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 § 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 § 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 § 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
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are performing the job duties listed in
proposed § 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 § 26.195(b)(2) [Collective
work hours].) The requirements of
proposed § 26.199(f) would address the
control of work hours over extended
periods of time, by contrast to the shortterm work hour controls in proposed
§ 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 § 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 § 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 § 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.
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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 § 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
§ 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
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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 § 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 § 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
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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 × 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
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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.
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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 workweek 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 § 26.199(f)(1) would be
added to exclude the first 8 weeks of
plant outages from the collective work
limit in proposed § 26.199(f) for the job
duty groups that are specified in
proposed § 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
§ 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
§ 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 § 26.199(f).
The collective work hour limits of
proposed § 26.199(f) would address the
long-term control of work hours while
permitting the occasional use of limited
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overtime for circumstances such as
equipment failure, personnel illness, or
attrition. The NRC proposes to address
the control of work hours during shortand medium-length outages separately
and permit licensees to waive the
collective work hour controls for the
first 8 weeks of an outage in proposed
§ 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
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50599
of work at the limits permitted by
proposed § 26.199(d), individuals who
are performing the duties specified in
proposed § 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 8week 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 § 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
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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 § 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 § 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 § 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 48hour group average is discussed with
respect to proposed § 26.199(f)(1).
However, that exclusion would be only
applicable to individuals who are
performing the duties listed in proposed
§ 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 § 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
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limits, during the first 8 weeks of a plant
outage.
Proposed § 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
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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 48hour 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 § 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, postmaintenance 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
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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 § 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 § 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
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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 60hour 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 § 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 § 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 § 26.199(f)(2)(iii) would
establish a more stringent exception
period.
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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 § 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 § 26.199(f)(5) would provide a
means for extending the proposed 8week exclusion period, as discussed
with respect to that provision.
Proposed § 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
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respect to proposed § 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 § 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
§ 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 § 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 § 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 § 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
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actions to prevent cumulative fatigue
should the increased threat condition be
sustained for a period that is longer than
8 weeks.
Proposed § 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 § 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
§ 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 § 26.199(f)(3) would be
added to permit the collective work
hours of any job duty group specified in
proposed § 26.199(a) to exceed an
average of 48 hours per week in one
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averaging period if all of the conditions
specified in proposed § 26.199(f)(3)(i)–
(f)(3)(iii) are met. The collective work
hour controls of proposed § 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 § 26.199(f) would
be to ensure that fatigue resulting from
the routine work hours of individuals
performing the functions listed in
proposed § 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 § 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 § 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, shortterm, exigent circumstances.
Proposed § 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 § 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 § 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
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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 §§ 26.199(d)(1) and (d)(2)]
while continuing to ensure the
availability of some recovery days.
Proposed § 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 § 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 § 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
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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 § 26.199(f)(3) to
exceed the 48-hours per person per
week collective work hour limit in
proposed § 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 § 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 48hour 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 § 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 § 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
§ 26.199(f)(4)(ii). This schedule
manipulation could result in
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50603
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
§ 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 § 26.199(f)(5) would be
added to permit licensees to exceed any
collective work hour limit of proposed
§ 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 § 26.199(f)(5)(i)–(f)(5)(iii).
Proposed § 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
§ 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 § 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 § 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
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fatigue mitigation strategies that the
licensee would be required to establish
in proposed § 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 § 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 § 26.199(f)(5)(iii) are
appropriate for the time period
requested.
Proposed § 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 § 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
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proposed § 26.199(f), which are
generally only applicable during nonoutage 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 § 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 8week exclusion period must be
calculated from the beginning of the
refueling outage.
Proposed § 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 fatigueinduced 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 § 26.199(i) [Plant
emergencies] would be added to
temporarily waive the requirements of
proposed § 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 § 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
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require licensees to again comply with
the work hour controls.
Proposed § 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 § 26.199(a). The work hour
controls in proposed § 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 § 26.199
consistent with the general performance
objective in proposed § 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 § 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 § 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
§ 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 § 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 § 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
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compromised. The proposed
requirement would be necessary to
ensure that licensees’ use of waivers did
not result in degraded worker fitnessfor-duty.
Proposed § 26.199(j)(1)(ii) would be
added to require the assessments to
include individuals who were assessed
for fatigue in accordance with § 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 § 26.199(j)(1)(iii) would be
added to require the assessments to
include individuals who performed the
job duties listed in proposed § 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 § 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 § 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
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same reasons discussed with respect to
the individuals who would be evaluated
under proposed § 26.199(j)(1)(iii).
Proposed § 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
§ 26.199. The proposed collective work
hour controls of § 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 subgroups 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 § 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 § 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 § 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
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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 § 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
§ 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 § 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
§ 26.199 would provide only partial
assurance that individuals are not
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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 § 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 § 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 § 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 §§ 26.31(c) and 26.77, if a
worker is observed to be in a condition
of impaired alertness and there is a
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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
§ 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 § 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
§ 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 § 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
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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 forcause testing. Accordingly, the proposed
requirement would permit licensees to
assess only fatigue, if there are no
indications of possible substance abuse.
Proposed § 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 § 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. Selfdeclarations provide assurance that
instances of worker fatigue, including
those that are not prevented by the work
hour controls in proposed § 26.199, are
appropriately addressed, regardless of
the number of hours the individual has
worked or rested. Current § 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
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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
§ 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
§ 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 § 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. Selfdeclarations 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 selfdeclare 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-
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declaration as part of the fatigue
assessment.
Proposed § 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 coworker 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 selfdeclaration must be made to the
individual’s supervisor. However, as
discussed with respect to proposed
§ 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 § 26.201(a)(1).
Proposed § 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
§ 26.31(c)(3). Proposed § 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 § 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
§ 26.31(d)(5)(ii), the proposed
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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 § 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 § 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 §§ 26.29 and
26.197(c), must conduct any fatigue
assessment that would be required
under proposed § 26.201. In accordance
with proposed § 26.201(c), fatigue
assessments would provide the basis for
subsequent actions for fatigue
management (e.g., relieving an
individual of duties or requiring
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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 §§ 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 § 26.29(b) to demonstrate
successful completion of the training by
passing a comprehensive examination
that addresses the KAs.
Proposed § 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 § 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
§ 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
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be performed by an independent third
party to provide reasonable assurance of
an objective assessment.
Proposed § 26.201(b)(2) would be
added to prohibit individuals from
performing a post-event fatigue
assessment in those circumstances
specified in proposed § 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 § 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 § 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.
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Proposed § 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 § 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 § 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 § 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 § 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
§ 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 § 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
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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 § 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 ‘‘catchup’’ 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 sevenfold 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, tensionanxiety, 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
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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 § 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 § 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 § 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
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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 § 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
§ 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 § 26.37
[Protection of information], licensees
would be required to keep any
information from the individual’s selfdisclosures confidential.
Proposed § 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
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work hours have not exceeded any of
the limits specified in proposed
§ 26.199(d)(1) or that the individual has
had the minimum rest breaks required
in proposed § 26.199(d)(2). The
individual work hour controls of
proposed § 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
§ 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 § 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
§ 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 § 26.201(f) would be added
to require that licensees must document
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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 § 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 § 26.211 [General
provisions] would be added to define
general requirements related to
recordkeeping and reporting under Part
26.
Proposed § 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 § 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,
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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 § 26.213 [Recordkeeping
requirements for licensees and other
entities] would amend current § 26.71
[Recordkeeping requirements]. Current
§ 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
§ 26.217 [Fitness-for-duty program
performance data]. Proposed § 26.213
would retain but amend current
§ 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 § 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 § 26.213(a)(1) would amend
current § 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
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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 §§ 26.61 [Selfdisclosure and employment history] and
26.63 [Suitable inquiry]. In addition, the
current cross-reference to § 26.27(a)
would be updated to cross-reference the
related portions of the proposed rule.
Proposed § 26.213(a)(2) would amend
current § 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 § 26.69
[Authorization with potentially
disqualifying fitness-for-duty
information].
Proposed § 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 § 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 § 26.189
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[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 § 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 § 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
§§ 26.21(b) and 26.22(c) for training
records, and § 26.80(c) for audit findings
and corrective action records.
Proposed § 26.213(c) would amend
current § 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 § 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 § 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
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50611
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 § 26.213(d) would replace
the recordkeeping requirement in
current § 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 § 26.213(e) would amend
the requirement in current § 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 § 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
§ 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
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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 § 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 § 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 § 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
§§ 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
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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 § 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 § 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 § 26.20
and § 26.71(a); and in Appendix A to
Part 26, Sections 2.7(a)(1), 2.7(f)(2),
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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 § 26.217 [Fitness-for-duty
program performance data] would
amend the requirements in current
§ 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 § 26.71 for consistency with
other revisions to the rule, as follows:
Proposed § 26.217(a) would retain the
requirement in current § 26.71(d) that
each FFD program subject to Part 26
must collect and compile FFD
performance data.
Proposed § 26.217(b)(1)–(b)(8) would
amend the second sentence of current
§ 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
§§ 26.31(d)(3)(i) and 26.75(b). Although
this information would be available to
NRC inspection personnel at each site,
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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
§ 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 § 26.217(c) would amend
the portions of current § 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 § 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 § 26.217(d) would retain the
last sentence of current § 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
§ 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
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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 § 26.217(e) would amend
portions of current § 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 semiannual 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 § 26.217(c),
as discussed with respect to that
paragraph.
Proposed § 26.217(f) would retain the
requirement in current § 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 § 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 § 26.3(d).
Section 26.219 Reporting
Requirements
A new § 26.219 [Reporting
requirements] would replace current
§ 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
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50613
improve clarity in the organization and
language of the rule.
Proposed § 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
§ 26.73(c) that significant events must be
reported under this section, rather than
under the provisions of 10 CFR 73.71.
Proposed § 26.219(b) [Significant FFD
policy violations or programmatic
failures] would reorganize and amend
current § 26.73(a)(1), (a)(2), and (b).
Proposed § 26.219(b) would retain the
requirement in current § 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 § 26.219(b)(1) would amend
current § 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 § 26.75(e). The proposed
change would also be consistent with
the revised performance objective in
proposed § 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 § 26.219(b)(2) would amend
current § 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
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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 § 26.219(b)(2)(i) would
retain current § 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 § 26.219(b)(2)(ii) would
combine and amend current
§ 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 § 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
§ 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 § 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 § 26.219(b)(2)(iii) would
amend current § 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
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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
§ 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
§ 26.219(b)(2) while they are performing
the duties that require them to be
subject to this part at any location.
Proposed § 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-andcontrol 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
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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 § 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
§ 26.219(b)(4) to clarify that significant
events and programmatic failures are
not limited to those listed in proposed
§ 26.219(b), but would include any
programmatic failures or weaknesses
that potentially could permit substance
abuse to be undetected.
Proposed § 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 §§ 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.
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Proposed § 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
§ 26.39 [Review process for fitness-forduty violations] and proposed § 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 § 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
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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 HHScertified 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 § 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 § 26.75(h). Second, donors
would be protected from adverse
consequences of false positive errors
because any specimen that yields a nonnegative 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
§ 26.137(c). Therefore, reporting of false
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50615
positive errors would be unnecessary to
protect the interests of either donors or
the public.
Proposed § 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 §§ 26.70
[Inspections], 26.90 [Violations] and
26.91 [Criminal penalties]. Proposed
§ 26.221 [Inspections] would retain the
requirements in current § 26.70.
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Proposed § 26.223 [Violations] would
retain the requirements in current
§ 26.90 [Violations]. Proposed § 26.225
[Criminal penalties] would retain the
requirements in current § 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 § 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 § 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 § 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 § 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
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§ 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 §§ 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 6acetylmorphine (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 §§ 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 § 26.137 would establish
quality assurance and quality control
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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 §§ 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 § 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 noninstrumented validity tests to determine
whether a urine specimen appears to be
adulterated, diluted, or substituted and
requires further testing at an HHScertified 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:
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a. Proposed § 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 § 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 § 26.197(e)(1) would require
licensees to report the number of
waivers granted in a year.
c. Proposed § 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 § 26.199, the NRC is
seeking public comment on workscheduling 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 §§ 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 § 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 § 26.199. Other
individuals, beyond those specified
within the scope of § 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 § 26.199(a). The NRC is also
seeking comments on an alternative
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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 riskimportant equipment) that would fall
within the scope of the proposed work
hour control provisions in § 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 §§ 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 nonnegative by the MRO; (2) the donor has
requested a review under proposed
§ 26.39 or initiated legal proceedings;
and (3) the testing is conducted in
accordance with proposed § 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
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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
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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
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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
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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 nonradiological 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.
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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
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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: https://www.nrc.gov/public-involve/
doc-comment/omb/ for 60
days after the signature date of this
proposed rule and are also available at
the rule forum site, https://
ruleforum.llnl.gov.
Send comments on any aspect of
these proposed information collections,
including suggestions for reducing the
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50619
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
INFOCOLLECTS@NRC.GOV 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–
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$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
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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 § 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 § 26.10(a) and
§ 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;
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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
§ 50.109(c) [which applies to power
reactors], § 70.76(b) [which applies to
formula quantity strategic special
nuclear material licensees], and
§ 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 mixedoxide 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 mixedoxide 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.
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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 § 50.109(a)(3),
§ 70.76(a)(3) and § 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
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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.
XVII. References
Akerstedt, T. (2004). Predictions from the
three-process model of alertness. Aviation,
Space and Environmental Medicine, 75(3),
2, A75–A83.
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Copies of publicly available reference items
are available for inspection and/or copying
for a fee in the NRC Public Document
Room, One White Flint North, 11555
Rockville Pike, Room O–F21, Rockville,
MD 20852–2738. Copyrighted materials
may be viewed at the NRC Public
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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.
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Purpose.
Scope.
Definitions.
Interpretations.
Information collection requirements:
OMB approval.
26.9 Specific exemptions.
26.11 Communications.
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 B—Program Elements
26.21 Fitness-for-duty program.
26.23 Performance objectives.
26.25 Individuals subject to the fitness-forduty 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.
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 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 G—Laboratories Certified by the
Department of Health and Human Services
Subpart D—Management Actions and
Sanctions To Be Imposed
26.75 Sanctions.
26.77 Management actions regarding
possible impairment.
Subpart H—Determining Fitness-for-Duty
Policy Violations and Determining Fitness
26.1
26.3
26.5
26.7
26.8
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.
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Subpart F—Licensee Testing Facilities
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.
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.
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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).
This part prescribes requirements and
standards for the establishment,
implementation, and maintenance of
fitness-for-duty (FFD) programs.
(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.
§ 26.3
§ 26.5
Subpart A—Administrative Provisions
§ 26.1
Purpose.
Scope.
(a) The regulations in this part apply
to licensees who are authorized to
operate a nuclear power reactor (under
§ 50.57 of this chapter) and holders of a
combined license after the Commission
has made the finding under § 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
§ 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
§ 52.103 of this chapter, combined
license applicants who have received
authorization to construct under
§ 50.10(e)(3), construction permit
holders (under Part 50 of this chapter),
construction permit applicants who
have received authorization to construct
under § 50.10(e)(3), and holders of
manufacturing licenses (under Part 52 of
this chapter) shall—
(1) Comply with §§ 26.23, 26.41, and
26.189;
(2) Implement a drug and alcohol
testing program, including random
testing; and
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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
§ 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
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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.
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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 nonnegative 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.
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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
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(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 nonnegative 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 § 26.29(c)(2) and the nominal
12-month frequency required for certain
audits in § 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 § 26.3(c) and (d), but is not
licensed by the NRC.
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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
§§ 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 § 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 § 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), uranium233, or plutonium.
Substance abuse means the use, sale,
or possession of illegal drugs, or the
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abuse of prescription and over-thecounter 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.
§ 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.
§ 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 §§ 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,
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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.
§ 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.
§ 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 https://
www.nrc.gov/site-help/eie.html, by
calling (301) 415–6030, by e-mail at
EIE@nrc.gov, 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
§ 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-forduty programs subject to this part may
rely upon the FFD program or program
elements of a C/V, as defined in § 26.5,
if the C/V’s FFD program or program
elements meet the applicable
requirements of this part.
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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.
§ 26.25 Individuals subject to the fitnessfor-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;
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(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 preaccess (or pre-employment), random,
for-cause, and post-event testing for the
drugs and drug metabolites specified in
§ 26.31(d)(1) at or below the cutoff
levels specified in § 26.163(a)(1) for
initial drug testing and in § 26.163(b)(1)
for confirmatory drug testing;
(2) The individuals are subject to preaccess (or pre-employment), random,
for-cause, and post-event testing for
alcohol at or below the cutoff levels
specified in § 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 § 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
§ 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
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(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.
§ 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 § 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;
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(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 § 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 § 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
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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.
§ 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
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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 § 26.55, and
must be current before the licensee or
other entity grants an authorization
update, as defined in § 26.57, or
authorization reinstatement, as defined
in § 26.59;
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(2) Individuals shall complete
refresher training on a nominal 12month 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.
§ 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
§ 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
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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 § 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 § 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:
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(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 § 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
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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
§ 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 § 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
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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
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50631
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 HHScertified laboratories must be subject to
initial validity and drug testing by the
laboratory. Specimens that yield nonnegative 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 § 26.163(a)(1) for
initial drug testing and in § 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 § 26.163(a)(1) for initial drug testing
and in § 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 §§ 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 § 26.31(d)(1)(i)(D).
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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 § 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 § 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.
§ 26.33
Behavioral observation.
Licensees and other entities who are
subject to this part shall ensure that the
individuals listed in § 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 § 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
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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.
§ 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, shortterm 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
§ 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
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that the requirements of §§ 26.69(d) and
26.77(b) are implemented, as applicable.
§ 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 § 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-ofcertification proceedings from the HHS-
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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.
§ 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 § 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.
§ 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
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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 12month 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 § 26.25(b)(1).
(d) Contracts. (1) Licensees’ and other
entities’ contracts with C/Vs and HHScertified 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
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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
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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
§ 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 § 26.25(a).
§ 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 § 26.69 in order to grant
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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
§§ 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.
§ 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 selfdisclosure in accordance with the
applicable requirements of § 26.61;
(2) Complete a suitable inquiry in
accordance with the applicable
requirements of § 26.63;
(3) Ensure that the individual is
subject to pre-access drug and alcohol
testing in accordance with the
applicable requirements of § 26.65; and
(4) Ensure that the individual is
subject to random drug and alcohol
testing in accordance with the
applicable requirements of § 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 § 26.69.
§ 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 selfdisclosure in accordance with the
applicable requirements of § 26.61;
(2) Complete a suitable inquiry in
accordance with the applicable
requirements of § 26.63;
(3) Ensure that the individual is
subject to pre-access drug and alcohol
testing in accordance with the
applicable requirements of § 26.65; and
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(4) Ensure that the individual is
subject to random drug and alcohol
testing in accordance with the
applicable requirements of § 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 § 26.69.
§ 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 selfdisclosure in accordance with the
applicable requirements of § 26.61;
(2) Complete a suitable inquiry in
accordance with the requirements of
§ 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 § 26.65; and
(4) Ensure that the individual is
subject to random drug and alcohol
testing in accordance with the
applicable requirements of § 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 § 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.
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(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 selfdisclosure in accordance with the
applicable requirements of § 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 § 26.65; and
(3) Ensure that the individual is
subject to random drug and alcohol
testing in accordance with the
applicable requirements of § 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 § 26.69.
§ 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 arrestreporting 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
§§ 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;
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(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 § 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.
§ 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 arrestreporting 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
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50635
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
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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 email. 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 §§ 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.
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§ 26.65 Pre-access drug and alcohol
testing.
(a) Purpose. This section contains preaccess 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 preaccess 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 preaccess 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
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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 arrestreporting 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
§ 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
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(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 preaccess 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 nonnegative 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 §§ 26.75(b),
(d), (e)(2), or (g);
(2) Terminate the individual’s
authorization, if it has been reinstated,
in accordance with §§ 26.75(e)(1) or (f);
or
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(3) Grant authorization to the
individual only in accordance with the
requirements of § 26.69.
§ 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 §§ 26.65 or 26.69, and
thereafter, the licensee or other entity
shall subject the individual to random
testing in accordance with § 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 §§ 26.65 or 26.69 has been
met, the licensee or other entity may
grant authorization before random
testing is completed in accordance with
§ 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 §§ 26.75(b),
(d), (e)(2), or (g);
(2) Terminate the individual’s
authorization, if it has been granted, as
required by §§ 26.75(e)(1) or (f); or
(3) Grant authorization to the
individual only in accordance with the
requirements of § 26.69.
§ 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
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50637
been disclosed or discovered about the
individual by any means, including, but
not limited to, the individual’s selfdisclosure, 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 § 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 selfdisclosure 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 selfdisclosure in accordance with the
requirements of § 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;
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(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 preaccess 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 § 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
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Jkt 205001
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 selfdisclosure and employment history
addresses the applicable period in
§ 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 selfdisclosure in accordance with the
requirements of § 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
§ 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
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§ 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 nonnegative drug and alcohol test results. If
an individual has confirmed nonnegative 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 §§ 26.75(b),
(d), (e)(2), or (g); or
(2) Terminate the individual’s
authorization, if it has been granted, as
required by §§ 26.75(e)(1) or (f).
§ 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 § 26.5;
(2) The individual remains subject to
a drug and alcohol testing program that
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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 § 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
§ 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
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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-thecounter 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 § 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
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50639
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 § 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 § 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 § 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
§ 26.213 and § 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.
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§ 26.77 Management actions regarding
possible impairment.
licensee or other entity shall notify the
NRC Operations Center.
(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
§ 26.27(c)(3) and § 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 § 26.201 and need not perform
drug and alcohol tests nor a
determination of fitness under § 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., email or fax) to document the verbal
notification. If the Regional
Administrator cannot be reached, the
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Subpart E—Collecting Specimens for
Testing
§ 26.81
Purpose.
This subpart contains requirements
for collecting specimens for drug and
alcohol testing.
§ 26.83
Specimens to be collected.
Except as permitted under
§ 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.
§ 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
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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, clearlyillustrated, 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 nonnegative alcohol, validity, or drug test
results from specimens collected by or
under contract to the licensee or other
entity.
§ 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
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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
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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, onsite rest room, or hospital examining
room according to the following
procedures:
(1) The facility must be secured by
visual inspection to ensure that no
unauthorized persons are present, and
that undetected access (e.g., through a
rear door not in the view of the
collector) is impossible. Security during
the collection may be maintained by
restricting access to collection materials
and specimens. In the case of a public
rest room, a sign must be posted or an
individual assigned to ensure that no
unauthorized personnel are present
during the entire collection procedure to
avoid embarrassment of the donor and
distraction of the collector.
(2) If practical, a water coloring agent
that meets the requirements of
§ 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 custodyand-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
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subversion attempt and shall then flush
the toilet. The collector shall instruct
the donor to participate with the
collector in completing the chain-ofcustody 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 § 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.
§ 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
§ 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
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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 overthe-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 § 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-ofcustody form has been executed, and
the donor has departed the collection
site.
§ 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
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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
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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.
§ 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 15minute 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.
§ 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
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in paragraph § 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.
§ 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
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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.
§ 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.
§ 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
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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 § 26.91(b) and (c) was
used for the initial alcohol test, the same
EBT may be used for confirmatory
testing.
§ 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
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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.
§ 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
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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.
§ 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 § 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
§ 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
§ 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.
§ 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
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include 30 milliliters (mL) to ensure
that a sufficient quantity of urine is
available for initial and confirmatory
validity and drug tests at an HHScertified laboratory, and for retesting of
an aliquot of the specimen if requested
by the donor in accordance with
§ 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 § 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
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specimen’s characteristics, as specified
in § 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 § 26.115.
§ 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 temperaturemeasuring 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 °F
to 100 °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
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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.
§ 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
§ 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
§ 26.31(d)(3)(ii), or to test for additional
drugs, as permitted under
§ 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.
§ 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
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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 § 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
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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.
§ 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 tamperevident 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-ofcustody 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.
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(g) While any part of the chain-ofcustody 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 HHScertified 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 colocated, 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
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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 °C (42.8 °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.
§ 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.
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(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
§ 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.
§ 26.123
Testing facility capabilities.
Each licensee testing facility shall
have the capability, at the same
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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.
§ 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.
§ 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
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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 noninstrumented 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.
§ 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
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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-andcontrol 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-andcontrol 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.
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(e) Urine specimens identified as nonnegative 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 °C (42.8 °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 § 26.135(c).
(g) Licensee testing facility personnel
shall ensure that the original custodyand-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.
§ 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
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facility shall forward any specimen that
yields a non-negative validity screening
or initial validity test result to the HHScertified 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
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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).
§ 26.133 Cutoff levels for drugs and drug
metabolites.
Subject to the provisions of
§ 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
Drug or metabolites
(a) Marijuana metabolites .......
(b) Cocaine metabolites .........
(c) Opiate metabolites ............
(d) Phencyclidine ....................
(e) Amphetamines ..................
§ 26.135
Cutoff level
(ng/mL)
50
300
2,000
25
1,000
Split specimens.
(a) If the FFD program follows splitspecimen procedures, as described in
§ 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 HHScertified 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
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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 °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.
§ 26.137
control.
Quality assurance and quality
(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 noninstrumented 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
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50649
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 HHScertified 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 HHScertified 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
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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 8hour 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 § 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
§ 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
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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 HHScertified 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
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(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 HHScertified 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
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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 HHScertified 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.
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(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.
§ 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 §§ 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
§ 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 § 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.
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50651
(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 HHScertified 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
§ 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.
§ 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 § 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
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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 HHScertified laboratory that is being used by
another licensee or entity who is subject
to this part, in accordance with the
requirements of § 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 § 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.
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§ 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 multispecialty 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 inservice 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
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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 § 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) HHScertified 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
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that are reported both negative and nonnegative.
(c) Day-to-day operations and
supervision of analysts. HHS-certified
laboratories shall assign one or more
individuals who are responsible for dayto-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-ofcustody; 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.
§ 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;
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(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.
§ 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
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50653
forms. Any direct evidence of tampering
or discrepancies in the information on
the specimen bottles and the custodyand-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-andcontrol forms when conducting initial
and confirmatory tests. The original
specimen and the original custody-andcontrol form must remain in secure
storage.
(d) The laboratory’s internal custodyand-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-andcontrol 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
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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 °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 °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.
§ 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;
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(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
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(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., multiwavelength 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
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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., multiwavelength 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
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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;
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(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.
§ 26.163 Cutoff levels for drugs and drug
metabolites.
(a) Initial drug testing. (1) HHScertified 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:
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INITIAL TEST CUTOFF LEVELS FOR
DRUGS AND DRUG METABOLITES
Drug or metabolites
(i) Marijuana metabolites ......
(ii) Cocaine metabolites ........
(iii) Opiate metabolites ..........
(iv) Phencyclidine .................
(v) Amphetamines ................
Cutoff level
(ng/mL)
50
300
2,000
25
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 HHScertified 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
Drug or metabolites
(i) Marijuana metabolite 1 ......
(ii) Cocaine metabolite 2 .......
(iii) Opiates:
(A) Morphine ..................
(B) Codeine ...................
(C) 6-acetylmorphine 3 ...
(iv) Phencyclidine .................
(v) Amphetamines:
(A) Amphetamine ..........
(B) Methamphetamine 4
Cutoff level
(ng/mL)
15
150
2000
2000
10
25
500
500
1 As
delta-9-tetrahydrocannabinol-9-carboxylic acid.
2 As benzoylecgonine.
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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.
§ 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 HHScertified 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 nonnegative 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 nonnegative 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
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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 HHScertified 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 drugpositive, 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 nonnegative 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 § 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 HHScertified 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
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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
§ 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
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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 § 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 § 26.41, or to NRC
inspectors; and
(iv) Shall provide the tested
individual with a written statement that
the records specified in §§ 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 selfdisclosure 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 nonnegative 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 preaccess 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
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confirmed non-negative test result in
determining the appropriate sanctions.
§ 26.167
control.
Quality assurance and quality
(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.
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(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:
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(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 § 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 HHScertified 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
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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 HHScertified 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
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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—
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(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 HHScertified 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
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50659
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 nonnegative 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.
§ 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
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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 § 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 nonnegative 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
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‘‘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 § 26.37(b). This paragraph does
not preclude either the laboratory or the
MRO from providing program
performance data, as required under
§ 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 HHScertified 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 custodyand-control form to the MRO.
(j) For a specimen that has a nonnegative 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
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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 § 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-forDuty Policy Violations and Determining
Fitness
§ 26.181
Purpose.
This subpart contains requirements
for determining whether a donor has
violated the FFD policy and for making
a determination of fitness.
§ 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
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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 nonnegative 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.
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(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-andcontrol forms that require corrective
action(s), but shall forward the custodyand-control forms to the MRO for
review and approval of the resolution.
(iii) The staff may not conduct
interviews with donors to discuss nonnegative drug test results nor request
medical information from a donor. Only
the MRO may request and review
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50661
medical information related to a nonnegative 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.
§ 26.185 Determining a fitness-for-duty
policy violation.
(a) MRO review required. A nonnegative 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 HHScertified 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
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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 24hour 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 nonnegative 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 drugpositive, 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
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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
§ 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.
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(3) If the dilute specimen was
collected under direct observation as
required under § 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 § 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.
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(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
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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 § 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
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50663
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 HHScertified 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
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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-9tetrahydrocannabinol-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-9tetrahydrocannabinol-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
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manner designed to ensure the
confidentiality of the information.
§ 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 controlledsubstance 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 returnto-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
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(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.
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(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 inpatient 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).
§ 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 § 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
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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-thecounter 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
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50665
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 § 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
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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
§ 26.195
Applicability.
The requirements in this subpart
apply only to the licensees and other
entities identified in § 26.3(a) and (d).
§ 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 § 26.27(b).
(b) Procedures. In addition to the
procedures required in § 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
§ 26.25(a)(1) or (2) makes a selfdeclaration 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 selfdeclaration;
(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 § 26.201(a)(2);
(2) Describe the process for
implementing the work hour controls
required under § 26.199 for the
individuals who are performing the
duties listed in § 26.199(a);
(3) Describe the process to be
followed in conducting fatigue
assessments under § 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 § 26.29(a) and the
comprehensive examination required in
§ 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
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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 § 26.199;
(2) The documentation of waivers that
is required in § 26.199(d)(3)(iv),
including the bases for granting the
waivers;
(3) The documentation of work hour
reviews that is required in § 26.199(j)(3);
(4) The documentation of fatigue
assessments that is required in
§ 26.201(g); and
(5) Documentation of the collective
work hours of each job duty group, as
calculated in accordance with
§ 26.199(b)(2).
(e) Reporting. Licensees shall include
the following information in the annual
FFD program performance report
required under § 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
§ 26.199(d)(1) and (d)(2) for individuals
within each job duty group in
§ 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 § 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 § 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 § 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,
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if any, resulting from each fatigue
assessment.
§ 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;
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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
§ 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 § 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
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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 §§ 26.29 and
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50667
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
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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 § 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 forceon-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
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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
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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 § 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
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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.
§ 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 §§ 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 selfdeclaration 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 selfdeclaration, 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 § 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
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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 § 26.29 and § 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 § 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
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50669
the limits specified in § 26.199(d)(1) or
that the individual has had the
minimum rest breaks required in
§ 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
§ 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 recreation of the original records.
§ 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
§§ 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 § 26.189.
(b) Each licensee and other entity who
is subject to this part shall retain the
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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 § 26.29;
and
(2) Records of audits, audit findings,
and corrective actions taken under
§ 26.41.
(c) Licensees and other entities shall
ensure the retention and availability of
records pertaining to any 5-year denial
of authorization under § 26.75(c), (d), or
(e)(2) and any permanent denial of
authorization under § 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 §§ 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 § 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 § 26.31(d)(1), or uses
more stringent cutoff levels than those
specified in this part, as permitted
under § 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 § 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.
§ 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
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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.
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§ 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
§ 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
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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.
§ 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 § 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
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unsatisfactory performance discovered
in blind performance testing at either a
licensee testing facility or an HHScertified laboratory, in the testing of
actual specimens, or through the
processing of reviews under § 26.39 and
MRO reviews under § 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
§ 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 nonreportable 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
§ 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
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50671
program under the scope of the
contracted activities.
§ 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.
§ 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: §§ 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.
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TABLE 1.—DERIVATION TABLE FOR PART 26
New section
Based on
26.1 ...........................................................................................................
26.3(a) ......................................................................................................
26.3(b) ......................................................................................................
26.3(c) .......................................................................................................
26.3(d) ......................................................................................................
26.3(e) ......................................................................................................
26.3(f) .......................................................................................................
26.5 ...........................................................................................................
26.7 ...........................................................................................................
26.8 ...........................................................................................................
26.9 ...........................................................................................................
26.11 .........................................................................................................
26.21 .........................................................................................................
26.23(a) ....................................................................................................
26.23(b) ....................................................................................................
26.23(c) .....................................................................................................
26.23(d) ....................................................................................................
26.23(e) ....................................................................................................
26.25(a)(1) ................................................................................................
26.25(a)(2) ................................................................................................
26.25(a)(3) ................................................................................................
26.25(a)(4) ................................................................................................
26.25(b)(1) ................................................................................................
26.25(b)(2) ................................................................................................
26.25(b)(3) ................................................................................................
26.25(c) .....................................................................................................
26.25(d) ....................................................................................................
26.27(a) ....................................................................................................
26.27(b)(1) ................................................................................................
26.27(b)(2) ................................................................................................
26.27(b)(3) ................................................................................................
26.27(b)(4)(i) .............................................................................................
26.27(b)(4)(ii) ............................................................................................
26.27(b)(5) ................................................................................................
26.27(b)(6) ................................................................................................
26.27(b)(7) ................................................................................................
26.27(b)(8) ................................................................................................
26.27(b)(9) ................................................................................................
26.27(b)(10) ..............................................................................................
26.27(b)(11) ..............................................................................................
26.27(c) .....................................................................................................
26.29 .........................................................................................................
26.31 .........................................................................................................
26.33 .........................................................................................................
26.35 .........................................................................................................
26.37 .........................................................................................................
26.39 .........................................................................................................
26.41 .........................................................................................................
26.51 .........................................................................................................
26.53 .........................................................................................................
26.55(a) ....................................................................................................
26.55(b) ....................................................................................................
26.57(a) ....................................................................................................
26.57(b) ....................................................................................................
26.59 .........................................................................................................
26.61(a) ....................................................................................................
26.61(b) ....................................................................................................
26.61(c) .....................................................................................................
26.61(d) ....................................................................................................
26.63(a) ....................................................................................................
26.63(b) ....................................................................................................
26.63(c) .....................................................................................................
26.63(d) ....................................................................................................
26.63(e) ....................................................................................................
26.63(f)(1) .................................................................................................
26.63(f)(2) .................................................................................................
26.63(f)(3) .................................................................................................
26.65(a) ....................................................................................................
26.65(b) ....................................................................................................
26.65(c)(1) ................................................................................................
26.65(c)(2) ................................................................................................
26.65(d) ....................................................................................................
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26.1 first sentence.
26.2(a).
26.1 (2nd sentence) and 26.2(a) (1st sentence).
26.2(d).
26.23(a)(1).
26.2(c).
26.2(b).
26.3 and Appendix A Subpart 1.2.
26.4.
26.8.
26.6.
NEW.
26.23(b).
26.10(a).
26.10(a).
26.10(b).
26.10(c).
NEW.
26.2(a) and 26.2(d).
26.2(a) and 26.2(d).
26.2(a) and 26.2(d).
NEW.
NEW.
26.2(b).
26.2(b).
NEW.
NEW.
26.20 1st paragraph.
26.20(a).
NEW.
NEW.
26.20(a)(1).
26.20(a)(2).
NEW.
26.20(a).
26.20(b).
26.20(d).
NEW.
NEW.
NEW.
26.20(d).
26.21.
26.24.
26.22.
26.25.
26.29.
26.27.
26.80.
26.1.
NEW.
26.27(a).
NEW.
NEW.
NEW.
NEW.
26.27(a)(1).
26.27(a)(2).
NEW.
26.27(a)(4).
NEW.
NEW.
NEW.
26.27(a)(3).
NEW.
26.71(c) and 26.27(b)(2)(vii).
NEW.
NEW.
NEW.
NEW.
26.24(a)(1).
NEW.
NEW.
Sfmt 4702
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26AUP2
Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules
TABLE 1.—DERIVATION TABLE FOR PART 26—Continued
New section
Based on
26.65(e) ....................................................................................................
26.65(f) .....................................................................................................
26.65(g) ....................................................................................................
26.65(h) ....................................................................................................
26.67(a) ....................................................................................................
26.67(b) ....................................................................................................
26.67(c) .....................................................................................................
26.69(a) ....................................................................................................
26.69(b)(1) ................................................................................................
26.69(b)(2) ................................................................................................
26.69(b)(3) ................................................................................................
26.69(b)(4) ................................................................................................
26.69(b)(5) ................................................................................................
26.69(b)(6) ................................................................................................
26.69(b)(7) ................................................................................................
26.69(c)(1) ................................................................................................
26.69(c)(2) ................................................................................................
26.69(c)(3) ................................................................................................
26.69(c)(4) ................................................................................................
26.69(c)(5) ................................................................................................
26.69(d) ....................................................................................................
26.69(e) ....................................................................................................
26.69(f) .....................................................................................................
26.71 .........................................................................................................
26.75(a) (1st sentence) ............................................................................
26.75(a) (2nd sentence) ...........................................................................
26.75(b) ....................................................................................................
26.75(c) .....................................................................................................
26.75(d) ....................................................................................................
26.75(e) ....................................................................................................
26.75(f) .....................................................................................................
26.75(g) ....................................................................................................
26.75(h) ....................................................................................................
26.77(a) ....................................................................................................
26.77(b)(1) ................................................................................................
26.77(b)(2) ................................................................................................
26.77(b)(3) ................................................................................................
26.77(c) .....................................................................................................
26.81 .........................................................................................................
26.83(a) ....................................................................................................
26.83(b) ....................................................................................................
26.85(a) ....................................................................................................
26.85(b) ....................................................................................................
26.85(c) .....................................................................................................
26.87(a) ....................................................................................................
26.87(b) ....................................................................................................
26.87(c) .....................................................................................................
26.87(d) ....................................................................................................
26.87(d)(1) ................................................................................................
26.87(d)(2) ................................................................................................
26.87(d)(3) ................................................................................................
26.87(e) ....................................................................................................
26.87(f)(1) .................................................................................................
26.87(f)(2) .................................................................................................
26.87(f)(3) .................................................................................................
26.87(f)(4) .................................................................................................
26.87(f)(5) .................................................................................................
26.89 .........................................................................................................
26.91 .........................................................................................................
26.93 .........................................................................................................
26.95 .........................................................................................................
26.97 .........................................................................................................
26.99 .........................................................................................................
26.101 .......................................................................................................
26.103 .......................................................................................................
26.105 .......................................................................................................
26.107 .......................................................................................................
26.109 .......................................................................................................
26.111 .......................................................................................................
26.113 .......................................................................................................
26.115 .......................................................................................................
26.117 .......................................................................................................
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NEW.
NEW.
NEW.
Appendix A Subpart B 2.9(c) and 26.27(a)(2).
NEW.
NEW.
Appendix A Subpart B 2.9(c) and 26.27(a)(2).
NEW.
26.27(b)(4).
NEW.
26.27(b)(4).
NEW.
NEW.
26.27(b)(4).
26.27(b)(4).
26.27(a)(3).
NEW.
26.27(a)(3).
NEW.
NEW.
NEW.
NEW.
26.27(a)(2).
NEW.
NEW.
26.27(b) (1st sentence).
NEW.
26.27(b)(3).
26.27(c).
26.27(b)(2).
26.27(b)(5).
26.27(b)(4).
26.24(d)(2).
NEW.
26.27(b)(1).
NEW.
NEW.
26.27(d).
NEW.
NEW.
26.24(b).
Appendix A Subpart B 2.2(d).
NEW.
Appendix A Subpart B 2.2(d)(2) (last sentence).
Appendix A Subpart B 2.4(a).
Appendix A Subpart B 2.4(f) (1st sentence).
Appendix A Subpart B 2.7(m).
Appendix A Subpart B 2.4(c).
Appendix A Subpart B 2.4(e).
Appendix A Subpart B 2.4(c) (2nd sentence).
Appendix A Subpart B 2.4(c).
Appendix A Subpart B 2.4(g)(1).
Appendix A Subpart B 2.4(c).
Appendix A Subpart B 2.4(c).
Appendix A Subpart B 2.4(c).
NEW.
Appendix A Subpart B 2.4(c)(2).
NEW.
NEW.
Appendix A Subpart B 2.4 and new material.
NEW.
NEW.
Appendix A Subpart B 2.4 and new material.
Appendix A Subpart B 2.4 and new material.
NEW.
Appendix A Subpart B 2.4 and new material.
Appendix A Subpart B 2.4 and new material.
NEW.
NEW.
Appendix A Subpart B 2.4 and new material.
Appendix A Subpart B 2.4 and new material.
Appendix A Subpart B 2.4 and new material.
Sfmt 4702
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26AUP2
50673
50674
Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules
TABLE 1.—DERIVATION TABLE FOR PART 26—Continued
New section
Based on
26.119 .......................................................................................................
26.121 .......................................................................................................
26.123 .......................................................................................................
26.133 .......................................................................................................
26.125(a) ..................................................................................................
26.125(b) ..................................................................................................
26.125(c) ...................................................................................................
26.127(a) ..................................................................................................
26.127(b) ..................................................................................................
26.127(b) ..................................................................................................
26.127(c) ...................................................................................................
26.127(d) ..................................................................................................
26.127(e) ..................................................................................................
26.129(a) ..................................................................................................
26.129(b) ..................................................................................................
26.129(c) ...................................................................................................
26.129(d) ..................................................................................................
26.129(e) ..................................................................................................
26.129(f) ...................................................................................................
26.129(g) ..................................................................................................
26.129(h) ..................................................................................................
26.131 .......................................................................................................
26.133 .......................................................................................................
26.135 .......................................................................................................
26.137 .......................................................................................................
26.137(e)(4–5) ..........................................................................................
26.137(e)(6–8) ..........................................................................................
26.137(f) ...................................................................................................
26.137(g) ..................................................................................................
26.137(h) ..................................................................................................
26.139(a) ..................................................................................................
26.139(b) ..................................................................................................
26.139(c) ...................................................................................................
26.139(d) ..................................................................................................
26.139(e) ..................................................................................................
26.139(f) ...................................................................................................
26.151 .......................................................................................................
26.153(a) ..................................................................................................
26.153(b) ..................................................................................................
26.153(c) ...................................................................................................
26.153(d) ..................................................................................................
26.153(f)(5) ...............................................................................................
26.153(f) 1st paragraph ............................................................................
26.155 .......................................................................................................
26.157(a) ..................................................................................................
26.157(b) ..................................................................................................
26.157(c) ...................................................................................................
26.157(d) ..................................................................................................
26.157(e) ..................................................................................................
26.159(a) ..................................................................................................
26.159(b) ..................................................................................................
26.159(c) ...................................................................................................
26.159(d) ..................................................................................................
26.159(e) ..................................................................................................
26.159(f) ...................................................................................................
26.159(g) ..................................................................................................
26.161 .......................................................................................................
26.163 .......................................................................................................
26.165 .......................................................................................................
26.167(a) through (g) ...............................................................................
26.167(h) ..................................................................................................
26.167(i) ....................................................................................................
26.169 .......................................................................................................
26.181 .......................................................................................................
26.183(a) ..................................................................................................
26.183(b) ..................................................................................................
26.183(b)1st sentence ..............................................................................
26.183(c) ...................................................................................................
26.183(d) ..................................................................................................
26.185(a) ..................................................................................................
26.185(b) ..................................................................................................
26.185(c) ...................................................................................................
Appendix A Subpart B 2.4 and new material.
NEW.
NEW.
Appendix A Subpart B 2.7(e)(1).
Appendix A Subpart B 2.6(a).
Appendix A Subpart B 2.6(b).
Appendix A Subpart B 2.6(c).
Appendix A Subpart B 2.2 1st paragraph.
Appendix A Subpart B 2.2(a) and 2.4(d).
Appendix A Subpart B 2.4(d).
Appendix A Subpart B 2.7(o)(1).
Appendix A Subpart B 2.2(d).
Appendix A Subpart B 2.7(o)(3)(iii).
Appendix A Subpart B 2.4(c) and 2.7(a)(1).
Appendix A Subpart B 2.2(b).
Appendix A Subpart B 2.7(b)(2).
Appendix A Subpart B 2.7(a)(2).
Appendix A Subpart B 2.7(d) 1st sentence.
Appendix A Subpart B 2.7(c).
Appendix A Subpart B 2.4(i).
NEW.
Appendix A Subpart B 2.4(e).
Appendix A Subpart B 2.7.
Appendix A Subpart B 2.7(j).
Appendix A Subpart B 2.8(a).
Appendix A Subpart B 2.8(b).
Appendix A Subpart B 2.8(c).
Appendix A Subpart B 2.8(e)(6).
Appendix A Subpart B 2.7(o).
Appendix A Subpart B 2.7(o).
Appendix A Subpart B 2.7(g)(2).
26.24(d)(1).
Appendix A Subpart B 2.7(o)(5).
Appendix A Subpart B 2.7(g)(6).
Appendix A Subpart B 2.7(g)(7).
NEW.
NEW.
26.24(f) and Appendix A Subpart D 4.1.
Appendix A Subpart B 2.7(l)(2).
Appendix A Subpart B 2.7(k).
Appendix A Subpart A 1.1(2).
Appendix A Subpart B 2.3(1).
Appendix A Subpart B 2.3 1st paragraph.
Appendix A Subpart B 2.5.
Appendix A Subpart B 2.2 1st paragraph.
Appendix A Subpart B 2.2(a) and 2.4(d).
Appendix A Subpart B 2.7(o)(1).
Appendix A Subpart B 2.2(d).
Appendix A Subpart B 2.7(o)(3)(iii).
Appendix A Subpart B 2.4(c) and 2.7(a)(1).
Appendix A Subpart B 2.2(b).
Appendix A Subpart B 2.7(b)(2).
Appendix A Subpart B 2.7(a)(2).
Appendix A Subpart B 2.7(a)(2).
Appendix A Subpart B 2.4(i).
NEW.
NEW.
Appendix A Subpart B 2.7(e)(1) (substantially revised).
Appendix A Subpart B 2.7(j) (substantially revised).
Appendix A Subpart B 2.8 (substantially revised).
Appendix A Subpart B 2.7(o)(3)(i).
Appendix A Subpart B 2.8(d).
Appendix A Subpart B 2.7(g) (substantially revised).
NEW.
26.3 and Appendix A Subpart A 1.2 and Appendix. A Subpart B 2.9(b).
NEW.
Appendix A Subpart B 2.9(b) 1st sentence.
26.3 and Appendix A Subparts A 1.2,B 2.4 (J),B 2.9(a), and b 2.9(b).
NEW.
Appendix A Subpart B 2.9(a).
Appendix A Subpart B 2.9(a) last sentence.
Appendix A Subpart B 2.9(c).
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26AUP2
Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules
TABLE 1.—DERIVATION TABLE FOR PART 26—Continued
New section
Based on
26.185(d) ..................................................................................................
26.185(e) ..................................................................................................
26.185(f) ...................................................................................................
26.185(g) ..................................................................................................
26.185(h) ..................................................................................................
26.185(i) ....................................................................................................
26.185(j)(1) ...............................................................................................
26.185(j)(2) ...............................................................................................
26.185(j)(3) ...............................................................................................
26.185(j)(4) ...............................................................................................
26.185(j)(5) ...............................................................................................
26.185(j)(6) ...............................................................................................
26.185(k) ...................................................................................................
26.185(l) ....................................................................................................
26.185(m) .................................................................................................
26.185(n) ..................................................................................................
26.185(o) ..................................................................................................
26.185(p) ..................................................................................................
26.187 .......................................................................................................
26.189 .......................................................................................................
26.195 .......................................................................................................
26.197 .......................................................................................................
26.199 .......................................................................................................
26.201 .......................................................................................................
26.211(a) ..................................................................................................
26.211(b) ..................................................................................................
26.213(a)(1) ..............................................................................................
26.213(a)(2) ..............................................................................................
26.213(a)(3) ..............................................................................................
26.213(a)(4) ..............................................................................................
26.213(b)(1) ..............................................................................................
26.213(b)(2) ..............................................................................................
26.213(c) ...................................................................................................
26.213(d) ..................................................................................................
26.213(e) ..................................................................................................
26.213(f) ...................................................................................................
26.213(g) ..................................................................................................
26.215(a) ..................................................................................................
26.215(b) ..................................................................................................
26.217(a) ..................................................................................................
26.217(b) ..................................................................................................
26.217(c) ...................................................................................................
26.217(d) ..................................................................................................
26.217(e) ..................................................................................................
26.217(f) ...................................................................................................
26.217(g) ..................................................................................................
26.219(a) ..................................................................................................
26.219(b)(1) ..............................................................................................
26.219(b)(2)(i) ...........................................................................................
26.219(b)(2)(ii) ..........................................................................................
26.219(b)(2)(iii) .........................................................................................
26.219(b)(3) ..............................................................................................
26.219(b)(4) ..............................................................................................
26.219(c)(1) ..............................................................................................
26.219(c)(2) ..............................................................................................
26.219(c)(3) ..............................................................................................
26.219(d) ..................................................................................................
NEW (more detailed than Appendix A Subpart B 2.9(c)).
NEW.
NEW.
NEW.
NEW.
NEW.
Appendix A Subpart B 2.9(d).
Appendix A Subpart B 2.9(d).
NEW.
NEW.
NEW.
NEW.
Appendix A Subpart B 2.9(f).
Appendix A Subpart B 2.9(e).
Appendix A Subpart B 2.9(g).
NEW.
NEW.
26.24(e).
NEW.
NEW.
NEW.
NEW.
NEW.
NEW.
NEW.
NEW.
26.71(a).
26.71(b).
NEW.
NEW.
26.21(b), 26.22(c), and 26.80(c).
26.21(b), 26.22(c), and 26.80(c).
26.71(c).
26.2.
26.23(a).
NEW.
NEW.
Appendix A Subpart B 2.7(n).
NEW.
26.71(d).
26.71(d).
26.71(d).
26.71(d).
26.71(d).
26.71(d).
NEW.
NEW.
26.73(a)(1).
26.73(a)(2)(i).
26.73(a)(2)(ii) + (iv) combined.
26.73(a)(2)(iii).
NEW.
NEW.
Appendix A Subpart B 2.8(e)(4).
Appendix A Subpart B 2.8(e)(5).
NEW.
NEW.
TABLE 2.—DISTRIBUTION TABLE FOR PART 26
Current section
Replaced by:
26.1 (from beginning to ‘‘programs’’) .......................................................
26.1 (following ‘‘programs’’) ......................................................................
26.2(a) (first clause) .................................................................................
26.2(a) (balance of 1st sentence) ............................................................
26.2(a) (2nd sentence) .............................................................................
26.2(a) (3rd sentence to end) ..................................................................
26.2(b) (1st sentence) ..............................................................................
26.2(b) (2nd sentence to end) ..................................................................
26.2(c) (1st sentence) ..............................................................................
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26.1.
Deleted.
26.2(a) (to ‘‘and’’).
26.2(b) (from ‘‘to’’ to end).
26.21 (1st sentence).
26.25(a) (1)(2) and (3).
26.25(a).
26.3(f).
26.3(e).
Sfmt 4702
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26AUP2
50675
50676
Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules
TABLE 2.—DISTRIBUTION TABLE FOR PART 26—Continued
Current section
Replaced by:
26.2(c) (from ‘‘shall implement’’ to end) ...................................................
26.2(d) ......................................................................................................
26.3 ...........................................................................................................
26.4 ...........................................................................................................
26.6 ...........................................................................................................
26.8 ...........................................................................................................
26.10(a) (from beginning through ‘‘manner’’) ...........................................
26.10(a) (balance of 1st sentence) ..........................................................
26.10(b) ....................................................................................................
26.10(c) .....................................................................................................
26.20 (introductory paragraph, 1st sentence) ..........................................
26.20 (introductory paragraph, 2nd sentence) .........................................
26.20 (introductory paragraph, final sentence) ........................................
26.20(a) ....................................................................................................
26.20(b) ....................................................................................................
26.20(c) .....................................................................................................
26.20(d) ....................................................................................................
26.20(e) ....................................................................................................
26.20(f) .....................................................................................................
26.21(a) ....................................................................................................
26.21(b) ....................................................................................................
26.21(b) (last sentence) ...........................................................................
26.22 .........................................................................................................
26.23(a) ....................................................................................................
26.23(b) ....................................................................................................
26.24(a) (first sentence to ‘‘(1)’’) ..............................................................
26.24(a) (balance of paragraph) ..............................................................
26.24(b) ....................................................................................................
26.24(c) .....................................................................................................
26.24(d) ....................................................................................................
26.24(e) ....................................................................................................
26.24(f) .....................................................................................................
26.24(g) ....................................................................................................
26.25 .........................................................................................................
26.27(a) ....................................................................................................
26.27(b) ....................................................................................................
26.27(c) .....................................................................................................
26.27(d) ....................................................................................................
26.28 .........................................................................................................
26.29 .........................................................................................................
26.70 .........................................................................................................
26.71 .........................................................................................................
26.73 .........................................................................................................
26.80 .........................................................................................................
26.90 .........................................................................................................
26.91 .........................................................................................................
Appendix A Subpart A, 1.1(1) ..................................................................
Appendix A Subpart A, 1.1(2) ..................................................................
Appendix A Subpart A, 1.1(3) ..................................................................
Appendix A Subpart A, 1.2 .......................................................................
Appendix A Subpart B, 2.1(a) ..................................................................
Appendix A Subpart B, 2.1(b) ..................................................................
Appendix A Subpart B.2.1(c) ....................................................................
Appendix A Subpart B.2.1(d) ...................................................................
Appendix A Subpart B.2.1(e) ...................................................................
Appendix A Subpart B.2.2 (Initial paragraph) ..........................................
Appendix A Subpart B.2.2(a), (b), and (c) ...............................................
Appendix A Subpart B.2.2(d)(1), (2), and (3) ...........................................
Appendix A Subpart B.2.2(d)(4) ...............................................................
Appendix A Subpart B.2.3 ........................................................................
Appendix A Subpart B.2.4(a) ...................................................................
Appendix A Subpart B.2.4(b) ...................................................................
Appendix A Subpart B.2.4(c) ....................................................................
Appendix A Subpart B 2.4(d) ...................................................................
Appendix A Subpart B 2.4(e) ...................................................................
Appendix A Subpart B 2.4(f) 1st sentence ..............................................
Appendix A Subpart B 2.4(f)(1) through (f)(4) .........................................
Appendix A Subpart B 2.4(g)(1) through (g)(24) .....................................
Appendix A Subpart B 2.4(h) (1st sentence) ...........................................
Appendix A Subpart B 2.4(h) (balance of section) ..................................
Appendix A Subpart B 2.4(i) ....................................................................
Appendix A Subpart B 2.4(j) (first two sentences) ...................................
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26.3(f).
26.3(c).
26.5.
26.7.
26.9.
26.13.
26.23(a).
26.23(b).
26.23(c).
26.23(d).
26.27(a).
26.213(d).
26.27(b) (sentence before ‘‘(1)’’).
26.27(b).
26.27(b)(7).
26.27(c)(1).
26.27(c)(2).
26.27(c)(3).
26.27(d).
26.29(a).
26.29(c).
26.213(b)(1).
Deleted.
26.3(d) and 26.21.
26.21.
26.31(a).
26.31(c) (substantially revised).
Subparts E, F, and G.
26.31(d).
Subparts E, F, and G.
Subpart H.
26.31(d)(3) and requirements in Subpart G.
26.31(d)(4) and Subparts E, F, and G.
26.35.
Subpart C.
Subpart D.
Subpart D.
26.77(c).
26.39.
26.37.
26.221.
26.211, 26.213, and 26.215.
26.219 (substantially revised).
26.41 (substantially revised).
26.223.
26.225.
26.3.
26.31(d) (substantially revised).
Subparts F and G.
26.5.
26.31(d)(1).
26.31(d)(1).
Subparts E, F, and G.
26.31(d)(6).
26.31.
Subparts F and G.
26.115, 26.117, 26.129, 26.159, 26.169.
26.85.
Deleted.
26.31(b), and requirements in Subparts E, F, and G.
26.87(a).
26.85.
26.87(d) and (f).
26.117.
26.87(d)(1).
26.87(b).
26.95 through 26.115 and Subparts F and G.
Subparts E, F, and G.
26.87(f)(5).
26.113, 26.117, and 26.135.
26.117.
26.115 and 26.185.
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26AUP2
Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules
50677
TABLE 2.—DISTRIBUTION TABLE FOR PART 26—Continued
Current section
Subpart
Subpart
Subpart
Subpart
Subpart
Subpart
Subpart
Subpart
Subpart
Subpart
Subpart
Subpart
Subpart
Subpart
Subpart
B
B
B
B
B
B
B
B
B
B
B
B
B
B
B
Replaced by:
Appendix
Appendix
Appendix
Appendix
Appendix
Appendix
Appendix
Appendix
Appendix
Appendix
Appendix
Appendix
Appendix
Appendix
Appendix
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
2.4(j) (final sentence) ..........................................
2.5(a) ...................................................................
2.5(b) ...................................................................
2.5(c) ...................................................................
2.5(d) ...................................................................
2.5(e) ...................................................................
2.5(f) ....................................................................
2.6(a) ...................................................................
2.6(b) ...................................................................
2.6(c) ...................................................................
2.7(a) ...................................................................
2.7(b) ...................................................................
2.7(c) ...................................................................
2.7(d) ...................................................................
2.7(e) ...................................................................
Appendix
Appendix
Appendix
Appendix
Appendix
Appendix
Appendix
Appendix
Appendix
Appendix
Appendix
Appendix
Appendix
Appendix
Appendix
Appendix
Appendix
Appendix
Appendix
Appendix
Appendix
Appendix
(g).
Appendix
Appendix
Appendix
A Subpart B 2.7(f) ....................................................................
A Subpart B 2.7(g)(1) through (5) ............................................
A Subpart B 2.7(g)(6) and (7) ..................................................
A Subpart B 2.7(g)(8) ...............................................................
A Subpart B 2.7(h) ...................................................................
A Subpart B 2.7(i) ....................................................................
A Subpart B 2.7(j) ....................................................................
A Subpart B 2.7(k) ...................................................................
A Subpart B 2.7(l) ....................................................................
A Subpart B 2.7(m) ..................................................................
A Subpart B 2.7(n) ...................................................................
A Subpart B 2.7(o)(1) ...............................................................
A Subpart B 2.7(o)(2), (o)(3), and (o)(4) ..................................
A Subpart B 2.7(o)(5) ...............................................................
A Subpart B 2.8(a) ...................................................................
A Subpart B 2.8(b) ...................................................................
A Subpart B 2.8(c) ...................................................................
A Subpart B 2.8(d) ...................................................................
A Subpart B 2.8(e)(1) to (e)(3) .................................................
A Subpart B 2.8(e)(4), (e)(5), and (e)(6) ..................................
A Subpart B 2.9(a) and (b) (through ‘‘contract employee’’) .....
A Subpart B 2.9(b) (balance of section), (c), (d), (e), (f), and
Deleted.
26.155(a).
26.153.
26.155(c).
26.155(d).
26.155(e).
26.155(f).
26.125(a).
26.125(b).
26.125(c).
26.127, 26.129, 26.157, and 26.159.
26.129(b) and 26.159(b).
26.129(f) and 26.159(h).
26.157 and 26.159.
Validity screening and initial validity test requirements in 26.131 and
26.161 and initial cutoff levels in 26.133 and 26.163(a).
26.163(b).
26.169.
Requirement for annual summary in 26.169(k).
26.215.
26.159(i) and by 26.135(c).
Subparts F and G.
26.113, 26.135, 26.165.
26.153(c).
26.153((f)(1) and 26.153(b).
26.87(c) and 26.221.
26.215(a).
26.127(c) and 26.157(c).
26.137 and 26.167.
26.139(c) and 26.153(f)(2).
26.137(a) and 26.167(a).
26.137.
26.167.
26.137 and 26.167.
26.137.
26.137 and 26.219.
26.183.
26.185.
A Subpart C 3.1 .......................................................................
A Subpart C 3.2 .......................................................................
A Subpart D 4.1 .......................................................................
26.37(e) and 26.153(f)(3).
26.75(i)(4), 26.165(f).
26.153.
[FR Doc. 05–15576 Filed 8–25–05; 8:45 am]
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Agencies
[Federal Register Volume 70, Number 165 (Friday, August 26, 2005)]
[Proposed Rules]
[Pages 50442-50677]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-15576]
[[Page 50441]]
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Part II
Nuclear Regulatory Commission
-----------------------------------------------------------------------
10 CFR Part 26
Fitness for Duty Programs; Proposed Rule
Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 /
Proposed Rules
[[Page 50442]]
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
10 CFR Part 26
RIN 3150-AF12
Fitness for Duty Programs
AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed rule.
-----------------------------------------------------------------------
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: SECY@nrc.gov. 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 https://ruleforum.llnl.gov. Address questions
about our rulemaking Web site to Carol Gallagher (301) 415-5905; e-mail
cag@nrc.gov.
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 https://www.nrc.gov/NRC/ADAMS/. 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 pdr@nrc.gov.
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 FITNESSFORDUTY@NRC.GOV.
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, https://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
https://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, https://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
authoriz